82_FR_7020 82 FR 7008 - Importation, Interstate Movement, and Environmental Release of Certain Genetically Engineered Organisms

82 FR 7008 - Importation, Interstate Movement, and Environmental Release of Certain Genetically Engineered Organisms

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 82, Issue 12 (January 19, 2017)

Page Range7008-7039
FR Document2017-00858

APHIS is proposing to revise its regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered organisms in order to update the regulations in response to advances in genetic engineering and understanding of the plant pest and noxious weed risk posed by genetically engineered (GE) organisms, thereby reducing burden for regulated entities whose organisms pose no plant pest or noxious weed risks. This would be the first comprehensive revision of the regulations since they were established in 1987.

Federal Register, Volume 82 Issue 12 (Thursday, January 19, 2017)
[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)]
[Proposed Rules]
[Pages 7008-7039]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-00858]



[[Page 7007]]

Vol. 82

Thursday,

No. 12

January 19, 2017

Part VI





Department of Agriculture





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Animal and Plant Health Inspection Service





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7 CFR Parts 340





Importation, Interstate Movement, and Environmental Release of Certain 
Genetically Engineered Organisms; Proposed Rule

Federal Register / Vol. 82 , No. 12 / Thursday, January 19, 2017 / 
Proposed Rules

[[Page 7008]]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 340

[Docket No. APHIS-2015-0057]
RIN 0579-AE15


Importation, Interstate Movement, and Environmental Release of 
Certain Genetically Engineered Organisms

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: APHIS is proposing to revise its regulations regarding the 
importation, interstate movement, and environmental release of certain 
genetically engineered organisms in order to update the regulations in 
response to advances in genetic engineering and understanding of the 
plant pest and noxious weed risk posed by genetically engineered (GE) 
organisms, thereby reducing burden for regulated entities whose 
organisms pose no plant pest or noxious weed risks. This would be the 
first comprehensive revision of the regulations since they were 
established in 1987.

DATES: We will consider all comments that we receive on or before May 
19, 2017.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0057.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2015-0057, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2015-
0057 or in our reading room, which is located in room 1141 of the USDA 
South Building, 14th Street and Independence Avenue SW., Washington, 
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 799-7039 before coming.

FOR FURTHER INFORMATION CONTACT: Dr. Sidney Abel, Assistant Deputy 
Administrator, Biotechnology Regulatory Services, APHIS, 4700 River 
Road, Unit 147, Riverdale, MD 20737-1238; (301) 851-3896.

SUPPLEMENTARY INFORMATION: 

Background

Overview of the Current Regulations

    The Animal and Plant Health Inspection Service (APHIS) of the 
United States Department of Agriculture (USDA) administers regulations 
in 7 CFR part 340, ``Introduction of Organisms and Products Altered or 
Produced Through Genetic Engineering Which are Plant Pests or Which 
There is Reason to Believe are Plant Pests'' (referred to below as the 
regulations). The current regulations govern the introduction 
(importation, interstate movement, or release into the environment) of 
certain genetically engineered (GE) organisms that are considered 
``regulated articles.''
    Under the current regulations, a GE organism is considered to be a 
regulated article if the donor organism, recipient organism, vector, or 
vector agent \1\ is a plant pest or if the Administrator has reason to 
believe the GE organism is a plant pest. A plant pest is defined in 
Sec.  340.1 as ``Any living stage (including active and dormant forms) 
of insects, mites, nematodes, slugs, snails, protozoa, or other 
invertebrate animals, bacteria, fungi, other parasitic plants or 
reproductive parts thereof; viruses; or any organisms similar to or 
allied with any of the foregoing; or any infectious agents or 
substances, which can directly or indirectly injure or cause disease or 
damage in or to any plants or parts thereof, or any processed, 
manufactured, or other products of plants.'' If a GE organism is a 
regulated article, in order for the organism to be imported into the 
United States, to be moved in interstate commerce, or to be released 
into the environment through a confined release (collectively referred 
to in the regulations as an ``introduction''), a permit must be issued 
or the movement or environmental release must occur under a 
notification procedure. The organism must also be moved in a container 
that meets certain regulatory requirements, and the container must be 
marked in accordance with the regulations.
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    \1\ These terms are defined in Sec.  340.1 of the regulations.
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    The regulations also provide a process to petition APHIS to 
determine that a GE organism is nonregulated. A determination of 
nonregulated status means that the regulated article is no longer 
subject to the regulations in 7 CFR part 340 and, therefore, there is 
no longer any authority for APHIS to require a permit or notification 
for the importation, interstate movement, or environmental release of 
the regulated article pursuant to 7 CFR part 340. Agency Actions 
Following Promulgation of the Current Regulations
    APHIS first issued these regulations in 1987 under the authority of 
the Federal Plant Pest Act of 1957 (FPPA) and the Plant Quarantine Act 
of 1912 (PQA), two acts that were subsumed into the Plant Protection 
Act (PPA, 7 U.S.C. 7701 et seq.) in 2000, along with other provisions. 
Since 1987, APHIS has amended the regulations six times, in 1988, 1990, 
1993, 1994, 1997, and 2005, to institute exemptions from permitting for 
certain microorganisms and Arabidopsis, to institute the notification, 
petition, and extension procedures referenced above, and to exclude 
plants engineered to produce industrial compounds from the notification 
process.
    Although, as discussed above, the current regulations have various 
functions, their primary function to date has been as a means for APHIS 
to authorize the importation, interstate movement, and introduction of 
certain GE organisms via the permit and notification procedures 
referred to above. Permits and notifications are collectively known as 
``authorizations.'' To date, APHIS has issued more than 18,000 
authorizations for the environmental release of GE organisms in 
multiple sites, primarily for research and development of improved crop 
varieties for agriculture. Additionally, APHIS has issued more than 
12,000 authorizations for the importation of GE organisms, and nearly 
12,000 authorizations for the interstate movement of GE organisms. 
APHIS has, to date, denied slightly more than 1,500 requests for 
permits or notifications, many of which were denied because APHIS 
ultimately decided the requests lacked sufficient information on which 
to base an Agency decision.
    For authorizations under notification, the regulations require the 
environmental release to meet performance-based standards set forth in 
the regulations. These include, among other things, that, when the 
regulated article is a plant and is to be used for environmental 
release, it must be planted in such a way that it is not inadvertently 
mixed with non-regulated plant material that is not part of the 
environmental release. In addition, the environmental release must be 
conducted such that the regulated article will not persist in the 
environment, and no offspring can be produced that could persist in the 
environment. This latter requirement is accomplished through various 
measures such as required minimum isolation distances from sexually 
compatible

[[Page 7009]]

plants, effective removal or devitalization of viable plant materials, 
and monitoring of release sites after completion of the tests and 
removal of any ``volunteer'' plants that are found. APHIS conducts 
inspections of authorized facilities or environmental release sites to 
evaluate compliance with the regulations.
    The interstate movement, importation, or environmental release of 
regulated articles may be authorized under permit if developers follow 
the permit conditions specified by the Administrator to be necessary 
for each activity to prevent the dissemination and establishment of the 
GE organism. Such conditions include, but are not limited to, 
maintenance of the regulated article's identity through labeling, 
retention of records related to the article's specified use, 
segregation of the regulated article from other organisms, inspection 
of a site or facility where regulated articles are to undergo 
environmental release or will be contained after their interstate 
movement or importation, and the maintenance and disposal of the 
regulated article and all packing material, shipping containers, and 
any other material accompanying the regulated article to prevent the 
dissemination and establishment of plant pests. If a permit holder has 
been found out of compliance with any of the permit conditions, the 
permit may be canceled, and if so, further movement or environmental 
release of GE organisms under that permit will be prohibited.
    In addition to issuing permits and authorizing notifications, APHIS 
has responded to petitions requesting nonregulated status under these 
regulations. Under this petition procedure, which is described in Sec.  
340.6, a petitioner must present detailed information and scientific 
data regarding the regulated article indicating why the article should 
not be regulated. To date, APHIS has granted 124 determinations of 
nonregulated status, of 159 submitted for APHIS review, and all of 
these determinations have been for GE plants (more information about 
these is posted at https://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml). Many of these plants are grown for 
agricultural production in the United States. APHIS determinations of 
nonregulated status apply to the GE plant(s) as well as their progeny, 
meaning the deregulated GE plant can be used in plant breeding programs 
and in agriculture without further oversight from APHIS.
Basis for the Proposed Rule
Advances in APHIS' Understanding of Genetically Engineered Organisms
    While the current regulations have been effective in ensuring the 
safe importation, interstate movement, and environmental release of GE 
organisms developed using genetic engineering during the past 29 years, 
advances in genetic engineering have occurred since they were 
promulgated and new challenges have emerged. Additionally, APHIS has 
now accumulated nearly three decades of experience in evaluating GE 
organisms for plant pest risk. The Agency's evaluations to date have 
provided evidence that most genetic engineering techniques, even those 
that use a plant pest as a vector, vector agent, or donor, do not 
result in a GE organism that presents a plant pest risk. This is 
discussed at greater length later in this document, under the section 
titled ``General Restrictions and Scope (Sec.  340.0).'' Additionally, 
genetic engineering techniques, such as genome editing and synthetic 
genomics, have been developed that do not employ plant pests as donor 
organisms, recipient organisms, vectors, or vector agents; such 
techniques could be used to produce GE organisms with plant pest risks 
without falling within the scope of regulated article.
Need To Evaluate GE Plants for Noxious Weed Risks
    Advances in genetic engineering have also made the need to evaluate 
GE plants for noxious weed risk more pressing. When APHIS issued the 
current regulations under the authority of the FPPA and PQA, APHIS' 
authority to regulate noxious weeds was the Federal Noxious Weed Act of 
1974 (7 U.S.C. 2801, FNWA). That act defined noxious weed as ``Any 
living stage (including but not limited to, seeds and reproductive 
parts) of any parasitic or other plant of a kind, or subdivision of a 
kind, which is of foreign origin, is new to or not widely prevalent in 
the United States, and can directly or indirectly injure crops, other 
useful plants, livestock, or poultry or other interests of agriculture, 
including irrigation, or navigation or the fish or wildlife resources 
of the United States or the public health.'' Because APHIS' noxious 
weed authority was limited at the time to plants that were of foreign 
origin and new to or not widely prevalent in the United States, and 
most GE plants at the time were modified crops that were developed in 
the United States and were widely prevalent, in their unmodified form, 
within the United States, APHIS had no basis that would allow it to 
evaluate most GE plants for noxious weed risk.
    In 1994, Congress amended the FNWA to allow APHIS to issue permits 
for the interstate movement of noxious weeds. This amendment, however, 
did not revise the definition of noxious weed in the Act.
    In 2000, the PPA was issued; In addition to subsuming the FPPA and 
PQA, it also replaced the FNWA, and provided a new definition of 
noxious weed: ``Any plant or plant product that can directly or 
indirectly injure or cause damage to crops (including nursery stock or 
plant products), livestock, poultry, or other interests of agriculture, 
irrigation, navigation, the natural resources of the United States, the 
public health, or the environment.'' The PPA also provided explicit 
authority to issue regulations listing noxious weeds that are 
prohibited or restricted from entering the United States or that are 
subject to restrictions on interstate movement within the United 
States, and provided persons with the right to petition APHIS to add or 
remove noxious weeds from this list.
    This revised noxious weed authority led APHIS in 2010 to revise the 
noxious weed regulations, found in 7 CFR part 360, to reflect the 
provisions of the PPA. It also led APHIS to revise the manner in which 
APHIS evaluates plants for noxious weed risk to determine whether to 
list them in part 360. Under the revised approach that APHIS uses for 
part 360, the first two considerations in determining whether a plant 
is a noxious weed are: (1) Identifying what direct injury or damage 
(physical harm) the plant causes; and (2) identifying what indirect 
damage the plant may cause to interests of agriculture, irrigation, 
navigation, the natural resources of the United States, the public 
health, or the environment. APHIS then evaluates how likely the plant 
is to become established in areas within the United States in which it 
was not known to exist, in the absence of Federal regulation; for 
example, if it can only become established in tropical climates, 
Federal regulation is not necessary to prevent its establishment in 
temperate and subarctic climates. APHIS' final consideration is whether 
placing the plant under Federal regulation will affect the likelihood 
of introduction or dissemination of the plant. In general, APHIS lists 
a plant as a Federal noxious weed if APHIS determines the plant to be 
invasive and to have significant negative impacts, if introduced or 
disseminated within the United States, and if APHIS determines that 
Federal regulation could reduce the likelihood of such introduction or

[[Page 7010]]

dissemination. If APHIS determines that Federal regulation of a GE 
plant--pursuant to the authorities granted in the PPA--is incapable of 
mitigating identified noxious weed risks, the plant would not be 
regulated.
    This approach means that there are certain plants that APHIS has 
determined to be weeds, but not to be Federal noxious weeds. This 
distinction between a weed and a Federal noxious weed warrants 
emphasis. ``Weeds,'' in the broadest sense of the term, could include 
any plant growing where and/or when it is unwanted; even plants that 
are desirable in some settings could be considered weeds in others. The 
plants that APHIS evaluates for inclusion on the Federal noxious weed 
list are, in general, a particular type of weed: An invasive, usually 
non-native plant that impacted natural and/or agronomic ecosystems, 
often with significant negative consequences. Of the problematic weeds 
APHIS evaluates, only a fraction \2\ are determined to be ones for 
which Federal regulatory controls to prevent their introduction or 
dissemination are justified; these plant taxa are added to the list of 
Federal noxious weeds in part 360. Part 360 currently lists 111 
aquatic, terrestrial, or parasitic plant taxa as Federal noxious weeds. 
Many weeds in the United States are not regulated as Federal noxious 
weeds because they have reached the extent of their ecological range 
and regulation (i.e., controls on movement) would be costly and provide 
little if any benefit.
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    \2\ Since 2011, 1700 weeds have been evaluated. Only 24 have 
been deemed to meet the criteria for inclusion on the list of 
Federal noxious weeds.
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    The regulations in part 360, while effective, continue to have a 
significant restriction that limits their applicability to GE 
organisms: They are predicated on a determination by APHIS that a taxon 
is a Federal noxious weed. This determination is easier for plants that 
have not been genetically engineered, because there are usually many 
reference points that are available and pertinent to this 
determination, including international experience with the weed, 
scientific literature regarding the plant's biology, published studies, 
and other data.
    For GE plants, there is usually a great deal of data and experience 
with the non-GE organism. In most cases these non-GE organisms are 
highly domesticated and cultivated widely within the United States, and 
there is an extensive body of scientific literature regarding their 
biology. However, when a GE trait is introduced into the plant, there 
may in certain instances be little data or previous experience 
available for APHIS to rely on in evaluating the properties of the 
resulting GE plant. Instead, in order to determine whether the GE plant 
could function as a noxious weed, APHIS would have to rely on its own 
independent evaluation of the plant itself, based on information 
provided by the plant's developers.
    Historically, there has not been a significant need for such a 
noxious weed evaluation of GE plants. Most of the GE plants that APHIS 
regulated in the past, such as varieties of corn and soybeans modified 
with common agronomic traits, do not qualify as ``noxious weeds.'' This 
is because most GE plants to date have been agricultural crops, and 
most agricultural crops are not biologically weeds prior to 
modification. Indeed, in order to domesticate a plant for crop 
production, farmers often had to deliberately eliminate weedy traits, 
such as seed shattering, thorns, and seed dormancy, from the plant 
using traditional breeding techniques. Moreover, the phenotypic traits 
that have historically been introduced into crops through genetic 
engineering do not confer weediness. Because the plants have not been 
weeds prior to genetic engineering, and genetic engineering has not 
introduced weediness, evaluating the plant solely for plant pest risk 
has not been problematic.
    Additionally, the means by which most GE plants to date have been 
genetically engineered has brought them under APHIS' regulatory 
authority. To date, most GE plants have been engineered using a plant 
pest as either the donor or vector of genetic material. Because of this 
use of a plant pest as a donor, vector agent, or vector, the resulting 
GE organisms fall within the scope of regulated articles.
    However, in recent years, there has been an increasing diversity of 
both agronomic and non-agronomic traits engineered in plants. There has 
also been an increased use of plants in genetic engineering that, in 
their unmodified state, are known to possess weedy traits. This is 
especially true of plants used in the production of biofuel. For 
example, switchgrass (Panicum virgatum), which has long been used in 
the production of ethanol biofuel, has growth patterns in an unmodified 
state that are characteristic of a weed, and, recently, has been 
genetically engineered for increased ethanol production. Accordingly, 
since such plants are somewhat weedy in their unmodified state, and 
genetic engineering can, in certain instances, enhance the weeediness 
traits that are already present in a plant in its unmodified state, 
there is a correspondingly higher risk that such a plant may be 
genetically engineered into a noxious weed.
    Moreover, APHIS' current regulatory structure, which entails 
evaluating such plants solely for plant pest risk, is not sufficient to 
properly identify all risks that these plants present to other plants 
and plant products. Indeed, under the current structure, such plants 
may entirely escape regulation. While, in the past, GE plants have 
almost always used a plant pest to vector genetic material, as we 
mentioned previously in this document, in recent years, GE techniques 
have arisen that do not use plant pests as donor organisms or vectors. 
Moreover, if plants are genetically engineered without the use of a 
plant pest as a vector or donor, this would require APHIS to consider 
the plant itself to be a plant pest in order to designate it as a 
regulated article. However, under the PPA's definition of plant pest, a 
plant must be parasitic in order to be considered a plant pest. With 
limited exceptions, such as mistletoe, dodder, and striga, few plants 
are known to be parasitic. Thus, APHIS considers it both appropriate 
and necessary to begin to evaluate GE plants for noxious weed risk.
    While APHIS discusses the nature of this proposed evaluation later 
in this document, it is important to delineate, in broad terms, how the 
Agency would consider a GE plant to be a noxious weed under the 
proposed regulations. For purposes of the regulations in part 340, 
APHIS would begin by evaluating whether the plant, in its unmodified 
state, has weedy characteristics, that is, a plant biologically capable 
of causing notable physical injury or damage. This would serve as the 
baseline against which to evaluate the genotype of the GE plant. In 
evaluating the GE plant, APHIS would assess the likelihood that the 
modifications made to the genome of the plant alter its ability to 
cause notable physical harm or injury.
    For GE plants that APHIS determines to be weedy prior to genetic 
modification, APHIS would endeavor to determine whether the plant's 
weediness has been enhanced to an extent that it has been engineered 
into a noxious weed. For GE plants that APHIS determines not to possess 
weedy traits prior to modification, APHIS would endeavor to determine 
whether weediness had been introduced into the organism through genetic 
engineering. Finally, in the event that a Federal noxious weed is 
genetically engineered (something that has not occurred to date), APHIS 
would endeavor to determine whether the GE plant is still

[[Page 7011]]

a noxious weed and warrants continued regulation.
    If APHIS determines that the GE plant is a noxious weed, it would 
endeavor to gauge the direct or indirect injury or damage it could 
cause to crops, livestock, poultry, or other interests of agriculture, 
irrigation, navigation, the natural resources of the United States, the 
public health, or the environment. APHIS would make the results of this 
evaluation publicly available and share both the evaluation and the 
information on which it is based with the Environmental Protection 
Agency (EPA) and the U.S. Food and Drug Administration (FDA), as 
warranted.
    Maintaining communication with EPA and FDA as we evaluate GE plants 
for noxious weed risks is consistent with APHIS' role in the 
Coordinated Federal Framework for Regulation of Biotechnology 
(Coordinated Framework).\3\ Since 1986, the U.S. government has 
regulated GE organisms consistent with the regulatory framework 
described in the Coordinated Framework. The Coordinated Framework, 
published by the Office of Science and Technology Policy, describes the 
comprehensive Federal regulatory policy for ensuring the safety of 
biotechnology research and products, and explains how Federal agencies 
use existing Federal statutes in a manner to ensure public health and 
environmental safety while maintaining regulatory flexibility to avoid 
impeding the growth of the biotechnology industry. The Coordinated 
Framework explains the regulatory roles and authorities for the three 
major agencies involved in exercising oversight and/or review of GE 
organisms: APHIS, EPA, and FDA.
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    \3\ To view the framework, go to https://www.aphis.usda.gov/brs/fedregister/coordinated_framework.pdf.
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    The Coordinated Framework provides as a guiding principle that, 
``[i]n order to ensure that limited Federal oversight resources are 
applied where they will accomplish the greatest net beneficial 
protection of public health and the environment, oversight will be 
exercised only where the risk posed by the introduction is 
unreasonable.'' APHIS considers this proposed rule to be entirely 
consistent with this principle: It will no longer consider GE organisms 
to be regulated articles solely because of the donor, vector, or vector 
agent used in genetic engineering, thereby focusing APHIS resources on 
those GE organisms that may present a plant pest and/or noxious weed 
risk. However, it is worth noting, as the Coordinated Framework itself 
does, that a ``mosaic'' of statutes have, to date, provided Agencies 
with authority to exercise oversight of GE organisms. APHIS 
acknowledges that the Agencies functioning within the Coordinated 
Framework oversee different aspects of risk and that, accordingly, 
other Federal Agencies may continue to exercise oversight over GE crops 
that APHIS no longer views as plant pests or noxious weeds. To that 
end, APHIS acknowledges that the proposed revisions to 7 CFR part 340 
could have direct or indirect impacts on the manner in which FDA and 
EPA exercise their roles within the Coordinated Framework. To the 
extent that the public health impacts are due to changes in APHIS 
regulatory oversight, APHIS discusses them within this document. 
Economic impacts, in contrast, are discussed in the economic analysis 
prepared for this rule, while potential environmental impacts are 
discussed in the draft programmatic environmental impact statement 
prepared for the rule.
OIG Audits and 2008 Farm Bill
    Audits conducted by USDA's Office of Inspector General (OIG) are 
another basis for this rule. In 2005, OIG conducted an audit of APHIS' 
regulatory program for GE organisms. OIG found that the use of 
performance-based standards in APHIS' notification process allowed for 
a broad spectrum of methods to meet the standards, particularly 
regarding how the release would be contained to its test field, but 
Agency practices did not require responsible persons to provide written 
protocols detailing the exact methods that person would use to meet the 
standards. OIG suggested that APHIS revise the regulations to minimize 
the risk of inadvertent dissemination of regulated articles from a test 
field. Specific recommendations were to require GPS coordinates of all 
test field sites; to require scientific protocols or study designs from 
applicants prior to authorizing a field test of a GE organism; and to 
seek legislative authority to require applicants to provide proof of 
financial responsibility in the event of an unauthorized release, as 
APHIS considered necessary.
    OIG also suggested that APHIS develop risk-based criteria for 
conducting inspections and exercising oversight of field tests for the 
release of GE organisms, and suggested that APHIS provide more explicit 
guidance regarding how to terminate a field test and document this 
termination.
    In 2015, OIG issued another audit, urging APHIS to implement the 
recommendations from the 2005 audit that APHIS had not yet implemented.
    Finally, in 2008, The Food, Conservation, and Energy Act of 2008 
(Farm Bill) was promulgated. Section 10204 of the Farm Bill requires 
the Secretary of Agriculture to take action on each issue identified in 
the APHIS document entitled ``Lessons Learned and Revisions under 
Consideration for APHIS' Biotechnology Framework,'' \4\ and, where 
appropriate, promulgate regulations. Like the 2005 OIG audit, this 
APHIS document suggested the need for greater regulatory oversight of 
field tests of regulated articles.
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    \4\ https://www.aphis.usda.gov/biotechnology/downloads/supportingdocs/LessonsLearned10-2007.pdf.
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    On October 9, 2008, APHIS published a proposal \4\ in the Federal 
Register (73 FR 60007-60048, Docket No. APHIS-2008-0023) to amend the 
regulations to address advances in genetic engineering, to make 
explicit our evaluation of GE organisms for noxious weed potential, and 
to respond to the recommendations of the 2005 OIG audit and the 
provisions of the Farm Bill.
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    \4\ To view the 2008 proposed rule, the subsequent withdrawal, 
all supporting documents, and comments APHIS received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2008-0023.
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    APHIS sought public comment on the proposal from October 9, 2008, 
to June 29, 2009. APHIS received more than 88,300 comments during the 
comment period. These were received in 5,580 submissions that included 
unique comments, form letters, and signatories to petitions. Many 
commenters expressed concerns regarding the lack of details surrounding 
a proposed risk-based system that would determine which organisms would 
fall under APHIS oversight, as well as concerns about a proposed multi-
tiered permit system. Commenters also expressed concern about what they 
perceived to be a significant expansion of Agency regulatory authority.
    Based on the breadth and nature of the comments received, APHIS 
published a notice in the Federal Register on March 4, 2015, 
withdrawing the proposal to allow APHIS to begin a fresh stakeholder 
engagement process aimed at exploring a variety of regulatory 
approaches.
    Based on the feedback received following the withdrawal of the 
proposed rule, as well as to reflect provisions of The Food, 
Conservation, and Energy Act of 2008 (Farm Bill) and recommendations 
received from the 2005 and 2015 OIG audits, APHIS is proposing to 
update its regulations in 7 CFR part 340. APHIS is proposing to 
evaluate GE organisms for noxious weed potential using a different 
approach

[[Page 7012]]

from that of the 2008 proposed rule, and proposing a new risk analysis 
process to determine which organisms would require a permit. As 
previously proposed in 2008, APHIS is also proposing to eliminate the 
notification process in favor of permitting. APHIS is committed to 
working with stakeholders to ensure a smooth transition from the 
current regulatory process to the proposed regulatory process. We 
request comment on suggestions for ways to smooth the transition 
period, avoiding disruption in the market, while continuing to ensure 
that APHIS meets its statutory requirements.
Regulation of GE Biological Control Agents
    Additionally, under the new approach, APHIS would regulate a GE 
organism that is intended for use as a biological control (biocontrol) 
agent if APHIS determines that it is a plant pest or noxious weed, with 
a limited exception. Biocontrol involves the reduction of plant pest 
and weed populations through the use of natural enemies such as 
parasitoids, predators, pathogens, antagonists, or competitors to 
suppress plant pest and weed populations.
    The exception would be for GE vertebrate biocontrol agents. 
Although such organisms could fall within the scope of the PPA's 
definition of plant pest, particularly if they are herbivores, it is 
long-standing APHIS policy not to regulate vertebrates as plant pests. 
This policy is discussed later in this document.
Regulation of Plants That Produce Plant-Made Industrials and 
Pharmaceuticals
    APHIS recognizes that certain plants are genetically engineered in 
order to produce pharmaceutical and industrial compounds, also known as 
plant-made pharmaceuticals and industrials (PMPIs).
    When plants are genetically engineered in such a manner, the plants 
and the pharmaceutical and/or industrial products they produce may fall 
within the purview of multiple regulatory Agencies: APHIS, EPA, and/or 
FDA.
    Under the current regulations in 7 CFR part 340, APHIS requires 
permits, as opposed to Notifications, for the environmental release of 
all GE plants that meet the definition of a regulated article and 
produce PMPIs. APHIS exercises oversight of all outdoor plantings of 
these regulated PMPI-producing plants. This oversight includes 
establishment of appropriate environmental release conditions, 
inspections, and monitoring. Products obtained from PMPI-producing 
plants may be regulated by FDA (authority over pharmaceuticals) or EPA 
(chemical substances as defined by the Toxic Substances Control Act 
(TSCA)), depending on their intended use. To date, producers of PMPI-
producing plants, or products derived from such plants, have not 
intended for such plants or plant products to be used for human or 
animal food. However, if such a plant or plant product is used for 
human or animal food, the food would be subject to applicable statutory 
and regulatory requirements under the Federal Food, Drug, and Cosmetic 
Act.
    To date, PMPI-producing GE plants regulated by APHIS have been 
genetically engineered using a plant pest as the donor, vector, or 
vector agent, and thus fall under the scope of regulated article in the 
current regulations in 7 CFR part 340. However, under the provisions of 
this proposed rule, as discussed at greater length later in this 
document, a GE plant that is developed using a plant pest as a vector, 
vector agent, or donor of genetic materials would not necessarily be a 
regulated organism. Rather, the GE plant would be a regulated organism 
if it had a plant/trait combination that the Agency has not yet 
evaluated for plant pest and/or noxious weed risk, if it has received 
DNA from a taxon that contains plant pests and the DNA from the donor 
organism is sufficient to produce an infectious entity capable of 
causing plant disease or encodes a compound known to be pathogenesis-
related that is expected to cause plant disease symptoms, or if it was 
evaluated and found to represent plant pest or noxious weed risks. 
Additionally, APHIS' evaluations of GE plants for plant pest or noxious 
weed risk would generally not require data from outdoor plantings.
    Even if the plant represents a new plant/trait combination not 
previously reviewed, there is a likelihood that most, if not all, GE 
PMPI-producing plants that are currently under APHIS permits could be 
determined not regulated under the provisions of the proposed 
regulations after a regulatory status evaluation because they do not 
represent risks as a plant pest or noxious weed. Thus, such plants 
could be grown outdoors without the need for permits and without APHIS 
oversight.
    Federal oversight of outdoor plantings of PMPI-producing plants, 
however, could be necessary to prevent unlawful entry into the food 
supply of material from such plants. Establishing growing and handling 
conditions to confine such plants, and inspecting to ensure such 
conditions are followed, may enable corrective actions before material 
from the plants is inadvertently released and causes public health or 
economic impacts. One of the reasons APHIS' oversight of such crops has 
been an important part of the coordinated framework for oversight of GE 
plants is that companies are not necessarily required to notify FDA or 
EPA when the company plants PMPI-producing plants. For example, for 
PMPI-producing plants whose products fall under FDA authority, FDA has 
no regulations governing planting of such crops. For crops genetically 
engineered to produce pharmaceuticals, companies only have to come to 
FDA when they have reached the point that they are ready to begin 
clinical trials with the pharmaceutical derived from the plant. This 
could be years after they first started growing the pharmaceutical-
producing plant in the field.
    Under TSCA, EPA has requirements for new chemical substances, 
including industrial compounds produced in genetically engineered 
plants. However, given existing APHIS oversight, EPA does not currently 
have an oversight program nor regulations for genetically engineered 
plants with industrial compounds.
    A gap in Federal oversight of PMPI producing-plants could result in 
the intentional or inadvertent introduction into the human or animal 
food supply of unevaluated pharmaceutical or industrial PMPI products, 
even when the principal purpose of the plants is not for human or 
animal food use. For example, a company could self-determine that the 
PMPI produced by the plant was generally recognized as safe (GRAS), and 
therefore conclude it had no legal obligation to keep surplus PMPI-
producing plants out of the human or animal food supply, to keep such 
PMPI-producing plants from spreading pollen to plants grown for human 
and animal food purposes, or even to notify any Federal agency that 
they were planting such crops. In addition to potential food safety 
risks posed by such plants should they enter the food supply, a gap in 
Federal oversight could generate concerns from the general public 
regarding the safety and wholesomeness of the human or animal food 
supply, which could adversely impact agricultural interests.
    APHIS has identified several options that have the potential for 
adequate Federal oversight of outdoor plantings of plants engineered to 
produce PMPIs. Under one option, a statute would be enacted, or 
existing statutory authority amended, to grant one or more Federal 
agencies explicit authority to provide oversight of outdoor plantings 
of all GE

[[Page 7013]]

PMPI-producing plants and to evaluate GE PMPI-producing plants for all 
possible risks, beyond plant pest and noxious weed risks. For 
industrial-producing plants subject to EPA's jurisdiction, a second 
option is for EPA to develop a program to regulate industrial-producing 
plants and issue regulations if warranted. Under a third option, APHIS 
would enter into a memorandum of understanding (MOU) and services 
agreement with the appropriate Federal Agencies to provide personnel 
and other resources to assist those Agencies in their oversight of 
outdoor plantings of PMPI-producing GE plants, recognizing that Federal 
agencies may not have authority to require notification and/or 
oversight of the outdoor planting of some of these plants. Under a 
fourth option, those Federal Agencies would supply their own personnel 
and resources to exercise oversight of outdoor plantings of PMPI-
producing GE plants, recognizing that Federal agencies may not have 
authority to require notification and/or oversight of the outdoor 
planting of some of these plants.
    APHIS recognizes that there are challenges associated with each of 
these options. For example, the first option would require legislation 
to be enacted, which is not within the purview of the Executive Branch 
of the Federal government. Additionally, all options could require 
Federal Agencies to incur the costs associated with setting up new 
regulatory programs. The second option would require time for EPA to 
stand up a genetically engineered industrial-producing plant oversight 
program for plants subject to EPA jurisdiction. The third option, in 
turn, would require policies, procedures, and guidance regarding APHIS' 
interaction with other Federal Agencies to be developed prior to 
implementation. To that end, it is important to note that APHIS does 
not prefer any of these options over the other, nor does the Agency 
consider the options listed above necessarily to be exhaustive. Rather, 
we put them forward to indicate that the Agency is aware of the 
implications of this rule with regard to PMPIs, and to request specific 
public comment regarding the best manner to address this issue.
Plant-Incorporated Protectant Small-Scale Field Testing
    Certain plants are genetically engineered to produce plant-
incorporated protectants (PIPs), meaning that they produce pesticides. 
PIPs fall under the regulatory oversight of EPA. However, currently 
only APHIS exercises regulatory oversight of PIP plantings on 10 acres 
or less of land. Under the proposed rule, APHIS would only require 
permits for PIPs planted on 10 acres or less if they present a plant 
pest or noxious weed risk or have not yet been evaluated by APHIS for 
such risk. Under the current regulations in 7 CFR part 340, APHIS 
requires permits or notifications for the environmental release of all 
GE plants that meet the definition of a regulated article and produce 
PIPs. APHIS exercises oversight of all outdoor plantings of these 
regulated PIP-producing plants. This oversight includes establishment 
of appropriate environmental release conditions, inspections, and 
monitoring.
    To date, PIP-producing GE plants regulated by APHIS have been 
genetically engineered using a plant pest as the donor, vector, or 
vector agent, and thus fall under the scope of regulated article in the 
current regulations in 7 CFR part 340. However, under the provisions of 
this proposed rule, as discussed at greater length later in this 
document, a GE plant that is developed using a plant pest as a vector, 
vector agent, or donor of genetic materials would not necessarily be a 
regulated organism. Rather, the GE plant would be a regulated organism 
if it had a plant/trait combination that the Agency has not yet 
evaluated for plant pest and/or noxious weed risk, or if it has 
received DNA from a taxon that contains plant pests and the DNA from 
the donor organism is sufficient to produce an infectious entity 
capable of causing plant disease or that encodes a compound known to be 
pathogenesis-related that is expected to cause plant disease symptoms. 
Additionally, APHIS' evaluations of GE plants for plant pest or noxious 
weed risk would generally not require data from outdoor plantings.
    Even if the plant represents a new plant/trait combination not 
previously reviewed, there is a likelihood that many GE PIP-producing 
plants that are currently regulated under APHIS permits or 
notifications could be determined not regulated under the provisions of 
the proposed regulations after a regulatory status evaluation because 
they do not represent risks as a plant pest or noxious weed. Thus, such 
plants could be grown outdoors without the need for an APHIS permit and 
without undergoing APHIS oversight.
    APHIS understands that this proposal would shift Federal oversight 
of small-scale (10 acres or less) outdoor plantings of PIPs to EPA. EPA 
may decide to require experimental use permits (EUP) for all, some, or 
none of such PIPs, and may conduct inspections of all, some, or none of 
those PIPs under permit. EPA would need to develop a program to oversee 
small-scale testing of PIPs and issue regulations if warranted. APHIS 
is fully committed to coordinating with EPA in this matter in order to 
give EPA sufficient time to stand up such a program. APHIS understands 
that an MOU and services agreement may be necessary to provide 
personnel and other resources to assist EPA during the interim period 
while EPA implements its own program of oversight for the oversight of 
outdoor planting of PIPs 10 acres or less.
    APHIS recognizes that there are challenges associated with such a 
transition that would also require EPA to incur the costs associated 
with setting up a revised regulatory program. Further, such a 
transition would require policies, procedures, and guidance regarding 
APHIS' interaction with EPA. APHIS does not consider the approach 
listed above necessarily to be exhaustive. Rather, APHIS puts it 
forward to indicate that the Agency is aware of the implications of 
this rule with regard to small-scale testing of PIPs and to request 
specific public comment regarding the best manner to address this 
issue.
Herbicide Resistant GE Crops and Herbicides--Synchronous Decisions With 
EPA
    Certain plants are genetically engineered to make them resistant to 
herbicides. EPA registers the herbicide products used on herbicide 
resistant crops, but does not regulate herbicide-resistant crops 
themselves. APHIS has evaluated and deregulate many GE herbicide 
resistant plants. To date, the herbicide-resistant GE plants regulated 
by APHIS have been genetically engineered using a plant pest as the 
donor, vector, or vector agent, and thus fall under the scope of 
regulated article in the current regulations in 7 CFR part 340. 
However, under the provisions of this proposed rule, as discussed at 
greater length later in this document, a GE plant that is developed 
using a plant pest as a vector, vector agent, or donor of genetic 
materials would not necessarily be a regulated organism. Rather, the GE 
plant would be a regulated organism if it had a plant/trait combination 
that the Agency has not yet evaluated for plant pest and/or noxious 
weed risk, or if it has received DNA from a taxon that contains plant 
pests and the DNA from the donor organism is sufficient to produce an 
infectious entity capable of causing plant disease or that encodes a 
compound known to be pathogenesis-related that is expected to cause 
plant disease symptoms, or has been evaluated by APHIS in accordance 
with and determined to pose a risk as

[[Page 7014]]

a plant pest or noxious weed. Additionally, APHIS' evaluations of GE 
plants for plant pest or noxious weed risk would generally not require 
data from outdoor plantings.
    Even if the plant represents a new plant/trait combination not 
previously reviewed, there is a likelihood that many GE herbicide-
resistant plants that are currently regulated under APHIS permits or 
notifications could be determined not regulated under the provisions of 
the proposed regulations after a regulatory status evaluation because 
they do not represent risks as a plant pest or noxious weed. Thus, such 
plants could be grown outdoors without the need for permits and without 
APHIS oversight.
    Commenters to the proposed update to the Coordinated Framework on 
the Regulation of Biotechnology published on September 22, 2016 (81 FR 
65414-65415), expressed the need for coordination between USDA and EPA 
regarding the timing of deregulation/determination of nonregulated 
status of herbicide-resistant crops and the registration of herbicides. 
APHIS recognizes that the asynchronous timing of the deregulation of 
herbicide- resistant plants and the associated herbicide registration 
has led to situations where a developer could sell the herbicide-
resistant plant/seed without waiting for the associated herbicide 
registration. In such a situation, farmers may be tempted to illegally 
use an unregistered herbicide on a crop.
    In light of the challenges associated with the asynchronous 
regulatory actions on the part of APHIS and EPA, APHIS will work with 
EPA to explore possible solutions to better coordinate the commercial 
availability of seed for herbicide resistant crops concomitant with the 
registration of herbicides intended to be used on those crops. 
Furthermore, APHIS intends to limit the scope of its decisions to be on 
an individual/specific herbicide resistant crop basis (e.g., glyphosate 
resistant cotton) so that the EPA and APHIS are making decisions on the 
same specific herbicide resistant crop/herbicide combinations. This 
coordination presents challenges because once APHIS determines a GE 
organism does not represent a risk as a plant pest or noxious weed, 
APHIS cannot continue to regulate the GE organism or delay announcing 
the regulatory status determination. When APHIS receives a request for 
regulatory status determination of an herbicide resistant crop, it is 
likely to be three or more years before a developer is ready to undergo 
registration review at EPA. If APHIS determines that the herbicide 
resistant plant is not a risk as a plant pest or noxious weed, APHIS 
does not have the authority in the PPA to require permits with 
regulatory controls for the movement and outdoor planting of that 
herbicide tolerant plant during those subsequent years. Nor is it 
within APHIS authority for APHIS to withhold making a regulatory status 
evaluation decision for several years and requiring permits for field 
testing during that time. The issue has not been the illegal use of 
pesticide during the field testing of herbicide resistant crops by 
developers but instead is the illegal use of pesticide by farmers on 
seed that has been deregulated by APHIS and is commercially available 
before the commercial availability of the herbicide designed for those 
crops. One option to address this coordination would be to enact a new 
statute or amend an existing statute to make it illegal to sell seeds 
for herbicide resistant crops before the registrations were completed 
for use on those crops. Another option might involve a voluntary 
agreement by seed developers to withhold selling seed of herbicide-
resistant crops until EPA registrations are completed for the herbicide 
products designed for those crops. In cases where APHIS makes a 
decision deregulating an herbicide-resistant crop or determines under 
Sec.  340.4 that an herbicide-resistant crop is unlikely to pose a risk 
as a plant pest and/or noxious weed and will no longer be a regulated 
organism and no herbicide product has been registered by EPA for use on 
that herbicide-resistant crop, APHIS would indicate on the APHIS 
Regulatory Status List Web site and Web sites associated with 
deregulation decisions that no herbicide product is registered bv EPA 
for use on this herbicide-resistant crop and it is illegal to use any 
herbicide product on these crops unless registered by EPA for such use. 
Additionally, APHIS would include language in deregulation decision 
letters sent to the developer and Federal Register notices associated 
with Sec.  340.4 final determinations indicating it is illegal to use 
herbicides on these crops until the herbicide product is registered by 
EPA for use on the herbicide-resistant crop. This decision letter and 
all other information regarding APHIS's decisions would also be made 
available to the public on the APHIS Web site.
    APHIS does not consider the approaches listed above necessarily to 
be exhaustive and recognizes that one of the options listed would 
require legislation to be enacted, which is not within the purview of 
the Executive Branch of the Federal government. However, APHIS puts 
them forward to indicate that the Agency is aware that asynchronous 
timing of the deregulation of herbicide-resistant plants and the 
associated herbicide registrations can lead to significant problems, 
and to request specific public comment regarding the best manner to 
address this issue.
An Overview of Our Proposed Regulatory Structure
    Before discussing the specifics of these proposed revisions, APHIS 
wishes to provide an overview of how the Agency generally envisions the 
various sections of the proposed rule interacting, from the perspective 
of a developer of a GE organism. This overview assumes that the 
organism falls within the scope of our proposed definition of GE 
organism, and is a regulated organism under proposed Sec.  340.0.
    Until such time as the developer wishes to import the organism, 
move it interstate, or release it into the environment, no action would 
be required of the developer. However, if the developer believes that 
it possesses sufficient information to demonstrate that the organism 
presents no plant pest or noxious weed risk, and wished to release it 
into the environment, it would have to submit this information to APHIS 
and request that APHIS conduct an evaluation of such risk. The process 
for submitting such a request, as well as the possibilities for how 
APHIS would act on that request, is set forth in proposed Sec.  340.4.
    If APHIS evaluates the GE organism in accordance with Sec.  340.4 
and determines that it is unlikely to pose a risk as a plant pest and/
or noxious weed, it would no longer be a regulated organism and may be 
imported, moved interstate, or released into the environment without 
further restriction under the proposed regulations. APHIS would 
maintain a list of such organisms on a Web site. If new information is 
obtained which indicates that a previously deregulated GE organism may 
present a plant pest and/or noxious weed risk, APHIS may reevaluate the 
GE organism and reconsider its regulatory decision.
    If the organism is still a regulated organism following such an 
evaluation, with one, limited exception (the interstate movement of GE 
Arabidopsis thaliana under certain conditions, which APHIS discusses 
later in this document) the developer would need to obtain a permit for 
its importation, interstate movement, or environmental

[[Page 7015]]

release. APHIS' proposed permitting process is set forth in Sec.  
340.3.
    If APHIS issues a permit to the developer for the importation, 
interstate movement, or release into the environment of the organism, 
the developer would have to comply with permitting conditions regarding 
such importation, interstate movement, or release into the environment. 
The developer would also have to comply with container and shipment 
requirements that pertain to the movement of regulated organisms. These 
requirements would also be set forth in Sec.  340.3.
    The developer would also have to retain certain records regarding 
permitted activities. These are set forth in proposed Sec.  340.5. 
Failure to retain such records, or comply with other regulatory 
requirements or permitting conditions, could result in enforcement 
activities. These would also be set forth in Sec.  340.5.
    If, in the course of interacting with APHIS, the developer had to 
provide the Agency with confidential business information (CBI), the 
developer could denote such CBI in accordance with Sec.  340.6.
    Finally, Sec.  340.7 would provide the developer with information 
regarding APHIS policy related to costs and charges incident to 
compliance with the regulations.
    This is, again, a general overview of the proposed regulations. As 
such, it does not attempt to capture every nuance of the proposed 
regulations, nor does it apply to every scenario that may occur under 
those regulations.
    What follows is a more in-depth discussion of the provisions of the 
rule.
What Constitutes a Genetically Engineered Organism Under the Proposed 
Regulations
    While APHIS discusses most of its proposed definitions later in 
this document, the Agency considers it necessary, at the outset of 
discussion of the provisions of the proposed rule, to discuss two of 
its proposed definitions, for the terms genetic engineering and 
genetically engineered (GE) organism. This is because the proposed 
regulations would not apply to organisms that are created using 
techniques that APHIS does not consider to constitute genetic 
engineering or that fall outside the scope of GE organism. Such 
organisms, which would not be regulated by APHIS under 7 CFR part 340, 
would not be expected to come to APHIS for evaluation. However, if such 
organisms are submitted to APHIS, APHIS would evaluate them for plant 
pest and/or noxious weed risk and provide guidance on their regulatory 
status.
    By genetic engineering, APHIS would mean techniques that use 
recombinant or synthetic nucleic acids with the intent to create or 
alter a genome. APHIS considers synthetic nucleic acids to be nucleic 
acid molecules that are chemically or by other means synthesized or 
amplified, including those that are chemically or otherwise modified 
but can base pair with naturally occurring nucleic acid molecules.
    APHIS would exclude from the definition of genetic engineering 
traditional breeding techniques (including, but not limited to, marker-
assisted breeding, as well as tissue culture and protoplast, cell, or 
embryo fusion) or chemical or radiation-based mutagenesis. APHIS would 
do so because the Agency has never considered such techniques to 
constitute genetic engineering. Accordingly, organisms created through 
such techniques are currently excluded from regulation under 7 CFR part 
340, and would continue to be so excluded.
    For the purposes of proposed 7 CFR part 340, APHIS would define GE 
organism as an organism developed using genetic engineering. Thus, if 
an organism is created using techniques that do not fall within the 
scope of genetic engineering, the organism itself would not fall within 
the scope of GE organism. APHIS would also exclude, from its definition 
of GE organism, certain organisms that are created using techniques 
that fall within the scope of genetic engineering, but that could 
otherwise have been produced using traditional breeding techniques or 
chemical or radiation-based mutagenesis. Such organisms are essentially 
identical, despite the method of creation, because while there may be 
small genetic differences, those differences are not phenotypically 
observable and these types of changes occur naturally in all organisms. 
APHIS would also exclude ``null segregants,'' that is, the progeny of a 
GE organism where the only genetic modification was the insertion of 
donor nucleic acid into the recipient's genome, but the donor nucleic 
acid is not passed to the recipient organism's progeny and the donor 
nucleic acid has not altered the DNA sequence of the progeny. 
Specifically, for purposes of the revised regulations, an organism 
would not be considered a GE organism if:
     The genetic modification to the organism is solely a 
deletion of any size or a single base pair substitution which could 
otherwise be obtained through the use of chemical- or radiation-based 
mutagenesis.\5\
---------------------------------------------------------------------------

    \5\ A single base pair substitution is the most common type of 
substitution induced by chemical mutagenesis or natural variation 
and, therefore, most similar to the type of genetic variation that 
is possible through conventional breeding.
---------------------------------------------------------------------------

     The genetic modification to the organism is solely 
introducing only naturally occurring nucleic acid sequences from a 
sexually compatible relative that could otherwise cross with the 
recipient organism and produce viable progeny through traditional 
breeding (including, but not limited to, marker-assisted breeding, as 
well as tissue culture and protoplast, cell, or embryo fusion).
     The organism is a ``null segregant.''
    APHIS would exclude the first two types of organisms from the 
definition of GE organism for three reasons. First, as mentioned above, 
it would do so because the organisms could otherwise have been produced 
from practices that APHIS is proposing to exclude from the definition 
of genetic engineering. Genetic engineering is often used instead of 
traditional breeding practices, including chemical or radiation-based 
mutagenesis, in order to expedite development of an organism with a 
desired genotype and/or phenotype.
    Examples from the realm of GE plants illustrate these practices. 
Chemical and radiation-based mutagenesis creates thousands of mutations 
in a single organism, and most of the plant breeders' subsequent 
efforts involve eliminating unwanted mutations by repeated crosses and 
selection, each of which can take months to years to complete. 
Conversely, using genetic engineering, single base pair substitutions, 
as well as deletions of differing sizes, can be precisely administered 
very quickly, avoiding this lengthy process of eliminating unwanted 
mutations. The resulting organism, however, remains identical to one 
that could otherwise have been developed using chemical or radiation-
based mutagenesis.
    Similarly, traditional breeding techniques may require many 
generations of crossing to introduce a naturally occurring trait. For 
example, it can take decades to introduce a disease-resistant trait to 
apples through traditional breeding techniques. However, genetic 
engineering can introduce the same trait in a fraction of the time 
while maintaining all other cultivar characteristics of the apple.
    The second reason for the exclusions is that GE plants as a class, 
which constitute the vast preponderance of GE organisms to date, pose 
no greater plant pest or noxious weed risk than their

[[Page 7016]]

counterparts developed through traditional breeding techniques or 
chemical or radiation-based mutagenesis. Moreover, it is both 
impracticable and unnecessary to regulate plants created through 
traditional breeding techniques or chemical or radiation-based 
mutagenesis for plant pest or noxious weed risk.
    This is not to say that plants with undesirable phenotypes have 
never been bred through traditional breeding, or chemical or radiation-
based mutagenesis never result it mutations that are undesirable. 
Indeed, as mentioned above, chemical and radiation-based mutagenesis 
tend to create thousands of mutations in an organism, most of which are 
undesirable.
    However, traditional breeding techniques, in the form of deliberate 
selection and breeding of those plants with desirable phenotypes, have 
been used since the advent of sedentary agriculture, and nearly every 
domesticated crop has, at one point, been subject to traditional 
breeding techniques. Chemical and radiation-based mutagenesis, in turn, 
have been used for nearly a century in the development of thousands of 
commodities, including such commercial commodities as ruby red 
grapefruit and many commercial varieties of wheat and rice. If APHIS 
were to regulate organisms developed through traditional breeding 
techniques or chemical or radiation-based mutagenesis, that would 
entail the regulation, at least provisionally, of almost every 
commercially available human or animal food crop. This is 
impracticable.
    Such regulations would also fail to take into consideration the 
usual purpose of applying traditional breeding techniques or chemical 
or radiation-based mutagenesis to a plant: To introduce desirable 
phenotypic traits into the organism or remove phenotypically 
undesirable traits from the organism. Additionally, it would fail to 
take into adequate consideration that phenotypic traits that could 
increase the plant pest or noxious weed risk posed by a plant tend to 
also adversely impact its vitality, uniformity, or commercial 
viability. For example, a mutation caused by chemical or radiation-
based mutagenesis could render a plant more susceptible to certain 
viroids or pathogens and able to transfer this increased susceptibility 
to sexually compatible relatives, and thus increase the plant pest risk 
associated with the plant. However, it would also directly adversely 
affect the plant's vitality. For these reasons, farmers and developers 
have long bred out unwanted phenotypic traits that arise as the result 
of traditional breeding techniques and/or chemical or radiation-based 
mutagenesis, and planted and/or commercialized the most phenotypically 
desirable plant produced using such techniques.
    In this regard, it is important to note that genetic engineering is 
used to create this phenotypically desirable organism, rather than the 
other products created through traditional breeding techniques, 
including chemical or radiation-based mutagenesis. In 1987, the Council 
of the National Academy of Sciences concluded that there is no evidence 
of a unique risk inherent in the use of recombinant DNA techniques or 
the movement of genes between unrelated organisms. This means that 
risks associated with the introduction of recombinant DNA engineered 
organisms are the same as those associated with non-genetically 
engineered organisms and organisms modified by other methods and that 
the assessment of such risks should be based on the nature of the 
organism and the environment into which it is introduced rather than 
the methods by which it was produced. Furthermore, this same conclusion 
is a basis of the Coordinated Framework that regulation should be based 
on the risks of the organism and not the process used to create it. 
Accordingly, because the plant pest and noxious weed risk posed by the 
plant is equivalent, regardless of whether it was created through 
genetic engineering or traditional breeding (including chemical or 
radiation-based mutagenesis), and such risk is likely to be low because 
of the purpose of applying traditional breeding techniques, including 
chemical or radiation-based mutagenesis to a plant,, APHIS is proposing 
to exclude GE plants that could have otherwise been developed through 
traditional breeding techniques, including chemical or radiation-based 
mutagenesis, from the definition of ``genetically engineered organism'' 
and hence from regulation under the revised 7 CFR part 340.
    This same exclusion would apply to non-plant organisms. Non-plant 
organisms, which fall under the scope of the regulations as defined in 
Sec.  340.0, are either plant pests, or organisms which have received 
genetic material sufficient to produce an infectious entity capable of 
causing plant disease or that encodes a compound known to be 
pathogenesis-related that is expected to cause plant disease symptoms. 
Organisms of the latter type would not qualify for the exclusion, as 
receipt of genetic material capable of conferring the new properties 
could not be achieved through traditional breeding techniques, 
including chemical or radiation-based mutagenesis. However, it can be 
envisioned that plant pests might be altered in such a way that the 
exclusion would apply. In these cases, since the resulting plant pest 
would not be defined as a genetically engineered organism under 7 CFR 
part 340, they would be regulated, if needed, under APHIS's plant pest 
regulations in7 CFR part 330. This is appropriate since these organisms 
are biologically analogous to non-GE plant pests with mutations. It is 
important to note that, to date, we have not encountered GE organisms 
of this type and that the GE plant pests that we do have experience 
with (e.g., pink bollworm expressing marker genes, citrus tristeza 
virus expressing antimicrobial compounds) would still be regulated 
under 7 CFR part 340 since this exclusion would not apply. The two 
APHIS program areas responsible for regulating under 7 CFR parts 330 
and 340 are coordinating to ensure that together they are prepared to 
regulate any type of plant pest as needed.
    However, APHIS has prepared a proposed rule that would remove this 
exception. In its place, all plant pests would require permits issued 
pursuant to part 330, unless the importation, interstate movement, or 
environmental release of the organism is explicitly authorized in other 
APHIS regulations in 7 CFR. Under APHIS' proposed revision to the 
regulations in part 340, the importation, interstate movement, or 
environmental release of GE organisms that could have otherwise been 
developed through traditional breeding techniques or chemical or 
radiation-based mutagenesis would not be explicitly authorized; rather, 
such organisms would be exempted from the regulations in part 340, with 
no reference to the conditions for movement or environmental release of 
such organisms. Accordingly, GE organisms that could have otherwise 
been created through traditional breeding techniques, including 
chemical or irradiation-based mutagenesis, and could pose a potential 
plant pest risk, would now be subject to 7 CFR part 330.
    This touches on several important caveats with regard to the first 
two proposed exemptions from the definition of genetically engineered 
organism. The first is that the exemptions pertain only to 7 CFR part 
340. As noted above, an organism may be exempted from regulation under 
7 CFR part 340, and yet still subject to other APHIS regulations. The 
second

[[Page 7017]]

caveat is that the proposed exemptions are based on APHIS' statutory 
authority under the PPA. They should therefore be taken as a statement 
of one Agency's regulatory policy, rather than scientific findings 
regarding all possible risks posed by such organisms. Accordingly, for 
organisms that APHIS determines to present negligible plant pest or 
noxious weed risk, FDA and EPA may anticipate more substantial human or 
animal food adulterant or pesticide risks, and therefore not reduce 
their oversight of the same organisms.
    The third caveat is that APHIS is not claiming that additions, 
deletions, and substitutions to an organism's genome are inherently 
risk-free. Indeed, as discussed later in this document, the addition 
into an organism's genome of a sequence that encodes an infectious 
entity capable of causing plant disease or encodes a compound known to 
be pathogenesis-related that is expected to cause plant disease 
symptoms introduces plant pest risk into that organism, and would be 
one of APHIS' criteria for regulating the organism under the proposed 
regulations. Rather, APHIS considers such additions, deletions, or 
substitutions to present an acceptable plant pest and/or noxious weed 
risk when they are used to create an organism that could otherwise have 
been created through traditional breeding techniques and/or chemical or 
radiation-based mutagenesis; in other words, it is the product, rather 
than the techniques used to derive the product, that APHIS considers to 
present an acceptable level of risk. The Agency considers this to be 
consistent with the principles set forth in the Coordinated Framework.
    The third proposed exclusion is for progeny of GE organisms where 
the only genetic modification was the insertion of donor nucleic acid 
into the recipient's genome, but the inserted donor nucleic acid is not 
passed to the recipient organism's progeny and has not altered the DNA 
sequence of the recipient organism's progeny. Such progeny are often 
referred to as null segregants. Traits can sometimes be introduced by 
genetic engineering into breeding lines to simplify breeding without 
altering the DNA sequence of progeny; the traits can be eliminated with 
a simple cross and are no longer present in the final organism. An 
example of use of such techniques to facilitate traditional breeding 
would be the introduction of certain genes into trees solely to reduce 
the time to flowering, thereby speeding up a tree-breeding program. In 
this example, the progeny do not contain the early flowering gene and 
their DNA sequence has not been altered by the early flowering gene. 
Because the DNA of the progeny is no different from the DNA of the 
recipient organism prior to the use of genetic engineering, APHIS does 
not consider the progeny to be GE organisms for purposes of the 
proposed regulations.
    APHIS requests specific comment on its definition of genetically 
engineered organism, specifically the appropriateness of the proposed 
exemptions, and whether commenters can identify any scenarios in which 
they would exempt from APHIS regulation an organism that presents a 
plant pest and/or noxious weed risk. APHIS also requests specific 
comment on whether any other types of organisms should be excluded from 
the definition of genetically engineered organism. Finally, APHIS is 
interested in whether the terms ``traditional breeding techniques'' and 
``chemical or radiation-based mutagenesis'' should be defined, and 
whether the exclusions themselves are sufficiently delineated.
    APHIS wishes to point out that its proposed definition for 
genetically engineered organism is limited to the regulations in 7 CFR 
part 340 and may not reflect the definition of genetically engineered 
organism that is in use by other Federal Agencies. Differences in 
definitions are, in part, attributable to the differences in the 
agencies' statutory and regulatory authorities. Under the Coordinated 
Framework for the Regulation of Biotechnology, we intend to work 
cooperatively with other relevant agencies that may also be considering 
their policies or approaches related to genome editing applications 
within their jurisdictions.
General Restrictions and Scope (Sec.  340.0)
    Section 340.0 would set forth general restrictions regarding the 
movement and environmental release of GE organisms, as well as the 
scope of the revised regulations in part 340.
    Paragraph (a) of Sec.  340.0 would provide that no person may move 
any regulated GE organisms except in accordance with part 340. Movement 
of regulated organisms that is not in accordance with the part could 
present a risk of introducing or disseminating plant pests and noxious 
weeds within the United States.
    Paragraph (b) of Sec.  340.0 would specify the types of GE 
organisms APHIS would consider to be regulated organisms under the 
revised regulations.
    Under our proposed regulations, a GE organism would be a regulated 
organism if:
     Prior to genetic engineering, the GE organism belonged to 
any taxon listed in accordance with Sec.  340.2 and met the definition 
of plant pest in Sec.  340.1. (As Sec.  340.2 currently does, proposed 
Sec.  340.2, which APHIS discusses below, would specify that certain 
taxa are plant pests or are known to contain plant pests. Section 340.1 
would contain definitions of terms used in the proposed regulations.)
     The GE organism has received DNA from any taxon listed in 
accordance with Sec.  340.2, the DNA from the donor organism is 
sufficient to produce an infectious entity capable of causing plant 
disease or encodes a compound known to be pathogenesis-related that is 
expected to cause plant disease symptoms, and the GE organism has not 
been evaluated by APHIS for plant pest risk in accordance with Sec.  
340.4.
     The GE organism is a plant that has a plant and trait 
combination that has not been evaluated by APHIS for plant pest and 
noxious weed risk in accordance with Sec.  340.4 \5\; or
---------------------------------------------------------------------------

    \5\ As APHIS discusses below, APHIS would maintain a list of 
plant and trait combinations that APHIS has evaluated for plant pest 
and noxious weed risk online if this rule is finalized.
---------------------------------------------------------------------------

     The GE organism is any of the foregoing that has been 
evaluated by APHIS in accordance with Sec.  340.4 and determined to 
pose a risk as a plant pest or noxious weed, or is a GE organism that 
has otherwise been determined by the Administrator to pose a risk as a 
plant pest or noxious weed.
    The proposed criteria differ from the current criteria in several 
respects. First, the current criteria consider a GE organism to be a 
regulated article if the donor, vector, or vector agent is a plant 
pest. This reflects the concern in the 1980s that if an organism was 
modified using genetic material taken from a plant pest, or a plant 
pest was used as a vector or vector agent to carry genetic material 
into an organism, the resulting GE organism could also be a plant pest.
    Based on APHIS' experience evaluating field trial data from 
thousands of permits that authorize environmental release of regulated 
organisms, as well as more than 150 petitions for nonregulated status, 
this has not proven to be the case. Although a plant pest may 
contribute or vector genes to a GE organism, this has not been shown in 
APHIS' evaluation of data to cause that GE organism, particularly if it 
is a plant, to become a plant pest. Indeed, experience has shown that 
the use of genes from donor organisms which are plant pests, as well as 
the use of vectors which are from plant pests, has not resulted in 
plant pest risks of any sort in recipient organisms.

[[Page 7018]]

    Rather, the most common use of plant pest components in genetic 
engineering involve either the use of a disarmed version of the plant 
pathogenic bacterium Agrobacterium tumefaciens to vector genes into a 
plant or use of genetic material from plant pest donors which function 
as regulatory sequences in the plant. Use of Agrobacterium tumefaciens 
as a vector of genetic material does not leave viable bacteria behind 
in the recipient organism and does not cause disease. Likewise, 
regulatory sequences such as the 35S promoter from Cauliflower Mosaic 
Virus and the nopaline synthase (nos) terminator from A. tumefaciens 
are themselves unable to be expressed and do not confer plant pest 
traits. Rather, they facilitate the expression of other genes in the GE 
organism. The use of plant pests in these ways either as donors of 
regulatory sequences or for vectoring genetic material into a recipient 
organism has a long history of safe use and does not result in disease 
or injury to the recipient organism.
    It is conceivable that a donor organism that is a plant pest could 
result in a GE organism that is itself a plant pest if (1) the DNA 
sequence that is encoded in the organism is able in itself to be 
expressed phenotypically or confers plant pest traits, or (2) if the 
inserted DNA enables the organism to produce pathogenesis-related 
compounds, that is, compounds that are typically produced by pathogens 
and involved in producing disease symptoms. Examples of such compounds 
would include plant degrading enzymes, plant growth regulators, 
phytotoxins, or compounds that can clog plant vascular systems. In 
either instance, APHIS would not expect phenotypic expression of plant 
disease unless large portions of a genome from a plant pest were 
introduced to a recipient organism, a practice that APHIS considers 
unlikely for developers to use based on their practices to date.
    Likewise, based on APHIS' evaluation of field trial data to date, 
there is no evidence that the use of plant pests as vectors or vector 
agents in the production of GE organisms results in a GE organism that 
is itself a plant pest.
    Accordingly, APHIS would regulate GE organisms that have received 
DNA from a taxon containing a plant pest only if the DNA from the donor 
organism is sufficient to produce an infectious entity or encodes a 
pathogenesis-related compound that is expected to cause plant disease 
symptoms. By ``sufficient to produce an infectious entity,'' APHIS 
means that the DNA sequence that is encoded in the organism is able in 
itself to be expressed phenotypically or confers traits that meets the 
definition of plant pest. In such instances, APHIS considers it 
appropriate and prudent to regulate the GE organism until such time as 
APHIS evaluates the risk it poses as a plant pest in accordance with 
proposed Sec.  340.4, and thereafter to regulate it only if APHIS 
determine it to pose a risk as a plant pest.
    Additionally, APHIS would no longer regulate a GE organism solely 
because its vector or vector agent is a plant pest. APHIS adopted this 
approach in 1987 because the use of plant pest vectors in recombinant 
DNA technologies was, at the time, a relatively recent development, and 
there was a corresponding need to exercise precaution in regulating 
such use until the plant pest risk associated with the practice was 
further evaluated. In twenty-nine years of regulating GE organisms 
because of the use a plant pest as a vector or vector agent, APHIS has 
no evidence that using genetic material from plant pests as vectors or 
vector agents for other genetic material results in a GE organism that 
is itself a plant pest. Accordingly, this proposed rule would change 
APHIS' approach, and GE organisms that were created using a plant pest 
as a vector or vector agent would no longer be regulated solely because 
of the use of such a vector or vector agent. Instead, the organisms 
would be regulated if they themselves presented a known or unevaluated 
plant pest risk. This is in keeping with the overarching aim of this 
proposed rule, which is to regulate the products of genetic 
engineering, rather than the methods by which those products are 
developed.
    A second difference from the current criteria is that, for reasons 
discussed previously in this document, APHIS is proposing that APHIS 
may regulate a GE plant under 7 CFR part 340 if APHIS determines that 
it is a noxious weed.
    Our proposed criteria would also attempt to clarify a current 
category of regulated articles, GE plants that are regulated because 
the Administrator has reason to believe they are a plant pest. When the 
current regulations were issued, APHIS had less experience regulating 
GE organisms, and there was corresponding uncertainty regarding the 
degree to which subjecting a plant to genetic engineering, without the 
use of a plant pest as a donor, vector, or vector agent, would cause 
the plant to become a plant pest. This category was intended to allow 
APHIS to consider such plants to be regulated articles, until APHIS had 
sufficient information to classify it either definitively as a plant 
pest, or to determine that it presented no plant pest risk. The 
category was especially useful when a GE plant was developed using 
novel genetic engineering techniques.
    In the 29 years since the current regulations were issued, APHIS' 
evaluation of petitions for nonregulated status for more than 150 GE 
plants has provided a basis to help the Agency delineate the plant and 
trait combinations that cause a GE organism to act as a plant pest from 
the combinations that pose no plant pest risk.
    Accordingly, APHIS now considers there to be two instances in which 
a GE plant should be a regulated organism. The first instance is when 
APHIS has reached a determination that the plant and trait combination 
associated with the GE plant causes it to act as a plant pest or 
noxious weed. APHIS is making a draft list of such combinations 
available along with this proposed rule, as well as a list of 
combinations that APHIS has determined to present no plant pest or 
noxious weed risk,\6\ and APHIS invites public comment on these draft 
lists. For purposes of this proposed rule, the lists would be 
maintained at the following Web site: http://www.aphis.usda.gov/biotechnology/2016-340-proposed-rule. If the rule is finalized, APHIS 
would develop a different URL that would contain the lists, as well as 
all other information regarding this rule, and that would indicate that 
the rule had been finalized.
---------------------------------------------------------------------------

    \6\ APHIS encourages stakeholders to review these lists and 
submit specific public comment regarding the listed plant/trait 
combinations. In particular, while the vast majority of listed 
plant/trait combinations correspond to specific organisms that have 
been granted nonregulated status under the current regulations, the 
list would not be event-specific. This means that if a crop-trait 
combination has nonregulated status on the list, all specific events 
that have that crop-trait combination would be nonregulated. 
Practically speaking, this means that the list would grant 
nonregulated status to almost all GE corn and soybean that 
developers have brought to APHIS to date.
---------------------------------------------------------------------------

    The second instance in which APHIS would consider it necessary to 
regulate a GE plant is when APHIS is presented with a GE plant with a 
novel plant and trait combination, and has not yet evaluated this plant 
and trait combination for its plant pest and noxious weed risk.
    On a related matter, APHIS acknowledges that a novel GE organism 
could be developed that does not fall into any of the Agency's other 
categories of regulated organisms, but that APHIS determines poses a 
risk as a plant pest or noxious weed. APHIS's last criteria for 
regulated organisms would allow APHIS to regulate such an organism.

[[Page 7019]]

Taxa That Are or Contain Plant Pests (Sec.  340.2)
    As stated previously, Sec.  340.2 contains a list of taxa that are 
considered to be plant pests. That list has not been amended since it 
was established in 1987.
    To improve regulatory flexibility and help ensure the list remains 
current, APHIS is proposing to remove the list of taxa from Sec.  340.2 
and place it on the Internet at http://www.aphis.usda.gov/biotechnology/2016-340-proposed-rule. APHIS would advise the public of 
changes to the list through notices published in the Federal Register. 
These notices would request public comment.
    APHIS is not proposing any changes to the listed taxa at this time, 
however.
    Per the definition of ``plant pest'' in the PPA, any organism 
belonging to any taxon contained within any listed genus or taxon is 
only considered to be a plant pest if the organism ``can directly or 
indirectly injure, or cause disease, or damage in any plants or parts 
thereof, or any processed, manufactured, or other products of plants.'' 
Thus a particular unlisted species within a listed genus would be 
deemed a plant pest if the scientific evidence indicates that the 
organism is a cause of direct or indirect injury, disease, or damage to 
any plants, plant parts, or products of plants.
    Section 7711 of the PPA generally requires permits for the 
importation or interstate movement of plant pests, but allows the 
Secretary to create ``exceptions'' to this general permitting 
requirement when the Secretary deems that a permit is not necessary. 
That is, these regulated activities are allowed, under certain 
conditions, without seeking prior authorization via permit. The current 
APHIS regulations refer to these PPA exceptions as ``exemptions.'' 
Paragraph (b) of current Sec.  340.2 contains a list of exemptions from 
the requirement for a permit for the interstate movement of certain GE 
strains of the microorganisms Escherichia coli, Saccharomyces 
cerevisiae, and Bacillus subtilis, and the plant Arabidopsis thaliana. 
One of the conditions for this exemption for the listed microorganisms 
is that the cloned material does not include the complete infectious 
genome of a known plant pest.
    Because, under Sec.  340.0, APHIS must have determined that a GE 
microorganism is a plant pest in order for it to be a regulated 
organism, the GE microorganism strains mentioned above, which APHIS has 
evaluated and determined to present no plant pest risk, would not be 
regulated organisms. Thus APHIS would not need to retain specific 
permitting exemptions for them in Sec.  340.2.
    APHIS would also retain the exemption from interstate movement 
permits for GE organism A. thaliana due to its historically exempted 
status. The exemption would be contained in Sec.  340.3.
    APHIS would propose changes to the list through publication of a 
Federal Register notice. The notice would state why APHIS has 
determined it necessary to add or remove a taxon from the list, and 
would request public comment.
    APHIS would review the comments received and publish its final 
decision in the Federal Register.
    The PPA also allows for a person to petition the Secretary to add 
or remove a plant pest from the regulations. Currently, Sec.  340.5 
contains provisions for petitioning the Administrator to amend the list 
of organisms in Sec.  340.2 by either adding or deleting any genus, 
species, or subspecies. The list of requirements for petitioning the 
Administrator include formatting and submission procedures that are 
currently contained in Sec.  340.5(b).
    However, these procedures have not been updated since 1994. While 
most of the procedures are still accurate, some of them have changed. 
For example, the requirements do not consider the potential for 
electronic submission of a petition via email. They also provide an 
obsolete address for postal submissions. Therefore, APHIS is proposing 
to remove the specific requirements related to formatting and 
submission procedures for petitions from the regulations. The 
procedures would instead be located on the Internet at http://www.aphis.usda.gov/biotechnology/2016-340-proposed-rule. APHIS is also 
proposing to revise the submission procedure to allow petitions to be 
submitted via email, and to update the address for postal submissions.
    These changes would update the submission procedure, and allow for 
greater flexibility in revising procedures, if, for example, the 
address for submissions changes in the future.
    Please note that, regarding the formatting procedures, APHIS is 
proposing to retain a requirement that the petition not contain trade 
secrets or CBI. APHIS often needs CBI for permit applications, 
particularly for those that request the release of a GE organism into 
the environment, in order to determine the appropriate permitting 
conditions, and APHIS may need CBI as part of a regulatory status 
evaluation in accordance with proposed Sec.  340.4 in order to assess 
the plant pest and/or noxious weed risk associated with the organism 
submitted for evaluation. However, a determination that a taxon is or 
contains a plant pest will be based on a review of scientific 
literature, and thus, CBI is not germane to our determination.
    Following the receipt of a petition to amend the list of organisms 
in Sec.  340.2, APHIS would publish a notice announcing the 
availability of the petition in the Federal Register and solicit public 
comment on the petition for 60 days. Following the close of the comment 
period, the Administrator would announce his or her decision to either 
approve the petition in whole or in part or deny the petition in a 
subsequent Federal Register notice.
    Finally, APHIS is proposing to add an appeals process in the event 
that the Administrator denies a request to amend the list of taxa that 
are described in Sec.  340.2. Any person whose petition has been denied 
would be able to appeal the decision in writing to the Administrator 
within 30 days after receiving the written notification of the denial. 
The appeal would have to state all of the facts and reasons upon which 
the person relies to assert that the petition was wrongfully denied. 
The Administrator would then grant or deny the appeal, in writing, 
stating the reasons for the decision as promptly as circumstances 
allow.
Notification
    The current regulations in Sec.  340.3 provide criteria for a 
notification procedure whereby certain GE plants may be authorized for 
importation, interstate movement, or environmental release in lieu of a 
permit. As mentioned previously in this document, rather than using 
customized requirements, like the permitting conditions used for the 
permitting procedure, the notification procedure uses performance-based 
standards that are described in the regulations themselves. The use of 
the performance-based standards that do not vary from one notification 
to the next facilitates rapid administrative turnaround on 
notifications. However, in some ways, the term ``notification'' has 
been misleading to the public, since sending a notification does not 
mean automatic authorization by APHIS.
    Rather, currently, APHIS reviews notifications to verify that the 
GE plants meet the eligibility criteria and also evaluates whether the 
proposed importation, interstate movement, or environmental release can 
be done in a manner that meets the performance-based standards 
described in the regulation. In many ways, these APHIS evaluations for 
notifications are very

[[Page 7020]]

similar to those done for permit applications, but the notification 
procedure relies on applicants agreeing to meet the performance-based 
standards described in the regulations rather than submitting an 
application for APHIS review describing the specific measures they will 
employ for the activity (as is the case for permits). With permits, but 
not with notifications, APHIS can accept the proposed measures or add 
to them, and the result is a set of binding customized permit 
conditions.
    Because the notification procedure uses only the performance-based 
standards in the regulations, it is more administratively streamlined, 
but the general nature of the standards has made it difficult for APHIS 
inspectors to determine if a notification holder is in compliance with 
the standards. This, in turn, can also make enforcement more difficult.
    For example, under the current regulations, one of the performance-
based standards for notifications relevant to controlled outdoor uses 
states that: ``The field trial must be conducted such that (1) the 
regulated article will not persist in the environment, and (2) no 
offspring can be produced that could persist in the environment.'' 
Conversely, conditions which APHIS places on permits are more specific, 
and do not rely as much on subjective determinations by APHIS 
personnel. A specific permit condition that could be used to address 
just part of the performance-based standard described above might read: 
``After final harvest of the plants covered under this environmental 
release permit, the site will be monitored every 4 weeks for the 
emergence of volunteer seedlings for 1 year, and any emerging volunteer 
plants will be devitalized before they produce pollen. Records of the 
monitoring and management of volunteers must be maintained by the 
permit holder and made available to APHIS upon request.''
    The use of performance-based standards under the notification 
procedure has some benefits, such as providing the responsible person 
with flexibility in how the standard is met, e.g., allowing for 
appropriate changes in protocols used during the growing season. 
However, there are some disadvantages in not specifically enumerating 
the specific measures that constitute compliance with the regulations. 
The permitting procedure avoids this disadvantage, because the permit 
conditions specify which actions need to be taken by the responsible 
person to be in compliance.
    Because of this, APHIS has determined that it would have more risk-
appropriate oversight, better regulatory enforcement, and improved 
transparency if all regulated movements are authorized under the 
permitting procedure. Therefore, APHIS is proposing to remove current 
notification provisions from the regulations and require that all 
authorizations for movement be conducted under permit.
    As mentioned earlier in this document, the use of the permitting 
procedure in lieu of notifications is also necessary for APHIS to 
address some of the recommendations arising from the OIG audits and the 
provisions of the 2008 Farm Bill. Both the OIG audit and the Farm Bill 
expressed concern with the use of performance-based standards to 
regulate field tests of regulated organisms, and recommended that APHIS 
amend the regulations to exercise greater oversight and enforcement of 
such field tests and to require more extensive reporting and record 
retention regarding such tests. These requirements can be added to a 
permit as permitting conditions, but do not lend themselves to 
performance-based standards. Some permit conditions, however, are, and 
have always been, performance-based. APHIS acknowledges that there is 
more than one way to manage risks and works with the permit applicant 
to find a mutually acceptable way to do so. In some instances, permit 
conditions may allow for the flexibility inherent in performance 
standards, while ensuring a specific requirement is addressed, 
something not possible with the notification procedure.
    In short, if APHIS were to retain the notification procedure, in 
order to be responsive to the risk factors that may be associated with 
certain field trials, but not others, to make it easier to assess 
compliance, and to be responsive to both the OIG audits and the 2008 
Farm Bill, APHIS would need to significantly revise the procedure to 
substantially reduce its reliance on performance-based standards. 
However, doing so would eliminate the primary benefit of the current 
notification procedure, which is that it is more administratively 
streamlined than the permitting procedure. Indeed, a revised procedure 
which took into consideration all risk factors that may be associated 
with specific field trials would be both complex and exhaustive. For 
these reasons, APHIS is proposing to do away with the notification 
procedure, rather than revise it.
Permits (Sec.  340.3)
    The permitting procedure found in Sec.  340.4 of the current 
regulations describes types of permits, information required for permit 
applications, standard permit conditions, and administrative 
information (e.g., time frames, appeal procedure, etc.). Permits 
include specific conditions that must be followed by the permit holder. 
Standard permit conditions, or ``general conditions,'' are listed in 
the current regulations and APHIS can supplement these with additional 
conditions as necessary. The current regulations specify the amount of 
time that APHIS is allotted for review of complete permit applications: 
60 days for permits for importation and interstate movement; 120 days 
for controlled outdoor use. The current regulations also outline 
requirements for protecting CBI when submitting a permit application.
    APHIS proposes to reorganize the regulations to improve the clarity 
of the permit application and evaluation procedures. In addition, APHIS 
is proposing changes to the regulations to reflect certain provisions 
of the 2008 Farm Bill. As APHIS mentioned previously in this document, 
section 10204 of Title X of the Farm Bill requires the Secretary of 
Agriculture to take action on each issue identified in the document 
entitled ``Lessons Learned and Revisions under Consideration for APHIS' 
Biotechnology Framework'' and, where appropriate, promulgate 
regulations.
    APHIS is proposing certain regulatory changes concerning permit 
application information requirements, permit conditions, records, and 
reports that address many of the considerations outlined in the 
``Lessons Learned and Revisions under Consideration for APHIS' 
Biotechnology Framework.'' The permitting procedure would continue to 
identify and obtain information relevant to evaluating the risks 
associated with a proposed movement, and determine and document 
whether, and under what conditions, the activity should be allowed.
    Paragraph (a)(1) of proposed Sec.  340.3 would provide that, except 
as provided in paragraph (a)(2) of the section, APHIS must have 
evaluated a regulated organism in accordance with Sec.  340.4 before 
APHIS will issue a permit for its importation, interstate movement, or 
release into the environment. As mentioned previously in this document, 
Sec.  340.4 would contain our process for evaluating regulated 
organisms for plant pest or noxious weed risk. In order to draft 
permitting conditions that are commensurate with the risk a GE organism 
poses as a plant pest or noxious weed, it is necessary for APHIS to 
have evaluated this risk.
    If this rule is finalized, when it is fully implemented, APHIS 
believes that such

[[Page 7021]]

evaluations will take a matter of months. Additionally, such 
evaluations could often result in a determination that the organism 
poses no risk as a plant pest and/or noxious weed, and thus is not 
subject to the regulations. For these reasons, APHIS envision that, if 
this rule is finalized, most developers would wait for APHIS to issue a 
final determination of regulatory status, in accordance with Sec.  
340.4, before submitting a permit application to import the regulated 
organism, move it interstate, or release it into the environment.
    However, APHIS also envisions that there could be instances in 
which there would be an immediate need to import a regulated organism 
or move it interstate, even though APHIS has not yet evaluated the risk 
it poses as a plant pest and/or noxious weed. This could occur when, 
for example, a developer consolidates research laboratories. To allow 
for such instances, proposed paragraph (a)(2) of Sec.  340.3 would 
provide that APHIS may issue a permit pursuant to the section for the 
importation or interstate movement of a regulated organism that has not 
been evaluated in accordance with Sec.  340.4. For the purposes of 
permitting conditions, APHIS would assume that the regulated organism 
presents a risk as a plant pest and/or noxious weed. If the regulatory 
status of the organism is evaluated in accordance with Sec.  340.4 
during the duration of the permit, APHIS could amend the permit, or, if 
the organism is determined to pose no risk as a plant pest and/or 
noxious weed, terminate the permit and communicate this termination to 
the permittee.
    While APHIS could foresee the need for the Agency to issue such 
permits, APHIS does wish the public to be aware of some of the issues 
that it has identified with doing so. First, because APHIS would not 
have evaluated the organism for plant pest and/or noxious weed risk, 
the Agency would need to presume a high degree of such risk. 
Accordingly, permitting conditions could be significantly more 
stringent for such unevaluated organisms than they would be for the 
same organisms, following evaluation in accordance with Sec.  340.4. 
Second, unlike organisms evaluated in accordance with Sec.  340.4 prior 
to permitting, determining nonregulated status for such organisms would 
not be a category of action that is exempt under APHIS' regulations 
implementing the National Environmental Policy Act (43 U.S.C. 4321 et 
seq.).
    For these reasons, APHIS requests specific public comment regarding 
whether paragraph (a)(2) of Sec.  340.3 is necessary, or addresses a 
scenario that is unlikely to occur under the proposed regulations. 
APHIS also requests public comment regarding whether there are any 
instances in which there would be an immediate need to issue a permit 
for the environmental release of a regulated organism that had not yet 
been evaluated in accordance with Sec.  340.4.
    Paragraph (a)(3) of Sec.  340.3 would state that, except as 
provided in paragraph (c) of Sec.  340.3, a permit must be issued by 
APHIS for the importation, interstate movement, or release into the 
environment of all regulated organisms. Paragraph (c) would provide 
exemptions from interstate permitting requirements for GE A. thaliana.
    Paragraph (b) of proposed Sec.  340.3 would outline how to submit a 
permit application. Applicants would have to submit a permit 
application through a method listed at the Web address contained in the 
regulations; for purposes of this proposed rule, that address is http://www.aphis.usda.gov/biotechnology/2016-340-proposed-rule. That Web site 
specifies that permit applications must be submitted using APHIS' 
current electronic permitting system, ePermits, or the paper-based 
APHIS form 2000.
    APHIS is proposing to list the methods for submitting a permit 
application on the Internet, rather than in the regulations, in order 
to make it easier to ensure they remain up-to-date. For example, APHIS 
is currently developing a new electronic permitting system to replace 
ePermits.
    APHIS is also proposing to remove the specific requirements for 
what should be included in a permit application from the regulations. 
Instead, they would be listed on an APHIS Web site; for purposes of the 
proposed rule, that Web site is http://www.aphis.usda.gov/biotechnology/2016-340-proposed-rule.
    That Web site would first list general application requirements for 
all permit applications, and then break out additional requirements for 
specific permit applications. General information requirements that all 
types of permit applications would have to provide include the name, 
title, and contact information of the responsible person and agent, if 
possible; the country and locality where regulated organism was 
collected, developed, manufactured, reared, cultivated or cultured; the 
intended activity (i.e., importation, interstate movement, or release 
into the environment) for the regulated organism; and information 
regarding how the regulated organism was developed using genetic 
engineering.
    For interstate movement or importation, the permit application 
would also have to contain the origin and destination of the regulated 
organism, including information on the addresses and contact details of 
the sender and recipient, if different from the responsible person; the 
method of shipment, and means of ensuring the security of the shipment 
against unauthorized release of the regulated article, to be used in 
the importation or interstate movement; and the manner in which 
packaging material, shipping containers, and any other material 
accompanying the regulated organism will be disposed to prevent the 
unauthorized release of the regulated article.
    Permit applications for release into the environment would have to 
address the spread, persistence risk, and potential harm of the 
regulated organism in the environment, including but not limited to a 
description of how the phenotype of the regulated organism differs from 
the phenotype of the recipient organism, particularly with respect to 
potential interactions with, and its likelihood of spread and/or 
persistence in, the environment; and the location and size of all 
proposed environmental release sites, including area, geographic 
coordinates, addresses, land use history of the site and adjacent 
areas, and name and contact information of a person at each 
environmental release site, if different from the responsible person. 
In the even that additional release sites are requested after the 
issuance of a permit, APHIS would continue the practice of evaluating 
and amending permits to add new release sites.
    The categories of information listed above reflect the categories 
of information that APHIS considers necessary to be included in all 
permit applications, as well as additional basic information required 
for each permit type. APHIS has learned that there are certain areas 
that are not specified in the current regulations where APHIS routinely 
needs information from the applicant in order to ensure safety. These 
areas do not become apparent to applicants until they submit a permit 
application and APHIS subsequently follows up for additional 
information in order to assess the activities listed on each permit 
application for plant pest and/or noxious weed risk. This had led to 
two de facto lists of information requirements for permit applications: 
The list in the regulations themselves, and the list of information 
that APHIS routinely requires in order to decide

[[Page 7022]]

whether to grant a permit. By maintaining a single list of permit 
application requirements on the Internet, APHIS can ensure that the 
list is up-to-date and increase clarity regarding the information that 
the Agency needs.
    The categories of information above also align with the 
recommendations of the 2005 and 2015 OIG audits, and the provisions of 
the 2008 Farm Bill. For example, the OIG recommendations have led to 
provisions that would enable APHIS to require geographic coordinates 
for the locations of environmental releases.
    As mentioned previously, paragraph (c) of Sec.  340.3 would 
continue to exempt A. thaliana from permitting requirements for 
interstate movement. This is based on that organism's historically 
exempt status, which has not resulted in the dissemination of plant 
pests within the United States. In the 1990 proposed rule (55 FR 28637-
28638, Docket No. 90-052) in which APHIS proposed to grant such an 
exemption, the Agency stated its rationale for the exemption: A. 
thaliana has desirable phenotypic traits (including small size, short 
generation times, high seed set, and ease of growth) that lend 
themselves to use in scientific studies; A. thaliana's small genome 
size, lack of repetitive DNA, and ease of genetic modification using 
Agrobacterium tumefaciens make it especially useful for molecular 
genetic analysis; GE A. thaliana often needs to be moved interstate 
between laboratories and other containment facilities as part of 
scientific studies; and safeguards exist which can adequately mitigate 
the plant pest risk associated with such movement. This rationale still 
holds true.
    APHIS contemplated a Web-based list of other regulated organisms 
that have been granted exemptions from permitting requirements for 
interstate movement. However, APHIS was not able to identify any 
organisms that would fall within the same category as A. thaliana: A 
taxon for which certain, but not all, types of movement have been 
evaluated and present no plant pest risk. That said, APHIS requests 
public comment regarding any taxa that may be similarly situated.
    Paragraph (d) of Sec.  340.3 would contain specifics regarding 
APHIS' review of permit applications. APHIS would review permit 
applications to determine completeness. If the application is 
incomplete, APHIS would notify the applicant in writing, and the 
applicant would be provided an opportunity to revise the application. 
APHIS is proposing to institute a time limit for receiving additional 
information in the event that a permit application is determined to be 
incomplete. If the applicant does not respond to a request for more 
information within 30 days of receipt of APHIS' request, APHIS would 
deem the permit application withdrawn and return it to the applicant. 
This time limit would help preclude the Agency from acting on a permit 
application when the responsible person no longer desires a permit, and 
would allow APHIS to focus its review of permit applications, while 
also affording applicants sufficient time to provide APHIS additional 
information in the event that they submit incomplete applications.
    Once an application is complete, APHIS would review it to determine 
whether to approve or deny the permit application.
    Paragraph (d)(2) of proposed Sec.  340.3 would contain provisions 
regarding APHIS' assignment of permit conditions. If a permit 
application is approved, permit conditions would be assigned to each 
permit commensurate with the risk of the regulated organism and 
activity. General permit conditions, which APHIS is proposing to list 
in paragraph (e) of Sec.  340.3, would be assigned to all permits. 
Additional or expanded permit conditions may also be assigned that are 
commensurate to the risk that the activities listed on the permit 
application present of disseminating the regulated organism, or other 
plant pests or noxious weeds. Examples of such additional requirements 
include, but are not limited to, specific requirements for 
reproductive, cultural, spatial, and temporal controls; monitoring; 
post-termination land use; site security or access restrictions; 
management practices such as training of personnel involved in the 
movement; and practices to prevent articles associated with the 
movement of a regulated organism from becoming contaminated with plant 
pests or noxious weeds.
    Under paragraph (d)(3) of proposed Sec.  340.3, all premises 
associated with the permit would be subject to inspection before and 
after permit issuance. APHIS would require that the responsible person 
provide APHIS inspectors access to inspect any relevant premises, 
facility, location, storage area, waypoint, materials, equipment, means 
of conveyance, and other articles related to the movement of organisms 
regulated under 7 CFR part 340. While this requirement is functionally 
the same as current inspection requirements, it clarifies what 
locations and articles may be subject to inspection. Failure to allow 
the inspection of premises prior to the issuance of a permit would be 
grounds for the denial of a permit application. Failure to allow an 
inspection after permit issuance would be grounds for revocation of the 
permit.
    While the current regulations provide for review of permit 
applications by State regulatory officials, they do not include review 
by Tribal officials when a permit application is submitted for the 
importation into, interstate movement through, or release into the 
environment on Tribal lands of a regulated organism. To correct this 
oversight, APHIS proposes to state in proposed Sec.  340.3(d)(4) that 
APHIS will include relevant Tribal officials when it provides copies of 
permit applications to State regulatory officials.
    Under the current regulations, the permitting procedure does not 
include a formal acknowledgement from the applicant prior to permit 
issuance that they are aware of and consent to the permit conditions. 
APHIS considers such an acknowledgement to be necessary, however, in 
order to verify that applicants are aware of and willing to abide by 
the conditions. Accordingly, APHIS is proposing to add a requirement in 
Sec.  340.3(d)(5) that, prior to permit issuance, applicants must 
agree, in writing and in a manner prescribed by the Administrator, that 
they are aware of, understand, and will comply with all permit 
conditions. If an applicant fails to comply with this provision, their 
application would be denied.
    The use of permits and permit conditions gives APHIS and the 
responsible person an understanding as to what actions must be taken 
for the permit holder to comply with the regulations. However, in the 
current regulations, APHIS also provides a list of general permitting 
conditions that are assigned to all permits in order to provide as much 
transparency and predictability as possible about permit conditions. To 
that end, as APHIS mentioned above, APHIS would continue to maintain 
general conditions that APHIS would assign to all permits issued under 
the regulations within the regulations themselves. Paragraph (e) of 
Sec.  340.3 would contain these general conditions. APHIS would require 
that:
     The regulated organism must be maintained and disposed of 
in a manner so as to prevent the unauthorized release of the regulated 
organism.
     The regulated organism must be kept separate from other 
organisms, except as specifically allowed in the permit.

[[Page 7023]]

     The regulated organism must be maintained only in areas 
and premises specified in the permit.
     The regulated organism's identity must be maintained at 
all times.
     In the event of an unauthorized release, the regulated 
organism must undergo the application of remedial measures determined 
by the Administrator to be necessary to prevent the spread of regulated 
organism, and the responsible person must contact APHIS as described in 
the permit within 24 hours of discovery, and subsequently supply a 
statement of facts in writing no later than 5 business days after 
discovery.
     The duration that a permit is valid will be listed on the 
permit itself. During that time, the responsible person must maintain 
records related to permitted activities of sufficient quality and 
completeness to demonstrate compliance with all permit conditions and 
requirements under the proposed regulations. The responsible person 
must submit reports and notices to APHIS at the times specified in the 
permit and containing the information specified within the permit. 
Inspectors must be allowed access, during regular business hours, to 
the place where the regulated organism is located and to any records 
relating to the movement of a regulated organism. APHIS access to 
records includes visual inspection and reproduction (photocopying, 
digital reproduction, etc.) of all records required to be maintained 
under the proposed regulations, as requested by APHIS.
     The responsible person must notify APHIS in writing if any 
permitted activity associated with environmental release will not be 
conducted.
     Within 28 days after the initiation of any permitted 
activity related to environmental release, the responsible person must 
report to APHIS in writing the actual release site coordinates and 
details of the release, such as how many acres planted, how many 
organisms released, etc., based on permit conditions, as well as every 
28 days thereafter until all releases are completed.
     A person who has been issued a permit must submit to APHIS 
an environmental release report within 6 months after the termination 
of any release into the environment. The report must include the APHIS 
reference number, methods of observation, resulting data, and analysis 
regarding all deleterious effects on plants, non-target organisms, or 
the environment.
    Most of the conditions listed above are drawn from the conditions 
found in the current regulations, although APHIS has added some 
additional details to clarify their meaning. For example, while the 
existing regulations provide that APHIS inspectors shall be allowed 
access to records related to the permit, they do not specify what 
``access to records'' means. APHIS would clarify that this includes 
visual inspection and reproduction (photocopying, digital reproduction, 
etc.) of all records required to be maintained under the proposed 
regulations. APHIS believes that these additional details will better 
communicate with applicants what the general permitting conditions are, 
and will better support administration of the permitting program, 
including compliance and enforcement.
    APHIS is also proposing to specify that regular reporting regarding 
any activities associated with environmental release of a regulated 
organism is a general permitting condition. As APHIS mentioned 
previously in this document, the 2005 and 2015 OIG audits suggested 
that APHIS exercise greater and more coordinated oversight over field 
tests of GE organisms. APHIS identified regular reporting regarding 
actual release site coordinates and details of the release as a key 
means of exercising such oversight. Adding this reporting requirement 
as a general permitting condition will ensure that it is communicated 
to all permittees.
    Similarly, to respond to the recommendations of the 2005 and 2015 
OIG audits, APHIS would add a requirement for Agency notification if 
any permitted activity associated with environmental release will not 
be conducted as a general permitting condition. This general condition 
would work in tandem with the reporting requirement mentioned above, 
and help APHIS resolve what could otherwise be considered 
inconsistencies between the permit conditions and the regular reports.
    In addition, while the current general permitting conditions 
require a field test report following termination of a field test, in 
recent years, APHIS has required a more extensive report, an 
environmental release report, through permitting conditions. Our 
general permitting conditions would reflect this.
    APHIS recognizes that these last three general permitting 
conditions pertain only to activities associated with environmental 
release of a regulated organism. APHIS also recognizes that it is 
possible that certain permit applications may not request to release 
the regulated organism into the environment. However, the permit issued 
would still contain these general conditions to communicate to the 
permittee APHIS' general requirements regarding environmental release 
of regulated organisms. This will ensure that all permitees are aware 
of those requirements, and is consistent with the recommendations of 
the OIG audits. The conditions would also prove useful, should the 
responsible person subsequently request amendments to the permit to 
authorize environmental release.
    While the general permitting conditions that are currently in the 
regulations contain a condition that pertains to packing material used 
to transport the regulated organism, APHIS would not retain this as a 
general permitting condition. This is because it would be covered by 
shipping requirements that APHIS is proposing to add to the regulations 
in paragraph (i) of Sec.  340.3.
    Under the current regulations, the Administrator may deny or cancel 
a permit if the applicant has not complied with one or more of the 
conditions listed on the permit. The Administrator will confirm the 
reasons for the cancellation or denial in writing within 10 days, and 
the applicant may appeal the decision in writing within 10 days after 
receiving the written notification of cancelation or denial. The 
Administrator may then grant or deny the appeal, in writing, stating 
the reason for the decision as promptly as circumstances allow.
    APHIS is proposing to elaborate on the circumstances under which a 
permit application may be denied in Sec.  340.3(f)(1). Such 
circumstances would include when the Administrator concludes that, 
based on the application or additional information, the actions 
proposed under the permit may result in the unauthorized release of a 
regulated organism, or another plant pest or noxious weed; or when the 
Administrator determines that the responsible person or any agent of 
the responsible person has failed to comply at any time with any APHIS 
regulation or the conditions of any permit that has previously been 
issued in accordance with the regulations.
    The first condition pertains to instances in which APHIS cannot 
reach a conclusion that the risk of dissemination of regulated 
organisms, plant pests, or noxious weeds will be adequately mitigated 
if APHIS issued a permit authorizing the actions requested on the 
permit application. This could occur when, for example, a responsible 
person does not formally acknowledge that he or she understands the 
permitting conditions.
    The second condition would pertain to instances in which prior 
actions taken by the applicant or his or her

[[Page 7024]]

agents call into question their ability to abide by permitting 
conditions.
    While the current regulations contain procedures for denying a 
permit application, they do not detail measures for APHIS to revoke a 
permit. Therefore, APHIS proposes to establish explicit procedures for 
the revocation of permits. Procedures for revoking a permit would be 
contained in Sec.  340.3(f)(2). These procedures would state that a 
permit may be revoked if, following issuance of the permit, the 
Administrator receives information that would otherwise have provided 
grounds for APHIS to deny the permit application; if the Administrator 
determines that actions taken under the permit have resulted in the 
unauthorized release of a regulated organism, or another plant pest or 
noxious weed; or if the Administrator determines that the responsible 
person or any agent of the responsible person has failed to comply at 
any time with any APHIS regulation or the conditions of any permit 
issued.
    Paragraph (g) would contain the current procedures for appealing 
the denial of a permit application or revocation of a permit.
    APHIS is also proposing to clarify in Sec.  340.3(h) of the 
regulations the procedure to be used when amendment of existing permit 
conditions is sought by the responsible person or required by APHIS. 
Such amendments may include the transfer of the permit to a new 
responsible person. Currently, the administrative practices that APHIS 
uses to amend permits have not been explicit in the regulations, and 
these additions would provide increased transparency and efficiency.
    Under the current regulations, notifications for environmental 
releases and interstate movement are valid for 1 year. Interstate 
movement permits are only valid for 1 year from the date of issuance, 
and a new import permit must be obtained for each imported shipment. 
These permits are referred to as ``limited permits.'' The duration 
period for a permit issued solely for an environmental release is not 
currently specified.
    APHIS has found that it often takes considerably longer than 1 year 
for activities authorized under a permit to be completed. For example, 
with a perennial plant such as a tree, it may take much longer than a 
year to gather relevant data about the plant for the purpose of 
determining risk. Additionally, monitoring activities may be required 
for several years after a field test is complete. In other cases, 
multiyear research projects may require multiple shipments of regulated 
organisms for analysis. APHIS is therefore proposing to eliminate the 
current limits in the regulations on the duration of permits for 
interstate movement and importation. APHIS also would continue not to 
specify a duration that an environmental release permit is valid in the 
regulations. The duration that a permit is valid would instead be 
specified on the permit itself, as a permitting condition. These 
changes should give APHIS the flexibility to issue these permits with 
suitable durations to meet individual circumstances.
    Paragraph (i) of Sec.  340.3 would contain shipping requirements 
for regulated organisms. These would specify that all shipments of 
regulated organisms must be secure shipments, which APHIS would define 
as shipments in a container or a means of conveyance of sufficient 
strength and integrity to withstand leakage of contents, shocks, 
pressure changes, and other conditions incident to ordinary handling in 
transportation.
    Currently, Sec.  340.8 contains container requirements for 
regulated organisms. These requirements are very prescriptive. While 
they do allow responsible persons to request variances from the 
requirements, this request process, by its nature, results in a case-
by-case determination that other types of containers are acceptable for 
the transportation of regulated organisms. The current regulations also 
do not clearly reflect the performance-based standard that APHIS used 
to develop the requirements, which was that the container should be 
sufficient to prevent dissemination of a regulated organism during 
movement. Our proposed requirements would maintain this performance-
based standard, while making this standard more explicit and the 
requirements less prescriptive, thus eliminating the need for a request 
process for variances.
    APHIS would, however, retain a provision in the current 
regulations, currently a footnote to Sec.  340.8, that specifies that 
all regulated organisms must be shipped in accordance with the 
regulations in 49 CFR part 178. Those regulations, which are 
administered by the Department of Transportation (DOT), provide 
packaging requirements for materials, including regulated organisms 
that DOT has designated as hazardous materials.
    Paragraph (i) of Sec.  340.3 would also specify that the container 
must be accompanied by a document that includes the names and contact 
details for the sender and the recipient. It would also specify that, 
following the completion of the shipment, all packing material, 
shipping containers, and any other material accompanying the regulated 
organism would have to be treated or disposed of in such a manner so as 
to prevent the unauthorized dissemination and establishment of 
regulated organisms. As mentioned above, this latter requirement is 
currently a general permitting condition, but could more accurately be 
described as a shipping requirement.
    Finally, paragraph (i) would contain container marking and identity 
requirements for imported GE organisms. These requirements are 
currently found in Sec.  340.7.
    APHIS has occasionally received inquiries from stakeholders 
regarding whether a permit could authorize the commercial distribution 
of a regulated organism. Currently, most developers of GE organisms 
generally have not commercialized their products until after those 
products were granted a determination of nonregulated status. However, 
APHIS does not prohibit commercializing GE organisms that have not been 
granted a determination of nonregulated status. APHIS currently 
authorizes a small number of permits for such commercial production.
    Under the proposed regulations, there may be some regulated 
organisms that an entity wishes to commercialize or grow on a large 
scale, under permit. As currently occurs, APHIS would evaluate these 
permit applications on a case-by-case basis, to determine whether 
permitting conditions can be developed that adequately address the risk 
associated with the permitted actions.
Courtesy Permits
    The current regulations in Sec.  340.4(h) provide APHIS with the 
ability to issue courtesy permits in order to facilitate the movement 
of GE organisms that are not subject to the regulations in 7 CFR part 
340 but whose movement might otherwise be hindered because of their 
similarity to organisms or articles that are regulated by other APHIS 
programs. APHIS commits significant resources to the issuance of these 
courtesy permits for the movement of organisms that are not subject to 
the provisions of part 340.
    Courtesy permits have been part of the regulations since their 
inception in 1987, and have been useful to inform shippers and State 
and Federal inspectors not yet fully familiar with requirements for GE 
organisms that the shipments in question were not regulated. However, 
their continued use has led to the widespread misunderstanding by some 
researchers that courtesy permits are actually required for the 
movement of certain organisms, or that issuance of a courtesy

[[Page 7025]]

permit removes the requirement for applicants to follow other 
applicable regulations, such as the plant pest regulations found in 7 
CFR part 330. This confusion partially stems from the similarities 
between the application form for courtesy permits and those for other 
types of permits, as well as between the courtesy permit itself and 
other permits. Therefore, in an effort to alleviate confusion and to 
better focus and allocate APHIS resources, APHIS is proposing to remove 
the regulations concerning courtesy permits. It has been common APHIS 
practice to facilitate the importation of non-regulated articles 
through the use of letters indicating that no permit is required. APHIS 
would continue to work with researchers and relevant government 
regulatory officials to facilitate the transition.
Petitions for Nonregulated Status
    The current regulations in Sec.  340.6(a) provide that any person 
may submit a petition to APHIS seeking a determination that an article 
should not be regulated under 7 CFR part 340. Paragraphs (b) and (c) of 
Sec.  340.6 describe the form that a petition for a determination of 
nonregulated status must take and the information that must be included 
in the petition. Those organisms which are granted nonregulated status 
are free of all requirements under 7 CFR part 340. This nonregulated 
status is different from that of certain organisms that meet the 
definition of regulated articles, but which are exempt from the 
requirement for a permit when moved interstate under the specific 
conditions specified in the regulations.
    Published APHIS decisions made under the current regulations have 
used different ways to express the basic standard ``unlikely to pose a 
plant pest risk'' in determining whether to grant nonregulated status 
to a specific GE organism. In its determinations, APHIS has conveyed 
the basic standard of ``unlikely to pose a plant pest risk'' by 
concluding that the GE organism ``poses no more of a plant pest risk 
than its non-GE counterpart,'' ``will not pose a plant pest risk''; or 
that there is ``no plant pest risk,'' or ``no direct or indirect plant 
pest effects.'' Regardless of the phrases used in its determination of 
nonregulated status to date, APHIS has applied the same basic 
evaluation criteria to each determination to conclude that the GE 
organism is unlikely to pose a plant pest risk and therefore is not 
subject to the part 340 regulations. Those criteria include, among 
other things, conclusions on the potential of the GE organism to create 
pest or disease problems; the potential for nontarget effects that 
might affect organisms beneficial to agriculture; changes in 
agricultural practices that might exacerbate pest or disease problems; 
and potential of the GE organism to transmit the introduced trait to 
organisms with which it does not interbreed.
    The current regulations also have a provision in Sec.  340.6(e) to 
extend a determination of nonregulated status to a GE organism based on 
its similarity to an antecedent organism that has already been granted 
nonregulated status. This existing ``extension procedure'' was designed 
for APHIS to take into account the previous evaluation used to grant 
nonregulated status conducted by APHIS and thereby afford the potential 
for expedited evaluations of a petition for extension.
    These provisions in the current regulations are necessary because 
of the manner in which regulated article is defined in the current 
regulations. As APHIS mentioned previously, the current regulations 
consider a GE organism to be a regulated article if the donor organism, 
recipient organism, vector, or vector agent is a plant pest. However, 
because of complexities in the science, and the changing nature of the 
technologies, questions can arise as to whether certain GE organisms 
meet the definition of regulated article. To address these questions, a 
process is necessary to allow parties to request that APHIS evaluate 
the GE organism for plant pest properties, and deregulate it if the 
Agency determines that it is not.
    APHIS does not consider it necessary to retain this process in the 
regulations. As mentioned in our discussion of proposed Sec.  340.0, 
APHIS would no longer regulate a GE organism solely because the donor 
organism, recipient organism, vector, or vector agent of the organism 
is a plant pest. Rather, for the GE organism to be regulated, APHIS 
would have to determine that it is a plant pest or noxious weed, or the 
GE organism would have to not yet be evaluated for plant pest and/or 
noxious weed risk. In other words, APHIS' focal point would change from 
the method by which the organism is genetically engineered, to the 
resulting GE organism itself, and the Agency would no longer assume 
that the use of a plant pest within the development of the GE organism 
necessarily and in every instance results in a GE organism with plant 
pest properties.
    Based on the manner in which proposed Sec.  340.0 is structured, 
APHIS envisions four types of inquiries from developers of GE organisms 
if this rule is finalized. The first would be from developers of 
organisms that are uncertain of the regulatory status of their 
organism, but that consider it to either be outside the scope of 
regulated organisms or similar to an organism that APHIS has already 
evaluated and assigned nonregulated status. The developers would 
present what they consider to be the regulatory status of the organism, 
as well as the information on which the developers rely to support this 
consideration. In such instances, APHIS would review the information 
\7\ and communicate to the developer whether the regulatory status that 
they presented to APHIS was accurate. This is substantially similar to 
the structure of APHIS' current ``Am I regulated?'' program.\8\ That 
being said, because there would be some changes to that program based 
on the provisions of this proposed rule, if it is finalized APHIS would 
make guidance available to aid developers in making such inquiries of 
APHIS.
---------------------------------------------------------------------------

    \7\ In evaluating the similarity between two GE plants, APHIS 
considers whether the mechanisms of action of the introduced traits 
are functionally equivalent. For example, one mechanism of action 
for resistance in plants to the herbicide glyphosate relies on an 
inability of glyphosate molecules to bind and inactivate an enzyme 
called EPSPS, which is responsible for an essential step in a 
biochemical pathway for the synthesis of certain amino acids. If 
glyphosate cannot bind to the EPSPS enzyme, the plant is resistant 
to the herbicide. APHIS has granted nonregulated status to two very 
similar types of GE plants which differed in the donor organism for 
the EPSPS genes: One version of the gene was derived from corn 
(mEPSPS) and the other from a strain of Agrobacterium (CP4 EPSPS). 
However, in both cases the added gene encodes an EPSPS protein which 
does not bind to glyphosate. Accordingly, these two glyphosate 
resistance traits have mechanisms of action which are functionally 
equivalent.
    \8\ See https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/am-i-regulated.
---------------------------------------------------------------------------

    The second type of inquiries that APHIS would expect to receive 
would come from developers of GE organisms that belonged to taxa that 
are listed in accordance with proposed Sec.  340.2 prior to genetic 
engineering, or that have received DNA from such taxa during genetic 
engineering. The developers would provide information regarding the 
development of the GE organism, and would provide information regarding 
why they do, or not consider, the GE organism to be a plant pest, or to 
have received DNA sufficient to produce an infectious entity or encode 
a pathogenesis-related compound that is expected to cause plant disease 
symptoms. Such requests would have to be made in accordance with 
proposed Sec.  340.4.
    The third category of inquiries would come from developers of GE 
plants that APHIS has not yet evaluated for plant pest and noxious weed 
risk and developers of other GE organisms, such as GE insects and other 
invertebrates,

[[Page 7026]]

that were not plant pests prior to genetic engineering, but that APHIS 
has not yet evaluated for plant pest risk as GE organisms. These 
inquiries would request APHIS to evaluate the regulatory status of the 
GE organism. Such requests would also have to be made in accordance 
with proposed Sec.  340.4.
    The fourth category of inquiries would come from developers of GE 
organisms that APHIS has determined to be plant pests or noxious weeds, 
asking for a reevaluation of this determination. Such requests would 
have to be made in accordance with proposed Sec.  340.4.
Regulatory Status Evaluation (Sec.  340.4)
    Proposed Sec.  340.4 would contain the process by which persons 
could request an initial evaluation or subsequent reevaluation of the 
regulatory status of a GE organism. The outcome of a regulatory status 
evaluation is a determination by the agency that a GE organism is a 
nonregulated organism or a regulated organism subject to permitting.
Requests for Evaluation or Reevaluation
    Paragraph (a) of proposed Sec.  340.4 would state that any person 
may submit a request to APHIS to have a GE organism's regulatory status 
evaluated, or to request the reevaluation of the regulatory status of a 
previously evaluated regulated organism. It would provide that the 
information that would have to be submitted with a regulatory status 
request in order for APHIS to evaluate the request is on the Internet, 
at http://www.aphis.usda.gov/biotechnology/2016-340-proposed-rule. Such 
information would include:
     A description of the recipient organism (including common 
name; genus, species, and any relevant subspecies information that 
would distinguish the organism; and, for microorganisms, the strain).
     The genotype of the GE organism, including a detailed 
description of the differences in genotype between the organism subject 
to the request and the non-GE organism. If genetic material is inserted 
into the genome, the method of transformation would also have to be 
described and the following provided for each gene:
    [cir] For gene sequences, the name of the sequence, donor 
organism(s) or source, function of sequence, nucleic acid sequence, and 
publicly available sequence identification. If the genes have been 
modified, the nature of the modification and its purpose would have to 
be stated, and the request would have to identify and highlight the 
modifications by submitting an alignment of the modified sequence with 
the unmodified sequence. If the gene is not naturally occurring, the 
request would have to state whether the sequence is based on that of a 
specific organism, and, if so, identify the organism and gene it was 
based on.
    [cir] For regulatory sequences, the function of each regulatory 
sequence as it relates to the gene sequence and the source of each 
regulatory sequence. Promoters (sites on DNA to which the enzyme RNA 
polymerase can bind to initiate the transcription of DNA into RNA) 
would have to be identified as constitutive, inducible, developmental, 
or tissue-specific. If inducible, the inducer would have to be 
described. If developmental, stages at which the promoter is active 
would have to be described. If tissue-specific, the tissues in which 
the promoter is active would have to be described. The strength of the 
promoter would also have to be described. Finally, for microorganisms, 
descriptions of mobile genetic elements would also have to be included.
    [cir] If the genome is edited, the following would also have to be 
provided: The nature of the edit(s) and the gene(s) and function(s) 
being modified, as well as what pathways are expected to be affected; 
for multiple substituted base pairs, the number of substitutions; the 
original unmodified sequence aligned to the modified sequence; and if 
the edits were created using genetic material which was integrated into 
the chromosome, but later eliminated through segregation, techniques 
used to confirm absence of the genetic material.
     A detailed description of the intended phenotype(s) of the 
GE organism. This would include the purpose of the new phenotype and 
the mechanisms of action by which the intended phenotype is conferred; 
any new enzymes, other gene products, or expected changes in 
metabolism; if applicable, the protein accession number and the enzyme 
commission number; and the known and potential differences from the 
non-GE organism that would substantiate that the GE organism is 
unlikely to pose a greater noxious weed risk or plant pest risk than 
the non-GE organism from which it was derived.
     For plants, any information that exists on known or likely 
changes that may affect any of the following would have to be provided: 
Weediness and plant pest characteristics of the plant; competitive 
growth ability; reproduction, spread, and persistence; stress 
tolerance, including a consideration of abiotic stresses such as cold 
and drought tolerance and biotic stresses such as herbivory 
(consumption of the plant) or diseases; and any other weediness or 
plant pest characteristics identified of the plant or other plants with 
which the plant can interbreed.
     For non-plant, non-vertebrate organisms, any information 
that exists on known or likely differences to herbivory or virulence 
must be provided, including: Any observed or anticipated changes due to 
the genetic modification that might affect the ability of the organism 
to cause direct or indirect damage to plants; a description of any 
changes to known factors of pathogenesis and virulence factors such as 
polysaccharides (complex sugars consisting of multiple sugar molecules 
bonded together) and suppressors (genes that suppress expression of 
another gene); a consideration of changes that might affect geographic 
distributions, host range, means of dissemination, horizontal gene 
transfer, reproductive cycle, and persistence; and a description of any 
characteristics introduced to mitigate harm to plants.
     Any experimental data (including field tests) and 
publications that the developer believes might be relevant to APHIS's 
evaluation of the potential of the organism to affect plant health.
    APHIS considers the categories of information specified above, 
which are drawn from our current conditions in Sec.  340.7 for a 
petition for nonregulated status for a GE organism, to be sufficient 
for APHIS to evaluate a GE organism and determine its appropriate 
regulatory status. That being said, the Agency solicits public comment 
on the adequacy of the requested information in proposed 340.4(a), and 
whether additional or alternate requirements would be more appropriate. 
Specifically, APHIS is interested in instances that commenters identify 
in which the above information may be insufficient to reach a 
regulatory status determination.
    To that end, APHIS wishes to highlight some of the differences 
between the above information and the information currently required 
for a request for deregulated status of a GE organism. With regard to 
the genotype of the GE organism, APHIS would add specific information 
requirements for gene sequences, regulatory sequences, and genome 
editing. The current regulations require the petitioner to supply a 
detailed description of the genotype of the GE organism, but do not 
specify that a description of the gene sequences, regulatory sequences, 
or genome editing of the organism is required. Operationally, however, 
APHIS considers this information to be necessary in order for the 
petitioner to provide a detailed description of the

[[Page 7027]]

genotype, and the revised regulations would reflect this operational 
need.
    APHIS would also remove a current regulatory requirement that 
requires the petition to state the country and locality of the donor 
organism from which a GE organism has received genetic material in 
order for APHIS to evaluate the genotype of the GE organism. In the 
Agency's experience, this information has not proven germane to 
evaluating the genome of the GE organism, since it does not provide 
information regarding the modified genome of the GE organism, or the 
manner in which the genome was modified.
    With regard to the phenotype of the GE organism, the proposed 
requirements would contain additional details that APHIS considers 
necessary in order to evaluate the plant pest risk of microorganisms, 
insects, and other invertebrates. For GE plants, it would also include 
information that APHIS needs in order to prepare a plant pest risk 
assessment and/or a weed risk assessment (WRA, discussed below).
    APHIS is also proposing a significant departure from the current 
requirements for a petition for nonregulated status. The current 
requirements specify that a petition must contain field reports for all 
trials conducted under permit or notification procedures involving the 
regulated organism, including the APHIS reference number, methods of 
observation, resulting data, and analysis regarding all deleterious 
effects on plants, non-target organisms, or the environment.
    Currently, most of the field data submitted by the regulated 
community to meet this requirement is to demonstrate that there have 
not been unintended deleterious effects on plants, non-target 
organisms, or the environment. To date, APHIS has authorized more than 
100,000 field trials--a single permit or notification may authorize 
multiple trials--and APHIS has not received a report of plant pest or 
noxious weed issues. In addition, APHIS has not received any 
information in such reports indicating a potential for such effects. 
Rather, the Agency has discovered that the expressed phenotype of the 
regulated organism provides the most reliable indicator of the 
organism's potential for deleterious effects on plants and plant 
products. These observations are expected and are consistent with 
findings of several reports of the National Research Council.\9\
---------------------------------------------------------------------------

    \9\ See: NRC (National Research Council). 1989. Field Testing 
Genetically Modified Organisms: Framework for Decisions. Washington, 
DC: National Academy Press.
     NRC (National Research Council). 2004. Safety of Genetically 
Engineered Foods: Approaches to Assessing Unintended Health Effects. 
Washington, DC: National Academies Press.
---------------------------------------------------------------------------

    Accordingly, APHIS considers information from field tests to not 
always be necessary for a determination of regulatory status under the 
proposed regulations. The approach APHIS is proposing focuses primarily 
on evaluating the genetics and expressed phenotype of the regulated 
organism, and the likelihood that, based on these genetics and 
phenotype, the organism will act as a plant pest or noxious weed if it 
is released into the environment for the uses intended by the 
developer.
    This would not preclude a developer from providing field test 
information, if he or she considered such information to be pertinent 
to our determination. For example, if a developer wished APHIS to 
reevaluate the status of an organism that the Agency had previously 
considered to be a regulated organism, field test information 
demonstrating a lack of adverse effects on plants and plant products 
could be provided in support of that request. Nor would the provisions 
preclude APHIS from asking for field test information if APHIS 
considers it necessary in order to conclude review of a particular 
request. However, field test information would not be a generally 
applicable requirement for requests for a regulatory status 
determination, and would only be requested rarely, and on an as-needed 
basis.
Risk Analyses in Response to Regulatory Status Requests
    Paragraph (b) would outline the actions the Administrator would 
take in response to a regulatory status request. If the request is 
complete, APHIS would conduct a risk analysis that includes an 
evidence-based, standardized approach to analyzing plant pest and/or 
noxious weed risks associated with the GE organism.
    Currently, when APHIS receives petitions for a determination of 
regulated status, APHIS conducts risk assessments. Historically, these 
assessments have focused on evaluating the plant pest risk of the 
regulated organism. However, in recent years, they have also included a 
weediness assessment when the regulated organism is a plant.
    The proposed regulations would specify that, if APHIS receives a 
request to evaluate the regulatory status of a GE organism, the Agency 
will conduct a risk analysis. The analysis would include, inter alia, 
preparation of a plant pest risk assessment, a weed risk assessment, or 
both. APHIS would prepare a plant pest risk assessment (PPRA) for 
organisms that have received DNA from any taxon listed in accordance 
with Sec.  340.2, if the DNA from the donor organisms are sufficient to 
produce an infectious entity capable of causing plant disease or 
encodes a compound known to be pathogenesis-related that is expected to 
cause plant disease symptoms, and the GE organisms have not been 
evaluated by APHIS for plant pest risk. APHIS would also prepare a PPRA 
for GE plants, if our initial evaluation of the plant suggested the 
plant may be parasitic. APHIS would also prepare a weed risk assessment 
for GE plants with plant and trait combinations that have not been 
evaluated by APHIS for noxious weed risk.
    APHIS' weed risk analysis processes would use a WRA, a system 
developed by APHIS for the purpose of assessing noxious weed risk of GE 
organisms. Regulatory status decisions for GE plants would be informed 
based on a risk manager's evaluation and interpretation of the results 
of the WRA (and, for parasitic plants or plants that may otherwise fall 
within the scope of the definition of plant pest, the PPRA).
    While this risk analysis would be informed by APHIS's risk 
assessment experience with GE organisms as well as APHIS' evaluation of 
other existing weed risk assessment systems that have been developed, 
since the WRA system for GE organisms is new, APHIS is making the WRA 
system publicly available along with this proposed rule. (To view the 
WRA system or guidance, go to http://www.aphis.usda.gov/biotechnology/2016-340-proposed-rule.) Similarly, APHIS will make WRAs available to 
the public to help make our risk management decisions as transparent as 
possible.
Notices of Request for Evaluation of Regulatory Status
    Proposed paragraph (c) of Sec.  340.4 would discuss our proposed 
notice-based process for making evaluation of regulatory status 
available to the public. APHIS would make both the request and the risk 
analysis available for public review through a notice published in the 
Federal Register. This first notice would request public comment, and 
would propose a regulatory status for the organism.
    If no comments are received on the notice, or if the comments do 
not affect the conclusions of the risk analysis or the proposed 
regulatory status of the organism, APHIS would provide notification 
through the APHIS stakeholder registry at the end of the

[[Page 7028]]

comment period announcing that the proposed regulatory status has been 
finalized.\10\ APHIS would subsequently publish a notice in the Federal 
Register compiling these determinations.
---------------------------------------------------------------------------

    \10\ To subscribe to the APHIS stakeholder registry, go to: 
https://public.govdelivery.com/accounts/USDAAPHIS/subscriber/new.
---------------------------------------------------------------------------

    Alternatively, if comments lead APHIS to change its proposed 
regulatory status for the organism, APHIS would publish a subsequent 
notice in the Federal Register characterizing these comments and 
announcing the new regulatory status.
Record Retention, Compliance and Enforcement (Sec.  340.5)
    APHIS is proposing to consolidate all record retention, compliance, 
and enforcement requirements in 7 CFR part 340 into a new Sec.  340.5. 
APHIS is also proposing to strengthen its program in order to manage 
compliance with the regulations more efficiently, to augment the 
approaches used to prevent or remediate potential risks to plant 
health, and to utilize appropriate enforcement strategies. These 
proposed regulatory changes also reflect certain provisions of the 2008 
Farm Bill and align with recommendations of the 2005 and 2015 OIG 
audits.
    The current regulations require a responsible person to retain 
records demonstrating that a regulated organism that was imported or 
moved interstate under a permit arrived at its intended destination for 
1 year, but contain no record retention requirements related to 
environmental release of a regulated organism. While APHIS has 
frequently added this record retention requirement as a permitting 
condition, both the 2005 and 2015 OIG audits and the 2008 Farm Bill 
recommended that the Agency specify the retention requirement in the 
regulations themselves, recommendations that are corroborated by the 
Agency's own experience administering the regulations.
    Therefore, APHIS is proposing that all records related to permit 
conditions, other than those demonstrating that a regulated organism 
that was imported or moved interstate arrived at its intended 
destination, be retained for 10 years following permit expiration, 
unless APHIS determines otherwise and documents an alternate record 
retention requirement. In the event of an investigation into the 
possible unauthorized environmental release of a regulated organism, or 
the escape of a regulated organism from a containment facility, a 
thorough record of activities taken under the permit is necessary in 
order for APHIS to assess compliance and determine whether enforcement 
actions are needed. When APHIS has investigated unauthorized 
environmental releases of regulated organisms, this has necessitated 
obtaining information from field trials that were conducted up to 10 
years prior to the investigation. In instances in which the information 
was not available, this adversely impacted APHIS' ability to do an 
expeditious and thorough investigation.
    APHIS is also proposing to extend the record retention requirement 
that demonstrates that a regulated organism that was imported or moved 
interstate arrived at its intended destination from 1 to 2 years. In 
the event that there is uncertainty regarding whether the organism 
arrived at this location, it may take APHIS more than 1 year to 
investigate the matter.
    APHIS recognizes that, in practice, our proposed requirements would 
require most records associated with permitted activities to be 
retained 10 years, and that this is a significant duration to retain 
potentially a substantial number of records pertaining to permit 
activities. However, retaining documents for less than 10 years may 
impede an investigation into compliance infractions. The Agency 
requests specific public comment regarding whether a shorter duration 
is warranted for certain records pertaining to permit activities, and 
which activities these may be. Additionally, APHIS requests comment on 
any alternate means that stakeholders may identify for the Agency to 
obtain necessary information from developers in the event of an 
investigation of possible regulatory noncompliance.
    The section would specify that responsible persons and their agents 
must comply with the proposed regulations. Failure to comply with the 
regulations could result in denial of a permit application or 
revocation of a permit, application of remedial measures in accordance 
with the PPA, or criminal or civil penalties.
    Pursuant to sections 7714 and 7731 of the PPA, APHIS may seize, 
quarantine, treat, destroy, or apply other remedial measures to a 
regulated organism that is new to or not widely prevalent or 
distributed in the United States to prevent dissemination of the 
organism. APHIS typically issues an Emergency Action Notifications or 
administrative order to the owner of the regulated organism to specify 
these remedial measures.
    If APHIS intends to issue a civil penalty, the Agency may enter 
into a stipulation prior to issuance of the complaint seeking the 
penalty. Our regulations regarding such stipulations are located in 7 
CFR 380.10.
    Finally, the section would specify that for purposes of enforcing 
the regulations, the act, omission, or failure of any agent for a 
responsible person may be deemed also to be the act, omission, or 
failure of the responsible person.
Container and Shipment Requirements
    The regulations in current Sec. Sec.  340.7 and 340.8 provide 
detailed requirements for identifying and securely shipping containers 
of regulated organisms. In the revised regulations, general 
requirements which apply to all shipments of regulated GE organisms 
under permit are now listed in paragraph (i) of Sec.  340.3. Additional 
supplemental conditions will be used when permits are issued to add 
additional case-specific measures. These supplemental conditions will 
be listed on the permit itself as permitting conditions. This will 
allow the agency to take into account the widely varying types and 
quantities of GE organisms to be shipped and apply highly effective yet 
reasonable requirements.
Confidential Business Information (Sec.  340.6)
    As mentioned previously, in the current regulations, there are 
guidelines for denoting information on a permit application or petition 
for a determination of nonregulated status as CBI in different sections 
of the regulations. In the proposed regulations, APHIS is proposing to 
consolidate these guidelines for protecting CBI into a single section, 
Sec.  340.6. This change would support the overall administration of 
the program by consolidating all relevant requirements, thereby making 
it easier for interested persons to find the necessary information.
Definitions (Sec.  340.1)
    APHIS proposes to retain certain definitions currently found in 
Sec.  340.1 of the regulations, to change other definitions, to add 
some new definitions, and to remove definitions that no longer appear 
in the regulations.
    APHIS is proposing to retain the following definitions from the 
current regulations, without change: Administrator, Animal and Plant 
Health Inspection Service (APHIS), donor organism, environment, 
organism, and person.
    APHIS is proposing to change the definitions of the following terms 
from those in the current regulations:
    As mentioned in the discussion of proposed Sec.  340.0, the 
definition of

[[Page 7029]]

genetic engineering would read ``techniques that use recombinant or 
synthetic nucleic acids with the intent to create or alter a genome,'' 
and would exclude traditional breeding techniques (including, but not 
limited to, marker-assisted breeding and chemical or radiation-based 
mutagenesis, as well as tissue culture and protoplast, cell, or embryo 
fusion).
    This would replace the current definition for genetic engineering, 
``the genetic modification of organisms by recombinant DNA 
techniques.'' The regulations do not define ``recombinant DNA 
techniques,'' and the current definition could also be construed to 
exclude the use of synthetic DNA, in-vivo DNA manipulation, and genome 
editing. For the purposes of this rule, APHIS is proposing to consider 
genome editing to be within the definition of genetic engineering. 
APHIS is also proposing to exclude from the definition of genetically 
engineered organism GE organisms that could have been produced via 
traditional breeding.
    APHIS recognizes that APHIS had previously suggested this proposed 
rule would use the term biotechnology, and would define biotechnology 
in the following manner: ``Laboratory-based techniques to create 
omodify a genome that result in a viable organism with intended altered 
phenotypes. Such techniques include, but are not limited to, deleting 
specific segments of the genome, adding segments to the genome, 
directed altering of the genome, creating additional genomes, or direct 
injection and cell fusion beyond the taxonomic family that overcomes 
natural physiological reproductive or recombination barriers. For the 
purposes of this part, this definition does not include traditional 
breeding, marker-assisted breeding, or chemical or radiation-based 
mutagenesis.''
    A number of stakeholders understood the limitations associated with 
the current definition of genetic engineering, but questioned the need 
to abandon the term in favor of biotechnology. They pointed to APHIS' 
long-standing use of the term genetic engineering, and suggested that 
using a different term could lead to confusion among the regulated 
community and the general public.
    Additionally, several stakeholders expressed concern regarding the 
proposed definition of biotechnology. They pointed out to APHIS that 
traditional breeding often uses laboratory-based techniques, such as 
tissue culture and embryo rescue, to create or modify a genome, and 
radiation-based mutagenesis, which modifies genomes, is often conducted 
in a laboratory. The stakeholders expressed concern that the definition 
could result in widespread confusion regarding which laboratory-based 
techniques to alter a genome are considered biotechnology, and which 
are not.
    Stakeholders also encouraged APHIS to refer to other existing 
definitions used to define biotechnology or genetic engineering.
    When APHIS issued the current regulations, the Agency relied on 
guidelines developed by the National Institutes of Health (NIH) 
regarding research on genetically engineered organisms to craft the 
definition of ``genetic engineering.'' Accordingly, in light of the 
above stakeholder concerns, APHIS revisited NIH guidelines regarding 
research on genetically engineered organisms. The definition that APHIS 
is proposing is based on NIH's ``Guidelines for Research Involving 
Recombinant or Synthetic Nucleic Acid Molecules,'' which are located at 
http://osp.od.nih.gov/sites/default/files/NIH_Guidelines.html. The 
section in that document that pertains to research on plants that have 
been genetically engineered contextually delineates the scope of 
genetic engineering in a manner that is equivalent to the scope of our 
proposed definition.
    Inspector would read ``Any individual authorized by the 
Administrator of APHIS or the Commissioner of Customs and Border 
Protection, Department of Homeland Security, to enforce the regulations 
in this part.'' The current definition predates the establishment of 
the Department of Homeland Security, as well as the transfer of certain 
inspection responsibilities for imported organisms from APHIS to 
Customs and Border Protection.
    Interstate would read ``From one State into or through any other 
State or within the District of Columbia, Guam, the Virgin Islands of 
the United States, or any other territory or possession of the United 
States.'' This change aligns the definition of ``interstate'' in 7 CFR 
part 340 with the definition of ``interstate'' used in the PPA.
    Move (moving, movement) would read ``To carry, enter, import, mail, 
ship, or transport; aid, abet, cause, or induce the carrying, entering, 
importing, mailing, shipping, or transporting; to offer to carry, 
enter, import, mail, ship, or transport; to receive to carry, enter, 
import, mail, ship, or transport; to release into the environment; or 
to allow any of the above activities to occur.'' This change aligns the 
definition of ``move'' in 7 CFR part 340 with the definition of 
``move'' used in the PPA.
    Permit would read ``A written authorization, including by 
electronic methods, by the Administrator to move regulated organisms 
and associated articles under conditions prescribed by the 
Administrator.''
    This change generally aligns the definition of permit in 7 CFR part 
340 with the definition of permit used in the PPA. However, whereas the 
definition in the PPA mentions that a permit may authorize the movement 
of plants, plant products, and biological control organisms, plant 
pests, noxious weeds, and associated articles, APHIS would specify 
that, for purposes of part 340, it pertains to the movement of 
regulated organisms and associated articles. This reflects the scope of 
the proposed regulations.
    Additionally, while the PPA allows for the issuance of oral 
permits, APHIS would not. Oral permits do not provide adequate 
documentation that a responsible person was aware of and understood 
permitting conditions at the time the permit was issued.
    Plant would read ``Any plant (including any plant part) for or 
capable of propagation, including a tree, a tissue culture, a plantlet 
culture, pollen, a shrub, a vine, a cutting, a graft, a scion, a bud, a 
bulb, a root, and a seed.'' This change is necessary because the 
current definition of ``plant'' used in the regulations precedes the 
issuance of the PPA, and is broader than that definition. Therefore, 
APHIS would align the definition with the definition in the PPA itself.
    A result of this alignment would be that APHIS would no longer 
consider ``cellular components,'' such as ribosomes, to be plants. 
However, cellular components are not capable of propagating to cause 
plant pest or noxious weed risks.
    Plant pest would read ``Any living stage of a protozoan, 
invertebrate nonhuman animal, parasitic plant, bacterium, fungus, virus 
or viroid, infectious agent or other pathogen, or any article similar 
to or allied with any of the foregoing, that can directly or indirectly 
injure, cause damage to, or cause disease in any plant or plant 
product.'' This change generally aligns the definition of ``plant 
pest'' in 7 CFR part 340 with the definition of ``plant pest'' used in 
the PPA. However, while the PPA gives APHIS authority to regulate any 
nonhuman animal as a plant pest, it is longstanding APHIS policy not to 
regulate vertebrate animals as plant pests. In the absence of such a 
policy, all herbivores and omnivores could be considered plant pests, 
and thus subject to regulation, an untenable position considering that 
this would

[[Page 7030]]

require APHIS to consider livestock, such as cows, sheep, and horses, 
to be plant pests.
    Recipient organism would read ``The organism whose nucleic acid 
sequence will be altered through the use of genetic engineering.'' In 
contrast, the current definition is ``the organism which receives 
genetic material from a donor organism.'' This change from the former 
definition is intended to be more precise by distinguishing an organism 
with altered traits from the same organism prior to transformation.
    Release into the environment (environmental release) would read 
``The use of a regulated organism outside the physical constraints 
found in a contained facility.'' This change from the former definition 
removes the word ``regulated article,'' which APHIS proposes to replace 
with the term ``regulated organism.'' This change also removes examples 
of types of physical confinement and replaces them with the term 
``contained facility,'' which APHIS is proposing to define. Finally, 
this term clarifies that ``release into the environment'' and 
``environmental release'' are synonymous terms. This can be inferred 
from the current regulations, but is not explicit.
    Responsible person would read ``The person who has control and will 
maintain control over a regulated organism during its movement and 
ensures compliance with all conditions contained in any applicable 
permit or exemption as well as other requirements in this part. A 
responsible person must be at least 18 years of age and be a legal 
resident of the United States.'' This change would remove the term 
``introduction'' and replace it with the term ``movement.'' It would 
also replace the term ``GE organism'' with the term ``regulated 
organism'' and add that a responsible person must be ``at least 18 
years of age.'' The first two changes are to reflect the nomenclature 
used in the proposed regulations. The last change is necessary because 
individuals under the age of 18 are minors.
    State would read ``Any of the several States of the United States, 
the Commonwealth of the Northern Mariana Islands, the Commonwealth of 
Puerto Rico, the District of Columbia, the Virgin Islands of the United 
States, or other Territories or possessions of the United States.'' 
This change aligns the definition of ``State'' in 7 CFR part 340 with 
the definition of ``State'' used in the PPA.
    State or Tribal regulatory official would read ``State or Tribal 
official with responsibilities for plant health, or any other duly 
designated State or Tribal official, in the State or on the Tribal 
lands where the importation, interstate movement, or environmental 
release is to take place.'' The change from the former definition is 
the acknowledgement of Tribal authority on Tribal lands.
    APHIS proposes to add definitions of the following new terms:
    Agent would read ``A person who is authorized to act on behalf of 
the responsible person to maintain control over a regulated organism 
during its movement and ensures compliance with all conditions 
contained in any applicable permit or exemption as well as other 
requirements in this part. Agents may be, but are not limited to, 
brokers, farmers, researchers, or site cooperators. An agent must be at 
least 18 years of age and be a legal resident of the United States.'' 
This proposed definition would clarify that the responsible person may 
designate another person to act on the responsible person's behalf, but 
that the person so designated must comply with all relevant regulations 
regarding the regulated organism as the responsible person must.
    Contained facility would read ``A structure for the storage and/or 
propagation of living organisms designed with physical barriers capable 
of preventing the escape of the enclosed organisms. Examples could 
include laboratories, growth chambers, fermenters, and containment 
greenhouses.'' While the current regulations use the term contained 
facility, the term is not currently defined. APHIS proposes to add this 
definition to clarify what constitutes a contained facility.
    Genetically engineered organism (GE organism) would read ``an 
organism developed using genetic engineering.'' As mentioned previously 
in this document, for purposes of the proposed regulations, APHIS would 
not consider an organism to be a GE organism if any of the following 
are the case:
     The genetic modification to the organism is solely a 
deletion of any size or a single base pair substitution which could 
otherwise be obtained through the use of chemical- or radiation-based 
mutagenesis.\4\
     The genetic modification to the organism is solely 
introducing only naturally occurring nucleic acid sequences from a 
sexually compatible relative that could otherwise cross with the 
recipient organism and produce viable progeny through traditional 
breeding (including, but not limited to, marker-assisted breeding, as 
well as tissue culture and protoplast, cell, or embryo fusion).
     The organism is a ``null segregant,'' that is, the progeny 
of a GE organism where the only genetic modification was the insertion 
of donor nucleic acid into the recipient's genome, but the donor 
nucleic acid is not passed to the recipient organism's progeny and the 
donor nucleic acid has not altered the DNA sequence of the progeny.
    Import (importation) would read ``To move into, or the act of 
movement into, the territorial limits of the United States.'' This is 
the definition of ``import'' used in the PPA.
    Interstate movement would read ``To move interstate.'' This 
proposed definition is necessary to clarify the specific type of 
movement referenced in the regulations.
    Noxious weed would read ``Any plant or plant product that can 
directly or indirectly injure or cause damage to crops (including 
nursery stock or plant products), livestock, poultry, or other 
interests of agriculture, irrigation, navigation, the natural resources 
of the United States, the public health, or the environment.'' This is 
the definition for noxious weed found in the PPA.
    Nucleic acid would read ``A chain or chains of nucleotides found in 
either DNA or RNA.'' This proposed definition is necessary to clarify 
the term ``nucleic acid,'' which is used in reference to ``regulatory 
sequences'' in the proposed regulations.
    Plant pest risk assessment would read ``An assessment evaluating 
whether a GE organism is a plant pest.''
    Plant product would read ``Any flower, fruit, vegetable, root, 
bulb, seed, or other plant part that is not included in the definition 
of plant or any manufactured or processed plant or plant part.'' This 
is the definition of plant products found in the PPA. This definition 
is more precise than the current definition of ``product'' in 7 CFR 
part 340, which this definition would replace. For example, the current 
definition of product includes ``anything made by or from, or derived 
from an organism, living or dead.'' APHIS does not plan to regulate 
dead organisms as APHIS has found that they do not present plant pest 
or noxious weed risks.
    Regulated organism would read ``Any GE organism that is regulated 
pursuant to Sec.  340.0.'' This definition would replace the definition 
of ``regulated article.''
    Regulatory sequence would read ``A segment of nucleic acid molecule 
that is capable of increasing or decreasing the expression of specific 
genes within an organism.'' This definition would be added to ensure 
clarity within the

[[Page 7031]]

requirements for regulatory status determinations.
    Secure shipment would read ``Shipment in a container or a means of 
conveyance of sufficient strength and integrity to withstand leakage of 
contents, shocks, pressure changes, and other conditions incident to 
ordinary handling in transportation.'' This definition would be used to 
clarify the container requirements in the proposed rule.
    Unauthorized release would read: ``The intentional or accidental 
release of a regulated organism in a manner not authorized by a permit 
issued pursuant to 7 CFR part 340.''
    Weed risk assessment would read ``An assessment of the 
characteristics of a plant as these relate to weediness.''
    APHIS proposes to remove the following definitions from the 
regulations: Antecedent organism, courtesy permit, expression vector, 
introduce or introduction, product, regulated article, Secretary, 
stably integrated, vector or vector agent, and well-characterized and 
contains only non-coding regulatory regions.
    These definitions would be removed because the terms would no 
longer be used in the regulations. APHIS proposes to eliminate the term 
regulated article partly because the use of the term ``article'' in 
current part 340 is not consistent with usage in the PPA, which uses 
the term article to mean ``any material or tangible object that could 
harbor plant pests or noxious weeds''--that is, things like packing 
materials, shipping containers, commodities, etc.--and not a plant pest 
or noxious weed itself. Under the current regulation, however, 
regulated article refers exclusively to certain genetically engineered 
organisms. For this reasons, the term ``regulated article'' in the 
current regulations is both inconsistent with the terminology of the 
PPA and difficult for the public to comprehend.
    APHIS also proposes to remove the definition for introduction. 
APHIS currently uses the term in part 340 to denote certain kinds of 
activities that fall within the scope of the regulations, namely 
importation, interstate movement, and release into the environment. The 
PPA, however, does not specifically define the term introduction. 
Therefore, to avoid confusion, instead of using the term introduction 
to define the different types of regulated activities, APHIS will 
instead refer to these activities in the regulations as movement in 
accordance with the definition of move in the PPA. Additionally, as 
APHIS mentioned above, the regulations will specify and define the 
types of movements to which the regulations would apply, namely, 
importation, interstate movement, and release into the environment.
    Finally, based on the terms that APHIS is proposing to add or 
remove from the regulations, as well as the revised scope of the 
regulations, the Agency would revise the title of part 340 to 
``Movement of organisms altered or produced through genetic engineering 
that are noxious weeds or plant pests or that there is reason to 
believe are noxious weeds or plant pests.''
Costs and Charges (Sec.  340.7)
    Section 340.7 would contain APHIS' policy regarding costs and 
charges for the services of inspector, which are found in the current 
regulations in Sec.  340.9. Currently, the section provides that the 
services of an inspector during regularly assigned hours of duty are 
provided free of charge, but that APHIS will not be responsible for any 
other costs or charges incident to inspections or compliance, apart 
from the services of this inspector. These provisions would be 
unchanged.
Technical Evaluations
    APHIS recognizes that many aspects of our proposed rule hinge on a 
determination by APHIS regarding the plant pest or noxious weed risk 
posed by a particular GE organism or class of GE organisms. Often, 
APHIS will be able to make a determination of plant pest or noxious 
weed risk based on our collective experience regulating genetic 
engineering and review of relevant scientific literature.
    However, as genetic engineering evolves and new genetic engineering 
techniques are developed, APHIS may lack technical expertise to fully 
evaluate certain GE organisms or classes of GE organisms. This is 
particularly likely when new or emerging genetic engineering techniques 
are applied to recipient organisms that have not previously been 
subject to genetic engineering.
    In such instances, APHIS may rely on researchers or other Federal, 
State, Tribal, or industry experts to provide information to help APHIS 
determines the organism's appropriate regulatory status. APHIS may 
solicit such information through a variety of means, including, but not 
limited to, working groups, workshops, peer review of documents 
(particularly risk analyses), or webinars.
National Environmental Policy Act
    To provide the public with documentation of APHIS' review and 
analysis of any potential environmental impacts associated with the 
revision of our regulations regarding the movement of certain GE 
organisms, APHIS has prepared a programmatic environmental impact 
statement (PEIS). The PEIS was prepared in accordance with: (1) The 
National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 
4321 et seq.), (2) regulations of the Council on Environmental Quality 
for implementing the procedural provisions of NEPA (40 CFR parts 1500-
1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) 
APHIS' NEPA Implementing Procedures (7 CFR part 372).
    The PEIS may be viewed on the Regulations.gov Web site or in our 
reading room. (A link to Regulations.gov and information on the 
location and hours of the reading room are provided under the heading 
ADDRESSES at the beginning of this proposed rule.) In addition, copies 
may be obtained by calling or writing to the individual listed under 
FOR FURTHER INFORMATION CONTACT.
Executive Orders 12866 and 13563 and Regulatory Flexibility Act
    This proposed rule has been determined to be significant for the 
purposes of Executive Order 12866 and, therefore, has been reviewed by 
the Office of Management and Budget.
    We have prepared an economic analysis for this rule. The economic 
analysis provides a cost-benefit analysis, as required by Executive 
Orders 12866 and 13563, which direct agencies to assess all costs and 
benefits of available regulatory alternatives and, if regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety 
effects, and equity). Executive Order 13563 emphasizes the importance 
of quantifying both costs and benefits, of reducing costs, of 
harmonizing rules, and of promoting flexibility. The economic analysis 
also provides an initial regulatory flexibility analysis that examines 
the potential economic effects of this rule on small entities, as 
required by the Regulatory Flexibility Act. The economic analysis is 
summarized below. Copies of the full analysis are available by 
contacting the person listed under FOR FURTHER INFORMATION CONTACT or 
on the Regulations.gov Web site (see ADDRESSES above for instructions 
for accessing Regulations.gov).
    Under the PPA, the Secretary of Agriculture is authorized to 
regulate the movement into and through the United States of plants, 
plant products, and other articles to prevent the

[[Page 7032]]

introduction or dissemination of plant pests and noxious weeds. As one 
part of its implementation of the PPA, APHIS regulates the safe 
introduction (environmental release, interstate movement, and 
importation) of certain GE organisms that might be plant pests (7 CFR 
part 340). APHIS is proposing to revise its regulation of GE organisms 
to respond to emerging trends in genetic engineering, to more 
efficiently use APHIS resources, and eliminate unnecessary regulatory 
burdens.
    The proposed revisions to 7 CFR part 340 would create the framework 
for more focused, risk-based regulation of the GE organisms that pose 
plant pest and/or noxious weed risks. They would establish a regulatory 
status evaluation process in which risk analysis would be used to 
assess whether permitting of a GE organism is necessary. Shipping 
standards would be less prescriptive and more generally applicable, and 
the rule would provide for the issuance of multi-year permits. The 
proposed rule would also exclude certain techniques from the definition 
of genetic engineering and certain organisms from the definition of 
genetically engineered organism. These changes would improve the 
efficiency and clarity of the regulations.
    The proposed amendments would benefit developers, producers, and 
consumers of certain GE organisms, public and private research 
entities, and the Agency. There would not be any decrease in the level 
of protection provided against plant pest risks, and protection against 
noxious weed risks would be enhanced. The risk-based process used to 
determine regulatory status under the proposed rule would provide cost 
savings to the biotech industry and allow for reallocation of APHIS 
resources to Biotechnology Regulatory Services (BRS) priorities.
    Based on APHIS' experience evaluating field trial data from 
thousands of permits that authorize environmental release of regulated 
organisms, as well as more than 150 petitions for non-regulated status, 
APHIS has determined that most of the GE organisms evaluated by the 
Agency do not merit regulatory oversight under the PPA. There would be 
both direct and indirect economic benefits of not subjecting the 
majority of these organisms to permitting requirements.
    Direct regulatory costs to biotech developers would be reduced for 
those organisms that are not considered to pose plant pest and/or 
noxious weed risk. Savings to the regulated community would result from 
a reduced need to collect field data, fewer reporting requirements, and 
lower management costs. Petitions for non-regulated status--and the 
petition costs incurred--would be eliminated. There would be some new 
costs borne by regulated entities under the proposed rule including 
rule familiarization and recordkeeping. Recordkeeping cost tabulations 
are based on the information collection categories from the paperwork 
burden section of the rule, and are estimated to total about $275,000. 
About 1,100 distinct entities have applied for permits or notifications 
under part 340. APHIS estimates that those entities would spend about 8 
hours becoming familiar with the provisions of this rule at a total 
cost of about $576,000.
    Cost savings for these entities are expected to more than offset 
the new costs. APHIS estimated the cost savings for two regulatory 
oversight scenarios, based on a study of the costs encountered by 
private biotech developers as they pursue regulatory authorization of 
their innovations. When only USDA has regulatory oversight, compliance 
cost savings under the proposed rule could range from $1.5 million to 
$5.4 million for the development of a given GE trait. If EPA and/or FDA 
also have an oversight role in the development of a given GE trait, 
compliance cost savings could range from $485,000 to $861,000. Since 
1992, between 2 and 14 petitions have been processed (granted non-
regulated status or the petition withdrawn) in a given year, with an 
average of just under 6.
    Because the rule is expected to spur innovation, we expect the 
number of new organisms developed annually to increase over time. In 
the following discussion, the annual number of new GE organisms 
developed under the proposed rule would range from 6 (the current 
annual average), to 12 (twice this average), with 10 as an intermediate 
number. For GE organisms that would have solely required USDA 
oversight, the annual savings could range from $8.8 million to $32.4 
million (6 new organisms), from $14.7 million to $53.9 million (10 new 
organisms), and from $17.6 million to $64.7 million (12 new organisms). 
For organisms that are submitted for multi-agency evaluation, the 
annual savings could range from $2.9 million to $5.2 million (6 new 
organisms), from $4.9 million to $8.6 million (10 new organisms), and 
from $5.8 million to $10.3 million (12 new organisms).
    APHIS costs of regulating GE organisms that may pose plant pest or 
noxious weed risks also are expected to change under the proposed rule. 
Fewer permits would be issued and notifications and petitions for non-
regulated status would be eliminated, but more risk assessments for 
regulatory determination would be performed. Current annual personnel 
costs of conducting GE activities (costs of activities that would be 
affected by the proposed rule) are estimated to total about $5.6 
million. With the proposed rule, annual costs are expected to range 
from $2.5 million to $7.8 million, depending on the volume of permits, 
weed risk assessments, inspections, and NEPA activities. In addition, 
costs to APHIS of implementing the proposed rule would include outreach 
activities, developing guidance documents, training, and adjusting the 
current permit system. APHIS estimates that the public outreach, 
guidance and training would cost about $88,000. Requests for regulatory 
status and response letters under the proposed rule could be handled in 
a manner similar to the current ``Am I Regulated'' process outside the 
electronic permitting system without incurring new costs.
    A quicker USDA evaluation process and related reduction to firms' 
regulatory uncertainty may facilitate small companies' ability to raise 
venture capital. Reduced regulatory requirements may also lead to 
greater participation by the public sector in GE research. These 
indirect benefits of the proposed rule may spur GE innovations, 
particularly in small acreage crops where genetic engineering has not 
been widely utilized due to the expense of regulation. While the 
proposed rule may help promote biotech innovations, the pace of 
commercialization and volume of GE products commercialized are not 
expected to change dramatically from current levels. Nor is control 
over the development process expected to be materially altered by the 
proposed rule. It would be in a biotech developer's own best interest 
to maintain the same level of supervision and control over the 
development process as at present to prevent undesired cross-
pollination or commingling with non-GE crops.
    GE crop varieties, in general, are not required to be reviewed or 
approved for safety by the FDA before going to market. However, the 
developer is responsible for ensuring product safety and developers 
consider voluntary consultations with FDA on food safety to be an 
absolute necessity for applicable GE products.\11\ Developers also have 
various legal, quality control

[[Page 7033]]

and marketing motivations to maintain rigorous voluntary stewardship 
measures. APHIS therefore believes that developers would continue to 
utilize such measures for field testing even in cases where USDA would 
not require a permit.
---------------------------------------------------------------------------

    \11\ Genetically Engineered Crops: Past Experience and Future 
Prospects. Committee on Genetically Engineered Crops: Past 
Experience and Future Prospects; Board on Agriculture and Natural 
Resources; Division on Earth and Life Studies; National Academies of 
Sciences, Engineering, and Medicine.
---------------------------------------------------------------------------

    Certain plants are genetically engineered in order to produce 
pharmaceutical or industrial compounds (plant-made pharmaceuticals or 
industrials), or PMPIs. Under the provisions of the proposed rule, 
there is a possibility that APHIS could reach a determination that a GE 
plant that produces PMPIs is not a regulated organism. Such a plant 
would not be subject to field trial oversight by USDA, and could be 
planted before or without an evaluation by FDA or EPA. Several options 
have been identified for addressing this potential gap in oversight. 
APHIS estimates that current PMPI inspections cost roughly $35,000 in 
total annually or about $800 each on average. Assuming that oversight 
continues in the same manner as APHIS oversight, a similar government 
expenditure could be expected under any of the PMPI oversight 
scenarios.
    Certain plants are genetically engineered to produce PIPs. PIPs 
fall under the regulatory oversight of EPA. However, APHIS exercises 
regulatory oversight of all PIP plantings on 10 acres or less of land. 
Under the proposed rule, APHIS would only require permits for PIPs 
planted on 10 acres or less if they present a plant pest or noxious 
weed risk or have not yet been evaluated by APHIS for such risk. This 
proposal would shift Federal oversight of small-scale (10 acres or 
less) outdoor plantings of PIPs to EPA. EPA may decide to require EUPs 
for all, some, or none of such PIPs, and may conduct inspections of 
all, some, or none of those PIPs under permit. EPA would need to 
develop a program to oversee small-scale testing of PIPs and issue 
regulations if warranted. APHIS is fully committed to coordinating with 
EPA in this matter in order to give EPA time to stand up such a 
program. APHIS understands that a memorandum of understanding (MOU) and 
services agreement may be necessary to provide personnel and other 
resources to assist EPA during the interim period while EPA implements 
its own program of oversight of outdoor planting of PIPs on 10 acres or 
less. APHIS recognizes that there are challenges associated with such a 
transition that also would require EPA to incur the costs associated 
with setting up a revised regulatory program. Further, it would require 
policies, procedures, and guidance regarding APHIS' interaction with 
EPA.
    Farmers who adopt GE crops also may indirectly benefit from the 
proposed rule. The adoption of GE crops in the United States has 
generally reduced costs and improved profitability at the farm level. 
As mentioned, under the proposed rule, regulatory costs are expected to 
be lower, thereby potentially spurring developer innovation, especially 
among small companies and universities. Farmers may benefit by having 
access to a wider variety of traits as well as a greater number of new 
GE crop species, affording them a broader selection of crops to suit 
their particular management needs. Among the types of innovations 
expected are crops with greater resistance to disease and insect pests, 
greater tolerance of stress conditions such as drought, high 
temperature, low temperature, and salt, and more efficient use of 
fertilizer. These types of traits can lower farmer input costs (water, 
fertilizer, pesticide) and increase yields during times of adverse 
growing conditions.
    On the other hand, some farmers (e.g., growers of organic and or 
identity-preserved crops) could be negatively impacted by these same 
innovations. Some consumers choose not to purchase products derived 
from GE crops and instead purchase commodities such as those labeled 
``non-GMO'' or organic. When crops intended for the non-GE or identity-
preserved marketplace contain unintended GE products, the value of the 
non-GE or identity-preserved product is diminished. Effects of the 
proposed rule on the variety of GE crop species grown in the United 
States and their wider adoption may increase risks of cross-pollination 
or commingling. As more small acreage crops are modified using genetic 
engineering, the unintended presence of a GE organism becomes 
increasingly possible. Unauthorized releases of regulated GE crop 
plants and the entry of regulated plant material in the commercial food 
and feed supply can have impacts on domestic or international markets. 
While such releases have occurred and may occur again, such incidents 
are expected to be rare.
    Entities potentially affected by the proposed rule fall under 
various categories of the North American Industry Classification 
System. While economic data are not available on business size for some 
entities, based on industry data obtained from the Economic Census and 
the Census of Agriculture we can assume that the majority of the 
businesses affected by the proposed rule would be small. APHIS welcomes 
public comment on the proposed rule's possible impacts.
    The following table provides a summary statement of the expected 
direct benefits and costs of the proposed rule:

    Expected Annual Benefits and Costs of the Proposed Rule for the Biotechnology Industry and for USDA, 2015
                                                     Dollars
----------------------------------------------------------------------------------------------------------------
 
----------------------------------------------------------------------------------------------------------------
                Entity
----------------------------------------------------------------------------------------------------------------
Biotechnology Industry...............                                Costs ($1,000)
                                      --------------------------------------------------------------------------
Developer costs (recordkeeping and                                        851
 rule familiarization) \1\.
----------------------------------------------------------------------------------------------------------------
                                                            Cost Savings per Trait ($1,000)
----------------------------------------------------------------------------------------------------------------
        Developer Savings \2\                                     Proposed rule, lower     Proposed rule, upper
                                                                          bound                    bound
----------------------------------------------------------------------------------------------------------------
USDA sole regulatory agency..........  .......................  -1,468.................  -5,393
USDA with FDA and/or EPA oversight...                           -485...................  -861
----------------------------------------------------------------------------------------------------------------
APHIS Biotechnology Regulatory                                       Costs ($1,000)
 Services.
----------------------------------------------------------------------------------------------------------------

[[Page 7034]]

 
Costs for public outreach, training,                                       88
 and epermitting \3\.
----------------------------------------------------------------------------------------------------------------
   Activities affected by the rule           Current rule         Proposed rule, lower     Proposed rule, upper
                                                                          bound                    bound
----------------------------------------------------------------------------------------------------------------
Notifications........................  203....................  0......................  0
Petitions............................  2,130..................  0......................  0
Interstate movement and environmental  239....................  139....................  261
 release permits.
Courtesy permits.....................  19.....................  0......................  0
Letters of No Permit Required........  0......................  3......................  3
``Am I Regulated'' Process...........  7......................  0......................  0
Weed risk assessments................  0......................  700....................  1,265
Compliance and Inspections...........  361....................  361....................  1,014
NEPA/ESA.............................  2,648..................  1,324..................  5,297
                                      --------------------------------------------------------------------------
    Total \4\........................  5,607..................  2,527..................  7,840
----------------------------------------------------------------------------------------------------------------
\1\ Becoming familiar with the rule are one-time costs.
\2\ These savings are shown on a per trait basis. If between 6 and 12 GE organisms are developed each year that
  would have solely required USDA oversight, annual savings could range from $9 million to $64.8 million. If
  between 6 and 12 new GE organisms per year are submitted for multi-agency evaluation, the annual savings could
  be from $2.9 million to $10.3 million.
\3\ Requests for regulatory status and response letters under the proposed rule could be handled in a manner
  similar to the current `Am I Regulated' process outside the electronic permitting system without new costs.
\4\ Annual staffing costs of APHIS Biotechnology Regulatory Services total about $19 million.

Executive Order 12372
    This program/activity is listed in the Catalog of Federal Domestic 
Assistance under No. 10.025 and is subject to Executive Order 12372, 
which requires intergovernmental consultation with State and local 
officials. (See 2 CFR chapter IV.)
Executive Order 12988
    This proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. If this proposed rule is adopted: (1) All State 
and local laws and regulations that are inconsistent with this rule 
will be preempted; (2) no retroactive effect will be given to this 
rule; and (3) administrative proceedings will not be required before 
parties may file suit in court.
Executive Order 13175
    This rule has been reviewed in accordance with the requirements of 
Executive Order 13175, ``Consultation and Coordination with Indian 
Tribal Governments.'' Executive Order 13175 requires Federal agencies 
to consult and coordinate with Tribes on a government-to-government 
basis on policies that have Tribal implications, including regulations, 
legislative comments or proposed legislation, and other policy 
statements that have substantial direct effects on one or more Indian 
Tribes, on the relationship between the Federal Government and Indian 
Tribes, or on the distribution of power and responsibilities between 
the Federal Government and Indian Tribes.
    The Animal and Plant Health Inspection Service has assessed the 
impact of this rule on Indian Tribes and determined that this rule does 
have Tribal implications that require Tribal consultation under E.O. 
13175. If a Tribe requests consultation, the Animal and Plant Health 
Inspection Service will work with the Office of Tribal Relations to 
ensure meaningful consultation is provided where changes, additions, 
and modifications identified herein are not expressly mandated by 
Congress.
Paperwork Reduction Act
    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), some of the reporting, recordkeeping, 
and third party disclosure requirements included in this proposed rule 
have been approved under 0579-0085. The new reporting, recordkeeping, 
and third party disclosure requirements proposed by this rule have been 
submitted as a new information collection package for approval to the 
Office of Management and Budget (OMB). Upon approval of this new 
information collection, it will be merged into the existing 0579-0085.
    Please send comments on the Information Collection Request (ICR) to 
OMB's Office of Information and Regulatory Affairs via email to 
[email protected], Attention: Desk Officer for APHIS, 
Washington, DC 20503. Please state that your comments refer to Docket 
No. APHIS-2015-0057. Please send a copy of your comments to: USDA, 
using one of the methods described under ADDRESSES at the beginning of 
this document.
    APHIS is proposing to revise its regulations governing the 
importation, interstate movement, and release into the environment of 
organisms developed using genetic engineering. Organisms would be 
regulated because APHIS has determined them to present a plant pest or 
noxious weed risk, or has not yet evaluated them for such risk.
    Persons would be able to submit a request for APHIS to evaluate the 
regulatory status of a GE organism. They would also be able to petition 
APHIS to add a genus, species, or subspecies to a list of taxa that are 
or contain plant pests. Finally, permits would be required for the 
importation, interstate movement, and environmental release of all 
regulated GE organisms. Responsible persons who are issued permits 
would be required to retain records, and would have to submit reports 
if they conduct field testing.
    APHIS is soliciting comments from the public (as well as affected 
agencies) concerning our proposed information collection and 
recordkeeping requirements. These comments will help APHIS:
    (1) Evaluate whether the proposed information collection is 
necessary for the proper performance of our agency's functions, 
including whether the information will have practical utility;
    (2) Evaluate the accuracy of our estimate of the burden of the 
proposed information collection, including the validity of the 
methodology and assumptions used;
    (3) Enhance the quality, utility, and clarity of the information to 
be collected; and
    (4) Minimize the burden of the information collection on those who 
are to respond (such as through the use of appropriate automated, 
electronic, mechanical, or other technological

[[Page 7035]]

collection techniques or other forms of information technology; e.g., 
permitting electronic submission of responses).
    Estimate of burden: Public reporting burden for this collection of 
information is estimated to average 0.828 hours per response.
    Respondents: Developers of organisms regulated under 7 CFR part 
340; businesses and individuals associated with such organisms; Tribal 
governments.
    Estimated Annual Number of Respondents: 311.
    Estimated Annual Number of Responses per Respondent: 16.
    Estimated Annual Number of Responses: 5035.
    Estimated Total Annual Burden on Respondents: 4174 hours. (Due to 
averaging, the total annual burden hours may not equal the product of 
the annual number of responses multiplied by the reporting burden per 
response.)
    A copy of the information collection may be viewed on the 
Regulations.gov Web site or in our reading room. (A link to 
Regulations.gov and information on the location and hours of the 
reading room are provided under the heading ADDRESSES at the beginning 
of this proposed rule.) Copies can also be obtained from Ms. Kimberly 
Hardy, APHIS' Information Collection Coordinator, at (301) 851-2483. 
APHIS will respond to any ICR-related comments in the final rule. All 
comments will also become a matter of public record.
E-Government Act Compliance
    The Animal and Plant Health Inspection Service is committed to 
compliance with the E-Government Act to promote the use of the Internet 
and other information technologies, to provide increased opportunities 
for citizen access to Government information and services, and for 
other purposes. For information pertinent to E-Government Act 
compliance related to this proposed rule, please contact Ms. Kimberly 
Hardy, APHIS' Information Collection Coordinator, at (301) 851-2483.

List of Subjects in 7 CFR Part 340

    Administrative practice and procedure, Biotechnology, Genetic 
engineering, Imports, Packaging and containers, Plant diseases and 
pests, Transportation.

    Accordingly, we are proposing to revise 7 CFR part 340 to read as 
follows:

PART 340--MOVEMENT OF ORGANISMS ALTERED OR PRODUCED THROUGH GENETIC 
ENGINEERING THAT ARE NOXIOUS WEEDS OR PLANT PESTS OR THAT THERE IS 
REASON TO BELIEVE ARE NOXIOUS WEEDS OR PLANT PESTS

Sec.
340.0 General restrictions and scope.
340.1 Definitions.
340.2 Taxa that are or contain plant pests.
340.3 Permits.
340.4 Regulatory status evaluation.
340.5 Record retention, compliance, and enforcement.
340.6 Confidential business information.
340.7 Costs and charges.

    Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 
CFR 2.22, 2.80, and 371.3.


Sec.  340.0   General restrictions and scope.

    (a) No person may move any regulated organism except in accordance 
with this part.
    (b) A regulated organism is any GE organism that either:
    (1) Prior to genetic engineering, belonged to any taxon listed in 
accordance with Sec.  340.2 and met the definition of plant pest in 
Sec.  340.1; or
    (2) Has received deoxyribonucleic acid (DNA) from any taxon listed 
in accordance with Sec.  340.2, the DNA from the donor organism is 
sufficient to produce an infectious entity capable of causing plant 
disease or encodes a compound known to be pathogenesis-related that is 
expected to cause plant disease symptoms, and the organism has not been 
evaluated by APHIS for plant pest risk in accordance with Sec.  340.4; 
or
    (3) Is a plant that has a plant and trait combination that has not 
been evaluated by APHIS for plant pest and noxious weed risk in 
accordance with Sec.  340.4; or
    (4) Is any of the foregoing that has been evaluated by APHIS in 
accordance with Sec.  340.4 and determined to pose a risk as a plant 
pest and/or noxious weed or is a GE organism that has otherwise been 
determined by the Administrator to pose a risk as a plant pest or 
noxious weed.\1\
---------------------------------------------------------------------------

    \1\ The importation, interstate movement, and release into the 
environment of regulated organisms is subject to any other 
applicable restrictions of this chapter. For example, in ``Subpart--
Plants for Planting'' (Sec. Sec.  319.37-319.37-14 of this chapter), 
a permit is required for the importation of certain plants for 
planting, regardless of whether the plants for planting have been 
genetically engineered.
---------------------------------------------------------------------------


Sec.  340.1  Definitions.

    Terms used in the singular form in this part shall be construed as 
the plural, and vice versa, as the case may demand. The following 
terms, when used in this part, shall be construed, respectively, to 
mean:
    Administrator. The Administrator of the Animal and Plant Health 
Inspection Service (APHIS) or any other employee of APHIS to whom 
authority has been or may be delegated to act in the Administrator's 
stead.
    Agent. A person who is authorized to act on behalf of the 
responsible person to maintain control over a regulated organism during 
its importation, interstate movement, or environmental release and 
ensures compliance with all conditions contained in any applicable 
permit or exemption as well as other requirements in this part. Agents 
may be, but are not limited to, brokers, farmers, researchers, or site 
cooperators. An agent must be at least 18 years of age and be a legal 
resident of the United States.
    Animal and Plant Health Inspection Service (APHIS). An agency of 
the United States Department of Agriculture.
    Contained facility. A structure for the storage and/or propagation 
of living organisms designed with physical barriers capable of 
preventing the escape of the enclosed organisms. Examples include 
laboratories, growth chambers, fermenters, and containment greenhouses.
    Donor organism. The organism from which genetic material is 
obtained for transfer to the recipient organism.
    Environment. All the land, air, and water; and all living organisms 
in association with land, air, and water.
    Genetic engineering. Techniques that use recombinant or synthetic 
nucleic acids with the intent to create or alter a genome. Genetic 
engineering does not include traditional breeding techniques 
(including, but not limited to, marker-assisted breeding and chemical 
or radiation-based mutagenesis, as well as tissue culture and 
protoplast, cell, or embryo fusion).
    Genetically engineered organism (GE organism). An organism 
developed using genetic engineering. For the purposes of this part, an 
organism will not be considered a genetically engineered organism if:
    (1) The genetic modification to the organism is solely a deletion 
of any size or a single base pair substitution which could otherwise be 
obtained through the use of chemical- or radiation-based mutagenesis; 
or
    (2) The genetic modification to the organism is solely introducing 
only naturally occurring nucleic acid sequences from a sexually 
compatible relative that could otherwise cross with the recipient 
organism and produce viable progeny through traditional breeding 
(including, but not limited to, marker-assisted breeding, as well as

[[Page 7036]]

tissue culture and protoplast, cell, or embryo fusion); or
    (3) The organism is a ``null segregant,'' that is, the progeny of a 
GE organism where the only genetic modification was the insertion of 
donor nucleic acid into the recipient's genome, but the donor nucleic 
acid is not passed to the recipient organism's progeny and the donor 
nucleic acid has not altered the DNA sequence of the progeny.
    Import (importation). To move into, or the act of movement into, 
the territorial limits of the United States.
    Inspector. Any individual authorized by the Administrator of APHIS 
or the Commissioner of Customs and Border Protection, Department of 
Homeland Security, to enforce the regulations in this part.
    Interstate. From one State into or through any other State or 
within the District of Columbia, Guam, the Virgin Islands of the United 
States, or any other territory or possession of the United States.
    Interstate movement. To move interstate.
    Move (moving, movement). To carry, enter, import, mail, ship, or 
transport; aid, abet, cause, or induce the carrying, entering, 
importing, mailing, shipping, or transporting; to offer to carry, 
enter, import, mail, ship, or transport; to receive to carry, enter, 
import, mail, ship, or transport; to release into the environment; or 
to allow any of the above activities to occur.
    Noxious weed. Any plant or plant product that can directly or 
indirectly injure or cause damage to crops (including nursery stock or 
plant products), livestock, poultry, or other interests of agriculture, 
irrigation, navigation, the natural resources of the United States, the 
public health, or the environment.
    Nucleic acid. A chain or chains of nucleotides found in either DNA 
or ribonucleic acid.
    Organism. Any active, infective, or dormant stage of life form of 
an entity characterized as living, including vertebrate and 
invertebrate animals, plants, bacteria, fungi, mycoplasmas, mycoplasma-
like organisms, as well as entities such as viroids, viruses, or any 
entity characterized as living, related to the foregoing.
    Permit. A written authorization, including by electronic methods, 
by the Administrator to move regulated organisms and associated 
articles under conditions prescribed by the Administrator.
    Person. Any individual, partnership, corporation, company, society, 
association, or other organized group.
    Plant. Any plant (including any plant part) for or capable of 
propagation, including a tree, a tissue culture, a plantlet culture, 
pollen, a shrub, a vine, a cutting, a graft, a scion, a bud, a bulb, a 
root, and a seed.
    Plant pest. Any living stage of a protozoan, invertebrate nonhuman 
animal, parasitic plant, bacterium, fungus, virus or viroid, infectious 
agent or other pathogen, or any article similar to or allied with any 
of the foregoing, that can directly or indirectly injure, cause damage 
to, or cause disease in any plant or plant product.
    Plant pest risk assessment. An assessment evaluating whether a GE 
organism is a plant pest.
    Plant product. Any flower, fruit, vegetable, root, bulb, seed, or 
other plant part that is not included in the definition of plant or any 
manufactured or processed plant or plant part.
    Recipient organism. The organism whose nucleic acid sequence will 
be altered through the use of genetic engineering.
    Regulated organism. Any GE organism that is regulated pursuant to 
Sec.  340.0.
    Regulatory sequence. A segment of nucleic acid molecule that is 
capable of increasing or decreasing the expression of specific genes 
within an organism.
    Release into the environment (environmental release). The use of a 
regulated organism outside the physical constraints found in a 
contained facility.
    Responsible person. The person who has control and will maintain 
control over a regulated organism during its movement and ensures 
compliance with all conditions contained in any applicable permit or 
exemption as well as other requirements in this part. A responsible 
person must be at least 18 years of age and be a legal resident of the 
United States.
    Secure shipment. Shipment in a container or a means of conveyance 
of sufficient strength and integrity to withstand leakage of contents, 
shocks, pressure changes, and other conditions incident to ordinary 
handling in transportation.
    State. Any of the several States of the United States, the 
Commonwealth of the Northern Mariana Islands, the Commonwealth of 
Puerto Rico, the District of Columbia, the Virgin Islands of the United 
States, or other Territories or possessions of the United States.
    State or Tribal regulatory official. State or Tribal official with 
responsibilities for plant health, or any other duly designated State 
or tribal official, in the State or on the Tribal lands where the 
movement is to take place.
    Unauthorized release. The intentional or accidental release of a 
regulated organism in a manner that is not authorized by a permit 
issued pursuant to this part.
    Weed risk assessment. An assessment of the characteristics of a 
plant as these relate to weediness.


Sec.  340.2   Taxa that are or contain plant pests.

    (a) Taxa that are or contain plant pests are listed on the APHIS 
Web site at http://www.aphis.usda.gov/biotechnology/2016-340-proposed-rule. Within any taxonomic group included on the list, the lowest unit 
of classification actually listed is the taxon or group which may 
contain organisms that are regulated. Organisms belonging to all lower 
taxa contained within the group listed are included as organisms that 
may be or may contain plant pests, and are regulated if they meet the 
definition of a plant pest in Sec.  340.1.
    (b) APHIS-initiated changes to listed taxa. APHIS may propose to 
add or remove a taxon from the list referred to in paragraph (a) of 
this section through a notice published in the Federal Register. The 
notice will state why APHIS has determined it necessary to add or 
remove the taxon, and will request public comment. If no comments are 
received on the notice, or the comments received do not affect APHIS' 
determination, APHIS will publish a subsequent notice in the Federal 
Register stating that the taxon has been added or removed from the list 
referred to in paragraph (a) of this section.
    (c) Petitions to amend the list of taxa. Any person may submit to 
the Administrator a petition to amend the list of taxa referred to in 
paragraph (a) of this section by adding or removing any taxon. The 
petitioner may supplement, amend, or withdraw a petition in writing 
without prior approval of the Administrator and without prejudice to 
resubmission at any time until the Administrator rules on the request. 
A petition to amend the list of taxa must be submitted in accordance 
with the procedures and format provided on the APHIS Web site at http://www.aphis.usda.gov/biotechnology/2016-340-proposed-rule.
    (d) Administrative action on a petition. (1) A petition to amend 
the list of taxa that meets the requirements of paragraph (b) of this 
section as well as the date of the petition will be acknowledged by 
APHIS. If a request does not meet the requirements of paragraph (b) of 
this section, the requester will be sent a notice indicating how the 
request is deficient.

[[Page 7037]]

    (2) APHIS will publish in the Federal Register, for 60 days public 
comment, a notice announcing the availability of a petition to amend 
the list of organisms. Following the close of the comment period, APHIS 
will review the comments received and publish its final decision in the 
Federal Register.
    (e) Appeal of denial. Any person whose petition has been denied may 
appeal the decision in writing to the Administrator within 30 days 
after receiving the written notification of the denial. The appeal must 
state all of the facts and reasons upon which the person relies to 
assert that the petition was wrongfully denied. The Administrator will 
grant or deny the appeal, in writing, stating the reasons for the 
decision as promptly as circumstances allow.


Sec.  340.3  Permits.

    (a)(1) Except as provided in paragraph (a)(2) of this section, 
APHIS must have evaluated a regulated organism in accordance with Sec.  
340.4 before it will issue permits for importation, interstate 
movement, or release into the environment of the organism pursuant to 
this section.
    (2) APHIS may issue a permit pursuant to this section for the 
importation or interstate movement of a regulated organism that has not 
been evaluated in accordance with Sec.  340.4, at the request of an 
applicant. For the purposes of permitting conditions, APHIS will assume 
the regulated organism presents a risk as a plant pest and/or noxious 
weed. If the regulatory status of the organism is evaluated in 
accordance with Sec.  340.4 during the duration of the permit, APHIS 
may amend or terminate the permit accordingly.
    (3) Except as provided in paragraph (c) of this section, a permit 
must be issued by APHIS for the importation, interstate movement, or 
release into the environment of all regulated organisms.
    (b) A responsible person must apply for and obtain a permit through 
a method listed at http://www.aphis.usda.gov/biotechnology/2016-340-proposed-rule. The application must also contain all the categories of 
information listed at that Web site for the type of permit being 
requested.
    (c) A permit for interstate movement is not required for 
genetically engineered Arabidopsis thaliana, provided that it is moved 
as a secure shipment, the cloned genetic material is stably integrated 
into the plant genome, and the cloned material does not include the 
complete infectious genome of a plant pest.
    (d) Administrative actions. (1) APHIS will review the application 
to determine if it is complete. APHIS will notify the applicant in 
writing if the application is incomplete, and the applicant will be 
provided the opportunity to revise the application. If the applicant 
does not respond to the request for additional information within 30 
days of receipt of APHIS's request, APHIS will deem the application 
withdrawn. Once an application is complete, APHIS will review it to 
determine whether to approve or deny the application.
    (2) APHIS assignment of permit conditions. If a permit application 
is approved, the Administrator will assign permit conditions to each 
permit commensurate with the risk of the regulated organism and 
activity. General conditions assigned to all permits are located in 
paragraph (e) of this section. The Administrator may assign additional 
or expanded permit conditions commensurate with the risk that the 
activities listed on the permit application present of disseminating 
the regulated organism, or other plant pests or noxious weeds.
    (3) Inspections. All premises associated with the permit are 
subject to inspection before and after permit issuance. The responsible 
person must provide APHIS inspectors access to inspect any relevant 
premises, facility, release location, storage area, waypoint, 
materials, equipment, means of conveyance, and other articles related 
to the proposed movement of organisms regulated under this part. 
Failure to allow the inspection of a premises prior to the issuance of 
a permit will be grounds for the denial of a permit application. 
Failure to allow the inspection of a premises following permit issuance 
will be grounds for revocation of the permit.
    (4) State or Tribal review and comment. The Administrator will 
submit for notice and review a copy of the permit application and any 
permit conditions to the appropriate State or Tribal regulatory 
official. Comments received from the State or Tribal regulatory 
official may be considered by the Administrator prior to permit 
issuance.
    (5) Agreement with permit conditions. Prior to issuance of a 
permit, the responsible person must agree in writing, in a manner 
prescribed by the Administrator, that the responsible person and all 
agents of the responsible person are aware of, understand, and will 
comply with the permit conditions. Failure to comply with this 
provision will be grounds for the denial of a permit.
    (e) General permit conditions. The following conditions will be 
assigned to all permits issued under this section. A responsible 
person, and his/her agents, must ensure compliance with these 
conditions, as well as any additional or expanded conditions listed on 
the permit:
    (1) The regulated organism must be maintained and disposed of in a 
manner so as to prevent the unauthorized release of the regulated 
organism.
    (2) The regulated organism must be kept separate from other 
organisms, except as specifically allowed in the permit.
    (3) The regulated organism must be maintained only in areas and 
premises specified in the permit.
    (4) The regulated organism's identity must be maintained at all 
times.
    (5) In the event of an unauthorized release:
    (i) The regulated organism must undergo the application of remedial 
measures determined by the Administrator to be necessary to prevent the 
spread of regulated organism;
    (ii) The responsible person must contact APHIS as described in the 
permit within 24 hours of discovery, and subsequently supply a 
statement of facts in writing no later than 5 business days after 
discovery.
    (6) The duration that the permit is valid will be listed on the 
permit itself. During such time, the responsible person must maintain 
records related to permitted activities of sufficient quality and 
completeness to demonstrate compliance with all permit conditions and 
requirements under this part. The responsible person must submit 
reports and notices to APHIS at the times specified in the permit and 
containing the information specified within the permit. Inspectors must 
be allowed access, during regular business hours, to the place where 
the regulated organism is located and to any records relating to the 
movement of a regulated organism. APHIS' access to records includes 
visual inspection and reproduction (photocopying, digital reproduction, 
etc.) of all records required to be maintained under this part, as 
requested by APHIS.
    (7) The responsible person must notify APHIS in writing if any 
permitted activity associated with environmental release will not be 
conducted.
    (8) Within 28 days after the initiation of any permitted activity 
related to environmental release, the responsible person must report to 
APHIS in writing the actual release site coordinates and details of the 
release, such as how many acres planted, how many organisms released, 
etc., based on permit

[[Page 7038]]

conditions, as well as every 28 days thereafter until all releases are 
completed.
    (9) A person who has been issued a permit must submit to APHIS an 
environmental release report within 6 months after the termination of 
any release into the environment. The report must include the APHIS 
reference number, methods of observation, resulting data, and analysis 
regarding all deleterious effects on plants, nontarget organisms, or 
the environment.
    (f) Denial or revocation of a permit. Permit applications may be 
denied, or permits revoked, in accordance with this paragraph.
    (1) Denial. The Administrator may deny, either orally or in 
writing, any application for a permit. If the denial is oral, the 
Administrator will communicate the denial and the reasons for it in 
writing as promptly as circumstances allow. The Administrator may deny 
a permit application if:
    (i) The Administrator concludes that, based on the application or 
on additional information, the actions proposed under the permit may 
result in the unauthorized release of the regulated organism, or 
another plant pest or noxious weed; or
    (ii) The Administrator determines that the responsible person or 
any agent of the responsible person has failed to comply at any time 
with any provision of this part or any other part of the regulations, 
or any permit that has previously been issued in accordance with this 
part.
    (2) Revocation. The Administrator may revoke, either orally or in 
writing, any permit which has been issued. If the revocation is oral, 
the Administrator will communicate the revocation and the reasons for 
it in writing as promptly as circumstances allow. The Administrator may 
revoke a permit if:
    (i) Following issuance of the permit, the Administrator receives 
information that would otherwise have provided grounds for APHIS to 
deny the permit application;
    (ii) The Administrator determines that actions taken under the 
permit have resulted in the unauthorized release of the regulated 
organism, or another plant pest or noxious weed; or
    (iii) The Administrator determines that the responsible person or 
any agent of the responsible person has failed to comply at any time 
with any provision of this part or any other part of the regulations. 
This includes failure to comply with the conditions of any permit 
issued.
    (g) Appeal of denial or revocation of permit. Any person whose 
permit application has been denied or whose permit has been or revoked 
may appeal the decision in writing to the Administrator. Any appeal 
must occur within 10 days after receiving the written notification of 
the denial or revocation. The appeal must state all of the facts and 
reasons upon which the person relies to assert that the permit was 
wrongfully denied or revoked. The Administrator will grant or deny the 
appeal, in writing, stating the reasons for the decision as promptly as 
circumstances allow. If there is a conflict as to any material fact, a 
hearing shall be held to resolve such conflict. Rules of practice 
concerning such a hearing will be adopted by the Administrator.
    (h) Amendment of permits.
    (1) Amendment at responsible person's request. If a responsible 
person determines that circumstances have changed since the permit was 
initially issued and wishes the permit to be amended accordingly, he or 
she must request the amendment by contacting APHIS directly. The 
responsible person may have to provide supporting information 
justifying the amendment. APHIS will review the amendment request, and 
may amend the permit if only minor changes are necessary. Requests for 
more substantive changes may require a new permit application. Prior to 
issuance of an amended permit, the responsible person may be required 
to agree in writing that he or she, and his or her agents, will comply 
with the amended permit and conditions.
    (2) Amendment initiated by APHIS. APHIS may amend any permit and 
its conditions at any time, upon determining that the amendment is 
needed to address newly identified considerations concerning the risks 
presented by the organism or the activities being conducted under the 
permit. APHIS may also amend a permit at any time to ensure that the 
permit conditions are consistent with all of the requirements of this 
part. As soon as circumstances allow, APHIS will notify the responsible 
person of the amendment to the permit and the reason(s) for it. 
Depending on the nature of the amendment, the responsible person may 
have to agree in writing or electronically that he or she, and his or 
her agents, will comply with the permit and conditions as amended 
before APHIS will issue the amended permit. If APHIS requests such an 
agreement, and the responsible person does not so agree, the existing 
permit will be revoked.
    (i) Shipping under a permit. All shipments of regulated organisms 
must be secure shipments. Regulated organisms must also be shipped in 
accordance with the regulations in 49 CFR part 178. The container must 
be accompanied by a document that includes the names and contact 
details for the sender and recipient. Following the completion of the 
shipment, all packing material, shipping containers, and any other 
material accompanying the regulated organism must be treated or 
disposed of in such a manner so as to prevent the unauthorized 
dissemination and establishment of regulated organisms. Additionally, 
for any regulated organism to be imported into the United States, the 
outmost container must bear the nature and quantity of the contents; 
the country and locality where collected, developed, manufactured, 
reared, cultivated, or cultured; the name and address of the shipper, 
owner, or person shipping or forwarding the organism; the name, 
address, and telephone number of the consignee; the identifying 
shipper's mark and number; and the number of written permit authorizing 
the importation. For regulated organisms imported by mail, the 
container must also be addressed to a plant inspection station listed 
in Sec.  319.37-14 of this chapter. All imported containers of 
regulated organisms must be accompanied by an invoice or packing list 
indicating the contents of the shipment.


Sec.  340.4  Regulatory status evaluation.

    (a) Any person may submit a request to APHIS to have a GE 
organism's regulatory status evaluated, or to request the reevaluation 
of the regulatory status of a previously evaluated regulated organism. 
Information needed for such a request is found on the Internet, at 
http://www.aphis.usda.gov/biotechnology/2016-340-proposed-rule.
    (b) Administrative action. (1) Upon receiving or initiating a 
regulatory status request, APHIS will evaluate the request for 
completeness, and may contact the person submitting the request for 
additional information.
    (2) If the request is complete, APHIS will conduct an analysis of 
plant pest and/or weed risks of the GE organism.
    (c)(1) APHIS will make both the request and the risk analysis 
available for public review through a notice published in the Federal 
Register. The notice will request public comment, and will propose a 
regulatory status for the organism.
    (2) If no comments are received on the notice, or if the comments 
do not affect the conclusions of the risk analysis or the proposed 
regulatory status of the organism, APHIS will provide notification 
through the APHIS stakeholder registry at the end of the

[[Page 7039]]

comment period announcing that the proposed regulatory status has been 
finalized. APHIS will subsequently publish a notice in the Federal 
Register compiling these determinations.
    (3) If comments lead APHIS to change its proposed regulatory status 
for the organism, APHIS will publish a subsequent notice in the Federal 
Register characterizing these comments and announcing the new 
regulatory status.


Sec.  340.5  Record retention, compliance, and enforcement.

    (a) Record retention. Responsible persons or their agents are 
required to establish and keep the following records and reports:
    (1) All records and reports required as a condition of a permit;
    (2) Addresses and any other information needed to identify all 
contained facilities where the regulated organism was stored or 
utilized, and all locations where the regulated organism was used in an 
environmental release;
    (3) A record identifying which APHIS permit, if any, authorized the 
permitted activity; and
    (4) Copies of contracts between the responsible person and all 
agents that conduct activities subject to this part for the responsible 
person, and copies and documents relating to agreements made without a 
written contract.
    (b) Record retention. Records indicating that a regulated organism 
that was imported or moved interstate reached its intended destination 
must be retained for at least 2 years. All other records must be 
retained for 10 years following permit expiration, unless determined 
otherwise by the Administrator and documented in the supplemental 
permit conditions or other regulatory requirements.
    (c) Compliance and enforcement. (1) Responsible persons and their 
agents must comply with all of the requirements of this part. Failure 
to comply with any of the requirements of this part may result in any 
or all of the following:
    (i) Denial of a permit application or revocation of a permit;
    (ii) Application of remedial measures in accordance the Plant 
Protection Act, 7 U.S.C. 7701 et seq.; and/or
    (iii) Criminal and/or civil penalties.
    (2) Prior to the issuance of a complaint seeking a civil penalty, 
the Administrator may enter into a stipulation, in accordance with 
Sec.  380.10 of this chapter.
    (d) Liability for acts of an agent. For purposes of enforcing this 
part, the act, omission, or failure of any agent for a responsible 
person may be deemed also to be the act, omission, or failure of the 
responsible person.


Sec.  340.6  Confidential business information.

    Persons submitting confidential business information in any 
document submitted to APHIS under this part should do so in the 
following manner. If there are portions of a document deemed to contain 
confidential business information, those portions must be identified, 
and each page containing such information must be marked ``CBI Copy.'' 
A second copy of each such document must be submitted with all such CBI 
deleted and marked on each page where the CBI was deleted: ``CBI 
Deleted.'' In addition, any person submitting CBI must justify how each 
piece of information requested to be treated as CBI is a trade secret 
or is commercial or financial information and is privileged or 
confidential.


Sec.  340.7  Costs and charges.

    The services of the inspector related to carrying out this part and 
provided during regularly assigned hours of duty and at the usual 
places of duty will be furnished without cost.\2\ The U.S. Department 
of Agriculture will not be responsible for any costs or charges 
incident to inspections or compliance with the provisions of this part, 
other than for the services of the inspector.
---------------------------------------------------------------------------

    \2\ The Department's provisions relating to overtime charges for 
an inspector's services are set forth in part 354 of this chapter.

    Done in Washington, DC, this 10th day of January 2017.
Ben Thomas,
Deputy Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 2017-00858 Filed 1-18-17; 8:45 am]
 BILLING CODE 3410-34-P



                                                      7008                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      DEPARTMENT OF AGRICULTURE                               SUPPLEMENTARY INFORMATION:                             article pursuant to 7 CFR part 340.
                                                                                                                                                                     Agency Actions Following
                                                      Animal and Plant Health Inspection                      Background
                                                                                                                                                                     Promulgation of the Current Regulations
                                                      Service                                                 Overview of the Current Regulations                      APHIS first issued these regulations
                                                                                                                 The Animal and Plant Health                         in 1987 under the authority of the
                                                      7 CFR Part 340                                          Inspection Service (APHIS) of the                      Federal Plant Pest Act of 1957 (FPPA)
                                                                                                              United States Department of Agriculture                and the Plant Quarantine Act of 1912
                                                      [Docket No. APHIS–2015–0057]                                                                                   (PQA), two acts that were subsumed
                                                                                                              (USDA) administers regulations in 7
                                                      RIN 0579–AE15                                           CFR part 340, ‘‘Introduction of                        into the Plant Protection Act (PPA, 7
                                                                                                              Organisms and Products Altered or                      U.S.C. 7701 et seq.) in 2000, along with
                                                      Importation, Interstate Movement, and                   Produced Through Genetic Engineering                   other provisions. Since 1987, APHIS has
                                                      Environmental Release of Certain                        Which are Plant Pests or Which There                   amended the regulations six times, in
                                                      Genetically Engineered Organisms                        is Reason to Believe are Plant Pests’’                 1988, 1990, 1993, 1994, 1997, and 2005,
                                                                                                              (referred to below as the regulations).                to institute exemptions from permitting
                                                      AGENCY:  Animal and Plant Health                                                                               for certain microorganisms and
                                                      Inspection Service, USDA.                               The current regulations govern the
                                                                                                              introduction (importation, interstate                  Arabidopsis, to institute the
                                                      ACTION: Proposed rule.                                                                                         notification, petition, and extension
                                                                                                              movement, or release into the
                                                                                                              environment) of certain genetically                    procedures referenced above, and to
                                                      SUMMARY:    APHIS is proposing to revise                                                                       exclude plants engineered to produce
                                                      its regulations regarding the                           engineered (GE) organisms that are
                                                                                                              considered ‘‘regulated articles.’’                     industrial compounds from the
                                                      importation, interstate movement, and                                                                          notification process.
                                                      environmental release of certain                           Under the current regulations, a GE
                                                                                                              organism is considered to be a regulated                 Although, as discussed above, the
                                                      genetically engineered organisms in                                                                            current regulations have various
                                                      order to update the regulations in                      article if the donor organism, recipient
                                                                                                              organism, vector, or vector agent 1 is a               functions, their primary function to date
                                                      response to advances in genetic                                                                                has been as a means for APHIS to
                                                      engineering and understanding of the                    plant pest or if the Administrator has
                                                                                                              reason to believe the GE organism is a                 authorize the importation, interstate
                                                      plant pest and noxious weed risk posed                                                                         movement, and introduction of certain
                                                      by genetically engineered (GE)                          plant pest. A plant pest is defined in
                                                                                                              § 340.1 as ‘‘Any living stage (including               GE organisms via the permit and
                                                      organisms, thereby reducing burden for                                                                         notification procedures referred to
                                                      regulated entities whose organisms pose                 active and dormant forms) of insects,
                                                                                                              mites, nematodes, slugs, snails,                       above. Permits and notifications are
                                                      no plant pest or noxious weed risks.                                                                           collectively known as ‘‘authorizations.’’
                                                      This would be the first comprehensive                   protozoa, or other invertebrate animals,
                                                                                                              bacteria, fungi, other parasitic plants or             To date, APHIS has issued more than
                                                      revision of the regulations since they                                                                         18,000 authorizations for the
                                                                                                              reproductive parts thereof; viruses; or
                                                      were established in 1987.                                                                                      environmental release of GE organisms
                                                                                                              any organisms similar to or allied with
                                                      DATES: We will consider all comments                    any of the foregoing; or any infectious                in multiple sites, primarily for research
                                                      that we receive on or before May 19,                    agents or substances, which can directly               and development of improved crop
                                                      2017.                                                   or indirectly injure or cause disease or               varieties for agriculture. Additionally,
                                                                                                              damage in or to any plants or parts                    APHIS has issued more than 12,000
                                                      ADDRESSES:   You may submit comments
                                                                                                              thereof, or any processed,                             authorizations for the importation of GE
                                                      by either of the following methods:
                                                                                                                                                                     organisms, and nearly 12,000
                                                        • Federal eRulemaking Portal: Go to                   manufactured, or other products of
                                                                                                              plants.’’ If a GE organism is a regulated              authorizations for the interstate
                                                      http://www.regulations.gov/                                                                                    movement of GE organisms. APHIS has,
                                                      #!docketDetail;D=APHIS-2015-0057.                       article, in order for the organism to be
                                                                                                                                                                     to date, denied slightly more than 1,500
                                                        • Postal Mail/Commercial Delivery:                    imported into the United States, to be
                                                                                                                                                                     requests for permits or notifications,
                                                      Send your comment to Docket No.                         moved in interstate commerce, or to be
                                                                                                              released into the environment through a                many of which were denied because
                                                      APHIS–2015–0057, Regulatory Analysis                                                                           APHIS ultimately decided the requests
                                                      and Development, PPD, APHIS, Station                    confined release (collectively referred to
                                                                                                              in the regulations as an ‘‘introduction’’),            lacked sufficient information on which
                                                      3A–03.8, 4700 River Road Unit 118,                                                                             to base an Agency decision.
                                                      Riverdale, MD 20737–1238.                               a permit must be issued or the
                                                                                                                                                                       For authorizations under notification,
                                                        Supporting documents and any                          movement or environmental release
                                                                                                                                                                     the regulations require the
                                                      comments we receive on this docket                      must occur under a notification
                                                                                                                                                                     environmental release to meet
                                                      may be viewed at http://                                procedure. The organism must also be
                                                                                                                                                                     performance-based standards set forth
                                                      www.regulations.gov/                                    moved in a container that meets certain
                                                                                                                                                                     in the regulations. These include,
                                                      #!docketDetail;D=APHIS-2015-0057 or                     regulatory requirements, and the
                                                                                                                                                                     among other things, that, when the
                                                      in our reading room, which is located in                container must be marked in accordance
                                                                                                                                                                     regulated article is a plant and is to be
                                                      room 1141 of the USDA South Building,                   with the regulations.
                                                                                                                 The regulations also provide a process              used for environmental release, it must
                                                      14th Street and Independence Avenue                                                                            be planted in such a way that it is not
                                                      SW., Washington, DC. Normal reading                     to petition APHIS to determine that a
                                                                                                              GE organism is nonregulated. A                         inadvertently mixed with non-regulated
                                                      room hours are 8 a.m. to 4:30 p.m.,                                                                            plant material that is not part of the
                                                      Monday through Friday, except                           determination of nonregulated status
                                                                                                                                                                     environmental release. In addition, the
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      holidays. To be sure someone is there to                means that the regulated article is no
                                                                                                              longer subject to the regulations in 7                 environmental release must be
                                                      help you, please call (202) 799–7039                                                                           conducted such that the regulated
                                                      before coming.                                          CFR part 340 and, therefore, there is no
                                                                                                              longer any authority for APHIS to                      article will not persist in the
                                                      FOR FURTHER INFORMATION CONTACT: Dr.                    require a permit or notification for the               environment, and no offspring can be
                                                      Sidney Abel, Assistant Deputy                           importation, interstate movement, or                   produced that could persist in the
                                                      Administrator, Biotechnology                            environmental release of the regulated                 environment. This latter requirement is
                                                      Regulatory Services, APHIS, 4700 River                                                                         accomplished through various measures
                                                      Road, Unit 147, Riverdale, MD 20737–                      1 These terms are defined in § 340.1 of the          such as required minimum isolation
                                                      1238; (301) 851–3896.                                   regulations.                                           distances from sexually compatible


                                                 VerDate Sep<11>2014   00:19 Jan 19, 2017   Jkt 241001   PO 00000   Frm 00002   Fmt 4701   Sfmt 4702   E:\FR\FM\19JAP4.SGM   19JAP4


                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                            7009

                                                      plants, effective removal or                            Basis for the Proposed Rule                            evaluate most GE plants for noxious
                                                      devitalization of viable plant materials,               Advances in APHIS’ Understanding of                    weed risk.
                                                      and monitoring of release sites after                                                                             In 1994, Congress amended the
                                                                                                              Genetically Engineered Organisms
                                                      completion of the tests and removal of                                                                         FNWA to allow APHIS to issue permits
                                                      any ‘‘volunteer’’ plants that are found.                   While the current regulations have                  for the interstate movement of noxious
                                                      APHIS conducts inspections of                           been effective in ensuring the safe                    weeds. This amendment, however, did
                                                      authorized facilities or environmental                  importation, interstate movement, and                  not revise the definition of noxious
                                                      release sites to evaluate compliance                    environmental release of GE organisms                  weed in the Act.
                                                      with the regulations.                                   developed using genetic engineering                       In 2000, the PPA was issued; In
                                                                                                              during the past 29 years, advances in                  addition to subsuming the FPPA and
                                                        The interstate movement,                              genetic engineering have occurred since                PQA, it also replaced the FNWA, and
                                                      importation, or environmental release of                they were promulgated and new                          provided a new definition of noxious
                                                      regulated articles may be authorized                    challenges have emerged. Additionally,                 weed: ‘‘Any plant or plant product that
                                                      under permit if developers follow the                   APHIS has now accumulated nearly                       can directly or indirectly injure or cause
                                                      permit conditions specified by the                      three decades of experience in                         damage to crops (including nursery
                                                      Administrator to be necessary for each                  evaluating GE organisms for plant pest                 stock or plant products), livestock,
                                                      activity to prevent the dissemination                   risk. The Agency’s evaluations to date                 poultry, or other interests of agriculture,
                                                      and establishment of the GE organism.                   have provided evidence that most                       irrigation, navigation, the natural
                                                      Such conditions include, but are not                    genetic engineering techniques, even                   resources of the United States, the
                                                      limited to, maintenance of the regulated                those that use a plant pest as a vector,               public health, or the environment.’’ The
                                                      article’s identity through labeling,                    vector agent, or donor, do not result in               PPA also provided explicit authority to
                                                      retention of records related to the                     a GE organism that presents a plant pest               issue regulations listing noxious weeds
                                                      article’s specified use, segregation of the             risk. This is discussed at greater length              that are prohibited or restricted from
                                                      regulated article from other organisms,                 later in this document, under the                      entering the United States or that are
                                                      inspection of a site or facility where                  section titled ‘‘General Restrictions and              subject to restrictions on interstate
                                                      regulated articles are to undergo                       Scope (§ 340.0).’’ Additionally, genetic               movement within the United States, and
                                                      environmental release or will be                        engineering techniques, such as genome                 provided persons with the right to
                                                      contained after their interstate                        editing and synthetic genomics, have                   petition APHIS to add or remove
                                                      movement or importation, and the                        been developed that do not employ                      noxious weeds from this list.
                                                      maintenance and disposal of the                         plant pests as donor organisms,                           This revised noxious weed authority
                                                      regulated article and all packing                       recipient organisms, vectors, or vector                led APHIS in 2010 to revise the noxious
                                                      material, shipping containers, and any                  agents; such techniques could be used                  weed regulations, found in 7 CFR part
                                                      other material accompanying the                         to produce GE organisms with plant                     360, to reflect the provisions of the PPA.
                                                      regulated article to prevent the                        pest risks without falling within the                  It also led APHIS to revise the manner
                                                      dissemination and establishment of                      scope of regulated article.                            in which APHIS evaluates plants for
                                                      plant pests. If a permit holder has been                Need To Evaluate GE Plants for Noxious                 noxious weed risk to determine whether
                                                      found out of compliance with any of the                                                                        to list them in part 360. Under the
                                                                                                              Weed Risks
                                                      permit conditions, the permit may be                                                                           revised approach that APHIS uses for
                                                                                                                 Advances in genetic engineering have                part 360, the first two considerations in
                                                      canceled, and if so, further movement or
                                                                                                              also made the need to evaluate GE                      determining whether a plant is a
                                                      environmental release of GE organisms
                                                                                                              plants for noxious weed risk more                      noxious weed are: (1) Identifying what
                                                      under that permit will be prohibited.
                                                                                                              pressing. When APHIS issued the                        direct injury or damage (physical harm)
                                                        In addition to issuing permits and                    current regulations under the authority                the plant causes; and (2) identifying
                                                      authorizing notifications, APHIS has                    of the FPPA and PQA, APHIS’ authority                  what indirect damage the plant may
                                                      responded to petitions requesting                       to regulate noxious weeds was the                      cause to interests of agriculture,
                                                      nonregulated status under these                         Federal Noxious Weed Act of 1974 (7                    irrigation, navigation, the natural
                                                      regulations. Under this petition                        U.S.C. 2801, FNWA). That act defined                   resources of the United States, the
                                                      procedure, which is described in                        noxious weed as ‘‘Any living stage                     public health, or the environment.
                                                      § 340.6, a petitioner must present                      (including but not limited to, seeds and               APHIS then evaluates how likely the
                                                      detailed information and scientific data                reproductive parts) of any parasitic or                plant is to become established in areas
                                                      regarding the regulated article                         other plant of a kind, or subdivision of               within the United States in which it was
                                                      indicating why the article should not be                a kind, which is of foreign origin, is new             not known to exist, in the absence of
                                                      regulated. To date, APHIS has granted                   to or not widely prevalent in the United               Federal regulation; for example, if it can
                                                      124 determinations of nonregulated                      States, and can directly or indirectly                 only become established in tropical
                                                      status, of 159 submitted for APHIS                      injure crops, other useful plants,                     climates, Federal regulation is not
                                                      review, and all of these determinations                 livestock, or poultry or other interests of            necessary to prevent its establishment in
                                                      have been for GE plants (more                           agriculture, including irrigation, or                  temperate and subarctic climates.
                                                      information about these is posted at                    navigation or the fish or wildlife                     APHIS’ final consideration is whether
                                                      https://www.aphis.usda.gov/                             resources of the United States or the                  placing the plant under Federal
                                                      biotechnology/petitions_table_                          public health.’’ Because APHIS’ noxious                regulation will affect the likelihood of
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                                                      pending.shtml). Many of these plants                    weed authority was limited at the time                 introduction or dissemination of the
                                                      are grown for agricultural production in                to plants that were of foreign origin and              plant. In general, APHIS lists a plant as
                                                      the United States. APHIS                                new to or not widely prevalent in the                  a Federal noxious weed if APHIS
                                                      determinations of nonregulated status                   United States, and most GE plants at the               determines the plant to be invasive and
                                                      apply to the GE plant(s) as well as their               time were modified crops that were                     to have significant negative impacts, if
                                                      progeny, meaning the deregulated GE                     developed in the United States and were                introduced or disseminated within the
                                                      plant can be used in plant breeding                     widely prevalent, in their unmodified                  United States, and if APHIS determines
                                                      programs and in agriculture without                     form, within the United States, APHIS                  that Federal regulation could reduce the
                                                      further oversight from APHIS.                           had no basis that would allow it to                    likelihood of such introduction or


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                                                      7010                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      dissemination. If APHIS determines that                 data or previous experience available for              unmodified state, there is a
                                                      Federal regulation of a GE plant—                       APHIS to rely on in evaluating the                     correspondingly higher risk that such a
                                                      pursuant to the authorities granted in                  properties of the resulting GE plant.                  plant may be genetically engineered into
                                                      the PPA—is incapable of mitigating                      Instead, in order to determine whether                 a noxious weed.
                                                      identified noxious weed risks, the plant                the GE plant could function as a                          Moreover, APHIS’ current regulatory
                                                      would not be regulated.                                 noxious weed, APHIS would have to                      structure, which entails evaluating such
                                                         This approach means that there are                   rely on its own independent evaluation                 plants solely for plant pest risk, is not
                                                      certain plants that APHIS has                           of the plant itself, based on information              sufficient to properly identify all risks
                                                      determined to be weeds, but not to be                   provided by the plant’s developers.                    that these plants present to other plants
                                                      Federal noxious weeds. This distinction                    Historically, there has not been a                  and plant products. Indeed, under the
                                                      between a weed and a Federal noxious                    significant need for such a noxious                    current structure, such plants may
                                                      weed warrants emphasis. ‘‘Weeds,’’ in                   weed evaluation of GE plants. Most of                  entirely escape regulation. While, in the
                                                      the broadest sense of the term, could                   the GE plants that APHIS regulated in                  past, GE plants have almost always used
                                                      include any plant growing where and/                    the past, such as varieties of corn and                a plant pest to vector genetic material,
                                                      or when it is unwanted; even plants that                soybeans modified with common                          as we mentioned previously in this
                                                      are desirable in some settings could be                 agronomic traits, do not qualify as                    document, in recent years, GE
                                                      considered weeds in others. The plants                  ‘‘noxious weeds.’’ This is because most                techniques have arisen that do not use
                                                      that APHIS evaluates for inclusion on                   GE plants to date have been agricultural               plant pests as donor organisms or
                                                      the Federal noxious weed list are, in                   crops, and most agricultural crops are                 vectors. Moreover, if plants are
                                                      general, a particular type of weed: An                  not biologically weeds prior to                        genetically engineered without the use
                                                      invasive, usually non-native plant that                 modification. Indeed, in order to                      of a plant pest as a vector or donor, this
                                                      impacted natural and/or agronomic                       domesticate a plant for crop production,               would require APHIS to consider the
                                                      ecosystems, often with significant                      farmers often had to deliberately                      plant itself to be a plant pest in order
                                                      negative consequences. Of the                           eliminate weedy traits, such as seed                   to designate it as a regulated article.
                                                      problematic weeds APHIS evaluates,                      shattering, thorns, and seed dormancy,                 However, under the PPA’s definition of
                                                      only a fraction 2 are determined to be                  from the plant using traditional                       plant pest, a plant must be parasitic in
                                                      ones for which Federal regulatory                       breeding techniques. Moreover, the                     order to be considered a plant pest.
                                                      controls to prevent their introduction or               phenotypic traits that have historically               With limited exceptions, such as
                                                      dissemination are justified; these plant                been introduced into crops through                     mistletoe, dodder, and striga, few plants
                                                      taxa are added to the list of Federal                   genetic engineering do not confer                      are known to be parasitic. Thus, APHIS
                                                      noxious weeds in part 360. Part 360                     weediness. Because the plants have not                 considers it both appropriate and
                                                      currently lists 111 aquatic, terrestrial, or            been weeds prior to genetic engineering,               necessary to begin to evaluate GE plants
                                                      parasitic plant taxa as Federal noxious                 and genetic engineering has not                        for noxious weed risk.
                                                      weeds. Many weeds in the United States                  introduced weediness, evaluating the                      While APHIS discusses the nature of
                                                      are not regulated as Federal noxious                    plant solely for plant pest risk has not               this proposed evaluation later in this
                                                      weeds because they have reached the                     been problematic.                                      document, it is important to delineate,
                                                      extent of their ecological range and                       Additionally, the means by which                    in broad terms, how the Agency would
                                                      regulation (i.e., controls on movement)                 most GE plants to date have been                       consider a GE plant to be a noxious
                                                      would be costly and provide little if any               genetically engineered has brought them                weed under the proposed regulations.
                                                      benefit.                                                under APHIS’ regulatory authority. To                  For purposes of the regulations in part
                                                         The regulations in part 360, while                   date, most GE plants have been                         340, APHIS would begin by evaluating
                                                      effective, continue to have a significant               engineered using a plant pest as either                whether the plant, in its unmodified
                                                      restriction that limits their applicability             the donor or vector of genetic material.               state, has weedy characteristics, that is,
                                                      to GE organisms: They are predicated on                 Because of this use of a plant pest as a               a plant biologically capable of causing
                                                      a determination by APHIS that a taxon                   donor, vector agent, or vector, the                    notable physical injury or damage. This
                                                      is a Federal noxious weed. This                         resulting GE organisms fall within the                 would serve as the baseline against
                                                      determination is easier for plants that                 scope of regulated articles.                           which to evaluate the genotype of the
                                                      have not been genetically engineered,                      However, in recent years, there has                 GE plant. In evaluating the GE plant,
                                                      because there are usually many                          been an increasing diversity of both                   APHIS would assess the likelihood that
                                                      reference points that are available and                 agronomic and non-agronomic traits                     the modifications made to the genome
                                                      pertinent to this determination,                        engineered in plants. There has also                   of the plant alter its ability to cause
                                                                                                              been an increased use of plants in                     notable physical harm or injury.
                                                      including international experience with
                                                                                                              genetic engineering that, in their                        For GE plants that APHIS determines
                                                      the weed, scientific literature regarding
                                                                                                              unmodified state, are known to possess                 to be weedy prior to genetic
                                                      the plant’s biology, published studies,
                                                                                                              weedy traits. This is especially true of               modification, APHIS would endeavor to
                                                      and other data.
                                                         For GE plants, there is usually a great              plants used in the production of biofuel.              determine whether the plant’s
                                                      deal of data and experience with the                    For example, switchgrass (Panicum                      weediness has been enhanced to an
                                                      non-GE organism. In most cases these                    virgatum), which has long been used in                 extent that it has been engineered into
                                                      non-GE organisms are highly                             the production of ethanol biofuel, has                 a noxious weed. For GE plants that
                                                                                                              growth patterns in an unmodified state                 APHIS determines not to possess weedy
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                                                      domesticated and cultivated widely
                                                                                                              that are characteristic of a weed, and,                traits prior to modification, APHIS
                                                      within the United States, and there is an
                                                                                                              recently, has been genetically                         would endeavor to determine whether
                                                      extensive body of scientific literature
                                                                                                              engineered for increased ethanol                       weediness had been introduced into the
                                                      regarding their biology. However, when
                                                                                                              production. Accordingly, since such                    organism through genetic engineering.
                                                      a GE trait is introduced into the plant,
                                                                                                              plants are somewhat weedy in their                     Finally, in the event that a Federal
                                                      there may in certain instances be little
                                                                                                              unmodified state, and genetic                          noxious weed is genetically engineered
                                                        2 Since 2011, 1700 weeds have been evaluated.         engineering can, in certain instances,                 (something that has not occurred to
                                                      Only 24 have been deemed to meet the criteria for       enhance the weeediness traits that are                 date), APHIS would endeavor to
                                                      inclusion on the list of Federal noxious weeds.         already present in a plant in its                      determine whether the GE plant is still


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                                   7011

                                                      a noxious weed and warrants continued                   provided Agencies with authority to                       Finally, in 2008, The Food,
                                                      regulation.                                             exercise oversight of GE organisms.                    Conservation, and Energy Act of 2008
                                                         If APHIS determines that the GE plant                APHIS acknowledges that the Agencies                   (Farm Bill) was promulgated. Section
                                                      is a noxious weed, it would endeavor to                 functioning within the Coordinated                     10204 of the Farm Bill requires the
                                                      gauge the direct or indirect injury or                  Framework oversee different aspects of                 Secretary of Agriculture to take action
                                                      damage it could cause to crops,                         risk and that, accordingly, other Federal              on each issue identified in the APHIS
                                                      livestock, poultry, or other interests of               Agencies may continue to exercise                      document entitled ‘‘Lessons Learned
                                                      agriculture, irrigation, navigation, the                oversight over GE crops that APHIS no                  and Revisions under Consideration for
                                                      natural resources of the United States,                 longer views as plant pests or noxious                 APHIS’ Biotechnology Framework,’’ 4
                                                      the public health, or the environment.                  weeds. To that end, APHIS                              and, where appropriate, promulgate
                                                      APHIS would make the results of this                    acknowledges that the proposed                         regulations. Like the 2005 OIG audit,
                                                      evaluation publicly available and share                 revisions to 7 CFR part 340 could have                 this APHIS document suggested the
                                                      both the evaluation and the information                 direct or indirect impacts on the manner               need for greater regulatory oversight of
                                                      on which it is based with the                           in which FDA and EPA exercise their                    field tests of regulated articles.
                                                      Environmental Protection Agency (EPA)                   roles within the Coordinated                              On October 9, 2008, APHIS published
                                                      and the U.S. Food and Drug                              Framework. To the extent that the                      a proposal 4 in the Federal Register (73
                                                      Administration (FDA), as warranted.                     public health impacts are due to                       FR 60007–60048, Docket No. APHIS–
                                                         Maintaining communication with                       changes in APHIS regulatory oversight,                 2008–0023) to amend the regulations to
                                                      EPA and FDA as we evaluate GE plants                    APHIS discusses them within this                       address advances in genetic
                                                      for noxious weed risks is consistent                    document. Economic impacts, in                         engineering, to make explicit our
                                                      with APHIS’ role in the Coordinated                     contrast, are discussed in the economic                evaluation of GE organisms for noxious
                                                      Federal Framework for Regulation of                     analysis prepared for this rule, while                 weed potential, and to respond to the
                                                      Biotechnology (Coordinated                              potential environmental impacts are                    recommendations of the 2005 OIG audit
                                                      Framework).3 Since 1986, the U.S.                       discussed in the draft programmatic                    and the provisions of the Farm Bill.
                                                      government has regulated GE organisms                   environmental impact statement                            APHIS sought public comment on the
                                                      consistent with the regulatory                          prepared for the rule.                                 proposal from October 9, 2008, to June
                                                      framework described in the Coordinated                                                                         29, 2009. APHIS received more than
                                                                                                              OIG Audits and 2008 Farm Bill
                                                      Framework. The Coordinated                                                                                     88,300 comments during the comment
                                                      Framework, published by the Office of                      Audits conducted by USDA’s Office                   period. These were received in 5,580
                                                      Science and Technology Policy,                          of Inspector General (OIG) are another                 submissions that included unique
                                                      describes the comprehensive Federal                     basis for this rule. In 2005, OIG                      comments, form letters, and signatories
                                                      regulatory policy for ensuring the safety               conducted an audit of APHIS’ regulatory                to petitions. Many commenters
                                                      of biotechnology research and products,                 program for GE organisms. OIG found                    expressed concerns regarding the lack of
                                                      and explains how Federal agencies use                   that the use of performance-based                      details surrounding a proposed risk-
                                                      existing Federal statutes in a manner to                standards in APHIS’ notification process               based system that would determine
                                                      ensure public health and environmental                  allowed for a broad spectrum of                        which organisms would fall under
                                                      safety while maintaining regulatory                     methods to meet the standards,                         APHIS oversight, as well as concerns
                                                      flexibility to avoid impeding the growth                particularly regarding how the release                 about a proposed multi-tiered permit
                                                      of the biotechnology industry. The                      would be contained to its test field, but              system. Commenters also expressed
                                                      Coordinated Framework explains the                      Agency practices did not require                       concern about what they perceived to be
                                                      regulatory roles and authorities for the                responsible persons to provide written                 a significant expansion of Agency
                                                      three major agencies involved in                        protocols detailing the exact methods                  regulatory authority.
                                                      exercising oversight and/or review of GE                that person would use to meet the                         Based on the breadth and nature of
                                                      organisms: APHIS, EPA, and FDA.                         standards. OIG suggested that APHIS                    the comments received, APHIS
                                                         The Coordinated Framework provides                   revise the regulations to minimize the                 published a notice in the Federal
                                                      as a guiding principle that, ‘‘[i]n order               risk of inadvertent dissemination of                   Register on March 4, 2015, withdrawing
                                                      to ensure that limited Federal oversight                regulated articles from a test field.                  the proposal to allow APHIS to begin a
                                                      resources are applied where they will                   Specific recommendations were to                       fresh stakeholder engagement process
                                                      accomplish the greatest net beneficial                  require GPS coordinates of all test field              aimed at exploring a variety of
                                                      protection of public health and the                     sites; to require scientific protocols or              regulatory approaches.
                                                      environment, oversight will be                          study designs from applicants prior to                    Based on the feedback received
                                                      exercised only where the risk posed by                  authorizing a field test of a GE organism;             following the withdrawal of the
                                                      the introduction is unreasonable.’’                     and to seek legislative authority to                   proposed rule, as well as to reflect
                                                      APHIS considers this proposed rule to                   require applicants to provide proof of                 provisions of The Food, Conservation,
                                                      be entirely consistent with this                        financial responsibility in the event of               and Energy Act of 2008 (Farm Bill) and
                                                      principle: It will no longer consider GE                an unauthorized release, as APHIS                      recommendations received from the
                                                      organisms to be regulated articles solely               considered necessary.                                  2005 and 2015 OIG audits, APHIS is
                                                      because of the donor, vector, or vector                    OIG also suggested that APHIS                       proposing to update its regulations in 7
                                                      agent used in genetic engineering,                      develop risk-based criteria for                        CFR part 340. APHIS is proposing to
                                                                                                              conducting inspections and exercising
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                                                      thereby focusing APHIS resources on                                                                            evaluate GE organisms for noxious weed
                                                      those GE organisms that may present a                   oversight of field tests for the release of            potential using a different approach
                                                      plant pest and/or noxious weed risk.                    GE organisms, and suggested that
                                                      However, it is worth noting, as the                     APHIS provide more explicit guidance                     4 https://www.aphis.usda.gov/biotechnology/

                                                      Coordinated Framework itself does, that                 regarding how to terminate a field test                downloads/supportingdocs/LessonsLearned10-
                                                                                                              and document this termination.                         2007.pdf.
                                                      a ‘‘mosaic’’ of statutes have, to date,                                                                          4 To view the 2008 proposed rule, the subsequent
                                                                                                                 In 2015, OIG issued another audit,
                                                                                                                                                                     withdrawal, all supporting documents, and
                                                        3 To view the framework, go to https://               urging APHIS to implement the                          comments APHIS received, go to http://
                                                      www.aphis.usda.gov/brs/fedregister/coordinated_         recommendations from the 2005 audit                    www.regulations.gov/#!docketDetail;D=APHIS-
                                                      framework.pdf.                                          that APHIS had not yet implemented.                    2008-0023.



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                                                      7012                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      from that of the 2008 proposed rule, and                obtained from PMPI-producing plants                    corrective actions before material from
                                                      proposing a new risk analysis process to                may be regulated by FDA (authority                     the plants is inadvertently released and
                                                      determine which organisms would                         over pharmaceuticals) or EPA (chemical                 causes public health or economic
                                                      require a permit. As previously                         substances as defined by the Toxic                     impacts. One of the reasons APHIS’
                                                      proposed in 2008, APHIS is also                         Substances Control Act (TSCA)),                        oversight of such crops has been an
                                                      proposing to eliminate the notification                 depending on their intended use. To                    important part of the coordinated
                                                      process in favor of permitting. APHIS is                date, producers of PMPI-producing                      framework for oversight of GE plants is
                                                      committed to working with stakeholders                  plants, or products derived from such                  that companies are not necessarily
                                                      to ensure a smooth transition from the                  plants, have not intended for such                     required to notify FDA or EPA when the
                                                      current regulatory process to the                       plants or plant products to be used for                company plants PMPI-producing plants.
                                                      proposed regulatory process. We request                 human or animal food. However, if such                 For example, for PMPI-producing plants
                                                      comment on suggestions for ways to                      a plant or plant product is used for                   whose products fall under FDA
                                                      smooth the transition period, avoiding                  human or animal food, the food would                   authority, FDA has no regulations
                                                      disruption in the market, while                         be subject to applicable statutory and                 governing planting of such crops. For
                                                      continuing to ensure that APHIS meets                   regulatory requirements under the                      crops genetically engineered to produce
                                                      its statutory requirements.                             Federal Food, Drug, and Cosmetic Act.                  pharmaceuticals, companies only have
                                                                                                                To date, PMPI-producing GE plants                    to come to FDA when they have reached
                                                      Regulation of GE Biological Control                     regulated by APHIS have been                           the point that they are ready to begin
                                                      Agents                                                  genetically engineered using a plant                   clinical trials with the pharmaceutical
                                                         Additionally, under the new                          pest as the donor, vector, or vector                   derived from the plant. This could be
                                                      approach, APHIS would regulate a GE                     agent, and thus fall under the scope of                years after they first started growing the
                                                      organism that is intended for use as a                  regulated article in the current                       pharmaceutical-producing plant in the
                                                      biological control (biocontrol) agent if                regulations in 7 CFR part 340. However,                field.
                                                      APHIS determines that it is a plant pest                under the provisions of this proposed                     Under TSCA, EPA has requirements
                                                      or noxious weed, with a limited                         rule, as discussed at greater length later             for new chemical substances, including
                                                      exception. Biocontrol involves the                      in this document, a GE plant that is                   industrial compounds produced in
                                                      reduction of plant pest and weed                        developed using a plant pest as a vector,              genetically engineered plants. However,
                                                      populations through the use of natural                  vector agent, or donor of genetic                      given existing APHIS oversight, EPA
                                                      enemies such as parasitoids, predators,                 materials would not necessarily be a                   does not currently have an oversight
                                                      pathogens, antagonists, or competitors                  regulated organism. Rather, the GE plant               program nor regulations for genetically
                                                      to suppress plant pest and weed                         would be a regulated organism if it had                engineered plants with industrial
                                                      populations.                                            a plant/trait combination that the                     compounds.
                                                         The exception would be for GE                        Agency has not yet evaluated for plant                    A gap in Federal oversight of PMPI
                                                      vertebrate biocontrol agents. Although                  pest and/or noxious weed risk, if it has               producing-plants could result in the
                                                      such organisms could fall within the                    received DNA from a taxon that                         intentional or inadvertent introduction
                                                      scope of the PPA’s definition of plant                  contains plant pests and the DNA from                  into the human or animal food supply
                                                      pest, particularly if they are herbivores,              the donor organism is sufficient to                    of unevaluated pharmaceutical or
                                                      it is long-standing APHIS policy not to                 produce an infectious entity capable of                industrial PMPI products, even when
                                                      regulate vertebrates as plant pests. This               causing plant disease or encodes a                     the principal purpose of the plants is
                                                      policy is discussed later in this                       compound known to be pathogenesis-                     not for human or animal food use. For
                                                      document.                                               related that is expected to cause plant                example, a company could self-
                                                                                                              disease symptoms, or if it was evaluated               determine that the PMPI produced by
                                                      Regulation of Plants That Produce Plant-                                                                       the plant was generally recognized as
                                                                                                              and found to represent plant pest or
                                                      Made Industrials and Pharmaceuticals                                                                           safe (GRAS), and therefore conclude it
                                                                                                              noxious weed risks. Additionally,
                                                         APHIS recognizes that certain plants                 APHIS’ evaluations of GE plants for                    had no legal obligation to keep surplus
                                                      are genetically engineered in order to                  plant pest or noxious weed risk would                  PMPI-producing plants out of the
                                                      produce pharmaceutical and industrial                   generally not require data from outdoor                human or animal food supply, to keep
                                                      compounds, also known as plant-made                     plantings.                                             such PMPI-producing plants from
                                                      pharmaceuticals and industrials                           Even if the plant represents a new                   spreading pollen to plants grown for
                                                      (PMPIs).                                                plant/trait combination not previously                 human and animal food purposes, or
                                                         When plants are genetically                          reviewed, there is a likelihood that                   even to notify any Federal agency that
                                                      engineered in such a manner, the plants                 most, if not all, GE PMPI-producing                    they were planting such crops. In
                                                      and the pharmaceutical and/or                           plants that are currently under APHIS                  addition to potential food safety risks
                                                      industrial products they produce may                    permits could be determined not                        posed by such plants should they enter
                                                      fall within the purview of multiple                     regulated under the provisions of the                  the food supply, a gap in Federal
                                                      regulatory Agencies: APHIS, EPA, and/                   proposed regulations after a regulatory                oversight could generate concerns from
                                                      or FDA.                                                 status evaluation because they do not                  the general public regarding the safety
                                                         Under the current regulations in 7                   represent risks as a plant pest or                     and wholesomeness of the human or
                                                      CFR part 340, APHIS requires permits,                   noxious weed. Thus, such plants could                  animal food supply, which could
                                                      as opposed to Notifications, for the                    be grown outdoors without the need for                 adversely impact agricultural interests.
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      environmental release of all GE plants                  permits and without APHIS oversight.                      APHIS has identified several options
                                                      that meet the definition of a regulated                   Federal oversight of outdoor plantings               that have the potential for adequate
                                                      article and produce PMPIs. APHIS                        of PMPI-producing plants, however,                     Federal oversight of outdoor plantings
                                                      exercises oversight of all outdoor                      could be necessary to prevent unlawful                 of plants engineered to produce PMPIs.
                                                      plantings of these regulated PMPI-                      entry into the food supply of material                 Under one option, a statute would be
                                                      producing plants. This oversight                        from such plants. Establishing growing                 enacted, or existing statutory authority
                                                      includes establishment of appropriate                   and handling conditions to confine such                amended, to grant one or more Federal
                                                      environmental release conditions,                       plants, and inspecting to ensure such                  agencies explicit authority to provide
                                                      inspections, and monitoring. Products                   conditions are followed, may enable                    oversight of outdoor plantings of all GE


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                            7013

                                                      PMPI-producing plants and to evaluate                   Under the proposed rule, APHIS would                   oversee small-scale testing of PIPs and
                                                      GE PMPI-producing plants for all                        only require permits for PIPs planted on               issue regulations if warranted. APHIS is
                                                      possible risks, beyond plant pest and                   10 acres or less if they present a plant               fully committed to coordinating with
                                                      noxious weed risks. For industrial-                     pest or noxious weed risk or have not                  EPA in this matter in order to give EPA
                                                      producing plants subject to EPA’s                       yet been evaluated by APHIS for such                   sufficient time to stand up such a
                                                      jurisdiction, a second option is for EPA                risk. Under the current regulations in 7               program. APHIS understands that an
                                                      to develop a program to regulate                        CFR part 340, APHIS requires permits or                MOU and services agreement may be
                                                      industrial-producing plants and issue                   notifications for the environmental                    necessary to provide personnel and
                                                      regulations if warranted. Under a third                 release of all GE plants that meet the                 other resources to assist EPA during the
                                                      option, APHIS would enter into a                        definition of a regulated article and                  interim period while EPA implements
                                                      memorandum of understanding (MOU)                       produce PIPs. APHIS exercises oversight                its own program of oversight for the
                                                      and services agreement with the                         of all outdoor plantings of these                      oversight of outdoor planting of PIPs 10
                                                      appropriate Federal Agencies to provide                 regulated PIP-producing plants. This                   acres or less.
                                                      personnel and other resources to assist                 oversight includes establishment of                       APHIS recognizes that there are
                                                      those Agencies in their oversight of                    appropriate environmental release                      challenges associated with such a
                                                      outdoor plantings of PMPI-producing                     conditions, inspections, and monitoring.               transition that would also require EPA
                                                      GE plants, recognizing that Federal                        To date, PIP-producing GE plants                    to incur the costs associated with setting
                                                      agencies may not have authority to                      regulated by APHIS have been                           up a revised regulatory program.
                                                      require notification and/or oversight of                genetically engineered using a plant                   Further, such a transition would require
                                                      the outdoor planting of some of these                   pest as the donor, vector, or vector                   policies, procedures, and guidance
                                                      plants. Under a fourth option, those                    agent, and thus fall under the scope of                regarding APHIS’ interaction with EPA.
                                                      Federal Agencies would supply their                     regulated article in the current                       APHIS does not consider the approach
                                                      own personnel and resources to exercise                 regulations in 7 CFR part 340. However,                listed above necessarily to be
                                                      oversight of outdoor plantings of PMPI-                 under the provisions of this proposed                  exhaustive. Rather, APHIS puts it
                                                      producing GE plants, recognizing that                   rule, as discussed at greater length later             forward to indicate that the Agency is
                                                      Federal agencies may not have authority                 in this document, a GE plant that is                   aware of the implications of this rule
                                                      to require notification and/or oversight                developed using a plant pest as a vector,              with regard to small-scale testing of PIPs
                                                      of the outdoor planting of some of these                vector agent, or donor of genetic                      and to request specific public comment
                                                      plants.                                                 materials would not necessarily be a                   regarding the best manner to address
                                                        APHIS recognizes that there are                       regulated organism. Rather, the GE plant               this issue.
                                                      challenges associated with each of these                would be a regulated organism if it had
                                                                                                                                                                     Herbicide Resistant GE Crops and
                                                      options. For example, the first option                  a plant/trait combination that the
                                                                                                                                                                     Herbicides—Synchronous Decisions
                                                      would require legislation to be enacted,                Agency has not yet evaluated for plant
                                                                                                                                                                     With EPA
                                                      which is not within the purview of the                  pest and/or noxious weed risk, or if it
                                                      Executive Branch of the Federal                         has received DNA from a taxon that                        Certain plants are genetically
                                                      government. Additionally, all options                   contains plant pests and the DNA from                  engineered to make them resistant to
                                                      could require Federal Agencies to incur                 the donor organism is sufficient to                    herbicides. EPA registers the herbicide
                                                      the costs associated with setting up new                produce an infectious entity capable of                products used on herbicide resistant
                                                      regulatory programs. The second option                  causing plant disease or that encodes a                crops, but does not regulate herbicide-
                                                      would require time for EPA to stand up                  compound known to be pathogenesis-                     resistant crops themselves. APHIS has
                                                      a genetically engineered industrial-                    related that is expected to cause plant                evaluated and deregulate many GE
                                                      producing plant oversight program for                   disease symptoms. Additionally,                        herbicide resistant plants. To date, the
                                                      plants subject to EPA jurisdiction. The                 APHIS’ evaluations of GE plants for                    herbicide-resistant GE plants regulated
                                                      third option, in turn, would require                    plant pest or noxious weed risk would                  by APHIS have been genetically
                                                      policies, procedures, and guidance                      generally not require data from outdoor                engineered using a plant pest as the
                                                      regarding APHIS’ interaction with other                 plantings.                                             donor, vector, or vector agent, and thus
                                                      Federal Agencies to be developed prior                     Even if the plant represents a new                  fall under the scope of regulated article
                                                      to implementation. To that end, it is                   plant/trait combination not previously                 in the current regulations in 7 CFR part
                                                      important to note that APHIS does not                   reviewed, there is a likelihood that                   340. However, under the provisions of
                                                      prefer any of these options over the                    many GE PIP-producing plants that are                  this proposed rule, as discussed at
                                                      other, nor does the Agency consider the                 currently regulated under APHIS                        greater length later in this document, a
                                                      options listed above necessarily to be                  permits or notifications could be                      GE plant that is developed using a plant
                                                      exhaustive. Rather, we put them                         determined not regulated under the                     pest as a vector, vector agent, or donor
                                                      forward to indicate that the Agency is                  provisions of the proposed regulations                 of genetic materials would not
                                                      aware of the implications of this rule                  after a regulatory status evaluation                   necessarily be a regulated organism.
                                                      with regard to PMPIs, and to request                    because they do not represent risks as a               Rather, the GE plant would be a
                                                      specific public comment regarding the                   plant pest or noxious weed. Thus, such                 regulated organism if it had a plant/trait
                                                      best manner to address this issue.                      plants could be grown outdoors without                 combination that the Agency has not yet
                                                                                                              the need for an APHIS permit and                       evaluated for plant pest and/or noxious
                                                      Plant-Incorporated Protectant Small-                    without undergoing APHIS oversight.                    weed risk, or if it has received DNA
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                                                      Scale Field Testing                                        APHIS understands that this proposal                from a taxon that contains plant pests
                                                        Certain plants are genetically                        would shift Federal oversight of small-                and the DNA from the donor organism
                                                      engineered to produce plant-                            scale (10 acres or less) outdoor plantings             is sufficient to produce an infectious
                                                      incorporated protectants (PIPs),                        of PIPs to EPA. EPA may decide to                      entity capable of causing plant disease
                                                      meaning that they produce pesticides.                   require experimental use permits (EUP)                 or that encodes a compound known to
                                                      PIPs fall under the regulatory oversight                for all, some, or none of such PIPs, and               be pathogenesis-related that is expected
                                                      of EPA. However, currently only APHIS                   may conduct inspections of all, some, or               to cause plant disease symptoms, or has
                                                      exercises regulatory oversight of PIP                   none of those PIPs under permit. EPA                   been evaluated by APHIS in accordance
                                                      plantings on 10 acres or less of land.                  would need to develop a program to                     with and determined to pose a risk as


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                                                      7014                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      a plant pest or noxious weed.                           APHIS determines that the herbicide                    Branch of the Federal government.
                                                      Additionally, APHIS’ evaluations of GE                  resistant plant is not a risk as a plant               However, APHIS puts them forward to
                                                      plants for plant pest or noxious weed                   pest or noxious weed, APHIS does not                   indicate that the Agency is aware that
                                                      risk would generally not require data                   have the authority in the PPA to require               asynchronous timing of the deregulation
                                                      from outdoor plantings.                                 permits with regulatory controls for the               of herbicide-resistant plants and the
                                                         Even if the plant represents a new                   movement and outdoor planting of that                  associated herbicide registrations can
                                                      plant/trait combination not previously                  herbicide tolerant plant during those                  lead to significant problems, and to
                                                      reviewed, there is a likelihood that                    subsequent years. Nor is it within                     request specific public comment
                                                      many GE herbicide-resistant plants that                 APHIS authority for APHIS to withhold                  regarding the best manner to address
                                                      are currently regulated under APHIS                     making a regulatory status evaluation                  this issue.
                                                      permits or notifications could be                       decision for several years and requiring
                                                      determined not regulated under the                                                                             An Overview of Our Proposed
                                                                                                              permits for field testing during that
                                                      provisions of the proposed regulations                                                                         Regulatory Structure
                                                                                                              time. The issue has not been the illegal
                                                      after a regulatory status evaluation                    use of pesticide during the field testing                 Before discussing the specifics of
                                                      because they do not represent risks as a                of herbicide resistant crops by                        these proposed revisions, APHIS wishes
                                                      plant pest or noxious weed. Thus, such                  developers but instead is the illegal use              to provide an overview of how the
                                                      plants could be grown outdoors without                  of pesticide by farmers on seed that has               Agency generally envisions the various
                                                      the need for permits and without APHIS                  been deregulated by APHIS and is                       sections of the proposed rule
                                                      oversight.                                              commercially available before the                      interacting, from the perspective of a
                                                         Commenters to the proposed update                    commercial availability of the herbicide               developer of a GE organism. This
                                                      to the Coordinated Framework on the                     designed for those crops. One option to                overview assumes that the organism
                                                      Regulation of Biotechnology published                   address this coordination would be to                  falls within the scope of our proposed
                                                      on September 22, 2016 (81 FR 65414–                     enact a new statute or amend an existing               definition of GE organism, and is a
                                                      65415), expressed the need for                          statute to make it illegal to sell seeds for           regulated organism under proposed
                                                      coordination between USDA and EPA                       herbicide resistant crops before the                   § 340.0.
                                                      regarding the timing of deregulation/                   registrations were completed for use on                   Until such time as the developer
                                                      determination of nonregulated status of                 those crops. Another option might                      wishes to import the organism, move it
                                                      herbicide-resistant crops and the                       involve a voluntary agreement by seed                  interstate, or release it into the
                                                      registration of herbicides. APHIS                       developers to withhold selling seed of                 environment, no action would be
                                                      recognizes that the asynchronous timing                 herbicide-resistant crops until EPA                    required of the developer. However, if
                                                      of the deregulation of herbicide-                       registrations are completed for the                    the developer believes that it possesses
                                                      resistant plants and the associated                     herbicide products designed for those                  sufficient information to demonstrate
                                                      herbicide registration has led to
                                                                                                              crops. In cases where APHIS makes a                    that the organism presents no plant pest
                                                      situations where a developer could sell
                                                                                                              decision deregulating an herbicide-                    or noxious weed risk, and wished to
                                                      the herbicide-resistant plant/seed
                                                                                                              resistant crop or determines under                     release it into the environment, it would
                                                      without waiting for the associated
                                                                                                              § 340.4 that an herbicide-resistant crop               have to submit this information to
                                                      herbicide registration. In such a
                                                                                                              is unlikely to pose a risk as a plant pest             APHIS and request that APHIS conduct
                                                      situation, farmers may be tempted to
                                                                                                              and/or noxious weed and will no longer                 an evaluation of such risk. The process
                                                      illegally use an unregistered herbicide
                                                                                                              be a regulated organism and no                         for submitting such a request, as well as
                                                      on a crop.
                                                         In light of the challenges associated                herbicide product has been registered by               the possibilities for how APHIS would
                                                      with the asynchronous regulatory                        EPA for use on that herbicide-resistant                act on that request, is set forth in
                                                      actions on the part of APHIS and EPA,                   crop, APHIS would indicate on the                      proposed § 340.4.
                                                      APHIS will work with EPA to explore                     APHIS Regulatory Status List Web site                     If APHIS evaluates the GE organism in
                                                      possible solutions to better coordinate                 and Web sites associated with                          accordance with § 340.4 and determines
                                                      the commercial availability of seed for                 deregulation decisions that no herbicide               that it is unlikely to pose a risk as a
                                                      herbicide resistant crops concomitant                   product is registered bv EPA for use on                plant pest and/or noxious weed, it
                                                      with the registration of herbicides                     this herbicide-resistant crop and it is                would no longer be a regulated
                                                      intended to be used on those crops.                     illegal to use any herbicide product on                organism and may be imported, moved
                                                      Furthermore, APHIS intends to limit the                 these crops unless registered by EPA for               interstate, or released into the
                                                      scope of its decisions to be on an                      such use. Additionally, APHIS would                    environment without further restriction
                                                      individual/specific herbicide resistant                 include language in deregulation                       under the proposed regulations. APHIS
                                                      crop basis (e.g., glyphosate resistant                  decision letters sent to the developer                 would maintain a list of such organisms
                                                      cotton) so that the EPA and APHIS are                   and Federal Register notices associated                on a Web site. If new information is
                                                      making decisions on the same specific                   with § 340.4 final determinations                      obtained which indicates that a
                                                      herbicide resistant crop/herbicide                      indicating it is illegal to use herbicides             previously deregulated GE organism
                                                      combinations. This coordination                         on these crops until the herbicide                     may present a plant pest and/or noxious
                                                      presents challenges because once APHIS                  product is registered by EPA for use on                weed risk, APHIS may reevaluate the GE
                                                      determines a GE organism does not                       the herbicide-resistant crop. This                     organism and reconsider its regulatory
                                                      represent a risk as a plant pest or                     decision letter and all other information              decision.
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                                                      noxious weed, APHIS cannot continue                     regarding APHIS’s decisions would also                    If the organism is still a regulated
                                                      to regulate the GE organism or delay                    be made available to the public on the                 organism following such an evaluation,
                                                      announcing the regulatory status                        APHIS Web site.                                        with one, limited exception (the
                                                      determination. When APHIS receives a                       APHIS does not consider the                         interstate movement of GE Arabidopsis
                                                      request for regulatory status                           approaches listed above necessarily to                 thaliana under certain conditions,
                                                      determination of an herbicide resistant                 be exhaustive and recognizes that one of               which APHIS discusses later in this
                                                      crop, it is likely to be three or more                  the options listed would require                       document) the developer would need to
                                                      years before a developer is ready to                    legislation to be enacted, which is not                obtain a permit for its importation,
                                                      undergo registration review at EPA. If                  within the purview of the Executive                    interstate movement, or environmental


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                                       7015

                                                      release. APHIS’ proposed permitting                     noxious weed risk and provide guidance                 use of chemical- or radiation-based
                                                      process is set forth in § 340.3.                        on their regulatory status.                            mutagenesis.5
                                                        If APHIS issues a permit to the                          By genetic engineering, APHIS would                    • The genetic modification to the
                                                      developer for the importation, interstate               mean techniques that use recombinant                   organism is solely introducing only
                                                      movement, or release into the                           or synthetic nucleic acids with the                    naturally occurring nucleic acid
                                                      environment of the organism, the                        intent to create or alter a genome.                    sequences from a sexually compatible
                                                      developer would have to comply with                     APHIS considers synthetic nucleic acids                relative that could otherwise cross with
                                                      permitting conditions regarding such                    to be nucleic acid molecules that are                  the recipient organism and produce
                                                      importation, interstate movement, or                    chemically or by other means                           viable progeny through traditional
                                                      release into the environment. The                       synthesized or amplified, including                    breeding (including, but not limited to,
                                                      developer would also have to comply                     those that are chemically or otherwise                 marker-assisted breeding, as well as
                                                      with container and shipment                             modified but can base pair with                        tissue culture and protoplast, cell, or
                                                      requirements that pertain to the                        naturally occurring nucleic acid                       embryo fusion).
                                                      movement of regulated organisms.                        molecules.                                                • The organism is a ‘‘null segregant.’’
                                                      These requirements would also be set                       APHIS would exclude from the                           APHIS would exclude the first two
                                                      forth in § 340.3.                                       definition of genetic engineering                      types of organisms from the definition
                                                                                                              traditional breeding techniques                        of GE organism for three reasons. First,
                                                        The developer would also have to
                                                                                                              (including, but not limited to, marker-                as mentioned above, it would do so
                                                      retain certain records regarding
                                                                                                              assisted breeding, as well as tissue                   because the organisms could otherwise
                                                      permitted activities. These are set forth
                                                                                                              culture and protoplast, cell, or embryo                have been produced from practices that
                                                      in proposed § 340.5. Failure to retain
                                                                                                              fusion) or chemical or radiation-based                 APHIS is proposing to exclude from the
                                                      such records, or comply with other
                                                                                                              mutagenesis. APHIS would do so                         definition of genetic engineering.
                                                      regulatory requirements or permitting
                                                                                                              because the Agency has never                           Genetic engineering is often used
                                                      conditions, could result in enforcement
                                                                                                              considered such techniques to                          instead of traditional breeding practices,
                                                      activities. These would also be set forth
                                                                                                              constitute genetic engineering.                        including chemical or radiation-based
                                                      in § 340.5.                                                                                                    mutagenesis, in order to expedite
                                                        If, in the course of interacting with                 Accordingly, organisms created through
                                                                                                                                                                     development of an organism with a
                                                      APHIS, the developer had to provide the                 such techniques are currently excluded
                                                                                                                                                                     desired genotype and/or phenotype.
                                                      Agency with confidential business                       from regulation under 7 CFR part 340,                     Examples from the realm of GE plants
                                                      information (CBI), the developer could                  and would continue to be so excluded.                  illustrate these practices. Chemical and
                                                      denote such CBI in accordance with                         For the purposes of proposed 7 CFR                  radiation-based mutagenesis creates
                                                      § 340.6.                                                part 340, APHIS would define GE                        thousands of mutations in a single
                                                        Finally, § 340.7 would provide the                    organism as an organism developed                      organism, and most of the plant
                                                      developer with information regarding                    using genetic engineering. Thus, if an                 breeders’ subsequent efforts involve
                                                      APHIS policy related to costs and                       organism is created using techniques                   eliminating unwanted mutations by
                                                      charges incident to compliance with the                 that do not fall within the scope of                   repeated crosses and selection, each of
                                                      regulations.                                            genetic engineering, the organism itself               which can take months to years to
                                                        This is, again, a general overview of                 would not fall within the scope of GE                  complete. Conversely, using genetic
                                                      the proposed regulations. As such, it                   organism. APHIS would also exclude,                    engineering, single base pair
                                                      does not attempt to capture every                       from its definition of GE organism,                    substitutions, as well as deletions of
                                                      nuance of the proposed regulations, nor                 certain organisms that are created using               differing sizes, can be precisely
                                                      does it apply to every scenario that may                techniques that fall within the scope of               administered very quickly, avoiding this
                                                      occur under those regulations.                          genetic engineering, but that could                    lengthy process of eliminating
                                                        What follows is a more in-depth                       otherwise have been produced using                     unwanted mutations. The resulting
                                                      discussion of the provisions of the rule.               traditional breeding techniques or                     organism, however, remains identical to
                                                                                                              chemical or radiation-based                            one that could otherwise have been
                                                      What Constitutes a Genetically                          mutagenesis. Such organisms are                        developed using chemical or radiation-
                                                      Engineered Organism Under the                           essentially identical, despite the method              based mutagenesis.
                                                      Proposed Regulations                                    of creation, because while there may be                   Similarly, traditional breeding
                                                        While APHIS discusses most of its                     small genetic differences, those                       techniques may require many
                                                      proposed definitions later in this                      differences are not phenotypically                     generations of crossing to introduce a
                                                      document, the Agency considers it                       observable and these types of changes                  naturally occurring trait. For example, it
                                                      necessary, at the outset of discussion of               occur naturally in all organisms. APHIS                can take decades to introduce a disease-
                                                      the provisions of the proposed rule, to                 would also exclude ‘‘null segregants,’’                resistant trait to apples through
                                                      discuss two of its proposed definitions,                that is, the progeny of a GE organism                  traditional breeding techniques.
                                                      for the terms genetic engineering and                   where the only genetic modification was                However, genetic engineering can
                                                      genetically engineered (GE) organism.                   the insertion of donor nucleic acid into               introduce the same trait in a fraction of
                                                      This is because the proposed regulations                the recipient’s genome, but the donor                  the time while maintaining all other
                                                      would not apply to organisms that are                   nucleic acid is not passed to the                      cultivar characteristics of the apple.
                                                      created using techniques that APHIS                     recipient organism’s progeny and the                      The second reason for the exclusions
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                                                      does not consider to constitute genetic                 donor nucleic acid has not altered the                 is that GE plants as a class, which
                                                      engineering or that fall outside the scope              DNA sequence of the progeny.                           constitute the vast preponderance of GE
                                                      of GE organism. Such organisms, which                   Specifically, for purposes of the revised              organisms to date, pose no greater plant
                                                      would not be regulated by APHIS under                   regulations, an organism would not be                  pest or noxious weed risk than their
                                                      7 CFR part 340, would not be expected                   considered a GE organism if:
                                                      to come to APHIS for evaluation.                           • The genetic modification to the                     5 A single base pair substitution is the most

                                                                                                              organism is solely a deletion of any size              common type of substitution induced by chemical
                                                      However, if such organisms are                                                                                 mutagenesis or natural variation and, therefore,
                                                      submitted to APHIS, APHIS would                         or a single base pair substitution which               most similar to the type of genetic variation that is
                                                      evaluate them for plant pest and/or                     could otherwise be obtained through the                possible through conventional breeding.



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                                                      7016                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      counterparts developed through                          these reasons, farmers and developers                  capable of conferring the new properties
                                                      traditional breeding techniques or                      have long bred out unwanted                            could not be achieved through
                                                      chemical or radiation-based                             phenotypic traits that arise as the result             traditional breeding techniques,
                                                      mutagenesis. Moreover, it is both                       of traditional breeding techniques and/                including chemical or radiation-based
                                                      impracticable and unnecessary to                        or chemical or radiation-based                         mutagenesis. However, it can be
                                                      regulate plants created through                         mutagenesis, and planted and/or                        envisioned that plant pests might be
                                                      traditional breeding techniques or                      commercialized the most                                altered in such a way that the exclusion
                                                      chemical or radiation-based                             phenotypically desirable plant                         would apply. In these cases, since the
                                                      mutagenesis for plant pest or noxious                   produced using such techniques.                        resulting plant pest would not be
                                                      weed risk.                                                 In this regard, it is important to note             defined as a genetically engineered
                                                         This is not to say that plants with                  that genetic engineering is used to create             organism under 7 CFR part 340, they
                                                      undesirable phenotypes have never                       this phenotypically desirable organism,                would be regulated, if needed, under
                                                      been bred through traditional breeding,                 rather than the other products created                 APHIS’s plant pest regulations in7 CFR
                                                      or chemical or radiation-based                          through traditional breeding techniques,               part 330. This is appropriate since these
                                                      mutagenesis never result it mutations                   including chemical or radiation-based                  organisms are biologically analogous to
                                                      that are undesirable. Indeed, as                        mutagenesis. In 1987, the Council of the               non-GE plant pests with mutations. It is
                                                      mentioned above, chemical and                           National Academy of Sciences                           important to note that, to date, we have
                                                      radiation-based mutagenesis tend to                     concluded that there is no evidence of                 not encountered GE organisms of this
                                                      create thousands of mutations in an                     a unique risk inherent in the use of                   type and that the GE plant pests that we
                                                      organism, most of which are                             recombinant DNA techniques or the                      do have experience with (e.g., pink
                                                      undesirable.                                            movement of genes between unrelated                    bollworm expressing marker genes,
                                                         However, traditional breeding                        organisms. This means that risks                       citrus tristeza virus expressing
                                                      techniques, in the form of deliberate                   associated with the introduction of                    antimicrobial compounds) would still
                                                      selection and breeding of those plants                  recombinant DNA engineered organisms                   be regulated under 7 CFR part 340 since
                                                      with desirable phenotypes, have been                    are the same as those associated with                  this exclusion would not apply. The two
                                                      used since the advent of sedentary                      non-genetically engineered organisms                   APHIS program areas responsible for
                                                      agriculture, and nearly every                           and organisms modified by other                        regulating under 7 CFR parts 330 and
                                                      domesticated crop has, at one point,                    methods and that the assessment of                     340 are coordinating to ensure that
                                                      been subject to traditional breeding                    such risks should be based on the nature               together they are prepared to regulate
                                                      techniques. Chemical and radiation-                     of the organism and the environment                    any type of plant pest as needed.
                                                      based mutagenesis, in turn, have been                   into which it is introduced rather than                   However, APHIS has prepared a
                                                      used for nearly a century in the                        the methods by which it was produced.                  proposed rule that would remove this
                                                      development of thousands of                             Furthermore, this same conclusion is a                 exception. In its place, all plant pests
                                                      commodities, including such                             basis of the Coordinated Framework that                would require permits issued pursuant
                                                      commercial commodities as ruby red                      regulation should be based on the risks                to part 330, unless the importation,
                                                      grapefruit and many commercial                          of the organism and not the process                    interstate movement, or environmental
                                                      varieties of wheat and rice. If APHIS                   used to create it. Accordingly, because                release of the organism is explicitly
                                                      were to regulate organisms developed                    the plant pest and noxious weed risk                   authorized in other APHIS regulations
                                                      through traditional breeding techniques                 posed by the plant is equivalent,                      in 7 CFR. Under APHIS’ proposed
                                                      or chemical or radiation-based                          regardless of whether it was created                   revision to the regulations in part 340,
                                                      mutagenesis, that would entail the                      through genetic engineering or                         the importation, interstate movement, or
                                                      regulation, at least provisionally, of                  traditional breeding (including chemical               environmental release of GE organisms
                                                      almost every commercially available                     or radiation-based mutagenesis), and                   that could have otherwise been
                                                      human or animal food crop. This is                      such risk is likely to be low because of               developed through traditional breeding
                                                      impracticable.                                          the purpose of applying traditional                    techniques or chemical or radiation-
                                                         Such regulations would also fail to                  breeding techniques, including                         based mutagenesis would not be
                                                      take into consideration the usual                       chemical or radiation-based                            explicitly authorized; rather, such
                                                      purpose of applying traditional breeding                mutagenesis to a plant,, APHIS is                      organisms would be exempted from the
                                                      techniques or chemical or radiation-                    proposing to exclude GE plants that                    regulations in part 340, with no
                                                      based mutagenesis to a plant: To                        could have otherwise been developed                    reference to the conditions for
                                                      introduce desirable phenotypic traits                   through traditional breeding techniques,               movement or environmental release of
                                                      into the organism or remove                             including chemical or radiation-based                  such organisms. Accordingly, GE
                                                      phenotypically undesirable traits from                  mutagenesis, from the definition of                    organisms that could have otherwise
                                                      the organism. Additionally, it would fail               ‘‘genetically engineered organism’’ and                been created through traditional
                                                      to take into adequate consideration that                hence from regulation under the revised                breeding techniques, including
                                                      phenotypic traits that could increase the               7 CFR part 340.                                        chemical or irradiation-based
                                                      plant pest or noxious weed risk posed                      This same exclusion would apply to                  mutagenesis, and could pose a potential
                                                      by a plant tend to also adversely impact                non-plant organisms. Non-plant                         plant pest risk, would now be subject to
                                                      its vitality, uniformity, or commercial                 organisms, which fall under the scope of               7 CFR part 330.
                                                      viability. For example, a mutation                      the regulations as defined in § 340.0, are                This touches on several important
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                                                      caused by chemical or radiation-based                   either plant pests, or organisms which                 caveats with regard to the first two
                                                      mutagenesis could render a plant more                   have received genetic material sufficient              proposed exemptions from the
                                                      susceptible to certain viroids or                       to produce an infectious entity capable                definition of genetically engineered
                                                      pathogens and able to transfer this                     of causing plant disease or that encodes               organism. The first is that the
                                                      increased susceptibility to sexually                    a compound known to be pathogenesis-                   exemptions pertain only to 7 CFR part
                                                      compatible relatives, and thus increase                 related that is expected to cause plant                340. As noted above, an organism may
                                                      the plant pest risk associated with the                 disease symptoms. Organisms of the                     be exempted from regulation under 7
                                                      plant. However, it would also directly                  latter type would not qualify for the                  CFR part 340, and yet still subject to
                                                      adversely affect the plant’s vitality. For              exclusion, as receipt of genetic material              other APHIS regulations. The second


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                                      7017

                                                      caveat is that the proposed exemptions                  has not been altered by the early                      accordance with § 340.2 and met the
                                                      are based on APHIS’ statutory authority                 flowering gene. Because the DNA of the                 definition of plant pest in § 340.1. (As
                                                      under the PPA. They should therefore                    progeny is no different from the DNA of                § 340.2 currently does, proposed
                                                      be taken as a statement of one Agency’s                 the recipient organism prior to the use                § 340.2, which APHIS discusses below,
                                                      regulatory policy, rather than scientific               of genetic engineering, APHIS does not                 would specify that certain taxa are plant
                                                      findings regarding all possible risks                   consider the progeny to be GE                          pests or are known to contain plant
                                                      posed by such organisms. Accordingly,                   organisms for purposes of the proposed                 pests. Section 340.1 would contain
                                                      for organisms that APHIS determines to                  regulations.                                           definitions of terms used in the
                                                      present negligible plant pest or noxious                   APHIS requests specific comment on                  proposed regulations.)
                                                      weed risk, FDA and EPA may anticipate                   its definition of genetically engineered                  • The GE organism has received DNA
                                                      more substantial human or animal food                   organism, specifically the                             from any taxon listed in accordance
                                                      adulterant or pesticide risks, and                      appropriateness of the proposed                        with § 340.2, the DNA from the donor
                                                      therefore not reduce their oversight of                 exemptions, and whether commenters                     organism is sufficient to produce an
                                                      the same organisms.                                     can identify any scenarios in which they               infectious entity capable of causing
                                                         The third caveat is that APHIS is not                would exempt from APHIS regulation                     plant disease or encodes a compound
                                                      claiming that additions, deletions, and                 an organism that presents a plant pest                 known to be pathogenesis-related that is
                                                      substitutions to an organism’s genome                   and/or noxious weed risk. APHIS also                   expected to cause plant disease
                                                      are inherently risk-free. Indeed, as                    requests specific comment on whether                   symptoms, and the GE organism has not
                                                      discussed later in this document, the                   any other types of organisms should be                 been evaluated by APHIS for plant pest
                                                      addition into an organism’s genome of                   excluded from the definition of                        risk in accordance with § 340.4.
                                                      a sequence that encodes an infectious                   genetically engineered organism.                          • The GE organism is a plant that has
                                                      entity capable of causing plant disease                 Finally, APHIS is interested in whether                a plant and trait combination that has
                                                      or encodes a compound known to be                       the terms ‘‘traditional breeding                       not been evaluated by APHIS for plant
                                                      pathogenesis-related that is expected to                techniques’’ and ‘‘chemical or radiation-              pest and noxious weed risk in
                                                      cause plant disease symptoms                            based mutagenesis’’ should be defined,                 accordance with § 340.4 5; or
                                                      introduces plant pest risk into that                    and whether the exclusions themselves                     • The GE organism is any of the
                                                      organism, and would be one of APHIS’                    are sufficiently delineated.                           foregoing that has been evaluated by
                                                      criteria for regulating the organism                       APHIS wishes to point out that its                  APHIS in accordance with § 340.4 and
                                                      under the proposed regulations. Rather,                 proposed definition for genetically                    determined to pose a risk as a plant pest
                                                      APHIS considers such additions,                         engineered organism is limited to the                  or noxious weed, or is a GE organism
                                                      deletions, or substitutions to present an               regulations in 7 CFR part 340 and may                  that has otherwise been determined by
                                                      acceptable plant pest and/or noxious                    not reflect the definition of genetically              the Administrator to pose a risk as a
                                                      weed risk when they are used to create                  engineered organism that is in use by                  plant pest or noxious weed.
                                                      an organism that could otherwise have                   other Federal Agencies. Differences in                    The proposed criteria differ from the
                                                      been created through traditional                        definitions are, in part, attributable to              current criteria in several respects. First,
                                                      breeding techniques and/or chemical or                  the differences in the agencies’ statutory             the current criteria consider a GE
                                                      radiation-based mutagenesis; in other                   and regulatory authorities. Under the                  organism to be a regulated article if the
                                                      words, it is the product, rather than the               Coordinated Framework for the                          donor, vector, or vector agent is a plant
                                                      techniques used to derive the product,                  Regulation of Biotechnology, we intend                 pest. This reflects the concern in the
                                                      that APHIS considers to present an                      to work cooperatively with other                       1980s that if an organism was modified
                                                      acceptable level of risk. The Agency                    relevant agencies that may also be                     using genetic material taken from a
                                                      considers this to be consistent with the                considering their policies or approaches               plant pest, or a plant pest was used as
                                                      principles set forth in the Coordinated                 related to genome editing applications                 a vector or vector agent to carry genetic
                                                      Framework.                                              within their jurisdictions.                            material into an organism, the resulting
                                                         The third proposed exclusion is for
                                                                                                              General Restrictions and Scope (§ 340.0)               GE organism could also be a plant pest.
                                                      progeny of GE organisms where the only                                                                            Based on APHIS’ experience
                                                      genetic modification was the insertion                      Section 340.0 would set forth general              evaluating field trial data from
                                                      of donor nucleic acid into the                          restrictions regarding the movement and                thousands of permits that authorize
                                                      recipient’s genome, but the inserted                    environmental release of GE organisms,                 environmental release of regulated
                                                      donor nucleic acid is not passed to the                 as well as the scope of the revised                    organisms, as well as more than 150
                                                      recipient organism’s progeny and has                    regulations in part 340.                               petitions for nonregulated status, this
                                                      not altered the DNA sequence of the                         Paragraph (a) of § 340.0 would                     has not proven to be the case. Although
                                                      recipient organism’s progeny. Such                      provide that no person may move any                    a plant pest may contribute or vector
                                                      progeny are often referred to as null                   regulated GE organisms except in                       genes to a GE organism, this has not
                                                      segregants. Traits can sometimes be                     accordance with part 340. Movement of                  been shown in APHIS’ evaluation of
                                                      introduced by genetic engineering into                  regulated organisms that is not in                     data to cause that GE organism,
                                                      breeding lines to simplify breeding                     accordance with the part could present
                                                      without altering the DNA sequence of                                                                           particularly if it is a plant, to become a
                                                                                                              a risk of introducing or disseminating                 plant pest. Indeed, experience has
                                                      progeny; the traits can be eliminated                   plant pests and noxious weeds within
                                                      with a simple cross and are no longer                                                                          shown that the use of genes from donor
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                                                                              the United States.                                     organisms which are plant pests, as well
                                                      present in the final organism. An                           Paragraph (b) of § 340.0 would specify
                                                      example of use of such techniques to                                                                           as the use of vectors which are from
                                                                                                              the types of GE organisms APHIS would
                                                      facilitate traditional breeding would be                                                                       plant pests, has not resulted in plant
                                                                                                              consider to be regulated organisms
                                                      the introduction of certain genes into                                                                         pest risks of any sort in recipient
                                                                                                              under the revised regulations.
                                                      trees solely to reduce the time to                          Under our proposed regulations, a GE               organisms.
                                                      flowering, thereby speeding up a tree-                  organism would be a regulated organism                  5 As APHIS discusses below, APHIS would
                                                      breeding program. In this example, the                  if:                                                    maintain a list of plant and trait combinations that
                                                      progeny do not contain the early                            • Prior to genetic engineering, the GE             APHIS has evaluated for plant pest and noxious
                                                      flowering gene and their DNA sequence                   organism belonged to any taxon listed in               weed risk online if this rule is finalized.



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                                                      7018                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                         Rather, the most common use of plant                 the organism is able in itself to be                   determine that it presented no plant
                                                      pest components in genetic engineering                  expressed phenotypically or confers                    pest risk. The category was especially
                                                      involve either the use of a disarmed                    traits that meets the definition of plant              useful when a GE plant was developed
                                                      version of the plant pathogenic                         pest. In such instances, APHIS                         using novel genetic engineering
                                                      bacterium Agrobacterium tumefaciens                     considers it appropriate and prudent to                techniques.
                                                      to vector genes into a plant or use of                  regulate the GE organism until such                       In the 29 years since the current
                                                      genetic material from plant pest donors                 time as APHIS evaluates the risk it                    regulations were issued, APHIS’
                                                      which function as regulatory sequences                  poses as a plant pest in accordance with               evaluation of petitions for nonregulated
                                                      in the plant. Use of Agrobacterium                      proposed § 340.4, and thereafter to                    status for more than 150 GE plants has
                                                      tumefaciens as a vector of genetic                      regulate it only if APHIS determine it to              provided a basis to help the Agency
                                                      material does not leave viable bacteria                 pose a risk as a plant pest.                           delineate the plant and trait
                                                      behind in the recipient organism and                       Additionally, APHIS would no longer                 combinations that cause a GE organism
                                                      does not cause disease. Likewise,                       regulate a GE organism solely because                  to act as a plant pest from the
                                                      regulatory sequences such as the 35S                    its vector or vector agent is a plant pest.            combinations that pose no plant pest
                                                      promoter from Cauliflower Mosaic Virus                  APHIS adopted this approach in 1987                    risk.
                                                      and the nopaline synthase (nos)                         because the use of plant pest vectors in                  Accordingly, APHIS now considers
                                                      terminator from A. tumefaciens are                      recombinant DNA technologies was, at                   there to be two instances in which a GE
                                                      themselves unable to be expressed and                   the time, a relatively recent                          plant should be a regulated organism.
                                                      do not confer plant pest traits. Rather,                development, and there was a                           The first instance is when APHIS has
                                                      they facilitate the expression of other                 corresponding need to exercise                         reached a determination that the plant
                                                      genes in the GE organism. The use of                    precaution in regulating such use until                and trait combination associated with
                                                      plant pests in these ways either as                     the plant pest risk associated with the                the GE plant causes it to act as a plant
                                                      donors of regulatory sequences or for                   practice was further evaluated. In                     pest or noxious weed. APHIS is making
                                                      vectoring genetic material into a                       twenty-nine years of regulating GE                     a draft list of such combinations
                                                      recipient organism has a long history of                organisms because of the use a plant                   available along with this proposed rule,
                                                      safe use and does not result in disease                 pest as a vector or vector agent, APHIS                as well as a list of combinations that
                                                      or injury to the recipient organism.                    has no evidence that using genetic                     APHIS has determined to present no
                                                         It is conceivable that a donor                       material from plant pests as vectors or                plant pest or noxious weed risk,6 and
                                                      organism that is a plant pest could                     vector agents for other genetic material               APHIS invites public comment on these
                                                      result in a GE organism that is itself a                results in a GE organism that is itself a              draft lists. For purposes of this proposed
                                                      plant pest if (1) the DNA sequence that                 plant pest. Accordingly, this proposed                 rule, the lists would be maintained at
                                                      is encoded in the organism is able in                   rule would change APHIS’ approach,                     the following Web site: http://
                                                      itself to be expressed phenotypically or                and GE organisms that were created                     www.aphis.usda.gov/biotechnology/
                                                      confers plant pest traits, or (2) if the                using a plant pest as a vector or vector               2016-340-proposed-rule. If the rule is
                                                      inserted DNA enables the organism to                    agent would no longer be regulated                     finalized, APHIS would develop a
                                                      produce pathogenesis-related                            solely because of the use of such a                    different URL that would contain the
                                                      compounds, that is, compounds that are                  vector or vector agent. Instead, the                   lists, as well as all other information
                                                      typically produced by pathogens and                     organisms would be regulated if they                   regarding this rule, and that would
                                                      involved in producing disease                           themselves presented a known or                        indicate that the rule had been finalized.
                                                      symptoms. Examples of such                              unevaluated plant pest risk. This is in                   The second instance in which APHIS
                                                      compounds would include plant                           keeping with the overarching aim of this               would consider it necessary to regulate
                                                      degrading enzymes, plant growth                         proposed rule, which is to regulate the                a GE plant is when APHIS is presented
                                                      regulators, phytotoxins, or compounds                   products of genetic engineering, rather                with a GE plant with a novel plant and
                                                      that can clog plant vascular systems. In                than the methods by which those                        trait combination, and has not yet
                                                      either instance, APHIS would not                        products are developed.                                evaluated this plant and trait
                                                      expect phenotypic expression of plant                      A second difference from the current
                                                                                                                                                                     combination for its plant pest and
                                                      disease unless large portions of a                      criteria is that, for reasons discussed
                                                                                                                                                                     noxious weed risk.
                                                      genome from a plant pest were                           previously in this document, APHIS is
                                                                                                                                                                        On a related matter, APHIS
                                                      introduced to a recipient organism, a                   proposing that APHIS may regulate a GE
                                                                                                                                                                     acknowledges that a novel GE organism
                                                      practice that APHIS considers unlikely                  plant under 7 CFR part 340 if APHIS
                                                                                                                                                                     could be developed that does not fall
                                                      for developers to use based on their                    determines that it is a noxious weed.
                                                                                                                 Our proposed criteria would also                    into any of the Agency’s other categories
                                                      practices to date.                                                                                             of regulated organisms, but that APHIS
                                                         Likewise, based on APHIS’ evaluation                 attempt to clarify a current category of
                                                                                                              regulated articles, GE plants that are                 determines poses a risk as a plant pest
                                                      of field trial data to date, there is no
                                                                                                              regulated because the Administrator has                or noxious weed. APHIS’s last criteria
                                                      evidence that the use of plant pests as
                                                                                                              reason to believe they are a plant pest.               for regulated organisms would allow
                                                      vectors or vector agents in the
                                                                                                              When the current regulations were                      APHIS to regulate such an organism.
                                                      production of GE organisms results in a
                                                      GE organism that is itself a plant pest.                issued, APHIS had less experience                         6 APHIS encourages stakeholders to review these
                                                         Accordingly, APHIS would regulate                    regulating GE organisms, and there was                 lists and submit specific public comment regarding
                                                      GE organisms that have received DNA                     corresponding uncertainty regarding the
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                                                                                                                                     the listed plant/trait combinations. In particular,
                                                      from a taxon containing a plant pest                    degree to which subjecting a plant to                  while the vast majority of listed plant/trait
                                                      only if the DNA from the donor                          genetic engineering, without the use of                combinations correspond to specific organisms that
                                                                                                                                                                     have been granted nonregulated status under the
                                                      organism is sufficient to produce an                    a plant pest as a donor, vector, or vector             current regulations, the list would not be event-
                                                      infectious entity or encodes a                          agent, would cause the plant to become                 specific. This means that if a crop-trait combination
                                                      pathogenesis-related compound that is                   a plant pest. This category was intended               has nonregulated status on the list, all specific
                                                      expected to cause plant disease                         to allow APHIS to consider such plants                 events that have that crop-trait combination would
                                                                                                                                                                     be nonregulated. Practically speaking, this means
                                                      symptoms. By ‘‘sufficient to produce an                 to be regulated articles, until APHIS had              that the list would grant nonregulated status to
                                                      infectious entity,’’ APHIS means that                   sufficient information to classify it                  almost all GE corn and soybean that developers
                                                      the DNA sequence that is encoded in                     either definitively as a plant pest, or to             have brought to APHIS to date.



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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                            7019

                                                      Taxa That Are or Contain Plant Pests                    APHIS would not need to retain specific                organism submitted for evaluation.
                                                      (§ 340.2)                                               permitting exemptions for them in                      However, a determination that a taxon
                                                         As stated previously, § 340.2 contains               § 340.2.                                               is or contains a plant pest will be based
                                                                                                                 APHIS would also retain the                         on a review of scientific literature, and
                                                      a list of taxa that are considered to be
                                                                                                              exemption from interstate movement                     thus, CBI is not germane to our
                                                      plant pests. That list has not been
                                                                                                              permits for GE organism A. thaliana due                determination.
                                                      amended since it was established in
                                                                                                              to its historically exempted status. The                  Following the receipt of a petition to
                                                      1987.
                                                                                                              exemption would be contained in                        amend the list of organisms in § 340.2,
                                                         To improve regulatory flexibility and
                                                                                                              § 340.3.                                               APHIS would publish a notice
                                                      help ensure the list remains current,                      APHIS would propose changes to the                  announcing the availability of the
                                                      APHIS is proposing to remove the list of                list through publication of a Federal                  petition in the Federal Register and
                                                      taxa from § 340.2 and place it on the                   Register notice. The notice would state                solicit public comment on the petition
                                                      Internet at http://www.aphis.usda.gov/                  why APHIS has determined it necessary                  for 60 days. Following the close of the
                                                      biotechnology/2016-340-proposed-rule.                   to add or remove a taxon from the list,                comment period, the Administrator
                                                      APHIS would advise the public of                        and would request public comment.                      would announce his or her decision to
                                                      changes to the list through notices                        APHIS would review the comments                     either approve the petition in whole or
                                                      published in the Federal Register.                      received and publish its final decision                in part or deny the petition in a
                                                      These notices would request public                      in the Federal Register.                               subsequent Federal Register notice.
                                                      comment.                                                   The PPA also allows for a person to                    Finally, APHIS is proposing to add an
                                                         APHIS is not proposing any changes                   petition the Secretary to add or remove                appeals process in the event that the
                                                      to the listed taxa at this time, however.               a plant pest from the regulations.                     Administrator denies a request to
                                                         Per the definition of ‘‘plant pest’’ in              Currently, § 340.5 contains provisions                 amend the list of taxa that are described
                                                      the PPA, any organism belonging to any                  for petitioning the Administrator to                   in § 340.2. Any person whose petition
                                                      taxon contained within any listed genus                 amend the list of organisms in § 340.2                 has been denied would be able to appeal
                                                      or taxon is only considered to be a plant               by either adding or deleting any genus,                the decision in writing to the
                                                      pest if the organism ‘‘can directly or                  species, or subspecies. The list of                    Administrator within 30 days after
                                                      indirectly injure, or cause disease, or                 requirements for petitioning the                       receiving the written notification of the
                                                      damage in any plants or parts thereof, or               Administrator include formatting and                   denial. The appeal would have to state
                                                      any processed, manufactured, or other                   submission procedures that are                         all of the facts and reasons upon which
                                                      products of plants.’’ Thus a particular                 currently contained in § 340.5(b).                     the person relies to assert that the
                                                      unlisted species within a listed genus                     However, these procedures have not                  petition was wrongfully denied. The
                                                      would be deemed a plant pest if the                     been updated since 1994. While most of                 Administrator would then grant or deny
                                                      scientific evidence indicates that the                  the procedures are still accurate, some                the appeal, in writing, stating the
                                                      organism is a cause of direct or indirect               of them have changed. For example, the                 reasons for the decision as promptly as
                                                      injury, disease, or damage to any plants,               requirements do not consider the                       circumstances allow.
                                                      plant parts, or products of plants.                     potential for electronic submission of a
                                                         Section 7711 of the PPA generally                    petition via email. They also provide an               Notification
                                                      requires permits for the importation or                 obsolete address for postal submissions.                 The current regulations in § 340.3
                                                      interstate movement of plant pests, but                 Therefore, APHIS is proposing to                       provide criteria for a notification
                                                      allows the Secretary to create                          remove the specific requirements                       procedure whereby certain GE plants
                                                      ‘‘exceptions’’ to this general permitting               related to formatting and submission                   may be authorized for importation,
                                                      requirement when the Secretary deems                    procedures for petitions from the                      interstate movement, or environmental
                                                      that a permit is not necessary. That is,                regulations. The procedures would                      release in lieu of a permit. As
                                                      these regulated activities are allowed,                 instead be located on the Internet at                  mentioned previously in this document,
                                                      under certain conditions, without                       http://www.aphis.usda.gov/                             rather than using customized
                                                      seeking prior authorization via permit.                 biotechnology/2016-340-proposed-rule.                  requirements, like the permitting
                                                      The current APHIS regulations refer to                  APHIS is also proposing to revise the                  conditions used for the permitting
                                                      these PPA exceptions as ‘‘exemptions.’’                 submission procedure to allow petitions                procedure, the notification procedure
                                                      Paragraph (b) of current § 340.2 contains               to be submitted via email, and to update               uses performance-based standards that
                                                      a list of exemptions from the                           the address for postal submissions.                    are described in the regulations
                                                      requirement for a permit for the                           These changes would update the                      themselves. The use of the performance-
                                                      interstate movement of certain GE                       submission procedure, and allow for                    based standards that do not vary from
                                                      strains of the microorganisms                           greater flexibility in revising                        one notification to the next facilitates
                                                      Escherichia coli, Saccharomyces                         procedures, if, for example, the address               rapid administrative turnaround on
                                                      cerevisiae, and Bacillus subtilis, and the              for submissions changes in the future.                 notifications. However, in some ways,
                                                      plant Arabidopsis thaliana. One of the                     Please note that, regarding the                     the term ‘‘notification’’ has been
                                                      conditions for this exemption for the                   formatting procedures, APHIS is                        misleading to the public, since sending
                                                      listed microorganisms is that the cloned                proposing to retain a requirement that                 a notification does not mean automatic
                                                      material does not include the complete                  the petition not contain trade secrets or              authorization by APHIS.
                                                      infectious genome of a known plant                      CBI. APHIS often needs CBI for permit                    Rather, currently, APHIS reviews
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      pest.                                                   applications, particularly for those that              notifications to verify that the GE plants
                                                         Because, under § 340.0, APHIS must                   request the release of a GE organism into              meet the eligibility criteria and also
                                                      have determined that a GE                               the environment, in order to determine                 evaluates whether the proposed
                                                      microorganism is a plant pest in order                  the appropriate permitting conditions,                 importation, interstate movement, or
                                                      for it to be a regulated organism, the GE               and APHIS may need CBI as part of a                    environmental release can be done in a
                                                      microorganism strains mentioned above,                  regulatory status evaluation in                        manner that meets the performance-
                                                      which APHIS has evaluated and                           accordance with proposed § 340.4 in                    based standards described in the
                                                      determined to present no plant pest risk,               order to assess the plant pest and/or                  regulation. In many ways, these APHIS
                                                      would not be regulated organisms. Thus                  noxious weed risk associated with the                  evaluations for notifications are very


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                                                      7020                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      similar to those done for permit                        risk-appropriate oversight, better                     required for permit applications,
                                                      applications, but the notification                      regulatory enforcement, and improved                   standard permit conditions, and
                                                      procedure relies on applicants agreeing                 transparency if all regulated movements                administrative information (e.g., time
                                                      to meet the performance-based                           are authorized under the permitting                    frames, appeal procedure, etc.). Permits
                                                      standards described in the regulations                  procedure. Therefore, APHIS is                         include specific conditions that must be
                                                      rather than submitting an application                   proposing to remove current notification               followed by the permit holder. Standard
                                                      for APHIS review describing the specific                provisions from the regulations and                    permit conditions, or ‘‘general
                                                      measures they will employ for the                       require that all authorizations for                    conditions,’’ are listed in the current
                                                      activity (as is the case for permits). With             movement be conducted under permit.                    regulations and APHIS can supplement
                                                      permits, but not with notifications,                       As mentioned earlier in this                        these with additional conditions as
                                                      APHIS can accept the proposed                           document, the use of the permitting                    necessary. The current regulations
                                                      measures or add to them, and the result                 procedure in lieu of notifications is also             specify the amount of time that APHIS
                                                      is a set of binding customized permit                   necessary for APHIS to address some of                 is allotted for review of complete permit
                                                      conditions.                                             the recommendations arising from the                   applications: 60 days for permits for
                                                         Because the notification procedure                   OIG audits and the provisions of the                   importation and interstate movement;
                                                      uses only the performance-based                         2008 Farm Bill. Both the OIG audit and                 120 days for controlled outdoor use. The
                                                      standards in the regulations, it is more                the Farm Bill expressed concern with                   current regulations also outline
                                                      administratively streamlined, but the                   the use of performance-based standards                 requirements for protecting CBI when
                                                      general nature of the standards has                     to regulate field tests of regulated                   submitting a permit application.
                                                      made it difficult for APHIS inspectors to               organisms, and recommended that                           APHIS proposes to reorganize the
                                                      determine if a notification holder is in                APHIS amend the regulations to                         regulations to improve the clarity of the
                                                      compliance with the standards. This, in                 exercise greater oversight and                         permit application and evaluation
                                                      turn, can also make enforcement more                    enforcement of such field tests and to                 procedures. In addition, APHIS is
                                                      difficult.                                              require more extensive reporting and                   proposing changes to the regulations to
                                                         For example, under the current                       record retention regarding such tests.                 reflect certain provisions of the 2008
                                                      regulations, one of the performance-                    These requirements can be added to a                   Farm Bill. As APHIS mentioned
                                                      based standards for notifications                       permit as permitting conditions, but do                previously in this document, section
                                                      relevant to controlled outdoor uses                     not lend themselves to performance-                    10204 of Title X of the Farm Bill
                                                      states that: ‘‘The field trial must be                  based standards. Some permit                           requires the Secretary of Agriculture to
                                                      conducted such that (1) the regulated                   conditions, however, are, and have                     take action on each issue identified in
                                                      article will not persist in the                         always been, performance-based. APHIS                  the document entitled ‘‘Lessons Learned
                                                      environment, and (2) no offspring can                   acknowledges that there is more than                   and Revisions under Consideration for
                                                      be produced that could persist in the                   one way to manage risks and works with                 APHIS’ Biotechnology Framework’’ and,
                                                      environment.’’ Conversely, conditions                   the permit applicant to find a mutually                where appropriate, promulgate
                                                      which APHIS places on permits are                       acceptable way to do so. In some                       regulations.
                                                      more specific, and do not rely as much                  instances, permit conditions may allow                    APHIS is proposing certain regulatory
                                                      on subjective determinations by APHIS                   for the flexibility inherent in                        changes concerning permit application
                                                      personnel. A specific permit condition                  performance standards, while ensuring                  information requirements, permit
                                                      that could be used to address just part                 a specific requirement is addressed,                   conditions, records, and reports that
                                                      of the performance-based standard                       something not possible with the                        address many of the considerations
                                                      described above might read: ‘‘After final               notification procedure.                                outlined in the ‘‘Lessons Learned and
                                                      harvest of the plants covered under this                   In short, if APHIS were to retain the               Revisions under Consideration for
                                                      environmental release permit, the site                  notification procedure, in order to be                 APHIS’ Biotechnology Framework.’’ The
                                                      will be monitored every 4 weeks for the                 responsive to the risk factors that may                permitting procedure would continue to
                                                      emergence of volunteer seedlings for 1                  be associated with certain field trials,               identify and obtain information relevant
                                                      year, and any emerging volunteer plants                 but not others, to make it easier to assess            to evaluating the risks associated with a
                                                      will be devitalized before they produce                 compliance, and to be responsive to                    proposed movement, and determine and
                                                      pollen. Records of the monitoring and                   both the OIG audits and the 2008 Farm                  document whether, and under what
                                                      management of volunteers must be                        Bill, APHIS would need to significantly                conditions, the activity should be
                                                      maintained by the permit holder and                     revise the procedure to substantially                  allowed.
                                                      made available to APHIS upon request.’’                 reduce its reliance on performance-                       Paragraph (a)(1) of proposed § 340.3
                                                         The use of performance-based                         based standards. However, doing so                     would provide that, except as provided
                                                      standards under the notification                        would eliminate the primary benefit of                 in paragraph (a)(2) of the section, APHIS
                                                      procedure has some benefits, such as                    the current notification procedure,                    must have evaluated a regulated
                                                      providing the responsible person with                   which is that it is more administratively              organism in accordance with § 340.4
                                                      flexibility in how the standard is met,                 streamlined than the permitting                        before APHIS will issue a permit for its
                                                      e.g., allowing for appropriate changes in               procedure. Indeed, a revised procedure                 importation, interstate movement, or
                                                      protocols used during the growing                       which took into consideration all risk                 release into the environment. As
                                                      season. However, there are some                         factors that may be associated with                    mentioned previously in this document,
                                                      disadvantages in not specifically                       specific field trials would be both                    § 340.4 would contain our process for
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      enumerating the specific measures that                  complex and exhaustive. For these                      evaluating regulated organisms for plant
                                                      constitute compliance with the                          reasons, APHIS is proposing to do away                 pest or noxious weed risk. In order to
                                                      regulations. The permitting procedure                   with the notification procedure, rather                draft permitting conditions that are
                                                      avoids this disadvantage, because the                   than revise it.                                        commensurate with the risk a GE
                                                      permit conditions specify which actions                                                                        organism poses as a plant pest or
                                                      need to be taken by the responsible                     Permits (§ 340.3)                                      noxious weed, it is necessary for APHIS
                                                      person to be in compliance.                               The permitting procedure found in                    to have evaluated this risk.
                                                         Because of this, APHIS has                           § 340.4 of the current regulations                        If this rule is finalized, when it is fully
                                                      determined that it would have more                      describes types of permits, information                implemented, APHIS believes that such


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                            7021

                                                      evaluations will take a matter of                       whether paragraph (a)(2) of § 340.3 is                 was developed using genetic
                                                      months. Additionally, such evaluations                  necessary, or addresses a scenario that                engineering.
                                                      could often result in a determination                   is unlikely to occur under the proposed                   For interstate movement or
                                                      that the organism poses no risk as a                    regulations. APHIS also requests public                importation, the permit application
                                                      plant pest and/or noxious weed, and                     comment regarding whether there are                    would also have to contain the origin
                                                      thus is not subject to the regulations.                 any instances in which there would be                  and destination of the regulated
                                                      For these reasons, APHIS envision that,                 an immediate need to issue a permit for                organism, including information on the
                                                      if this rule is finalized, most developers              the environmental release of a regulated               addresses and contact details of the
                                                      would wait for APHIS to issue a final                   organism that had not yet been                         sender and recipient, if different from
                                                      determination of regulatory status, in                  evaluated in accordance with § 340.4.                  the responsible person; the method of
                                                      accordance with § 340.4, before                            Paragraph (a)(3) of § 340.3 would state             shipment, and means of ensuring the
                                                      submitting a permit application to                      that, except as provided in paragraph (c)              security of the shipment against
                                                      import the regulated organism, move it                  of § 340.3, a permit must be issued by                 unauthorized release of the regulated
                                                      interstate, or release it into the                      APHIS for the importation, interstate                  article, to be used in the importation or
                                                      environment.                                            movement, or release into the                          interstate movement; and the manner in
                                                         However, APHIS also envisions that                   environment of all regulated organisms.                which packaging material, shipping
                                                      there could be instances in which there                 Paragraph (c) would provide                            containers, and any other material
                                                      would be an immediate need to import                    exemptions from interstate permitting                  accompanying the regulated organism
                                                      a regulated organism or move it                         requirements for GE A. thaliana.                       will be disposed to prevent the
                                                      interstate, even though APHIS has not                      Paragraph (b) of proposed § 340.3                   unauthorized release of the regulated
                                                      yet evaluated the risk it poses as a plant              would outline how to submit a permit                   article.
                                                      pest and/or noxious weed. This could                    application. Applicants would have to                     Permit applications for release into
                                                      occur when, for example, a developer                    submit a permit application through a                  the environment would have to address
                                                      consolidates research laboratories. To                                                                         the spread, persistence risk, and
                                                                                                              method listed at the Web address
                                                      allow for such instances, proposed                                                                             potential harm of the regulated
                                                                                                              contained in the regulations; for
                                                      paragraph (a)(2) of § 340.3 would                                                                              organism in the environment, including
                                                                                                              purposes of this proposed rule, that
                                                      provide that APHIS may issue a permit                                                                          but not limited to a description of how
                                                                                                              address is http://www.aphis.usda.gov/
                                                      pursuant to the section for the                                                                                the phenotype of the regulated organism
                                                                                                              biotechnology/2016-340-proposed-rule.
                                                      importation or interstate movement of a                                                                        differs from the phenotype of the
                                                                                                              That Web site specifies that permit
                                                      regulated organism that has not been                                                                           recipient organism, particularly with
                                                                                                              applications must be submitted using
                                                      evaluated in accordance with § 340.4.                                                                          respect to potential interactions with,
                                                                                                              APHIS’ current electronic permitting
                                                      For the purposes of permitting                                                                                 and its likelihood of spread and/or
                                                                                                              system, ePermits, or the paper-based
                                                      conditions, APHIS would assume that                                                                            persistence in, the environment; and the
                                                                                                              APHIS form 2000.                                       location and size of all proposed
                                                      the regulated organism presents a risk as
                                                                                                                 APHIS is proposing to list the                      environmental release sites, including
                                                      a plant pest and/or noxious weed. If the
                                                                                                              methods for submitting a permit                        area, geographic coordinates, addresses,
                                                      regulatory status of the organism is
                                                                                                              application on the Internet, rather than               land use history of the site and adjacent
                                                      evaluated in accordance with § 340.4
                                                      during the duration of the permit,                      in the regulations, in order to make it                areas, and name and contact
                                                      APHIS could amend the permit, or, if                    easier to ensure they remain up-to-date.               information of a person at each
                                                      the organism is determined to pose no                   For example, APHIS is currently                        environmental release site, if different
                                                      risk as a plant pest and/or noxious                     developing a new electronic permitting                 from the responsible person. In the even
                                                      weed, terminate the permit and                          system to replace ePermits.                            that additional release sites are
                                                      communicate this termination to the                        APHIS is also proposing to remove                   requested after the issuance of a permit,
                                                      permittee.                                              the specific requirements for what                     APHIS would continue the practice of
                                                         While APHIS could foresee the need                   should be included in a permit                         evaluating and amending permits to add
                                                      for the Agency to issue such permits,                   application from the regulations.                      new release sites.
                                                      APHIS does wish the public to be aware                  Instead, they would be listed on an                       The categories of information listed
                                                      of some of the issues that it has                       APHIS Web site; for purposes of the                    above reflect the categories of
                                                      identified with doing so. First, because                proposed rule, that Web site is http://                information that APHIS considers
                                                      APHIS would not have evaluated the                      www.aphis.usda.gov/biotechnology/                      necessary to be included in all permit
                                                      organism for plant pest and/or noxious                  2016-340-proposed-rule.                                applications, as well as additional basic
                                                      weed risk, the Agency would need to                        That Web site would first list general              information required for each permit
                                                      presume a high degree of such risk.                     application requirements for all permit                type. APHIS has learned that there are
                                                      Accordingly, permitting conditions                      applications, and then break out                       certain areas that are not specified in the
                                                      could be significantly more stringent for               additional requirements for specific                   current regulations where APHIS
                                                      such unevaluated organisms than they                    permit applications. General                           routinely needs information from the
                                                      would be for the same organisms,                        information requirements that all types                applicant in order to ensure safety.
                                                      following evaluation in accordance with                 of permit applications would have to                   These areas do not become apparent to
                                                      § 340.4. Second, unlike organisms                       provide include the name, title, and                   applicants until they submit a permit
                                                      evaluated in accordance with § 340.4                    contact information of the responsible                 application and APHIS subsequently
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      prior to permitting, determining                        person and agent, if possible; the                     follows up for additional information in
                                                      nonregulated status for such organisms                  country and locality where regulated                   order to assess the activities listed on
                                                      would not be a category of action that                  organism was collected, developed,                     each permit application for plant pest
                                                      is exempt under APHIS’ regulations                      manufactured, reared, cultivated or                    and/or noxious weed risk. This had led
                                                      implementing the National                               cultured; the intended activity (i.e.,                 to two de facto lists of information
                                                      Environmental Policy Act (43 U.S.C.                     importation, interstate movement, or                   requirements for permit applications:
                                                      4321 et seq.).                                          release into the environment) for the                  The list in the regulations themselves,
                                                         For these reasons, APHIS requests                    regulated organism; and information                    and the list of information that APHIS
                                                      specific public comment regarding                       regarding how the regulated organism                   routinely requires in order to decide


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                                                      7022                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      whether to grant a permit. By                           limit for receiving additional                         the inspection of premises prior to the
                                                      maintaining a single list of permit                     information in the event that a permit                 issuance of a permit would be grounds
                                                      application requirements on the                         application is determined to be                        for the denial of a permit application.
                                                      Internet, APHIS can ensure that the list                incomplete. If the applicant does not                  Failure to allow an inspection after
                                                      is up-to-date and increase clarity                      respond to a request for more                          permit issuance would be grounds for
                                                      regarding the information that the                      information within 30 days of receipt of               revocation of the permit.
                                                      Agency needs.                                           APHIS’ request, APHIS would deem the                      While the current regulations provide
                                                         The categories of information above                  permit application withdrawn and                       for review of permit applications by
                                                      also align with the recommendations of                  return it to the applicant. This time                  State regulatory officials, they do not
                                                      the 2005 and 2015 OIG audits, and the                   limit would help preclude the Agency                   include review by Tribal officials when
                                                      provisions of the 2008 Farm Bill. For                   from acting on a permit application                    a permit application is submitted for the
                                                      example, the OIG recommendations                        when the responsible person no longer                  importation into, interstate movement
                                                      have led to provisions that would                       desires a permit, and would allow                      through, or release into the environment
                                                      enable APHIS to require geographic                      APHIS to focus its review of permit                    on Tribal lands of a regulated organism.
                                                      coordinates for the locations of                        applications, while also affording                     To correct this oversight, APHIS
                                                      environmental releases.                                 applicants sufficient time to provide                  proposes to state in proposed
                                                         As mentioned previously, paragraph                   APHIS additional information in the                    § 340.3(d)(4) that APHIS will include
                                                      (c) of § 340.3 would continue to exempt                 event that they submit incomplete
                                                      A. thaliana from permitting                                                                                    relevant Tribal officials when it
                                                                                                              applications.                                          provides copies of permit applications
                                                      requirements for interstate movement.                      Once an application is complete,
                                                      This is based on that organism’s                                                                               to State regulatory officials.
                                                                                                              APHIS would review it to determine
                                                      historically exempt status, which has                   whether to approve or deny the permit                     Under the current regulations, the
                                                      not resulted in the dissemination of                    application.                                           permitting procedure does not include a
                                                      plant pests within the United States. In                   Paragraph (d)(2) of proposed § 340.3                formal acknowledgement from the
                                                      the 1990 proposed rule (55 FR 28637–                    would contain provisions regarding                     applicant prior to permit issuance that
                                                      28638, Docket No. 90–052) in which                      APHIS’ assignment of permit                            they are aware of and consent to the
                                                      APHIS proposed to grant such an                         conditions. If a permit application is                 permit conditions. APHIS considers
                                                      exemption, the Agency stated its                        approved, permit conditions would be                   such an acknowledgement to be
                                                      rationale for the exemption: A. thaliana                assigned to each permit commensurate                   necessary, however, in order to verify
                                                      has desirable phenotypic traits                         with the risk of the regulated organism                that applicants are aware of and willing
                                                      (including small size, short generation                 and activity. General permit conditions,               to abide by the conditions. Accordingly,
                                                      times, high seed set, and ease of growth)               which APHIS is proposing to list in                    APHIS is proposing to add a
                                                      that lend themselves to use in scientific               paragraph (e) of § 340.3, would be                     requirement in § 340.3(d)(5) that, prior
                                                      studies; A. thaliana’s small genome size,               assigned to all permits. Additional or                 to permit issuance, applicants must
                                                      lack of repetitive DNA, and ease of                     expanded permit conditions may also be                 agree, in writing and in a manner
                                                      genetic modification using                              assigned that are commensurate to the                  prescribed by the Administrator, that
                                                      Agrobacterium tumefaciens make it                       risk that the activities listed on the                 they are aware of, understand, and will
                                                      especially useful for molecular genetic                 permit application present of                          comply with all permit conditions. If an
                                                      analysis; GE A. thaliana often needs to                 disseminating the regulated organism,                  applicant fails to comply with this
                                                      be moved interstate between                             or other plant pests or noxious weeds.                 provision, their application would be
                                                      laboratories and other containment                      Examples of such additional                            denied.
                                                      facilities as part of scientific studies;               requirements include, but are not                         The use of permits and permit
                                                      and safeguards exist which can                          limited to, specific requirements for                  conditions gives APHIS and the
                                                      adequately mitigate the plant pest risk                 reproductive, cultural, spatial, and                   responsible person an understanding as
                                                      associated with such movement. This                     temporal controls; monitoring; post-                   to what actions must be taken for the
                                                      rationale still holds true.                             termination land use; site security or                 permit holder to comply with the
                                                         APHIS contemplated a Web-based list                  access restrictions; management                        regulations. However, in the current
                                                      of other regulated organisms that have                  practices such as training of personnel                regulations, APHIS also provides a list
                                                      been granted exemptions from                            involved in the movement; and                          of general permitting conditions that are
                                                      permitting requirements for interstate                  practices to prevent articles associated               assigned to all permits in order to
                                                      movement. However, APHIS was not                        with the movement of a regulated                       provide as much transparency and
                                                      able to identify any organisms that                     organism from becoming contaminated                    predictability as possible about permit
                                                      would fall within the same category as                  with plant pests or noxious weeds.                     conditions. To that end, as APHIS
                                                      A. thaliana: A taxon for which certain,                    Under paragraph (d)(3) of proposed
                                                                                                                                                                     mentioned above, APHIS would
                                                      but not all, types of movement have                     § 340.3, all premises associated with the
                                                                                                                                                                     continue to maintain general conditions
                                                      been evaluated and present no plant                     permit would be subject to inspection
                                                                                                                                                                     that APHIS would assign to all permits
                                                      pest risk. That said, APHIS requests                    before and after permit issuance. APHIS
                                                                                                                                                                     issued under the regulations within the
                                                      public comment regarding any taxa that                  would require that the responsible
                                                                                                                                                                     regulations themselves. Paragraph (e) of
                                                      may be similarly situated.                              person provide APHIS inspectors access
                                                                                                                                                                     § 340.3 would contain these general
                                                         Paragraph (d) of § 340.3 would                       to inspect any relevant premises,
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                                                                                                                                                                     conditions. APHIS would require that:
                                                      contain specifics regarding APHIS’                      facility, location, storage area, waypoint,
                                                      review of permit applications. APHIS                    materials, equipment, means of                            • The regulated organism must be
                                                      would review permit applications to                     conveyance, and other articles related to              maintained and disposed of in a manner
                                                      determine completeness. If the                          the movement of organisms regulated                    so as to prevent the unauthorized
                                                      application is incomplete, APHIS would                  under 7 CFR part 340. While this                       release of the regulated organism.
                                                      notify the applicant in writing, and the                requirement is functionally the same as                   • The regulated organism must be
                                                      applicant would be provided an                          current inspection requirements, it                    kept separate from other organisms,
                                                      opportunity to revise the application.                  clarifies what locations and articles may              except as specifically allowed in the
                                                      APHIS is proposing to institute a time                  be subject to inspection. Failure to allow             permit.


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                            7023

                                                         • The regulated organism must be                     has added some additional details to                   regarding environmental release of
                                                      maintained only in areas and premises                   clarify their meaning. For example,                    regulated organisms. This will ensure
                                                      specified in the permit.                                while the existing regulations provide                 that all permitees are aware of those
                                                         • The regulated organism’s identity                  that APHIS inspectors shall be allowed                 requirements, and is consistent with the
                                                      must be maintained at all times.                        access to records related to the permit,               recommendations of the OIG audits. The
                                                         • In the event of an unauthorized                    they do not specify what ‘‘access to                   conditions would also prove useful,
                                                      release, the regulated organism must                    records’’ means. APHIS would clarify                   should the responsible person
                                                      undergo the application of remedial                     that this includes visual inspection and               subsequently request amendments to
                                                      measures determined by the                              reproduction (photocopying, digital                    the permit to authorize environmental
                                                      Administrator to be necessary to prevent                reproduction, etc.) of all records                     release.
                                                      the spread of regulated organism, and                   required to be maintained under the                       While the general permitting
                                                      the responsible person must contact                     proposed regulations. APHIS believes                   conditions that are currently in the
                                                      APHIS as described in the permit within                 that these additional details will better              regulations contain a condition that
                                                      24 hours of discovery, and subsequently                 communicate with applicants what the                   pertains to packing material used to
                                                      supply a statement of facts in writing no               general permitting conditions are, and                 transport the regulated organism, APHIS
                                                      later than 5 business days after                        will better support administration of the              would not retain this as a general
                                                      discovery.                                              permitting program, including                          permitting condition. This is because it
                                                         • The duration that a permit is valid                compliance and enforcement.                            would be covered by shipping
                                                      will be listed on the permit itself.                       APHIS is also proposing to specify                  requirements that APHIS is proposing to
                                                      During that time, the responsible person                that regular reporting regarding any                   add to the regulations in paragraph (i)
                                                      must maintain records related to                        activities associated with environmental               of § 340.3.
                                                      permitted activities of sufficient quality              release of a regulated organism is a                      Under the current regulations, the
                                                      and completeness to demonstrate                         general permitting condition. As APHIS                 Administrator may deny or cancel a
                                                      compliance with all permit conditions                   mentioned previously in this document,                 permit if the applicant has not complied
                                                      and requirements under the proposed                     the 2005 and 2015 OIG audits suggested                 with one or more of the conditions
                                                      regulations. The responsible person                     that APHIS exercise greater and more                   listed on the permit. The Administrator
                                                      must submit reports and notices to                      coordinated oversight over field tests of              will confirm the reasons for the
                                                      APHIS at the times specified in the                     GE organisms. APHIS identified regular                 cancellation or denial in writing within
                                                      permit and containing the information                   reporting regarding actual release site                10 days, and the applicant may appeal
                                                      specified within the permit. Inspectors                 coordinates and details of the release as              the decision in writing within 10 days
                                                      must be allowed access, during regular                  a key means of exercising such                         after receiving the written notification of
                                                      business hours, to the place where the                  oversight. Adding this reporting                       cancelation or denial. The
                                                      regulated organism is located and to any                requirement as a general permitting                    Administrator may then grant or deny
                                                      records relating to the movement of a                   condition will ensure that it is                       the appeal, in writing, stating the reason
                                                      regulated organism. APHIS access to                     communicated to all permittees.                        for the decision as promptly as
                                                      records includes visual inspection and                     Similarly, to respond to the                        circumstances allow.
                                                      reproduction (photocopying, digital                     recommendations of the 2005 and 2015                      APHIS is proposing to elaborate on
                                                      reproduction, etc.) of all records                      OIG audits, APHIS would add a                          the circumstances under which a permit
                                                      required to be maintained under the                     requirement for Agency notification if                 application may be denied in
                                                      proposed regulations, as requested by                   any permitted activity associated with                 § 340.3(f)(1). Such circumstances would
                                                      APHIS.                                                  environmental release will not be                      include when the Administrator
                                                         • The responsible person must notify                 conducted as a general permitting                      concludes that, based on the application
                                                      APHIS in writing if any permitted                       condition. This general condition would                or additional information, the actions
                                                      activity associated with environmental                  work in tandem with the reporting                      proposed under the permit may result in
                                                      release will not be conducted.                          requirement mentioned above, and help                  the unauthorized release of a regulated
                                                         • Within 28 days after the initiation                APHIS resolve what could otherwise be                  organism, or another plant pest or
                                                      of any permitted activity related to                    considered inconsistencies between the                 noxious weed; or when the
                                                      environmental release, the responsible                  permit conditions and the regular                      Administrator determines that the
                                                      person must report to APHIS in writing                  reports.                                               responsible person or any agent of the
                                                      the actual release site coordinates and                    In addition, while the current general              responsible person has failed to comply
                                                      details of the release, such as how many                permitting conditions require a field test             at any time with any APHIS regulation
                                                      acres planted, how many organisms                       report following termination of a field                or the conditions of any permit that has
                                                      released, etc., based on permit                         test, in recent years, APHIS has required              previously been issued in accordance
                                                      conditions, as well as every 28 days                    a more extensive report, an                            with the regulations.
                                                      thereafter until all releases are                       environmental release report, through                     The first condition pertains to
                                                      completed.                                              permitting conditions. Our general                     instances in which APHIS cannot reach
                                                         • A person who has been issued a                     permitting conditions would reflect this.              a conclusion that the risk of
                                                      permit must submit to APHIS an                             APHIS recognizes that these last three              dissemination of regulated organisms,
                                                      environmental release report within 6                   general permitting conditions pertain                  plant pests, or noxious weeds will be
                                                      months after the termination of any                     only to activities associated with                     adequately mitigated if APHIS issued a
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      release into the environment. The report                environmental release of a regulated                   permit authorizing the actions requested
                                                      must include the APHIS reference                        organism. APHIS also recognizes that it                on the permit application. This could
                                                      number, methods of observation,                         is possible that certain permit                        occur when, for example, a responsible
                                                      resulting data, and analysis regarding all              applications may not request to release                person does not formally acknowledge
                                                      deleterious effects on plants, non-target               the regulated organism into the                        that he or she understands the
                                                      organisms, or the environment.                          environment. However, the permit                       permitting conditions.
                                                         Most of the conditions listed above                  issued would still contain these general                  The second condition would pertain
                                                      are drawn from the conditions found in                  conditions to communicate to the                       to instances in which prior actions
                                                      the current regulations, although APHIS                 permittee APHIS’ general requirements                  taken by the applicant or his or her


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                                                      7024                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      agents call into question their ability to              organisms for analysis. APHIS is                       material, shipping containers, and any
                                                      abide by permitting conditions.                         therefore proposing to eliminate the                   other material accompanying the
                                                         While the current regulations contain                current limits in the regulations on the               regulated organism would have to be
                                                      procedures for denying a permit                         duration of permits for interstate                     treated or disposed of in such a manner
                                                      application, they do not detail measures                movement and importation. APHIS also                   so as to prevent the unauthorized
                                                      for APHIS to revoke a permit. Therefore,                would continue not to specify a                        dissemination and establishment of
                                                      APHIS proposes to establish explicit                    duration that an environmental release                 regulated organisms. As mentioned
                                                      procedures for the revocation of                        permit is valid in the regulations. The                above, this latter requirement is
                                                      permits. Procedures for revoking a                      duration that a permit is valid would                  currently a general permitting
                                                      permit would be contained in                            instead be specified on the permit itself,             condition, but could more accurately be
                                                      § 340.3(f)(2). These procedures would                   as a permitting condition. These                       described as a shipping requirement.
                                                      state that a permit may be revoked if,                  changes should give APHIS the                             Finally, paragraph (i) would contain
                                                      following issuance of the permit, the                   flexibility to issue these permits with                container marking and identity
                                                      Administrator receives information that                 suitable durations to meet individual                  requirements for imported GE
                                                      would otherwise have provided grounds                   circumstances.                                         organisms. These requirements are
                                                      for APHIS to deny the permit                               Paragraph (i) of § 340.3 would contain              currently found in § 340.7.
                                                      application; if the Administrator                       shipping requirements for regulated                       APHIS has occasionally received
                                                      determines that actions taken under the                 organisms. These would specify that all                inquiries from stakeholders regarding
                                                      permit have resulted in the                             shipments of regulated organisms must                  whether a permit could authorize the
                                                      unauthorized release of a regulated                     be secure shipments, which APHIS                       commercial distribution of a regulated
                                                      organism, or another plant pest or                      would define as shipments in a                         organism. Currently, most developers of
                                                      noxious weed; or if the Administrator                   container or a means of conveyance of                  GE organisms generally have not
                                                      determines that the responsible person                  sufficient strength and integrity to                   commercialized their products until
                                                      or any agent of the responsible person                  withstand leakage of contents, shocks,                 after those products were granted a
                                                      has failed to comply at any time with                   pressure changes, and other conditions                 determination of nonregulated status.
                                                      any APHIS regulation or the conditions                  incident to ordinary handling in                       However, APHIS does not prohibit
                                                      of any permit issued.                                   transportation.                                        commercializing GE organisms that
                                                         Paragraph (g) would contain the                         Currently, § 340.8 contains container               have not been granted a determination
                                                      current procedures for appealing the                    requirements for regulated organisms.                  of nonregulated status. APHIS currently
                                                      denial of a permit application or                       These requirements are very                            authorizes a small number of permits for
                                                      revocation of a permit.                                 prescriptive. While they do allow                      such commercial production.
                                                         APHIS is also proposing to clarify in                responsible persons to request variances                  Under the proposed regulations, there
                                                      § 340.3(h) of the regulations the                       from the requirements, this request                    may be some regulated organisms that
                                                      procedure to be used when amendment                     process, by its nature, results in a case-             an entity wishes to commercialize or
                                                      of existing permit conditions is sought                 by-case determination that other types                 grow on a large scale, under permit. As
                                                      by the responsible person or required by                of containers are acceptable for the                   currently occurs, APHIS would evaluate
                                                      APHIS. Such amendments may include                      transportation of regulated organisms.                 these permit applications on a case-by-
                                                      the transfer of the permit to a new                     The current regulations also do not                    case basis, to determine whether
                                                      responsible person. Currently, the                      clearly reflect the performance-based                  permitting conditions can be developed
                                                      administrative practices that APHIS                     standard that APHIS used to develop                    that adequately address the risk
                                                      uses to amend permits have not been                     the requirements, which was that the                   associated with the permitted actions.
                                                      explicit in the regulations, and these                  container should be sufficient to prevent
                                                      additions would provide increased                                                                              Courtesy Permits
                                                                                                              dissemination of a regulated organism
                                                      transparency and efficiency.                            during movement. Our proposed                            The current regulations in § 340.4(h)
                                                         Under the current regulations,                       requirements would maintain this                       provide APHIS with the ability to issue
                                                      notifications for environmental releases                performance-based standard, while                      courtesy permits in order to facilitate
                                                      and interstate movement are valid for 1                 making this standard more explicit and                 the movement of GE organisms that are
                                                      year. Interstate movement permits are                   the requirements less prescriptive, thus               not subject to the regulations in 7 CFR
                                                      only valid for 1 year from the date of                  eliminating the need for a request                     part 340 but whose movement might
                                                      issuance, and a new import permit must                  process for variances.                                 otherwise be hindered because of their
                                                      be obtained for each imported shipment.                    APHIS would, however, retain a                      similarity to organisms or articles that
                                                      These permits are referred to as ‘‘limited              provision in the current regulations,                  are regulated by other APHIS programs.
                                                      permits.’’ The duration period for a                    currently a footnote to § 340.8, that                  APHIS commits significant resources to
                                                      permit issued solely for an                             specifies that all regulated organisms                 the issuance of these courtesy permits
                                                      environmental release is not currently                  must be shipped in accordance with the                 for the movement of organisms that are
                                                      specified.                                              regulations in 49 CFR part 178. Those                  not subject to the provisions of part 340.
                                                         APHIS has found that it often takes                  regulations, which are administered by                   Courtesy permits have been part of
                                                      considerably longer than 1 year for                     the Department of Transportation                       the regulations since their inception in
                                                      activities authorized under a permit to                 (DOT), provide packaging requirements                  1987, and have been useful to inform
                                                      be completed. For example, with a                       for materials, including regulated                     shippers and State and Federal
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      perennial plant such as a tree, it may                  organisms that DOT has designated as                   inspectors not yet fully familiar with
                                                      take much longer than a year to gather                  hazardous materials.                                   requirements for GE organisms that the
                                                      relevant data about the plant for the                      Paragraph (i) of § 340.3 would also                 shipments in question were not
                                                      purpose of determining risk.                            specify that the container must be                     regulated. However, their continued use
                                                      Additionally, monitoring activities may                 accompanied by a document that                         has led to the widespread
                                                      be required for several years after a field             includes the names and contact details                 misunderstanding by some researchers
                                                      test is complete. In other cases,                       for the sender and the recipient. It                   that courtesy permits are actually
                                                      multiyear research projects may require                 would also specify that, following the                 required for the movement of certain
                                                      multiple shipments of regulated                         completion of the shipment, all packing                organisms, or that issuance of a courtesy


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                                     7025

                                                      permit removes the requirement for                      effects that might affect organisms                    their organism, but that consider it to
                                                      applicants to follow other applicable                   beneficial to agriculture; changes in                  either be outside the scope of regulated
                                                      regulations, such as the plant pest                     agricultural practices that might                      organisms or similar to an organism that
                                                      regulations found in 7 CFR part 330.                    exacerbate pest or disease problems; and               APHIS has already evaluated and
                                                      This confusion partially stems from the                 potential of the GE organism to transmit               assigned nonregulated status. The
                                                      similarities between the application                    the introduced trait to organisms with                 developers would present what they
                                                      form for courtesy permits and those for                 which it does not interbreed.                          consider to be the regulatory status of
                                                      other types of permits, as well as                         The current regulations also have a                 the organism, as well as the information
                                                      between the courtesy permit itself and                  provision in § 340.6(e) to extend a                    on which the developers rely to support
                                                      other permits. Therefore, in an effort to               determination of nonregulated status to                this consideration. In such instances,
                                                      alleviate confusion and to better focus                 a GE organism based on its similarity to               APHIS would review the information 7
                                                      and allocate APHIS resources, APHIS is                  an antecedent organism that has already                and communicate to the developer
                                                      proposing to remove the regulations                     been granted nonregulated status. This                 whether the regulatory status that they
                                                      concerning courtesy permits. It has been                existing ‘‘extension procedure’’ was                   presented to APHIS was accurate. This
                                                      common APHIS practice to facilitate the                 designed for APHIS to take into account                is substantially similar to the structure
                                                      importation of non-regulated articles                   the previous evaluation used to grant                  of APHIS’ current ‘‘Am I regulated?’’
                                                      through the use of letters indicating that              nonregulated status conducted by                       program.8 That being said, because there
                                                      no permit is required. APHIS would                      APHIS and thereby afford the potential                 would be some changes to that program
                                                      continue to work with researchers and                   for expedited evaluations of a petition                based on the provisions of this proposed
                                                      relevant government regulatory officials                for extension.                                         rule, if it is finalized APHIS would
                                                      to facilitate the transition.                              These provisions in the current                     make guidance available to aid
                                                                                                              regulations are necessary because of the               developers in making such inquiries of
                                                      Petitions for Nonregulated Status                       manner in which regulated article is                   APHIS.
                                                         The current regulations in § 340.6(a)                defined in the current regulations. As                    The second type of inquiries that
                                                      provide that any person may submit a                    APHIS mentioned previously, the                        APHIS would expect to receive would
                                                      petition to APHIS seeking a                             current regulations consider a GE                      come from developers of GE organisms
                                                      determination that an article should not                organism to be a regulated article if the              that belonged to taxa that are listed in
                                                      be regulated under 7 CFR part 340.                      donor organism, recipient organism,                    accordance with proposed § 340.2 prior
                                                      Paragraphs (b) and (c) of § 340.6                       vector, or vector agent is a plant pest.               to genetic engineering, or that have
                                                      describe the form that a petition for a                 However, because of complexities in the                received DNA from such taxa during
                                                      determination of nonregulated status                    science, and the changing nature of the                genetic engineering. The developers
                                                      must take and the information that must                 technologies, questions can arise as to                would provide information regarding
                                                      be included in the petition. Those                      whether certain GE organisms meet the                  the development of the GE organism,
                                                      organisms which are granted                             definition of regulated article. To                    and would provide information
                                                      nonregulated status are free of all                     address these questions, a process is                  regarding why they do, or not consider,
                                                      requirements under 7 CFR part 340.                      necessary to allow parties to request that             the GE organism to be a plant pest, or
                                                      This nonregulated status is different                   APHIS evaluate the GE organism for                     to have received DNA sufficient to
                                                      from that of certain organisms that meet                plant pest properties, and deregulate it               produce an infectious entity or encode
                                                      the definition of regulated articles, but               if the Agency determines that it is not.               a pathogenesis-related compound that is
                                                      which are exempt from the requirement                      APHIS does not consider it necessary                expected to cause plant disease
                                                      for a permit when moved interstate                      to retain this process in the regulations.             symptoms. Such requests would have to
                                                      under the specific conditions specified                 As mentioned in our discussion of                      be made in accordance with proposed
                                                      in the regulations.                                     proposed § 340.0, APHIS would no                       § 340.4.
                                                         Published APHIS decisions made                       longer regulate a GE organism solely                      The third category of inquiries would
                                                      under the current regulations have used                 because the donor organism, recipient                  come from developers of GE plants that
                                                      different ways to express the basic                     organism, vector, or vector agent of the               APHIS has not yet evaluated for plant
                                                      standard ‘‘unlikely to pose a plant pest                organism is a plant pest. Rather, for the              pest and noxious weed risk and
                                                      risk’’ in determining whether to grant                  GE organism to be regulated, APHIS                     developers of other GE organisms, such
                                                      nonregulated status to a specific GE                    would have to determine that it is a                   as GE insects and other invertebrates,
                                                      organism. In its determinations, APHIS                  plant pest or noxious weed, or the GE
                                                      has conveyed the basic standard of                      organism would have to not yet be                         7 In evaluating the similarity between two GE

                                                      ‘‘unlikely to pose a plant pest risk’’ by               evaluated for plant pest and/or noxious                plants, APHIS considers whether the mechanisms
                                                      concluding that the GE organism ‘‘poses                 weed risk. In other words, APHIS’ focal                of action of the introduced traits are functionally
                                                      no more of a plant pest risk than its non-                                                                     equivalent. For example, one mechanism of action
                                                                                                              point would change from the method by                  for resistance in plants to the herbicide glyphosate
                                                      GE counterpart,’’ ‘‘will not pose a plant               which the organism is genetically                      relies on an inability of glyphosate molecules to
                                                      pest risk’’; or that there is ‘‘no plant pest           engineered, to the resulting GE organism               bind and inactivate an enzyme called EPSPS, which
                                                      risk,’’ or ‘‘no direct or indirect plant pest           itself, and the Agency would no longer                 is responsible for an essential step in a biochemical
                                                      effects.’’ Regardless of the phrases used                                                                      pathway for the synthesis of certain amino acids.
                                                                                                              assume that the use of a plant pest                    If glyphosate cannot bind to the EPSPS enzyme, the
                                                      in its determination of nonregulated                    within the development of the GE                       plant is resistant to the herbicide. APHIS has
                                                      status to date, APHIS has applied the                   organism necessarily and in every
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                                                                                                                                     granted nonregulated status to two very similar
                                                      same basic evaluation criteria to each                  instance results in a GE organism with                 types of GE plants which differed in the donor
                                                      determination to conclude that the GE                                                                          organism for the EPSPS genes: One version of the
                                                                                                              plant pest properties.                                 gene was derived from corn (mEPSPS) and the other
                                                      organism is unlikely to pose a plant pest                  Based on the manner in which                        from a strain of Agrobacterium (CP4 EPSPS).
                                                      risk and therefore is not subject to the                proposed § 340.0 is structured, APHIS                  However, in both cases the added gene encodes an
                                                      part 340 regulations. Those criteria                    envisions four types of inquiries from                 EPSPS protein which does not bind to glyphosate.
                                                      include, among other things,                            developers of GE organisms if this rule                Accordingly, these two glyphosate resistance traits
                                                                                                                                                                     have mechanisms of action which are functionally
                                                      conclusions on the potential of the GE                  is finalized. The first would be from                  equivalent.
                                                      organism to create pest or disease                      developers of organisms that are                          8 See https://www.aphis.usda.gov/aphis/

                                                      problems; the potential for nontarget                   uncertain of the regulatory status of                  ourfocus/biotechnology/am-i-regulated.



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                                                      7026                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      that were not plant pests prior to genetic              with the unmodified sequence. If the                   of the plant) or diseases; and any other
                                                      engineering, but that APHIS has not yet                 gene is not naturally occurring, the                   weediness or plant pest characteristics
                                                      evaluated for plant pest risk as GE                     request would have to state whether the                identified of the plant or other plants
                                                      organisms. These inquiries would                        sequence is based on that of a specific                with which the plant can interbreed.
                                                      request APHIS to evaluate the regulatory                organism, and, if so, identify the                        • For non-plant, non-vertebrate
                                                      status of the GE organism. Such requests                organism and gene it was based on.                     organisms, any information that exists
                                                      would also have to be made in                              Æ For regulatory sequences, the                     on known or likely differences to
                                                      accordance with proposed § 340.4.                       function of each regulatory sequence as                herbivory or virulence must be
                                                        The fourth category of inquiries                      it relates to the gene sequence and the                provided, including: Any observed or
                                                      would come from developers of GE                        source of each regulatory sequence.                    anticipated changes due to the genetic
                                                      organisms that APHIS has determined to                  Promoters (sites on DNA to which the                   modification that might affect the ability
                                                      be plant pests or noxious weeds, asking                 enzyme RNA polymerase can bind to                      of the organism to cause direct or
                                                      for a reevaluation of this determination.               initiate the transcription of DNA into                 indirect damage to plants; a description
                                                      Such requests would have to be made in                  RNA) would have to be identified as                    of any changes to known factors of
                                                      accordance with proposed § 340.4.                       constitutive, inducible, developmental,                pathogenesis and virulence factors such
                                                                                                              or tissue-specific. If inducible, the                  as polysaccharides (complex sugars
                                                      Regulatory Status Evaluation (§ 340.4)                  inducer would have to be described. If                 consisting of multiple sugar molecules
                                                         Proposed § 340.4 would contain the                   developmental, stages at which the                     bonded together) and suppressors (genes
                                                      process by which persons could request                  promoter is active would have to be                    that suppress expression of another
                                                      an initial evaluation or subsequent                     described. If tissue-specific, the tissues             gene); a consideration of changes that
                                                      reevaluation of the regulatory status of                in which the promoter is active would                  might affect geographic distributions,
                                                      a GE organism. The outcome of a                         have to be described. The strength of the              host range, means of dissemination,
                                                      regulatory status evaluation is a                       promoter would also have to be                         horizontal gene transfer, reproductive
                                                      determination by the agency that a GE                   described. Finally, for microorganisms,                cycle, and persistence; and a description
                                                      organism is a nonregulated organism or                  descriptions of mobile genetic elements                of any characteristics introduced to
                                                      a regulated organism subject to                         would also have to be included.                        mitigate harm to plants.
                                                      permitting.                                                Æ If the genome is edited, the                         • Any experimental data (including
                                                                                                              following would also have to be                        field tests) and publications that the
                                                      Requests for Evaluation or Reevaluation
                                                                                                              provided: The nature of the edit(s) and                developer believes might be relevant to
                                                         Paragraph (a) of proposed § 340.4                    the gene(s) and function(s) being                      APHIS’s evaluation of the potential of
                                                      would state that any person may submit                  modified, as well as what pathways are                 the organism to affect plant health.
                                                      a request to APHIS to have a GE                         expected to be affected; for multiple                     APHIS considers the categories of
                                                      organism’s regulatory status evaluated,                 substituted base pairs, the number of                  information specified above, which are
                                                      or to request the reevaluation of the                   substitutions; the original unmodified                 drawn from our current conditions in
                                                      regulatory status of a previously                       sequence aligned to the modified                       § 340.7 for a petition for nonregulated
                                                      evaluated regulated organism. It would                  sequence; and if the edits were created                status for a GE organism, to be sufficient
                                                      provide that the information that would                 using genetic material which was                       for APHIS to evaluate a GE organism
                                                      have to be submitted with a regulatory                  integrated into the chromosome, but                    and determine its appropriate regulatory
                                                      status request in order for APHIS to                    later eliminated through segregation,                  status. That being said, the Agency
                                                      evaluate the request is on the Internet,                techniques used to confirm absence of                  solicits public comment on the
                                                      at http://www.aphis.usda.gov/                           the genetic material.                                  adequacy of the requested information
                                                      biotechnology/2016-340-proposed-rule.                      • A detailed description of the                     in proposed 340.4(a), and whether
                                                      Such information would include:                         intended phenotype(s) of the GE                        additional or alternate requirements
                                                         • A description of the recipient                     organism. This would include the                       would be more appropriate.
                                                      organism (including common name;                        purpose of the new phenotype and the                   Specifically, APHIS is interested in
                                                      genus, species, and any relevant                        mechanisms of action by which the                      instances that commenters identify in
                                                      subspecies information that would                       intended phenotype is conferred; any                   which the above information may be
                                                      distinguish the organism; and, for                      new enzymes, other gene products, or                   insufficient to reach a regulatory status
                                                      microorganisms, the strain).                            expected changes in metabolism; if                     determination.
                                                         • The genotype of the GE organism,                   applicable, the protein accession                         To that end, APHIS wishes to
                                                      including a detailed description of the                 number and the enzyme commission                       highlight some of the differences
                                                      differences in genotype between the                     number; and the known and potential                    between the above information and the
                                                      organism subject to the request and the                 differences from the non-GE organism                   information currently required for a
                                                      non-GE organism. If genetic material is                 that would substantiate that the GE                    request for deregulated status of a GE
                                                      inserted into the genome, the method of                 organism is unlikely to pose a greater                 organism. With regard to the genotype
                                                      transformation would also have to be                    noxious weed risk or plant pest risk                   of the GE organism, APHIS would add
                                                      described and the following provided                    than the non-GE organism from which                    specific information requirements for
                                                      for each gene:                                          it was derived.                                        gene sequences, regulatory sequences,
                                                         Æ For gene sequences, the name of the                   • For plants, any information that                  and genome editing. The current
                                                      sequence, donor organism(s) or source,                  exists on known or likely changes that                 regulations require the petitioner to
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      function of sequence, nucleic acid                      may affect any of the following would                  supply a detailed description of the
                                                      sequence, and publicly available                        have to be provided: Weediness and                     genotype of the GE organism, but do not
                                                      sequence identification. If the genes                   plant pest characteristics of the plant;               specify that a description of the gene
                                                      have been modified, the nature of the                   competitive growth ability;                            sequences, regulatory sequences, or
                                                      modification and its purpose would                      reproduction, spread, and persistence;                 genome editing of the organism is
                                                      have to be stated, and the request would                stress tolerance, including a                          required. Operationally, however,
                                                      have to identify and highlight the                      consideration of abiotic stresses such as              APHIS considers this information to be
                                                      modifications by submitting an                          cold and drought tolerance and biotic                  necessary in order for the petitioner to
                                                      alignment of the modified sequence                      stresses such as herbivory (consumption                provide a detailed description of the


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                            7027

                                                      genotype, and the revised regulations                      Accordingly, APHIS considers                        assessment, or both. APHIS would
                                                      would reflect this operational need.                    information from field tests to not                    prepare a plant pest risk assessment
                                                         APHIS would also remove a current                    always be necessary for a determination                (PPRA) for organisms that have received
                                                      regulatory requirement that requires the                of regulatory status under the proposed                DNA from any taxon listed in
                                                      petition to state the country and locality              regulations. The approach APHIS is                     accordance with § 340.2, if the DNA
                                                      of the donor organism from which a GE                   proposing focuses primarily on                         from the donor organisms are sufficient
                                                      organism has received genetic material                  evaluating the genetics and expressed                  to produce an infectious entity capable
                                                      in order for APHIS to evaluate the                      phenotype of the regulated organism,                   of causing plant disease or encodes a
                                                      genotype of the GE organism. In the                     and the likelihood that, based on these                compound known to be pathogenesis-
                                                      Agency’s experience, this information                   genetics and phenotype, the organism                   related that is expected to cause plant
                                                      has not proven germane to evaluating                    will act as a plant pest or noxious weed               disease symptoms, and the GE
                                                      the genome of the GE organism, since it                 if it is released into the environment for             organisms have not been evaluated by
                                                      does not provide information regarding                  the uses intended by the developer.                    APHIS for plant pest risk. APHIS would
                                                      the modified genome of the GE                              This would not preclude a developer                 also prepare a PPRA for GE plants, if our
                                                      organism, or the manner in which the                    from providing field test information, if              initial evaluation of the plant suggested
                                                      genome was modified.                                    he or she considered such information                  the plant may be parasitic. APHIS
                                                         With regard to the phenotype of the                  to be pertinent to our determination. For              would also prepare a weed risk
                                                      GE organism, the proposed                               example, if a developer wished APHIS                   assessment for GE plants with plant and
                                                      requirements would contain additional                   to reevaluate the status of an organism                trait combinations that have not been
                                                      details that APHIS considers necessary                  that the Agency had previously                         evaluated by APHIS for noxious weed
                                                      in order to evaluate the plant pest risk                considered to be a regulated organism,                 risk.
                                                      of microorganisms, insects, and other                   field test information demonstrating a                    APHIS’ weed risk analysis processes
                                                      invertebrates. For GE plants, it would                  lack of adverse effects on plants and                  would use a WRA, a system developed
                                                      also include information that APHIS                     plant products could be provided in                    by APHIS for the purpose of assessing
                                                      needs in order to prepare a plant pest                  support of that request. Nor would the                 noxious weed risk of GE organisms.
                                                      risk assessment and/or a weed risk                      provisions preclude APHIS from asking                  Regulatory status decisions for GE
                                                      assessment (WRA, discussed below).                      for field test information if APHIS                    plants would be informed based on a
                                                         APHIS is also proposing a significant                considers it necessary in order to                     risk manager’s evaluation and
                                                      departure from the current requirements                 conclude review of a particular request.               interpretation of the results of the WRA
                                                      for a petition for nonregulated status.                 However, field test information would                  (and, for parasitic plants or plants that
                                                      The current requirements specify that a                 not be a generally applicable                          may otherwise fall within the scope of
                                                      petition must contain field reports for                 requirement for requests for a regulatory              the definition of plant pest, the PPRA).
                                                      all trials conducted under permit or                                                                              While this risk analysis would be
                                                                                                              status determination, and would only be
                                                      notification procedures involving the                                                                          informed by APHIS’s risk assessment
                                                                                                              requested rarely, and on an as-needed
                                                      regulated organism, including the                                                                              experience with GE organisms as well as
                                                                                                              basis.
                                                      APHIS reference number, methods of                                                                             APHIS’ evaluation of other existing
                                                      observation, resulting data, and analysis               Risk Analyses in Response to Regulatory                weed risk assessment systems that have
                                                      regarding all deleterious effects on                    Status Requests                                        been developed, since the WRA system
                                                      plants, non-target organisms, or the                       Paragraph (b) would outline the                     for GE organisms is new, APHIS is
                                                      environment.                                            actions the Administrator would take in                making the WRA system publicly
                                                         Currently, most of the field data                    response to a regulatory status request.               available along with this proposed rule.
                                                      submitted by the regulated community                    If the request is complete, APHIS would                (To view the WRA system or guidance,
                                                      to meet this requirement is to                          conduct a risk analysis that includes an               go to http://www.aphis.usda.gov/
                                                      demonstrate that there have not been                    evidence-based, standardized approach                  biotechnology/2016-340-proposed-rule.)
                                                      unintended deleterious effects on                       to analyzing plant pest and/or noxious                 Similarly, APHIS will make WRAs
                                                      plants, non-target organisms, or the                    weed risks associated with the GE                      available to the public to help make our
                                                      environment. To date, APHIS has                         organism.                                              risk management decisions as
                                                      authorized more than 100,000 field                         Currently, when APHIS receives                      transparent as possible.
                                                      trials—a single permit or notification                  petitions for a determination of                       Notices of Request for Evaluation of
                                                      may authorize multiple trials—and                       regulated status, APHIS conducts risk                  Regulatory Status
                                                      APHIS has not received a report of plant                assessments. Historically, these                         Proposed paragraph (c) of § 340.4
                                                      pest or noxious weed issues. In                         assessments have focused on evaluating                 would discuss our proposed notice-
                                                      addition, APHIS has not received any                    the plant pest risk of the regulated                   based process for making evaluation of
                                                      information in such reports indicating a                organism. However, in recent years,                    regulatory status available to the public.
                                                      potential for such effects. Rather, the                 they have also included a weediness                    APHIS would make both the request
                                                      Agency has discovered that the                          assessment when the regulated                          and the risk analysis available for public
                                                      expressed phenotype of the regulated                    organism is a plant.                                   review through a notice published in
                                                      organism provides the most reliable                        The proposed regulations would                      the Federal Register. This first notice
                                                      indicator of the organism’s potential for               specify that, if APHIS receives a request              would request public comment, and
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      deleterious effects on plants and plant                 to evaluate the regulatory status of a GE              would propose a regulatory status for
                                                      products. These observations are                        organism, the Agency will conduct a                    the organism.
                                                      expected and are consistent with                        risk analysis. The analysis would                        If no comments are received on the
                                                      findings of several reports of the                      include, inter alia, preparation of a                  notice, or if the comments do not affect
                                                      National Research Council.9                             plant pest risk assessment, a weed risk                the conclusions of the risk analysis or
                                                        9 See: NRC (National Research Council). 1989.
                                                                                                                                                                     the proposed regulatory status of the
                                                                                                                NRC (National Research Council). 2004. Safety of
                                                      Field Testing Genetically Modified Organisms:           Genetically Engineered Foods: Approaches to
                                                                                                                                                                     organism, APHIS would provide
                                                      Framework for Decisions. Washington, DC: National       Assessing Unintended Health Effects. Washington,       notification through the APHIS
                                                      Academy Press.                                          DC: National Academies Press.                          stakeholder registry at the end of the


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                                                      7028                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      comment period announcing that the                      and determine whether enforcement                      regulations regarding such stipulations
                                                      proposed regulatory status has been                     actions are needed. When APHIS has                     are located in 7 CFR 380.10.
                                                      finalized.10 APHIS would subsequently                   investigated unauthorized                                Finally, the section would specify that
                                                      publish a notice in the Federal Register                environmental releases of regulated                    for purposes of enforcing the
                                                      compiling these determinations.                         organisms, this has necessitated                       regulations, the act, omission, or failure
                                                         Alternatively, if comments lead                      obtaining information from field trials                of any agent for a responsible person
                                                      APHIS to change its proposed regulatory                 that were conducted up to 10 years prior               may be deemed also to be the act,
                                                      status for the organism, APHIS would                    to the investigation. In instances in                  omission, or failure of the responsible
                                                      publish a subsequent notice in the                      which the information was not                          person.
                                                      Federal Register characterizing these                   available, this adversely impacted
                                                                                                                                                                     Container and Shipment Requirements
                                                      comments and announcing the new                         APHIS’ ability to do an expeditious and
                                                      regulatory status.                                      thorough investigation.                                  The regulations in current §§ 340.7
                                                                                                                 APHIS is also proposing to extend the               and 340.8 provide detailed requirements
                                                      Record Retention, Compliance and                        record retention requirement that                      for identifying and securely shipping
                                                      Enforcement (§ 340.5)                                   demonstrates that a regulated organism                 containers of regulated organisms. In the
                                                         APHIS is proposing to consolidate all                that was imported or moved interstate                  revised regulations, general
                                                      record retention, compliance, and                       arrived at its intended destination from               requirements which apply to all
                                                      enforcement requirements in 7 CFR part                  1 to 2 years. In the event that there is               shipments of regulated GE organisms
                                                      340 into a new § 340.5. APHIS is also                   uncertainty regarding whether the                      under permit are now listed in
                                                      proposing to strengthen its program in                  organism arrived at this location, it may              paragraph (i) of § 340.3. Additional
                                                      order to manage compliance with the                     take APHIS more than 1 year to                         supplemental conditions will be used
                                                      regulations more efficiently, to augment                investigate the matter.                                when permits are issued to add
                                                      the approaches used to prevent or                          APHIS recognizes that, in practice,                 additional case-specific measures. These
                                                      remediate potential risks to plant health,              our proposed requirements would                        supplemental conditions will be listed
                                                      and to utilize appropriate enforcement                  require most records associated with                   on the permit itself as permitting
                                                      strategies. These proposed regulatory                   permitted activities to be retained 10                 conditions. This will allow the agency
                                                      changes also reflect certain provisions of              years, and that this is a significant                  to take into account the widely varying
                                                      the 2008 Farm Bill and align with                       duration to retain potentially a                       types and quantities of GE organisms to
                                                      recommendations of the 2005 and 2015                    substantial number of records pertaining               be shipped and apply highly effective
                                                      OIG audits.                                             to permit activities. However, retaining               yet reasonable requirements.
                                                         The current regulations require a                    documents for less than 10 years may
                                                                                                              impede an investigation into                           Confidential Business Information
                                                      responsible person to retain records
                                                                                                              compliance infractions. The Agency                     (§ 340.6)
                                                      demonstrating that a regulated organism
                                                      that was imported or moved interstate                   requests specific public comment                          As mentioned previously, in the
                                                      under a permit arrived at its intended                  regarding whether a shorter duration is                current regulations, there are guidelines
                                                      destination for 1 year, but contain no                  warranted for certain records pertaining               for denoting information on a permit
                                                      record retention requirements related to                to permit activities, and which activities             application or petition for a
                                                      environmental release of a regulated                    these may be. Additionally, APHIS                      determination of nonregulated status as
                                                      organism. While APHIS has frequently                    requests comment on any alternate                      CBI in different sections of the
                                                      added this record retention requirement                 means that stakeholders may identify                   regulations. In the proposed regulations,
                                                      as a permitting condition, both the 2005                for the Agency to obtain necessary                     APHIS is proposing to consolidate these
                                                      and 2015 OIG audits and the 2008 Farm                   information from developers in the                     guidelines for protecting CBI into a
                                                      Bill recommended that the Agency                        event of an investigation of possible                  single section, § 340.6. This change
                                                      specify the retention requirement in the                regulatory noncompliance.                              would support the overall
                                                      regulations themselves,                                    The section would specify that                      administration of the program by
                                                      recommendations that are corroborated                   responsible persons and their agents                   consolidating all relevant requirements,
                                                      by the Agency’s own experience                          must comply with the proposed                          thereby making it easier for interested
                                                      administering the regulations.                          regulations. Failure to comply with the                persons to find the necessary
                                                         Therefore, APHIS is proposing that all               regulations could result in denial of a                information.
                                                      records related to permit conditions,                   permit application or revocation of a
                                                                                                              permit, application of remedial                        Definitions (§ 340.1)
                                                      other than those demonstrating that a
                                                      regulated organism that was imported or                 measures in accordance with the PPA,                     APHIS proposes to retain certain
                                                      moved interstate arrived at its intended                or criminal or civil penalties.                        definitions currently found in § 340.1 of
                                                      destination, be retained for 10 years                      Pursuant to sections 7714 and 7731 of               the regulations, to change other
                                                      following permit expiration, unless                     the PPA, APHIS may seize, quarantine,                  definitions, to add some new
                                                      APHIS determines otherwise and                          treat, destroy, or apply other remedial                definitions, and to remove definitions
                                                      documents an alternate record retention                 measures to a regulated organism that is               that no longer appear in the regulations.
                                                      requirement. In the event of an                         new to or not widely prevalent or                        APHIS is proposing to retain the
                                                      investigation into the possible                         distributed in the United States to                    following definitions from the current
                                                                                                              prevent dissemination of the organism.                 regulations, without change:
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                                                      unauthorized environmental release of a
                                                      regulated organism, or the escape of a                  APHIS typically issues an Emergency                    Administrator, Animal and Plant Health
                                                      regulated organism from a containment                   Action Notifications or administrative                 Inspection Service (APHIS), donor
                                                      facility, a thorough record of activities               order to the owner of the regulated                    organism, environment, organism, and
                                                      taken under the permit is necessary in                  organism to specify these remedial                     person.
                                                      order for APHIS to assess compliance                    measures.                                                APHIS is proposing to change the
                                                                                                                 If APHIS intends to issue a civil                   definitions of the following terms from
                                                        10 To subscribe to the APHIS stakeholder registry,    penalty, the Agency may enter into a                   those in the current regulations:
                                                      go to: https://public.govdelivery.com/accounts/         stipulation prior to issuance of the                     As mentioned in the discussion of
                                                      USDAAPHIS/subscriber/new.                               complaint seeking the penalty. Our                     proposed § 340.0, the definition of


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                            7029

                                                      genetic engineering would read                          a laboratory. The stakeholders expressed                  Permit would read ‘‘A written
                                                      ‘‘techniques that use recombinant or                    concern that the definition could result               authorization, including by electronic
                                                      synthetic nucleic acids with the intent                 in widespread confusion regarding                      methods, by the Administrator to move
                                                      to create or alter a genome,’’ and would                which laboratory-based techniques to                   regulated organisms and associated
                                                      exclude traditional breeding techniques                 alter a genome are considered                          articles under conditions prescribed by
                                                      (including, but not limited to, marker-                 biotechnology, and which are not.                      the Administrator.’’
                                                      assisted breeding and chemical or                          Stakeholders also encouraged APHIS                     This change generally aligns the
                                                      radiation-based mutagenesis, as well as                 to refer to other existing definitions                 definition of permit in 7 CFR part 340
                                                      tissue culture and protoplast, cell, or                 used to define biotechnology or genetic                with the definition of permit used in the
                                                      embryo fusion).                                         engineering.                                           PPA. However, whereas the definition
                                                         This would replace the current                          When APHIS issued the current                       in the PPA mentions that a permit may
                                                      definition for genetic engineering, ‘‘the               regulations, the Agency relied on                      authorize the movement of plants, plant
                                                      genetic modification of organisms by                    guidelines developed by the National                   products, and biological control
                                                      recombinant DNA techniques.’’ The                       Institutes of Health (NIH) regarding                   organisms, plant pests, noxious weeds,
                                                      regulations do not define ‘‘recombinant                 research on genetically engineered                     and associated articles, APHIS would
                                                      DNA techniques,’’ and the current                       organisms to craft the definition of                   specify that, for purposes of part 340, it
                                                      definition could also be construed to                   ‘‘genetic engineering.’’ Accordingly, in               pertains to the movement of regulated
                                                      exclude the use of synthetic DNA, in-                   light of the above stakeholder concerns,               organisms and associated articles. This
                                                      vivo DNA manipulation, and genome                       APHIS revisited NIH guidelines                         reflects the scope of the proposed
                                                      editing. For the purposes of this rule,                 regarding research on genetically                      regulations.
                                                      APHIS is proposing to consider genome                   engineered organisms. The definition                      Additionally, while the PPA allows
                                                      editing to be within the definition of                  that APHIS is proposing is based on                    for the issuance of oral permits, APHIS
                                                      genetic engineering. APHIS is also                      NIH’s ‘‘Guidelines for Research                        would not. Oral permits do not provide
                                                      proposing to exclude from the definition                                                                       adequate documentation that a
                                                                                                              Involving Recombinant or Synthetic
                                                      of genetically engineered organism GE                                                                          responsible person was aware of and
                                                                                                              Nucleic Acid Molecules,’’ which are
                                                      organisms that could have been                                                                                 understood permitting conditions at the
                                                                                                              located at http://osp.od.nih.gov/sites/
                                                      produced via traditional breeding.                                                                             time the permit was issued.
                                                                                                              default/files/NIH_Guidelines.html. The                    Plant would read ‘‘Any plant
                                                         APHIS recognizes that APHIS had
                                                                                                              section in that document that pertains to              (including any plant part) for or capable
                                                      previously suggested this proposed rule
                                                                                                              research on plants that have been                      of propagation, including a tree, a tissue
                                                      would use the term biotechnology, and
                                                                                                              genetically engineered contextually                    culture, a plantlet culture, pollen, a
                                                      would define biotechnology in the
                                                                                                              delineates the scope of genetic                        shrub, a vine, a cutting, a graft, a scion,
                                                      following manner: ‘‘Laboratory-based
                                                                                                              engineering in a manner that is                        a bud, a bulb, a root, and a seed.’’ This
                                                      techniques to create omodify a genome
                                                                                                              equivalent to the scope of our proposed                change is necessary because the current
                                                      that result in a viable organism with
                                                      intended altered phenotypes. Such                       definition.                                            definition of ‘‘plant’’ used in the
                                                      techniques include, but are not limited                    Inspector would read ‘‘Any individual               regulations precedes the issuance of the
                                                      to, deleting specific segments of the                   authorized by the Administrator of                     PPA, and is broader than that definition.
                                                      genome, adding segments to the                          APHIS or the Commissioner of Customs                   Therefore, APHIS would align the
                                                      genome, directed altering of the genome,                and Border Protection, Department of                   definition with the definition in the
                                                      creating additional genomes, or direct                  Homeland Security, to enforce the                      PPA itself.
                                                      injection and cell fusion beyond the                    regulations in this part.’’ The current                   A result of this alignment would be
                                                      taxonomic family that overcomes                         definition predates the establishment of               that APHIS would no longer consider
                                                      natural physiological reproductive or                   the Department of Homeland Security,                   ‘‘cellular components,’’ such as
                                                      recombination barriers. For the                         as well as the transfer of certain                     ribosomes, to be plants. However,
                                                      purposes of this part, this definition                  inspection responsibilities for imported               cellular components are not capable of
                                                      does not include traditional breeding,                  organisms from APHIS to Customs and                    propagating to cause plant pest or
                                                      marker-assisted breeding, or chemical or                Border Protection.                                     noxious weed risks.
                                                      radiation-based mutagenesis.’’                             Interstate would read ‘‘From one State                 Plant pest would read ‘‘Any living
                                                         A number of stakeholders understood                  into or through any other State or within              stage of a protozoan, invertebrate
                                                      the limitations associated with the                     the District of Columbia, Guam, the                    nonhuman animal, parasitic plant,
                                                      current definition of genetic                           Virgin Islands of the United States, or                bacterium, fungus, virus or viroid,
                                                      engineering, but questioned the need to                 any other territory or possession of the               infectious agent or other pathogen, or
                                                      abandon the term in favor of                            United States.’’ This change aligns the                any article similar to or allied with any
                                                      biotechnology. They pointed to APHIS’                   definition of ‘‘interstate’’ in 7 CFR part             of the foregoing, that can directly or
                                                      long-standing use of the term genetic                   340 with the definition of ‘‘interstate’’              indirectly injure, cause damage to, or
                                                      engineering, and suggested that using a                 used in the PPA.                                       cause disease in any plant or plant
                                                      different term could lead to confusion                     Move (moving, movement) would read                  product.’’ This change generally aligns
                                                      among the regulated community and the                   ‘‘To carry, enter, import, mail, ship, or              the definition of ‘‘plant pest’’ in 7 CFR
                                                      general public.                                         transport; aid, abet, cause, or induce the             part 340 with the definition of ‘‘plant
                                                         Additionally, several stakeholders                   carrying, entering, importing, mailing,                pest’’ used in the PPA. However, while
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                                                      expressed concern regarding the                         shipping, or transporting; to offer to                 the PPA gives APHIS authority to
                                                      proposed definition of biotechnology.                   carry, enter, import, mail, ship, or                   regulate any nonhuman animal as a
                                                      They pointed out to APHIS that                          transport; to receive to carry, enter,                 plant pest, it is longstanding APHIS
                                                      traditional breeding often uses                         import, mail, ship, or transport; to                   policy not to regulate vertebrate animals
                                                      laboratory-based techniques, such as                    release into the environment; or to allow              as plant pests. In the absence of such a
                                                      tissue culture and embryo rescue, to                    any of the above activities to occur.’’                policy, all herbivores and omnivores
                                                      create or modify a genome, and                          This change aligns the definition of                   could be considered plant pests, and
                                                      radiation-based mutagenesis, which                      ‘‘move’’ in 7 CFR part 340 with the                    thus subject to regulation, an untenable
                                                      modifies genomes, is often conducted in                 definition of ‘‘move’’ used in the PPA.                position considering that this would


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                                                      7030                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      require APHIS to consider livestock,                    lands where the importation, interstate                   • The organism is a ‘‘null segregant,’’
                                                      such as cows, sheep, and horses, to be                  movement, or environmental release is                  that is, the progeny of a GE organism
                                                      plant pests.                                            to take place.’’ The change from the                   where the only genetic modification was
                                                         Recipient organism would read ‘‘The                  former definition is the                               the insertion of donor nucleic acid into
                                                      organism whose nucleic acid sequence                    acknowledgement of Tribal authority on                 the recipient’s genome, but the donor
                                                      will be altered through the use of                      Tribal lands.                                          nucleic acid is not passed to the
                                                      genetic engineering.’’ In contrast, the                    APHIS proposes to add definitions of                recipient organism’s progeny and the
                                                      current definition is ‘‘the organism                    the following new terms:                               donor nucleic acid has not altered the
                                                      which receives genetic material from a                     Agent would read ‘‘A person who is                  DNA sequence of the progeny.
                                                      donor organism.’’ This change from the                  authorized to act on behalf of the                        Import (importation) would read ‘‘To
                                                      former definition is intended to be more                responsible person to maintain control                 move into, or the act of movement into,
                                                      precise by distinguishing an organism                   over a regulated organism during its                   the territorial limits of the United
                                                      with altered traits from the same                       movement and ensures compliance with                   States.’’ This is the definition of
                                                      organism prior to transformation.                       all conditions contained in any                        ‘‘import’’ used in the PPA.
                                                         Release into the environment                         applicable permit or exemption as well                    Interstate movement would read ‘‘To
                                                      (environmental release) would read                      as other requirements in this part.                    move interstate.’’ This proposed
                                                      ‘‘The use of a regulated organism                       Agents may be, but are not limited to,                 definition is necessary to clarify the
                                                      outside the physical constraints found                  brokers, farmers, researchers, or site                 specific type of movement referenced in
                                                      in a contained facility.’’ This change                  cooperators. An agent must be at least                 the regulations.
                                                      from the former definition removes the                  18 years of age and be a legal resident                   Noxious weed would read ‘‘Any plant
                                                      word ‘‘regulated article,’’ which APHIS                 of the United States.’’ This proposed                  or plant product that can directly or
                                                      proposes to replace with the term                       definition would clarify that the                      indirectly injure or cause damage to
                                                      ‘‘regulated organism.’’ This change also                responsible person may designate                       crops (including nursery stock or plant
                                                      removes examples of types of physical                   another person to act on the responsible               products), livestock, poultry, or other
                                                      confinement and replaces them with the
                                                                                                              person’s behalf, but that the person so                interests of agriculture, irrigation,
                                                      term ‘‘contained facility,’’ which APHIS
                                                                                                              designated must comply with all                        navigation, the natural resources of the
                                                      is proposing to define. Finally, this term
                                                                                                              relevant regulations regarding the                     United States, the public health, or the
                                                      clarifies that ‘‘release into the
                                                                                                              regulated organism as the responsible                  environment.’’ This is the definition for
                                                      environment’’ and ‘‘environmental
                                                                                                              person must.                                           noxious weed found in the PPA.
                                                      release’’ are synonymous terms. This
                                                                                                                 Contained facility would read ‘‘A                      Nucleic acid would read ‘‘A chain or
                                                      can be inferred from the current
                                                      regulations, but is not explicit.                       structure for the storage and/or                       chains of nucleotides found in either
                                                         Responsible person would read ‘‘The                  propagation of living organisms                        DNA or RNA.’’ This proposed definition
                                                      person who has control and will                         designed with physical barriers capable                is necessary to clarify the term ‘‘nucleic
                                                      maintain control over a regulated                       of preventing the escape of the enclosed               acid,’’ which is used in reference to
                                                      organism during its movement and                        organisms. Examples could include                      ‘‘regulatory sequences’’ in the proposed
                                                      ensures compliance with all conditions                  laboratories, growth chambers,                         regulations.
                                                      contained in any applicable permit or                   fermenters, and containment                               Plant pest risk assessment would read
                                                      exemption as well as other requirements                 greenhouses.’’ While the current                       ‘‘An assessment evaluating whether a
                                                      in this part. A responsible person must                 regulations use the term contained                     GE organism is a plant pest.’’
                                                      be at least 18 years of age and be a legal              facility, the term is not currently                       Plant product would read ‘‘Any
                                                      resident of the United States.’’ This                   defined. APHIS proposes to add this                    flower, fruit, vegetable, root, bulb, seed,
                                                      change would remove the term                            definition to clarify what constitutes a               or other plant part that is not included
                                                      ‘‘introduction’’ and replace it with the                contained facility.                                    in the definition of plant or any
                                                      term ‘‘movement.’’ It would also replace                   Genetically engineered organism (GE                 manufactured or processed plant or
                                                      the term ‘‘GE organism’’ with the term                  organism) would read ‘‘an organism                     plant part.’’ This is the definition of
                                                      ‘‘regulated organism’’ and add that a                   developed using genetic engineering.’’                 plant products found in the PPA. This
                                                      responsible person must be ‘‘at least 18                As mentioned previously in this                        definition is more precise than the
                                                      years of age.’’ The first two changes are               document, for purposes of the proposed                 current definition of ‘‘product’’ in 7 CFR
                                                      to reflect the nomenclature used in the                 regulations, APHIS would not consider                  part 340, which this definition would
                                                      proposed regulations. The last change is                an organism to be a GE organism if any                 replace. For example, the current
                                                      necessary because individuals under the                 of the following are the case:                         definition of product includes
                                                      age of 18 are minors.                                      • The genetic modification to the                   ‘‘anything made by or from, or derived
                                                         State would read ‘‘Any of the several                organism is solely a deletion of any size              from an organism, living or dead.’’
                                                      States of the United States, the                        or a single base pair substitution which               APHIS does not plan to regulate dead
                                                      Commonwealth of the Northern Mariana                    could otherwise be obtained through the                organisms as APHIS has found that they
                                                      Islands, the Commonwealth of Puerto                     use of chemical- or radiation-based                    do not present plant pest or noxious
                                                      Rico, the District of Columbia, the                     mutagenesis.4                                          weed risks.
                                                      Virgin Islands of the United States, or                    • The genetic modification to the                      Regulated organism would read ‘‘Any
                                                      other Territories or possessions of the                 organism is solely introducing only                    GE organism that is regulated pursuant
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                                                      United States.’’ This change aligns the                 naturally occurring nucleic acid                       to § 340.0.’’ This definition would
                                                      definition of ‘‘State’’ in 7 CFR part 340               sequences from a sexually compatible                   replace the definition of ‘‘regulated
                                                      with the definition of ‘‘State’’ used in                relative that could otherwise cross with               article.’’
                                                      the PPA.                                                the recipient organism and produce                        Regulatory sequence would read ‘‘A
                                                         State or Tribal regulatory official                  viable progeny through traditional                     segment of nucleic acid molecule that is
                                                      would read ‘‘State or Tribal official with              breeding (including, but not limited to,               capable of increasing or decreasing the
                                                      responsibilities for plant health, or any               marker-assisted breeding, as well as                   expression of specific genes within an
                                                      other duly designated State or Tribal                   tissue culture and protoplast, cell, or                organism.’’ This definition would be
                                                      official, in the State or on the Tribal                 embryo fusion).                                        added to ensure clarity within the


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                             7031

                                                      requirements for regulatory status                      the regulations would apply, namely,                   impacts associated with the revision of
                                                      determinations.                                         importation, interstate movement, and                  our regulations regarding the movement
                                                         Secure shipment would read                           release into the environment.                          of certain GE organisms, APHIS has
                                                      ‘‘Shipment in a container or a means of                   Finally, based on the terms that                     prepared a programmatic environmental
                                                      conveyance of sufficient strength and                   APHIS is proposing to add or remove                    impact statement (PEIS). The PEIS was
                                                      integrity to withstand leakage of                       from the regulations, as well as the                   prepared in accordance with: (1) The
                                                      contents, shocks, pressure changes, and                 revised scope of the regulations, the                  National Environmental Policy Act of
                                                      other conditions incident to ordinary                   Agency would revise the title of part                  1969 (NEPA), as amended (42 U.S.C.
                                                      handling in transportation.’’ This                      340 to ‘‘Movement of organisms altered                 4321 et seq.), (2) regulations of the
                                                      definition would be used to clarify the                 or produced through genetic                            Council on Environmental Quality for
                                                      container requirements in the proposed                  engineering that are noxious weeds or                  implementing the procedural provisions
                                                      rule.                                                   plant pests or that there is reason to                 of NEPA (40 CFR parts 1500–1508), (3)
                                                         Unauthorized release would read:                     believe are noxious weeds or plant                     USDA regulations implementing NEPA
                                                      ‘‘The intentional or accidental release of              pests.’’                                               (7 CFR part 1b), and (4) APHIS’ NEPA
                                                      a regulated organism in a manner not                                                                           Implementing Procedures (7 CFR part
                                                      authorized by a permit issued pursuant                  Costs and Charges (§ 340.7)                            372).
                                                      to 7 CFR part 340.’’                                      Section 340.7 would contain APHIS’                      The PEIS may be viewed on the
                                                         Weed risk assessment would read                      policy regarding costs and charges for                 Regulations.gov Web site or in our
                                                      ‘‘An assessment of the characteristics of               the services of inspector, which are                   reading room. (A link to Regulations.gov
                                                      a plant as these relate to weediness.’’                 found in the current regulations in                    and information on the location and
                                                         APHIS proposes to remove the                         § 340.9. Currently, the section provides               hours of the reading room are provided
                                                      following definitions from the                          that the services of an inspector during               under the heading ADDRESSES at the
                                                      regulations: Antecedent organism,                       regularly assigned hours of duty are                   beginning of this proposed rule.) In
                                                      courtesy permit, expression vector,                     provided free of charge, but that APHIS                addition, copies may be obtained by
                                                      introduce or introduction, product,                     will not be responsible for any other                  calling or writing to the individual
                                                      regulated article, Secretary, stably                    costs or charges incident to inspections               listed under FOR FURTHER INFORMATION
                                                      integrated, vector or vector agent, and                 or compliance, apart from the services                 CONTACT.
                                                      well-characterized and contains only                    of this inspector. These provisions
                                                      non-coding regulatory regions.                                                                                 Executive Orders 12866 and 13563 and
                                                                                                              would be unchanged.                                    Regulatory Flexibility Act
                                                         These definitions would be removed
                                                      because the terms would no longer be                    Technical Evaluations                                     This proposed rule has been
                                                      used in the regulations. APHIS proposes                   APHIS recognizes that many aspects                   determined to be significant for the
                                                      to eliminate the term regulated article                 of our proposed rule hinge on a                        purposes of Executive Order 12866 and,
                                                      partly because the use of the term                      determination by APHIS regarding the                   therefore, has been reviewed by the
                                                      ‘‘article’’ in current part 340 is not                  plant pest or noxious weed risk posed                  Office of Management and Budget.
                                                      consistent with usage in the PPA, which                 by a particular GE organism or class of                   We have prepared an economic
                                                      uses the term article to mean ‘‘any                     GE organisms. Often, APHIS will be able                analysis for this rule. The economic
                                                      material or tangible object that could                  to make a determination of plant pest or               analysis provides a cost-benefit analysis,
                                                      harbor plant pests or noxious weeds’’—                  noxious weed risk based on our                         as required by Executive Orders 12866
                                                      that is, things like packing materials,                 collective experience regulating genetic               and 13563, which direct agencies to
                                                      shipping containers, commodities,                       engineering and review of relevant                     assess all costs and benefits of available
                                                      etc.—and not a plant pest or noxious                    scientific literature.                                 regulatory alternatives and, if regulation
                                                      weed itself. Under the current                            However, as genetic engineering                      is necessary, to select regulatory
                                                      regulation, however, regulated article                  evolves and new genetic engineering                    approaches that maximize net benefits
                                                      refers exclusively to certain genetically               techniques are developed, APHIS may                    (including potential economic,
                                                      engineered organisms. For this reasons,                 lack technical expertise to fully evaluate             environmental, public health and safety
                                                      the term ‘‘regulated article’’ in the                   certain GE organisms or classes of GE                  effects, and equity). Executive Order
                                                      current regulations is both inconsistent                organisms. This is particularly likely                 13563 emphasizes the importance of
                                                      with the terminology of the PPA and                     when new or emerging genetic                           quantifying both costs and benefits, of
                                                      difficult for the public to comprehend.                 engineering techniques are applied to                  reducing costs, of harmonizing rules,
                                                         APHIS also proposes to remove the                    recipient organisms that have not                      and of promoting flexibility. The
                                                      definition for introduction. APHIS                      previously been subject to genetic                     economic analysis also provides an
                                                      currently uses the term in part 340 to                  engineering.                                           initial regulatory flexibility analysis that
                                                      denote certain kinds of activities that                   In such instances, APHIS may rely on                 examines the potential economic effects
                                                      fall within the scope of the regulations,               researchers or other Federal, State,                   of this rule on small entities, as required
                                                      namely importation, interstate                          Tribal, or industry experts to provide                 by the Regulatory Flexibility Act. The
                                                      movement, and release into the                          information to help APHIS determines                   economic analysis is summarized
                                                      environment. The PPA, however, does                     the organism’s appropriate regulatory                  below. Copies of the full analysis are
                                                      not specifically define the term                        status. APHIS may solicit such                         available by contacting the person listed
                                                      introduction. Therefore, to avoid                       information through a variety of means,                under FOR FURTHER INFORMATION
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                                                      confusion, instead of using the term                    including, but not limited to, working                 CONTACT or on the Regulations.gov Web
                                                      introduction to define the different                    groups, workshops, peer review of                      site (see ADDRESSES above for
                                                      types of regulated activities, APHIS will               documents (particularly risk analyses),                instructions for accessing
                                                      instead refer to these activities in the                or webinars.                                           Regulations.gov).
                                                      regulations as movement in accordance                                                                             Under the PPA, the Secretary of
                                                      with the definition of move in the PPA.                 National Environmental Policy Act                      Agriculture is authorized to regulate the
                                                      Additionally, as APHIS mentioned                          To provide the public with                           movement into and through the United
                                                      above, the regulations will specify and                 documentation of APHIS’ review and                     States of plants, plant products, and
                                                      define the types of movements to which                  analysis of any potential environmental                other articles to prevent the


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                                                      7032                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      introduction or dissemination of plant                  management costs. Petitions for non-                   regulated status would be eliminated,
                                                      pests and noxious weeds. As one part of                 regulated status—and the petition costs                but more risk assessments for regulatory
                                                      its implementation of the PPA, APHIS                    incurred—would be eliminated. There                    determination would be performed.
                                                      regulates the safe introduction                         would be some new costs borne by                       Current annual personnel costs of
                                                      (environmental release, interstate                      regulated entities under the proposed                  conducting GE activities (costs of
                                                      movement, and importation) of certain                   rule including rule familiarization and                activities that would be affected by the
                                                      GE organisms that might be plant pests                  recordkeeping. Recordkeeping cost                      proposed rule) are estimated to total
                                                      (7 CFR part 340). APHIS is proposing to                 tabulations are based on the information               about $5.6 million. With the proposed
                                                      revise its regulation of GE organisms to                collection categories from the                         rule, annual costs are expected to range
                                                      respond to emerging trends in genetic                   paperwork burden section of the rule,                  from $2.5 million to $7.8 million,
                                                      engineering, to more efficiently use                    and are estimated to total about                       depending on the volume of permits,
                                                      APHIS resources, and eliminate                          $275,000. About 1,100 distinct entities                weed risk assessments, inspections, and
                                                      unnecessary regulatory burdens.                         have applied for permits or notifications              NEPA activities. In addition, costs to
                                                         The proposed revisions to 7 CFR part                 under part 340. APHIS estimates that                   APHIS of implementing the proposed
                                                      340 would create the framework for                      those entities would spend about 8                     rule would include outreach activities,
                                                      more focused, risk-based regulation of                  hours becoming familiar with the                       developing guidance documents,
                                                      the GE organisms that pose plant pest                   provisions of this rule at a total cost of             training, and adjusting the current
                                                      and/or noxious weed risks. They would                   about $576,000.                                        permit system. APHIS estimates that the
                                                      establish a regulatory status evaluation                  Cost savings for these entities are                  public outreach, guidance and training
                                                      process in which risk analysis would be                 expected to more than offset the new                   would cost about $88,000. Requests for
                                                      used to assess whether permitting of a                  costs. APHIS estimated the cost savings                regulatory status and response letters
                                                      GE organism is necessary. Shipping                      for two regulatory oversight scenarios,                under the proposed rule could be
                                                      standards would be less prescriptive                    based on a study of the costs                          handled in a manner similar to the
                                                      and more generally applicable, and the                  encountered by private biotech                         current ‘‘Am I Regulated’’ process
                                                      rule would provide for the issuance of                  developers as they pursue regulatory                   outside the electronic permitting system
                                                      multi-year permits. The proposed rule                   authorization of their innovations.                    without incurring new costs.
                                                      would also exclude certain techniques                   When only USDA has regulatory                             A quicker USDA evaluation process
                                                      from the definition of genetic                          oversight, compliance cost savings                     and related reduction to firms’
                                                      engineering and certain organisms from                  under the proposed rule could range                    regulatory uncertainty may facilitate
                                                      the definition of genetically engineered                from $1.5 million to $5.4 million for the              small companies’ ability to raise venture
                                                      organism. These changes would                           development of a given GE trait. If EPA                capital. Reduced regulatory
                                                      improve the efficiency and clarity of the               and/or FDA also have an oversight role                 requirements may also lead to greater
                                                      regulations.                                            in the development of a given GE trait,                participation by the public sector in GE
                                                         The proposed amendments would                        compliance cost savings could range                    research. These indirect benefits of the
                                                      benefit developers, producers, and                      from $485,000 to $861,000. Since 1992,                 proposed rule may spur GE innovations,
                                                      consumers of certain GE organisms,                      between 2 and 14 petitions have been                   particularly in small acreage crops
                                                      public and private research entities, and               processed (granted non-regulated status                where genetic engineering has not been
                                                      the Agency. There would not be any                      or the petition withdrawn) in a given                  widely utilized due to the expense of
                                                      decrease in the level of protection                     year, with an average of just under 6.                 regulation. While the proposed rule may
                                                      provided against plant pest risks, and                    Because the rule is expected to spur                 help promote biotech innovations, the
                                                      protection against noxious weed risks                   innovation, we expect the number of                    pace of commercialization and volume
                                                      would be enhanced. The risk-based                       new organisms developed annually to                    of GE products commercialized are not
                                                      process used to determine regulatory                    increase over time. In the following                   expected to change dramatically from
                                                      status under the proposed rule would                    discussion, the annual number of new                   current levels. Nor is control over the
                                                      provide cost savings to the biotech                     GE organisms developed under the                       development process expected to be
                                                      industry and allow for reallocation of                  proposed rule would range from 6 (the                  materially altered by the proposed rule.
                                                      APHIS resources to Biotechnology                        current annual average), to 12 (twice                  It would be in a biotech developer’s
                                                      Regulatory Services (BRS) priorities.                   this average), with 10 as an intermediate              own best interest to maintain the same
                                                         Based on APHIS’ experience                           number. For GE organisms that would                    level of supervision and control over the
                                                      evaluating field trial data from                        have solely required USDA oversight,                   development process as at present to
                                                      thousands of permits that authorize                     the annual savings could range from                    prevent undesired cross-pollination or
                                                      environmental release of regulated                      $8.8 million to $32.4 million (6 new                   commingling with non-GE crops.
                                                      organisms, as well as more than 150                     organisms), from $14.7 million to $53.9                   GE crop varieties, in general, are not
                                                      petitions for non-regulated status,                     million (10 new organisms), and from                   required to be reviewed or approved for
                                                      APHIS has determined that most of the                   $17.6 million to $64.7 million (12 new                 safety by the FDA before going to
                                                      GE organisms evaluated by the Agency                    organisms). For organisms that are                     market. However, the developer is
                                                      do not merit regulatory oversight under                 submitted for multi-agency evaluation,                 responsible for ensuring product safety
                                                      the PPA. There would be both direct                     the annual savings could range from                    and developers consider voluntary
                                                      and indirect economic benefits of not                   $2.9 million to $5.2 million (6 new                    consultations with FDA on food safety
                                                      subjecting the majority of these                        organisms), from $4.9 million to $8.6
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                                                                                                                                     to be an absolute necessity for
                                                      organisms to permitting requirements.                   million (10 new organisms), and from                   applicable GE products.11 Developers
                                                         Direct regulatory costs to biotech                   $5.8 million to $10.3 million (12 new                  also have various legal, quality control
                                                      developers would be reduced for those                   organisms).
                                                      organisms that are not considered to                      APHIS costs of regulating GE                           11 Genetically Engineered Crops: Past Experience

                                                      pose plant pest and/or noxious weed                     organisms that may pose plant pest or                  and Future Prospects. Committee on Genetically
                                                      risk. Savings to the regulated                          noxious weed risks also are expected to                Engineered Crops: Past Experience and Future
                                                                                                                                                                     Prospects; Board on Agriculture and Natural
                                                      community would result from a reduced                   change under the proposed rule. Fewer                  Resources; Division on Earth and Life Studies;
                                                      need to collect field data, fewer                       permits would be issued and                            National Academies of Sciences, Engineering, and
                                                      reporting requirements, and lower                       notifications and petitions for non-                   Medicine.



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                                                                                 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                                                              7033

                                                      and marketing motivations to maintain                            permit. EPA would need to develop a                                        and increase yields during times of
                                                      rigorous voluntary stewardship                                   program to oversee small-scale testing of                                  adverse growing conditions.
                                                      measures. APHIS therefore believes that                          PIPs and issue regulations if warranted.                                     On the other hand, some farmers (e.g.,
                                                      developers would continue to utilize                             APHIS is fully committed to                                                growers of organic and or identity-
                                                      such measures for field testing even in                          coordinating with EPA in this matter in                                    preserved crops) could be negatively
                                                      cases where USDA would not require a                             order to give EPA time to stand up such                                    impacted by these same innovations.
                                                      permit.                                                          a program. APHIS understands that a                                        Some consumers choose not to purchase
                                                         Certain plants are genetically                                memorandum of understanding (MOU)                                          products derived from GE crops and
                                                      engineered in order to produce                                   and services agreement may be                                              instead purchase commodities such as
                                                      pharmaceutical or industrial                                     necessary to provide personnel and                                         those labeled ‘‘non-GMO’’ or organic.
                                                      compounds (plant-made                                            other resources to assist EPA during the                                   When crops intended for the non-GE or
                                                      pharmaceuticals or industrials), or                              interim period while EPA implements                                        identity-preserved marketplace contain
                                                      PMPIs. Under the provisions of the                               its own program of oversight of outdoor                                    unintended GE products, the value of
                                                      proposed rule, there is a possibility that                       planting of PIPs on 10 acres or less.                                      the non-GE or identity-preserved
                                                      APHIS could reach a determination that                           APHIS recognizes that there are                                            product is diminished. Effects of the
                                                      a GE plant that produces PMPIs is not                            challenges associated with such a                                          proposed rule on the variety of GE crop
                                                      a regulated organism. Such a plant                               transition that also would require EPA                                     species grown in the United States and
                                                      would not be subject to field trial                              to incur the costs associated with setting                                 their wider adoption may increase risks
                                                      oversight by USDA, and could be                                  up a revised regulatory program.                                           of cross-pollination or commingling. As
                                                      planted before or without an evaluation                          Further, it would require policies,                                        more small acreage crops are modified
                                                      by FDA or EPA. Several options have                              procedures, and guidance regarding                                         using genetic engineering, the
                                                      been identified for addressing this                              APHIS’ interaction with EPA.                                               unintended presence of a GE organism
                                                      potential gap in oversight. APHIS                                                                                                           becomes increasingly possible.
                                                      estimates that current PMPI inspections                             Farmers who adopt GE crops also may                                     Unauthorized releases of regulated GE
                                                      cost roughly $35,000 in total annually or                        indirectly benefit from the proposed                                       crop plants and the entry of regulated
                                                      about $800 each on average. Assuming                             rule. The adoption of GE crops in the                                      plant material in the commercial food
                                                      that oversight continues in the same                             United States has generally reduced                                        and feed supply can have impacts on
                                                      manner as APHIS oversight, a similar                             costs and improved profitability at the                                    domestic or international markets.
                                                      government expenditure could be                                  farm level. As mentioned, under the                                        While such releases have occurred and
                                                      expected under any of the PMPI                                   proposed rule, regulatory costs are                                        may occur again, such incidents are
                                                      oversight scenarios.                                             expected to be lower, thereby                                              expected to be rare.
                                                         Certain plants are genetically                                potentially spurring developer                                               Entities potentially affected by the
                                                      engineered to produce PIPs. PIPs fall                            innovation, especially among small                                         proposed rule fall under various
                                                      under the regulatory oversight of EPA.                           companies and universities. Farmers                                        categories of the North American
                                                      However, APHIS exercises regulatory                              may benefit by having access to a wider                                    Industry Classification System. While
                                                      oversight of all PIP plantings on 10 acres                       variety of traits as well as a greater                                     economic data are not available on
                                                      or less of land. Under the proposed rule,                        number of new GE crop species,                                             business size for some entities, based on
                                                      APHIS would only require permits for                             affording them a broader selection of                                      industry data obtained from the
                                                      PIPs planted on 10 acres or less if they                         crops to suit their particular                                             Economic Census and the Census of
                                                      present a plant pest or noxious weed                             management needs. Among the types of                                       Agriculture we can assume that the
                                                      risk or have not yet been evaluated by                           innovations expected are crops with                                        majority of the businesses affected by
                                                      APHIS for such risk. This proposal                               greater resistance to disease and insect                                   the proposed rule would be small.
                                                      would shift Federal oversight of small-                          pests, greater tolerance of stress                                         APHIS welcomes public comment on
                                                      scale (10 acres or less) outdoor plantings                       conditions such as drought, high                                           the proposed rule’s possible impacts.
                                                      of PIPs to EPA. EPA may decide to                                temperature, low temperature, and salt,                                      The following table provides a
                                                      require EUPs for all, some, or none of                           and more efficient use of fertilizer.                                      summary statement of the expected
                                                      such PIPs, and may conduct inspections                           These types of traits can lower farmer                                     direct benefits and costs of the proposed
                                                      of all, some, or none of those PIPs under                        input costs (water, fertilizer, pesticide)                                 rule:

                                                      EXPECTED ANNUAL BENEFITS AND COSTS OF THE PROPOSED RULE FOR THE BIOTECHNOLOGY INDUSTRY AND FOR USDA,
                                                                                                  2015 DOLLARS

                                                                                       Entity

                                                      Biotechnology Industry ....................................................                                                           Costs ($1,000)

                                                      Developer costs (recordkeeping and rule familiariza-                                                                                          851
                                                        tion) 1.

                                                                                                                                                                                   Cost Savings per Trait ($1,000)
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                                                                              Developer Savings 2                                                                                       Proposed rule, lower                   Proposed rule, upper
                                                                                                                                                                                              bound                                  bound

                                                      USDA sole regulatory agency .........................................         ............................................    ¥1,468 ..............................    ¥5,393
                                                      USDA with FDA and/or EPA oversight ...........................                                                                ¥485 .................................   ¥861

                                                      APHIS Biotechnology Regulatory Services .....................                                                                         Costs ($1,000)




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                                                      7034                           Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      EXPECTED ANNUAL BENEFITS AND COSTS OF THE PROPOSED RULE FOR THE BIOTECHNOLOGY INDUSTRY AND FOR USDA,
                                                                                             2015 DOLLARS—Continued
                                                      Costs for public outreach, training, and epermitting 3 .....                                                                                             88

                                                                          Activities affected by the rule                                                 Current rule                           Proposed rule, lower                       Proposed rule, upper
                                                                                                                                                                                                       bound                                      bound

                                                      Notifications .....................................................................     203 .....................................     0 .........................................   0
                                                      Petitions ...........................................................................   2,130 ..................................      0 .........................................   0
                                                      Interstate movement and environmental release permits                                   239 .....................................     139 .....................................     261
                                                      Courtesy permits .............................................................          19 .......................................    0 .........................................   0
                                                      Letters of No Permit Required ........................................                  0 .........................................   3 .........................................   3
                                                      ‘‘Am I Regulated’’ Process ..............................................               7 .........................................   0 .........................................   0
                                                      Weed risk assessments ..................................................                0 .........................................   700 .....................................     1,265
                                                      Compliance and Inspections ...........................................                  361 .....................................     361 .....................................     1,014
                                                      NEPA/ESA .......................................................................        2,648 ..................................      1,324 ..................................      5,297

                                                            Total 4 .......................................................................   5,607 ..................................      2,527 ..................................      7,840
                                                         1 Becoming  familiar with the rule are one-time costs.
                                                         2 These savings are shown on a per trait basis. If between 6 and 12 GE organisms are developed each year that would have solely required
                                                      USDA oversight, annual savings could range from $9 million to $64.8 million. If between 6 and 12 new GE organisms per year are submitted for
                                                      multi-agency evaluation, the annual savings could be from $2.9 million to $10.3 million.
                                                         3 Requests for regulatory status and response letters under the proposed rule could be handled in a manner similar to the current ‘Am I Regu-
                                                      lated’ process outside the electronic permitting system without new costs.
                                                         4 Annual staffing costs of APHIS Biotechnology Regulatory Services total about $19 million.




                                                      Executive Order 12372                                                     determined that this rule does have                                         developed using genetic engineering.
                                                        This program/activity is listed in the                                  Tribal implications that require Tribal                                     Organisms would be regulated because
                                                      Catalog of Federal Domestic Assistance                                    consultation under E.O. 13175. If a                                         APHIS has determined them to present
                                                      under No. 10.025 and is subject to                                        Tribe requests consultation, the Animal                                     a plant pest or noxious weed risk, or has
                                                      Executive Order 12372, which requires                                     and Plant Health Inspection Service will                                    not yet evaluated them for such risk.
                                                      intergovernmental consultation with                                       work with the Office of Tribal Relations                                       Persons would be able to submit a
                                                      State and local officials. (See 2 CFR                                     to ensure meaningful consultation is                                        request for APHIS to evaluate the
                                                      chapter IV.)                                                              provided where changes, additions, and                                      regulatory status of a GE organism. They
                                                                                                                                modifications identified herein are not                                     would also be able to petition APHIS to
                                                      Executive Order 12988                                                     expressly mandated by Congress.                                             add a genus, species, or subspecies to a
                                                         This proposed rule has been reviewed                                                                                                               list of taxa that are or contain plant
                                                                                                                                Paperwork Reduction Act
                                                      under Executive Order 12988, Civil                                                                                                                    pests. Finally, permits would be
                                                      Justice Reform. If this proposed rule is                                    In accordance with section 3507(d) of                                     required for the importation, interstate
                                                      adopted: (1) All State and local laws and                                 the Paperwork Reduction Act of 1995                                         movement, and environmental release
                                                      regulations that are inconsistent with                                    (44 U.S.C. 3501 et seq.), some of the                                       of all regulated GE organisms.
                                                      this rule will be preempted; (2) no                                       reporting, recordkeeping, and third                                         Responsible persons who are issued
                                                      retroactive effect will be given to this                                  party disclosure requirements included                                      permits would be required to retain
                                                      rule; and (3) administrative proceedings                                  in this proposed rule have been                                             records, and would have to submit
                                                      will not be required before parties may                                   approved under 0579–0085. The new                                           reports if they conduct field testing.
                                                      file suit in court.                                                       reporting, recordkeeping, and third                                            APHIS is soliciting comments from
                                                                                                                                party disclosure requirements proposed                                      the public (as well as affected agencies)
                                                      Executive Order 13175                                                     by this rule have been submitted as a                                       concerning our proposed information
                                                        This rule has been reviewed in                                          new information collection package for                                      collection and recordkeeping
                                                      accordance with the requirements of                                       approval to the Office of Management                                        requirements. These comments will
                                                      Executive Order 13175, ‘‘Consultation                                     and Budget (OMB). Upon approval of                                          help APHIS:
                                                      and Coordination with Indian Tribal                                       this new information collection, it will                                       (1) Evaluate whether the proposed
                                                      Governments.’’ Executive Order 13175                                      be merged into the existing 0579–0085.                                      information collection is necessary for
                                                      requires Federal agencies to consult and                                    Please send comments on the                                               the proper performance of our agency’s
                                                      coordinate with Tribes on a                                               Information Collection Request (ICR) to                                     functions, including whether the
                                                      government-to-government basis on                                         OMB’s Office of Information and                                             information will have practical utility;
                                                      policies that have Tribal implications,                                   Regulatory Affairs via email to oira_                                          (2) Evaluate the accuracy of our
                                                      including regulations, legislative                                        submissions@omb.eop.gov, Attention:                                         estimate of the burden of the proposed
                                                      comments or proposed legislation, and                                     Desk Officer for APHIS, Washington, DC                                      information collection, including the
                                                      other policy statements that have                                         20503. Please state that your comments                                      validity of the methodology and
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      substantial direct effects on one or more                                 refer to Docket No. APHIS–2015–0057.                                        assumptions used;
                                                      Indian Tribes, on the relationship                                        Please send a copy of your comments to:                                        (3) Enhance the quality, utility, and
                                                      between the Federal Government and                                        USDA, using one of the methods                                              clarity of the information to be
                                                      Indian Tribes, or on the distribution of                                  described under ADDRESSES at the                                            collected; and
                                                      power and responsibilities between the                                    beginning of this document.                                                    (4) Minimize the burden of the
                                                      Federal Government and Indian Tribes.                                       APHIS is proposing to revise its                                          information collection on those who are
                                                        The Animal and Plant Health                                             regulations governing the importation,                                      to respond (such as through the use of
                                                      Inspection Service has assessed the                                       interstate movement, and release into                                       appropriate automated, electronic,
                                                      impact of this rule on Indian Tribes and                                  the environment of organisms                                                mechanical, or other technological


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                               7035

                                                      collection techniques or other forms of                 PART 340—MOVEMENT OF                                         Administrator. The Administrator of
                                                      information technology; e.g., permitting                ORGANISMS ALTERED OR                                      the Animal and Plant Health Inspection
                                                      electronic submission of responses).                    PRODUCED THROUGH GENETIC                                  Service (APHIS) or any other employee
                                                         Estimate of burden: Public reporting                 ENGINEERING THAT ARE NOXIOUS                              of APHIS to whom authority has been
                                                      burden for this collection of information               WEEDS OR PLANT PESTS OR THAT                              or may be delegated to act in the
                                                      is estimated to average 0.828 hours per                 THERE IS REASON TO BELIEVE ARE                            Administrator’s stead.
                                                                                                              NOXIOUS WEEDS OR PLANT PESTS                                 Agent. A person who is authorized to
                                                      response.                                                                                                         act on behalf of the responsible person
                                                         Respondents: Developers of organisms                 Sec.                                                      to maintain control over a regulated
                                                      regulated under 7 CFR part 340;                         340.0 General restrictions and scope.                     organism during its importation,
                                                      businesses and individuals associated                   340.1 Definitions.                                        interstate movement, or environmental
                                                                                                              340.2 Taxa that are or contain plant pests.
                                                      with such organisms; Tribal                             340.3 Permits.                                            release and ensures compliance with all
                                                      governments.                                            340.4 Regulatory status evaluation.                       conditions contained in any applicable
                                                         Estimated Annual Number of                           340.5 Record retention, compliance, and                   permit or exemption as well as other
                                                      Respondents: 311.                                            enforcement.                                         requirements in this part. Agents may
                                                                                                              340.6 Confidential business information.                  be, but are not limited to, brokers,
                                                         Estimated Annual Number of                           340.7 Costs and charges.                                  farmers, researchers, or site cooperators.
                                                      Responses per Respondent: 16.                             Authority: 7 U.S.C. 7701–7772 and 7781–                 An agent must be at least 18 years of age
                                                         Estimated Annual Number of                           7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and               and be a legal resident of the United
                                                      Responses: 5035.                                        371.3.                                                    States.
                                                         Estimated Total Annual Burden on                                                                                  Animal and Plant Health Inspection
                                                                                                              § 340.0    General restrictions and scope.
                                                      Respondents: 4174 hours. (Due to                                                                                  Service (APHIS). An agency of the
                                                                                                                 (a) No person may move any regulated                   United States Department of
                                                      averaging, the total annual burden hours                organism except in accordance with this                   Agriculture.
                                                      may not equal the product of the annual                 part.                                                        Contained facility. A structure for the
                                                      number of responses multiplied by the                      (b) A regulated organism is any GE                     storage and/or propagation of living
                                                      reporting burden per response.)                         organism that either:                                     organisms designed with physical
                                                         A copy of the information collection                    (1) Prior to genetic engineering,
                                                                                                                                                                        barriers capable of preventing the
                                                      may be viewed on the Regulations.gov                    belonged to any taxon listed in
                                                                                                                                                                        escape of the enclosed organisms.
                                                      Web site or in our reading room. (A link                accordance with § 340.2 and met the
                                                                                                                                                                        Examples include laboratories, growth
                                                                                                              definition of plant pest in § 340.1; or
                                                      to Regulations.gov and information on                                                                             chambers, fermenters, and containment
                                                                                                                 (2) Has received deoxyribonucleic
                                                      the location and hours of the reading                   acid (DNA) from any taxon listed in                       greenhouses.
                                                      room are provided under the heading                                                                                  Donor organism. The organism from
                                                                                                              accordance with § 340.2, the DNA from
                                                      ADDRESSES at the beginning of this                                                                                which genetic material is obtained for
                                                                                                              the donor organism is sufficient to
                                                      proposed rule.) Copies can also be                                                                                transfer to the recipient organism.
                                                                                                              produce an infectious entity capable of                      Environment. All the land, air, and
                                                      obtained from Ms. Kimberly Hardy,                       causing plant disease or encodes a
                                                      APHIS’ Information Collection                                                                                     water; and all living organisms in
                                                                                                              compound known to be pathogenesis-                        association with land, air, and water.
                                                      Coordinator, at (301) 851–2483. APHIS                   related that is expected to cause plant
                                                      will respond to any ICR-related                                                                                      Genetic engineering. Techniques that
                                                                                                              disease symptoms, and the organism has                    use recombinant or synthetic nucleic
                                                      comments in the final rule. All                         not been evaluated by APHIS for plant
                                                      comments will also become a matter of                                                                             acids with the intent to create or alter
                                                                                                              pest risk in accordance with § 340.4; or                  a genome. Genetic engineering does not
                                                      public record.                                             (3) Is a plant that has a plant and trait              include traditional breeding techniques
                                                      E-Government Act Compliance                             combination that has not been evaluated                   (including, but not limited to, marker-
                                                                                                              by APHIS for plant pest and noxious                       assisted breeding and chemical or
                                                         The Animal and Plant Health                          weed risk in accordance with § 340.4; or                  radiation-based mutagenesis, as well as
                                                      Inspection Service is committed to                         (4) Is any of the foregoing that has
                                                                                                                                                                        tissue culture and protoplast, cell, or
                                                      compliance with the E-Government Act                    been evaluated by APHIS in accordance
                                                                                                                                                                        embryo fusion).
                                                      to promote the use of the Internet and                  with § 340.4 and determined to pose a                        Genetically engineered organism (GE
                                                      other information technologies, to                      risk as a plant pest and/or noxious weed                  organism). An organism developed
                                                      provide increased opportunities for                     or is a GE organism that has otherwise                    using genetic engineering. For the
                                                      citizen access to Government                            been determined by the Administrator                      purposes of this part, an organism will
                                                      information and services, and for other                 to pose a risk as a plant pest or noxious                 not be considered a genetically
                                                      purposes. For information pertinent to                  weed.1                                                    engineered organism if:
                                                      E-Government Act compliance related                     § 340.1    Definitions.                                      (1) The genetic modification to the
                                                      to this proposed rule, please contact Ms.                 Terms used in the singular form in                      organism is solely a deletion of any size
                                                      Kimberly Hardy, APHIS’ Information                      this part shall be construed as the                       or a single base pair substitution which
                                                      Collection Coordinator, at (301) 851–                   plural, and vice versa, as the case may                   could otherwise be obtained through the
                                                      2483.                                                   demand. The following terms, when                         use of chemical- or radiation-based
                                                                                                                                                                        mutagenesis; or
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                                                      List of Subjects in 7 CFR Part 340                      used in this part, shall be construed,
                                                                                                                                                                           (2) The genetic modification to the
                                                                                                              respectively, to mean:
                                                        Administrative practice and                                                                                     organism is solely introducing only
                                                      procedure, Biotechnology, Genetic                          1 The importation, interstate movement, and            naturally occurring nucleic acid
                                                                                                              release into the environment of regulated organisms       sequences from a sexually compatible
                                                      engineering, Imports, Packaging and
                                                                                                              is subject to any other applicable restrictions of this   relative that could otherwise cross with
                                                      containers, Plant diseases and pests,                   chapter. For example, in ‘‘Subpart—Plants for             the recipient organism and produce
                                                      Transportation.                                         Planting’’ (§§ 319.37–319.37–14 of this chapter), a
                                                                                                              permit is required for the importation of certain
                                                                                                                                                                        viable progeny through traditional
                                                        Accordingly, we are proposing to                      plants for planting, regardless of whether the plants     breeding (including, but not limited to,
                                                      revise 7 CFR part 340 to read as follows:               for planting have been genetically engineered.            marker-assisted breeding, as well as


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                                                      7036                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      tissue culture and protoplast, cell, or                    Plant. Any plant (including any plant                 Unauthorized release. The intentional
                                                      embryo fusion); or                                      part) for or capable of propagation,                   or accidental release of a regulated
                                                         (3) The organism is a ‘‘null                         including a tree, a tissue culture, a                  organism in a manner that is not
                                                      segregant,’’ that is, the progeny of a GE               plantlet culture, pollen, a shrub, a vine,             authorized by a permit issued pursuant
                                                      organism where the only genetic                         a cutting, a graft, a scion, a bud, a bulb,            to this part.
                                                      modification was the insertion of donor                 a root, and a seed.                                      Weed risk assessment. An assessment
                                                      nucleic acid into the recipient’s genome,                  Plant pest. Any living stage of a                   of the characteristics of a plant as these
                                                      but the donor nucleic acid is not passed                protozoan, invertebrate nonhuman                       relate to weediness.
                                                      to the recipient organism’s progeny and                 animal, parasitic plant, bacterium,
                                                                                                                                                                     § 340.2   Taxa that are or contain plant
                                                      the donor nucleic acid has not altered                  fungus, virus or viroid, infectious agent              pests.
                                                      the DNA sequence of the progeny.                        or other pathogen, or any article similar
                                                                                                                                                                        (a) Taxa that are or contain plant pests
                                                         Import (importation). To move into, or               to or allied with any of the foregoing,
                                                                                                                                                                     are listed on the APHIS Web site at
                                                      the act of movement into, the territorial               that can directly or indirectly injure,
                                                                                                                                                                     http://www.aphis.usda.gov/
                                                      limits of the United States.                            cause damage to, or cause disease in any
                                                                                                                                                                     biotechnology/2016-340-proposed-rule.
                                                         Inspector. Any individual authorized                 plant or plant product.
                                                                                                                 Plant pest risk assessment. An                      Within any taxonomic group included
                                                      by the Administrator of APHIS or the                                                                           on the list, the lowest unit of
                                                      Commissioner of Customs and Border                      assessment evaluating whether a GE
                                                                                                              organism is a plant pest.                              classification actually listed is the taxon
                                                      Protection, Department of Homeland                                                                             or group which may contain organisms
                                                      Security, to enforce the regulations in                    Plant product. Any flower, fruit,
                                                                                                              vegetable, root, bulb, seed, or other                  that are regulated. Organisms belonging
                                                      this part.                                                                                                     to all lower taxa contained within the
                                                         Interstate. From one State into or                   plant part that is not included in the
                                                                                                              definition of plant or any manufactured                group listed are included as organisms
                                                      through any other State or within the                                                                          that may be or may contain plant pests,
                                                      District of Columbia, Guam, the Virgin                  or processed plant or plant part.
                                                                                                                 Recipient organism. The organism                    and are regulated if they meet the
                                                      Islands of the United States, or any                                                                           definition of a plant pest in § 340.1.
                                                      other territory or possession of the                    whose nucleic acid sequence will be
                                                                                                              altered through the use of genetic                        (b) APHIS-initiated changes to listed
                                                      United States.                                                                                                 taxa. APHIS may propose to add or
                                                         Interstate movement. To move                         engineering.
                                                                                                                 Regulated organism. Any GE                          remove a taxon from the list referred to
                                                      interstate.                                                                                                    in paragraph (a) of this section through
                                                                                                              organism that is regulated pursuant to
                                                         Move (moving, movement). To carry,                                                                          a notice published in the Federal
                                                                                                              § 340.0.
                                                      enter, import, mail, ship, or transport;                   Regulatory sequence. A segment of                   Register. The notice will state why
                                                      aid, abet, cause, or induce the carrying,               nucleic acid molecule that is capable of               APHIS has determined it necessary to
                                                      entering, importing, mailing, shipping,                 increasing or decreasing the expression                add or remove the taxon, and will
                                                      or transporting; to offer to carry, enter,              of specific genes within an organism.                  request public comment. If no
                                                      import, mail, ship, or transport; to                       Release into the environment                        comments are received on the notice, or
                                                      receive to carry, enter, import, mail,                  (environmental release). The use of a                  the comments received do not affect
                                                      ship, or transport; to release into the                 regulated organism outside the physical                APHIS’ determination, APHIS will
                                                      environment; or to allow any of the                     constraints found in a contained facility.             publish a subsequent notice in the
                                                      above activities to occur.                                 Responsible person. The person who                  Federal Register stating that the taxon
                                                         Noxious weed. Any plant or plant                     has control and will maintain control                  has been added or removed from the list
                                                      product that can directly or indirectly                 over a regulated organism during its                   referred to in paragraph (a) of this
                                                      injure or cause damage to crops                         movement and ensures compliance with                   section.
                                                      (including nursery stock or plant                       all conditions contained in any                           (c) Petitions to amend the list of taxa.
                                                      products), livestock, poultry, or other                 applicable permit or exemption as well                 Any person may submit to the
                                                      interests of agriculture, irrigation,                   as other requirements in this part. A                  Administrator a petition to amend the
                                                      navigation, the natural resources of the                responsible person must be at least 18                 list of taxa referred to in paragraph (a)
                                                      United States, the public health, or the                years of age and be a legal resident of                of this section by adding or removing
                                                      environment.                                            the United States.                                     any taxon. The petitioner may
                                                         Nucleic acid. A chain or chains of                      Secure shipment. Shipment in a                      supplement, amend, or withdraw a
                                                      nucleotides found in either DNA or                      container or a means of conveyance of                  petition in writing without prior
                                                      ribonucleic acid.                                       sufficient strength and integrity to                   approval of the Administrator and
                                                         Organism. Any active, infective, or                  withstand leakage of contents, shocks,                 without prejudice to resubmission at
                                                      dormant stage of life form of an entity                 pressure changes, and other conditions                 any time until the Administrator rules
                                                      characterized as living, including                      incident to ordinary handling in                       on the request. A petition to amend the
                                                      vertebrate and invertebrate animals,                    transportation.                                        list of taxa must be submitted in
                                                      plants, bacteria, fungi, mycoplasmas,                      State. Any of the several States of the             accordance with the procedures and
                                                      mycoplasma-like organisms, as well as                   United States, the Commonwealth of the                 format provided on the APHIS Web site
                                                      entities such as viroids, viruses, or any               Northern Mariana Islands, the                          at http://www.aphis.usda.gov/
                                                      entity characterized as living, related to              Commonwealth of Puerto Rico, the                       biotechnology/2016-340-proposed-rule.
                                                      the foregoing.                                          District of Columbia, the Virgin Islands                  (d) Administrative action on a
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                                                         Permit. A written authorization,                     of the United States, or other Territories             petition. (1) A petition to amend the list
                                                      including by electronic methods, by the                 or possessions of the United States.                   of taxa that meets the requirements of
                                                      Administrator to move regulated                            State or Tribal regulatory official.                paragraph (b) of this section as well as
                                                      organisms and associated articles under                 State or Tribal official with                          the date of the petition will be
                                                      conditions prescribed by the                            responsibilities for plant health, or any              acknowledged by APHIS. If a request
                                                      Administrator.                                          other duly designated State or tribal                  does not meet the requirements of
                                                         Person. Any individual, partnership,                 official, in the State or on the Tribal                paragraph (b) of this section, the
                                                      corporation, company, society,                          lands where the movement is to take                    requester will be sent a notice indicating
                                                      association, or other organized group.                  place.                                                 how the request is deficient.


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                           7037

                                                        (2) APHIS will publish in the Federal                    (d) Administrative actions. (1) APHIS                  (e) General permit conditions. The
                                                      Register, for 60 days public comment, a                 will review the application to determine               following conditions will be assigned to
                                                      notice announcing the availability of a                 if it is complete. APHIS will notify the               all permits issued under this section. A
                                                      petition to amend the list of organisms.                applicant in writing if the application is             responsible person, and his/her agents,
                                                      Following the close of the comment                      incomplete, and the applicant will be                  must ensure compliance with these
                                                      period, APHIS will review the                           provided the opportunity to revise the                 conditions, as well as any additional or
                                                      comments received and publish its final                 application. If the applicant does not                 expanded conditions listed on the
                                                      decision in the Federal Register.                       respond to the request for additional                  permit:
                                                        (e) Appeal of denial. Any person                      information within 30 days of receipt of                  (1) The regulated organism must be
                                                      whose petition has been denied may                      APHIS’s request, APHIS will deem the                   maintained and disposed of in a manner
                                                      appeal the decision in writing to the                   application withdrawn. Once an                         so as to prevent the unauthorized
                                                      Administrator within 30 days after                      application is complete, APHIS will                    release of the regulated organism.
                                                      receiving the written notification of the               review it to determine whether to                         (2) The regulated organism must be
                                                      denial. The appeal must state all of the                approve or deny the application.                       kept separate from other organisms,
                                                      facts and reasons upon which the                           (2) APHIS assignment of permit                      except as specifically allowed in the
                                                      person relies to assert that the petition               conditions. If a permit application is                 permit.
                                                      was wrongfully denied. The                              approved, the Administrator will assign                   (3) The regulated organism must be
                                                      Administrator will grant or deny the                    permit conditions to each permit                       maintained only in areas and premises
                                                      appeal, in writing, stating the reasons                 commensurate with the risk of the                      specified in the permit.
                                                      for the decision as promptly as                         regulated organism and activity. General                  (4) The regulated organism’s identity
                                                      circumstances allow.                                    conditions assigned to all permits are                 must be maintained at all times.
                                                                                                                                                                        (5) In the event of an unauthorized
                                                      § 340.3   Permits.                                      located in paragraph (e) of this section.
                                                                                                                                                                     release:
                                                                                                              The Administrator may assign
                                                         (a)(1) Except as provided in paragraph                                                                         (i) The regulated organism must
                                                                                                              additional or expanded permit
                                                      (a)(2) of this section, APHIS must have                                                                        undergo the application of remedial
                                                                                                              conditions commensurate with the risk
                                                      evaluated a regulated organism in                                                                              measures determined by the
                                                                                                              that the activities listed on the permit
                                                      accordance with § 340.4 before it will                                                                         Administrator to be necessary to prevent
                                                                                                              application present of disseminating the
                                                      issue permits for importation, interstate                                                                      the spread of regulated organism;
                                                                                                              regulated organism, or other plant pests                  (ii) The responsible person must
                                                      movement, or release into the
                                                                                                              or noxious weeds.                                      contact APHIS as described in the
                                                      environment of the organism pursuant
                                                      to this section.                                           (3) Inspections. All premises                       permit within 24 hours of discovery,
                                                         (2) APHIS may issue a permit                         associated with the permit are subject to              and subsequently supply a statement of
                                                      pursuant to this section for the                        inspection before and after permit                     facts in writing no later than 5 business
                                                      importation or interstate movement of a                 issuance. The responsible person must                  days after discovery.
                                                      regulated organism that has not been                    provide APHIS inspectors access to                        (6) The duration that the permit is
                                                      evaluated in accordance with § 340.4, at                inspect any relevant premises, facility,               valid will be listed on the permit itself.
                                                      the request of an applicant. For the                    release location, storage area, waypoint,              During such time, the responsible
                                                      purposes of permitting conditions,                      materials, equipment, means of                         person must maintain records related to
                                                      APHIS will assume the regulated                         conveyance, and other articles related to              permitted activities of sufficient quality
                                                      organism presents a risk as a plant pest                the proposed movement of organisms                     and completeness to demonstrate
                                                      and/or noxious weed. If the regulatory                  regulated under this part. Failure to                  compliance with all permit conditions
                                                      status of the organism is evaluated in                  allow the inspection of a premises prior               and requirements under this part. The
                                                      accordance with § 340.4 during the                      to the issuance of a permit will be                    responsible person must submit reports
                                                      duration of the permit, APHIS may                       grounds for the denial of a permit                     and notices to APHIS at the times
                                                      amend or terminate the permit                           application. Failure to allow the                      specified in the permit and containing
                                                      accordingly.                                            inspection of a premises following                     the information specified within the
                                                         (3) Except as provided in paragraph                  permit issuance will be grounds for                    permit. Inspectors must be allowed
                                                      (c) of this section, a permit must be                   revocation of the permit.                              access, during regular business hours, to
                                                      issued by APHIS for the importation,                       (4) State or Tribal review and                      the place where the regulated organism
                                                      interstate movement, or release into the                comment. The Administrator will                        is located and to any records relating to
                                                      environment of all regulated organisms.                 submit for notice and review a copy of                 the movement of a regulated organism.
                                                         (b) A responsible person must apply                  the permit application and any permit                  APHIS’ access to records includes visual
                                                      for and obtain a permit through a                       conditions to the appropriate State or                 inspection and reproduction
                                                      method listed at http://                                Tribal regulatory official. Comments                   (photocopying, digital reproduction,
                                                      www.aphis.usda.gov/biotechnology/                       received from the State or Tribal                      etc.) of all records required to be
                                                      2016-340-proposed-rule. The                             regulatory official may be considered by               maintained under this part, as requested
                                                      application must also contain all the                   the Administrator prior to permit                      by APHIS.
                                                      categories of information listed at that                issuance.                                                 (7) The responsible person must
                                                      Web site for the type of permit being                      (5) Agreement with permit conditions.               notify APHIS in writing if any permitted
                                                      requested.                                              Prior to issuance of a permit, the                     activity associated with environmental
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                                                         (c) A permit for interstate movement                 responsible person must agree in                       release will not be conducted.
                                                      is not required for genetically                         writing, in a manner prescribed by the                    (8) Within 28 days after the initiation
                                                      engineered Arabidopsis thaliana,                        Administrator, that the responsible                    of any permitted activity related to
                                                      provided that it is moved as a secure                   person and all agents of the responsible               environmental release, the responsible
                                                      shipment, the cloned genetic material is                person are aware of, understand, and                   person must report to APHIS in writing
                                                      stably integrated into the plant genome,                will comply with the permit conditions.                the actual release site coordinates and
                                                      and the cloned material does not                        Failure to comply with this provision                  details of the release, such as how many
                                                      include the complete infectious genome                  will be grounds for the denial of a                    acres planted, how many organisms
                                                      of a plant pest.                                        permit.                                                released, etc., based on permit


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                                                      7038                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      conditions, as well as every 28 days                    permit has been or revoked may appeal                  accordance with the regulations in 49
                                                      thereafter until all releases are                       the decision in writing to the                         CFR part 178. The container must be
                                                      completed.                                              Administrator. Any appeal must occur                   accompanied by a document that
                                                        (9) A person who has been issued a                    within 10 days after receiving the                     includes the names and contact details
                                                      permit must submit to APHIS an                          written notification of the denial or                  for the sender and recipient. Following
                                                      environmental release report within 6                   revocation. The appeal must state all of               the completion of the shipment, all
                                                      months after the termination of any                     the facts and reasons upon which the                   packing material, shipping containers,
                                                      release into the environment. The report                person relies to assert that the permit                and any other material accompanying
                                                      must include the APHIS reference                        was wrongfully denied or revoked. The                  the regulated organism must be treated
                                                      number, methods of observation,                         Administrator will grant or deny the                   or disposed of in such a manner so as
                                                      resulting data, and analysis regarding all              appeal, in writing, stating the reasons                to prevent the unauthorized
                                                      deleterious effects on plants, nontarget                for the decision as promptly as                        dissemination and establishment of
                                                      organisms, or the environment.                          circumstances allow. If there is a                     regulated organisms. Additionally, for
                                                        (f) Denial or revocation of a permit.                 conflict as to any material fact, a hearing            any regulated organism to be imported
                                                      Permit applications may be denied, or                   shall be held to resolve such conflict.                into the United States, the outmost
                                                      permits revoked, in accordance with                     Rules of practice concerning such a                    container must bear the nature and
                                                      this paragraph.                                         hearing will be adopted by the                         quantity of the contents; the country
                                                        (1) Denial. The Administrator may                     Administrator.                                         and locality where collected, developed,
                                                      deny, either orally or in writing, any                     (h) Amendment of permits.                           manufactured, reared, cultivated, or
                                                      application for a permit. If the denial is                 (1) Amendment at responsible                        cultured; the name and address of the
                                                      oral, the Administrator will                            person’s request. If a responsible person              shipper, owner, or person shipping or
                                                      communicate the denial and the reasons                  determines that circumstances have                     forwarding the organism; the name,
                                                      for it in writing as promptly as                        changed since the permit was initially                 address, and telephone number of the
                                                      circumstances allow. The Administrator                  issued and wishes the permit to be                     consignee; the identifying shipper’s
                                                      may deny a permit application if:                       amended accordingly, he or she must                    mark and number; and the number of
                                                        (i) The Administrator concludes that,                 request the amendment by contacting                    written permit authorizing the
                                                      based on the application or on                          APHIS directly. The responsible person                 importation. For regulated organisms
                                                      additional information, the actions                     may have to provide supporting                         imported by mail, the container must
                                                      proposed under the permit may result in                 information justifying the amendment.                  also be addressed to a plant inspection
                                                      the unauthorized release of the                         APHIS will review the amendment                        station listed in § 319.37–14 of this
                                                      regulated organism, or another plant                    request, and may amend the permit if                   chapter. All imported containers of
                                                      pest or noxious weed; or                                only minor changes are necessary.                      regulated organisms must be
                                                        (ii) The Administrator determines that                Requests for more substantive changes                  accompanied by an invoice or packing
                                                      the responsible person or any agent of                  may require a new permit application.                  list indicating the contents of the
                                                      the responsible person has failed to                    Prior to issuance of an amended permit,                shipment.
                                                      comply at any time with any provision                   the responsible person may be required
                                                      of this part or any other part of the                   to agree in writing that he or she, and                § 340.4   Regulatory status evaluation.
                                                      regulations, or any permit that has                     his or her agents, will comply with the                   (a) Any person may submit a request
                                                      previously been issued in accordance                    amended permit and conditions.                         to APHIS to have a GE organism’s
                                                      with this part.                                            (2) Amendment initiated by APHIS.                   regulatory status evaluated, or to request
                                                        (2) Revocation. The Administrator                     APHIS may amend any permit and its                     the reevaluation of the regulatory status
                                                      may revoke, either orally or in writing,                conditions at any time, upon                           of a previously evaluated regulated
                                                      any permit which has been issued. If the                determining that the amendment is                      organism. Information needed for such
                                                      revocation is oral, the Administrator                   needed to address newly identified                     a request is found on the Internet, at
                                                      will communicate the revocation and                     considerations concerning the risks                    http://www.aphis.usda.gov/
                                                      the reasons for it in writing as promptly               presented by the organism or the                       biotechnology/2016-340-proposed-rule.
                                                      as circumstances allow. The                             activities being conducted under the                      (b) Administrative action. (1) Upon
                                                      Administrator may revoke a permit if:                   permit. APHIS may also amend a permit                  receiving or initiating a regulatory status
                                                        (i) Following issuance of the permit,                 at any time to ensure that the permit                  request, APHIS will evaluate the request
                                                      the Administrator receives information                  conditions are consistent with all of the              for completeness, and may contact the
                                                      that would otherwise have provided                      requirements of this part. As soon as                  person submitting the request for
                                                      grounds for APHIS to deny the permit                    circumstances allow, APHIS will notify                 additional information.
                                                      application;                                            the responsible person of the                             (2) If the request is complete, APHIS
                                                        (ii) The Administrator determines that                amendment to the permit and the                        will conduct an analysis of plant pest
                                                      actions taken under the permit have                     reason(s) for it. Depending on the nature              and/or weed risks of the GE organism.
                                                      resulted in the unauthorized release of                 of the amendment, the responsible                         (c)(1) APHIS will make both the
                                                      the regulated organism, or another plant                person may have to agree in writing or                 request and the risk analysis available
                                                      pest or noxious weed; or                                electronically that he or she, and his or              for public review through a notice
                                                        (iii) The Administrator determines                    her agents, will comply with the permit                published in the Federal Register. The
                                                      that the responsible person or any agent                and conditions as amended before                       notice will request public comment, and
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                                                      of the responsible person has failed to                 APHIS will issue the amended permit.                   will propose a regulatory status for the
                                                      comply at any time with any provision                   If APHIS requests such an agreement,                   organism.
                                                      of this part or any other part of the                   and the responsible person does not so                    (2) If no comments are received on the
                                                      regulations. This includes failure to                   agree, the existing permit will be                     notice, or if the comments do not affect
                                                      comply with the conditions of any                       revoked.                                               the conclusions of the risk analysis or
                                                      permit issued.                                             (i) Shipping under a permit. All                    the proposed regulatory status of the
                                                        (g) Appeal of denial or revocation of                 shipments of regulated organisms must                  organism, APHIS will provide
                                                      permit. Any person whose permit                         be secure shipments. Regulated                         notification through the APHIS
                                                      application has been denied or whose                    organisms must also be shipped in                      stakeholder registry at the end of the


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                                      7039

                                                      comment period announcing that the                      reached its intended destination must                  deemed to contain confidential business
                                                      proposed regulatory status has been                     be retained for at least 2 years. All other            information, those portions must be
                                                      finalized. APHIS will subsequently                      records must be retained for 10 years                  identified, and each page containing
                                                      publish a notice in the Federal Register                following permit expiration, unless                    such information must be marked ‘‘CBI
                                                      compiling these determinations.                         determined otherwise by the                            Copy.’’ A second copy of each such
                                                         (3) If comments lead APHIS to change                 Administrator and documented in the                    document must be submitted with all
                                                      its proposed regulatory status for the                  supplemental permit conditions or other                such CBI deleted and marked on each
                                                      organism, APHIS will publish a                          regulatory requirements.                               page where the CBI was deleted: ‘‘CBI
                                                      subsequent notice in the Federal                           (c) Compliance and enforcement. (1)                 Deleted.’’ In addition, any person
                                                      Register characterizing these comments                  Responsible persons and their agents                   submitting CBI must justify how each
                                                      and announcing the new regulatory                       must comply with all of the                            piece of information requested to be
                                                      status.                                                 requirements of this part. Failure to
                                                                                                                                                                     treated as CBI is a trade secret or is
                                                                                                              comply with any of the requirements of
                                                      § 340.5 Record retention, compliance, and                                                                      commercial or financial information and
                                                                                                              this part may result in any or all of the
                                                      enforcement.                                                                                                   is privileged or confidential.
                                                                                                              following:
                                                        (a) Record retention. Responsible                        (i) Denial of a permit application or               § 340.7   Costs and charges.
                                                      persons or their agents are required to                 revocation of a permit;
                                                      establish and keep the following records                   (ii) Application of remedial measures                 The services of the inspector related
                                                      and reports:                                            in accordance the Plant Protection Act,                to carrying out this part and provided
                                                        (1) All records and reports required as               7 U.S.C. 7701 et seq.; and/or                          during regularly assigned hours of duty
                                                      a condition of a permit;                                   (iii) Criminal and/or civil penalties.              and at the usual places of duty will be
                                                        (2) Addresses and any other                              (2) Prior to the issuance of a                      furnished without cost.2 The U.S.
                                                      information needed to identify all                      complaint seeking a civil penalty, the                 Department of Agriculture will not be
                                                      contained facilities where the regulated                Administrator may enter into a                         responsible for any costs or charges
                                                      organism was stored or utilized, and all                stipulation, in accordance with § 380.10               incident to inspections or compliance
                                                      locations where the regulated organism                  of this chapter.                                       with the provisions of this part, other
                                                      was used in an environmental release;                      (d) Liability for acts of an agent. For             than for the services of the inspector.
                                                        (3) A record identifying which APHIS                  purposes of enforcing this part, the act,
                                                      permit, if any, authorized the permitted                omission, or failure of any agent for a                  Done in Washington, DC, this 10th day of
                                                      activity; and                                           responsible person may be deemed also                  January 2017.
                                                        (4) Copies of contracts between the                   to be the act, omission, or failure of the             Ben Thomas,
                                                      responsible person and all agents that                  responsible person.                                    Deputy Under Secretary for Marketing and
                                                      conduct activities subject to this part for                                                                    Regulatory Programs.
                                                      the responsible person, and copies and                  § 340.6    Confidential business information.
                                                                                                                                                                     [FR Doc. 2017–00858 Filed 1–18–17; 8:45 am]
                                                      documents relating to agreements made                      Persons submitting confidential
                                                                                                                                                                     BILLING CODE 3410–34–P
                                                      without a written contract.                             business information in any document
                                                        (b) Record retention. Records                         submitted to APHIS under this part                       2 The Department’s provisions relating to
                                                      indicating that a regulated organism that               should do so in the following manner.                  overtime charges for an inspector’s services are set
                                                      was imported or moved interstate                        If there are portions of a document                    forth in part 354 of this chapter.
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Document Created: 2018-02-01 15:16:18
Document Modified: 2018-02-01 15:16:18
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionProposed rule.
DatesWe will consider all comments that we receive on or before May 19, 2017.
ContactDr. Sidney Abel, Assistant Deputy Administrator, Biotechnology Regulatory Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD 20737-1238; (301) 851-3896.
FR Citation82 FR 7008 
RIN Number0579-AE15
CFR AssociatedAdministrative Practice and Procedure; Biotechnology; Genetic Engineering; Imports; Packaging and Containers; Plant Diseases and Pests and Transportation

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