82_FR_6992 82 FR 6980 - Plant Pest Regulations; Update of Provisions

82 FR 6980 - Plant Pest Regulations; Update of Provisions

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

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

Page Range6980-7005
FR Document2017-00532

We are proposing to revise our regulations regarding the movement of plant pests. We are proposing criteria regarding the movement and environmental release of biological control organisms, and are proposing to establish regulations to allow the importation and movement in interstate commerce of certain types of plant pests without restriction by granting exceptions from permitting requirements for those pests. We are also proposing to revise our regulations regarding the movement of soil. This proposed rule replaces a previously published proposed rule, which we are withdrawing as part of this document. This proposal would clarify the factors that would be considered when assessing the risks associated with the movement of certain organisms and facilitate the movement of regulated organisms and articles in a manner that also protects U.S. agriculture.

Federal Register, Volume 82 Issue 12 (Thursday, January 19, 2017)
[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)]
[Proposed Rules]
[Pages 6980-7005]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-00532]



[[Page 6979]]

Vol. 82

Thursday,

No. 12

January 19, 2017

Part V





Department of Agriculture





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Animal and Plant Health Inspection Service





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7 CFR Parts 318, 319, 330, et al.





Plant Pest Regulations; Update of Provisions; Proposed Rule

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

[[Page 6980]]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Parts 318, 319, 330, and 352

[Docket No. APHIS-2008-0076]
RIN 0579-AC98


Plant Pest Regulations; Update of Provisions

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule; withdrawal and reproposal.

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SUMMARY: We are proposing to revise our regulations regarding the 
movement of plant pests. We are proposing criteria regarding the 
movement and environmental release of biological control organisms, and 
are proposing to establish regulations to allow the importation and 
movement in interstate commerce of certain types of plant pests without 
restriction by granting exceptions from permitting requirements for 
those pests. We are also proposing to revise our regulations regarding 
the movement of soil. This proposed rule replaces a previously 
published proposed rule, which we are withdrawing as part of this 
document. This proposal would clarify the factors that would be 
considered when assessing the risks associated with the movement of 
certain organisms and facilitate the movement of regulated organisms 
and articles in a manner that also protects U.S. agriculture.

DATES: We will consider all comments that we receive on or before March 
20, 2017.

ADDRESSES: You may submit comments by either of the following methods:

     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2008-0076.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2008-0076, 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-2008-
0076 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. Colin D. Stewart, Assistant 
Director; Pests, Pathogens, and Biocontrol Permits Branch, Plant Health 
Programs, PPQ, APHIS, 4700 River Road, Unit 133, Riverdale, MD 20737-
1236; (301) 851-2237.

SUPPLEMENTARY INFORMATION:

Background

    Under the Plant Protection Act (7 U.S.C. 7712 et seq., referred to 
below as the PPA or the Act), the Secretary of Agriculture has 
authority to carry out operations or measures to detect, control, 
eradicate, suppress, prevent, or retard the spread of plant pests. 
Section 7711(a) of the Act provides that ``no person shall import, 
enter, export, or move in interstate commerce any plant pest, unless 
the importation, entry, exportation, or movement is authorized under 
general or specific permit and in accordance with such regulations as 
the Secretary may issue to prevent the introduction of plant pests into 
the United States or the dissemination of plant pests within the United 
States.'' The Act gives the United States Department of Agriculture 
(USDA) the flexibility to respond appropriately to a wide range of 
needs and circumstances to protect American agriculture against plant 
pests. The Act defines a plant pest as ``any living stage of any of the 
following that can directly or indirectly injure, cause damage to, or 
cause disease in any plant or plant product: (A) A protozoan; (B) A 
nonhuman animal; (C) A parasitic plant; (D) A bacterium; (E) A fungus; 
(F) A virus or viroid; (G) An infectious agent or other pathogen; (H) 
Any article similar to or allied with any of the articles specified in 
the preceding subparagraphs.''
    In addition, section 412(a) of the Act provides that the Secretary 
may prohibit or restrict the importation, entry, exportation, or 
movement in interstate commerce of, among other things, any biological 
control organism if the Secretary determines that the prohibition or 
restriction is necessary to prevent the introduction into the United 
States or the dissemination of a plant pest or noxious weed within the 
United States. The Act defines a biological control organism as ``any 
enemy, antagonist, or competitor used to control a plant pest or 
noxious weed.''
    The purpose of the regulations in ``Subpart--Movement of Plant 
Pests'' (7 CFR 330.200 through 330.212) and ``Subpart--Movement of 
Soil, Stone, and Quarry Products'' (7 CFR 330.300 through 330.301) is 
to prevent the dissemination of plant pests into the United States, or 
interstate, by regulating the importation and interstate movement of 
plant pests, soil, stone, and quarry products.
    These regulations were issued by the Animal and Plant Health 
Inspection Service (APHIS) under the authority provided by, among other 
statutes, the Department of Agriculture Organic Act of 1944, as amended 
(7 U.S.C. 147a), and the Federal Plant Pest Act, as amended (7 U.S.C. 
150aa through 150jj), both of which were superseded and repealed by the 
PPA. Most of the provisions of the PPA regarding the importation and 
movement of plant pests were modeled on or directly derived from these 
two Acts; thus, the enactment of the PPA did not necessitate a major 
revision of the subpart. However, the PPA did contain provisions that 
clarified the authority in the earlier Acts regarding, among other 
things, our ability to regulate the importation and interstate movement 
of biological control organisms, as well as noxious weeds and 
associated articles.
    Accordingly, on October 9, 2001 (66 FR 51340-51358, Docket No. 95-
095-2), we published in the Federal Register a proposed rule which 
would have revised the plant pest regulations. Among other proposed 
provisions, it would have established a notification process that could 
be used as an alternative to the permitting system, provided for the 
environmental release of organisms for the biological control of weeds, 
and updated the text of the subpart to reflect the provisions of the 
PPA.
    We solicited comments for 60 days ending December 10, 2001. We 
received 1,332 comments by that date. They were from State Departments 
of Agriculture, a State fish and wildlife agency, universities, plant 
societies, biocontrol organizations, USDA's Forest Service and 
Agricultural Research Service, the U.S. Environmental Protection Agency 
(EPA), zoological associations, the World Trade Organization, 
pharmaceutical groups and biological supply companies, wildlife 
protection and conservation groups, trade organizations, butterfly 
breeders and associations, elementary schools, and private citizens.
    The majority of the comments that we received were from schools and 
students who requested that we continue to allow the environmental 
release of Monarch butterflies as part of a learning curriculum. Some 
of these commenters also requested that we continue to allow the 
environmental

[[Page 6981]]

release of Monarch butterflies for weddings and other ceremonies.\1\
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    \1\ Under this proposed rule, which withdraws our 2001 proposal, 
we would authorize the issuance of permits for the environmental 
release of Monarch butterflies in accordance with current practices. 
Under these practices, permits issued to permittees who reside east 
of the Rocky Mountains would authorize the environmental release of 
Monarch butterflies east of the Rockies, while those issued for 
permittees who reside west of the Rocky Mountains would authorize 
the environmental release of Monarch butterflies west of the 
Rockies. This is because there are two distinct ecological ranges 
for Monarchs in the United States, with each terminating at the 
Rocky Mountains.
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    We also received comments that addressed the proposed rule both 
generally and in regard to its specific provisions. Commenters often 
requested clarification regarding or suggested modification to several 
of the rule's provisions, but were, on the whole, generally supportive 
of the proposed rule. Accordingly, based on our evaluation of the 
comments that we received, we planned to issue a final rule.
    However, the events of September 11, 2001, led to a further 
evaluation of our proposal to determine whether the proposed provisions 
had sufficient safeguards governing our permitting process. 
Specifically, we evaluated whether an aspect of our proposal, which 
would have authorized the importation of regulated organisms without 
prior issuance of a permit, provided that the party receiving the 
organisms had entered into a compliance agreement with APHIS, could 
serve as a potential venue for bioterrorism. We also temporarily 
suspended issuance of new plant pest permits.
    In addition, on March 31, 2003, USDA's Office of the Inspector 
General (OIG) issued an audit of APHIS' permitting programs. Among 
other things, the audit examined APHIS' issuance of plant pest permits, 
and its administration of the permitting process. The audit suggested 
that we implement ePermits, a more thorough and technologically 
advanced permitting database than that used at the time, that we 
discontinue our practice at the time of issuing ``blanket'' permits to 
individuals or organizations to move plant pests and biological control 
organisms in favor of specific permits for each movement of a regulated 
organism, that we require more thorough documentation of an organism's 
intended use on each permit application, that we develop risk-based 
criteria for deciding whether or not to issue a permit for a particular 
movement, that we inspect the destinations listed on permit 
applications more regularly to evaluate their suitability for the 
organisms held onsite, and that we establish clear protocols, with an 
adequate degree of APHIS oversight, regarding the disposal of organisms 
once a permit expires. A 2007 followup OIG audit again encouraged us to 
fully implement ePermits, particularly at ports of entry into the 
United States.
    Although APHIS has not substantively revised the regulations in the 
subpart since the promulgation of the PPA and the release of the OIG 
audits, these audit reports have informed Agency decisions regarding 
our regulation of the movement of plant pests, biological control 
organisms, and associated articles.
    In this proposal, we are withdrawing our 2001 proposed rule and 
replacing it with an alternative proposal. This proposal retains 
several of the provisions of the 2001 proposal. For example, the 
conditions under which we would consider an organism a plant pest, and 
thus regulated by the subpart, remain similar to those of the 2001 
proposal. However, this proposal also removes or modifies other 
provisions of the 2001 proposal. For example, we have removed 
provisions that would have authorized the movement of regulated 
organisms through a process consisting of compliance agreements and 
notification of movement.
    Additionally, this proposal also incorporates new provisions that 
were not contained in the 2001 proposed rule but that would codify 
procedures that we have identified as best practices since that time 
but not yet added to the regulations.
    The most significant changes in this new proposal are:
     We are proposing to establish criteria for the movement 
and environmental release of both biological control organisms of 
noxious weeds and those of plant pests; and
     We are proposing to remove ``Subpart--Movement of Soil, 
Stone, and Quarry Products'' and would instead regulate these articles 
in a subpart titled ``Subpart--Movement of Plant Pests, Biological 
Control Organisms, and Associated Articles.''
    The full text of the proposed regulations appears in the rule 
portion of this document. Our discussion of the proposed provisions 
follows.

Definitions

    In addition to our proposed revision of ``Subpart--Movement Plant 
Pests'' and removal of ``Subpart--Movement of Soil, Stone, and Quarry 
Products,'' we would also revise Sec.  330.100, ``Definitions,'' of 
``Subpart--General Provisions,'' to incorporate the applicable new 
definitions provided by the PPA and to update or eliminate some of the 
definitions currently provided in that section.
    From the PPA, we would add definitions for the terms article, 
biological control organism, enter (entry), export (exportation), 
import (importation), noxious weed, plant, and plant product; and we 
would replace the current definitions of move (moved and movement), 
permit, person, plant pest, and State with the definitions provided for 
those terms in the PPA. However, regarding the definition of permit, 
although the PPA definition mentions the issuance of oral permits, our 
proposed definition does not. For the purposes of the plant pest 
regulations, oral permits would not provide a reliable means of 
verifying that a permittee was aware of the permit conditions at the 
time he or she was issued the permit, and would, we believe, adversely 
affect APHIS' ability to ensure appropriate compliance and enforcement 
of our regulatory requirements.
    We would also add definitions for Animal and Plant Health 
Inspection Service (APHIS), biocontainment facility, EPA, hand-carry, 
interstate movement, living, permittee, responsible individual, secure 
shipment, sterilization (sterile, sterilized), taxon (taxa), transit, 
and U.S. Customs and Border Protection (CBP). We will first discuss 
what we mean by the term taxon (taxa). We will then discuss, in 
alphabetical order, the definitions of the other new terms that we are 
proposing to add to the regulations.
    We would define taxon (taxa) as: ``Any recognized grouping or rank 
within the biological nomenclature of organisms, such as class, order, 
family, genus, species, subspecies, pathovar, biotype, race, forma 
specialis, or cultivar.'' This proposed definition is based on the 
International Plant Protection Convention's (IPPC's) Glossary of 
Phytosanitary Terms,\2\ which uses taxon, at various points, in 
reference to family, species, and subspecies.
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    \2\ International Standard for Phytosanitary Measures (ISPM) 
Number 5. To view this and other ISPMS, go to https://www.ippc.int/en/core-activities/standards-setting/ispms/#publications.
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    We would define the term Animal and Plant Health Inspection Service 
(APHIS) as: ``The Animal and Plant Health Inspection Service of the 
United States Department of Agriculture.''
    We would define the term biocontainment facility as: ``A physical 
structure, or portion thereof,

[[Page 6982]]

constructed and maintained in order to contain plant pests, biological 
control organisms, or associated articles.''
    We would define the term EPA as: ``The Environmental Protection 
Agency of the United States.''
    We would define the term hand-carry as: ``Importation of an 
organism that remains in one's personal possession and in close 
proximity to one's person.'' Our requirements governing the movement of 
plant pests by baggage, currently found in Sec.  330.212, are commonly 
referred to as the ``hand-carry'' regulations; we are proposing to 
revise these requirements.
    We would define the term interstate movement as: ``Movement from 
one State into or through any other State; or movement within the 
District of Columbia, Guam, the U.S. Virgin Islands, or any other 
territory or possession of the United States.''
    We would define the term living as: ``Viable or potentially 
viable.'' We are including ``potentially viable'' within our definition 
of living because most viruses and retroviruses of plants and plant 
products cannot grow or reproduce outside of a host cell; however, once 
inserted into the cell, they are capable of both growth and self-
replication, and, over time, exhibit pathogenic effects. Because of 
this potential for both growth and self-replication, it is generally 
our policy to consider such viruses living plant pests, and to require 
a permit for their importation, interstate movement, transit, or 
continued curation.
    We would define the term permittee as: ``The person to whom APHIS 
has issued a permit in accordance with this part and who must comply 
with the provisions of the permit and the regulations in this part.''
    We would define the term responsible individual as: ``The 
individual who a permittee designates to oversee and control the 
actions taken under a permit issued in accordance with this part for 
the movement or curation of a plant pest, biological control organism, 
or associated article. For the duration of the permit, the individual 
must be physically present during normal business hours at or near the 
location specified on the permit as the ultimate destination of the 
plant pest, biological control organism, or associated article, and 
must serve as a primary contact for communication with APHIS. The 
permittee may designate him or herself as the responsible individual. 
The responsible individual must be at least 18 years of age. In 
accordance with section 7734 of the PPA, the act, omission, or failure 
of any responsible individual will also be deemed the act, omission, or 
failure of a permittee.''
    Historically, we have only issued permits for the movement of plant 
pests, biological control organisms, and associated articles to 
individuals. However, as provided for in the definition of permittee, 
we would allow corporate entities to obtain permits under the revised 
regulations. This change will allow for better tracking and 
communication regarding a permit or permit application, and will also 
make it clear that the corporation as a whole is responsible for the 
permit. In such instances, we believe that it is of paramount 
importance that the permittee specifies a person whom APHIS may contact 
regarding the actions authorized under the permit who has first-hand 
knowledge of these actions. The responsible individual would fulfill 
this role.
    We anticipate that, if this rule is finalized, we would still issue 
a significant number of permits to individuals, rather than corporate 
entities. We expect that, for the majority of such permits, the 
permittee would wish to designate him or herself as the responsible 
individual; therefore, the definition of responsible individual would 
allow for such designation.
    Finally, Section 7734 of the PPA provides that a person will be 
held liable for the acts, omissions, and failures of an agent acting 
for that person, as long as the agent is acting within the scope of his 
or her office. Responsible individuals would be agents of the permittee 
pursuant to this section of the PPA.
    We would define the term secure shipment as: ``Shipment of a 
regulated plant pest, biological control organism, or associated 
article in a container or a means of conveyance of sufficient strength 
and integrity to prevent leakage of contents and to withstand shocks, 
pressure changes, and other conditions incident to ordinary handling in 
transportation.''
    We would define the term sterilization (sterile, sterilized) as: 
``A chemical or physical process that results in the death of all 
living organisms on or within the article subject to the process. 
Examples include, but are not limited to, autoclaving and 
incineration.''
    Note that, for the purposes of this subpart, the term sterilization 
does not refer to techniques that neutralize an organism by rendering 
it incapable of sexual reproduction. We recognize that this alternate 
meaning of the term ``sterilization'' might be more common within the 
regulated community, but believe that it is clear from the manner in 
which we would use the term in the revised subpart that it would have a 
different meaning within these regulations.
    We would define the term transit as: ``Movement from and to a 
foreign destination through the United States.'' This definition would 
replace a definition currently in the regulations, through the United 
States, which we define as: ``From and to places outside the United 
States.''
    We would define the term U.S. Customs and Border Protection (CBP) 
as: ``U.S. Customs and Border Protection within the Department of 
Homeland Security.'' This definition would replace the now outdated 
definition of Customs in the current regulations.
    In addition, we would substantively revise the definition of soil. 
We currently define soil as: ``The loose surface material of the earth 
in which plants grow, in most cases consisting of disintegrated rock 
with an admixture of organic material and soluble salts.'' We would 
redefine soil as: ``The unconsolidated material from the earth's 
surface that consists of rock and mineral particles and that supports 
or is capable of supporting biotic communities.'' This definition 
aligns with the current scientific understanding of soil, and would 
resolve ambiguities in the current definition that could be construed 
to suggest that soil includes consolidated or sterile matter that does 
not present a risk of harboring plant pests or noxious weeds. (For 
purposes of the regulations, it does not.) We would also remove the 
definition of earth, ``the softer matter composing part of the surface 
of the globe, in distinction from the firm rock, and including the soil 
and subsoil, as well as finely divided rock and other soil formation 
materials down to the rock layer,'' from the regulations.
    We would remove the definition of Plant Protection Act. The Act is 
cited in the authority citation for part 330, and we do not believe it 
is necessary to define it in the regulations.
    We would make nonsubstantive editorial changes to the definitions 
of administrative instructions, Administrator, Department, Deputy 
Administrator, inspector, means of conveyance, owner, and Plant 
Protection and Quarantine Programs.
    Finally, we would retain, without modification, the existing 
definitions of garbage, regulated garbage, and shelf-stable.

Titles of the Part and Subpart

    Currently, the title of part 330, ``Federal Plant Pest Regulations; 
General; Plant Pests; Soil, Stone, and Quarry Products; Garbage,'' 
reflects the

[[Page 6983]]

titles of its four subparts. As mentioned above, we are proposing to 
revise the second subpart, currently titled ``Subpart--Movement of 
Plant Pests,'' to clarify that it regulates the movement not only of 
plant pests, but also of biological control organisms and associated 
articles, including soil. Since we would now regulate soil within that 
subpart, we would remove and reserve the third subpart, ``Subpart--
Soil, Stone, and Quarry Products.''
    For this reason, we would also update the title of the second 
subpart. As amended, it would now be titled ``Subpart--Movement of 
Plant Pests, Biological Control Organisms, and Associated Articles.''
    As a result of these proposed revisions, we would also revise the 
title of the part. It would now be titled: ``Federal Plant Pest 
Regulations; General; Plant Pests, Biological Control Organisms, and 
Associated Articles; Garbage.''

Scope and General Restrictions (Sec.  330.200)

    The proposed regulations would begin by establishing the scope of 
the revised subpart. Paragraph (a) would state that no person shall 
import, move interstate, transit, or release into the environment plant 
pests, biological control organisms, or associated articles, unless the 
importation, interstate movement, transit, or release into the 
environment of the plant pests, biological control organisms, or 
associated articles is:
     Authorized under an import, interstate movement, or 
continued curation permit issued in accordance with proposed Sec.  
330.201;
     Authorized in accordance with other APHIS regulations in 7 
CFR chapter III;
     Explicitly granted an exception or exemption in the 
revised subpart from permitting requirements.
     Authorized under a general permit issued by the 
Administrator.
    By ``authorized in accordance with other APHIS regulations in 7 CFR 
chapter III,'' we mean that certain movements of plant pests or 
associated articles are regulated under other APHIS regulations in 
title 7. For example, the transit of a plant pest through the United 
States would require a permit issued in accordance with Sec.  352.5 of 
the plant quarantine safeguard regulations in 7 CFR part 352, and the 
interstate movement of regulated associated articles of domestic 
quarantine pests (e.g., host articles of pine shoot beetle or Asian 
citrus psyllid) normally require certificates or limited permits issued 
in accordance with their respective subparts in the domestic quarantine 
notice regulations of 7 CFR part 301.
    We discuss the exemptions from permitting requirements that we are 
proposing to grant for certain categories of biological control 
organisms in the discussion under the heading ``Biological control 
organisms (Sec.  330.202),'' and the exceptions from permitting 
requirements that we are proposing to grant for certain plant pests in 
the discussion under the heading ``Exceptions to permitting 
requirements for the importation or interstate movement of certain 
plant pests (Sec.  330.204).''
    Finally, to date, we have only issued specific permits, that is, 
permits issued to specific persons, for the interstate movement of 
plant pests. However, pursuant to section 7711 of the PPA, the 
Administrator may also issue general permits, that is, general 
authorizations, for the importation or interstate movement of plant 
pests.
    In recent years, we have contemplated issuing a general, Web-based 
permit for the interstate movement of certain plant pests that we 
regard to be low-risk unless they are moved into certain areas of the 
United States, rather than specific permits for the movement of these 
pests. If we finalize proposed paragraph (a) of Sec.  330.200 and 
decide to issue such a permit, we would announce the existence, 
location, and content of this general permit through a notice in the 
Federal Register.
    Paragraph (b) of Sec.  330.200 would specify the types of plant 
pests that we would regulate under the revised subpart. The paragraph 
would state that, for the purposes of the subpart, we would consider an 
organism to be a plant pest if the organism either directly or 
indirectly injures, causes damage to, or causes disease in a plant or 
plant product, or if the organism or part is an unknown risk to plants 
or plant products, but is similar to an organism known to directly or 
indirectly injure, cause damage to, or cause disease in a plant or 
plant product.
    This paragraph, which is not found in the current regulations, is 
similar to the criteria for designating an organism a plant pest that 
were contained in our 2001 proposal. We have, however, made two changes 
to those criteria.
    First, while our 2001 proposal would have designated certain 
organisms as plant pests if they directly or indirectly adversely 
affected plants, plant parts, or plant products, in this proposed rule, 
we would designate these organisms as plant pests if the organisms 
directly or indirectly injure, cause damage to, or cause disease in a 
plant or plant product. These latter criteria are based on the 
definition of plant pest found in the PPA, and have been our framework 
in recent years for determining whether an organism is a plant pest.
    We would also expand the scope of our 2001 proposal so that we may 
consider organisms of an unknown risk to plants or plant products to be 
plant pests, provided that the organisms are similar to an organism 
known to directly or indirectly injure, cause damage to, or cause 
disease in a plant or plant product.
    In our 2001 proposal, we did propose that organisms of an unknown 
risk to plants or plant products would require a permit, but we would 
have designated them regulated organisms rather than plant pests. We 
also stated that permitting conditions for such organisms would be 
aimed primarily at affording us an opportunity to identify and deal 
with the organisms with some initial degree of regulatory oversight, in 
order to prevent the dissemination of plant pests into or within the 
United States. We thus framed permitting requirements for such 
organisms as a necessary stopgap measure pending positive 
identification of the organism and an assessment of the organism's 
potential risk to plants and plant products.
    However, since 2001, there have been numerous occasions when 
applicants have requested authorization to import organisms that cannot 
readily be identified to the species level for a significant portion of 
their lifespans, but that may be plant pests. For example, we have 
issued several plant pest permits for the importation of larval 
scarabs. Before becoming mature, all scarabs are morphologically 
similar to one another and exhibit similar feeding patterns, but are 
not plant pests. However, once mature, certain scarab species are plant 
pests. In order to take this potential for future effects on plants, 
plant parts, and plant products into consideration, in issuing a permit 
for any scarab grub, we have considered it to be a plant pest, and 
tailored permitting and containment requirements accordingly.
    Paragraph (c) of Sec.  330.200 would specify the types of 
biological control organisms that we would regulate under the revised 
subpart. Although the PPA defines a biological control organism as 
``any enemy, antagonist, or competitor used to control a plant pest or 
noxious weed,'' practically speaking, we have only required permits for 
certain types

[[Page 6984]]

of biological control organisms since the PPA was promulgated.\3\ These 
are:
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    \3\ It is worth noting that, prior to the PPA, we issued permits 
for the movement and release of invertebrate herbivores used to 
control noxious weeds and microbial pathogens used to control 
noxious weeds pursuant to authority in the Federal Plant Pest Act 
(FPPA). The FPPA was superseded and repealed by the PPA.
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     Invertebrate predators and parasites (parasitoids) used to 
control invertebrate plant pests,
     Invertebrate competitors used to control invertebrate 
plant pests,
     Invertebrate herbivores used to control noxious weeds,
     Microbial pathogens used to control invertebrate plant 
pests,
     Microbial pathogens used to control noxious weeds, and
     Microbial parasites used to control plant pathogens.
    Regarding these types of biological control organisms, we recognize 
that biological control organisms used to control noxious weeds are 
also plant pests, insofar as they injure, cause damage to, or cause 
disease in plants. However, since this effect is desirable and 
ultimately beneficial to other plants, plant parts, and plant products, 
it has been our policy to draft permitting conditions for the movement 
and environmental release of these organisms in a manner that 
encourages these effects, unless we have reason to believe that the 
organisms may also have plant pest effects on non-target plants or 
plant products.
    As noted in the previous paragraphs, there are some types of 
biological control organisms for which we have not historically issued 
permits. However, there may be times when there would be a risk-based 
need to regulate the importation or interstate movement of an organism 
that falls within the PPA's definition of a biological control 
organism, but does not fall into any of the types of organisms listed 
above. For example, if a microbial parasite that has not previously 
been evaluated is put forth for the control of pathogenic fungi, it 
would not fall within the above categories, but could be an organism we 
would wish to regulate out of concern of the possibility of effects on 
non-target plants, such as fungi without phytopathogenic properties. To 
this end, paragraph (c) would also provide that other types of 
biological control organisms could be regulated under the revised 
subpart, as determined by APHIS. This determination would typically be 
on a case-by-case basis, and would be based on a permit application for 
movement of an organism which did not belong to any of the above types, 
but for which the Administrator determined it necessary to exercise a 
degree of regulatory oversight in order to prevent the introduction of 
a plant pest into the United States or the dissemination of a plant 
pest within the United States.
    Paragraph (d) would exempt biological control organism products 
that EPA has issued experimental use permits for or that EPA has 
registered as microbial pesticide products having outdoor uses from 
regulatory oversight under the revised subpart. Under the authority of 
the Federal Insecticide, Fungicide and Rodenticide Act (7 U.S.C. 136 et 
seq., FIFRA), EPA regulates certain biological control organisms 
(eukaryotic microorganisms, prokaryotic microorganisms, and viruses) as 
``substances,'' and has established a registration process for their 
use as microbial pesticides. EPA issues experimental use permits (EUPs) 
to allow persons to release these organisms into the environment on a 
limited basis in order to obtain information necessary to apply to have 
the organisms registered as microbial pesticides. EPA also allows the 
transfer, sale, and/or distribution of unregistered pesticides under 
certain circumstances in accordance with its regulations in 40 CFR 
152.30. Because registered or permitted products are already subject to 
extensive regulation by EPA, we have entered into a memorandum of 
understanding with EPA stating that we consider the products to be 
exempt from our regulatory oversight, and paragraph (d) would largely 
codify the policy in this memorandum. It would also address EPA's 
provision for the transfer, sale, and/or distribution of unregistered 
pesticides under certain circumstances, and allow for the importation 
and interstate movement of such unregistered pesticides without APHIS' 
oversight, because of EPA's oversight.

Permit Requirements (Sec.  330.201)

    Section 330.201 would describe the types of permits that APHIS 
issues for plant pests, biological control organisms, and associated 
articles, the process for applying for a permit, and the manner in 
which APHIS acts on permit applications.
    Paragraph (a) of Sec.  330.201 would provide information regarding 
the types of permits that APHIS issues for plant pests, biological 
control organisms, and associated articles. It would state that we 
issue import permits, interstate movement permits, continued curation 
permits, and transit permits.
    Paragraph (a)(1) would provide information regarding import 
permits. It would state that APHIS issues import permits to persons for 
secure shipment from outside the United States into the territorial 
limits of the United States; that, when import permits are issued to 
individuals, these individuals must be 18 years of age or older and 
have a physical address within the United States; and that, when import 
permits are issued to corporate persons, these persons must maintain an 
address or business office in the United States with a designated 
individual for service of process.\4\
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    \4\ Please note that other Federal agencies have separate 
regulatory authority related to the importation of secure shipments 
of plant pests, biological control organisms, and associated 
articles. For example, pursuant to their general regulatory 
authority, DHS requires formal entry for organisms and soil that are 
imported via hand-carry or express courier organizations.
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    Paragraph (a)(2) would provide information regarding interstate 
movement permits. It would state that interstate movement permits are 
issued to persons for secure shipment from any State into or through 
any other State; that, when interstate movement permits are issued to 
individuals, these individuals must be 18 years of age or older and 
have a physical address within the United States; and that, when 
interstate movement permits are issued to corporate persons, these 
persons must maintain an address or business office in the United 
States with a designated individual for service of process.
    Both import and interstate movement permits may contain conditions 
regarding the manner in which an organism may be moved from the 
destination listed on the permit. Such conditions are necessary to 
ensure that the organism is moved in a manner that will prevent its 
escape and dissemination and to ensure that the new facility to which 
it will be moved is capable of providing the necessary level of 
containment.
    On a related matter, applicants for import and interstate movement 
permits should be aware that States and localities may have laws and 
regulations that restrict the movement or release of plant pests, 
biological control organisms, and associated articles for various 
reasons (for example, impact on the environment of the State or 
locality). We encourage applicants to consult with these authorities 
prior to applying for a permit.
    Paragraph (a)(3) would provide information regarding continued 
curation permits. It would state that continued curation permits are 
issued in conjunction with and prior to the expiration date for an 
import permit or interstate movement permit, in order for the permittee 
to continue the actions listed on the import permit or interstate

[[Page 6985]]

movement permit following the expiration of the original permit. It 
would also state that, when continued curation permits are issued to 
individuals, these individuals must be 18 years of age or older and 
have a physical address within the United States. It would further 
state that, when continued curation permits are issued to corporate 
persons, these persons must maintain an address or business office in 
the United States with a designated individual for service of process.
    Paragraph (a)(4) would provide information regarding transit 
permits. It would state that transit permits are issued for secure 
shipments through the United States, and that such permits are issued 
in accordance with 7 CFR part 352. As we mentioned above, Sec.  352.5 
of that part contains permitting requirements for transit permits.
    However, part 352 currently provides for the transit of plant 
pests, but does not provide for the transit of biological control 
organisms. Therefore, we would amend part 352 to include references to 
biological control organisms. (For this reason, we would also amend 
part 352 to add definitions for the terms biological control organism 
and noxious weed, and to revise the definitions for Deputy 
Administrator, person, plant pest, and soil. The revised definitions 
would be identical to the ones we are proposing for part 330.)
    Currently, part 330 contains provisions for the issuance of several 
additional types of permits: Permits for plant pest movement associated 
with national defense projects, permits for means of conveyance, and 
courtesy permits for organisms that are not subject to APHIS 
regulation. However, we no longer issue a special type of permit 
specifically for national defense projects; if such a permit 
application arises, we issue the appropriate type of movement permit, 
and specify as a permit condition that the use of the organism is for a 
national defense project. Similarly, we do not issue permits 
specifically for means of conveyance; if we have reason to believe the 
means of conveyance may be an associated article, we regulate it as 
such and issue the appropriate movement permit.
    Until 2009, we issued courtesy permits in order to facilitate the 
movement of organisms that were not regulated under 7 CFR part 330, but 
that were similar enough to a known plant pest or biological control 
organism that their movement might otherwise be impeded if they were 
not accompanied by some sort of documentation from APHIS during 
transit. However, courtesy permits historically generated much 
confusion in the public and especially in the research community. The 
application form for courtesy permits was identical to the application 
for other types of permits, and the courtesy permit itself looked like 
other permits. This periodically led to the misunderstanding by some 
researchers that courtesy permits were required for the movement of 
certain organisms that were, in actuality, not subject to APHIS 
regulation. For these reasons, in recent years, Plant Protection and 
Quarantine (PPQ) has discontinued its issuance of courtesy permits for 
organisms that are similar to plant pests or biological control 
organisms, and it would not be necessary to include courtesy permits in 
the revised subpart.
    In a related matter, Sec.  330.207 of the current regulations 
states that APHIS recognizes permits issued by other Federal Agencies 
for the movement of regulated organisms and will issue administrative 
instructions or engage in correspondence with a permittee to augment 
the provisions of these permits through further conditions, rather than 
issue a duplicative permit.
    We do not consider it necessary to retain those provisions in the 
revised subpart. First, we seldom engage in correspondence with the 
permittee for permits issued by another Federal agency, such as EUPs 
issued by EPA. Rather, if we believe that the actions authorized under 
the permit may place plants or plant products at risk, we discuss the 
matter with the issuing agency itself. Correspondingly, it is rare that 
we receive permit applications from applicants who have submitted a 
prior application to another regulatory agency. Therefore, the 
provisions do not reflect current Agency practices, and we believe that 
it is generally presupposed by the regulated community that we will 
recognize permits issued by other regulatory agencies for the movement 
of plant pests, biological control organisms, and associated articles.
    Finally, we have periodically received requests from individuals to 
issue permits certifying organisms and associated articles that are 
destined for export from the United States. We note that foreign 
countries, rather than APHIS, set the conditions under which they will 
allow the importation of plant pests, biological control organisms, and 
associated articles from the United States. To this end, we would 
include a footnote stating that persons contemplating the shipment of 
plant pests, biological control organisms, or associated articles to 
places outside the United States should make arrangements directly, or 
through the recipient, with the country of destination for the export 
of the plant pests, biological control organisms, or associated 
articles into that country.
    That being said, for certain high-risk plant pests, interstate 
movement permits may place conditions on the interstate movement of the 
organism for export purposes. This is not included in the current 
regulations, but reflects recent Agency policy. Such conditions are 
necessary to safeguard the movement of the organism to the port of 
export.
    Paragraph (b) of Sec.  330.201 would provide that permit 
applications must be submitted by the applicant in writing or 
electronically through one of the methods specified at http://www.aphis.usda.gov/plant_health/permits/index.shtml, and must be 
submitted in advance of the action(s) proposed on the permit 
application. That Web page would specify that persons may apply for a 
permit via the Internet through APHIS' secure site for online permit 
applications, and would provide a link to that portal. It would also 
provide that a person may submit a permit application by faxing the 
application to APHIS, and would specify the appropriate fax number. 
Additionally, it would state that an application may be obtained by 
calling PPQ at the number provided. Finally, it would provide that a 
person may submit a permit application by mailing it to APHIS at the 
address provided. We note that because of the need for additional 
administrative processing, permit applications that are submitted via 
fax or by mail may not be reviewed as expeditiously as those submitted 
through APHIS' online portal. We encourage applicants to submit their 
applications electronically.
    Paragraph (c) of Sec.  330.201 would provide that a permit 
application must be complete before we will evaluate it in order to 
determine whether to issue the permit requested. Guidance regarding how 
to complete a permit application, including guidance specific to 
various information blocks on the application, would be available at 
http://www.aphis.usda.gov/plant_health/permits/index.shtml. The 
guidance would also specify that, in order to facilitate timely 
issuance of a permit, an application should be submitted at least 90 
days before the actions proposed on the permit application are 
scheduled to take place, with additional time allotted for complex or 
novel applications, or applications for high-risk plant pests.
    Paragraph (d) of Sec.  330.301 would describe the actions APHIS 
takes on receiving a permit application. The introductory text to the 
paragraph

[[Page 6986]]

would state that APHIS reviews the information on the application to 
determine whether it is complete. In order to consider an application 
complete, APHIS may request additional information that we determine to 
be necessary in order to assess the risk to plants and plant products 
that may be posed by the actions proposed on the application. When it 
is determined that an application is complete, we commence review of 
the information provided.
    Paragraph (d)(1) would describe the first part of APHIS' formal 
review, consultation with States, Tribes, and other individuals. We 
share a copy of the permit application, and the proposed permit 
conditions, with the appropriate State or Tribal regulatory officials, 
and may share them with other persons or groups to provide comment. For 
instance, we may share the permit application with persons or groups 
other than State or Tribal regulatory officials when we lack technical 
expertise to evaluate certain aspects of a permit application and need 
to solicit the opinion of individuals or groups with such expertise.
    Paragraph (d)(2) would describe the second part of our review, our 
initial assessment of sites and facilities where the organism or 
article will be held or released that are listed on the permit 
application. Such sites and facilities may include private residences, 
biocontainment facilities, and field locations. Although we may not do 
an onsite inspection in some cases, all sites and facilities would be 
subject to inspection as part of the assessment. All facilities would 
have to be determined by APHIS to be constructed and maintained in a 
manner that prevents the dissemination or dispersal of plant pests, 
biological control organisms, or associated articles from the facility. 
Finally, the applicant would have to provide all information requested 
by APHIS regarding this assessment, and to allow all inspections 
requested by APHIS during normal business hours (8 a.m. to 4:30 p.m., 
Monday through Friday, excluding holidays). Failure to do so would 
constitute grounds for denial of the permit application.
    Paragraphs (d)(3) and (d)(4) would describe the two possible 
actions we would take upon concluding review of the permit application: 
Issuance or denial of the requested permit. Paragraph (d)(3) would 
discuss permit issuance. APHIS may issue a permit to an applicant if 
APHIS concludes that the actions allowed under the permit would be 
highly unlikely to result in the introduction or dissemination of a 
plant pest, biological control organism, or noxious weed within the 
United States in a manner that presents an unacceptable risk to plants 
and plant products.
    We would specify that the actions allowed under the permit must be 
highly unlikely to result in the introduction or dissemination of a 
plant pest, biological control organism, or noxious weed within the 
United States in a manner that presents an unacceptable risk to plants 
and plant products because we would allow the environmental release of 
certain plant pests and biological control organisms under the revised 
subpart. The considerations that lead us to determine whether to 
authorize the environmental release of such organisms are discussed 
later in this document.
    Paragraphs (d)(3)(i) through (d)(3)(iv) would describe the manner 
in which APHIS would issue a permit under the revised subpart. Prior to 
issuing the permit, APHIS would notify the applicant in writing or 
electronically of all proposed permit conditions. The applicant would 
have to agree in writing or electronically that he or she, and all his 
or her employees, agents, and/or officers, would comply with all permit 
conditions and all provisions of the regulations. If the organism or 
associated article will be contained in a private residence, the 
applicant would have to state in this agreement that he or she 
authorizes APHIS to conduct unscheduled assessments of the residence 
during normal business hours if a permit is issued.
    APHIS would issue the permit after it receives and reviews the 
applicant's agreement. The permit would be valid for no more than 3 
years. During that period, the permittee would have to abide by all 
permitting conditions,\5\ and use of the organism or article would have 
to conform to the intended use on the permit. Moreover, the use of 
organisms derived from a regulated parent organism during that period 
would have to conform to the intended use specified on the permit for 
the parent organism.
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    \5\ Permitting conditions may reference the regulations and 
policies of other Federal agencies. For example, an import permit 
may provide conditions that a permittee must abide by in order for 
customs entry of his or her shipment to occur pursuant to CBP's 
regulations in title 19 of the CFR.
---------------------------------------------------------------------------

    We would specify that the use of the organism or article under the 
permit must conform to the intended use on the permit, because, on 
occasion, laboratories have obtained a permit for the movement of a 
plant pest or biological control organism into biocontainment, and then 
used the organism for purposes that differed from those specified as 
the intended use on the permit. In such instances, APHIS was not 
afforded an opportunity to evaluate the uses and determine whether they 
present a risk to plants and plant products within the United States. 
There have also been instances when laboratories have claimed that 
subsequent generations derived from a parent organism during the time 
period specified on a permit are distinct organisms, and thus should 
not be subject to the conditions specified on the permit and may be 
used at the laboratory's discretion. Such unregulated use of subsequent 
generations or progeny could present a risk of dissemination of the 
pest. Hence, we would require that the use of organisms derived from a 
regulated parent organism must conform to the intended use specified on 
the permit application for the parent organism.
    All activities carried out under the permit would have to cease on 
or before the expiration date of the permit, unless, prior to that 
expiration date, the permittee has submitted a new permit application 
and a new permit has been issued to authorize continuation of the 
actions.
    Finally, at any point following issuance of a permit but prior to 
its expiration date, an inspector could conduct unscheduled assessments 
of the site or facility in which the organisms or associated articles 
are held, to determine whether they are constructed and are being 
maintained in a manner that prevents the dissemination of organisms or 
associated articles from the site or facility. As with inspections 
associated with our initial assessment of sites or facilities prior to 
permit issuance, the permittee would have to allow all such assessments 
that we request during normal business hours. Failure to allow such 
assessments would constitute grounds for revocation of the permit.
    Paragraph (d)(4) would set forth the conditions under which APHIS 
may deny an application for a permit. Currently, in Sec.  330.204 of 
the regulations, APHIS will deny a permit application when such 
movement would involve a danger of dissemination of the pest. Danger of 
plant pest dissemination may be deemed to exist when any of the 
following five conditions occurs:
     No acceptable safeguards adequate to prevent plant pest 
dissemination can be arranged.
     The destructive potential of the plant pest to plants, and 
parts and products thereof, should it escape despite proposed 
safeguards, outweighs the probable benefits to be derived from

[[Page 6987]]

the proposed movement and use of the pest.
     The applicant, as a previous permittee, failed to maintain 
the safeguards or otherwise observe the conditions prescribed in a 
previous permit and failed to demonstrate his ability or intent to 
observe them in the future.
     The movement is adverse to the conduct of an eradication, 
suppression, control, or regulatory program of APHIS.
     The movement is objected to in writing by an appropriate 
official of a State, Territory, or possession, or the District of 
Columbia, on the ground it will involve a danger of dissemination of 
the plant pest into the State, Territory or possession, or District.
    Although the current regulations set out criteria that will factor 
into APHIS' judgment of risk and may lead us to deny a permit 
application, certain of the considerations have been understood by 
regulated entities to be absolute, and may have dissuaded persons from 
submitting applications for which we would have likely issued a permit. 
For example, for several years, there was an erroneous but widespread 
interpretation that the last condition afforded States and territories 
the right to ``veto'' permit applications. From this perspective, the 
current criteria may appear too strict.
    Conversely, the current regulations do not mention circumstances 
that may arise during the application process that would call into 
question that person's ability to comply effectively with permitting 
conditions, such as an applicant refusing to allow APHIS to inspect a 
biocontainment facility listed on the application, and would thus make 
it unlikely that we would issue him or her a permit.
    Accordingly, we are proposing to revise the conditions under which 
the Administrator may deny a permit application. The revised conditions 
would be the following:
     APHIS concludes that the actions proposed in the permit 
application would present an unacceptable risk to plants and plant 
products because of the introduction or dissemination of a plant pest, 
biological control organism, or noxious weed within the United States.
    This condition is intended to replace the current first condition, 
which does not appear to allow for environmental release of a plant 
pest or biological control organism, and the second condition, 
sometimes referred to as the ``balancing'' condition, which can be 
construed to suggest that APHIS will issue a permit for a high-risk 
movement or use of a regulated organism, provided that the benefits 
potentially derived from that movement or use may be equally great or 
greater. However, it is APHIS policy to base its decisions regarding 
permit issuance for the movement or use of plant pests, biological 
control organisms, and associated articles solely on an assessment of 
potential risk to plants and plant products associated with that 
movement or use.
    We would retain the following two conditions drawn substantially 
from the current regulations:
     The actions proposed in the permit application would be 
adverse to the conduct of an APHIS eradication, suppression, control, 
or regulatory program.
     A State or Tribal executive official, or a State or Tribal 
plant protection official authorized to do so, objects to the movement 
in writing and provides specific, detailed information that there is a 
risk the movement will result in the dissemination of a plant pest or 
noxious weed into the State, APHIS evaluates the information and 
agrees, and APHIS determines that such plant pest or noxious weed risk 
cannot be adequately addressed or mitigated.
    We would add the following conditions:
     The applicant does not agree to observe all of the 
proposed permit conditions that APHIS has determined are necessary to 
mitigate identified risks.
     The applicant does not provide information requested by 
APHIS as part of an assessment of sites or facilities, or does not 
allow APHIS to inspect sites or facilities associated with the actions 
listed on the permit application.
     APHIS determines that the applicant has not followed prior 
permit conditions, or has not adequately demonstrated that they can 
meet the requirements for the current application.
    This last condition is intended to clarify the current third 
condition, which states that a permit application may be denied if the 
applicant, as a previous permittee, failed to maintain the safeguards 
or otherwise observe the conditions prescribed in a previous permit and 
failed to demonstrate his ability or intent to observe them in the 
future. Certain applicants have sought to interpret this current 
condition to suggest that actions taken under a previous permit cannot, 
on their own, serve as a basis for denying a future permit.
    This interpretation is incorrect. In deciding to issue a permit, 
APHIS often relies on the previous actions of an applicant to render a 
judgment regarding the likelihood that the applicant can comply with 
the permitting conditions. As a result, this last condition would also 
provide a list of factors that could lead us to a determination that 
the applicant cannot comply with the permit conditions:
     The applicant, or a partnership, firm, corporation, or 
other legal entity in which the applicant has a substantial interest, 
financial or otherwise, has not complied with any permit that was 
previously issued by APHIS.
     Issuing the permit would circumvent any order denying or 
revoking a previous permit issued by APHIS (for example, by issuing a 
permit to an immediate family member of a person with a lengthy record 
of non-compliance with previous permits issued.)
     The applicant has previously failed to comply with any 
APHIS regulation.
     The applicant has previously failed to comply with any 
other Federal, State, or local laws, regulations, or instructions 
pertaining to plant health.
     The applicant has previously failed to comply with the 
laws or regulations of a national plant protection organization or 
equivalent body, as these pertain to plant health.
     APHIS has determined that the applicant has made false or 
fraudulent statements or provided false or fraudulent records to APHIS.
     The applicant has been convicted or has pled nolo 
contendere to any crime involving fraud, bribery, extortion, or any 
other crime involving a lack of integrity.
    Proposed paragraph (d)(5) would discuss withdrawal of a permit 
application. Any permit application could be withdrawn; however, 
applicants who wish to withdraw a permit application would have to 
provide this request in writing to APHIS. APHIS would provide written 
notification to the applicant as promptly as circumstances allow 
regarding reception of the request and withdrawal of the application.
    Proposed paragraph (d)(6) of Sec.  330.201 would discuss 
cancellation of a permit. Any permit that has been issued could be 
canceled at the request of the permittee. If a permittee wishes a 
permit to be canceled, he or she would have to provide the request in 
writing to APHIS-PPQ. Whenever a permit is canceled, APHIS would notify 
the permittee in writing regarding such cancellation.
    Paragraph (d)(7) would discuss revocation of a permit. APHIS could 
revoke a permit for any of the following reasons:
     After issuing the permit, APHIS obtains information that 
would have

[[Page 6988]]

otherwise provided grounds for us to deny the permit application.
     APHIS determines that the actions undertaken under the 
permit have resulted in or are likely to result in the introduction 
into or dissemination within the United States of a plant pest or 
noxious weed in a manner that presents an unacceptable risk to plants 
or plant products.
     APHIS determines that the permittee, or any employee, 
agent, or officer of the permittee, has failed to comply with a 
provision of the permit or the regulations under which the permit was 
issued.\6\
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    \6\ Pursuant to section 424 of the PPA, such failure, whether on 
the part of the permittee or on that of his or her employees, 
agents, or officers, may result in the assessment of civil or 
criminal penalties.
---------------------------------------------------------------------------

    Paragraph (d)(8) would discuss amendment of permits. Amendments 
could occur at the request of the permittee, or may be initiated by 
APHIS. If a permittee determines that circumstances have changed since 
the permit was initially issued and wishes the permit to be amended 
accordingly, he or she would have to contact APHIS to request the 
amendment and may have to provide supporting information justifying the 
amendment.
    APHIS would review the request, and may amend the permit if only 
minor changes are necessary. Requests for more substantive changes 
could require a new permit application.
    Prior to issuance of an amended permit, depending on the nature of 
the amendments, the permittee may have to agree in writing that he or 
she, and his or her employees, agents, and/or officers, would comply 
with the amended permit and conditions.
    With regard to amendments initiated by APHIS, we could 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. We would also be able to amend a permit at 
any time to ensure that the permit conditions are consistent with all 
of the requirements of the regulations; for example, if a subsequent 
rulemaking prohibits certain categories or types of organisms from 
being moved in certain means of conveyance, and the permit lacks these 
specific prohibitions.
    As soon as circumstances allow, APHIS would notify the permittee of 
the amendment to the permit and the reason(s) for it. Depending on the 
nature of the amendment, the permittee may have to agree in writing or 
electronically that he or she, and his or her employees, agents, and/or 
officers, will comply with the permit and conditions as amended before 
APHIS would issue the amended permit. If APHIS requests such an 
agreement, and the permittee does not agree in writing that he or she, 
and his or her employees, agents, and/or officers, will comply with the 
amended permit and conditions, the existing permit would be revoked.
    Paragraph (d)(9) would discuss suspension of actions authorized 
under a permit. It would state that we may suspend authorization of 
actions authorized under a permit if we identify new factors that cause 
us to reevaluate the risk associated with those actions. In such 
instances, we would notify the permittee in writing of this suspension 
and the reasons for it. This notification would also state the actions 
for which we are suspending authorization. Depending on the results of 
our evaluation, we would subsequently contact the permittee to remove 
the suspension, amend the permit, or revoke the permit.
    Paragraph (d)(10) would establish procedures in the event that a 
person whose application has been denied, whose permit has been revoked 
or amended, or whose authorization for actions authorized under a 
permit has been suspended, wishes to appeal the decision.

Biological Control Organisms (Sec.  330.202)

    The PPA defines a biological control organism as ``any enemy, 
antagonist, or competitor used to control a plant pest or noxious 
weed.''
    The PPA finds that ``biological control is often a desirable, low-
risk means of ridding crops and other plants of plant pests, and its 
use should be facilitated'' by APHIS and other agencies. In accordance 
with the PPA, APHIS authorizes the movement and environmental release 
of both biological control organisms through the issuance of permits.
    Since the PPA was enacted, we have published several documents in 
the Federal Register that have discussed codifying our permitting 
processes for biological control organisms. On each occasion, 
individuals who support the use of biological control have requested 
that we consider such organisms to be distinct from plant pests, and to 
regulate them in a manner that facilitates, rather than restricts, 
their movement and environmental release. Certain of these commenters 
have stated that APHIS should regulate biological control organisms 
only when their efficacy in controlling their target plant pest or 
noxious weed is not adequately established.
    We regulate biological control organisms pursuant to the PPA 
insofar as they may pose a plant pest risk. We consider it necessary to 
exercise a degree of regulatory oversight regarding the movement or 
environmental release of such biological control organisms, even when 
their efficacy is well established.
    It is worth noting, in that regard, that biological control 
organisms are usually moved for eventual environmental release. This is 
alluded to in the PPA's definition of biological control organism, 
which specifies that an organism must be used, that is, actively 
employed to control a plant pest or noxious weed in order for it to be 
considered a biological control organism. Because biological control 
organisms are almost always intended for eventual release into the 
environment, it is not sufficient for us only to consider their use in 
controlling their target plant pest or noxious weed. We must also take 
into consideration the plant pest effects that the organism may pose to 
non-target plants or plant products.
    If the organism is known to have non-target plant pest effects, it 
is consistent with APHIS' mission to prohibit or restrict its release. 
To the extent that we do not know these likely non-target plant pest 
effects, it is also prudent for us to place regulatory controls on its 
movement and release until these impacts and effects are better 
understood.
    Paragraph (a) of proposed Sec.  330.202 would provide, as a general 
condition for the importation, interstate movement, and environmental 
release of biological control organisms that are regulated under the 
proposed regulations, that no such biological control organism may be 
imported, moved interstate, or released into the environment unless a 
permit has been issued in accordance with proposed Sec.  330.201 
authorizing such importation, interstate movement, or environmental 
release, and the organism is moved or released in accordance with this 
permit and the proposed regulations.
    Because applications for the movement of biological control 
organisms often request that we authorize the release of the organism 
into the environment, several regulations issued pursuant to the 
National Environmental Policy Act of 1969, as amended (NEPA, 42 U.S.C. 
4321 et seq.) require certain procedural actions before APHIS may issue 
a permit: 40 CFR parts 1500-1508, which contains the regulations of the 
Council

[[Page 6989]]

on Environmental Quality for implementing the procedural provisions of 
NEPA; 7 CFR part 1b, which contains USDA's NEPA implementing 
regulations; and 7 CFR part 372, which contains APHIS' implementing 
regulations. In accordance with these regulations under NEPA, before 
issuing a permit, APHIS must assess whether the actions proposed on the 
applications, either individually or cumulatively, are likely to have 
significant impacts on the human environment.
    In order to make such an assessment, we often have to request 
additional information from applicants regarding the proposed release 
of the organism as part of our evaluation of the permit application. 
The end of paragraph (a) of Sec.  330.202 would alert interested 
parties to this fact, and direct them to our portal on the Internet for 
further information regarding the types of information that may be 
requested and the manner in which this information will be evaluated.
    The requirements in proposed paragraph (a) of Sec.  330.202 would 
apply to the importation, interstate movement, and environmental 
release of most biological control organisms. However, we are aware 
that certain taxa of biological control organisms have become 
established throughout their geographical or ecological range in the 
continental United States, such that the additional release of pure 
cultures derived from field populations of a taxon of these organisms 
into the environment of the continental United States will present no 
additional plant pest risk (direct or indirect) to plants or plant 
products. For such organisms, we do not consider there to be a 
sufficient basis in risk to require permits for their interstate 
movement or environmental release within the continental United States.
    To reflect this, paragraph (b) of Sec.  330.202 would state that 
APHIS has determined that certain biological control organisms have 
become established throughout their geographical or ecological range in 
the continental United States, such that the additional release of pure 
cultures derived from field populations of taxa of such organisms into 
the environment of the continental United States will present no 
additional plant pest risk (direct or indirect) to plants or plant 
products within the United States. The paragraph would direct persons 
to APHIS' online portal for permit applications for a list of all such 
organisms.
    Paragraph (b)(1) of Sec.  330.202 would provide that pure cultures 
of organisms on that list may be imported into or moved interstate 
within the continental United States without further restriction under 
the regulations, and paragraph (b)(2) of Sec.  330.202 would provide 
that pure cultures of organisms on the list may be released into the 
environment of the continental United States without further 
restriction under the regulations.
    We have made a draft list of such organisms available on 
Regulations.gov as a supporting document for this proposed rule (see 
ADDRESSES at the beginning of this proposed rule) and request public 
comment on the list. While we will consider comments received on the 
draft list to be distinct from those received on the proposed rule, the 
comments received on the draft list will inform our evaluation of the 
suitability of the exemptions from permitting requirements contained in 
proposed paragraph (b) of Sec.  330.202.
    Proposed paragraph (c) of Sec.  330.202 would establish a petition-
based process by which biological control organisms would be added to 
the list of organisms granted exceptions from permitting requirements 
for their importation or interstate movement. Any person would be able 
to request that APHIS add a biological control organism to the list 
referred to in paragraph (b) of Sec.  330.202 by submitting a petition 
to APHIS. We would specify that individuals should submit the petition 
via email to [email protected], or through any other means 
listed on APHIS' Web site at http://www.aphis.usda.gov/plant_health/permits/index.shtml.
    The petition would have to include the following information:
     Evidence indicating that the organism is indigenous to the 
continental United States throughout its geographical or ecological 
range, or evidence indicating that the organism has produced self-
replicating populations within the continental United States for an 
amount of time sufficient, based on the organism's taxon, to consider 
that taxon established throughout its geographical or ecological range 
in the continental United States.
     Results from a field study where data was collected from 
representative habitats occupied by the biological control organism. 
Studies would have to include sampling for any direct or indirect 
impacts on target and non-target hosts of the biological control 
organism in these habitats. Supporting scientific literature would have 
to be cited.
     Any other data, including published scientific reports, 
that suggest that that subsequent releases of the organism into the 
environment of the continental United States would present no 
additional plant pest risk (direct or indirect) to plants or plant 
products.
    APHIS would review the petition to determine whether it is 
complete. If the petition is complete, we would conduct an evaluation 
of the petition to determine whether there is sufficient evidence that 
the organism exists throughout its geographical or ecological range in 
the continental United States and that subsequent releases of pure 
cultures of field populations the organism into the environment of the 
continental United States will present no additional plant pest risk 
(direct or indirect) to plants or plant products.
    If we determine that there is sufficient evidence that that the 
organism exists throughout its geographical or ecological range in the 
continental United States and that subsequent releases of pure cultures 
of the organism into the environment of the continental United States 
will present no additional plant pest risk (direct or indirect) to 
plants or plant products, we would publish a notice in the Federal 
Register announcing the availability of the petition and requesting 
public comment on that document.
    If no comments are received on the notice, or if the comments 
received do not lead us to reconsider our determination, we would 
publish a subsequent notice in the Federal Register describing the 
comments received and stating that the organism has been added to the 
list referred to in proposed paragraph (b) of Sec.  330.202.
    If the comments received lead us to reconsider our determination, 
we would publish a subsequent notice in the Federal Register describing 
the comments received and stating our reasons for determining not to 
add the organism to the list referred to in proposed paragraph (b).
    Proposed paragraph (e) of Sec.  330.202 would provide that any 
biological control organism may be removed from the list referred to in 
paragraph (b) of the section if information emerges that would have 
otherwise led us to deny the petition to add the organism to the list. 
Whenever an organism is removed from the list, APHIS would publish a 
notice in the Federal Register announcing that action and the basis for 
it.

Soil (Sec.  330.203)

    The regulations governing the importation, interstate movement, and 
transit of soil and certain stone and quarry products under permit are 
currently found in ``Subpart--Movement of Soil, Stone, and Quarry

[[Page 6990]]

Products,'' Sec. Sec.  330.300 through 330.302. We are proposing to 
remove and reserve that subpart and integrate the regulations for soil 
into the revised ``Subpart--Plant Pests, Biological Control Organisms, 
Soil, and Associated Articles'' as Sec.  330.203. We are proposing to 
do so primarily in order to clarify that we regulate soil insofar as it 
is or may be an associated article. That is, we regulate soil insofar 
as it may harbor plant pests or noxious weeds: When a permit 
application for soil is submitted to APHIS, a soil specialist evaluates 
this likelihood of contamination with plant pests or noxious weeds and 
determines whether a permit should be issued.
    As part of our revision to the soil regulations, we would also 
update the regulations in light of the current scientific understanding 
of soil and the spread of soil-borne pathogens within Canada.
    Proposed paragraph (a) of Sec.  330.203 would state that the 
Administrator has determined that, unless it has been sterilized, soil 
is an associated article, and is thus subject to the permitting 
requirements of Sec.  330.201. It would also provide two conditions 
under which the movement of soil would not be subject to the permitting 
requirements of Sec.  330.201: If the movement is regulated pursuant to 
other APHIS regulations in 7 CFR chapter III (e.g., Sec.  301.86-5 
requires certificates for the interstate movement of soil from an area 
quarantined for pale cyst nematode), or if Sec.  330.203 states that 
the movement does not require such a permit. This second condition 
would apply to the importation of most soil from Canada, and most 
interstate movement of soil.
    Proposed paragraphs (b)(1) through (b)(3) of Sec.  330.203 would 
provide conditions governing the importation of soil. First, in a 
similar manner to our conditions for the importation of most biological 
control organisms, we would require an import permit to be issued in 
accordance with Sec.  330.201 for the importation of soil, and the soil 
to be imported under the conditions specified on the permit. We are 
requiring a permit so that we can evaluate the risks associated with 
any particular importation of soil and assign the appropriate 
mitigation measures.
    Currently, soil may be imported from Canada without a permit, 
unless the soil is from Newfoundland or the Land District of Central 
Saanich on Vancouver Island in the Province of British Columbia; these 
two areas are known to be infested with pale cyst nematodes (PCN). We 
are proposing to amend the regulations so that soil from any area of 
Canada regulated by the Canadian Food Inspection Agency (CFIA), the 
national plant protection organization of Canada, for a soil-borne 
plant pest would require a permit. We are doing this because there have 
been recent detections of soil-borne plant pests of quarantine 
significance in Canada (such as PCN in Quebec and potato wart disease 
on Prince Edward's Island) that are not reflected in the current 
regulations.
    We would also clarify that the proposed regulations do not pertain 
to soil used as a growing medium for plants for planting from Canada. 
Plants for planting that are intended to be imported into the United 
States and their growing media are regulated under 7 CFR part 319, 
``Subpart--Plants for Planting.''
    Plants for planting that can be inspected, treated, or handled to 
prevent them from spreading plant pests are designated in that subpart 
as restricted articles. Section 319.37-4 requires all restricted 
articles imported into the United States to be accompanied by a 
phytosanitary certificate of inspection, unless the section explicitly 
exempts the articles from this requirement. Paragraph (a)(1) of Sec.  
319.37-4 exempts greenhouse-grown plants from Canada imported in 
accordance with the provisions of a certification program administered 
by CFIA from this requirement; paragraph (c) of that section contains 
the provisions of CFIA's program.
    Section 319.37-8 addresses the growing media in which a restricted 
article may be imported. Currently, paragraph (a) of the section 
prohibits the use of soil as a growing medium for plants for planting 
from all countries other than Canada. Paragraph (b) allows a restricted 
article from Canada to be imported in any medium, with the restriction 
that articles from Newfoundland or a certain portion of the 
Municipality of Central Saanich in the Province of British Columbia 
must be accompanied by a phytosanitary certificate containing an 
additional declaration that the plants were grown in a manner to 
prevent infestation with potato cyst nematode. We are proposing to 
revise paragraph (b) of Sec.  319.37-8 so that articles from any area 
of Canada that is regulated by CFIA for a soil-borne plant pest would 
have to be accompanied by a phytosanitary certificate with an 
additional declaration that the plants were grown in a manner to 
prevent infestation with that soil-borne plant pest.
    Proposed paragraphs (b)(2) through (b)(4) of Sec.  330.203 would 
set forth additional conditions for certain types of importations of 
soil. Paragraph (b)(2) would provide additional conditions for the 
importation of soil via hand-carry. In addition to the requirements of 
proposed paragraph (b)(1), we would allow soil to be hand-carried into 
the United States only if the importation meets the conditions of Sec.  
330.205. That section, which is discussed later in this document, would 
contain our regulations governing the hand-carry of plant pests, 
biological control organisms, and soil.
    Proposed paragraph (b)(3) would provide additional conditions for 
the importation of soil intended for the extraction of plant pests. 
Since this soil is imported precisely because it is known to contain 
plant pests, with very few exceptions, it is not rerouted for 
sterilization upon arrival in the United States. Therefore, to mitigate 
the risk that such soil could present a pathway for the introduction or 
dissemination of plant pests within the United States, we would require 
all such soil to be imported directly to an approved biocontainment 
facility.
    On occasion, soil that presents a risk of harboring plant pests is 
imported into the United States for disposal; for example, this 
sometimes occurs when a natural disaster strikes an area quarantined 
for a soil-borne pathogen and emergency management personnel need to 
dispose of the resulting debris. Proposed paragraph (b)(4) would 
contain additional conditions for the importation of such soil. In 
addition to general conditions for the importation of soil, soil 
infested with plant pests and intended for disposal would have to be 
imported directly to an APHIS-approved disposal facility. Although all 
such facilities are subject to evaluation and approval by EPA, we would 
require independent APHIS approval of the facility because certain of 
these EPA-approved facilities are municipal landfills that may not 
provide adequate safeguards against plant pest dissemination.
    Currently, Sec.  330.301 restricts the importation into the United 
States of stone and quarry products from areas in Canada that are 
infested with gypsy moth. This section has at times led to confusion 
regarding the relationship between soil and stone and quarry products, 
as well as questions regarding the regulated status of articles, such 
as clay, that are similar to but fundamentally distinct from soil.
    Proposed paragraph (b)(5) of Sec.  330.203 would list certain 
articles that are not soil, and that, because of their composition or 
origin, present a negligible risk of serving as a medium for plant 
pests or noxious weeds, provided that they are free of organic 
material. The articles could be imported

[[Page 6991]]

into the United States without an import permit, unless the 
Administrator has issued an order stating that a particular article is 
an associated article. (Such orders would be maintained on PPQ's Web 
site, at http://www.aphis.usda.gov/plant_health/permits/organism/soil/index.shtml.) However, all such articles would be subject to inspection 
at the port of first arrival, subsequent reinspection at other 
locations, and other remedial measures deemed necessary by an inspector 
to remove any risk the items pose of disseminating plant pests or 
noxious weeds, and any other restrictions or prohibitions in 7 CFR 
chapter III. The articles would be:
     Consolidated material derived from any strata or substrata 
of the earth. Examples include clay (laterites, bentonite, china clay, 
attapulgite, tierrafino), talc, chalk, slate, iron ore, and gravel.
     Sediment, mud, or rock from saltwater bodies of water.
     Cosmetic mud and other commercial mud products.
     Stones, rocks, and quarry products.
    These provisions do not mean that we would no longer restrict the 
movement of stone and quarry products from areas in Canada that are 
infested with gypsy moth. Instead, we would amend ``Subpart--Gypsy Moth 
Host Material from Canada,'' Sec.  319.77-1 through Sec.  319.77-5, to 
incorporate those restrictions. Section 319.77-2 of that subpart 
contains a list of articles designated regulated articles; we would 
amend that section by adding a new paragraph (i) that would designate 
stone and quarry products as regulated articles. Section 319.77-4 
contains conditions for the importation of regulated articles; we would 
amend the section by adding a new paragraph (d) that would provide that 
stone and quarry products originating in a Canadian area known to be 
infested with gypsy moth may be imported into the United States only if 
they are destined for an infested area of the United States and will 
not be moved through any noninfested areas of the United States, and 
may be moved through the United States if they are moved only through 
infested areas. We consider this subpart a more appropriate location 
for the restrictions.
    Proposed paragraph (c) of Sec.  330.203 would provide general 
conditions governing the interstate movement of soil. Most soil could 
be moved interstate without prior issuance of an interstate movement 
permit in accordance with Sec.  330.201, or further restriction under 
the regulations. However, all soil moved interstate within the United 
States would still be subject to any movement restrictions and remedial 
measures specified for such movement in 7 CFR part 301.
    As we mentioned earlier in this document, part 301 contains our 
regulations that designate certain areas of the United States as 
quarantined areas for a particular plant pest, and that prohibit or 
restrict the movement in interstate commerce of certain host articles 
of that pest. The provisions currently in our regulations in Sec.  
330.302 mention certain sections of part 301 in which soil is 
considered a regulated article, such as our Japanese beetle and gypsy 
moth regulations, but omit others, such as our golden nematode and PCN 
regulations, and do not take into consideration the possibility that 
outbreaks of new plant pests within the United States may lead us to 
regulate the interstate movement of soil from areas quarantined for 
those or other pests.
    Proposed paragraph (c)(2) would provide conditions for the 
interstate movement within the continental United States of soil 
intended for the extraction of plant pests. Again, since such soil is 
moved precisely because it is known to contain plant pests, it is, by 
definition, an associated article, and therefore would require an 
interstate movement permit issued in accordance with Sec.  330.201 in 
order to be moved. Moreover, because of the intended use of the soil, 
in order to mitigate the risk of the dissemination of plant pests, the 
soil would have to be moved directly to an approved biocontainment 
facility, and in a secure manner that prevents its dissemination into 
the outside environment.
    Proposed paragraph (c)(3) would contain additional conditions for 
the interstate movement within the continental United States of soil 
infested with plant pests and intended for disposal. We would require 
issuance of an interstate movement permit prior to movement, and would 
require that all such soil to be moved directly to an APHIS-approved 
disposal facility, and in a secure manner that prevents its 
dissemination into the outside environment.
    Proposed paragraph (c)(4) would contain additional conditions for 
the interstate movement of soil samples from an area quarantined in 
accordance with 7 CFR part 301 for chemical or compositional testing or 
analysis. Such soil could be moved without prior issuance of an 
interstate movement permit in accordance with Sec.  330.201 or further 
restriction under 7 CFR chapter III, provided that the soil is moved to 
a laboratory that has entered into and is operating under a compliance 
agreement with APHIS, is abiding by all terms and conditions of the 
compliance agreement, and is approved by APHIS to test and/or analyze 
such samples.
    Proposed paragraph (c)(5) would contain additional conditions for 
the interstate movement of soil to, from, or between Hawaii, the 
territories, and the continental United States. In addition to all 
general conditions for interstate movement of soil, soil could be moved 
interstate to, from, or between Hawaii, the territories, and the 
continental United States only if an interstate movement permit has 
been issued for its movement in accordance with Sec.  330.201. This 
condition would apply to all soil moved to, from, or between Hawaii, 
the territories, and the continental United States. In addition to this 
provision, soil moved to, from, or between Hawaii, the territories, and 
the continental United States with the intent of extracting plant pests 
would still be subject to the conditions of proposed paragraph (c)(2) 
of the section, and would therefore have to be moved directly to an 
approved biocontainment facility. Similarly, soil infested with plant 
pests and intended for disposal would be subject to the conditions of 
proposed paragraph (c)(3) of the section, and would therefore have to 
be moved directly to an APHIS-approved disposal facility.
    Proposed paragraph (d) would contain conditions regarding the 
transit of soil. Such movement would require a transit permit issued in 
accordance with 7 CFR part 352.
    The regulations in Sec.  330.300 currently exempt movements of soil 
governed by Sec.  318.60 or Sec.  319.69 from permitting requirements. 
Section 318.60 currently prohibits the movement of sand (other than 
clean ocean sand), soil, or earth around the roots of plants from 
Hawaii, Puerto Rico, or the Virgin Islands into or through any other 
State, Territory, or District of the United States, unless the movement 
is in either direction between Puerto Rico and the Virgin Islands, or 
the soil is intended for experimental or scientific use by USDA. We 
would amend Sec.  318.60 to clarify that it pertains only to the 
movement of soil around the roots of plants, and that all other 
movement of soil from Hawaii, Puerto Rico, or the Virgin Islands, other 
than that soil around the roots of plants, is regulated under 7 CFR 
part 330. We consider this amendment necessary primarily so that we 
would not regulate the movement of such soil in two different subparts, 
and secondarily so that the section may not be used to circumvent the 
regulations in part 330.
    ``Subpart--Packing Materials,'' Sec.  319.69 through Sec.  319.69-
5, contains

[[Page 6992]]

our regulations regarding plants and plant products used as packing 
materials for imported commodities. Section 319.69 prohibits the use of 
soil containing an appreciable mixture of vegetable matter from being 
used as packing material, except for soil authorized as safe for 
packing by other rules and regulations in the subpart. Section 319.69-1 
specifies that soil containing an appreciable admixture of vegetable 
matter is covered by this prohibition because its decaying vegetation 
or plant remains carries a definite pest risk. Finally, Sec.  319.69-5 
states that the following soil may be used as packing material: Peat, 
peat moss, or osmunda fiber.
    After reviewing this section in light of the current scientific 
understanding of soil, as reflected in our proposed revision to the 
definition of soil in Sec.  330.100, we have determined that this 
section does not refer to soil, as it is currently understood, but to 
the organic decaying vegetative matter for which soil may serve as a 
medium, and of which peat, peat moss, and osmunda fiber are all 
examples. We have also determined that an instance may arise when the 
mitigation measures that we require in part 319 for the importation of 
a plant, plant part, or plant product may also address the risk 
associated with using organic decaying vegetative matter as a packing 
material for that commodity.
    Therefore, we would amend the existing prohibition in Sec.  319.69 
on the use of soil as a packing material so that it instead prohibits 
the use of organic decaying vegetative matter as a packing material. We 
would remove Sec.  319.69-1(b), which considers matter containing 
decaying vegetation or plant remains to be soil. We would establish an 
exemption for any organic decaying vegetative matter expressly 
authorized to be used as a packing material elsewhere in part 319. 
Finally, we would revise the heading of Sec.  319.69-5 to make it clear 
that it does not pertain to the use of soil as a packing material, but 
organic decaying vegetative matter.

Exceptions to Permitting Requirements for the Importation or Interstate 
Movement of Certain Plant Pests (Sec.  330.204)

    Section 7711 of the PPA provides that the Secretary of Agriculture 
may issue regulations to allow the importation and the movement in 
interstate commerce of plant pests without further restriction, if the 
Secretary finds that a permit for such movement is not necessary. The 
section further states that if the Secretary does issue such 
regulations, any person may petition him or her to add a plant pest or 
remove a plant pest from this list of pests. Finally, the section 
provides that if a petition is submitted, the Secretary will act on the 
petition and notify the petitioner of the action he or she will take on 
the petition.
    Section 330.204 would establish such regulations and petition 
process. The introductory paragraph would state that, pursuant to 
section 7711 of the PPA, the Administrator has determined that certain 
plant pests may be imported into or may move in interstate commerce 
within the continental United States without restriction. The list of 
all such plant pests would be on the PPQ Web site.
    Paragraph (a) of the section would describe the three categories of 
plant pests that comprise the list. In order to be included on the 
list, a plant pest would have to:
     Be from field populations or lab cultures derived from 
field populations of a taxon that is established throughout its entire 
geographical or ecological range within the continental United States; 
or
     Be sufficiently attenuated so that it no longer poses a 
risk to plants or plant products; or
     Be commercially available and raised under the regulatory 
purview of other Federal agencies.
    In our 2001 proposed rule, paragraph (c) of Sec.  330.202 would 
have established a ``no permit necessary'' list for certain indigenous 
plant pest species that were already distributed throughout the 
continental United States and are known to commonly accompany plants or 
plant products moved in commerce. The first category aligns with the 
criterion for that 2001 list. We would not require permits for plant 
pests from a field population or lab culture derived from a field 
population of a taxon that is established throughout its entire 
geographical or ecological range within the United States because such 
pests are ubiquitous within the continental United States.
    The second category reflects the fact that in vitro attenuation of 
plant pests such as phytopathogenic fungi, while rare, does occur. When 
a pest becomes attenuated, there is no longer a sufficient basis for us 
to presume that the pest presents a risk of directly or indirectly 
injuring, causing damage to, or causing disease in plants or plant 
products; in other words, an attenuated pest de facto no longer falls 
within the scope of the definition of plant pest under the PPA.
    (In order to avoid confusion and the possible unregulated movement 
of the virulent strains of the plant pest, the list would specify the 
strains of the plant pest that APHIS considers attenuated of their 
pathogenicity.)
    The third category of plant pests is intended to avoid duplicative 
or conflicting regulatory oversight of certain plant pests. For 
example, although it is a plant pest, Penicillium chrysogenum is 
regulated by the Food and Drug Administration (FDA).
    We have made a draft list of plant pests that may be imported or 
move in interstate commerce within the continental United States 
without restriction available on Regulations.gov as a supporting 
document for this proposed rule, and request public comment regarding 
that list. The list largely mirrors the list contained in the 2001 
proposed rule, but also contains certain plant pests that belong to the 
second and third categories.
    Paragraph (b) of Sec.  330.204 would contain a petition process to 
add a plant pest to the list. Any person would be able to petition to 
have an additional plant pest added to the list. To submit a petition, 
the person would have to provide, in writing, information supporting 
the placement of a particular pest in one of the categories listed in 
paragraph (a) of Sec.  330.204.
    Information that the plant pest belongs to a taxon that is 
established throughout its entire geographical or ecological range 
within the United States would have to include scientific literature, 
unpublished studies, or data regarding:
     The biology of the plant pest, including characteristics 
that allow it to be identified, known hosts, and virulence;
     The geographical or ecological range of the plant pest 
within the continental United States; and
     The areas of the continental United States within which 
the plant pest is established.
    The first category of information is intended to provide us with 
basic information regarding the plant pest for which unrestricted 
movement is sought. The second and third categories would aid our 
determination regarding whether the plant pest is established 
throughout its ecological or geographical range within the continental 
United States.
    Information that the plant pest has been attenuated of its 
pathogenicity would have to include experimental data, published 
references, or scientific information regarding such attenuation.
    Information that the plant pest is commercially available and 
raised under the regulatory purview of another Federal agency would 
have to include a citation to the relevant law, regulation,

[[Page 6993]]

or order under which the agency exercises such oversight. For example, 
Penicillium chrysogenum is regulated by FDA under the Kefauver-Harris 
drug amendments of 1962.
    APHIS would review the information contained in the petition to 
determine whether it is complete. In order to consider the petition 
complete, APHIS may require additional information to determine whether 
the plant pest belongs to one of the categories listed in paragraph (a) 
of Sec.  330.204. When it is determined that the information is 
complete, we would commence review of the petition.
    If, after review of the petition, we determine that there is 
insufficient evidence that the plant pest belongs to one of the three 
categories listed in paragraph (a) of Sec.  330.204--for example, the 
plant pest is known to exist throughout its entire geographical range 
in the continental United States, but population densities in certain 
areas are not sufficient to consider it established throughout its 
range--we would deny the petition, and notify the petitioner in writing 
regarding this denial.
    Conversely, if, after review of the petition, we determine that the 
plant pest belongs to one of the categories in paragraph (a), we would 
publish a notice in the Federal Register that announces the 
availability of the petition and any supporting documentation to the 
public, that states that we intend to add the plant pest to the list of 
plant pests that may be imported into or move in interstate commerce 
within the continental United States without restriction, and that 
requests public comment.
    If no comments are received on the notice, or if, based on the 
comments received, we determine that our conclusions regarding the 
petition have not been affected, we will publish in the Federal 
Register a subsequent notice stating that the plant pest has been added 
to the list.
    Under paragraph (c) of Sec.  330.204, any person could submit, in 
writing, a petition to have a plant pest removed from the list. The 
petition would have to contain independently verifiable information 
demonstrating that our initial determination that the plant pest 
belongs to one of the categories in paragraph (a) of the section should 
be changed, or that additional information is now available that would 
have caused us to change the initial decision.
    APHIS would review the information contained in the petition to 
determine whether it is complete. In order to consider the petition 
complete, we may require additional information supporting the 
petitioner's claim. When it is determined that the information is 
complete, we would commence review of the petition.
    If, after review of the petition, we determine that there is 
insufficient evidence to suggest that our initial determination should 
be changed, we would deny the petition, and notify the petitioner in 
writing regarding this denial.
    If, after review of the petition, we determine that there is a 
sufficient basis to suggest that our initial determination should be 
changed, we would publish a notice in the Federal Register that 
announces the availability of the petition, and that requests public 
comment regarding removing the plant pest from the list of plant pests 
that may be imported into or move in interstate commerce within the 
continental United States without restriction.
    If no comments are received on the notice, or if the comments 
received do not affect our conclusions regarding the petition, we would 
publish in the Federal Register a subsequent notice stating that the 
plant pest has been removed from the list.
    Paragraph (d) of Sec.  330.204 would provide for APHIS-initiated 
changes to the list. It would provide that APHIS may propose to add a 
plant pest to or remove a pest from the list without a petition, if we 
determine that there is sufficient evidence that the plant pest belongs 
to one of the categories listed in paragraph (a) of the section, or if 
evidence emerges that leads us to reconsider our initial determination 
that the plant pest was or was not in one of the categories listed in 
paragraph (a) of the section. We would publish a notice in the Federal 
Register announcing this proposed addition or removal, making available 
any supporting documentation that we prepare, and requesting public 
comment.
    If no comments are received on the notice, or if the comments 
received do not affect our conclusions, we will publish a subsequent 
notice in the Federal Register stating that the plant pest has been 
added to or removed from the list.

Hand-Carry of Plant Pests, Biological Control Organisms, and Soil 
(Sec.  330.205)

    Currently, we authorize the importation of plant pests in personal 
baggage (referred to as ``hand-carry'') under Sec.  330.212 of the 
regulations. The regulations provide that the person importing the 
plant pest must show the permit authorizing the importation to an 
inspector at the port of arrival where the baggage will be inspected, 
that the conditions specified on the permit must be observed, that an 
inspector will oversee the movement of the plant pest, that the owner 
of the plant pest will be responsible for all costs incidental to 
forwarding the plant pest prior to clearance, and that an inspector may 
specify and supervise the application of safeguards to prevent the 
dissemination of the pest until it is forwarded.
    The 2003 OIG audit referenced at the beginning of this document 
pointed out that the hand-carry process in place at the time did not 
provide guidance regarding what materials may be hand-carried or who 
may hand-carry, and that APHIS did not track hand-carried materials to 
ensure that they arrive at the point of destination listed on the 
permit. For these reasons, the audit strongly suggested that we issue 
regulations to prohibit hand-carry of regulated organisms into the 
United States, and to explicitly state that all organisms must be 
imported into the United States via a bonded commercial carrier.
    However, certain plant pests and biological control organisms are 
highly perishable, and may remain viable only if they are imported into 
the United States directly and without rerouting. We have also found 
that it is often useful, from a safeguarding perspective, to authorize 
hand-carry in order to have an expert regarding the organism or article 
exercise direct and continuous oversight of its importation.
    Therefore, we would include provisions for hand-carry in this 
proposed rule. These provisions, which would be contained in Sec.  
330.205, would reflect current Agency processes regarding hand-carry.
    The introductory text of Sec.  330.205 would state that plant 
pests, biological control organisms, and soil may be hand-carried into 
the United States only in accordance with the provisions of the 
section.
    Proposed paragraph (a) of Sec.  330.205 would discuss the first 
such provision, authorization to hand-carry. In order to obtain such 
authorization, a person would have to apply for an import permit for 
the plant pest, biological control organism, or soil, in accordance 
with Sec.  330.201, and specify hand-carry of the organism or article 
as the method of proposed movement.
    The application would also have to specify the individual or 
individuals who would hand-carry the plant pest, biological control 
organism, or soil into the United States. If we authorize this 
individual or these individuals to hand-carry, this authorization could 
not be transferred to, nor actions under it performed by, individuals 
other than those identified on the permit application.

[[Page 6994]]

    Under proposed paragraph (b) of Sec.  330.205, the permittee would 
have to notify APHIS through our online portal for permit applications 
or by fax after the permittee has obtained an import permit but no less 
than 20 days prior to movement and provide the following information in 
order to receive a hand-carry authorization:
     A copy of the face page of the passport for the individual 
or individuals who will hand-carry the plant pest, biological control 
organism, or soil.
     A description of the means of conveyance in which the 
individual or individuals will travel, including flight number and 
airline name for air travel, or vehicle license number or other 
identifying number for other modes of transportation.
     Expected date and time of first arrival.
     Expected port of first arrival.
     Travel itinerary from port of first arrival to final 
destination.
    We would require authorized identification, the description of the 
means of conveyance, and the expected date, time, and port of first 
arrival because, pursuant to the regulations in Sec.  330.105, hand-
carried organisms or soil, like all other imported articles, must be 
presented for inspection at the port of first arrival, and this 
information would help us ensure that the inspection takes place as 
expeditiously as possible. We would require the travel itinerary from 
the port of first arrival to the final destination in order to ensure 
that the individual does not intend to make prolonged stops en route 
that could result in breach of safeguarding and increase the risk of 
accidental dissemination of the organism or soil. The information also 
would help us respond promptly to accidental dissemination of the 
organism or soil en route to the final destination.
    Under proposed paragraph (c) of Sec.  330.205, the permittee or his 
or her designee would have to notify APHIS within 24 hours of arrival 
of the hand-carried plant pest, biological control organism, or soil at 
the biocontainment facility or other authorized point of destination. 
This notification would have to state that the plant pest, biological 
control organism, or soil has arrived at its destination and that the 
package in which it was hand-carried has remained sealed until arrival. 
Notification could be by fax or email, or via APHIS' permitting Web 
site.
    Proposed paragraph (d) of Sec.  330.205 would discuss denial, 
amendment, or cancellation of authorization to hand-carry. It would 
state that APHIS may deny a request to hand-carry, or amend or cancel 
any hand-carry authorization at any time, if we deem such action 
necessary to prevent the introduction or dissemination of plant pests 
or noxious weeds within the United States.
    In a similar manner, proposed paragraph (e) of Sec.  330.205 would 
state that any person whose request to hand-carry has been denied, or 
whose hand-carry authorization has been amended or canceled, would be 
able to appeal the decision in writing to APHIS.

Packaging Requirements (Sec.  330.206)

    We are proposing to revise the packaging requirements for the 
movement of plant pests, currently found in Sec.  330.210. The revised 
requirements would be contained in proposed Sec.  330.206.
    The introductory text of the section would state that shipments in 
which plant pests, biological control organisms, and associated 
articles are imported into, moved interstate, or transited through the 
United States must meet the general packaging requirements of the 
section, as well as all specific packaging requirements on the permit 
itself.
    Proposed paragraph (a) would contain general packaging 
requirements. All shipments would have to consist of an outer shipping 
container and at least two packages within the container. Both the 
container and the inner packages would have to be securely sealed to 
prevent the dissemination of the enclosed plant pests, biological 
control organisms, or associated articles.
    Paragraph (a)(1) would contain general requirements for the outer 
shipping container. The outer shipping container would have to be 
rigid, impenetrable, and durable enough to remain sealed and 
structurally intact in the event of dropping, lateral impact with other 
objects, and other shocks incidental to handling.
    Paragraph (a)(2) would contain requirements for inner packages. The 
innermost package or packages within the shipping container would have 
to contain all of the organisms or articles that will be moved. As a 
safeguard, the innermost package would have to be placed within 
another, larger package, for example, bagged and sealed petri samples 
placed within a sealed cooler. All packages within the shipping 
container would have to be constructed or safeguarded so that they will 
remain sealed and structurally intact throughout transit. The packages 
would also have to be able to withstand changes in pressure, 
temperature, and other climatic conditions incidental to shipment.
    Paragraph (b) would contain general requirements for packing 
material. It would specify that packing material must be free of plant 
pests, noxious weeds, or associated articles, and must be new, or must 
have been sterilized or disinfected prior to reuse. Packing material 
would also have to be suited for the enclosed organism or article, as 
well as any medium in which the organism or article will be maintained, 
and should not be capable of harboring or being a means of the 
dissemination of the organism or article.
    We would provide guidance regarding suitable outer shipping 
containers, inner packages, and packaging on the PPQ Web site.
    Paragraph (c) would provide that packing materials, including media 
and substrates, would have to be destroyed by incineration, be 
decontaminated using autoclaving or another approved method, or 
otherwise be disposed of in a manner specified in the permit itself. It 
would also provide that shipping containers could not be reused, except 
those that have been sterilized or disinfected prior to reuse.
    Proposed paragraph (d) would state that permittees who fail to meet 
the requirements of the section may be held responsible for all costs 
incident to inspection, rerouting, repackaging, subsequent movement, 
and any treatments.

Cost and Charges (Sec.  330.207)

    Proposed Sec.  330.207 would state that the inspection services of 
APHIS inspectors during regularly assigned hours of duty and at the 
usual places of duty would be furnished without cost. It would also 
state that APHIS would not be responsible for any costs or charges 
incidental to inspections or compliance with the provisions of this 
subpart, other than for the inspection services of the inspector.
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

[[Page 6995]]

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).
    Based on the information we have, there is no reason to conclude 
that adoption of this proposed rule would result in any significant 
economic effect on a substantial number of small entities. However, we 
do not currently have all of the data necessary for a comprehensive 
analysis of the effects of this proposed rule on small entities. 
Therefore, we are inviting comments on potential effects. In 
particular, we are interested in determining the number and kind of 
small entities that may incur benefits or costs from the implementation 
of this proposed rule.
    APHIS is proposing to revise its regulations regarding the 
importation, interstate movement, and environmental release of plant 
pests to incorporate provisions regarding biological control organisms 
(BCOs) and the movement of soils from which plant pests and BCOs are 
extracted. The proposed rule would revise and add definitions, 
streamline the permitting and compliance processes, and provide APHIS 
with increased flexibility in the regulation of plant pests. Parts 318, 
319, and 352 of 7 CFR chapter III would also be updated to reflect the 
proposed changes in part 330.
    A principal consequence of the proposed rule would be a 
streamlining of our permitting process and possible reduction in the 
number of permits issued under part 330, which numbered 6,538 in 2015. 
Approximately 33 percent of these permits (2,158) authorized the 
movement or environmental release of a plant pest or BCO that APHIS is 
proposing to exempt from permitting. While we do not expect the 
proposed rule would result in one-third fewer permits as one permit may 
list multiple BCOs or plant pests, we can say with confidence that the 
permitting burden would be reduced for applicants and that the 
permitting process could be expedited. We expect that affected entities 
would benefit from a 10 to 30 percent reduction in the overall time 
spent applying for and receiving permits under part 330. Assuming the 
time required to submit an application is 1 hour and assuming an 
average hourly wage of $45.50 per hour, then for the 6,538 permits 
issued in 2015, the time savings expected under the proposed rule would 
have totaled between 654 and 1,961 hours, which equates to a cost 
savings of between about $29,748 and $89,244.
    The proposed rule would codify existing practices by allowing 
entities requesting permits to apply electronically rather than by 
using the mail only. Expanded use of online permit applications through 
APHIS' portal would result in time and cost savings as compared to 
applying by mail using paper applications.
    Listing of exempted organisms on an APHIS-PPQ Web site, transparent 
procedures for petitioning for exceptions or exemptions to permitting, 
and provision for a notice-based process for adding and removing listed 
organisms would also combine to make an efficient, transparent, and 
user-responsive system that would facilitate the movement and 
environmental release of plant pests and BCOs.
    Regulated entities would continue to incur time costs associated 
with providing information during the permitting application process, 
and with meeting somewhat more robust recordkeeping (maintaining 
records) requirements in certain instances such as with soil imports 
and risk based permits. The time required overall for permitting would 
be reduced, however, because of the newly excepted organisms.
    The proposed revisions to 7 CFR part 330 would benefit entities, 
large and small, by increasing the efficiency of the permitting and 
compliance processes for plant pests, BCOs, and soils from which plant 
pests and BCOs are extracted, and by improving the general clarity and 
transparency of these regulations. The proposed rule also would 
facilitate the Agency's coordination with other Federal and State 
agencies in regulating the movement and environmental release of plant 
pests and BCOs. The majority of entities that would benefit from this 
rule are small entities, based on information obtained from the 
Economic Census.
National Environmental Policy Act
    To provide the public with documentation of APHIS' review and 
analysis of any potential environmental impacts associated with the 
processes established by this proposed rule, we have prepared a draft 
environmental impact statement (EIS). The EIS 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 draft EIS is available on Regulations.gov for review and 
comment, and may be accessed via the Internet address provided above 
under the heading ADDRESSES. Copies may also be obtained by contacting 
the individual listed below the section titled FOR FURTHER INFORMATION 
CONTACT.
    A notice of availability regarding the draft EIS will also be 
published by the Environmental Protection Agency in the Federal 
Register.
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 
are in the process of being reinstated under Office of Management and 
Budget (OMB) control number 0579-0054. The new reporting requirements 
included in this proposed rule have been submitted as a new information 
collection for approval to OMB.
    Please send comments on the information collection request to OMB's 
Office of Information and Regulatory Affairs via email to 
[email protected], Attention: Desk Officer for APHIS. Please 
state that your comments refer to Docket No. APHIS-2008-0076. Please 
send a copy of your comments to USDA, using one of the methods 
described under ADDRESSES at the beginning of this document.
    Under the PPA, the Secretary of Agriculture has authority to carry 
out operations or measures to detect, control, eradicate, suppress, 
prevent, or retard the spread of plant pests. Section 7711(a) of the 
Act provides that ``no person shall import, enter, export, or move in 
interstate commerce any plant pest, unless the importation, entry, 
exportation, or movement is authorized under general or specific permit 
and in accordance with such regulations as the Secretary may issue to 
prevent the introduction of plant pests into the United States or the 
dissemination of plant pests within the United States.'' The Act gives 
USDA the flexibility to respond appropriately to a wide range of needs 
and circumstances to protect American agriculture against plant pests.

[[Page 6996]]

    In addition, section 412(a) of the Act provides that the Secretary 
may prohibit or restrict the importation, entry, exportation, or 
movement in interstate commerce of, among other things, any biological 
control organism if the Secretary determines that the prohibition or 
restriction is necessary to prevent the introduction into the United 
States or the dissemination of a plant pest or noxious weed within the 
United States. The Act defines a biological control organism as ``any 
enemy, antagonist, or competitor used to control a plant pest or 
noxious weed.''
    APHIS regulations implementing these aspects of the Plant 
Protection Act are contained (in part) in 7 CFR part 330.
    APHIS is proposing to revise: (1) Regulations regarding the 
movement of plant pests; (2) criteria regarding the movement and 
environmental release of biological control organisms, and proposing to 
establish regulations to allow the importation and movement in 
interstate commerce of certain types of plant pests without restriction 
by granting exceptions from permitting requirements for those pests; 
and (3) regulations regarding the movement of soil. This proposal would 
clarify the factors that would be considered when assessing the risks 
associated with the movement of certain organisms and facilitate the 
movement of regulated organisms and articles in a manner that also 
protects U.S. agriculture.
    This proposed rule replaces a previously published proposed rule, 
which APHIS is withdrawing as part of this document. This proposal 
would clarify the factors that would be considered when assessing the 
risks associated with the movement of certain organisms and facilitate 
the movement of regulated organisms and articles in a manner that also 
protects U.S. agriculture.
    Implementing this rule will require respondents to complete a new 
petition process to remove permitting requirements for the interstate 
movement of certain plant pests or biological control organisms.
    We are soliciting comments from the public (as well as affected 
agencies) concerning our proposed information collection and 
recordkeeping requirements. These comments will help us:
    (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 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 160 hours per response.
    Respondents: Importers and distributors of plants and plant 
products; importers, brokers, distributors, retailers, and exhibitors 
of biological control organisms and associated articles; and operators 
of biocontainment facilities.
    Estimated Annual Number of Respondents: 6.
    Estimated Annual Number of Responses per Respondent: 1.
    Estimated Annual Number of Responses: 6.
    Estimated Total Annual Burden on Respondents: 960 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 information collection request-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.

Lists of Subjects

7 CFR Part 318

    Cotton, Cottonseeds, Fruits, Guam, Hawaii, Plant diseases and 
pests, Puerto Rico, Quarantine, Transportation, Vegetables, Virgin 
Islands.

7 CFR Part 319

    Coffee, Cotton, Fruits, Imports, Logs, Nursery stock, Plant 
diseases and pests, Quarantine, Reporting and recordkeeping 
requirements, Rice, Vegetables.

7 CFR Part 330

    Customs duties and inspection, Imports, Plant diseases and pests, 
Quarantine, Reporting and recordkeeping requirements, Transportation.

7 CFR Part 352

    Customs duties and inspection, Imports, Plant diseases and pests, 
Quarantine, Reporting and recordkeeping requirements, Transportation.

    Accordingly, we propose to amend 7 CFR parts 318, 319, 330, and 352 
as follows:

PART 318--STATE OF HAWAII AND TERRITORIES QUARANTINE NOTICES

0
1. The authority citation for part 318 continues to read as follows:

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


Sec.  318.60  [Amended]

0
2. In Sec.  318.60, paragraph (c) is amended by adding the words ``: 
And provided finally, that the prohibitions in this paragraph do not 
apply to the movement of soil from Hawaii, Puerto Rico, and the Virgin 
Islands, other than that soil around the roots of plants; movement of 
soil that is not around the roots of plants is regulated under part 330 
of this chapter'' after the words ``paragraphs (c)(1), (2), and (3) of 
this section''.

PART 319--FOREIGN QUARANTINE NOTICES

0
3. The authority citation for part 319 continues to read as follows:

    Authority:  7 U.S.C. 450, 7701-7772, and 7781-7786; 21 U.S.C. 
136 and 136a; 7 CFR 2.22, 2.80, and 371.3.

0
4. In Sec.  319.37-8, paragraph (b)(2) is revised to read as follows:


Sec.  319.37-8   Growing media.

* * * * *
    (b) * * *
    (2) A restricted article from an area of Canada regulated by the 
national plant

[[Page 6997]]

protection organization of Canada for a soil-borne plant pest may only 
be imported in an approved growing medium if the phytosanitary 
certificate accompanying it contains an additional declaration that the 
plant was grown in a manner to prevent infestation by that soil-borne 
plant pest.
* * * * *
0
5. Section 319.69 is amended as follows:
0
a. By revising paragraph (a)(8); and
0
b. By removing paragraph (b)(4).
    The revision to read as follows:


Sec.  319.69  Notice of quarantine.

    (a) * * *
    (8) Organic decaying vegetative matter from all countries, unless 
the matter is expressly authorized to be used as a packing material in 
this part. Exceptions to the above prohibitions may be authorized in 
the case of specific materials which has been so prepared, 
manufactured, or processed that in the judgment of the inspector no 
pest risk is involved in their entry.
* * * * *


Sec.  319.69-1   [Amended]

0
6. Section 319.69-1 is amended by removing paragraph (b), and 
redesignating paragraph (c) as paragraph (b).
0
7. Section 319.69-5 is amended by revising the section heading to read 
as follows:


Sec.  319.69-5  Types of organic decaying vegetative matter authorized 
for packing.

* * * * *
0
8. Section 319.77-2 is amended as follows:
0
a. In paragraph (g), by removing the word ``and'';
0
b. By revising paragraph (h); and
0
c. By adding paragraph (i).
    The addition and revision to read as follows:


Sec.  319.77-2  Regulated articles.

* * * * *
    (h) Mobile homes and their associated equipment; and
    (i) Stone and quarry products.
0
9. Section 319.77-4 is amended by adding paragraph (d) to read as 
follows:


Sec.  319.77-4  Conditions for the importation of regulated articles.

* * * * *
    (d) Stone and quarry products. Stone and quarry products 
originating in a Canadian infested area may be imported into the United 
States only if they are destined for an infested area of the United 
States and will not be moved through any noninfested areas of the 
United States, and may be moved through the United States if they are 
moved only through infested areas.
* * * * *

PART 330--FEDERAL PLANT PEST REGULATIONS; GENERAL; PLANT PESTS, 
BIOLOGICAL CONTROL ORGANISMS, AND ASSOCIATED ARTICLES; GARBAGE

0
10. The authority citation for part 330 continues to read as follows:

    Authority:  7 U.S.C. 450, 7701-7772, 7781-7786, and 8301-8317; 
21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.

0
11. The heading of part 330 is revised to read as set forth above.
0
12. Section 330.100 is revised to read as follows:


Sec.  330.100  Definitions.

    The following terms, when used in this part, shall be construed, 
respectively, to mean:
    Administrative instructions. Published documents relating to the 
enforcement of this part, and issued under authority thereof by the 
Administrator.
    Administrator. The Administrator of the Animal and Plant Health 
Inspection Service (APHIS), United States Department of Agriculture, or 
any employee of APHIS to whom authority has been delegated to act in 
the Administrator's stead.
    Animal and Plant Health Inspection Service (APHIS). The Animal and 
Plant Health Inspection Service of the United States Department of 
Agriculture.
    Article. Any material or tangible object, including a living 
organism, that could harbor living plant pests or noxious weeds.
    Biocontainment facility. A physical structure, or portion thereof, 
constructed and maintained in order to contain plant pests, biological 
control organisms, or associated articles.
    Biological control organism. Any enemy, antagonist, or competitor 
used to control a plant pest or noxious weed.
    Continental United States. The contiguous 48 States, Alaska, and 
the District of Columbia.
    Department. The United States Department of Agriculture.
    Deputy Administrator. The Deputy Administrator of the Plant 
Protection and Quarantine Programs or any employee of the Plant 
Protection and Quarantine Programs delegated to act in his or her 
stead.
    Enter (entry). To move into, or the act of movement into, the 
commerce of the United States.
    EPA. The Environmental Protection Agency of the United States.
    Export (exportation). To move from, or the act of movement from, 
the United States to any place outside the United States.
    Garbage. That material designated as ``garbage'' in Sec.  
330.400(b).
    Hand-carry. Importation of an organism that remains in one's 
personal possession and in close proximity to one's person.
    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 CBP to enforce the regulations in this part.
    Interstate movement. Movement from one State into or through any 
other State; or movement within the District of Columbia, Guam, the 
U.S. Virgin Islands, or any other territory or possession of the United 
States.
    Living. Viable or potentially viable.
    Means of conveyance. Any personal or public property used for or 
intended for use for the movement of any other property. This 
specifically includes, but is not limited to, automobiles, trucks, 
railway cars, aircraft, boats, freight containers, and other means of 
transportation.
    Move (moved and movement). To carry, enter, import, mail, ship, or 
transport; to 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 those activities.
    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.
    Owner. The owner, or his or her agent, having possession of a plant 
pest, biological control organism, associated article, or any other 
means of conveyance, products, or article subject to the regulations in 
this part.
    Permit. A written authorization, including by electronic methods, 
by the Administrator to move plant pests, biological control organisms, 
or associated articles under conditions prescribed by the 
Administrator.
    Permittee. The person to whom APHIS has issued a permit in 
accordance with this part and who must comply with the provisions of 
the permit and the regulations in this part.

[[Page 6998]]

    Person. Any individual, partnership, corporation, association, 
joint venture, or other legal entity.
    Plant. Any plant (including any plant part) for or capable of 
propagation including trees, tissue cultures, plantlet cultures, 
pollen, shrubs, vines, cuttings, grafts, scions, buds, bulbs, roots, 
and seeds.
    Plant pest. Any living stage of any of the following that can 
directly or indirectly injure, cause damage to, or cause disease in any 
plant or plant product: A protozoan, 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.
    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.
    Plant Protection and Quarantine Programs. The Plant Protection and 
Quarantine Programs of the Animal and Plant Inspection Health Service.
    Regulated garbage. That material designated as ``regulated 
garbage'' in Sec.  330.400(c) and Sec.  330.400(d).
    Responsible individual. The individual who a permittee designates 
to oversee and control the actions taken under a permit issued in 
accordance with this part for the movement or curation of a plant pest, 
biological control organism, or associated article. For the duration of 
the permit, the individual must be physically present during normal 
business hours at or near the location specified on the permit as the 
ultimate destination of the plant pest, biological control organism, or 
associated article, and must serve as a primary contact for 
communication with APHIS. The permittee may designate him or herself as 
the responsible individual. The responsible individual must be at least 
18 years of age. In accordance with section 7734 of the Plant 
Protection Act (7 U.S.C. 7701 et seq.), the act, omission, or failure 
of any responsible individual will also be deemed the act, omission, or 
failure of a permittee.
    Secure shipment. Shipment of a regulated plant pest, biological 
control organism, or associated article in a container or a means of 
conveyance of sufficient strength and integrity to prevent leakage of 
contents and to withstand shocks, pressure changes, and other 
conditions incident to ordinary handling in transportation.
    Shelf-stable. The condition achieved in a product, by application 
of heat, alone or in combination with other ingredients and/or other 
treatments, of being rendered free of microorganisms capable of growing 
in the product at nonrefrigerated conditions (over 50 [deg]F or 10 
[deg]C).
    Soil. The unconsolidated material from the earth's surface that 
consists of rock and mineral particles and that supports or is capable 
of supporting biotic communities.
    State. Any of the States of the United States, the Commonwealth of 
the Northern Mariana Islands, the Commonwealth of Puerto Rico, the 
District of Columbia, Guam, the U.S. Virgin Islands, and all other 
territories or possessions of the United States.
    Sterilization (sterile, sterilized). A chemical or physical process 
that results in the death of all living organisms on or within the 
article subject to the process. Examples include, but are not limited 
to, autoclaving and incineration.
    Taxon (taxa). Any recognized grouping or rank within the biological 
nomenclature of organisms, such as class, order, family, genus, 
species, subspecies, pathovar, biotype, race, forma specialis, or 
cultivar.
    Transit. Movement from and to a foreign destination through the 
United States.
    United States. All of the States.
    U.S. Customs and Border Protection (CBP). U.S. Customs and Border 
Protection within the Department of Homeland Security.
0
13. Subpart--Movement of Plant Pests, Sec. Sec.  330.200 through 
330.212, is revised to read as follows:
Subpart--Movement of Plant Pests, Biological Control Organisms, and 
Associated Articles
Sec.
330.200 Scope and general restrictions.
330.201 Permit requirements.
330.202 Biological control organisms.
330.203 Soil.
330.204 Exceptions to permitting requirements for the importation or 
interstate movement of certain plant pests.
330.205 Hand-carry of plant pests, biological control organisms, and 
soil.
330.206 Packaging requirements.
330.207 Costs and charges.

Subpart--Movement of Plant Pests, Biological Control Organisms, and 
Associated Articles


Sec.  330.200  Scope and general restrictions.

    (a) No person shall import, move interstate, transit, or release 
into the environment plant pests, biological control organisms, or 
associated articles, unless the importation, interstate movement, 
transit, or release into the environment of the plant pests, biological 
control organisms, or plant pests is:
    (1) Authorized under an import, interstate movement, or continued 
curation permit issued in accordance with Sec.  330.201; or
    (2) Authorized in accordance with other APHIS regulations in this 
chapter; or
    (3) Explicitly granted an exception or exemption in this subpart 
from permitting requirements; or
    (4) Authorized under a general permit issued by the Administrator.
    (b) Plant pests regulated by this subpart. For the purposes of this 
subpart, APHIS will consider an organism to be a plant pest if the 
organism directly or indirectly injures, causes damage to, or causes 
disease in a plant or plant product, or if the organism is an unknown 
risk to plants or plant products, but is similar to an organism known 
to directly or indirectly injure, cause damage to, or cause disease in 
a plant or plant product.
    (c) Biological control organisms regulated by this subpart. For the 
purposes of this subpart, biological control organisms include:
    (1) Invertebrate predators and parasites (parasitoids) used to 
control invertebrate plant pests,
    (2) Invertebrate competitors used to control invertebrate plant 
pests,
    (3) Invertebrate herbivores used to control noxious weeds,
    (4) Microbial pathogens used to control invertebrate plant pests,
    (5) Microbial pathogens used to control noxious weeds,
    (6) Microbial parasites used to control plant pathogens, and
    (7) Any other types of biological control organisms, as determined 
by APHIS.
    (d) Biological control organisms not regulated by this subpart. The 
preceding paragraph notwithstanding, biological control organism-
containing products that are currently under an EPA outdoor 
experimental use permit or that are currently registered with EPA as a 
microbial pesticide product having outdoor uses are not regulated under 
this subpart. Additionally, biological control organisms that are 
pesticides that are not registered with EPA, but are being transferred, 
sold, or distributed in accordance with EPA's regulations in 40 CFR 
152.30, are not regulated under this subpart for their interstate 
movement or importation. However, an importer desiring to import a 
shipment of biological control organisms subject to the Federal 
Insecticide Fungicide and Rodenticide Act must submit to the EPA 
Administrator a Notice of Arrival of Pesticides and Devices as required 
by CBP regulations at 19 CFR 12.112. The Administrator will provide 
notification

[[Page 6999]]

to the importer indicating the disposition to be made of shipment upon 
its entry into the customs territory of the United States.


Sec.  330.201  Permit requirements.

    (a) Types of permits. APHIS issues import permits, interstate 
movement permits, continued curation permits, and transit permits for 
plant pests, biological control organisms, and associated articles.\1\
---------------------------------------------------------------------------

    \1\ Persons contemplating the shipment of plant pests, 
biological control organisms, or associated articles to places 
outside the United States should make arrangements directly, or 
through the recipient, with the country of destination for the 
export of the plant pests, biological control organisms, or 
associated articles into that country.
---------------------------------------------------------------------------

    (1) Import permit. Import permits are issued to persons for secure 
shipment from outside the United States into the territorial limits of 
the United States. When import permits are issued to individuals, these 
individuals must be 18 years of age or older and have a physical 
address within the United States. When import permits are issued to 
corporate persons, these persons must maintain an address or business 
office in the United States with a designated individual for service of 
process.
    (2) Interstate movement permit. Interstate movement permits are 
issued to persons for secure shipment from any State into or through 
any other State. When interstate movement permits are issued to 
individuals, these individuals must be 18 years of age or older and 
have a physical address within the United States. When interstate 
movement permits are issued to corporate persons, these persons must 
maintain an address or business office in the United States with a 
designated individual for service of process.
    (3) Continued curation permits. Continued curation permits are 
issued in conjunction with and prior to the expiration date for an 
import permit or interstate movement permit, in order for the permittee 
to continue the actions listed on the import permit or interstate 
movement permit. When continued curation permits are issued to 
individuals, these individuals must be 18 years of age or older and 
have a physical address within the United States. When continued 
curation permits are issued to corporate persons, these persons must 
maintain an address or business office in the United States with a 
designated individual for service of process.
    (4) Transit permits. Transit permits are issued for secure 
shipments through the United States. Transit permits are issued in 
accordance with part 352 of this chapter.
    (b) Applying for a permit. Permit applications must be submitted by 
the applicant in writing or electronically through one of the means 
listed at http://www.aphis.usda.gov/plant_health/permits/index.shtml in 
advance of the action(s) proposed on the permit application.
    (c) Completing a permit application. A permit application must be 
complete before APHIS will evaluate it in order to determine whether to 
issue the permit requested. Guidance regarding how to complete a permit 
application, including guidance specific to the various information 
blocks on the application, is available at http://www.aphis.usda.gov/plant_health/permits/index.shtml.
    (d) APHIS action on permit applications. APHIS will review the 
information on the application to determine whether it is complete. In 
order to consider an application complete, APHIS may request additional 
information that it determines to be necessary in order to assess the 
risk to plants and plant products that may be posed by the actions 
proposed on the application. When it is determined that an application 
is complete, APHIS will commence review of the information provided.
    (1) State or Tribal consultation and comment; consultation with 
other individuals. APHIS will share a copy of the permit application, 
and the proposed permit conditions, with the appropriate State or 
Tribal regulatory officials, and may share the application and the 
proposed conditions with other persons or groups to provide comment.
    (2) Initial assessment of sites and facilities. Prior to issuance 
of a permit, APHIS will assess all sites and facilities that are listed 
on the permit application, including private residences, biocontainment 
facilities, and field locations where the organism or article will be 
held or released. As part of this assessment, all sites and facilities 
are subject to inspection. All facilities must be determined by APHIS 
to be constructed and maintained in a manner that prevents the 
dissemination or dispersal of plant pests, biological control 
organisms, or associated articles from the facility. The applicant must 
provide all information requested by APHIS regarding this assessment, 
and must allow all inspections requested by APHIS during normal 
business hours (8 a.m. to 4:30 p.m., Monday through Friday, excluding 
holidays). Failure to do so constitutes grounds for denial of the 
permit application.
    (3) Issuance of a permit. APHIS may issue a permit to an applicant 
if APHIS concludes that the actions allowed under the permit will be 
highly unlikely to result in the introduction or dissemination of a 
plant pest, biological control organism, or noxious weed within the 
United States in a manner that presents an unacceptable risk to plants 
and plant products. Issuance will occur as follows:
    (i) Prior to issuing the permit, APHIS will notify the applicant in 
writing or electronically of all proposed permit conditions. The 
applicant must agree in writing or electronically that he or she, and 
all his or her employees, agents, and/or officers, will comply with all 
permit conditions and all provisions of this subpart. If the organism 
or associated article will be contained in a private residence, the 
applicant must state in this agreement that he or she authorizes APHIS 
to conduct unscheduled assessments of the residence during normal 
business hours if a permit is issued.
    (ii) APHIS will issue the permit after it receives and reviews the 
applicant's agreement. The permit will be valid for no more than 3 
years. During that period, the permittee must abide by all permitting 
conditions, and the use of the organism or article must conform to the 
intended use on the permit. Moreover, the use of organisms derived from 
a regulated parent organism during that period must conform to the 
intended use specified on the permit for the parent organism.
    (iii) All activities carried out under the permit must cease on or 
before the expiration date for the permit, unless, prior to that 
expiration date, the permittee has submitted a new permit application 
and a new permit has been issued to authorize continuation of those 
actions.
    (iv) At any point following issuance of a permit but prior to its 
expiration date, an inspector may conduct unscheduled assessments of 
the site or facility in which the organisms or associated articles are 
held, to determine whether they are constructed and are being 
maintained in a manner that prevents the dissemination of organisms or 
associated articles from the site or facility. The permittee must allow 
all such assessments requested by APHIS during normal business hours. 
Failure to allow such assessments constitutes grounds for revocation of 
the permit.
    (4) Denial of a permit application. APHIS may deny an application 
for a permit if:
    (i) APHIS concludes that the actions proposed in the permit 
application would present an unacceptable risk to plants and plant 
products because of the introduction or dissemination of a plant

[[Page 7000]]

pest, biological control organism, or noxious weed within the United 
States; or
    (ii) The actions proposed in the permit application would be 
adverse to the conduct of an APHIS eradication, suppression, control, 
or regulatory program; or
    (iii) A State or Tribal executive official, or a State or Tribal 
plant protection official authorized to do so, objects to the movement 
in writing and provides specific, detailed information that there is a 
risk the movement will result in the dissemination of a plant pest or 
noxious weed into the State, APHIS evaluates the information and 
agrees, and APHIS determines that such plant pest or noxious weed risk 
cannot be adequately addressed or mitigated; or
    (iv) The applicant does not agree to observe all of the proposed 
permit conditions that APHIS has determined are necessary to mitigate 
identified risks; or
    (v) The applicant does not provide information requested by APHIS 
as part of an assessment of sites or facilities, or does not allow 
APHIS to inspect sites or facilities associated with the actions listed 
on the permit application; or
    (vi) APHIS determines that the applicant has not followed prior 
permit conditions, or has not adequately demonstrated that they can 
meet the requirements for the current application. Factors that may 
contribute to such a determination include, but are not limited to:
    (A) The applicant, or a partnership, firm, corporation, or other 
legal entity in which the applicant has a substantial interest, 
financial or otherwise, has not complied with any permit that was 
previously issued by APHIS.
    (B) Issuing the permit would circumvent any order denying or 
revoking a previous permit issued by APHIS.
    (C) The applicant has previously failed to comply with any APHIS 
regulation.
    (D) The applicant has previously failed to comply with any other 
Federal, State, or local laws, regulations, or instructions pertaining 
to plant health.
    (E) The applicant has previously failed to comply with the laws or 
regulations of a national plant protection organization or equivalent 
body, as these pertain to plant health.
    (F) APHIS has determined that the applicant has made false or 
fraudulent statements or provided false or fraudulent records to APHIS.
    (G) The applicant has been convicted or has pled nolo contendere to 
any crime involving fraud, bribery, extortion, or any other crime 
involving a lack of integrity.
    (5) Withdrawal of a permit application. Any permit application may 
be withdrawn at the request of the applicant. If the applicant wishes 
to withdraw a permit application, he or she must provide the request in 
writing to APHIS. APHIS will provide written notification to the 
applicant as promptly as circumstances allow regarding reception of the 
request and withdrawal of the application.
    (6) Cancellation of a permit. Any permit that has been issued may 
be canceled at the request of the permittee. If a permittee wishes a 
permit to be canceled, he or she must provide the request in writing to 
APHIS-PPQ. Whenever a permit is canceled, APHIS will notify the 
permittee in writing regarding such cancellation.
    (7) Revocation of a permit. APHIS may revoke a permit for any of 
the following reasons:
    (i) After issuing the permit, APHIS obtains information that would 
have otherwise provided grounds for it to deny the permit application; 
or
    (ii) APHIS determines that the actions undertaken under the permit 
have resulted in or are likely to result in the introduction into or 
dissemination within the United States of a plant pest or noxious weed 
in a manner that presents an unacceptable risk to plants or plant 
products; or
    (iii) APHIS determines that the permittee, or any employee, agent, 
or officer of the permittee, has failed to comply with a provision of 
the permit or the regulations under which the permit was issued.
    (8) Amendment of permits. (i) Amendment at permittee's request. If 
a permittee 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, either through APHIS' online 
portal for permit applications, or by contacting APHIS directly via 
phone or email. The permittee 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 permittee may 
be required to agree in writing that he or she, and his or her 
employees, agents, and/or officers will comply with the amended permit 
and conditions.
    (ii) 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 permittee 
of the amendment to the permit and the reason(s) for it. Depending on 
the nature of the amendment, the permittee may have to agree in writing 
or electronically that he or she, and his or her employees, agents, 
and/or officers, will comply with the permit and conditions as amended 
before APHIS will issue the amended permit. If APHIS requests such an 
agreement, and the permittee does not agree in writing that he or she, 
and his or her employees, agents, and/or officers, will comply with the 
amended permit and conditions, the existing permit will be revoked.
    (9) Suspension of permitted actions. APHIS may suspend 
authorization of actions authorized under a permit if it identifies new 
factors that cause it to reevaluate the risk associated with those 
actions. APHIS will notify the permittee in writing of this suspension 
explaining the reasons for it and stating the actions for which APHIS 
is suspending authorization. Depending on the results of APHIS' 
evaluation, APHIS will subsequently contact the permittee to remove the 
suspension, amend the permit, or revoke the permit.
    (10) Appeals. Any person whose application has been denied, whose 
permit has been revoked or amended, or whose authorization for actions 
authorized under a permit has been suspended, may appeal the decision 
in writing to the Administrator within 10 business days after receiving 
the written notification of the denial, revocation, amendment, or 
suspension. The appeal shall state all of the facts and reasons upon 
which the person relies to show that the application was wrongfully 
denied, permit revoked or amended, or authorization for actions under a 
permit suspended. The Administrator shall grant or deny the appeal, 
stating the reasons for the decision as promptly as circumstances 
allow.


Sec.  330.202  Biological control organisms.

    (a) General conditions for importation, interstate movement, and 
environmental release of biological control organisms. Except as 
provided in paragraph (b) of this section, no biological control 
organism regulated under this subpart may be imported, moved 
interstate, or released into the

[[Page 7001]]

environment unless a permit has been issued in accordance with Sec.  
330.201 authorizing such importation, interstate movement, or 
environmental release, and the organism is moved or released in 
accordance with this permit and the regulations in this subpart. The 
regulations in 40 CFR parts 1500-1508, 7 CFR part 1b, and 7 CFR part 
372 may require APHIS to request additional information from an 
applicant regarding the proposed release of a biological control 
organism as part of its evaluation of a permit application. Further 
information regarding the types of information that may be requested, 
and the manner in which this information will be evaluated, is found at 
http://www.aphis.usda.gov/plant_health/permits/index.shtml.
    (b) Exceptions from permitting requirements for certain biological 
control organisms. APHIS has determined that certain biological control 
organisms have become established throughout their geographical or 
ecological range in the continental United States, such that the 
additional release of pure cultures derived from field populations of 
taxa of such organisms into the environment of the continental United 
States will present no additional plant pest risk (direct or indirect) 
to plants or plant products. A list of these organisms is maintained 
online, at http://www.aphis.usda.gov/plant_health/permits/index.shtml.
    (1) Importation and interstate movement of listed organisms. Pure 
cultures of organisms on the list may be imported into or moved 
interstate within the continental United States without further 
restriction under this subpart.
    (2) Environmental release of listed organisms. Pure cultures of 
organisms on the list may be released into the environment of the 
continental United States without further restriction under this 
subpart.
    (c) Additions to the list of organisms granted exceptions from 
permitting requirements for their importation or interstate movement. 
Any person may request that APHIS add a biological control organism to 
the list referred to in paragraph (b) of this section by submitting a 
petition to APHIS via email to [email protected] or through 
any means listed at http://www.aphis.usda.gov/plant_health/permits/index.shtml. The petition must include the following information:
    (1) Evidence indicating that the organism is indigenous to the 
continental United States throughout its geographical or ecological 
range, or evidence indicating that the organism has produced self-
replicating populations within the continental United States for an 
amount of time sufficient, based on the organism's taxon, to consider 
that taxon established throughout its geographical or ecological range 
in the continental United States.
    (2) Results from a field study where data was collected from 
representative habitats occupied by the biological control organism. 
Studies must include sampling for any direct or indirect impacts on 
target and non-target hosts of the biological control organism in these 
habitats. Supporting scientific literature must be cited.
    (3) Any other data, including published scientific reports, that 
suggest that subsequent releases of the organism into the environment 
of the continental United States will present no additional plant pest 
risk (direct or indirect) to plants or plant products.
    (d) APHIS review of petitions. (1) APHIS will review the petition 
to determine whether it is complete. If APHIS determines that the 
petition is complete, it will conduct an evaluation of the petition to 
determine whether there is sufficient evidence that the organism exists 
throughout its geographical or ecological range in the continental 
United States and that subsequent releases of pure cultures of field 
populations of the organism into the environment of the continental 
United States will present no additional plant pest risk (direct or 
indirect) to plants or plant products.
    (2) Notice of availability of the petition. If APHIS determines 
that there is sufficient evidence that the organism exists throughout 
its geographical or ecological range in the continental United States 
and that subsequent releases of pure cultures of the organism into the 
environment of the continental United States will present no additional 
plant pest risk to plants or plant products, APHIS will publish a 
notice in the Federal Register announcing the availability of the 
petition and requesting public comment on that document.
    (3) Notice of determination. (i) If no comments are received, or if 
the comments received do not lead APHIS to reconsider its 
determination, APHIS will publish in the Federal Register a subsequent 
notice describing the comments received and stating that the organism 
has been added to the list referred to in paragraph (b) of this 
section.
    (ii) If the comments received lead APHIS to reconsider its 
determination, APHIS will publish in the Federal Register a subsequent 
notice describing the comments received and stating its reasons for 
determining not to add the organism to the list referred to in 
paragraph (b) of this section.
    (e) Removal of organisms from the list of exempt organisms. Any 
biological control organism may be removed from the list referred to in 
paragraph (b) of this section if information emerges that would have 
otherwise led APHIS to deny the petition to add the organism to the 
list. Whenever an organism is removed from the list, APHIS will publish 
a notice in the Federal Register announcing that action and the basis 
for it.


Sec.  330.203  Soil.

    (a) The Administrator has determined that, unless it has been 
sterilized, soil is an associated article, and is thus subject to the 
permitting requirements of Sec.  330.201, unless its movement:
    (1) Is regulated pursuant to other APHIS regulations in this 
chapter; or
    (2) Does not require such a permit under the provisions of 
paragraphs (b)(1) or (c)(1) of this section.
    (b) Conditions governing the importation of soil.
    (1) Permit. Except as provided in Sec.  319.37-8(b)(2) of this 
chapter and except for soil imported from areas of Canada other than 
those areas of Canada regulated by the national plant protection 
organization of Canada for a soil-borne plant pest, soil may only be 
imported into the United States if an import permit has been issued for 
its importation in accordance with Sec.  330.201, and the soil will be 
imported under the conditions specified on the permit.
    (2) Additional conditions for the importation of soil via hand-
carry. In addition to the condition of paragraph (b)(1) of this 
section, soil may be hand-carried into the United States only if the 
importation meets the conditions of Sec.  330.205.
    (3) Additional conditions for the importation of soil intended for 
the extraction of plant pests. In addition to the condition of 
paragraph (b)(1) of this section, soil may be imported into the United 
States for the extraction of plant pests if the soil will be imported 
directly to a biocontainment facility approved by APHIS.
    (4) Additional conditions for the importation of soil contaminated 
with plant pests and intended for disposal. In addition to the 
condition of paragraph (b)(1) of this section, soil may be imported 
into the United States for the disposal of plant pests if the soil will 
be imported directly to an APHIS-approved disposal facility.

[[Page 7002]]

    (5) Exemptions. The articles listed in this paragraph are not soil, 
provided that they are free of organic material. Therefore, they may be 
imported into the United States without an import permit issued in 
accordance with Sec.  330.201, unless the Administrator has issued an 
order stating that a particular article is an associated article. All 
such articles are, however, subject to inspection at the port of first 
arrival, subsequent reinspection at other locations, other remedial 
measures deemed necessary by an inspector to remove any risk the items 
pose of disseminating plant pests or noxious weeds, and any other 
restrictions of this chapter:
    (i) Consolidated material derived from any strata or substrata of 
the earth. Examples include clay (laterites, bentonite, china clay, 
attapulgite, tierrafino), talc, chalk, slate, iron ore, and gravel.
    (ii) Sediment, mud, or rock from saltwater bodies of water.
    (iii) Cosmetic mud and other commercial mud products.
    (iv) Stones, rocks, and quarry products.
    (c) Conditions governing the interstate movement of soil. (1) 
General conditions. Except for soil moved in accordance with paragraphs 
(c)(2) through (5) of this section, soil may be moved interstate within 
the United States without prior issuance of an interstate movement 
permit in accordance with Sec.  330.201 or further restriction under 
this subpart. However, all soil moved interstate is subject to any 
movement restrictions and remedial measures specified for such movement 
in part 301 of this chapter.
    (2) Conditions for the interstate movement within the continental 
United States of soil intended for the extraction of plant pests. Soil 
may be moved interstate within the continental United States with the 
intent of extracting plant pests, only if an interstate movement permit 
has been issued for its movement in accordance with Sec.  330.201, and 
the soil will be moved directly to a biocontainment facility approved 
by APHIS in a secure manner that prevents its dissemination into the 
outside environment.
    (3) Conditions for the interstate movement within the continental 
United States of soil infested with plant pests and intended for 
disposal. Soil may be moved interstate within the continental United 
States with the intent of disposing of plant pests, only if an 
interstate movement permit has been issued for its movement in 
accordance with Sec.  330.201, and the soil will be moved directly to 
an APHIS-approved disposal facility in a secure manner that prevents 
its dissemination into the outside environment.
    (4) Conditions for the interstate movement of soil samples from an 
area quarantined in accordance with part 301 of this chapter for 
chemical or compositional testing or analysis. Soil samples may be 
moved for chemical or compositional testing or analysis from an area 
that is quarantined in accordance with part 301 of this chapter without 
prior issuance of an interstate movement permit in accordance with 
Sec.  330.201 or further restriction under this chapter, provided that 
the soil is moved to a laboratory that has entered into and is 
operating under a compliance agreement with APHIS, is abiding by all 
terms and conditions of the compliance agreement, and is approved by 
APHIS to test and/or analyze such samples.
    (5) Additional conditions for interstate movement of soil to, from, 
or between Hawaii, the territories, and the continental United States. 
In addition to all general conditions for interstate movement of soil, 
soil may be moved interstate to, from, or between Hawaii, the 
territories, and the continental United States only if an interstate 
movement permit has been issued for its movement in accordance with 
Sec.  330.201. In addition, soil moved to, from, or between Hawaii, the 
territories, and the continental United States with the intent of 
extracting plant pests is subject to the conditions of paragraph (c)(2) 
of this section, while soil infested with plant pests and intended for 
disposal is subject to the conditions of paragraph (c)(3) of this 
section.
    (d) Conditions governing the transit of soil through the United 
States. Soil may transit through the United States only if a transit 
permit has been issued for its movement in accordance with part 352 of 
this chapter.


Sec.  330.204  Exceptions to permitting requirements for the 
importation or interstate movement of certain plant pests.

    Pursuant to section 7711 of the Plant Protection Act (7 U.S.C. 7701 
et seq.), the Administrator has determined that certain plant pests may 
be imported into or may move in interstate commerce within the 
continental United States without restriction. The list of all such 
plant pests is listed on the Internet at http://www.aphis.usda.gov/plant_health/permits/index.shtml.
    (a) Categories. In order to be included on the list, a plant pest 
must:
    (1) Be from field populations or lab cultures derived from field 
populations of a taxon that established throughout its entire 
geographical or ecological range within the continental United States; 
or
    (2) Be sufficiently attenuated so that it no longer poses a risk to 
plants or plant products; or
    (3) Be commercially available and raised under the regulatory 
purview of other Federal agencies.
    (b) Petition process to add plant pests to the list. (1) Petition. 
Any person may petition APHIS to have an additional plant pest added to 
the list of plant pests that may be imported into or move in interstate 
commerce within the continental United States without restriction. To 
submit a petition, the person must provide, in writing, information 
supporting the placement of a particular pest in one of the categories 
listed in paragraph (a) of this section.
    (i) Information that the plant pest belongs to a taxon that is 
established throughout its entire geographical or ecological range 
within the United States must include scientific literature, 
unpublished studies, or data regarding:
    (A) The biology of the plant pest, including characteristics that 
allow it to be identified, known hosts, and virulence;
    (B) The geographical or ecological range of the plant pest within 
the continental United States; and
    (C) The areas of the continental United States within which the 
plant pest is established.
    (ii) Information that the plant pest has been attenuated of its 
pathogenicity must include experimental data, published references, or 
scientific information regarding such attenuation.
    (iii) Information that the plant pest is commercially available and 
raised under the regulatory purview of another Federal agency must 
include a citation to the relevant law, regulation, or order under 
which the agency exercises such oversight.
    (2) APHIS review. APHIS will review the information contained in 
the petition to determine whether it is complete. In order to consider 
the petition complete, APHIS may require additional information to 
determine whether the plant pest belongs to one of the categories 
listed in paragraph (a) of this section. When it is determined that the 
information is complete, APHIS will commence review of the petition.
    (3) Action on petitions to add pests. (i) If, after review of the 
petition, APHIS determines there is insufficient evidence that the 
plant pest belongs to one of the three categories listed in paragraph 
(a) of this section, APHIS will deny the petition, and notify the 
petitioner in writing regarding this denial.

[[Page 7003]]

    (ii) If, after review of the petition, APHIS determines that the 
plant pest belongs to one of the categories in paragraph (a) of this 
section, APHIS will publish a notice in the Federal Register that 
announces the availability of the petition and any supporting 
documentation to the public, that states that APHIS intends to add the 
plant pest to the list of plant pests that may be imported into or move 
in interstate commerce within the continental United States without 
restriction, and that requests public comment. If no comments are 
received on the notice, or if, based on the comments received, APHIS 
determines that its conclusions regarding the petition have not been 
affected, APHIS will publish in the Federal Register a subsequent 
notice stating that the plant pest has been added to the list.
    (c) Petition process to have plant pests removed from the list. (1) 
Petition. Any person may petition to have a plant pest removed from the 
list of plant pests that may be imported into or move in interstate 
commerce within the continental United States without restriction by 
writing to APHIS. The petition must contain independently verifiable 
information demonstrating that APHIS' initial determination that the 
plant pest belongs to one of the categories in paragraph (a) of the 
section should be changed, or that additional information is now 
available that would have caused us to change the initial decision.
    (2) APHIS review. APHIS will review the information contained in 
the petition to determine whether it is complete. In order to consider 
the petition complete, APHIS may require additional information 
supporting the petitioner's claim. When it is determined that the 
information is complete, APHIS will commence review of the petition.
    (3) APHIS action on petitions to remove pests. (i) If, after review 
of the petition, APHIS determines that there is insufficient evidence 
to suggest that its initial determination should be changed, APHIS will 
deny the petition, and notify the petitioner in writing regarding this 
denial.
    (ii) If, after review of the petition, APHIS determines that there 
is a sufficient basis to suggest that its initial determination should 
be changed, APHIS will publish a notice in the Federal Register that 
announces the availability of the petition, and that requests public 
comment regarding removing the plant pest from the list of plant pests 
that may be imported into or move in interstate commerce within the 
continental United States without restriction. If no comments are 
received on the notice, or if the comments received do not affect 
APHIS' conclusions regarding the petition, APHIS will publish a 
subsequent notice in the Federal Register stating that the plant pest 
has been removed from the list.
    (d) APHIS-initiated changes to the list. (1) APHIS may propose to 
add a plant pest to or remove a pest from the list of plant pests that 
may be imported into or move in interstate commerce within the 
continental United States without restriction without a petition, if it 
determines that there is sufficient evidence that the plant pest 
belongs to one of the categories listed in paragraph (a) of the 
section, or if evidence emerges that leads APHIS to reconsider its 
initial determination that the plant pest was or was not in one of the 
categories lists in paragraph (a) of this section. APHIS will publish a 
notice in the Federal Register announcing this proposed addition or 
removal, making available any supporting documentation that it 
prepares, and requesting public comment.
    (2) If no comments are received on the notice or if the comments 
received do not affect the conclusions of the notice, APHIS will 
publish a subsequent notice in the Federal Register stating that the 
plant pest has been added to or removed from the list.


Sec.  330.205  Hand-carry of plant pests, biological control organisms, 
and soil.

    Plant pests, biological control organisms, and soil may be hand-
carried into the United States only in accordance with the provisions 
of this section.
    (a) Authorization to hand-carry.
    (1) Application for a permit; specification of ``hand-carry'' as 
proposed method of movement. A person must apply for an import permit 
for the plant pest, biological control organism, or soil, in accordance 
with Sec.  330.201, and specify hand-carry of the organism or article 
as the method of proposed movement.
    (2) Specification of individual who will hand-carry. The 
application must also specify the individual or individuals who will 
hand-carry the plant pest, biological control organism, or soil into 
the United States. If APHIS authorizes this individual or these 
individuals to hand-carry, the authorization may not be transferred to, 
nor actions under it performed by, individuals other than those 
identified on the permit application.
    (b) Notification of intent to hand-carry. After the permittee has 
obtained an import permit but no less than 20 days prior to movement, 
the permittee must notify APHIS through APHIS' online portal for permit 
applications or by fax and provide the following information in order 
to receive a hand-carry shipping authorization:
    (1) A copy of the face page of the passport for the individual or 
individuals who will hand-carry the plant pest, biological control 
organism, or soil;
    (2) A description of the means of conveyance in which the 
individual or individuals will travel, including flight number and 
airline name for air travel, or vehicle license number or other 
identifying number for other modes of transportation;
    (3) Expected date and time of first arrival;
    (4) Expected port of first arrival; and
    (5) Travel itinerary from port of first arrival to final 
destination.
    (c) Notification of arrival at the facility or point of 
destination. The permittee or his or her designee must notify APHIS 
within 24 hours of arrival of the hand-carried plant pest, biological 
control organism, or soil at the biocontainment facility or other 
authorized point of destination. This notification must state that the 
plant pest, biological control organism, or soil has arrived at its 
destination and that the package in which it was hand-carried has 
remained sealed until arrival. Notification must be by fax or email, or 
via the Internet at http://www.aphis.usda.gov/plant_health/permits/index.shtml.
    (d) Denial, amendment, or cancellation of authorization to hand-
carry. APHIS may deny a request to hand-carry, or amend or cancel any 
hand-carry authorization at any time, if it deems such action necessary 
to prevent the introduction or dissemination of plant pests or noxious 
weeds within the United States.
    (e) Appeal of denial, amendment, or cancellation. Any person whose 
request to hand-carry has been denied, or whose authorization to hand-
carry has been amended or canceled, may appeal the decision in writing 
to APHIS.


Sec.  330.206  Packaging requirements.

    Shipments in which plant pests, biological control organisms, and 
associated articles are imported into, moved interstate, or transited 
through the United States must meet the general packaging requirements 
of this section, as well as all specific packaging requirements on the 
permit itself.
    (a) Packaging requirements. All shipments must consist of an outer 
shipping container and at least two packages within the container. Both 
the

[[Page 7004]]

container and inner packages must be securely sealed to prevent the 
dissemination of the enclosed plant pests, biological control 
organisms, or associated articles.
    (1) Outer shipping container. The outer shipping container must be 
rigid, impenetrable and durable enough to remain closed and 
structurally intact in the event of dropping, lateral impact with other 
objects, and other shocks incidental to handling.
    (2) Inner packages. The innermost package or packages within the 
shipping container must contain all of the organisms or articles that 
will be moved. As a safeguard, the innermost package must be placed 
within another, larger package. All packages within the shipping 
container must be constructed or safeguarded so that they will remain 
sealed and structurally intact throughout transit. The packages must be 
able to withstand changes in pressure, temperature, and other climatic 
conditions incidental to shipment.
    (b) Packing material. Packing material must be free of plant pests, 
noxious weeds, or associated articles, and must be new, or must have 
been sterilized or disinfected prior to reuse. Packing material must be 
suited for the enclosed organism or article, as well as any medium in 
which the organism or article will be maintained, and should not be 
capable of harboring or being a means of the dissemination of the 
organism or article.\2\
---------------------------------------------------------------------------

    \2\ Guidance regarding suitable outer shipping containers, inner 
packages, and packaging is provided at http://www.aphis.usda.gov/plant_health/permits/index.shtml.
---------------------------------------------------------------------------

    (c) Requirements following receipt of the shipment at the point of 
destination. (1) Packing material, including media and substrates, must 
be destroyed by incineration, be decontaminated using autoclaving or 
another approved method, or otherwise be disposed of in a manner 
specified in the permit itself.
    (2) Shipping containers may not be reused, except those that have 
been sterilized or disinfected prior to reuse.
    (d) Costs. Permittees who fail to meet the requirements of this 
section may be held responsible for all costs incident to inspection, 
rerouting, repackaging, subsequent movement, and any treatments.


Sec.  330.207  Cost and charges.

    The inspection services of APHIS inspectors during regularly 
assigned hours of duty and at the usual places of duty will be 
furnished without cost. APHIS will not be responsible for any costs or 
charges incidental to inspections or compliance with the provisions of 
this subpart, other than for the inspection services of the inspector.

Subpart--Movement of Soil, Stone, and Quarry Products [Removed and 
Reserved]

0
14. Subpart--Movement of Soil, Stone, and Quarry Products, Sec. Sec.  
330.300 through 330.302, is removed and reserved.

PART 352--PLANT QUARANTINE SAFEGUARD REGULATIONS

0
15. The authority citation continues to read as follows:

    Authority: 7 U.S.C. 7701-7772 and 7781-7786; 21 U.S.C. 136 and 
136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.

0
16. In Sec.  352.1, paragraph (b) is amended by adding, in alphabetical 
order, definitions for biological control organism and noxious weed, 
and by revising the definitions for Deputy Administrator, person, plant 
pest, and soil to read as follows:


Sec.  352.1  Definitions.

* * * * *
    (b) * * *
    Biological control organism. Any enemy, antagonist, or competitor 
used to control a plant pest or noxious weed.
* * * * *
    Deputy Administrator. The Deputy Administrator of the Plant 
Protection and Quarantine Programs or any employee of the Plant 
Protection and Quarantine Programs delegated to act in his or her 
stead.
* * * * *
    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.
* * * * *
    Person. Any individual, partnership, corporation, association, 
joint venture, society, or other legal entity.
    Plant pest. Any living stage of any of the following that can 
directly or indirectly injure, cause damage to, or cause disease in any 
plant or plant product: A protozoan, 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 above.
* * * * *
    Soil. The unconsolidated material from the earth's surface that 
consists of rock and mineral particles and that supports or is capable 
of supporting biotic communities.
* * * * *


Sec.  352.2  [Amended]

0
17. In Sec.  352.2, paragraph (a) introductory text, the first sentence 
is amended by removing the words ``plant pests, noxious weeds, soil,'' 
and adding the words ``plant pests, biological control organisms, 
noxious weeds, soil,'' in their place, and by removing the words 
``contain plant pests or noxious weeds'' and adding the words ``contain 
plant pests, biological control organisms, or noxious weeds'' in their 
place.


Sec.  352.3   [Amended]

0
18. In Sec.  352.3, paragraph (a) is amended by adding the words 
``biological control organisms,'' after the words ``plant pests,'' each 
time they occur.


Sec.  352.5   [Amended]

0
19. Section 352.5 is amended by adding the words ``biological control 
organisms,'' after the words ``plant pests,'' each time they occur.


Sec.  352.6   [Amended]

0
20. Section 352.6 is amended as follows:
0
a. By removing footnote 2;
0
b. In paragraph (b), by removing the words ``as specified by'' and 
adding the words ``in accordance with'' in their place; and
0
c. In paragraph (c), by removing the citation ``Sec.  330.300(b)'' and 
adding the citation ``Sec.  330.203'' in its place.


Sec.  352.9  [Amended]

0
21. Section 352.9 is amended by adding the words ``biological control 
organisms,'' after the words ``plant pests,''.


Sec.  352.10   [Amended]

0
22. Section 352.10 is amended as follows:
0
a. By redesignating footnote 3 as footnote 2;
0
b. By removing the words ``plant pest or noxious weed dissemination'' 
each time they occur and adding the words ``plant pest, noxious weed, 
or biological control organism dissemination'' in their place;
0
c. In paragraph (b)(1), by adding the words ``biological control 
organisms,'' after the words ``Prohibited or restricted plants, plant 
products, plant pests,'';
0
d. In paragraph (b)(2)(i), by adding the words ``or biological control 
organisms,'' after the words ``plant pests'';

[[Page 7005]]

0
e. In paragraph (b)(2)(ii), by adding the words ``biological control 
organisms,'' after the words ``plant pests,''; and
0
f. In paragraph (b)(2)(iv), by removing the words ``plant pest 
dispersal'' and adding the words ``plant pest or biological control 
organism dispersal'' in their place.


Sec.  352.11   [Amended]

0
23. In Sec.  352.11, paragraph (a)(1) is amended by adding the words 
``biological control organisms,'' after the words ``plant pests,''.


Sec.  352.13   [Amended]

0
24. Section 352.13 is amended by adding the words ``biological control 
organisms,'' after the words ``plant pests,''.


Sec.  352.30   [Amended]

0
25. Section 352.30 is amended by redesignating footnotes 4 and 5 as 
footnotes 3 and 4, respectively.

    Done in Washington, DC, this 6th day of January 2017.
David Howard,
Acting Deputy Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 2017-00532 Filed 1-18-17; 8:45 am]
 BILLING CODE 3410-34-P



                                                      6980                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      DEPARTMENT OF AGRICULTURE                               help you, please call (202) 799–7039                   dissemination of plant pests into the
                                                                                                              before coming.                                         United States, or interstate, by
                                                      Animal and Plant Health Inspection                      FOR FURTHER INFORMATION CONTACT: Dr.                   regulating the importation and interstate
                                                      Service                                                 Colin D. Stewart, Assistant Director;                  movement of plant pests, soil, stone,
                                                                                                              Pests, Pathogens, and Biocontrol                       and quarry products.
                                                      7 CFR Parts 318, 319, 330, and 352                      Permits Branch, Plant Health Programs,                    These regulations were issued by the
                                                      [Docket No. APHIS–2008–0076]                            PPQ, APHIS, 4700 River Road, Unit 133,                 Animal and Plant Health Inspection
                                                                                                              Riverdale, MD 20737–1236; (301) 851–                   Service (APHIS) under the authority
                                                      RIN 0579–AC98                                           2237.                                                  provided by, among other statutes, the
                                                      Plant Pest Regulations; Update of                       SUPPLEMENTARY INFORMATION:                             Department of Agriculture Organic Act
                                                      Provisions                                                                                                     of 1944, as amended (7 U.S.C. 147a),
                                                                                                              Background                                             and the Federal Plant Pest Act, as
                                                      AGENCY:  Animal and Plant Health                           Under the Plant Protection Act (7                   amended (7 U.S.C. 150aa through 150jj),
                                                      Inspection Service, USDA.                               U.S.C. 7712 et seq., referred to below as              both of which were superseded and
                                                      ACTION: Proposed rule; withdrawal and                   the PPA or the Act), the Secretary of                  repealed by the PPA. Most of the
                                                      reproposal.                                             Agriculture has authority to carry out                 provisions of the PPA regarding the
                                                                                                              operations or measures to detect,                      importation and movement of plant
                                                      SUMMARY:    We are proposing to revise                  control, eradicate, suppress, prevent, or              pests were modeled on or directly
                                                      our regulations regarding the movement                  retard the spread of plant pests. Section              derived from these two Acts; thus, the
                                                      of plant pests. We are proposing criteria               7711(a) of the Act provides that ‘‘no                  enactment of the PPA did not
                                                      regarding the movement and                              person shall import, enter, export, or                 necessitate a major revision of the
                                                      environmental release of biological                     move in interstate commerce any plant                  subpart. However, the PPA did contain
                                                      control organisms, and are proposing to                 pest, unless the importation, entry,                   provisions that clarified the authority in
                                                      establish regulations to allow the                      exportation, or movement is authorized                 the earlier Acts regarding, among other
                                                      importation and movement in interstate                  under general or specific permit and in                things, our ability to regulate the
                                                      commerce of certain types of plant pests                accordance with such regulations as the                importation and interstate movement of
                                                      without restriction by granting                         Secretary may issue to prevent the                     biological control organisms, as well as
                                                      exceptions from permitting                              introduction of plant pests into the                   noxious weeds and associated articles.
                                                      requirements for those pests. We are                    United States or the dissemination of                     Accordingly, on October 9, 2001 (66
                                                      also proposing to revise our regulations                plant pests within the United States.’’                FR 51340–51358, Docket No. 95–095–2),
                                                      regarding the movement of soil. This                    The Act gives the United States                        we published in the Federal Register a
                                                      proposed rule replaces a previously                     Department of Agriculture (USDA) the                   proposed rule which would have
                                                      published proposed rule, which we are                   flexibility to respond appropriately to a              revised the plant pest regulations.
                                                      withdrawing as part of this document.                   wide range of needs and circumstances                  Among other proposed provisions, it
                                                      This proposal would clarify the factors                 to protect American agriculture against                would have established a notification
                                                      that would be considered when                           plant pests. The Act defines a plant pest              process that could be used as an
                                                      assessing the risks associated with the                 as ‘‘any living stage of any of the                    alternative to the permitting system,
                                                      movement of certain organisms and                       following that can directly or indirectly              provided for the environmental release
                                                      facilitate the movement of regulated                    injure, cause damage to, or cause                      of organisms for the biological control of
                                                      organisms and articles in a manner that                 disease in any plant or plant product:                 weeds, and updated the text of the
                                                      also protects U.S. agriculture.                         (A) A protozoan; (B) A nonhuman                        subpart to reflect the provisions of the
                                                      DATES: We will consider all comments                    animal; (C) A parasitic plant; (D) A                   PPA.
                                                      that we receive on or before March 20,                  bacterium; (E) A fungus; (F) A virus or
                                                      2017.                                                                                                             We solicited comments for 60 days
                                                                                                              viroid; (G) An infectious agent or other
                                                                                                                                                                     ending December 10, 2001. We received
                                                      ADDRESSES: You may submit comments                      pathogen; (H) Any article similar to or
                                                                                                                                                                     1,332 comments by that date. They were
                                                      by either of the following methods:                     allied with any of the articles specified
                                                                                                                                                                     from State Departments of Agriculture,
                                                                                                              in the preceding subparagraphs.’’
                                                                                                                                                                     a State fish and wildlife agency,
                                                        • Federal eRulemaking Portal: Go to                      In addition, section 412(a) of the Act
                                                                                                                                                                     universities, plant societies, biocontrol
                                                      http://www.regulations.gov/                             provides that the Secretary may prohibit
                                                                                                                                                                     organizations, USDA’s Forest Service
                                                      #!docketDetail;D=APHIS-2008-0076.                       or restrict the importation, entry,
                                                                                                                                                                     and Agricultural Research Service, the
                                                        • Postal Mail/Commercial Delivery:                    exportation, or movement in interstate
                                                                                                                                                                     U.S. Environmental Protection Agency
                                                      Send your comment to Docket No.                         commerce of, among other things, any
                                                                                                                                                                     (EPA), zoological associations, the
                                                      APHIS–2008–0076, Regulatory Analysis                    biological control organism if the
                                                                                                                                                                     World Trade Organization,
                                                      and Development, PPD, APHIS, Station                    Secretary determines that the
                                                                                                                                                                     pharmaceutical groups and biological
                                                      3A–03.8, 4700 River Road, Unit 118,                     prohibition or restriction is necessary to
                                                                                                                                                                     supply companies, wildlife protection
                                                      Riverdale, MD 20737–1238.                               prevent the introduction into the United
                                                                                                                                                                     and conservation groups, trade
                                                        Supporting documents and any                          States or the dissemination of a plant
                                                                                                                                                                     organizations, butterfly breeders and
                                                      comments we receive on this docket                      pest or noxious weed within the United
                                                                                                                                                                     associations, elementary schools, and
                                                      may be viewed at http://                                States. The Act defines a biological
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                                                                                                                                     private citizens.
                                                      www.regulations.gov/                                    control organism as ‘‘any enemy,
                                                      #!docketDetail;D=APHIS-2008-0076 or                     antagonist, or competitor used to control                 The majority of the comments that we
                                                      in our reading room, which is located in                a plant pest or noxious weed.’’                        received were from schools and
                                                      Room 1141 of the USDA South                                The purpose of the regulations in                   students who requested that we
                                                      Building, 14th Street and Independence                  ‘‘Subpart—Movement of Plant Pests’’ (7                 continue to allow the environmental
                                                      Avenue SW., Washington, DC. Normal                      CFR 330.200 through 330.212) and                       release of Monarch butterflies as part of
                                                      reading room hours are 8 a.m. to 4:30                   ‘‘Subpart—Movement of Soil, Stone,                     a learning curriculum. Some of these
                                                      p.m., Monday through Friday, except                     and Quarry Products’’ (7 CFR 330.300                   commenters also requested that we
                                                      holidays. To be sure someone is there to                through 330.301) is to prevent the                     continue to allow the environmental


                                                 VerDate Sep<11>2014   00:15 Jan 19, 2017   Jkt 241001   PO 00000   Frm 00002   Fmt 4701   Sfmt 4702   E:\FR\FM\19JAP3.SGM   19JAP3


                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                                  6981

                                                      release of Monarch butterflies for                      applications more regularly to evaluate                Provisions,’’ to incorporate the
                                                      weddings and other ceremonies.1                         their suitability for the organisms held               applicable new definitions provided by
                                                         We also received comments that                       onsite, and that we establish clear                    the PPA and to update or eliminate
                                                      addressed the proposed rule both                        protocols, with an adequate degree of                  some of the definitions currently
                                                      generally and in regard to its specific                 APHIS oversight, regarding the disposal                provided in that section.
                                                      provisions. Commenters often requested                  of organisms once a permit expires. A                     From the PPA, we would add
                                                      clarification regarding or suggested                    2007 followup OIG audit again                          definitions for the terms article,
                                                      modification to several of the rule’s                   encouraged us to fully implement                       biological control organism, enter
                                                      provisions, but were, on the whole,                     ePermits, particularly at ports of entry               (entry), export (exportation), import
                                                      generally supportive of the proposed                    into the United States.                                (importation), noxious weed, plant, and
                                                      rule. Accordingly, based on our                            Although APHIS has not                              plant product; and we would replace
                                                      evaluation of the comments that we                      substantively revised the regulations in               the current definitions of move (moved
                                                      received, we planned to issue a final                   the subpart since the promulgation of                  and movement), permit, person, plant
                                                      rule.                                                   the PPA and the release of the OIG                     pest, and State with the definitions
                                                         However, the events of September 11,                 audits, these audit reports have                       provided for those terms in the PPA.
                                                      2001, led to a further evaluation of our                informed Agency decisions regarding                    However, regarding the definition of
                                                      proposal to determine whether the                       our regulation of the movement of plant                permit, although the PPA definition
                                                      proposed provisions had sufficient                      pests, biological control organisms, and               mentions the issuance of oral permits,
                                                      safeguards governing our permitting                     associated articles.                                   our proposed definition does not. For
                                                      process. Specifically, we evaluated                        In this proposal, we are withdrawing                the purposes of the plant pest
                                                      whether an aspect of our proposal,                      our 2001 proposed rule and replacing it                regulations, oral permits would not
                                                      which would have authorized the                         with an alternative proposal. This                     provide a reliable means of verifying
                                                      importation of regulated organisms                      proposal retains several of the                        that a permittee was aware of the permit
                                                      without prior issuance of a permit,                     provisions of the 2001 proposal. For                   conditions at the time he or she was
                                                      provided that the party receiving the                   example, the conditions under which                    issued the permit, and would, we
                                                      organisms had entered into a                            we would consider an organism a plant                  believe, adversely affect APHIS’ ability
                                                      compliance agreement with APHIS,                        pest, and thus regulated by the subpart,               to ensure appropriate compliance and
                                                      could serve as a potential venue for                    remain similar to those of the 2001                    enforcement of our regulatory
                                                      bioterrorism. We also temporarily                       proposal. However, this proposal also                  requirements.
                                                      suspended issuance of new plant pest                    removes or modifies other provisions of                   We would also add definitions for
                                                      permits.                                                the 2001 proposal. For example, we                     Animal and Plant Health Inspection
                                                         In addition, on March 31, 2003,                      have removed provisions that would                     Service (APHIS), biocontainment
                                                      USDA’s Office of the Inspector General                  have authorized the movement of                        facility, EPA, hand-carry, interstate
                                                      (OIG) issued an audit of APHIS’                         regulated organisms through a process                  movement, living, permittee, responsible
                                                      permitting programs. Among other                        consisting of compliance agreements                    individual, secure shipment,
                                                      things, the audit examined APHIS’                       and notification of movement.                          sterilization (sterile, sterilized), taxon
                                                      issuance of plant pest permits, and its                    Additionally, this proposal also                    (taxa), transit, and U.S. Customs and
                                                      administration of the permitting                        incorporates new provisions that were                  Border Protection (CBP). We will first
                                                      process. The audit suggested that we                    not contained in the 2001 proposed rule                discuss what we mean by the term
                                                      implement ePermits, a more thorough                     but that would codify procedures that                  taxon (taxa). We will then discuss, in
                                                      and technologically advanced                            we have identified as best practices                   alphabetical order, the definitions of the
                                                      permitting database than that used at                   since that time but not yet added to the               other new terms that we are proposing
                                                      the time, that we discontinue our                       regulations.                                           to add to the regulations.
                                                      practice at the time of issuing ‘‘blanket’’                The most significant changes in this                   We would define taxon (taxa) as:
                                                      permits to individuals or organizations                 new proposal are:                                      ‘‘Any recognized grouping or rank
                                                      to move plant pests and biological                         • We are proposing to establish                     within the biological nomenclature of
                                                      control organisms in favor of specific                  criteria for the movement and                          organisms, such as class, order, family,
                                                      permits for each movement of a                          environmental release of both biological               genus, species, subspecies, pathovar,
                                                      regulated organism, that we require                     control organisms of noxious weeds and                 biotype, race, forma specialis, or
                                                      more thorough documentation of an                       those of plant pests; and                              cultivar.’’ This proposed definition is
                                                      organism’s intended use on each permit                     • We are proposing to remove                        based on the International Plant
                                                      application, that we develop risk-based                 ‘‘Subpart—Movement of Soil, Stone,                     Protection Convention’s (IPPC’s)
                                                      criteria for deciding whether or not to                 and Quarry Products’’ and would                        Glossary of Phytosanitary Terms,2
                                                      issue a permit for a particular                         instead regulate these articles in a                   which uses taxon, at various points, in
                                                      movement, that we inspect the                           subpart titled ‘‘Subpart—Movement of                   reference to family, species, and
                                                      destinations listed on permit                           Plant Pests, Biological Control                        subspecies.
                                                                                                              Organisms, and Associated Articles.’’                     We would define the term Animal
                                                                                                                 The full text of the proposed
                                                        1 Under this proposed rule, which withdraws our
                                                                                                                                                                     and Plant Health Inspection Service
                                                      2001 proposal, we would authorize the issuance of       regulations appears in the rule portion
                                                                                                                                                                     (APHIS) as: ‘‘The Animal and Plant
                                                                                                              of this document. Our discussion of the
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      permits for the environmental release of Monarch
                                                      butterflies in accordance with current practices.                                                              Health Inspection Service of the United
                                                                                                              proposed provisions follows.
                                                      Under these practices, permits issued to permittees                                                            States Department of Agriculture.’’
                                                      who reside east of the Rocky Mountains would            Definitions                                               We would define the term
                                                      authorize the environmental release of Monarch                                                                 biocontainment facility as: ‘‘A physical
                                                      butterflies east of the Rockies, while those issued        In addition to our proposed revision
                                                      for permittees who reside west of the Rocky             of ‘‘Subpart—Movement Plant Pests’’                    structure, or portion thereof,
                                                      Mountains would authorize the environmental             and removal of ‘‘Subpart—Movement of
                                                      release of Monarch butterflies west of the Rockies.                                                              2 International Standard for Phytosanitary

                                                      This is because there are two distinct ecological
                                                                                                              Soil, Stone, and Quarry Products,’’ we                 Measures (ISPM) Number 5. To view this and other
                                                      ranges for Monarchs in the United States, with each     would also revise § 330.100,                           ISPMS, go to https://www.ippc.int/en/core-
                                                      terminating at the Rocky Mountains.                     ‘‘Definitions,’’ of ‘‘Subpart—General                  activities/standards-setting/ispms/#publications.



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                                                      6982                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      constructed and maintained in order to                  individual will also be deemed the act,                in which we would use the term in the
                                                      contain plant pests, biological control                 omission, or failure of a permittee.’’                 revised subpart that it would have a
                                                      organisms, or associated articles.’’                       Historically, we have only issued                   different meaning within these
                                                         We would define the term EPA as:                     permits for the movement of plant pests,               regulations.
                                                      ‘‘The Environmental Protection Agency                   biological control organisms, and                         We would define the term transit as:
                                                      of the United States.’’                                 associated articles to individuals.                    ‘‘Movement from and to a foreign
                                                         We would define the term hand-carry                  However, as provided for in the                        destination through the United States.’’
                                                      as: ‘‘Importation of an organism that                   definition of permittee, we would allow                This definition would replace a
                                                      remains in one’s personal possession                    corporate entities to obtain permits                   definition currently in the regulations,
                                                      and in close proximity to one’s person.’’               under the revised regulations. This                    through the United States, which we
                                                      Our requirements governing the                          change will allow for better tracking and              define as: ‘‘From and to places outside
                                                      movement of plant pests by baggage,                     communication regarding a permit or                    the United States.’’
                                                      currently found in § 330.212, are                       permit application, and will also make                    We would define the term U.S.
                                                      commonly referred to as the ‘‘hand-                     it clear that the corporation as a whole               Customs and Border Protection (CBP)
                                                      carry’’ regulations; we are proposing to                is responsible for the permit. In such                 as: ‘‘U.S. Customs and Border Protection
                                                      revise these requirements.                              instances, we believe that it is of                    within the Department of Homeland
                                                         We would define the term interstate                  paramount importance that the                          Security.’’ This definition would replace
                                                      movement as: ‘‘Movement from one                        permittee specifies a person whom                      the now outdated definition of Customs
                                                      State into or through any other State; or               APHIS may contact regarding the                        in the current regulations.
                                                                                                              actions authorized under the permit                       In addition, we would substantively
                                                      movement within the District of
                                                                                                              who has first-hand knowledge of these                  revise the definition of soil. We
                                                      Columbia, Guam, the U.S. Virgin
                                                                                                              actions. The responsible individual                    currently define soil as: ‘‘The loose
                                                      Islands, or any other territory or
                                                                                                              would fulfill this role.                               surface material of the earth in which
                                                      possession of the United States.’’
                                                                                                                 We anticipate that, if this rule is                 plants grow, in most cases consisting of
                                                         We would define the term living as:
                                                                                                              finalized, we would still issue a                      disintegrated rock with an admixture of
                                                      ‘‘Viable or potentially viable.’’ We are
                                                                                                              significant number of permits to                       organic material and soluble salts.’’ We
                                                      including ‘‘potentially viable’’ within
                                                                                                              individuals, rather than corporate                     would redefine soil as: ‘‘The
                                                      our definition of living because most                   entities. We expect that, for the majority             unconsolidated material from the earth’s
                                                      viruses and retroviruses of plants and                  of such permits, the permittee would                   surface that consists of rock and mineral
                                                      plant products cannot grow or                           wish to designate him or herself as the                particles and that supports or is capable
                                                      reproduce outside of a host cell;                       responsible individual; therefore, the                 of supporting biotic communities.’’ This
                                                      however, once inserted into the cell,                   definition of responsible individual                   definition aligns with the current
                                                      they are capable of both growth and self-               would allow for such designation.                      scientific understanding of soil, and
                                                      replication, and, over time, exhibit                       Finally, Section 7734 of the PPA                    would resolve ambiguities in the current
                                                      pathogenic effects. Because of this                     provides that a person will be held                    definition that could be construed to
                                                      potential for both growth and self-                     liable for the acts, omissions, and                    suggest that soil includes consolidated
                                                      replication, it is generally our policy to              failures of an agent acting for that                   or sterile matter that does not present a
                                                      consider such viruses living plant pests,               person, as long as the agent is acting                 risk of harboring plant pests or noxious
                                                      and to require a permit for their                       within the scope of his or her office.                 weeds. (For purposes of the regulations,
                                                      importation, interstate movement,                       Responsible individuals would be                       it does not.) We would also remove the
                                                      transit, or continued curation.                         agents of the permittee pursuant to this               definition of earth, ‘‘the softer matter
                                                         We would define the term permittee                   section of the PPA.                                    composing part of the surface of the
                                                      as: ‘‘The person to whom APHIS has                         We would define the term secure                     globe, in distinction from the firm rock,
                                                      issued a permit in accordance with this                 shipment as: ‘‘Shipment of a regulated                 and including the soil and subsoil, as
                                                      part and who must comply with the                       plant pest, biological control organism,               well as finely divided rock and other
                                                      provisions of the permit and the                        or associated article in a container or a              soil formation materials down to the
                                                      regulations in this part.’’                             means of conveyance of sufficient                      rock layer,’’ from the regulations.
                                                         We would define the term responsible                 strength and integrity to prevent leakage                 We would remove the definition of
                                                      individual as: ‘‘The individual who a                   of contents and to withstand shocks,                   Plant Protection Act. The Act is cited in
                                                      permittee designates to oversee and                     pressure changes, and other conditions                 the authority citation for part 330, and
                                                      control the actions taken under a permit                incident to ordinary handling in                       we do not believe it is necessary to
                                                      issued in accordance with this part for                 transportation.’’                                      define it in the regulations.
                                                      the movement or curation of a plant                        We would define the term                               We would make nonsubstantive
                                                      pest, biological control organism, or                   sterilization (sterile, sterilized) as: ‘‘A            editorial changes to the definitions of
                                                      associated article. For the duration of                 chemical or physical process that results              administrative instructions,
                                                      the permit, the individual must be                      in the death of all living organisms on                Administrator, Department, Deputy
                                                      physically present during normal                        or within the article subject to the                   Administrator, inspector, means of
                                                      business hours at or near the location                  process. Examples include, but are not                 conveyance, owner, and Plant
                                                      specified on the permit as the ultimate                 limited to, autoclaving and                            Protection and Quarantine Programs.
                                                      destination of the plant pest, biological               incineration.’’                                           Finally, we would retain, without
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                                                      control organism, or associated article,                   Note that, for the purposes of this                 modification, the existing definitions of
                                                      and must serve as a primary contact for                 subpart, the term sterilization does not               garbage, regulated garbage, and shelf-
                                                      communication with APHIS. The                           refer to techniques that neutralize an                 stable.
                                                      permittee may designate him or herself                  organism by rendering it incapable of
                                                      as the responsible individual. The                      sexual reproduction. We recognize that                 Titles of the Part and Subpart
                                                      responsible individual must be at least                 this alternate meaning of the term                        Currently, the title of part 330,
                                                      18 years of age. In accordance with                     ‘‘sterilization’’ might be more common                 ‘‘Federal Plant Pest Regulations;
                                                      section 7734 of the PPA, the act,                       within the regulated community, but                    General; Plant Pests; Soil, Stone, and
                                                      omission, or failure of any responsible                 believe that it is clear from the manner               Quarry Products; Garbage,’’ reflects the


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                             6983

                                                      titles of its four subparts. As mentioned               subparts in the domestic quarantine                    on the definition of plant pest found in
                                                      above, we are proposing to revise the                   notice regulations of 7 CFR part 301.                  the PPA, and have been our framework
                                                      second subpart, currently titled                           We discuss the exemptions from                      in recent years for determining whether
                                                      ‘‘Subpart—Movement of Plant Pests,’’ to                 permitting requirements that we are                    an organism is a plant pest.
                                                      clarify that it regulates the movement                  proposing to grant for certain categories
                                                                                                              of biological control organisms in the                    We would also expand the scope of
                                                      not only of plant pests, but also of
                                                                                                              discussion under the heading                           our 2001 proposal so that we may
                                                      biological control organisms and
                                                                                                              ‘‘Biological control organisms                         consider organisms of an unknown risk
                                                      associated articles, including soil. Since
                                                      we would now regulate soil within that                  (§ 330.202),’’ and the exceptions from                 to plants or plant products to be plant
                                                      subpart, we would remove and reserve                    permitting requirements that we are                    pests, provided that the organisms are
                                                      the third subpart, ‘‘Subpart—Soil,                      proposing to grant for certain plant pests             similar to an organism known to
                                                      Stone, and Quarry Products.’’                           in the discussion under the heading                    directly or indirectly injure, cause
                                                         For this reason, we would also update                ‘‘Exceptions to permitting requirements                damage to, or cause disease in a plant
                                                      the title of the second subpart. As                     for the importation or interstate                      or plant product.
                                                      amended, it would now be titled                         movement of certain plant pests                           In our 2001 proposal, we did propose
                                                      ‘‘Subpart—Movement of Plant Pests,                      (§ 330.204).’’                                         that organisms of an unknown risk to
                                                      Biological Control Organisms, and                          Finally, to date, we have only issued
                                                                                                                                                                     plants or plant products would require
                                                      Associated Articles.’’                                  specific permits, that is, permits issued
                                                                                                                                                                     a permit, but we would have designated
                                                         As a result of these proposed                        to specific persons, for the interstate
                                                                                                              movement of plant pests. However,                      them regulated organisms rather than
                                                      revisions, we would also revise the title
                                                                                                              pursuant to section 7711 of the PPA, the               plant pests. We also stated that
                                                      of the part. It would now be titled:
                                                                                                              Administrator may also issue general                   permitting conditions for such
                                                      ‘‘Federal Plant Pest Regulations;
                                                      General; Plant Pests, Biological Control                permits, that is, general authorizations,              organisms would be aimed primarily at
                                                      Organisms, and Associated Articles;                     for the importation or interstate                      affording us an opportunity to identify
                                                      Garbage.’’                                              movement of plant pests.                               and deal with the organisms with some
                                                                                                                 In recent years, we have contemplated               initial degree of regulatory oversight, in
                                                      Scope and General Restrictions                          issuing a general, Web-based permit for                order to prevent the dissemination of
                                                      (§ 330.200)                                             the interstate movement of certain plant               plant pests into or within the United
                                                         The proposed regulations would                       pests that we regard to be low-risk                    States. We thus framed permitting
                                                      begin by establishing the scope of the                  unless they are moved into certain areas               requirements for such organisms as a
                                                      revised subpart. Paragraph (a) would                    of the United States, rather than specific             necessary stopgap measure pending
                                                      state that no person shall import, move                 permits for the movement of these pests.               positive identification of the organism
                                                      interstate, transit, or release into the                If we finalize proposed paragraph (a) of               and an assessment of the organism’s
                                                      environment plant pests, biological                     § 330.200 and decide to issue such a                   potential risk to plants and plant
                                                      control organisms, or associated articles,              permit, we would announce the                          products.
                                                      unless the importation, interstate                      existence, location, and content of this
                                                      movement, transit, or release into the                  general permit through a notice in the                    However, since 2001, there have been
                                                      environment of the plant pests,                         Federal Register.                                      numerous occasions when applicants
                                                      biological control organisms, or                           Paragraph (b) of § 330.200 would                    have requested authorization to import
                                                      associated articles is:                                 specify the types of plant pests that we               organisms that cannot readily be
                                                         • Authorized under an import,                        would regulate under the revised                       identified to the species level for a
                                                      interstate movement, or continued                       subpart. The paragraph would state that,               significant portion of their lifespans, but
                                                      curation permit issued in accordance                    for the purposes of the subpart, we                    that may be plant pests. For example,
                                                      with proposed § 330.201;                                would consider an organism to be a                     we have issued several plant pest
                                                         • Authorized in accordance with                      plant pest if the organism either directly             permits for the importation of larval
                                                      other APHIS regulations in 7 CFR                        or indirectly injures, causes damage to,               scarabs. Before becoming mature, all
                                                      chapter III;                                            or causes disease in a plant or plant                  scarabs are morphologically similar to
                                                         • Explicitly granted an exception or                 product, or if the organism or part is an              one another and exhibit similar feeding
                                                      exemption in the revised subpart from                   unknown risk to plants or plant                        patterns, but are not plant pests.
                                                      permitting requirements.                                products, but is similar to an organism                However, once mature, certain scarab
                                                         • Authorized under a general permit                  known to directly or indirectly injure,                species are plant pests. In order to take
                                                      issued by the Administrator.                            cause damage to, or cause disease in a
                                                         By ‘‘authorized in accordance with                                                                          this potential for future effects on
                                                                                                              plant or plant product.                                plants, plant parts, and plant products
                                                      other APHIS regulations in 7 CFR                           This paragraph, which is not found in
                                                      chapter III,’’ we mean that certain                     the current regulations, is similar to the             into consideration, in issuing a permit
                                                      movements of plant pests or associated                  criteria for designating an organism a                 for any scarab grub, we have considered
                                                      articles are regulated under other APHIS                plant pest that were contained in our                  it to be a plant pest, and tailored
                                                      regulations in title 7. For example, the                2001 proposal. We have, however, made                  permitting and containment
                                                      transit of a plant pest through the                     two changes to those criteria.                         requirements accordingly.
                                                      United States would require a permit                       First, while our 2001 proposal would                   Paragraph (c) of § 330.200 would
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                                                      issued in accordance with § 352.5 of the                have designated certain organisms as                   specify the types of biological control
                                                      plant quarantine safeguard regulations                  plant pests if they directly or indirectly             organisms that we would regulate under
                                                      in 7 CFR part 352, and the interstate                   adversely affected plants, plant parts, or             the revised subpart. Although the PPA
                                                      movement of regulated associated                        plant products, in this proposed rule,                 defines a biological control organism as
                                                      articles of domestic quarantine pests                   we would designate these organisms as                  ‘‘any enemy, antagonist, or competitor
                                                      (e.g., host articles of pine shoot beetle or            plant pests if the organisms directly or               used to control a plant pest or noxious
                                                      Asian citrus psyllid) normally require                  indirectly injure, cause damage to, or                 weed,’’ practically speaking, we have
                                                      certificates or limited permits issued in               cause disease in a plant or plant
                                                                                                                                                                     only required permits for certain types
                                                      accordance with their respective                        product. These latter criteria are based


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                                                      6984                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      of biological control organisms since the               for which the Administrator determined                 from outside the United States into the
                                                      PPA was promulgated.3 These are:                        it necessary to exercise a degree of                   territorial limits of the United States;
                                                         • Invertebrate predators and parasites               regulatory oversight in order to prevent               that, when import permits are issued to
                                                      (parasitoids) used to control invertebrate              the introduction of a plant pest into the              individuals, these individuals must be
                                                      plant pests,                                            United States or the dissemination of a                18 years of age or older and have a
                                                         • Invertebrate competitors used to                   plant pest within the United States.                   physical address within the United
                                                      control invertebrate plant pests,                          Paragraph (d) would exempt                          States; and that, when import permits
                                                         • Invertebrate herbivores used to                    biological control organism products                   are issued to corporate persons, these
                                                      control noxious weeds,                                  that EPA has issued experimental use                   persons must maintain an address or
                                                         • Microbial pathogens used to control                permits for or that EPA has registered as              business office in the United States with
                                                      invertebrate plant pests,                               microbial pesticide products having                    a designated individual for service of
                                                         • Microbial pathogens used to control                outdoor uses from regulatory oversight                 process.4
                                                      noxious weeds, and                                      under the revised subpart. Under the                      Paragraph (a)(2) would provide
                                                         • Microbial parasites used to control                authority of the Federal Insecticide,                  information regarding interstate
                                                      plant pathogens.                                        Fungicide and Rodenticide Act (7 U.S.C.                movement permits. It would state that
                                                         Regarding these types of biological                  136 et seq., FIFRA), EPA regulates                     interstate movement permits are issued
                                                      control organisms, we recognize that                    certain biological control organisms                   to persons for secure shipment from any
                                                      biological control organisms used to                    (eukaryotic microorganisms, prokaryotic                State into or through any other State;
                                                      control noxious weeds are also plant                    microorganisms, and viruses) as                        that, when interstate movement permits
                                                      pests, insofar as they injure, cause                    ‘‘substances,’’ and has established a                  are issued to individuals, these
                                                      damage to, or cause disease in plants.                  registration process for their use as                  individuals must be 18 years of age or
                                                      However, since this effect is desirable                 microbial pesticides. EPA issues                       older and have a physical address
                                                      and ultimately beneficial to other                      experimental use permits (EUPs) to                     within the United States; and that, when
                                                      plants, plant parts, and plant products,                allow persons to release these organisms               interstate movement permits are issued
                                                      it has been our policy to draft permitting              into the environment on a limited basis                to corporate persons, these persons must
                                                      conditions for the movement and                         in order to obtain information necessary               maintain an address or business office
                                                      environmental release of these                          to apply to have the organisms                         in the United States with a designated
                                                      organisms in a manner that encourages                   registered as microbial pesticides. EPA                individual for service of process.
                                                      these effects, unless we have reason to                 also allows the transfer, sale, and/or                    Both import and interstate movement
                                                      believe that the organisms may also                     distribution of unregistered pesticides                permits may contain conditions
                                                      have plant pest effects on non-target                   under certain circumstances in                         regarding the manner in which an
                                                      plants or plant products.                               accordance with its regulations in 40                  organism may be moved from the
                                                         As noted in the previous paragraphs,                 CFR 152.30. Because registered or                      destination listed on the permit. Such
                                                      there are some types of biological                      permitted products are already subject                 conditions are necessary to ensure that
                                                      control organisms for which we have                     to extensive regulation by EPA, we have                the organism is moved in a manner that
                                                      not historically issued permits.                        entered into a memorandum of                           will prevent its escape and
                                                      However, there may be times when                        understanding with EPA stating that we                 dissemination and to ensure that the
                                                      there would be a risk-based need to                     consider the products to be exempt from                new facility to which it will be moved
                                                      regulate the importation or interstate                  our regulatory oversight, and paragraph                is capable of providing the necessary
                                                      movement of an organism that falls                      (d) would largely codify the policy in                 level of containment.
                                                      within the PPA’s definition of a                        this memorandum. It would also                            On a related matter, applicants for
                                                      biological control organism, but does                   address EPA’s provision for the transfer,              import and interstate movement permits
                                                      not fall into any of the types of                       sale, and/or distribution of unregistered              should be aware that States and
                                                      organisms listed above. For example, if                 pesticides under certain circumstances,                localities may have laws and regulations
                                                      a microbial parasite that has not                       and allow for the importation and                      that restrict the movement or release of
                                                      previously been evaluated is put forth                  interstate movement of such                            plant pests, biological control
                                                      for the control of pathogenic fungi, it                 unregistered pesticides without APHIS’                 organisms, and associated articles for
                                                      would not fall within the above                         oversight, because of EPA’s oversight.                 various reasons (for example, impact on
                                                      categories, but could be an organism we                                                                        the environment of the State or locality).
                                                      would wish to regulate out of concern                   Permit Requirements (§ 330.201)
                                                                                                                                                                     We encourage applicants to consult
                                                      of the possibility of effects on non-target               Section 330.201 would describe the                   with these authorities prior to applying
                                                      plants, such as fungi without                           types of permits that APHIS issues for                 for a permit.
                                                      phytopathogenic properties. To this                     plant pests, biological control                           Paragraph (a)(3) would provide
                                                      end, paragraph (c) would also provide                   organisms, and associated articles, the                information regarding continued
                                                      that other types of biological control                  process for applying for a permit, and                 curation permits. It would state that
                                                      organisms could be regulated under the                  the manner in which APHIS acts on                      continued curation permits are issued in
                                                      revised subpart, as determined by                       permit applications.                                   conjunction with and prior to the
                                                      APHIS. This determination would                           Paragraph (a) of § 330.201 would                     expiration date for an import permit or
                                                      typically be on a case-by-case basis, and               provide information regarding the types                interstate movement permit, in order for
                                                                                                              of permits that APHIS issues for plant
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                                                      would be based on a permit application                                                                         the permittee to continue the actions
                                                      for movement of an organism which did                   pests, biological control organisms, and               listed on the import permit or interstate
                                                      not belong to any of the above types, but               associated articles. It would state that
                                                                                                              we issue import permits, interstate                      4 Please note that other Federal agencies have
                                                        3 Itis worth noting that, prior to the PPA, we        movement permits, continued curation                   separate regulatory authority related to the
                                                      issued permits for the movement and release of          permits, and transit permits.                          importation of secure shipments of plant pests,
                                                      invertebrate herbivores used to control noxious           Paragraph (a)(1) would provide                       biological control organisms, and associated
                                                      weeds and microbial pathogens used to control                                                                  articles. For example, pursuant to their general
                                                      noxious weeds pursuant to authority in the Federal
                                                                                                              information regarding import permits. It               regulatory authority, DHS requires formal entry for
                                                      Plant Pest Act (FPPA). The FPPA was superseded          would state that APHIS issues import                   organisms and soil that are imported via hand-carry
                                                      and repealed by the PPA.                                permits to persons for secure shipment                 or express courier organizations.



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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                          6985

                                                      movement permit following the                           much confusion in the public and                       destination for the export of the plant
                                                      expiration of the original permit. It                   especially in the research community.                  pests, biological control organisms, or
                                                      would also state that, when continued                   The application form for courtesy                      associated articles into that country.
                                                      curation permits are issued to                          permits was identical to the application                 That being said, for certain high-risk
                                                      individuals, these individuals must be                  for other types of permits, and the                    plant pests, interstate movement
                                                      18 years of age or older and have a                     courtesy permit itself looked like other               permits may place conditions on the
                                                      physical address within the United                      permits. This periodically led to the                  interstate movement of the organism for
                                                      States. It would further state that, when               misunderstanding by some researchers                   export purposes. This is not included in
                                                      continued curation permits are issued to                that courtesy permits were required for                the current regulations, but reflects
                                                      corporate persons, these persons must                   the movement of certain organisms that                 recent Agency policy. Such conditions
                                                      maintain an address or business office                  were, in actuality, not subject to APHIS               are necessary to safeguard the
                                                      in the United States with a designated                  regulation. For these reasons, in recent               movement of the organism to the port of
                                                      individual for service of process.                      years, Plant Protection and Quarantine                 export.
                                                         Paragraph (a)(4) would provide                       (PPQ) has discontinued its issuance of                   Paragraph (b) of § 330.201 would
                                                      information regarding transit permits. It               courtesy permits for organisms that are                provide that permit applications must
                                                      would state that transit permits are                    similar to plant pests or biological                   be submitted by the applicant in writing
                                                      issued for secure shipments through the                 control organisms, and it would not be                 or electronically through one of the
                                                      United States, and that such permits are                necessary to include courtesy permits in               methods specified at http://
                                                      issued in accordance with 7 CFR part                    the revised subpart.                                   www.aphis.usda.gov/plant_health/
                                                      352. As we mentioned above, § 352.5 of                     In a related matter, § 330.207 of the               permits/index.shtml, and must be
                                                      that part contains permitting                           current regulations states that APHIS                  submitted in advance of the action(s)
                                                      requirements for transit permits.                       recognizes permits issued by other                     proposed on the permit application.
                                                         However, part 352 currently provides                 Federal Agencies for the movement of                   That Web page would specify that
                                                      for the transit of plant pests, but does                regulated organisms and will issue                     persons may apply for a permit via the
                                                      not provide for the transit of biological               administrative instructions or engage in               Internet through APHIS’ secure site for
                                                      control organisms. Therefore, we would                  correspondence with a permittee to                     online permit applications, and would
                                                      amend part 352 to include references to                 augment the provisions of these permits                provide a link to that portal. It would
                                                      biological control organisms. (For this                 through further conditions, rather than                also provide that a person may submit
                                                      reason, we would also amend part 352                    issue a duplicative permit.                            a permit application by faxing the
                                                      to add definitions for the terms                           We do not consider it necessary to                  application to APHIS, and would
                                                      biological control organism and noxious                 retain those provisions in the revised                 specify the appropriate fax number.
                                                      weed, and to revise the definitions for                 subpart. First, we seldom engage in                    Additionally, it would state that an
                                                      Deputy Administrator, person, plant                     correspondence with the permittee for                  application may be obtained by calling
                                                      pest, and soil. The revised definitions                 permits issued by another Federal                      PPQ at the number provided. Finally, it
                                                      would be identical to the ones we are                   agency, such as EUPs issued by EPA.                    would provide that a person may submit
                                                      proposing for part 330.)                                Rather, if we believe that the actions                 a permit application by mailing it to
                                                         Currently, part 330 contains                         authorized under the permit may place                  APHIS at the address provided. We note
                                                      provisions for the issuance of several                  plants or plant products at risk, we                   that because of the need for additional
                                                      additional types of permits: Permits for                discuss the matter with the issuing                    administrative processing, permit
                                                      plant pest movement associated with                     agency itself. Correspondingly, it is rare             applications that are submitted via fax
                                                      national defense projects, permits for                  that we receive permit applications from               or by mail may not be reviewed as
                                                      means of conveyance, and courtesy                       applicants who have submitted a prior                  expeditiously as those submitted
                                                      permits for organisms that are not                      application to another regulatory                      through APHIS’ online portal. We
                                                      subject to APHIS regulation. However,                   agency. Therefore, the provisions do not               encourage applicants to submit their
                                                      we no longer issue a special type of                    reflect current Agency practices, and we               applications electronically.
                                                      permit specifically for national defense                believe that it is generally presupposed                 Paragraph (c) of § 330.201 would
                                                      projects; if such a permit application                  by the regulated community that we                     provide that a permit application must
                                                      arises, we issue the appropriate type of                will recognize permits issued by other                 be complete before we will evaluate it
                                                      movement permit, and specify as a                       regulatory agencies for the movement of                in order to determine whether to issue
                                                      permit condition that the use of the                    plant pests, biological control                        the permit requested. Guidance
                                                      organism is for a national defense                      organisms, and associated articles.                    regarding how to complete a permit
                                                      project. Similarly, we do not issue                        Finally, we have periodically received              application, including guidance specific
                                                      permits specifically for means of                       requests from individuals to issue                     to various information blocks on the
                                                      conveyance; if we have reason to believe                permits certifying organisms and                       application, would be available at
                                                      the means of conveyance may be an                       associated articles that are destined for              http://www.aphis.usda.gov/
                                                      associated article, we regulate it as such              export from the United States. We note                 plant_health/permits/index.shtml. The
                                                      and issue the appropriate movement                      that foreign countries, rather than                    guidance would also specify that, in
                                                      permit.                                                 APHIS, set the conditions under which                  order to facilitate timely issuance of a
                                                         Until 2009, we issued courtesy                       they will allow the importation of plant               permit, an application should be
                                                      permits in order to facilitate the                      pests, biological control organisms, and               submitted at least 90 days before the
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      movement of organisms that were not                     associated articles from the United                    actions proposed on the permit
                                                      regulated under 7 CFR part 330, but that                States. To this end, we would include                  application are scheduled to take place,
                                                      were similar enough to a known plant                    a footnote stating that persons                        with additional time allotted for
                                                      pest or biological control organism that                contemplating the shipment of plant                    complex or novel applications, or
                                                      their movement might otherwise be                       pests, biological control organisms, or                applications for high-risk plant pests.
                                                      impeded if they were not accompanied                    associated articles to places outside the                Paragraph (d) of § 330.301 would
                                                      by some sort of documentation from                      United States should make                              describe the actions APHIS takes on
                                                      APHIS during transit. However,                          arrangements directly, or through the                  receiving a permit application. The
                                                      courtesy permits historically generated                 recipient, with the country of                         introductory text to the paragraph


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                                                      6986                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      would state that APHIS reviews the                      noxious weed within the United States                   those specified as the intended use on
                                                      information on the application to                       in a manner that presents an                            the permit. In such instances, APHIS
                                                      determine whether it is complete. In                    unacceptable risk to plants and plant                   was not afforded an opportunity to
                                                      order to consider an application                        products.                                               evaluate the uses and determine
                                                      complete, APHIS may request                                We would specify that the actions                    whether they present a risk to plants
                                                      additional information that we                          allowed under the permit must be                        and plant products within the United
                                                      determine to be necessary in order to                   highly unlikely to result in the                        States. There have also been instances
                                                      assess the risk to plants and plant                     introduction or dissemination of a plant                when laboratories have claimed that
                                                      products that may be posed by the                       pest, biological control organism, or                   subsequent generations derived from a
                                                      actions proposed on the application.                    noxious weed within the United States                   parent organism during the time period
                                                      When it is determined that an                           in a manner that presents an                            specified on a permit are distinct
                                                      application is complete, we commence                    unacceptable risk to plants and plant                   organisms, and thus should not be
                                                      review of the information provided.                     products because we would allow the                     subject to the conditions specified on
                                                         Paragraph (d)(1) would describe the                  environmental release of certain plant                  the permit and may be used at the
                                                      first part of APHIS’ formal review,                     pests and biological control organisms                  laboratory’s discretion. Such
                                                      consultation with States, Tribes, and                   under the revised subpart. The                          unregulated use of subsequent
                                                      other individuals. We share a copy of                   considerations that lead us to determine                generations or progeny could present a
                                                      the permit application, and the                         whether to authorize the environmental                  risk of dissemination of the pest. Hence,
                                                      proposed permit conditions, with the                    release of such organisms are discussed                 we would require that the use of
                                                      appropriate State or Tribal regulatory                  later in this document.                                 organisms derived from a regulated
                                                      officials, and may share them with other                   Paragraphs (d)(3)(i) through (d)(3)(iv)              parent organism must conform to the
                                                      persons or groups to provide comment.                   would describe the manner in which                      intended use specified on the permit
                                                      For instance, we may share the permit                   APHIS would issue a permit under the                    application for the parent organism.
                                                      application with persons or groups                      revised subpart. Prior to issuing the                      All activities carried out under the
                                                      other than State or Tribal regulatory                   permit, APHIS would notify the                          permit would have to cease on or before
                                                      officials when we lack technical                        applicant in writing or electronically of               the expiration date of the permit, unless,
                                                      expertise to evaluate certain aspects of                all proposed permit conditions. The                     prior to that expiration date, the
                                                      a permit application and need to solicit                applicant would have to agree in writing                permittee has submitted a new permit
                                                      the opinion of individuals or groups                    or electronically that he or she, and all               application and a new permit has been
                                                      with such expertise.                                    his or her employees, agents, and/or                    issued to authorize continuation of the
                                                         Paragraph (d)(2) would describe the                  officers, would comply with all permit                  actions.
                                                      second part of our review, our initial                  conditions and all provisions of the                       Finally, at any point following
                                                      assessment of sites and facilities where                regulations. If the organism or                         issuance of a permit but prior to its
                                                      the organism or article will be held or                 associated article will be contained in a               expiration date, an inspector could
                                                      released that are listed on the permit                  private residence, the applicant would                  conduct unscheduled assessments of the
                                                      application. Such sites and facilities                  have to state in this agreement that he                 site or facility in which the organisms
                                                      may include private residences,                         or she authorizes APHIS to conduct                      or associated articles are held, to
                                                      biocontainment facilities, and field                    unscheduled assessments of the                          determine whether they are constructed
                                                      locations. Although we may not do an                    residence during normal business hours                  and are being maintained in a manner
                                                      onsite inspection in some cases, all sites              if a permit is issued.                                  that prevents the dissemination of
                                                      and facilities would be subject to                         APHIS would issue the permit after it                organisms or associated articles from the
                                                      inspection as part of the assessment. All               receives and reviews the applicant’s                    site or facility. As with inspections
                                                      facilities would have to be determined                  agreement. The permit would be valid                    associated with our initial assessment of
                                                      by APHIS to be constructed and                          for no more than 3 years. During that                   sites or facilities prior to permit
                                                      maintained in a manner that prevents                    period, the permittee would have to                     issuance, the permittee would have to
                                                      the dissemination or dispersal of plant                 abide by all permitting conditions,5 and                allow all such assessments that we
                                                      pests, biological control organisms, or                 use of the organism or article would                    request during normal business hours.
                                                      associated articles from the facility.                  have to conform to the intended use on                  Failure to allow such assessments
                                                      Finally, the applicant would have to                    the permit. Moreover, the use of                        would constitute grounds for revocation
                                                      provide all information requested by                    organisms derived from a regulated                      of the permit.
                                                      APHIS regarding this assessment, and to                 parent organism during that period                         Paragraph (d)(4) would set forth the
                                                      allow all inspections requested by                      would have to conform to the intended                   conditions under which APHIS may
                                                      APHIS during normal business hours                      use specified on the permit for the                     deny an application for a permit.
                                                      (8 a.m. to 4:30 p.m., Monday through                    parent organism.                                        Currently, in § 330.204 of the
                                                      Friday, excluding holidays). Failure to                    We would specify that the use of the                 regulations, APHIS will deny a permit
                                                      do so would constitute grounds for                      organism or article under the permit                    application when such movement
                                                      denial of the permit application.                       must conform to the intended use on the                 would involve a danger of
                                                         Paragraphs (d)(3) and (d)(4) would                   permit, because, on occasion,                           dissemination of the pest. Danger of
                                                      describe the two possible actions we                    laboratories have obtained a permit for                 plant pest dissemination may be
                                                      would take upon concluding review of                    the movement of a plant pest or                         deemed to exist when any of the
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      the permit application: Issuance or                     biological control organism into                        following five conditions occurs:
                                                      denial of the requested permit.                         biocontainment, and then used the                          • No acceptable safeguards adequate
                                                      Paragraph (d)(3) would discuss permit                   organism for purposes that differed from                to prevent plant pest dissemination can
                                                      issuance. APHIS may issue a permit to                                                                           be arranged.
                                                      an applicant if APHIS concludes that                      5 Permitting conditions may reference the                • The destructive potential of the
                                                      the actions allowed under the permit                    regulations and policies of other Federal agencies.     plant pest to plants, and parts and
                                                                                                              For example, an import permit may provide
                                                      would be highly unlikely to result in the               conditions that a permittee must abide by in order
                                                                                                                                                                      products thereof, should it escape
                                                      introduction or dissemination of a plant                for customs entry of his or her shipment to occur       despite proposed safeguards, outweighs
                                                      pest, biological control organism, or                   pursuant to CBP’s regulations in title 19 of the CFR.   the probable benefits to be derived from


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                            6987

                                                      the proposed movement and use of the                    equally great or greater. However, it is               permitting conditions. As a result, this
                                                      pest.                                                   APHIS policy to base its decisions                     last condition would also provide a list
                                                         • The applicant, as a previous                       regarding permit issuance for the                      of factors that could lead us to a
                                                      permittee, failed to maintain the                       movement or use of plant pests,                        determination that the applicant cannot
                                                      safeguards or otherwise observe the                     biological control organisms, and                      comply with the permit conditions:
                                                      conditions prescribed in a previous                     associated articles solely on an                          • The applicant, or a partnership,
                                                      permit and failed to demonstrate his                    assessment of potential risk to plants                 firm, corporation, or other legal entity in
                                                      ability or intent to observe them in the                and plant products associated with that                which the applicant has a substantial
                                                      future.                                                 movement or use.                                       interest, financial or otherwise, has not
                                                         • The movement is adverse to the                        We would retain the following two                   complied with any permit that was
                                                      conduct of an eradication, suppression,                 conditions drawn substantially from the                previously issued by APHIS.
                                                      control, or regulatory program of APHIS.                current regulations:                                      • Issuing the permit would
                                                         • The movement is objected to in                        • The actions proposed in the permit                circumvent any order denying or
                                                      writing by an appropriate official of a                 application would be adverse to the                    revoking a previous permit issued by
                                                      State, Territory, or possession, or the                 conduct of an APHIS eradication,                       APHIS (for example, by issuing a permit
                                                      District of Columbia, on the ground it                  suppression, control, or regulatory                    to an immediate family member of a
                                                      will involve a danger of dissemination                  program.                                               person with a lengthy record of non-
                                                      of the plant pest into the State, Territory                • A State or Tribal executive official,             compliance with previous permits
                                                      or possession, or District.                             or a State or Tribal plant protection                  issued.)
                                                         Although the current regulations set                 official authorized to do so, objects to                  • The applicant has previously failed
                                                      out criteria that will factor into APHIS’               the movement in writing and provides                   to comply with any APHIS regulation.
                                                      judgment of risk and may lead us to                     specific, detailed information that there                 • The applicant has previously failed
                                                      deny a permit application, certain of the               is a risk the movement will result in the              to comply with any other Federal, State,
                                                      considerations have been understood by                  dissemination of a plant pest or noxious               or local laws, regulations, or
                                                      regulated entities to be absolute, and                  weed into the State, APHIS evaluates                   instructions pertaining to plant health.
                                                      may have dissuaded persons from                         the information and agrees, and APHIS
                                                      submitting applications for which we                                                                              • The applicant has previously failed
                                                                                                              determines that such plant pest or                     to comply with the laws or regulations
                                                      would have likely issued a permit. For                  noxious weed risk cannot be adequately
                                                      example, for several years, there was an                                                                       of a national plant protection
                                                                                                              addressed or mitigated.                                organization or equivalent body, as
                                                      erroneous but widespread interpretation                    We would add the following
                                                      that the last condition afforded States                                                                        these pertain to plant health.
                                                                                                              conditions:
                                                      and territories the right to ‘‘veto’’ permit               • The applicant does not agree to                      • APHIS has determined that the
                                                      applications. From this perspective, the                observe all of the proposed permit                     applicant has made false or fraudulent
                                                      current criteria may appear too strict.                 conditions that APHIS has determined                   statements or provided false or
                                                         Conversely, the current regulations do               are necessary to mitigate identified                   fraudulent records to APHIS.
                                                      not mention circumstances that may                      risks.                                                    • The applicant has been convicted or
                                                      arise during the application process that                  • The applicant does not provide                    has pled nolo contendere to any crime
                                                      would call into question that person’s                  information requested by APHIS as part                 involving fraud, bribery, extortion, or
                                                      ability to comply effectively with                      of an assessment of sites or facilities, or            any other crime involving a lack of
                                                      permitting conditions, such as an                       does not allow APHIS to inspect sites or               integrity.
                                                      applicant refusing to allow APHIS to                    facilities associated with the actions                    Proposed paragraph (d)(5) would
                                                      inspect a biocontainment facility listed                listed on the permit application.                      discuss withdrawal of a permit
                                                      on the application, and would thus                         • APHIS determines that the                         application. Any permit application
                                                      make it unlikely that we would issue                    applicant has not followed prior permit                could be withdrawn; however,
                                                      him or her a permit.                                    conditions, or has not adequately                      applicants who wish to withdraw a
                                                         Accordingly, we are proposing to                     demonstrated that they can meet the                    permit application would have to
                                                      revise the conditions under which the                   requirements for the current                           provide this request in writing to
                                                      Administrator may deny a permit                         application.                                           APHIS. APHIS would provide written
                                                      application. The revised conditions                        This last condition is intended to                  notification to the applicant as promptly
                                                      would be the following:                                 clarify the current third condition,                   as circumstances allow regarding
                                                         • APHIS concludes that the actions                   which states that a permit application                 reception of the request and withdrawal
                                                      proposed in the permit application                      may be denied if the applicant, as a                   of the application.
                                                      would present an unacceptable risk to                   previous permittee, failed to maintain                    Proposed paragraph (d)(6) of
                                                      plants and plant products because of the                the safeguards or otherwise observe the                § 330.201 would discuss cancellation of
                                                      introduction or dissemination of a plant                conditions prescribed in a previous                    a permit. Any permit that has been
                                                      pest, biological control organism, or                   permit and failed to demonstrate his                   issued could be canceled at the request
                                                      noxious weed within the United States.                  ability or intent to observe them in the               of the permittee. If a permittee wishes
                                                         This condition is intended to replace                future. Certain applicants have sought to              a permit to be canceled, he or she would
                                                      the current first condition, which does                 interpret this current condition to                    have to provide the request in writing to
                                                      not appear to allow for environmental                   suggest that actions taken under a                     APHIS–PPQ. Whenever a permit is
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      release of a plant pest or biological                   previous permit cannot, on their own,                  canceled, APHIS would notify the
                                                      control organism, and the second                        serve as a basis for denying a future                  permittee in writing regarding such
                                                      condition, sometimes referred to as the                 permit.                                                cancellation.
                                                      ‘‘balancing’’ condition, which can be                      This interpretation is incorrect. In                   Paragraph (d)(7) would discuss
                                                      construed to suggest that APHIS will                    deciding to issue a permit, APHIS often                revocation of a permit. APHIS could
                                                      issue a permit for a high-risk movement                 relies on the previous actions of an                   revoke a permit for any of the following
                                                      or use of a regulated organism, provided                applicant to render a judgment                         reasons:
                                                      that the benefits potentially derived                   regarding the likelihood that the                         • After issuing the permit, APHIS
                                                      from that movement or use may be                        applicant can comply with the                          obtains information that would have


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                                                      6988                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      otherwise provided grounds for us to                    agents, and/or officers, will comply with              noxious weed is not adequately
                                                      deny the permit application.                            the permit and conditions as amended                   established.
                                                         • APHIS determines that the actions                  before APHIS would issue the amended                      We regulate biological control
                                                      undertaken under the permit have                        permit. If APHIS requests such an                      organisms pursuant to the PPA insofar
                                                      resulted in or are likely to result in the              agreement, and the permittee does not                  as they may pose a plant pest risk. We
                                                      introduction into or dissemination                      agree in writing that he or she, and his               consider it necessary to exercise a
                                                      within the United States of a plant pest                or her employees, agents, and/or                       degree of regulatory oversight regarding
                                                      or noxious weed in a manner that                        officers, will comply with the amended                 the movement or environmental release
                                                      presents an unacceptable risk to plants                 permit and conditions, the existing                    of such biological control organisms,
                                                      or plant products.                                      permit would be revoked.                               even when their efficacy is well
                                                         • APHIS determines that the                            Paragraph (d)(9) would discuss                       established.
                                                      permittee, or any employee, agent, or                   suspension of actions authorized under                    It is worth noting, in that regard, that
                                                      officer of the permittee, has failed to                 a permit. It would state that we may                   biological control organisms are usually
                                                      comply with a provision of the permit                   suspend authorization of actions                       moved for eventual environmental
                                                      or the regulations under which the                      authorized under a permit if we identify               release. This is alluded to in the PPA’s
                                                      permit was issued.6                                     new factors that cause us to reevaluate                definition of biological control
                                                         Paragraph (d)(8) would discuss                       the risk associated with those actions. In             organism, which specifies that an
                                                      amendment of permits. Amendments                        such instances, we would notify the                    organism must be used, that is, actively
                                                      could occur at the request of the                       permittee in writing of this suspension                employed to control a plant pest or
                                                      permittee, or may be initiated by APHIS.                and the reasons for it. This notification              noxious weed in order for it to be
                                                      If a permittee determines that                          would also state the actions for which                 considered a biological control
                                                      circumstances have changed since the                    we are suspending authorization.                       organism. Because biological control
                                                      permit was initially issued and wishes                  Depending on the results of our                        organisms are almost always intended
                                                      the permit to be amended accordingly,                   evaluation, we would subsequently                      for eventual release into the
                                                      he or she would have to contact APHIS                   contact the permittee to remove the                    environment, it is not sufficient for us
                                                      to request the amendment and may have                                                                          only to consider their use in controlling
                                                                                                              suspension, amend the permit, or
                                                      to provide supporting information                                                                              their target plant pest or noxious weed.
                                                                                                              revoke the permit.
                                                      justifying the amendment.                                                                                      We must also take into consideration
                                                                                                                Paragraph (d)(10) would establish
                                                         APHIS would review the request, and                                                                         the plant pest effects that the organism
                                                                                                              procedures in the event that a person                  may pose to non-target plants or plant
                                                      may amend the permit if only minor                      whose application has been denied,
                                                      changes are necessary. Requests for                                                                            products.
                                                                                                              whose permit has been revoked or                          If the organism is known to have non-
                                                      more substantive changes could require                  amended, or whose authorization for
                                                      a new permit application.                                                                                      target plant pest effects, it is consistent
                                                                                                              actions authorized under a permit has                  with APHIS’ mission to prohibit or
                                                         Prior to issuance of an amended                      been suspended, wishes to appeal the
                                                      permit, depending on the nature of the                                                                         restrict its release. To the extent that we
                                                                                                              decision.                                              do not know these likely non-target
                                                      amendments, the permittee may have to
                                                                                                              Biological Control Organisms                           plant pest effects, it is also prudent for
                                                      agree in writing that he or she, and his
                                                                                                              (§ 330.202)                                            us to place regulatory controls on its
                                                      or her employees, agents, and/or
                                                                                                                                                                     movement and release until these
                                                      officers, would comply with the                            The PPA defines a biological control                impacts and effects are better
                                                      amended permit and conditions.                          organism as ‘‘any enemy, antagonist, or                understood.
                                                         With regard to amendments initiated                  competitor used to control a plant pest                   Paragraph (a) of proposed § 330.202
                                                      by APHIS, we could amend any permit                     or noxious weed.’’                                     would provide, as a general condition
                                                      and its conditions at any time, upon                       The PPA finds that ‘‘biological control             for the importation, interstate
                                                      determining that the amendment is                       is often a desirable, low-risk means of                movement, and environmental release
                                                      needed to address newly identified                      ridding crops and other plants of plant                of biological control organisms that are
                                                      considerations concerning the risks                     pests, and its use should be facilitated’’             regulated under the proposed
                                                      presented by the organism or the                        by APHIS and other agencies. In                        regulations, that no such biological
                                                      activities being conducted under the                    accordance with the PPA, APHIS                         control organism may be imported,
                                                      permit. We would also be able to amend                  authorizes the movement and                            moved interstate, or released into the
                                                      a permit at any time to ensure that the                 environmental release of both biological               environment unless a permit has been
                                                      permit conditions are consistent with all               control organisms through the issuance                 issued in accordance with proposed
                                                      of the requirements of the regulations;                 of permits.                                            § 330.201 authorizing such importation,
                                                      for example, if a subsequent rulemaking                    Since the PPA was enacted, we have                  interstate movement, or environmental
                                                      prohibits certain categories or types of                published several documents in the                     release, and the organism is moved or
                                                      organisms from being moved in certain                   Federal Register that have discussed                   released in accordance with this permit
                                                      means of conveyance, and the permit                     codifying our permitting processes for                 and the proposed regulations.
                                                      lacks these specific prohibitions.                      biological control organisms. On each                     Because applications for the
                                                         As soon as circumstances allow,                      occasion, individuals who support the                  movement of biological control
                                                      APHIS would notify the permittee of the                 use of biological control have requested               organisms often request that we
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      amendment to the permit and the                         that we consider such organisms to be                  authorize the release of the organism
                                                      reason(s) for it. Depending on the nature               distinct from plant pests, and to regulate             into the environment, several
                                                      of the amendment, the permittee may                     them in a manner that facilitates, rather              regulations issued pursuant to the
                                                      have to agree in writing or electronically              than restricts, their movement and                     National Environmental Policy Act of
                                                      that he or she, and his or her employees,               environmental release. Certain of these                1969, as amended (NEPA, 42 U.S.C.
                                                        6 Pursuant to section 424 of the PPA, such failure,
                                                                                                              commenters have stated that APHIS                      4321 et seq.) require certain procedural
                                                      whether on the part of the permittee or on that of
                                                                                                              should regulate biological control                     actions before APHIS may issue a
                                                      his or her employees, agents, or officers, may result   organisms only when their efficacy in                  permit: 40 CFR parts 1500–1508, which
                                                      in the assessment of civil or criminal penalties.       controlling their target plant pest or                 contains the regulations of the Council


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                            6989

                                                      on Environmental Quality for                            on that list may be imported into or                   organism into the environment of the
                                                      implementing the procedural provisions                  moved interstate within the continental                continental United States would present
                                                      of NEPA; 7 CFR part 1b, which contains                  United States without further restriction              no additional plant pest risk (direct or
                                                      USDA’s NEPA implementing                                under the regulations, and paragraph                   indirect) to plants or plant products.
                                                      regulations; and 7 CFR part 372, which                  (b)(2) of § 330.202 would provide that                   APHIS would review the petition to
                                                      contains APHIS’ implementing                            pure cultures of organisms on the list                 determine whether it is complete. If the
                                                      regulations. In accordance with these                   may be released into the environment of                petition is complete, we would conduct
                                                      regulations under NEPA, before issuing                  the continental United States without                  an evaluation of the petition to
                                                      a permit, APHIS must assess whether                     further restriction under the regulations.             determine whether there is sufficient
                                                      the actions proposed on the                                We have made a draft list of such                   evidence that the organism exists
                                                      applications, either individually or                    organisms available on Regulations.gov                 throughout its geographical or
                                                      cumulatively, are likely to have                        as a supporting document for this                      ecological range in the continental
                                                      significant impacts on the human                        proposed rule (see ADDRESSES at the                    United States and that subsequent
                                                      environment.                                            beginning of this proposed rule) and                   releases of pure cultures of field
                                                        In order to make such an assessment,                  request public comment on the list.                    populations the organism into the
                                                      we often have to request additional                     While we will consider comments                        environment of the continental United
                                                      information from applicants regarding                   received on the draft list to be distinct              States will present no additional plant
                                                      the proposed release of the organism as                 from those received on the proposed                    pest risk (direct or indirect) to plants or
                                                      part of our evaluation of the permit                    rule, the comments received on the draft               plant products.
                                                      application. The end of paragraph (a) of                list will inform our evaluation of the                   If we determine that there is sufficient
                                                      § 330.202 would alert interested parties                suitability of the exemptions from                     evidence that that the organism exists
                                                      to this fact, and direct them to our portal             permitting requirements contained in                   throughout its geographical or
                                                      on the Internet for further information                 proposed paragraph (b) of § 330.202.                   ecological range in the continental
                                                      regarding the types of information that                    Proposed paragraph (c) of § 330.202                 United States and that subsequent
                                                      may be requested and the manner in                      would establish a petition-based process               releases of pure cultures of the organism
                                                      which this information will be                          by which biological control organisms                  into the environment of the continental
                                                      evaluated.                                              would be added to the list of organisms                United States will present no additional
                                                        The requirements in proposed                          granted exceptions from permitting                     plant pest risk (direct or indirect) to
                                                      paragraph (a) of § 330.202 would apply                  requirements for their importation or                  plants or plant products, we would
                                                      to the importation, interstate movement,                interstate movement. Any person would                  publish a notice in the Federal Register
                                                      and environmental release of most                       be able to request that APHIS add a                    announcing the availability of the
                                                      biological control organisms. However,                  biological control organism to the list                petition and requesting public comment
                                                      we are aware that certain taxa of                       referred to in paragraph (b) of § 330.202              on that document.
                                                      biological control organisms have                       by submitting a petition to APHIS. We                    If no comments are received on the
                                                      become established throughout their                     would specify that individuals should                  notice, or if the comments received do
                                                      geographical or ecological range in the                 submit the petition via email to                       not lead us to reconsider our
                                                      continental United States, such that the                Pests.permits@aphis.usda.gov, or                       determination, we would publish a
                                                      additional release of pure cultures                     through any other means listed on                      subsequent notice in the Federal
                                                      derived from field populations of a                     APHIS’ Web site at http://                             Register describing the comments
                                                      taxon of these organisms into the                       www.aphis.usda.gov/plant_health/                       received and stating that the organism
                                                      environment of the continental United                   permits/index.shtml.                                   has been added to the list referred to in
                                                      States will present no additional plant                    The petition would have to include                  proposed paragraph (b) of § 330.202.
                                                      pest risk (direct or indirect) to plants or             the following information:                               If the comments received lead us to
                                                      plant products. For such organisms, we                     • Evidence indicating that the                      reconsider our determination, we would
                                                      do not consider there to be a sufficient                organism is indigenous to the                          publish a subsequent notice in the
                                                      basis in risk to require permits for their              continental United States throughout its               Federal Register describing the
                                                      interstate movement or environmental                    geographical or ecological range, or                   comments received and stating our
                                                      release within the continental United                   evidence indicating that the organism                  reasons for determining not to add the
                                                      States.                                                 has produced self-replicating                          organism to the list referred to in
                                                        To reflect this, paragraph (b) of                     populations within the continental                     proposed paragraph (b).
                                                      § 330.202 would state that APHIS has                    United States for an amount of time                      Proposed paragraph (e) of § 330.202
                                                      determined that certain biological                      sufficient, based on the organism’s                    would provide that any biological
                                                      control organisms have become                           taxon, to consider that taxon established              control organism may be removed from
                                                      established throughout their                            throughout its geographical or                         the list referred to in paragraph (b) of
                                                      geographical or ecological range in the                 ecological range in the continental                    the section if information emerges that
                                                      continental United States, such that the                United States.                                         would have otherwise led us to deny the
                                                      additional release of pure cultures                        • Results from a field study where                  petition to add the organism to the list.
                                                      derived from field populations of taxa of               data was collected from representative                 Whenever an organism is removed from
                                                      such organisms into the environment of                  habitats occupied by the biological                    the list, APHIS would publish a notice
                                                      the continental United States will                      control organism. Studies would have to                in the Federal Register announcing that
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      present no additional plant pest risk                   include sampling for any direct or                     action and the basis for it.
                                                      (direct or indirect) to plants or plant                 indirect impacts on target and non-
                                                      products within the United States. The                  target hosts of the biological control                 Soil (§ 330.203)
                                                      paragraph would direct persons to                       organism in these habitats. Supporting                    The regulations governing the
                                                      APHIS’ online portal for permit                         scientific literature would have to be                 importation, interstate movement, and
                                                      applications for a list of all such                     cited.                                                 transit of soil and certain stone and
                                                      organisms.                                                 • Any other data, including                         quarry products under permit are
                                                        Paragraph (b)(1) of § 330.202 would                   published scientific reports, that suggest             currently found in ‘‘Subpart—
                                                      provide that pure cultures of organisms                 that that subsequent releases of the                   Movement of Soil, Stone, and Quarry


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                                                      6990                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      Products,’’ §§ 330.300 through 330.302.                 (CFIA), the national plant protection                  the importation of soil via hand-carry.
                                                      We are proposing to remove and reserve                  organization of Canada, for a soil-borne               In addition to the requirements of
                                                      that subpart and integrate the                          plant pest would require a permit. We                  proposed paragraph (b)(1), we would
                                                      regulations for soil into the revised                   are doing this because there have been                 allow soil to be hand-carried into the
                                                      ‘‘Subpart—Plant Pests, Biological                       recent detections of soil-borne plant                  United States only if the importation
                                                      Control Organisms, Soil, and Associated                 pests of quarantine significance in                    meets the conditions of § 330.205. That
                                                      Articles’’ as § 330.203. We are proposing               Canada (such as PCN in Quebec and                      section, which is discussed later in this
                                                      to do so primarily in order to clarify that             potato wart disease on Prince Edward’s                 document, would contain our
                                                      we regulate soil insofar as it is or may                Island) that are not reflected in the                  regulations governing the hand-carry of
                                                      be an associated article. That is, we                   current regulations.                                   plant pests, biological control
                                                      regulate soil insofar as it may harbor                     We would also clarify that the                      organisms, and soil.
                                                      plant pests or noxious weeds: When a                    proposed regulations do not pertain to                    Proposed paragraph (b)(3) would
                                                      permit application for soil is submitted                soil used as a growing medium for                      provide additional conditions for the
                                                      to APHIS, a soil specialist evaluates this              plants for planting from Canada. Plants                importation of soil intended for the
                                                      likelihood of contamination with plant                  for planting that are intended to be                   extraction of plant pests. Since this soil
                                                      pests or noxious weeds and determines                   imported into the United States and                    is imported precisely because it is
                                                      whether a permit should be issued.                      their growing media are regulated under                known to contain plant pests, with very
                                                         As part of our revision to the soil                  7 CFR part 319, ‘‘Subpart—Plants for                   few exceptions, it is not rerouted for
                                                      regulations, we would also update the                   Planting.’’                                            sterilization upon arrival in the United
                                                      regulations in light of the current                        Plants for planting that can be                     States. Therefore, to mitigate the risk
                                                      scientific understanding of soil and the                inspected, treated, or handled to prevent              that such soil could present a pathway
                                                      spread of soil-borne pathogens within                   them from spreading plant pests are                    for the introduction or dissemination of
                                                      Canada.                                                 designated in that subpart as restricted               plant pests within the United States, we
                                                         Proposed paragraph (a) of § 330.203                  articles. Section 319.37–4 requires all                would require all such soil to be
                                                      would state that the Administrator has                  restricted articles imported into the                  imported directly to an approved
                                                      determined that, unless it has been                     United States to be accompanied by a                   biocontainment facility.
                                                      sterilized, soil is an associated article,              phytosanitary certificate of inspection,                  On occasion, soil that presents a risk
                                                      and is thus subject to the permitting                   unless the section explicitly exempts                  of harboring plant pests is imported into
                                                      requirements of § 330.201. It would also                the articles from this requirement.                    the United States for disposal; for
                                                      provide two conditions under which the                  Paragraph (a)(1) of § 319.37–4 exempts                 example, this sometimes occurs when a
                                                      movement of soil would not be subject                   greenhouse-grown plants from Canada                    natural disaster strikes an area
                                                      to the permitting requirements of                       imported in accordance with the                        quarantined for a soil-borne pathogen
                                                      § 330.201: If the movement is regulated                 provisions of a certification program                  and emergency management personnel
                                                      pursuant to other APHIS regulations in                  administered by CFIA from this                         need to dispose of the resulting debris.
                                                      7 CFR chapter III (e.g., § 301.86–5                     requirement; paragraph (c) of that                     Proposed paragraph (b)(4) would
                                                      requires certificates for the interstate                section contains the provisions of                     contain additional conditions for the
                                                      movement of soil from an area                           CFIA’s program.                                        importation of such soil. In addition to
                                                      quarantined for pale cyst nematode), or                    Section 319.37–8 addresses the                      general conditions for the importation of
                                                      if § 330.203 states that the movement                   growing media in which a restricted                    soil, soil infested with plant pests and
                                                      does not require such a permit. This                    article may be imported. Currently,                    intended for disposal would have to be
                                                      second condition would apply to the                     paragraph (a) of the section prohibits the             imported directly to an APHIS-approved
                                                      importation of most soil from Canada,                   use of soil as a growing medium for                    disposal facility. Although all such
                                                      and most interstate movement of soil.                   plants for planting from all countries                 facilities are subject to evaluation and
                                                         Proposed paragraphs (b)(1) through                   other than Canada. Paragraph (b) allows                approval by EPA, we would require
                                                      (b)(3) of § 330.203 would provide                       a restricted article from Canada to be                 independent APHIS approval of the
                                                      conditions governing the importation of                 imported in any medium, with the                       facility because certain of these EPA-
                                                      soil. First, in a similar manner to our                 restriction that articles from                         approved facilities are municipal
                                                      conditions for the importation of most                  Newfoundland or a certain portion of                   landfills that may not provide adequate
                                                      biological control organisms, we would                  the Municipality of Central Saanich in                 safeguards against plant pest
                                                      require an import permit to be issued in                the Province of British Columbia must                  dissemination.
                                                      accordance with § 330.201 for the                       be accompanied by a phytosanitary                         Currently, § 330.301 restricts the
                                                      importation of soil, and the soil to be                 certificate containing an additional                   importation into the United States of
                                                      imported under the conditions specified                 declaration that the plants were grown                 stone and quarry products from areas in
                                                      on the permit. We are requiring a permit                in a manner to prevent infestation with                Canada that are infested with gypsy
                                                      so that we can evaluate the risks                       potato cyst nematode. We are proposing                 moth. This section has at times led to
                                                      associated with any particular                          to revise paragraph (b) of § 319.37–8 so               confusion regarding the relationship
                                                      importation of soil and assign the                      that articles from any area of Canada                  between soil and stone and quarry
                                                      appropriate mitigation measures.                        that is regulated by CFIA for a soil-borne             products, as well as questions regarding
                                                         Currently, soil may be imported from                 plant pest would have to be                            the regulated status of articles, such as
                                                      Canada without a permit, unless the soil                accompanied by a phytosanitary                         clay, that are similar to but
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                                                      is from Newfoundland or the Land                        certificate with an additional                         fundamentally distinct from soil.
                                                      District of Central Saanich on                          declaration that the plants were grown                    Proposed paragraph (b)(5) of § 330.203
                                                      Vancouver Island in the Province of                     in a manner to prevent infestation with                would list certain articles that are not
                                                      British Columbia; these two areas are                   that soil-borne plant pest.                            soil, and that, because of their
                                                      known to be infested with pale cyst                        Proposed paragraphs (b)(2) through                  composition or origin, present a
                                                      nematodes (PCN). We are proposing to                    (b)(4) of § 330.203 would set forth                    negligible risk of serving as a medium
                                                      amend the regulations so that soil from                 additional conditions for certain types                for plant pests or noxious weeds,
                                                      any area of Canada regulated by the                     of importations of soil. Paragraph (b)(2)              provided that they are free of organic
                                                      Canadian Food Inspection Agency                         would provide additional conditions for                material. The articles could be imported


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                           6991

                                                      into the United States without an import                restrictions and remedial measures                     agreement with APHIS, is abiding by all
                                                      permit, unless the Administrator has                    specified for such movement in 7 CFR                   terms and conditions of the compliance
                                                      issued an order stating that a particular               part 301.                                              agreement, and is approved by APHIS to
                                                      article is an associated article. (Such                    As we mentioned earlier in this                     test and/or analyze such samples.
                                                      orders would be maintained on PPQ’s                     document, part 301 contains our                           Proposed paragraph (c)(5) would
                                                      Web site, at http://www.aphis.usda.gov/                 regulations that designate certain areas               contain additional conditions for the
                                                      plant_health/permits/organism/soil/                     of the United States as quarantined                    interstate movement of soil to, from, or
                                                      index.shtml.) However, all such articles                areas for a particular plant pest, and that            between Hawaii, the territories, and the
                                                      would be subject to inspection at the                   prohibit or restrict the movement in                   continental United States. In addition to
                                                      port of first arrival, subsequent                       interstate commerce of certain host                    all general conditions for interstate
                                                      reinspection at other locations, and                    articles of that pest. The provisions                  movement of soil, soil could be moved
                                                      other remedial measures deemed                          currently in our regulations in § 330.302              interstate to, from, or between Hawaii,
                                                      necessary by an inspector to remove any                 mention certain sections of part 301 in                the territories, and the continental
                                                      risk the items pose of disseminating                    which soil is considered a regulated                   United States only if an interstate
                                                      plant pests or noxious weeds, and any                   article, such as our Japanese beetle and               movement permit has been issued for its
                                                      other restrictions or prohibitions in 7                 gypsy moth regulations, but omit others,               movement in accordance with
                                                      CFR chapter III. The articles would be:                 such as our golden nematode and PCN                    § 330.201. This condition would apply
                                                         • Consolidated material derived from                 regulations, and do not take into                      to all soil moved to, from, or between
                                                      any strata or substrata of the earth.                   consideration the possibility that                     Hawaii, the territories, and the
                                                      Examples include clay (laterites,                       outbreaks of new plant pests within the                continental United States. In addition to
                                                      bentonite, china clay, attapulgite,                     United States may lead us to regulate                  this provision, soil moved to, from, or
                                                      tierrafino), talc, chalk, slate, iron ore,              the interstate movement of soil from                   between Hawaii, the territories, and the
                                                      and gravel.                                             areas quarantined for those or other                   continental United States with the
                                                         • Sediment, mud, or rock from                        pests.                                                 intent of extracting plant pests would
                                                      saltwater bodies of water.                                 Proposed paragraph (c)(2) would                     still be subject to the conditions of
                                                         • Cosmetic mud and other                             provide conditions for the interstate                  proposed paragraph (c)(2) of the section,
                                                      commercial mud products.                                movement within the continental                        and would therefore have to be moved
                                                         • Stones, rocks, and quarry products.                United States of soil intended for the                 directly to an approved biocontainment
                                                         These provisions do not mean that we                 extraction of plant pests. Again, since                facility. Similarly, soil infested with
                                                      would no longer restrict the movement                   such soil is moved precisely because it                plant pests and intended for disposal
                                                      of stone and quarry products from areas                 is known to contain plant pests, it is, by             would be subject to the conditions of
                                                      in Canada that are infested with gypsy                  definition, an associated article, and                 proposed paragraph (c)(3) of the section,
                                                      moth. Instead, we would amend                           therefore would require an interstate                  and would therefore have to be moved
                                                      ‘‘Subpart—Gypsy Moth Host Material                      movement permit issued in accordance                   directly to an APHIS-approved disposal
                                                      from Canada,’’ § 319.77–1 through                       with § 330.201 in order to be moved.                   facility.
                                                      § 319.77–5, to incorporate those                        Moreover, because of the intended use                     Proposed paragraph (d) would contain
                                                      restrictions. Section 319.77–2 of that                  of the soil, in order to mitigate the risk             conditions regarding the transit of soil.
                                                      subpart contains a list of articles                     of the dissemination of plant pests, the               Such movement would require a transit
                                                      designated regulated articles; we would                 soil would have to be moved directly to                permit issued in accordance with 7 CFR
                                                      amend that section by adding a new                      an approved biocontainment facility,                   part 352.
                                                      paragraph (i) that would designate stone                and in a secure manner that prevents its                  The regulations in § 330.300 currently
                                                      and quarry products as regulated                        dissemination into the outside                         exempt movements of soil governed by
                                                      articles. Section 319.77–4 contains                     environment.                                           § 318.60 or § 319.69 from permitting
                                                      conditions for the importation of                          Proposed paragraph (c)(3) would                     requirements. Section 318.60 currently
                                                      regulated articles; we would amend the                  contain additional conditions for the                  prohibits the movement of sand (other
                                                      section by adding a new paragraph (d)                   interstate movement within the                         than clean ocean sand), soil, or earth
                                                      that would provide that stone and                       continental United States of soil                      around the roots of plants from Hawaii,
                                                      quarry products originating in a                        infested with plant pests and intended                 Puerto Rico, or the Virgin Islands into
                                                      Canadian area known to be infested                      for disposal. We would require issuance                or through any other State, Territory, or
                                                      with gypsy moth may be imported into                    of an interstate movement permit prior                 District of the United States, unless the
                                                      the United States only if they are                      to movement, and would require that all                movement is in either direction between
                                                      destined for an infested area of the                    such soil to be moved directly to an                   Puerto Rico and the Virgin Islands, or
                                                      United States and will not be moved                     APHIS-approved disposal facility, and                  the soil is intended for experimental or
                                                      through any noninfested areas of the                    in a secure manner that prevents its                   scientific use by USDA. We would
                                                      United States, and may be moved                         dissemination into the outside                         amend § 318.60 to clarify that it pertains
                                                      through the United States if they are                   environment.                                           only to the movement of soil around the
                                                      moved only through infested areas. We                      Proposed paragraph (c)(4) would                     roots of plants, and that all other
                                                      consider this subpart a more appropriate                contain additional conditions for the                  movement of soil from Hawaii, Puerto
                                                      location for the restrictions.                          interstate movement of soil samples                    Rico, or the Virgin Islands, other than
                                                         Proposed paragraph (c) of § 330.203                  from an area quarantined in accordance                 that soil around the roots of plants, is
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      would provide general conditions                        with 7 CFR part 301 for chemical or                    regulated under 7 CFR part 330. We
                                                      governing the interstate movement of                    compositional testing or analysis. Such                consider this amendment necessary
                                                      soil. Most soil could be moved interstate               soil could be moved without prior                      primarily so that we would not regulate
                                                      without prior issuance of an interstate                 issuance of an interstate movement                     the movement of such soil in two
                                                      movement permit in accordance with                      permit in accordance with § 330.201 or                 different subparts, and secondarily so
                                                      § 330.201, or further restriction under                 further restriction under 7 CFR chapter                that the section may not be used to
                                                      the regulations. However, all soil moved                III, provided that the soil is moved to a              circumvent the regulations in part 330.
                                                      interstate within the United States                     laboratory that has entered into and is                   ‘‘Subpart—Packing Materials,’’
                                                      would still be subject to any movement                  operating under a compliance                           § 319.69 through § 319.69–5, contains


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                                                      6992                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      our regulations regarding plants and                    add a plant pest or remove a plant pest                would specify the strains of the plant
                                                      plant products used as packing                          from this list of pests. Finally, the                  pest that APHIS considers attenuated of
                                                      materials for imported commodities.                     section provides that if a petition is                 their pathogenicity.)
                                                      Section 319.69 prohibits the use of soil                submitted, the Secretary will act on the                  The third category of plant pests is
                                                      containing an appreciable mixture of                    petition and notify the petitioner of the              intended to avoid duplicative or
                                                      vegetable matter from being used as                     action he or she will take on the                      conflicting regulatory oversight of
                                                      packing material, except for soil                       petition.                                              certain plant pests. For example,
                                                      authorized as safe for packing by other                    Section 330.204 would establish such                although it is a plant pest, Penicillium
                                                      rules and regulations in the subpart.                   regulations and petition process. The                  chrysogenum is regulated by the Food
                                                      Section 319.69–1 specifies that soil                    introductory paragraph would state that,               and Drug Administration (FDA).
                                                      containing an appreciable admixture of                  pursuant to section 7711 of the PPA, the                  We have made a draft list of plant
                                                      vegetable matter is covered by this                     Administrator has determined that                      pests that may be imported or move in
                                                      prohibition because its decaying                        certain plant pests may be imported into               interstate commerce within the
                                                      vegetation or plant remains carries a                   or may move in interstate commerce                     continental United States without
                                                      definite pest risk. Finally, § 319.69–5                 within the continental United States                   restriction available on Regulations.gov
                                                      states that the following soil may be                   without restriction. The list of all such              as a supporting document for this
                                                      used as packing material: Peat, peat                    plant pests would be on the PPQ Web                    proposed rule, and request public
                                                      moss, or osmunda fiber.                                 site.                                                  comment regarding that list. The list
                                                         After reviewing this section in light of                Paragraph (a) of the section would                  largely mirrors the list contained in the
                                                      the current scientific understanding of                 describe the three categories of plant                 2001 proposed rule, but also contains
                                                      soil, as reflected in our proposed                      pests that comprise the list. In order to              certain plant pests that belong to the
                                                      revision to the definition of soil in                   be included on the list, a plant pest                  second and third categories.
                                                      § 330.100, we have determined that this                 would have to:                                            Paragraph (b) of § 330.204 would
                                                      section does not refer to soil, as it is                   • Be from field populations or lab                  contain a petition process to add a plant
                                                      currently understood, but to the organic                cultures derived from field populations                pest to the list. Any person would be
                                                      decaying vegetative matter for which                    of a taxon that is established throughout              able to petition to have an additional
                                                      soil may serve as a medium, and of                      its entire geographical or ecological                  plant pest added to the list. To submit
                                                      which peat, peat moss, and osmunda                      range within the continental United                    a petition, the person would have to
                                                      fiber are all examples. We have also                    States; or                                             provide, in writing, information
                                                      determined that an instance may arise                      • Be sufficiently attenuated so that it             supporting the placement of a particular
                                                      when the mitigation measures that we                    no longer poses a risk to plants or plant              pest in one of the categories listed in
                                                      require in part 319 for the importation                 products; or                                           paragraph (a) of § 330.204.
                                                      of a plant, plant part, or plant product                   • Be commercially available and                        Information that the plant pest
                                                      may also address the risk associated                    raised under the regulatory purview of                 belongs to a taxon that is established
                                                      with using organic decaying vegetative                  other Federal agencies.                                throughout its entire geographical or
                                                      matter as a packing material for that                      In our 2001 proposed rule, paragraph                ecological range within the United
                                                      commodity.                                              (c) of § 330.202 would have established                States would have to include scientific
                                                         Therefore, we would amend the                        a ‘‘no permit necessary’’ list for certain             literature, unpublished studies, or data
                                                      existing prohibition in § 319.69 on the                 indigenous plant pest species that were                regarding:
                                                      use of soil as a packing material so that               already distributed throughout the                        • The biology of the plant pest,
                                                      it instead prohibits the use of organic                 continental United States and are                      including characteristics that allow it to
                                                      decaying vegetative matter as a packing                 known to commonly accompany plants                     be identified, known hosts, and
                                                      material. We would remove § 319.69–                     or plant products moved in commerce.                   virulence;
                                                      1(b), which considers matter containing                 The first category aligns with the                        • The geographical or ecological
                                                      decaying vegetation or plant remains to                 criterion for that 2001 list. We would                 range of the plant pest within the
                                                      be soil. We would establish an                          not require permits for plant pests from               continental United States; and
                                                      exemption for any organic decaying                      a field population or lab culture derived                 • The areas of the continental United
                                                      vegetative matter expressly authorized                  from a field population of a taxon that                States within which the plant pest is
                                                      to be used as a packing material                        is established throughout its entire                   established.
                                                      elsewhere in part 319. Finally, we                      geographical or ecological range within                   The first category of information is
                                                      would revise the heading of § 319.69–5                  the United States because such pests are               intended to provide us with basic
                                                      to make it clear that it does not pertain               ubiquitous within the continental                      information regarding the plant pest for
                                                      to the use of soil as a packing material,               United States.                                         which unrestricted movement is sought.
                                                      but organic decaying vegetative matter.                    The second category reflects the fact               The second and third categories would
                                                                                                              that in vitro attenuation of plant pests               aid our determination regarding
                                                      Exceptions to Permitting Requirements                   such as phytopathogenic fungi, while                   whether the plant pest is established
                                                      for the Importation or Interstate                       rare, does occur. When a pest becomes                  throughout its ecological or
                                                      Movement of Certain Plant Pests                         attenuated, there is no longer a                       geographical range within the
                                                      (§ 330.204)                                             sufficient basis for us to presume that                continental United States.
                                                         Section 7711 of the PPA provides that                the pest presents a risk of directly or                   Information that the plant pest has
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      the Secretary of Agriculture may issue                  indirectly injuring, causing damage to,                been attenuated of its pathogenicity
                                                      regulations to allow the importation and                or causing disease in plants or plant                  would have to include experimental
                                                      the movement in interstate commerce of                  products; in other words, an attenuated                data, published references, or scientific
                                                      plant pests without further restriction, if             pest de facto no longer falls within the               information regarding such attenuation.
                                                      the Secretary finds that a permit for                   scope of the definition of plant pest                     Information that the plant pest is
                                                      such movement is not necessary. The                     under the PPA.                                         commercially available and raised
                                                      section further states that if the                         (In order to avoid confusion and the                under the regulatory purview of another
                                                      Secretary does issue such regulations,                  possible unregulated movement of the                   Federal agency would have to include a
                                                      any person may petition him or her to                   virulent strains of the plant pest, the list           citation to the relevant law, regulation,


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                           6993

                                                      or order under which the agency                         it is determined that the information is               oversee the movement of the plant pest,
                                                      exercises such oversight. For example,                  complete, we would commence review                     that the owner of the plant pest will be
                                                      Penicillium chrysogenum is regulated                    of the petition.                                       responsible for all costs incidental to
                                                      by FDA under the Kefauver-Harris drug                      If, after review of the petition, we                forwarding the plant pest prior to
                                                      amendments of 1962.                                     determine that there is insufficient                   clearance, and that an inspector may
                                                         APHIS would review the information                   evidence to suggest that our initial                   specify and supervise the application of
                                                      contained in the petition to determine                  determination should be changed, we                    safeguards to prevent the dissemination
                                                      whether it is complete. In order to                     would deny the petition, and notify the                of the pest until it is forwarded.
                                                      consider the petition complete, APHIS                   petitioner in writing regarding this                      The 2003 OIG audit referenced at the
                                                      may require additional information to                   denial.                                                beginning of this document pointed out
                                                      determine whether the plant pest                           If, after review of the petition, we                that the hand-carry process in place at
                                                      belongs to one of the categories listed in              determine that there is a sufficient basis             the time did not provide guidance
                                                      paragraph (a) of § 330.204. When it is                  to suggest that our initial determination              regarding what materials may be hand-
                                                      determined that the information is                      should be changed, we would publish a                  carried or who may hand-carry, and that
                                                      complete, we would commence review                      notice in the Federal Register that                    APHIS did not track hand-carried
                                                      of the petition.                                        announces the availability of the                      materials to ensure that they arrive at
                                                         If, after review of the petition, we                 petition, and that requests public                     the point of destination listed on the
                                                      determine that there is insufficient                    comment regarding removing the plant                   permit. For these reasons, the audit
                                                      evidence that the plant pest belongs to                 pest from the list of plant pests that may             strongly suggested that we issue
                                                      one of the three categories listed in                   be imported into or move in interstate                 regulations to prohibit hand-carry of
                                                      paragraph (a) of § 330.204—for example,                 commerce within the continental                        regulated organisms into the United
                                                      the plant pest is known to exist                        United States without restriction.                     States, and to explicitly state that all
                                                      throughout its entire geographical range                   If no comments are received on the                  organisms must be imported into the
                                                      in the continental United States, but                   notice, or if the comments received do                 United States via a bonded commercial
                                                      population densities in certain areas are               not affect our conclusions regarding the               carrier.
                                                      not sufficient to consider it established               petition, we would publish in the                         However, certain plant pests and
                                                      throughout its range—we would deny                      Federal Register a subsequent notice                   biological control organisms are highly
                                                      the petition, and notify the petitioner in              stating that the plant pest has been                   perishable, and may remain viable only
                                                      writing regarding this denial.                          removed from the list.                                 if they are imported into the United
                                                         Conversely, if, after review of the                     Paragraph (d) of § 330.204 would                    States directly and without rerouting.
                                                      petition, we determine that the plant                   provide for APHIS-initiated changes to                 We have also found that it is often
                                                      pest belongs to one of the categories in                the list. It would provide that APHIS                  useful, from a safeguarding perspective,
                                                      paragraph (a), we would publish a                       may propose to add a plant pest to or                  to authorize hand-carry in order to have
                                                      notice in the Federal Register that                     remove a pest from the list without a                  an expert regarding the organism or
                                                      announces the availability of the                       petition, if we determine that there is                article exercise direct and continuous
                                                      petition and any supporting                             sufficient evidence that the plant pest                oversight of its importation.
                                                      documentation to the public, that states                belongs to one of the categories listed in                Therefore, we would include
                                                      that we intend to add the plant pest to                 paragraph (a) of the section, or if                    provisions for hand-carry in this
                                                      the list of plant pests that may be                     evidence emerges that leads us to                      proposed rule. These provisions, which
                                                      imported into or move in interstate                     reconsider our initial determination that              would be contained in § 330.205, would
                                                      commerce within the continental                         the plant pest was or was not in one of                reflect current Agency processes
                                                      United States without restriction, and                  the categories listed in paragraph (a) of              regarding hand-carry.
                                                      that requests public comment.                           the section. We would publish a notice                    The introductory text of § 330.205
                                                         If no comments are received on the                   in the Federal Register announcing this                would state that plant pests, biological
                                                      notice, or if, based on the comments                    proposed addition or removal, making                   control organisms, and soil may be
                                                      received, we determine that our                         available any supporting documentation                 hand-carried into the United States only
                                                      conclusions regarding the petition have                 that we prepare, and requesting public                 in accordance with the provisions of the
                                                      not been affected, we will publish in the               comment.                                               section.
                                                      Federal Register a subsequent notice                       If no comments are received on the                     Proposed paragraph (a) of § 330.205
                                                      stating that the plant pest has been                    notice, or if the comments received do                 would discuss the first such provision,
                                                      added to the list.                                      not affect our conclusions, we will                    authorization to hand-carry. In order to
                                                         Under paragraph (c) of § 330.204, any                publish a subsequent notice in the                     obtain such authorization, a person
                                                      person could submit, in writing, a                      Federal Register stating that the plant                would have to apply for an import
                                                      petition to have a plant pest removed                   pest has been added to or removed from                 permit for the plant pest, biological
                                                      from the list. The petition would have                  the list.                                              control organism, or soil, in accordance
                                                      to contain independently verifiable                                                                            with § 330.201, and specify hand-carry
                                                      information demonstrating that our                      Hand-Carry of Plant Pests, Biological                  of the organism or article as the method
                                                      initial determination that the plant pest               Control Organisms, and Soil (§ 330.205)                of proposed movement.
                                                      belongs to one of the categories in                       Currently, we authorize the                             The application would also have to
                                                      paragraph (a) of the section should be                  importation of plant pests in personal                 specify the individual or individuals
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      changed, or that additional information                 baggage (referred to as ‘‘hand-carry’’)                who would hand-carry the plant pest,
                                                      is now available that would have caused                 under § 330.212 of the regulations. The                biological control organism, or soil into
                                                      us to change the initial decision.                      regulations provide that the person                    the United States. If we authorize this
                                                         APHIS would review the information                   importing the plant pest must show the                 individual or these individuals to hand-
                                                      contained in the petition to determine                  permit authorizing the importation to an               carry, this authorization could not be
                                                      whether it is complete. In order to                     inspector at the port of arrival where the             transferred to, nor actions under it
                                                      consider the petition complete, we may                  baggage will be inspected, that the                    performed by, individuals other than
                                                      require additional information                          conditions specified on the permit must                those identified on the permit
                                                      supporting the petitioner’s claim. When                 be observed, that an inspector will                    application.


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                                                      6994                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                         Under proposed paragraph (b) of                      or cancel any hand-carry authorization                    Paragraph (b) would contain general
                                                      § 330.205, the permittee would have to                  at any time, if we deem such action                    requirements for packing material. It
                                                      notify APHIS through our online portal                  necessary to prevent the introduction or               would specify that packing material
                                                      for permit applications or by fax after                 dissemination of plant pests or noxious                must be free of plant pests, noxious
                                                      the permittee has obtained an import                    weeds within the United States.                        weeds, or associated articles, and must
                                                      permit but no less than 20 days prior to                   In a similar manner, proposed                       be new, or must have been sterilized or
                                                      movement and provide the following                      paragraph (e) of § 330.205 would state                 disinfected prior to reuse. Packing
                                                      information in order to receive a hand-                 that any person whose request to hand-                 material would also have to be suited
                                                      carry authorization:                                    carry has been denied, or whose hand-                  for the enclosed organism or article, as
                                                         • A copy of the face page of the                     carry authorization has been amended                   well as any medium in which the
                                                      passport for the individual or                          or canceled, would be able to appeal the               organism or article will be maintained,
                                                      individuals who will hand-carry the                     decision in writing to APHIS.                          and should not be capable of harboring
                                                      plant pest, biological control organism,                                                                       or being a means of the dissemination
                                                      or soil.                                                Packaging Requirements (§ 330.206)                     of the organism or article.
                                                         • A description of the means of                         We are proposing to revise the                         We would provide guidance regarding
                                                      conveyance in which the individual or                   packaging requirements for the                         suitable outer shipping containers, inner
                                                      individuals will travel, including flight               movement of plant pests, currently                     packages, and packaging on the PPQ
                                                      number and airline name for air travel,                 found in § 330.210. The revised                        Web site.
                                                      or vehicle license number or other                      requirements would be contained in                        Paragraph (c) would provide that
                                                      identifying number for other modes of                   proposed § 330.206.                                    packing materials, including media and
                                                      transportation.                                            The introductory text of the section                substrates, would have to be destroyed
                                                         • Expected date and time of first                    would state that shipments in which                    by incineration, be decontaminated
                                                      arrival.                                                plant pests, biological control                        using autoclaving or another approved
                                                         • Expected port of first arrival.                                                                           method, or otherwise be disposed of in
                                                         • Travel itinerary from port of first                organisms, and associated articles are
                                                                                                              imported into, moved interstate, or                    a manner specified in the permit itself.
                                                      arrival to final destination.                                                                                  It would also provide that shipping
                                                         We would require authorized                          transited through the United States must
                                                                                                              meet the general packaging                             containers could not be reused, except
                                                      identification, the description of the                                                                         those that have been sterilized or
                                                      means of conveyance, and the expected                   requirements of the section, as well as
                                                                                                              all specific packaging requirements on                 disinfected prior to reuse.
                                                      date, time, and port of first arrival                                                                             Proposed paragraph (d) would state
                                                      because, pursuant to the regulations in                 the permit itself.
                                                                                                                 Proposed paragraph (a) would contain                that permittees who fail to meet the
                                                      § 330.105, hand-carried organisms or                                                                           requirements of the section may be held
                                                      soil, like all other imported articles,                 general packaging requirements. All
                                                                                                              shipments would have to consist of an                  responsible for all costs incident to
                                                      must be presented for inspection at the                                                                        inspection, rerouting, repackaging,
                                                      port of first arrival, and this information             outer shipping container and at least
                                                                                                              two packages within the container. Both                subsequent movement, and any
                                                      would help us ensure that the                                                                                  treatments.
                                                      inspection takes place as expeditiously                 the container and the inner packages
                                                      as possible. We would require the travel                would have to be securely sealed to                    Cost and Charges (§ 330.207)
                                                      itinerary from the port of first arrival to             prevent the dissemination of the                          Proposed § 330.207 would state that
                                                      the final destination in order to ensure                enclosed plant pests, biological control               the inspection services of APHIS
                                                      that the individual does not intend to                  organisms, or associated articles.                     inspectors during regularly assigned
                                                      make prolonged stops en route that                         Paragraph (a)(1) would contain                      hours of duty and at the usual places of
                                                      could result in breach of safeguarding                  general requirements for the outer                     duty would be furnished without cost.
                                                      and increase the risk of accidental                     shipping container. The outer shipping                 It would also state that APHIS would
                                                      dissemination of the organism or soil.                  container would have to be rigid,                      not be responsible for any costs or
                                                      The information also would help us                      impenetrable, and durable enough to                    charges incidental to inspections or
                                                      respond promptly to accidental                          remain sealed and structurally intact in               compliance with the provisions of this
                                                      dissemination of the organism or soil en                the event of dropping, lateral impact                  subpart, other than for the inspection
                                                      route to the final destination.                         with other objects, and other shocks                   services of the inspector.
                                                         Under proposed paragraph (c) of                      incidental to handling.
                                                      § 330.205, the permittee or his or her                     Paragraph (a)(2) would contain                      Executive Orders 12866 and 13563 and
                                                      designee would have to notify APHIS                     requirements for inner packages. The                   Regulatory Flexibility Act
                                                      within 24 hours of arrival of the hand-                 innermost package or packages within                      This proposed rule has been
                                                      carried plant pest, biological control                  the shipping container would have to                   determined to be significant for the
                                                      organism, or soil at the biocontainment                 contain all of the organisms or articles               purposes of Executive Order 12866 and,
                                                      facility or other authorized point of                   that will be moved. As a safeguard, the                therefore, has been reviewed by the
                                                      destination. This notification would                    innermost package would have to be                     Office of Management and Budget.
                                                      have to state that the plant pest,                      placed within another, larger package,                    We have prepared an economic
                                                      biological control organism, or soil has                for example, bagged and sealed petri                   analysis for this rule. The economic
                                                      arrived at its destination and that the                 samples placed within a sealed cooler.                 analysis provides a cost-benefit analysis,
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      package in which it was hand-carried                    All packages within the shipping                       as required by Executive Orders 12866
                                                      has remained sealed until arrival.                      container would have to be constructed                 and 13563, which direct agencies to
                                                      Notification could be by fax or email, or               or safeguarded so that they will remain                assess all costs and benefits of available
                                                      via APHIS’ permitting Web site.                         sealed and structurally intact                         regulatory alternatives and, if regulation
                                                         Proposed paragraph (d) of § 330.205                  throughout transit. The packages would                 is necessary, to select regulatory
                                                      would discuss denial, amendment, or                     also have to be able to withstand                      approaches that maximize net benefits
                                                      cancellation of authorization to hand-                  changes in pressure, temperature, and                  (including potential economic,
                                                      carry. It would state that APHIS may                    other climatic conditions incidental to                environmental, public health and safety
                                                      deny a request to hand-carry, or amend                  shipment.                                              effects, and equity). Executive Order


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                           6995

                                                      13563 emphasizes the importance of                      receiving permits under part 330.                      National Environmental Policy Act of
                                                      quantifying both costs and benefits, of                 Assuming the time required to submit                   1969 (NEPA), as amended (42 U.S.C.
                                                      reducing costs, of harmonizing rules,                   an application is 1 hour and assuming                  4321 et seq.), (2) regulations of the
                                                      and of promoting flexibility. The                       an average hourly wage of $45.50 per                   Council on Environmental Quality for
                                                      economic analysis also provides an                      hour, then for the 6,538 permits issued                implementing the procedural provisions
                                                      initial regulatory flexibility analysis that            in 2015, the time savings expected                     of NEPA (40 CFR parts 1500–1508), (3)
                                                      examines the potential economic effects                 under the proposed rule would have                     USDA regulations implementing NEPA
                                                      of this rule on small entities, as required             totaled between 654 and 1,961 hours,                   (7 CFR part 1b), and (4) APHIS’ NEPA
                                                      by the Regulatory Flexibility Act. The                  which equates to a cost savings of                     Implementing Procedures (7 CFR part
                                                      economic analysis is summarized                         between about $29,748 and $89,244.                     372).
                                                      below. Copies of the full analysis are                     The proposed rule would codify                         The draft EIS is available on
                                                      available by contacting the person listed               existing practices by allowing entities                Regulations.gov for review and
                                                      under FOR FURTHER INFORMATION                           requesting permits to apply                            comment, and may be accessed via the
                                                      CONTACT or on the Regulations.gov Web                   electronically rather than by using the                Internet address provided above under
                                                      site (see ADDRESSES above for                           mail only. Expanded use of online                      the heading ADDRESSES. Copies may also
                                                      instructions for accessing                              permit applications through APHIS’                     be obtained by contacting the individual
                                                      Regulations.gov).                                       portal would result in time and cost                   listed below the section titled FOR
                                                         Based on the information we have,                    savings as compared to applying by mail                FURTHER INFORMATION CONTACT.
                                                      there is no reason to conclude that                     using paper applications.                                 A notice of availability regarding the
                                                      adoption of this proposed rule would                       Listing of exempted organisms on an                 draft EIS will also be published by the
                                                      result in any significant economic effect               APHIS–PPQ Web site, transparent                        Environmental Protection Agency in the
                                                      on a substantial number of small                        procedures for petitioning for                         Federal Register.
                                                      entities. However, we do not currently                  exceptions or exemptions to permitting,
                                                                                                                                                                     Paperwork Reduction Act
                                                      have all of the data necessary for a                    and provision for a notice-based process
                                                      comprehensive analysis of the effects of                for adding and removing listed                           In accordance with section 3507(d) of
                                                      this proposed rule on small entities.                   organisms would also combine to make                   the Paperwork Reduction Act of 1995
                                                      Therefore, we are inviting comments on                  an efficient, transparent, and user-                   (44 U.S.C. 3501 et seq.), some of the
                                                      potential effects. In particular, we are                responsive system that would facilitate                reporting, recordkeeping, and third
                                                      interested in determining the number                    the movement and environmental                         party disclosure requirements included
                                                      and kind of small entities that may                     release of plant pests and BCOs.                       in this proposed rule are in the process
                                                      incur benefits or costs from the                           Regulated entities would continue to                of being reinstated under Office of
                                                      implementation of this proposed rule.                   incur time costs associated with                       Management and Budget (OMB) control
                                                         APHIS is proposing to revise its                     providing information during the                       number 0579–0054. The new reporting
                                                      regulations regarding the importation,                  permitting application process, and                    requirements included in this proposed
                                                      interstate movement, and environmental                  with meeting somewhat more robust                      rule have been submitted as a new
                                                      release of plant pests to incorporate                   recordkeeping (maintaining records)                    information collection for approval to
                                                      provisions regarding biological control                 requirements in certain instances such                 OMB.
                                                      organisms (BCOs) and the movement of                    as with soil imports and risk based                      Please send comments on the
                                                      soils from which plant pests and BCOs                   permits. The time required overall for                 information collection request to OMB’s
                                                      are extracted. The proposed rule would                  permitting would be reduced, however,                  Office of Information and Regulatory
                                                      revise and add definitions, streamline                  because of the newly excepted                          Affairs via email to oira_submission@
                                                      the permitting and compliance                           organisms.                                             omb.eop.gov, Attention: Desk Officer for
                                                      processes, and provide APHIS with                          The proposed revisions to 7 CFR part                APHIS. Please state that your comments
                                                      increased flexibility in the regulation of              330 would benefit entities, large and                  refer to Docket No. APHIS–2008–0076.
                                                      plant pests. Parts 318, 319, and 352 of                 small, by increasing the efficiency of the             Please send a copy of your comments to
                                                      7 CFR chapter III would also be updated                 permitting and compliance processes for                USDA, using one of the methods
                                                      to reflect the proposed changes in part                 plant pests, BCOs, and soils from which                described under ADDRESSES at the
                                                      330.                                                    plant pests and BCOs are extracted, and                beginning of this document.
                                                         A principal consequence of the                       by improving the general clarity and                     Under the PPA, the Secretary of
                                                      proposed rule would be a streamlining                   transparency of these regulations. The                 Agriculture has authority to carry out
                                                      of our permitting process and possible                  proposed rule also would facilitate the                operations or measures to detect,
                                                      reduction in the number of permits                      Agency’s coordination with other                       control, eradicate, suppress, prevent, or
                                                      issued under part 330, which numbered                   Federal and State agencies in regulating               retard the spread of plant pests. Section
                                                      6,538 in 2015. Approximately 33                         the movement and environmental                         7711(a) of the Act provides that ‘‘no
                                                      percent of these permits (2,158)                        release of plant pests and BCOs. The                   person shall import, enter, export, or
                                                      authorized the movement or                              majority of entities that would benefit                move in interstate commerce any plant
                                                      environmental release of a plant pest or                from this rule are small entities, based               pest, unless the importation, entry,
                                                      BCO that APHIS is proposing to exempt                   on information obtained from the                       exportation, or movement is authorized
                                                      from permitting. While we do not                        Economic Census.                                       under general or specific permit and in
                                                      expect the proposed rule would result                                                                          accordance with such regulations as the
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      in one-third fewer permits as one permit                National Environmental Policy Act                      Secretary may issue to prevent the
                                                      may list multiple BCOs or plant pests,                    To provide the public with                           introduction of plant pests into the
                                                      we can say with confidence that the                     documentation of APHIS’ review and                     United States or the dissemination of
                                                      permitting burden would be reduced for                  analysis of any potential environmental                plant pests within the United States.’’
                                                      applicants and that the permitting                      impacts associated with the processes                  The Act gives USDA the flexibility to
                                                      process could be expedited. We expect                   established by this proposed rule, we                  respond appropriately to a wide range of
                                                      that affected entities would benefit from               have prepared a draft environmental                    needs and circumstances to protect
                                                      a 10 to 30 percent reduction in the                     impact statement (EIS). The EIS was                    American agriculture against plant
                                                      overall time spent applying for and                     prepared in accordance with: (1) The                   pests.


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                                                      6996                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                         In addition, section 412(a) of the Act               validity of the methodology and                        Lists of Subjects
                                                      provides that the Secretary may prohibit                assumptions used;
                                                                                                                                                                     7 CFR Part 318
                                                      or restrict the importation, entry,                        (3) Enhance the quality, utility, and
                                                      exportation, or movement in interstate                  clarity of the information to be                         Cotton, Cottonseeds, Fruits, Guam,
                                                      commerce of, among other things, any                    collected; and                                         Hawaii, Plant diseases and pests, Puerto
                                                      biological control organism if the                         (4) Minimize the burden of the                      Rico, Quarantine, Transportation,
                                                      Secretary determines that the                           information collection on those who are                Vegetables, Virgin Islands.
                                                      prohibition or restriction is necessary to              to respond (such as through the use of                 7 CFR Part 319
                                                      prevent the introduction into the United                appropriate automated, electronic,
                                                      States or the dissemination of a plant                                                                           Coffee, Cotton, Fruits, Imports, Logs,
                                                                                                              mechanical, or other technological                     Nursery stock, Plant diseases and pests,
                                                      pest or noxious weed within the United                  collection techniques or other forms of
                                                      States. The Act defines a biological                                                                           Quarantine, Reporting and
                                                                                                              information technology; e.g., permitting               recordkeeping requirements, Rice,
                                                      control organism as ‘‘any enemy,                        electronic submission of responses).
                                                      antagonist, or competitor used to control                                                                      Vegetables.
                                                                                                                 Estimate of Burden: Public reporting
                                                      a plant pest or noxious weed.’’                                                                                7 CFR Part 330
                                                         APHIS regulations implementing                       burden for this collection of information
                                                      these aspects of the Plant Protection Act               is estimated to average 160 hours per                    Customs duties and inspection,
                                                      are contained (in part) in 7 CFR part                   response.                                              Imports, Plant diseases and pests,
                                                      330.                                                       Respondents: Importers and                          Quarantine, Reporting and
                                                         APHIS is proposing to revise: (1)                    distributors of plants and plant                       recordkeeping requirements,
                                                      Regulations regarding the movement of                   products; importers, brokers,                          Transportation.
                                                      plant pests; (2) criteria regarding the                 distributors, retailers, and exhibitors of             7 CFR Part 352
                                                      movement and environmental release of                   biological control organisms and
                                                      biological control organisms, and                       associated articles; and operators of                    Customs duties and inspection,
                                                      proposing to establish regulations to                   biocontainment facilities.                             Imports, Plant diseases and pests,
                                                      allow the importation and movement in                      Estimated Annual Number of                          Quarantine, Reporting and
                                                      interstate commerce of certain types of                 Respondents: 6.                                        recordkeeping requirements,
                                                      plant pests without restriction by                                                                             Transportation.
                                                                                                                 Estimated Annual Number of
                                                      granting exceptions from permitting                     Responses per Respondent: 1.                             Accordingly, we propose to amend 7
                                                      requirements for those pests; and (3)                                                                          CFR parts 318, 319, 330, and 352 as
                                                                                                                 Estimated Annual Number of
                                                      regulations regarding the movement of                                                                          follows:
                                                                                                              Responses: 6.
                                                      soil. This proposal would clarify the                      Estimated Total Annual Burden on
                                                      factors that would be considered when                                                                          PART 318—STATE OF HAWAII AND
                                                                                                              Respondents: 960 hours (Due to                         TERRITORIES QUARANTINE NOTICES
                                                      assessing the risks associated with the                 averaging, the total annual burden hours
                                                      movement of certain organisms and                       may not equal the product of the annual                ■ 1. The authority citation for part 318
                                                      facilitate the movement of regulated                    number of responses multiplied by the                  continues to read as follows:
                                                      organisms and articles in a manner that                 reporting burden per response.)
                                                      also protects U.S. agriculture.                                                                                  Authority: 7 U.S.C. 7701–7772 and 7781–
                                                         This proposed rule replaces a                           A copy of the information collection                7786; 7 CFR 2.22, 2.80, and 371.3.
                                                      previously published proposed rule,                     may be viewed on the Regulations.gov
                                                                                                                                                                     § 318.60   [Amended]
                                                      which APHIS is withdrawing as part of                   Web site or in our reading room. (A link
                                                                                                              to Regulations.gov and information on                  ■  2. In § 318.60, paragraph (c) is
                                                      this document. This proposal would                                                                             amended by adding the words ‘‘: And
                                                      clarify the factors that would be                       the location and hours of the reading
                                                                                                              room are provided under the heading                    provided finally, that the prohibitions in
                                                      considered when assessing the risks                                                                            this paragraph do not apply to the
                                                      associated with the movement of certain                 ADDRESSES at the beginning of this
                                                                                                              proposed rule.) Copies can also be                     movement of soil from Hawaii, Puerto
                                                      organisms and facilitate the movement                                                                          Rico, and the Virgin Islands, other than
                                                      of regulated organisms and articles in a                obtained from Ms. Kimberly Hardy,
                                                                                                              APHIS’ Information Collection                          that soil around the roots of plants;
                                                      manner that also protects U.S.                                                                                 movement of soil that is not around the
                                                      agriculture.                                            Coordinator, at (301) 851–2483. APHIS
                                                                                                              will respond to any information                        roots of plants is regulated under part
                                                         Implementing this rule will require                                                                         330 of this chapter’’ after the words
                                                      respondents to complete a new petition                  collection request-related comments in
                                                                                                              the final rule. All comments will also                 ‘‘paragraphs (c)(1), (2), and (3) of this
                                                      process to remove permitting                                                                                   section’’.
                                                      requirements for the interstate                         become a matter of public record.
                                                      movement of certain plant pests or                      E-Government Act Compliance                            PART 319—FOREIGN QUARANTINE
                                                      biological control organisms.                                                                                  NOTICES
                                                         We are soliciting comments from the                     The Animal and Plant Health
                                                      public (as well as affected agencies)                   Inspection Service is committed to                     ■ 3. The authority citation for part 319
                                                      concerning our proposed information                     compliance with the E-Government Act                   continues to read as follows:
                                                      collection and recordkeeping                            to promote the use of the Internet and                   Authority: 7 U.S.C. 450, 7701–7772, and
                                                      requirements. These comments will                       other information technologies, to                     7781–7786; 21 U.S.C. 136 and 136a; 7 CFR
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      help us:                                                provide increased opportunities for                    2.22, 2.80, and 371.3.
                                                         (1) Evaluate whether the proposed                    citizen access to Government                           ■ 4. In § 319.37–8, paragraph (b)(2) is
                                                      information collection is necessary for                 information and services, and for other                revised to read as follows:
                                                      the proper performance of our agency’s                  purposes. For information pertinent to
                                                      functions, including whether the                        E-Government Act compliance related                    § 319.37–8   Growing media.
                                                      information will have practical utility;                to this proposed rule, please contact Ms.              *     *     *     *     *
                                                         (2) Evaluate the accuracy of our                     Kimberly Hardy, APHIS’ Information                       (b) * * *
                                                      estimate of the burden of the proposed                  Collection Coordinator, at (301) 851–                    (2) A restricted article from an area of
                                                      information collection, including the                   2483.                                                  Canada regulated by the national plant


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                                                                               Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                           6997

                                                      protection organization of Canada for a                   through the United States if they are                     Export (exportation). To move from,
                                                      soil-borne plant pest may only be                         moved only through infested areas.                     or the act of movement from, the United
                                                      imported in an approved growing                           *    *    *     *    *                                 States to any place outside the United
                                                      medium if the phytosanitary certificate                                                                          States.
                                                      accompanying it contains an additional                    PART 330—FEDERAL PLANT PEST                               Garbage. That material designated as
                                                      declaration that the plant was grown in                   REGULATIONS; GENERAL; PLANT                            ‘‘garbage’’ in § 330.400(b).
                                                      a manner to prevent infestation by that                   PESTS, BIOLOGICAL CONTROL                                 Hand-carry. Importation of an
                                                      soil-borne plant pest.                                    ORGANISMS, AND ASSOCIATED                              organism that remains in one’s personal
                                                      *     *     *     *     *                                 ARTICLES; GARBAGE                                      possession and in close proximity to
                                                      ■ 5. Section 319.69 is amended as                                                                                one’s person.
                                                                                                                ■ 10. The authority citation for part 330
                                                      follows:                                                                                                            Import (importation). To move into, or
                                                                                                                continues to read as follows:
                                                      ■ a. By revising paragraph (a)(8); and                                                                           the act of movement into, the territorial
                                                      ■ b. By removing paragraph (b)(4).                          Authority: 7 U.S.C. 450, 7701–7772, 7781–            limits of the United States.
                                                                                                                7786, and 8301–8317; 21 U.S.C. 136 and                    Inspector. Any individual authorized
                                                        The revision to read as follows:
                                                                                                                136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and
                                                                                                                                                                       by the Administrator of APHIS or the
                                                      § 319.69   Notice of quarantine.                          371.3.
                                                                                                                                                                       Commissioner of CBP to enforce the
                                                         (a) * * *                                              ■ 11. The heading of part 330 is revised               regulations in this part.
                                                         (8) Organic decaying vegetative matter                 to read as set forth above.                               Interstate movement. Movement from
                                                      from all countries, unless the matter is                  ■ 12. Section 330.100 is revised to read               one State into or through any other
                                                      expressly authorized to be used as a                      as follows:                                            State; or movement within the District
                                                      packing material in this part. Exceptions                                                                        of Columbia, Guam, the U.S. Virgin
                                                                                                                § 330.100    Definitions.
                                                      to the above prohibitions may be                                                                                 Islands, or any other territory or
                                                      authorized in the case of specific                           The following terms, when used in
                                                                                                                                                                       possession of the United States.
                                                      materials which has been so prepared,                     this part, shall be construed,
                                                                                                                                                                          Living. Viable or potentially viable.
                                                      manufactured, or processed that in the                    respectively, to mean:
                                                                                                                                                                          Means of conveyance. Any personal
                                                      judgment of the inspector no pest risk                       Administrative instructions.
                                                                                                                                                                       or public property used for or intended
                                                      is involved in their entry.                               Published documents relating to the
                                                                                                                                                                       for use for the movement of any other
                                                                                                                enforcement of this part, and issued
                                                      *      *    *    *     *                                                                                         property. This specifically includes, but
                                                                                                                under authority thereof by the
                                                                                                                                                                       is not limited to, automobiles, trucks,
                                                      § 319.69–1       [Amended]                                Administrator.
                                                                                                                   Administrator. The Administrator of                 railway cars, aircraft, boats, freight
                                                      ■ 6. Section 319.69–1 is amended by                                                                              containers, and other means of
                                                      removing paragraph (b), and                               the Animal and Plant Health Inspection
                                                                                                                Service (APHIS), United States                         transportation.
                                                      redesignating paragraph (c) as paragraph                                                                            Move (moved and movement). To
                                                      (b).                                                      Department of Agriculture, or any
                                                                                                                employee of APHIS to whom authority                    carry, enter, import, mail, ship, or
                                                      ■ 7. Section 319.69–5 is amended by                                                                              transport; to aid, abet, cause, or induce
                                                      revising the section heading to read as                   has been delegated to act in the
                                                                                                                Administrator’s stead.                                 the carrying, entering, importing,
                                                      follows:                                                                                                         mailing, shipping, or transporting; to
                                                                                                                   Animal and Plant Health Inspection
                                                      § 319.69–5 Types of organic decaying                      Service (APHIS). The Animal and Plant                  offer to carry, enter, import, mail, ship,
                                                      vegetative matter authorized for packing.                 Health Inspection Service of the United                or transport; to receive to carry, enter,
                                                                                                                States Department of Agriculture.                      import, mail, ship, or transport; to
                                                      *     *     *     *     *
                                                                                                                   Article. Any material or tangible                   release into the environment, or to allow
                                                      ■ 8. Section 319.77–2 is amended as
                                                                                                                object, including a living organism, that              any of those activities.
                                                      follows:
                                                                                                                could harbor living plant pests or                        Noxious weed. Any plant or plant
                                                      ■ a. In paragraph (g), by removing the
                                                                                                                noxious weeds.                                         product that can directly or indirectly
                                                      word ‘‘and’’;
                                                                                                                   Biocontainment facility. A physical                 injure or cause damage to crops
                                                      ■ b. By revising paragraph (h); and
                                                                                                                structure, or portion thereof,                         (including nursery stock or plant
                                                      ■ c. By adding paragraph (i).
                                                                                                                constructed and maintained in order to                 products), livestock, poultry, or other
                                                        The addition and revision to read as
                                                                                                                contain plant pests, biological control                interests of agriculture, irrigation,
                                                      follows:
                                                                                                                organisms, or associated articles.                     navigation, the natural resources of the
                                                      § 319.77–2       Regulated articles.                         Biological control organism. Any                    United States, the public health, or the
                                                      *     *     *    *    *                                   enemy, antagonist, or competitor used                  environment.
                                                        (h) Mobile homes and their associated                   to control a plant pest or noxious weed.                  Owner. The owner, or his or her agent,
                                                      equipment; and                                               Continental United States. The                      having possession of a plant pest,
                                                        (i) Stone and quarry products.                          contiguous 48 States, Alaska, and the                  biological control organism, associated
                                                      ■ 9. Section 319.77–4 is amended by                       District of Columbia.                                  article, or any other means of
                                                      adding paragraph (d) to read as follows:                     Department. The United States                       conveyance, products, or article subject
                                                                                                                Department of Agriculture.                             to the regulations in this part.
                                                      § 319.77–4 Conditions for the importation                    Deputy Administrator. The Deputy                       Permit. A written authorization,
                                                      of regulated articles.                                    Administrator of the Plant Protection                  including by electronic methods, by the
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                                                      *     *    *     *     *                                  and Quarantine Programs or any                         Administrator to move plant pests,
                                                        (d) Stone and quarry products. Stone                    employee of the Plant Protection and                   biological control organisms, or
                                                      and quarry products originating in a                      Quarantine Programs delegated to act in                associated articles under conditions
                                                      Canadian infested area may be imported                    his or her stead.                                      prescribed by the Administrator.
                                                      into the United States only if they are                      Enter (entry). To move into, or the act                Permittee. The person to whom
                                                      destined for an infested area of the                      of movement into, the commerce of the                  APHIS has issued a permit in
                                                      United States and will not be moved                       United States.                                         accordance with this part and who must
                                                      through any noninfested areas of the                         EPA. The Environmental Protection                   comply with the provisions of the
                                                      United States, and may be moved                           Agency of the United States.                           permit and the regulations in this part.


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                                                      6998                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                         Person. Any individual, partnership,                 capable of growing in the product at                      (1) Authorized under an import,
                                                      corporation, association, joint venture,                nonrefrigerated conditions (over 50 °F                 interstate movement, or continued
                                                      or other legal entity.                                  or 10 °C).                                             curation permit issued in accordance
                                                         Plant. Any plant (including any plant                  Soil. The unconsolidated material                    with § 330.201; or
                                                      part) for or capable of propagation                     from the earth’s surface that consists of                 (2) Authorized in accordance with
                                                      including trees, tissue cultures, plantlet              rock and mineral particles and that                    other APHIS regulations in this chapter;
                                                      cultures, pollen, shrubs, vines, cuttings,              supports or is capable of supporting                   or
                                                      grafts, scions, buds, bulbs, roots, and                 biotic communities.                                       (3) Explicitly granted an exception or
                                                      seeds.                                                    State. Any of the States of the United               exemption in this subpart from
                                                         Plant pest. Any living stage of any of               States, the Commonwealth of the                        permitting requirements; or
                                                      the following that can directly or                      Northern Mariana Islands, the                             (4) Authorized under a general permit
                                                      indirectly injure, cause damage to, or                  Commonwealth of Puerto Rico, the                       issued by the Administrator.
                                                      cause disease in any plant or plant                     District of Columbia, Guam, the U.S.                      (b) Plant pests regulated by this
                                                      product: A protozoan, nonhuman                          Virgin Islands, and all other territories              subpart. For the purposes of this
                                                      animal, parasitic plant, bacterium,                     or possessions of the United States.                   subpart, APHIS will consider an
                                                      fungus, virus or viroid, infectious agent                 Sterilization (sterile, sterilized). A               organism to be a plant pest if the
                                                      or other pathogen, or any article similar               chemical or physical process that results              organism directly or indirectly injures,
                                                      to or allied with any of the foregoing.                                                                        causes damage to, or causes disease in
                                                                                                              in the death of all living organisms on
                                                         Plant product. Any flower, fruit,                                                                           a plant or plant product, or if the
                                                                                                              or within the article subject to the
                                                      vegetable, root, bulb, seed, or other                                                                          organism is an unknown risk to plants
                                                                                                              process. Examples include, but are not
                                                      plant part that is not included in the                                                                         or plant products, but is similar to an
                                                                                                              limited to, autoclaving and incineration.
                                                      definition of plant; or any manufactured                                                                       organism known to directly or indirectly
                                                      or processed plant or plant part.                         Taxon (taxa). Any recognized
                                                                                                                                                                     injure, cause damage to, or cause
                                                         Plant Protection and Quarantine                      grouping or rank within the biological
                                                                                                                                                                     disease in a plant or plant product.
                                                      Programs. The Plant Protection and                      nomenclature of organisms, such as
                                                                                                                                                                        (c) Biological control organisms
                                                      Quarantine Programs of the Animal and                   class, order, family, genus, species,
                                                                                                                                                                     regulated by this subpart. For the
                                                      Plant Inspection Health Service.                        subspecies, pathovar, biotype, race,
                                                                                                                                                                     purposes of this subpart, biological
                                                         Regulated garbage. That material                     forma specialis, or cultivar.
                                                                                                                                                                     control organisms include:
                                                      designated as ‘‘regulated garbage’’ in                    Transit. Movement from and to a                         (1) Invertebrate predators and
                                                      § 330.400(c) and § 330.400(d).                          foreign destination through the United                 parasites (parasitoids) used to control
                                                         Responsible individual. The                          States.                                                invertebrate plant pests,
                                                      individual who a permittee designates                     United States. All of the States.                       (2) Invertebrate competitors used to
                                                      to oversee and control the actions taken                  U.S. Customs and Border Protection                   control invertebrate plant pests,
                                                      under a permit issued in accordance                     (CBP). U.S. Customs and Border                            (3) Invertebrate herbivores used to
                                                      with this part for the movement or                      Protection within the Department of                    control noxious weeds,
                                                      curation of a plant pest, biological                    Homeland Security.                                        (4) Microbial pathogens used to
                                                      control organism, or associated article.                ■ 13. Subpart—Movement of Plant                        control invertebrate plant pests,
                                                      For the duration of the permit, the                     Pests, §§ 330.200 through 330.212, is                     (5) Microbial pathogens used to
                                                      individual must be physically present                   revised to read as follows:                            control noxious weeds,
                                                      during normal business hours at or near                 Subpart—Movement of Plant Pests,
                                                                                                                                                                        (6) Microbial parasites used to control
                                                      the location specified on the permit as                 Biological Control Organisms, and                      plant pathogens, and
                                                      the ultimate destination of the plant                   Associated Articles                                       (7) Any other types of biological
                                                      pest, biological control organism, or                                                                          control organisms, as determined by
                                                                                                              Sec.
                                                      associated article, and must serve as a                 330.200 Scope and general restrictions.
                                                                                                                                                                     APHIS.
                                                      primary contact for communication                       330.201 Permit requirements.                              (d) Biological control organisms not
                                                      with APHIS. The permittee may                           330.202 Biological control organisms.                  regulated by this subpart. The preceding
                                                      designate him or herself as the                         330.203 Soil.                                          paragraph notwithstanding, biological
                                                      responsible individual. The responsible                 330.204 Exceptions to permitting                       control organism-containing products
                                                      individual must be at least 18 years of                      requirements for the importation or               that are currently under an EPA outdoor
                                                      age. In accordance with section 7734 of                      interstate movement of certain plant              experimental use permit or that are
                                                      the Plant Protection Act (7 U.S.C. 7701                      pests.                                            currently registered with EPA as a
                                                                                                              330.205 Hand-carry of plant pests,                     microbial pesticide product having
                                                      et seq.), the act, omission, or failure of                   biological control organisms, and soil.
                                                      any responsible individual will also be                                                                        outdoor uses are not regulated under
                                                                                                              330.206 Packaging requirements.
                                                      deemed the act, omission, or failure of                 330.207 Costs and charges.                             this subpart. Additionally, biological
                                                      a permittee.                                                                                                   control organisms that are pesticides
                                                         Secure shipment. Shipment of a                       Subpart—Movement of Plant Pests,                       that are not registered with EPA, but are
                                                      regulated plant pest, biological control                Biological Control Organisms, and                      being transferred, sold, or distributed in
                                                      organism, or associated article in a                    Associated Articles                                    accordance with EPA’s regulations in 40
                                                      container or a means of conveyance of                                                                          CFR 152.30, are not regulated under this
                                                      sufficient strength and integrity to                    § 330.200    Scope and general restrictions.           subpart for their interstate movement or
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                                                      prevent leakage of contents and to                        (a) No person shall import, move                     importation. However, an importer
                                                      withstand shocks, pressure changes, and                 interstate, transit, or release into the               desiring to import a shipment of
                                                      other conditions incident to ordinary                   environment plant pests, biological                    biological control organisms subject to
                                                      handling in transportation.                             control organisms, or associated articles,             the Federal Insecticide Fungicide and
                                                         Shelf-stable. The condition achieved                 unless the importation, interstate                     Rodenticide Act must submit to the EPA
                                                      in a product, by application of heat,                   movement, transit, or release into the                 Administrator a Notice of Arrival of
                                                      alone or in combination with other                      environment of the plant pests,                        Pesticides and Devices as required by
                                                      ingredients and/or other treatments, of                 biological control organisms, or plant                 CBP regulations at 19 CFR 12.112. The
                                                      being rendered free of microorganisms                   pests is:                                              Administrator will provide notification


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                           6999

                                                      to the importer indicating the                             (b) Applying for a permit. Permit                   concludes that the actions allowed
                                                      disposition to be made of shipment                      applications must be submitted by the                  under the permit will be highly unlikely
                                                      upon its entry into the customs territory               applicant in writing or electronically                 to result in the introduction or
                                                      of the United States.                                   through one of the means listed at                     dissemination of a plant pest, biological
                                                                                                              http://www.aphis.usda.gov/                             control organism, or noxious weed
                                                      § 330.201    Permit requirements.                       plant_health/permits/index.shtml in                    within the United States in a manner
                                                         (a) Types of permits. APHIS issues                   advance of the action(s) proposed on the               that presents an unacceptable risk to
                                                      import permits, interstate movement                     permit application.                                    plants and plant products. Issuance will
                                                      permits, continued curation permits,                       (c) Completing a permit application.                occur as follows:
                                                      and transit permits for plant pests,                    A permit application must be complete                     (i) Prior to issuing the permit, APHIS
                                                      biological control organisms, and                       before APHIS will evaluate it in order to              will notify the applicant in writing or
                                                      associated articles.1                                   determine whether to issue the permit                  electronically of all proposed permit
                                                         (1) Import permit. Import permits are                requested. Guidance regarding how to                   conditions. The applicant must agree in
                                                      issued to persons for secure shipment                   complete a permit application,                         writing or electronically that he or she,
                                                      from outside the United States into the                 including guidance specific to the                     and all his or her employees, agents,
                                                      territorial limits of the United States.                various information blocks on the                      and/or officers, will comply with all
                                                      When import permits are issued to                       application, is available at http://                   permit conditions and all provisions of
                                                      individuals, these individuals must be                  www.aphis.usda.gov/plant_health/                       this subpart. If the organism or
                                                      18 years of age or older and have a                     permits/index.shtml.                                   associated article will be contained in a
                                                      physical address within the United                         (d) APHIS action on permit                          private residence, the applicant must
                                                      States. When import permits are issued                  applications. APHIS will review the                    state in this agreement that he or she
                                                      to corporate persons, these persons must                information on the application to                      authorizes APHIS to conduct
                                                      maintain an address or business office                  determine whether it is complete. In                   unscheduled assessments of the
                                                      in the United States with a designated                  order to consider an application                       residence during normal business hours
                                                      individual for service of process.                      complete, APHIS may request                            if a permit is issued.
                                                         (2) Interstate movement permit.                      additional information that it                            (ii) APHIS will issue the permit after
                                                      Interstate movement permits are issued                  determines to be necessary in order to                 it receives and reviews the applicant’s
                                                      to persons for secure shipment from any                 assess the risk to plants and plant                    agreement. The permit will be valid for
                                                      State into or through any other State.                  products that may be posed by the                      no more than 3 years. During that
                                                      When interstate movement permits are                    actions proposed on the application.                   period, the permittee must abide by all
                                                      issued to individuals, these individuals                When it is determined that an                          permitting conditions, and the use of
                                                      must be 18 years of age or older and                    application is complete, APHIS will                    the organism or article must conform to
                                                      have a physical address within the                      commence review of the information                     the intended use on the permit.
                                                      United States. When interstate                          provided.                                              Moreover, the use of organisms derived
                                                      movement permits are issued to                             (1) State or Tribal consultation and                from a regulated parent organism during
                                                      corporate persons, these persons must                   comment; consultation with other                       that period must conform to the
                                                      maintain an address or business office                  individuals. APHIS will share a copy of                intended use specified on the permit for
                                                      in the United States with a designated                  the permit application, and the                        the parent organism.
                                                      individual for service of process.                      proposed permit conditions, with the                      (iii) All activities carried out under
                                                         (3) Continued curation permits.                      appropriate State or Tribal regulatory                 the permit must cease on or before the
                                                      Continued curation permits are issued                   officials, and may share the application               expiration date for the permit, unless,
                                                      in conjunction with and prior to the                    and the proposed conditions with other                 prior to that expiration date, the
                                                      expiration date for an import permit or                 persons or groups to provide comment.                  permittee has submitted a new permit
                                                      interstate movement permit, in order for                   (2) Initial assessment of sites and                 application and a new permit has been
                                                      the permittee to continue the actions                   facilities. Prior to issuance of a permit,             issued to authorize continuation of
                                                      listed on the import permit or interstate               APHIS will assess all sites and facilities             those actions.
                                                      movement permit. When continued                         that are listed on the permit application,                (iv) At any point following issuance of
                                                      curation permits are issued to                          including private residences,                          a permit but prior to its expiration date,
                                                      individuals, these individuals must be                  biocontainment facilities, and field                   an inspector may conduct unscheduled
                                                      18 years of age or older and have a                     locations where the organism or article                assessments of the site or facility in
                                                      physical address within the United                      will be held or released. As part of this              which the organisms or associated
                                                      States. When continued curation                         assessment, all sites and facilities are               articles are held, to determine whether
                                                      permits are issued to corporate persons,                subject to inspection. All facilities must             they are constructed and are being
                                                      these persons must maintain an address                  be determined by APHIS to be                           maintained in a manner that prevents
                                                      or business office in the United States                 constructed and maintained in a manner                 the dissemination of organisms or
                                                      with a designated individual for service                that prevents the dissemination or                     associated articles from the site or
                                                      of process.                                             dispersal of plant pests, biological                   facility. The permittee must allow all
                                                         (4) Transit permits. Transit permits                 control organisms, or associated articles              such assessments requested by APHIS
                                                      are issued for secure shipments through                 from the facility. The applicant must                  during normal business hours. Failure
                                                                                                              provide all information requested by                   to allow such assessments constitutes
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                                                      the United States. Transit permits are
                                                      issued in accordance with part 352 of                   APHIS regarding this assessment, and                   grounds for revocation of the permit.
                                                      this chapter.                                           must allow all inspections requested by                   (4) Denial of a permit application.
                                                                                                              APHIS during normal business hours (8                  APHIS may deny an application for a
                                                        1 Persons contemplating the shipment of plant         a.m. to 4:30 p.m., Monday through                      permit if:
                                                      pests, biological control organisms, or associated      Friday, excluding holidays). Failure to                   (i) APHIS concludes that the actions
                                                      articles to places outside the United States should     do so constitutes grounds for denial of                proposed in the permit application
                                                      make arrangements directly, or through the
                                                      recipient, with the country of destination for the      the permit application.                                would present an unacceptable risk to
                                                      export of the plant pests, biological control              (3) Issuance of a permit. APHIS may                 plants and plant products because of the
                                                      organisms, or associated articles into that country.    issue a permit to an applicant if APHIS                introduction or dissemination of a plant


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                                                      7000                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      pest, biological control organism, or                   extortion, or any other crime involving                determining that the amendment is
                                                      noxious weed within the United States;                  a lack of integrity.                                   needed to address newly identified
                                                      or                                                         (5) Withdrawal of a permit                          considerations concerning the risks
                                                         (ii) The actions proposed in the                     application. Any permit application                    presented by the organism or the
                                                      permit application would be adverse to                  may be withdrawn at the request of the                 activities being conducted under the
                                                      the conduct of an APHIS eradication,                    applicant. If the applicant wishes to                  permit. APHIS may also amend a permit
                                                      suppression, control, or regulatory                     withdraw a permit application, he or                   at any time to ensure that the permit
                                                      program; or                                             she must provide the request in writing                conditions are consistent with all of the
                                                         (iii) A State or Tribal executive                    to APHIS. APHIS will provide written                   requirements of this part. As soon as
                                                      official, or a State or Tribal plant                    notification to the applicant as promptly              circumstances allow, APHIS will notify
                                                      protection official authorized to do so,                as circumstances allow regarding                       the permittee of the amendment to the
                                                      objects to the movement in writing and                  reception of the request and withdrawal                permit and the reason(s) for it.
                                                      provides specific, detailed information                 of the application.                                    Depending on the nature of the
                                                      that there is a risk the movement will                     (6) Cancellation of a permit. Any                   amendment, the permittee may have to
                                                      result in the dissemination of a plant                  permit that has been issued may be                     agree in writing or electronically that he
                                                      pest or noxious weed into the State,                    canceled at the request of the permittee.              or she, and his or her employees, agents,
                                                      APHIS evaluates the information and                     If a permittee wishes a permit to be                   and/or officers, will comply with the
                                                      agrees, and APHIS determines that such                  canceled, he or she must provide the                   permit and conditions as amended
                                                      plant pest or noxious weed risk cannot                  request in writing to APHIS–PPQ.                       before APHIS will issue the amended
                                                      be adequately addressed or mitigated; or                Whenever a permit is canceled, APHIS                   permit. If APHIS requests such an
                                                         (iv) The applicant does not agree to                 will notify the permittee in writing                   agreement, and the permittee does not
                                                      observe all of the proposed permit                      regarding such cancellation.                           agree in writing that he or she, and his
                                                                                                                 (7) Revocation of a permit. APHIS                   or her employees, agents, and/or
                                                      conditions that APHIS has determined
                                                                                                              may revoke a permit for any of the                     officers, will comply with the amended
                                                      are necessary to mitigate identified
                                                                                                              following reasons:                                     permit and conditions, the existing
                                                      risks; or
                                                                                                                 (i) After issuing the permit, APHIS                 permit will be revoked.
                                                         (v) The applicant does not provide                   obtains information that would have
                                                      information requested by APHIS as part                                                                            (9) Suspension of permitted actions.
                                                                                                              otherwise provided grounds for it to                   APHIS may suspend authorization of
                                                      of an assessment of sites or facilities, or             deny the permit application; or
                                                      does not allow APHIS to inspect sites or                                                                       actions authorized under a permit if it
                                                                                                                 (ii) APHIS determines that the actions              identifies new factors that cause it to
                                                      facilities associated with the actions                  undertaken under the permit have                       reevaluate the risk associated with those
                                                      listed on the permit application; or                    resulted in or are likely to result in the             actions. APHIS will notify the permittee
                                                         (vi) APHIS determines that the                       introduction into or dissemination                     in writing of this suspension explaining
                                                      applicant has not followed prior permit                 within the United States of a plant pest               the reasons for it and stating the actions
                                                      conditions, or has not adequately                       or noxious weed in a manner that                       for which APHIS is suspending
                                                      demonstrated that they can meet the                     presents an unacceptable risk to plants                authorization. Depending on the results
                                                      requirements for the current                            or plant products; or                                  of APHIS’ evaluation, APHIS will
                                                      application. Factors that may contribute                   (iii) APHIS determines that the                     subsequently contact the permittee to
                                                      to such a determination include, but are                permittee, or any employee, agent, or                  remove the suspension, amend the
                                                      not limited to:                                         officer of the permittee, has failed to                permit, or revoke the permit.
                                                         (A) The applicant, or a partnership,                 comply with a provision of the permit                     (10) Appeals. Any person whose
                                                      firm, corporation, or other legal entity in             or the regulations under which the                     application has been denied, whose
                                                      which the applicant has a substantial                   permit was issued.                                     permit has been revoked or amended, or
                                                      interest, financial or otherwise, has not                  (8) Amendment of permits. (i)                       whose authorization for actions
                                                      complied with any permit that was                       Amendment at permittee’s request. If a                 authorized under a permit has been
                                                      previously issued by APHIS.                             permittee determines that circumstances                suspended, may appeal the decision in
                                                         (B) Issuing the permit would                         have changed since the permit was                      writing to the Administrator within 10
                                                      circumvent any order denying or                         initially issued and wishes the permit to              business days after receiving the written
                                                      revoking a previous permit issued by                    be amended accordingly, he or she must                 notification of the denial, revocation,
                                                      APHIS.                                                  request the amendment, either through                  amendment, or suspension. The appeal
                                                         (C) The applicant has previously                     APHIS’ online portal for permit                        shall state all of the facts and reasons
                                                      failed to comply with any APHIS                         applications, or by contacting APHIS                   upon which the person relies to show
                                                      regulation.                                             directly via phone or email. The                       that the application was wrongfully
                                                         (D) The applicant has previously                     permittee may have to provide                          denied, permit revoked or amended, or
                                                      failed to comply with any other Federal,                supporting information justifying the                  authorization for actions under a permit
                                                      State, or local laws, regulations, or                   amendment. APHIS will review the                       suspended. The Administrator shall
                                                      instructions pertaining to plant health.                amendment request, and may amend the                   grant or deny the appeal, stating the
                                                         (E) The applicant has previously                     permit if only minor changes are                       reasons for the decision as promptly as
                                                      failed to comply with the laws or                       necessary. Requests for more                           circumstances allow.
                                                      regulations of a national plant                         substantive changes may require a new
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      protection organization or equivalent                   permit application. Prior to issuance of               § 330.202   Biological control organisms.
                                                      body, as these pertain to plant health.                 an amended permit, the permittee may                     (a) General conditions for
                                                         (F) APHIS has determined that the                    be required to agree in writing that he                importation, interstate movement, and
                                                      applicant has made false or fraudulent                  or she, and his or her employees, agents,              environmental release of biological
                                                      statements or provided false or                         and/or officers will comply with the                   control organisms. Except as provided
                                                      fraudulent records to APHIS.                            amended permit and conditions.                         in paragraph (b) of this section, no
                                                         (G) The applicant has been convicted                    (ii) Amendment initiated by APHIS.                  biological control organism regulated
                                                      or has pled nolo contendere to any                      APHIS may amend any permit and its                     under this subpart may be imported,
                                                      crime involving fraud, bribery,                         conditions at any time, upon                           moved interstate, or released into the


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                             7001

                                                      environment unless a permit has been                    has produced self-replicating                          the comments received and stating its
                                                      issued in accordance with § 330.201                     populations within the continental                     reasons for determining not to add the
                                                      authorizing such importation, interstate                United States for an amount of time                    organism to the list referred to in
                                                      movement, or environmental release,                     sufficient, based on the organism’s                    paragraph (b) of this section.
                                                      and the organism is moved or released                   taxon, to consider that taxon established                  (e) Removal of organisms from the list
                                                      in accordance with this permit and the                  throughout its geographical or                         of exempt organisms. Any biological
                                                      regulations in this subpart. The                        ecological range in the continental                    control organism may be removed from
                                                      regulations in 40 CFR parts 1500–1508,                  United States.                                         the list referred to in paragraph (b) of
                                                      7 CFR part 1b, and 7 CFR part 372 may                      (2) Results from a field study where                this section if information emerges that
                                                      require APHIS to request additional                     data was collected from representative                 would have otherwise led APHIS to
                                                      information from an applicant regarding                 habitats occupied by the biological                    deny the petition to add the organism to
                                                      the proposed release of a biological                    control organism. Studies must include                 the list. Whenever an organism is
                                                      control organism as part of its                         sampling for any direct or indirect                    removed from the list, APHIS will
                                                      evaluation of a permit application.                     impacts on target and non-target hosts of              publish a notice in the Federal Register
                                                      Further information regarding the types                 the biological control organism in these               announcing that action and the basis for
                                                      of information that may be requested,                   habitats. Supporting scientific literature             it.
                                                      and the manner in which this                            must be cited.
                                                      information will be evaluated, is found                    (3) Any other data, including                       § 330.203   Soil.
                                                      at http://www.aphis.usda.gov/                           published scientific reports, that suggest               (a) The Administrator has determined
                                                      plant_health/permits/index.shtml.                       that subsequent releases of the organism               that, unless it has been sterilized, soil is
                                                         (b) Exceptions from permitting                       into the environment of the continental                an associated article, and is thus subject
                                                      requirements for certain biological                     United States will present no additional               to the permitting requirements of
                                                      control organisms. APHIS has                            plant pest risk (direct or indirect) to                § 330.201, unless its movement:
                                                      determined that certain biological                      plants or plant products.                                (1) Is regulated pursuant to other
                                                      control organisms have become                              (d) APHIS review of petitions. (1)                  APHIS regulations in this chapter; or
                                                      established throughout their                            APHIS will review the petition to
                                                                                                                                                                       (2) Does not require such a permit
                                                      geographical or ecological range in the                 determine whether it is complete. If
                                                                                                                                                                     under the provisions of paragraphs
                                                      continental United States, such that the                APHIS determines that the petition is
                                                                                                                                                                     (b)(1) or (c)(1) of this section.
                                                      additional release of pure cultures                     complete, it will conduct an evaluation
                                                                                                                                                                       (b) Conditions governing the
                                                      derived from field populations of taxa of               of the petition to determine whether
                                                                                                              there is sufficient evidence that the                  importation of soil.
                                                      such organisms into the environment of
                                                                                                              organism exists throughout its                           (1) Permit. Except as provided in
                                                      the continental United States will
                                                                                                              geographical or ecological range in the                § 319.37–8(b)(2) of this chapter and
                                                      present no additional plant pest risk
                                                                                                              continental United States and that                     except for soil imported from areas of
                                                      (direct or indirect) to plants or plant
                                                                                                              subsequent releases of pure cultures of                Canada other than those areas of Canada
                                                      products. A list of these organisms is
                                                                                                              field populations of the organism into                 regulated by the national plant
                                                      maintained online, at http://
                                                                                                              the environment of the continental                     protection organization of Canada for a
                                                      www.aphis.usda.gov/plant_health/
                                                                                                              United States will present no additional               soil-borne plant pest, soil may only be
                                                      permits/index.shtml.
                                                         (1) Importation and interstate                       plant pest risk (direct or indirect) to                imported into the United States if an
                                                      movement of listed organisms. Pure                      plants or plant products.                              import permit has been issued for its
                                                      cultures of organisms on the list may be                   (2) Notice of availability of the                   importation in accordance with
                                                      imported into or moved interstate                       petition. If APHIS determines that there               § 330.201, and the soil will be imported
                                                      within the continental United States                    is sufficient evidence that the organism               under the conditions specified on the
                                                      without further restriction under this                  exists throughout its geographical or                  permit.
                                                      subpart.                                                ecological range in the continental                       (2) Additional conditions for the
                                                         (2) Environmental release of listed                  United States and that subsequent                      importation of soil via hand-carry. In
                                                      organisms. Pure cultures of organisms                   releases of pure cultures of the organism              addition to the condition of paragraph
                                                      on the list may be released into the                    into the environment of the continental                (b)(1) of this section, soil may be hand-
                                                      environment of the continental United                   United States will present no additional               carried into the United States only if the
                                                      States without further restriction under                plant pest risk to plants or plant                     importation meets the conditions of
                                                      this subpart.                                           products, APHIS will publish a notice                  § 330.205.
                                                         (c) Additions to the list of organisms               in the Federal Register announcing the                    (3) Additional conditions for the
                                                      granted exceptions from permitting                      availability of the petition and                       importation of soil intended for the
                                                      requirements for their importation or                   requesting public comment on that                      extraction of plant pests. In addition to
                                                      interstate movement. Any person may                     document.                                              the condition of paragraph (b)(1) of this
                                                      request that APHIS add a biological                        (3) Notice of determination. (i) If no              section, soil may be imported into the
                                                      control organism to the list referred to                comments are received, or if the                       United States for the extraction of plant
                                                      in paragraph (b) of this section by                     comments received do not lead APHIS                    pests if the soil will be imported
                                                      submitting a petition to APHIS via email                to reconsider its determination, APHIS                 directly to a biocontainment facility
                                                      to pest.permits@aphis.usda.gov or                       will publish in the Federal Register a                 approved by APHIS.
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      through any means listed at http://                     subsequent notice describing the                          (4) Additional conditions for the
                                                      www.aphis.usda.gov/plant_health/                        comments received and stating that the                 importation of soil contaminated with
                                                      permits/index.shtml. The petition must                  organism has been added to the list                    plant pests and intended for disposal. In
                                                      include the following information:                      referred to in paragraph (b) of this                   addition to the condition of paragraph
                                                         (1) Evidence indicating that the                     section.                                               (b)(1) of this section, soil may be
                                                      organism is indigenous to the                              (ii) If the comments received lead                  imported into the United States for the
                                                      continental United States throughout its                APHIS to reconsider its determination,                 disposal of plant pests if the soil will be
                                                      geographical or ecological range, or                    APHIS will publish in the Federal                      imported directly to an APHIS-approved
                                                      evidence indicating that the organism                   Register a subsequent notice describing                disposal facility.


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                                                      7002                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                         (5) Exemptions. The articles listed in               disposal facility in a secure manner that              range within the continental United
                                                      this paragraph are not soil, provided                   prevents its dissemination into the                    States; or
                                                      that they are free of organic material.                 outside environment.                                      (2) Be sufficiently attenuated so that
                                                      Therefore, they may be imported into                       (4) Conditions for the interstate                   it no longer poses a risk to plants or
                                                      the United States without an import                     movement of soil samples from an area                  plant products; or
                                                      permit issued in accordance with                        quarantined in accordance with part                       (3) Be commercially available and
                                                      § 330.201, unless the Administrator has                 301 of this chapter for chemical or                    raised under the regulatory purview of
                                                      issued an order stating that a particular               compositional testing or analysis. Soil                other Federal agencies.
                                                      article is an associated article. All such              samples may be moved for chemical or                      (b) Petition process to add plant pests
                                                      articles are, however, subject to                       compositional testing or analysis from                 to the list. (1) Petition. Any person may
                                                      inspection at the port of first arrival,                an area that is quarantined in                         petition APHIS to have an additional
                                                      subsequent reinspection at other                        accordance with part 301 of this chapter               plant pest added to the list of plant
                                                      locations, other remedial measures                      without prior issuance of an interstate                pests that may be imported into or move
                                                      deemed necessary by an inspector to                     movement permit in accordance with                     in interstate commerce within the
                                                      remove any risk the items pose of                       § 330.201 or further restriction under                 continental United States without
                                                      disseminating plant pests or noxious                    this chapter, provided that the soil is                restriction. To submit a petition, the
                                                      weeds, and any other restrictions of this               moved to a laboratory that has entered                 person must provide, in writing,
                                                      chapter:                                                into and is operating under a                          information supporting the placement of
                                                         (i) Consolidated material derived from               compliance agreement with APHIS, is                    a particular pest in one of the categories
                                                      any strata or substrata of the earth.                   abiding by all terms and conditions of                 listed in paragraph (a) of this section.
                                                      Examples include clay (laterites,                       the compliance agreement, and is                          (i) Information that the plant pest
                                                      bentonite, china clay, attapulgite,                     approved by APHIS to test and/or                       belongs to a taxon that is established
                                                      tierrafino), talc, chalk, slate, iron ore,              analyze such samples.                                  throughout its entire geographical or
                                                      and gravel.                                                (5) Additional conditions for                       ecological range within the United
                                                         (ii) Sediment, mud, or rock from                     interstate movement of soil to, from, or               States must include scientific literature,
                                                      saltwater bodies of water.                              between Hawaii, the territories, and the               unpublished studies, or data regarding:
                                                         (iii) Cosmetic mud and other                         continental United States. In addition to
                                                      commercial mud products.                                                                                          (A) The biology of the plant pest,
                                                                                                              all general conditions for interstate                  including characteristics that allow it to
                                                         (iv) Stones, rocks, and quarry                       movement of soil, soil may be moved
                                                      products.                                                                                                      be identified, known hosts, and
                                                                                                              interstate to, from, or between Hawaii,                virulence;
                                                         (c) Conditions governing the interstate
                                                                                                              the territories, and the continental                      (B) The geographical or ecological
                                                      movement of soil. (1) General
                                                                                                              United States only if an interstate                    range of the plant pest within the
                                                      conditions. Except for soil moved in
                                                                                                              movement permit has been issued for its                continental United States; and
                                                      accordance with paragraphs (c)(2)
                                                                                                              movement in accordance with                               (C) The areas of the continental
                                                      through (5) of this section, soil may be
                                                                                                              § 330.201. In addition, soil moved to,                 United States within which the plant
                                                      moved interstate within the United
                                                                                                              from, or between Hawaii, the territories,              pest is established.
                                                      States without prior issuance of an
                                                                                                              and the continental United States with                    (ii) Information that the plant pest has
                                                      interstate movement permit in
                                                                                                              the intent of extracting plant pests is                been attenuated of its pathogenicity
                                                      accordance with § 330.201 or further
                                                                                                              subject to the conditions of paragraph                 must include experimental data,
                                                      restriction under this subpart. However,
                                                                                                              (c)(2) of this section, while soil infested            published references, or scientific
                                                      all soil moved interstate is subject to
                                                                                                              with plant pests and intended for                      information regarding such attenuation.
                                                      any movement restrictions and remedial
                                                                                                              disposal is subject to the conditions of                  (iii) Information that the plant pest is
                                                      measures specified for such movement
                                                                                                              paragraph (c)(3) of this section.                      commercially available and raised
                                                      in part 301 of this chapter.                               (d) Conditions governing the transit of
                                                         (2) Conditions for the interstate                                                                           under the regulatory purview of another
                                                                                                              soil through the United States. Soil may               Federal agency must include a citation
                                                      movement within the continental United
                                                                                                              transit through the United States only if              to the relevant law, regulation, or order
                                                      States of soil intended for the extraction
                                                                                                              a transit permit has been issued for its               under which the agency exercises such
                                                      of plant pests. Soil may be moved
                                                                                                              movement in accordance with part 352                   oversight.
                                                      interstate within the continental United
                                                                                                              of this chapter.                                          (2) APHIS review. APHIS will review
                                                      States with the intent of extracting plant
                                                      pests, only if an interstate movement                   § 330.204 Exceptions to permitting                     the information contained in the
                                                      permit has been issued for its movement                 requirements for the importation or                    petition to determine whether it is
                                                      in accordance with § 330.201, and the                   interstate movement of certain plant pests.            complete. In order to consider the
                                                      soil will be moved directly to a                           Pursuant to section 7711 of the Plant               petition complete, APHIS may require
                                                      biocontainment facility approved by                     Protection Act (7 U.S.C. 7701 et seq.),                additional information to determine
                                                      APHIS in a secure manner that prevents                  the Administrator has determined that                  whether the plant pest belongs to one of
                                                      its dissemination into the outside                      certain plant pests may be imported into               the categories listed in paragraph (a) of
                                                      environment.                                            or may move in interstate commerce                     this section. When it is determined that
                                                         (3) Conditions for the interstate                    within the continental United States                   the information is complete, APHIS will
                                                      movement within the continental United                  without restriction. The list of all such              commence review of the petition.
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      States of soil infested with plant pests                plant pests is listed on the Internet at                  (3) Action on petitions to add pests.
                                                      and intended for disposal. Soil may be                  http://www.aphis.usda.gov/                             (i) If, after review of the petition, APHIS
                                                      moved interstate within the continental                 plant_health/permits/index.shtml.                      determines there is insufficient
                                                      United States with the intent of                           (a) Categories. In order to be included             evidence that the plant pest belongs to
                                                      disposing of plant pests, only if an                    on the list, a plant pest must:                        one of the three categories listed in
                                                      interstate movement permit has been                        (1) Be from field populations or lab                paragraph (a) of this section, APHIS will
                                                      issued for its movement in accordance                   cultures derived from field populations                deny the petition, and notify the
                                                      with § 330.201, and the soil will be                    of a taxon that established throughout                 petitioner in writing regarding this
                                                      moved directly to an APHIS-approved                     its entire geographical or ecological                  denial.


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                              7003

                                                         (ii) If, after review of the petition,               restriction. If no comments are received               days prior to movement, the permittee
                                                      APHIS determines that the plant pest                    on the notice, or if the comments                      must notify APHIS through APHIS’
                                                      belongs to one of the categories in                     received do not affect APHIS’                          online portal for permit applications or
                                                      paragraph (a) of this section, APHIS will               conclusions regarding the petition,                    by fax and provide the following
                                                      publish a notice in the Federal Register                APHIS will publish a subsequent notice                 information in order to receive a hand-
                                                      that announces the availability of the                  in the Federal Register stating that the               carry shipping authorization:
                                                      petition and any supporting                             plant pest has been removed from the                      (1) A copy of the face page of the
                                                      documentation to the public, that states                list.                                                  passport for the individual or
                                                      that APHIS intends to add the plant pest                   (d) APHIS-initiated changes to the                  individuals who will hand-carry the
                                                      to the list of plant pests that may be                  list. (1) APHIS may propose to add a                   plant pest, biological control organism,
                                                      imported into or move in interstate                     plant pest to or remove a pest from the                or soil;
                                                      commerce within the continental                         list of plant pests that may be imported                  (2) A description of the means of
                                                      United States without restriction, and                  into or move in interstate commerce                    conveyance in which the individual or
                                                      that requests public comment. If no                     within the continental United States                   individuals will travel, including flight
                                                      comments are received on the notice, or                 without restriction without a petition, if             number and airline name for air travel,
                                                      if, based on the comments received,                     it determines that there is sufficient                 or vehicle license number or other
                                                      APHIS determines that its conclusions                   evidence that the plant pest belongs to                identifying number for other modes of
                                                      regarding the petition have not been                    one of the categories listed in paragraph              transportation;
                                                      affected, APHIS will publish in the                     (a) of the section, or if evidence emerges                (3) Expected date and time of first
                                                      Federal Register a subsequent notice                    that leads APHIS to reconsider its initial             arrival;
                                                      stating that the plant pest has been                    determination that the plant pest was or                  (4) Expected port of first arrival; and
                                                      added to the list.                                      was not in one of the categories lists in                 (5) Travel itinerary from port of first
                                                         (c) Petition process to have plant pests             paragraph (a) of this section. APHIS will              arrival to final destination.
                                                      removed from the list. (1) Petition. Any                publish a notice in the Federal Register                  (c) Notification of arrival at the
                                                      person may petition to have a plant pest                announcing this proposed addition or                   facility or point of destination. The
                                                      removed from the list of plant pests that               removal, making available any                          permittee or his or her designee must
                                                      may be imported into or move in                         supporting documentation that it                       notify APHIS within 24 hours of arrival
                                                      interstate commerce within the                          prepares, and requesting public                        of the hand-carried plant pest, biological
                                                      continental United States without                       comment.                                               control organism, or soil at the
                                                      restriction by writing to APHIS. The                       (2) If no comments are received on the              biocontainment facility or other
                                                      petition must contain independently                     notice or if the comments received do                  authorized point of destination. This
                                                      verifiable information demonstrating                    not affect the conclusions of the notice,              notification must state that the plant
                                                      that APHIS’ initial determination that                  APHIS will publish a subsequent notice                 pest, biological control organism, or soil
                                                      the plant pest belongs to one of the                    in the Federal Register stating that the               has arrived at its destination and that
                                                      categories in paragraph (a) of the section              plant pest has been added to or removed                the package in which it was hand-
                                                      should be changed, or that additional                   from the list.                                         carried has remained sealed until
                                                      information is now available that would                                                                        arrival. Notification must be by fax or
                                                      have caused us to change the initial                    § 330.205 Hand-carry of plant pests,                   email, or via the Internet at http://
                                                      decision.                                               biological control organisms, and soil.                www.aphis.usda.gov/plant_health/
                                                         (2) APHIS review. APHIS will review                    Plant pests, biological control                      permits/index.shtml.
                                                      the information contained in the                        organisms, and soil may be hand-carried                   (d) Denial, amendment, or
                                                      petition to determine whether it is                     into the United States only in                         cancellation of authorization to hand-
                                                      complete. In order to consider the                      accordance with the provisions of this                 carry. APHIS may deny a request to
                                                      petition complete, APHIS may require                    section.                                               hand-carry, or amend or cancel any
                                                      additional information supporting the                     (a) Authorization to hand-carry.                     hand-carry authorization at any time, if
                                                      petitioner’s claim. When it is                            (1) Application for a permit;                        it deems such action necessary to
                                                      determined that the information is                      specification of ‘‘hand-carry’’ as                     prevent the introduction or
                                                      complete, APHIS will commence review                    proposed method of movement. A                         dissemination of plant pests or noxious
                                                      of the petition.                                        person must apply for an import permit                 weeds within the United States.
                                                         (3) APHIS action on petitions to                     for the plant pest, biological control                    (e) Appeal of denial, amendment, or
                                                      remove pests. (i) If, after review of the               organism, or soil, in accordance with                  cancellation. Any person whose request
                                                      petition, APHIS determines that there is                § 330.201, and specify hand-carry of the               to hand-carry has been denied, or whose
                                                      insufficient evidence to suggest that its               organism or article as the method of                   authorization to hand-carry has been
                                                      initial determination should be                         proposed movement.                                     amended or canceled, may appeal the
                                                      changed, APHIS will deny the petition,                    (2) Specification of individual who                  decision in writing to APHIS.
                                                      and notify the petitioner in writing                    will hand-carry. The application must
                                                      regarding this denial.                                  also specify the individual or                         § 330.206   Packaging requirements.
                                                         (ii) If, after review of the petition,               individuals who will hand-carry the                      Shipments in which plant pests,
                                                      APHIS determines that there is a                        plant pest, biological control organism,               biological control organisms, and
                                                      sufficient basis to suggest that its initial            or soil into the United States. If APHIS               associated articles are imported into,
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      determination should be changed,                        authorizes this individual or these                    moved interstate, or transited through
                                                      APHIS will publish a notice in the                      individuals to hand-carry, the                         the United States must meet the general
                                                      Federal Register that announces the                     authorization may not be transferred to,               packaging requirements of this section,
                                                      availability of the petition, and that                  nor actions under it performed by,                     as well as all specific packaging
                                                      requests public comment regarding                       individuals other than those identified                requirements on the permit itself.
                                                      removing the plant pest from the list of                on the permit application.                               (a) Packaging requirements. All
                                                      plant pests that may be imported into or                  (b) Notification of intent to hand-                  shipments must consist of an outer
                                                      move in interstate commerce within the                  carry. After the permittee has obtained                shipping container and at least two
                                                      continental United States without                       an import permit but no less than 20                   packages within the container. Both the


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                                                      7004                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      container and inner packages must be                    provisions of this subpart, other than for             supports or is capable of supporting
                                                      securely sealed to prevent the                          the inspection services of the inspector.              biotic communities.
                                                      dissemination of the enclosed plant                                                                            *     *    *     *    *
                                                      pests, biological control organisms, or                 Subpart—Movement of Soil, Stone,
                                                      associated articles.                                    and Quarry Products [Removed and                       § 352.2    [Amended]
                                                         (1) Outer shipping container. The                    Reserved]                                              ■ 17. In § 352.2, paragraph (a)
                                                      outer shipping container must be rigid,                                                                        introductory text, the first sentence is
                                                      impenetrable and durable enough to                      ■ 14. Subpart—Movement of Soil,
                                                                                                              Stone, and Quarry Products, §§ 330.300                 amended by removing the words ‘‘plant
                                                      remain closed and structurally intact in                                                                       pests, noxious weeds, soil,’’ and adding
                                                      the event of dropping, lateral impact                   through 330.302, is removed and
                                                                                                              reserved.                                              the words ‘‘plant pests, biological
                                                      with other objects, and other shocks                                                                           control organisms, noxious weeds, soil,’’
                                                      incidental to handling.                                 PART 352—PLANT QUARANTINE                              in their place, and by removing the
                                                         (2) Inner packages. The innermost                                                                           words ‘‘contain plant pests or noxious
                                                                                                              SAFEGUARD REGULATIONS
                                                      package or packages within the shipping                                                                        weeds’’ and adding the words ‘‘contain
                                                      container must contain all of the                       ■ 15. The authority citation continues to              plant pests, biological control
                                                      organisms or articles that will be moved.               read as follows:                                       organisms, or noxious weeds’’ in their
                                                      As a safeguard, the innermost package                                                                          place.
                                                                                                                Authority: 7 U.S.C. 7701–7772 and 7781–
                                                      must be placed within another, larger                   7786; 21 U.S.C. 136 and 136a; 31 U.S.C.
                                                      package. All packages within the                        9701; 7 CFR 2.22, 2.80, and 371.3.                     § 352.3    [Amended]
                                                      shipping container must be constructed                                                                         ■  18. In § 352.3, paragraph (a) is
                                                      or safeguarded so that they will remain                 ■ 16. In § 352.1, paragraph (b) is
                                                                                                              amended by adding, in alphabetical                     amended by adding the words
                                                      sealed and structurally intact                                                                                 ‘‘biological control organisms,’’ after the
                                                      throughout transit. The packages must                   order, definitions for biological control
                                                                                                              organism and noxious weed, and by                      words ‘‘plant pests,’’ each time they
                                                      be able to withstand changes in                                                                                occur.
                                                      pressure, temperature, and other                        revising the definitions for Deputy
                                                      climatic conditions incidental to                       Administrator, person, plant pest, and                 § 352.5    [Amended]
                                                      shipment.                                               soil to read as follows:
                                                                                                                                                                     ■ 19. Section 352.5 is amended by
                                                         (b) Packing material. Packing material                                                                      adding the words ‘‘biological control
                                                                                                              § 352.1    Definitions.
                                                      must be free of plant pests, noxious                                                                           organisms,’’ after the words ‘‘plant
                                                      weeds, or associated articles, and must                 *      *    *     *     *
                                                                                                                 (b) * * *                                           pests,’’ each time they occur.
                                                      be new, or must have been sterilized or
                                                      disinfected prior to reuse. Packing                        Biological control organism. Any                    § 352.6    [Amended]
                                                      material must be suited for the enclosed                enemy, antagonist, or competitor used
                                                                                                                                                                     ■ 20. Section 352.6 is amended as
                                                      organism or article, as well as any                     to control a plant pest or noxious weed.
                                                                                                                                                                     follows:
                                                      medium in which the organism or                         *      *    *     *     *                              ■ a. By removing footnote 2;
                                                      article will be maintained, and should                     Deputy Administrator. The Deputy
                                                                                                                                                                     ■ b. In paragraph (b), by removing the
                                                      not be capable of harboring or being a                  Administrator of the Plant Protection
                                                      means of the dissemination of the                                                                              words ‘‘as specified by’’ and adding the
                                                                                                              and Quarantine Programs or any
                                                      organism or article.2                                                                                          words ‘‘in accordance with’’ in their
                                                                                                              employee of the Plant Protection and
                                                         (c) Requirements following receipt of                                                                       place; and
                                                                                                              Quarantine Programs delegated to act in
                                                      the shipment at the point of destination.                                                                      ■ c. In paragraph (c), by removing the
                                                                                                              his or her stead.
                                                      (1) Packing material, including media                                                                          citation ‘‘§ 330.300(b)’’ and adding the
                                                                                                              *      *    *     *     *                              citation ‘‘§ 330.203’’ in its place.
                                                      and substrates, must be destroyed by                       Noxious weed. Any plant or plant
                                                      incineration, be decontaminated using                   product that can directly or indirectly                § 352.9    [Amended]
                                                      autoclaving or another approved                         injure or cause damage to crops
                                                      method, or otherwise be disposed of in                                                                         ■ 21. Section 352.9 is amended by
                                                                                                              (including nursery stock or plant                      adding the words ‘‘biological control
                                                      a manner specified in the permit itself.                products), livestock, poultry, or other
                                                         (2) Shipping containers may not be                                                                          organisms,’’ after the words ‘‘plant
                                                                                                              interests of agriculture, irrigation,                  pests,’’.
                                                      reused, except those that have been
                                                                                                              navigation, the natural resources of the
                                                      sterilized or disinfected prior to reuse.                                                                      § 352.10   [Amended]
                                                         (d) Costs. Permittees who fail to meet               United States, the public health, or the
                                                      the requirements of this section may be                 environment.                                           ■  22. Section 352.10 is amended as
                                                      held responsible for all costs incident to              *      *    *     *     *                              follows:
                                                      inspection, rerouting, repackaging,                        Person. Any individual, partnership,                ■ a. By redesignating footnote 3 as
                                                      subsequent movement, and any                            corporation, association, joint venture,               footnote 2;
                                                      treatments.                                             society, or other legal entity.                        ■ b. By removing the words ‘‘plant pest
                                                                                                                 Plant pest. Any living stage of any of              or noxious weed dissemination’’ each
                                                      § 330.207    Cost and charges.                          the following that can directly or                     time they occur and adding the words
                                                        The inspection services of APHIS                      indirectly injure, cause damage to, or                 ‘‘plant pest, noxious weed, or biological
                                                      inspectors during regularly assigned                    cause disease in any plant or plant                    control organism dissemination’’ in
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                                                      hours of duty and at the usual places of                product: A protozoan, nonhuman                         their place;
                                                      duty will be furnished without cost.                    animal, parasitic plant, bacterium,                    ■ c. In paragraph (b)(1), by adding the
                                                      APHIS will not be responsible for any                   fungus, virus or viroid, infectious agent              words ‘‘biological control organisms,’’
                                                      costs or charges incidental to                          or other pathogen, or any article similar              after the words ‘‘Prohibited or restricted
                                                      inspections or compliance with the                      to or allied with any of the above.                    plants, plant products, plant pests,’’;
                                                        2 Guidance regarding suitable outer shipping
                                                                                                              *      *    *     *     *                              ■ d. In paragraph (b)(2)(i), by adding the
                                                      containers, inner packages, and packaging is
                                                                                                                 Soil. The unconsolidated material                   words ‘‘or biological control
                                                      provided at http://www.aphis.usda.gov/                  from the earth’s surface that consists of              organisms,’’ after the words ‘‘plant
                                                      plant_health/permits/index.shtml.                       rock and mineral particles and that                    pests’’;


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                                 7005

                                                      ■ e. In paragraph (b)(2)(ii), by adding the             ‘‘biological control organisms,’’ after the            § 352.30   [Amended]
                                                      words ‘‘biological control organisms,’’                 words ‘‘plant pests,’’.                                ■ 25. Section 352.30 is amended by
                                                      after the words ‘‘plant pests,’’; and                                                                          redesignating footnotes 4 and 5 as
                                                      ■ f. In paragraph (b)(2)(iv), by removing               § 352.13    [Amended]                                  footnotes 3 and 4, respectively.
                                                      the words ‘‘plant pest dispersal’’ and                  ■ 24. Section 352.13 is amended by                       Done in Washington, DC, this 6th day of
                                                      adding the words ‘‘plant pest or                        adding the words ‘‘biological control                  January 2017.
                                                      biological control organism dispersal’’                 organisms,’’ after the words ‘‘plant                   David Howard,
                                                      in their place.
                                                                                                              pests,’’.                                              Acting Deputy Under Secretary for Marketing
                                                      § 352.11   [Amended]                                                                                           and Regulatory Programs.
                                                      ■23. In § 352.11, paragraph (a)(1) is                                                                          [FR Doc. 2017–00532 Filed 1–18–17; 8:45 am]
                                                      amended by adding the words                                                                                    BILLING CODE 3410–34–P
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Document Created: 2018-02-01 15:16:09
Document Modified: 2018-02-01 15:16:09
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; withdrawal and reproposal.
DatesWe will consider all comments that we receive on or before March 20, 2017.
ContactDr. Colin D. Stewart, Assistant Director; Pests, Pathogens, and Biocontrol Permits Branch, Plant Health Programs, PPQ, APHIS, 4700 River Road, Unit 133, Riverdale, MD 20737- 1236; (301) 851-2237.
FR Citation82 FR 6980 
RIN Number0579-AC98
CFR Citation7 CFR 318
7 CFR 319
7 CFR 330
7 CFR 352
CFR AssociatedCotton; Cottonseeds; Fruits; Guam; Hawaii; Plant Diseases and Pests; Puerto Rico; Quarantine; Transportation; Vegetables; Virgin Islands; Coffee; Imports; Logs; Nursery Stock; Reporting and Recordkeeping Requirements; Rice and Customs Duties and Inspection

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