81_FR_6249 81 FR 6225 - Environmental Impact Statement; Introduction of the Products of Biotechnology

81 FR 6225 - Environmental Impact Statement; Introduction of the Products of Biotechnology

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 81, Issue 24 (February 5, 2016)

Page Range6225-6229
FR Document2016-02247

We are advising the public that the Animal and Plant Health Inspection Service (APHIS) plans to prepare a programmatic environmental impact statement in connection with potential changes to the regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered organisms. This notice identifies reasonable alternatives and potential issues to be evaluated in the environmental impact statement and requests public comments to further define the scope of the alternatives and environmental impacts and issues for APHIS to consider.

Federal Register, Volume 81 Issue 24 (Friday, February 5, 2016)
[Federal Register Volume 81, Number 24 (Friday, February 5, 2016)]
[Notices]
[Pages 6225-6229]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-02247]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2014-0054]


Environmental Impact Statement; Introduction of the Products of 
Biotechnology

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice of intent to prepare an environmental impact statement.

-----------------------------------------------------------------------

SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service (APHIS) plans to prepare a programmatic 
environmental impact statement in connection with potential changes to 
the regulations regarding the importation, interstate movement, and 
environmental release of certain genetically engineered organisms. This 
notice identifies reasonable alternatives and potential issues to be 
evaluated in the environmental impact statement and requests public 
comments to further define the scope of the alternatives and 
environmental impacts and issues for APHIS to consider.

DATES: We will consider all comments that we receive on or before March 
7, 2016.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0054.
     Postal Mail/Commercial Delivery: Send your comments to 
Docket No. APHIS-2014-0054, 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-2014-
0054 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: Sidney W. Abel, Assistant Deputy

[[Page 6226]]

Administrator, Biotechnology Regulatory Services, APHIS, 4700 River 
Road Unit 147, Riverdale, MD 20737-1236; (301) 851-3943.

SUPPLEMENTARY INFORMATION:

Background

    The Plant Protection Act (PPA) authorizes the Animal and Plant 
Health Inspection Service (APHIS) to protect plant health in the United 
States. Under that authority, APHIS currently regulates the 
introduction (movement into the United States or interstate, or release 
into the environment) of genetically engineered (GE) organisms that may 
present a plant pest risk through its regulations in 7 CFR part 340, 
``Introduction of Organisms and Products Altered or Produced Through 
Genetic Engineering Which Are Plant Pests or Which There Is Reason to 
Believe Are Plant Pests.'' These regulations are intended to protect 
against plant pest risks to plant health by providing for the safe 
importation, interstate movement, or release into the environment of 
certain GE organisms.
    APHIS' regulation of certain GE organisms to protect plant health 
is aligned with the Federal Coordinated Framework for the Regulation of 
Biotechnology (henceforth referred to as the Coordinated Framework), 
the comprehensive Federal regulatory policy for ensuring the safety of 
biotechnology research and products in the United States. The 
Coordinated Framework describes how Federal agencies will use existing 
Federal statutes to ensure public health and environmental safety while 
maintaining regulatory flexibility to avoid impeding the growth of the 
biotechnology industry. The Coordinated Framework sets forth a risk-
based, scientifically sound basis for the oversight of activities that 
introduce biotechnology products into the environment and describes the 
roles and responsibilities for the three major Federal agencies 
involved in regulating biotechnology products: APHIS, the Environmental 
Protection Agency (EPA), and the Food and Drug Administration (FDA). 
Currently, the Federal agencies are in the process of working with the 
Executive Office of the President to modernize a number of Coordinated 
Framework issues and activities; that effort is distinct from and 
entirely compatible with APHIS' effort to revise its biotechnology 
regulations at 7 CFR part 340. This notice only addresses proposed 
changes to the APHIS regulations. It is not intended to circumscribe, 
restrict, or otherwise preclude future actions taken under other 
Federal statutes and their respective authorities.
    During the past 28 years of APHIS' regulation of certain GE 
organisms pursuant to the PPA and 7 CFR part 340, advances in 
biotechnology and new issues raised by a range of stakeholders have 
emerged. Over this period, APHIS has also gained considerable 
experience in assessing the plant pest and noxious weed risks of GE 
organisms. Our evaluations of any potential plant pest risks of APHIS 
regulated GE organisms have included assessments of weediness of the 
regulated article or other plants with which it can interbreed. 
Accordingly, APHIS is considering amending the 7 CFR part 340 
regulations pertaining to introductions of certain GE organisms to 
address the advances in biotechnology and the new issues raised by 
stakeholders. This update to APHIS' biotechnology regulations will 
increase the efficiency and precision of our regulations. The proposed 
revisions would align the range of potential risks that may be 
considered under APHIS' regulations in 7 CFR part 340 with both the 
plant pest and noxious weed authorities of the PPA, to ensure a high 
level of environmental protection pursuant to APHIS' PPA authorities to 
regulate plant pest and noxious weeds, improve regulatory processes so 
that they are more transparent to stakeholders and the public, and 
provide regulatory relief to the extent possible so that unnecessary 
regulatory burdens are eliminated. Changes to the regulations would 
ensure that the Agency can continue to effectively regulate the 
products of biotechnology that may pose plant pest or noxious weed 
risks to U.S. agriculture and the environment.
    In our current regulations found at 7 CFR part 340, APHIS defines 
the term ``genetically engineered organisms'' to mean organisms that 
have been genetically modified by recombinant DNA techniques.
    The following terms are defined by the Plant Protection Act (7 
U.S.C. 7701-7772):
    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.
    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. 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.
    Under the provisions of the National Environmental Policy Act of 
1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), Federal agencies must 
examine the potential environmental impacts of proposed Federal actions 
and alternatives. We are planning to prepare a programmatic 
environmental impact statement (EIS) in connection with the proposed 
revisions and amendments to APHIS' biotechnology regulations that are 
being considered. Aspects of the human environment that may be 
potentially affected by such proposed regulatory revisions and 
amendments that we have preliminarily identified for evaluation in the 
EIS will include: Potential impacts on U.S. agriculture and forestry 
production (e.g., conventional, biotechnology-based, and organic); 
potential impacts on current and potential future uses of products of 
biotechnology in agriculture and forestry; agronomic practices employed 
in biotechnology crop production that may have environmental 
consequences or impacts (i.e., tillage, crop rotation, and agronomic 
inputs); potential impacts on aspects of the physical environment that 
include soil quality, water resources, air quality, and climate change; 
potential impacts on aspects of the biological environment such as 
animal and plant communities, weed and insect resistance to herbicides 
and insecticides (respectively), the potential gene flow and weediness 
of regulated GE crop plants, and biodiversity; potential impacts on 
consumer health and agricultural worker safety; animal feed and health; 
and socioeconomic considerations, to include potential impacts of 
regulated GE crop plants on the domestic economic environment, 
international trade, and coexistence among all forms of U.S. 
agriculture, conventional, biotechnology-based, and organic, in 
providing market demand for food, feed, fiber, and fuel.
    This notice describes the range of proposed reasonable alternatives 
that are currently under consideration for evaluation in the EIS and 
the issues that will be evaluated in the EIS, and requests public 
comment to further define the issues and scope of the EIS' 
alternatives. We are also requesting public comment to help us identify

[[Page 6227]]

other environmental issues that should be examined in the EIS.
    The EIS will be prepared in accordance with: (1) NEPA, (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).
    In considering the envisioned revisions to 7 CFR part 340, APHIS 
has preliminarily identified possible new definitions to be used in its 
proposed part 340 biotechnology regulations for consideration and 
analysis in the EIS:
    Biotechnology. Laboratory-based techniques to create or modify a 
genome that result in a viable organism with intended altered 
phenotypes. Such techniques include, but are not limited to, deleting 
specific segments of the genome, adding segments to the genome, 
directed altering of the genome, creating additional genomes, or direct 
injection and cell fusion beyond the taxonomic family that overcomes 
natural physiological reproductive or recombination barriers. This 
definition does not include and is intended not to include traditional 
breeding, marker assisted breeding, or chemical or radiation-based 
mutagenesis.
    Product of biotechnology. An organism developed using 
biotechnology.
    Regulated organism. An organism developed using biotechnology that 
poses plant pest or noxious weed risks as documented in an APHIS risk 
analysis that APHIS has determined to regulate.
    APHIS is considering, and invites public input on, these proposed 
definitions. Such input should address APHIS' regulatory objectives to 
safeguard agricultural plants and agriculturally important natural 
resources from plant pest or noxious weed damage (biological, chemical, 
or physical) caused by a ``product of biotechnology,'' including its 
potential, or lack of potential to pose plant pest or noxious weed 
risks.
    These proposed definitions will be used in the four proposed 
alternatives that are proposed to be examined in the EIS. These 
proposed alternatives are:
    First Alternative: Take no action. Under this ``no action'' 
alternative, APHIS would make no changes to the existing 7 CFR part 340 
regulations for certain GE organisms that pose a potential plant pest 
risk and APHIS would continue to regulate certain GE organisms as it 
does today. APHIS would not revise its current regulations to add the 
definitions outlined above. The No Action alternative represents the 
baseline against which the proposed revisions to the regulations will 
be compared.
    Second Alternative: Revise the current APHIS regulations concerning 
the introduction of certain GE organisms to provide for a process to 
review and regulate certain products of biotechnology to protect plant 
health; analyze potential plant pest and/or noxious weed risks first; 
and thereafter regulate only when appropriate and necessary.
    Under this alternative, APHIS would revise its current regulations 
to implement a two-step process that would ensure a thorough review of 
a product of biotechnology's potential to pose plant health risks 
(plant pest and/or noxious weed)--analyze such plant health risks first 
and only thereafter determine the use of any regulatory action as 
appropriate and needed. Such a two-step process will enable the agency 
to consider and place risk-appropriate regulatory controls on the 
importation, movement, or ``outdoor'' use of those products that are 
determined by the agency to pose actual plant pest or noxious weed 
risks (regulate only when APHIS has determined that certain plant 
health risks are appropriate and necessary to require some regulatory 
action to be taken and implemented).
    Analyze First: APHIS would use established and delineated criteria 
to identify certain products of biotechnology for which the Agency 
would conduct a review process. The Agency's review process would be 
used to determine whether the product of biotechnology poses an actual 
documented plant pest or noxious weed risk and should therefore be 
regulated. The criteria that would ``trigger'' the Agency's review 
process are those which would indicate the potential for the product of 
biotechnology to pose documented plant pest or noxious weed risks, and 
may include:
    1. Whether the recipient organism is a biocontrol organism, a 
microorganism that has been modified for altered plant-microbe 
interactions, or a plant; and
    2. Whether the product of biotechnology's donor or recipient 
organism, or the vector used in its development meet the definition of 
a plant pest, is included in the list of plant pest taxa, or is unknown 
or unclassified.
    APHIS is considering, and invites public input, on these two 
proposed regulatory review criteria and also invites public input on 
proposing other possible regulatory review criteria for APHIS' 
consideration.
    It is important that the public be aware that the Coordinated 
Framework has consistently held and proceeded pursuant to the concept 
and position that the process of genetic modification has not been 
shown to be inherently dangerous. The Executive Office of the President 
has, through the Coordinated Framework, underscored the importance of a 
risk based, scientifically sound, flexible regulatory approach that 
balances regulatory oversight with the need to avoid impeding 
biotechnology research and innovation. With that in mind, APHIS is 
considering and would like public input on potential justifiable 
exceptions or exemptions that would exclude certain ``products of 
biotechnology'' from APHIS' regulatory review and oversight because 
they lack the realistic potential to pose documented plant pest or 
noxious weed risks. For example, some possible candidates to be 
exempted from regulation might be:
    a. Plant products of biotechnology in which the genetic 
modification was obtained through a process of biotechnology including 
nucleotide deletions, single base pair substitutions, or other 
modifications that could reasonably be expected to be obtained through 
mutagenic techniques that have commonly been used for plant development 
since the early 1900s.
    b. Insects which are not plant pests transformed using the PiggyBac 
transposon, but not otherwise containing sequences from plant pests.
    Those products of biotechnology which APHIS determines do meet the 
proposed criteria 1 and 2 listed above and will not be exempted, would 
undergo a regulatory review. This regulatory review would employ a 
plant pest and/or noxious weed risk analysis process to determine 
whether the product of biotechnology poses either a plant pest or 
noxious weed risk, and therefore would be a regulated organism as 
defined above.
    Regulate When Necessary: Once the review process is completed by 
the Agency, the importation, interstate movement or ``outdoor'' use of 
those products of biotechnology that were determined to pose plant pest 
or noxious weed risks, as documented and confirmed in an APHIS risk 
analysis, would be subject to APHIS regulatory controls that ensure the 
protection of plant health. The regulatory control would typically be 
the issuance of permits with risk-appropriate conditions to mitigate 
risks.
    Under this second alternative, APHIS proposes to eliminate the 
notification

[[Page 6228]]

procedure (currently 7 CFR 340.3), as APHIS anticipates that many GE 
organisms currently regulated under the notification procedures would 
not be regulated nor subject to further review under this alternative.
    Under this alternative, APHIS also proposes to eliminate the 
current petition process for non-regulated status (currently 7 CFR 
340.6), as APHIS will conduct new risk analyses consistent with the 
``analyze first, regulate when necessary'' when new information is made 
available.
    Under this second alternative, APHIS is considering whether or how 
products of biotechnology that are developed for pharmaceutical or 
industrial purposes would be regulated under the proposed revised 
regulations. APHIS appreciates that there are aspects of its regulatory 
program that are well suited to address these types of products, and 
would like public input on how public health and safety objectives 
might be achieved for pharmaceutical or industrial products of 
biotechnology that would pose plant pest or noxious weed risks.
    Third Alternative: Revise the current APHIS regulations concerning 
the introduction of certain GE organisms to provide for the regulation 
of ``products of biotechnology'' as either plant pests or noxious weeds 
using the existing plant pest ``analysis trigger'' or a noxious weed 
``analysis trigger'' that might classify plants produced through 
biotechnology as potential plant pests or noxious weeds.
    Under this third alternative, APHIS' proposed regulations would 
substantially increase oversight and resources over those currently 
used to regulate GE organisms. APHIS would not exempt certain 
``products of biotechnology'' from APHIS regulatory oversight if a 
``product of biotechnology'' was developed using a plant pest; or, if 
it posed a risk as a noxious weed pursuant to the PPA definition of a 
noxious weed. Introductions of products of biotechnology that posed a 
plant pest risk or noxious weed risk would require a permit and 
conditions would be applied for import, interstate movement, or 
``outdoor'' use.
    Under this third alternative, APHIS' proposed regulatory scheme 
would include the range of actions and processes that would enable 
APHIS to become, to the extent permitted by its PPA authorities, an 
all-encompassing, wide-scale regulatory permitting authority but still 
fully comply with the Coordinated Framework and support the continued 
development of products of biotechnology. APHIS would use its plant 
pest and/or noxious weed risk analyses to inform the establishment of 
appropriate permit conditions to protect agricultural plants and 
agriculturally important natural resources. For example, APHIS' 
proposed regulatory scheme under this alterative would evaluate and 
consider agricultural and mitigation practices such as crop exclusion 
zones, risk appropriate isolation distances, or other measures that 
would address and mitigate ``damage'' as included in the PPA definition 
of a noxious weed (e.g., direct or indirect damage to crops or other 
interests of agriculture). APHIS requests and would appreciate public 
input on these practices or others that might be appropriate for this 
third alternative.
    Under this third alternative, APHIS' proposed regulatory scheme 
would also eliminate the notification (currently 7 CFR 340.3) and 
petition procedures (currently 7 CFR 340.6) since this alternative's 
regulatory scheme would propose that all ``products of biotechnology'' 
that are plants and are captured by the existing plant pest or noxious 
weed ``analysis triggers,'' as defined by the PPA, and currently used 
and applied by APHIS pursuant to the regulations in 7 CFR parts 340 and 
360, would require a permit to enable the agency to establish risk 
appropriate conditions. APHIS would appreciate public input on its 
proposal, under this alternative, to eliminate notifications and 
petitions.
    Fourth Alternative: Withdraw the current 7 CFR part 340 regulations 
completely and implement a voluntary, non-regulatory consultative 
process for certain products of biotechnology whereby APHIS would 
document plant pest or noxious weed risks, if any, of certain products 
of biotechnology as defined above.
    Under this fourth alternative, developers would be responsible for 
ensuring that their respective products of biotechnology do not pose 
risks as a plant pest or noxious weed pursuant to their respective PPA 
definitions, and that their activities related to the importation, 
interstate movement, or release into the environment of their 
respective products of biotechnology are not in violation of any 
existing statutes or Federal regulations that relate to plant pests or 
noxious weeds.
    Under this fourth alternative, APHIS would not have a dedicated 
regulatory scheme to specifically regulate any products of 
biotechnology that may pose plant pest or noxious weed risks and 
therefore would not require consultation nor prescribe methods or 
practices related to any products of biotechnology. Any products of 
biotechnology that pose plant pests or noxious weed risks would be 
managed by APHIS using its other existing regulations pursuant to the 
PPA; e.g., 7 CFR parts 330 and 360. Those existing APHIS regulations 
relating to plant pests or noxious weeds, would be used as applicable 
to regulate any products of biotechnology, but would regulate them 
under their respective current regulatory schemes. Thus this 
alternative would be using a very different scheme than the current 7 
CFR part 340 or the regulatory schemes proposed in the second and third 
EIS alternatives since APHIS would not plan on revising, amending, or 
requiring any regulatory changes to 7 CFR parts 330 and/or 360 to 
address plant pest or noxious weed risks specifically related to 
products of biotechnology. However, APHIS would maintain expertise in 
regulating the products of biotechnology pursuant to its PPA plant pest 
and noxious weed risks and create a non-regulatory program providing 
voluntary, non-regulatory consultative services to provide developers 
with Federal support and services intended to facilitate importation, 
interstate movement or ``outdoor'' use of products of biotechnology 
that do not present PPA plant pest or noxious weed risks. Under this 
fourth alternative and approach, APHIS would provide, upon request for 
consultation, for an analysis of PPA plant pest or noxious weed risks 
as part of it routine and continuing operations, and such analyses 
might facilitate the commercialization of the products of biotechnology 
by providing an objective analysis of plant pest or noxious weed risks 
using APHIS risk analysis processes that document a scientific review 
of the literature and findings related to plant pest or noxious weed 
risks. APHIS would appreciate public input on its proposal, under this 
alternative.
    APHIS is requesting comments and information related to the topics 
and issues presented in this notice so that the scope of the analysis 
in the draft EIS, including the types and range of reasonable 
alternatives, is reasonable and appropriate, and proposed revisions to 
7 CFR part 340 are well-evaluated. Public input will be helpful in 
further defining the scope of the issues and reasonable alternatives 
under consideration. A notice will be published in the Federal Register 
to announce the availability of a draft EIS when it is issued and to 
invite the public to provide comments on it.


[[Page 6229]]


    Done in Washington, DC, this 1st day of February 2016.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2016-02247 Filed 2-4-16; 8:45 am]
BILLING CODE 3410-34-P



                                                                                                                                                                                                   6225

                                                  Notices                                                                                                       Federal Register
                                                                                                                                                                Vol. 81, No. 24

                                                                                                                                                                Friday, February 5, 2016



                                                  This section of the FEDERAL REGISTER                    displays a currently valid OMB control                DEPARTMENT OF AGRICULTURE
                                                  contains documents other than rules or                  number and the agency informs
                                                  proposed rules that are applicable to the               potential persons who are to respond to               Animal and Plant Health Inspection
                                                  public. Notices of hearings and investigations,                                                               Service
                                                                                                          the collection of information that such
                                                  committee meetings, agency decisions and
                                                  rulings, delegations of authority, filing of            persons are not required to respond to                [Docket No. APHIS–2014–0054]
                                                  petitions and applications and agency                   the collection of information unless it
                                                  statements of organization and functions are            displays a currently valid OMB control                Environmental Impact Statement;
                                                  examples of documents appearing in this                 number.                                               Introduction of the Products of
                                                  section.                                                                                                      Biotechnology
                                                                                                          Agricultural Research Service
                                                                                                                                                                AGENCY:  Animal and Plant Health
                                                  DEPARTMENT OF AGRICULTURE                                  Title: Electronic Mailing List                     Inspection Service, USDA.
                                                                                                          Subscription Form—Nutrition and Food                  ACTION: Notice of intent to prepare an
                                                  Agricultural Research Service                           Safety.                                               environmental impact statement.
                                                                                                             Omb Control Number: 0518–0036.
                                                  Submission for OMB Review;                                                                                    SUMMARY:   We are advising the public
                                                  Comment Request                                            Summary of Collection: The National                that the Animal and Plant Health
                                                                                                          Agricultural Library’s Food and                       Inspection Service (APHIS) plans to
                                                  February 1, 2016.                                       Nutrition Information Center (FNIC)                   prepare a programmatic environmental
                                                    The Department of Agriculture has                     currently maintains several on-line                   impact statement in connection with
                                                  submitted the following information                     ‘‘discussion groups.’’ This voluntary                 potential changes to the regulations
                                                  collection requirement(s) to OMB for                    ‘‘Electronic Mailing List Subscription                regarding the importation, interstate
                                                  review and clearance under the                          Form’’ gives individuals working in the               movement, and environmental release
                                                  Paperwork Reduction Act of 1995,                        area of nutrition and food safety an                  of certain genetically engineered
                                                  Public Law 104–13. Comments are                                                                               organisms. This notice identifies
                                                                                                          opportunity to participate in these
                                                  requested regarding (1) whether the                                                                           reasonable alternatives and potential
                                                                                                          groups. Data collected using this form
                                                  collection of information is necessary                                                                        issues to be evaluated in the
                                                                                                          will help FNIC determine a person’s
                                                  for the proper performance of the                                                                             environmental impact statement and
                                                  functions of the agency, including                      eligibility to participate in these
                                                                                                          discussion groups. The authority for the              requests public comments to further
                                                  whether the information will have                                                                             define the scope of the alternatives and
                                                  practical utility; (2) the accuracy of the              National Agricultural Library (NAL) to
                                                                                                          collect this information is contained in              environmental impacts and issues for
                                                  agency’s estimate of burden including                                                                         APHIS to consider.
                                                  the validity of the methodology and                     the CFR, Title 7, Volume 1, Part 2, and
                                                                                                                                                                DATES: We will consider all comments
                                                  assumptions used; (3) ways to enhance                   Subpart K, Sec. 2.65 (92).
                                                                                                                                                                that we receive on or before March 7,
                                                  the quality, utility and clarity of the                    Need and Use of the Information:                   2016.
                                                  information to be collected; and (4)                    FNIC will collect the name, email
                                                  ways to minimize the burden of the                                                                            ADDRESSES: You may submit comments
                                                                                                          address, job title, employer, mailing
                                                  collection of information on those who                                                                        by either of the following methods:
                                                                                                          address and telephone number in order                    • Federal eRulemaking Portal: Go to
                                                  are to respond, including through the                   to approve subscriptions for nutrition
                                                  use of appropriate automated,                                                                                 http://www.regulations.gov/#!docket
                                                                                                          and food safety on-line discussion                    Detail;D=APHIS-2014-0054.
                                                  electronic, mechanical, or other                        groups. Failure to collect this
                                                  technological collection techniques or                                                                           • Postal Mail/Commercial Delivery:
                                                                                                          information would inhibit FNIC’s ability              Send your comments to Docket No.
                                                  other forms of information technology.                  to provide subscription services to these
                                                    Comments regarding this information                                                                         APHIS–2014–0054, Regulatory Analysis
                                                                                                          discussion groups.                                    and Development, PPD, APHIS, Station
                                                  collection received by March 7, 2016
                                                  will be considered. Written comments                       Description of Respondents:                        3A–03.8, 4700 River Road Unit 118,
                                                  should be addressed to: Desk Officer for                Individuals or households; State, Local               Riverdale, MD 20737–1238.
                                                  Agriculture, Office of Information and                  and Tribal Governments.                                  Supporting documents and any
                                                  Regulatory Affairs, Office of                                                                                 comments we receive on this docket
                                                                                                             Number of Respondents: 1,000.                      may be viewed at http://www.
                                                  Management and Budget (OMB), New
                                                  Executive Office Building, 725 17th                        Frequency of Responses: Reporting:                 regulations.gov/#!docketDetail;D=
                                                  Street NW., Washington, DC 20502.                       Annually.                                             APHIS-2014-0054 or in our reading
                                                  Commenters are encouraged to submit                        Total Burden Hours: 17.                            room, which is located in room 1141 of
                                                  their comments to OMB via email to:                                                                           the USDA South Building, 14th Street
                                                  OIRA_Submission@OMB.EOP.GOV or
                                                                                                          Ruth Brown,                                           and Independence Avenue SW.,
                                                                                                          Departmental Information Collection                   Washington, DC. Normal reading room
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                  fax (202) 395–5806 and to Departmental
                                                  Clearance Office, USDA, OCIO, Mail                      Clearance Officer.                                    hours are 8 a.m. to 4:30 p.m., Monday
                                                  Stop 7602, Washington, DC 20250–                        [FR Doc. 2016–02211 Filed 2–4–16; 8:45 am]            through Friday, except holidays. To be
                                                  7602. Copies of the submission(s) may                   BILLING CODE 3410–03–P
                                                                                                                                                                sure someone is there to help you,
                                                  be obtained by calling (202) 720–8958.                                                                        please call (202) 799–7039 before
                                                    An agency may not conduct or                                                                                coming.
                                                  sponsor a collection of information                                                                           FOR FURTHER INFORMATION CONTACT:
                                                  unless the collection of information                                                                          Sidney W. Abel, Assistant Deputy


                                             VerDate Sep<11>2014   18:22 Feb 04, 2016   Jkt 238001   PO 00000   Frm 00001   Fmt 4703   Sfmt 4703   E:\FR\FM\05FEN1.SGM   05FEN1


                                                  6226                           Federal Register / Vol. 81, No. 24 / Friday, February 5, 2016 / Notices

                                                  Administrator, Biotechnology                            other Federal statutes and their                         B. A nonhuman animal.
                                                  Regulatory Services, APHIS, 4700 River                  respective authorities.                                  C. A parasitic plant.
                                                  Road Unit 147, Riverdale, MD 20737–                        During the past 28 years of APHIS’                    D. A bacterium.
                                                  1236; (301) 851–3943.                                   regulation of certain GE organisms                       E. A fungus.
                                                  SUPPLEMENTARY INFORMATION:                              pursuant to the PPA and 7 CFR part 340,                  F. A virus or viroid.
                                                                                                          advances in biotechnology and new                        G. An infectious agent or other
                                                  Background                                              issues raised by a range of stakeholders              pathogen.
                                                     The Plant Protection Act (PPA)                       have emerged. Over this period, APHIS                    H. Any article similar to or allied with
                                                  authorizes the Animal and Plant Health                  has also gained considerable experience               any of the articles specified in the
                                                  Inspection Service (APHIS) to protect                   in assessing the plant pest and noxious               preceding subparagraphs.
                                                  plant health in the United States. Under                weed risks of GE organisms. Our                          Under the provisions of the National
                                                  that authority, APHIS currently                         evaluations of any potential plant pest               Environmental Policy Act of 1969
                                                  regulates the introduction (movement                    risks of APHIS regulated GE organisms                 (NEPA), as amended (42 U.S.C. 4321 et
                                                  into the United States or interstate, or                have included assessments of weediness                seq.), Federal agencies must examine
                                                  release into the environment) of                        of the regulated article or other plants              the potential environmental impacts of
                                                  genetically engineered (GE) organisms                   with which it can interbreed.                         proposed Federal actions and
                                                  that may present a plant pest risk                      Accordingly, APHIS is considering                     alternatives. We are planning to prepare
                                                  through its regulations in 7 CFR part                   amending the 7 CFR part 340                           a programmatic environmental impact
                                                  340, ‘‘Introduction of Organisms and                    regulations pertaining to introductions               statement (EIS) in connection with the
                                                  Products Altered or Produced Through                    of certain GE organisms to address the                proposed revisions and amendments to
                                                  Genetic Engineering Which Are Plant                     advances in biotechnology and the new                 APHIS’ biotechnology regulations that
                                                                                                          issues raised by stakeholders. This
                                                  Pests or Which There Is Reason to                                                                             are being considered. Aspects of the
                                                                                                          update to APHIS’ biotechnology
                                                  Believe Are Plant Pests.’’ These                                                                              human environment that may be
                                                                                                          regulations will increase the efficiency
                                                  regulations are intended to protect                                                                           potentially affected by such proposed
                                                                                                          and precision of our regulations. The
                                                  against plant pest risks to plant health                                                                      regulatory revisions and amendments
                                                                                                          proposed revisions would align the
                                                  by providing for the safe importation,                                                                        that we have preliminarily identified for
                                                                                                          range of potential risks that may be
                                                  interstate movement, or release into the                                                                      evaluation in the EIS will include:
                                                                                                          considered under APHIS’ regulations in
                                                  environment of certain GE organisms.                                                                          Potential impacts on U.S. agriculture
                                                                                                          7 CFR part 340 with both the plant pest
                                                     APHIS’ regulation of certain GE                                                                            and forestry production (e.g.,
                                                                                                          and noxious weed authorities of the
                                                  organisms to protect plant health is                                                                          conventional, biotechnology-based, and
                                                                                                          PPA, to ensure a high level of
                                                  aligned with the Federal Coordinated                    environmental protection pursuant to                  organic); potential impacts on current
                                                  Framework for the Regulation of                         APHIS’ PPA authorities to regulate plant              and potential future uses of products of
                                                  Biotechnology (henceforth referred to as                pest and noxious weeds, improve                       biotechnology in agriculture and
                                                  the Coordinated Framework), the                         regulatory processes so that they are                 forestry; agronomic practices employed
                                                  comprehensive Federal regulatory                        more transparent to stakeholders and                  in biotechnology crop production that
                                                  policy for ensuring the safety of                       the public, and provide regulatory relief             may have environmental consequences
                                                  biotechnology research and products in                  to the extent possible so that                        or impacts (i.e., tillage, crop rotation,
                                                  the United States. The Coordinated                      unnecessary regulatory burdens are                    and agronomic inputs); potential
                                                  Framework describes how Federal                         eliminated. Changes to the regulations                impacts on aspects of the physical
                                                  agencies will use existing Federal                      would ensure that the Agency can                      environment that include soil quality,
                                                  statutes to ensure public health and                    continue to effectively regulate the                  water resources, air quality, and climate
                                                  environmental safety while maintaining                  products of biotechnology that may pose               change; potential impacts on aspects of
                                                  regulatory flexibility to avoid impeding                plant pest or noxious weed risks to U.S.              the biological environment such as
                                                  the growth of the biotechnology                         agriculture and the environment.                      animal and plant communities, weed
                                                  industry. The Coordinated Framework                        In our current regulations found at 7              and insect resistance to herbicides and
                                                  sets forth a risk-based, scientifically                 CFR part 340, APHIS defines the term                  insecticides (respectively), the potential
                                                  sound basis for the oversight of                        ‘‘genetically engineered organisms’’ to               gene flow and weediness of regulated
                                                  activities that introduce biotechnology                 mean organisms that have been                         GE crop plants, and biodiversity;
                                                  products into the environment and                       genetically modified by recombinant                   potential impacts on consumer health
                                                  describes the roles and responsibilities                DNA techniques.                                       and agricultural worker safety; animal
                                                  for the three major Federal agencies                       The following terms are defined by                 feed and health; and socioeconomic
                                                  involved in regulating biotechnology                    the Plant Protection Act (7 U.S.C. 7701–              considerations, to include potential
                                                  products: APHIS, the Environmental                      7772):                                                impacts of regulated GE crop plants on
                                                  Protection Agency (EPA), and the Food                      Noxious weed: Any plant or plant                   the domestic economic environment,
                                                  and Drug Administration (FDA).                          product that can directly or indirectly               international trade, and coexistence
                                                  Currently, the Federal agencies are in                  injure or cause damage to crops                       among all forms of U.S. agriculture,
                                                  the process of working with the                         (including nursery stock or plant                     conventional, biotechnology-based, and
                                                  Executive Office of the President to                    products), livestock, poultry, or other               organic, in providing market demand for
                                                  modernize a number of Coordinated                       interests of agriculture, irrigation,                 food, feed, fiber, and fuel.
                                                  Framework issues and activities; that                   navigation, the natural resources of the                 This notice describes the range of
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                                                  effort is distinct from and entirely                    United States, the public health, or the              proposed reasonable alternatives that
                                                  compatible with APHIS’ effort to revise                 environment.                                          are currently under consideration for
                                                  its biotechnology regulations at 7 CFR                     Plant pest: Any living stage of any of             evaluation in the EIS and the issues that
                                                  part 340. This notice only addresses                    the following that can directly or                    will be evaluated in the EIS, and
                                                  proposed changes to the APHIS                           indirectly injure, cause damage to, or                requests public comment to further
                                                  regulations. It is not intended to                      cause disease in any plant or plant                   define the issues and scope of the EIS’
                                                  circumscribe, restrict, or otherwise                    product:                                              alternatives. We are also requesting
                                                  preclude future actions taken under                        A. A protozoan.                                    public comment to help us identify


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                                                                                 Federal Register / Vol. 81, No. 24 / Friday, February 5, 2016 / Notices                                            6227

                                                  other environmental issues that should                  to add the definitions outlined above.                possible regulatory review criteria for
                                                  be examined in the EIS.                                 The No Action alternative represents the              APHIS’ consideration.
                                                    The EIS will be prepared in                           baseline against which the proposed                      It is important that the public be
                                                  accordance with: (1) NEPA, (2)                          revisions to the regulations will be                  aware that the Coordinated Framework
                                                  regulations of the Council on                           compared.                                             has consistently held and proceeded
                                                  Environmental Quality for                                  Second Alternative: Revise the current             pursuant to the concept and position
                                                  implementing the procedural provisions                  APHIS regulations concerning the                      that the process of genetic modification
                                                  of NEPA (40 CFR parts 1500–1508), (3)                   introduction of certain GE organisms to               has not been shown to be inherently
                                                  USDA regulations implementing NEPA                      provide for a process to review and                   dangerous. The Executive Office of the
                                                  (7 CFR part 1b), and (4) APHIS’ NEPA                    regulate certain products of                          President has, through the Coordinated
                                                  Implementing Procedures (7 CFR part                     biotechnology to protect plant health;                Framework, underscored the
                                                  372).                                                   analyze potential plant pest and/or                   importance of a risk based, scientifically
                                                    In considering the envisioned                         noxious weed risks first; and thereafter              sound, flexible regulatory approach that
                                                  revisions to 7 CFR part 340, APHIS has                  regulate only when appropriate and                    balances regulatory oversight with the
                                                  preliminarily identified possible new                   necessary.                                            need to avoid impeding biotechnology
                                                  definitions to be used in its proposed                     Under this alternative, APHIS would                research and innovation. With that in
                                                  part 340 biotechnology regulations for                  revise its current regulations to                     mind, APHIS is considering and would
                                                  consideration and analysis in the EIS:                  implement a two-step process that                     like public input on potential justifiable
                                                    Biotechnology. Laboratory-based                                                                             exceptions or exemptions that would
                                                                                                          would ensure a thorough review of a
                                                  techniques to create or modify a genome                                                                       exclude certain ‘‘products of
                                                                                                          product of biotechnology’s potential to
                                                  that result in a viable organism with                                                                         biotechnology’’ from APHIS’ regulatory
                                                                                                          pose plant health risks (plant pest and/
                                                  intended altered phenotypes. Such                                                                             review and oversight because they lack
                                                                                                          or noxious weed)—analyze such plant
                                                  techniques include, but are not limited                                                                       the realistic potential to pose
                                                                                                          health risks first and only thereafter
                                                  to, deleting specific segments of the                                                                         documented plant pest or noxious weed
                                                                                                          determine the use of any regulatory
                                                  genome, adding segments to the                                                                                risks. For example, some possible
                                                                                                          action as appropriate and needed. Such
                                                  genome, directed altering of the genome,                                                                      candidates to be exempted from
                                                                                                          a two-step process will enable the
                                                  creating additional genomes, or direct                                                                        regulation might be:
                                                                                                          agency to consider and place risk-
                                                  injection and cell fusion beyond the                                                                             a. Plant products of biotechnology in
                                                                                                          appropriate regulatory controls on the
                                                  taxonomic family that overcomes                                                                               which the genetic modification was
                                                                                                          importation, movement, or ‘‘outdoor’’
                                                  natural physiological reproductive or                                                                         obtained through a process of
                                                                                                          use of those products that are
                                                  recombination barriers. This definition                                                                       biotechnology including nucleotide
                                                                                                          determined by the agency to pose actual
                                                  does not include and is intended not to                                                                       deletions, single base pair substitutions,
                                                                                                          plant pest or noxious weed risks
                                                  include traditional breeding, marker                                                                          or other modifications that could
                                                                                                          (regulate only when APHIS has                         reasonably be expected to be obtained
                                                  assisted breeding, or chemical or
                                                                                                          determined that certain plant health                  through mutagenic techniques that have
                                                  radiation-based mutagenesis.
                                                    Product of biotechnology. An                          risks are appropriate and necessary to                commonly been used for plant
                                                  organism developed using                                require some regulatory action to be                  development since the early 1900s.
                                                  biotechnology.                                          taken and implemented).                                  b. Insects which are not plant pests
                                                    Regulated organism. An organism                          Analyze First: APHIS would use                     transformed using the PiggyBac
                                                  developed using biotechnology that                      established and delineated criteria to                transposon, but not otherwise
                                                  poses plant pest or noxious weed risks                  identify certain products of                          containing sequences from plant pests.
                                                  as documented in an APHIS risk                          biotechnology for which the Agency                       Those products of biotechnology
                                                  analysis that APHIS has determined to                   would conduct a review process. The                   which APHIS determines do meet the
                                                  regulate.                                               Agency’s review process would be used                 proposed criteria 1 and 2 listed above
                                                    APHIS is considering, and invites                     to determine whether the product of                   and will not be exempted, would
                                                  public input on, these proposed                         biotechnology poses an actual                         undergo a regulatory review. This
                                                  definitions. Such input should address                  documented plant pest or noxious weed                 regulatory review would employ a plant
                                                  APHIS’ regulatory objectives to                         risk and should therefore be regulated.               pest and/or noxious weed risk analysis
                                                  safeguard agricultural plants and                       The criteria that would ‘‘trigger’’ the               process to determine whether the
                                                  agriculturally important natural                        Agency’s review process are those                     product of biotechnology poses either a
                                                  resources from plant pest or noxious                    which would indicate the potential for                plant pest or noxious weed risk, and
                                                  weed damage (biological, chemical, or                   the product of biotechnology to pose                  therefore would be a regulated organism
                                                  physical) caused by a ‘‘product of                      documented plant pest or noxious weed                 as defined above.
                                                  biotechnology,’’ including its potential,               risks, and may include:                                  Regulate When Necessary: Once the
                                                  or lack of potential to pose plant pest or                 1. Whether the recipient organism is               review process is completed by the
                                                  noxious weed risks.                                     a biocontrol organism, a microorganism                Agency, the importation, interstate
                                                    These proposed definitions will be                    that has been modified for altered plant-             movement or ‘‘outdoor’’ use of those
                                                  used in the four proposed alternatives                  microbe interactions, or a plant; and                 products of biotechnology that were
                                                  that are proposed to be examined in the                    2. Whether the product of                          determined to pose plant pest or
                                                  EIS. These proposed alternatives are:                   biotechnology’s donor or recipient                    noxious weed risks, as documented and
                                                    First Alternative: Take no action.                    organism, or the vector used in its                   confirmed in an APHIS risk analysis,
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                                                  Under this ‘‘no action’’ alternative,                   development meet the definition of a                  would be subject to APHIS regulatory
                                                  APHIS would make no changes to the                      plant pest, is included in the list of                controls that ensure the protection of
                                                  existing 7 CFR part 340 regulations for                 plant pest taxa, or is unknown or                     plant health. The regulatory control
                                                  certain GE organisms that pose a                        unclassified.                                         would typically be the issuance of
                                                  potential plant pest risk and APHIS                        APHIS is considering, and invites                  permits with risk-appropriate
                                                  would continue to regulate certain GE                   public input, on these two proposed                   conditions to mitigate risks.
                                                  organisms as it does today. APHIS                       regulatory review criteria and also                      Under this second alternative, APHIS
                                                  would not revise its current regulations                invites public input on proposing other               proposes to eliminate the notification


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                                                  6228                           Federal Register / Vol. 81, No. 24 / Friday, February 5, 2016 / Notices

                                                  procedure (currently 7 CFR 340.3), as                   analyses to inform the establishment of               noxious weed risks would be managed
                                                  APHIS anticipates that many GE                          appropriate permit conditions to protect              by APHIS using its other existing
                                                  organisms currently regulated under the                 agricultural plants and agriculturally                regulations pursuant to the PPA; e.g., 7
                                                  notification procedures would not be                    important natural resources. For                      CFR parts 330 and 360. Those existing
                                                  regulated nor subject to further review                 example, APHIS’ proposed regulatory                   APHIS regulations relating to plant
                                                  under this alternative.                                 scheme under this alterative would                    pests or noxious weeds, would be used
                                                     Under this alternative, APHIS also                   evaluate and consider agricultural and                as applicable to regulate any products of
                                                  proposes to eliminate the current                       mitigation practices such as crop                     biotechnology, but would regulate them
                                                  petition process for non-regulated status               exclusion zones, risk appropriate                     under their respective current regulatory
                                                  (currently 7 CFR 340.6), as APHIS will                  isolation distances, or other measures                schemes. Thus this alternative would be
                                                  conduct new risk analyses consistent                    that would address and mitigate
                                                  with the ‘‘analyze first, regulate when                                                                       using a very different scheme than the
                                                                                                          ‘‘damage’’ as included in the PPA
                                                  necessary’’ when new information is                     definition of a noxious weed (e.g., direct            current 7 CFR part 340 or the regulatory
                                                  made available.                                         or indirect damage to crops or other                  schemes proposed in the second and
                                                     Under this second alternative, APHIS                 interests of agriculture). APHIS requests             third EIS alternatives since APHIS
                                                  is considering whether or how products                  and would appreciate public input on                  would not plan on revising, amending,
                                                  of biotechnology that are developed for                 these practices or others that might be               or requiring any regulatory changes to 7
                                                  pharmaceutical or industrial purposes                   appropriate for this third alternative.               CFR parts 330 and/or 360 to address
                                                  would be regulated under the proposed                      Under this third alternative, APHIS’               plant pest or noxious weed risks
                                                  revised regulations. APHIS appreciates                  proposed regulatory scheme would also                 specifically related to products of
                                                  that there are aspects of its regulatory                eliminate the notification (currently 7               biotechnology. However, APHIS would
                                                  program that are well suited to address                 CFR 340.3) and petition procedures                    maintain expertise in regulating the
                                                  these types of products, and would like                 (currently 7 CFR 340.6) since this                    products of biotechnology pursuant to
                                                  public input on how public health and                   alternative’s regulatory scheme would                 its PPA plant pest and noxious weed
                                                  safety objectives might be achieved for                 propose that all ‘‘products of                        risks and create a non-regulatory
                                                  pharmaceutical or industrial products of                biotechnology’’ that are plants and are               program providing voluntary, non-
                                                  biotechnology that would pose plant                     captured by the existing plant pest or                regulatory consultative services to
                                                  pest or noxious weed risks.                             noxious weed ‘‘analysis triggers,’’ as                provide developers with Federal
                                                     Third Alternative: Revise the current                defined by the PPA, and currently used
                                                  APHIS regulations concerning the                                                                              support and services intended to
                                                                                                          and applied by APHIS pursuant to the
                                                  introduction of certain GE organisms to                                                                       facilitate importation, interstate
                                                                                                          regulations in 7 CFR parts 340 and 360,
                                                  provide for the regulation of ‘‘products                                                                      movement or ‘‘outdoor’’ use of products
                                                                                                          would require a permit to enable the
                                                  of biotechnology’’ as either plant pests                agency to establish risk appropriate                  of biotechnology that do not present
                                                  or noxious weeds using the existing                     conditions. APHIS would appreciate                    PPA plant pest or noxious weed risks.
                                                  plant pest ‘‘analysis trigger’’ or a                    public input on its proposal, under this              Under this fourth alternative and
                                                  noxious weed ‘‘analysis trigger’’ that                  alternative, to eliminate notifications               approach, APHIS would provide, upon
                                                  might classify plants produced through                  and petitions.                                        request for consultation, for an analysis
                                                  biotechnology as potential plant pests or                  Fourth Alternative: Withdraw the                   of PPA plant pest or noxious weed risks
                                                  noxious weeds.                                          current 7 CFR part 340 regulations                    as part of it routine and continuing
                                                     Under this third alternative, APHIS’                 completely and implement a voluntary,                 operations, and such analyses might
                                                  proposed regulations would                              non-regulatory consultative process for               facilitate the commercialization of the
                                                  substantially increase oversight and                    certain products of biotechnology                     products of biotechnology by providing
                                                  resources over those currently used to                  whereby APHIS would document plant                    an objective analysis of plant pest or
                                                  regulate GE organisms. APHIS would                      pest or noxious weed risks, if any, of                noxious weed risks using APHIS risk
                                                  not exempt certain ‘‘products of                        certain products of biotechnology as                  analysis processes that document a
                                                  biotechnology’’ from APHIS regulatory                   defined above.                                        scientific review of the literature and
                                                  oversight if a ‘‘product of                                Under this fourth alternative,                     findings related to plant pest or noxious
                                                  biotechnology’’ was developed using a                   developers would be responsible for
                                                                                                                                                                weed risks. APHIS would appreciate
                                                  plant pest; or, if it posed a risk as a                 ensuring that their respective products
                                                                                                                                                                public input on its proposal, under this
                                                  noxious weed pursuant to the PPA                        of biotechnology do not pose risks as a
                                                  definition of a noxious weed.                           plant pest or noxious weed pursuant to                alternative.
                                                  Introductions of products of                            their respective PPA definitions, and                    APHIS is requesting comments and
                                                  biotechnology that posed a plant pest                   that their activities related to the                  information related to the topics and
                                                  risk or noxious weed risk would require                 importation, interstate movement, or                  issues presented in this notice so that
                                                  a permit and conditions would be                        release into the environment of their                 the scope of the analysis in the draft
                                                  applied for import, interstate movement,                respective products of biotechnology are              EIS, including the types and range of
                                                  or ‘‘outdoor’’ use.                                     not in violation of any existing statutes             reasonable alternatives, is reasonable
                                                     Under this third alternative, APHIS’                 or Federal regulations that relate to                 and appropriate, and proposed revisions
                                                  proposed regulatory scheme would                        plant pests or noxious weeds.                         to 7 CFR part 340 are well-evaluated.
                                                  include the range of actions and                           Under this fourth alternative, APHIS               Public input will be helpful in further
                                                  processes that would enable APHIS to                    would not have a dedicated regulatory                 defining the scope of the issues and
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                                                  become, to the extent permitted by its                  scheme to specifically regulate any                   reasonable alternatives under
                                                  PPA authorities, an all-encompassing,                   products of biotechnology that may pose               consideration. A notice will be
                                                  wide-scale regulatory permitting                        plant pest or noxious weed risks and
                                                                                                                                                                published in the Federal Register to
                                                  authority but still fully comply with the               therefore would not require consultation
                                                                                                                                                                announce the availability of a draft EIS
                                                  Coordinated Framework and support                       nor prescribe methods or practices
                                                                                                                                                                when it is issued and to invite the
                                                  the continued development of products                   related to any products of
                                                  of biotechnology. APHIS would use its                   biotechnology. Any products of                        public to provide comments on it.
                                                  plant pest and/or noxious weed risk                     biotechnology that pose plant pests or


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                                                                                 Federal Register / Vol. 81, No. 24 / Friday, February 5, 2016 / Notices                                                 6229

                                                    Done in Washington, DC, this 1st day of               Foreign Agricultural Service                             Total Burden Hours: 85,304.
                                                  February 2016.
                                                                                                             Title: Foreign Market Development                  Ruth Brown,
                                                  Kevin Shea,
                                                                                                          Cooperator Program (FMD) and Market                   Departmental Information Collection
                                                  Administrator, Animal and Plant Health
                                                                                                          Access Program (MAP).                                 Clearance Officer.
                                                  Inspection Service.
                                                                                                                                                                [FR Doc. 2016–02208 Filed 2–4–16; 8:45 am]
                                                  [FR Doc. 2016–02247 Filed 2–4–16; 8:45 am]                 OMB Control Number: 0551–0026.
                                                                                                                                                                BILLING CODE 3410–10–P
                                                  BILLING CODE 3410–34–P
                                                                                                             Summary of Collection: The basic
                                                                                                          authority for the Foreign Market
                                                                                                          Development Cooperator Program                        DEPARTMENT OF AGRICULTURE
                                                  DEPARTMENT OF AGRICULTURE
                                                                                                          (FMD) is contained in Title VII of the
                                                  Foreign Agricultural Service                            Agricultural Trade Act of 1978, 7 U.S.C.              Forest Service
                                                                                                          5721, et seq. Program regulations appear
                                                                                                                                                                Ochoco, Umatilla, Wallowa-Whitman
                                                  Submission for OMB Review;                              at 7 CFR part 1484. Title VII directs the
                                                                                                                                                                National Forests; Oregon and
                                                  Comment Request                                         Secretary of Agriculture to ‘‘establish               Washington; Blue Mountains Forest
                                                                                                          and, in cooperation with eligible trade               Resiliency Project
                                                  February 1, 2016.
                                                                                                          organization, carry out a foreign market
                                                    The Department of Agriculture has                                                                           AGENCY: Forest Service, USDA.
                                                                                                          development cooperator program to
                                                  submitted the following information
                                                                                                          maintain and develop foreign markets                  ACTION:Notice of intent to prepare an
                                                  collection requirement(s) to OMB for
                                                                                                          for United States agricultural                        environmental impact statement.
                                                  review and clearance under the
                                                  Paperwork Reduction Act of 1995,                        commodities and products.’’ The Market
                                                                                                                                                                SUMMARY:    The Ochoco, Umatilla, and
                                                  Public Law 104–13. Comments are                         Access Program (MAP) is authorized by
                                                                                                                                                                Wallowa-Whitman National Forests, are
                                                  requested regarding (1) whether the                     section 203 of the Agricultural Trade
                                                                                                                                                                proposing forest restoration and fuels
                                                  collection of information is necessary                  Act of 1978, as amended. Program
                                                                                                                                                                reduction on portions of approximately
                                                  for the proper performance of the                       regulations appear at 7 CFR part 1485.                1,270,000 acres of National Forest
                                                  functions of the agency, including                      The primary objective of the Market                   System lands. The project area consists
                                                  whether the information will have                       Access Program (MAP) is to encourage                  of selected watersheds amounting to
                                                  practical utility; (2) the accuracy of the              the development, maintenance, and                     200,000 acres on the Ochoco, 520,000
                                                  agency’s estimate of burden including                   expansion of commercial export markets                acres on the Umatilla, and 550,000 acres
                                                  the validity of the methodology and                     for U.S. agricultural products through                on the Wallowa-Whitman National
                                                  assumptions used; (3) ways to enhance                   cost-share assistance to eligible trade               Forests. Proposed thinning and
                                                  the quality, utility and clarity of the                 organizations that implement a foreign                prescribed fire treatments encompass
                                                  information to be collected; and (4)                    market development program. The                       approximately 580,000 acres across the
                                                  ways to minimize the burden of the                      programs are administered by personnel                three National Forests. The project area
                                                  collection of information on those who                  of the Foreign Agricultural Service                   lies within the Blue Mountain ecoregion
                                                  are to respond, including through the                   (FAS).                                                in northeast Oregon and southeast
                                                  use of appropriate automated,                              Need and Use of the Information: The               Washington, encompasses portions of
                                                  electronic, mechanical, or other                        collected information will be used by                 thirteen counties, and includes shared
                                                  technological collection techniques or                  FAS to manage, plan, evaluate, and                    boundaries with private, tribal, state and
                                                  other forms of information technology.                  account for government resources.                     other federal lands.
                                                    Comments regarding this information                                                                            Studies of historical forest conditions
                                                                                                          Specifically, data is used to assess the
                                                  collection received by March 7, 2016                                                                          can be used to help inform natural
                                                                                                          extent to which: Applicant
                                                  will be considered. Written comments                                                                          ranges of variation in forest structure,
                                                                                                          organizations represent U.S. commodity
                                                  should be addressed to: Desk Officer for                                                                      composition and density, which are
                                                  Agriculture, Office of Information and                  interests; benefits derived from market
                                                                                                                                                                assumed to be resilient to disturbance
                                                  Regulatory Affairs, Office of                           development effort will translate back to
                                                                                                                                                                and change. Fire suppression and past
                                                  Management and Budget (OMB), New                        the broadest possible range of                        timber management practices in dry
                                                  Executive Office Building, 725 17th                     beneficiaries; the market development                 forests have increased the abundance of
                                                  Street NW., Washington, DC 20502.                       efforts will lead to increases in                     closed-canopied forest stands
                                                  Commenters are encouraged to submit                     consumption and imports of U.S.                       dominated by smaller diameter, young
                                                  their comments to OMB via email to:                     agricultural commodities; the applicant               trees than were present historically.
                                                  OIRA_Submission@OMB.EOP.GOV or                          is able and willing to commit personnel               Increased canopy closure has also
                                                  fax (202) 395–5806 and to Departmental                  and financial resources to assure                     reduced the amount of forest openings
                                                  Clearance Office, USDA, OCIO, Mail                      adequate development, supervision and                 and early seral habitat. Fire suppression
                                                  Stop 7602, Washington, DC 20250–                        execution of project activities; and                  has also caused expansion of conifers
                                                  7602. Copies of the submission(s) may                   private organizations are able and                    into aspen stands and historically non-
                                                  be obtained by calling (202) 720–8958.                  willing to support the promotional                    forested areas. Denser forests combined
                                                    An agency may not conduct or                          program with aggressive marketing of                  with drought conditions in recent years
                                                  sponsor a collection of information                     the commodity in question. Without the                have contributed to a record number of
                                                  unless the collection of information                    collected information the program could               wildfires, and less resilient forest
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                                                  displays a currently valid OMB control                  not be implemented.                                   conditions. There is a need to reduce
                                                  number and the agency informs                              Description of Respondents: Not-for-               fuels and move forests to a more
                                                  potential persons who are to respond to                 profit institutions; State, Local, or Tribal          resilient structure, composition, density,
                                                  the collection of information that such                 Government.                                           and pattern.
                                                  persons are not required to respond to                                                                           The purpose of the project is to
                                                  the collection of information unless it                    Number of Respondents: 64.                         enhance landscape and species
                                                  displays a currently valid OMB control                     Frequency of Responses:                            resilience to future wildfire by restoring
                                                  number.                                                 Recordkeeping; Reporting: Annually.                   forests to their natural (historical) range


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Document Created: 2016-02-05 00:17:12
Document Modified: 2016-02-05 00:17:12
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of intent to prepare an environmental impact statement.
DatesWe will consider all comments that we receive on or before March 7, 2016.
ContactSidney W. Abel, Assistant Deputy Administrator, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 851-3943.
FR Citation81 FR 6225 

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