[Federal Register Volume 83, Number 126 (Friday, June 29, 2018)]
[Notices]
[Pages 30688-30689]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14019]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2018-0034]


Notice of Intent To Prepare an Environmental Impact Statement; 
Movement and Outdoor Use of Certain Genetically Engineered Organisms

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice of intent to prepare a programmatic environmental impact 
statement.

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SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service (APHIS) plans to prepare a programmatic 
environmental impact statement (EIS) in connection with potential 
changes to the regulations regarding the importation, interstate 
movement, and environmental release of certain genetically engineered 
organisms. This notice identifies potential issues to be evaluated in 
the EIS and requests public comments to 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 July 
30, 2018.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2018-0034.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2018-0034, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-
1238.
    Any comments we receive may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2018-0034 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: Ms. Joanne Serrels, Biotechnologist, 
Biotechnology Regulatory Services, APHIS, 4700 River Road, Unit 147, 
Riverdale, MD 20737-1238; (301) 851-3867.

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 their 
regulatory authorities under 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 science- and risk-based approach 
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

[[Page 30689]]

regulating biotechnology products: APHIS, the Environmental Protection 
Agency, and the Food and Drug Administration. This document addresses 
only proposed changes to the APHIS regulations and is not intended to 
circumscribe, restrict, or otherwise preclude future actions taken by 
other Federal agencies under their respective authorities.
    During the past 30 years, there have been major advances in the 
science of biotechnology, and new issues have been brought to APHIS' 
attention by a range of stakeholders. Over this period, APHIS has also 
gained considerable experience in assessing the plant health risks of 
GE organisms. Accordingly, APHIS is considering amending the 
regulations pertaining to movement and outdoor use of certain GE 
organisms to address the advances in biotechnology and APHIS' 
understanding of the issues raised by stakeholders. The proposed 
revisions would allow APHIS to more effectively protect plant health 
under the PPA by focusing APHIS' regulations in 7 CFR part 340 on risks 
that may be posed by certain GE organisms rather than on the methods 
used to produce the products and would also make the regulatory 
processes more transparent while removing unnecessary regulatory 
burdens.
    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 to APHIS' biotechnology regulations that are being 
considered. Aspects of the human environment that may be affected by 
the proposed regulatory changes and 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);
     Current and future uses of certain GE organisms in 
agriculture and forestry;
     Agronomic practices employed in GE crop production that 
may have environmental consequences or effects (e.g., tillage, crop 
rotation, weed and pest control, and agronomic inputs);
     Aspects of the physical environment, including soil 
quality, water resources, and air quality, with consideration given to 
the effects of dynamic climate conditions;
     Aspects of the biological environment, such as animal and 
plant communities, the development of weed, pathogen, and insect 
resistance to pesticides, the potential gene flow from certain GE 
organisms to sexually compatible species, the weediness of GE crop 
plants, and biodiversity;
     Consumer health and agricultural worker safety; and
     Animal feed safety, availability, quality, and animal 
health.
    We will also examine socioeconomic considerations, such as the 
potential impacts of crop plants that are GE organisms on the domestic 
economic environment, international trade, and coexistence among all 
forms of U.S. agriculture--conventional, biotechnology-based, and 
organic--and on market demand for food, feed, fiber, and fuel.
    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) U.S. 
Department of Agriculture regulations implementing NEPA (7 CFR part 
1b), and (4) APHIS' NEPA Implementing Procedures (7 CFR part 372).
    This notice identifies the potential issues that will be evaluated 
in the EIS, and requests public comment to help APHIS further define 
the issues and alternatives that should be considered and to help APHIS 
identify additional impacts, both positive and negative, to the human 
environment that should be examined in the EIS. Public input will also 
be helpful in developing our proposed regulations. All comments 
received during the comment period will be carefully considered. A 
notice will be published in the Federal Register to announce the 
availability of the draft EIS when it is issued and to invite the 
public to provide comments.

    Done in Washington, DC, this 26th day of June 2018.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2018-14019 Filed 6-28-18; 8:45 am]
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