Availability of an Environmental Assessment for the Field Release of Genetically Engineered Diamondback Moths

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice.

SUMMARY:

We are advising the public that the Animal and Plant Health Inspection Service is making available for public comment our environmental assessment for the field release of diamondback moths which have been genetically engineered for repressible female lethality and to express red fluorescence as a marker. The purpose of the field release is to assess the feasibility and efficacy of these moths in reducing populations of non-genetically engineered diamondback moths.

DATES:

We will consider all comments that we receive on or before September 29, 2014.

ADDRESSES:

You may submit comments by either of the following methods:

• Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0056.
• Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2014-0056, 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-2014-0056 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. Cindy Eck, Document Control Officer/Team Leader, Environmental Risk Analysis Programs, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 851-3892, email: cynthia.a.eck@aphis.usda.gov.

SUPPLEMENTARY INFORMATION:

The 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,” regulate, among other things, the introduction (importation, interstate movement, or release into the environment) of organisms and products altered or produced through genetic engineering that are plant pests or that there is reason to believe are plant pests. Such genetically engineered (GE) organisms and products are considered “regulated articles.” A permit must be obtained or a notification acknowledged before a regulated article may be released into the environment. The regulations set forth the permit application requirements and the notification procedures for the importation, interstate movement, or release into the environment of a regulated article.

On October 24, 2013, the Animal and Plant Health Inspection Service (APHIS) received a permit application from Cornell University (APHIS Permit Number 13-297-102r) seeking the permitted field release of three strains of GE diamondback moth (DBM), Plutella xylostella, strains designated as OX4319L-Pxy, OX4319N-Pxy, and OX4767A-Pxy. The GE DBM have been genetically engineered to exhibit red fluorescence (DsRed2) as a marker and repressible female lethality, also known as female autocide. The GE DBMs are considered a regulated article under the regulations in 7 CFR part 340 because the recipient organism is or may be a plant pest. APHIS has previously issued Cornell University a permit authorizing the importation of GE DBM strains OX4319L-Pxy, OX4319N-Pxy, and OX4767A-Pxy from the United Kingdom to the Cornell University New York State Agricultural Experiment Station (NYSAES, APHIS Permit Number 12-227-102m) in Geneva, NY.

The purpose of the requested field release is to assess the efficacy of GE DBM strains OX4319L-Pxy, OX4319N-Pxy, and OX4767A-Pxy in reducing pest populations of non-GE DBM. The female autocidal trait permits the selection of DBM males during rearing. When released, it is likely that any female progeny produced from GE DBM males and non-GE DBM females will die.

The proposed release would be at NYSAES and would not exceed 3 years. The release would be limited to 6 sites not exceeding 10 acres per site, surrounded by other agricultural fields within NYSAES' 870 total acres. The release of 20,000 GE DBMs per release per site would be allowed, with up to 5 releases per week per site. Post-experiment monitoring of DBM with traps would continue for 2 weeks after the conclusion of each release to assess field longevity of GE DBM. The red fluorescent marker will allow the GE DBMs to be positively identified.

To provide the public with documentation of APHIS' review and analysis of any potential environmental impacts associated with the proposed release of the GE DBM, an environmental assessment (EA) has been prepared. The EA was prepared in accordance with: (1) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), (2) regulations of the Council on Environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing Procedures (7 CFR part 372). APHIS will accept written comments on our EA regarding the proposed release of the GE DBM from interested or affected persons for a period of 30 days from the date of this notice. Copies of the EA are available as indicated in the ADDRESSES and FOR FURTHER INFORMATION CONTACT sections of this notice.

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