Skip to Content

We invite you to try out our new beta eCFR site at We’ve made big changes to make the eCFR easier to use. Be sure to leave feedback using the 'Feedback' button on the bottom right of each page!


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

Document Details

Information about this document as published in the Federal Register.

Document Statistics
Document page views are updated periodically throughout the day and are cumulative counts for this document. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day.
Enhanced Content

Relevant information about this document from provides additional context. This information is not part of the official Federal Register document.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble Start Printed Page 18416


Animal and Plant Health Inspection Service, USDA.




We are advising the public that the Animal and Plant Health Inspection Service is making available for public comment an environmental assessment prepared in connection with a permit application for the field release of diamondback moths that have been genetically engineered for repressible female lethality and to express red fluorescence as a marker. The purpose of the proposed field release is to assess the feasibility and efficacy of these moths in reducing populations of diamondback moths that are known plant pests and a serious threat to agriculture.


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


You may submit comments by either of the following methods:

Supporting documents and any comments we receive on this docket may be viewed at​#!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.

Start Further Info


Ms. Chessa Huff-Woodard, Esq., Policy, Program and International Collaboration Chief, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 851-3943, email:

End Further Info End Preamble Start Supplemental 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.

The Animal and Plant Health Inspection Service (APHIS) has previously issued Cornell University a permit (APHIS Permit Number 12-227-102m) authorizing the importation of GE diamondback moths (DBM, Plutella xylostella) strains OX4319L-Pxy, OX4319N-Pxy, and OX4767A-Pxy from the United Kingdom to the university's New York State Agricultural Experiment Station (NYSAES) in Geneva, NY. The GE DBM were 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 a plant pest.

On October 24, 2013, APHIS received a permit application from Cornell University (APHIS Permit Number 13-297-102r) seeking the permitted field release of the three imported strains of GE DBM. Permits were issued and caged releases occurred in 2015. However, all permits relative to the October 2013 application have since been withdrawn.

On March 16, 2016, APHIS received a permit application from Cornell University (APHIS Permit Number 16-076-101r) seeking the permitted field release of a single strain of GE DBM, designated as OX4319L-Pxy, in both open and caged releases.

The purpose of the requested field release is to assess the feasibility and efficacy of GE DBM strain OX4319L-Pxy in reducing pest populations of DBM. According to the applicant, these GE DBM may serve as an insecticide-free means of controlling field populations of DBM in a species-specific manner.

The proposed release would be at the NYSAES and would not exceed 2 years in length. The release would be limited to an experimental field, up to 10 acres in size, within which there would be a single point at which the open air release would occur. The release site is surrounded by other agricultural fields within NYSAES' 870 total acres where DBMs occur naturally. The applicant would release up to 10,000 male GE DBMs per release (up to 30,000 males per week). Post-experiment monitoring of DBM with traps would continue until no GE DBMs are captured for 2 consecutive months.

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 Start Printed Page 18417FURTHER INFORMATION CONTACT sections of this notice.

Start Authority

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

End Authority Start Signature

Done in Washington, DC, this 12th day of April 2017.

Michael C. Gregoire,

Acting Administrator, Animal and Plant Health Inspection Service.

End Signature End Supplemental Information

[FR Doc. 2017-07840 Filed 4-18-17; 8:45 am]