2016-26935. Withdrawal 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 we are withdrawing an environmental assessment that was prepared by the Animal and Plant Health Inspection Service relative to a permitted environmental release of diamondback moths which have been genetically engineered for repressible female lethality and to express red fluorescence as a marker. While we reached a finding of no significant impact (FONSI) in connection with this action and posted that FONSI on our Web site, the public was not notified of the FONSI via publication of an associated notice in the Federal Register. We are therefore withdrawing the environmental assessment and FONSI.

FOR FURTHER INFORMATION CONTACT:

Mrs. Chessa Huff-Woodard, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 146, Riverdale, MD 20737-1236; [phone].

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.

Subsequent to 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, which have been genetically engineered to exhibit red fluorescence (DsRed2) as a marker and repressible female lethality, on August 28, 2014, the Animal and Plant Health Inspection Service (APHIS) published in the Federal Register a notice ^[1] (79 FR 51299-51300, Docket No. APHIS-2014-0056) in which we announced the availability, for public review and comment, of an environmental assessment (EA) that examined the potential environmental impacts associated with the proposed release of the GE DBMs.

We solicited comments on the EA for 30 days ending September 29, 2014. We received 287 comments by that date. The comments were from industry organizations, environmental and consumer advocacy groups, researchers, and private citizens.

Based upon analysis described in the EA and a thorough review of the comments we received, APHIS determined that release of the GE DBMs would not have a significant impact on the quality of the human environment. This finding of no significant impact (FONSI) was posted on the APHIS Web site.

In November 2014, APHIS issued Permit Number 13-297-102r, which allowed for open field release of the GE DBMs. No open field releases took place under this permit. In July 2015, the initial permit was amended to add caged releases to the list of allowable actions (APHIS Permit Number 13-297-102r-a1). Caged releases pursuant to the amended permit occurred between July 2015 and March 11, 2016, when the permit was withdrawn.

Although, as mentioned previously, we posted the FONSI on our Web site, we failed to formally advise the public of our FONSI regarding the release of GE DBMs via publication of a second notice in the Federal Register. Therefore, we are withdrawing the EA and FONSI associated with the August 28, 2014, notice.

On March 16, 2016, APHIS received a permit application from Cornell University (APHIS Permit Number 16-076-101r) seeking the permitted field release of GE DBMs in both open and caged releases. We are currently preparing an EA for this new application and will publish notices associated with the EA and FONSI (if one is reached) in the Federal Register.

Done in Washington, DC, this 2nd day of November 2016.

Kevin Shea,

Administrator, Animal and Plant Health Inspection Service.

Footnotes

1.  To view the notice, supporting documents, and comments we received, go to http://www.regulations.gov/​#!docketDetail;​D=​APHIS-2014-0056.