USA – GM SALMON SAFE FOR ENVIRONMENT


USA – GM SALMON SAFE FOR ENVIRONMENT

www.gpo.gov/fdsys/pkg/FR-2012-12-26/pdf/2012-31118.pdf

The US Food and Drug Administration has released its Draft Environmental Assessment for a GM variety of salmon for a public comment period. The FDA assessment found the GM salmon had “no significant impact” on the environment.

The public comment period closes on 25 February 2013.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Draft Environmental Assessment and Preliminary Finding of No Significant Impact Concerning a Genetically Engineered Atlantic Salmon; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA, the Agency) is announcing the availability for public comment of the Agency’s draft environmental assessment (EA) of the proposed conditions of use specified in materials submitted by AquaBounty Technologies, Inc., in support of a new animal drug application (NADA) concerning a genetically engineered (GE) Atlantic salmon. Also available for comment is the Agency’s preliminary finding of no significant impact (FONSI) for those specific conditions of use.

DATES: Submit either electronic or written comments on the Agency’s draft EA and preliminary FONSI by February 25, 2013.
SUPPLEMENTARY INFORMATION: Notice is given that a draft EA prepared by FDA in support of an NADA associated with AQUADVANTAGE Salmon, a GE Atlantic salmon containing the opAFP– GHc2 recombinant DNA construct is being made available for public comment. FDA is also making available for comment the Agency’s preliminary FONSI for those specific conditions of use. In the event of an approval of the application, the approval would only allow AQUADVANTAGE Salmon to be produced and grown-out in the physically contained freshwater culture facilities specified in the sponsor’s NADA.

To encourage public participation consistent with regulations implementing the National Environmental Policy Act (40 CFR 1501.4(b)), the Agency is placing the draft EA and the preliminary FONSI that are the subject of this notice on public display at the Division of Dockets Management (see DATES and ADDRESSES) for public review and comment for 60 days.

Dated: December 20, 2012.