Regulatory Brief

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

​Formal Title: [Docket No. FDA-2011-N-0899] Draft Environmental Assessment and Preliminary Finding of No Significant Impact Concerning a Genetically Engineered Atlantic Salmon - December 26, 2012

Brief Description:

The Food and Drug Administration announced the availability of the agency's draft environmental assessment (EA) concerning AquaBounty Technologies new animal drug application (NADA) for genetically engineered (GE) Atlantic salmon, for public comment. The agency also provided their preliminary finding of no significant impact for specific conditions of use for GE salmon.

Excerpts from the AVMA Response:

 The AVMA agrees with FDA’s preliminary finding of no significant environmental impact for the specific conditions of use described in the NADA for the AquAdvantage salmon.  We believe the multiple layers of protection required in the NADA for preventing animal escape and establishment in the environment, provides the greatest degree of protection possible.

As noted in earlier comments submitted concerning FDA’s approval of AquAdvantage salmon, the AVMA recognizes the importance and value of genetic engineered biotechnology.  In particular, we note that humans have altered animals, plants, and even microbes through selective breeding for millennia, to the great benefit of society.  Biotechnology, and in particular genetic engineering, increases our ability to continue this process at an accelerated pace and in a more directed manner.  However, with these powerful tools comes an increased ability to do great good and it is imperative that biotechnology be used responsibly and ethically.  It is equally important that these powerful techniques for advancement not be sequestered due to unfounded fear of potential adverse consequences. 
 
The AVMA noted that genetic engineering provides a tool to make more rapid advances in developing animals with preferred traits.  The AVMA strongly supports a science-based regulatory policy for the approval of products developed through biotechnology and regulations that require evaluation of product safety and efficacy by USDA, FDA, EPA, or other appropriate government agencies, before they can be marketed for the intended uses.  It is therefore the opinion of the AVMA that the creation of new genetically engineered food animals should not be needlessly restricted, so long as it does not negatively impact the integrity of the environment and/or the general health and welfare of the genetically modified animals, and meets human values and needs. 
 
To that end, and in particular, the AVMA welcomes and supports the opportunity to use biotechnology for a variety of applications including:
  •  The benefit and protection of public, animal, and environmental health and welfare
  • Enhancing infectious disease resistance and eliminating genetic-based diseases
  •  Increased efficiency of food and fiber production
  •  Improving the utility, nutritional value, and safety of human food and animal feeds
  • The production of improved animal medicinal products and diagnostic tools, and
  • The mitigation of any negative environmental impacts of crop and agricultural animal production.
 The AVMA therefore urged FDA to not further delay the approval of the NADA for the AquAdvantage genetically engineered (GE) Atlantic salmon.

 Background Documents:

Relevant AVMA Policy: