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January 01, 2009

 

 AVMA comments on regulation of genetically engineered animals

posted December 15, 2008

 

The AVMA recognizes the benefits of genetically engineered animals as well as the welfare concerns, according to comments that the Association submitted to the Food and Drug Administration and Department of Agriculture.

In late 2008, the FDA solicited input on draft guidance regarding requirements for developers of GE animals and products from GE animals. The USDA requested comments on potential complementary actions.

The AVMA response reads, in part: "The development and implementation of appropriate regulation of this technology has widespread applications in advancing our knowledge of diseases, food safety, environmental conservation, and efficient food and fiber production."

The Association also noted the need to protect animal welfare in the development and delivery of GE technology.

"Welfare concerns related to GE include, but may not be limited to, abnormalities in embryonic development and death in utero; abnormal, variable, unexpected or uncontrolled expression of inserted genes; and the large number of donor, recipient, and breeding animals involved and their ultimate disposition," according to the AVMA.

The AVMA urged all federal agencies with oversight of GE animals to work with the Department of Agriculture to ensure that regulations and policies for enforcement of the Animal Welfare Act are sufficient to address GE technology—particularly because the act does not cover certain animals that are common subjects of genetic engineering.

Voluntary programs at public institutions and private companies have closed some of these gaps in coverage. Furthermore, the FDA's draft guidance includes requirements relevant to product safety and effectiveness that would protect the welfare of GE animals, such as a requirement to provide information about potentially disruptive DNA sequences.