FDA drafts guidelines for genetically engineered animals

The U.S. Food and Drug Administration, part of the Department of Health and Human Services, today released for public comment draft guidance on the regulation of genetically engineered (GE) animals. The guidance document is intended to clarify the FDA's regulatory authority in this field, as well as the requirements and recommendations for producers of GE animals and products derived from GE animals.

The comment period for the draft guidance, titled "The Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs," runs for 60 days and closes Nov. 18, 2008. The 25-page document is available online at http://www.fda.gov/cvm/GEAnimals.htm.

Bonnie - from our initial assessment, there is no place in the directive for labeling when sold to market. This is crucial for the consumer. We will have more comments once we scrutinize the doc.

9/19/08
After reviewing the draft guidelines, I want to reiterate that these are non-binding recommendations. This describes the FDA's current thinking. Public comment will be accepted until November 18, 2008. Here is our assessment:

• GE animals are here to stay. It just depends on how they are delivered (properly labeled or hidden) to the marketplace.
• They would like a directive that covers GE animals being developed to enhance food quality, improve animal health, products for therapeutic use, enhance animals interaction with humans, develop animal models for human disease, and produce industrial/consumer products.
• There concerns with regard to safety are evident throughout the directive.
• One glaring issue that we anticipated has to do with labeling these products in the marketplace. The FDA does not feel that as long as they decide a certain GE animal product is safe, it would not have to be labeled GE. This is the same feeling they have about GE plants. This is not acceptable.
• Based upon the language in their directive, the FDA seems to be taking a much more thorough approach to assessing safety before approving these products. However, all of this can change once the lobbyists get hold of them before policy implementation.

Our recommendation is to make a public comment by requesting well constructed, 10-15 year, peer-reviewed, independently funded safety studies before being allowed to market. If this cannot happen, then every GE animal product should be labeled at the retail level.