The USDA and the FDA have been seeking public comment on how to handle genetically engineered animals, specifically those that will be entering our food chain such as livestock. The USDA docket title is: Guidance for Industry: Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs; You can use this link to post your comment with the USDA/FDA. Once you are on the page click on the Yellow Comment Icon.  There are many unknowns to be considered and/or fully researched before Genetically Engineered Organisms (GMOs) are allow into our food supply.

Consider the following from Yale Environment 360.

Genetically engineered pigs, cows, and fish moved closer to the marketplace, as the U.S. Food and Drug Administration issued draft rules for their approval. The regulations, which are similar to the agency’s drug-approval process, would require companies to prove that a modified animal is healthy and that products derived from it are safe. In animals grown for food, potential benefits of genetic engineering range from faster growth to disease resistance to added nutrients. Other animals could be engineered to produce drugs. But animals are not drugs and shouldn’t be treated that way, said a policy analyst at the nonprofit Center for Food Safety in Washington: “Drugs don’t go out and breed with each other. When a drug gets loose, you figure you can control it. When a bull gets loose, it would be harder to corral.” Critics also said the guidelines allow industry to shield too much information from the public.

Also here is some background information, article was originally published on September 19, 2008 from the LA Times.

FDA proposes approval process for genetically modified animals

The regulations would treat genetically engineered creatures like drugs. Critics suggest environmental concerns aren’t being given proper weight.

The Food and Drug Administration on Thursday opened the way for a bevy of genetically engineered salmon, cows and other animals to leap from the laboratory to the marketplace, unveiling an approval process that would treat the modified creatures like drugs.

The guidelines for the first time make explicit the regulatory hoops companies would have to jump through to sell engineered salmon that grow twice as fast as wild fish; pigs with high levels of healthy omega-3 fatty acids in their meat; or goats that produce beneficial proteins, such as insulin, in their milk.

“It’s about time the federal government has acknowledged that these animals are on its doorstep and need to be regulated to ensure their safety,” said Greg Jaffe, biotechnology director at the Center for Science in the Public Interest in Washington.

Many experts, however, say the proposed regulations may not go far enough to protect the public. In particular, they argue that the approval process would be highly secretive to guard the commercial interests of the companies involved, and that the new rules do not place sufficient weight on the potential environmental effect of what many consider to be Frankenstein animals.

Animals can’t be treated exactly like drugs, said Jaydee Hanson, a policy analyst at the Center for Food Safety in Washington. “Drugs don’t go out and breed with each other. When a drug gets loose, you figure you can control it. When a bull gets loose, it would be harder to corral.” (More)

Below is the Docket item summary from the Federal Registry.

SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document (GFI187) entitled “Regulation of Genetically Engineered Animals Containing Heritable
rDNA Constructs.” This draft guidance is intended to clarify FDA’s requirements and recommendations for producers and developers of genetically engineered (GE) animals and their products. The draft guidance describes how the new animal drug provisions of the Federal Food, Drug, and Cosmetic Act (the act) apply with respect to GE animals, including FDA’s intent to exercise enforcement discretion regarding requirements for certain GE animals.
    Elsewhere in this same issue of the Federal Register, the Animal and Plant Health Inspection Service (APHIS) is soliciting public comment on any potential implications of activities such as the importation or interstate movement of GE animals on the health of the U.S. livestock population under the authority of the Animal Health Protection Act (AHPA).

DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance by November 18, 2008.

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