For Immediate Release

FDA To Announce New Rules for Engineered Animals

Statement of CSPI Biotechnology Director Gregory Jaffe

WASHINGTON - Today the government formally acknowledged that genetically engineered animals need regulation and oversight.
It may seem strange to consumers that the Food and Drug Administration
wants to treat genetically engineered animals as "new animal drugs."
But if FDA implements what it has proposed, the agency will at least
have to determine whether these newly designed foods are safe to eat.

Although FDA's announcement is a good first start, it does
not address the risks that GE animals might pose to the environment.
Would it be the FDA that would determine whether fast-growing
genetically engineered salmon would endanger native salmon populations?
In addition, FDA's post-market regulatory authorities are limited and
may be insufficient to deal with any problems that might arise after an
engineered animal is commercialized.

FDA's proposal also does not indicate what information the
public will be provided about the safety of GE animals. The safety
assessments of new animal drugs are confidential, and FDA makes safety
decisions behind closed doors. If the FDA evaluates GE animals in
secret, consumers will be leery of the safety of these foods.

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