Tell the Biden administration to implement strict oversight for GMO animals!

The first genetically engineered animal -- GMO salmon -- was unlawfully approved. Now a new GMO pig was just approved, with no public comments or notice.

Trump’s outgoing administration is trying to make it even easier for GMO animals to enter the market with almost no scrutiny by giving USDA authority to approve them. We need your help to stop it.

Comments

To Department of Health and Human Services,

I support a transparent and comprehensive regulatory system which prioritize the environment, public health and animal welfare over corporate profit. Moving regulatory responsibilities for GMO animals from the FDA to the USDA would make an already problematic regulatory system worse. USDA may not implement adequate regulations for gene-edited animals, but FDA has the expertise and mandate to do so. In addition to keeping authority with FDA, there should be an overhaul of regulations for genetically engineered organisms at FDA in order to strengthen its regulations.

A growing body of science suggests that GMO animals, particularly those engineered with gene editing techniques, may pose serious environmental and public health risks. FDA should explicitly name that all applications derived from genetic engineering, including gene editing, will be evaluated.

FDA should allow for public review of all GMO animals designated for food. In order to fully understand the risks that GMO animals may pose to public health, the environment, and to animal welfare, FDA should assess the full genetic sequences of all genetically engineered animals. They should also evaluate all off-target changes to the genetic sequence, as some off-target consequences may have significant impacts on the animal. In addition, FDA should ensure that the genetically engineered changes do not cause animal suffering.

Currently, the FDA assesses and regulates GMO animals as “animal drugs.” However, any genetic engineering changes in an animal should be considered a “new food additive” and evaluated with this additional lens by the FDA before the animals can be approved for market sale. FDA should require food safety testing of the new meat to make sure it doesn’t contain toxins, pathogens or cause allergic reactions.

For full market transparency, the genetically engineered animals, including gene-edited animals, should be slaughtered in facilities that are separate from slaughterhouses for conventional animals, and they should be clearly labeled as genetically engineered upon leaving the slaughterhouse. Consumers deserve the right to know what they are eating, and without segregation of the animals, this will not be possible.

FDA must regulate all genetically engineered animals, including those that have been gene-edited. This proposed rule should require a full NEPA and Endangered Species Act review, review of full genetic sequences and off-target impacts, must include gene edited animals, and should require segregation for slaughtering and full labeling as genetically engineered. Without increased transparency and attention to detail, genetically engineered animals will irresponsibly enter the market and environment while posing risks to ecosystems, public health, and animal welfare.

Sincerely,
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