GE Animals: Coming to a Supermarket Near You?‏
From: Center for Food Safety (office@centerforfoodsafety.org)
Sent: Thu 11/13/08 11:12 AM

It Came From The Grocery Store: Genetically Engineered Meat May Be Heading To A Supermarket Near You

Dear anna,

Genetically engineered animals may be heading to your local supermarket faster than you think. Though creating animals in a lab sounds like science fiction, it’s happening right now: Genetically engineered super salmon, which grow twice as fast as normal farmed salmon, goats engineered with spider genes to produce silk in their milk, and pigs engineered with mouse and bacterial DNA to improve digestion.

The Food and Drug Administration (FDA) is currently accepting public comments on its draft guidance for the commercialization of such GE animals, opening the way for grocery stores to sell food made from genetically engineered animals. And the agency is proposing that these products be sold to you without your knowledge.

The jury is still out on whether food from these animals is safe for humans or the environment. And the ethics of such changes have yet to be considered. In fact, FDA says the ethics of engineering animals for food production cannot even be considered in its decision-making!

FDA says they will conduct a safety review before these foods can be sold for human consumption. But consumers won’t know if they’re buying food from genetically engineered animals, because the agency is refusing to require labeling—robbing us of our right to know what’s in our food.

The FDA draft guidance would treat genetically engineered animals under its new animal drug provisions. While the new guidance would require a long-overdue review process, the proposed FDA rules are seriously flawed. While regulating genetically engineered animals through the more rigorous “new animal drug” provisions is good news—meaning each new GE animal would have to get FDA approval before going to market, like new drugs do—the secrecy inherent in our current drug approval process is bad news for consumers. In addition, FDA’s limited review will only be for efficiency of the GE process, the safety of the GE process on the animal, and will not require extensive testing of the foods derived from such animals. Moreover, the review will not cover environmental issues like impacts to wildlife or biodiversity.

Under this draft, the public cannot know if the review of a product met the highest scientific standards until after its approval, and then they cannot avoid the product in the marketplace because it is not labeled. The FDA feels it deserves the public’s trust, but refuses to give us the tools to verify that it is doing its job fairly and adequately.

What’s worse, FDA is not proposing actual regulations, but rather a non-binding “guidance” document that continues the anti-regulatory shift of risk from those producing genetically engineered animals and foods to those consuming them.

The public comment period is only open until November 18th – Tell FDA to ban the use of such animals for food. If any such animals are to be considered, FDA must require labeling of food products from all genetically engineered animals, an open, transparent, and participatory review process of any such genetically engineered animals, and include a meaningful consideration of the ethical implications and environmental impacts of genetically engineering animals.

Send a letter to the following decision maker(s):
Docket No. FDA-2008-D-0394

Below is the sample letter:

Subject: Docket No. FDA-2008-D-0394 and Request for Extension of Comment Period

Dear [decision maker name automatically inserted here],

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane
Room 2061
Rockville, MD 20852
Cc: www.regulations.gov

Re: Docket No. FDA-2008-D-0394 and Request for Extension

I am writing to comment on Docket No. FDA-2008-D-0394, "Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs." I am deeply concerned that the Food and Drug Administration has issued Draft Guidance that will allow meat and milk from genetically engineered animals into the food supply without any way for me to know whether I'm buying or eating such food. I am opposed to Genetically Engineered Animals being used as food and strongly urge FDA to ban these animals from the food supply.

While the new guidance would require a long-overdue review process, the proposed FDA rules are seriously flawed. Regulating genetically engineered animals through the more rigorous "new animal drug" provisions is good news, but the secrecy inherent in our current drug approval process is bad news for consumers.

Under this draft, the public cannot know if the review of a product met the highest scientific standards until after its approval, and then they cannot avoid the product in the marketplace because it is not labeled. The FDA feels it deserves the public's trust, but refuses to give us the tools to verify that it is doing its job fairly and adequately.

At a time when the FDA has inadequate resources to protect the food system and is reeling under allegations of conflicts of interest, this new proposal uses a secret approval process wherein no one other than FDA reviewers can see the data submitted before final approval. And, unlike drugs which can be recalled because they are labeled, FDA maintains that genetically engineered animals should not be labeled.

FDA has said that each of these animals is different enough from the normal version that it has to go through a full safety assessment. But FDA has refused to require labeling, and says that the ethics of such changes cannot even be considered in its decision-making.

These animals are obviously different than their counterparts that have not had their genes altered. Not only should the milk and meat from these animals be studied to determine if they are safe, they should be labeled so we know exactly what we are buying.

I urge you to revise your Draft Guidance for Industry on Regulation of Genetically Engineered Animals to ban the use of such animals for food. If any such animals are to be considered, FDA must require labeling of food products from all genetically engineered animals, an open, transparent, and participatory review process of any such genetically engineered animals, and to include a meaningful consideration of the ethical implications and environmental impacts of genetically engineering animals.

In addition, given the gravity of the decision FDA is contemplating, FDA should also extend the comment period for at least another 60 days, through January 17, 2009 so that people have the opportunity to thoroughly review the docket and submit informed comments to the agency.

Sincerely,

anna poulin