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Daily News Archives
From January 24, 2005

FDA Guidelines Threaten Consumers, Farmers, and the Environment;
Submit Comments to FDA by TODAY Monday, January 24!
(Beyond Pesticides, January 24, 2005)
Comments on the Food and Drug Administration's (FDA) Draft Guidance for Industry for New Plant Varieties Intended for Food Use are due today, Monday, January 24, 2005. The guidelines are voluntary and do nothing to protect consumers, farmers, or the environment from dangerous contamination. Rather, they appear to serve no other purpose than to provide legal protection to the bio-tech industry.


The Genetic Engineering in Agriculture Committee of the National Campaign for Sustainable Agriculture has developed simple, BASIC COMMENTS THAT YOU CAN EASILY submit to FDA by today January 24. The comments were drafted under the guidance of committee members Joe Mendelson (Center for Food Safety), Kerry-Ann Powell (U.S. PIRG), Michael Hansen (Consumers Union), and Rick North (Oregon Physicians for Social Responsibility).


Just e-mail comments to: [email protected].



January 24, 2005

Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane
Room 1061
Rockville, MD 20852

RE: Docket No. 2004D-0369
FDA’s Draft Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended for Food Use; Availability

Dear FDA:

Thank you for the opportunity to comment on FDA’s Draft Guidance.


[INSERT THE NAME OF YOUR ORGANIZATION] is extremely alarmed that FDA is proposing to weaken, rather than fortify, the oversight of genetically engineered crops. The potential dangers of genetic engineering are immeasurable. The consequences of contamination of the food supply can be deadly and irreversible. It is incumbent on FDA to ensure that consumers, farmers, and the environment are absolutely protected from contamination by experimental genetically engineered crops.

However, FDA’s proposed Guidance does nothing to protect consumers, farmers, or the environment. The Guidelines are completely inadequate for the following very basic reasons:

• The Guidance is merely voluntary. Industry developing a new product is not even required to notify FDA.

• The recommended “safety tests” neither provide, nor comply with, any set of standards for testing.

• Widely accepted International Standards for performing safety tests are ignored.

• The Guidance not only fails to require oversight, it actually discourages it. For example, “It is not necessary to have a meeting with [FDA] to communicate about your early food safety evaluation of your new protein."

• The Guidance is apathetic at best, suggesting that an early food safety evaluation be encouraged “prior to the time you have concerns that the new protein could enter the food supply, for example via pollen flow or commingling.”

• The Guidance provides dangerous recommendations: For example, “If a protein has been evaluated in an early food safety evaluation and no safety concerns are identified, we would not expect an additional early food safety evaluation to be submitted if the same protein is introduced into another plant species."

• Ultimately, the Guidance provides no safety evaluation, merely the statement that “we have no questions at this time regarding your view that the new protein raises no food safety concerns."

• The Guidance appears to serve no other purpose than to provide legal protection to the bio-tech industry, since it provides no assurances of safety to the public.


We recommend that FDA’s proposed Guidance be scrapped and that FDA draft new regulations that provide meaningful protection to consumers, farmers, and the environment. At a minimum, FDA needs to:

1. Require independent, mandatory pre-market approval of GE crops for human health and environmental safety. The food safety assessment should be at least as stringent as the range of tests laid out in the internationally accepted Codex Alimentarius “Guidelines for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants.”
2. Maintain and enforce zero tolerance for any contamination of the food supply with any genetic material or gene product from a transgenic crop that is undergoing field testing and for which a full food safety assessment has not be completed.
3. Require that all experiments involving crops genetically engineered to produce pharmaceuticals and/or industrial compounds be conducted in greenhouses or similarly controlled environments.
4. Require labeling of all foods that contain genetically engineered material.

Thank you for your consideration.


For more information, contact Pam Browning, Policy Coordinator, National Campaign for Sustainable Agriculture, 110 Maryland Avenue, NE, Suite 306, Washington, DC 20002, Phone and Fax: 202-544-5466, [email protected], http://www.sustainableagriculture.net/.