Letter to USDA, FDA, etc. (12/1/2006)

Sierra Club executive director Carl Pope has addressed a letter to USDA, APHIS, the FDA and others on the "pharm" issue. Apropos of the USDA Inspector General's recently released report, he calls not just for better implementation of the present ineffective system but for a better, more effective system. He notes that Sierra Club has been demanding a better regulatory framework for all genetically engineered crops for many years.

The full text of Pope's letter follows:

January 10, 2006

The Honorable Mike Johanns
Secretary of Agriculture
U.S. Department of Agriculture
1400 Independence Ave., S.W.
Washington, DC 20250

Dear Secretary Johanns:

The U.S. Department of Agriculture's Inspector General recently released an audit demonstrating that the Animal and Plant Health Inspection Service (APHIS) issued permits for, but had little to no knowledge of where, genetically engineered "pharm" crops were planted. ("Pharm" crops are genetically engineered crops made by splicing human, animal and other unrelated genes into plants in order to produce biopharmaceuticals or industrial compounds.) It also found that there was too little monitoring to ensure public health and safety.

The Inspector General's audit recommends a number of controls that should be immediately instituted. The Sierra Club, the country's largest grassroots conservation organization with more than 750,000 members, is dismayed that the regulatory agency continues to fail to ensure that common agricultural products are not contaminated by non-approved substances. As a result, USDA is not meeting its obligation to protect the public and farmers.

The solution is to create a better regulatory framework, something we and others have been asking for for many years. Among the elements of a new and more effective system would be:

* No "pharm" in food crops. Food crops should not be genetically engineered to produce pharmaceuticals.

* No outdoor field trials of pharm crops — experimental work should be done in secure, enclosed spaces.

* Applications must include a plan for extreme weather conditions (tornadoes, hurricanes, floods, etc.).

* The full genetic sequence of the insert and any partial inserts or induced mutations, and the name of the biopharmaceutical chemicals must be included in the application, not shielded as confidential business information.

* A test kit able to detect contamination must be made available to the Agency for free and to the public for a reasonable price.

* The application process should be open to public scrutiny.

* Test locations should be accurately specified including GPS latitude and longitude coordinates.

* Companies and institutions should be required to have adequate insurance against liability caused by gene outflow into farms or wilderness.

* No genetically engineered biopharm product should ever be categorized as GRAS.

* There should be labeling and post-marketing surveillance of any genetically engineered products.

I urge you to establish an effective regulatory program to protect the public from genetically engineered pharm crops. Thank you for your consideration, and I look forward to your response.

Carl Pope
Executive Director
The Sierra Club

Steven L. Johnson, Administrator
Environmental Protection Agency
Ariel Rios Building
1200 Pennsylvania Avenue, N.W.
Washington, DC 20460
William Hawks
Under Secretary for Marketing and Regulatory Programs Jamie L. Whitten
Federal Bldg., Rm. 228-W 1400 Independence Ave. SW
Washington, DC 20250
W. Ron DeHaven, Administrator
USDA Animal and Plant Health Inspection Service Jamie L. Whitten Federal Bldg., Rm. 312-E 1400 Independence Ave. SW
Washington, DC 20250
Cindy Smith, Director
Biotechnology Regulatory Services
4700 River Road, Unit 147
Riverdale, MD 20737
Jim Jones, Director
Office of Pesticide Programs
U.S. Environmental Protection Agency
Ariel Rios Building
1200 Pennsylvania Ave. NW
Washington, D.C. 20460
Andrew C. vonEschenbach, M.D.
Commissioner, U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857-0001

Jim Diamond, M.D.
Member, Sierra Club Sustainable Planet Strategy Team
Member, Genetic Engineering Committee
[email protected]
Laurel Hopwood, Chair
Sierra Club Genetic Engineering Committee
[email protected]


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