Subj: Carl Pope letter to USDA
Date: 1/12/2006 1:15:33 PM Central Standard Time
From:    [log in to unmask] (Jim Diamond)
Sender:    [log in to unmask] (Biotech Forum)
Reply-to: [log in to unmask] (Biotech Forum)
To:    [log in to unmask]




A NEW KIND OF DRUG PROBLEM
Once, the idea of pharmacologic crops brought to mind opium poppies, marijuana and coca.  Genetic engineering may change that.  Pharmaceutical companies want to produce drugs outdoors by "pharming," which means putting human and other genes in ordinary crops so that they produce novel pharmaceuticals such as vaccines or drugs to fight cancer.  A recent report by the Inspector General of the U.S. Department of Agriculture found that the Animal Plant and Inspection Service (APHIS) has granted over a thousand permits for field tests -- producing potentially dangerous drugs out of doors with low security -- but is doing little monitoring to ensure public safety and has often lost track of where these drugs crops are being grown.
Sierra Club executive director Carl Pope has addressed a letter to USDA, APHIS, the FDA and others calling for a better regulatory framework.  Pope says, "USDA is not meeting its obligation to protect the public and farmers" and notes that this is something that Sierra Club, the nation's largest grassroots environmental organization with over 750,000 members, has been asking for for many years.  Among the points in Pope's letter are demands that "biopharm" should not use food crops like corn and rice, and that testing should be done, if at all, in indoor, enclosed spaces.
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.

Sincerely,

Carl Pope
Executive Director
The Sierra Club


Copies:
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
USDA APHIS
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

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - To get off the CONS-SPST-BIOTECH-FORUM list, send any message to: [log in to unmask]

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - To get off the IOWA-TOPICS list, send any message to: [log in to unmask]