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: <A HREF="mailto:[log in to unmask]">[log in to unmask]</A> (Biotech Forum)
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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 

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