DC, June 3, 2004 (ENS): The use of genetic
engineering to grow drugs or industrial chemicals in
food crops is gaining ground, according to a new report
from the Center for Science in the Public Interest (CSPI),
nonprofit health advocacy group.
The U.S. Department of Agriculture (USDA) has received
16 new applications for biopharming permits in the past
12 months. About two-thirds of those applications involved
a food crop such as corn, rice or barley, but no other
detail about the application, including the name of
the drug or chemical being produced, is kept from the
"It is impossible to know whether these biopharmed
crops present any food safety or environmental risk,
since the whole process is shrouded in secrecy. Even
the Food and Drug Administration is out of the loop,"
said Gregory Jaffe, director of CSPI’s biotechnology
project and the author of the report.
"What is clear is that the biopharming industry
has been given a big green light by federal regulators,
even though there is great concern among food producers
and consumers about using food crops to produce drugs,"
According to the report, six permit applications involved
genetically engineered (GE) corn, two involved GE barley,
and one permit application each involved GE rice, safflower,
and Indian mustard. Five permits involved tobacco, a
"When non-food crops like tobacco can be used
for biopharming, it is unnecessarily risky to use crops
like corn or rice without a much stronger and more transparent
regulatory system," said Jaffe. "It would
be a public relations catastrophe for both the biotechnology
industry and the food industry if even minuscule amounts
of vaccines or other drugs ended up in cereal."
Although the public portions of the permit applications
do not disclose the proposed acreage of the crop, they
do list states. Four permit applications identified
Kentucky as the location; three identified Texas; Missouri,
South Carolina, California, and Iowa were each identified
on two applications; Hawaii, Florida, Washington, Nebraska,
and Arizona were each identified on one.
Nothing in the public parts of the applications details
whether the permit would be for a field trial or for
full scale commercial production. Nor do the applications
fully disclose which organism's genes are being spliced
into the crop or what substance the company hopes to
Judging from USDA's past record, the CSPI expects that
most of the outstanding permit applications will be
approved. While CSPI advocates for strict regulatory
oversight of genetically engineered crops, it believes
that agricultural biotechnology holds great promise
for human health and the environment.
The CSPI's report recommends that food crops should
not be used for biopharming unless protection is assured
through a strong regulatory system. The group also recommends
that the USDA conduct environmental risk analyses before
permits are issued, and that the Food and Drug Administration
conduct food safety risk analyses if a food crop is
to be used to produce substances commercially.
An incident in 2002 set alarm bells ringing even for
major manufacturers of processed foods who may support
genetic engineering to improve crop yields or resist
insects. The U.S. Department of Agriculture’s
Animal and Plant Health Inspection Service identified
two violations of ProdiGene, Inc.’s field test
permits - one in Nebraska and another in Iowa. Volunteer
corn in both locations contained traces of unidentified
biopharmaceuticals from 2001 field trials.
The National Food Processors Association said at the
time that it "finds there is an unacceptable risk
to the integrity of the food supply associated with
use of food and feed crops as 'factories' for the production
of pharmaceutical or industrial chemicals."
Grocery Manufacturers of America (GMA) Director of
New Technologies and Environment Karil Kochenderfer
said at the time, “These incidents reaffirm GMA’s
concerns about the use of food crops for the development
of plant-made pharmaceuticals.”
The CSPI report, "Sowing Secrecy: The Biotech
Industry, USDA, and America’s Secret Pharm Belt"
is online at: http://cspinet.org/new/pdf/pharma_report.pdf.