[Date Prev][Date Next][Thread Prev][Thread Next][Date Index][Thread Index]
[SANET-MG] open secretive biopharm permit process
The article below makes an important point. The end point of such tests
may be more serious than mentioned in the article, human death as in
the case of aprotinin which is used in surgery. A single exposure to
corn with aprotinin in the field may sensitize a person fatally to
exposure during surgery or a second exposure to the modified corn. Or a
person having had surgery could be killed by exposure to the modified
corn test plot that frequently are a hundred acres or more. Death by
anaphylactic shock is not fun.
Open secretive biopharm permit process 2004-06-02
By Christopher Doering
Washington - The United States agriculture department's process for
approving permits to grow biopharmaceutical crops is "shrouded in
secrecy", making it difficult to know if the crops pose a risk to humans
or the environment, a study said on Wednesday.
The activist group Centre for Science in the Public Interest (CPSI) said
the USDA's failure to disclose more details, such as the drug or
chemical being produced, could lead to problems.
"It is impossible to know whether these biopharmed crops present any
food-safety or environmental risk, since the whole process is shrouded
in secrecy," said Greg Jaffe, a director of biotech projects at CSPI who
authored the study.
'It is impossible to know whether these crops present any risk'
Biopharming, which uses plants to generate proteins that now cost
millions of dollars to make in large fermentation facilities, has drawn
the interest of several biotech companies.
Developers believe that plants engineered to produce specific proteins
or compounds to treat illnesses like diabetes could cut the costs of
producing some drugs.
Biopharming has shown signs of recovering from a 2002 incident when
experimental corn plants grown by ProdiGene were mixed with soya beans.
Cindy Smith, deputy administrator of biotech regulations at the USDA's
Animal and Plant Health Inspection Service, said the agency had already
planned to issue a report this month that addressed many of the changes
recommended by CSPI.
Smith said the USDA would begin releasing the size of the field test and
the risk assessment on the environment for each application. In
addition, the public would have 30 days to comment when the agency does
a more in-depth report on the crop's impact on the environment before a
permit is issued.
'Our regulatory system now offers those safeguards'
"Our regulatory system now offers those safeguards" to protect human
health and the environment, said Smith. "I think the difference is the
safeguards we have in place will soon be more transparent to the public
and that will allow the public greater confidence in our regulatory system."
The CSPI report called for an overhaul of the USDA permit process that
would centre on allowing the public to review the application and the
permit after it is issued.
It also recommended the USDA determine each crop's impact on the
environment, with the Food and Drug Administration assessing if the
biopharm crop would have any adverse effects if it entered the food supply.
Smith said the USDA already determined the crop's impact on the
environment before deciding whether to issue a permit.
In the past 12 months, the USDA has received 16 applications to grow
biopharm crops, with half of those in the past three months.
Six applications proposed growing corn, according to CSPI. ProdiGene
submitted four of the applications to produce pharmaceuticals with corn
in Nebraska and Texas.
"What we worry about is the potential for more ProdiGene incidents or a
contamination of the food supply or for some other detrimental effect,"
After ProdiGene, the USDA imposed tougher rules on planting industrial
and pharmaceutical crops. Biotech companies must obtain a USDA permit
that sets strict planting requirements to minimise environmental risks.
That includes planting experimental crops at certain distances from
other crops and cleaning farm equipment.
Environmentalists, consumer advocates and food industry groups have said
the USDA must impose stricter regulations on pharmaceutical crops to
prevent unapproved plants from entering the food supply. Many of the
groups oppose using crops such as corn that are consumed by humans to
generate pharmaceuticals without a stronger regulatory process.
To unsubscribe from SANET-MG:
1- Visit http://lists.sare.org/archives/sanet-mg.html to unsubscribe or;
2- Send a message to <email@example.com> from the address subscribed to the list. Type "unsubscribe sanet-mg" in the body of the message.
Visit the SANET-MG archives at: http://lists.sare.org/archives/sanet-mg.html
For more information on grants and other resources available through the SARE program, please visit http://www.sare.org.