|
The testing conducted by the FDA and CDC could easily miss possible
allergic reactions to StarLink's Cry9C protein due to three major
flaws in the test protocol:
- The group that was tested is too small
to be representative of the potentially affected population;
- The FDA used a questionable testing
method; and
- Special risks to infants, children
and farm workers were not taken into consideration.
These issues, first raised by independent allergy experts on the
EPA's StarLink Scientific Advisory Panel (SAP), must be addressed
before the EPA decides whether or not to approve StarLink corn in
the food supply.
The group tested for allergic reactions is too small; hundreds
of allergy reports not investigated.
The FDA has tested only 18-20 people, "a handful of self-reported
cases." Because millions of people have been exposed to StarLink,
negative results from just 18-20 cases only show that more
testing is needed.
This is why the SAP called on the FDA to widen the scope of the
investigation by collecting additional corn-related allergic complaints
from the medical and allergy communities, and testing farm workers
exposed to StarLink. The FDA has not only disregarded these recommendations,
it has also ignored hundreds of allergy
reports from the food industry.
Food company data submitted to the FDA show a dramatic increase
in allergic complaints after the first disclosure of StarLink contamination
(Kraft Taco Bell taco shells) on Sept. 18, 2000. The food industry
says these reports are media-driven. But Dr. Hugh Sampson, a leading
allergist who served on two expert StarLink panels, points out that
because normal corn is rarely allergenic, few people would have
suspected StarLink as the cause of their allergic reactions until
news of the contamination broke.
"Test results from such a small sample
could easily have missed allergic reactions," said
Bill Freese of Friends of the Earth. "The EPA¹s scientific
advisors specifically said that the investigation should be broadened,
yet FDA chose to ignore that advice. A thorough investigation is
exactly what the public deserves."
"There is no way a credible scientist could rule out Cry9C
as a potential human allergen," said Dr. Rebecca Goldburg,
Senior Scientist at the Environmental Defense. "I'm especially
concerned about the risk to children, who are much more vulnerable
to allergies than adults. The FDA¹s investigation should have
included more children."
Despite the Scientific Advisory Panel's (SAP) recommendation to
widen the scope of the investigation, FDA
chose to ignore hundreds of consumers who reported allergic reactions
to corn products that may contain StarLink. These reports were unearthed
from FDA and EPA documents obtained by Genetically Engineered Food
Alert. In one report, 210 consumers blamed corn for allergic reactions,
74 visited doctors, while 20 more had to seek emergency care.
"It would be unacceptable to approve StarLink for human consumption
when the science is clearly incomplete," said Matt Rand, Biotechnology
Campaign Manager at the National Environmental Trust. "The
American public deserves a full and thorough testing of StarLink
corn so they do not become the guinea pigs for a dangerous experiment
on food allergens."
Other suggestions that the Scientific Advisory Panel made and the
FDA ignored include:
According to the SAP's allergy experts, young children are at the
greatest risk of developing allergies to novel genetically engineered
proteins such as Cry9C. Yet FDA seems to have tested only one child.
The SAP recommended that the medical community should be informed
of the investigation into the allergenicity of Cry9C in corn products.
In addition, FDA should monitor reports from the medical community
to supplement the cases currently under investigation and to provide
additional support for proving or refuting the allergenicity of
Cry9C.
Friends
of the Earth June
13, 2001
For more information, contact Bill Freese of Friends
of the Earth (FoE), part of the Genetically Engineered Food
Coalition. Phone: 301- 985-3011, e-mail: billfreese@prodigy.net
| 