FDA Takes Close Look at Bioengineered Food
By STEVE MITCHELL, UPI Medical Correspondent
WASHINGTON, Aug 12, 2002 (United Press International via COMTEX) -- Concerns
about the potential for future genetically engineered foods to cause allergic
reactions has spurred the Food and Drug Administration to hold a meeting to look
into the best methods for determining whether these foods pose an allergic risk.
The meeting, to be held Tuesday and Wednesday, is the first of the newly
developed food biotechnology subcommittee, an FDA spokeswoman who requested
anonymity told United Press International.
The subcommittee, which includes representatives from industry and a consumer
interest group, will "discuss different approaches to assess whether
proteins in bioengineered foods would be likely to cause allergic reactions or
not," the spokeswoman said.
The meeting will be used to develop guidance for the tests industry should
conduct on the products they are developing to "ensure the safety of new
bioengineered foods for consumers," she said.
Asked whether the agency was concerned about the allergic potential of these
foods, she said, "We're looking into it."
Gregory Jaffe, director of Center for Science in the Public Interest's
biotechnology project, said the potential for bioengineered foods to cause
allergic reactions "is definitely of concern."
So far none of the bioengineered foods currently on the market appear to be
causing allergies or other adverse reactions in people, Jaffe said.
However, there are concerns about future generations of bioengineered crops
because they are likely to contain more complicated genetic modifications, he
said. "The next generation will be more complex and may raise additional
safety concerns," he said. "Toxicities and unintended effects are of
concern too."
Mike Rodemyer, executive director of the Pew Initiative on Food and
Biotechnology, which does not take a position on genetically modified foods but
seeks to stimulate dialogue and debate about the issues pertinent to this new
field, concurred with Jaffe.
"The issue really is trying to look ahead at next generation of products
where we really haven't had experience before," Rodemyer told UPI. The next
generation may have proteins that have not been in the food supply before, so
"it's really an unknown and the question is how do you screen for that
ahead of time," he said.
Jaffe said the FDA should have been advising companies on the appropriate
tests to rule out allergenicity "a lot earlier." This is because
several bioengineered foods are already on the market and in the food supply,
including Monsanto's Roundup Ready corn and soybeans, which have a gene that
makes them resistant to herbicides.
Rodemyer said the real concerns regarding bioengineered foods are about
allergenicity rather than toxicity. There "isn't really a good scientific
test to predict ahead of time whether a protein causes allergies," he said,
but "we know how to screen for the kind of obvious changes in
toxicity."
Allergen screening involves comparing proteins from genetically modified food
plants to known allergens and testing for digestibility -- a characteristic of
allergens is that they do not readily break down in the digestive tract. But
these tests may not always reliably indicate whether a bioengineered food will
cause allergies.
Rodemyer said some companies have bioengineered products they believe are
safe but because the tests are so crude they cannot prove they are safe. Thus
they are prohibited from bringing them to market.
A lack of good allergen tests is one factor that kept the genetically
modified corn StarLink from being approved for use in humans, Rodemyer noted.
There was no indication that it caused allergies, but it had flunked some of the
crude tests so authorities had to reject it, he said.
StarLink was approved for use in animal feed and in 2000 it accidentally got
into the human food supply and untold number of people consumed the
bioengineered corn. Although numerous people claimed to have developed reactions
as a result of eating products containing the StarLink corn, there is no
credible evidence that it caused any allergic reactions in people, Rodemyer
said.
Jaffe criticized the current approval system for bioengineered foods because
it is voluntary and does not require companies to submit safety data to the FDA.
"I don't think that instills a lot of consumer confidence nor does it give
us a chance to check what industry is doing to make sure what they are doing
really safeguards the consumer."
The General Accounting Office issued a report in May that "found that
FDA's evaluation process (of bioengineered foods) could be enhanced." The
GAO recommended that FDA randomly verify test data provided by the companies and
clarify its evaluation process of these products.
In 2001, the FDA proposed making the approval process mandatory but so far it
has not made a final decision on that proposal.
Although the current system is voluntary, companies have largely complied
with it and every company that has brought bioengineered foods to the market has
submitted safety data to the FDA.
Bryan Hurley, spokesman for Monsanto, said the company already focuses a lot
of attention on ensuring their bioengineered foods do not cause allergic
reactions. But he added that there have been improvements in tests in recent
years and Monsanto would "certainly" want to improve their allergen
testing by incorporating the latest technology.
Hurley said Monsanto has not received any reports of allergic reactions to
their bioengineered corn or soy.
The company has a number of bioengineered crops in development. The furthest
along is a new insect-resistant corn, which goes before an advisory panel to the
Environmental Protection Agency this month. It already has FDA approval and the
U.S. Department of Agriculture is in its final stages of reviewing the product,
Hurley said.
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