Subj:   ENS coverage of FDA proposed rules
Date:   01-01-19 16:14:03 EST
From:   JMDia

       This is much better coverage of the issues than was in the newspapers.
 If you can't read the below because of formatting problems, it's all
available at <A
HREF="http://ens-news.com/ens/jan2001/2001L-01-18-07.html">http://ens-news.com

/ens/jan2001/2001L-01-18-07.html</A>
             Jim

Biotech Foods Rule Fails to Protect American Public
By Cat LazaroffWASHINGTON, DC, January 18, 2001 (ENS) - Consumers concerned
about the potential health and environmental effects of genetically
engineered foods will not find much to like in new federal regulations
released this week. The regulations, which provide guidance for the release
and marketing of food developed through biotechnology, do not require
labeling or premarket testing of engineered foods. Geneticist Ann Blechl
looks at root growth on genetically engineered wheat plants that may carry
new genes for resistance to a bacteria (Two photos by Jack Dykinga, courtesy
Agricultural Research Service)After months of controversy, the Food and Drug
Administration (FDA) released its proposed biotechnology foods rule on
Wednesday. Despite receiving tens of thousands of comments supporting
mandatory labeling of genetically engineered (GE) foods, the FDA opted to
support voluntary labeling guidelines. The proposed rule, if finalized, would
require food developers to notify the FDA at least 120 days in advance of
their intent to market a food or animal feed developed through biotechnology.
The FDA agency said it would post information submitted by manufacturers, as
well as FDA's responses, in the agency's electronic reading room, located at:
<A
HREF="http://www.fda.gov/foi/electrr.htm">http://www.fda.gov/foi/electrr.htm</

A> Manufacturers would also need to provide information to demonstrate that
the product is as safe as its conventional counterparts, but the FDA did not
set out requirements for how that information is obtained. Critics of GE
foods and many scientists had pushed for minimum research requirements, such
as 90 day safety tests, before new GE foods could be approved for the market.
In a separate but related action, FDA issued a draft guidance document which
would provide direction to manufacturers who wish to label their food
products as being made with or without ingredients developed through
biotechnology. Labeling of GE foods would be entirely voluntary, and would
focus largely on "truth in advertising" requirements that the labels
accurately reflect the foods' contents. Half the soybeans planted in the U.S.
in 2000 came from genetically modified seeds (Photo by Scott Bauer, four
photos courtesy Agricultural Research Service)"These initiatives will further
assure that all food products developed using the tools of modern
biotechnology are known to the Food and Drug Administration, so that FDA can
continue to examine these products before they reach the market" said FDA
commissioner Jane Henney, MD. "These measures will permit the review process
to be more transparent to the public, one of the primary issues voiced during
FDA's public hearings on this issue." But the new rule has come under heavy
criticism from science and environmental groups who say that the FDA's
proposal fails to protect public health and the environment. "This is a
terrible day for American consumers - the government has failed to protect
their health and their interests," said Kimberly Wilson, a Greenpeace genetic
engineering campaigner in San Francisco. "While the rest of the world is
moving to label genetic foods, U.S. consumers are still denied free choice in
the grocery store. Americans deserve to know what's in their food, yet FDA is
working with industry to keep genetic engineering a secret ingredient." This
bioengineered barley carries a gene that may help the plants resist attack by
barley yellow dwarf virus (Photo by Jack Dykinga)Labeling of genetically
engineered foods is required throughout Europe, and in Japan, Russia,
Australia, New Zealand and other countries. "These powerless proposals fly in
the face of public and expert input. In 1999 FDA received 35,000 letters
making it clear that consumers want genetically engineered foods to be safety
tested and to be labeled. These proposals do not require either," said
Environmental Defense senior scientist Dr. Rebecca Goldburg. Environmental
groups charge that the industry backed studies that the FDA relies on for
information about the safety of GE foods are rarely rigorously conducted or
peer reviewed, nor are they available for public scrutiny. The FDA's pledge
to post information on its own website does not correct this problem, critics
said. "Clearly the FDA doesn't have a taste for regulating genetically
engineered foods and continues to avoid industry oversight that has any
substance," said Goldburg. "This consultation process is watered down
consumer protection, calling only for notification, not true regulatory
review. FDA will not require industry to demonstrate the safety of new
biotech foods before they go on supermarket shelves. To make matters worse,
consumers may be shut out of the consultations, since industry is allowed to
keep safety data confidential until consultations are finished." Plant
physiologist Ken Gross examines tomato fruit used in a genetic engineering
research program (Photo by Keith Weller)Doctors and scientists have warned
that genetically engineered foods could trigger allergies, have increased
levels of toxins, or could hasten the spread of antibiotic resistance. The
medical journal "Lancet" has stated: "It is astounding that FDA has not
changed their stance on genetically modified food. Governments should never
have allowed these products into the food chain without insisting on rigorous
testing for effects on health." Last year, StarLink genetically engineered
corn, which is not approved for human consumption, was found in tacos shells
and other corn products on grocery store shelves. The Genetically Engineered
Food Alert, a campaign endorsed by scientists, religious leaders, doctors,
chefs, environmental and health leaders, as well as farm groups, uncovered
the presence of the GE corn through independent testing, only later confirmed
by the FDA and other federal agencies. The Starlink debacle prompted over
three hundred food product recalls, causing millions of dollars in losses to
food processors, grain mills and farmers across the country. Many countries
will not accept shipments of American corn, fearing that even corn labeled as
organic may be contaminated by one of the handful of GE varieties now on the
market. Corn engineered to produce the Bt toxin reduces the impact of
European corn borers ... "Regulation, labeling, and an open decision making
process are vital for consumer confidence abroad as well as at home," said
Goldburg. "FDA's proposals can only hurt U.S. food exports and the U.S.
economy." Currently, developers of food and feed developed through
biotechnology participate in a voluntary consultation program with FDA. To
date, all such food and feed marketed in the U.S. have gone through the
consultation program before they have entered the market. These voluntary
consultations have not reassured foreign markets of the safety of GE foods,
and the FDA's new rule does not provide substantial additional protections,
critics charge. ... but pollen from Bt corn could harm monarch butterfly
larvae (Photo by Kent Loeffler, courtesy Cornell University)"This policy
means that the FDA will not require any mandatory testing on genetically
engineered food," said Andrew Kimbrell, executive director of the Center for
Food Safety and member of the Genetically Engineered Food Alert coalition.
"Under these rules, American consumers will still be the guinea pigs testing
the safety of these foods. Voluntary labeling means consumers won't see any
labels out of this, and won't have a right to choose." In fact, the burden of
proof will fall largely on those companies who wish to market their products
as "GE free." These companies will be forced to perform a battery of tests,
at their own expense, in order to prove that their "GE free" labels are not
"false advertising." "FDA's new voluntary labeling policy serves the
interests of a few biotechnology companies at the expense of the rest of the
food industry and millions of consumers," said Richard Caplan, environmental
advocate at the State Public Interest Research Groups. The full text of the
FDA proposal is available at: <A
HREF="http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm">http://www.acc

essdata.fda.gov/scripts/oc/ohrms/index.cfm</A>, under the listing for January
18, 2001 The draft guidance on voluntary labeling is available at:<A
HREF="http://www.cfsan.fda.gov/~dms/guidance.html">http://www.cfsan.fda.gov/~d

ms/guidance.html</A>, under "Food Labeling"

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