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FDA Ignored Troubling Data on Monsato's Gene-Altered Soybeans

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Los Angeles Times
January 7, 2001, Sunday
BIOTECH: SOME FOOD FOR FDA REGULATION
Barbara Keeler and Marc Lappe,

Barbara Keeler is a medical writer. Marc Lappe, former head of,
California's Hazard Evaluation System, is the author of "Against the,
Grain" and director of the Center for Ethics and Toxics

Despite consumer pleas, the Food and Drug Administration has declined
since 1992 to require that genetically modified food seeds be proved
safe for consumption before their release into the food supply. Nor does
the FDA require ingredient labels for genetically modified foods.
Instead, the agency encourages producers to voluntarily submit safety
data. Its rationale is that genetically modified foods are substantially
equivalent to their conventionally grown counterparts. In other words,
food is food, and according to food and drug law, foods are presumed
safe. The flaw in this policy is that the presumption of equivalence
does not rest on a substantial body of research comparing genetically
modified and conventional foods. Far from being confirmed by extensive
research, this presumption is challenged even by the producers
themselves, notably in a study that Monsanto conducted on one of its
biotech foods. Rather than prove safety, this study raised red flags
that should have prompted researchers and the FDA to call for more
testing.

Instead of requiring further testing, the FDA allowed the most commonly
consumed genetically modified soybeans, which are produced by Monsanto,
to flood the market and rapidly pervade the food supply. To create its
soy, Monsanto scientists spliced a gene into a soybean
seed that instructed it to grow even when sprayed with Monsanto's potent
weed killer, Roundup. Accordingly, when Roundup is sprayed on soy
fields, Monsanto's Roundup Ready soy plants are left standing while
nearly everything else is smoked. This strategy is not exclusive to
Monsanto. The most common genetically modified foods that the FDA
regulates tolerate a specific herbicide manufactured by the company
engineering the seed. Consumers don't benefit, but sales of the
companies' herbicides soar. Herbicide-tolerant plants survive weed
killers, but what about the health of consumers who eat genetically
modified beans?

According to the FDA's 1992 policy, Monsanto was not required by law to
prove the safety of its beans to the FDA before marketing Roundup Ready
soybeans. This regulatory effect must be corrected. Toward that end,
legislation compelling the FDA to require premarket proof of safety for
all genetically modified food seeds should be passed. Monsanto did turn
over a study to the FDA in 1994. Eventually published by the Journal of
Nutrition in March 1996, the study claimed to prove that Roundup-
tolerant soybean seeds are equivalent to conventional ones. But combined
data from the study's three experiments showed significant differences
in fat, carbohydrates, ash and some fatty acids. Also, the brain-
boosting vitamin choline was 29% lower in Roundup Ready lecithin, which
is commonly used as a source of choline.

Monsanto's researchers decided in advance to test Roundup Ready soybeans
that would differ in important respects from the beans people would
eventually eat. While both the tested beans and those on the market
carried the Roundup-tolerant gene, the Roundup Ready beans now common in
food products were actually treated with Roundup; the ones Monsanto
tested and fed to animals were not. Beyond differences in nutrient
content, the findings also raised questions about allergens. Allergic
reactions are most commonly triggered by undigested proteins. One table
in Monsanto's study shows that, relative to conventional soy meal, raw
Roundup Ready soy meal contained 27% more trypsin inhibitor, a potential
allergen that interferes with protein digestion and has been associated
with enlarged cells in rat pancreases. This important measurement was
camouflaged in a table on unrelated information. Because its policy does
not require premarket proof of safety or equivalence for genetically
modified food, the FDA had little basis for rejecting the study's
results. Perhaps more important, the FDA did not see all the data,
specifically, that from Experiment 1, the first of the study's three
experiments. According to FDA representatives, the agency did not ask to
see the data.

What did the omitted data show? Significantly lower levels of protein
and one fatty acid in Roundup Ready soybeans. Significantly lower levels
of phenylalanine, an essential amino acid that can potentially affect
levels of key estrogen-boosting phytoestrogens, for which soy products
are often prescribed and consumed. And higher levels of the allergen
trypsin inhibitor in toasted Roundup Ready soy meal than in the control
group of soy. Even more unsettling was one measurement of trypsin
inhibitor in toasted Roundup Ready soy meal that exceeded what the
authors reported as the highest levels measured for soybeans by other
researchers. After a second toasting, the levels of another allergen,
called lectin, in Roundup Ready soy meal, were nearly double those in
conventional beans. Monsanto also conducted a study of the effects of
consuming its genetically modified beans, which was also presented to
the FDA. Besides possible allergic reactions, what might be expected
from consuming higher levels of trypsin-inhibitor and lectin? Slower, or
lower, growth, for starters. That is what happened to male rats fed
unprocessed meal from Roundup Ready soybeans. Compared with controls,
cumulative body weight gains were significantly lower in male rats fed
Roundup Ready soy. Although the growth of dairy cattle was not affected,
higher levels of fat were measured in the milk of cows fed Roundup Ready
soy meal.

These analyses did not reveal all the differences between Roundup Ready
and conventional beans. In May 2000, Monsanto reported to the FDA the
discovery of a genetic surprise package in its soybeans. When company
scientists spliced the Roundup-tolerant gene into the bean, they accidentally
threw in two extra gene fragments. Not to worry, according to Monsanto
representatives: The gene fragments were contained in the Roundup Ready
beans approved by the FDA in 1994 and have been consumed nearly
worldwide ever since.

But this discovery further challenges the presumption of equivalence
between genetically modified and conventional foods, while undermining
the contention that genetic engineering is precise or predictable. Even
so, the genetic hitchhikers, like the red flags in the 1994 study, were
barely mentioned in the U.S. media and did not appear to raise FDA
concern. Do Monsanto's own findings prove that Roundup Ready soy
products will slow or stunt growth in animals and children, or change
the fat content of milk in cows and breast-feeding mothers? Of course
not. Do they prove that all Roundup Ready soy will always contain more
allergens and less protein? No. But the studies do confirm that
transgenic foods need rigorous testing--by someone other than the
affected industries and the researchers they fund--before they're
released into the food supply. They also suggest that consumers may not
be adequately protected when the FDA leaves the question of biofood
safety up to the companies selling the biofoods. A promised and
long-awaited revision of FDA biotech-food policy is expected to make
some improvements in oversight, but as outlined in the agency's press
release, it is expected to fall far short of what is needed to ensure
the safety of biotech foods.

In drafting its 1992 policy, FDA representatives relied primarily on an
opinion by FDA attorneys that food and drug law did not give the agency
responsibility for labeling transgenic foods, and the relevant food and
drug law has not changed. Rep. Dennis J. Kucinich (D-Ohio) and Sen.
Barbara Boxer (D-Calif.) have introduced legislation calling to alter
this situation. The Genetically Engineered Food Safety Act, co-authored
by Kucinich, provides for mandatory safety testing of genetically
modified foods before they are released into the food supply. Many
food-safety activists target food manufacturers, food retailers and
fast-food chains when demanding a recall of genetically modified foods.
Given the pervasiveness of biofoods in the marketplace, and the challenges
in detecting them, their time and energy would be better spent supporting
legislation proposed to change regulatory policy that victimizes food
manufacturers, retailers and consumers alike.

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