Los Angeles Times
January 7, 2001,
Sunday
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.