The lie of substantial equivalence

The biotech industry has persuaded the FDA that GE foods do not need to be
safety tested because they are "substantially equivalent" to their non-GE
counterparts. Substantial equivalence is not a scientific definition. The
concept was invented by the biotech industry to enable companies to get
their products to market as quickly as possible in order to recoup
development costs -- without the need for rigorous testing. Under U.S. law,
any new food additive must be proven safe before it can be released. But
new genes -- in spite of the fact that they can create profound and
unpredictable changes in the GE plant -- are not considered to be an
additive. If the companies provide data showing that their GE food has
roughly the same amount of protein, fat, starch, etc. as a non-GE
equivalent food, then it is deemed to be substantially equivalent to the
non-GE food and to be as safe.

The shortcomings of this approach are obvious. It cannot spot unexpected
toxins or allergens in the GE food. Such toxins and allergens may show up
in rigorous toxicological tests such as those begun by Pusztai, but these
are not being done.

As an example of the inadequacy of the "substantial equivalence" dogma, we
can look at a favorite health staple, soybeans. Soybeans have at least 16
proteins that can cause allergic reactions. In one study, a major allergen,
trypsin-inhibitor, which can block the absorption of nutrients and retard
growth, was found to be 26.7 percent higher in GE giant Monsanto's GE
Roundup Ready soybeans than in non-GE equivalents. Trypsin-inhibitor can
block the absorption of nutrients and retard growth, so perhaps it is not
surprising that the GE-fed rats did show slower and reduced growth. The
study also found other significant differences in the levels of some
nutrients and a fatty acid. Yet this study was presented to the FDA
purporting to show that the GE soy was substantially equivalent to the
non-GE type -- and FDA fell for this example of industry doublethink!9 The
GE soy was duly approved for market on the basis of "substantial
equivalence."

The same GE soy was also found to increase milk fat in cows.10 It is also
believed to have higher levels of phytoestrogens linked to reproductive
abnormalities in mice, rats and ewes as well as humans.11 Women with
estrogen-induced breast cancer, pregnant women and children may be
particularly susceptible to phytoestrogens.12

At least the soy studies were peer reviewed and published and thus open to
scrutiny by other scientists and the public. Most of the "studies" that are
presented to government regulators by the biotech industry as proof of
safety are neither peer-reviewed nor published. Because they are classed as
"commercially confidential," it is difficult, if not impossible, to gain
access to them. An increasing number of independent scientists are
challenging the quality of the "research" behind the GE drive.

As an example, Chardon LL, a GE maize intended for animal feed, is claimed
by its manufacturer, Aventis, to be not "materially different" from current
commercial varieties. The maize is currently being held up from marketing
approval in the United Kingdom by scientists and activists who have invoked
a little-used law to challenge its acceptance for sale. They have forced a
public hearing at which the feeding safety studies carried out by Aventis
have been scrutinized by independent scientists.

The scientists, from the University of Bristol's department of clinical
veterinary science, told the hearing that they had found "a failure to
investigate suspicious trends" in the death of chickens fed the GE protein
which would be expected to be in the maize. Bizarrely, the GE protein was
not even extracted from the maize in question. It was isolated from canola,
even though a GE insertion will express differently and produce different
effects in different host plants. This point has been called into question
by Pusztai and Friends of the Earth.13

Ten male broiler birds out of 140 (7.14 percent) who were fed the GE
protein in a small trial died compared to five (3.57 percent) who died in
the control group. This, they said, suggested "either a fault in the study
or a real direct effect of diet and should act as a spur for further
investigation."

The Bristol scientists also questioned the methods and conclusions of the
Aventis study. They said that the nutrition tests done by the company were
"inadequate" and "not of a standard that would be acceptable for
publication in a scientific journal."14

The GE protein (extracted from canola, not maize) also was tested on rats.
Notably, as Pusztai has pointed out, no results of examination of the gut
tissues were carried out. This is in spite of the fact the main target of a
GE food will be the gastrointestinal tract, and that there are three
published feeding studies in which the experimental rats or mice fed GE
foods showed lesions in the gut.15

Pusztai also points out that the GE protein-fed rats showed a significantly
lower weight gain than control rats. This shows that this feed -- intended,
remember, as feed for livestock -- had a poor "feed conversion efficiency."
In animal nutrition, careful consideration of feed conversion efficiency --
the amount of weight the animal puts on in relation to the amount of fodder
the farmer feeds him -- is, as Pusztai says, "one of the Ten Commandments."
In the laboratory, feed conversion efficiency is a first step in
identifying any possible anti-nutritional or toxicological effects. Once
the fodder is marketed, feed conversion efficiency can be a vital factor in
the financial viability of a farm. So any differences in feed conversion
efficiency between a GE strain and a comparable non-GE strain should be
investigated and an explanation sought before it is released onto the
market.

Yet Aventis' study concluded that "there were no differences that could be
attributed to the treatment of the test article [GE protein]." Period. Thus
substantial equivalence has become a dogma that, in practice, means that
any differences in composition or nutritional effects noted in GE-fed test
subjects are simply ignored.

To many campaigners, though, the most shocking aspect of this story is not
that it drives a coach and horses through the dogma of substantial
equivalence. It is not even that the study raises safety questions about
the maize, serious though that is. It is that this story -- like the fiasco
of the recent contamination of the U.S. corn crop with an unapproved GE
corn, Starlink -- was brought to light not by government regulators, and
not by the companies responsible, but by Joe Public.

Similarly, the Starlink contamination, now thought to affect scores of
products, only came to light because lay members of consumer groups thought
to have some taco shells tested by a lab. The Aventis study never would
have been scrutinized by independent scientists if Friends of the Earth
hadn't gone to the time, trouble and expense of arranging the review. Even
some of the more worrying aspects of the published Padgette study on GE soy
were not made public until a campaigner unearthed the details.16

The rBGH scandal

The sad history of suspect science continues with other GE products now in
the U.S. food chain. Millions of Americans drink milk from cows treated
with Monsanto's genetically modified Bovine Growth Hormone (rBGH or
rbST)17, injected into cows to increase milk yield. Monsanto claims that
milk produced in this way is "substantially equivalent" to milk from
untreated cows and therefore does not need to be labeled. In fact, the
company has aggressively opposed labeling and has sued two dairies that
labeled their milk as coming from rBGH-free herds, forcing the dairies out
of business. Studies show, however, that rBGH causes excessive suffering
and illness in cows and that it increases an insulin-like growth factor,
IGF-1, in their milk. Raised levels of IGF-1 are linked to breast and
prostate cancers in humans.18

Despite intense lobbying from Monsanto, Canada and Europe have refused to
approve rBGH. In Canada, the approval process was plagued with allegations
of conflicts of interest among regulators, cover-ups and harassment of
whistle-blowers. Six Health Canada scientists testified to a labor board
that they were pressured by their employers to approve the hormone despite
their concerns that it was not safe. They also said they were ordered not
to speak publicly about their findings.19

How did the hormone get past the U.S. regulators? At the time the FDA
formed its rBGH policy, its deputy director of new animal drugs was
Margaret Miller, a former Monsanto scientist who had worked on the
company's rBGH "safety studies." And a reviewer for rBGH in FDA's office of
new animal drugs was Suzanne Sechen, who had done several Monsanto-funded
studies on the drug. Former Monsanto lawyer Michael Taylor wrote for the
FDA its guidelines that virtually prohibit dairy corporations from giving
information on use of rBGH on product labels.20 U.S. government documents
released by the Sierra Club of Canada showed that the study that led to the
approval of the hormone in the United States actually found that 30 percent
of the rats given the drug reacted with increased levels of antibodies and
lesions and cysts in their thyroid glands.21