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6-Regulation: Are GMOs being regulated in the U.S. or not?

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TITLE:  Are GMOs being regulated or not?
SOURCE: Farm News from Cropchoice, USA, by Claire Hope Cummings
DATE:   June 11, 2003

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Are GMOs being regulated or not? 

by Claire Hope Cummings, M.A., J.D.

(Wednesday, June 11, 2003 -- CropChoice guest commentary) -- New genetically
modified organisms (GMOs) are on the loose and they are causing trouble.
These are not the GMOs most people hear about: soybeans that resist weed killers
or corn that kills insects. These are experimental crops that contain
pharmaceutical proteins, industrial chemicals, even human genes.

They are being grown outdoors in hundreds of secret locations all over the
country, in open-pollinated plants such as corn. This powerful new use of
biotechnology is called "pharming," and it poses very real threats to our
personal and environmental health. Cases of pharm contamination have already
occurred, raising new criticisms of the regulatory system in the United States.

When GMOs were first introduced into agriculture, farmers and consumer
groups questioned the lack of basic protections. Since then, GMO contamination has
spread from the corn fields in the Midwest to the birthplace of corn in the
remote mountains of Mexico. Farmers have not been able to protect themselves
from this genetic trespass. Instead of holding GMO manufacturers liable, the
courts are upholding the patent rights of seed companies and making the
farmers pay. Taxpayers are subsidizing the costs of GMO food recalls. While
national polls show that well over 90% of U.S. consumers want GMO food labeled,
government regulators still refuse to consider it.

By almost any measure, regulatory oversight of agricultural biotechnology is
failing to protect the public interest. The reason is, it was designed that
way. Long before there were any products ready for market, the GMO
manufacturers were in Washington, D.C. taking pre-emptive action to ensure that the
regulatory climate would favor their interests. The industry wanted to leave
just enough regulation in place to give the public a sense of assurance, while
leaving the manufacturers free of any real restraint.

In 1986, then Vice-President George Bush hosted Monsanto executives at the
White House to discuss the "deregulation" of biotechnology. Then, after he
became President, the framework that had been constructed during years of
behind-the-scenes negotiations was announced by his Vice- President, Dan Quayle.
Brushing aside the concerns voiced by independent scientists, farmers and
consumer groups, Quayle said that "biotech products will receive the same
oversight as other products" and not be "hampered by unnecessary regulation."

The system that was created then is still in force today, with only a few
minor exceptions. Basically, it was decided that there would be no new laws
passed governing biotechnology. As a result, federal agencies are still
struggling to evaluate and approve a plethora of new and potentially dangerous
products, using laws designed to deal with chemicals and pathogens, not genetics.
And they continue to be constrained by concepts developed with the best
science available in the 1960s.

The reporting system is essentially voluntary and industry is trusted to
inform the government of any problems that arise. It's sort of a "don't tell,
don't ask" arrangement. If industry does not tell government what it knows or
suspects about its GMOs, the government does not ask. Once crops are released,
there is no monitoring or follow-up. Agencies are free to ignore significant
findings from independent sources, including reports about the nutritional
deficits in food made from GMO crops, how genes wander when GMO crops cross
with other plants, about recombinant viruses on the loose, and the growing
problems of resistance and tolerance, to name just a few. As a result, evidence
of emerging human health and ecological problems are routinely disregarded.

The federal government says that its processes are rigorous. It says that
the lack of any reported human health problems associated with GMOs is evidence
of its effectiveness. The biotech industry claims that their products are
"the most studied" on the market. But the industry is simply referring to the
studies they have done as they develop the product. They are not referring to
any post-market evaluation. Underneath the government 's claims of safety
lies a little known but fundamentally flawed idea that undermines the whole

The governing principle behind the regulation of GMO food and agriculture is
a concept called "substantial equivalence." It means that a GMO crop can be
considered to be just the same as a conventional crop. Unfortunately there is
no scientific justification for this idea. According to an article in the
prestigious scientific journal Nature, the concept of substantial equivalence
is "pseudo-scientific." The article calls this idea a "commercial and
political judgment masquerading as if it were scientific" and it was "created
primarily to provide an excuse for not requiring biochemical or toxicological
tests." Legislators have never agreed on the meaning of substantial equivalence.
This ambiguity, according to the article, "acts as a barrier to further
research into the possible risks of eating GMOs."

As applied, substantial equivalence means that regulators only look at a GMO
product itself. They do not take the process used to manufacture it into
consideration. This is a crucial mistake, because it is the process that makes
GMOs unique. GMOs are organisms that can not be created using traditional
breeding methods. The process is imprecise and unpredictable and more often than
not, it results in failure. Getting a useful product out of that process
depends on the use of viral vectors, anti-bacterial markers, promoters, switches
and other genetically altered molecules to succeed. And it is these
process-related molecules that should trouble us. They are the basis for some of the
safety concerns of other countries and international biosafety protocols.

It is also revealing to take a look at how the three executive agencies that
are primarily responsible for GMOs operate. The Food and Drug Administration
(FDA), an agency of the Department of Health and Human Services, oversees
GMO foods. The Environmental Protection Agency (EPA) deals with GMO pesticides.
The Animal and Plant Health Inspection Service (APHIS), an agency of the
United States Department of Agriculture (USDA), administers GMO plant testing in
the field. All three operate only under their own legislation and none of
their efforts are coordinated. The USDA relies on the Plant Pest Act, which
narrowly defines plant pests and does not include all the processes or organisms
currently used in genetic engineering. Permits for field tests are obtained
from APHIS through a simple notification process, after which they are
deregulated. There are only bare standards for biological containment of the field
test and no provisions for evaluating certain ecological risks. APHIS can
require an environmental assessment if the applicant indicates one might be
required. A study of over 8,000 field test results submitted to the USDA showed
that not one resulted in an environmental assessment.

The FDA uses the Food, Drug, and Cosmetic Act to review GMOs. The
substantial equivalence doctrine fits nicely with FDA logic. It goes like this: any
"novel" substances in food must be tested and perhaps labeled. However, if
something can be "generally regarded as safe" (GRAS), as most conventional foods
are, then they are exempt. Since GMOs are "substantially equivalent" to
conventional food, they are considered GRAS and thus they do not require testing or
labels. The EPA makes some effort to deal with the environmental impacts of
GMOs. It regulates GMO pesticides (primarily the Bt crops) under the Federal
Insecticide, Fungicide, and Rodenticide Act and the Toxic Substances Control
Act. The EPA operates under the assumption that Bt is safe, even though GMO
Bt has been shown to have detrimental impacts on soil micro-organisms and
beneficial insect populations. The EPA recommendations and permit requirements,
such as its Insect Resistance Management Plans for farmers, which are supposed
to slow down the development of resistance to Bt, are not adequate to the

Here is an example of how this regulatory patchwork plays out in the field:
In April 2003, the EPA announced that a company growing experimental GMO corn
in Hawaii had finally satisfied the agency's regulatory requirements. The
company, Pioneer Hi-Bred, had been fined for permit violations in 2002 and was
ordered to test and report its findings to the EPA to ensure that their
experimental corn did not contaminate nearby fields. When the company failed to
report on its testing, in direct violation of its agreement with EPA, it was
fined again. Later, after acquiring and reviewing the test findings, the EPA
said it was satisfied that the company was in compliance. But did that mean
there was no contamination? No, there was. But it involved fields that were
regulated by the USDA, so the EPA was not concerned about that. For their part,
the USDA had no comment, saying it was investigating. Meanwhile, the company
has asked neighboring farmers on the island not to plant any of the crops that
Pioneer is using in its experiments, as a way of avoiding


Claire Hope Cummings was a lawyer for the USDA during the Carter
Administration. She has farmed in California and in Vietnam where she had an organic
farm along the Mekong River. As a print and broadcast journalist, she covers the
environmental and cultural costs of industrial agriculture and follows the
progress of the sustainable agriculture movement. Her latest work on
agricultural biotechnology "Risking Corn, Risking Culture" was published in World
Watch Magazine in December, 2002, and she has written A Farmer's Guide to GMOs
for Farm Aid and The National Family Farm Coalition, and the Environmental
Media Services Reporter's and Editor's Guide to Genetic Engineering in
Agriculture. She is a 2001 Food and Society Policy Fellow.



 Hartmut Meyer       
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