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People are talking
Why all GE foods
should be labeled
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Alliance for Bio-Integrity
Preserving the Safety of Our Food, the Health of Our Environment,
and the Harmony of Our Relationship with Nature
www.biointegrity.org
October 10, 2002
Governor John A. Kitzhaber, M.D.
State Capitol Building
900 Court Street NE
Salem, OR 97301-4047
Dear Governor Kitzhaber,
I wish to inform you that the letter you recently received from
the Deputy Commissioner of the FDA contains several major misrepresentations
that give the false impression there are no reasonable grounds for
concerns about health risks of genetically engineered foods. In
fact, such grounds do exist, and the FDA is well aware of them through
extensive information provided by its own scientific staff. The
following paragraphs explain some of the key misrepresentations
and suggest how you can perform a valuable service to all Americans
by speaking out on behalf of science and the truth on this important
issue.
In his letter, Dr. Crawford asserts: “FDA is not aware of
any information or data that would suggest that any genetically
engineered foods that have been allowed for human use are not as
safe as conventional foods.” This assertion is made despite
the fact the FDA’s files contain numerous memos from its own
scientific experts informing it about the unique health risks posed
by GE foods. The existence of these memos only came to light when
a coalition of public interest groups and scientists headed by my
organization filed a lawsuit against the FDA that forced it to divulge
its internal files.
For example, Dr. Louis Pribyl of the FDA Microbiology Group wrote,
"There is a profound difference between the types of unexpected
effects from traditional breeding and genetic engineering ...”
He added that some aspects of gene splicing "...may be more
hazardous." (4) (Numbers refer to the document number in the
collection of photocopies of twenty-four FDA documents on our website
www.biointegrity.org ) Dr. E.J. Matthews of the FDA's Toxicology
Group warned that GE plants could contain unexpected toxins that
could "...be uniquely different chemicals that are usually
expressed in unrelated plants." (2) Citing the potential for
such unintended dangers, the Director of FDA's Center for Veterinary
Medicine (CVM) called for GE products to be demonstrated safe prior
to marketing. He stated: "... CVM believes that animal feeds
derived from genetically modified plants present unique animal and
food safety concerns." (10) He explained that residues of unexpected
substances could make meat and milk products harmful to humans.
These memos were written during the months before the FDA issued
its May 1992 policy statement on genetically engineered foods. The
pervasiveness of the concerns within the scientific staff is attested
by a January 8, 1991 memo to the agency’s biotechnology coordinator
from an FDA official responsible for monitoring the expert input.
She stated: "The processes of genetic engineering and traditional
breeding are different, and according to the technical experts in
the agency, they lead to different risks." (1). Nevertheless,
FDA political appointees – who admit they have been operating
under a White House directive “to foster” the biotechnology
industry – covered up their scientists’ warnings and
in their policy statement professed themselves “not aware
of any information” showing that GE foods differ from others
in any meaningful way. They then allowed all GE foods to be marketed
without any testing by claiming there is an overwhelming consensus
among experts they are safe. They did so despite their knowledge
that no such expert consensus exists outside the FDA either –
as evidenced by an October 23, 1991 letter from FDA’s biotechnology
coordinator to a Canadian health official. (8) To this day, FDA’s
false claim about scientific consensus remains the sole purported
legal basis for the marketing of GE foods.
It is disappointing that Dr. Crawford has renewed the fraudulent
claim that the FDA is “not aware of any information or data
that would suggest that any genetically engineered foods …
are not as safe as conventional foods.” It is especially troubling
that he is employing this falsehood in an attempt to defeat an Oregon
ballot initiative that would begin to restore the rights of consumers
to have material information about genetic alterations made to the
food supply. It is clear that the FDA has not only been denying
American citizens the labeling that could supply some of this information,
it has been intentionally deceiving them by misrepresenting the
facts and covering up the concerns about health hazards raised by
its own experts.
Dr. Crawford’s letter further misrepresents the facts by
stating: “FDA's scientific evaluation of bioengineered foods
continues to show that these foods, as currently marketed in the
United States, are as safe as their conventional counterparts.”
This claim is quite curious in light of the agency’s statement
reported in The Lancet, May 29, 1999: “FDA has not found it
necessary to conduct comprehensive scientific reviews of foods derived
from bioengineered plants … consistent with its 1992 policy.”
Since the FDA requires no testing of GE foods, acknowledges it does
not conduct comprehensive reviews of them, and does not make formal
empirical findings that particular GE foods are safe, it’s
amazing the agency would now claim its evaluation process shows
they are as safe as other foods. There is no scientific basis for
such a claim. To the extent the FDA did a meaningful evaluation,
its scientists concluded that GE foods entail unique risks.
The inadequacy of the FDA’s approach to safety evaluation
is further highlighted by Dr. Crawford’s
statement: “FDA's scientific evaluation to date has shown
that the substances added to food via bioengineering have been well-characterized
proteins that are functionally very similar to other proteins that
are commonly and safely consumed in the diet every day.” Even
if the substances that have been intentionally added to the engineered
organisms may appear to be safe, they were not the main concern
of the FDA scientists. Their primary concern was about the potential
of the bioengineering process to generate unintended harmful substances
that are difficult to predict and detect. Dr. Crawford’s letter
makes it clear that the FDA is disregarding this hazard and failing
to monitor for unintended side effects. Consequently, he has no
grounds for claiming the FDA has evaluated all the substances that
have been added to food via bioengineering, since the agency is
ignoring a major class of potential contaminants. This is one more
reason his assertion about having demonstrated safety is bogus.
It’s important to note that many other experts have expressed
the same kind of concerns that were stated by the FDA’s scientists.
For instance:
- Professors of molecular biology at leading universities such
as Harvard, M.I.T., and the University of California, Berkeley
have issued cautions about the abnormal risks of GE foods.
- Professor Philip Regal, a renowned expert in plant genetics
at the University of Minnesota, has written: "…there
are scientifically justified concerns about the safety of genetically
engineered foods, and some of them could be quite dangerous.”
See Declaration at www.biointegrity.org
- The editors of the respected UK medical journal The Lancet have
strongly criticized the presumption that GE foods entail no greater
risks of unexpected effects than conventional ones. They state
that there are “good reasons to believe that specific risks
may exist” and that “governments should never have
allowed these products into the food chain without insisting on
rigorous testing for effects on health.” Vol. 353, No. 9167,
p. 1811 (May 29, 1999).
- The Public Health Association of Australia analyzed Monsanto’s
data from controlled studies on three of its GE plants (herbicide
resistant corn and canola, and pesticide-producing corn) and in
all three cases found several statistically significant differences
in chemical composition between the GE organism and its non-GE
counterpart. Their report (October 2000) states that the differences
cannot be attributed solely to the known products of the inserted
genes and cautions that these plants may contain unexpected –
and to date unidentified – new substances that could be
harmful to humans.
- The January 2001 report of the expert panel of the Royal Society
of Canada states it is “scientifically unjustifiable”
to presume that GE foods are safe. (p.ix) It explains that the
“default prediction” for any gene-spliced food organism
is that “…expression of a new gene (and its products)
… will be accompanied by a range of collateral changes in
expression of other genes, changes in the pattern of proteins
produced and/or changes in metabolic activities.”(p.185)
Accordingly, the report observes that novel toxins or other harmful
substances could be generated (46-47; 184-85; 188-89) and notes
the need for testing for short and long-term human toxicity, allergenicity
and other health effects. It also notes that unless the whole
food is tested, not merely an extract of the expected new substance(s),
the assessment would be incomplete. (47)
(The FDA has been alerted to most of the above information through
formal channels.)
Governor Kitzhaber, while in office you have consistently sought
to protect the health of the public and of the environment. Hopefully,
the information I have provided will stimulate you to issue a statement
that can counter the misinformation the FDA has injected into this
Oregon ballot contest and clarify the facts for the public. You
may first wish to write Dr. Crawford and ask him to respond to a
set of questions that can bring the truth into clearer focus. I
suggest questions along the lines of those that follow.
- Does FDA still maintain that genetically engineered foods are
generally recognized as safe? (which as a matter of law, entails
there must be an overwhelming consensus among scientists that
they are so safe they require no testing, a consensus that must
approach unanimity.) If so, how does the agency justify such a
presumption in light of the fact that numerous experts have expressed
the opinion that these foods entail added risks and must be rigorously
tested to screen for unexpected side effects before they are marketed?
- You have stated, “FDA is not aware of any information
or data that would suggest that any genetically engineered foods
that have been allowed for human use are not as safe as conventional
foods.” Please state whether you regard the memos written
by the agency’s scientific staff during 1990 – 92
explaining why GE foods entail different health risks than do
their conventional counterparts as constituting “information.”
If you do not think they can be categorized as information, how
do you categorize them?
- In its evaluation of GE foods, has the FDA made any formal determinations
that particular products are safe according to the standard set
by the Food, Drug and Cosmetic Act for foods containing new additives
or has the agency merely reaffirmed its presumption that the food
in question can continue to be presumed generally recognized as
safe? If the former, please specifically list the foods so determined.
- For every GE food that is either being marketed or has been
the subject of a voluntary consultation with the FDA, please provide
the evidence on the basis of which the agency claims that it has
been shown to be as safe as its conventional counterpart.
- On February 5, 1992 the Director of FDA's Center for Veterinary
Medicine (CVM) sent a memo to the agency’s biotechnology
coordinator arguing that GE products should be demonstrated safe
prior to marketing. He stated: "... CVM believes that animal
feeds derived from genetically modified plants present unique
animal and food safety concerns." As a doctor of veterinary
medicine, do you agree with this official position taken by the
CVM when it was functioning in an objective, scientific capacity?
Has the CVM ever changed its position? If you say that it has,
please provide the written record documenting such a change and
the reasons on which it was based.
I further suggest that you note the importance of receiving his
answers as soon as possible so you can complete your assessment
in time to make a public comment while the citizens of Oregon are
still in the process of deciding how to vote on Measure 27.
Please contact me if you desire clarification or elaboration of
any of the points in my letter. I am scheduled to be in Oregon between
October 13 and 25 and would be happy to meet with you and discuss
this important issue in depth.
Best wishes to you and the citizens of Oregon for safe and nutritious
food,
Steven M. Druker
Executive Director
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