国民とEUを欺いた米政府とブッシュ政権
GM食品の安全性は組織的詐欺
2003年7月9日
スティ−ブン・ブルーカー
米公益弁護人<http://www.globalcountry.org.uk/#bio>
全文は<http://www.globalcountry.org.uk/#PR>
要約 山田勝巳
アメリカの公益弁護士が暴く。いかにアメリカのEUのGM食品政策攻撃は組織的欺きであるか、またEU立法者自身が市民に誤解を招きかつ｢予防原則を｣心底支持してこなかったかを。
（要点）
ブッシュ政権は｢予防原則｣が不当な貿易障壁だと言っているが、予防原則はアメリカ食品安全法の基礎となっているものだ。 米国法では明確にGM食品に予防原則を適用すべきことが書かれており、それもEU法よりも厳しい内容になっている。EUがGM食品を承認したのは、米国FDAが専門家の広範囲に亘る警告を隠して事実を露骨に歪曲し、自国の法律違反をしたことによるものだ。EUの規制プロセスは健全な科学性を欠いており、全く不十分で健康危害の懸念さえ示しているデータに基づいてGM食品を承認している。
報道問い合わせ: Leopold Fransen +32
4965 78520 leopold.fransen@pi.be
スティーブン・ドルーカーとの連絡法
7月：地球の友 ガート・リツェマ気付 31 6 290 05 908
(mobile)
7月以降：米国1-641-472-8008
sdruker@biointegrity.org
GM食品がEU市場に入り込んだのは米国政府の組織的ごまかしがあったが故で、ブッシュ政権はEU規制政策を覆してGM食品を警告や表示無しでヨーロッパ人に押し付けようとすることで更に欺かんとしている。これが、非営利のバイオ・インテグリティ(生物完全性)連盟を指揮するアメリカ人公益弁護士スティーブン・M・ドルーカーが率直に非難するところである。また、EU為政者については自ら予防原則に泥を塗りGM食品を人間の消費用に認めることで健全な科学を貶めたという。
ドルーカー氏は、いかにFDAの役人がGM食品特有の危険性に対する研究者の警告を隠したかを曝露する44,000ページに亘る内部資料引きずり出した訴訟を起こすのに一役買っている。彼はGM食品の科学的側面と法律の権威で国立研究審議会やFDAが主催する会議に専門化パネリストとして参加したり、世界中の政府関係者と交流がある。以下に彼の主張を詳細に記す。
(訳注：本文の中では、日本の『安全審査申請書点検グループ』・河田昌東によるモンサントの除草剤耐性大豆の問題点の指摘も引用されている：遺伝子組換え情報室HPの「安全審査のチェック」及び英文参照)
(以下英文のまま)
GM Foods Got Approved in the EU Because
the US Food and Drug AdministrationCovered Up Warnings of Its Own Experts About
their Risks and Misrepresentedthe Facts
The FDA's records reveal its own
scientific experts overwhelmingly concluded that genetic engineering has unique
potential to produce unintended and essentially unpredictable new toxins and
other harmful substances. They cautioned that a GM food could not be considered
safe unless it had undergone rigorous toxicological tests using the whole food.
The uniformity of opinion is attested by the FDA official responsible for
summarizing the expert input, who reported: "The processes of genetic
engineering and traditional breeding are different, and according to the
technical experts in the agency, they lead to different risks."
(Photocopies of 24 key FDA
documents are in a numbered set at
www.biointegrity.org <http://www.biointegrity.org/> The preceding quote
is from #1.)
Nevertheless, FDA bureaucrats, who admit
they have been operating under an on-going White House directive "to
foster" the biotech industry, disregarded their experts¹ warnings and
covered them up. They then declared there is an overwhelming consensus among
experts that GM foods are so safe they don¹t need to be tested, even though
they knew their own experts regarded them as uniquely hazardous and even
though they knew there was not a consensus about safety in the scientific
community at large, as evidenced in a letter by the FDA Biotechnology
Coordinator. (FDA document #8 at
www.biointegrity.org
<http://www.biointegrity.org/> ) And to deepen the deception, they
claimed they were not aware of any information showing that GM foods differ
from others in any meaningful way.
Druker states: "If the US government
had told the truth, no GM foods would have come to market in the US or the EU,
since the EU would not have approved them if the US had not."
The Bush Team¹s Assault on the
Precautionary Principle is a Hoax Because US Food Safety Law Is Based On It
"Having duped the EU into approving
GM foods in the first place, the US is now trying to force open the European
market as widely as possible by dismantling the EU¹s precautionary safeguards
and destroying its new labeling laws," says Druker. "This attack on
EU¹s precautionary policy relies on another major deception: the false pretense
that such use of the precautionary principle is an illegal restraint on trade
and that the US is free to resist it. In reality, Mr. Bush is obligated to
uphold the precautionary principle at home and respect it abroad because it is
the cornerstone of US food safety law." He points out that this has been
the case since Congress passed the Food Additive Amendment in 1958, which
unequivocally requires that new additives be proven safe. As the official
Senate report described the intent of this law: "While Congress did not
want to unnecessarily stifle technological advances, it nevertheless intended
that additives created through new technologies be proven safe before they go
to market." S. Rep. 2422, 1958 U.S.C.C.A.N. 5301-2. (emphasis added)
"This law clearly applies to GM
foods,"states Druker. "By allowing them on the market without proof
of safety, the FDA is flagrantly breaking it in order to promote the interests
of Monsanto, Dupont, and other giant corporations. And yet the US government
self-righteously accuses the EU of violating international law by implementing
an even a lower degree of precaution than is required by US law."
EU Regulators Have Themselves Disregarded
Sound Science and Failed to Uphold the Precautionary Approach Required by Law
"Unfortunately, EU regulators
themselves went on to mislead the public by claiming they¹re applying the
precautionary principle to GM foods when in fact they have been disregarding
well-recognized risks and failing to institute the level of safety testing
required by their own law," says Druker. He notes that they have ignored
the unique potential of GM foods for unpredictable results, failed to require
the kinds of tests recommended by the FDA experts, and have instead relied on
tests that do not adequately screen for the potential negative effects about
which they warned. "EU regulation is based on the presumption that the
only changes that will occur
in a GMO are those that are intended. The
Royal Society of Canada has branded this presumption Œscientifically
unjustifiable¹ and stated that instead the Œdefault presumption¹ for every GM
food should be that the genetic alteration has induced unintended and
potentially hazardous side effects." (Expert Panel Report of 2001)
Further, even within the narrow
parameters in which they have operated, EU regulators have failed to uphold
adequate standards. For one thing, the research on which they¹ve relied does
not meet basic scientific standards.
Experts with the Public Health Association of Australia (PHAA)
thoroughly reviewed many of the data packages the manufacturers submitted to
the regulators and have reported they lack key information that is routinely
provided in scientific research and is required to enable meaningful review by
others. They stated that such research could not have qualified for publication
in peer-reviewed journals and should not have been accepted by the regulators.
(PHAA Written Comments to ANZFA, October 2000.) And a team of Japanese
scientists who reviewed Monsanto¹s tests on its "Roundup Ready"
soybean (which has been approved in the EU) found so many irregularities in the
safety assessment they concluded it was "inadequate and incomplete."
(The team was headed by Dr. Masaharu Kawata, an Assistant Professor in the
School of Science at Nagoya University. Their report was published in the
Japanese journal Technology and Human Beings, vol.11, Nov. 2000, pp. 24-33)
Druker points out that even this
deficient data has in many cases revealed potential problems that the
regulators have ignored. For instance, the PHAA analyzed Monsanto¹s data from
controlled studies on three of its GM plants (herbicide resistant maize and
canola, and pesticide-producing corn) and in all three cases discovered several
statistically significant differences in chemical composition (including amino
acid profiles) between the GM organism and its non-GM counterpart. The PHAA
report (October 2000) states that the differences in the amino acids 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 proteins that could be harmful to humans. Nonetheless, the EU has approved
two of these plants for human consumption.
"One of the most glaring flaws in EU
regulation is the acceptance of untested GM animal feed," says Druker.
"EU citizens have for years been unknowingly consuming meat, milk and eggs
from animals raised on this feed because no labels have been required, and the
new laws still fail to do so for the end product. This is troubling in light of
the fact the FDA experts stated that GM animal feed presents Œunique Š food
safety concerns¹ because residues of unexpected substances could make meat and
milk products harmful to humans. (See FDA document #10 at www.biointegrity.org
<http://www.biointegrity.org/> ) However, their warnings were covered up
and the kinds of tests they called for have yet to be adequately
conducted."
"In light of the flawed presumption
on which it rests, the deficient data it accepts, and the potential dangers
toward which even this data frequently points, it¹s clear that EU regulation of
GM foods is out of line with both sound science and the precautionary
principle," says Druker. "This means the regulators are breaching EU
food law, which calls for the precautionary principle Œin cases where the
scientific basis is insufficient or some uncertainty exists.¹" Green
Paper: General Principles of Food Law in the EU, 30/4/97.
The Venture to Genetically Reconfigure
Our Food Is Scientifically Untenable and Ultimately Unsustainable and
Resources Should Be Redirected to Organic, Sustainable Forms of Agriculture
Druker concludes, "It¹s astounding
that this venture to radically transform the production of our food continues
to be portrayed as based in sound science and rigorous regulation when in fact
it depends on flagrant disregard of both science and the food safety laws. Such
deception ranks as one of the greatest frauds ever perpetrated." He
continues: " It should be clear by now that genetic engineering is the
wrong way for agriculture to go. The technology is inherently risky, but
industry refuses to perform the kinds of tests that are minimally required to
screen for the full range of hazards. And if regulators actually required the
tests that sound science dictates, it would be an economic disaster for the
industry because, in contrast to the pharmaceutical industry, the food industry
is not structured to bear the costs of rigorous long-term toxicological tests
for each new product. The economic realities of GM food are incompatible with
thescientific necessities."
Druker notes that the obvious choice is
to stop plowing massive resources into genetic engineering and, for a small
fraction of the cost, foster development of safe and sustainable organic
agriculture.
More detailed documentation of the points
in this release are provided by the accompanying documents, which will also be
available at www.biointegrity.org <http://www.biointegrity.org/>
END
How the us government is misrepresenting
the facts about the risks of genetically engineered foods, And how EU
regulators approved them by disregarding sound science and the precautionary
principle
STEVEN M. DRUKER, J.D.
Executive Director
Alliance for Bio-Integrity (A U S-Based
Public Interest Group)
www.biointegrity.org
<http://www.biointegrity.org/>
The US Food and Drug Administration
Covered Up the Warnings of Its Own Scientists About the Risks of GE Foods and
Has Been Systematically Misrepesenting the Key Facts
Genetically engineered (GE) foods have
been allowed on the market in the United States, Europe, and other nations
because of systematic misrepresentations by the US government, and their
continued marketing depends on continuation of the misrepresentations. This
fraud was exposed by a lawsuit against the US Food and Drug Administration (FDA)
that compelled it to release its internal files on GE foods. I coordinated this
lawsuit as Executive Director of the Alliance for Bio-Integrity.
The FDA's records reveal that its own
scientific experts overwhelmingly concluded that genetic engineering differs
from conventional breeding and has unique potential to produce unintended and
essentially unpredictable new toxins and other harmful substances. They
cautioned that a GE food could not be considered safe unless it had undergone
rigorous toxicological tests using the whole food. The uniformity of opinion is
attested by the FDA official responsible for summarizing the expert input, who
reported: "The processes of genetic engineering and traditional breeding
are different, and according to the technical experts in the agency, they lead
to different risks." (Photocopies of 24 key FDA documents are in a
numbered set on our
website www.biointegrity.org
<http://www.biointegrity.org/> The preceding quote is from #1.)
Nevertheless, FDA bureaucrats, who admit they have been operating under an
on-going White House directive "to foster" the biotech industry,
disregarded their experts¹ input and in May, 1992 instituted a policy that
presumes GE foods are as safe as conventional ones and do not require any
testing. Further, they covered up the warnings from their scientists and then
declared themselves unaware of any information showing that GE foods differ
from others in any meaningful way. They additionally claimed there is
overwhelming recognition among experts that GE foods are as safe as others,
even though they knew their own experts regarded them as uniquely hazardous
and even though they knew that there was not a consensus about
the safety of GE foods in the scientific
community at large. For example, the FDA Biotechnology Coordinator acknowledged
this lack of consensus in a letter to a Canadian health official on October 23,
1991 commenting on a document that discussed GE foods. He stated: "As I
know you are aware, there are a number of specific issues addressed in the
document for which a scientific consensus does not exist currently, especially
the need for specific toxicology tests." (FDA document #8 at
www.biointegrity.org <http://www.biointegrity.org/> ) The FDA has
continued to issue deceptive statements for nine years. For instance, on May 3,
2000, the FDA Commissioner declared: "FDA¹s scientific review continues to
show that all bioengineered foods sold here in the United States today are as
safe as their non-bioengineered counterparts." But the year before, the
FDA clearly acknowledged it does not perform substantial reviews of GE foods,
stating: "FDA has not found it necessary to conduct comprehensive
scientific reviews of foods derived from bioengineered plants Š consistent with
its 1992 policy." (Reported in The Lancet, Vol. 353, No. 9167, May 29,
1999) As of July 2003 the FDA continues to claim there is an overwhelming
consensus among experts that GE foods are safe despite the fact the agency has
repeatedly been notified through formal channels that numerous eminent
scientists consider these new foods to be
inherently more hazardous than their conventional counterparts. If the FDA had
not misrepresented the facts about the unique risks and the scientific concerns
but instead had honestly acknowledged them, no GE foods would yet have come to
market in the US. Nor would they have yet been marketed in Europe, since if the
US had not approved them, the EU would not have done so. EU Regulators Have
Failed to Follow Sound Science and the Requirements of Their Law
Moreover, the EU regulators have ignored
the unique potential of GE foods for unpredictable results, failed to require
the kinds of tests recommended by the FDA experts, and have instead relied on
tests that do not adequately screen for the potential negative effects about
which they warned. The inadequacy of the current tests is highlighted by the
fact that eminent experts submitted declarations to a US federal court in May
1999 asserting there is no reliable evidence demonstrating that any GE food is
safe. (e.g. www.biointegrity.org/laceydeclaration.html
<http://www.biointegrity.org/laceydeclaration.html> ) Accordingly, the
court stated that there are "significant disagreements among scientific
experts" regarding safety. The basic approach on which EU (and Canadian)
regulation of GE foods is based the concept of "substantial
equivalence" is so unsound that a report from the Royal Society of
Canada issued February 5, 2001 criticizes it as "scientifically
unjustifiable." In the words of the Toronto Star: "The experts say
this approach is fatally flawed Š and exposes Canadians to several potential
health risks, including toxicity and allergic reactions." (Feb. 5, 2001)
Further, even within the narrow
parameters in which they have operated, the EU regulators have failed to uphold
adequate standards. For one thing, the research on which they have relied is
generally deficient and does not meet basic scientific protocols. Experts with
the Public Health Association of Australia (PHAA) thoroughly reviewed many of
the data packages the manufacturers submitted to the regulators and have
reported they lack key information that is routinely provided in scientific
research and is required to enable meaningful review by others. They stated
that such research could not have qualified for publication in peer-reviewed
journals and should not have been accepted by the regulators. (PHAA Written
Comments to ANZFA, October 2000.) And a team of Japanese scientists who
reviewed Monsanto¹s tests on its "Roundup Ready" soybean (which has
been approved in the EU) found so many irregularities in the safety assessment
they concluded it was "inadequate and incomplete." Their November
2000 report concludes: "The safety assessment of the Monsanto Roundup
Ready soybean needs to be reassessed." (The team was headed by Dr.
Masaharu Kawata, an Assistant Professor in the School of Science at Nagoya
University. Their report was published in the Japanese journal Technology and
Human Beings, vol.11, Nov.2000, pp. 24-33) Moreover, even this deficient data has in many cases
revealed potential problems that the regulators have ignored. For instance, the
EU authorities
have approved several GE foods that are
clearly different from their conventional counterparts, even though the
differences raise reasonable doubts about safety. These foods include three of
Monsanto¹s GE crops: a variety of maize, a variety of canola, and the Roundup
Ready soybean.(Details provided in # 14 below.) Although consumer resistance
has prevented most GE foods from being marketed in Europe, large quantities of
GE crops have been imported for animal feed; and EU citizens have for years
been
unknowingly consuming meat, milk and eggs
from animals raised on this feed because no labels have been required. Nor will
they be required on the end product by the new laws of 2003. Moreover, the US
FDA experts stated that feeding GE crops to farm animals presents "unique
Š food safety concerns" because residues of unexpected substances could
make meat and milk products harmful to humans. (See FDA document #10 at
www.biointegrity.org <http://www.biointegrity.org/> ) However, their
warnings were covered up by the FDA administrators, and the kinds of tests they
called for have not been conducted. Consequently, the marketing of GE foods in
the EU is contrary to the guiding principle of EU food law, which is based on
the precautionary
principle. For instance, the European
Commission has stated it "...will be guided in its risk analysis by the
precautionary principle in cases where the scientific basis is insufficient or
some uncertainty exists." Green Paper: General Principles of Food Law in
the EU, 30 April 1997. Recent evidence provides added justification for concern
about unexpected harmful side effects. First, the discoveries of the human
genome project released February 2001 (a) confirm that the foundational
assumptions of genetic engineering are overly simplistic and seriously unsound
and (b) indicate
that recombinant DNA techniques entail
greater potential for unpredictable hazards than was previously suspected even
by experts advocating a more precautionary approach. Second, there is mounting
evidence of GE plants with substantial and unexpected alterations in
chemical composition. (a) Aventis¹s data shows statistically significant
differences between T25 herbicide-resistant maize and its conventional
counterpart in terms of carbohydrate, amino acid and fatty acid composition.
(b) The Public Health Association of Australia (PHAA) analyzed Monsanto¹s data
from controlled studies on three of its GE plants (herbicide resistant maize
and canola, and pesticide-producing corn) and in all three cases discovered
several statistically significant differences in chemical composition
(including amino acid profiles) between the GE organism and its non-GE
counterpart. The PHAA report (October 2000) states that the differences in the
amino acids 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 proteins that could be harmful to humans. (c) Recent
investigation by Japanese scientists reveals that Monsanto¹s data on its
Roundup Ready soybean, the most widely planted GE crop, shows important
differences between the GE bean and its conventional counterpart. For instance,
after heat processing of both the GE and non-GE beans, the concentrations of
three harmful substances were significantly higher in the GE samples. Third,
research at UK¹s John Innes Centre confirms that the viral promoter used in
almost all GE plants can facilitate various abnormalgenetic recombinations.
This could lead to serious disruptions or to generation of new and hazardous
chemicals. Additionally, experts warn that parts of existing viruses could
recombine into novel and more dangerous viruses.
Accordingly, hundreds of scientists have
signed an open letter to the world¹s governments warning of the hazards and
calling for a moratorium on all GE foods. Signatories include professors of biology
from Harvard and the Massachusetts Institute of Technology, and the director of
the renowned Woods Hole Research Center. Further, nine scientific experts were
so concerned they took the unprecedented step of joining as plaintiffs in the
Alliance for Bio-Integrity¹s lawsuit against the U.S. Food and Drug
Administration (FDA). By asserting that they regard GE foods to entail unique
risks, they refuted FDA¹s claim that experts overwhelmingly recognize
them as safe. They include a professor of
molecular biology at the University of California, Berkeley; the co-director of
Targeted Mutagenics at Northwestern University Medical School; and a renowned
expert in plant genetics at the University of Minnesota whose declaration to
the court stated: "Šthere are scientifically justified concerns about the
safety of genetically engineered foods, and some of them could be quite
dangerous." Further, the respected UK medical journal The Lancet has
strongly criticized the presumption that GE foods entail no greater risks of
unexpected effects than conventional ones, stating 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." (May 29,
1999). Because of the systematic misrepresentations by the US government and
the extensive warnings about the risks of GE foods raised by that government¹s
own experts, the EU should boldly resist US pressures to import additional GE
foods. Moreover, in light of the above facts, it is evident that (a) there is
insufficient evidence to demonstrate that any GE food is safe and (b) there is
a deep degree of doubt about their safety on the part of numerous experts.
Accordingly, it is difficult to see how the presence of any GE food on the EU
market is consistent with the precautionary principle that EU regulators are
legally bound to uphold "Š in cases where the scientific basis is
insufficient or some uncertainty exists." Green Paper: General Principles
of Food Law in the EU, 30 April 1997. Therefore, it is prudent and proper for
the EU authorities to promptly ban all GE foods, including those they have
already approved.