'GMron' - US GM testing system recipe for Enron style bio scandal - NLPWessex, 12 June 2002
'GM-ron' - Off balance sheet biotech scientific data
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Americans will no doubt be delighted to know that the Food and
Drug
Administration does not regularly check GM food safety testing
data provided
by biotech companies (see full articles below):
"Currently, the FDA only reviews safety data on biotech
crops provided by
seed companies on a voluntary basis." (May 3, 2002, CSPI
Press Release)
"The FDA said it agreed with the studys findings but
said it should not be
obliged to check data on a regular basis. The agency said the
risk of
criminal penalties for submitting false data was a significant
deterrent for
biotech companies, reported Reuters." (29 May 2002
just-food.com)
Yeah, Enron and Anderson were terrified of such penalties too.
Basically this means companies may submit or withold whatever
data they
like. Data can be held 'off balance sheet', Enron-style if
necessary.
This process is part of a so-called regulatory system that was
installed
against the advice of many of the FDA's own scientists
(see: http://www.biointegrity.org/
).
Meanwhile a huge explosion in food related illnesses has taken
place
in the US since the introduction of GM foods and nobody has found
out what
is causing it. See:
http://www.btinternet.com/~nlpwessex/Documents/GMhealthstatistics.htm
NATURAL LAW PARTY WESSEX
nlpwessex@bigfoot.com
www.btinternet.com/~nlpwessex
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IS IT POSSIBLE THAT A BIOTECH COMPANY WOULD WITHOLD INFORMATION
UNDER THIS
SYSTEM? - JUDGE FOR YOURSELF
"Buried Data in Monsanto's Study on Roundup Ready
Soybeans"
http://www.biotech-info.net/buried_data.html
Monsanto's genetically engineered Bovine Growth Hormone scandal
http://www.geocities.com/Athens/1527/text4.html
Revolving Doors: Monsanto and the Regulators
http://www.psrast.org/ecologmons.htm
Monsanto employees and government regulatory agencies
employees are the same people!
http://www.purefood.org/Monsanto/revolvedoor.cfm
"I was recently on a TV talk show where I debated the safety
of genetically
modified food with someone representing the Food Technology
Association. I
began with a brief statement on the hazards of rBGH, the
synthetic
bovine-growth hormone that is now present in nearly all U.S.
dairy products.
I described how, in 1989, someone dropped off at my office a
batch of
documents that had been stolen from the Food and Drug
Administration's files
on Monsanto, the company that manufactures rBGH. Included
was a Monsanto
document from 1987 indicating that the company was fully aware of
rBGH's
danger and was conspiring with the FDA to suppress information
critical to
veterinary and public health....."
From: 'An Epidemic of Deception: Why We Can't Trust The Cancer
Establishment', An Interview With Dr Samuel Epstein by Derrick
Jensen,
originally published in The Sun [not the UK one!], March
2000. In 1996,
Epstein represented the European Union at World Trade
Organization talks
about the use of genetically engineered hormones in meat
production. He is
currently professor emeritus of environmental and occupational
medicine at
the University of Illinois School of Public Health in Chicago.
http://home.earthlink.net/~dbjensen1/epstein.html
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"Monsanto should not have to vouchsafe the safety of biotech
food. Our
interest is in selling as much of it as possible. Assuring its
safety is the
F.D.A's [Food and Drug Administration] job."
Phil Angell, Monsanto's director of corporate communications, in
an
interview with the New York Times, October 25, 1998
http://www.purefood.org/monlink.html
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REGULATORY GAP MEANS GE FOODS ARRIVE ON THE MARKET WITHOUT FDA
APPROVAL AND POSSIBLY WITHOUT NOTICE
May 3, 2002
CSPI Press Release
http://www.cspinet.org/new/gefoodspr_050302.html
WASHINGTON -- Biotechnology companies can market genetically
engineered
(GE) foods without notifying the Food and Drug Administration
(FDA) or
obtaining its approval, thanks to regulatory gaps in a system
that
consumer and environmental groups today asked Health and Human
Services
(HHS) Secretary Tommy Thompson to fix. HHS could begin fixing
that
system, the groups say, by finalizing a rule stalled at the FDA
for more
than a year. The period for public comment on the rule ended a
year ago
today.
The proposed rule would require premarket notification of
bioengineered
foods. And while the rule would not require government approval
for GE
foods, consumer groups say the rule would be a small step in the
right
direction.
The signatories of today's letter to Secretary Thompson include
the
Center for Science in the Public Interest (CSPI), Environmental
Defense,
the Consumer Federation of America, the Union of Concerned
Scientists,
the Institute for Environment and Agriculture, and the Whole
Foods
Market grocery chain. The letter also called on Secretary
Thompson and
the FDA to ask Congress to amend the current food-safety laws so
that
biotech companies are required to seek approval before putting GE
foods
on the market.
"Finalizing this rule should be noncontroversial, and it
would improve
the current regulatory system by ensuring that FDA and the public
are
notified before new biotech foods are marketed," said
Gregory Jaffe,
director of CSPI's biotechnology project. "But to truly
protect
consumers from any unsafe genetically engineered foods, we really
need
new legislation. Only a mandatory pre-market approval process for
biotech foods will adequately safeguard our food supply."
Currently, the FDA only reviews safety data on biotech crops
provided by
seed companies on a voluntary basis. In contrast, the FDA has a
mandatory approval process for GE food animals.
The Environmental Protection Agency (EPA) also has a mandatory
approval
process, including a food-safety component, but only for crops
that have
pesticides engineered into them.
In 2001, two products, including a controversial Bt corn rootworm
product from Monsanto, were voluntarily reviewed by FDA without
having
the benefits of the mandatory notification process.
Also, Monsanto did not consult with the FDA before it
inadvertently may
have marketed a variety of GE canola. If the FDA had finalized
its
proposed rule, Monsanto would have been in violation of those
regulations. Under current rules, though, Monsanto's actions were
completely legal.
"The public shouldn't have to rely entirely on the word of a
big biotech
company when it comes to the safety of food," Jaffe said.
"But under the
current rules, companies can bypass the FDA with impunity."
The FDA's food safety priority plan for 2002 states that the
agency does
not plan to move forward with the rule at issue until 2003.
"The public
should not have to wait two or more years for finalization of a
non-controversial food-safety rule," the groups wrote.
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USA: GM foods pose no additional risk to health - report
29 May 2002
just-food.com editorial team
The investigative arm of the US Congress said that genetically
modified
foods pose no greater threat to health than conventionally
produced foods.
[That is not what many of the FDA's own scientists said when it
was setting
up the regulatory system.
Rather the FDA chose to ignore their advice as part of an
admitted
governmental policy to promote biotechnology.
See: http://www.biointegrity.org/FDADeception.html
and
http://www.biointegrity.org/list.html,
nlpwessex]
A study prepared for Congress by the US General Accounting Office
found
that consumers of genetically modified foods are at no greater
risk of
allergies or toxic reactions. Researchers found that the US Food
and Drug
Administration had carried out sufficient tests on to ascertain
the safety
of biotech foods before clearing them for the market. The average
risk
assessment by the FDA for a new genetically modified food product
takes
between 18 months and three years.
The study, which did not address the environmental impact of GM
foods,
nevertheless had some recommendations for how the government
could improve
its procedures. For example, the FDA should more frequently
validate the
accuracy of safety data provided by food companies.
The FDA said it agreed with the studys findings but said it
should not be
obliged to check data on a regular basis. The agency said the
risk of
criminal penalties for submitting false data was a significant
deterrent
for biotech companies, reported Reuters.
A number of governments around the world are currently drawing up
labelling requirements to inform consumers about biotech foods. A
widespread antipathy towards genetically modified foods in Europe
has not
been imitated in the US.
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"There is a profound difference between the types of
unexpected effects from
traditional breeding and genetic engineering which is just
glanced over in
this document.....
Unexpected Effects - This is the industry's pet idea, namely that
there are
no unintended effects that will raise the FDA's level of concern.
But time
and time again, there is no data to backup their contention,
while the
scientific literature does contain many examples of naturally
occurring
pleitropic [multi-response] effects. When the introduction of
gene's into
[a] plant's genome randomly occurs, as in the case of the current
technology
(but not traditional breeding) it seems that many pleiotropic
[multi-response] effects will occur. Many of these effects might
not be seen
by the breeder because of the more or less similar growing
conditions in the
limited trials that are performed...
.......introduced proteins (enzymes) that while acting on one
specific,
intended substrate to produce a desired effect, will also affect
other
cellular molecules, either as substrates, or by swamping the
plant's
regulatory/metabolic system and depriving the plant of resources
needed for
other things. It is not prudent to rely on plant breeders always
finding
these types of changes (especially when they are under pressure
to get a
product out)."
Dr. Louis Priybl of the US Food and Drug Administation
Microbiology Group -
internal memorandum on FDA GM food safety testing policy
document, 6 March
1992, http://www.biointegrity.org/FDAdocs/04/index.html