How Corporations Engineered the Non-Regulation of Dangerous Genetically Modified

[Guest guest]

How Corporations Engineered the Non-Regulation of Dangerous Genetically

Modified Foods _http://www.organicconsumers.org/articles/article_7623.cfm_

(http://www.organicconsumers.org/articles/article_7623.cfm)

An FDA-Created Health Crisis Circles the Globe

By Jeffrey Smith

October 11,2007

_Straight to the Source _ (http://www.seedsofdeception.com/)

 

 

 

Government officials around the globe have been coerced, infiltrated, and

paid off by the agricultural biotech giants. In Indonesia, Monsanto gave bribes

and questionable payments to at least 140 officials, attempting to get their

genetically modified (GM) cotton approved.[1] On the basis of this

manufactured and false notion of no meaningful differences, the FDA does not

require

GM food safety testing.

 

To further justify their lack of oversight, they claimed that GM crops were

" substantially equivalent " to their natural counterparts. But this concept

does not hold up to scrutiny. The Royal Society of Canada described substantial

equivalence as " scientifically unjustifiable and inconsistent with

precautionary regulation of the technology. " In sharp contrast to the FDA's

position,

the Royal Society of Canada said that " the default prediction " for GM crops

would include " a range of collateral changes in expression of other genes,

changes in the pattern of proteins produced and/or changes in metabolic

activities. " [11]

 

Fake safety assessments Biotech companies do participate in a voluntary

consultation process with the FDA, but it is derided by critics as a

meaningless

exercise. Companies can submit whatever information they choose, and the FDA

does not conduct or commission any studies of their own. Former EPA scientist

Doug Gurian-Sherman, who analyzed FDA review records obtained through the

Freedom of Information Act, states flatly, " It is clear that FDA's current

voluntary notification process (even if made mandatory) is not up to the task

of

ensuring the safety of future GE [genetically engineered] crops. " He says,

" The FDA consultation process does not allow the agency to require submission

of data, misses obvious errors in company-submitted data summaries, provides

insufficient testing guidance, and does not require sufficiently detailed data

to enable the FDA to assure that GE crops are safe to eat. " [12] Similarly, a

Friends of the Earth review of company and FDA documents concluded:

 

" If industry chooses to submit faulty, unpublishable studies, it does so

without consequence. If it should respond to an agency request with deficient

data, it does so without reprimand or follow-up. . . . If a company finds it

disadvantageous to characterize its product, then its properties remain

uncertain or unknown. If a corporation chooses to ignore scientifically sound

testing standards . . . then faulty tests are conducted instead, and the

results are considered legitimate. In the area of genetically engineered food

regulation, the 'competent' agencies rarely if ever (know how to) conduct

independent research to verify or supplement industry findings. " [13]

 

At the end of the consultation, the FDA doesn't actually approve the crops.

Rather, they issue a letter including a statement such as the following:

 

" Based on the safety and nutritional assessment you have conducted, it is

our understanding that Monsanto has concluded that corn products derived from

this new variety are not materially different in composition, safety, and

other relevant parameters from corn currently on the market, and that the

genetically modified corn does not raise issues that would require premarket

review or approval by FDA. . . . As you are aware, it is Monsanto's

responsibility to ensure that foods marketed by the firm are safe, wholesome

and in

compliance with all applicable legal and regulatory requirements. " [14]

 

The National Academy of Sciences and even the pro-GM Royal Society of

London[15] describe the US system as inadequate and flawed. The editor of the

prestigious journal Lancet said, " It is astounding that the US Food and Drug

Administration has not changed their stance on genetically modified food

adopted

in 1992. . . . The policy is that genetically modified crops will receive the

same consideration for potential health risks as any other new crop plant.

This stance is taken despite good reasons to believe that specific risks may

exist. . . . Governments should never have allowed these products into the food

chain without insisting on rigorous testing for effects on health. " [16]

 

Promoting and regulating don't mix The FDA and other regulatory agencies are

officially charged with both regulating biotech products and promoting

them-a clear conflict. Suzanne Wuerthele, a US EPA toxicologist, says, " This

technology is being promoted, in the face of concerns by respectable scientists

and in the face of data to the contrary, by the very agencies which are

supposed to be protecting human health and the environment. The bottom line in

my

view is that we are confronted with the most powerful technology the world has

ever known, and it is being rapidly deployed with almost no thought

whatsoever to its consequences. " Canadian regulators are similarly conflicted.

The

Royal Society of Canada reported that, " In meetings with senior managers from

the various Canadian regulatory departments . . . their responses uniformly

stressed the importance of maintaining a favorable climate for the biotechnology

industry to develop new products and submit them for approval on the Canadian

market. . . . The conflict of interest involved in both promoting and

regulating an industry or technology . . . is also a factor in the issue of

maintaining the transparency, and therefore the scientific integrity, of the

regulatory process. In effect, the public interest in a regulatory system that

is

'science based'-that meets scientific standards of objectivity, a major aspect

of which is full openness to scientific peer review-is significantly

compromised when that openness is negotiated away by regulators in exchange for

cordial and supportive relationships with the industries being regulated. " [17]

 

The conflict of interest among scientists at the European Food Safety

Authority (EFSA) GMO Panel is quite explicit. According to Friends of the

Earth,

" One member has direct financial links with the biotech industry and others

have indirect links, such as close involvement with major conferences organized

by the biotech industry. Two members have even appeared in promotional videos

produced by the biotech industry. . . . Several members of the Panel,

including the chair Professor Kuiper, have been involved with the EU-funded

ENTRANSFOOD project. The aim of this project was to agree [to] safety

assessment,

risk management and risk communication procedures that would 'facilitate market

introduction of GMOs in Europe, and therefore bring the European industry in

a competitive position.' Professor Kuiper, who coordinated the ENTRANSFOOD

project, sat on a working group that also included staff from Monsanto, Bayer

CropScience and Syngenta. " The report concludes that EFSA is " being used to

create a false impression of scientific agreement when the real situation is

one of intense and continuing debate and uncertainty. " [18] This parallels the

deceptive façade at the FDA. The pro-GM European Commission repeats the same

ruse. According to leaked documents obtained by Friends of the Earth, while

they privately appreciate " the uncertainties and gaps in knowledge that exist

in relation to the safety of GM crops . . . the Commission normally keeps

this uncertainty concealed from the public whilst presenting its decisions

about

the safety of GM crops and foods as being certain and scientifically based. "

Further, in private " they frequently criticize the European Food Safety

Authority (EFSA) and its assessments of the safety of GM foods and crops, even

though the Commission relies on these evaluations to make recommendations to

member states. . . [and] to justify its decisions to approve new GM foods. " [19]

For example, the Commission privately condemned the submission information

for one crop as " mixed, scarce, delivered consecutively all over years, and

not convincing. " They said there is " No sufficient experimental evidence to

assess the safety. " [20]

 

Evaluations miss most health problems Although the body of safety studies on

GM foods is quite small, it has verified the concerns expressed by FDA

scientists and others. The gene inserted into plant DNA may produce a protein

that is inherently unhealthy. The inserted gene has been found to transfer

into human gut bacteria and may even end up in human cellular DNA, where it

might produce its protein over the long-term. Toxic substances in GM animal

feed

might bioaccumulate into milk and meat products. Farmer and medical

reports link GM feed to thousands of sick, sterile, and dead animals. But

there is

not a single government safety assessment program in the world that is

competent to even identify most of these potential health problems, let alone

protect its citizens from the effects.[21]

 

A review of approved GM crops in Canada by professor E. Ann Clark, for

example, reveals that 70% (28 of 40) " of the currently available GM crops . . .

have not been subjected to any actual lab or animal toxicity testing, either as

refined oils for direct human consumption or indirectly as feedstuffs for

livestock. The same finding pertains to all three GM tomato Decisions, the only

GM flax, and to five GM corn crops. " In the remaining 30% (12) of the other

crops tested, animals were not fed the whole GM feed. They were given just

the isolated GM protein that the plant was engineered to produce. But even this

protein was not extracted from the actual GM plant. Rather, it was

manufactured in genetically engineered bacteria. This method of testing would

never

identify problems associated with collateral damage to GM plant DNA,

unpredicted changes in the GM protein, transfer of genes to bacteria or human

cells,

excessive herbicide residues, or accumulation of toxins in the food chain,

among others. Clark asks, " Where are the trials showing lack of harm to fed

livestock, or that meat and milk from livestock fed on GM feedstuffs are

safe? " [22]

 

Epidemiologist and GM safety expert Judy Carman shows that assessments by

Food Safety Australia New Zealand (FSANZ) similarly overlook serious potential

problems, including cancer, birth defects, or long-term effects of

nutritional deficiencies. [23]

 

" A review of twelve reports covering twenty-eight GM crops - four soy, three

corn, ten potatoes, eight canola, one sugar beet and two cotton - revealed

no feeding trials on people. In addition, one of the GM corn varieties had

gone untested on animals. Some seventeen foods involved testing with only a

single oral gavage (a type of forced-feeding), with observation for seven to

fourteen days, and only of the substance that had been genetically engineered

to

appear [the GM protein], not the whole food. Such testing assumes that the

only new substance that will appear in the food is the one genetically

engineered to appear, that the GM plant-produced substance will act in the same

manner as the tested substance that was obtained from another source [GM

bacteria], and that the substance will create disease within a few days. All

are

untested hypotheses and make a mockery of GM proponents' claims that the risk

assessment of GM foods is based on sound science. Furthermore, where the whole

food was given to animals to eat, sample sizes were often very low - for

example, five to six cows per group for Roundup Ready soy - and they were fed

for

only four weeks. " [24]

 

Hidden information, lack of standards, and breaking laws Companies claim

that their submissions to government regulators are " confidential business

information " so they are kept secret. Some industry studies that have been

forced

into the public domain through Freedom of Information requests or lawsuits

have been appalling in design and execution. This is due in part to the lack of

meaningful and consistent standards required for assessments. Gurian-Sherman

says of the FDA's voluntary consultation, " Some submissions are hundreds of

pages long while others are only 10 or 20. " [25] A Friends of the Earth report

on US regulation and corporate testing practices states, " Without

standardization, companies can and do design test procedures to get the results

they

want. " [26] Regulators also reference international standards as it suits them.

According to the Centre for Integrated Research in Biosafety, for example,

FSANZ " relaxed adherence to international standards for safety testing when

that better suited the Applicant's submitted work, and imposed international

standards whenever that was a lower standard than we recommended. " [27]

 

Regulators also break laws. The declaration of GRAS status by the FDA

deviated from the Food and Cosmetic Act and years of legal precedent. In

Europe,

the law requires that when EFSA and member states have different opinions, they

" are obliged to co-operate with a view to either resolving the divergence or

preparing a joint document clarifying the contentious scientific issues and

identifying the relevant uncertainties in the data. " [28] According to FOE, in

the case of all GM crop reviews, none of these legal obligations were

followed.[29]

 

Humans as guinea pigs Since GM foods are not properly tested before they

enter the market, consumers are the guinea pigs. But this doesn't even qualify

as an experiment. There are no controls and no monitoring. Without

post-marketing surveillance, the chances of tracing health problems to GM food

are low.

The incidence of a disease would have to increase dramatically before it was

noticed, meaning that millions may have to get sick before a change is

investigated. Tracking the impact of GM foods is even more difficult in North

America, where the foods are not labeled. Regulators at Health Canada announced

in

2002 that they would monitor Canadians for health problems from eating GM

foods. A spokesperson said, " I think it's just prudent and what the public

expects, that we will keep a careful eye on the health of Canadians. " But

according to CBC TV news, Health Canada " abandoned that research less than a

year

later saying it was 'too difficult to put an effective surveillance system in

place.' " The news anchor added, " So at this point, there is little research

into the health effects of genetically modified food. So will we ever know for

sure if it's safe? " [30]

 

Not with the biotech companies in charge. Consider the following statement

in a report submitted to county officials in California by pro-GM members of a

task force. " [it is] generally agreed that long-term monitoring of the human

health risks of GM food through epidemiological studies is not necessary

because there is no scientific evidence suggesting any long-term harm from

these

foods. " [31] Note the circular logic: Because no long-term epidemiological

studies are in place, we have no evidence showing long-term harm. And since we

don't have any evidence of long-term harm, we don't need studies to look for

it. What are these people thinking? Insight into the pro-GM mindset was

provided by Dan Glickman, the US Secretary of Agriculture under President

Clinton.

" What I saw generically on the pro-biotech side was the attitude that the

technology was good, and that it was almost immoral to say that it wasn't good,

because it was going to solve the problems of the human race and feed the

hungry and clothe the naked. . . . And there was a lot of money that had been

invested in this, and if you're against it, you're Luddites, you're stupid.

That, frankly, was the side our government was on. Without thinking, we had

basically taken this issue as a trade issue and they, whoever 'they' were,

wanted to keep our product out of their market. And they were foolish, or

stupid,

and didn't have an effective regulatory system. There was rhetoric like that

even here in this department. You felt like you were almost an alien,

disloyal, by trying to present an open-minded view on some of the issues being

raised. So I pretty much spouted the rhetoric that everybody else around here

spouted; it was written into my speeches. " [32]

 

Fortunately, not everyone feels that questioning GM foods is disloyal. On

the contrary, millions of people around the world are unwilling to participate

in this uncontrolled experiment. They refuse to eat GM foods. Manufacturers

in Europe and Japan have committed to avoid using GM ingredients. And the US

natural foods industry, not waiting for the government to test or label GMOs,

is now engaged in removing all remaining GM ingredients from their sector

using a third party verification system. The Campaign for Healthier Eating in

America will circulate non-GMO shopping guides in stores nationwide so that

consumers have clear, healthy non-GMO choices. With no governmental regulation

of biotech corporations, it is left to consumers to protect themselves. To

learn how to opt-out of the eating GMOs and to find non-GM alternative brands,

visit www.responsibletechnology.org http://www.responsibletechnology.org/ .

 

New Book Genetic Roulette Documents Serious Health Dangers The sourcebook

for the Campaign is the newly released Genetic Roulette: The Documented Health

Risks of Genetically Engineered Foods. With input from more than 30

scientists over two years, it presents 65 health risks of GM foods and why

current

safety assessments are not competent to protect us from most of them. The book

documents lab animals with damage to virtually every system and organ studied;

thousands of sick, sterile, or dead livestock; and people around the world

who have traced toxic or allergic reactions to eating GM products, breathing

GM pollen, or touching GM crops at harvest. It also exposes many incorrect

assumptions that were used to support GM approvals. Organizations worldwide are

presenting the book to policy makers as evidence that GM foods are unsafe and

need to be removed immediately. But we don't need to wait for governments to

step in. We can make healthier choices for ourselves, our families, and our

schools now, and together we can inspire the tipping point for healthier,

non-GM eating in America. We believe that this can be achieved within the next

24 months. *******

 

The GM crops sold in the US include soy (including soy lecithin used in

chocolate and thousands of other products as an emulsifier), corn (including

high

fructose corn syrup), cottonseed and canola (both used in vegetable oil),

Hawaiian papaya, and a small amount of zucchini and crook-neck squash. There is

also alfalfa for cattle (the sale of which was halted by a federal judge on

March 13, 2007), GM additives such as aspartame, and milk from cows treated

with GM bovine growth hormone. There is not yet any GM popcorn, white corn or

blue corn. And the industry is threatening to introduce GM sugar from sugar

beets next year. To learn more, for online shopping guides and to find out how

to get involved, go to www.ResponsibleTechnology.org

http://www.responsibletechnology.org/ .

 

The Institute for Responsible Technology's plans to achieve the tipping

point on GMOs through consumer education has inspired the Mercola.com

Foundation

to match donations and membership fees to the Institute at this time. Please

help end the genetic engineering of our food supply by contributing to the

implementation of this important project. Click here

http://www.seedsofdeception.com/utility/showPage/index.cfm?objectID=gmfree, 5112

..

 

Jeffrey M. Smith is the author of the newly released book, Genetic Roulette:

The documented health risks of genetically engineered foods. He is the

director of the Institute for Responsible Technology and the Campaign for

Healthier Eating in America, the international bestselling author of Seeds of

Deception, and the producer of the DVD Hidden Dangers in Kids' Meals.

 

REFERENCES:

 

[1] " Monsanto Bribery Charges in Indonesia by DoJ and USSEC, " Third World

Network, Malaysia, Jan 27, 2005,

_http://www.mindfully.org/GE/2005/Monsanto-Indonesia-Bribery27jan05.htm_

(http://www.mindfully.org/GE/2005/Monsanto-Indonesia-Bribery27jan05.htm)

 

2] " Greenpeace exposes Government-Monsanto nexus to cheat Indian farmers:

calls on GEAC to revoke BT cotton permission, " Press release, March 3, 2005,

http://www.greenpeace.org/india_en/news/details?item_id=771071

 

[3] Jeffrey M. Smith, Seeds of Deception, (Iowa: Yes! Books, 2003), 224.

 

[4] See Federal Food, Drug and Cosmetic Act (FFDCA)

 

[5] Dan Quayle, " Speech in the Indian Treaty Room of the Old Executive

Office Building, " May 26, 1992.

 

[6] See Smith, Seeds of Deception; and for copies of FDA memos, see The

Alliance for Bio-Integrity, www.biointegrity.org http://www.biointegrity.org/

 

[7] Steven M. Druker, " How the US Food and Drug Administration approved

genetically engineered foods despite the deaths one had caused and the warnings

of its own scientists about their unique risks, " Alliance for Bio-Integrity,

http://www.biointegrity.org/ext-summary.html

 

[8] Louis J. Pribyl, " Biotechnology Draft Document, 2/27/92, " March 6, 1992,

www.biointegrity.org http://www.biointegrity.org/

http://www.biointegrity.org/FDAdocs/04/view1.html

 

[9] Linda Kahl, Memo to James Maryanski about Federal Register Document

" Statement of Policy: Foods from Genetically Modified Plants, " Alliance for

Bio-Integrity(January 8, 1992) http://www.biointegrity.org

http://www.biointegrity.org/

 

[10] " Statement of Policy: Foods Derived from New Plant Varieties, " Federal

Register 57, no. 104 (May 29, 1992): 22991.

 

[11] " Elements of Precaution: Recommendations for the Regulation of Food

Biotechnology in Canada; An Expert Panel Report on the Future of Food

Biotechnology prepared by The Royal Society of Canada at the request of Health

Canada

Canadian Food Inspection Agency and Environment Canada " The Royal Society of

Canada, January 2001.

 

[12] Doug Gurian-Sherman, " Holes in the Biotech Safety Net, FDA Policy Does

Not Assure the Safety of Genetically Engineered Foods, " Center for Science in

the Public Interest, http://www.cspinet.org/new/pdf/fda_report__final.pdf

 

[13] Bill Freese, " The StarLink Affair, Submission by Friends of the Earth

to the FIFRA Scientific Advisory Panel considering Assessment of Additional

Scientific Information Concerning StarLink Corn, " July 17 & shy;19, 2001.

 

[14] FDA Letter, Letter from Alan M. Rulis, Office of Premarket Approval,

Center for Food Safety and Applied Nutrition, FDA to Dr. Kent Croon, Regulatory

Affairs Manager, Monsanto Company, Sept 25, 1996. See Letter for BNF No. 34

at http://www.cfsan.fda.gov/~lrd/biocon.html

 

[15] See for example, " Good Enough To Eat? " New Scientist (February 9,

2002), 7.

 

[16] " Health risks of genetically modified foods, " editorial, Lancet, 29 May

1999.

 

[17] " Elements of Precaution, " The Royal Society of Canada, January 2001.

 

[18] Friends of the Earth Europe, " Throwing Caution to the Wind: A review of

the European Food Safety Authority and its work on genetically modified

foods and crops, " November 2004.

 

[19] Friends of the Earth Europe and Greenpeace, " Hidden Uncertainties What

the European Commission doesn't want us to know about the risks of GMOs, "

April 2006.

 

[20] European Communities submission to World Trade Organization dispute

panel, 28 January 2005.

 

[21] Jeffrey M. Smith, Genetic Roulette: The Documented Health Risks of

Genetically Engineered Foods, Yes! Books, Fairfield, IA USA 2007

 

[22] E. Ann Clark, " Food Safety of GM Crops in Canada: toxicity and

allergenicity, " GE Alert, 2000.

 

[23] FLRAG of the PHAA of behalf of the PHAA, " Comments to ANZFA about

Applications A372, A375, A378 and A379. "

 

[24] Judy Carman, " Is GM Food Safe to Eat? " in R. Hindmarsh, G. Lawrence,

eds., Recoding Nature Critical Perspectives on Genetic Engineering (Sydney:

UNSW Press, 2004): 82 & shy;93.

 

[25] Doug Gurian-Sherman, " Holes in the Biotech Safety Net, FDA Policy Does

Not Assure the Safety of Genetically Engineered Foods, " Center for Science in

the Public Interest, http://www.cspinet.org/new/pdf/fda_report__final.pdf

 

[26] William Freese, " Genetically Engineered Crop Health Impacts Evaluation:

A Critique of U.S. Regulation of Genetically Engineered Crops and Corporate

Testing Practices, with a Case Study of Bt Corn, " Friends of the Earth U.S.,

http://www.foe.org/camps/comm/safefood/gefood/index.html

 

[27] M. Cretenet, J. Goven, J. A. Heinemann, B. Moore, and C.

Rodriguez-Beltran, " Submission on the DAR for Application A549 Food Derived

from

High-Lysine Corn LY038: to permit the use in food of high-lysine corn, 2006,

www.inbi.canterbury.ac.nz

 

[28] EU Regulation 178/2002 (Article 30)

 

[29] Friends of the Earth Europe, " Throwing Caution to the Wind: A review of

the European Food Safety Authority and its work on genetically modified

foods and crops, " November 2004.

 

[30] " Genetically modified foods, who knows how safe they are? " CBC News and

Current Affairs, September 25, 2006.

 

[31] Mike Zelina, et al., The Health Effects of Genetically Engineered Crops

on San Luis Obispo County, " A Citizen Response to the SLO Health Commission

GMO Task Force Report, 2006.

 

[32] Bill Lambrecht, Dinner at the New Gene Café, St. Martin's Press,

September 2001, pg 139.