FDA Critics Cite Food Safety Concerns

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GMW: FDA Critics Cite Food Safety Concerns

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Fri, 15 Apr 2005 22:34:16 +0100

 

 

 

 

 

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EXCERPT: " If somebody was to submit a study like those presented to the

FDA for peer review, it would be rejected flat out, " said Doug

Gurian-Sherman, a senior scientist at the nonprofit Center for Food

Safety in

Washington, D.C., and a onetime biotech safety reviewer with the

Environmental Protection Agency.

 

Industry studies don't thoroughly explain how the study was done, which

a peer review would demand, Mr. Gurian-Sherman said. And they often

cite only summaries of data, not the raw data needed to verify the

studies' conclusions.

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Vioxx Recall Prompt Biotech Questions

FDA Critics Cite Food Safety Concerns

April 15, 2005

 

[sidebar: Biotech Food Safety Research - see end]

 

By Robert Mullins, Newsdesk.org

http://www.newsdesk.org/archives/000173.php

 

Stymied by legal setbacks and a lack of public interest, critics of

genetically engineered foods expressed impatience with the federal Food

and Drug Administration for putting its regulatory foot down on

pharmaceuticals such as Vioxx and Bextra, but keeping its hands off

biotechnology.

 

While the FDA must approve pharmaceuticals before they are sold, and

regulates them once they hit the market, it requires only voluntary

consultations with food and biotech corporations about the safety of any

genetically engineered foods they want to sell.

 

James Maryanski, biotechnology coordinator for the FDA's Center for

Food Safety and Nutrition, said that this is consistent with the agency's

mandate.

 

Medicines are newly created products combining different chemicals and

other ingredients to treat diseases, and so must be pre-tested for

possible side effects, he said, while genetically engineered food

crops are

still just plants, and therefore " substantially equivalent " to what's

already on the market.

 

" [T]he foods we eat today are all derived from crops we've had for

centuries, " Mr. Maryanski said.

 

Activists and medical researchers alike say that this attitude

underestimates the complexity of genetic engineering.

 

" If we have problems because of drugs ... think of the problems of G.E.

foods, " said Steven Druker, executive director of the Alliance for

Bio-Integrity of Fairfield, Iowa.

 

He said that modern genetic technology is dramatically different from

traditional plant breeding, and can potentially create entirely new

kinds of chemical and biological reactions.

 

The effects of these on humans are unknown, however, because the FDA

does not require food corporations to conduct long-term safety testing,

and has overlooked warnings about potential biotech food health risks

from its own researchers.

 

" They have purposely tied their hands behind their back, " said Druker,

whose organization unsuccessfully sued the FDA to improve safety

testing in 1998.

 

He said the FDA is " statutorily mandated " to regulate biotech foods,

and called for obligatory long-term safety testing, and labeling of any

such products that do make it to grocery store shelves.

 

Currently, food corporations are only asked to participate in a

voluntary consultation with the FDA prior to marketing a genetically

engineered food product.

 

There have been 65 voluntary consultations between 1994 and March of

this year, and an industry representative said businesses don't consider

them optional.

 

" There is not a single biotech company that doesn't treat the process

as mandatory, " said Stephanie Chiles, spokeswoman for the Grocery

Manufacturers of America, a trade organization for the $500

billion-a-year

U.S. food industry.

 

She said genetically engineered food safety should be based on the

quality of the end product, not the process used to create it.

 

According to the GMA, 70 to 75 percent of the foods sold in the U.S.

already contain genetically engineered ingredients.

 

Most of the letters to companies posted on the FDA's Web site approving

a new biotech food product are brief:

 

" Based on the information Monsanto has presented to FDA, we have no

further questions ... However, as you are aware, it is Monsanto's

continued responsibility to ensure that foods marketed by the firm are

safe,

wholesome and in compliance with all applicable legal and regulatory

requirements, " a January 2005 letter reads.

 

But the testing methods used by food corporations have drawn fire.

 

" If somebody was to submit a study like those presented to the FDA for

peer review, it would be rejected flat out, " said Doug Gurian-Sherman,

a senior scientist at the nonprofit Center for Food Safety in

Washington, D.C., and a onetime biotech safety reviewer with the

Environmental

Protection Agency.

 

Industry studies don't thoroughly explain how the study was done, which

a peer review would demand, Mr. Gurian-Sherman said. And they often

cite only summaries of data, not the raw data needed to verify the

studies' conclusions.

 

Philip Regal, an ecology professor at the University of Minnesota-St.

Paul, a longtime skeptic of the business side of genetic engineering,

and one of the plaintiffs in the Alliance for Bio-Integrity's 1998

lawsuit against the FDA, said most of the testing conducted by food

corporations was not necessarily for safety.

 

" [T]hey throw around phrases like, 'This is the most intensively tested

food in history.' This is probably true, " he wrote in an e-mail

correspondence, " but it is quite misleading because the testing was

mostly for

commercial properties " such as crop yield, and a plant's ability to

handle different types of soil and climate.

 

Regal also said the FDA has a history of ignoring research that raises

red flags about genetically engineered foods.

 

About 44,000 pages of internal FDA documents were made public as part

of the Alliance for Bio-Integrity lawsuit, including memos that revealed

dissent within the agency about biotech food safety.

 

For example, a 1993 memo from an FDA pathologist revealed that four of

20 female rats fed genetically engineered tomatoes developed stomach

lesions. In a control group fed only non-engineered tomatoes, no lesions

were found.

 

The research was conducted on the FlavrSavr tomato, introduced in 1994

by Calgene, a biotech firm since acquired by Monsanto. Production of

FlavrSavr tomatoes ended in 1997.

 

According to the FDA's Maryanski, the critical memos were " a very small

part " of all the documents produced by the agency as it was determining

its policy on food produced through biotechnology.

 

" The fact that we have differences of opinion [within the agency] is a

good thing, " he said.

 

In September 2000, Federal District Judge Colleen Kollar-Kotelly found

that FDA administrators were entitled to overrule their research staff.

 

While acknowledging considerable disagreement in the scientific

community about genetic engineering and food safety, the judge also

ruled that

the agency was technically justified in assuming that there was

scientific consensus that such foods were safe when it developed its

policy of

voluntary consultation.

 

The plaintiffs dropped their appeal, and according to Druker planned

instead to challenge a new set of proposed regulations. But the FDA never

moved forward with the new rules, leaving the plaintiffs with no new

opportunity for legal action.

 

At the grassroots level, activists are also having trouble.

 

Only 27 percent of Americans polled in 2003 said they considered

genetically engineered foods to be " basically safe, " and 25 percent

considered them " basically unsafe, " according to a survey done for the

Pew

Initiative on Food and Biotechnology.

 

But when informed that a majority of the foods already on store shelves

are made using some form of biotechnology, the belief that such

products are safe rose to 44 percent, while the belief that they are

unsafe

dropped to 20 percent, the survey showed.

 

Additional reporting by Newsdesk.org staff.

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Genetically Engineered Food: Safety Research

April 15, 2005

http://www.newsdesk.org/archives/000174.php

 

Although the FDA does not conduct safety testing on genetically

engineered foods, research is ongoing throughout the world, and not

always

free of controversy. The following is a brief overview:

 

--Food-safety researcher Dr. Arpad Pusztai reported in 1998 that rats

fed genetically engineered potatoes at a British lab developed immune

system deficiencies and stunted growth. After announcing his findings,

Pusztai was suspended by the lab at which he worked. Other independent

researchers supported his conclusions.

 

--Reports of soy allergies in the United Kingdom rose by 50 percent in

1998 after soy milk from genetically engineered, pesticide-resistant

crops was introduced there.

 

--StarLink corn, a genetically engineered ingredient that accidentally

made it into the food supply was suspected as the cause of several

severe allergic reaction cases in the U.S. in 2000, but a U.S Centers for

Disease Control and Prevention study was inconclusive.

 

--Experimental studies have shown that genetically modified,

antibiotic-resistant plant genes have been found in the intestines of

human

volunteers, according to a 2003 report from a global independent science

panel.

 

R.M.

 

 

 

 

 

 

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