[Sidebar: Biotech Food Safety Research]
By Robert Mullins, Newsdesk.org
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 “generally recognized as safe.”
“[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.
[Editor’s Note: Here follows a comment from the FDA regarding this article; it was originally sent as correspondence with the Newsdesk.org editor; we are including the letter in full to provide the best context and background on our coverage.]
Please let Mr. Wilson know that I appreciate his interest in making an
accurate description of FDA’s approach. One thing I try hard to avoid is
giving the public the impression that FDA says that biotech foods per se are
safe, because someone could develop a food that would not be found to be
safe. So, I prefer to explain that the bioengineered foods that FDA has
evaluated to date have been found to be as safe as conventional foods. I
also usually try to focus statements on “food” rather than “crops” because
food is what falls under our authority.
Regarding GRAS, in its 1992 statement of policy, FDA explained that if a new
substance that is present in food as a result of G.E. has been present and
safely consumed in food or is very similar to substances that have been
safely consumed in food, FDA would “presume” that the substance is GRAS and
would not require pre-market review as a food additive. So, we did not make
a conclusion that the substance was GRAS, nor that the food was GRAS.
I also think that it would help the reader to explain that while to date FDA
has not found the new substances in biotech foods to be food additives, that
FDA would require pre-market approval if a biotech food contains a substance
that is not recognized as safe for consumers.
This is a “wordy” explanation of the difficulties I see with the proposed
The FDA’s Maryanski said that because the government considers
G.E. food crops to be “generally recognized as safe” compared to
those cross-bred by conventional means, corporations are only
asked to participate in a voluntary consultation with the FDA prior
to marketing a G.E. food product.
Let me see if I can suggest a fix that is not too wordy (tough job for a
The FDA’s Maryanski said that because FDA has found that the foods produced
from G.E. crops that are on the market today are as safe for consumers as
those derived from crops cross-bred by conventional means, corporations are
only asked to participate in a voluntary consultation with the FDA prior to
marketing a G.E. food product. He also said that FDA will require pre-market
review for any future food products that are not “generally recognized as
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