When earlier this week we forwarded to the pro-GM AgBioView list Arpad Pusztai's latest demolition of CSIRO biotechnologist's assertions -- that GM foods are carefully tested for safety and that there is an extensive bibliography of peer-reviewed papers to support that -- Morton responded by saying, amongst other things, that he was sure US regulation was not as flimsy as Pusztai had suggested. He was promptly seconded by Drew L. Kershen, professor of law at the University of Oklahoma:
"Dr. Morton asked whether in the United States anybody producing a food from genetically improved plants must present data of its safety before the food may be marketed.
The answer, as Dr. Morton correctly surmised, is "YES" (purposefully in capital letters). The FDA does use an approach to food regulations which asks first whether the GMO food is substantially equivalent."
However, it seems not all law professors are as impressed as Drew Smith with US regulation via substantial equivalence, as the following Reuters coverage of a new Consumer Federation of America report on the regulation of biotech foods makes abundantly clear.
According to the report, coauthored by Thomas O. McGarity of the University of Texas law school, US regulation "is, at bottom, an elaborate and complicated regulatory charade based upon a few regulatory policies posing as science''
McGarity also says there is no way of knowing how many manufacturers or importers have applied the, anyway questionable, substantial equivalence doctrine **on their own** in order to conclude that they do not need to consult with the FDA prior to marketing biotech foods.
The report concludes: "It may be time...for Congress to take a fresh look at GM foods through committees that are not mere cheerleaders for the regulated industries''.
There is, of course, no reason for European complacency. The "principle" of substantial equivalence is also the cornerstone of European GM food regulation even though, as Dr Pusztai pointed out, applied to a cow with BSE and to a healthy cow it would show them as substantially equivalent and require no further investigation into their implications for human health.
Dr Pusztai also queried Morton's assertion that the harmful GM potatoes Pusztai's team worked on would have been halted prior to market approval by a "proper safety assessment including animal feeding studies". Pusztai asked who exactly would have undertaken this kind of assessment: "After all, ACNFP, our [UK] regulatory authority, have no labs of their own and only ask for the companies to submit the results of their own testing."
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Report Damns U.S. Regulation of Biotech Foods
By Meg Bryant
Friday January 12 10:54 AM ET
WASHINGTON (Reuters Health) - The US government, in its enthusiasm to speed genetically altered foods to the market, has forsaken its responsibility to regulate in the public interest and allows the companies that make and sell those products to decide their safety, a new report by the Consumer Federation of America concludes.
By relying on a regulatory system that exempts biotechnology products deemed ``substantially equivalent'' to existing foods from rigorous regulatory review, the government has put the public and the environment at possible risk from potential allergens, herbicides, creation of ``superweeds,'' and other unknown consequences, the report suggests.
"That system assumes that a company with a big investment in a new product can always be trusted to put the public interest first, and it assumes that one of those companies will never make a mistake,'' CFA's Carol Tucker Foreman said at a briefing to release the report.
The hands-off regulatory approach is hobbling US companies' efforts to export their biotech products, the report contends. Both the European Union (news - websites) and Brazil, which are cited in the report, require mandatory review and labeling of all biotech foods, and have frowned on US imports because of what they view as lax regulation in this country.
According to the report, worldwide sales of genetically modified foods grew an estimated $75 million in 1995, when the first commercial plantings occurred, to approximately $2.3 billion in 1999. More than 40 modified food plants have been marketed in the US for general use, most of them corn and soy products.
The report, produced under a grant from the Rockefeller Foundation, levels its sharpest criticism at the Food and Drug Administration.
Noting that FDA relies solely on voluntary compliance from the regulated industry, coauthor Thomas O. McGarity of the University of Texas law school said: ``We suspect that most manufacturers have in the past voluntarily consulted with the FDA (Food and Drug Administration), but the real finding of this report is that they're not required to legally.''
McGarity said there is no way of knowing how many manufacturers or importers have applied the substantial equivalence doctrine on their own to conclude that they need not consult with FDA prior to marketing biotech foods.
Worse yet, he said, ``we're not even designing into the regulatory process the capacity to monitor for genetically modified foods on the grocery shelves or in the fields.'' The report comes as FDA is poised to propose minor changes to its policy.
How FDA regulates genetically altered foods contrasts with the strict premarket requirements it imposes on food additives.
In addition to concerns about how companies interpret substantial equivalence, McGarity said effective regulation is thwarted by outmoded statutes that predate the agricultural biotech field.
"It is, at bottom, an elaborate and complicated regulatory charade based upon a few regulatory policies posing as science,'' he declared.
The Environmental Protection Agency, which regulates genetically modified products under its pesticide regulatory authority, does a somewhat better job but still suffers from over-reliance on the substantial equivalence policy and inadequate monitoring and enforcement resources, McGarity said. The recent StarLink corn episode, where genetically altered corn intended as animal feed wound up on grocery shelves, might have been avoided if EPA had required the manufacturer to tint the modified seeds as is done with seeds that contain chemical pesticides, he added.
The report urges Congress to pass new legislation that specifically addresses the problems of genetically engineered organisms, or, at the least, that FDA abandon the policy of substantial equivalence. It also calls for mandatory premarket testing and labeling of all foods containing biotech products.
"It may be time...for Congress to take a fresh look at GM foods through committees that are not mere cheerleaders for the regulated industries,'' the report concludes.
The EU-US Consultative Forum on Biotechnology issued a report last month calling for similar controls.