Rockefeller Foundation Report

Damns US Regulation of Biotech Foods

Reuters Health 12jan01

WASHINGTON - 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 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.

Report Says U.S. Regulation of Genetically Modified Foods

Includes Huge Loopholes that Permit Marketing with Little Government Oversight

Potentially Dangerous GM Products Allowed to Enter the Food Supply

The U.S. system for regulating genetically modified foods includes huge loopholes that allow manufacturers to market these products to consumers with little government oversight and frees the Food and Drug Administration from blame if these foods are later found to be unsafe, according to an exhaustive legal analysis issued today by the Consumer Federation of America Foundation.

While there is little mandatory federal regulation of any genetically modified plant product, there is effectively no federal standard for human safety, the CFAF report said.

"FDA allows manufacturers complete freedom to assert a new product is 'substantially equivalent' to an existing food," said Carol Tucker Foreman, a former assistant secretary of agriculture who oversaw the writing of the report for CFAF. "Products declared 'substantially equivalent' do not require any additional safety testing before they are sold to the public. Not surprisingly, all of the products now on the market were declared by their manufacturer to be substantially equivalent and safe."

This "hands off" regulatory approach, which rests on voluntary industry consultation with government, is in stark contrast to that applied by FDA to food additives. The result is too few health and environmental safety checks, too much information concealed from the public about the genetically modified products, the report said.

This also virtually guarantees continued trade disputes with the European Union, which has elected to regulate these new foods more vigorously.

What the report calls a "laissez faire approach" to GM food regulation was devised by openly pro-business U.S. administrations in part to benefit the fledgling agricultural biotechnology industry and in part to allow FDA to avoid seeking new staff or authority to perform safety checks similar to those it requires for other products.

While this has allowed manufacturers to move full-speed-ahead in marketing new GM products, it may be backfiring, as public confidence in the adequacy of the GM food regulation erodes, some food processors avoid the products, and trading partners deride the safety of U.S. commodities.

"It seems reasonably certain that the agricultural biotechnology industry has a bumpy road ahead...if some changes are not implemented fairly quickly," the report said. It recommended a long list of changes aimed at enhancing the safety of and public confidence in GM foods. Among them:

• Abandoning the 1992 assumption by the Food and Drug Administration that most GM foods are essentially the same as non-GM foods and therefore not subject to the lengthy FDA safety reviews required for "food additives."
• Extensive health and environmental testing of GM food products by both manufacturers and academics, including government-sponsored long-term testing of the consequences of introducing GM plants into the environment and the food supply.
• Requiring manufacturers to put labels on or near all food products containing more than a negligible amount of GM material to give consumers the option to avoid them.
• Requiring manufacturers to notify regulatory agencies of plans to market GM foods and making those plans available for public comment, along with as much health and safety testing data as possible.

In addition, the report said the attitude of federal agencies must change from that of a cheerleader for

GM technologies to that of cautious regulators of new and potentially risky products.

Breeding Distrust: An Assessment and Recommendations for Improving the Regulation of Plant Derived Genetically Modified Foods was written for CFAF primarily by Professor Thomas O. McGarity of the University of Texas School of Law. McGarity is a leading scholar in administrative and environmental law and author of several books on the regulatory process. The report was prepared under a grant from the Rockefeller Foundation.

Heavy reliance on the principle that GM foods are substantially equivalent to non-GM foods and, therefore, generally assumed to be safe is a key fault of the current U.S. regulatory approach, the report said. This allows most GM foods to enter the market without a formal FDA safety determination, as is required for food additives. The report added that FDA essentially leaves the determination of whether a GM product is the same as a non-GM product up to the manufacturer.

Testing requirements for GM foods are equally lax. "The present testing regime, in which a manufacturer can avoid virtually all testing by simply finding that its product is substantially equivalent to existing food, is probably not adequate to protect human health and the environment, and it is certainly not sufficient to secure public trust in the regulatory process," the report said.

"Federal regulators contorted questionable doctrines to avoid meaningful safety examination or regulation of these products," said Foreman, who heads the Food Policy Institute at CFA. "This has turned FDA into a biotechnology cheerleader and set the stage for a continuing trade dispute with the European Union and others who have passed laws to assure the safety of GM foods."

Said McGarity: "This is a regulatory system that doesn't regulate, because of exemptions that create gaping holes. Consumers are told public agencies are looking at these products when in fact they are not. And as the recent Starlink incident has shown, one or two well-publicized incidents of disease or destruction linked to GM foods may well be enough to cause society to shelve agricultural biotechnology for the foreseeable future."

The FDA formalized its regulatory system for GM foods in 1992. At the time, the report noted, then-Vice President Dan Quayle told biotechnology industry representatives the policy was "designed to provide 'regulatory relief' for the industry so that it would remain a world leader" in biotechnology. "With an introduction like this, it is not surprising that many consumers were reluctant to trust the output of the regulatory regime that resulted," the report said.

Most of the changes suggested in the report can be adopted by regulatory agencies without legislation. But, the report noted, "it may be time for Congress to take a fresh look at GM foods...and write a new statute that addresses directly the risks and benefits of GM foods and provides an adequate regulatory regime..." While the European Union has adopted laws and regulations specifically for GM foods, the U.S. regulates them under rules set up for toxic chemicals.

The report comes as the Food and Drug Administration is expected to propose minimal changes in how it regulates GE foods. FDA favors requiring consultation by companies seeking to market new GE foods but opposes full-fledged government safety reviews.

The CFAF study is the second major report in recent weeks to recommend pre-market safety reviews and mandatory labeling of GM foods. Similar recommendations were made in mid-December by a diverse panel of non-government experts from both the United States and Europe.

The CFAF report listed potential benefits of GM foods including increased crop yields, reduced pesticide use, and the improved safety and nutrition of foods. But it also listed risks including the development of super weeds, threats to non-target insects such as monarch butterflies, and development of pesticide-resistant pests. Possible threats to health, it added, include increased resistance to antibiotics, and the possibility that some GM foods will be either toxic or trigger allergic reactions. These risks, the report said, should cause regulators to proceed cautiously.

To open up the process to public scrutiny, the report said, at minimum government should require notification of regulatory agencies any time a manufacturer seeks to market a GM food. In addition, it said, federal agencies should publish and post on the Internet all requests to market GM foods. They should also make as much health and safety testing data public as possible, despite industry claims to trade secrecy. "In the age of the Internet," the report said., "There is simply no excuse for the opacity of the existing process."

On labeling, the report said, "there appears to be an emerging worldwide consensus that GM foods should be labeled to allow consumers to choose" whether to purchase them. While some food processors and the FDA now favor voluntary labeling, the report said "the reasons for requiring labeling of GM foods are so compelling that the matter should no longer be voluntary. Public acceptance of GM foods, even in the U.S., probably requires that consumers be given a choice."

The complete 258 page report is available from CFA for $7. [Executive Summary available on mindfully.org]

The Consumer Federation of America Foundation is a nonprofit research and education organization that completes the work of the Consumer Federation of America. CFA is an association of approximately 270 pro-consumer groups, including Consumers Union, AARP, credit unions and grassroots activists. CFA was founded in 1968 to advance the consumer interest through advocacy and education.\

CONTACT: Art Jaeger or Thursday, January 11, 2001 Carol Tucker Foreman, 202-387-6121

source: http://www.consumerfed.org 13jan01