Report Damns U.S. Regulation of Biotech Foods

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Report Damns U.S. Regulation of Biotech Foods

 

By Meg Bryant

 

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 - web

sites) 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 (news - web sites).

 

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.

 

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