Deputy Secretary of Agriculture Ann Veneman announcedFriday a USDA proposal to ease regulating biotech-derivedplants by simplifying the approval process for field tests andexempting adequately tested plants from any furtherregulations.

However, the agency's Animal and Plant Health InspectionService (APHIS) does not intend to totally deregulate agbiotech.Where currently a company or academic institution must applyto USDA for a permit to field-test an engineered plant, in thefuture it may merely need to notify the agency of its intent andthen certify that it will "abide by published procedures andperformance standards," USDA said.

As for the other aspect of this proposal -- to no longer regulatespecific genetically engineered plants -- APHIS has already"deregulated" Calgene Inc.'s Flavr Savr tomato via "interpretiverule making." The agency proposes to formalize this procedurethrough petitions from researchers.

APHIS based its proposed changes on its years of experience inthe field. "Since 1987 APHIS has issued researchers more than1,000 permits to move regulated materials and 335 permits tofield-test them. Each of these permits has been closelymonitored by the agency," it said.

Thus, APHIS has developed a list of notification criteriacovering safety and risk factors for the six transgenic cropplants on its list: corn, cotton, soybean, tomato, tobacco andpotato.

"The notification procedure will cover 85 percent of the cropsthat we've received permits on before," John Payne, associatedirector of APHIS's division of biotechnology, biologics andenvironmental protection, told BioWorld. This should save 90percent of the cost of preparing permits, not to mentionconsiderable paperwork.

But even though USDA proposes to "lighten the load" foreveryone concerned, it doesn't intend to lose control of theprocess. Once USDA has received a notice, it will inform thestate(s) that are the sites of the proposed field trials. And USDAis "maintaining its privilege to inspect" these trials, Payne said.

The agency will also ask researchers to file reports at the endof the year, verifying that "nothing unexpected occurred; therewere no symptoms of crown gall disease (caused by thecommon genetic vector Agrobacterium); there were no signs ofweediness; and the field test was terminated," Payne explained.

Payne said that APHIS "hopes for a high level of voluntarycompliance" with its proposed notification process.

Biotech analyst George Dahlman of Piper, Jaffray & Hopwood inMinneapolis said the significance of the USDA's proposal is"more psychological than real."

While the agency's statement acknowledges implicitly that"scientists know what they're doing," in reality "it will notspeed up the process of getting genetically engineered productsinto the marketplace, although it may make it less expensive,"Dahlman said. "You still have to do the research."

Nonetheless, biotech companies and their industry associationspraised the USDA's proposals.

"This is an excellent example of the prudent evolution ofregulatory oversight," Russell Smestad, vice president offinance and commercial development at Agracetus of Madison,Wisc., told BioWorld. "This will facilitate us moving forwardwith oversight, but at the appropriate level."

"This will benefit industry generally and us specifically as weget plants into the field to test them more quickly and morecost effectively, " said Joseph Panetta, director of regulatoryaffairs at Mycogen Corp. of San Diego.

It's a "win-win situation," Richard Godown, president of theIndustrial Biotechnology Association (IBA), told BioWorld."USDA has managed to ease the regulatory burden whilemaintaining government oversight," he said. "The newregulatory scheme will benefit industrial and academicresearchers alike. That's a fine achievement, and one whichdeserves congratulations on all sides."

And Thomas Wiggans president of the Association ofBiotechnology Companies, said, "This policy reflects thecontinued understanding of the safety issues which areminimal. ... We applaud this administration for recognizing thesafety of biotechnology."

However, not everyone is cheering.

The most vehement protest came from Jeremy Rifkin, aspresident of his newest anti-biotech initiative the Pure FoodCampaign. Rifkin called the proposals "grossly negligent andillegal."

To Margaret Mellon of the National Wildlife Federation, theproposals are "not acceptable." Not only is there "no scientificbasis for deregulation at this time," but "it gives the regulatedcommunity the first-line decision as to what products aredangerous," she said. "We still have no data base for safety."

Mellon does not oppose the principal of the proposals per se,she told BioWorld, but "in practice this has turned into acomplete abdication of responsibility by the agency. ... They areunder enormous pressure from the (president's)Competitiveness Council."

Washington activist Ted Howard, director of the Pure FoodCampaign, sees the policy proposal as "one more example of theadministration's great support for biotechnology (the othersbeing the refusal to sign the Biodiversity Treaty and FDA'sderegulation of engineered foods.)"

The USDA said it will publish the proposals in an upcomingedition of the Federal Register. And "the opportunity tocomment" is one of the options that the National WildlifeFederation will explore, Mellon told BioWorld. Rifkin's PureFood Campaign, meanwhile, has already filed a formal legalcomplaint with USDA.

-- Jennifer Van Brunt Senior Editor

(c) 1997 American Health Consultants. All rights reserved.

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