WASHINGTON -- President Bush announced on Monday "majornew ground rules for regulation of biotechnology," developedby the White House Council on Competitiveness to streamlineregulation of new biotechnology products.

Key to Monday's announcement is the definition of "risk" thatmust be used by federal agencies in determining the extent ofregulation of biotech products.

The administration's policy on risk, as stated in Monday's "FinalScope Document for Planned Introductions of BiotechnologyProducts into the Environment," will clear the way for finalreview and publication of biotechnology regulations by theWhite House Office of Management and Budget (OMB).

Both the industry, which is seeking to clarify regulations andreassure consumers, and environmental organizations, whichwould like to see tighter restrictions on potentially hazardousproducts, have been pushing for the final rules.

"Some have argued that the reason the regulations have beendelayed was because the federal government could not decideon the scope for oversight," said Alan Goldhammer, director oftechnical affairs for the Industrial Biotechnology Association."Now that we have the scope document, they need wait nolonger."

The impending review and publication of federal agencyregulations includes the Environmental Protection Agency'sFederal Insecticide, Fungicide and Rodenticide Act (FIFRA),which regulates microbial pesticides, and its Toxic SubstancesControl Act (TSCA), which regulates other microbial products.Also to be covered are the USDA's Agricultural BiotechnologyResearch Advisory Committee's recommended guidelines forfield releases, and the FDA's Federal Food, Drug and CosmeticAct.

A subsequent phase of the regulatory initiative will be thedevelopment of detailed "road maps" for "one-stop shopping"for federal approvals of biotech products.

"This $4 billion industry should grow to $50 billion by the endof the decade -- if we let it," Bush said. "The rewards we willreap include new medicines, safer ways to clean up hazardouswastes, and a revolution in agriculture. The United States leadsthe world in biotechnology, and I intend, through sensibleregulation and, in some instances, deregulation, to keep it justexactly that way."

The "Final Scope" document, to be officially released later thisweek by the White House Office of Science and TechnologyPolicy, instructs agencies to regulate planned introductions ofbiotech based only on risk and "not turn on the fact than anorganism has been modified by a particular process ortechnique."

Under this test, "oversight will be exercised only where the riskposed by the introduction is unreasonable, that is, when thevalue of the reduction in risk obtained by additional oversightis greater than the cost thereby imposed." Regulators are totake into account "the gravity and type of risk being addressed,the costs of alternative oversight options, and the effect ofadditional oversight on existing safety incentives."

The policy gives agencies wide latitude in defining how toregulate at net benefit and least cost, stating that they canchoose from a "menu of measures" rather than face a stark"oversight-no oversight" choice.

"The bottom line is that they are giving the federal agencies alittle more discretion about how to read their statutes thanmight otherwise have been the case," said Margaret Mellon,director of the National Wildlife Federation's BiotechnologyPolicy Center.

"Some people feared that this final statement of scoperequiring evidence of unreasonable risk would basically makeit impossible for agencies to come forward with any of theregulations currently in the pipeline," Mellon told BioWorld."But there is room in that statement to find justification for anyof the regulations in the pipeline, and very (environmentally)protective versions of those regulations.

"There is also room within this statement for the OMB to look atthe rules and say, 'No, these risks are not unreasonable.' It onlymeans whatever the OMB says it means."

Final judgment will have to await the appearance ofbiotechnology guidelines from the federal agencies, said theIBA's Goldhammer. "I would defer comment on this until wesee what regulations develop out of this."

-- Kris Herbst BioWorld Washington Bureau

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