August 2, 2002
WASHINGTON--The United States is looking into updating testing requirements for biotech crops intended to be used for human food or animal feed, as well as establishing early food safety assessments on proteins produced by such crops. The White House's Office of Science and Technology Policy (OSTP), working with the Department of Agriculture (USDA), Health and Human Services (HHS) and the Environmental Protection Agency (EPA), published these actions in the Aug. 2 Federal Register under the title "Proposed Federal Actions To Update Field Test Requirements for Biotechnology Derived Plants and To Establish Early Food Safety Assessments for New Proteins Produced by Such Plants."
According to OSTP, there has been a rapid development in the science of genomics, leading to an increase in commercialization of a greater number and a wider diversity of biotech crops. The reasoning behind OSTP's proposals is the number of biotech crops have markedly increased: from 7,000 acres in 1994 under USDA field-test authorizations to 57,000 in 2001. In 2001, 88 million acres of biotech crops were planted in the United States, and 130 million were grown worldwide.
OSTP reported that while existing field-testing requirements have been appropriate for current biotech development and commercialization activities, federal regulations must be prepared for what the future holds, especially since the likelihood of cross-pollination with non-biotech crops may increase. "This could result in intermittent, low levels of biotechnology-derived genes and gene products occurring in commerce that have not gone through all applicable regulatory reviews," OSTP stated. "These measures are aimed at preventing low levels of biotechnology-derived genes and gene products from being found in commercial seed, commodities, and processed food and feed until appropriate safety standards can be met." These proposed actions would be implemented through the Food and Drug Administration (FDA), EPA and USDA.
Under the proposed actions, FDA would publish for comment draft guidance on procedures to address the possible intermittent, low-level presence of new, non-pesticidal proteins from biotech crops in food and feed. Through this guidance, FDA would encourage domestic and foreign sponsors to submit protein safety information before non-pesticidal proteins from field-tested plants were found in commercial seed, commodities or food/feed. FDA would also maintain a list on its Web site, consistent with confidentiality requirements, of all proteins it had evaluated and considered as either acceptable or unacceptable.
EPA would rely on its existing processes to address residues of pesticidal proteins in food, and would publish for comment a guidance for individuals and organizations conducting field tests on plant-incorporated protectants (PIPs). EPA would encourage developers to seek approval for residues of PIPs in food early in the research and development process of biotech proteins if there was a likelihood for the pesticide to be in food because of gene flow. EPA would also look into requiring a person to obtain an experimental use permit prior to conducting field research with a pesticide.
On USDA's part, the agency would amend its regulations to provide criteria under which applicable articles may be allowable in commercial seed and commodities if they posed no unacceptable environmental risk.
OSTP is welcoming public comment on the proposed federal actions, which should be sent by Sept. 30 by e-mail ([email protected]) or FAX (202-456-6027).
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