Administration Fields Biotechnology Policy

August 7, 2002

The Bush administration has proposed its policy for early safety assessment of genetically modified crops. The proposals are aimed at further reducing the likelihood of intermittent, low levels of biotechnology-derived genes and gene products from crops under development for food or feed use until all appropriate safety standards have been met.

Making the announcement was the White House Office of Science and Technology which noted, "While the expansion of biotechnology-derived crops is expected to result in net benefits to producers, consumers, and the environment, the federal government must maintain appropriate regulatory oversight, adjusting its requirements based on scientific developments and industry trends."

The Food and Drug Administration would develop procedures to address the possible intermittent, low level presence in food and feed of new non-pesticidal proteins from biotechnology-derived crops under development for food or feed use but that have not gone through FDA´s premarket consultation process.

Through these procedures, FDA would encourage sponsors (domestic and foreign) to submit protein safety information. That information would be submitted once field testing was about to reach a stage of development where there could be concerns that new non-pesticidal proteins produced in the field-tested plants might be found in commercial seed, commodities, or food or feed.

For this kind of low-level intermittent exposure, FDA does not believe there is a need to evaluate "potential unintended compositional changes in food" that might be associated with separate transformation events, OST said.

Consequently, the agency would propose to establish procedures under which developers could provide FDA with food/feed safety information on any non-pesticidal protein engineered into a food/feed crop when that protein has not previously been evaluated by FDA and is new to the food crop into which it was engineered.

FDA would be interested principally in looking at data and other information addressing potential toxicity and allergenicity.

The Environmental Protection Agency would rely on its existing processes to address residues of pesticidal proteins in food and would publish for comment guidance for individuals and organizations conducting field-testing on plant-incorporated protectants (PIPs). Proposals would involve the process for obtaining EPA review of the safety of the presence of low-level intermittent residues of PIPs in food and guidance on containment controls that a person should employ when conducting experimental field trials, in order to minimize the potential occurrence of unapproved PIPs in food.

EPA would encourage developers to seek approval for residues of PIPs in food very early in the research and development process, if there is a likelihood for the pesticide to be in food through gene flow.

USDA has strengthened field-testing controls for permits on those bioengineered traits that are not intended for commodity uses, such as pharmaceuticals, veterinary biologics, or certain industrial products by requiring specific additional safeguards as a condition of permits for confined release into the environment of such products.

The potential for exposure would be mitigated through additional safeguards that may include overall confinement procedures, performance standards, and monitoring/auditing practices for ensuring that out-crossing or commingling of non-commodity appropriate traits with seeds and commodities are prevented.

USDA also would propose to amend its regulations to provide criteria under which regulated articles may be allowed in commercial seed and commodities, if they pose no unacceptable environmental risk.

American Seed Trade Association Chief Executive Richard Crowder said there must be a consistency to technology, marketing and regulation developments.

"The proposal being made by the government will help ensure that science based regulations and technology move together. It will also provide additional confidence in biotech derived products for customers of the seed industry and for feed and food product users, domestically and internationally" he added.

Michael J. Phillips, executive director of food and agriculture at the Biotechnology Industry Organization (BIO), said the new regulatory review process gives consumers "yet another layer of assurance to the existing regulatory review of agricultural crops intended for both food and feed."

Phillips added, "The Food and Drug Administration now has an additional step in the process to ensure protective and thorough review of crops enhanced through biotechnology while those crops are at the early stages of development in field trials that are already regulated" by USDA.

BIO members "will comply with this added layer of oversight and consider it to be a mandatory requirement in the development of crops improved through the use of biotechnology."