APHIS proposes revisions to its biotechnology regulations

by Jay Sjerven
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WASHINGTON — The food industry applauded the Animal and Plant Health Inspection Service of the U.S. Department of Agriculture for its effort to modernize its biotechnology regulations as outlined in a proposed final rule on the importation, interstate movement and environmental release of certain bioengineered organisms published in October but asserted the APHIS proposals fell far short of addressing concerns over food and feed safety.

APHIS indicated its proposed revisions to its current biotechnology regulations were made in response to advances in science and technology.

Under the proposed final rule, APHIS would broaden its regulatory oversight of bioengineered organisms that may damage crops and other plants (i.e. plant pests) to include bioengineered organisms that "may pose a broader array of risks to agriculture and the environment (i.e. noxious weeds)." Additionally, APHIS proposed to extend its oversight to certain bioengineered non-plant and non-vertebrate organisms.

Currently, APHIS maintains a two-tiered system of notification and permit procedure regarding bioengineered organisms. The notification process was designed to expedite permitting for bioengineered plants considered to be lower risk. Permits are more restrictive and are used for an organism that may pose elevated risk to plant health, "such as plants engineered to produce pharmaceutical or industrial compounds."

APHIS proposed to eliminate the notification procedure and rely solely on a revised risk-based permitting process. Under the proposal, APHIS would assign bioengineered organisms to administrative categories based on risk. A complete risk assessment would follow for each that would determine the appropriate permit conditions before authorizing a release.

"The permit conditions and degree of oversight would be risk-proportionate and vary by category," the agency said.

Another proposal would "improve and clarify" the petition procedure to approve the non-regulated status for a bioengineered organism whereby it would no longer be subject to APHIS biotechnology regulations.

Dr. Craig Henry, senior vice-president and chief operating officer of the Grocery Manufacturers Association, in his comments on the proposed final rule asserted plant-made pharmaceuticals (P.M.P.s) and plant-made industrial compounds (P.M.I.C.s) should not be produced in food or feed crops and APHIS should steer biotechnology efforts to produce such pharmaceuticals or compounds to non-food and non-feed crops.

"While food crops modified to produce P.M.P.s and P.M.I.C.s are not intended to enter the food supply, experience has shown they can and will," Dr. Henry said.

Dr. Henry noted APHIS asserted it has no direct role in evaluating the safety of foods and would not assess the safety of bioengineered plants for human or animal consumption. At the same time, the agency indicated it would consider available information about toxicity and food safety in assessing the noxious weed risk posed by the plants growing in the environment.

Kendell W. Keith, president of the National Grain and Feed Association, said APHIS should exempt from its proposed deregulation procedure any biotechnology-enhanced plants that express pharmaceutical or industrial properties not intended for use in food or feed. Mr. Keith said such products should continue to be governed by a stringent permit system so they are strictly separated from crops grown for food and feed at all stages of production and use.

Mr. Keith said APHIS should limit the use of conditional exemptions from permit requirements and encouraged the agency to impose restrictions on commercial plantings of biotechnology-enhanced commodities until all regulatory requirements have been met.

"Allowing commercialization before full deregulation may reduce the regulatory burden for technology providers, but it creates increased potential risks to other growers, grain handlers, exporters, feed manufacturers and food processors that U.S. products may be contaminated and deemed adulterated or rejected by importers," he said.

This article can also be found in the digital edition of Food Business News, January 6, 2009, starting on Page 21. Click here to search that archive.

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