Committee to Advise on Reassessment and Transition - Paper #7
Regulation of Plant-Pesticides
What Products of Biotechnology does EPA Regulate?
How Does EPA Ensure the Safety of Plant-pesticides?
- Under FIFRA, EPA regulates microbial pesticides, which are naturally occurring and genetically engineered, and plant-pesticides (pesticidal substances produced by plants).
- EPA regulates the herbicides used on herbicide-tolerant plants, but the regulation of the plants themselves and the food crops is done by USDA and FDA, respectively.
What is EPA Doing About Expiring Registrations for Bt Corn and Cotton?
- Genetically engineered microorganisms are regulated using essentially the same data requirements as for naturally occurring microbial pesticides. Some additional data are required concerning the genetic engineering process used and results from that process. EPA requires a notification process for genetically engineered microbial pesticides before they are field tested, even below the typical 10-acre cutoff for conventional pesticides.
- There are also genetically engineered microorganisms that produce proteins that are harvested and used as pesticides. These products may have the same test requirements as the microbial pesticide products, but mostly follow the biochemical test guidelines if (as is typical) the microorganism is killed before the product is released to the environment.
- Data requirements for plant-pesticides are set on a case-by-case basis. The Agency held a series of public meetings with the FIFRA Scientific Advisory Panel (SAP) and a special Biotechnology Scientific Advisory Committee to gain expert review and consider comments from the public regarding data requirements. EPA held a series of SAP meetings between December 1999 and June 2000 to review past data requirements and determine if any changes to those requirements should be made.
- EPA conducts rigorous reviews to ensure pesticides will not harm human health or the environment. Detailed fact sheets on the products are available on the Agency's web site www.epa.gov/pesticides/biopesticides.
- EPA expects to issue a final rule by the end of 2000 on the regulation of plant-pesticides. After these regulations are final, EPA will propose regulations to codify data requirements for the registration of plant-pesticides.
- EPA is considering all currently available information on the risks and benefits of Bt corn, cotton, and potato plant-pesticides.
- EPA scientists are developing an updated risk assessment for Bt plant-pesticides, which will receive outside scientific peer review by the SAP in September 2000 and will include opportunities for public comment.
- Following the SAP review and public comment on the risk assessment, EPA will develop a risk management proposal, solicit comment on the risk management proposal, and develop a final risk management proposal.
How is the U.S. Responding to Concern over Genetically-Engineered Crops?
- In addition to the SAP meetings, EPA recently responded to a petition to cancel Bt crop registrations (see above web address for the response).
- The Agency has also held workshops and other forums and has attended numerous scientific meetings to gather information on these products.
- EPA is joining other Federal agencies in a review of how biotechnology products are regulated in the U.S. This White House-led effort emphasizes ecological effects. Participants include the Food and Drug Administration, the Department of Agriculture, the Fish and Wildlife Service, and the Department of Interior, in addition to EPA.
- This assessment, which emphasizes ecological impacts, will help identify opportunities for strengthening the existing regulatory framework for assessing environmental risks associated with biotechnology.
- EPA plans to participate fully in this interagency assessment of biotechnology regulations and to change data requirements, require additional research, or adopt other appropriate measures, and factor such recommendations, as appropriate, into its reassessment of the Bt plant-pesticides and its regulation of plant-pesticides in general.
- In April 2000, the National Academy of Sciences completed a review of the regulation of plant-pesticides and issued a report that generally supports EPA's science and its approach to regulating these products.
- For the 2000 growing season, EPA moved to have the refuge (set-aside acreage) for resistance management changed from voluntary to mandatory for Bt potatoes. For Bt corn products, EPA required, among other things, an enhanced refuge system and required industry and growers to conduct expanded field monitoring to detect potential resistance.
- Finally, EPA has set sales and planting restrictions in certain limited areas for some Bt corn products and is working with industry and growers to implement voluntary measures to reduce potential exposure to non-target insects.
For more information:
- Fact sheets on the plant-pesticide products are available on the Agency's web site www.epa.gov/pesticides/biopesticides.
- Contact the National Pesticide Telecommunications Network (800-858-7378; http://npic.orst.edu for information on the toxicity of pesticides.
- EPA's pesticide homepage www.epa.gov/pesticides has information about pesticide regulation as well as publications about pesticide issues for consumers.