Threshold of Regulation–Science Policy Paper
Note: This information is provided for reference purposes only. Although the information provided here was accurate and current when first created, it is now outdated.
Committee to Advise on
Reassessment and Transition
Paper # 22
Science Policy Addresses Deciding Whether a Food Use Pesticide Needs a Tolerance
- On October 27, EPA published a notice in the Federal Register announcing the availability of the revised science policy paper, "Threshold of Regulation Policy–Deciding Whether a Pesticide with a Food Use Pattern Needs a Tolerance" (Federal Register Vol. 64, No. 207, Pages 57881-57884).
- This policy addresses situations where residues are not detected.
- Under this policy, there would be no need for a tolerance or tolerance exemption under the Federal Food Drug and Cosmetic Act if:
- using a reliable and appropriately sensitive analytical method to measure residues in the commodity, no residues are detected in the commodity under expected conditions of use when the commodity enters interstate commerce; and
- using reasonably protective criteria, the estimated potential risk of any theoretically possible residues in food is not of concern.
This policy protects food safety while supporting efficient use of Agency resources
There are several advantages offered by the Threshold of Regulation policy:
- It allows the Agency to approve registration of new pesticide uses or to permit the continuation of existing registrations of pesticide uses that pose "essentially zero" risk.
- It is intended to make Agency resources available for pre-market review of safer pesticides to replace pesticides that do not meet the new safety standard for tolerances established by the Food Quality Protection Act on 1996 (FQPA).
- It also supports a reasonable transition for agriculture by retaining some pesticide uses that might otherwise be discontinued and by expanding the number of potential replacements for higher risk food use pesticides.
Certain types of products could qualify under this policy
- Fumigants incorporated into soil before planting
- Pre-bloom and dormant applications in orchards
- Seed treatments, where the seed is not diverted for animal feed
- Some livestock treatments (e.g., early in the life of the animal)
- Use of antimicrobials in food-handling establishments
- Crack and crevice treatments in food-handling establishments where food is removed or covered during application
- Pre-plant or pre-emergence uses of low-application-rate herbicides
For more information:
- Copies of OPP’s science policies are available on the Internet: http://www.epa.gov/oppfead1/trac/science/ or from the OPP Docket (703-305-5805.
- Status information and the available risk assessment and risk management documents on the organophosphate pesticides are available on EPA’s web page www.epa.gov/pesticides/op.
- Contact the National Pesticide Telecommunications Network 800-858-7378; www.ace.orst.edu/info/nptn for information on the toxicity of pesticides.