Setting Tolerances for Pesticide Residues in Foods
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Pesticides are widely used in producing food. These pesticides may remain in small amounts (called residues) in or on fruits, vegetables, grains, and other foods. To ensure the safety of the food supply, EPA regulates the amount of each pesticide that may remain in and on foods. This fact sheet briefly describes how EPA sets limits, called tolerances, for pesticide residues in food.
Pesticide Registration is the First Step
EPA Sets Tolerances to Ensure Food Safety
Tolerance are not Required for Some Products
Other Agencies are Involved
Tolerance Setting Requires Numerous Scientific Studies
Tolerances and Exemptions are Published in the Federal Register
EPA is Reassessing Old Tolerances
For More Information
The term pesticide includes many kinds of ingredients used in products, such as insecticides, fungicides, rodenticides, insect repellants, weed killers, antimicrobials, and swimming pool chemicals, which are designed to prevent, destroy, repel, or reduce pests of any sort. Before a pesticide may be marketed and used in the United States, EPA evaluates the proposed pesticide thoroughly to ensure that it will not harm human health or the environment. Pesticides that pass this evaluation are granted a license or "registration" that permits their sale and use according to requirements set by EPA to protect human health and the environment. Pesticide registration is described in a separate fact sheet. See "For More Information" to find out how to obtain a copy.
Before allowing the use of a pesticide on food crops, EPA sets a tolerance, or maximum residue limit, which is the amount of pesticide residue allowed to remain in or on each treated food commodity. The tolerance is the residue level that triggers enforcement actions. That is, if residues are found above that level, the commodity will be subject to seizure by the government.
In setting the tolerance, EPA must make a safety finding that the pesticide can be used with "reasonable certainty of no harm." To make this finding, EPA considers
the toxicity of the pesticide and its break-down products
how much of the pesticide is applied and how often
how much of the pesticide (i.e., the residue) remains in or on food by the time it is marketed and prepared
EPA ensures that the tolerance selected will be safe. The tolerance applies to food imported into this country, as well as to food grown here in the U.S.
Some pesticides are exempted from the requirement to have a tolerance. EPA may grant exemptions in cases where the exemption is found to be safe. That is, EPA must review toxicity and exposure data the same as for tolerance setting. In addition, there must be a practical method for detecting and measuring levels of the pesticide residues so regulatory officials can ensure that any residues are below the level found to be safe.
Several government agencies enforce EPA's pesticide tolerances in food.
The federal Food and Drug Administration (FDA) tests food produced in the United States and food imported from other countries for compliance with these residue limits.
State enforcement agencies also check foods produced in this country.
In addition, the U.S. Department of Agriculture tests meat and milk.
USDA and FDA have programs designed to develop statistically valid information on pesticide residues in foods. They provide this information to EPA to use in its risk assessment for pesticides.
If USDA staff detect violations of tolerances in their data collection program, they notify FDA.
Pesticide companies, or registrants, must submit a wide variety of scientific studies for review before EPA will set a tolerance. The data are designed to identify possible harmful effects the chemical could have on humans (its toxicity), the amount of the chemical (or breakdown products) likely to remain in or on food, and other possible sources of exposures to the pesticide (e.g., through use in homes or other places).
All of this information is used in EPA's risk assessment process. A separate fact sheet, "Assessing Human Health Risks from Pesticides", describes this process. (Please see "For More Information" to find out how to obtain a copy). The risk assessment includes consideration of the amounts and types of food people eat and how widely the pesticide is used (that is, how much of the crop is actually treated with the pesticide), as well as chemistry, toxicity, and exposure information. EPA also uses data from USDA on what foods people eat and the quantity they eat, collected through the Pesticide Data Program. Through these evaluations, EPA is ensuring the overall safety of proposed pesticide uses, as required by FQPA.
Before EPA sets a tolerance or grants an exemption, the public has an opportunity to comment on proposed new pesticide tolerances. EPA publishes a notice in the Federal Register announcing the receipt of a petition for a tolerance or exemption. This is called a Notice of Filing. This notice includes a summary by the petitioner. A public comment period follows these notices.
After reviewing public comments and all the scientific data, EPA makes a decision regarding the new tolerance or exemption and announces it in the Federal Register. This announcement includes EPA's assessment of risks posed by the pesticide and the safety finding that allows establishment of the tolerance or exemption. A 60-day period for filing objections and hearing requests is provided after publication of the tolerance.
The list of tolerances and exemptions is compiled in the Code of Federal Regulations (CFR), Chapter 40, Part 180. The CFR is revised once a year, in July. Therefore, during the year, information on new or changed tolerances is available from the Federal Register notices.
EPA has reassessed all the pesticide and other ingredient tolerances and exemptions that were in effect as of August 3, 1996 when the Food Quality Protection Act was signed. This effort was designed to ensure that existing tolerances and exemptions meet the safety standard set by FQPA. Reassessment of tolerances and exemptions was done based on a schedule requiring one-third to be completed by August 1999, one-third by August 2002, and the remainder by August 2006.
EPA gave highest priority to pesticides that appeared to pose the greatest risk. This reassessment was a large task: More than 450 pesticides and other ingredients have tolerances or exemptions from the requirement for a tolerance. Approximately 9,700 tolerances were in effect at the passage of FQPA. There can be many tolerances associated with a given chemical (that is, a chemical might be used on various food crops), which contributes to the complexity of the review. For more information see EPA's FQPA accomplishments.
EPA's focus in registering pesticides for use on food crops and reassessing their safety is on protecting human health and the environment. EPA uses the best available scientific information in conducting these reviews and is committed to ensuring that the public is informed about the process.
Information on EPA's pesticide regulatory program and a variety of pesticide-related publications, such as the fact sheets on registration and risk assessment, are available from the Office of Pesticide Programs, Communication Services Branch, Ariel Rios Building, 1200 Pennsylvania Ave. NW, Washington, D.C. 20460. Or call us at 703-305-5017.
Also, the EPA Office of Pesticide Programs' home page contains further information on EPA's pesticide regulatory program, including fact sheets on various topics. Periodic updates on new registrations and tolerances as well as progress in implementing the tolerance reassessment schedule and other provisions of the FQPA also will be published at this Internet site.
Information on pesticides and their toxicity is available from the National Pesticide Information Center at 1-800-858-7378.