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Related Topics: Pesticide Tolerances 

# Setting Tolerances for Pesticide Residues in Foods 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 for human consumption, EPA re gulates the amount of each pesticide that may remain in and on foods. This Web page briefly describes how EPA sets limits, called tolerances, for pesticide residues in foods and animal feeds. On this page:

• Pesticide registration is the first step

• EPA sets tolerances as part of the food safety equation

• Tolerances are not re quired for some products

• Other agencies are involved

• Tolerance setting requires numerous scientific studies

• Tolerances and exemptions are published in the federal register

• For more information 

## Pesticide Registration is the First Step The term pesticide includes many kinds of ingred ients used in products, such as insecticides, fungicides, rodenticides, insectrepellants, weed killers, antimicrobials, and swimming pool chemicals, that are designed to prevent, destr oy, repel, or reduce pests of any sort. Before a pesticide may be marketed and used in the Unit ed States, EPA evaluates the proposed pesticide thoroughly to ensure that it will not harm human health or the environm ent. 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. More information about:

• Ingredients used inpesticide products

• Pesticide registration 

## EPA Sets Tolerances as Part of the Food Safety Equation Page 1 of 5 Setting Tolerances for Pesticide Residues inFoods | Regulation of Pesticide Residues on ...

12 / 3 /201 5 http://www2.epa.gov/pesticid e -tolerances/settin g -tolerances-pesticid e -residues-foodsBefore allowing the use of a pest icide on food crops, we set a tolerance, or maximum residue limit, which is the amount of pesticide residue allowed to remain in or on each treated food commodity. Actual residues are unlikely to exceed this level when a pesticide is applied according to label directions. The tolerance is the residue level that triggers enforcement acti ons. That is, if residues are found above that level, the commodity wi ll be subject to seizure by the government. In setting the tolerance, we mu st make a safety finding that th e pesticide can be used with "reasonable certainty of no harm." To make this finding, we consider: • The toxicity of the pestic ide and its break-down products. • How much of the pesticide is applied and how often. • How much of the pesticide (i.e., the residue) re mains in or on food by the time it is marketed

and prepared. • All possible routes of exposure to that pest icide (residues on each crop use, as well as

exposure from drinking water and residential exposure). We perform dietary risk assessments to ensure that all tolerances established for each pesticide are safe. These assessments account for the fact that the diets of infants and children may be quite different from those of adults and that they c onsume more food for their size than adults. We address these differences by combining survey information on food consumption by infants and children with data on pesticide residues to esti mate their exposure from food. We also estimate exposure of other age groups such as women of reproductive age, ethnic groups and regional populations. We then combine information about pesticide e xposure (from food, drinking water and residential uses) to infants, children and other subgroups with information about toxicity to determine potential risks posed by pesticide residues. If risks are unacceptable, we won't approve the tolerances. The tolerance applies to food imported into this country, as well as to food grown here in the United States. 

## Tolerances are not Required for Some Products Some pesticides are exempted from the requirement to have a tolerance. We may grant exemptions in cases where the exemption is found to be safe. That is, we must review toxicity and exposure data the same as for tolerance setting. 

## Other Agencies are Involved Several government agencies enforce EPA's pesticide tolerances in food. • The Food and Drug Administration (FDA) tests food produced in the United States and food

imported from other countries for comp liance with these residue limits. • State enforcement agencies also ch eck foods produced in this country. • The U.S. Department of Agriculture (USDA) tests meat and milk. Page 2 of 5 Setting Tolerances for Pesticide Residues inFoods | Regulation of Pesticide Residues on ...

12 / 3 /201 5 http://www2.epa.gov/pesticid e -tolerances/settin g -tolerances-pesticid e -residues-foods• USDA and FDA have programs designed to de velop statistically valid information on pesticide residues in foods. They provide this info rmation to us to use in our risk assessment for pesticides.

◦ Pesticide Data Program (USDA)

◦ Food and Drug Administration residue monitoring data If USDA staff detect viol ations of tolerances in their datacollection program, they notify FDA. 

## Tolerance Setting Requires Numerous Scientific Studies Pesticide companies, or re gistrants, must submit a wide variet y of scientific studies for review before EPA will set a tolerance. The data are designed to identify: • Possible harmful effects the chemicalcould have on humans (its toxicity). • The amount of the chemical (or breakdown products) likely to remain in or on food. • Other possible sources of exposures to the pesticide (e.g., through use in homes or other

places). All of this informat ion is used in our risk assessment process . The risk assessment includes consideration of: 

## Studies about Pesticides in Food

Studies to determine potent ial residues in food include: • Field trials, which are studies of resi dues found on crops grown in the field when

pesticides are applied using the highest rate allowed by the pesticide product label. • Studies of residues in processed f oods (e.g., apple juice, tomato paste). • Data on residues in animal products if live stock are exposed directly or through their feed. • Monitoring data, such as from the Pesticide Data Program

. • The amounts and types of food people eat.

◦ Food consumption by infants and chil dren is specifically considered. • How widely the pesticide is used (that is, howmuch of the crop is actually treated with the

pesticide). • Information on chemistry, toxicity, and exposure. We use data on what foods people eat and the qua ntity they eat, collected through the National Health and Nutrition Survey (NHANES). Through th ese evaluations, we ensure the overall safety of proposed pesticide us es, as required by FQPA. More information on food consumption data: Page 3 of 5 Setting Tolerances for Pesticide Residues inFoods | Regulation of Pesticide Residues on ...

12 / 3 /201 5 http://www2.epa.gov/pesticid e -tolerances/settin g -tolerances-pesticid e -residues-foods• National Health and Nutrition Survey • Food Commodity Intake Database In addition, there must be a prac tical method for detect ing and measuring levels of the pesticide residues so regulatory officials can ensure that any residues are below the level found to be safe. See the OECD calculator, used in the numeric al portion of the tole rance-setting process

. 

## Tolerances and Exemptions are Published in the Federal Register Before we set a tolerance or grant an exemption, the public ha s an opportunity to comment on proposed new pesticide tolerances. We publish 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 publ ic comment period follows these notices. After reviewing public comments and all the scientif ic data, we make a decision regarding the new tolerance or exemption and announce it in the Federal Register. This announcement includes our assessment of risks posed by the pesticide and the safety finding that allo ws establishment of the tolerance or exemption. A 60-day period for filing objections and hearing requests is provided after publication of the tolerance. More information on public noti ces about pesticide tolerances

. The list of tolerances and exemptions is compil ed 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 avai lable from the Federal Register notices or by accessing the electronic CFR (e-CFR). More information on finding tolerances

. Tolerances are published in the:

• Federal Register - publishes new tolerances and changes to tolerances

• Code of Federal Regulations (CFR) 

## For More Information Information on pesticides and their toxicity is available from the National Pesticide Information Center at 1-800-858-7378. EPA's Risk Assessment Proce ss for Tolerance Reassessment

Last updated on November 18, 2015 Exit Page 4 of 5 Setting Tolerances for Pesticide Residues inFoods | Regulation of Pesticide Residues on ...

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12 / 3 /201 5 http://www2.epa.gov/pesticid e -tolerances/settin g -tolerances-pesticid e -residues-foods