Attachment L -Setting Tolerances

Setting Tolerances for Pesticide Residues in Foods | Regulation of Pesticide Residues on ...

Page 1 of 5

Menu

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 regulates 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 required 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 ingredients used in products, such as insecticides,
fungicides, rodenticides, insect repellants, weed killers, antimicrobials, and swimming pool
chemicals, that 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.
More information about:
• Ingredients used in pesticide products
• Pesticide registration

EPA Sets Tolerances as Part of the Food Safety Equation

http://www2.epa.gov/pesticide-tolerances/setting-tolerances-pesticide-residues-foods

12/3/2015

Setting Tolerances for Pesticide Residues in Foods | Regulation of Pesticide Residues on ...

Page 2 of 5

Before allowing the use of a pesticide 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 actions. That is, if residues
are found above that level, the commodity will be subject to seizure by the government.
In setting the tolerance, we must make a safety finding that the pesticide can be used with
"reasonable certainty of no harm." To make this finding, we consider:
• 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.
• All possible routes of exposure to that pesticide (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 consume 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 estimate 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 exposure (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 compliance with these residue limits.
• State enforcement agencies also check foods produced in this country.
• The U.S. Department of Agriculture (USDA) tests meat and milk.

http://www2.epa.gov/pesticide-tolerances/setting-tolerances-pesticide-residues-foods

12/3/2015

Setting Tolerances for Pesticide Residues in Foods | Regulation of Pesticide Residues on ...

Page 3 of 5

• USDA and FDA have programs designed to develop statistically valid information on
pesticide residues in foods. They provide this information 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 violations of tolerances in their data collection program, they notify FDA.

Tolerance Setting Requires Numerous Scientific Studies
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.
• Other possible sources of exposures to the pesticide (e.g., through use in homes or other
places).
All of this information is used in our risk assessment process. The risk assessment includes
consideration of:

Studies about Pesticides in Food

Studies to determine potential residues in food include:
• Field trials, which are studies of residues 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 foods (e.g., apple juice, tomato paste).
• Data on residues in animal products if livestock 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 children is specifically considered.
• How widely the pesticide is used (that is, how much 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 quantity they eat, collected through the National
Health and Nutrition Survey (NHANES). Through these evaluations, we ensure the overall safety
of proposed pesticide uses, as required by FQPA.
More information on food consumption data:

http://www2.epa.gov/pesticide-tolerances/setting-tolerances-pesticide-residues-foods

12/3/2015

Setting Tolerances for Pesticide Residues in Foods | Regulation of Pesticide Residues on ...

Page 4 of 5

• National Health and Nutrition Survey
• Food Commodity Intake Database
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.
See the OECD calculator, used in the numerical portion of the tolerance-setting process.

Tolerances and Exemptions are Published in the Federal
Register
Before we set a tolerance or grant an exemption, the public has 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 public comment period follows these notices.
After reviewing public comments and all the scientific 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 allows 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 notices about pesticide tolerances.
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 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 Exit at 1-800-858-7378.
EPA's Risk Assessment Process for Tolerance Reassessment

Last updated on November 18, 2015

http://www2.epa.gov/pesticide-tolerances/setting-tolerances-pesticide-residues-foods

12/3/2015

Setting Tolerances for Pesticide Residues in Foods | Regulation of Pesticide Residues on ...

http://www2.epa.gov/pesticide-tolerances/setting-tolerances-pesticide-residues-foods

Page 5 of 5

12/3/2015