Need for Tolerances and Tolerance Exemptions for Minimum Risk Pesticides

• Are exempted products required to have tolerances or tolerance exemptions under the Federal Food, Drug, and Cosmetic Act?
• If a minimum risk pesticide product is intended for residential use in or on food commodities, must all ingredients in the product be covered by either a pesticide tolerance or an exemption from the requirement of a tolerance, as established under FFDCA?
• How can I find out if my active and inert ingredients have tolerances or are exempt from the requirement of a tolerance, and can therefore be applied to a food-use site?
• If an ingredient does not have a tolerance or an exemption from the requirement of a tolerance, how do I request a tolerance or tolerance exemption?

Are exempted products required to have tolerances or tolerance exemptions under the Federal Food, Drug, and Cosmetic Act (FFDCA)?

A product that meets all the criteria of the minimum risk pesticide exemption, 40 CFR 152.25(f), is only exempt from the requirements of FIFRA. The use of pesticides on food use sites (food, food crops, food contact surfaces, and animal feed) can result in residues of pesticides on or in treated foods or foods that come into contact with treated surfaces. Therefore, if the pesticide is to be used on food-use sites,  and the food will enter into interstate commerce, every ingredient (both inert and active) in the product must have a tolerance or tolerance exemption under the Federal Food, Drug, and Cosmetic Act. 

• Tolerances are maximum legally permissible levels of pesticide residues, including active and inert ingredients, that may be found in foods.
• In some instances, pesticide active or inert ingredients are exempted from the requirement of a tolerance because the chemical is considered to be safe enough for the use described in the tolerance exemption that a maximum permissible level does not need to be established.

If a minimum risk pesticide product is intended for residential use in or on food commodities, must all ingredients in the product (active and inert) be covered by either a pesticide tolerance or an exemption from the requirement of a tolerance, as established under the Federal Food, Drug, and Cosmetic Act (FFDCA)?

EPA does not require tolerances or exemptions for pesticide chemical residues in or on foods that will not be introduced into interstate commerce. An example of food not introduced into interstate commerce are foods grown in home gardens or intended strictly for home/residential use.

FFDCA prohibits the “introduction or delivery for introduction into interstate commerce” of adulterated food [21 USC 331(a)]. With respect to pesticides, adulterated food is any food that contains pesticide chemical residues not covered by a tolerance or exemption from tolerance [21 USC 342(a)(2)(B), 346a(a)]. Residues of pesticide chemicals in or on food or animal feed that are not covered by a tolerance or exemption do not violate the FFDCA if that food or feed is not introduced into interstate commerce. The label of the pesticide product must clearly state that food containing residues of the product may not be introduced into interstate commerce.

If a pesticide is to be used in a manner that will result in residues in food or feed that will be introduced into interstate commerce and the necessary tolerances or exemptions are not in place, the pesticide will not qualify for the minimum risk exemption. This is reflected in the following excerpt of text from 40 CFR 152.25(f), bolded for emphasis:

“Under section 408 of the Federal Food, Drug, and Cosmetic Act and EPA (FFDCA) implementing regulations at part 180 of this chapter, food and animal feed in commerce can bear pesticide residues only for those ingredients that have tolerances or tolerance exemptions in part 180 of this chapter.”

How can I find out if my active and inert ingredients have tolerances or are exempt from the requirement of a tolerance, and can therefore be applied to a food-use site?

Information about:

• The active ingredients for which tolerances or tolerance exemptions are established. 
• Whether the inert ingredient can be used in a minimum risk product applied to a food-use site. 

If an ingredient does not have a tolerance or an exemption from the requirement of a tolerance, how do I request a tolerance or tolerance exemption?

When considering minimum risk products used on food, food crops, food contact surfaces, or animal feed commodities, the ingredients used in such products generally have a tolerance exemption, not a numerical tolerance. Given the length of time that is typically needed to complete the process for requesting a tolerance exemption, most producers of minimum risk pesticides will choose to use those ingredients that already have tolerance exemptions when they produce a minimum risk product intended for application to food-use sites.  

No tolerance or tolerance exemption is necessary where the label clearly states that the product is not to be applied to food-use sites, or only specifies surface areas that are not considered to be food-use sites. For example, a producer of a minimum risk lawn care product could state that the product is not to be applied to home vegetable gardens. Similarly, the producer of a cleaning/ deodorizing product should not include “food preparation surfaces” or “high chairs” in the listing of use sites.

However, it is possible that a producer may wish to establish a tolerance exemption for a minimum risk active or inert ingredient that does not currently have a tolerance exemption. For those who want to petition EPA to establish a pesticide tolerance exemption for a minimum risk pesticide ingredient, please consider the following information:

• It is the responsibility of the petitioner to provide sufficient information to EPA regarding the potential human health effects and environmental impacts of the ingredient.
• The petitioner needs to prepare a petition (an application) that includes information to support a tolerance or tolerance exemption. 
• Such information could include, for example:
  • Test data developed by the petitioner.
  • Publically available literature and data, including peer-reviewed assessments and journals (e.g., WHO, OECD SIDS, IUCLID, EPA HPV, etc.).
  • Modeled data.
  • Analog/surrogate data. 
•  ​Part of the submission is a Notice of Filing (NOF), prepared by the petitioner, which summarizes this information
• EPA publishes the NOF in the Federal Register. 
• There may also be a fee associated with the application.
• Regulations regarding these petitions are found at 40 CFR 180.7.
• Also see Chapter 11 of the Pesticide Registration Manual, Tolerance Petitions.

EPA then reviews and evaluates the submitted information. To establish a tolerance or tolerance exemption in response to a petition under the Federal Food, Drug, and Cosmetic Act, EPA is required to publish its determination, in the form of a final rule or order, in the Federal Register. 

Only after the final rule is published, establishing the tolerance or tolerance exemption, can the ingredient be used in a pesticide formulation that is applied to a food-use site.