Need for Tolerances and Tolerance Exemptions for Minimum Risk Pesticides
Disclaimer about Minimum Risk Pesticide Web Content
These Web pages provide guidance to persons who are interested in manufacturing, selling or distributing minimum risk pesticides under 40 CFR 152.25(f). This guidance does not create any binding requirements, although it refers to existing statutory and regulatory requirements and guidance. More…
- Are exempted products required to have tolerances or tolerance exemptions under the Federal Food, Drug, and Cosmetic Act?
- 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?
A product that meets all of 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 pesticide products on or in treated foods or foods that come into contact with treated surfaces. Therefore, i f the product is to be used on food-use sites, 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, which 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 level does not need to be established.
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?
- 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.