Biopesticides for food crops: What to submit in a tolerance exemption petition

When submitting a pesticide registration package to the United States Environmental Protection Agency (US EPA), biopesticide producers commonly intend for their products to be used on food crops. While biopesticides are generally exempt from tolerances, producers are still required to file a petition to request an exemption from the requirement of a tolerance. Developing such a petition can be complex, time consuming and daunting to prepare.

In this paper, experts at TSG Consulting help demystify tolerance exemption petitions, providing guidance on the detail producers need to include in submissions.

What are biopesticides?

Biopesticides are pesticides that are derived from natural materials including plants, microbes and minerals. Indeed, everyday ingredients such as baking soda and garlic oil are considered biopesticides due to their pesticidal activity.

Even though biopesticides are generally less toxic than conventional pesticides, they are still regulated under the Federal Food, Drug, and Cosmetic Act (FFDCA) when applied to food crops.

One of the regulatory requirements that must be met relates to the amount of residue that can lawfully be present on the food or animal feed treated with the biopesticide, otherwise known as a tolerance. As part of the EPA submission package, the registrant must prepare a petition to either request the establishment of a tolerance or, generally in the case of biopesticides, to request an exemption from the requirement of a tolerance.

What is a tolerance exemption petition?

Under the FFDCA, a ‘tolerance’ is the maximum residue level of a pesticide that legally can be present in food or animal feed. The EPA is responsible for regulating tolerances and granting exemptions from the requirement of a tolerance in the US.

An exemption from the requirement of a tolerance for a biopesticide means that there is a reasonable certainty of no harm to the general US population, including infants and children, from exposure to residues of the biopesticide under conditions of prevailing or proposed use.