EPA Sets New Fluindapyr Tolerances for Soybean-Based Food Products

New Tolerances and Scope

The EPA's final rule sets maximum residue limits for fluindapyr, a fungicide, on various soybean commodities. These limits are as follows:

• Soybean forage: 15 parts per million (ppm)
• Soybean hay: 30 ppm
• Soybean hulls: 0.6 ppm
• Soybean seed: 0.2 ppm

These established tolerances apply to agricultural producers and food manufacturers who use soy-based products. This decision is documented under docket ID EPA–HQ–OPP–2023–0062.

Risk Assessment and Safety Determination

The EPA has conducted a rigorous risk assessment to ensure consumer safety, as required under the Federal Food, Drug, and Cosmetic Act (FFDCA). This process includes evaluating acute, chronic, and short-term risks of fluindapyr exposure through dietary and drinking water sources. After assessing toxicological data, EPA concluded there is a “reasonable certainty of no harm” from the established fluindapyr residue levels. This includes protections for sensitive groups such as infants and children, for whom special safety considerations are applied.

Public Comments and Objection Process

Stakeholders have until January 7, 2025, to submit any objections or hearing requests regarding the ruling. Comments can be filed through the Federal eRulemaking Portal or submitted in writing to the EPA Docket Center.

Aggregate Exposure Limits

In making its safety determination, the EPA accounted for aggregate exposure, including dietary intake from food, water, and potential residential exposure. For children aged one to two years, a high-exposure group, the acute dietary exposure from food and water was found to occupy only 9% of the acute Population Adjusted Dose (aPAD), with chronic exposure utilizing 44% of the chronic PAD (cPAD). This assessment suggests that fluindapyr residues in these soy products are within safe limits.

Enforcement and Compliance

The EPA encourages adherence to the new limits and has made available analytical methods for enforcement purposes. These standards align with the agency’s goal of harmonizing U.S. regulations with international guidelines, although the Codex Alimentarius has not set equivalent maximum residue limits (MRLs) for fluindapyr.