Zero Tolerance on Chlorpyrifos Residue Heightens Need for Traceability
If the food you produce, or any of its ingredients, may have been treated with the pesticide chemical chlorpyrifos, that food will be considered adulterated if any detectable residues remain, with some exception based on the date and legality of the pesticide treatment and amount of residue.
In follow-up to a final rule published August 30, 2021, by the EPA which revoked all tolerances for chlorpyrifos residues in food as of February 28, 2022, the FDA has published guidance to help food producers and processors. The EPA rule was based on the currently available data and registered uses for chlorpyrifos, from which EPA stated it was “unable to conclude that the risk from aggregate exposure from the use of chlorpyrifos meets the safety standard of the Federal Food, Drug, and Cosmetic Act (FFDCA).”
You may be thinking – why does this matter to me? The reason is that the rule applies to a long, diverse list of commodities for both human and animal foods regulated by both FDA and USDA. The FDA guidance applies to foods regulated by that agency. Enforcement of residues in animal foods to be addressed by the FDA’s Center for Veterinary Medicine, and any matter involving USDA-regulated foods by that agency.
FDA enforcement is planned to roll out in two stages for both raw agricultural commodities and processed foods:
- Stage 1: FDA intends to exercise enforcement discretion for 6 months to two years following the publication of the EPA rule, depending on the commodity, by not requesting documentation for residues that were within the previous tolerance levels. The time periods are based on FDA’s estimate of how long raw agricultural commodities would remain on the market (e.g., time for growing and postharvest storage, distribution, and sale).
- Stage 2: After the relevant time period for each commodity, a food can be excepted from the zero-tolerance rule if documentation demonstrates that the chlorpyrifos was applied lawfully and before the tolerance expired on February 28, 2022, and the residue does not exceed the level permitted by the tolerance that was in place at the time of the application.
While this seems to provide the industry with some leeway, TAG expects that proving that the chlorpyrifos which left the residue was applied before revocation and within the previous tolerance levels may be onerous should the FDA detect residue and ask a firm for documentation.
As a common insecticide, the use of chlorpyrifos is widespread, especially in the produce sector. So obtaining documentation to prove that chlorpyrifos residues, if found, were applied prior to the revocation date will be difficult especially since companies may not have a full line of site up and down their supply chain. Traceability will also be challenged by any comingling of commodities from multiple farms (e.g. grains, fruits, vegetables), and the potential of pesticide drift from adjacent farms – as detectability in the parts per billion range is feasible in several crops.
Getting a line on traceability will require focused communication among suppliers and manufacturers – which should be initiated quickly – to ensure all parties are aware of the rule and FDA guidance; to attain and/or require chlorpyrifos application documentation; and to define expectations for ingredients and products going forward to avoid a regulatory non-compliance. And companies should immediately begin taking proactive measures to analytically monitor for chlorpyrifos up and down their supply chains to minimize regulatory risk and potential recalls or other regulatory action.
Time will tell how aggressive FDA will be in the enforcement of these requirements, but clearly the risk of regulatory action is present. As has been demonstrated in other parts of the world with ethylene oxide, the repercussions and impact to the industry for the presence of very low levels of substances deemed to be adulterants can have significant economic impact on businesses. So the key point is: Know your risk exposure and begin to address it.
