The Food and Drug Administration (“FDA”) published a Notice in the Oct. 16, 2017 Federal Register regarding enforcement of pesticide residue levels on FDA-regulated products. The Notice focuses on situations where FDA-regulated products are found in the “channels of trade” to contain pesticide residue levels in excess of current allowable levels, but such residue is present as the result of an application of the pesticide that was lawful at the time of application. The FDA’s Notice confirms that so long as a company can demonstrate that the pesticides were applied in accordance with the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”) at the time they were applied, then the FDA will not take enforcement action against that company for pesticide residue exceedances discovered during a subsequent inspection. A key takeaway from the FDA’s Notice is that regulated companies should keep adequate documentation (e.g., batch records, packing codes, inventory records) to prove when (and how) pesticides were applied to the companies’ food.
Pesticide residue levels on food are regulated by both the FDA and the Environmental Protection Agency (“EPA”). Under the FIFRA, the EPA is responsible for regulating the use of pesticides and for establishing tolerances (or exemptions from the requirements for tolerances) for residues of pesticide chemicals in food commodities. The EPA has the ability to change or revoke tolerance levels for a pesticide based on, among other things, new information concerning the safety of that pesticide. (Typically, it takes more than 180 days for such change/revocation to become effective.) When the EPA takes such action, food derived from a commodity that was lawfully treated with the pesticide may not have cleared the channels of trade by the time the revocation or new tolerance level takes effect. In such instances, the FDA, which is responsible for monitoring pesticide residue levels and enforcing the pesticide tolerances in most food, may find such food during an inspection and deem such food to be in violation of the law by virtue of it bearing an illegal pesticide residue (and therefore subject to enforcement for being “adulterated”).
Congress attempted to address this conundrum by including a “channels of trade” provision in Section 408(l)(5) of the Federal Food, Drug and Cosmetic Act, which states that food containing a pesticide residue shall not be “adulterated” if the residue is within the former allowed tolerance and the responsible party can demonstrate to the FDA’s satisfaction that the residue is present as the result of an application of the pesticide at a time and in a manner that were lawful under the FIFRA. The FDA expounded on this provision by providing additional guidance on May 18, 2005. In its 2005 guidance, the FDA stated that if it encounters food bearing a residue of a pesticide chemical for which the tolerance has been revoked, suspended or modified, it anticipates that the party responsible for the food will be able to demonstrate that such food was handled (e.g., packed or processed) during the acceptable timeframes cited in the guidance by providing appropriate documentation to the FDA. The FDA reiterated in its Oct. 16, 2017 Notice that regulated companies are not required to maintain an inflexible set of documents where anything less or different would likely be considered unacceptable. Instead, the FDA leaves it to each company’s discretion to maintain appropriate documentation to demonstrate that the food was so handled during the acceptable timeframes. Examples of documentation that the FDA anticipates will serve this purpose include documentation associated with packing codes, batch records and inventory records.
The FDA’s most recent Notice serves as a reminder to regulated companies to maintain adequate documentation to prove that their food products complied, at all relevant times, with EPA and FDA pesticide residue requirements. You can access the FDA’s Federal Register Notice here. Comments in response to the FDA’s Notice are due by Nov. 15, 2017.