Frequent Questions about the Chlorpyrifos 2021 Final Rule
- How did the agency come to the conclusion to revoke all tolerances?
- What is the role of epidemiology data in this decision for chlorpyrifos?
- How does this decision impact current crops where chlorpyrifos was used and will be harvested this Fall 2021?
- What is the impact of the final rule on chlorpyrifos registration review?
- What about imported food treated with chlorpyrifos?
- Can chlorpyrifos still be used on crops if they are exported and not used for domestic food or feed consumption?
- How does this rule impact commodities that have both food and non-food products derived from those commodities? Are there any non-crop uses that are impacted by this decision?
- If there are going to be label changes, when will they occur?
- What is the impact of this rule on existing stocks?
- What is the process for providing feedback on a final rule?
Based on currently available data and taking into consideration all currently registered uses for chlorpyrifos, EPA cannot determine that there is a reasonable certainty of no harm from aggregate exposure to chlorpyrifos. The agency’s evaluation indicates that currently registered uses of chlorpyrifos result in exposures exceeding the safe levels of exposure, and thus have the potential to result in adverse effects. The final rule revokes tolerances and will reduce risks to our most vulnerable populations, including children, by reducing chlorpyrifos exposure via food and drinking water.
EPA sought to address the potential neurodevelopmental effects associated with chlorpyrifos exposure over the past decade, but these efforts ultimately concluded with the lack of a suitable regulatory endpoint based on these potential effects. While EPA sought to verify the conclusions of the epidemiology studies conducted by Columbia University, it has been unable to confirm the findings of the CCCEH papers or conduct alternative statistical analyses to evaluate the findings. The inhibition of AChE leading to cholinergic neurotoxicity and the potential for effects on the developing brain (i.e., neurodevelopmental effects) are the most sensitive effects seen in the available data.
It is the timing of application that determines whether food treated with chlorpyrifos is adulterated. Until the date the tolerances expire, chlorpyrifos may be used on food commodities in accordance with label directions and the existing tolerances. These conditions are described in section 408(l)(5) of the Federal Food, Drug, and Cosmetic Act (FFDCA) and allow that residues of chlorpyrifos in or on the food after the tolerances expire would not render the food adulterated, as long as those conditions are met. After the tolerances are revoked, new applications of chlorpyrifos will render any food so treated adulterated and unable to be distributed in interstate commerce. Food in the channels of trade that was treated prior to the expiration of the tolerances would be governed by section 408(l)(5) of the FFDCA, as described above. EPA has been working closely with the Food and Drug Administration (FDA) on a guidance for treated commodities in the channels of trade.
EPA will continue to evaluate the non-agricultural, non-food uses as part of the ongoing registration review for chlorpyrifos, which is expected to be completed by 2022.
On January 18, 2017, as part of the registration review process and to meet its obligation under Section 7 of the Endangered Species Act (ESA), EPA issued nationwide biological evaluations (BEs) for chlorpyrifos, diazinon, and malathion to assess risks to threatened and endangered (listed) species from registered uses of these organophosphate pesticides. EPA also initiated formal consultation with the U.S. Fish and Wildlife Service (FWS) and has reinitiated formal consultation with the National Marine Fisheries Service (NMFS) (the Services) based on the BE conclusions that these pesticides may affect certain listed species and/or their designated critical habitats. EPA continues to be in consultation with the Services on chlorpyrifos.
When the chlorpyrifos tolerances expire and are revoked in six months, chlorpyrifos residues in food must have resulted from lawful application as provided under 21 U.S.C. 346a(l)(5) (also referred to as the “channels of trade provision”) in order for the food to be legally distributed in interstate commerce. FDA stated in its channels of trade policy that it intends to subject the importation of any food bearing a residue (within the former tolerance) of a pesticide chemical for which a tolerance has been revoked, suspended, or modified to the same enforcement approach as for a domestic food. For information on FDA’s channels of trade policy, please refer to FDA’s “Guidance for Industry: Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations.” EPA will assist FDA in its development of specific guidance which will address treated commodities with chlorpyrifos residues, including imported foods, consistent with the channels of trade provision.
Information on contacting FDA is available at: https://www.fda.gov/food/resources-you-food/industry-and-consumer-assistance-cfsan
Unless cancelled, chlorpyrifos can still be used on food crops intended solely for export, as long as certain conditions are met: use of the pesticide “accords to the specifications of the foreign purchaser, is not in conflict with the laws of the country to which it is intended for export, is labeled on the outside of the shipping package that it is intended for export, and is not sold or offered for sale in domestic commerce”(21 USC 381 (e)(1)). For additional information on exported crops, please contact the Center for Food Safety and Applied Nutrition at FDA (CFSANTradepress@fda.hhs.gov).
The revocation of tolerances impacts any food products derived from crops that produce both food and non-food commodities. It is the timing of application that determines whether food treated with chlorpyrifos is adulterated. Until the date the tolerances expire, chlorpyrifos may be used on food commodities in accordance with label directions and the existing tolerances. These conditions are described in section 408(l)(5) of the FFDCA (21 U.S.C. 346a(1)(5)), and allow that residues of chlorpyrifos in or on the food after the tolerances expire would not render the food adulterated, as long as those conditions are met. The full citation can be found on page 41 in the FFDCA.
After the tolerances are revoked, new applications of chlorpyrifos will render any food so treated adulterated and unable to be distributed in interstate commerce. Food in the channels of trade that was treated prior to the expiration of the tolerances would be governed by section 408(l)(5) of the FFDCA, as described above. EPA has been working closely with FDA on a guidance for treated commodities in the channels of trade. Additionally, tolerances are only required for food products; if the commodity produced from a crop is not a food, then the lack of a tolerance does not matter. Where there is uncertainty about whether a commodity is for food or non-food purposes, it is possible that it could be subject to regulatory action as a food.
Any registrant, including those who hold registrations of chlorpyrifos, can cancel the registration of a pesticide product or use at any time by voluntarily submitting a request to the agency. Additionally, the agency plans to issue a Notice of Intent to Cancel (NOIC) under the Federal Insecticide, Fungicide, and Rodenticide Act to cancel registered food uses of chlorpyrifos associated with the revoked tolerances. When EPA issues an NOIC, it will be published in the Federal Register. For more information on the NOIC process, visit EPA's website.
Existing stocks is a term under FIFRA generally used in connection with the pesticide products that have been released for shipment as of the date a product registration is cancelled. EPA has not cancelled any chlorpyrifos products as a result of the final tolerance rule; therefore, there are no existing stocks at this time.
The tolerance rule issued on August 30, 2021, does not prohibit sale and distribution of registered pesticide products. However, once the tolerances expire and are revoked in six months, sale and distribution of chlorpyrifos products labeled for use on food crops would be considered misbranded; therefore, it would be a violation of FIFRA to sell and distribute those products.
EPA intends to cancel registered food uses of chlorpyrifos associated with the revoked tolerances under FIFRA, as appropriate. That cancellation action would only address the registered food uses of chlorpyrifos; it would not impact nonfood uses of chlorpyrifos, including public health uses for mosquito control and USDA quarantine use for fire ant control. EPA will continue to evaluate the non-agricultural, non-food uses as part of the ongoing registration review for chlorpyrifos. Following the cancellation of food uses, there may be some products that have label instructions for both food and non-food uses. Those labels would need to be amended to remove any food-uses that were cancelled.
Additionally, a registrant, including those of chlorpyrifos, can cancel the registration of a pesticide product or use at any time by voluntarily submitting a request to the agency.
Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before October 29, 2021. Please see Section 1C of the final rule for instructions on providing feedback.
EPA will review any objections and hearing requests in accordance with 40 CFR 178.30, and will publish its determination with respect to each in the Federal Register. A request for a hearing will be granted only to resolve factual disputes; objections of a purely policy or legal nature will be resolved in the Agency's final order, and will only be subject to judicial review pursuant to 21 U.S.C. 346a(h)(1), (40 CFR 178.20(c) and 178.32(b)(1)).