On February 14, 2023, EPA released a compliance advisory regarding pesticide devices regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”). EPA released the advisory in response to “substantial non-compliance with FIFRA in the device and pesticide marketplace. Examples of non-compliance include unregistered pesticides claiming to be devices, devices bearing false and misleading statements, and devices being sold and distributed that were not produced in an EPA registered establishment.” While the compliance advisory provides a helpful overview of requirements applicable to pesticide devices, it does not provide new substantive guidance, including on key questions facing many device manufacturers and distributors. The advisory also suggests that EPA may increase its enforcement efforts in this area, so companies producing devices (or products that may arguably be devices) should consider taking proactive steps to ensure their product lines comply with FIFRA’s requirements.
EPA’s compliance advisory outlines the key requirements applicable to pesticide devices, including:
- Devices must be produced in an EPA-registered establishment and bear an EPA establishment number.
- Devices may not make claims that are false or misleading, including several categories of claims EPA has determined via notice and comment rulemaking are false or misleading.
- Entities importing devices must ensure that appropriate Notices of Arrival are submitted to Customs in connection with each import.
- States may impose their own requirements, and a number of states require pre-market registration of devices.
However, the compliance advisory does not break new ground, and leaves open a number of significant questions, including:
- The precise demarcation between devices and pesticides, including how novel technologies are classified; the advisory does not discuss precedent or provide additional guidance that device manufacturers should be aware of in evaluating whether their product is properly categorized as a device.
- What efficacy data companies marketing pesticide devices must generate in order to prevent efficacy claims from being false or misleading. As this blog has previously noted, this was a particularly significant question during the COVID-19 pandemic.
- Notably, as part of the 2023 Consolidated Appropriations Act, Congress enacted the fifth iteration of the Pesticide Registration Improvement Act, which contains a provision requiring EPA “to develop efficacy test methods for antimicrobial pesticide devices making public health claims.” To date, EPA has not publicly released such test methods.
- What testing or other steps device manufacturers should take to ensure that their devices are safe.
Given EPA’s continued focus on this area, as well as the lack of guidance on several key issues, companies should carefully monitor EPA developments and take affirmative steps to minimize the risk of a potential enforcement action.