In August 2014, EPA settled alleged violations of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) alleged against Walkfit, LLC and other entities, involving shoe inserts containing nanosilver. This follows a separate FIFRA settlement earlier this year against another company, Pathway Investment Corp., also alleging FIFRA violations involving nanosilver in a consumer product (food containers). It’s unlikely that EPA is targeting nanosilver per se; for years EPA has pursued enforcement actions against entities making public health claims for products that have not been registered under FIFRA. Still, the commonality of nanosilver in both of these cases should make entities using nanosilver in consumer products double-check their label and marketing claims to ensure they comply with the FIFRA treated article exemption — and thereby avoid the risk of a FIFRA enforcement action.
FIFRA requires the registration of any substance intended to prevent, destroy, repel or mitigate pests. Whether registration is required depends at least in part on the kind of claims a company makes for its product. If a company makes public health claims for a product, like “Helps reduce growth of bacteria,” then EPA likely would deem the product subject to the FIFRA registration requirement, with all of its attendant resource-intensive data and other requirements.
FIFRA regulations exempt “treated articles” from the registration requirement. A treated article is an article treated with or containing a pesticide to protect the article itself, if the pesticide is registered for such use. A company seeking the benefit of this exemption cannot make public health claims for the product; such claims would render the article subject to the registration requirement. Rather, as EPA’s website states, the company may make only non-public health claims like, “Antimicrobial properties are built in to inhibit the growth of bacteria that may affect the product. The antimicrobial properties do not protect users or others against bacteria, viruses, germs or other disease organisms.” In other words, the claims must be clear that the pesticide is being used to protect the article, and not being used to protect the user. However, it’s not always easy to delineate what is a public health claim under the exemption, and what is not.
Beyond the problem of the gray area about what is an acceptable non-public health claim, problems frequently occur when a company’s regulatory personnel and its marketing personnel do not communicate sufficiently well. With their sometimes divergent goals — for regulatory personnel, to ensure regulatory compliance and for marketing departments, to sell product — disconnects sometimes arise about what marketing claims should be, and ultimately are, made. These kinds of disconnects are exactly what can lead to EPA enforcement actions.