Products with Antimicrobial Claims May Need to Be Registered as Pesticides

Food and Agriculture Law  

February 18, 2015

In recent months, the California Department of Pesticide Regulation (“DPR”) and the United States Environmental Protection Agency (“EPA”) have increasingly penalized retailers and manufacturers for selling products claiming to have antimicrobial properties. These administrative actions typically allege violations of federal and state pesticide registration laws and regulations because the products are not registered as pesticides. In many cases, the offending products are everyday household items such as shower curtains, pillow covers, cleaning gloves, and mops that have been treated with chemicals to protect the product by combating the growth of bacteria, mold, fungus, and other microorganisms. If such products are not appropriately labeled and registered with DPR and the EPA, then retailers, distributors, and manufacturers alike face substantial fines and penalties for their sale into or within California, including fines of up to $10,000 per violation under state law.   

Although the average American would be unlikely to equate an antimicrobial shower curtain with a “pesticide,” both California and federal law broadly define “pesticide” to encompass any substance or mixture of substances intended for “preventing, destroying, repelling, or mitigating any pest,” including any fungus, bacterium, virus, or other microorganism. Importantly, it is unlawful for any person to sell or deliver into or within California a pesticide that is not appropriately registered with DPR and the EPA, with certain limited exceptions. Liability is not limited to the manufacturer of the offending product, but also extends to retailers and distributors.

In an effort to avoid rigorous and expensive registration requirements, many manufacturers, distributors and retailers rely on the so-called “treated articles” exemption. This exemption, set forth in 40 CFR section 152.25(a), pertains to any article or substance “treated with, or containing, a pesticide to protect the article or substance itself…, if the pesticide is registered for such use.” In other words, the regulation provides an exemption from the requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) for articles or substances treated with, or containing a pesticide, if: (1) the incorporated pesticide is registered for use in or on the article or substance, and; (2) the sole purpose of the treatment is to protect the article or substance itself.    

Despite the broad language of the “treated articles” exemption, both the EPA and DPR have adopted a narrow view of the exemption, relying on a guidance document from the EPA entitled “Pesticide Registration Notice 2000-1.” The agencies have taken the position that to qualify for the “treated articles” exemption, the product name, label, and marketing materials (including statements on any brochures and websites) must not make any implicit or explicit “public health” claims.  Generally speaking, product claims that either directly or impliedly suggest that the antimicrobial properties of the product will protect people, as opposed to the product itself, are “public health” claims. The EPA and DPR require that all references to a product’s pesticidal properties be accompanied by qualifying statements that clearly and affirmatively identify their non-public health use—for example: to prevent the growth of mildew on the treated article; to preserve the treated article from spoilage or fouling; or to inhibit offensive odors in the treated article. These qualifying statements must be in the same location and in the same font size, style, and color as the pesticidal claim, or the product could be categorized by the EPA/DPR as falling outside the “treated articles” exemption.    

Because the claims made on the packaging and marketing materials of a product with antimicrobial properties play a key role in determining whether that particular product fits within the “treated articles” exemption, retailers should periodically audit their product lists and associated marketing materials to ensure that any antimicrobial claims conform to applicable legal guidelines. Retailers should further take steps to ensure that products received from manufacturers are in compliance with federal and state pesticide laws and regulations before they are selected for sale and/or distribution. Finally, retailers should include in their agreements with manufacturers specific representations and warranties to the effect that the products are properly registered and labeled for sale in California.

Being aware of these laws, and taking steps to ensure all products offered in stores comply, will help retailers avoid the unpleasant experience of a DPR enforcement action.