By Philip L. Comella and Craig B. Simonsen

The U.S. Environmental Protection Agency recently ordered an orthotic shoe insert manufacturer to pay over $210,000 in civil penalties for making “unsubstantiated antimicrobial claims” about their orthotic shoe inserts – resulting in the sale and distribution of an unregistered pesticide, a violation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

This case follows an earlier proceeding, with similar facts, where another shoe product manufacturer agreed to pay a $230,000 civil penalty. The Agency noted at that time that “we’re seeing more and more consumer products making a wide variety of antimicrobial claims.” “Whether they involve shoes or other common household products, EPA takes these unsubstantiated public health claims seriously.” (Emphasis added).

Under FIFRA, products that “claim to kill or repel bacteria or germs” are considered pesticides. As such, those products must be registered with the EPA prior to distribution or sale. Generally, the EPA will not register a pesticide until it has been tested to show that it will not pose an unreasonable risk when used according to the label directions.

The possible presence of microorganisms, such as bacteria, fungi, and viruses, in or on consumer products is a common concern for manufacturers and consumers alike. In response to this concern, many products today are being treated with antimicrobial pesticides. Antimicrobial pesticides are “substances or mixtures of substances used to destroy or limit the growth of microorganisms, whether bacteria, viruses, or fungi – many of which are harmful-on inanimate objects and surfaces.” (See Fact Sheet).

At issue in these cases is the “treated articles exemption” under FIFRA. 40 CFR 152.25(a). The provision exempts a treated article from regulation under FIFRA if the treatment protects the article or substance itself.  At times a manufacturer claim may suggest that the product contains a chemical that kills human pathogens as opposed to protecting the product against such things as deterioration or odors.  In those instances – where a public health claim is made about the product – the treated articles exemption does not apply, and the substance is subject to regulation under FIFRA.

For example, the claim that a shoe component “contains an antimicrobial agent to control odors” is acceptable because it is a statement about the product itself, while a claim that the product “kills pathogenic bacteria” is not acceptable because it can be read as a public health claim. Therefore, in sum, manufacturers that add antimicrobial pesticides to their products need to be careful about whether any product claims are directed only to the product or to the public health as well.