New EPA Guidance on Articles Treated with Antimicrobial Pesticides Takes Effect
Your company has just developed a new houseware product that is treated with an antimicrobial, and you desire to market its antimicrobial properties. Be wary! The U.S. Environmental Protection Agency has and will continue to scrutinize closely advertising claims and product labels for compliance with the Federal Insecticide, Fungicide, and Rodenticide Act.
On April 30, 2001, EPA began relying on guidance found in PR Notice 2000-1 in evaluating what claims are permissible and whether a product, itself, must be registered as a pesticide under FIFRA. In recent years, manufacturers have responded to the public's concern about bacterial contamination by introducing a range of consumer products—such as cutting boards, kitchen utensils, toothbrushes, sponges, and even toys—treated with antimicrobial pesticides. Many of these products bear implicit or explicit claims that the product will protect against harmful microorganisms such as bacteria, fungi, and viruses.
EPA responded by taking enforcement action in several highly publicized cases against companies that marketed unregistered pesticide-treated products with what the agency interpreted as illegal, unsubstantiated "public health claims." The companies incurred substantial fines and were forced to re-label their products; as a result, they suffered market disruption and negative publicity. In an attempt to clarify the types of claims that are permissible, EPA issued PR Notice 2000-1 last March, and industry was ultimately given until April 30, 2001, to comply with this new guidance.
While the Food and Drug Administration regulates antibacterial products such as soaps, lotions, and other personal care products used on humans or other living animals, EPA regulates pesticides that kill bacteria or viruses on nonliving surfaces pursuant to the agency's authority under FIFRA. EPA, however, exempts from FIFRA's pesticide registration requirements articles that have been treated with a pesticide. Under this exemption, an article or substance treated with, or containing, a pesticide to protect the article itself does not require registration, provided that the incorporated pesticide is registered for such use. This means that the underlying registration and labeling of the antimicrobial pesticide being incorporated into the product must specifically include treatment of the article as a registered use.
EPA provides two examples of treated articles not requiring registration in its FIFRA-implementing regulations: paint treated with a pesticide to protect the paint coating, and wood products treated to protect the wood itself from insect or fungus infection. Although neither of these examples involves houseware products, EPA's message is clear: In order for an article or substance to qualify for the treated article exemption, the incorporated pesticide must be registered for use in or on the article or substance and the sole purpose of the treatment must be to protect the article or substance itself. As a result, reliance on the treated article exemption is misplaced if you intend to make public health claims (e.g., "fights germs" or "controls fungus") for your product, or otherwise suggest that the product produces a pesticidal effect apart from the article itself.
PR Notice 2000-1 describes in detail the types of claims that EPA categorizes as public health claims requiring registration and provides numerous examples of phrases that are considered unacceptable. Impermissible public health claims include: "antibacterial," "bactericidal," "germicidal," "reduces the risk of food-borne illness from bacteria," "provides a bacteria or germ-resistant surface," and "effective against E. coli and Staphylococcus." EPA even regards trademarked product names as potential sources of public health claims that could render a product ineligible for the treated articles exemption. In short, names or claims that imply or express protection that extends beyond the treated article or substance itself are not allowed. Notwithstanding the free speech protections of the First Amendment, EPA intends to police such claims whether they show up in the labeling, marketing, or advertising of products.
In addition to describing impermissible public health claims, PR Notice 2000-1 includes examples of non-public health claims that the agency is likely to find acceptable. In general, carefully worded mold- and mildew-resistant claims, as well as odor-resistant claims are permitted, and the article will remain within the scope of the treated articles exemption. Likewise, a claim to inhibit microorganisms that may cause spoilage or fouling of the treated article or substance is acceptable.
The agency will permit the use of terms such as "antimicrobial," "fungistatic," "mildew- resistant," and "preservative" as long as these claims are "properly" qualified as to their intended non-public health use. For example, if the product is to be used in an area where food-borne or disease-causing organisms may be present, then additional qualifying statements such as "this product does not protect users against food-borne or disease-causing bacteria" would be necessary to remedy an inference that the article protects the user against such bacteria. Qualifying statements and any references to the pesticidal properties of the product must be located together, printed in the same font, and be no more prominent than any other feature on product labels.
If you desire to market a treated article with public health claims, then the article must be registered with EPA. Registration of a pesticide is not simple and it can be especially burdensome when making public health claims, as EPA requires applicants to submit efficacy data to support these claims. Unfortunately, EPA has not yet established protocols for the development of these data. Nevertheless, an applicant must obtain prior approval of an efficacy- testing protocol, and this protocol must be independently validated for accuracy and reproducibility. We are aware of only one published example of a protocol that EPA has approved for conducting such testing, and we encourage companies to review this document for insight regarding the type of an approach the agency might deem acceptable.
As evidenced by several recent, high-profile cases, EPA is actively seeking to curb what the agency perceives as a growing trend of companies' marketing unregistered pesticide-treated products with illegal, unsubstantiated public health claims. Thus, it is vital that manufacturers understand current agency thinking on what is acceptable before distributing products in commerce without registration under the "treated article" exemption.