Products claiming to protect users against microbes, such as those that are currently being used to protect us from COVID-19, are flying off the shelves. Manufacturers of these products must comply with regulations governing the use of such pesticides. One of said regulations is the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
Under FIFRA, EPA regulates all pesticides distributed or sold in the United States. EPA defines a pesticide as a product that is intended for: (i) preventing, destroying, repelling or mitigating any pest; (ii) use as a plant regulator, defoliant, or desiccant; or (iii) use as a nitrogen stabilizer. FIFRA generally requires that pesticide products be registered (licensed) by EPA.
However, there is an exemption to the requirement for FIFRA registration, known as the "Treated Articles Exemption." This exemption applies to qualifying treated articles that bear claims stating the article itself is protected. To qualify for the exemption, the product being sold must be: (i) registered for such use in or on the article and (ii) the product label must only bear claims that the product itself is protected.
Registered for such use in or on the article
To meet the requirement that the pesticide in a treated article is "registered for such use," the pesticide itself must be registered with EPA. Therefore, when developing a product label which informs the user how the pesticide may be used, careful consideration to the pesticide's EPA registration license must be given in order to that comply with the Treated Articles Exemption. The pesticide in the treated article must be present in the article as the result of incorporating the pesticide (it is not sufficient if the treated article simply resembles or acts like a registered pesticide).
Labeling can only claim the product itself is protected
To meet the labeling requirements, the product label may only bear claims that the product itself is protected by the pesticide. For example, a claim must make clear that the article has been treated with the antimicrobial product to protect the product from the growth of microbes. Product labeling that does not clearly meet this requirement, is likely not acceptable under the Treated Articles Exemption because it expresses or implies protection that extends beyond the article itself.
Failure to meet the above labeling requirements
To qualify for the Treated Articles Exemption, both conditions stated above must be met, otherwise the article does not qualify for the exemption and is subject to regulation under FIFRA. If a product does not qualify for the exemption, it may not be legally sold or distributed unless it is registered with EPA subject to all the requirements of FIFRA.
In order to obtain FIFRA registration, an applicant must submit data supporting the claims that are to be marketed and meet registration requirements. EPA does not currently have testing protocols for the development of data, therefore an applicant must submit its testing protocols to EPA before the applicant develops data. The data must be validated by a third-party lab, which rigorously tests product samples to evaluate the claims. When the third-party lab releases the results of its testing, EPA then issues a statement that the applicant is allowed to make about its product with respect to the pesticidal properties, along with a registration number.
This article is presented for informational purposes only and is not intended to constitute legal advice.