Taken together, EPA's recent actions are significant and provide opportunities for companies to develop novel products that could have significant public health benefits. But they also highlight that significant uncertainty remains in this area, which presents risks that companies must carefully navigate to ensure regulatory compliance.
- Residual Antimicrobial Products
EPA's guidance regarding residual antimicrobial products sets out a new framework governing products that seek to make claims of residual efficacy against viruses or bacteria. This is significant: in the wake of the COVID-19 pandemic, the ability to use a product to kill viruses and bacteria on a surface not only at the time of application, but for weeks, months, or even years thereafter, has the potential for significant public health benefits. EPA had provided interim guidance in October 2020, but is now providing more detailed guidance and a test method. EPA's new guidance distinguishes between three categories of residual products: (1) residual disinfectants, (2) antimicrobial surface coatings and films, and (3) fixed/solid surfaces, such as copper, or other impregnated materials.
Residual disinfectants are essentially standard disinfectants demonstrating residual efficacy, and may make claims that they "kill" microbes for up to 24 hours after application.Coatings and films cannot make "kill" claims, and instead must contain disclaimer language, including the statement that the product is not a disinfectant but "can provide some additional protection against microorganism(s)] for up to X days." Fixed/solid surfaces and impregnated materials—for example, a copper door knob—may make claims such as the following: "kills 99.9% of [insert microorganism/s] within 1-2 hours of exposure when used as part of a comprehensive infection control program/protocol."
For second and third categories of products (surface coatings and fixed surfaces), a "stewardship plan" must be included as a condition of registration. The stewardship plan must address "the proper sale (including advertising and promotional materials), distribution, and responsible use of the supplemental residual coatings and antimicrobial surface products." EPA suggests that plans could include elements such as outreach to infection-control specialists regarding product efficacy and appropriate use!万博体育app手机登录development of a website to convey accurate information about the product and to "correct any false or misleading third-party statements or publications," and participating in regular meetings with EPA and others to discuss the product.
In requiring a stewardship plan, EPA is signaling that it intends to closely monitor these products, likely in part out of concerns that end users may view these products as a substitute for standard disinfection and thus not take adequate precautions. By making the registrations conditional on implementation of a stewardship plan, EPA has the ability to cancel the registration in a more streamlined fashion as compared to an unconditional registration.
Accordingly, companies developing products for which a stewardship plan will be required will need to carefully develop and robustly implement their stewardship plan, to mitigate the risk of a potentially abrupt registration cancellation.
Companies interested in developing these types of products, or adding claims to existing products, will need to generate appropriate data and secure registration with EPA (and the states) before making these claims. Applicants may also need to develop and secure EPA approval of test methods if they wish to make differing claims or seek to use products on use-sites not within the scope of EPA's guidance (for example, EPA's guidance for surface coatings and fixed surfaces does not cover porous surfaces). Ultimately, while this guidance provides a significant amount of information regarding these product categories, numerous questions remain about how EPA will implement it.
- Air Sanitization & Indoor Air Quality
The registration of the first product approved to kill both viruses and bacteria in the air (rather than just bacteria) is also significant: EPA has now approved a product that can kill 99.9% of viruses in the air if used as directed, and so there is now an opportunity for pesticides to be developed to directly combat the spread of viruses in the air. That said, significant challenges likely remain in developing products that are both effective and easy to use to treat the air. That is demonstrated by the instructions for the approved product, which may pose some practical issues—they call for closing or covering "all doors, windows, air vents and returns" in the room, spraying for 30 seconds, and then leaving the room for 12 minutes. The instructions also note that there is "no residual effect after room is reopened." Still, this product provides a novel use, and may pave the way for other types of registered pesticides that kill airborne viruses and bacteria.
As to the other category of EPA-regulated products that are intended to kill viruses or bacteria in the air—pesticide devices—EPA has not provided additional guidance. However, on October 5, 2022, EPA's Office of Radiation and Indoor Air requested comment regarding indoor air quality matters, and announced its intent to "promote and advance the widespread adoption of actions that lead to improvements in indoor air quality .... to help mitigate disease transmission (e.g., COVID-19)." Among other issues on which EPA seeks comment are (1) what the federal government can do to help improve "ventilation, filtration, and air cleaning practices to reduce the risk of disease transmission," (2) whether and how to develop a building recognition program relating to "ventilation, filtration, and air cleaning," and (3) "qualitative or quantitative features could be helpful in assessing or describing ventilation, filtration, and air cleaning parameters in a building." Because many of these cleaning and filtering technologies are pesticide devices, stakeholders may want to submit comments to EPA, which are due by December 5, 2022.