EPA on May 12 announced a new framework for reviewing and approving products for use against the novel coronavirus. EPA’s framework explains which new product and existing product amendment requests will be expedited, and provides approximate timelines for EPA review and approval. Because of continued high demand for disinfectant products, companies seeking to launch new products or amend existing registrations should take care to ensure that their requests will receive expedited treatment. Seeking expedited treatment is particularly important given the concerns some companies have about making significant investments into EPA product registration, in light of the sometimes lengthy EPA-approval process.
There are five key takeaways from EPA’s new guidance:
- EPA Is Expediting New Broad-Spectrum and Hospital Disinfectant Approvals. EPA has announced that it is focused on approving these products within 3-4 months, as compared to the standard five-month timetable. Thus, manufacturers launching new disinfectant products should consider registering them as a broad-spectrum disinfectant, if adequate supporting data are available.
- Expedited Review Extends to “Cite-All” New Product Applications. For broad-spectrum and hospital disinfectants, EPA will expedite applications that satisfy the generic data requirements via citing all existing information in the agency’s file (as opposed to using newly-generated data). Companies launching new products similar to products already on the market should consider this option, which minimizes the need to conduct time-consuming studies.
- EPA Is Expediting New COVID-19 Claims for Existing Products. EPA is also expediting new anti-virus claims for registered products, including emerging pathogens claims relating to COVID-19, even where EPA needs to review new data. Previously, only new claims based on data EPA already possessed were expedited. The agency estimates a 2-3 month timeframe for such approvals, as compared to a standard four-month timeframe. Companies that believe their product is effective against the coronavirus, but need to generate new data to prove it, can now move forward on an expedited basis.
- Certain Changes to Formulations Do Not Require EPA Approval. EPA has further expanded the types of formulation changes that may be made simply by providing notice to EPA. Most notably, the concentration of fragrances and dyes may be increased or decreased, so long as they do not exceed 1% of the formulation. Previously, in many instances EPA approval and review of confirmatory efficacy data was required. This provides companies a streamlined ability to differentiate their products based on consumer preferences.
- There Is Now a “List N” App. EPA has launched an interactive, web-based application to assist consumers and businesses in identifying products that EPA has identified for use against the coronavirus, which are located on List N. This may help businesses and consumers identify the best products for particular uses, especially as workplaces begin to reopen. Disinfectant manufacturers may want to confirm that the information on their product is accurate, and the app may also assist in identifying comparator products when seeking approval for new products.
EPA’s disinfectant policy continues to evolve as the COVID-19 pandemic unfolds, and we can expect that EPA will continue to announce significant updates and revisions over the coming months.