EPA Loosens Regulatory Requirements For Disinfectant Manufacturers

This client alert briefly summarizes developments for existing and potential producers of disinfectant products. 

Part 1: EPA Waives Pre-approval Step for Changes to Active Ingredients in Disinfectants

To ease supply chain disruptions posed by the spread of SARS-CoV-2 (coronavirus), the U.S. Environmental Protection Agency (EPA) temporarily amended its guidance to allow manufacturers of currently registered disinfectant products to acquire certain “active ingredients” from new/alternative suppliers and forego the standard EPA pre-approval step required by the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) regulations (40 CFR Subchapter E).

Under normal circumstances, disinfectant manufacturers are required to obtain EPA approval prior to changing the supplier of an “active ingredient” in a regulated pesticide product (per EPA’s 1998 Pesticide Registration Notice (PRN) 98-10).  Pursuant to the recent temporary amendment to PRN 98-10, as long as the use of the new active ingredient results in a formulation that is chemically similar to its approved product, disinfectant manufacturers are authorized to substitute “active ingredients” from alternative suppliers and immediately begin production.  Manufacturers must notify EPA of the change but do not need to wait for EPA approval. 

The eligible active ingredients include those on EPA’s List N Disinfectants for Use Against SARS-CoV-2.  EPA has added hundreds of chemical substances to List N over the past several weeks and may continue to do so as additional products are shown to be effective against the virus. Manufacturers and end-users can find information about the approved substances here.

EPA’s goal is to reduce supply chain interruptions that were impeding pesticide producers who manufacture disinfectant products on EPA’s List N. The new measure will contribute to the protection of public health during the COVID-19 outbreak by bolstering the supply of surface disinfectants for consumers, essential workplaces and medical facilities. 

Part 2: EPA Expedites Requests to Register NEW Pesticide-producing Companies and Establishments

It is important to understand that the temporary amendment summarized in Part 1 does not provide authorization for manufacturers that are not usually in the business of producing disinfectants.  Several manufacturers, however, have recently converted (or are considering converting) existing facilities to create disinfectants and increase the availability of critical products during this time of need.  FIFRA requires that the production of pesticides and active ingredients be conducted in a registered pesticide-producing “establishment.”  Under FIFRA, companies that wish to register a pesticide with the EPA must also have a “company number.”  EPA has announced that it is expediting all requests  “establishment numbers” and “company numbers” to enable new pesticide-producing establishments to initiate work as quickly as possible.

Shipman’s environmental lawyers have experience helping clients evaluate and register disinfectant products and ensuring compliance with FIFRA and its implementing regulations.  Please contact us if you would like to discuss these developments or the potential opportunities of producing disinfectant products in this time of high demand and low supply.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.