Yesterday, the Environmental Protection Agency (EPA) issued two policy statements as a part of the Administration’s COVID-19 response. First, the EPA furthered its commitment to expediting the registration process for new surface disinfectant products. The EPA also announced an enforcement discretion policy under which the Agency will not seek penalties for certain civil violations related to the current crisis.
The EPA took steps to provide additional flexibility to manufacturers of disinfectants and other pesticides with the intention that this will increase the availability of products for Americans to use against the novel coronavirus. The EPA is allowing manufacturers to obtain certain inert (inactive) ingredients from different suppliers without checking with the agency for approval.
Commodity inert ingredients are individual inert ingredients – there are approximately 280 total – that can be obtained from different producers with no significant differences in the ingredient. Applicants for pesticide registration or registration amendments can now obtain commodity inert ingredients from various commercial sources without having to provide EPA with the supplier name and address. Only those inert ingredients designated as commodity inert ingredients would be eligible for this reduced Confidential Statement of Formula (CSF) reporting.
The full statement from the Office of Chemical Safety and Pollution Prevention (OCSPP) is available here.
The EPA additionally announced that is continuing to expedite the review of submissions from companies requesting to add emerging viral pathogen claims to their already registered surface disinfectant labels. In many cases, the Agency continues to be able to approve claims within 14 days, as resources allow, compared to the 90-day window these claims typically take. There have already been 70 new surface disinfectants added to the EPA’s List N: Disinfectants for Use Against SARS-CoV-2 (List N), bringing the total number of products on the list to more than 350.
The statement emphasizes that List N only includes surface disinfectants already registered by the EPA. Other disinfection products like hand sanitizers and body wipes are regulated the U.S. Food and Drug Administration and using an EPA-registered product in ways other than what is specified in the label is against the law and unsafe.
Finally, the EPA is seeing a rise in “Me Too” registration applications, as manufacturers are seeking to get new surface disinfectant products to market to meet increased demand. A “Me Too” application is a streamlined registration process for applicants that can compare their product to a registered product. Applicant in this process look to show their products (1) are identical in its uses and formulation; or (2) are substantially similar in its uses and formulation to one or more products that are currently registered and marketed in the United States; or (3) differ only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment. The EPA is working to expedite approval of these applications as well.
The EPA’s Office of Enforcement and Compliance Assurance (OECA) announced that it will exercise enforcement discretion and that it does not expect to seek penalties for noncompliance with certain routine monitoring and reporting obligations that are the result of the COVID-19 pandemic. The temporary policy makes it clear that EPA expects regulated facilities to comply with regulatory requirements, where reasonably practicable, and to return to compliance as quickly as possible. To be eligible for enforcement discretion, the policy also requires facilities to document decisions made to prevent or mitigate noncompliance and demonstrate how the noncompliance was caused by the COVID-19 pandemic.
The full statement from the Office of Enforcement and Compliance Assurance (OECA) is available here.
OFW Law will be monitoring these, and other, upcoming changes in policy from the EPA and its offices. For more information, please reach out to Elliot Belilos at OFWLaw.com.