A Tale of Two Policies: EPA Keeps Some, But Not All, COVID-related Antimicrobial Policy Changes
EPA has shown surprising flexibility and a willingness to modify its basic operating policies for regulating antimicrobial products in response to the societal and scientific challenges presented by the COVID-19 pandemic. However, in recent weeks, the Agency has begun to roll back some of the latitude it had granted to antimicrobial product makers confronting supply chain issues while simultaneously extending other policies which reflect a keen awareness that the current pandemic may be slow to recede, and the next viral threat could be looming just around the corner.
EPA has extensive requirements intended to ensure antimicrobial products are tested to demonstrate their efficacy against the human pathogens listed on a product’s label. In 2016, EPA issued guidance to address the need to identify and authorize for use certain EPA-registered disinfectant products to combat “emerging viral pathogens” not yet identified on registered products’ labels. The Emerging Viral Pathogen (EVP) Guidance provided a process enabling a company to receive permission to make an “emerging viral pathogen” claim, based on the product being previously shown to be effective against specific “hard-to-kill” viruses. If EPA concurs that existing data that supports the claim is acceptable, the company could make limited “off-label” claims in the event of a novel viral outbreak. EPA activated the EVP policy for antimicrobial pesticides for the first time in January 2020, in response to the emergence of SARS-CoV-2, the virus that causes COVID-19. By doing so, EPA provided an expedited review and approval process for surface disinfectant products to be distributed for use against SARS-CoV-2, including conducting accelerated reviews for products seeking to add EVP claims to product labels. To date, EPA has added approximately 400 products with emerging viral pathogens claims to its list of Disinfectants for use to combat Coronavirus.
A Little Give…
EVP claims are generally supposed to be removed from product messaging statements and literature no later than 24 months after the original notification of the outbreak, unless directed otherwise by EPA. On November 19, EPA announced that it has extended the Guidance for COVID-19. As a result, EVP claims can remain in use for now, and will not need to be removed by a date certain. Moreover, EPA announced it will give at least six months’ notice before inactivating the EVP guidance for COVID 19 to allow for time for manufacturers to modify marketing materials as necessary.
And A Little Take
This extension of regulatory “flexibility” in the antimicrobial space stands in contrast to another recent EPA action. EPA’s long-standing “Pesticide Registration Notice (PRN) 98-10” established procedures permitting registrants to make modifications to the terms of their antimicrobial registrations by stream-line processes known as “notification” and “non-notification” which expedites review of minor label and formulation changes, including for antimicrobial products. After the onset of the COVID 19 health crisis, supply chain disruptions affected the availability of active ingredients used in disinfection products. EPA responded by issuing Temporary Amendments to PRN 98-10 in March, April, and again in May 2020, that allowed registrants to simply notify EPA of certain formulation and manufacturing facility changes and to effectively immediately release the modified product for sale without waiting for EPA’s review and approval. These measures helped ensure that disinfectant manufacturers would be able to produce their products despite supply chain shortages, ensuring the availability of products seen as vital for addressing COVID 19, and addressing the considerable demands for ample supplies in the marketplace.
On September 15, EPA announced that it was terminating the Temporary Amendment. EPA explained that registrants have known from the time the Temporary Amendment was issued that it was temporary and therefore permanent changes should have been made through the routine amendment process. Furthermore, EPA stated that the Agency was not aware of any supply chain issues that would justify keeping the Temporary Amendment in place. However, because registrants may need time to adjust (or to revert to their previously authorized formulations), EPA is giving a year - until September 15, 2022 - for registrants to make any needed changes, or to file documents making registration amendments permanent.The coincidence of these EPA actions suggests that, on the one hand, EPA is acknowledging that COVID 19 remains a threat and that it will continue policies ensuring the availability of disinfectants to fight COVID as an Agency priority while on the other hand EPA believes that supply chain issues no longer present challenges to manufacturers’ ability to produce disinfectants. Whether supply chain issues have truly resolved only time will tell. If it is mistaken in its assessment, EPA may need to revisit these policies and once again allow for greater flexibilities to antimicrobial manufacturers to assist them in addressing the challenges of COVID 19.
© Arnold & Porter Kaye Scholer LLP 2021 All Rights Reserved. This blog post is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.