By Lisa M. Campbell, Heather F. Collins, M.S. and Barbara A. Christianson
On April 14, 2020, the U.S. Environmental Protection Agency (EPA) announced it is taking further action to help ease the production and availability of EPA-registered disinfectants by temporarily allowing registrants to notify EPA of certain formulation and manufacturing facility changes and immediately release the product for sale without waiting for EPA approval. This only applies to products on EPA’s List N: Disinfectants for Use Against SARS-CoV-2 (List N).
EPA’s announcement builds on EPA’s temporary amendment to Pesticide Registration (PR) Notice 98-10 announced on March 31, 2020. Among other changes, the temporary amendment to PR Notice 98-10 streamlines the process for adding additional registered sources of active ingredients to a formulation and setting up an approved pesticide manufacturing establishment. This enhanced flexibility allows List N with registered sources of active ingredients to be manufactured in those establishments without prior EPA approval.
EPA’s temporary amendment to PR Notice 98-10 states that registrants may submit a notification to substitute registered sources of active ingredients that are not similar. If registrants are unable to substitute a similar registered source (similar defined as the active or inert ingredient obtained from the source has the same Chemical Abstracts Service Registry Number (CASRN) and same purity) of the active ingredient, they may use an alternate source but must adjust the inert ingredient to ensure the nominal concentration of the active ingredient in the product does not change. As long as the nominal concentration of the active ingredient in the product remains the same and adjustments in inert ingredients is limited to water only, this change will be allowed by notification and confirmatory efficacy data will not be required.
Additionally, EPA’s temporary amendment to PR Notice 98-10 will allow registrants to submit a notification to add EPA-registered establishments for formulations having a registered source of the active ingredient and where there are no other changes to the formulation.
EPA states that the changes allowed through notification by this action will not result in any substantive changes to the final pesticide formulations already approved by EPA, and the products’ effectiveness will not be affected and the products’ current precautionary labeling will remain protective. EPA adds this action will not cause any unreasonable adverse effects to human health and the environment.
EPA states in its temporary amendment to Pesticide Registration (PR) Notice 98-10, the following procedures to submit a notification for currently registered disinfectant products listed on EPA’s List N:
- A cover letter with a subject line that clearly indicates that this is a “notification per TEMPORARY AMENDMENT TO PR NOTICE 98-10 (April 14, 2020) for EPA Registration No. XXXXXX and [insert product name]”;
- The active ingredient; and
- The following certification statement:
[Name of Registrant] is submitting this notification consistent with the provisions of PR Notice 98-10 and [insert section(s) of the Temporary Amendment to PR Notice 98-10 dated April 10, 2020, and no other changes have been made to the Confidential Statement of Formula or labeling of this product. I confirm that the ingredients statement of this label remains truthful. I understand that it is a violation of 18 U.S.C. Section 1001 to willfully make any false statement to EPA. I further understand that if this self-certification is not consistent with the terms of PR Notice 98-10, the Temporary Amendment 98-10 dated April 10, 2020, and 40 C.F.R. 152.46, this product may be in violation of FIFRA and I may be subject to enforcement actions and penalties under section 12 and 14 of FIFRA.
Applications must be submitted via the CDX portal. At this time, EPA is not accepting paper applications. Once an application is submitted, EPA requests that an email is sent to the Product Manager for the product with the CDX tracking number (CDX _ 2020 _ XXXXXXX). A registrant may distribute or sell a product modified according to this temporary amendment to PR Notice 98-10 once EPA receives the notification. Receipt to EPA occurs when the requestor receives a CDX number when submitting the application via the CDX portal.
Additional information on submission information for registrants is available at Temporary Amendment to PR Notice 98-10 and on our blog.