The new coronavirus SARS-CoV-2 continues its onslaught across the globe. According to the Johns Hopkins Virus Tracker as of this writing on April 20, 2020, worldwide cases number more than 2,424,000 cases and deaths number more than 167,000. Growth in cases and deaths continues across the U.S., with more than 762,000 cases and 40,700 deaths reported. New York continues to have by far the greatest concentration of cases and deaths in the U.S., accounting for approximately 32% of U.S. cases and 45% of deaths.
Last week the U.S. Environmental Protection Agency (EPA) announced further temporary regulatory actions to increase the availability of disinfectants labeled for the control of SARS-CoV-2 virus. These products are identified on EPA’s List N. These changes apply only to products on List N.
The new changes revise the notification process, and are reflected in EPA’s Revised Temporary Amendment to Pesticide Registration Notice 98-10 [April 14, 2020]. Most of the changes are to the scope of changes allowed by the original PR Notice 98-10. In addition to broadening the scope of changes allowed by notification, EPA has now waived the waiting period normally required before changes by notification can be implemented by the registrant. If the substitution meets the eligibility criteria, the product may be released for sale and distribution once EPA receives the notification.
To facilitate registrants’ ability to implement these changes, EPA has established a process for submission of such notifications through the Agency’s Central Data Exchange (CDX) portal. See EPA CDX Portal .
- Substitute Sources for Commodity Active Ingredients with Similar Purity
EPA is temporarily allowing registrants of eligible pesticide disinfectant products containing the following active ingredients to substitute any source of the active ingredient, whether registered or not, to produce their registered disinfectant products:
Hydrochloric acid 7647-01-0
Sodium Hypochlorite 7681-52-9
Hydrogen Peroxide 7722-84-1
Hypochlorous Acid 7790-92-3
Citric Acid 77-92-9
L-lactic Acid 79-33-4
Glycolic Acid 79-14-1
The purity of substitute product from the alternate source must fall within the certified limits of the currently registered formulation. Note that this authorization overrides the statement in Chapter 2 of the Registration Manual that an unregistered source will not be considered an “identical/substantially similar” product.”
- Substitute Sources of Commodity Active Ingredients with Purities That Are Not Similar
EPA is also authorizing substituting commodity sources of the identified commodity active ingredients with products with a purity that differs from the original source. The nominal concentration of the active ingredient in the product may not change; in order to achieve the same certified limits, adjustments in inert ingredient concentrations are limited to water only. Self-certification is allowed, and confirmatory efficacy data are not required.
2. Substitute Sources of Similar Registered Non-Commodity Active Ingredients
As has been the standard process, a registrant may substitute similar registered sources of active ingredients.
3. Substitute Sources of Registered Non-Commodity Active Ingredients That Are Not Similar
EPA is also authorizing substituting registered sources of non-commodity active ingredients with alternate sources with a purity that differs from the original source. The nominal concentration of the active ingredient in the product must not change; in order to achieve the same certified limits, adjustment in inert ingredient concentrations are limited to water only. Self-certification is allowed, and confirmatory efficacy data are not required.
4. Substituting Similar Inert Ingredients
Under existing arrangements, the Confidential Statement of Formula must identify the source of non-commodity inert ingredients, and registrants can substitute a similar inert ingredient source via notification. Composition information from the individual inert supplier must be provided to EPA. For commodity inert ingredients no notification is required, and a substitution may be made at any time. For the identification of commodity inert ingredients see EPA List of Commodity Inert Ingredients
5. Adding New Registered Pesticide Producing Establishments
Registrants with formulations that have a registered source of active ingredient may add already-registered producing establishments. This change is in addition to EPA’s already announced policy of expediting the registration of new producing establishments for disinfectants that fall within the designated list.
EPA also continues to expedite reviews of amendments seeking to add claims for control of SARS-CoV-2, but despite the measures described above, the expedited service is available only for products that already have approved claims for other emerging pathogens. See Guidance on Outbreak of Novel Coronavirus SARS-CoV-2. Registrants who wish to add claims for emerging pathogens for the first time still must go through the standard amendment process.