Citing continued reports of supply chain disruptions by manufacturers of registered disinfectant products approved for use against the novel coronavirus, the U.S. Environmental Protection Agency (“EPA”) announced on April 14, 2020 that it will further amend its registration procedures to, among other things, temporarily allow registrants to substitute registered sources of non-commodity active ingredients by “notification,” even if the ingredients have different purity levels. EPA’s action is the latest in a series of efforts taken over the last several weeks to help manufacturers quickly source and obtain the active and inert ingredients necessary to produce disinfectant products approved by the Agency on its “List N: Disinfectants for Use Against SARS-CoV-2.” EPA’s new announcement also incorporates and builds directly on the Agency’s March 30 announcement that it will temporarily allow manufacturers of such products to obtain certain “commodity” active ingredients from different suppliers without first obtaining a registration amendment.
According to EPA, these temporary changes are intended to streamline the process for adding additional registered sources of active ingredients to a formulation and setting up an approved pesticide manufacturing establishment. EPA does not anticipate that any of the temporary changes to its notification or approval requirements will result in substantive changes to final, EPA-approved pesticide formulations or to any product’s effectiveness.
An active ingredient is a chemical in a pesticide product that acts to prevent, destroy, repel, or mitigate a pest, or is a plant regulator, defoliant, desiccant, or nitrogen stabilizer. An inert ingredient is any substance or group of similar substances other than an active ingredient that is intentionally included in a pesticide product by its manufacturer. Consistent with the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) and Pesticide Registration Notice 98-10, EPA permits pesticide manufacturers to change the source of an active ingredient to an alternate, registered source by notification if the new source is chemically “similar” to its current source (i.e., it has the same CAS number and purity), but generally requires that manufacturers apply for and obtain EPA approval before changing to a non-similar registered source or an unregistered source of any active ingredient.
Manufacturers must also generally apply for and obtain EPA approval to add additional EPA-registered establishments to a product’s Confidential Statement of Formula (“CSF”) Form, which a manufacturer would need to do if obtaining an active ingredient from an alternate registered source. With its temporary amendments to PR Notice 98-10, EPA is will now allow manufacturers of List N disinfectant products to make certain changes to their product formulas and supply chains by notification only.
2. Procedures Applicable to List N Products Using “Commodity” Active Ingredients
EPA’s April 14 action confirms that manufacturers of listed anti-coronavirus disinfectants may temporarily source the following “widely available” and “easily-manufactured commodity” active ingredients from unregistered sources by notification alone, and without first obtaining Agency approval:
- Citric Acid
- Glycolic Acid
- Hydrochloric Acid
- Hypochlorous Acid
- Hydrogen Peroxide
- L-Lactic Acid
- Sodium Hypochlorite
In addition, EPA is also temporarily allowing List N product manufacturers to use these commodity active ingredients even if they vary in purity, so long as the nominal concentration of the active ingredient in the product remains the same and the only adjusted inert ingredient is water. In all cases, registrants must follow the notification procedures described in EPA’s PR 98-10 amendment.
On March 26, the Agency separately announced that pesticide manufacturers may also obtain certain “commodity inert ingredients” from different suppliers without first notifying EPA. Unlike the temporary amendments to PR Notice 98-10 for commodity active ingredients, this is a permanent change to earlier Agency procedures, which had required that manufacturers notify EPA before substituting sources for any similar inert ingredients used in their products. In connection with its April 14 announcement, EPA also confirmed that nine additional chemicals have now been to its list of commodity inert ingredients. Note that registrants must still notify EPA before substituting sources of any non-commodity inert ingredient in their products.
3. Procedures Applicable to List N Products Using Sources of Other Active Ingredients
In its latest action, EPA confirms that registrants must still notify EPA before substituting a similar, registered source of any non-commodity active ingredient. In addition, EPA is now temporarily allowing List N disinfectant manufacturers to make such a substitution by notification even if the active ingredient varies in purity from the original source (i.e., is not similar), so long as the nominal concentration of the active ingredient in the product remains the same and the only adjusted inert ingredient is water.
In connection with that change, EPA will also now allow registrants to add an EPA-registered establishment to a List N disinfectant’s formula by notification.
4. Duration of Temporary Amendments to PR Notice 98-10
Notifications submitted to EPA under this process will be valid only as long as the temporary amendment remains in effect. EPA will regularly assess the need for and scope of the new allowances, and will provide at least seven days’ notice prior to their termination. After that date, pesticide registrants will not be permitted to release for shipment any new registered product unless it is produced with ingredients as approved or permitted in the absence of the temporary amendment. No permanent modification to the regular approval or notification procedures for active ingredients will be made with first providing notice and an opportunity for public comment.