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EPA Continues to Expand Efforts to Ease the Production of Disinfectants Approved for Use Against the Novel Coronavirus

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. 

1. Background

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

  • Ethanol

  • 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.

© 2020 Beveridge & Diamond PC National Law Review, Volume X, Number 111

TRENDING LEGAL ANALYSIS


About this Author

Alan J. Sachs Regulatory Attorney Beveridge & Diamond Washington, DC
Principal

Alan’s practice focuses on the wide range of regulatory issues faced by the global agriculture, food, biotechnology, and bioenergy industries.

Practicing environmental law provides him with daily opportunities to use his legal skills and training to help clients overcome often extremely technical business and regulatory challenges in order to ensure compliance with applicable environmental requirements.

He advises numerous Forbes Global 2000 companies on the legal and regulatory requirements associated with both domestic and foreign production, and the import, export, and...

202-789-6049
Kathryn E. Szmuszkovicz Litigation Attorney Beveridge & Diamond Washington, DC
Managing Principal

Kathryn E. Szmuszkovicz litigates and provides strategic regulatory counsel.

Kathy litigates on behalf of individual companies, groups of companies and trade associations in federal and state courts across the country. She also provides alternative dispute resolution (ADR), compliance, strategic planning, and commercial services focused on the regulatory aspects of her clients’ businesses. Kathy’s practice focuses on clients who manufacture, sell, and use products regulated by EPA, USDA, FDA, DOI, DOC, and analogous state agencies under the environmental, health, and safety laws that these agencies implement.

In particular, Kathy works with clients in the agricultural sector (including pesticides and seeds businesses), and food, chemicals, and consumer products industries. This includes traditional products and products produced through biotechnology or nanotechnology. Examples of her work include:

  • Bringing or defending litigation where necessary to protect clients’ products, projects, or practices.
  • Advising clients on strategies for obtaining federal approvals for new products or substances, defending products once they are on the market, and phasing out products for regulatory or commercial reasons.
  • Advising clients who manufacture, sell, license, or use these regulated products on government requirements and commercial transactions.
  • Defending companies against enforcement actions.
  • Proposing and commenting on regulatory and legislative initiatives.
  • Supporting acquisition or sale of particular products or businesses.
  • Advising on stewardship and sustainability practices.

Kathy has litigated in federal courts across the country, including the United States Supreme Court, and has represented clients in every EPA region and many states. She has advocated for clients in ADR proceedings, including ADR mandated by statute, mini-trials and other ADR designed by parties to resolve disputes privately without court intervention, and mediation.

Kathy is Beveridge & Diamond’s firmwide Managing Principal. Before assuming this role, she served for many years on B&D's Management Committee and as the chair or co-chair of the firm’s pesticides and biotechnology practices. Kathy served for six years on the Board of Directors of a privately held company that discovers, manufactures, and sells proprietary chemicals. Before her legal career, Kathy served in federal and Michigan state government.

202-789-6037
Jack B. Zietman Regulatory Environmental Attorney Beveridge & Diamond Washington, DC
Associate

Jack litigates and practices regulatory environmental law with a focus on groundwater issues and the agriculture, food, and chemical manufacturing industries.

His representative experience includes work on products liability and environmental tort litigation, as well as regulatory counsel for products regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Toxic Substances Control Act (TSCA). He is also familiar with fishery management issues, particularly pertaining to the conservation of endangered species, and the evolving U.S. regulations of...

202-789-6036