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By James V. Aidala, Heather F. Collins, M.S., and Barbara A. Christianson

On January 20, 2022, the U.S. Environmental Protection Agency (EPA) announced it is extending supply-chain flexibilities for registrants of certain conventional and biopesticide products to alleviate a supply-chain issue facing the pesticide industry.

This is an extension of EPA’s July 2, 2021, action when EPA implemented supply-chain flexibilities that allowed registrants to substitute a combination of pre-approved alternate inert ingredients for inert ingredients derived from propylene oxide (PO) feedstocks. This was intended to address the limited supply of PO feedstocks due to weather events that occurred in the U.S. Gulf Coast in February 2021. This action was originally set to expire on December 31, 2021, but EPA has extended these supply-chain flexibilities until December 31, 2022, due to continued disruptions to production.

EPA emphasized in its initial July 2021 action that this relates only to non-antimicrobial pesticide products and that EPA will handle “not in-kind” substitutions for antimicrobial pesticide products on a case-by-case basis.

The pre-approved alternates for propylene glycol, a derivative of PO feedstocks, include:

  • glycerin (Chemical Abstracts Service Registry Number (CAS RN) 56-81-5);
  • diethylene glycol (CAS RN 111-46-6);
  • ethylene glycol (CAS RN 107-21-1); and/or
  • 1,3-propanediol (CAS RN 504-63-2).

These substitutions can be added to a product formulation or a brand name mixture.

Registrants must self-certify that the substitute inert ingredients will:

  • Serve the same function in the product as propylene glycol;
  • Maintain the validity of product-specific data submitted in support of the registration;
  • Maintain the product’s acute toxicity category and physical/chemical characteristics such that no label modifications are required; and
  • Maintain the product’s fitness for its intended purposes in terms of efficacy, phytotoxicity, and any other factor.

EPA states that any registrants that wish to make the substitution permanent will have to go through the standard amendment process outlined in Pesticide Registration Notice (PRN) 98-10.

Commentary

Supply-chain issues have become a national concern whether one is shopping for furniture or manufacturing pesticides. The Biden Administration across government agencies and programs has sought ways to ease difficulties as part of a national response to economic disruptions caused by the COVID-19 pandemic. Pesticide ingredients may not be subject to as much media coverage as consumer products, but in the end, could have impacts affecting availability of disinfectants and other pesticide products. In the broader economy, supply-chain issues have been identified as a factor affecting the availability of pesticides used to help meet the food and fiber production needs of the nation, along with concerns about freight capacity limiting the normal distribution of crop inputs and ultimately affecting the movement of finished crops.


 

By Heather F. Collins, M.S. and Barbara A. Christianson

On July 2, 2021, the U.S. Environmental Protection Agency (EPA) announced it is taking action to alleviate a supply-chain issue facing the pesticide industry. EPA stated that it is allowing registrants of non-antimicrobial pesticide products to substitute some combination of pre-approved alternate inert ingredients for inert ingredients derived from propylene oxide feedstocks that are in limited supply due to weather events that occurred in the U.S. Gulf Coast area in February 2021. EPA stated that it is allowing these substitutions even in cases where propylene glycol is added to the formulation or is part of a brand-name mixture in which the full composition is known to the registrant.

The pre-approved alternates are glycerin (Chemical Abstracts Service Registry Number (CAS RN) 56-81-5); diethylene glycol (CAS RN 111-46-6); ethylene glycol (CAS RN 107-21-1); and 1,3-propanediol (CAS RN 504-63-2).

EPA emphasizes that this action, known as “Propylene Glycol Phase 2 -- ‘Not In-Kind’ Substitution Mechanism,” relates only to non-antimicrobial pesticide products and that EPA will handle “not in-kind” substitutions for antimicrobial pesticide products on a case-by-case basis.

In April 2021, EPA implemented “Propylene Glycol Phase 1 -- ‘In-Kind’ Substitution Mechanism” to allow certain in-kind substitutions to address propylene glycol supply-chain shortages.

These actions require registrants to self-certify that the substitute inert ingredients serve the same function in the product as propylene glycol and that the change will not impact either the validity of any product-specific data submitted in support of the registration or the product’s acute toxicity category or physical/chemical characteristics in a way that would require label modifications. Registrants must also certify that the substitution will not affect the product’s fitness for its intended purposes in terms of efficacy, phytotoxicity, or any other factor.

This action is time limited, extending to December 31, 2021. Any registrants who wish to make the substitution permanent will have to go through the standard amendment process outlined in Pesticide Registration Notice (PRN) 98-10.