A Ray of Regulatory Sunshine

Posted on April 30, 2020 by Lynn L. Bergeson

We are all desperate for good news.  In my continuing efforts not to become further mired in the quiet despair we are all experiencing, I thought I would pass along some good news, ironically occasioned by the pandemic.

To help alleviate supply chain disruptions by pesticide registrants that manufacture disinfectant products included on List N, the U.S. Environmental Protection Agency (EPA), in March, announced it was taking action to help hasten the availability of EPA-registered disinfectants.  EPA explained that it is temporarily allowing manufacturers of select already-registered EPA disinfectant products to obtain certain active ingredients from any source without obtaining prior EPA approval. The action only applies to products listed on EPA’s List N: Disinfectants for Use Against SARS-CoV-2 (List N). For List N disinfectant manufacturers, EPA’s decision was very good news, and EPA has moved with extraordinary speed in qualifying products to be effective against the virus that causes COVID-19.  As of April 23, EPA now has over 400 such products, up from less than 100 such products pre-pandemic.

Typically, EPA requires disinfectant manufacturers to apply for and receive EPA approval prior to making a change in the source of the active ingredient.  Under EPA’s action, however, manufacturers can source certain active ingredients from alternate suppliers by simply informing EPA of the change.  Once EPA has been notified, the registrant can immediately distribute or sell a product modified according to this temporary amendment, provided that the resulting formulation is chemically similar to the current formulation.  Presumably after the crisis subsides, the program would revert back to the standard approval process.  Registrants would then be disallowed from releasing for shipment new registered product unless that product is produced using a source of active ingredient identified in the product’s approved Confidential Statement of Formula, or otherwise would have complied with relevant requirements in the absence of this temporary amendment.

When announcing its temporary action in March, EPA stated that it intended to assess the continued need for the temporary amendment on a regular basis.  More recently, EPA has done one better, resulting in yet more good news.  EPA Assistant Administrator Alexandra Dunn, our esteemed ACOEL colleague, announced on April 22, 2020, that EPA may well consider permanently dropping certain “administrative hoops” based on a review of the temporary policy after the coronavirus crisis subsides.  EPA’s commitment to review the “value added” of these and perhaps other administrative requirements, consider eliminating them, and possibly institutionalize the streamlined temporary approach could be a great take-away from the crisis and an unexpected benefit.  Any such decision would, of course, be firmly premised on the conclusion that in eliminating these administrative hurdles, there would be no risk to human health or the environment.

Crises have a tendency to sharpen focus and realign priorities.  Maybe this crisis will help distinguish essential requirements to protect health and the environment from non-essential, vestigial ones that we can all live without.



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