The U.S. Environmental Protection Agency (EPA) has issued a new temporary modification to Pesticide Registration Notice 98-10 with the intent of helping relieve disruptions in food manufacture and preparation supply chains due to the current COVID-19 public health emergency.
Previous temporary modifications to PR Notice 98-10 created relaxed amendment procedures for certain pesticide disinfectant products registered on EPA’s List N (products approved for use against SARS-CoV-2) to allow for more supply chain flexibility during the coronavirus emergency. After receiving feedback that food manufacturers are experiencing difficulty acquiring sanitizers used in production facilities processing low moisture products like grains, cereal, flour, and industrial baked goods, EPA has extended some of these flexibilities from the previous modifications to food contact surface sanitizer products containing isopropyl alcohol.
Specifically, the newest temporary policy allows registrants of food contact surface sanitizers containing isopropyl alcohol to use an unregistered similar source of alcohol simply by notifying EPA. Rather than applying for and waiting for EPA approval of an amendment to their pesticide registration that identifies the new source, registrants can now streamline the process through a simple notice. To qualify, the new source must be “similar,” meaning that the isopropyl alcohol obtained from the new source has the same Chemical Abstracts Service (CAS) registry number and the same purity.
Additionally, the new policy adds isopropyl alcohol to the list of active ingredients considered to be commodity chemicals, meaning that registrants producing currently registered List N disinfectant products with isopropyl alcohol as an active ingredient may also use this temporary notice process when using a new source.
To submit a notification under this temporary modification, registrants must include a copy of the revised confidential statement of formula (CSF) (EPA Form 8570-4) and a cover letter that includes:
- A subject line that clearly indicates the submission is a notification per the temporary amendment.
- The active ingredient.
- A certification statement.
Prior to terminating this temporary policy, EPA will post a notification online at least seven days in advance. After the policy is terminated, registrants will not be able to release for shipment new registered product unless that product is either (1) produced using a source of active ingredient identified in the product’s approved confidential statement of formula or (2) would have complied with relevant requirements in the absence of the temporary amendment.
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