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Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the U.S. Environmental Protection Agency (EPA) took two separate actions in regard to inert ingredients in pesticides.
On 7 September 2022 the EPA added 16 inert ingredients to the Commodity Inert Ingredients List.
On 13 September 2022 the EPA proposed removing 12 chemicals identified as per- and polyfluoroalkyl substances (PFAS) that are no longer used in any registered pesticide product from the inert ingredients list because the substances are PFAS.
3E Review
In general, when completing a Confidential Statement of Formula (CSF), pesticide applicants and registrants must include the name and address of an ingredient’s supplier. However, commodity inert ingredients can be obtained from different producers with no significant differences in the ingredient. Therefore, applicants or registrants can get the commodity inert ingredients from various sources without providing the supplier’s name or address to the EPA on the CSF.
Reduced CSF reporting does not apply to substances on the commodity inert ingredients list when used as active ingredients in pesticide products. It only applies to commodity inert ingredients used solely as inert ingredients.
In order to reduce the regulatory burden and increase flexibility in the supply chain, the EPA added the following 16 inert ingredients to the Commodity Inert Ingredients List:
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In addition, the EPA proposed removing the following PFAS from the current list of inert ingredients approved for use in pesticide products as they are not currently being used in these products:
- 2-Chloro-1,1,1,2-tetrafluoroethane (CAS RN 2837–89–0)
- ɑ-(Cyclohexylmethyl)-ɯ-hydropoly(difluoromethylene) (CAS RN 65530–85–0)
- Dichlorotetrafluoroethane (CAS RN 1320–37–2)
- Ethane, 1,1,1,2,2-pentafluoro- (CAS RN 354–33–6)
- Hexafluoropropene, polymer with tetrafluoroethylene (CAS RN 25067–11–2)
- Montmorillonite-type clay treated with polytetrafluoroethylene (No CAS RN)
- Poly(difluoromethylene), ɑ-chloro-ɯ-(1-chloro-1-fluoroethyl) (CAS RN 131324–06–6)
- Poly(difluoromethylene), ɑ-chloro-ɯ-(2,2-dichloro-1,1,2-trifluoroethyl)- (CAS RN 79070–11–4)
- Poly(difluoromethylene), ɑ-(2,2-dichloro-2-fluoroethyl)-, ɯ-hydro- (CAS RN 163440–89–9)
- Poly(difluoromethylene), ɑ-fluoro-ɯ-[2-[(2-methyl-1-oxo-2-propenyl)oxy]ethyl]- (CAS RN 65530–66–7)
- Poly(oxy-1,2-ethanediyl), ɑ-hydro-ɯ-hydroxy-, ether with ɑ-fluoro-ɯ-(2-hydroxyethyl)poly(difluoromethylene) (1:1) (CAS RN 65545–80–4)
- Propane, 1,1,1,2,3,3,3-heptafluoro- (CAS RN 431–89–0)
One of the reasons the EPA is taking this step is to prevent the introduction of these PFAS into pesticide formulations without additional review by the EPA. Once an inert ingredient is removed from the list, its future use must be supported by data provided to and reviewed by the EPA.
3E Analysis
The addition of 16 inert ingredients to the Commodity Inert Ingredients List means that applicants and registrants of these ingredients will not have to list the suppliers of these ingredients on the CSF effective 7 September 2022.
The proposed removal of the 12 PFAS from the Commodity Inert Ingredients List means that these substances cannot be used in pesticide formulations without first being reviewed by the EPA. Interested entities may submit comments on this proposal until 13 October 2022 at the Federal eRulemaking Portal website citing docket identification (ID) number EPA–HQ–OPP–2022–0542.