REGULATION & COMPLIANCE
Discussion
These cases raise two key issues . The first involves what constitutes ‘ diligent ’ prosecution . While this issue has been raised and litigated in other contexts , this question appears to be a first under TSCA . At issue here is whether the government ’ s actions to date are sufficiently ‘ diligent ’ to meet the standard .
Paragraph 35 of the citizens ’ complaint suggests the citizen plaintiffs are concerned with the government ’ s diligence . It reads : “ Because of the many redactions in the Complaint and the lengthy two-year delay between EPA ’ s initiation of discussions with Enhance [ sic ] and the filing of its suit , plaintiffs are concerned that EPA will not ‘ diligently prosecute ’ its action in the Eastern District of Pennsylvania , removing a possible bar to plaintiffs ’ suit in this Court under TSCA section 20 ( b )( 1 )( B ) and enabling plaintiffs to seek all relief authorized by law in this action .”
In that there have been relatively few Section 20 citizen actions to compel a person or company to come into TSCA compliance , this case is one to watch . Regardless of Inhance ’ s motion to dismiss , the citizens ’ lawsuit has turned up the heat on the government and highlighted what the citizens implicitly assert has been EPA ’ s ‘ slow walking ’ its enforcement action against the company .
The second issue is whether EPA has exceeded its statutory authority under TSCA by asserting that Inhance ’ s manufacturing activities identified in the complaint are ‘ new ’ uses subject to the SNUR . Inhance argues that the uses were pre-existing and ongoing well before the SNUR was issued .
Additionally , Inhance asserts that it had no reason to expect that the agency would require notification . It points to the EPA ’ s ‘ open letter to industry ’ issued on 16 March 2022 , after the NOV was sent to Inhance , explaining publicly for the first time that the agency was interpreting its SNUR to cover fluorination of containers .
Another interesting twist is whether the manufacture of the SNUR chemicals , both as a by-product of the fluorination process and also as impurities with no commercial purpose in the products being processed and distributed , is exempt from the SNUR notification requirements . Although the by-product exemption in the SNUR regulation itself , i . e . 40 CFR Section 721.45 ( e ), appears not to cover the activity , the premanufacture notice ( PMN ) regulations exempt under 40 CFR Section 720.30 ( h ) ( 2 ) any by-product “ which is not used for commercial purposes ”.
This would appear to cover the by-products relevant here , especially when read in the context of the chapeau to 40 CFR Section 720.30 ( h ) and 40 CFR Section 721.1 ( c ) of the SNUR regulations , which states : “ The provisions of part 720 of this chapter apply to this part 721 . For purposes of this part 721 , wherever the phrase ‘ new chemical substance ’ appears in part 720 of this chapter , it shall mean the chemical substance subject to this part 721 . In the event of a conflict between the provisions of part 720 of this chapter and the provisions of this part 721 , the provisions of this part 721 shall govern .”
Arguably , there is no conflict between the SNUR regulation and the PMN regulations regarding the applicability of the exemption at 40 CFR Section 720.30 ( h )( 2 ) to SNURs . In the absence of a provision making the exemption not applicable in specific SNURs , it would appear applicable . That the SNUR regulation exemptions duplicate certain PMN exemptions but exclude certain others should not necessarily be read to mean those excluded exemptions are not applicable , given the language in 40 CFR Section 721.1 ( c ), as noted above .
Another interesting question that appears relevant is whether the manufacture of a substance as a by-product that is also an impurity in a product that is processed and distributed in commerce is not subject to the SNUR because the substance is not being manufactured ‘ for a use ’ within the meaning of TSCA Section 5 ( a )( 1 )( A )( ii ) or , similarly , ‘ for any use ’ within the meaning of the SNUR , but is inadvertently produced and remains unintentionally present ( as impurities ) in the final product .
The EPA may be of the view that a by-product cannot also be an impurity if it is unintentionally present with another substance . This interpretation would be a dramatic departure from over 40 years of TSCA history .
Conclusion
Even if the citizen suit is dismissed on the grounds that the plaintiffs failed to show that the DOJ was not diligently prosecuting its case against Inhance , the court ’ s decision ( if articulated ) will help define the degree of prosecution that is sufficiently ‘ diligent ’ to preclude a citizen suit . A resolution of the issues here around the scope of the EPA ’ s Section 5 authority to regulate significant new uses of chemicals will be consequential and is much anticipated . While the EPA can be expected to assert broad authority to regulate the generation of PFAS , their status here as by-products and / or impurities , and in the context of longstanding fluorination processes that were announced as subject to the SNUR years after the long-chain PFAS SNUR was issued , raises fundamental questions of fair notice and due process .
In short , stay tuned . These cases and the EPA ’ s administrative deliberations on the SNURs will probably progress slowly but they will be worth the wait . ●
Lynn Bergeson
MANAGING PARTNER
BERGESON & CAMPBELL k + 1 202 557 3801 J lbergeson @ lawbc . com j www . lawbc . com
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