By Lynn L. Bergeson and Carla N. Hutton

On April 6, 2023, the U.S. District Court for the District of Columbia dismissed a suit brought by the Center for Environmental Health (CEH) and Public Employees for Environmental Responsibility (PEER) to prevent Inhance Technologies USA (Inhance) from generating per- and polyfluoroalkyl substances (PFAS) when fluorinating plastic containers. As reported in our January 6, 2023, blog item, CEH and PEER sought a court order restraining Inhance from continued manufacture of PFAS in violation of a 2020 significant new use rule (SNUR) “requiring it to stop all distribution of fluorinated containers in commerce until and unless [Toxic Substances Control Act (TSCA)] requirements are met and directing it to inform purchasers and users of these containers of the dangers of exposure to [perfluorooctanoic acid (PFOA)] and other PFAS.” While CEH and PEER filed suit on December 27, 2022, the U.S. Environmental Protection Agency (EPA) filed suit on December 19, 2022, in the U.S. District Court for the Eastern District of Pennsylvania. According to the court’s April 6, 2023, opinion, Inhance filed a motion to dismiss the case brought by CEH and PEER, “arguing that the TSCA’s diligent-prosecution bar requires dismissal of this separate action.” The court states that the United States filed an amicus brief in support of Inhance’s motion, “arguing that this lawsuit ‘is a textbook case for application of the diligent prosecution bar.’” The court found that CEH and PEER failed to prove that the U.S. Department of Justice (DOJ) is not “diligently prosecuting” the action. The court reviewed the days between when DOJ filed its suit and CEH and PEER filed their suit, and found “[n]othing in the eight days between when DOJ filed its lawsuit and when Plaintiffs filed theirs suggests that Justice was not diligently prosecuting the case.” The court granted Inhance’s motion, dismissing the case without prejudice. The court noted that CEH and PEER have “the options of intervening in DOJ’s separate action or returning to court another day if Justice starts to slack at the reins.” According to an April 7, 2023, PEER press release, PEER and CEH will now move to intervene in DOJ’s suit in the U.S. District Court for the Eastern District of Pennsylvania.

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By Lynn L. Bergeson, Christopher R. Blunck, and Carla N. Hutton

On December 27, 2022, the Center for Environmental Health (CEH) and Public Employees for Environmental Responsibility (PEER) filed a lawsuit in the U.S. District Court for the District of Columbia to prevent Inhance Technologies USA from generating per- and polyfluoroalkyl substances (PFAS) when fluorinating plastic containers. According to CEH and PEER’s joint press release, testing conducted by the U.S. Environmental Protection Agency (EPA), Notre Dame researchers, and other organizations “has found PFAS chemicals on the inner and outer surfaces of fluorinated containers and in the contents of the containers. The PFAS in the containers are likely formed as a result of chemical reactions that occur during the fluorination process conducted by Inhance.” According to the press release, Inhance “conducts fluorination operations at several facilities in the U.S. and is the leading supplier of post-mold fluorination services” in the United States. The press release notes that in 2020, EPA issued a significant new use rule (SNUR) under the Toxic Substances Control Act (TSCA) barring firms from producing perfluorooctanoic acid (PFOA) and certain other PFAS until EPA had been notified and determined whether the proposed uses of these PFAS might present an unreasonable risk to health. The press release states that [‌i]n this event, the law required EPA to ban or restrict the PFAS for these uses.” According to the lawsuit, Inhance did not notify EPA in 2020 and has been subsequently manufacturing PFOA and other PFAS in violation of TSCA.

CEH and PEER seek a court order restraining Inhance from continued manufacture of PFAS in violation of the SNUR, “requiring it to stop all distribution of fluorinated containers in commerce until and unless TSCA requirements are met and directing it to inform purchasers and users of these containers of the dangers of exposure to PFOA and other PFAS.”

The press release notes that on December 19, 2022, EPA filed suit against Inhance under TSCA. According to the press release, EPA’s suit “followed nearly two years of discussions between the agency and the company during which Inhance continued to produce PFAS in violation of TSCA without any EPA action to protect the public.” The press release states that EPA filed suit only after CEH and PEER wrote to the agency in late October 2022 “threatening to file suit against the company.” CEH and PEER intend to use their suit to ensure that EPA takes all actions authorized under TSCA “to put a stop to Inhance’s unlawful conduct and prevent unsafe exposure to PFAS by users of fluorinated containers.”

Commentary

This lawsuit raises many interesting issues. TSCA Section 20(b)(1)(B) appears to preclude commencement of a Section 20 action if EPA has commenced and “is diligently prosecuting a proceeding” to issue an order under TSCA Section 16 to require compliance. If the plaintiff has given appropriate notice of its pending action before EPA commences its action, it can, however, intervene in EPA’s action as a matter of right. A factual question relevant here is whether EPA is diligently prosecuting the proceeding. The plaintiff seems to address this issue in paragraph 35 of its complaint:

35. 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 TSCA Section 20 citizen actions to compel a person or company to come into TSCA compliance, this case could be one to watch. We question that the plaintiffs have made the case that EPA is not diligently prosecuting the case it filed, especially as only eight calendar days passed between the EPA filing and the plaintiffs’ filings, and that period included the Christmas holiday.

Another interesting issue relates to the likelihood that the manufacturing activities addressed in the complaint preceded proposal of the SNUR such that they would have been considered “ongoing,” thus arguably defeating application of the SNUR restrictions. Whether these activities preceded the proposed SNUR and whether EPA was made aware of this are unclear. Given the circumstances of the byproduct chemicals’ manufacture, it seems reasonable that such production would not be understood to be covered by the SNUR, as discussed further below -- and thus trigger the byproduct manufacturer to comment, noting to EPA the ongoing activity.

Notwithstanding EPA’s apparent position, it is questionable whether byproducts with no intentional use that become impurities in the products being processed and distributed are subject to SNURs. The manufacture of the substances of concern may be considered byproducts exempted by the SNUR. Although the byproduct exemption in Subpart A of Part 721 of the SNUR regulation itself, i.e., 40 C.F.R. Section 721.45(e), appears not to cover the activity, the PMN regulations exempt in 40 C.F.R. Section 720.30(h)(2) “[a]ny byproduct which is not used for commercial purposes.” This particular byproduct exemption appears to cover the byproducts in the facts at play, especially when read in the context of the chapeau to 40 C.F.R. Section 720.30(h) and 40 C.F.R. 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 with regard to the applicability of the exemption at 40 C.F.R. Section 720.30(h)(2) to SNURs. In the absence of a provision making the exemption not applicable in specific SNURs, the exemption would appear applicable (as would other exemptions in 40 C.F.R. Section 720.30(h) that are not specifically replicated in 40 C.F.R. Section 721.45, certain of which we assume EPA even more clearly would not intend to include as covered manufacturing activities for SNUR purposes, e.g., a “chemical substance which results from a chemical reaction that occurs incidental to storage or disposal of another chemical substance, mixture, or article” (40 C.F.R. Section 720.30(h)(4)), which could also become an impurity in a product processed and distributed in commerce.). That the SNUR regulation exemptions duplicate certain PMN exemptions but exclude certain others should not be read to mean those excluded exemptions are not applicable given the language in 40 C.F.R. Section 721.1(c), copied above. Another view is that the manufacture of a substance as a byproduct that becomes an impurity in a product that is processed and distributed in commerce is not subject to the SNUR as the substance is not being manufactured “for any use” within the meaning of the SNUR. It is merely being inadvertently produced. Notwithstanding, we recognize EPA’s authority under TSCA to gather information, assess, and manage any unreasonable risks associated with the activity.

This is an interesting case TSCA mavens should monitor.

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By Lynn L. Bergeson and Carla N. Hutton
 
On December 2, 2022, the U.S. Environmental Protection Agency (EPA) proposed significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for chemical substances that were the subject of premanufacture notices (PMN) and are also subject to Orders issued by EPA pursuant to TSCA. 87 Fed. Reg. 74072. The SNURs require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is proposed as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA’s evaluation of the use, under the conditions of use for that chemical substance, within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required by that determination. Comments are due January 3, 2023.
 
According to EPA, during review of the PMNs submitted for the chemical substances that are the subject of the proposed SNURs, EPA concluded that regulation was warranted under TSCA Section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. Based on its findings, EPA negotiated TSCA Section 5(e) Orders requiring the use of “appropriate exposure controls” with the PMN submitters. EPA states that as a general matter, it “believes it is necessary to follow the TSCA Orders with a SNUR that identifies the absence of those protective measures as significant new uses to ensure that all manufacturers and processors -- not just the original submitter -- are held to the same standard.” The proposed SNURs also include significant new uses that EPA proposes to determine are not ongoing based either on information showing that the chemical is not on the TSCA Inventory or based on EPA’s review of Chemical Data Reporting (CDR) submissions under TSCA Section 8(a). EPA states that it “believes that these uses could significantly increase the magnitude and duration of exposure to humans and the environment to these chemical substances. Accordingly, EPA wants the opportunity to evaluate and manage risks, where appropriate, from activities associated with those uses, before manufacturing or processing for those uses were to begin.”
 
EPA states that the SNURs advance one of the “key actions” in the PFAS Strategic Roadmap where EPA stated it plans to revisit past regulatory decisions concerning per- and polyfluoroalkyl substances (PFAS) and address those that are insufficiently protective by imposing additional notification requirements. According to EPA, in this way, it “can ensure it has the opportunity to review PFAS before they are used in new ways that might present concerns.” More information on the PFAS Strategic Roadmap is available in our October 19, 2021, memorandum.

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By Lynn L. Bergeson and Carla N. Hutton
 
On July 7, 2022, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) released a report entitled “The EPA Was Not Transparent About Changes Made to a Long-Chain PFAS Rule After Administrator Signature.” OIG evaluated the extent to which EPA followed applicable policies, procedures, and guidance for the changes made to the long-chain perfluoroalkyl carboxylate and perfluoroalkyl sulfonate chemical substances (LCPFAC) significant new use rule (SNUR) between the EPA Administrator’s signing of the final rule on June 22, 2020, and the publication of the final rule in the Federal Register on July 27, 2020. OIG states that it initiated the evaluation based on a Congressional request. OIG notes that the substances in question are types of per- and polyfluoroalkyl substances (PFAS), which are manufactured chemicals widely used in industry and consumer products. SNURs require that EPA be notified before regulated chemical substances are used in new ways that might cause environmental or human health concerns.
 
According to OIG, EPA did not follow all applicable policies, procedures, and guidance when making changes to the LCPFAC SNUR after the Administrator signed it and before it was published in the Federal Register. Specifically:

• Although EPA identified changes made to the SNUR in a post-signature change memorandum, which was signed by the Administrator, as required by EPA’s Changes to Rule Documents Prepared for the Administrator’s Signature procedures, EPA did not docket that memorandum, as stipulated in EPA’s Creating and Managing Dockets: Frequently Asked Questions for EPA Action Developers guidance.
   
• OIG states that because the request for changes was communicated via telephone, it could not identify the origin of the requested changes and could not determine whether EPA complied with the transparency provisions of Executive Order 12866, Regulatory Planning and Review.

OIG states that by not following all docketing procedures, EPA did not meet transparency expectations and risked compromising the public’s trust in the rulemaking process. OIG notes that EPA followed the Office of the Federal Register’s Document Drafting Handbook guidance for requesting changes to the final rule, however.
 
OIG recommends that the Assistant Administrator for Chemical Safety and Pollution Prevention update the LCPFAC SNUR docket by posting the post-signature change memorandum that outlines the changes made to the final rule after the Administrator signed it but before it was published in the Federal Register. OIG also makes two recommendations to the Associate Administrator for Policy, which include updating the applicable policies, procedures, and guidance regarding making changes to a regulatory action after it is submitted to the Office of Information and Regulatory Affairs for review and before it is published in the Federal Register. OIG states that EPA agreed with its first two recommendations and provided acceptable corrective actions. The first recommendation is completed, and the second is resolved with corrective actions pending. EPA disagreed with OIG’s third recommendation, and it remains unresolved. More information on the LCPFAC SNUR is available in our July 27, 2020, memorandum.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on March 4, 2022, the availability of the latest Toxic Substances Control Act (TSCA) Inventory. EPA states that the biannual update to the public TSCA Inventory is part of its regular posting of non-confidential TSCA Inventory data. EPA plans the next regular update of the Inventory for summer 2022. According to EPA, the Inventory contains 86,631 chemicals, of which 42,039 are active in U.S commerce. Other updates include new chemical substance additions, commercial activity data and regulatory flags, such as polymer exemptions, TSCA Section 4 test orders, and TSCA Section 5 significant new use rules (SNUR). EPA notes that on October 15, 2021, it announced a list of 377 specific chemical identities that were expected to lose their confidential status and move to the public portion of the Inventory. According to EPA, these 377 are listed in this public Inventory posting by their specific chemical identities.

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By Lynn L. Bergeson and Carla N. Hutton
 
According to an October 25, 2021, project notification memorandum, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) plans to begin an evaluation to determine the extent to which EPA followed applicable policies, procedures, and guidance for the changes made to the significant new use rule (SNUR) for long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate chemical substances between the EPA Administrator’s signing of the final rule on June 22, 2020, and the publication of the final rule in the Federal Register on July 27, 2020. The memorandum states that the anticipated benefits of the evaluation include greater assurance that EPA “has controls in place to maintain the integrity of signed final rules prior to final publication in the Federal Register.”
 
The memorandum states that the evaluation is the result of a Congressional request. The evaluation is part of OIG’s oversight plan for fiscal year (FY) 2022 and addresses the following FY 2022 top management challenge for EPA: ensuring safe use of chemicals.
 
More information on EPA’s July 27, 2020, final SNUR is available in our July 27, 2020, memorandum, “EPA Issues Final SNUR for LCPFAC and Perfluoroalkyl Sulfonate Chemical Substances.”

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on August 31, 2021, the availability of the latest Toxic Substances Control Act (TSCA) Inventory. EPA states that the biannual update to the public TSCA Inventory is part of its regular posting of non-confidential TSCA Inventory data. EPA plans the next regular update of the Inventory for winter 2022. According to EPA, the Inventory contains 86,607 chemicals of which 41,953 are active in U.S commerce. Other updates to the TSCA Inventory include new chemical substance additions, commercial activity data and regulatory flags, such as polymer exemptions, TSCA Section 4 test orders, and TSCA Section 5 significant new use rules (SNUR). In April 2021, EPA released a list of 390 chemicals expected to lose their confidential status and move to the public portion of the Inventory. EPA states that it continues to work on final declassifications for these chemicals and plans to include them in the next public posting of the TSCA Inventory.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on June 10, 2021, three actions intended to protect communities from per- and polyfluoroalkyl substances (PFAS). The actions include proposing a rule designed to obtain comprehensive data on more than 1,000 PFAS manufactured in the United States, withdrawing guidance that EPA believes weakened its July 2020 significant new use rule (SNUR) restricting certain long-chain PFAS, and publishing a final rule that incorporates three additional PFAS into the Toxics Release Inventory (TRI) maintained under the Emergency Planning and Community Right-to-Know Act (EPCRA). Below is a brief summary of the actions. More detailed information and an insightful commentary are available in our forthcoming memorandum that will be posted on our website.

Proposed TSCA Rule to Require Reporting on PFAS Manufactured in the United States

The fiscal year 2020 (FY2020) National Defense Authorization Act (NDAA) amended the Toxic Substances Control Act (TSCA) to add Section 8(a)(7), mandating that EPA promulgate a rule “requiring each person who has manufactured a chemical substance that is a [PFAS] in any year since January 1, 2011” to report certain information. EPA’s proposed rule would require all manufacturers (including importers) of PFAS in any year since 2011 to report information related to chemical identity, categories of use, volumes manufactured and processed, byproducts, environmental and health effects, worker exposure, and disposal. EPA states that the proposed rule will help it better understand the sources and quantities of PFAS manufactured in the United States and support its research, monitoring, and regulatory efforts. Publication of the proposed rule in the Federal Register will begin a 60-day comment period.

Withdrawing Compliance Guide on PFAS SNUR

In accordance with the Biden-Harris Administration’s Executive Orders and other directives, including those on environmental justice, scientific integrity, and regulatory review, EPA states that it has withdrawn a compliance guide that EPA believes weakened the July 27, 2020, final SNUR for long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate chemical substances (85 Fed. Reg. 45109). The final rule prohibits companies from importing certain long-chain PFAS as part of a “surface coating” on articles without prior EPA review and approval. EPA states that examples of articles that could contain these PFAS as part of a surface coating include, but are not limited to, automotive parts, carpet, furniture, and electronic components.

As reported in our January 20, 2021, blog item, EPA issued the compliance guide in January 2021 in the last days of the previous Administration and limited what would be considered a “surface coating” subject to the SNUR. EPA states that “[t]he guide was never deemed necessary by career staff and its development was directed by political officials serving in the last Administration.” Additionally, EPA prepared the final guide without considering or addressing comments submitted by the public. After further review, EPA “determined that the guide inappropriately narrowed the scope and weakened the prohibitions included in the SNUR.”

Implementing NDAA Requirements to Report PFAS to TRI

The NDAA provided a framework for additional PFAS to be added to TRI on an annual basis. For TRI Reporting Year 2021 (reporting forms due by July 1, 2022), the NDAA automatically added three PFAS to the TRI list because they are now subject to a SNUR under TSCA. EPA issued a final rule on June 3, 2021, incorporating these requirements into the Code of Federal Regulations for TRI (86 Fed. Reg. 29698). Per the NDAA requirements, the PFAS additions became effective as of January 1, 2021. Reporting forms for these PFAS will be due to EPA by July 1, 2022, for calendar year 2021 data.

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By Lynn L. Bergeson and Carla N. Hutton
 
On May 21, 2021, the U.S. Environmental Protection Agency (EPA) published its response to a portion of the petition it received February 8, 2021, from People for Protecting Peace River, Center for Biological Diversity, and 16 other organizations. 86 Fed. Reg. 27546. While the petition requested three actions related to the Toxic Substances Control Act (TSCA), EPA states that it has determined that only one of those actions is an appropriate request: a request to issue a test rule under TSCA requiring testing of phosphogypsum and process wastewater from phosphoric acid production. According to the notice, EPA is treating the other portions of the petition involving TSCA as a petition under the Administrative Procedure Act (APA); those other portions request EPA to initiate the prioritization process for designating phosphogypsum and process wastewater as high-priority substances for risk evaluation and to make a determination by rule under TSCA that the use of phosphogypsum in road construction is a significant new use. Therefore, the notice does not provide EPA’s response to these two TSCA-requested actions. Also, it does not address the petitioners’ requests under the Resource Conservation and Recovery Act (RCRA). EPA states that “[a]fter careful consideration,” it has denied the TSCA Section 21 portion of the petition for the following reasons:

• Request for prioritization under TSCA Section 6 and related testing under TSCA Section 4(a)(2)(B): Because TSCA Section 21 does not provide an avenue for petitioners to request the initiation of the prioritization process for phosphogypsum and process wastewater, EPA is treating this portion of the request as a petition for action under the APA. Petitioners assert that “should EPA initiate prioritization but find that the development of new information is necessary to finalize a prioritization decision for phosphogypsum and process wastewater, EPA should exercise its authority under section 4(a)(2)(B) to obtain that information and establish priority.” EPA states that because it is not addressing the request for prioritization and has not otherwise initiated prioritization on phosphogypsum or process wastewater, it is not in a position to exercise its authority under TSCA Section 4(a)(2)(B) in the manner and for the reason described by petitioners.
• Request for significant new use rule (SNUR) under TSCA Section 5: TSCA Section 21 does not provide for the submission of a petition seeking the initiation of a rule under TSCA Section 5. EPA states that SNURs are issued under the authority of TSCA Section 5(a)(2). Since TSCA Section 21 does not provide an avenue for petitioners to request the initiation of a proceeding to make a determination by rule under TSCA Section 5(a), EPA is treating this portion of the request as a petition for action under the APA.
• Request for issuance of a test rule under TSCA Section 4(a)(1)(A): According to the notice, TSCA Section 21 does provide for the submission of a petition seeking issuance of a test rule under TSCA Section 4(a)(1)(A). EPA states that it finds that the petitioners have not met their burden as defined in TSCA Sections 4(a)(1)(A) and 21(b)(1) because the petitioners have not provided the facts necessary to determine for phosphogypsum and process wastewater that existing information and experience are insufficient and testing with respect to such effects is necessary to develop such information.

More information about the petition is available in our March 12, 2021, memorandum, “EPA Receives Petition Seeking RCRA and TSCA Regulatory Action for Phosphogypsum and Process Wastewater.”

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By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on March 29, 2021, that it is evaluating its policies, guidance, templates, and regulations under the Toxic Substances Control Act (TSCA) new chemicals program to ensure they “adhere to statutory requirements,” the Biden-Harris Administration’s executive orders, and other directives.  EPA identified several instances where its approach for making determinations and managing risks associated with new chemicals can, according to EPA, more closely align with TSCA’s requirements to ensure protections for human health and the environment, including the use of significant new use rules (SNUR) and assumptions related to worker exposures.  EPA states that it will stop issuing determinations of “not likely to present an unreasonable risk” based on the existence of proposed SNURs.  According to EPA, “[r]ather than excluding reasonably foreseen conditions of use from EPA’s review of a new substance by means of a SNUR, Congress anticipated that EPA would review all conditions of use when making determinations on new chemicals and, where appropriate, issue orders to address potential risks.”  Going forward, when EPA concludes that one or more uses may present an unreasonable risk, or when EPA believes that it lacks the information needed to make a safety finding, EPA will issue an order to address those potential risks.

EPA states that as has been the “long-standing practice,” it intends to continue issuing SNURs following TSCA Section 5(e) and 5(f) orders for new chemicals to ensure the requirements imposed on the submitter via an order apply to any person who manufactures or processes the chemical in the future.  EPA notes that this ensures that other manufacturers of the same new chemical substance are held to the same conditions as the submitter subject to the TSCA Section 5(e) or 5(f) order.

EPA states that it now intends to ensure necessary protections for workers identified in its review of new chemicals through regulatory means.  According to the announcement, where EPA identifies a potential unreasonable risk to workers that could be addressed with appropriate personal protective equipment (PPE) and hazard communication, EPA will no longer assume that workers are protected adequately under the Occupational Safety and Health Administration’s (OSHA) worker protection standards and updated safety data sheets (SDS).  Instead, EPA will identify the absence of worker safeguards as “reasonably foreseen” conditions of use, and mandate necessary protections through a TSCA Section 5(e) order, as appropriate.

Commentary

The first policy change -- that the Office of Pollution Prevention and Toxics (OPPT) will no longer employ the “non-order SNUR” construction to regulate new chemicals without an order -- was somewhat predictable.  This construction, since its inception, has led to questions about whether this interpretation meets the requirements under TSCA Section 5.  In our view, EPA issuing a SNUR to prohibit conditions of use that EPA identifies as potentially leading to an unreasonable risk was an appropriate and expeditious means to achieve the protective end (the TSCA regulation) without the inefficiency and delays associated with the development of a consent order.  EPA would only use this option when EPA concluded the intended conditions of use were not likely to present an unreasonable risk.  It is not clear why a SNUR is viewed as being less protective than an order, when an order applies only to the premanufacture notice (PMN) submitter and a SNUR applies to all actors in the supply chain.  EPA is required to promulgate a SNUR that conforms to an order absent a reason otherwise.  The claim that undertaking a condition of use that is defined in a SNUR as a significant new use “requires only notification to EPA” misrepresents the rigor of the significant new use notice (SNUN) process.  A SNUN functions just like a PMN, with a similar level of effort required on the submitter’s and EPA’s parts and nearly identical determination outcomes (a consent order, modification of the existing SNUR, or revocation of the existing SNUR if warranted), so saying that a SNUN is “just a notification to EPA” is the equivalent of stating that a PMN is “just a notification to EPA.”  Detractors might also claim that orders include testing, but that presumes that testing is required for EPA to make an informed decision.  If EPA can, as it routinely does, make a decision based on conservative assumptions with analogs, models, and information provided by the submitter, EPA can similarly make an informed decision about what measures are necessary to achieve its protective goal without new test data.  In Bergeson & Campbell, P.C.’s (B&C^®) view, this policy change will add marginal, if any, protective benefit at a significant increase in effort by both EPA and the submitter.

EPA’s decision that it no longer views use of PPE as reasonably foreseeable is an unwelcome and unprincipled development.  B&C, on behalf of the TSCA New Chemicals Coalition (NCC), provided, at OPPT’s request, a robust data set that demonstrated that proper PPE is rarely not used in an industrial/commercial setting.  A database of 40 years of OSHA violations contained very few glove, goggle, and general dermal protection violations -- all obvious violations to any inspector.  The marginal number of OSHA violations supports the NCC’s view that standard PPE use is both reasonably foreseeable and highly likely and demonstrably so.  Today’s unexplained reversal is difficult to reconcile with these facts.  If EPA proceeds to issue orders for every PMN that may present a risk if workers do not take routine protective measures, then EPA will be required to regulate nearly every PMN in which EPA identifies a hazard other than “low hazard” for health and ecotoxicity, as was EPA’s practice when the Lautenberg amendments were passed in 2016.  As we have stated previously, that would mean that EPA will be implementing TSCA as a hazard-based law, instead of the clear risk-based law that it is.

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