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.

• Email This
• Print

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.

• Email This
• Print

Bergeson & Campbell, P.C. (B&C^®) is pleased to announce the release of the complete suite of TSCA Tutor™ regulatory training courses online and on-demand at www.TSCAtutor.com.  Professionals seeking expert, efficient, essential training can preview and enroll in on-demand classes to complete at their own pace and timing.  In addition to the newly released online e-learning courses, B&C’s TSCA Tutor™ training platform offers live in-person training at a company’s site and customized live webinar training, so companies can mix and match training modules and training approaches to provide the most suitable combination for their work needs.
 
Toxic Substances Control Act (TSCA) awareness is a critically important element in the 21st century work environment for any business that involves industrial chemicals.  The new normal requires awareness of TSCA’s application to a company’s operations to ensure consistent compliance with TSCA regulations and, importantly, to understand and anticipate how the U.S. Environmental Protection Agency’s (EPA) ongoing implementation of new TSCA will impact a company’s industrial chemical selection and use processes.
 
TSCA Tutor™ online training courses include:

• Video lessons.
• Detailed hand-out materials, including copies of all presentations and relevant course materials from EPA and other sources.
• Customizable, yet detailed and ready-to-use Standard Operating Procedures (SOP) for the regulatory topic covered in the session.

ONE-HOUR SESSIONS:

• An Overview of TSCA (Course number T101)
• New TSCA at a Glance (Course number T102)
• Import Requirements, TSCA Section 13 (Course number T103)
• Export Requirements, TSCA Section 12 (Course number T104)
• Confidential Business Information (CBI) (Course number T105)
• Reporting and Retention of Information, TSCA Section 8 (Course number T106)

TWO-HOUR SESSIONS:

• Inspections and Audits (Course number T201)
  • Preparing for a TSCA Audit
  • TSCA Penalties/Overview of Self-Confession Policy
• TSCA Section 5, Part 1:  TSCA Chemical Inventory, Exemptions (Course number T202)
  • TSCA Inventory
  • Exemptions
• TSCA Section 5, Part 2:  New Chemicals/New Use (Course number T203)
  • New Chemicals/New Use
  • SNURs
• Chemical Data Reporting (CDR) (Course number T204)
  • CDR Overview
  • Byproduct Reporting under CDR
• Chemical Testing (Regulatory)/Animal Welfare, TSCA Section 4 (Course number T205):
  • Chemical Testing
  • How to Prepare/Engage If a Chemical of Interest Is Listed under TSCA Section 4
• Prioritization and Risk Evaluation, TSCA Section 6 (Course number T206)
  • Overview of Section 6 Risk Framework -- Prioritization, Evaluation, and Management
  • How to Prepare/Engage If a Chemical of Interest Is Listed under Section 6

Bergeson & Campbell, P.C. is a Washington, D.C., law firm focusing on conventional, biobased, and nanoscale industrial, agricultural, and specialty chemical product approval and regulation, and associated business issues.  B&C represents clients in many businesses, including basic, specialty, and agricultural and antimicrobial chemicals; biotechnology, nanotechnology, and emerging transformative technologies; paints and coatings; plastic products; and chemical manufacturing, formulation, distribution, and consumer product sectors.  Visit www.lawbc.com for more information.

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton

On August 20, 2019, the U.S. Environmental Protection Agency (EPA) published in the Federal Register final significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 145 chemical substances that are the subject of premanufacture notices (PMN).  84 Fed. Reg. 43266.  According to EPA, the chemical substances are subject to orders issued by EPA pursuant to TSCA Section 5(e).  The final SNURs require persons who intend to manufacture (defined by statute to include import) or process any of the 145 chemical substances for an activity that is designated as a significant new use by the 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.  The final SNURs will take effect October 21, 2019.

EPA notes that the final SNURs may also affect certain entities through pre-existing import certification and export notification rules under TSCA.  Chemical importers are subject to TSCA Section 13 import certification requirements.  Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA.  Importers of chemicals subject to the SNURs must certify their compliance with the SNUR requirements. Any persons who export or intend to export a chemical substance that is the subject of the SNURs on or after September 19, 2019, are subject to the export notification provisions of TSCA Section 12(b) and must comply with export notification requirements.

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
Section 5(g) of the Toxic Substances Control Act (TSCA) requires the U.S. Environmental Protection Agency (EPA) to publish a statement of its findings after its review of TSCA Section 5(a) notices when EPA makes a finding that a new chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment.  On August 12, 2019, EPA published a statement of its findings for June 2019.  84 Fed. Reg. 39828.  EPA notes that such statements apply to premanufacture notices (PMN), microbial commercial activity notices (MCAN), and significant new use notices (SNUN) submitted to EPA under TSCA Section 5.  In the Federal Register notice, EPA provides the following information (to the extent that such information is not claimed as confidential business information (CBI)) on the PMNs, MCANs, and SNUNs for which, during this period, EPA has made findings under TSCA Section 5(a)(3)(C) that the new chemical substances or significant new uses are not likely to present an unreasonable risk of injury to health or the environment:  EPA case number assigned to the TSCA Section 5(a) notice; chemical identity (generic name, if the specific name is claimed as CBI); and website link to EPA’s decision document describing the basis of the “not likely to present an unreasonable risk” finding made by EPA under TSCA Section 5(a)(3)(C). 

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on August 1, 2019, that it is making additional information about new chemical notices available on its website.  The new web page, “Statistics for the New Chemicals Review Program under TSCA,” allows users to view and search monthly updates for any active Premanufacture Notice (PMN), Significant New Use Notice (SNUN) and Microbial Commercial Activity Notice (MCAN) of interest by case number.  Users can also download a spreadsheet with a list of all active cases and each case’s status.  More information and commentary is available in our August 5, 2019, memorandum, "EPA Improves Transparency for New Chemicals Review Program under TSCA."

• Email This
• Print

Bergeson & Campbell, P.C. (B&C^®) is pleased to present the complimentary webinar “New TSCA at 3: Key Implementation Issues.” The webinar will drill down on key implementation challenges facing industry and the U.S. Environmental Protection Agency (EPA) three years into navigating the legal, regulatory, and science policy issues arising under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). Alexandra Dapolito Dunn, Assistant Administrator, EPA Office of Chemical Safety and Pollution Prevention (OCSPP); Lynn L. Bergeson, Managing Partner, B&C; and Richard E. Engler, Ph.D., Director of Chemistry, B&C, will present. Register online now.

• Email This
• Print

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

On April 5, 2019, the U.S. Environmental Protection Agency (EPA) issued a final rule that will establish final significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 13 chemical substances that are the subject of premanufacture notices (PMN).  84 Fed. Reg. 13531. The final rule is significant because the 13 chemical substances are not also subject to consent orders.  During the review, EPA identified certain reasonably foreseen conditions of use that it designated as significant new uses in the final SNURs.  The final SNURs effectively prohibit the designated new use unless a person submits a notice to EPA, EPA makes a determination, and it takes any necessary action to mitigate any identified potential risk.  The final rule will become effective on June 4, 2019.  Please see our full memorandum for more information on this final rule.

• Email This
• Print

By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Margaret R. Graham

On February 1, 2019, Lynn Vendinello, Acting Director, Chemical Control Division, of the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) signed the pre-publication version of a notice announcing that, due to the recent lapse of appropriations and the Agency shutdown, EPA is extending the review periods for all Toxic Substances Control Act (TSCA) Section 5 Premanufacture Notices (PMN), Significant New Use Notices (SNUN), Microbial Commercial Activity Notices (MCAN), and exemption notices that were submitted to the Agency under TSCA Section 5 before December 29, 2018, and for which the review period had not expired as of December 29, 2018.  

Due to a lack of authorized funding, from December 29, 2018, until EPA operations for the TSCA New Chemicals operations fully resumed on January 31, 2019, certain EPA functions were suspended including the processing of submissions made through the Central Data Exchange (CDX), e-PMN, or other methods.  Further, no review work was performed on the TSCA section 5 notifications received by EPA on or before December 29, 2018, and for which the review period had not yet expired as of December 29, 2018.  Consequently, the review period for any TSCA Section 5 notice submitted during the shutdown did not begin until TSCA New Chemical operations fully resumed on January 31, 2019.

EPA states that the duration of the extension period will be a total of 33 days, which is equivalent to the duration of the time period from December 29, 2018 (the date on which certain EPA operations shutdown) and the date on which EPA operations for the TSCA New Chemicals Program fully resumed (January 31, 2019).  The notice states that EPA requires an extension of the review periods to complete its risk assessments, to examine its regulatory options, and to prepare the necessary documents associated with the relevant determination under TSCA Section 5(a)(3).  

• Email This
• Print

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

The U.S. Environmental Protection Agency (EPA) issued on October 16, 2018, a proposed rule that would establish significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 13 chemical substances that are the subject of premanufacture notices (PMN).  83 Fed. Reg. 52179.  The proposed rule is significant.  Unlike other recent SNURs (i.e., those enacted since entry into force of amended TSCA), the 13 chemical substances are not also subject to consent orders.  For this reason, the preamble contains novel language to address the new circumstances and legal issues encountered in the proposed rule.  The proposed SNURs would require persons who intend to manufacture (defined by statute to include import) or process any of the 13 chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity.  The required notification will initiate EPA’s evaluation of the intended use within the applicable review period.  Persons may not commence the 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 has taken such actions as are required with that determination.  Comments on the proposed SNURs are due November 15, 2018.

Please see the full memorandum for more information on the proposed rule and an illuminating commentary.

• Email This
• Print