Fifth Circuit TSCA Ruling: Established Process Not a “New Use”

A decades-old manufacturing process cannot constitute a significant new use under TSCA, the US Court of Appeals for the Fifth Circuit ruled on March 21, 2024, in the case Inhance Techs. v. EPA.

Inhance Technologies LLC (“Inhance”) has strengthened plastic containers using the same fluorination process since 1983.  Unbeknownst to Inhance and EPA until March 2022, the fluorination process resulted in the creation of multiple PFAS chemicals that were included in a significant new use rule (SNUR) for long-chain perfluoroalkyl carboxylate substances, which took effect in September 2020.

When EPA detected PFAS in a container manufactured by Inhance, it issued the Texas-based company a notice of violation of the SNUR because Inhance had not filed significant new use notices (SNUNs) for the PFAS created during the fluorination process.  EPA instructed Inhance to stop or change the fluorination process so that it no longer created PFAS.  Inhance filed two SNUNs in December 2022 but continued fluorinating plastic containers using the same process.  Following review of the SNUNs, in December 2023, EPA issued two orders under TSCA sections 5(e) and 5(f) prohibiting Inhance from manufacturing or processing PFAS through their fluorination process.  In response, Inhance successfully petitioned the Fifth Circuit for expedited review and a stay pending appeal, stating that the company would be forced to shut down if the orders were put into effect.

Inhance argued that EPA’s orders were unlawful for three reasons.  First, Inhance argued that its fluorination technology could not be understood as a “new” use under TSCA because it had been ongoing for over thirty years before EPA finalized the SNUR.  Second, Inhance argued that the PFAS created during the fluorination process constituted impurities, which are exempted from the scope of the SNUR.  Finally, Inhance argued that EPA’s interpretation of the SNUR as applying to all industries is a “reinterpretation” for which Inhance had not received fair notice.

In the end, the court did not address Inhance’s second and third points, finding the first argument sufficient to vacate EPA’s orders.  Though the statute does not define “new,” the court found Inhance’s interpretation, “not previously existing,” more compelling than EPA’s interpretation, “not previously known to the EPA,” for multiple reasons.  But ultimately, the court just did not think EPA’s interpretation was sensible, stating that it “lacks intuitive force.”  Inhance could not have been expected to submit its fluorination process as an ongoing use during the rulemaking process for the SNUR because it did not know that it created PFAS at that time, the court said.

Writing on behalf of the three-judge panel, Judge Cory T. Wilson concluded by stating that EPA is not powerless to regulate Inhance’s fluorination process.  TSCA section 6 allows for regulation of all chemical substances, unlike section 5, which only applies to new substances and significant new uses.  However, unlike section 5 rulemaking, section 6 requires EPA to conduct a cost-benefit analysis, which takes into account the substance’s benefits and economic considerations.  The court stressed that this requirement indicates that Congress wanted EPA to give more thoughtful consideration to the impact of its regulations on preexisting manufacturing processes.

Judge Wilson was joined by Chief Judge Priscilla Richman and Judge James E. Graves Jr., who concurred in the judgment only.

EPA Issues SNUR to Keep Inactive PFAS Out of Commerce

Inactive PFAS chemicals can no longer reenter commerce without EPA approval under a final significant new use rule (SNUR) issued by EPA on January 11, 2024.

The 329 PFAS subject to the SNUR are currently designated as inactive on the Toxic Substances Control Act (TSCA) Inventory and are not subject to an existing SNUR.  (An inactive designation indicates that a substance has not been manufactured, imported, or processed since 2006, with a handful of exceptions addressed below.)  To identify these chemicals, EPA applied the same definition of PFAS the Agency used in its TSCA section 8(a)(7) PFAS reporting rule issued in October 2023, discussed in a previous Verdant Law blog post.

The SNUR requires companies to notify EPA via a significant new use notification at least 90 days before commencing the manufacture, import, or processing of any of these substances.  Upon receiving notification, EPA will assess whether the new use may present an unreasonable risk to human health or the environment and take appropriate action, if necessary, as required under TSCA section 5.

Import and processing of inactive PFAS-containing articles are exempt from the SNUR.  Covered PFAS also fall outside the scope of the SNUR when they are manufactured, imported, or processed:

  • As impurities;
  • As byproducts not for commercial use purposes;
  • In small quantities solely for R&D;
  • For test marketing purposes;
  • For use as a non-isolated intermediate; or
  • Solely for export from the United States.

To establish a significant new use, EPA must determine that the use is not ongoing.  Because the above uses do not result in an active designation on the TSCA Inventory, EPA could not conclude that there are no ongoing uses for these activities.

EPA Proposes SNURs for Flame Retardants

EPA has proposed significant new use rules (SNURs) for three flame retardants under the Toxic Substances Control Act (TSCA). The three flame retardants are tris(2-chloroethyl) phosphate (TCEP), tetrabromobisphenol A (TBBPA), and triphenyl phosphate (TPP).  All three substances are currently undergoing TSCA risk evaluations.  The proposed significant new uses are manufacture (including import) or processing for any use, except for those uses being considered in the risk evaluations.  In the Federal Register notice, EPA explained that significant new uses would encompass the following categories:

  • Manufacture and processing for uses that have ceased;
  • Manufacture and processing for uses that have not yet ceased but for which all manufacture and processing has ceased; and
  • Manufacture and processing for uses for which EPA has no information demonstrating that the use has previously commenced in the United States.

The Agency sought public comment on its description of the significant new uses for the chemicals identified, including specific documentation of ongoing uses not identified by the Agency in the risk evaluation scope documents.

EPA noted that “The issuance of a SNUR is not a risk determination itself, only a notification requirement for ‘‘significant new uses,’’ so that the Agency has the opportunity to review the [Significant New Use Notification] for the significant new use and make a TSCA section 5(a)(3) risk determination.”  In other words, “Once EPA receives a SNUN, EPA must either determine that the significant new use is not likely to present an unreasonable risk of injury or take such regulatory action as is associated with an alternative determination under TSCA section 5 before the manufacture (including import) or processing for the significant new use can commence.”

In its discussion of the significant new use determination, EPA explained that the Agency considered information about the toxicity or expected toxicity of these substances, likely human exposures and environmental releases associated with possible uses, and the four factors listed in TSCA section 5(a)(2):

  • The projected volume of manufacturing and processing of a chemical substance,
  • The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance,
  • The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance and
  • The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

According to the Federal Register Notice, current uses of TCEP are as follows:  TCEP is imported into the United States and processed for commercial use in paints and coatings, for industrial or commercial use in polymers for use in aerospace equipment and products, and for commercial use as a laboratory chemical.

EPA found that TBBPA is currently manufactured (including imported) in the United States. It is processed as a reactant or intermediate to create other flame retardants; incorporated into formulation, mixture, or reaction products; and incorporated into articles. The Agency noted that the predominant uses for TBBPA are as a reactive flame retardant in electrical and electronic products and as an additive flame retardant in electrical and electronic products. In addition, epoxy resin containing TBBPA can be used in adhesives, laminate for aviation and automobile interiors and building/ construction materials.

The Agency reported that TPP is manufactured (including imported) in the United States.  It is processed as a reactant; incorporated into formulation, mixture, or reaction products; and incorporated into articles.  Commercial uses include in plastic and rubber products and in paints and coatings. The chemical is also used in lubricants and greases.  In addition, consumer uses were reported in foam seating and bedding products.

Comments can be viewed in docket EPA–HQ–OPPT–2023–0012 at regulations.gov.

EPA proposes updates to SNUR regulations on workplace protection and hazard communication.

On July 28, EPA published a proposed rule updating the Significant New Use Rule (SNUR) regulations, which implement section 5(a)(2) of the Toxic Substances Control Act (TSCA). In announcing the proposal, EPA emphasized the need to harmonize regulations based on Occupational Safety and Health Administration (OSHA) standards for respiratory protection and hazard communication, which have both been updated since the SNUR regulations were last revised in 1989.

The proposed rule also contains several other changes meant to address “issues identified through EPA’s experience issuing and administering SNURs,” including changes to the bona fide intent to manufacture procedure. Additional, minor changes include correcting typographical errors, updating “material safety data sheet” or “MSDS” to “safety data sheet” or “SDS,” and revising language to “more accurately use the terms manufacture, manufacturer, and manufacturing.”

Notably, many of the proposed changes to the SNUR regulations will affect previously-issued SNURs.

EPA notes that, due to regulatory updates from both the National Institute for Occupational Safety and Health (NIOSH) and OSHA, the current regulatory language for protection in the workplace, concerning respiratory protection, is inconsistent with NIOSH and OSHA requirements. Thus, EPA proposes to replace outdated references to old OSHA standards with the current NIOSH regulations on the certification and testing of respirators, as well as adding specific types of NIOSH-certified respirators to the list of approved respirators. According to the proposed rule, companies subject to previously-issued SNURs containing respirator requirements can either follow the updated requirements or continue using the older respirators, if they are still available, without triggering a Significant New Use Notification (SNUN) requirement.

EPA also proposes to modify a subsection on airborne forms of chemicals by adding “particulate or aerosol,” “gas/vapor,” and combinations thereof.

The proposed rule further revises the workplace protection section by inserting the requirement that a hierarchy of controls – such as enclosure of operations, ventilation, and workplace policies and procedures – must be “considered and implemented to prevent exposure, where feasible” before using personal protective equipment (PPE) for worker protection. This change is reportedly in response to previous comments criticizing “EPA’s approach of exclusively identifying the absence of adequate personal protective equipment as a significant new use” as out of step with best practices in industrial hygiene. EPA notes that the new language has been incorporated in all new chemical SNURs issued since June 26, 2013 and is consistent with OSHA requirements.

The agency’s proposed updates on hazard communication are based on OSHA’s updates to its Hazard Communication Standard (HCS), which was itself modified, in 2012, to conform to the United Nations’ Globally Harmonized System of Classification and Labelling of Chemicals (GHS). EPA also proposes adding a new requirement which could be used in new SNURs for a written hazard communication program in each workplace in accordance with the OSHA HCS. Another proposed addition provides specific statements and warnings that could be required under a SNUR and “would be based on EPA’s risk assessment of the chemical substance and would be consistent with the OSHA HCS and GHS recommendations.”

In addition to the changes to the workplace protection and hazard communication revisions, EPA proposes various other modifications, including:

  • Bona fide procedure: Currently, when EPA issues a SNUR in which the chemical identity is withheld as confidential business information (CBI), manufacturers and processors may submit information to EPA to “determine whether their substance is subject to the SNUR.” EPA now proposes to amend the process to apply to other kinds of CBI, such as production volume limits, so EPA may inform bona fide submitters whether and how the SNUR applies to them, including any confidential significant new use designations.
  • Notice submission requirements: EPA proposes that notification submissions such as premanufacture notifications or low volume exemptions, among others, must include any SDS that has already been developed for the relevant chemical.

EPA has specifically requested comments on the following issues:

  • the use of “next generation” respirators;
  • the incorporation of the hierarchy of controls approach to worker protection in the SNUR requirements; and
  • “any suggested methods for minimizing respondent burden, including revisions to the automated collection techniques being used for submissions to EPA under TSCA, …the Agency’s Central Data Exchange (CDX) portal.”

The deadline for comments on the proposed rule is September 26, 2016.

EPA issues final Significant New Use Rule for HBCD in textiles.

EPA has released the prepublication version [PDF] of its final Significant New Use Rule (SNUR) for the brominated flame retardants hexabromocyclododecane or 1,2,5,6,9,10-hexabromocyclododecane (HBCD). HBCD is persistent, bioaccumulative, toxic, and poses potential human health concerns, including reproductive and developmental effects. This Final Rule designates the use of HBCD in consumer textiles as a significant new use which must be reported to EPA at least 90 days in advance. Under this SNUR, consumer textiles include “bolts of cloth and draperies, as well as textiles that are part of household furniture and mattresses.” The Rule does not apply to the use of HBCD in motor vehicles or other current uses, such as non-consumer textiles, like firefighters’ suits, and building insulation.

The SNUR partially revokes the usual articles exemption, 40 CFR 721.45(f), meaning that the rule’s notification requirements apply to importers and processors of HBCD as part of a “textile article,” like an upholstered chair. Notably, the SNUR applies to all importers and processors of HBCD as part of a textile article, regardless of whether it is a “consumer textile.” EPA’s rationale is that “if the inapplicability of the exemption was limited to consumer textiles, undifferentiated textiles (e.g., the type of textiles that could be for a consumer use or a non-consumer use), could be imported or processed and distributed in commerce for consumer use without notification to the Agency.”

The SNUR subjects exporters of HBCD in consumer textiles to the export notification requirements of Section 12(b) of the Toxic Substances Control Act (TSCA). However, EPA declined to require § 13 import certification for HBCD as part of articles.

EPA has made two changes to this SNUR since it was first proposed in 2012. First, the agency narrowed the inapplicability of the articles exemption to apply only to importers and processors of HBCD as part of a textile article. Thus, importers and processors of HBCD in non-textile articles are not subject to the SNUR. In addition, EPA made minor clarifying changes to its definition of “consumer textile,” which is now defined as follows:

Consumer textile means any cloth, fabric, or other item produced during a milling process for textiles (including spinning, weaving, knitting, felting, or finishing), that is sold or made available either as a product or as part of a product, to a private individual who uses it in or around a permanent or temporary household or residence, during recreation, or for any personal use or enjoyment. Consumer textiles can include, but are not limited to, bolts of cloth and draperies, as well as textiles that are part of upholstered household furniture and mattresses.

EPA also rejected commenters’ requests to establish a “policy framework by rule for the issuance of article SNURs.” The agency responded that a policy framework was not necessary to reach the conclusion that notification should be required for importing or processing HBCD in consumer textiles.

HBCD has recently been subject to significant scrutiny by EPA and others. Last month, EPA issued initial documents for its TSCA Work Plan risk assessment of HBCD in foam and polystyrene products. In 2014, EPA’s Design for Environment (DfE) program released an Alternatives Assessment for HBCD, identifying safer alternatives in foam insulation applications. The Consumer Product Safety Commission (CPSC) has been petitioned by a coalition of environmental, health, and consumer advocates to ban certain products containing HBCD and related flame retardants. Outside the U.S., HBCD was added as a prohibited substance to the Stockholm Convention on Persistent Organic Pollutants and is being withdrawn in Europe under REACH.

 

Comments period extended for proposed perfluorinated chemicals SNUR.

EPA is extending the comment period for its proposed Significant New Use Rule (SNUR) for long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate (PFAS) chemical substances. The proposed SNUR, which was first released in January, designates as significant new uses the manufacturing or processing of certain LCPFACs for any use not ongoing after 2015, and any other LCPFACs for which there are currently no ongoing uses. The proposed SNUR also makes inapplicable the exemption for importing articles containing LCPFACs and carpets containing PFAS. EPA is extending the comment period because the agency received “several comments asserting that there may be significant implications for the supply chain.”

The comment period originally ran until March 23, 2015, but is now extended until June 26, 2015. The Federal Register notice of the extension is scheduled to be published on March 16, but is currently available in pre-publication form [PDF].

EPA promulgates Significant New Use Rules for 27 PMN substances.

In yesterday’s Federal Register, the EPA published Significant New Use Rules (SNUR) under the Toxic Substances Control Act (TSCA) for 27 substances that were already the subject of Premanufacture Notices (PMNs). Two of the substances – Phosphoric acid, iron (2+) lithium salt (1:1:1) and Polymer of terephthalic acid and ethyl benzene with multi-walled carbon nanotube (generic) – are also subject to “risk-based” consent orders under TSCA section 5(e), requiring protective measures to limit exposures or otherwise mitigate the potential unreasonable risk to human health and the environment presented by the substances. For these substances, the SNURs designate the absence of those protective measures as a “significant new use.”

Under all of the SNURs, EPA must be notified at least 90 days before beginning to manufacture or process the specified chemicals in a “significant new use.” For the chemicals not subject to § 5(e) consent orders, any use deviating from the use scenario reported in the corresponding PMN is designated as a “significant new use.” Specific requirements for each chemical are specified in the regulatory text.

The SNUR was promulgated by Direct Final Rule, and will go into effect on April 3, 2015, unless adverse comments are submitted by March 4.

Industry opposes proposed rule on nonylphenols and nonylphenol ethoxylates.

Companies and trade groups representing industries ranging from automakers to cleaning products have pushed back against an EPA proposal that would restrict certain chemicals widely used in industrial applications and consumer products such as detergents, cosmetics, paints, and sealants. As Bloomberg BNA reports, industry commenters argue that their ongoing uses of the chemicals preclude EPA from issuing the proposed rule. The commenters also criticize EPA’s nomenclature convention, which they contend is not generally used or understood, as well as EPA’s reliance on Chemical Data Reporting Rule (CDR) results as a basis for the rulemaking.

In late September, we wrote that EPA released its proposed Significant New Use Rule (SNUR), under the Toxic Substances Control Act (TSCA), for nonylphenols (NPs) and nonyphenol ethoxylates (NPEs). EPA later extended the comments period for the proposed rule by 45 days, to January 15, 2015.

The proposed SNUR identifies by CAS number 13 “linear NPs and NPEs” for which any use is a significant new use, as well as two branched NPs, for which any use besides “as an intermediate or use as an epoxy cure catalyst” is a significant new use. However, commenters argue that “the global industry practice is to use CAS names” without distinguishing between “branched” or “linear” forms. The American Chemistry Council contends that EPA has not provided sufficient explanation and guidance on its “poorly-understood” naming convention regarding whether an alkyl chain is linear or branched.

Many commenters were highly critical of EPA’s method of evaluating whether the CAS numbers listed in the proposed SNUR were in commerce, stating that many were identified in ongoing uses and included in a variety of public databases. Various commenters also criticized EPA for using the proposed SNUR as a method of collecting use information.

Other comments reported specific ongoing uses of certain chemical substances by Chemical Abstract Service (CAS) Number.

The San Francisco Bay Regional Water Quality Control Board also weighed in to request that EPA not exempt articles from this SNUR, particularly toilet paper, which “has the potential to be a major source of pollution for aquatic resources receiving treated or untreated wastewater discharges.”

EPA proposes new SNUR for perfluorinated chemicals, again eliminates articles exemption.

EPA has proposed another Significant New Use Rule (SNUR) under the Toxic Substances Control Act (TSCA) for long-chain perfluoroalkyl carboxylate (LCPFAC) chemical substances, including perfluorooctanoic acid (PFOA) and its salts. Under the proposal, significant new uses that would require filing a 90-day notice with EPA include: manufacturing, importing, or processing “an identified subset of LCPFAC chemical substances for any use that will not be ongoing after December 31, 2015, and all other LCPFAC chemicals substances for which there are currently no ongoing uses.” In addition, EPA is continuing its trend in making the articles exemption inapplicable for these substances when imported as part of an article.

In the same proposed rule, EPA also proposes amending a SNUR for perfluorylalkyl sulfonate (PFAS) substances to make the articles exemption inapplicable for importing PFAS substances as part of carpets.

The affected chemicals are used in a variety of industrial applications and consumer goods, including cleaners, textiles, paper and paints, fire-fighting foams, and wire insulation. Their risks to human health and the environment include toxicity, persistence in the environment, and bioaccumulation in humans and animals. The chemicals are found in the blood of the general U.S. population and studies indicate that they may cause reproductive, developmental and systemic effects.

EPA’s proposal targets LCPFAC chemicals containing PFOA and its higher homologues, including the salts and precursors of these substances. Based on data from the 2012 Chemical Data Reporting (CDR) rule, the LCPFAC substances identified in the proposed SNUR are known to have current or recent ongoing uses. Noting that it is not the agency’s intention to regulate fluoropolymers in this rule, the proposed SNUR’s definition of the LCPFAC category includes a perfluorinated carbon chain length upper limit of 20. However, certain LCPFAC substances intentionally used in fluoropolymer formulation would be subject to reporting for the designated significant new uses.

The proposal defines PFAS substances to mean “a category of perfluorinated sulfonate chemical substances of any chain length.” For PFAS substances, EPA proposes modifying an existing SNUR for the chemical substances listed at 40 CFR 721.9582(a)(1).

The proposed rule is just the latest step in the agency’s ongoing work to regulate perfluorinated chemicals. The SNUR supports EPA’s 2010/2015 PFOA Stewardship Program, a voluntary initiative launched in 2006 with the major global manufacturers of LCPFAC substances. The Stewardship Program aims for a complete emissions and product content phaseout of these chemicals by 2015, and the most recent progress reports on the Program for the years 2014 and 2013, released last week, finds that the participating companies are on track to meet this goal. EPA notes that the SNUR for LCPFACs is proposed “in part in anticipation of this 2015 phase-out deadline.” In addition, the SNUR is consistent with EPA’s 2009 LCPFAC Action Plan. In October 2013, EPA finalized another SNUR on LCPFACs in carpets and PFAS, and earlier SNURs regulated PFAS and perfluorooctane sulfonate (PFOS).

Comments on the proposed rule will be accepted through March 23, 2015. In particular, EPA seeks to confirm through comments on this action whether use (including in articles) of the affected chemicals – or related ones – is still ongoing and will cease by the 2015 deadline. The agency notes that the proposed SNUR would not affect any ongoing uses of the chemicals except those that will be phased out by the end of 2015, although “uses not already ongoing as of the publication date of this proposed rule, and ongoing uses that will be phased out by the end of 2015, would not be considered ongoing uses if they later arise, even if they are in existence upon the issuance of a final rule. Furthermore, uses that are ongoing as of the publication date of this proposed rule would not be considered ongoing uses if they have ceased by the date of issuance of a final rule (see Units IV. and VI. for further discussion of what constitutes an ongoing use).” EPA also requests comment on whether PFAS substances are currently imported as part of carpets.

EPA proposes restrictions on toluene diisocyanates in consumer products.

Today, EPA released a proposed rule regulating toluene diisocyanates (TDI), a group of chemicals mainly used to make polyurethanes like the flexible foam in furniture, as well as other consumer products, including coatings and adhesives. According to the agency, diisocyanates are “well known dermal and inhalation sensitizers in the workplace and can cause asthma, lung damage, and in severe cases, death.” Today’s proposal is a Significant New Use Rule (SNUR) under the Toxic Substances Control Act (TSCA), and applies to the domestic manufacture, processing, or import of TDI in consumer products.

The proposed SNUR [PDF] designates as a “significant new use” the use of certain types of TDI in any consumer products; for three other types of TDI, the “significant new use” designation contains a carve-out for use in coatings, adhesives, elastomers, binders, and sealants at no greater than 0.1% by weight. Under the SNUR, manufacturers, processors, and importers would be required to notify EPA at least 90 days before beginning or resuming the manufacture, processing, or import of TDI in a consumer product. The 90-day period would allow the EPA to evaluate the potential uses for any associated risks or hazards.

Following a recent trend, EPA has proposed making inapplicable the general SNUR exemption for importing or processing the SNUR chemical as part of an article. In the proposal, EPA explains that the articles exemption “is based on an assumption that people and the environment will generally not be exposed to chemical substances in articles…. However, TDI and related compounds are volatile and as such could migrate out of articles that contain them.” The agency cites studies finding that TDI have migrated from products, leading to potential exposure.

EPA notes that TDI, also a high production volume chemical (HPV), are “widely used in residual amounts.” According to the proposed rule, TDI use in consumer products was not reflected in Chemical Data Reporting (CDR) data, and agency staff only learned of its use, at residual concentrations no more than 0.1% by weight, in coatings, adhesives, and similar products, from direct conversations with manufacturers and a review of published literature and Safety Data Sheets for products in stores. Moreover, due to expected growth in the market for such products, “EPA is concerned that consumer products in the future might contain amounts of TDI above [current] levels.”

The chemicals covered by the proposed SNUR are:

  • Toluene diisocyanate trimer
  • Poly(toluene diisocyanate)
  • Toluene diisocyanate dimer
  • Toluene diisocyanate “cyclic” trimer
  • 2,4-toluene diisocyanate
  • 2,6-toluene diisocyanate
  • Toluene diisocyanate unspecified isomer

EPA requests comment on the proposed SNUR, and is particularly interested in “whether there are any ongoing uses of these consumer products of which the Agency is currently unaware and would welcome specific documentation of any such ongoing uses.” The proposal released today is a prepublication version [PDF], and is expected to appear in the Federal Register in the next week or two; comments will be accepted within 60 days after the proposal’s Federal Register publication. Additional material may be found and comments may be filed on Regulations.gov using the proposed rule’s docket number: EPA-HQ-OPPT-2011-0976.