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.

EPA finalizes SNURs, revokes articles exemption for benzidine dyes.

Today, EPA announced the promulgation of a final Significant New Use Rule (SNUR) [PDF] under Toxic Substances Control Act (TSCA) targeting three different chemical types: certain benzidine-based dyes, di-n-pentyl phthalate (DnPP), and alkanes, C12-13, chloro, a short-chain chlorinated paraffin (SCCP). Benzidine-based dyes can be used in textiles, paints, and inks; DnPP in PVC plastics; and alkanes in industrial lubricants. EPA found that all of the affected chemicals can cause health effects including aquatic toxicity, cancer, persistence and bioaccumulation, and reproductive and developmental effects.

Like other SNURs, the rule requires manufacturers (including importers) or processors of the identified substances to notify EPA at least 90 days before beginning any significant new use. Under this SNUR, any new use is considered a significant new use for the benzidine-based dyes and alkanes. For DnPP, EPA has designated “any use other than as a chemical standard for analytical experiments” as a significant new use. For the benzidine-based dyes, EPA is adding nine chemicals to an existing rule regulating benzidine-based chemicals.

Notably, the SNUR makes inapplicable the usual TSCA exemption for importing or processing chemicals as part of an article, calling it a “loophole.” Thus, 90-day notification will be required of importers or processors of any articles containing benzidine-based chemicals, encompassing both the nine newly-added dyes as well as those first regulated in 1996. The elimination of this articles exemption has been questioned by the chemical industry, and marks a shift in EPA’s policy. In today’s SNUR, the agency notes that it is “concerned that commencement of the manufacture (including import) or processing for any new uses, including resumption of past uses… could significantly increase the magnitude and duration of exposure to humans.”

Today’s rule is not the agency’s only effort at regulating these chemicals; benzidine dyes and SCCPs are both already subject to Action Plans, while other phthalates (not including DnPP), as well as medium-chain and long-chain chlorinated paraffins have been added for assessment under the TSCA Work Plan. SCCPs have been nominated for addition to the Stockholm Convention for Persistent Organic Pollutants, and manufacturing and importing in the U.S. has ceased following EPA enforcement actions in 2012. EPA also notes that its Design for the Environment program has identified safer dye and colorant alternatives on its Safer Chemical Ingredients List.

The SNUR will go into effect 60 days after its publication in the Federal Register, which will likely occur in the next week.

EPA finalizes Significant New Use Rules for ethylene glycol ethers.

In today’s Federal Register, the EPA has published a final Significant New Use Rule (SNUR) under the Toxic Substances Control Act (TSCA) for seven ethylene glycol ethers, also known as glymes. Glymes are used as industrial solvents or processing aids, and in some consumer products, such as inks, paints, coatings, adhesives, graffiti removers, and soldering compounds. The seven chemicals affected are:

  • monoethylene glycol dimethyl ether (monoglyme);

  • diethylene glycol dimethyl ether (diglyme);

  • diethylene glycol diethyl ether (ethyldiglyme);

  • triethylene glycol dimethyl ether (triglyme);

  • diethylene glycol dibutyl ether (butyl diglyme);

  • ethylene glycol diethyl ether (ethylglyme); and

  • triethylene glycol dibutyl ether (butyl triglyme).

The SNUR will require manufacturers (including importers) to notify EPA at least 90 days before starting any activity identified as a significant new use. For six of the glymes, the agency is designating all new consumer uses as significant new uses, while any new use constitutes a significant new use for the seventh glyme, triethylene glycol dibutyl ether (butyltriglyme). Three of the glymes subject to the SNUR contain carve-outs for certain uses, such as when diethylene glycol diethyl ether (ethyldiglyme) is used as a component of inks, coatings and adhesives, and as a component of paint/graffiti removers. In addition, in response to comments, EPA clarified that ethylene glycol ethers in brake fluid contained in a motor vehicle at point of sale would not be considered to have been “’sold or made available to consumers for their use,’ merely because it has been made available to motor vehicle manufacturers (as part of a brake fluid mixture for their use in manufacturing customers’ motor vehicles) or used car dealers.” Likewise, monoethylene glycol dimethyl ether (monoglyme) contained in sealed lithium batteries does not constitute use in a consumer product.

The agency is issuing this SNUR because glymes “have been shown to cause damage to reproductive organs and DNA, as well as toxicity to blood and blood forming organs.” EPA first proposed a SNUR for 14 glymes on July 12, 2011, but is not currently finalizing the rule for the other seven glymes “because the Agency believes that these chemicals are not sufficiently similar to the seven chemicals subject to this SNUR and therefore do not raise the same concern for potential exposure to these chemicals.”

EPA also notes that ethylene glycol dimethyl ether (monoglyme) is on the Work Plan for Chemical Assessments, because it met the criteria for priority assessment due to toxicity and use in commercial and consumer products. Under the Work Plan, EPA will conduct a risk assessment and determine if further risk reduction is necessary.

The SNUR goes into effect on February 17, 2015.

Industry group questions EPA's trend toward eliminating TSCA's articles exemption.

This week, Bloomberg BNA reported that American Chemistry Council attorneys recently met with representatives of the Office of Management and Budget (OMB) to ask that the Environmental Protection Agency (EPA) be required to conduct further information-gathering on a proposed rule under the Toxic Substances Control Act (TSCA) that would regulate benzidine-based dyes, among other chemicals. The proposed Significant New Use Rule (SNUR), published in March 2012, would add nine chemicals to the SNUR already listed at 40 C.F.R. § 721.1660 and make unavailable the customary “articles exemption,” which exempts persons processing or importing the regulated chemicals as part of an article. Under this SNUR, importers or processors of articles containing benzidine-based dyes would have to provide 90-day advance notice to EPA. According to Bloomberg BNA, the ACC told OMB of its concern that the proposed SNUR “lacked a rationale explaining how or why the EPA decided it was necessary to regulate articles rather than focus solely on chemicals as it typically does in new use rules.”

In its June 2012 comments on the proposed rule, the ACC noted that the proposed revocation of the articles exemption “herald[s] a shift by the Agency towards greater regulation of chemicals in articles.” The ACC argued that removing the articles exemption “should be limited to exceptional circumstances” and be “based on sound criteria,” and recommended that EPA “define a clear policy framework including criteria for determining when TSCA regulation of articles is appropriate. In any proposed SNUR, the Agency should present a compelling basis for a decision to apply a SNUR to articles.”

The OMB’s Office of Information and Regulatory Affairs (OIRA) reviews all significant rulemaking before publication, and may return an agency rule for further consideration and review if, for example, OIRA finds that the proposed rule is not justified by the analysis.

The articles restriction in the benzidine-based dyes SNUR is in line with other recent SNURs regulating articles; Bloomberg BNA reports that since 2012, EPA has proposed at least four SNURs that would eliminate the articles exemption for certain chemicals, including the 2013 rule on carpets containing long-chain perfluoralkyl carboxylates.

EPA promulgates 52 SNURs.

In today’s Federal Register, the EPA published Significant New Use Rules (SNURs) under the Toxic Substances Control Act (TSCA) applying to 52 chemical substances, ranging from “functionalized carbon nanotubes” to amine adducts. The affected chemicals were all subject to Premanufacture Notices (PMNs), and nine are also subject to consent orders under TSCA § 5(e). Today’s SNURs extend the provisions of the § 5(e) consent orders and require manufacturers and processors of the chemicals to notify EPA prior to engaging in any activity designated in the rules as a significant new use. The SNURs were issued by Direct Final Rule, meaning that the SNURs will go into effect in 60 days unless EPA receives written adverse or critical comments, or notice of intent to submit such comments, by November 26.

EPA updates TSCA Work Plan, 23 chemicals added to list for further review.

Today, EPA released its first update [PDF] to the Toxic Substances Control Act (TSCA) Work Plan for Chemical Assessments. Drawing on new data collected through Chemical Data Reporting (CDR) and the Toxic Release Inventory program, EPA adjusted the exposure rankings for the chemicals initially screened for the Work Plan and added 23 chemicals to the Work Plan list for further assessment. The agency also removed 15 chemicals which are mostly no longer in commerce; of the 15, mercury (and mercury compounds) and quartz were removed because risks associated with those substances are already sufficiently managed. In addition, benzo[a]pyrene was designated to be evaluated as part of the assessment of creosote. Today’s changes had no effect on 67 chemicals and bring the Work Plan total to 90 chemicals.

Included in the 23 new Work Plan chemicals, EPA added the following five Action Plan chemicals or chemical groups to the Work Plan for further assessment:

  • Bisphenol A (BPA)
  • Decabromodiphenyl ether (decaBDE)
  • Hexabromocyclododecane (HBCD)
  • Nonylphenols and nonylphenol ethoxylates (NP/NPE)
  • Group of phthalates (dibutyl phthalate (DBP), butyl benzyl phthalate (BBP), di(2-ethylhexyl) phthalate (DEHP), di-n-octyl phthalate (DnOP), di-isononyl phthalate (DINP), di-isodecyl phthalate (DIDP), and di-isobutyl phthalate (DIBP)

These Action Plan chemicals were all identified as highly-ranked for hazard and exposure; decaBDE and HBCD also had high rankings for persistence/bioaccumulation. The other five Action Plan chemicals not added to the Work Plan were not selected for reasons including lower toxicity and potential exposure or because they are no longer produced or imported into the United States. Of these non-Work Plan chemicals, the agency plans to propose Significant New Use Rules (SNURs) for benzidene dyes and toluene diisocyanate (TDI). In the case of long-chain perfluorinated chemicals (PFCs), EPA noted that while it has already begun risk management actions, including a voluntary stewardship program, it intends to gather “additional data regarding use of PFCs in imported articles before determining if these chemicals should be candidates for the assessment process.”

In addition to the Action Plan chemicals, EPA added ten chemicals which were previously screened for the Work Plan in 2012. These ten chemicals now have increased exposure scores, according to recent CDR and TRI data, due to “being domestically produced or imported in greater quantities and …used in a larger variety of consumer and children’s products.” Two flame retardants, triphenyl phosphate (TPP) and isopropylated phenol, phosphate (iPTPP), were also added.

EPA proposes new SNUR on nonylphenols and nonylphenol ethoxylates.

Yesterday, EPA released a pre-publication version of its proposed Significant New Use Rule (SNUR) under the Toxic Substances Control Act (TSCA) targeting nonylphenols (NPs) and nonylphenol ethoxylates (NPEs). NPEs are a type of nonionic surfactant used in a wide variety of industrial processes and applications, including detergents, dry cleaning, cosmetics, adhesives, and paints and coatings; NPs are primarily used as an intermediate in producing NPEs. Under the SNUR, any person intending to manufacture, import, or process NPs or NPEs for the identified significant new uses must notify EPA before beginning any such activity, so that the agency may have the opportunity to evaluate each intended use and impose any appropriate controls.

The proposed SNUR [PDF] applies to 15 chemical substances; for 13 of these, any use is considered a significant new use, while “any use other than use as an intermediate or use as an epoxy cure catalyst” constitutes a significant new use for 4-nonylphenol, branched and 2-nonylphenol, branched. In discussing the environmental effects of NPs and NPEs, EPA cited the chemicals’ persistence, high toxicity to aquatic life and wide usage that can lead to “widespread releases to the aquatic environment.”

NPs and NPEs were also the subject of an Advanced Notice of Proposed Rulemaking in 2009, following EPA’s settlement of a citizens petition to initiate rulemaking brought by several environmental groups and other NGOs. The release of the proposed SNUR is in line with EPA’s 2010 Action Plan for these chemicals. Other Action Plan efforts to regulate NPs and NPEs and reduce their risks include completing an alternatives assessment under the Design for Environment (DfE) program in 2012 and collaborating with the Textile Rental Services Association of America to phase out NPEs in industrial laundry detergents.

Comments will be accepted on the proposed SNUR for 60 days following the rule’s Federal Register publication, which is anticipated to occur the week of September 29.