EPA finalizes Significant New Use Rules for ethylene glycol ethers.

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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.

EPA invites submissions to add ingredients to Design for Environment Safer Chemical Ingredients List.

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Today, the EPA’s Office of Chemical Safety and Pollution Prevention announced a new initiative to expand the number of chemicals and functional use categories on its Design for Environment (DfE) Safer Chemical Ingredients List (SCIL). Under the new initiative, EPA is inviting manufacturers to voluntarily submit chemicals/ingredients for review and inclusion on the SCIL. Submitters must “fully disclose” the chemicals to the agency’s DfE program as well as to one of EPA’s authorized third-party profilers, who will compile a hazard profile for each chemical. After receiving the submission from the profiler, DfE will review the chemical profile to determine whether it meets DfE criteria for inclusion on the SCIL.

Interested manufacturers are instructed to contact one of the two authorized third-party profilers, NSF or ToxServices. For chemicals that would be the first ingredient in a component class, EPA also recommends requesting a consultation with the DfE program to discuss broader context implications before the SCIL evaluation takes place.

In addition, EPA encourages cleaning product formulators to participate in the independent CleanGredients program, noting that profiles prepared for SCIL screening may also be used to qualify for CleanGredients.

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

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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.

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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.

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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.

U.S.-Canada joint consultation process for new substances in the works.

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Last week, Chemical Watch reported that the U.S. EPA and Environment Canada are developing a joint process that will allow “companies planning to introduce a new substance in both countries to approach both governments simultaneously.” The joint consultation process, called the North American Notification Consultation (Nan-C), was described by an Environment Canada official on October 8 at a conference in Mississauga, Canada. Although it is still in an early stage of development, the official described it as based on the OECD’s “Parallel Process” standard operating procedures for new substance notifications. One company is already participating in the Nan-C process, and other companies interested in trying it are encouraged to contact Environment Canada through their substances management information line.

The idea for the process reportedly emerged from a nanotechnology workshop held earlier this year by the US-Canada Regulatory Cooperation Council. However, Environment Canada representatives stressed that Nan-C is not meant to replace the OECD parallel process, but is simply a more streamlined and bilateral version specific to the U.S. and Canada. Nan-C is also not a wholly new process, since bilateral consultation is already an option – instead, it is a response to a perceived need among stakeholders for a more formalized version of a pre-existing mechanism.

EPA's ChemView database updated with new chemical SNURs and consent orders.

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Yesterday, EPA announced updates to ChemView, its public online tool for accessing information about chemicals regulated under the Toxic Substances Control Act (TSCA). The updates include enhanced data functions as well as updated, more comprehensive information.

The improved data functions include:

  • Improving the display and content for the Chemical Data Reporting information;
  • Adding a new link that displays the pollution prevention information generated as part of the Toxics Release Inventory program; and
  • Launching an administrative tool that will save EPA resources by streamlining the loading of future information.

ChemView’s databases were updated with the following new information:

  • 244 consent orders;
  • An additional 1,205 Significant New Use Rules (SNURs) for new and existing chemicals;
  • 16 additional chemicals with test rule data, and
  • Updates to the Safer Chemicals Ingredient List (part of the agency’s Design for Environment program).

In EPA’s press release, Assistant Administrator for the Office of Chemical Safety and Pollution Prevention Jim Jones explained that the agency was acting since Congress’ attempts to reform TSCA have so far been unsuccessful: “In the absence of TSCA reform, EPA is moving ahead to improve access to chemical health and safety information, and increase the dialogue to help the public choose safer ingredients used in everyday products.”

With the updates, ChemView now covers 10,000 chemicals and includes for the first time consent orders and new chemical SNURs. ChemView was first launched in 2013 to improve the availability of information on existing chemicals by displaying “key health and safety information and uses data in a format that allows quick understanding.”

U.S. chemical industry opposes fracking disclosure rules.

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Trade groups representing the U.S. chemical industry are urging EPA not to adopt rules requiring the disclosure of hydraulic fracturing chemicals and mixtures. The Society of Chemical Manufacturers and Affiliates (SOCMA) and the American Chemistry Council (ACC) both filed comments in September responding to EPA’s May 19, 2014 Advance Notice of Proposed Rulemaking. That notice announced that the agency was “initiating a public participation process to seek comment on the information that should be reported or disclosed for hydraulic fracturing chemical substances and mixtures and the mechanism for obtaining this information.” EPA’s filing was made in response to a section 21 citizen petition under the Toxic Substances Control Act (TSCA) and suggested that the contemplated reporting mechanism could be authorized under TSCA §§ 8(a) or 8(d), voluntary, or a combination of both, and “could include best management practices, third-party certification and collection, and incentives for disclosure.”

Both groups argue that mandating disclosure of hydraulic fracturing chemicals and mixtures could reveal trade secrets. In its comments, the ACC wrote that EPA should first finalize its ongoing hydraulic fracturing study, and that voluntary programs “have worked well in the past” and state level regulation is more appropriate than federal. SOCMA proposed “the use of structurally descriptive generic names if a specific name would potentially reveal a trade secret” along with better information collection via EPA’s enhanced Chemical Data Reporting (CDR) in combination with the industry’s voluntary chemical registry, FracFocus.

EPA proposes new SNUR on nonylphenols and nonylphenol ethoxylates.

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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.

National Research Council advises EPA on sustainability-based decision-making.

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A new report advises the U.S. Environmental Protection Agency (EPA) to consider incorporating sustainability concepts used in the agency’s Design for Environment (DfE) program in its new chemicals screening process as it evolves, suggesting a new direction for Toxic Substances Control Act (TSCA) reform. The National Research Council (NRC) says that EPA should incorporate into its decision-making process an integrated strategy for evaluating effects on the three dimensions of sustainability – environmental, social, and economic – across all the agency’s activities.

This week, the NRC, the principal operating agency of the National Academies, released its report, Sustainability Concepts in Decision-Making: Tools and Approaches for the US Environmental Protection Agency. The NRC found that a wide variety of tools are available for the agency to use in integrating sustainability concepts into its decision-making, while declining to give “prescriptive advice” on “the use of specific tools and specific decisions” and recognizing that incorporating sustainability into EPA decision-making will be an “evolutionary process.”

The NRC’s report elaborates on issues left unresolved in the NRC’s 2011 report, Sustainability and the U.S. EPA (also known as the Green Book); this new report was commissioned by EPA “to examine applications of scientific tools and approaches for incorporating sustainability considerations into assessments that are used to support EPA decision-making.”

The report includes among five case studies examining how EPA could incorporate sustainability tools into its decision-making the agency’s DfE program. The NRC recommends that EPA use a “systems-thinking approach,” in contrast to the agency’s traditional focus on reducing releases from specific source categories. Likewise, in regulating products, EPA is urged to consider potential life-cycle effects of business processes along the entire value chain. In particular, the report advises EPA to consider applying lessons learned from the DfE program to the new chemicals screening process under TSCA. The NRC highlights the following approaches from the DfE program:

  • Convening public-private partnerships;
  • Using a variety of screening-level and quantitative analytic tools (like life-cycle analysis and alternatives assessments) relevant to sustainability; and
  • Using a variety of indicators (ecotoxicity, human toxicity, bioaccumulation, and environmental persistence) relevant to sustainability.

EPA is also advised to look to the private sector’s sustainability expertise to learn about tools used outside the agency, and to convene the private sector and NGOs “to define and implement value-chain-wide goals and performance outcomes.” In addition, the NRC recommends that EPA work to share insights and best practices learned from leading companies with other businesses.