EPA finalizes SNURs, revokes articles exemption for benzidine dyes.

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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.

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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 updates Alternatives Assessment for flame retardants in printed circuit boards.

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Today, EPA’s Design for the Environment (DfE) program released an updated draft Alternatives Assessment of flame retardants in printed circuit boards (PCBs) in electronics. The report [PDF] revises a draft released in 2008; according to the agency, the new report “is being released for a second public comment period because of the large amount of information added describing the combustion testing conducted between 2008 and 2012,” and to update hazard profiles to align with the 2011 DfE Hazard Assessment Criteria [PDF]. In addition, the new draft addresses comments made on the 2008 draft.

This report is the result of a partnership convened in 2006 by EPA and members of the electronics industry and other sectors to develop information to better understand materials used to provide fire safety for PCBs in electronic equipment like computers and cell phones. The report’s purpose is to provide objective information to help electronics-makers “more efficiently factor human health and environmental considerations into decision-making when selecting flame retardants for PCB applications.”

The new draft assessment provides health and environmental information on flame retardant alternatives to tetrabromobisphenol-A (TBBPA), one of the most commonly used flame retardants for printed circuit boards. Hazard profiles vary across the three categories studied: reactive flame retardant alternatives (TBBPA, DOPO, and Fyrol PMP), reactive flame retardant resins (TBBPA-based resin and DOPO-based resin), and additive flame retardant alternatives (aluminum diethylphosphinate, aluminum hydroxide, magnesium hydroxide, melamine polyphosphate, and silicon dioxide). Human health effects for all of the assessed substances varied, with a range of toxicity endpoints. In terms of environmental fate, the reactive flame retardant alternatives and reactive flame retardant resins were all rated High or Very High for persistence, although TBBPA and DOPO were rated Moderate and Low for bioaccumulation, respectively. All five of the additive flame retardant alternatives are expected to have High persistence and Low bioaccumulation potential.

The report applies “life-cycle thinking” to explore factors affecting exposure, including occupational best practices, raw material extraction, and manufacturing. Results of combustion testing experiments simulating end-of-life disposal processes are also described.

Comments will be accepted on the draft report through February 15, 2015, under docket number EPA-HQ-OPPT-2014-0893.

New chemical footprint tool released.

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Clean Production Action, an environmental nonprofit, and the Lowell Center for Sustainable Production at the University of Massachusetts Lowell yesterday announced the launch of a new tool for companies and investment firms to measure suppliers’ use of safer chemicals and evaluate their own progress towards sustainability. The Chemical Footprint Project (CFP) is a third-party benchmark facilitating the comparison of corporate chemical use practices, conceptually similar to carbon footprint metrics.

The CFP defines “chemical footprint” as “the total mass of chemicals of high concern (CoHCs) in products sold by a company and used in its manufacturing operations.” The CFP identifies chemicals of high concern as all chemicals on California’s Safer Consumer Products list of Candidate Chemicals.

The CFP’s Steering Committee and Technical Committee members are drawn from several major corporate and nonprofit stakeholders, including Target, Staples, Kaiser Permanente, Hewlett-Packard, Seagate Technology, ChemSec, Environmental Defense Fund, and the U.S. Green Building Council.

According to the Project’s press release, the CFP is “the first initiative to publicly measure overall corporate chemicals management performance by evaluating:

  • Management Strategy
  • Chemical Inventory
  • Progress Measurement
  • Public Disclosure.”

The Project is expected to be fully operational in early 2015. The CFP is only the latest initiative to measure and manage the environmental and health impacts of products based on chemicals in supply chains. In October, the World Business Council for Sustainable Development released a guidance document on life cycle assessment (LCA) methods for chemical products. Last year, retailers Target and Walmart both announced sustainable chemical products programs which were both based on private standards.

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.

Chemical industry sees improved prospects for passing TSCA modernization in new Congress.

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In the wake of last week’s Republican takeover of Congress, the chemical industry is optimistic that Congress will be able to quickly pass legislation updating the Toxic Substances Control Act (TSCA). Cal Dooley, the president of the American Chemistry Council (ACC), told journalists yesterday that the legislation proposed by Senators David Vitter (R-LA) and Tom Udall (D-NM) would “see committee action relatively soon in the congressional session,” since Sen. Barbara Boxer (D-CA), who opposed the bipartisan Chemical Safety Improvement Act (CSIA), will be replaced as chair of the Senate Environment and Public Works Committee by Sen. Jim Inhofe (R-OK).

Dooley also said he expected further developments in the House Energy and Commerce Committee, where Rep. John Shimkus (R-IL) has already introduced and held hearings on his proposed Chemicals in Commerce Act (CICA).

Although it remains unclear if enough Senate Democrats will support the CSIA, or if President Obama would back a law that preempts state restrictions, Dooley predicted that TSCA reform would pass both the House and Senate and be signed into law next year.

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.