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.

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.

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.

EPA both finalizes and withdraws Significant New Use Rules.

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EPA finalized Significant New Use Rules (SNURs) under the Toxic Substances Control Act (TSCA) for 36 substances on September 2, including several nanoengineered carbon compounds. The SNURs were first proposed in February 2013, and include several substances subject to § 5(e) consent orders. EPA is not finalizing the proposed SNUR for one substance, premanufacture notice (PMN) number P-11-155, in response to a comment from the PMN submitter urging the SNUR’s withdrawal while the agency’s recommended environmental toxicity testing is ongoing. Other changes in the final SNURs are mostly minor and involve ensuring consistency with existing consent orders and Occupational Safety and Health Administration (OSHA) requirements. In response to comments on the hierarchy of engineering and administrative controls and collaboration with OSHA and the National Institute for Occupational Safety and Health (NIOSH), EPA noted that it is “currently in the process of developing revisions to existing SNUR regulations that will serve as a template for future SNURs and SNURs already issued” and will consult with OSHA and NIOSH.

In July, we reported that EPA released two sets of SNURs by direct final rule. Earlier this month, EPA withdrew six of those SNURs after receiving notices of intent to submit adverse comment. The agency withdrew rules for the substances identified generically and by PMN number as follows:

  • 1,1′- methylenebis[isocyanatobenzene], polymer with polycarboxylic acids in alkane polyols;
  • aromatic dibenzoate (P-14-60);
  • propylene glycol, alpha isocyanate, omega silane (P-13-270);
  • aromatic dicarboxylic acid polymer with alkanediol, alkyl alkyl-2-alkenoate,1,4- dialkyl aromatic dicarboxylate, alkanedioic acid, alkanediol, .alpha.- hydro-.omega.-hydroxypoly[oxy(alkyl- alkanediyl)], hydroxyalkyl 2-alkyl-2- alkenoate, aromatic diisocyanate, alkyl 2-alkyl-2-alkenoate and 2-alkyl-2- alkenoic acid (P-13-563);
  • alkanedioic acid, polymer with alkyl 2- alkyl-2-alkenoate, alkanedioic acid, alkanediol, .alpha.-hydro-.omega.- hydroxypoly[oxy(alkyl-1 2-alkanediyl)], hydroxyalkyl 2-alkyl-2-alkenoate, aromatic diisocyanate, alkyl 2-alkyl-2- alkenoate and 2-alkyl-2-alkenoic acid (P-13-617); and
  • alkanedioic acid, polymer with alkyl alkyl- alkenoate, alkanedioic acid, alkanediol, .alpha.-hydro-.omega.- hydroxypoly[oxy(alkyl-1,2-alkanediyl)], aromatic diisocyanate, alkyl alkyl- alkeneoate and alkyl-alkenoic acid (P-13-619).

According to its Federal Register notice, EPA intends to publish proposed SNURs for these substances under separate notice-and-comment procedures in the near future.