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.

National Academy of Sciences propose framework on chemical alternatives assessments.

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A committee of the National Academy of Sciences’ National Research Council has released a proposal on decision-making in conducting alternatives assessments. The report, titled A Framework to Guide Selection of Chemical Alternatives and authored by the Committee on the Design and Evaluation of Safer Chemical Substitutions, also presents evaluations of existing frameworks and recommendations for implementation and future research. Suggested audiences and users of the report include regulatory agencies at every level, industry, organizations working for the adoption of safer chemicals, and developers of chemicals and chemical processes.

The recommended framework is 13 steps, with some steps and sub-steps treated as optional, and is designed for flexibility such that “certain steps are completed sequentially, in parallel, or iteratively, providing an opportunity for fit-for-purpose decision making.” The framework is summarized as follows (asterisks indicate optional activities):

  • Step 1: Identify Chemical of Concern
  • Step 2: Scoping and Problem Formulation
  • Step 3: Identify Potential Alternatives
  • Step 4: Initial Screening of Identified Alternatives
  • Step 5: Assess Physicochemical Properties
  • Step 6-1:Assess Human Health Hazards
  • Step 6-2: Assess Ecotoxicity
  • Step 6-3: Conduct Comparative Exposure Assessment
  • Step 7: Integration of Information to Identify Safer Alternatives
  • Step 8: Life Cycle Thinking
  • Step 9-1: Additional Life Cycle Assessment*
  • Step 9-2: Performance assessment*
  • Step 9-3: Economic assessment*
  • Step 10: Integrate Data and Identify Acceptable Alternatives
  • Step 11: Compare Alternatives*
  • Step 12: Implement Alternatives
  • Step 13: Research and Innovation*

The committee highlighted the following as the framework’s most important and unique elements:

  • a focus on scoping and problem formulation;
  • an increased emphasis on comparative exposure assessment;
  • increased use of physicochemical properties to assess human health and ecotoxicity hazards;
  • a two-tiered approach to evaluating chemical alternatives that includes health and ecotoxicity, followed by a consideration of broader impacts; and
  • recognition of the need for research and innovation.

California extends comments period on Safer Consumer Products draft Work Plan.

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Yesterday, the California Department of Toxic Substances Control (DTSC) made a series of announcements related to the Safer Consumer Products program. DTSC is extending the comments period for the Safer Consumer Products draft Priority Products Work Plan, and will now accept comments on the draft Plan until October 21.

DTSC also announced that its Candidate Chemicals database and downloadable list have been updated. The update reflects changes made in authoritative lists, such as the IARC (International Agency for Research on Cancer) carcinogens monographs.

In addition, DTSC invites the public to attend the next meeting of the Green Ribbon Science Panel. The Panel will convene on October 20-21 in Sacramento to “discuss and advise DTSC on evaluating Product Categories identified” in the draft Work Plan as well as alternative analysis topics. DTSC has posted the meeting’s agenda [PDF] and supporting documents including discussion topics for the draft Plan [PDF] and an Alternatives Analysis Guidance Document Synopsis [PDF].

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.”

CA, MD, and NY enact laws against flame retardant chemicals; federal legislation proposed.

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California, Maryland, and New York are the latest states with new laws regulating flame retardant chemicals in products.

On September 30, California Governor Jerry Brown signed into law a bill requiring manufacturers to disclose on labels whether furniture contains flame retardant chemicals. The requirement goes into effect on January 1, 2015.

Maryland’s HB 229, which bans child care products containing flame retardant chemicals, went into effect on October 1. Products intended for children under the age of three, like crib mattresses, car seats, and toys containing more than 0.01% by mass of tris(1,3-dichloro-2-propyl)phosphate (TDCPP) or tris(2-chloroethyl)phosphate (TCEP), may no longer be imported, sold, or offered for sale in Maryland.

In September, New York Governor Andrew Cuomo signed a law that would also ban TDCPP-containing child care products.

Meanwhile on the federal level, Senator Charles Schumer (D-NY) introduced a bill in the Senate that would ban the sale, manufacture, distribution, and import of children’s products and upholstered furniture containing the ten “most noxious” flame retardant chemicals, including TDCPP and TCEP. The legislation also directs the Consumer Product Safety Commission (CPSC) to study the health effects of other flame retardants and then extend the ban to any chemicals identified via this review that may cause substantial personal injury or illness.

Global chemical industry publishes guidance on environmental footprints for products.

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Ten global chemical companies and stakeholders have released guidance for the chemical sector on communicating a product’s environmental footprint using life cycle assessment (LCA) methods. Collaborating as a working group of the World Business Council for Sustainable Development (WBCSD), the members developed the guidance document – titled Life Cycle Metrics for Chemical Products – with the objective of facilitating “improved sustainability across value chains” by communicating reliable information using a “common language.” The guidance is based on ISO 14040:2006 and 14044:2006 and sets out requirements covering topics including:

  • Footprint system boundaries: Product footprint studies should be cradle-to-grave, except for business-to-business products, which may use cradle-to-gate studies. Cradle-to-gate studies must include end-of-life impacts for all waste generated in production.
  • Defining the functional unit and reference flow: The functional unit must be consistent with the goal and scope of the study, and the duration of the functional unit must be specified for cradle-to-grave studies. Compared solutions shall be assessed on main functionality, technical quality (stability, durability, ease of maintenance), and additional functions rendered during use and disposal.
  • Impact categories, energy, and other flows: The guidance names certain models to use in characterizing impacts ranging from global warming to marine eutrophication to human toxicity and ecotoxicity. Energy flows, including cumulative energy demand, renewable energy consumption, and non-renewable energy consumption, must also be assessed and reported.
  • Data source requirements and quality management: Primary data (from specific operations in the studied product’s life cycle) should be “the most accurate available data,” including on-site measurements of aggregated consumed water, energy, and raw material, as well as continual air and water emissions.
  • Main methodological choices: The guidance provides a decision tree for choosing how to allocate environmental impacts for multiple products with different functions coming from the same system. Other methodological choices addressed include: attribution of recycling benefits; avoided emissions; bio-based carbon storage; carbon storage and delayed emissions; and land-use change.
  • Uncertainties of results: At a minimum, studies should include a qualitative description of uncertainties. Quantitative assessments of uncertainty based on Monte Carle simulations are optional.
  • Critical/peer review: Chemical product footprint studies must undergo peer review to assess consistency with the guidance. Externally published comparative claims must undergo “an external critical review by a panel of LCA experts.” All studies must include a statement specifying that the study was critically or peer reviewed and summarizing the review’s conclusions.

This guide is the third release from the WBCSD Chemical Sector’s “Reaching Full Potential” project, which previously released guidance for the chemical industry on accounting and reporting corporate greenhouse gas emissions and avoided emissions. Together, the Project’s publications seek to provide for “consistent and credible communication on how the value chains of chemicals impact on and contribute to sustainability.”

The working group is comprised of major companies like BASF, Eastman Chemical, Evonik, and Solvay, as well as Cefic, the European Chemical Industry Council. The next step for the Reaching Full Potential project is to develop a guide for companies to assess social impacts and benefits of chemical products. Development of that guide is already under way, with release expected in late 2015.

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.