EPA issues two sets of SNURs by direct final rule.

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Today, EPA released a pre-publication version of Significant New Use Rules (SNURs) for 43 chemicals under the Toxic Substances Control Act (TSCA). All 43 substances have been subject to Premanufacture Notices (PMNs) and six of them are subject to section 5(e) consent orders, where EPA determined that activities associated with the substances may present unreasonable risk to human health or the environment. The SNURs are being promulgated by direct final rule and will be published in the Federal Register tomorrow, July 9.

The new SNURs cover a wide range of chemicals, including perfluorinated chemicals and lithium salts, in a variety of industrial uses, from herbicide intermediates to surfactants for laboratory use fluid.The SNURs impose various recordkeeping, notification, protective and other requirements on persons engaging in a “significant new use,” i.e., any use outside the use scenarios identified in the applicable PMNs or without specified protective measures, in the case of the 5(e) SNURs.

These 43 SNURs come a day after another set of 13 SNURs which were published in today’s Federal Register, all of which were subject to PMNs and three of which were subject to section 5(e) consent orders. Two of the substances covered in this set of SNURs are identified as carbon nanotubes.

The SNURs applying to the substances subject to section 5(e) consent orders are “based on and consistent with the provisions in the underlying consent orders.” The other substances subject to the new SNURs met the criteria of concern established at 40 CFR § 721.170.

Both sets of SNURs will go into effect 60 days following publication in the Federal Register (September 8 and 9) unless EPA receives written adverse or critical comments, or notice of intent to submit such comments, within 30 days of publication (August 7 and 8).

EPA recognizes industry leaders using safer chemicals, reiterates need for TSCA reform.

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Making products with safer chemicals meets consumer demand while improving companies’ bottom lines and benefiting human health and the environment at the same time, says EPA Assistant Administrator for Chemical Safety and Pollution Prevention Jim Jones. Today, Jones wrote on the agency’s “EPA Connect” blog to highlight several U.S. companies leading in the area of safer chemicals in consumer products, including as partners in EPA’s Design for Environment (DfE) program. Jones lauded these product makers and retailers for “advancing industry beyond the safety ‘floor’ set by the outdated Toxic Substances Control Act (TSCA).”

Acknowledging that the absence of a DfE label does not necessarily mean a product is unsafe, Jones points out that the DfE label promotes supply chain transparency: “With the DfE label, you know what is going into a product and that the formula is the safest for human health and the environment based on the best available science and protective criteria—above and beyond the minimum legal requirements set by existing TSCA.”

Jones’ focus on the need to update TSCA, which has been the subject of significant legislative activity this session, is consistent with his previous public statements. In today’s post, he pledged EPA’s continuing commitment to its DfE partners regardless of the outcome of the current TSCA reform effort.

New proposed rule on TSCA CBI claims expected in fall 2014.

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EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) will release its long-awaited proposed rule under the Toxic Substances Control Act (TSCA) regarding Confidential Business Information (CBI) by September 30 this year. Chemical Watch has flagged a recently released Office of Inspector General (OIG) report [PDF] that compiles and provides status updates on the many OIG recommendations that EPA has not yet implemented. The semiannual report includes recommendations stemming from a 2010 OIG report on EPA’s New Chemicals Program which found that the agency “does not have integrated procedures and measures in place to ensure that new chemicals entering commerce do not pose an unreasonable risk to human health and the environment.”

Specifically, OIG advised that OCSPP develop a “more detailed [TSCA CBI] classification guide that provides criteria for approving CBI coverage and establishes a time limit for all” CBI claims in order to permit “eventual” public access to chemical health and safety data. EPA originally agreed to implement OIG’s recommendation by proposing a rule establishing sunset provisions for CBI claims by January 31, 2012. According to the report, OCSPP informed OIG in January 2013 that the rule would be delayed because “senior management discussions” led to the decision to make a “more complex and comprehensive rule.” Last fall, the regulatory agenda released by the Office of Management and Budget CBI pegged the rule’s release for this spring.

In addition to the CBI rule, the OIG’s 2010 report on the New Chemicals Program recommended the establishment of “criteria and procedures outlining what chemicals or classes of chemicals will undergo risk assessments for low-level and cumulative exposure,” as well as updating and revising risk assessment tools and models to keep up with the latest science. OCSPP had agreed to conduct cumulative assessments of eight phthalates and EPA had agreed to consider rulemaking under TSCA § 6(a) for them by December 2012. However, the agency’s progress has been stymied by a long-delayed report on phthalates alternatives from the Consumer Product Safety Commission and Food and Drug Administration, the data from which EPA is relying on to complete its own assessments. OCSPP also agreed to implement guidance on cumulative exposure assessments by February 28, 2013, but EPA has yet to issue it. This guidance was planned for release in 2012; OCSPP now plans to implement it by December 31, 2014.

OIG also recommended that EPA make improvements in information security, including assessing the security controls on OCSPP’s online TSCA system. This assessment was to have been verified by September 6, 2013 but will not be considered past due by OIG until September 6, 2014.

CA's Green Ribbon Science Panel to discuss approaches to product category identification under Safer Consumer Products program.

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California’s Green Ribbon Science Panel invites members of the public to join its webinar and conference call on June 25, at 9 a.m., to discuss how the Department of Toxic Substances Control (DTSC) should identify product categories in its forthcoming 3-Year Priority Product Work Plan for the Safer Consumer Products (SCP) program. As we have previously discussed, DTSC has said a public workshop will be held on the Work Plan this summer; the Plan is expected to be finalized by October 1, 2014.

In preparation for the June 25 webinar, DTSC has posted online a background memo [PDF] discussing various approaches for product category identification and posing questions to the Panel soliciting recommendations. The approaches identified in the memo are:

  • Hazard Trait and Endpoint Screening
  • Route of Exposure
  • Chemical Prioritization
  • Evidence of Exposure
  • Sensitive Subpopulation Prioritization
  • Nomination Process

According to the agenda [PDF], the webinar will also include an update from DTSC staff on the SCP program and the status of the Work Plan. In addition, staff will accept comments from the public on agenda items. Specifics on how to participate in the webinar are available here.

REACH Candidate List updated with four new Substances of Very High Concern.

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The European Chemicals Agency (ECHA) has announced the addition of four new Substances of Very High Concern (SVHCs) to the Candidate List: cadmium chloride, a phthalate (1,2-benzenedicarboxylic acid, dihexyl ester, branched and linear), and two boron substances (sodium peroxometaborate and sodium perborate; perboric acid, sodium salt). This addition brings the Candidate List to a current total of 155 substances.

ECHA identified cadmium chloride as a carcinogenic, mutagenic, and toxic for reproduction (CMR) substance, as well as “being of an equivalent concern based on probable serious effects to human health,” with specific focus on effects to the kidneys and bones. The other three substances are identified as toxic for reproduction.

One of the boron substances was added directly to the Candidate List by ECHA because no relevant comments regarding its identification as an SVHC were submitted during public consultation. The Member State Committee (MSC) added the other three substances via unanimous agreement in written procedure regarding their identification as SVHCs. The addition of cadmium chloride and the borate substances to the Candidate List were proposed in March by Sweden and Denmark, respectively.

The addition of these substances to the Candidate List marks a first step towards the substances possibly becoming subject to authorization under REACH. Inclusion in the Candidate List triggers certain notification obligations for manufacturers or importers of the substances, including when they are present in mixtures or articles.

EPA identifies safer alternatives for flame retardants.

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Yesterday, EPA’s Design for Environment (DfE) program released two reports on flame retardants and their safer alternatives. One report is a draft update of a 2005 Alternatives Assessment on the flame retardant pentabromodiphenyl ether (pentaBDE) in flexible polyurethane foam; the other is a final Alternatives Assessment on Hexabromocyclododecane (HBCD), a brominated flame retardant used in polystyrene building insulation. Both chemicals pose risks to human health and the environment, including “potential reproductive, developmental, and neurological effects and can be persistent, bioaccumulative, and toxic to aquatic organisms.”

PentaBDE has already been phased out of use in the U.S.; in 2004, industry voluntarily agreed to cease production and EPA issued a Significant New Use Rule (SNUR) aimed at ending the chemical’s domestic manufacture. EPA proposed another SNUR in 2012 to address imports of pentaBDE-containing furniture or other articles. EPA identified oligomeric phosphonate polyol as a safer alternative to pentaBDE. PentaBDE has also been subject to flammability standards recently proposed and finalized by the Consumer Product Safety Commission and the state of California, respectively. EPA’s updated alternatives assessment is “[complementary to] the CPSC and California actions by providing important information for informed selection of flame retardants in the manufacture of home and office furniture, as well as the many home products not covered by these standards.” The draft update provides a hazard assessment for flame retardant chemicals used in upholstered consumer products containing polyurethane foam, including updated health and environmental profiles previously profiled in 2005 and new products in the category.

EPA issued this report on HBCD as part of the agency’s action plan for HBCD under the Existing Chemicals Management Plan. Although HBCD is also used as a flame retardant in textile back coatings and high-impact polystyrene in electronics housings, the Alternatives Assessment only addresses its use in expanded polystyrene (EPS) and extruded polystyrene (XPS) foam insulation produced for the building and construction industry for fire safety. Butadiene styrene brominated copolymer was identified as a safer alternative to HBCD based on hazard considerations, with lower human health, ecotoxicity, and exposure potentials, although it is also inherently persistent due to its molecule size. Butadiene styrene brominated copolymer is regulated by its own SNUR and is commercially available from chemical suppliers, according to EPA.

Industry criticizes House Democrats’ TSCA proposal and refocuses on Senate bill.

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A week after the release of House Democrats’ proposed revisions to the Chemicals in Commerce Act (CICA), industry groups have responded with criticism and a renewed interest in the Senate’s Chemical Safety Improvement Act (CSIA), the stalled legislation that also aims to modernize the Toxic Substances Control Act (TSCA). Meanwhile, the attorneys general of ten states have also expressed their support for the CSIA in a letter to Senators Barbara Boxer (D-CA) and David Vitter (R-LA), the Chairwoman and Ranking Member, respectively, of the Senate Environment and Public Works Committee.

In contrast to the April letter from 13 Democratic attorneys general opposing CICA, the pro-CSIA letter is at least nominally bipartisan: all of the signers are Republicans except for Arkansas Attorney General Dustin McDaniel. The letter tackles Democrats’ preemption concerns head-on by praising CSIA as balancing “States’ needs to protect the health of their citizens and resources with the need to create a coherent and cohesive regulatory framework for chemical manufacturers.” The AGs also write that the Senate bill “gives States direct routes to participate in the process of identifying and evaluating chemical safety, including requests to prioritize specific chemicals and to re-prioritize a chemical based on new information.” The preemption provisions in both bills have been a point of major contention, particularly with Sen. Boxer, who has stated that any TSCA reform that fails to preserve state laws like California’s Proposition 65 is “a non-starter.”

However, according to statements made by Sen. Vitter earlier this year, progress has been made on CSIA behind the scenes, although a spokesman for Sen. Vitter told E&E Daily that there is currently no timetable for passing the bill.

Major chemical industry groups have criticized the House Democrats’ negotiating language, pointing out its similarity to legislation introduced by Rep. Henry Waxman (D-CA) that failed in 2010. Chemical Week quoted leaders from the American Chemistry Council (ACC), the Society of Chemical Manufacturers and Affiliates (SOCMA), and the American Cleaning Institute (ACI) all disapproving of the Democrats’ proposal. Officials from the ACC and SOCMA both placed the blame squarely on Rep. Waxman, saying his proposal would “undermine the effort to move legislation forward in the House” and “would not be palatable for Republicans.”

Public health and advocacy NGOs have been more reticent. Andy Igrejas, of the Safer Chemicals, Health Families coalition, said his coalition had not adopted a formal position on the Democratic proposal but expressed support for some of its aspects, including the “smaller” prioritization scheme and “fixing ‘unreasonable risk’ in ways that makes it clear that it is a health only standard that protects vulnerable populations.”

House Democrats' negotiating language on TSCA reform: user fees and tighter deadlines.

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Democrats on the House Subcommittee on Environment and the Economy have proposed a revised version [PDF] of the Chemicals in Commerce Act (CICA), the bill which Rep. John Shimkus (R-IL) first introduced in April to modernize the Toxic Substances Control Act (TSCA). However, spokespeople from both sides of the aisle expressed that continued bipartisan work was still needed. A spokesperson for Rep. Paul Tonko (D-NY) told Chemical Watch that Democrats have “not heard back on the legislative language” they proposed, while Rep. Shimkus’ office said that the Congressman’s “door remains open to any serious attempts to find common ground and move bipartisan TSCA reform through the House this year.” The Democrats’ negotiating language, presented as a redlined version of CICA, proposes user fees that would be assessed on chemical manufacturers and processors and shortens deadlines. According to Bloomberg BNA, Republican committee aides called the Democratic proposal a nonstarter.

Meanwhile, there have been no reported updates on progress toward a new version of the Chemical Safety Improvement Act (CSIA) on the Senate side.

Comments from industry and NGO stakeholders reflect tempered hopes for the prospect of passing TSCA reform this year. The American Chemistry Council (ACC) stated that, “With good-faith efforts from the Committee Democrats to develop a workable consensus, we believe there may still be opportunities to pass meaningful reform this year,” while Bill Almond, Vice President of Government Relations of the Society of Chemical Manufacturers and Affiliates (SOCMA), said that if Democratic leaders would “move toward a more reasonable position,” then “TSCA reform still has a chance of passage this year.” Andy Ingrejas, director of the Safer Chemicals, Healthy Families coalition, said the chance for passage depends on whether Republicans decide “to negotiate for real on language now that they have it” or if they are “punting for next year.”

India's industry seeks to make National Chemicals Policy a top priority.

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Following the recent election of India’s new prime minister, Narendra Modi, the country’s burgeoning industry is making the adoption and implementation of the National Chemicals Policy (NCP) a top priority. According to Chemical Watch, analysts and industry members are supportive of Modi and hopeful that the NCP will be adopted by the end of the year. The Indian Chemical Council (ICC) has reportedly already engaged with the new coalition government and plans to continue urging that the NCP and the roadmap to the Strategic Approach to International Chemicals Management (SAICM) be pursued “on a high priority basis.”

Modi has appointed Ananth Kumar at the head of the Ministry of Chemicals and Fertilizers, which he has vowed to make an engine of growth.

The NCP was to have been approved by the last coalition government in April or May, but was not addressed in the buildup to the general election.

Priority Products workshop: California's Safer Consumer Products program continues to develop.

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Yesterday, California’s Department of Toxic Substances Control (DTSC) held the second of three public workshops on its initial Priority Products in Oakland. These workshops are being held to elicit feedback from stakeholders before the start of the formal rulemaking process, which is anticipated to begin in late June.

In his introductory presentation, DTSC Branch Chief of the Safer Consumer Products (SCP) program Karl Palmer explained that only three (instead of the possible five) Priority Products were initially chosen because the agency wanted to be deliberate, slow, accurate, and effective in rolling out the new SCP program. Palmer also noted that the agency was developing a new data system that may be available as soon as August, which would manage confidential business information (CBI) in submissions to the agency as well as rulemaking processes.

Agency staff explained various refinements that have been made since the first public workshop, focusing on revisions to the Priority Product profiles. Responding to industry comments, the profiles now contain a second-page “disclaimer” explaining that the profiles are non-regulatory documents showing a “snapshot in time” of the agency’s thinking, and are not meant to assert that certain products cannot be used safely, or to endorse alternatives. At the workshop, various commenters from the chemical industry continued to push back that the profile for Spray Polyurethane Foam (SPF) Systems contained inaccurate information and should require a more explicit disclaimer.

In addition to the profiles, product definitions have been revised on the program’s draft regulatory concepts [PDF]. Agency staff noted that, as shown in this document with strikeouts, the SPF definition was narrowed to focus only on applying unreacted diisocyanates to produce rigid foam. The regulatory concepts draft also updates the definition of paint strippers containing methylene chloride from the one contained in the Priority Product profile, now removing reference to surface cleaners, which are already barred from containing methylene chloride under the California Air Resources Board (CARB) General Consumer Products Regulation.

A general theme repeated throughout the workshop was that DTSC was eager to accept information from stakeholders, especially quantitative data on the products’ markets and supply chains, and the availability or viability of alternative products.

The third public workshop will take place on June 4 in Los Angeles. More information, including how to register to attend or file comments, is available on the Safer Consumer Products Workshops page. That page also links to various new documents, including presentations from the workshops. DTSC continues to accept comments on the Priority Products before rulemaking begins, through June 30.

Looking ahead, DTSC will release a three-year Work Plan and hold a public workshop on it in the late summer. The Work Plan, which should be finalized by October 1, 2014, will identify product categories the agency plans to consider next. Draft guidance on alternatives assessments, including input from the Green Ribbon Science Panel, is expected by the end of the year.