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.

 

Court denies motion to stay SEC conflict minerals rule, disclosures required by June 2.

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Last week, the saga of the U.S. Securities and Exchange Commission’s (SEC) conflict minerals disclosure rule took another turn as the U.S. Court of Appeals for the District of Columbia Circuit denied an emergency motion filed by industry groups to stay the rule. The rule, known as Exchange Act Rule 13p-1, was authorized by section 1502 of the Dodd-Frank Act and requires companies to make their first disclosures about their use of conflict minerals – such as gold, tantalum, tin, and tungsten from the Democratic Republic of Congo and adjacent countries – by June 2, 2014. The motion for stay was filed by three trade groups: the National Association of Manufacturers, the U.S. Chamber of Commerce, and the Business Roundtable.

We previously reported that in April, the D.C. Circuit Court of Appeals partially struck down the conflict minerals disclosure rule in National Association of Manufacturers v. Securities and Exchange Commission, finding that the rule’s requirement that companies describe whether their products have been found to be “DRC conflict free” constituted compelled commercial speech in violation of the First Amendment. Following that decision, the SEC released a statement on April 29 clarifying how companies should make disclosures under Rule 13p-1 while the court case continues. In that guidance, the SEC said companies need not use the phrase “DRC conflict free,” although companies could elect to do so as long as an independent private sector audit (IPSA) was conducted. Companies required by the rule to file a Conflict Minerals Report should describe “the due diligence that the company undertook.” In the case of products that cannot be determined to be DRC conflict-free, companies should disclose “the facilities used to produce the conflict minerals, the country of origin of the minerals and the efforts to determine the mine or location of origin.”

On May 2, the SEC itself issued a stay [PDF] applying to “those portions of [the rule] subject to the Court of Appeals’s constitutional holding… pending the completion of judicial review, at which point the stay will terminate.”

Following the Court’s denial of the motion for stay, companies must file their first Rule 13p-1 disclosures by June 2 in accordance with the SEC’s April 29 guidance. Yesterday, the Court held its en banc rehearing of oral arguments in a related case, American Meat Institute v. USDA, which the SEC has not sought to join.

European negotiating position on chemicals aims for regulatory cooperation in trade deal with U.S.

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Last week, the European Commission (EC) published papers describing its negotiating positions on five topics associated with the current EU-US talks on the Transatlantic Trade and Investment Partnership (TTIP). The position papers, released as part of the EC’s efforts at increasing transparency, propose improving the compatibility of rules governing chemicals, cosmetics, motor vehicles, pharmaceuticals, and textiles and clothing. Across all sectors, the EC proposes to end “unnecessary” or duplicative product testing and inspections; to recognize or better align existing regulations; and to harmonize procedures for registering and approving new products. The papers were published just before the latest round of trade talks begin this week in the U.S., and follows the late March release of a report by the U.S. International Trade Commission identifying REACH regulations as a main trade barrier for small and medium-sized businesses seeking to export chemicals to the EU.

With respect to chemicals [PDF], the EC’s position recognizes that the significant differences between existing regulations in the EU and US make harmonization and mutual recognition unattainable. Nevertheless, the position paper identifies four main objective areas in which “a higher degree of convergence” and cooperation in exchanging information would result in improved efficiency and reduced costs while maintaining the existing regulatory frameworks. These four areas are:

  • Prioritization of chemicals for assessment and agreed-upon testing procedures;
  • Classification and labeling;
  • Identifying and addressing new and emerging issues; and
  • More effective data-sharing and protection of confidential business information (CBI).

The position paper makes four concrete suggestions for achieving these objectives:

  • Establish a mechanism for mutual consultation on prioritizing chemicals for assessment or risk management as well as developing assessment methodologies. In addition, both sides would keep each other informed about related developments on the Member State/state level.
  • Determine a date by which the UN Globally Harmonized System (GHS) will be implemented for a broad range of chemicals in the U.S. A mechanism for mutual consultation on the process of classifying and labeling substances should also be established.
  • Establish a mechanism for regular consultation on new and emerging issues, focusing on those with regulatory relevance (e.g., endocrine disruptors, nanomaterials).
  • Identify and consider potential benefits and challenges to exchanging CBI, with the possibility of establishing a mechanism – including periodic reviews – to achieve such exchange if found to be appropriate.

Moreover, the position paper suggests that the TTIP’s “horizontal chapter” – a proposed section of the treaty that would set a framework for future regulatory convergence – should provide for an effective bilateral cooperation and consultation mechanism, as well as an improved way to provide feedback, so that both parties have sufficient time to comment on proposed regulations. In the chemical sector, this mechanism would apply to risk management proposals for substances at the federal/EU and Member State/U.S. state levels.

According to Chemical Watch, the proposals were well-received by the European Chemical Industry Council (Cefic). The industry group’s executive director, Lena Perenius, said the position papers applied the “same logic” as Cefic’s own.