EPA issues 35 SNURs.

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Yesterday, U.S. EPA issued Significant New Use Rules (SNURs) for 35 substances which were subject to Premanufacture Notices (PMNs) under the Toxic Substances Control Act (TSCA). The SNURs were promulgated as a Direct Final Rule, and take effect starting April 14, 2014.

Fourteen of the substances, including various polyfluorinated alkyl compounds and multi-walled carbon nanotubes, are subject to “risk-based” TSCA § 5(e) consent orders which require use of protective measures to limit exposure or otherwise mitigate risk; the SNURs for these substances designate as a significant new use the absence of these protective measures. The SNURs for the other 21 substances designate various significant new uses, including releases to water as well as certain industrial, commercial and consumer activities, and establish certain protection in the workplace requirements, such as the use of respirators.

Written adverse or critical comments, or notice of intent to submit such comments, must be received by E.P.A. by March 14, 2014.

California Prop. 65: TCE added as reproductive toxicant, new additions proposed.

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California’s Office of Environmental Health Hazard Assessment (OEHHA) has finalized the addition of trichloroethylene (TCE) to its Proposition 65 list of reproductive toxicants. OEHHA proposed the listing in November 2013, based on data and conclusions from U.S. EPA’s IRIS Assessment and report finding that TCE causes male reproductive and developmental toxicity in laboratory animals. TCE, which is used as an industrial solvent, was already listed under Prop. 65 as a carcinogen.

On February 7, OEHHA filed several Notices of Intent to List various substances as cancer-causing under Prop. 65. OEHHA proposed listing beta-myrcene and “nitrite in combination with amines or amides” as carcinogenic under the “authoritative bodies listing mechanism.” Beta-myrcene is a plant derivative used as a flavoring agent or fragrance in various consumer products, and is also synthesized as a high-production chemical for the manufacture of alcohols, polymers and other chemicals. The National Toxicology Program concluded in 2010 that beta-myrcene causes kidney and liver cancers in laboratory animals. Nitrites in combination with amines or amides are commonly found in food, and its proposed listing is based on a 2010 report from the International Agency for Research on Cancer (IARC), which found “sufficient evidence” of the substance’s carcinogenicity. OEHHA also proposed listing pulegone, a plant-derived compound, as carcinogenic under the Labor Code mechanism, which is based on the Federal Hazard Communication Standard and IARC’s identification of a substance as a human or animal carcinogen. Megestrol acetate was also proposed for listing as a carcinogen in accordance with requirements by the federal Food and Drug Administration.

In addition, OEHHA announced its intent to list the triazine-class herbicides atrazine, propazine, simazine and their chlorometabolites DACT, DEA and DIA as reproductive toxicants. The listing is proposed under the “authoritative bodies” mechanism, based on various EPA studies finding that the substances “cause developmental and reproductive effects through a common mechanism of toxic action.”

OEHHA is accepting public comments on all of the above proposed listings through March 10, 2014.

DTSC spring quarterly meeting will address Safer Consumer Products.

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Officials from California’s Department of Toxic Substances Control (DTSC) will discuss the Safer Consumer Products program and Priority Products at the agency’s upcoming Quarterly Public Meeting. DTSC recently posted the agenda [PDF] online, but more detailed presentation and supporting materials are not yet available. At the agency’s last quarterly public meeting [PDF], held in December, officials estimated that draft Priority Products would be identified before April 2014 and draft Alternatives Analysis guidance would be released in spring 2014.

In addition to Safer Consumer Products, other topics to be addressed at the meeting include DTSC’s proposed budget for 2014-15; an update on the ongoing permit program review; and an update on the agency’s work on cost recovery. The meeting will be held on March 17, 2014, at 9 a.m. in the Sierra Room of the Cal/EPA Building in Sacramento.

House Subcommittee holds fifth and final hearing on TSCA reform.

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Yesterday, the House Energy and Commerce’s Subcommittee on Environment and the Economy held its fifth hearing on the Toxic Substances Control Act (TSCA). In its last hearing on the subject for the 113th Congress, Subcommittee members focused on TSCA sections 4 and 8, which govern chemical testing and information reporting and retention requirements. (We previously covered Subcommittee hearings on TSCA here and here.)

In his opening remarks, Subcommittee Chair John Shimkus (R-IL) expressed his interest in reconsidering EPA’s authority to “produce tailored, necessary and high quality test data and other information to carry out TSCA.” Rep. Shimkus also highlighted the need to reexamine section 8’s exemptions to reporting requirements and the definition of “processor.”

Both Republican and Democratic members emphasized the importance of sending TSCA modernization legislation to the President this year. Committee Ranking Member Henry Waxman (D-CA) offered to work with Rep. Shimkus, whose office has reportedly been developing TSCA reform legislation without input from any Democratic members. Rep. Waxman also pointed out that the public interest community is deeply concerned with the bipartisan Senate bill known as the Chemical Safety Improvement Act (CSIA) and noted that the American Chemistry Council and Safer Chemicals, Healthy Families coalition had in 2011 identified and documented areas of agreement in a mediated discussion. Rep. Waxman and Subcommittee Ranking Member Paul Tonko (R-NY) sent a letter to the two organizations requesting this documentation in the hope that it might “provide a blueprint for legislative success.”

Hearing witnesses from the private and public sectors all voiced their support for TSCA modernization. Industry members called for a flexible, prioritized risk-based approach to screening and assessing chemicals. Public sector witnesses advocated for significant reform of TSCA’s testing and reporting requirements, including making it easier for EPA to require testing from manufacturers, especially for vulnerable populations such as children and pregnant women, and increasing transparency for data currently protectable as Confidential Business Information (CBI).

The January 9 chemical spill in West Virginia prompted witnesses and Democratic members to question the adequacy of TSCA’s data collection, pointing out the lack of basic health and safety data on the contaminant in that spill. Also on Tuesday, the Senate Subcommittee on Water and Wildlife, part of the Environment and Public Works Committee, held a hearing on the safety and security of drinking water supplies. Senator Joe Manchin (D-WV) testified at that hearing, calling for stronger chemical storage standards and more frequent safety inspections, as well as TSCA reform.

UK REACH survey: high costs and supply chain communications problems.

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According to a survey conducted by the UK’s Department for Environment, Food and Rural Affairs (Defra), REACH registration has forced some firms to withdraw products from the market. Defra’s REACH Business Impacts Survey collected information from over 150 respondents on the effects of REACH on UK businesses following the first and second registration deadlines, with the intent of developing a “better understanding of how the implementation of [REACH] might be improved.”

The UK Chemicals Stakeholder Forum – an advisory group to the UK government composed of industry, NGOs, trade unions, and academia – reviewed initial results of the survey at a January 28 meeting. Registrants or downstream users comprised the bulk of survey respondents, although some distributors, importers, and trade groups were also included. The survey posed questions specific to the various stages in the supply chain (registrants, distributors, downstream users) and about the quality of support provided by various entities (the Health and Safety Executive, ECHA, trade associations).

On the topic of Substance Information Exchange For a (SIEFs), registrants reported mixed experiences. Costs, time commitment, and workload were some of the major problems associated with SIEFs. However, SIEFs did appear to be effective in data-sharing among businesses to assemble the required data. In addition, participation in SIEFs was found to be easier in 2013 than in 2010.

Twenty-five registrants reported withdrawing substances because of REACH; in 17 cases, the withdrawal was due to the high cost of registration rather than supply chain pressure. The survey also found that most respondents were dissatisfied with the quality of information provided in supply chain communication. Businesses experienced particular difficulties with supply chain communications and confidentiality; customers were reportedly “generally very reluctant to give information about their specific uses.” Of 37 businesses that registered or attempted to register substances imported from outside the EU, nine “experienced difficulty with obtaining information from non-EU suppliers,” due to a lack of understanding of the REACH process and, e.g., the lack of test information from China.

The preliminary survey results did not identify any clear trends on whether registrants would adopt a different approach for the next REACH registration deadline, on June 1, 2018. Changes proposed by some respondents including more planning and spreading of costs, starting the process earlier, and taking a phased approach. With regard to specific concerns to be addressed in advance of the 2018 deadline, the comments revealed two areas of needed improvement: (1) more time; and (2) more guidance from the European Chemicals Agency (ECHA).

Analysis of the survey results are still at an early stage, but the validated findings will be shared with the European Commission and ECHA. Defra plans to commission follow-up interviews in summer 2014 to address issues highlighted in the survey in greater detail.

EPA publishes Alternatives Assessments for DecaBDE and BPA in thermal paper.

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EPA has released final Alternatives Assessment Reports for DecaBDE and bisphenol A (BPA) in thermal paper. The assessments were developed under the agency’s Design for Environment (DfE) program to characterize the environmental and human health hazards for the substances and their alternatives, and are intended to inform substitution decisions.

DecaBDE is a flame retardant belonging to the class of polybrominated diphenyl ethers (PBDEs), and has been used in a wide range of products from textiles to building materials. EPA has been concerned that DecaBDE and related chemicals may be persistent, bioaccumulative, and toxic to humans and the environment. The Alternatives Assessment released yesterday is part of the agency’s action plan for PBDEs, which encourages industry to voluntarily phase out the manufacture and import of these chemicals. The Alternatives Assessment Report [PDF] profiles 29 alternative flame retardants with varying hazard profiles, including substances that have been use for decades as well as others that are relatively new to the market.

BPA is widely used as a developer in thermal paper, as in the case of cash register receipts. The chemical is common in manufacturing polycarbonate plastics and epoxy resins; thermal paper represents a smaller percentage of overall BPA use, but EPA is concerned that “use of BPA in thermal paper could increase cumulative human exposures and direct and indirect environmental releases of BPA.” The Alternatives Assessment Report, also part of an EPA action plan, profiles 19 potential chemical alternatives evaluated for human health effects, ecotoxicity, and environmental fate. The report did not identify a clearly safer alternative to BPA, as “most alternatives have Moderate or High hazard designations for human health or aquatic toxicity endpoints.”

BPA in thermal paper has recently come under increased scrutiny in Europe as well. Last week, France submitted a dossier to the European Chemicals Agency (ECHA) proposing to restrict the use of the substance; in August, France proposed reclassifying BPA from a category 2 reprotoxicant to category 1B.

Senators introduce chemical spill and water protection bill after West Virginia leak.

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On Monday, Senator Joe Manchin (D-WV) introduced a bill to prevent future chemical spills like the one that recently contaminated the Elk River and the drinking water for 300,000 West Virginians. The Chemical Safety and Drinking Water Protection Act of 2014 (S. 1961), cosponsored by Senators Barbara Boxer (D-CA) and Jay Rockefeller (D-WV), provides a framework for overseeing chemical storage facilities and equipping states and public water companies to respond to spills and other emergencies. The bill amends the Safe Drinking Water Act (SDWA) by adding a new Part G, “Protection of Surface Water from Contamination by Chemical Storage Facilities.”

According to a press release from Sen. Manchin’s office, the Act is premised on four key principles:

1. Requiring regular state inspections of above-ground chemical storage facilities,
2. Requiring industry to develop state-approved emergency response plans that meet at least minimum guidelines established in this bill, 
3. Allowing states to recoup costs incurred from responding to emergencies, and 
4. Ensuring drinking water systems have the tools and information to respond to emergencies.

The Act applies to chemical storage facilities for which the EPA or delegated state authority has determined “that a release of the chemical from the facility poses a risk of harm to a public water system.” It establishes state programs under SDWA to oversee and inspect the facilities, building on existing water protection plans. The bill sets federal minimum standards for chemical facilities regarding construction, leak detection and spill requirements, emergency response plans, and notification to EPA, state officials, and public water systems of stored chemicals. Inspections would be required on a regular basis, either every three of five years, depending on drinking water protection plans. The Act also ensures that EPA or the states can recover costs from facility owners and operators for emergency response activities.

The bill does not tackle the current framework’s deficit of health hazard information for the over 60,000 chemicals “grandfathered” in by the passage of the Toxic Substances Control Act (TSCA) – a gap which has received significant public criticism in the wake of the Elk River spill. There has been no indication whether the TSCA reform bills currently pending in the Senate Environment and Public Works (EPW) Committee might be amended in response to the West Virginia spill.

The text of the legislation [PDF] and a one-page fact sheet [PDF] are available on Sen. Manchin’s website. The bill has been referred to the Senate EPW Committee; the Subcommittee on Water and Wildlife has scheduled a hearing for February 4 entitled, “Examination of the Safety and Security of Drinking Water Supplies Following the Central West Virginia Drinking Water Crisis.”

Member states, ECHA agree to improve substance evaluation interactions.

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Member states, the European Commission, and the European Chemicals Agency (ECHA) have agreed on recommendations for improving communications under the REACH Community Rolling Action Plan (Corap). Last month, we reported on the presentation and endorsement of a working group paper recommending the improvement of interactions during the REACH substance evaluation process. Earlier this week, ECHA released the paper [PDF], which is aimed at evaluating member states and intended to “give guidance for a common approach and create a level playing field.”

The nonbinding recommendations encourage evaluating member states to contact the lead registrant in the first instance. Registrants should be proactive, “speak with one voice” in communications, and send consolidated comments on draft decisions on behalf of all registrants.

The recommendations are not meant to be exhaustive, since interactions will vary by evaluation, and instead focus on the “informal interaction” between evaluators and registrants during the current evaluation year. The experience gained from first year of evaluations informed the recommendations, which will be revised as necessary based on further experiences. The paper is intended to complement the previously published leaflet, “Substance evaluation under REACH – Tips for registrants and downstream users” [PDF].

Nearly 50 chemicals added to EPA’s Safer Chemical Ingredients List.

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EPA Assistant Administrator Jim Jones took to the agency’s blog today to promote new additions to the Safer Chemical Ingredients List (SCIL), part of EPA’s Design for Environment (DfE) program. EPA has just added nearly 50 chemicals – including 40 fragrances – to the SCIL, which now totals 650 “safer” chemicals. SCIL chemicals are evaluated by third-party profilers to determine whether they meet the program’s protective criteria across a broad range of potential toxicological effects, ranging from carcinogens to asthmagens to chemicals on authoritative lists of chemicals of concern.

DfE is a voluntary labeling program which currently recognizes 2,500 products, such as household cleaners and firefighting foam, for high performance, cost effectiveness, and use of the safest chemical ingredients. The SCIL component of the DfE program is arranged by functional use class and is aimed at helping product manufacturers identify safer chemical ingredients, formulate safer products, and make it easier for products to earn the DfE label.

Members of California’s second Green Ribbon Science Panel announced.

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Yesterday, California’s Department of Toxic Substances Control (DTSC) announced the appointment of 15 members to the newly reconstituted Green Ribbon Science Panel. The appointments include reappointed members from the first panel as well as new members. Panel members include experts on public and environmental health as well as chemicals policy, law, and engineering, and are drawn from academia, NGOs, industry, and government. As we previously discussed, the Panel advises DTSC on green chemistry and chemicals policy issues, including implementation of the Safer Consumer Products regulations.

A Green Ribbon Science Panel Webinar Meeting will be held January 29, 2014. More information from DTSC will be posted online in the near future.