Lautenberg Act: EPA names ten Work Plan chemicals for initial risk evaluations.

The U.S. Environmental Protection Agency (EPA) has announced the ten Work Plan chemicals for review under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which updated the Toxic Substances Control Act (TSCA). Yesterday, the agency released the list of substances, which will be the first to undergo risk evaluations under the new law. The list is mainly made up of flame retardants and industrial solvents, many of which are used in consumer products, as well as asbestos, the notoriously carcinogenic mineral used in building materials.

The chemicals are:

  • 1,4-Dioxane
  • Bromopropane
  • Asbestos
  • Carbon Tetrachloride
  • Cyclic Aliphatic Bromide Cluster
  • Methylene Chloride
  • N-methylpyrrolidone (NMP)
  • Pigment Violet 29
  • Tetrachloroethylene, also known as perchloroethylene
  • Trichloroethylene (TCE)

Under the Lautenberg Act, EPA must select ten chemicals from the 2014 Work Plan by December 19, 2016. The Work Plan contains 90 chemicals with potential for high hazard and exposure, as well as considerations including persistence and bioaccumulation. The agency notes that in choosing the ten chemicals, it “took into account recommendations from the public, industry, environmental and public health groups, and members of Congress and tried to give weight to chemicals where work on assessing risks were underway.”

Among the listed chemicals, EPA has already completed risk assessments for methylene chloride, NMP, and TCE, and taken early steps towards assessments for 1,4-Dioxane and the Cyclic Aliphatic Bromides. For methylene chloride, NMP, and TCE, the agency plans to proceed with Section 6(a) rulemaking for the limited uses defined for the completed risk assessments; the chemicals’ remaining uses will now be newly evaluated. The ongoing rulemaking for these chemicals were included as “Immediate Actions” in EPA’s First Year Implementation Plan for the Lautenberg Act.

The reformed TSCA requires that EPA evaluate existing chemicals to determine whether they “present an unreasonable risk of injury to health or the environment.” The list’s publication in the Federal Register will trigger the three-year statutory deadline for completing the risk evaluations. In the next six months, EPA must release a scoping document for each chemical. The remaining 80 Work Plan chemicals will also be reviewed, as the law requires EPA to begin a new evaluation for every completed evaluation, with half of all EPA-initiated evaluations drawing from the Work Plan list until it is exhausted. In addition, EPA must have at least 20 chemical risk evaluations ongoing by the end of 2019.

Environmental groups mostly praised the decision to prioritize asbestos, a fire-resistant material that causes mesothelioma cancer which outgoing Senator Barbara Boxer (D-CA) called “the poster child for TSCA reform.” However, Earthjustice criticized EPA’s failure to include lead, citing children’s exposure to the neurotoxin via “ongoing, unnecessary uses of lead in consumer products.”

In a statement, the American Chemistry Council emphasized that a chemical’s inclusion in the list was only the first step in a process based on high quality data and the weight of scientific evidence. The industry group also said “it is imperative that EPA engage stakeholders early and often throughout the risk evaluation process, including through peer review and public comment.”

Science advisors urge EPA to complete 1-BP risk assessment.

The Chemical Safety Advisory Committee is urging the Environmental Protection Agency (EPA) to complete and publish its risk assessment of 1-bromopropane without delay, due to “the high risks of adverse effects” in occupational and consumer use scenarios that have already been evaluated. In meeting minutes [PDF] submitted to EPA last week, some Committee members commented that these risks might have been under-estimated. The chemical, also known as 1-BP, is used in spray adhesives, dry cleaning, and degreasing, and was among the chemicals identified in the 2012 Toxic Substances Control Act (TSCA) Work Plan.

The Committee, an independent panel of scientific advisors comprised of experts in toxicology, environmental risk assessment, exposure assessment and related fields, met in May to review the scientific and technical merit of EPA’s draft risk assessment for 1-BP, which was released in March 2016.

Overall, the Committee praised the draft risk assessment, concluding that “the conceptual model appropriately considers worker exposures and consumer uses, with the majority of exposure occurring via inhalation.” The Committee stressed the importance of including consumer uses with acute exposures, and several members called for better consideration of exposure from co-residence and community-level exposures near dry-cleaning facilities. The Committee provided recommendations “intended to improve the clarity and transparency of the scientific analyses,” including the adoption of systematic review processes to clarify how studies were selected and evaluated. Other recommendations include ways to refine occupational and consumer exposure assessments.

Under the new requirements of the Lautenberg Act, EPA must identify 10 Work Plan chemicals for risk evaluations to be initiated by December 2016. EPA will revamp the prioritization process for risk evaluations in 2017 and 2018, using new criteria to be established, through rule-making, by mid-June 2017.

EPA releases initial analysis for TSCA Work Plan assessment of 1,4-dioxane.

EPA today announced the release of its Problem Formulation and Initial Assessment for 1,4-dioxane, a widely used industrial solvent and ingredient in a variety of products, including cleaners, cosmetics, dyes and paint strippers, which the EPA has classified as “likely to be carcinogenic to humans.” The Problem Formulation and Initial Analysis, part of the agency’s Toxic Substances Control Act (TSCA) Work Plan risk assessment program, concludes that there is no concern for inhalation exposure of ambient air emissions by the general population. However, EPA plans to further assess potential risks to both workers exposed via inhalation during product formulation and use as a cleaning agent and to workers and consumers that use products containing 1,4-dioxane as a contaminant, such as paints, varnishes, adhesives, cleaners and detergents. EPA intends to use existing data and methods to conduct additional risk analysis, review previous health and exposure studies, and “develop margins of exposure and cancer risk estimates.” The Problem Formulation and Initial Assessment also concluded that assessing risk from drinking water exposure is not currently necessary due to ongoing monitoring by EPA’s Office of Water, so “decisions as to whether or not to regulate the contaminant in drinking water will be considered as part of the EPA’s Regulatory Determination process.” In addition, the agency announced that further environmental risk analysis would not be pursued because of the low hazard profile for 1,4-dioxane to aquatic organisms and the lack of hazard data for sediment and soil organisms.

EPA completes risk assessment for n-methylpyrrolidone (NMP).

EPA has made more progress with its Toxic Substances Control Act (TSCA) Work Plan with yesterday’s release of the agency’s final risk assessment for N-Methylpyrrolidone (NMP) or 1-methyl-2-pyrrolidinone, a chemical commonly used in paint and coating removal products. NMP is estimated to be used at over 184 million pounds per year, in paint strippers, agricultural chemicals, electronic cleaning, and petrochemical processing. The risk assessment identifies developmental toxicity risks for pregnant women and women of child-bearing age who have high exposure to NMP, as either consumers or workers. Risks were identified for both acute and chronic exposures, although acute exposure risks could be mitigated by using chemical-resistant gloves and using NMP products for less than four hours a day.

EPA is considering a range of voluntary and regulatory actions to reduce risks from NMP exposure. This is the fifth final risk assessment completed under the TSCA Work Plan.

EPA’s chemicals outlook for 2015.

Jim Jones, the EPA Assistant Administrator for Chemical Safety and Pollution Prevention, writes in Chemical Watch that his highest priority in 2015 is “to continue building on the progress” of the last few years in making a “credible” program to manage existing chemicals, “despite the widely acknowledged shortcomings of the Toxic Substances Control Act (TSCA).” In his outlook for 2015, Assistant Administrator Jones highlighted progress on the TSCA Work Plan for Chemical Assessments as well as various regulatory actions.

Assistant Administrator Jones noted that in 2014, EPA completed final assessments on four chemical substances. Of those, the assessments for trichloroethylene (TCE) and methylene chloride (DCM) identified health risks to consumers and workers working with the chemicals. In 2015, the agency intends to negotiate for voluntary risk reduction measures with TCE and DCM manufacturers, but would turn to TSCA § 6 to mandate risk management – a regulatory tool EPA has not used in 28 years. Under the TSCA Work Plan, assessments scheduled for 2015 will address the following:

  • N-Methylpyrrolidone (NMP) in paint stripper products;
  • three clusters of related chemicals, used as flame retardants;
  • several uses of 1-Bromopropane (1-BP); including occupational uses of 1-BP in dry-cleaning and foam gluing operations, consumer uses in aerosol solvent cleaners and spray adhesives;
  • 1,4-Dioxane; and
  • long- and medium-chained chlorinated paraffins used as metal working and compounding agents and its effects on ecological receptors.

EPA has a variety of regulatory actions planned for 2015. The agency plans to finalize a rule regulating formaldehyde emissions from composite wood products, thus making national the emissions standard already in place in California. In addition, EPA will make a determination on “whether renovations in commercial and public buildings create a hazard from lead-based paint.” Assistant Administrator Jones also announced that the agency will, in late 2015 or early 2016, propose the modification of existing use authorizations for polychlorinated biphenyls (PCBs) in several contexts. Finally, Assistant Administrator jones noted that 2015 would mark a “turning point” for the agency’s green chemistry programs as incentives and obstacles to adoption of greener chemistries are identified.

Other items on EPA’s agenda for 2015 include:

Elementis Chromium appeals $2.6 million penalty in TSCA 8(e) reportable data case.

In a case that may have broad implications for chemical manufacturers, Elementis Chromium has appealed the $2.57 million penalty handed down by an EPA Administrative Law Judge (ALJ) in November 2013. The ALJ ruled that Elementis, one of the world’s largest chromium manufacturers, had violated section 8(e) of the Toxic Substances Control Act (TSCA), which requires reporting information about serious health risks to EPA. In addition to the hefty penalty at stake, the Elementis case is worth watching because it signals that EPA is continuing to pursue a very broad interpretation of what constitutes reportable data under TSCA § 8(e).

In its appeal [PDF] to the Environmental Appeals Board (EAB), Elementis makes two arguments: (1) EPA’s enforcement action was barred by the federal five-year statute of limitations; and (2) the epidemiological study at issue was not required to be submitted under TSCA § 8(e).

According to Elementis, the study’s findings were consistent with previous studies and merely confirmed and corroborated risk findings already known to EPA and the industrial health community. Elementis argues that the ALJ erred in interpreting new “substantial risk information” under TSCA to include “mere differences in scientific study methods or subjects between studies.” Instead, Elementis argues that EPA was already aware of the study’s information on substantial risk of injury to human health, “namely that high cumulative exposures to hexavalent chromium lead to an increased risk of lung cancer.”

Elementis’ appeal also argues that since § 8(e) requires the “immediate” reporting of certain information to EPA, violations of the provision are not “continuing” in nature. Thus, if the five-year statute of limitations began running upon the company’s receipt of the study in 2002, EPA’s 2010 Complaint was filed beyond the statute of limitations. According to Elementis, a violation of § 8(e) is not “continuing,” since there is no clear indication in the statute that Congress intended for the continuing violation exception to apply and, moreover, the statute establishes a definite timeframe for compliance by requiring “immediate” reporting. The company’s appeal criticizes the ALJ’s interpretation of the statute, which is described as establishing a “never-ending duty to inform that begins immediately.”

Furthermore, Elementis argues that the Supreme Court’s decision in SEC v. Gabelli, declining to apply the “discovery rule” in the case of an SEC civil enforcement action for an alleged fraud, means that the EPA’s enforcement action is time-barred here. In Gabelli, the Supreme Court relied on public policy reasoning in criticizing “grafting the discovery rule onto” the federal five-year statute of limitations in actions for penalties. Elementis argues that the continuing violation exception functions like the discovery rule in Gabelli, and thus was applied by the ALJ in error.

The Response Brief from EPA Region 8 to Elementis’ Appeal Brief has not yet been posted to the EAB docket, although it is expected soon.

RoHS working group will consider restricting five substances.

The European Commission will present proposals to restrict five additional substances under the EU’s Restriction of Hazardous Substances Directive (RoHS), which applies to electrical and electronic equipment. Four of the substances – hexabromocyclododecane (HBCDD) and the phthalates DEHP, BBP and DBP – have already been assessed by the Austrian Environment Agency (UBA). These assessments are part of the RoHS 2 Annex II report, which UBA released on February 5. The consultancy Öko Institut is currently reviewing the fifth substance, the phthalate DIBP, and is expected to release results by the end of April.

The UBA’s assessments found that HBCDD, DEHP, BBP, and DBP pose unacceptable risks to workers’ health or the environment and thus should be added to Annex II of RoHS2. The report noted that the proposed bans would not be cost prohibitive, and safer alternatives are technical and economically feasible.

Under RoHS2 – a recast of RoHS adopted in 2011 – a first review of the list of restricted substances is required by July 2014. The Commission will establish a working group to review the priority list of substances, which was developed by UBA. Chemical Week reports that, according to the RoHS policy officer at the Commission’s Environment Directorate-General (DG Environment), the working group will include representatives from approximately three member states, various industries, DG Environment, and the Directorate-General for Enterprise and Industry.

In addition, the working group will consider the procedure for reviewing substances. The Directive does not require updating the review process, but the Annex II report examines issues associated with the methodology used for the substance assessments and makes recommendations for a four-year review cycle going forward. The report also discusses lessons learned from the substance review process, such as the scarcity of relevant information, the lack of integration of exposure estimates from waste treatment facilities, and overlaps with other legislation, like REACH. The Commission plans to release non-binding guidance on the review process near the end of the year.

Chromium manufacturer fined by EPA for failure to disclose health risks.

Last month, an Administrative Law Judge (ALJ) ruled on a relatively rare Toxic Substances Control Act (TSCA) enforcement case, ordering Elementis Chromium to pay a $2.57 million penalty for violating TSCA § 8(e), a provision of the law that required the company to disclose information about serious health risks.  The ALJ found that Elementis Chromium, one of the world’s largest manufacturers of chromium chemicals, failed to notify EPA of a study finding substantial risk of injury to human health from exposure to hexavalent chromium.

The November 12, 2013 decision [PDF] is the latest development in an enforcement action that EPA initiated in 2010. At issue in the case was an industry-backed study documenting health impacts – including increased cancer risks – on workers in chromium processing plants: EPA contended that the study filled a “data gap” in the literature, while Elementis argued, among other defenses, that EPA was already adequately informed of the information. However, the ALJ interpreted “information” broadly, following EPA guidance, in concluding that the study in question presented new substantial risk information about occupational hexavalent chromium exposure. Chief ALJ Susan Biro also thoroughly discussed and ultimately rejected Elementis’ contention that the study fell under an exception to TSCA § 8(e) as merely “corroborative of well-established adverse effects.”

The decision is also notable for its discussion interpreting the EPA’s penalty policy on “attitude,” a sub-factor of “culpability.” ALJ Biro increased the penalty amount by 10% for attitude, citing Elementis’ “bad faith” and attempts to influence the Occupational Safety and Health Administration’s exposure limits for chromium while keeping the study information in its “back pocket.” The decision concluded: “Over time, …the frontier in risk assessment is always going to be studying lower and lower exposures…. This decision takes into account that Congress intended to place the onus for understanding that frontier on the industries whose workers may be at risk.”

The decision becomes final 45 days after its issuance unless Elementis chooses to appeal to the Environmental Appeals Board.

IC2 Releases Draft Risk Reduction/Safer Alternatives Guidance

The Interstate Chemicals Clearinghouse (IC2) has released a draft guidance document for alternatives assessment and risk reduction.  The public comment period continues through Friday, May 3, 2013.

The IC2 is an association of state and local governments working together to coordinate inter-agency efforts promoting the use of safer chemicals and products.  Of the member states, only California currently has a robust green chemistry program. The draft Guidance for Alternatives Assessment and Risk Reduction was developed with technical support from EPA’s Design for the Environment and Clean Production Action.

The Guidance is designed to meet the needs of a wide range of users.  Principles instrumental to developing the Guidance include:

  • reducing risk by reducing hazards,
  • transparency, and
  • life cycle thinking.

The IC2 emphasizes that through life cycle thinking, users can avoid merely shifting impacts from one aspect of the product life cycle to another.  The Guidance observes that only in rare instances will no safer alternatives be available.

The Guidance includes four scoping modules to help users set parameters for the scope of the alternatives assessment process and seven decision modules to evaluate criteria, ranging from performance to hazard and materials management to cost and availability.  Within each module, users can select the level of complexity and corresponding data requirements appropriate to their needs and capabilities.  For example, criteria in the performance module include measures that test whether potential alternatives are technically feasible.  The Guidance also provides mechanisms to identify uncertainties and consider them in the decision-making process.

EU Commission Releases Roadmap on Substances of Very High Concern

EU REACH Substances of Very High Concern:

Last week, the EU Commission released its Roadmap on Substances of Very High Concern (SVHC). The Roadmap outlines a process for identifying and assessing potential SVHCs within the following categories: substances that are carcinogenic, mutagenic or toxic for reproduction (CMRs); substances that are persistent, bioaccumulative or toxic for the environment (PBTs); substances that are very persistent and very bioaccumulative (vPvBs); and substances of equivalent concern, such as endocrine disruptors. The Roadmap estimates that the process will evaluate up to 440 substances, a far lower number than the 1,900 substances originally anticipated, with an initial goal of completing 80 assessments by the end of 2014.

The Roadmap follows the Commission’s commitment to compile a comprehensive REACH candidate list of SVHCs and is designed to help meet the Commission’s plan to include all currently known SVHCs on the candidate list by 2020.

The SVHC Roadmap proposes first screening substances with REACH registration dossiers by applying a minimum quantity threshold and generally exempting substances registered only for intermediate uses. The second step entails conducting a “Risk Management Options” (RMO) analysis. Under this approach, the best regulatory option to manage a particular risk is chosen after considering actions available within REACH (like imposing authorization, restriction or substance evaluation requirements) or under other legislative schemes, such as RoHS. For example, the Roadmap suggests that substances with demonstrated risk should be restricted under REACH.

The roadmap is downloadable as a PDF from the EU website.