GlobalChem presentation: TSCA Enforcement and Compliance Issues for Industry.

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For those of you who weren’t able to make it to GlobalChem 2014 in Baltimore last week, we’ve posted Irene Hantman‘s presentation on enforcement and compliance issues associated with the Toxic Substances Control Act (TSCA). Irene’s presentation is targeted towards industry members, and was part of a panel discussing various aspects of TSCA compliance and enforcement which also featured Rosemarie Kelley, Director of the Waste and Chemical Enforcement Division at U.S. EPA, and Kindra Kirkeby, HSES Counsel at NewMarket Services. If you have any questions about the presentation, please feel free to contact Verdant or email Irene directly.

Download here: TSCA Enforcement and Compliance Issues for Industry [PDF]

House TSCA reform bill draws mixed reactions.

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More reactions and commentary from a range of stakeholders are beginning to roll in following last week’s release of the Chemicals in Commerce Act (CICA), the proposed House legislation to modernize the Toxic Substances Control Act (TSCA). As we discussed earlier, key Democrat Rep. Henry Waxman has said he does not support CICA in its current form, although he hopes to work with Republicans in crafting an improved version. Industry groups including the American Chemistry Council, American Cleaning Institute and Society of Chemical Manufacturers and Affiliates have expressed support for the draft bill by Rep. John Shimkus (R-IL), while many NGOs, including the Center for Environmental Health, Environmental Working Group, and Natural Resources Defense Council, have strongly criticized it. On its blog, Environmental Defense Fund (EDF), which expressed qualified support on the introduction of CICA, has identified two major flaws in the bill: state preemption and the “regulatory hoops” EPA would have to jump through in order to take any action, which EDF Senior Scientist Richard Denison says is “even more onerous and paralyzing” than the current law, and better addressed in the exemption provision in the Chemical Safety Improvement Act (CSIA), which was introduced in the Senate last May.

Both bills were a popular topic at this week’s GlobalChem Conference in Baltimore, where panelists were optimistic that bipartisan support could mean TSCA reform could pass Congress this year. Connie Deford, Director of Products Sustainability and Compliance at Dow Chemical, emphasized that passing reform was a priority for the chemical sector, noting that consumer confidence in the industry was at an all-time low, the current approach is short-sighted, and reform is needed to continue to foster domestic innovation and competitiveness in the global arena. David McCarthy, Counsel to the House Energy and Commerce Committee, also emphasized the need for reform to keep the U.S. competitive globally. Mark Duvall, Partner at Beveridge & Diamond, highlighted differences between CICA and CSIA, including varying reporting requirements for processors and tort implications regarding the admissibility of EPA’s safety determinations.

We will be bringing you more in-depth analysis of CICA, including side-by-side comparisons to CSIA and current law, in the near future.

Rep. Shimkus releases draft TSCA reform bill.

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Yesterday, Rep. John Shimkus (R-IL) introduced his proposal to reform the Toxic Substances Control Act (TSCA). The legislation unveiled yesterday, the “Chemicals in Commerce Act” (CICA) [PDF], is billed as a discussion draft; Rep. Shimkus has emphasized that he is open to reworking the proposal based on feedback.

The CICA broadly resembles the Senate’s bipartisan Chemical Safety Improvement Act (CSIA, S. 1009) in creating a prioritized two-tiered system for assessing existing chemicals. EPA would establish a system to designate chemicals as either high- or low-priority. The agency would be authorized to study whether high-priority chemicals pose risks to human health or the environment, including to vulnerable subpopulations, and to take regulatory actions – such as requiring labeling or volume limitations – as appropriate. CICA addresses the issue of preempting state laws – a major sticking point for critics of the CSIA – by keeping state measures in effect until EPA makes a final priority designation for each chemical.

In a statement, Rep. Henry Waxman (D-CA), Ranking Member of the House Energy and Commerce Committee, said he would not support the bill in its current form, as it would “endanger the public health,” but expressed his willingness to work with the bill’s backers on changes to make it sufficiently protective of health and the environment “while ensuring workability for industry.”

The American Chemistry Council praised the bill, calling it a “balanced approach” to passing a critically-needed update of the country’s chemical management law. The Environmental Defense Fund’s response was more cautious, calling the CICA draft a “starting line in the House, not the finish.” Safer Chemicals, Healthy Families, a coalition of public health groups, unions, and other NGOs, was more critical in its response statement, saying the bill would “roll back the very limited oversight that we currently have.”

Stay tuned for more detailed analysis of CICA next week.

Draft of House TSCA reform bill expected today.

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Rep. John Shimkus (R-IL) is expected to release today a discussion draft of his bill to modernize the Toxic Substances Control Act (TSCA). Rep. Shimkus, the Chairman of the House Energy and Commerce’s Subcommittee on Environment and the Economy, announced that he will discuss the draft with reporters tonight, and that he will work to build support with House Democrats, who were not involved in the bill’s development. Although the Subcommittee has held five hearings on TSCA, this proposal would be the first House legislation on the issue, while the Senate has considered two bipartisan bills this year. Rep. Shimkus said that he would hold two hearings on his legislation.

It is not yet known how the House proposal compares to the leading bipartisan Senate bill, the Chemical Safety Improvement Act (CSIA, S. 1009). Industry insiders expect Rep. Shimkus’ bill to resemble the CSIA, which some House Democrats have said they would not support in its current form. Sen. Barbara Boxer (D-CA), a vocal critic of certain provisions of the CSIA, acknowledged that she has had good communication with Rep. Shimkus on his bill, but is still looking for agreement on state preemption issues. Sen. Tom Udall (D-NM), who is working with CSIA cosponsor Sen. David Vitter (R-LA) to amend the Senate bill, says that “significant changes are happening” to the CSIA to gain support from critics like Sen. Boxer, and an updated version will be released soon.

Earlier this month, Rep. Shimkus told Bloomberg BNA that he expected the Subcommittee to approve his proposal by mid-March and to bring the bill before the full Energy Committee in late spring or early summer. At the time, Rep. Shimkus said the legislation would address three main issues: preemption of state regulations; industry concerns about protecting confidential business information; and the prioritization of new chemical reviews.

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

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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.

EPA will withdraw proposed rules for fourth set of High Production Volume chemicals.

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The EPA will withdraw a 2011 proposed rule requiring testing and other data for 23 High Production Volume (HPV) chemicals and imposing Significant New Use Rules (SNURs) on 22 other HPV chemicals. Last week, Bloomberg BNA reported that the agency had confirmed in an email that the rule will be formally withdrawn, although a timeline has not been established yet. Under the Toxic Substances Control Act (TSCA), HPV chemicals are those produced or imported into the U.S. at the rate of at least 1 million pounds per year. However, significant data gaps exist regarding the hazards associated with these substances.

The rules were part of the EPA’s HPV Challenge Program, which encouraged the voluntary submission of health and hazard data for approximately 1,400 HPV chemicals sponsored by companies. EPA previously issued three other test rules for “unsponsored chemicals.”

EPA justified the withdrawal of the fourth set of rules by alluding to higher priorities, such as the agency’s TSCA Work Plan, an initiative launched in 2012 that identified 83 substances on which to conduct risk assessments. When the regulatory package was proposed, industry groups commented that the proposal was duplicative in requesting data already developed for and collected by the European Chemicals Agency (ECHA), which implements REACH.

Data from over 860 chemicals was made publicly available to the HPV Challenge Program through international efforts. However, of the over 2,200 chemicals sponsored through the voluntary part of the HPV Challenge Program, data was received for only 82 percent of the substances – and not all of that data is complete.

Until the regulatory package is withdrawn, the substances subject to the SNURs remain subject to 12(b) export notification requirements.

EPA updates Endocrine Disruptor Screening Program plan.

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Today, the EPA announced the update of its Endocrine Disruptor Screening Program (EDSP) Comprehensive Management Plan. The EDSP was established by EPA in 1998 under the authority of 1996 amendments to the Federal Food, Drug and Cosmetic Act and Safe Drinking Water Act with the mission to screen chemicals in pesticides, commercial chemicals, and environmental contaminants for potential adverse effects on estrogen, androgen, and thyroid hormone systems. Generally, the EDSP provides for a two-tiered screening and testing program based on prioritized lists of chemicals.

The updated plan [PDF] outlines the critical activities for the program over the next five years, as well as strategic guidance for the agency. According to the EPA’s announcement email, a focus of the program’s activities will be “using informational technology to enhance data interpretation and applying computational methods to more efficiently prioritize and screen the universe of EDSP chemicals for potential effects on the endocrine system.”

The EDSP plan – which is non-binding – applies to fiscal year 2014 through fiscal year 2019, and will be evaluated on an annual basis for revisions. In fiscal year 2013, the program underwent four external scientific peer reviews on the critical science of the program; EPA will be considering the recommendations made by the reviewers in revising the plan moving forward, while undergoing further reviews on computational models and methods in the next few years. Other activities planned in 2014 include:

  • Completion of List 1, Tier 1 scientific review, data evaluation records, and weight of evidence decisions for 52 pesticide chemicals;
  • Completion of Tier 2 Test Methods Validation, development of test guidelines, guidance documents and standard evaluation procedures;
  • Issuance of List 1 Chemicals, Tier 2 test orders and review of other scientifically relevant information;
  • Develop various IT solutions to increase efficiency through electronic submission, tracking, and systematic data reviews; and
  • Issuance of List 2 Chemicals, Tier 1 test orders and review of other scientifically relevant information; test orders will be issued incrementally over three years.

The plan envisions completing all testing and scientific reviews, data evaluation records, and weight of evidence decisions by 2021-2023. More information on the EDSP is available on the program’s website.

CPSC finalizes new definition for "strong sensitizer."

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Last week, the U.S. Consumer Product Safety Commission (CPSC or the Commission) released a Final Rule changing the supplemental definition for “strong sensitizer” under the Federal Hazardous Substances Act (FHSA), which requires appropriate cautionary labeling on certain hazardous household products. The revised definition becomes effective March 17, 2014.

The FHSA defines “strong sensitizer” as “a substance which will cause [a hypersensitivity] on normal living tissue through an allergic or photodynamic process.” The CPSC promulgated a supplemental definition in a 1986 rule. In 2005, the Commission initiated an extensive process to update the definition, first convening a panel of scientific experts to make recommendations to CPSC staff, and then developing a draft technical report that underwent federal agency and external scientific peer review. A Notice of Proposed Rulemaking and accompanying guidance document (Strong Sensitizer Guidance) were published together on March 12, 2013.

The new supplemental definition of “strong sensitizer” aims to bring the definition in better alignment with current science on sensitization. According to the CPSC, the revised definition:

  • eliminates redundancy;
  • removes certain subjective factors;
  • incorporates new and anticipated technology;
  • ranks the criteria for classification in order of importance;
  • defines criteria for “severity of reaction”; and
  • provides for a “weight-of-evidence” approach to determining whether a substance qualifies as a strong sensitizer.

In promulgating the new definition, the CPSC addressed several comments, summarized as follows:

Implementing GHS would be too far-reaching. Two commenters urged the Commission to implement the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). The Commission clarified that GHS is not a standard-setting regulatory scheme but a set of criteria for classifying and communicating hazards. Moreover, CPSC stated that implementing GHS “would be broad-reaching, with potential impact beyond the FHSA,” and is far beyond the scope of the rulemaking.

No far-reaching effects. The CPSC rejected one commenter’s assertion that the revised definition would have “far-reaching effects,” since substances would still be subject to case-by-case hazard assessments which incorporate an approach based on science and risk.

No differentiation needed for different allergy types. The CPSC acknowledged a commenter’s recommendation to address Type I and Type IV allergies separately, but argued that this would make the definition “significantly and unnecessarily more complex.” Instead, the Commission posited that the criteria in the definition is sufficiently flexible to assess all types of allergic reactions without specifically differentiating them, and that the Strong Sensitizer Guidance released last year would provide further assistance in evaluating substances.

QSAR data accepted but not prioritized. The Commission emphasized that data from Quantitative Structure-Activity Relationship (QSAR) models was specified in the rule as a factor to be considered in a weight-of-evidence analysis of whether a substance has significant potential for causing hypersensitivity. However, QSAR data would not be given precedence over “high-quality human and animal data.”

Consumer incident reports may be considered. One comment urged including the CPSC’s and manufacturers’ records of incidents of hypersensitivity as factors to be considered in determining a substance’s ability to cause hypersensitivity. In response, the Commission emphasized that the revised definition includes “case histories” as a factor, which encompasses consumer-submitted incident reports received by the manufacturer or CPSC. The CPSC will also consider revising the Strong Sensitizer Guidance to elaborate on “the types and sources of incident reports” to use in determining whether a substance is a “strong sensitizer.”

The CPSC also defended and maintained the proposed order of ranked data criteria; changed the potential “clinically important reaction” of “substantial physical discomfort or distress” to “substantial physiological effects, such as discomfort and distress,” for purposes of clarity; and made other minor drafting changes.

Analysis: The “strong sensitizer” definition in the Final Rule does not significantly deviate from the revision proposed last year, so there is not much unexpected here. Moreover, a substance will, as before, have to undergo an individualized evaluation by the CPSC as to whether it can cause hypersensitivity and be determined to be a “strong sensitizer.” The CPSC’s possible revision of the Strong Sensitizer Guidance to address consumer incident reports will be an issue to keep an eye on.

RoHS working group will consider restricting five substances.

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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.

India’s first national chemical policy expected soon.

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India will soon publish its first national policy for the chemicals sectors, according to Chemical Watch. A “final draft” of the policy was circulated in January, and the document is expected to be finalized by the government in April or May, before the general election. The policy aims to improve the competitiveness and growth of India’s chemical sector by rationalizing regulations and creating a “robust framework for promoting safety and security of chemical facilities across the value chain.”

The final draft of the policy does not specifically address whether India will adopt REACH-like legislation, as was suggested in a 2012 draft, instead tasking the new National Chemical Centre with making recommendations for a “chemicals management framework.” The final draft does maintain the country’s commitment to developing its first national chemical inventory. This inventory is currently under production by the Ministry of Commerce and Industry-appointed chemical export council, Chemexcil, and will include data on production, consumption, imports, exports, toxicology, and classifications similar to the Globally Harmonized System (GHS) for hazard classification and labelling. Chemical Watch previously quoted a government official’s estimate that the inventory contained approximately 5,000 chemicals and would resemble inventories by other countries, such as Canada, Korea, and Japan.

Under the policy, the National Chemical Centre (NCC) will assume responsibility for the inventory after its completion. The NCC’s duties will also include establishing measures for phasing out and replacing hazardous chemicals and setting standards for test methods like high-throughput screening and alternative methods independent of animal testing.