Udall-Vitter TSCA reform bill approved by Senate EPW Committee.

The prospects for passing legislation to modernize the Toxic Substances Control Act (TSCA) have improved considerably with the approval of S. 697, the “Frank R. Lautenberg Chemical Safety for the 21st Century Act,” by the Senate Environment and Public Works Committee. In a 15-5 vote, the Senate panel passed a compromise version of the legislation, called a “manager’s amendment,” following weeks of negotiation which won over the support of Senators Sheldon Whitehouse (D-RI), Jeff Merkley (D-CO), and Cory Booker (D-NJ). Lawmakers announced late yesterday that they had reached an agreement on changes to the bill, which was originally introduced in March by Senators Tom Udall (D-NM) and David Vitter (R-LA). According to E&E Daily and the Huffington Post, the compromise changes include:

  • State preemption: States can regulate specific chemicals when EPA is in the process of making a safety determination, but new restrictions are preempted if EPA “defines the scope of the uses of a chemical.” If EPA fails to meet deadlines for safety determinations or state waiver requests, states automatically receive a waiver keeping state law in effect. States will also be allowed to impose chemical disclosure requirements and keep existing chemical bans effective before August 1, 2015 (previously January 1, 2015).
  • State co-enforcement: States will continue to be able to co-enforce federal laws; penalties may not be collected for the same offense.
  • Prioritization standards: Chemicals are to be designated as high priority if they present “significant” hazard and exposure, instead of “high” hazard and “widespread” exposure. The designation of a chemical as low priority will be subject to a 90-day comment period.
  • Persistent, bioaccumulative, and toxic (PBT) chemicals: EPA will be required to prioritize PBT chemicals for review from the current TSCA Work Plan list.
  • Requested assessments: Companies can request the assessment of a particular chemical, but EPA is not required to count such assessments towards the agency’s annual quota of assessments. These requested assessments would have no effect on state laws until a final regulatory action is taken by EPA. A limit on requested assessments relative to agency-initiated assessments will also be imposed.
  • Product imports: The compromise bill removed a section making it more difficult for EPA to regulate articles under the safety evaluation process.

Senator Barbara Boxer (D-CA), who had introduced a competing TSCA reform proposal, offered several amendments in Committee, but none attracted sufficient votes to pass. While vowing to continue lobbying for her amendments – which would give states more power, set tighter deadlines, and require EPA to target asbestos and track and act on local disease clusters, etc. – Sen. Boxer praised the compromises, saying, “We got rid of a horrible bill. We have a bill that makes progress.” Most environmental and health advocacy groups have also applauded the Senate panel’s work, calling it “an important milestone,” but are continuing to call for changes.

The bill is expected to proceed to the full Senate in the coming weeks.

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.

California’s Safer Consumer Products program finalizes Priority Products Work Plan.

Last week, California’s Department of Toxic Substances Control (DTSC) released its final 2015-17 Priority Product Work Plan outlining the agency’s policy priorities and product categories to be evaluated over the next three years. The Work Plan implements the Safer Consumer Products program, the part of California’s Green Chemistry Initiative that serves to “accelerate the quest for safer products.” In its final form, the Work Plan retains the same seven product categories as were included in the draft Work Plan released in September, although DTSC made changes like adding example products and clarifying or modifying the scope of certain categories.

Selected changes from the draft to final versions of the Work Plan include:

  • Beauty, Personal Care, and Hygiene Products – Sunscreen added as an example in this category.
  • Building Products – Carpet padding added as an example in this category, and nomenclature-related changes (“engineered wood,” “plywood subfloors,” and “compressed wood flooring products,” are now “Engineered Wood and Laminate Flooring” and “Plywood and OSB Subflooring.” The Work Plan’s list of changes from the Draft Work Plan also includes “insulation” and “wall coverings with flame retardants” as examples included in this category, although they are not actually discussed in the category’s narrative description or table of example products.
  • Household, Office Furniture and Furnishings – Curtains added as an example in this category. DTSC also adds that this category constitutes a subset of the Global Product Classification (GPC) standard segment “Household/Office Furniture/Furnishings,” which is divided into three families: “Fabric/Textile Furnishings,” “Household/Office Furniture,” and “Ornamental Furnishings.”
  • Cleaning Products – Surface cleaners and wax removers added as examples in this category.
  • Clothing – DTSC now states that it “will exclude consideration of protective wear intended exclusively for occupational safety.” In addition, chlorinated paraffins, halogenated compounds, and organophosphates – all flame retardants – were removed from the table of potential candidate chemicals in clothing products.
  • Fishing and Angling Equipment – DTSC has clarified the scope of this category, specifying that the agency is “most concerned about fishing weights and gear that might be consumed by water fowl due to characteristics of size, shape and density,” and thus will not consider large weights used in off-shore salmon fishing.
  • Office Machinery (Consumable Products) – The product example “Specialty paper” is narrowed down to thermal paper, while “Printer inks” is now ink cartridges.

DTSC stresses that the Work Plan is only “the first step in identifying the next set of Priority Products.” The Work Plan does not identify specific Priority Products or Chemicals of Concern, nor does it establish any new compliance requirements. Rather, the Work Plan is intended to help DTSC “move from these broad [product] categories to specific product-chemical combinations that warrant consideration as potential Priority Products.” Moreover, the Plan is meant to provide “a level of predictability to potential manufacturers, importers, retailers, and other stakeholders.”

According to the Work Plan, the number of Priority Products to be identified in 2015 “will likely be as many as three,” the same number as was announced in 2014. DTSC anticipates ramping up to more than five products in 2016 and 2017.

The Work Plan covers January 2015 through December 2017, and will be updated in 2017 with the next Work Plan, covering 2018 through 2010. However, DTSC could be required to revise this Work Plan before its expiration in the case of two scenarios: if instructed to take action on a particular chemical, product, or product-chemical combination by legislative mandate or executive order; or if the agency grants a petition to add a product-chemical combination to the Priority Products list.

DTSC encourages stakeholders to stay engaged with the Safer Consumer Products program through its “newly enhanced information management system,” CalSAFER. The system facilitates reading or writing comments on proposed regulations, filing petitions, and submitting other documents to DTSC.

House panel considers Rep. Shimkus’ TSCA reform proposal.

On Tuesday, members of the House Energy and Commerce Subcommittee reviewed the draft proposal introduced last week by Rep. John Shimkus (R-IL) to modernize the Toxic Substances Control Act (TSCA). The “TSCA Modernization Act of 2015,” takes a narrower approach to TSCA reform compared to previous proposals, and was crafted with input from members of both parties. The current bill is a “discussion draft,” and Rep. Shimkus announced that he planned to incorporate changes to it before holding a markup on May 14.

Lawmakers and witnesses alike agreed that significant progress had been made in working toward a much-needed update of the nation’s primary chemicals law, which was signed into law in 1976. The Subcommittee heard testimony from officials representing the Alliance of Automobile Manufacturers, American Chemistry Council, and Society of Chemical Manufacturers and Affiliates, and Safer Chemicals, Healthy Families, as well as Jim Jones, the EPA Assistant Administrator for Chemical Safety and Pollution Prevention.

Industry representatives were generally supportive of the bill, particularly its provisions on testing existing chemicals and improving risk management, and concluded that the sections on state preemption and co-enforcement were appropriate. However, because the proposal does not provide a detailed prioritization plan for screening chemicals or specific timelines for risk assessment, the industry witnesses emphasized the need for Congress and the White House to provide EPA with sufficient resources to accelerate the review of existing chemicals and that the bill should be amended to direct TSCA fee revenue to EPA for implementing TSCA, rather than to the general treasury. The chemical trade group representatives also called for various changes to the proposed TSCA Inventory “reset,” so, e.g., manufacturers would not have to submit new Pre-Manufacture Notices for substances that EPA removes from the Inventory and processors would be subject to reporting requirements on use and exposure data.

Assistant Administrator Jones acknowledged that the proposal complies with the Obama Administration’s principles for TSCA reform, but called for clarity on various issues, including the prioritization process and how EPA should consider cost when evaluating risk. Jones emphasized that funding was a major constraint on how many chemicals EPA can review each year, and even assessments requested and paid for by industry could not be completed within the “unrealistically optimistic” six-month timeframe proposed in the discussion draft. Jones expressed concern that by letting industry request unlimited assessments without a prioritization scheme or required minimum for agency-initiated assessments, the review process could be exploited to “delay evaluations for some of the most dangerous chemicals indefinitely.”

Andy Igrejas, director of the Safer Chemicals, Healthy Families coalition of environmental, public health, labor and other organizations, testified on several positive elements he saw in the draft as well as several areas of concern. According to Igrejas, the bill would not “fix the fundamental barrier in current law to EPA imposing risk management on an unsafe chemical,” because EPA would be required to conduct a cost-effectiveness analysis as to whether a chemical’s risk should be mitigated. Igrejas also testified that the legislation should include a “grandfather clause” for state laws that have “become settled matters of public health policy.” Despite these and other problems, Igrejas said the bill could be fixed with small changes to the language.

Environmental Appeals Board interprets TSCA § 8(e).

Last month, the U.S. Environmental Appeals Board (EAB) issued a rare and much-anticipated opinion interpreting the continuing violations doctrine and section 8(e) of the Toxic Substances Control Act (TSCA) in In re Elementis Chromium, TSCA Appeal No. 13-03 (March 13, 2015). The EAB overturned the November 2013 ruling [PDF] by the Administrative Law Judge (ALJ), which found that Elementis Chromium, Inc., a manufacturer of chromium chemicals, had violated TSCA § 8(e) by failing to report to EPA an epidemiological study on hexavalent chromium. In its March 13 decision, the EAB affirmed the ALJ in finding that the “continuing violations” doctrine applies to § 8(e) violations, thus rejecting Elementis’ statute of limitations argument. However, the EAB also held that Elementis had not violated TSCA § 8(e) because the corroborative information reporting exemption applied, and vacated the $2.5 million penalty imposed by the ALJ.

TSCA § 8(e) requires the immediate reporting to EPA of “information which reasonably supports the conclusion” that a substance “presents a substantial risk of injury to health or the environment.” In this case, a trade group of which Elementis was a member commissioned an epidemiological study on exposure to hexavalent chromium and lung cancer. EPA conducted a similar study in 2000, based on data from one facility, while the Elementis study, which finished in 2002, involved multiple “modernized” manufacturing plants. Both studies concluded that there was a positive association between hexavalent chromium exposure and lung cancer. EPA learned of the Elementis study in a 2006 Washington Post article, subpoenaed the study in 2008, and filed an administrative complaint against Elementis in 2010.

The EAB rejected Elementis’ claim that the general five-year federal statute of limitations barred EPA’s enforcement action. Elementis argued that the alleged violation accrued in 2002, when the company obtained the study, so the statute of limitations expired in 2007. However, the EAB found that the continuing violations doctrine, a special rule of accrual meaning that the period of limitations runs anew each day, applies to TSCA § 8(e), meaning that the limitations period only begins to run once the contested information is finally reported. The EAB concluded that the plain language and substance of § 8(e) imposes a continuing obligation, and violations of such are also continuing in nature. In Elementis, the company’s “last act of non-compliance” occurred on November 17, 2008, when the study was submitted to EPA, so the agency’s 2010 administrative complaint was within the five-year period.

Next, the EAB affirmed that the entire study was presumptively reportable as information which reasonably supports the conclusion that a substance presents a substantial risk of injury, rejecting Elementis’ argument that the only reportable information was “the single sentence conclusion regarding an elevated risk of cancer.” Instead, the EAB adopted a broad interpretation of the terms “information” and “reasonably supports,” concluding that Congress intended to address “the underlying data, assumptions, methodology, and analyses that actually provide the verification, corroboration, and substantiation” of the conclusion that a chemical poses a substantial risk of injury.

Nevertheless, the EAB found that the contested study was ultimately exempt from the reporting obligation because EPA established via guidance an exemption for information that is “corroborative of well-established adverse effects.” The EAB diverged from the ALJ’s analysis in finding that the Elementis study addressed a well-established adverse effect, i.e., increased incidence in lung cancer is a well-established adverse effect of exposure to hexavalent chromium. In contrast, the ALJ focused on the dose-response relationship between chromium and cancer, which the EAB characterized as an inapposite description of the potency of the chemical or conclusion about risk.

The EAB further found that the study was “corroborative” of well-established adverse effects, based not on the ordinary meaning of “corroborative,” but on agency guidance documents. This guidance describes that information is non-corroborative when it shows “the effects of a chemical are of ‘a more serious degree or different kind’ than previously perceived.” Therefore, information would be corroborative “if it shows that effects are less severe, they occur only at higher doses, or they occur in a species or strain of test animal, or by a route of exposure, that has been previously documented.” In this case, the study “only revealed statistically significant lung cancer effects at a substantially higher level” than in EPA’s own study. Thus, the Elementis study qualified for the exemption, although the EAB noted that it would have affirmed the ALJ’s decision but for EPA’s self-imposed limitation on “the broad reach of the statute with its interpretation of what information EPA is ‘adequately informed of’ in its guidance documents.”

The Elementis decision raises several interesting issues under TSCA, especially concerning the breadth of information companies must report under § 8(e) and which other TSCA sections might be interpreted as imposing continuing obligations. How EPA reacts to the decision will be instructive, especially if it chooses to refine or redefine its guidance on the corroborative information reporting exemption. Alternatively, Elementis may be of interest to legislators and stakeholders currently involved in negotiating a new framework for TSCA.

Rep. Shimkus introduces narrower TSCA reform “discussion draft” in House.

The House of Representatives has now joined the Senate in moving toward reforming the Toxic Substances Control Act (TSCA). Yesterday, the House Energy and Commerce Subcommittee on Environment and the Economy announced that it will hold a legislative hearing on a “discussion draft” of the “TSCA Modernization Act” on April 14. The newly unveiled proposal [PDF] comes from Subcommittee Chair Rep. John Shimkus (R-IL), who led last year’s unsuccessful TSCA reform effort in the House. As expected, the draft is significantly narrower in scope than either of the current Senate proposals or Rep. Shimkus’ “Chemicals in Commerce Act,” introduced one year ago.

The draft bill establishes a new system for EPA to evaluate and manage risks for chemicals already on the market, including testing authority, and excises the requirement that EPA take the “least burdensome” regulatory approach to managing risks from harmful chemicals. Instead, when developing a rule to manage a chemical’s risks, the agency would have to consider factors including benefits of the chemical substance, economic consequences, and cost-effectiveness. Under the new system, manufacturers would be able to designate chemicals for risk evaluation, in which case, manufacturers would pay the administrative costs EPA incurs in conducting the evaluation. In addition, the proposal sets timelines for completion of risk evaluations: three years for EPA-selected substances, and 180 days for evaluations initiated by manufacturers. However, there are no provisions for capping the number of evaluations industry can fast-track, or for requiring a minimum number of evaluations to be completed.

The bill would adopt a new safety standard requiring EPA to determine if there is “a reasonable basis for concluding that the combination of hazard from and exposure to the chemical substance under the intended conditions of use has the potential to be high enough to present an unreasonable risk to health or the environment.”

Notably, Rep. Shimkus’ proposal provides a more limited preemption of state laws, overriding them only once EPA has made a final decision on a chemical’s safety. However, there is no grandfather clause exempting California’s Proposition 65, which is included in the legislation from Senators Tom Udall (D-NM) and David Vitter (R-LA).

Rep. Shimkus’ bill authorizes certain state, local, and tribal government officials and healthcare professionals to access Confidential Business Information (CBI), on request, when responding to an environmental release or, in the case of healthcare professionals, to assist in the diagnosis or treatment of patients. It also proposes a system to renew CBI claims after ten years.

In the Subcommittee’s press release, Rep. Frank Pallone, Jr., (D-NJ), Ranking Member of the full committee, called the draft “a good starting point.”

Next week’s hearing will include testimony from EPA Assistant Administrator Jim Jones, of the Office of Chemical Safety and Pollution Prevention. Other panelists have yet to be named.