DTSC announces draft Priority Products under Safer Consumer Products program.

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This morning, California’s Department of Toxic Substances Control (DTSC) revealed its highly anticipated draft list [PDF] of Priority Products, a key step in rolling out agency’s new Safer Consumer Products (SCP) regulations.

As expected, the draft list is composed of three products. The products are:

  • Children’s foam padded sleep products containing TDCPP (chlorinated TRIS);
  • Spray Polyurethane Foam (SPF) systems containing unreacted diisocyanates; and
  • Paint and varnish strippers and surface cleaners containing methylene chloride.

The agency chose these products because they are widely used and contain at least one Candidate Chemical that has the potential to cause serious harm to human health or the environment. According to DTSC, all three of the products are known to cause serious health effects in humans, including cancer, severe asthma, and neurotoxicity. People who are at risk from these products include children and daycare workers in the case of foam sleeping products, and independent contractors, workers, and Do-It-Yourselfers in the case of SPF systems and paint strippers. Alternatives in the marketplace exist for children’s sleeping products and paint/varnish strippers and surface cleaners; however, DTSC officials said they were not aware of any spray-application alternatives for SPFs, which will present “a challenge for manufacturers.”

DTSC’s action today does not ban the products; rather, it starts an extended process that will include formal rulemaking procedures for the finalization of the Priority Products list, which may take up to a year. Next steps include DTSC’s quarterly public meeting on March 17; public workshops on the selection of the draft Priority Products, expected to be held in May and June; and a Work Plan to be released in October. After the final Priority Products list is finalized, manufacturers and sellers of Priority Products must notify DTSC that they are a “responsible entity,” and then submit a preliminary Alternatives Analysis (AA) report for state approval. A final AA report must be submitted a year later, after which DTSC will determine its regulatory response, which may range from requiring further research to imposing an outright ban on sales in California.

Moreover, DTSC intends that the SCP program will spur manufacturers and retailers to proactively reformulate products containing Candidate Chemicals. DTSC director Debbie Raphael emphasized that the measure of the success of the program would be the ability and willingness of product manufacturers to answer the question, “Is it necessary to use this chemical?” before the agency names a particular chemical-product combination.

For more information, see DTSC’s FAQ on the draft Priority Products [PDF] and press release [PDF].

Walmart’s sustainable chemicals policy promotes transparency and DfE.

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Last month, Walmart released the details of how its sustainable chemicals policy will be implemented, a move that will likely push suppliers to use safer chemicals in reformulating consumer products like cosmetics and cleaners. Walmart’s chemicals policy was first announced in September, and was quickly followed by the announcement of a “Sustainable Product Standard” developed by rival retail chain Target.

Walmart’s Sustainable Chemistry Implementation Guide is aimed at suppliers and provides details, resources, and metrics by which suppliers will be evaluated in their efforts to meet each element of the policy. The policy draws on various preexisting governmental, private sector, and voluntary programs addressing various aspects related to safer chemicals in products, particularly U.S. EPA’s Design for Environment (DfE) program.

The policy identifies “Walmart Priority Chemicals,” which are compiled from a list of authoritative and regulatory lists, including the EU’s endocrine disruptors priority list, various REACH lists, IARC’s and the U.S. NTP’s carcinogens lists, and California’s Proposition 65 developmental and reproductive toxicants list. From that compilation, the company has selected a subset of “approximately ten” “Walmart High Priority Chemicals,” which have not been publicly identified because of “business reasons.” Suppliers will learn whether a product contains a Walmart High Priority Chemical through The Wercs, a company whose WERCSmart platform facilitates the submission of product formulation information and lets retailers access and compile regulatory compliance and hazard communication data. The list of Walmart High Priority Chemicals is described in the Guide as “proprietary to Walmart,” and suppliers who are notified that their product contains a Walmart High Priority Chemical are asked not to disclose or use that information outside the supplier’s organization.

The Implementation Guide organizes the policy’s elements into three categories: (1) transparency; (2) advancing safer formulation of products; and (3) DfE in private brands.

Transparency: Suppliers will be measured based on, for example, the percentage of products (“by number of UPCs and sales”) for which formulation information has been fully disclosed to The Wercs. Walmart expects its suppliers to disclose product ingredients on their own websites, on a product-by-product basis, by January 2015; priority chemicals are to be disclosed on product packaging by January 2018. The Guide refers to EPA’s DfE Standard for Safer Products as well as the Consumer Specialty Products Association’s Ingredient Communication Initiative for guidance on how suppliers should disclose ingredients.

Safer formulation: Suppliers will be asked to complete the Sustainability Index, a questionnaire-based program developed by the Sustainability Consortium, to report progress on chemical disclosure, risk assessment, and hazard avoidance. Walmart has been using the Sustainability Index to assess suppliers and their products since 2009, and has built the resulting scorecards into the way Walmart’s buyers work. Walmart will also evaluate suppliers based on their performance in reducing, restricting, and eliminating priority chemicals and Walmart High Priority Chemicals “using informed substitution principles.” The Guide recommends the tenets of the Commons Principles of Alternatives Assessments, and recommends certain Alternatives Assessment ingredient lists and methodologies. Suppliers’ performance will be quantified based on metrics including: the aggregate weight volume of priority chemicals; number of UPCs and sales volume of products with priority chemicals; and number of products formulated with only DfE-approved ingredients. Progress on the initiatives in this category will be compared to a 2012 baseline.

DfE in private brands: Starting this year, Walmart and Sam’s Club’s own brand of cleaning products will be reformulated and relabeled to meet the criteria of EPA’s DfE program. This program will be expanded to other product categories in the future, although the Guide did not specify further details. Progress on this initiative will be measured by the percentage of private brand products which are DfE-certified.

Walmart will begin monitoring progress of all the initiatives this year, and aggregate progress will be reported publicly starting in 2016.

House subcommittee holds first hearing on Chemicals in Commerce Act.

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Today, the House Environment and the Economy Subcommittee of the Energy and Commerce Committee held its first hearing on Rep. John Shimkus’ (R-IL) Chemicals in Commerce Act (CICA), currently the only legislation to reform the Toxic Substances Control Act (TSCA) proposed on the House side. In his opening statement, Rep. Shimkus emphasized that bipartisan collaboration on the proposal was ongoing and that changes to his discussion draft version of the bill were expected. Rep. Henry Waxman (D-CA), ranking member of the Energy and Commerce Committee, repeated his opposition to the bill in its current state, particularly because of the legislation’s treatment of the state preemption issue. Rep. Waxman also repeated his willingness to work with Rep. Shimkus to find common ground, on which he said there had been little progress made since CICA was released. Witnesses representing industry, unions, and the public health sector testified on their views of the draft, generally agreeing on the need to modernize TSCA, although differing in their assessment of the bill’s overall effectiveness.

Dr. Carolyn Duran, Director of Chemical Risk and Compliance, Global Sourcing and Procurement at Intel Corporation, praised the discussion draft’s Section 6 provisions which would let companies like Intel “develop a technically feasible alternative” that is demonstrably safer within a “reasonable transition timeline.” In particular, Dr. Duran supported the draft’s treatment of articles, which would be regulated by EPA if the agency finds that an unreasonable risk of harm to human health or the environment may result from exposure to a substance in the article and that restrictions on the chemical at issue cannot adequately address the risk presented by the substance in the article.

In his testimony, Dr. Philip J. Landrigan, a pediatrician, professor, and Director of the Children’s Environmental Health Center in the Icahn School of Medicine at Mount Sinai, called the discussion draft “not satisfactory.” Dr. Landrigan referred to research on the sensitivity of children and fetuses to “even minutely low levels of chemicals,” which can cause injury to developing organs including the brain, and emphasized the need to conduct safety testing for new and existing chemicals. He called for prioritizing the testing of those chemicals “found through biomonitoring to be most widespread” in the population, for which there is evidence of toxicity, and that are persistent and bioaccumulative. Dr. Landrigan also advocated for a safety standard of “reasonable certainty of no harm,” compared to the “unreasonable risk” standard found in current law as well as the CICA draft.

The Environment and the Economy Subcommittee will likely hold at least one more hearing on “an adjusted draft” of the bill, according to Rep. Shimkus.

New warning requirements proposed for California's Prop. 65.

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This week, California’s Office of Environmental Health Hazard Assessment (OEHHA) announced its proposal to amend Proposition 65 warnings. OEHHA’s proposal is aimed at improving the quality of Prop. 65 warnings, and is part of the suite of Prop. 65 reforms advocated by Governor Jerry Brown.

A pre-regulatory public workshop on the same topic was held in July; the new proposal provides more detail and incorporates changes and feedback from comments received in response to the agency’s initial pre-regulatory proposal. OEHHA has prepared a Draft Pre-Regulatory Initial Statement of Reasons for the Warning Regulation [PDF] and Draft Pre-regulatory Warning Regulation [PDF], as well as a side-by-side comparison [PDF] between the draft regulatory language and current regulations.

Generally, the proposal establishes certain standards for what warning language counts as “clear and reasonable.” The draft regulations would require the word “WARNING” to appear in all capital letters and bold print, and specifies use of the word “expose” in the following warning language. Notably, the new proposal requires the use of a standard pictogram for toxic hazards from the Globally Harmonized System (GHS), except for on food products, drugs, and medical devices. A new OEHHA website would provide the public with more detailed information on warnings, including exposure pathways and methods of reducing exposure. The proposal also specifies the following twelve common substances (already listed under Prop. 65) that must be identified by name in the warning:

  • Acrylamide
  • Arsenic
  • Benzene
  • Cadmium
  • Chlorinated Tris
  • 1,4-Dioxane
  • Formaldehyde
  • Lead
  • Mercury
  • Phthalates
  • Tobacco smoke
  • Toluene

In addition, the proposal recognizes court-approved warning language and provides for “tailored” warning language for certain scenarios, such as dental care, apartment buildings and hotels, parking facilities, and amusement parks. OEHHA also proposes a new “Opportunity to Cure” provision for small retailers to fix certain minor violations within 14 days and avoid private enforcement actions, with the goal of avoiding frivolous litigation.

OEHHA will hold a public workshop to discuss the proposal on April 14 and will accept comments through May 14, 2014. After the workshop and comment period, OEHHA plans to propose the formal regulation in early summer 2014, with the expectation that final regulations could be adopted in the summer of 2015.

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.