A first look at the changes in the updated Chemicals in Commerce Act.

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As we briefly mentioned yesterday, Rep. John Shimkus (R-IL) released a new version of his proposal to reform the Toxic Substances Control Act (TSCA), the Chemicals in Commerce Act (CICA), and announced that another hearing on the bill will be held on Tuesday, April 29. Witnesses have not yet been announced.

The changes in the latest version of CICA do not constitute a major overhaul. Many of the changes in the bill are essentially changes in structure and nomenclature – for example, the “safety determinations” discussed in the initial “discussion draft” are renamed “risk evaluations.” Much discussion of scientific standards and considerations EPA must make in assessing scientific information – such as the use of a “weight of the evidence” approach – are stripped throughout the bill, only to be re-consolidated in new subsections on “Scientific Standards” and “Weight of Scientific Evidence.” However, the new version of CICA does remove requirements that EPA develop and establish specific standard practices and criteria for developing and evaluating high quality, reliable, and valid data.

The bill’s risk standards have also changed; previously, EPA was to determine whether new chemicals are “likely to result in” an “unreasonable risk of harm” to human health or the environment, but the new version instead asks if the chemical “may present” an unreasonable risk of harm. Chemicals are to be designated as low priority if EPA determines, based on available information, that the chemical is “not likely to present a significant risk of harm” under the intended conditions of use. In evaluating the risk of high priority existing chemicals, the Administrator is to determine whether a chemical might present, “in the absence of regulation,” a significant risk of harm under its intended conditions of use.

The new version of CICA elaborates on the risk evaluation (formerly “safety determination”) process – for example, specifying factors to be considered as well as factors not to be considered. Factors in the former category include the nature, circumstances, severity and magnitude of risk, as well as whether harm has occurred from the chemical under its intended conditions of use. In the latter category, EPA is precluded from considering the economic costs or benefits of either the intended use of the chemical or reducing the exposure of the chemical via rule. If a risk evaluation results in a determination of no significant risk, then that determination – which must be published, but is not required to be subject to public notice and comment rules – is considered a final agency action, and would not result in any further regulation (although EPA may choose to review risk evaluations). A determination of significant risk, however, does not become a final agency action until EPA promulgates a rule imposing restrictions or requirements “to protect adequately against an unreasonable risk of harm.” The updated CICA also adds a deadline for this section: risk evaluations must be published within four years of a chemical’s designation as high priority, although another provision authorizes EPA to grant extensions as necessary “but not to exceed a cumulative period of 3 years.”

Other changes to the updated CICA include:

  • Defines and incorporates more references to “potentially exposed subpopulations,” for example, effects on potentially exposed subpopulations are a factor that must be considered when EPA assigns a priority to an existing chemical;
  • Specifies in the definition of “intended conditions of use” and throughout the bill (e.g., as a test marketing activity that might qualify for a Section 5 exemption) that “disposal” is a covered activity (along with manufacturing, processing, etc.);
  • Strikes the notice and comment and Administrative Procedures Act requirements previously applied to “Risk-Based Exemptions” for new chemicals or uses;
  • Authorizes EPA to require manufacturers and processors to develop hazard and exposure information for priority designation purposes, upon the determination “that available information is not sufficient to make a priority designation”;
  • Adds an “Alternative Risk Evaluation” provision authorizing EPA to conduct a risk evaluation for a substance that is not designated as high-priority, to determine that the substance will not present a significant risk of harm in the absence of regulation and under specific conditions of use;
  • Adds a requirement that, in issuing a rule imposed on a chemical after making a significant risk determination, EPA must provide for a “reasonable” transition period for implementation; and
  • If considering a rule that would prohibit or substantially prevent a specific use of a chemical, EPA must determine whether technically and economically feasible alternatives “that benefit human health or environment, compared to the use proposed to be prohibited or substantially prevented,” will be “reasonably available as a substitute” when the rule would take effect. The discussion draft’s comparison point was whether the alternatives “materially reduce risk.”

A key sticking point for the bill’s detractors has been its express preemption provision, but the new CICA does not make substantial changes on this issue. If enacted, it appears that CICA would effectively preempt almost any state efforts to regulate or request information on chemicals covered by TSCA – except, perhaps, if the state law or regulation does not regulate the chemical substance under its intended conditions of use.

Chemical Watch reports that House Democrats have been negotiating with Rep. Shimkus on resolving their concerns with CICA, such as the scope of preemption. However, it appears that some disagreement among House Democrats remains as to the likelihood of reaching a resolution; Rep. Henry Waxman (D-CA), the Energy and Commerce Committee Ranking Member, reportedly remains concerned about establishing a “health-based safety standard,” among other issues. Currently, CICA is the only proposal on the House side; meanwhile, according to Chemical Watch, there is still no clear timeline for putting out a new version of the bipartisan bill in the Senate, the Chemical Safety Improvement Act.

Attorneys General from 13 states oppose House Republicans' TSCA reform bill.

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A coalition of Attorneys General from 13 states spoke out last week against the House Republicans’ plan to reform the Toxic Substances Control Act (TSCA). The Attorneys General sent a letter [PDF] to the leadership of the House Subcommittee on Environment and the Economy criticizing the Chemicals in Commerce Act (CICA), the proposal introduced by Subcommittee Chair Rep. John Shimkus (R-IL) in late February. Like other critics, the letter lauded the legislators’ efforts and the necessity of modernizing TSCA but took particular issue with CICA’s preemption provisions, arguing that they would “effectively eliminate the existing federal-state partnership on the regulation of toxic chemicals” and “cripple states’ ability to protect their citizens and the environment from the risks posed by toxic chemicals.” The Attorneys General on the letter are all Democrats and represent the following states: New York, California, Connecticut, Hawaii, Iowa, Maine, Maryland, Massachusetts, New Hampshire, New Mexico, Oregon, Vermont, and Washington.

CICA has already been the subject of one House Subcommittee hearing in March, and today, a second hearing on an updated draft of the bill was announced, to be held on April 29. The new draft [PDF] and a redline comparison [PDF], among other materials, are available on the hearing page.

According to the Attorneys General, CICA’s preemption provisions for both existing and new chemicals would preempt any state law or regulation that “prohibits or restricts the manufacture, processing, distribution in commerce, or use” of any chemical for which EPA has made a “safety determination,” prioritization decision, or promulgated a rule imposing requirements or restrictions. Since CICA contemplates that EPA would take at least one of those actions for all new and existing chemicals, states would eventually be preempted from regulating any chemicals. States would not be able to regulate, for example, chemicals EPA designates as low-priority but does not take further action to regulate, but which may still pose a high hazard or high exposure risk. Neither would preemption be affected by EPA’s failure to make a safety determination within the mandated 90 days.

The letter further criticizes the elimination of two of TSCA’s current “categorical exemptions” from preemption, which apply when a state regulation is identical to an EPA action, or if the state regulation prohibits the use of a chemical in the state, as well as the case-by-case exemption available under current law.

In addition, the Attorneys General argue that CICA’s preemption of states’ authority to obtain health and safety information about toxic chemicals is an unprecedented, “significant step backward in the realm of the ‘right to know’ about toxic chemicals.”

The Attorneys General pointed out that states have historically been leaders in reducing risks from toxic chemicals, as in the case of Connecticut’s early ban on polychlorinated biphenyls (PCBs) two years before the federal government’s nationwide ban came into effect under TSCA. The Attorneys General also emphasized more recent efforts by state legislatures on chemical management bills and phase-outs of particular substances and in certain applications, arguing that “[p]rotection of children’s health from harmful chemicals has been a particular focus of the states.” Under CICA, the letter argues, the states would no longer be able to serve as innovators and standard-setters for the whole nation’s benefit.

The letter is the latest critique of the House bill, which has come under attack from NGOs and some Democrats while receiving support from industry. Last month, Bloomberg BNA interviewed two former EPA officials were both more sanguine about CICA’s prospects. The officials argued that although CICA imposed serious implementation challenges on the EPA, those issues could be fixed with only minor changes. Although they agreed that CICA was relatively similar to the Senate TSCA reform proposal, the Chemical Safety Improvement Act, the officials also cautioned that the key challenge to achieving TSCA reform is addressing state preemption concerns.

Scientists: 100nm definition for nanoparticles may be "inappropriate."

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The 100 nanometer (nm) upper limit for defining nanoparticles may be “potentially inappropriate” and does not reflect the “complexity of ecological interactions” with nanoparticles, according to a viewpoint article [PDF] published in Environmental Sciences and Technology and highlighted by ChemicalWatch. According to a team of Chinese and American scientists, threshold sizes for nanoparticles likely exist and thus, critical sizes for environmental impacts are also likely to exist and exceed, or at least differ from, the 100 nm definition.

Studies show that nanoparticle threshold sizes vary with composition and shape, probably due to “changes in excess surface energy and crystallography of [nanoparticles] as size decreases.” Threshold size ranges have been established for nanoparticles based on physicochemical properties including particle dissolution, contaminant adsorption, and suspension stability, for example. However, further research is required to determine threshold sizes for complex biological effects like accumulation and toxicity, as nanoparticles may have size-specific mechanisms for transformation, reactive oxygen species production, etc.

The scientists point out that if threshold sizes for nanoparticles’ environmental impacts exist, changes in the effects could not be predicted by larger particle sizes, even under the 100 nm definition. Thus, to better assess and minimize environmental risks from nanoparticles, the size and functionalization of nanoparticles in development should be designed appropriately if that nanoparticle is determined to have substantially increased ecotoxicological effects below a certain threshold.

The scientists call for more research “to assess the potential for threshold sizes for environmental impacts and to assess if [nanoparticles] larger than the threshold sizes have different impacts than bulk particles of the same composition.” The results of such research could better inform the current size definition of nanoparticles and affect methods for modeling environmental impacts and risks.

D.C. Circuit Court partially strikes down SEC conflict minerals rule.

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On Monday, a federal appeals court struck down a rule implementing the Dodd-Frank Act’s requirement that companies disclose whether their products contain conflict materials originating from the Democratic Republic of Congo (DRC), or adjoining countries. A divided (2-1) panel of the U.S. Court of Appeals for the D.C. Circuit ruled [PDF] that the U.S. Securities and Exchange Commission (SEC) rule compelled commercial speech in violation of the First Amendment.

Industry groups challenged the SEC’s final rule on Administrative Procedure Act (APA), Exchange Act, and First Amendment claims. In National Association of Manufacturers v. Securities and Exchange Commission, the industry groups appealed the District Court’s rejection of their claims, but only prevailed with respect to the First Amendment challenge.

The APA claim in part attacked the rule’s lack of a de minimis exception. As we reported in November, because the SEC rule does not contain a de minimis exception, the disclosure requirement – which also calls for due diligence and auditing – could apply to firms that use conflict minerals in very small amounts as catalysts in the manufacturing process. The Court upheld the decision not to include a de minimis exception, finding that the SEC, “relying on text, context, and policy concerns, inferred that Congress wanted the disclosure regime to work even for small uses,” and a de minimis exception would thwart the statute’s goals.

The Exchange Act challenge also failed, as the Court found that the SEC’s cost-benefit analyses as required by the Exchange Act were “reasonable,” even though the rule’s “compelling social benefits” were not quantifiable.

However, the Court sided with the industry groups with regard to the SEC rule’s requirement that companies describe its products as not “DRC conflict free” in reports filed with the Commission and on the companies’ own websites. Writing for the Court (and joined by Judge Sentelle), Judge Randolph found that rational basis review was not appropriate for this type of speech, because it only applies to “purely factual and uncontroversial information,” in cases in which “disclosure requirements are reasonably related to the State’s interest in preventing deception of consumers.” In this case, the SEC did not argue that the rule related to preventing consumer deception. Judge Randolph concluded that requiring the use of the “conflict free” label was found to convey a “moral responsibility for the Congo war,” tantamount to “compelling an issuer to confess blood on its hands” in interference with the First Amendment.

The Court further found that the SEC’s rule failed to meet the intermediate standard for commercial speech set out in Central Hudson, which “invalidates regulations for which narrower restrictions on expression would serve the government’s interest as well.” (Quotations omitted.) In this case, the SEC presented no evidence that less restrictive means would be ineffective, and the Court rejected its argument that the rule’s minimal impact was dispositive of the “narrowly tailored” requirement.

Notably, Judge Srinivasan declined to join the Court’s opinion with respect to the First Amendment claim, arguing that the issue should have been held in abeyance and part of the SEC rule stayed until the Circuit’s en banc re-hearing of a related case, American Meat Institute v. United States Department of Agriculture, regarding meat labeling.

Moving forward, the rule’s effective date for compliance is June 2, and the SEC has not yet offered a stay or guidance to companies on how to comply with the partially-invalidated rule. The SEC has also not yet announced whether it will seek to participate in the AMI case; otherwise, the case will be remanded to the D.C. District Court.

Report: REACH a primary trade barrier for SMEs exporting to EU.

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Last week, the U.S. International Trade Commission (USITC) released a report identifying the high costs of complying with REACH as one of the primary trade barriers affecting American small and medium enterprises (SMEs) seeking to export to the EU. Although SMEs account for as much as 35 percent of U.S. chemicals exports to the EU, the complexities and costs of REACH disproportionately affect SMEs, meaning firms with less than 500 U.S.-based employees. SMEs reported that REACH compliance could add over 20 percent to the cost of the product.

REACH’s testing requirements and the need for a special representative in the EU are reportedly particularly burdensome for SMEs. Other problems with REACH cited by SMEs include what firms consider to be excessive disclosure requirements, especially of trade secrets; the prohibitive cost of registering chemical additives; the difficulty of communicating with the European Chemicals Agency (ECHA); and ECHA’s opaque rulemaking process. SMEs also reported that the Substance Information Exchange Forums (SIEFs) maintained under REACH “can hinder competition in that SMEs may have challenges accessing the necessary information and negotiating with the larger companies in the SIEF.” The report cited hearing testimony from the Society of Chemical Manufacturers and Affiliates (SOCMA) that the 2018 REACH deadline, applying the quantity threshold of just 1 metric ton per year, has already driven some companies to decide not to export to the EU market because of REACH’s costs and complexity.

In addition to REACH, the USITC report highlighted several other trade barriers facing U.S. SMEs exporting to the EU, including the Biocidal Products Regulation, the EU Cosmetics Directive, the Restriction of Hazardous Substances (RoHS) Directive, and the Waste Electrical and Electronic Equipment (WEEE) Directive. Challenges for SMEs dealing with these regulations reportedly include high compliance costs, increased product costs, expensive testing requirements, and lengthy certification processes.

The report, which was conducted at the request of the U.S. Trade Representative, was primarily based on information and statements collected from SMEs on a voluntary basis. The entire report is available for download here [PDF].

Legislators in other states following example set by CA's Safer Consumer Products regulations.

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California led the way in state-level regulation of chemicals in products, and now, other states are beginning to follow its example. Bills pending in both Massachusetts and Vermont are modeled after California’s Safer Consumer Products (SCP) regulations.

In Vermont, the State Senate yesterday voted to approve S. 239, a bill which has provoked controversy in the state and must pass final approval in the Senate today before moving to on to the House. Last week, the Massachusetts Joint Committee on Environment, Natural Resources and Agriculture held a hearing on H. 235, which would establish a SCP-like program. The proposals in both states entail creating a list of “priority” chemicals, as in the California program, which would likely be based on existing authoritative lists. Both bills also call for manufacturers to conduct alternatives assessments for certain products containing priority chemicals, and authorize state regulators to ban the sale of certain products. The Vermont bill provides for companies to apply for a waiver, and the Massachusetts bill provides for a range of regulatory responses besides an outright ban.

Various state legislatures are also considering more limited proposals targeting chemicals in children’s products, including Minnesota’s H.F. 605 and Connecticut’s S.B. 126.

ECHA finalizes REACH CoRAP list.

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The European Chemicals Agency (ECHA) has adopted its final substance evaluation plan for 2014-2016. This updates the REACH Community Rolling Action Plan (CoRAP) list to contain 120 substances, 51 of which will be evaluated by member states this year. The plan provides that 48 more substances will be evaluated in 2015 and 21 in 2016, although it will be updated annually. The update includes 52 substances which are new entries to the plan, including 17 to be evaluated in 2014.

Common initial concerns for listing these substances include: persistent, bioaccumulative and toxic (PBT) effects; suspected endocrine disruption; and carcinogenic, mutagenic, and reproductive toxicity (CMR); combined with wide dispersive or consumer use. Substances of note on the list include a handful of phthalates, shale oil bitumen, and silver nanoparticles.

The adopted plan differs only slightly from the draft update circulated in the fall of 2013 and approved by ECHA’s Member State Committee last month. The final CoRAP list adds trixylyl phosphate and removes four substances:

  • 3,4,5,6,7,8,9,10,11,12,13,14-dodecahydro-2H-cyclododeca[b]pyran;
  • yellow pigment additive;
  • 1,3,4,6,7,8-hexahydro-4,6,6,7,8,8-hexamethylindeno[5,6-c]pyran (HHCB); and
  • 1-(5,6,7,8-tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one.

Aluminum chloride and aluminum chloride, basic were originally covered as one entry but are treated separately in the final list. In addition, several other substances were evaluated under the last CoRAP – including shale oil bitumen and naphthalene – and were found to qualify for re-evaluation.

ECHA encourages registrants to follow its new best practices recommendations for interactions during substance evaluation, which we have previously discussed.

The complete CoRAP list is available online.

ECHA committee takes step towards reclassifying BPA as 1B reprotoxicant.

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The Risk Assessment Committee of the European Chemicals Agency (ECHA) has adopted an opinion to strengthen the harmonized classification and labeling (CLH) of bisphenol A (BPA), in line with a proposal by France regarding the substance’s adverse effects on sexual function and fertility. BPA is currently classified as a category 2 reproductive toxicant and would be reclassified as a category 1B reproductive toxicant.

The committee’s consensus-made action was based on “‘rock-solid’ multigenerational rodent studies” and tees up a final decision to be made by the European Commission. France’s reclassification proposal has received mixed responses [PDF] from member states and industry. If approved, the reclassification of BPA as category 1B would trigger Substance of Very High Concern (SVHC) criteria under REACH.

BPA is a monomer widely used in the production of polycarbonate plastics and epoxy resins and as a developer in thermal paper. In late 2013, ECHA followed up a German substance evaluation of BPA by issuing a request for further data on skin absorption and environmental exposure. The European Found Safety Authority (EFSA) also recently closed a public consultation period on a draft assessment of the human health risks of BPA via food exposure. A recent rodent study conducted by U.S. researchers at the National Center for Toxicology Research, however, concluded that orally-ingested BPA did not affect body weight, reproductive organs, or hormones at levels comparable to the amount Americans typically ingest.

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.