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

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.

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.

House subcommittee holds first hearing on Chemicals in Commerce Act.

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.

GlobalChem presentation: TSCA Enforcement and Compliance Issues for Industry.

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.

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.

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.

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.

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.

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 issues 35 SNURs.

Yesterday, U.S. EPA issued Significant New Use Rules (SNURs) for 35 substances which were subject to Premanufacture Notices (PMNs) under the Toxic Substances Control Act (TSCA). The SNURs were promulgated as a Direct Final Rule, and take effect starting April 14, 2014.

Fourteen of the substances, including various polyfluorinated alkyl compounds and multi-walled carbon nanotubes, are subject to “risk-based” TSCA § 5(e) consent orders which require use of protective measures to limit exposure or otherwise mitigate risk; the SNURs for these substances designate as a significant new use the absence of these protective measures. The SNURs for the other 21 substances designate various significant new uses, including releases to water as well as certain industrial, commercial and consumer activities, and establish certain protection in the workplace requirements, such as the use of respirators.

Written adverse or critical comments, or notice of intent to submit such comments, must be received by E.P.A. by March 14, 2014.