EPA recognizes industry leaders using safer chemicals, reiterates need for TSCA reform.

/in , , , ,

Making products with safer chemicals meets consumer demand while improving companies’ bottom lines and benefiting human health and the environment at the same time, says EPA Assistant Administrator for Chemical Safety and Pollution Prevention Jim Jones. Today, Jones wrote on the agency’s “EPA Connect” blog to highlight several U.S. companies leading in the area of safer chemicals in consumer products, including as partners in EPA’s Design for Environment (DfE) program. Jones lauded these product makers and retailers for “advancing industry beyond the safety ‘floor’ set by the outdated Toxic Substances Control Act (TSCA).”

Acknowledging that the absence of a DfE label does not necessarily mean a product is unsafe, Jones points out that the DfE label promotes supply chain transparency: “With the DfE label, you know what is going into a product and that the formula is the safest for human health and the environment based on the best available science and protective criteria—above and beyond the minimum legal requirements set by existing TSCA.”

Jones’ focus on the need to update TSCA, which has been the subject of significant legislative activity this session, is consistent with his previous public statements. In today’s post, he pledged EPA’s continuing commitment to its DfE partners regardless of the outcome of the current TSCA reform effort.

New proposed rule on TSCA CBI claims expected in fall 2014.

/in ,

EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) will release its long-awaited proposed rule under the Toxic Substances Control Act (TSCA) regarding Confidential Business Information (CBI) by September 30 this year. Chemical Watch has flagged a recently released Office of Inspector General (OIG) report [PDF] that compiles and provides status updates on the many OIG recommendations that EPA has not yet implemented. The semiannual report includes recommendations stemming from a 2010 OIG report on EPA’s New Chemicals Program which found that the agency “does not have integrated procedures and measures in place to ensure that new chemicals entering commerce do not pose an unreasonable risk to human health and the environment.”

Specifically, OIG advised that OCSPP develop a “more detailed [TSCA CBI] classification guide that provides criteria for approving CBI coverage and establishes a time limit for all” CBI claims in order to permit “eventual” public access to chemical health and safety data. EPA originally agreed to implement OIG’s recommendation by proposing a rule establishing sunset provisions for CBI claims by January 31, 2012. According to the report, OCSPP informed OIG in January 2013 that the rule would be delayed because “senior management discussions” led to the decision to make a “more complex and comprehensive rule.” Last fall, the regulatory agenda released by the Office of Management and Budget CBI pegged the rule’s release for this spring.

In addition to the CBI rule, the OIG’s 2010 report on the New Chemicals Program recommended the establishment of “criteria and procedures outlining what chemicals or classes of chemicals will undergo risk assessments for low-level and cumulative exposure,” as well as updating and revising risk assessment tools and models to keep up with the latest science. OCSPP had agreed to conduct cumulative assessments of eight phthalates and EPA had agreed to consider rulemaking under TSCA § 6(a) for them by December 2012. However, the agency’s progress has been stymied by a long-delayed report on phthalates alternatives from the Consumer Product Safety Commission and Food and Drug Administration, the data from which EPA is relying on to complete its own assessments. OCSPP also agreed to implement guidance on cumulative exposure assessments by February 28, 2013, but EPA has yet to issue it. This guidance was planned for release in 2012; OCSPP now plans to implement it by December 31, 2014.

OIG also recommended that EPA make improvements in information security, including assessing the security controls on OCSPP’s online TSCA system. This assessment was to have been verified by September 6, 2013 but will not be considered past due by OIG until September 6, 2014.

Industry criticizes House Democrats’ TSCA proposal and refocuses on Senate bill.

/in ,

A week after the release of House Democrats’ proposed revisions to the Chemicals in Commerce Act (CICA), industry groups have responded with criticism and a renewed interest in the Senate’s Chemical Safety Improvement Act (CSIA), the stalled legislation that also aims to modernize the Toxic Substances Control Act (TSCA). Meanwhile, the attorneys general of ten states have also expressed their support for the CSIA in a letter to Senators Barbara Boxer (D-CA) and David Vitter (R-LA), the Chairwoman and Ranking Member, respectively, of the Senate Environment and Public Works Committee.

In contrast to the April letter from 13 Democratic attorneys general opposing CICA, the pro-CSIA letter is at least nominally bipartisan: all of the signers are Republicans except for Arkansas Attorney General Dustin McDaniel. The letter tackles Democrats’ preemption concerns head-on by praising CSIA as balancing “States’ needs to protect the health of their citizens and resources with the need to create a coherent and cohesive regulatory framework for chemical manufacturers.” The AGs also write that the Senate bill “gives States direct routes to participate in the process of identifying and evaluating chemical safety, including requests to prioritize specific chemicals and to re-prioritize a chemical based on new information.” The preemption provisions in both bills have been a point of major contention, particularly with Sen. Boxer, who has stated that any TSCA reform that fails to preserve state laws like California’s Proposition 65 is “a non-starter.”

However, according to statements made by Sen. Vitter earlier this year, progress has been made on CSIA behind the scenes, although a spokesman for Sen. Vitter told E&E Daily that there is currently no timetable for passing the bill.

Major chemical industry groups have criticized the House Democrats’ negotiating language, pointing out its similarity to legislation introduced by Rep. Henry Waxman (D-CA) that failed in 2010. Chemical Week quoted leaders from the American Chemistry Council (ACC), the Society of Chemical Manufacturers and Affiliates (SOCMA), and the American Cleaning Institute (ACI) all disapproving of the Democrats’ proposal. Officials from the ACC and SOCMA both placed the blame squarely on Rep. Waxman, saying his proposal would “undermine the effort to move legislation forward in the House” and “would not be palatable for Republicans.”

Public health and advocacy NGOs have been more reticent. Andy Igrejas, of the Safer Chemicals, Health Families coalition, said his coalition had not adopted a formal position on the Democratic proposal but expressed support for some of its aspects, including the “smaller” prioritization scheme and “fixing ‘unreasonable risk’ in ways that makes it clear that it is a health only standard that protects vulnerable populations.”

House Democrats' negotiating language on TSCA reform: user fees and tighter deadlines.

/in ,

Democrats on the House Subcommittee on Environment and the Economy have proposed a revised version [PDF] of the Chemicals in Commerce Act (CICA), the bill which Rep. John Shimkus (R-IL) first introduced in April to modernize the Toxic Substances Control Act (TSCA). However, spokespeople from both sides of the aisle expressed that continued bipartisan work was still needed. A spokesperson for Rep. Paul Tonko (D-NY) told Chemical Watch that Democrats have “not heard back on the legislative language” they proposed, while Rep. Shimkus’ office said that the Congressman’s “door remains open to any serious attempts to find common ground and move bipartisan TSCA reform through the House this year.” The Democrats’ negotiating language, presented as a redlined version of CICA, proposes user fees that would be assessed on chemical manufacturers and processors and shortens deadlines. According to Bloomberg BNA, Republican committee aides called the Democratic proposal a nonstarter.

Meanwhile, there have been no reported updates on progress toward a new version of the Chemical Safety Improvement Act (CSIA) on the Senate side.

Comments from industry and NGO stakeholders reflect tempered hopes for the prospect of passing TSCA reform this year. The American Chemistry Council (ACC) stated that, “With good-faith efforts from the Committee Democrats to develop a workable consensus, we believe there may still be opportunities to pass meaningful reform this year,” while Bill Almond, Vice President of Government Relations of the Society of Chemical Manufacturers and Affiliates (SOCMA), said that if Democratic leaders would “move toward a more reasonable position,” then “TSCA reform still has a chance of passage this year.” Andy Ingrejas, director of the Safer Chemicals, Healthy Families coalition, said the chance for passage depends on whether Republicans decide “to negotiate for real on language now that they have it” or if they are “punting for next year.”

EPA exploring data-sharing possibilities with European regulators.

/in , , ,

The EPA is considering ways to share chemical data with European regulators, including research on endocrine disrupting chemicals (EDCs) and information submitted for REACH compliance. Chemical Watch reports that Jim Jones, EPA Assistant Administrator of the Office of Chemical Safety and Pollution Prevention, will discuss sharing EDC data with regulators in Brussels in late June. Mr. Jones also commented that the U.S. and EU will likely take different approaches to regulating EDCs, but that data-sharing could improve the development of regulations for both sides.

Speaking this week at the Safer Consumer Products Summit in Santa Clara, California, Mr. Jones noted that EPA is considering how to access data submitted via Substance Information Exchange Fora (SIEFs) for the preparation of REACH dossiers. Under current rules and data-sharing agreements, this information is restricted, but EPA has previously stated that it is contemplating using its subpoena authority under the Toxic Substances Control Act (TSCA) to require U.S. companies to submit such information. Mr. Jones said that EPA has selected one chemical as a starting point to test whether European regulators would be open to sharing health and safety information with the agency.

House Committee holds hearing on new Chemicals in Commerce Act.

/in ,

Today, the House Energy and Commerce Committee held its second hearing on the Chemicals in Commerce Act (CICA), introduced by Rep. John Shimkus (R-IL) as the House’s proposal to modernize the Toxic Substances Control Act (TSCA). Today’s hearing was based on an updated version of CICA which Rep. Shimkus, who is Chair of the Subcommittee on Environment and the Economy, unveiled last week.

Rep. Shimkus began the hearing by highlighting “significant changes” from the earlier version, including: new authority for EPA to develop information for priority designation purposes; new deadlines for EPA to take action on existing chemicals; and limits on the preemption effects of a low-priority designation, which now would leave in place state regulations that were in effect before the low-priority designation was made.

In his opening remarks, Environment and the Economy Subcommittee Ranking Member Paul Tonko (D-NY) argued that, as industry witnesses have agreed, CICA must restore the public confidence in the safety of chemical products by establishing a safety standard based on health and environmental information alone, while costs and benefits should be separately incorporated in risk management actions. Energy and Commerce Committee Ranking Member Henry Waxman (D-CA) alleged that the unilateral process of developing CICA and pointed out that under the bill, “EPA would be prohibited from revealing the identity of chemicals that cause serious health and environmental harms,” which would harm companies marketing safer consumer products.

In the hearing’s first panel, EPA Assistant Administrator Jim Jones of the Office of Chemical Safety and Pollution Prevention testified that the Administration had not yet developed a “formal position” on CICA, but noted that the bill did not align with the Administration’s announced principles for TSCA reform.  Mr. Jones commented that CICA does not provide EPA with a way to review existing chemicals that may pose a concern in a timely fashion, because the legislation uses a “significant risk” standard very similar to the current law. Similarly, according to Mr. Jones, the bill’s treatment of new chemicals, like current law, does not require EPA to conclude that a chemical is safe before it is allowed to enter the marketplace.

As in previous legislative hearings on TSCA reform, all of the witnesses agreed on the importance of modernizing the law. Industry witnesses included representatives from BASF, Procter & Gamble, the Society of Chemical Manufacturers and Affiliates, and the American Chemistry Council. These witnesses supported many of the changes in the updated version of CICA, including the bill’s risk evaluation provision, new authority for EPA to develop information for prioritization, and protection of Confidential Business Information (CBI). Industry witnesses did, however, raise questions about some issues related to the bill, including the length of EPA’s deadlines, the meaning of “significant risk,” the definition of “best available science,” and appropriate fee approaches to provide appropriate resources for EPA. Witnesses from the NGO Safer Chemicals and Healthy Families and the National Conference of State Legislatures criticized the bill’s broad preemption provisions.

Outside of today’s hearings, reactions to the new version of the bill continue to trickle in. Yesterday, leading Democrats Rep. Waxman and Rep. Tonko sent a letter to Rep. Shimkus expressing concern that the bill’s preemption provisions “could jeopardize state or local laws and regulations relating to hydraulic fracturing and the chemicals used in the hydraulic fracturing process.” Environmental and public health NGOs have also been critical; the Natural Resources Defense Council called it “a dud” and the Environmental Working Group described it as a “bad piece of legislation, pure and simple.”

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

/in ,

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.

/in ,

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.

/in ,

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.

/in ,

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]