Environmental groups increase pressure on EPA to release TSCA CBI rules.

Following the August 21 filing of a petition by a coalition of health, environmental and labor NGOs, EPA is under increased pressure to release its much-anticipated proposed rule on Confidential Business Information (CBI) under Toxic Substances Control Act (TSCA). Represented by Earthjustice, the coalition – whose members include the Environmental Defense Fund, BlueGreen Alliance, and Breast Cancer Fund – is petitioning EPA to propose rules to (1) automatically sunset “affirmative CBI determinations” after five years and (2) establish procedures for “reassertion” of CBI claims.

The rules sought by the Earthjustice coalition are the same ones that the EPA’s Office of Inspector General (OIG) has urged the agency to adopt. Last spring, EPA told the OIG that a proposed CBI rule would be released by September 30, 2014, although the same rule was previously slated for release in spring 2014 and then August 2014. The proposed rule is expected to set time limits with automatic expiration dates and establish reassertion and re-substantiation requirements.

The coalition’s petition was filed under a general provision of the Administrative Procedure Act – rather than the citizens’ petitions provision in TSCA – meaning that the EPA must only respond “within a reasonable time.” Earthjustice attorney Marianne Engelmann Lado told Chemical Watch that the coalition “wanted the clock ticking to actually finalize a rule and get it out the door.” The petition is available to read online [PDF].

TSCA reform still faces obstacles in Senate.

Congress’ efforts to pass legislation modernizing the Toxic Substances Control Act (TSCA) have flown under the radar in recent months, but this weekend, the Associated Press provided an update on the difficult path for TSCA reform in the Senate. The AP reports that during the summer, Senate Environment and Public Works Committee Chair Barbara Boxer (D-CA) rejected the revised version of the Chemical Safety Improvement Act (CSIA) presented to her by Sens. Tom Udall (D-NM) and David Vitter (R-LA). Sens. Boxer and Udall both agreed that the new draft’s state preemption provisions remained too broad and must be narrowed.

This latest draft has not been released publicly, although Sen. Udall said it makes “big progress” with regard to TSCA’s safety standard and stressed that it “is a huge improvement compared to the law as it stands now, and as it has stood since 1976.” In contrast, Sen. Boxer said the new draft does not make needed improvements to TSCA. Sen. Boxer pointed to the legislation’s long timelines for reviewing chemicals of concern, saying the bill “could leave nearly a thousand chemicals of greatest concern unaddressed.”

Sen. Boxer also told the AP she would propose a provision to specifically address toxic chemicals that could endanger drinking water, like the chemical MCHM that contaminated drinking water in a massive spill in West Virginia last January.

The AP article quotes NGO representatives from Safer Chemicals, Healthy Families and the Environmental Defense Fund as optimistic that TSCA reform will eventually pass. The American Chemistry Council, which backs the CSIA, has set passing TSCA reform as its top legislative priority, and spent almost $6 million in lobbying during the first half of the year.

National Research Council advises EPA on sustainability-based decision-making.

A new report advises the U.S. Environmental Protection Agency (EPA) to consider incorporating sustainability concepts used in the agency’s Design for Environment (DfE) program in its new chemicals screening process as it evolves, suggesting a new direction for Toxic Substances Control Act (TSCA) reform. The National Research Council (NRC) says that EPA should incorporate into its decision-making process an integrated strategy for evaluating effects on the three dimensions of sustainability – environmental, social, and economic – across all the agency’s activities.

This week, the NRC, the principal operating agency of the National Academies, released its report, Sustainability Concepts in Decision-Making: Tools and Approaches for the US Environmental Protection Agency. The NRC found that a wide variety of tools are available for the agency to use in integrating sustainability concepts into its decision-making, while declining to give “prescriptive advice” on “the use of specific tools and specific decisions” and recognizing that incorporating sustainability into EPA decision-making will be an “evolutionary process.”

The NRC’s report elaborates on issues left unresolved in the NRC’s 2011 report, Sustainability and the U.S. EPA (also known as the Green Book); this new report was commissioned by EPA “to examine applications of scientific tools and approaches for incorporating sustainability considerations into assessments that are used to support EPA decision-making.”

The report includes among five case studies examining how EPA could incorporate sustainability tools into its decision-making the agency’s DfE program. The NRC recommends that EPA use a “systems-thinking approach,” in contrast to the agency’s traditional focus on reducing releases from specific source categories. Likewise, in regulating products, EPA is urged to consider potential life-cycle effects of business processes along the entire value chain. In particular, the report advises EPA to consider applying lessons learned from the DfE program to the new chemicals screening process under TSCA. The NRC highlights the following approaches from the DfE program:

  • Convening public-private partnerships;
  • Using a variety of screening-level and quantitative analytic tools (like life-cycle analysis and alternatives assessments) relevant to sustainability; and
  • Using a variety of indicators (ecotoxicity, human toxicity, bioaccumulation, and environmental persistence) relevant to sustainability.

EPA is also advised to look to the private sector’s sustainability expertise to learn about tools used outside the agency, and to convene the private sector and NGOs “to define and implement value-chain-wide goals and performance outcomes.” In addition, the NRC recommends that EPA work to share insights and best practices learned from leading companies with other businesses.

EPA issues two sets of SNURs by direct final rule.

Today, EPA released a pre-publication version of Significant New Use Rules (SNURs) for 43 chemicals under the Toxic Substances Control Act (TSCA). All 43 substances have been subject to Premanufacture Notices (PMNs) and six of them are subject to section 5(e) consent orders, where EPA determined that activities associated with the substances may present unreasonable risk to human health or the environment. The SNURs are being promulgated by direct final rule and will be published in the Federal Register tomorrow, July 9.

The new SNURs cover a wide range of chemicals, including perfluorinated chemicals and lithium salts, in a variety of industrial uses, from herbicide intermediates to surfactants for laboratory use fluid.The SNURs impose various recordkeeping, notification, protective and other requirements on persons engaging in a “significant new use,” i.e., any use outside the use scenarios identified in the applicable PMNs or without specified protective measures, in the case of the 5(e) SNURs.

These 43 SNURs come a day after another set of 13 SNURs which were published in today’s Federal Register, all of which were subject to PMNs and three of which were subject to section 5(e) consent orders. Two of the substances covered in this set of SNURs are identified as carbon nanotubes.

The SNURs applying to the substances subject to section 5(e) consent orders are “based on and consistent with the provisions in the underlying consent orders.” The other substances subject to the new SNURs met the criteria of concern established at 40 CFR § 721.170.

Both sets of SNURs will go into effect 60 days following publication in the Federal Register (September 8 and 9) unless EPA receives written adverse or critical comments, or notice of intent to submit such comments, within 30 days of publication (August 7 and 8).

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

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.

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.

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.

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.

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.

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.”