EPA issues 35 SNURs.

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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.

House Subcommittee holds fifth and final hearing on TSCA reform.

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Yesterday, the House Energy and Commerce’s Subcommittee on Environment and the Economy held its fifth hearing on the Toxic Substances Control Act (TSCA). In its last hearing on the subject for the 113th Congress, Subcommittee members focused on TSCA sections 4 and 8, which govern chemical testing and information reporting and retention requirements. (We previously covered Subcommittee hearings on TSCA here and here.)

In his opening remarks, Subcommittee Chair John Shimkus (R-IL) expressed his interest in reconsidering EPA’s authority to “produce tailored, necessary and high quality test data and other information to carry out TSCA.” Rep. Shimkus also highlighted the need to reexamine section 8’s exemptions to reporting requirements and the definition of “processor.”

Both Republican and Democratic members emphasized the importance of sending TSCA modernization legislation to the President this year. Committee Ranking Member Henry Waxman (D-CA) offered to work with Rep. Shimkus, whose office has reportedly been developing TSCA reform legislation without input from any Democratic members. Rep. Waxman also pointed out that the public interest community is deeply concerned with the bipartisan Senate bill known as the Chemical Safety Improvement Act (CSIA) and noted that the American Chemistry Council and Safer Chemicals, Healthy Families coalition had in 2011 identified and documented areas of agreement in a mediated discussion. Rep. Waxman and Subcommittee Ranking Member Paul Tonko (R-NY) sent a letter to the two organizations requesting this documentation in the hope that it might “provide a blueprint for legislative success.”

Hearing witnesses from the private and public sectors all voiced their support for TSCA modernization. Industry members called for a flexible, prioritized risk-based approach to screening and assessing chemicals. Public sector witnesses advocated for significant reform of TSCA’s testing and reporting requirements, including making it easier for EPA to require testing from manufacturers, especially for vulnerable populations such as children and pregnant women, and increasing transparency for data currently protectable as Confidential Business Information (CBI).

The January 9 chemical spill in West Virginia prompted witnesses and Democratic members to question the adequacy of TSCA’s data collection, pointing out the lack of basic health and safety data on the contaminant in that spill. Also on Tuesday, the Senate Subcommittee on Water and Wildlife, part of the Environment and Public Works Committee, held a hearing on the safety and security of drinking water supplies. Senator Joe Manchin (D-WV) testified at that hearing, calling for stronger chemical storage standards and more frequent safety inspections, as well as TSCA reform.

Changes for TSCA CBI claims on the horizon.

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According to the OMB’s regulatory agenda, EPA is planning to issue a proposed rule on confidential business information (CBI) claims under TSCA.  The proposed rule, which is expected to be released in spring 2014, would require companies making CBI claims to reassert and re-substantiate those claims on a periodic basis. EPA’s intent in proposing the new regulation is to increase transparency and the availability of environmental and health effects information for existing chemicals in the marketplace.

Details about the proposed rule are not yet available, but ChemicalWatch identified two critical issues that will need to be addressed: (1) whether CBI claims will be evaluated immediately and (2) whether individual chemicals must be disclosed. According to ChemicalWatch, stakeholders expect that CBI claims would stand for five years before review and renewal is required.

The future of CBI claims may be further complicated by current legislative efforts to reform TSCA. The Chemical Safety Improvement Act (CSIA), the TSCA modernization bill currently before the Senate Environment and Public Works Committee, contains complex CBI provisions which have been criticized by NGOs as overly burdensome for EPA’s resources.

It is also unclear how the new CBI rule would affect EPA’s voluntary CBI Declassification Challenge. In December, Bloomberg discussed the state of the CBI Declassification Challenge with Jim Jones, EPA’s Assistant Administrator for chemical safety and pollution prevention. Through this initiative, EPA has determined that over half of the 22,000 CBI claims the agency had thought were submitted by chemical companies were in fact never made. The inflated number was due to a newly identified problem in EPA’s tracking system. Of the remaining claims, 909 cases have been declassified, 3,349 claims have been assessed as valid, and EPA is still investigating the last 7,000 claims.

Industry optimistic on passing TSCA reform; House bill in the works.

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Although there has been no reported progress on Senate attempts to amend the Chemical Safety Improvement Act (CSIA) since last month’s update, the American Chemistry Council (ACC) weighed in last week with confidence that legislation to reform the United States’ outdated Toxic Substances Control Act (TSCA) could pass before the 2014 elections. ACC President Cal Dooley told a press briefing: “There continues to build momentum that could result in enactment of CSIA or some version thereof prior to the November elections.”

The ACC, the major trade group representing chemical and plastics companies, has supported the CSIA since its introduction in May. Despite bipartisan support and backing from industry and some environmental groups, the CSIA has been strongly criticized by key Democrats, including Senate Environment and Public Works Chairwoman Barbara Boxer (D-CA), and a large coalition of environmental and public health groups. In response, the CSIA is quietly being reworked in the Senate to achieve broader support.

The Energy and Commerce Committee has held four hearings on TSCA, but similar legislation has yet to be introduced in the House. However, Chemical Watch reported last week that industry representatives, sharing Dooley’s optimism, said that a House version of the bill is being prepared in the office of Rep. John Shimkus (R-IL). The House bill is expected to address objections raised by critics of the CSIA such as preemption of state laws and protections for especially vulnerable populations.

Chromium manufacturer fined by EPA for failure to disclose health risks.

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Last month, an Administrative Law Judge (ALJ) ruled on a relatively rare Toxic Substances Control Act (TSCA) enforcement case, ordering Elementis Chromium to pay a $2.57 million penalty for violating TSCA § 8(e), a provision of the law that required the company to disclose information about serious health risks.  The ALJ found that Elementis Chromium, one of the world’s largest manufacturers of chromium chemicals, failed to notify EPA of a study finding substantial risk of injury to human health from exposure to hexavalent chromium.

The November 12, 2013 decision [PDF] is the latest development in an enforcement action that EPA initiated in 2010. At issue in the case was an industry-backed study documenting health impacts – including increased cancer risks – on workers in chromium processing plants: EPA contended that the study filled a “data gap” in the literature, while Elementis argued, among other defenses, that EPA was already adequately informed of the information. However, the ALJ interpreted “information” broadly, following EPA guidance, in concluding that the study in question presented new substantial risk information about occupational hexavalent chromium exposure. Chief ALJ Susan Biro also thoroughly discussed and ultimately rejected Elementis’ contention that the study fell under an exception to TSCA § 8(e) as merely “corroborative of well-established adverse effects.”

The decision is also notable for its discussion interpreting the EPA’s penalty policy on “attitude,” a sub-factor of “culpability.” ALJ Biro increased the penalty amount by 10% for attitude, citing Elementis’ “bad faith” and attempts to influence the Occupational Safety and Health Administration’s exposure limits for chromium while keeping the study information in its “back pocket.” The decision concluded: “Over time, …the frontier in risk assessment is always going to be studying lower and lower exposures…. This decision takes into account that Congress intended to place the onus for understanding that frontier on the industries whose workers may be at risk.”

The decision becomes final 45 days after its issuance unless Elementis chooses to appeal to the Environmental Appeals Board.

Congressional subcommittee reviews CSIA, EPA reveals its views.

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As we reported last week, the House Subcommittee on Environment and the Economy held a hearing to review the Chemical Safety Improvement Act (S. 1009) (CSIA) on November 13, 2013. At the hearing, EPA for the first time revealed its views on a number of CSIA provisions, although it has not developed a formal position on the Act.

Jim Jones, EPA assistant administrator of the Office of Chemical Safety and Pollution Prevention, was among the ten witnesses who testified at the hearing. During the questioning period of the hearing, Jones identified areas of CSIA that were improvements over TSCA, such as the requirement under Section 5 for an affirmative finding of safety by EPA on new chemical notifications, the ability to use order authority under Section 4 to obtain testing, and the ability to share confidential business information (CBI) with states.

Jones also identified issues that warranted further discussion, such as whether the requirement under Section 6 for extensive analysis of alternatives could lead to “paralysis by analysis,” whether judicial review of “low priority” decisions should be barred, and whether consideration of vulnerable populations under safety assessments should be extended to safety determinations and risk management actions. In addition, Jones called for a better balance of preemption issues, stronger deadlines, and clearer testing requirements under Section 4.

At the hearing, Senator Tom Udall (D-NM) said that he and Senator David Vitter (R-LA) were focused on three main issues: making sure EPA has the tools it needs to protect citizens and review the existing chemicals in commerce, preserving private rights of action against companies, and protecting the ability of states to safeguard their citizens. A day earlier, Sen. Vitter had made a renewed push for the CSIA’s passage, following a National Research Council (NRC) report that recommended improvements in the EPA’s assessment of inorganic arsenic. Sen. Vitter cited the report as a “prime example of why EPA’s risks assessments are flawed,” and called it “embarrassing” that EPA needed supervision in one of its key roles.

However, the overall tone at the hearing was very courteous among the Committee members and between the Chair and the witnesses. Sen. Vitter stressed his and Sen. Udall’s willingness to work with anyone committed to meaningful bipartisan reform, and most of those present at the hearing promised continued attempts to reach a consensus bill.

Congress making progress on amending TSCA reform bill.

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Congress continues to make progress in addressing concerns about the Chemical Safety Improvement Act (CSIA), with one congressional aide close to the process telling ChemicalWatch last week that “all the concerns and issues are solvable.” However, industry and NGO sources say the remaining issues that need to be dealt with make it unlikely that the TSCA reform bill will pass before the end of this year.

The CSIA is currently before the Senate Environment and Public Works (EPW) Committee, chaired by Barbara Boxer (D-CA). In August, Sen. Boxer dropped her opposition to the CSIA and promoted “fast-tracking” the compromise bill. However, Sen. Boxer has said that the bipartisan bill can move forward only if the Toxic Substances Control Act (TSCA) is amended to incorporate some “basic principles” such as specific protection for vulnerable populations, more definite time frames for EPA action, and holding all responsible parties accountable in cases of harm.  Most importantly, Sen. Boxer wants the bill’s language to ensure that state laws such as California’s Proposition 65 are not preempted.

Staff from the offices of Senators David Vitter (R-LA) and Tom Udall (D-NM), who co-sponsor the CSIA, have been working together on revisions to address concerns raised by Sen. Boxer and NGOs. As we previously reported, Sen. Vitter has said that the CSIA is not intended to eliminate private rights of action under state tort law, or remove the authority of any state to protect their water, air, or citizens.

The Congressional aide that spoke to ChemicalWatch said that whether the bill will be marked up this year depends largely on the EPW Committee’s other agenda items. Both industry and NGO sources do not expect passage of a TSCA reform bill this year, although prospects seem better for passage during the second year of the 113th Congress. Meanwhile, the House Subcommittee on Environment and the Economy, which held three informational hearings on TSCA this year, plans to hold its first hearing on the CSIA on November 13.

EPA agrees to update enforcement guidance for FIFRA and TSCA.

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The Environmental Protection Agency (EPA) has agreed to update its enforcement guidance for the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Toxic Substances Control Act (TSCA) following a report [PDF] from the agency’s Office of Inspector General (OIG) released on September 27, 2013. The report contained findings and recommendations related to FIFRA and TSCA good faith reductions and “ability to pay” penalties, based on the OIG’s review of 23 FIFRA cases and 20 TSCA cases (13 lead disclosure and 7 PCB cases).

The OIG found that EPA regions differed in how they assessed FIFRA and TSCA enforcement penalty reductions; some appeared to justify reductions automatically, without considering the good faith compliance efforts of the violators. Because of the lack of adequate guidance and supporting documentation for determining and justifying good faith penalty reductions, there is a risk that EPA might treat violators inequitably and might be losing opportunities to fully collect all penalties due. Based on the OIG’s findings and recommendations, EPA has agreed to reissue the enforcement policy document GM-88, “Documenting Penalty Calculations and Justifications in EPA Enforcement Actions.”

The OIG also found that EPA’s enforcement response and penalty policy for lead-based paint disclosure rule to address violators who are unable to pay penalties is inadequate. Specifically, no guidance exists for applying non-monetary penalty alternatives (such as public service or delayed payment plans) when violators do not have the cash to pay the penalty. EPA has agreed to evaluate whether additional guidance is needed to clarify whether non-monetary alternatives must meet the agency’s existing Supplemental Environmental Projects policy.

In addition, the OIG report found that EPA’s “INDIPAY” economic model may be limited in its ability to help teams evaluate individuals’ claims of inability to afford penalties or clean-up costs. According to the OIG, the INDIPAY model does not assess an individual’s assets and should be updated to improve its accuracy. Furthermore, the report found that EPA does not provide adequate guidance or case development training to help regional teams evaluate ability to pay cases. In order to improve the agency’s consistency in handling the growing number of ability to pay cases, EPA has agreed to provide regional staff with updated training for case development of ability to pay claims. EPA also agreed to update its 1986 document “Guidance on Determining a Violator’s Ability to Pay a Civil Penalty” [PDF] to further improve guidance on evaluating ability to pay cases and address the inadequacies of the INDIPAY model.

EPA issues SNUR restricting imports of allegedly harmful category of chemicals used in carpets.

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The U.S. Environmental Protection Agency (EPA) announced on Monday that it will soon finalize a Significant New Use Rule (SNUR) that will allow the agency to restrict imports of potentially harmful long-chain perfluoralkyl carboxylates (LCPFACs) that could be used in carpets. The regulation will require companies to submit a notification 90 days in advance of manufacturing, importing, or processing LCPFACs that will be used as part of carpets or carpet treatment products. LCPFACs, a sub-category of perfluorinated chemical (PFC), include perfluorooctanoic acid (PFOA, also known as “C8”), other higher homologues, and their salts and precursors.

The final rule [PDF], which is authorized under the Toxic Substances Control Act (TSCA), was originally proposed in August 2012, following the U.S. chemical industry’s voluntary phase-out of these chemicals. In 2006, the eight major U.S. manufacturers of fluoropolymers and telomers committed to the EPA’s voluntary 2010/2015 PFOA Stewardship Program. The companies committed to achieving a 95% reduction in emissions and product content levels of PFOA and related substances by 2010, and elimination of such chemicals by 2015.

While the new final rule makes TSCA’s articles exemption inapplicable to imports of LCPFACs in carpets, other articles containing LCPFACs are not affected. EPA has previously issued three other SNURS addressing perfluoroalkyl sulfonates (PFAS), another sub-category of PFC. The new rule will add new chemicals to the existing PFAS SNUR and amend the SNUR to include ”processing” in the definition of “significant new use” for PFAS chemicals. EPA anticipates proposing another SNUR on additional PFCs in early 2014 as well as SNURs on other chemicals that will include imported products.

As part of its long term action plan regarding long-chain PFCs, EPA will also evaluate the effects of such chemicals on children and other sub-populations Although long-chain PFCs have not been found to cause significant adverse effects in the general human population, they have caused reproductive, developmental, and systemic toxic effects on laboratory animals, bioaccumulate in humans and wildlife, and are persistent in the environment. Therefore, EPA anticipates that continued exposure could result in adverse outcomes.

Further information on the new final rule and other actions EPA has taken on perfluorinated chemicals can be found at: http://www.epa.gov/oppt/existingchemicals/pubs/actionplans/pfcs.html#final.

House Subcommittee convenes hearing on role of TSCA preemption.

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On September 18, 2013, the House Energy and Commerce Subcommittee on Environment and the Economy held its third in a series of hearings on Toxic Substances Control Act (TSCA) issues. The hearing focused on TSCA’s section 6, which relates to unreasonable risk from existing chemical substances, and section 18, which relates to preemption.

Section 6 has become a focal point for determining TSCA’s effectiveness in regulating hazardous chemicals. During the hearing, members of the subcommittee discussed the concepts of “unreasonable risk” and “least burdensome” alternatives, which have been pivotal in how the EPA approaches restricting or banning chemical use. Other issues raised by members of the subcommittee include whether the section 6 standard should be changed to eliminate cost-benefit analysis when EPA regulates existing chemicals, and the effects of the Corrosion Proof Fittings decision on EPA’s willingness to use its section 6 authority. Members disagreed over which aspect of the decision was more problematic—the court’s interpretation of the “least burdensome” requirement or the deficiencies in EPA rulemakings.

Section 18, which addresses when TSCA can pre-empt state law, has become particularly contentious in discussions about the draft Chemical Safety Improvement Act (CSIA). In the absence of federal action, U.S. states have enacted many local laws regulating certain chemicals, and they are concerned that proposed changes to TSCA might prevent these state laws from working effectively. Specific issues raised regarding TSCA preemption include the need for automobile manufacturers to have one national program for chemical regulation and for states to have access to confidential business information (CBI) in order to protect human health and the environment.

The Subcommittee’s background memorandum and an archived webcast of the September 18, 2013 hearing are available online.