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

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the American Chemistry Council (ACC) weighed in last week with confidence that legislation to reform the United States’ outdated Toxic Substances Control Act (TSCA) could pass before the 2014 elections.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.

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.

House votes to block federal fracking rules.

In one week in November, the House of Representatives voted to pass three energy bills (H.R. 2728, H.R. 1900, and H.R. 1965) simultaneously introduced by House Republicans to facilitate oil and gas development. Notably, Rep. Bill Flores’ (R-TX) bill, H.R. 2728, would block the Department of the Interior (DOI) from regulating hydraulic fracturing, known as “fracking,” on public lands in states that already have their own fracking regulations in place. The bill is expected to be defeated in the Senate.

Republicans said that states have safely and effectively regulated fracking for decades, and that the Obama administration has shown no evidence proving otherwise. House Natural Resources Committee Chairman Doc Hastings (R-WA) called federal regulation of fracking “redundant” and a waste of time and money that would slow down energy production and job creation. On the other hand, Democrats said that passing the bill would increase the risk of adverse health effects for people in less regulated states. Although some states, like California and Illinois [PDF], have recently passed stricter legislation governing fracking, many still don’t require companies to disclose what chemicals they are pumping underground in the extraction process. Those states that do require disclosure generally allow exceptions for trade secrets.

The DOI regulation would require full disclosure of all chemicals used during fracking and will likely also address well integrity and flowback water management. Rep. Flores’ bill would prevent the DOI from enforcing any federal fracking regulation on any federal or Indian lands in states that have passed their own fracking rules.  The bill would also require that an Environmental Protection Agency (EPA) study on fracking include “objective estimates of the probability, uncertainty and consequence of each identified impact, taking into account the risk management practices of states and industry.”

Ultimately, 12 Democrats voted for the bill, with two Republicans voting against it. The Obama administration has threatened to veto the bill, saying it would hinder the Bureau of Land Management (BLM)’s efforts to create fracking standards.

Scientists agree on EDC thresholds.

Scientists representing both sides of the Endocrine Disrupting Chemicals (EDCs) debate have agreed that thresholds for activity of EDCs may not exist. The conclusion is one of several reached during a recent meeting hosted by European Union (EU) chief scientific advisor Anne Glover in an attempt to identify areas of consensus and disagreement on the subject.

In the published minutes [PDF] of the meeting, the scientists say uncertainty about the existence of EDC activity thresholds—the exposure level or dose of a chemical above which toxicity or adverse health effects can occur—is due to experimental constraints and limited understanding of biological systems. They also agreed that defining EDC thresholds by in vivo experiments alone  is not possible. Rather, establishing whether thresholds exist must be defined by better understanding “the mechanisms of action in a quantitative systems approach.”

The scientists also agreed with the World Health Organization’s 2002 definition of EDCs and that criteria for identifying endocrine disruptors need to consider the disturbance of homeostasis at different stages of development. In addition, they agreed that non-monotonic dose response effects exist for some EDCs, both in in vitro and in vivo tests. However, although reliable study designs to find non-monotonic effects are available, the scientists say that more dedicated methods are needed to evaluate possible effects of EDCs on humans. Furthermore, they noted that validated OECD guidelines for testing do not cover all adverse effects or modes of action of EDCs.

Meanwhile, the German Chemical Industry Association (VCI), which recently published its opinion on EDCs, believes that EDC thresholds do exist, despite uncertainty, and any discussion about setting regulatory limits on EDCs should be viewed in that context. Furthermore, the association argued that while in vitro tests can be used in order to inform the mode of action for EDCs, they should not be used to derive regulatory thresholds. In vivo testing should be used to test for endocrine disruption since it allows scientists to more meaningfully investigate the complex interactions in the hormone system.

VCI also criticized the group’s conclusions on testing as overly pessimistic, since OECD guidelines cover the most relevant endpoints for EDCs and provide a solid foundation to test chemicals for their estrogenic, androgenic and thyroid-endocrine properties.

EU, U.S. TTIP negotiators discuss reducing chemical costs, regulating cosmetics.

Last week, U.S. and European Union (EU) negotiators held a second round of Transatlantic Trade and Investment Partnership (TTIP) discussions. During the week-long talks, negotiators examined how to reduce regulatory and industry costs for chemicals.

According to U.S. TTIP chief negotiator Dan Mullaney, a range of tools are available to reduce costs for chemicals and other sectors.  Ignacio Garcia Bercero, the EU’s chief negotiator, said specific ideas for cost reduction include harmonization of labeling requirements and better cooperation between the EPA and ECHA in performing risk assessment and exchanging data to avoid unnecessary testing. Bercero said the European and U.S. negotiating teams also discussed regulatory compatibility for cosmetics. Negotiators considered the feasibility of achieving “greater convergence” between the positive and negative lists of cosmetic ingredients in the EU and the U.S., which may be difficult since the U.S. allows certain cosmetic ingredients that are prohibited in the EU, said Bercero.

Meanwhile, NGOs have continued to express concerns over the lack of transparency in TTIP negotiations. Spokespeople from the European Consumer Organization (BEUC) and Friends of the Earth Europe said that open negotiations are necessary to ensure that the trade deal does not undermine or eliminate existing consumer legislation in the EU, as well as U.S. states like California with stricter chemical legislation. Both groups want access to the negotiating texts and regular consultations before and after each negotiating round. In response to NGO concerns, both Mullaney and Bercero said that talks on regulatory convergence in the chemical sector will not affect the level of protection or legislation under REACH or TSCA. The EPA has also stated that it does not believe TTIP negotiations will influence the agency’s “risk-based approach to chemicals management.”

The next round of TTIP negotiations will take place in Washington, D.C., between December 16 and 20.

Congressional subcommittee reviews CSIA, EPA reveals its views.

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.

California accepting applications for second Green Ribbon Science Panel.

California’s Department of Toxic Substances Control (DTSC) is currently accepting applications to serve on the Green Ribbon Science Panel. Members of the Panel come from both the private and public sectors and are experts in a variety of fields, including chemistry, public health, risk analysis, and materials science. The Panel draws on its scientific and technical expertise in advising the DTSC as well as the California Environmental Policy Council on various green chemistry and chemicals policy issues. The first Panel was assembled in 2009 and advised DTSC on developing the Safer Consumer Products regulations which just went into effect last month. Moving forward, the new Green Ribbon Science Panel will address implementation of the Safer Consumer Products program.

The deadline for applications is this Friday, November 15, 2013.

Congress making progress on amending TSCA reform bill.

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.

SEC defends its rule on conflict minerals, which may implicate catalysts.

In a recent court filing, the U.S. Securities and Exchange Commission (SEC) defended its decision not to provide a de minimis exception for uses of “conflict minerals” in its rules [PDF] implementing the Conflict Minerals Statutory Provision (Section 1502 of the Dodd-Frank Wall Street Reform and Consumer Protection Act). The rules require companies to disclose whether designated “conflict minerals” in their products originated in the Democratic Republic of the Congo or nine adjoining countries, and could potentially affect manufacturers who use conflict minerals as catalysts or in a similar manner in another process.

Business groups which had previously sought a de minimis exception, including the National Association of Manufacturers, the U.S. Chamber of Commerce and the Business Roundtable, challenged the rule in a lawsuit filed last year in October. The groups argued that the SEC did not fully consider the rule’s economic consequences as required by the Exchange Act, and that a failure to define the term “derivative” could mean that metals in forms that are chemically distinct from the base metals subject to the rule would also subject manufacturers to the rule’s disclosure requirements. When SEC adopted its final version [PDF] of the rule in August 2013, it clarified the definition of conflict mineral—which includes “cassiterite, columbite-tantalite, gold, wolframite, and their derivatives”—to specify that the term “derivatives” are limited to the “3Ts” (tantalum, tin, and tungsten).

In the new version of the rule, the SEC declined to include a de minimis exception. Instead, manufacturers must consider only if the conflict minerals used “are necessary to the functionality or production of a product.” In its guidance, SEC clarified that only conflict minerals contained in the product would be considered “necessary.”  Because they are not typically contained in the final product, the rule does not generally cover conflict minerals used as a catalyst,. However, SEC noted in its guidance that if a catalyst made from conflict minerals is contained in the final product, even if only in de minimis amounts, then the conflict mineral is considered “necessary” to its production and is therefore subject to the final rule.

On October 23, the SEC defended its position in a filing in the U.S. Court of Appeals for the D.C. Circuit, having previously prevailed in the U.S. District Court for the District of Columbia. The SEC stated that “creating a categorical exception for small uses of conflict minerals would thwart” the purposes of the statute.  The SEC noted that conflict minerals are frequently used in small amounts and those uses could have “large cumulative effects.” On October 31, a dozen current and former Democratic members of Congress filed an amicus brief in support of the SEC. The case is pending before the D.C. Circuit; oral arguments have not yet been scheduled.

FTC brings enforcement actions for biodegradability claims.

Last week, the Federal Trade Commission (FTC) announced enforcement actions against six companies for misleading and unsubstantiated environmental marketing claims. Five of the enforcement actions concern biodegradability claims for plastics, while the sixth relates to a company’s alleged violation of a consent order prohibiting making green claims for its paper plates and bags. These actions follow FTC’s July settlements with three mattress manufacturers regarding unsupported “VOC-free” claims. Together, these cases demonstrate that the FTC highly prioritizes ensuring compliance with its revised Green Guides, the Commission’s guidelines for how companies should properly make environmental claims, and sheds some light on how FTC interprets some of the Green Guides’ provisions.

This marks the first time the FTC has addressed claims for biodegradable plastic. In the plastics matters, FTC has filed complaints and proposed consent orders against four companies that make various plastic products – ranging from golf tees to shopping bags – and a fifth, ECM Biofilms, which sells plastic additives to product manufacturers, including to two of the other companies targeted by the FTC. In addition to various charges of misrepresentation related to the biodegradability claims, ECM Biofilms is also charged with providing customers and distributors with the means to deceive consumers by issuing its own “Certificates of Biodegradability.” Under the proposed consent orders, the companies face no fines but are barred from making biodegradability claims that are unsupported by competent and reliable scientific evidence.

Notably, the consent orders state that ASTM D5511, a test standard commonly used in the industry, cannot be used to substantiate unqualified biodegradability claims or claims beyond the parameters of the test. FTC appears to believe that ASTM D5511 does not simulate the conditions in landfills or other disposal facilities. The consent orders, like the Green Guides, require that unqualified biodegradability claims must be supported by evidence that the product will completely decompose into elements found in nature within one year after customary disposal. Qualified biodegradability claims must include certain appropriate caveats, such as the time period required for a product to completely decompose in a landfill or other disposal environment near where potential consumers live. The consent agreement packages are subject to public comment through November 29, 2013. According to Plastics News, all of the companies have agreed to the settlements except ECM Biofilms, which maintains that tests show that plastics made with its additives will biodegrade in environments mimicking landfills. FTC has scheduled a hearing before an Administrative Law Judge for ECM Biofilms in June.

In the sixth matter, FTC is seeking a $450,000 civil penalty against AJM Packaging Corporation, a manufacturer of paper products including plates, bags and napkins. The FTC’s complaint charges that AJM violated a 1994 consent order by failing to properly substantiate claims that its products were biodegradable, compostable, and/or recyclable.  The settlement with AJM vacates the prior consent order and enters a new one reflecting the updates to the Green Guides and requiring AJM to disclose certain information needed to qualify certain green claims.