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.

European Commission orders study of polymers for possible REACH registration requirements.

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Polymers are currently exempt from REACH registration requirements, but recent actions taken by the European Commission (EC or the Commission) suggest that polymers might face a heavier regulatory burden in the future. Today, ChemicalWatch reported that the Commission has awarded a contract to study whether and how polymers should be subject to REACH registration requirements. The contract was awarded to Bio-Intelligence, a consultancy, in December 2013, and the study is expected to be completed by October 2014.

Article 138(2) of REACH empowers the Commission to present legislative proposals for selecting polymers for registration after finding a practicable solution and publishing a report on the matter. This report must cover risks posed by polymers in comparison with other substances; and the need, if any, to register certain types of polymers, taking into account factors including competitiveness and innovation as well as human health and the environment.

Last year’s REACH Review concluded that there was insufficient information to conclude whether certain types of polymers should be registered. In 2012, the consultancy RPA conducted another study for the EC on registration requirements for polymers. Taken together, the studies may for the basis for a new proposal on registering certain polymers.

Verdant to sponsor 2014 GlobalChem Conference.

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Verdant is proud to announce our sponsorship of the upcoming American Chemistry Council and Society of Chemical Manufacturers & Affiliates GlobalChem Conference and Exhibition in Baltimore, Maryland. The conference will be held March 3-5, 2014 and will cover topics important to the chemical regulations field, ranging from TSCA modernization to California’s Safer Consumer Products program to updates on REACH registration.

Verdant’s Managing Principal, Philip Moffat, said:  “This is one of the premier chemical regulatory conferences in the United States.  We’re proud of our partnership with ACC, SOCMA, and the other conference sponsors.”

We will post more information about Verdant’s participation in the conference as it approaches.

REACH substance evaluation interactions to be improved.

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At a recent meeting of the Competent Authorities for REACH and CLP (Caracal), member states, the European Chemicals Agency (ECHA), and industry agreed on steps to improve interactions between registrants and member state competent authorities (MSCAs) during the REACH substance evaluation process. Chemical Watch reported last week that a working group presented a paper making a series of recommendations on how to improve communication under the REACH Community Rolling Action Plan (Corap). The working group was established at a May meeting of ECHA and industry representatives and was led by Ireland and the European Chemical Industry Council (Cefic), among others.

According to Chemical Watch, the paper – which has not yet been released – makes various recommendations for substances listed on Corap year one, generally specifying which communications should occur at certain points throughout the evaluation process; e.g., evaluators should contact registrants shortly after publication of the Corap, and a mechanism should be developed to ensure that all registrants are informed of an impending evaluation. For substances listed on Corap years two and three, the paper recommends that evaluating authorities communicate clarifications on the substance evaluation process, while registrants should provide status updates on ongoing tests or planned dossier changes which might affect the evaluation.

The purpose of the recommendations, according to ECHA representative Claudio Carlon, is to “to increase clarity on the Corap process and explain what registrants need to do before it starts and post draft decisions, and encourage informal interaction between member states and registrants.” The recommendations were reportedly supported by attendees of the Caracal meeting. Industry groups including Cefic are planning to publish “a comparable initiative,” focusing on how industry can prepare for interactions with MSCAs during the evaluation process. This initiative will also address “interactions with downstream users.”

ECHA is expected to publish the working group’s paper with “minor amendments” by the end of the year or early 2014.

A first look at EPA’s draft guidelines for greener government purchasing.

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On November 20, EPA released its Draft Guidelines for federal government procurement of greener products. Because the federal government purchases more than $500 billion per year in goods and services, changes in federal procurement policy can have broad ripple effects for product manufacturers and markets.

The Draft Guidelines were formulated with the General Services Administration and other agencies to help federal purchasers identify and buy environmentally preferable products; currently, agencies must meet a mandate that 95% of acquisitions be sustainable. EPA is also seeking input on how to assess existing, non-governmental environmental standards and ecolabels. Although many environmentally preferable products are identified with federal ecolabels such as Energy Star or Design for Environment, other products are not covered by such labels. When finalized, these guidelines will provide clarity regarding the term “environmentally preferable,” and help federal purchasers make consistent comparisons across different environmental standards and ecolabels.

The Draft Guidelines consist of four sets of guidelines, many of them referring to ISO 14024 and other existing standards for ecolabels, each addressing different aspects of the issue area:

  • Process for Developing the Standard
  • Environmental Effectiveness of the Standard
  • Conformity Assessment
  • Management of Ecolabeling Programs

Under EPA’s proposed approach, one or more NGO with expertise in the area would work with a multi-stakeholder panel to develop a process for applying the guidelines to private sector environmental standards and ecolabels. EPA envisions that the guidelines would be applied on product category basis to create a list of product standards and ecolabels that meet the guidelines for each product category. The resulting list would be made available to federal agencies for voluntary use and supplement existing federal standards or ecolabels.

The Draft Guidelines establish two tiers of guidelines: “Baseline” and “Leadership.” This approach was developed to allow flexibility in addressing the varying approaches to sustainability practices incorporated across different industries and product categories. According to EPA’s FAQ:

…draft “baseline” guidelines align with Federal goals and requirements, are relatively straightforward to evaluate, and are applicable across industry sectors. Draft “Leadership” guidelines represent EPA’s current assessment of best practices and are currently achievable by some standards and ecolabels.

The Draft Guidelines only address products, but EPA also expressed interest in public comments on environmental benchmarking for services such as hospitality, printing, and cleaning.

EPA is accepting comments on the draft guidelines through February 25, 2014.

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.

House votes to block federal fracking rules.

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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.

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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.

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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.