Changes for TSCA CBI claims on the horizon.

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.

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

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.

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.

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.

EPA agrees to update enforcement guidance for FIFRA and TSCA.

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.

US EPA unveils ChemView, substance information web portal.

The U.S. Environmental Protection Agency (EPA) has launched ChemView, a web portal that will serve as a hub for chemical-specific regulatory information developed by EPA, as well as data collected under the Toxic Substances Control Act (TSCA).

The portal presents key health and safety data in a format that allows users to compare chemicals by their use as well as their health and environmental effects. ChemView will also allow searches by chemical name or Chemical Abstracts Service (CAS) number, use, hazard effect or regulatory action. Users can customize their views of the information on individual chemicals, or compare multiple chemicals by use, hazard effect or other criteria. Links to background documents are also provided for more detail.

At this time, ChemView contains:

  • test rule data for 90 chemicals;
  • hazard characterizations for 1,016 chemicals;
  • Design for the Environment (DfE) Alternatives Assessments for 48 chemicals; and
  • Significant New Use Rules (SNURs) for 349 chemicals that did not go through pre-market EPA review – the so-called existing chemicals.

It also links to other data, including:

  • health and safety studies submitted under TSCA section 8(d) for 140 chemicals;
  • substantial risk reports submitted under TSCA section 8(e) for 261 chemicals;
  • high production volume voluntary submissions for 1,169 chemicals;
  • Integrated Risk Information System (IRIS) assessments for 548 chemicals;
  • DfE list of safer chemical ingredients for 602 chemicals;
  • Chemical Data Reporting information for 7,221 chemicals; and
  • Toxics Release Inventory data for 611 chemicals.

EPA said that in the months ahead, it will be continuously adding additional chemicals, functionality and links. When fully developed, the portal will hold data on thousands of chemicals. The agency stated that increasing health and safety information, as well as identifying safer chemical ingredients, would help manufacturers and retailers better differentiate their products by using safer ingredients.

The agency has considered stakeholder input in the design of the site and is currently seeking comments from the public on its usability.

EPA Expands List of Safer Chemical Ingredients.

This week, the U.S. Environmental Protection Agency (EPA) added more than 130 chemicals to its Safer Chemical Ingredients List, which contains chemicals that meet the criteria of EPA’s Design for the Environment (DfE) Safer Product Labeling Program. For the first time, 119 fragrance chemicals for commercial and consumer cleaning products have also been added to the list.

Fragrance, although still thought to be a relatively low safety hazard compared to other chemicals, has become a health concern because of its unlisted ingredients. A study by the consumer advocacy groups Environmental Working Group and the Campaign for Safe Cosmetics tested 17 popular fragrances and found that the average fragrance product contained 14 undisclosed chemicals. Among them were phthalates, which are used to soften plastic and belong to the class of endocrine-disrupting chemicals that may affect the body’s hormone system.

With the addition of the new chemicals, the Safer Chemical Ingredient list now contains 602 chemicals. Established in September 2012, it serves as a resource for consumers, product manufacturers, and environmental and health advocates interested in the use of safer chemical ingredients in products. Product manufacturers can also use the guide to identify chemical ingredients that meet the DfE program’s rigorous scientific standards for protecting human health and the environment. More than 2,500 products are certified under the DfE Standard for Safer Products including all-purpose cleaners, laundry and dishwasher detergents, window cleaners, car and boat care, and many other products.