EPA seeking feedback on new logo for Design for Environment label.

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Yesterday, the EPA’s Design for the Environment (DfE) program announced two listening sessions to solicit public input as part of the process of redesigning the new logo for the voluntary product labeling program. Chemical-based products – like cleaning solutions and laundry detergents – bearing the DfE label must meet certain standards that exclude ingredients that have been identified as chemicals of concern. Four proposed design concepts for the new logo are posted online. EPA’s stated goals for the new logo are:

  • Better convey the scientific rigor of EPA’s product evaluation and the benefits to people and the environment with a label that is easier to display on products, materials, and in digital media;
  • Increase buyers’ recognition of products bearing EPA’s Safer Product Label; and
  • Encourage innovation and development of safer chemicals and chemical-based products.

E&E News reports that industry groups are concerned with the logo redesign, quoting American Chemistry Council president Cal Dooley at a conference earlier this year calling the DfE program “unprecedented” in terms of the label’s “potential for significant market implications.” Dooley also expressed doubt that DfE met the Federal Trade Commission’s Green Guides guidelines for private labeling programs.

EPA’s listening sessions will be held as webinars on August 4 and 5, 2014, from 1pm to 2pm Eastern Time; participants must register no later than August 1. Comments are also accepted on the DfE label website. According to the Federal Register announcement, although EPA “does not intend to formally respond to all comments that are submitted, EPA will consider the information gathered from this notice and other sources as it selects a new DfE logo.”

EPA issues two sets of SNURs by direct final rule.

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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.

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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.

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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.

Partnering with EPA's Design for Environment at Walmart Sustainable Products Expo.

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EPA is a significant partner to companies leading innovation efforts in the arena of safer consumer products, according to Assistant Administrator Jim Jones, of EPA’s Office of Chemical Safety and Pollution Prevention. In a blog post yesterday, Jones describes how EPA’s Design for Environment (DfE) program recently participated in a “Supplier Panel on Sustainable Chemistry” at Walmart’s first ever Sustainable Products Expo, which brought together leaders from EPA, NGOs, and product manufacturers.

As we have previously discussed, EPA’s DfE program – which establishes voluntary sustainability-related standards for consumer products like household cleaners – plays a major role in Walmart’s Sustainable Chemistry Initiative. Jones writes that EPA’s contribution is “providing scientific expertise and understanding of health and environmental impacts throughout the supply chain, educating consumers and companies alike, and bringing people to the table to stimulate dialogue and partnerships.” Jones notes that with “growing consumer recognition” and trust for the DfE’s “Safer Products” label and program criteria, EPA’s partnerships with companies like Walmart and its participating suppliers can promote sustainability, health, and the environment while meeting consumer demand and growing their business.

The Expo also featured announcements from Walmart and its suppliers of various new sustainability commitments and initiatives. One such initiative is the Closed Loop Fund, which will invest $100 million seeded from suppliers including Coca-Cola, Pepsico, and Johnson & Johnson in recycling infrastructure with the goal of “transforming the recycling system in the United States.” Cargill made commitments to increase supply chain transparency in beef and Procter & Gamble pledged to reduce water use for liquid laundry detergent. Together, the suppliers participating across all of these voluntary sustainability efforts account for over $100 billion in sales at Walmart.

EPA exploring data-sharing possibilities with European regulators.

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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.

National Research Council issues two reports reviewing EPA's chemical testing and science.

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In the past week, the National Research Council (NRC) has released two reports on aspects of EPA’s chemical testing and science programs. Today, the NRC published a report reviewing EPA’s Integrated Risk Information System (IRIS) process for assessing chemical hazards and concluding that the agency has made substantial improvements in response to the NRC’s general recommendations made in 2011. The report published on May 2 found several key flaws in EPA’s draft “state-of-the-science” evaluation of nonmonotonic dose-response relationships for endocrine disruptors. Both reports were authored by committees of the NRC’s Board on Environmental Science and Toxicology.

The IRIS report was commissioned by Congress in response to a 2011 NRC report on EPA’s IRIS assessment of formaldehyde that found deficiencies in the agency’s general assessment methods. According to the new review, EPA is on track to make the IRIS process more effective and efficient. The agency has followed several of NRC’s 2011 recommendations; for example, EPA has implemented a new document structure that streamlines assessments, added a standard preamble explaining the process and its underlying principles, and drafted a handbook describing the process in greater detail. Noting that EPA is still in the process of making the changes recommended by the NRC, the study makes additional suggestions to strengthen to the IRIS process. Looking forward and considering the constantly evolving nature of the science involved, the report identifies critical steps to improve assessments in the future, calling for continuous updates to assessment methods, systematically identifying and addressing inefficiencies, and regular evaluation of chemical-assessment teams’ expertise and training.

The NRC took a dimmer view of EPA’s draft evaluation of nonmonotonic dose-response relationships, which intended to answer basic questions about the phenomenon wherein lower doses may be associated with larger responses, which may not be detected by traditional toxicological models. EPA’s evaluation tried to address, for example, the implications of nonmonotonic dose-response relationships for toxicity testing, weight of evidence conclusions, and risk assessment determinations. However, the authoring committee found that the process adopted by EPA in conducting the evaluation was “poorly described and inconsistent” in its approach to analyzing and summarizing data. The NRC report recommends that EPA develop and apply an “analytic plan” to predefine and document literature search strategies and establish criteria for selecting and analyzing studies, and analyze toxicity-testing strategies under more specific constraints. In addition, the NRC cited the lack of analysis supporting EPA’s conclusion that nonmonotonic dose-response relationships can have both qualitative and quantitative effects which would be considered appropriately using current risk-assessment practices. The report urges EPA to address how nonmonotonic dose-response relationships for estrogen, androgen, and thyroid pathways would be treated under current risk-assessment practices. Although the report does not address more fundamental questions – such as whether endocrine-disrupting chemicals are harmful, or the adequacy of EPA’s testing techniques – the NRC’s critique may raise issues in other areas, including the U.S.’ trade in chemicals with the European Union, which has adopted a more aggressive approach to regulating potential endocrine disruptors.

EPA’s new Strategic Plan: continuity in chemicals while enforcement focuses on Next Generation Compliance.

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In April, EPA published its final Strategic Plan for FY 2014-2018, which includes ensuring chemical safety as a top-level goal and emphasizes the agency’s new paradigm of “Next Generation Compliance.” As proposed in the draft plan released in November, EPA plans to reduce the number of inspections and enforcement actions in order to focus instead on large, complex cases with the “highest impact on protecting public health and the environment.” In the final Plan, the agency clarifies that the advanced monitoring and electronic reporting entailed in its Next Generation Compliance approach will be used to supplement traditional enforcement techniques, rather than replace them.

The Strategic Plan is organized around the following five goals:

  • Goal 1: Addressing climate change and improving air quality
  • Goal 2: Protecting America’s waters
  • Goal 3: Cleaning up communities and advancing sustainable development
  • Goal 4: Ensuring the safety of chemicals and preventing pollution
  • Goal 5: Protecting human health and the environment by enforcing laws and assuring compliance

We will discuss goals 4 and 5 in this blog post.

Goal 4: Safe chemicals and pollution prevention

In pursuit of Goal 4, the Agency’s announced “Priority Goal” for the next year is to “[a]ssess and reduce risks posed by chemicals and promote the use of safer chemicals in commerce.” EPA plans to complete more than 250 assessments of pesticides and other commercially available chemicals by September 30, 2015. These assessments will include the evaluation of potential risks to endocrine system disruption. By 2018, EPA plans to make Endocrine Disruptor Screening Program (EDSP) decisions for all “chemicals for which complete EDSP data are expected to be available by the end of 2017,” as well as complete assessments of all currently identified TSCA Work Plan chemicals. In addition, one of EPA’s strategic measures for pollution prevention is to increase the number of safer chemicals and safer chemical products by 1,900 by 2018 – currently, EPA’s Design for the Environment program recognizes 600 safer chemicals and 2,500 safer chemical products.

The Plan also emphasizes the agency’s support for strengthening and modernizing the Toxic Substances Control Act (TSCA), arguing that EPA needs the “mechanisms and authorities to expeditiously target and promptly assess and regulate new and existing chemicals.” In particular, EPA points to “large, troubling gaps” in the data available and current knowledge on many widely used chemicals.

The Plan also emphasizes EPA’s continuing effort to increase public access to the agency’s chemical information and assessment tools, such as ChemView and the Chemical Information System (CIS). EPA is planning to enhance both of these tools, which are both part of the Next Generation Compliance initiative. CIS will be upgraded to allow electronic reporting for “nearly all required TSCA submissions” and to add tools and models related to chemical risk management. Planned improvements to ChemView will expand public access to TSCA chemical information and enable faster, automated posting of non-confidential data for the public.

EPA plans to complete several evaluations of its work in this area over the next four years, the results of which may direct future agency efforts. In FY 2014, EPA will begin reviewing key factors affecting TSCA Work Plan chemical assessments, followed by an evaluation of the effectiveness of new aspects of the pesticide registration review process, in FY 2015. In addition, biennial reviews are scheduled for 2015 and 2017 of the fee levels charged to submitters of New Chemical Pre-Manufacture Notices.

Goal 5: Enforcement and compliance assurance

The EPA’s main objective under Goal 5 is to target the most serious hazards for enforcement actions, particularly cases “where noncompliance is a significant contributing factor, and where federal enforcement attention can have a significant impact.” EPA’s intent here is not only to address the problems with the biggest impact, but to take on the largest and most complex cases that states might not be equipped to handle. Notably, this includes situations where “the patterns of noncompliance are broad in scope and scale such that EPA is best suited to take action.”

Under the Plan, the Next Generation Compliance approach not only relies on improvements in monitoring and reporting technology, but also entails “embracing new strategies for rule design and case targeting.” Of particular interest to regulated entities is the agency’s focus on expanding transparency and sharing data. The agency plans to build “compliance drivers” into rules and permits to make them more effective, such as improved monitoring, self- and third-party certifications, public disclosure, and “easily monitored product designs or physical structures in facilities.” Another part of Next Generation Compliance is EPA’s use of data analysis and targeting tools to improve identification, public notification, and responses to serious violations. EPA is currently considering new enforcement approaches, such as “electronic responses to electronically reported violations.”

Notably, in the Plan’s table of “Strategic Enforcement and Compliance Measures,” the Next Generation Compliance Measures are described as supplemental “examples” which are still under discussion with states and other parties. These measures include: the number of settlements resulting from or incorporating advanced monitoring technologies; use by regulated entities of advanced self-monitoring technologies; and public use of compliance technology tools (such as ECHO). In addition, the Plan notes that new ways of measuring effectiveness under Next Generation Compliance may emerge in the future, such as credit for avoiding violations.

Effects of the Strategic Plan

EPA’s goals in the realm of chemicals management likely come as no surprise to those in the sector. The agency’s support for TSCA modernization has been clear for years, and the Strategic Plan maintains EPA’s commitment to assessing TSCA Work Plan chemicals – of course, both of these efforts may be affected if Congress manages to successfully pass new TSCA legislation this session. Likewise, the Plan renews the agency’s commitment to increasing the number of safer chemicals and safer chemical products through its Design for the Environment program, and to the evaluation of endocrine disruptors. The Strategic Plan’s incorporation of various programs to improve information access and handling may be of more immediate significance to regulated entities as new electronic reporting processes are rolled out. Firms will also have to continue to manage the balance between protecting Confidential Business Information and EPA’s desired transparency goals.

Ultimately, EPA’s enforcement focus on targeting the largest and most complex cases will likely mean that fewer federal enforcement actions will be pursued in the case of less serious violations and hazards. At the same time, the agency’s commitment to the Next Generation Compliance initiative means that EPA may be able to use more sophisticated data analytics and targeting to recognize broad patterns of noncompliance. More speculatively, the enhanced focus on self-certification, public disclosure, transparency and data sharing, together with improved cooperation with states, may result in increased citizen suits, toxic tort litigation, and state-level enforcement actions along with pressure on companies to reduce or eliminate certain chemicals.

Elementis Chromium appeals $2.6 million penalty in TSCA 8(e) reportable data case.

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In a case that may have broad implications for chemical manufacturers, Elementis Chromium has appealed the $2.57 million penalty handed down by an EPA Administrative Law Judge (ALJ) in November 2013. The ALJ ruled that Elementis, one of the world’s largest chromium manufacturers, had violated section 8(e) of the Toxic Substances Control Act (TSCA), which requires reporting information about serious health risks to EPA. In addition to the hefty penalty at stake, the Elementis case is worth watching because it signals that EPA is continuing to pursue a very broad interpretation of what constitutes reportable data under TSCA § 8(e).

In its appeal [PDF] to the Environmental Appeals Board (EAB), Elementis makes two arguments: (1) EPA’s enforcement action was barred by the federal five-year statute of limitations; and (2) the epidemiological study at issue was not required to be submitted under TSCA § 8(e).

According to Elementis, the study’s findings were consistent with previous studies and merely confirmed and corroborated risk findings already known to EPA and the industrial health community. Elementis argues that the ALJ erred in interpreting new “substantial risk information” under TSCA to include “mere differences in scientific study methods or subjects between studies.” Instead, Elementis argues that EPA was already aware of the study’s information on substantial risk of injury to human health, “namely that high cumulative exposures to hexavalent chromium lead to an increased risk of lung cancer.”

Elementis’ appeal also argues that since § 8(e) requires the “immediate” reporting of certain information to EPA, violations of the provision are not “continuing” in nature. Thus, if the five-year statute of limitations began running upon the company’s receipt of the study in 2002, EPA’s 2010 Complaint was filed beyond the statute of limitations. According to Elementis, a violation of § 8(e) is not “continuing,” since there is no clear indication in the statute that Congress intended for the continuing violation exception to apply and, moreover, the statute establishes a definite timeframe for compliance by requiring “immediate” reporting. The company’s appeal criticizes the ALJ’s interpretation of the statute, which is described as establishing a “never-ending duty to inform that begins immediately.”

Furthermore, Elementis argues that the Supreme Court’s decision in SEC v. Gabelli, declining to apply the “discovery rule” in the case of an SEC civil enforcement action for an alleged fraud, means that the EPA’s enforcement action is time-barred here. In Gabelli, the Supreme Court relied on public policy reasoning in criticizing “grafting the discovery rule onto” the federal five-year statute of limitations in actions for penalties. Elementis argues that the continuing violation exception functions like the discovery rule in Gabelli, and thus was applied by the ALJ in error.

The Response Brief from EPA Region 8 to Elementis’ Appeal Brief has not yet been posted to the EAB docket, although it is expected soon.

EPA will withdraw proposed rules for fourth set of High Production Volume chemicals.

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The EPA will withdraw a 2011 proposed rule requiring testing and other data for 23 High Production Volume (HPV) chemicals and imposing Significant New Use Rules (SNURs) on 22 other HPV chemicals. Last week, Bloomberg BNA reported that the agency had confirmed in an email that the rule will be formally withdrawn, although a timeline has not been established yet. Under the Toxic Substances Control Act (TSCA), HPV chemicals are those produced or imported into the U.S. at the rate of at least 1 million pounds per year. However, significant data gaps exist regarding the hazards associated with these substances.

The rules were part of the EPA’s HPV Challenge Program, which encouraged the voluntary submission of health and hazard data for approximately 1,400 HPV chemicals sponsored by companies. EPA previously issued three other test rules for “unsponsored chemicals.”

EPA justified the withdrawal of the fourth set of rules by alluding to higher priorities, such as the agency’s TSCA Work Plan, an initiative launched in 2012 that identified 83 substances on which to conduct risk assessments. When the regulatory package was proposed, industry groups commented that the proposal was duplicative in requesting data already developed for and collected by the European Chemicals Agency (ECHA), which implements REACH.

Data from over 860 chemicals was made publicly available to the HPV Challenge Program through international efforts. However, of the over 2,200 chemicals sponsored through the voluntary part of the HPV Challenge Program, data was received for only 82 percent of the substances – and not all of that data is complete.

Until the regulatory package is withdrawn, the substances subject to the SNURs remain subject to 12(b) export notification requirements.