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

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.

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.

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.

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.

House Committee holds hearing on new Chemicals in Commerce Act.

Today, the House Energy and Commerce Committee held its second hearing on the Chemicals in Commerce Act (CICA), introduced by Rep. John Shimkus (R-IL) as the House’s proposal to modernize the Toxic Substances Control Act (TSCA). Today’s hearing was based on an updated version of CICA which Rep. Shimkus, who is Chair of the Subcommittee on Environment and the Economy, unveiled last week.

Rep. Shimkus began the hearing by highlighting “significant changes” from the earlier version, including: new authority for EPA to develop information for priority designation purposes; new deadlines for EPA to take action on existing chemicals; and limits on the preemption effects of a low-priority designation, which now would leave in place state regulations that were in effect before the low-priority designation was made.

In his opening remarks, Environment and the Economy Subcommittee Ranking Member Paul Tonko (D-NY) argued that, as industry witnesses have agreed, CICA must restore the public confidence in the safety of chemical products by establishing a safety standard based on health and environmental information alone, while costs and benefits should be separately incorporated in risk management actions. Energy and Commerce Committee Ranking Member Henry Waxman (D-CA) alleged that the unilateral process of developing CICA and pointed out that under the bill, “EPA would be prohibited from revealing the identity of chemicals that cause serious health and environmental harms,” which would harm companies marketing safer consumer products.

In the hearing’s first panel, EPA Assistant Administrator Jim Jones of the Office of Chemical Safety and Pollution Prevention testified that the Administration had not yet developed a “formal position” on CICA, but noted that the bill did not align with the Administration’s announced principles for TSCA reform.  Mr. Jones commented that CICA does not provide EPA with a way to review existing chemicals that may pose a concern in a timely fashion, because the legislation uses a “significant risk” standard very similar to the current law. Similarly, according to Mr. Jones, the bill’s treatment of new chemicals, like current law, does not require EPA to conclude that a chemical is safe before it is allowed to enter the marketplace.

As in previous legislative hearings on TSCA reform, all of the witnesses agreed on the importance of modernizing the law. Industry witnesses included representatives from BASF, Procter & Gamble, the Society of Chemical Manufacturers and Affiliates, and the American Chemistry Council. These witnesses supported many of the changes in the updated version of CICA, including the bill’s risk evaluation provision, new authority for EPA to develop information for prioritization, and protection of Confidential Business Information (CBI). Industry witnesses did, however, raise questions about some issues related to the bill, including the length of EPA’s deadlines, the meaning of “significant risk,” the definition of “best available science,” and appropriate fee approaches to provide appropriate resources for EPA. Witnesses from the NGO Safer Chemicals and Healthy Families and the National Conference of State Legislatures criticized the bill’s broad preemption provisions.

Outside of today’s hearings, reactions to the new version of the bill continue to trickle in. Yesterday, leading Democrats Rep. Waxman and Rep. Tonko sent a letter to Rep. Shimkus expressing concern that the bill’s preemption provisions “could jeopardize state or local laws and regulations relating to hydraulic fracturing and the chemicals used in the hydraulic fracturing process.” Environmental and public health NGOs have also been critical; the Natural Resources Defense Council called it “a dud” and the Environmental Working Group described it as a “bad piece of legislation, pure and simple.”

DTSC announces Priority Products workshops and releases Draft Regulatory Concepts.

California’s Department of Toxic Substances Control (DTSC) has announced a series of Priority Product workshops intended to engage members of the public before official rulemaking for the initial Priority Products begins. Along with the announcement, DTSC released a document on “Priority Products Draft Regulatory Concepts and Topics for Stakeholder Input,” [PDF] to elicit input from the public during the workshops. The forthcoming Priority Products rules will be a significant step in implementing DTSC’s Safer Consumer Products Program.

The Draft Regulatory Concepts document contains several questions for stakeholder input, on the following topics:

  • Priority Product description (e.g., Are the definitions and terms clear and unambiguous as to which related products are included and excluded?);
  • Chemicals of Concern and alternatives (e.g., Are there other Candidate Chemicals in this product that you suggest be considered?); and
  • Market information (e.g., What is the market presence of the Priority Product?).

The document also describes the Priority Products, similar products that are excluded, and the chemicals of concern. Notably, the agency now includes bedside sleepers and co-sleepers as new examples of children’s foam padded sleeping products, explaining that these products were not included in the “Priority Product Profile” but were “later found to meet DTSC’s intent for this Priority Product.”

Three workshops have been announced, to take place in May through early June, in Sacramento, Oakland, and Los Angeles. The agenda for the first meeting, in Sacramento on May 7, is available here [PDF]. DTSC will accept written comments from the public submitted by June 30, 2014, so that the agency can consider them before releasing the proposed rulemaking package.

A first look at the changes in the updated Chemicals in Commerce Act.

As we briefly mentioned yesterday, Rep. John Shimkus (R-IL) released a new version of his proposal to reform the Toxic Substances Control Act (TSCA), the Chemicals in Commerce Act (CICA), and announced that another hearing on the bill will be held on Tuesday, April 29. Witnesses have not yet been announced.

The changes in the latest version of CICA do not constitute a major overhaul. Many of the changes in the bill are essentially changes in structure and nomenclature – for example, the “safety determinations” discussed in the initial “discussion draft” are renamed “risk evaluations.” Much discussion of scientific standards and considerations EPA must make in assessing scientific information – such as the use of a “weight of the evidence” approach – are stripped throughout the bill, only to be re-consolidated in new subsections on “Scientific Standards” and “Weight of Scientific Evidence.” However, the new version of CICA does remove requirements that EPA develop and establish specific standard practices and criteria for developing and evaluating high quality, reliable, and valid data.

The bill’s risk standards have also changed; previously, EPA was to determine whether new chemicals are “likely to result in” an “unreasonable risk of harm” to human health or the environment, but the new version instead asks if the chemical “may present” an unreasonable risk of harm. Chemicals are to be designated as low priority if EPA determines, based on available information, that the chemical is “not likely to present a significant risk of harm” under the intended conditions of use. In evaluating the risk of high priority existing chemicals, the Administrator is to determine whether a chemical might present, “in the absence of regulation,” a significant risk of harm under its intended conditions of use.

The new version of CICA elaborates on the risk evaluation (formerly “safety determination”) process – for example, specifying factors to be considered as well as factors not to be considered. Factors in the former category include the nature, circumstances, severity and magnitude of risk, as well as whether harm has occurred from the chemical under its intended conditions of use. In the latter category, EPA is precluded from considering the economic costs or benefits of either the intended use of the chemical or reducing the exposure of the chemical via rule. If a risk evaluation results in a determination of no significant risk, then that determination – which must be published, but is not required to be subject to public notice and comment rules – is considered a final agency action, and would not result in any further regulation (although EPA may choose to review risk evaluations). A determination of significant risk, however, does not become a final agency action until EPA promulgates a rule imposing restrictions or requirements “to protect adequately against an unreasonable risk of harm.” The updated CICA also adds a deadline for this section: risk evaluations must be published within four years of a chemical’s designation as high priority, although another provision authorizes EPA to grant extensions as necessary “but not to exceed a cumulative period of 3 years.”

Other changes to the updated CICA include:

  • Defines and incorporates more references to “potentially exposed subpopulations,” for example, effects on potentially exposed subpopulations are a factor that must be considered when EPA assigns a priority to an existing chemical;
  • Specifies in the definition of “intended conditions of use” and throughout the bill (e.g., as a test marketing activity that might qualify for a Section 5 exemption) that “disposal” is a covered activity (along with manufacturing, processing, etc.);
  • Strikes the notice and comment and Administrative Procedures Act requirements previously applied to “Risk-Based Exemptions” for new chemicals or uses;
  • Authorizes EPA to require manufacturers and processors to develop hazard and exposure information for priority designation purposes, upon the determination “that available information is not sufficient to make a priority designation”;
  • Adds an “Alternative Risk Evaluation” provision authorizing EPA to conduct a risk evaluation for a substance that is not designated as high-priority, to determine that the substance will not present a significant risk of harm in the absence of regulation and under specific conditions of use;
  • Adds a requirement that, in issuing a rule imposed on a chemical after making a significant risk determination, EPA must provide for a “reasonable” transition period for implementation; and
  • If considering a rule that would prohibit or substantially prevent a specific use of a chemical, EPA must determine whether technically and economically feasible alternatives “that benefit human health or environment, compared to the use proposed to be prohibited or substantially prevented,” will be “reasonably available as a substitute” when the rule would take effect. The discussion draft’s comparison point was whether the alternatives “materially reduce risk.”

A key sticking point for the bill’s detractors has been its express preemption provision, but the new CICA does not make substantial changes on this issue. If enacted, it appears that CICA would effectively preempt almost any state efforts to regulate or request information on chemicals covered by TSCA – except, perhaps, if the state law or regulation does not regulate the chemical substance under its intended conditions of use.

Chemical Watch reports that House Democrats have been negotiating with Rep. Shimkus on resolving their concerns with CICA, such as the scope of preemption. However, it appears that some disagreement among House Democrats remains as to the likelihood of reaching a resolution; Rep. Henry Waxman (D-CA), the Energy and Commerce Committee Ranking Member, reportedly remains concerned about establishing a “health-based safety standard,” among other issues. Currently, CICA is the only proposal on the House side; meanwhile, according to Chemical Watch, there is still no clear timeline for putting out a new version of the bipartisan bill in the Senate, the Chemical Safety Improvement Act.

Attorneys General from 13 states oppose House Republicans' TSCA reform bill.

A coalition of Attorneys General from 13 states spoke out last week against the House Republicans’ plan to reform the Toxic Substances Control Act (TSCA). The Attorneys General sent a letter [PDF] to the leadership of the House Subcommittee on Environment and the Economy criticizing the Chemicals in Commerce Act (CICA), the proposal introduced by Subcommittee Chair Rep. John Shimkus (R-IL) in late February. Like other critics, the letter lauded the legislators’ efforts and the necessity of modernizing TSCA but took particular issue with CICA’s preemption provisions, arguing that they would “effectively eliminate the existing federal-state partnership on the regulation of toxic chemicals” and “cripple states’ ability to protect their citizens and the environment from the risks posed by toxic chemicals.” The Attorneys General on the letter are all Democrats and represent the following states: New York, California, Connecticut, Hawaii, Iowa, Maine, Maryland, Massachusetts, New Hampshire, New Mexico, Oregon, Vermont, and Washington.

CICA has already been the subject of one House Subcommittee hearing in March, and today, a second hearing on an updated draft of the bill was announced, to be held on April 29. The new draft [PDF] and a redline comparison [PDF], among other materials, are available on the hearing page.

According to the Attorneys General, CICA’s preemption provisions for both existing and new chemicals would preempt any state law or regulation that “prohibits or restricts the manufacture, processing, distribution in commerce, or use” of any chemical for which EPA has made a “safety determination,” prioritization decision, or promulgated a rule imposing requirements or restrictions. Since CICA contemplates that EPA would take at least one of those actions for all new and existing chemicals, states would eventually be preempted from regulating any chemicals. States would not be able to regulate, for example, chemicals EPA designates as low-priority but does not take further action to regulate, but which may still pose a high hazard or high exposure risk. Neither would preemption be affected by EPA’s failure to make a safety determination within the mandated 90 days.

The letter further criticizes the elimination of two of TSCA’s current “categorical exemptions” from preemption, which apply when a state regulation is identical to an EPA action, or if the state regulation prohibits the use of a chemical in the state, as well as the case-by-case exemption available under current law.

In addition, the Attorneys General argue that CICA’s preemption of states’ authority to obtain health and safety information about toxic chemicals is an unprecedented, “significant step backward in the realm of the ‘right to know’ about toxic chemicals.”

The Attorneys General pointed out that states have historically been leaders in reducing risks from toxic chemicals, as in the case of Connecticut’s early ban on polychlorinated biphenyls (PCBs) two years before the federal government’s nationwide ban came into effect under TSCA. The Attorneys General also emphasized more recent efforts by state legislatures on chemical management bills and phase-outs of particular substances and in certain applications, arguing that “[p]rotection of children’s health from harmful chemicals has been a particular focus of the states.” Under CICA, the letter argues, the states would no longer be able to serve as innovators and standard-setters for the whole nation’s benefit.

The letter is the latest critique of the House bill, which has come under attack from NGOs and some Democrats while receiving support from industry. Last month, Bloomberg BNA interviewed two former EPA officials were both more sanguine about CICA’s prospects. The officials argued that although CICA imposed serious implementation challenges on the EPA, those issues could be fixed with only minor changes. Although they agreed that CICA was relatively similar to the Senate TSCA reform proposal, the Chemical Safety Improvement Act, the officials also cautioned that the key challenge to achieving TSCA reform is addressing state preemption concerns.

Scientists: 100nm definition for nanoparticles may be "inappropriate."

The 100 nanometer (nm) upper limit for defining nanoparticles may be “potentially inappropriate” and does not reflect the “complexity of ecological interactions” with nanoparticles, according to a viewpoint article [PDF] published in Environmental Sciences and Technology and highlighted by ChemicalWatch. According to a team of Chinese and American scientists, threshold sizes for nanoparticles likely exist and thus, critical sizes for environmental impacts are also likely to exist and exceed, or at least differ from, the 100 nm definition.

Studies show that nanoparticle threshold sizes vary with composition and shape, probably due to “changes in excess surface energy and crystallography of [nanoparticles] as size decreases.” Threshold size ranges have been established for nanoparticles based on physicochemical properties including particle dissolution, contaminant adsorption, and suspension stability, for example. However, further research is required to determine threshold sizes for complex biological effects like accumulation and toxicity, as nanoparticles may have size-specific mechanisms for transformation, reactive oxygen species production, etc.

The scientists point out that if threshold sizes for nanoparticles’ environmental impacts exist, changes in the effects could not be predicted by larger particle sizes, even under the 100 nm definition. Thus, to better assess and minimize environmental risks from nanoparticles, the size and functionalization of nanoparticles in development should be designed appropriately if that nanoparticle is determined to have substantially increased ecotoxicological effects below a certain threshold.

The scientists call for more research “to assess the potential for threshold sizes for environmental impacts and to assess if [nanoparticles] larger than the threshold sizes have different impacts than bulk particles of the same composition.” The results of such research could better inform the current size definition of nanoparticles and affect methods for modeling environmental impacts and risks.

D.C. Circuit Court partially strikes down SEC conflict minerals rule.

On Monday, a federal appeals court struck down a rule implementing the Dodd-Frank Act’s requirement that companies disclose whether their products contain conflict materials originating from the Democratic Republic of Congo (DRC), or adjoining countries. A divided (2-1) panel of the U.S. Court of Appeals for the D.C. Circuit ruled [PDF] that the U.S. Securities and Exchange Commission (SEC) rule compelled commercial speech in violation of the First Amendment.

Industry groups challenged the SEC’s final rule on Administrative Procedure Act (APA), Exchange Act, and First Amendment claims. In National Association of Manufacturers v. Securities and Exchange Commission, the industry groups appealed the District Court’s rejection of their claims, but only prevailed with respect to the First Amendment challenge.

The APA claim in part attacked the rule’s lack of a de minimis exception. As we reported in November, because the SEC rule does not contain a de minimis exception, the disclosure requirement – which also calls for due diligence and auditing – could apply to firms that use conflict minerals in very small amounts as catalysts in the manufacturing process. The Court upheld the decision not to include a de minimis exception, finding that the SEC, “relying on text, context, and policy concerns, inferred that Congress wanted the disclosure regime to work even for small uses,” and a de minimis exception would thwart the statute’s goals.

The Exchange Act challenge also failed, as the Court found that the SEC’s cost-benefit analyses as required by the Exchange Act were “reasonable,” even though the rule’s “compelling social benefits” were not quantifiable.

However, the Court sided with the industry groups with regard to the SEC rule’s requirement that companies describe its products as not “DRC conflict free” in reports filed with the Commission and on the companies’ own websites. Writing for the Court (and joined by Judge Sentelle), Judge Randolph found that rational basis review was not appropriate for this type of speech, because it only applies to “purely factual and uncontroversial information,” in cases in which “disclosure requirements are reasonably related to the State’s interest in preventing deception of consumers.” In this case, the SEC did not argue that the rule related to preventing consumer deception. Judge Randolph concluded that requiring the use of the “conflict free” label was found to convey a “moral responsibility for the Congo war,” tantamount to “compelling an issuer to confess blood on its hands” in interference with the First Amendment.

The Court further found that the SEC’s rule failed to meet the intermediate standard for commercial speech set out in Central Hudson, which “invalidates regulations for which narrower restrictions on expression would serve the government’s interest as well.” (Quotations omitted.) In this case, the SEC presented no evidence that less restrictive means would be ineffective, and the Court rejected its argument that the rule’s minimal impact was dispositive of the “narrowly tailored” requirement.

Notably, Judge Srinivasan declined to join the Court’s opinion with respect to the First Amendment claim, arguing that the issue should have been held in abeyance and part of the SEC rule stayed until the Circuit’s en banc re-hearing of a related case, American Meat Institute v. United States Department of Agriculture, regarding meat labeling.

Moving forward, the rule’s effective date for compliance is June 2, and the SEC has not yet offered a stay or guidance to companies on how to comply with the partially-invalidated rule. The SEC has also not yet announced whether it will seek to participate in the AMI case; otherwise, the case will be remanded to the D.C. District Court.