EPA Releases Working Guidance for the Nanoscale Material Reporting Rule

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On August 14, 2017, EPA released the Working Guidance for the Nanoscale Material Reporting Rule.  The Working Guidance considerably narrowed the scope of “reportable chemical substance” from the draft Guidance.  EPA considers the Guidance a “working” document because it intends to update the Guidance based on questions the Agency receives.

The Working Guidance also discusses other aspects of what makes a chemical a “reportable chemical substance” and a number of other issues.  It is divided into the following sections:

  • What Chemicals are Reportable?
  • Who is Required to Report?
  • What Information is to be Reported?
  • When is Reporting Required?
  • General Questions.

The most helpful information is found under “What Chemicals are Reportable?” and “Who is Required to Report?”

What Chemicals are Reportable.  A reportable chemical substance is one that it solid at 25º C, 1 – 100 nanometers in size in at least one dimension, and intentionally manufactured or processed to exhibit unique or novel properties because of its size.  The draft Guidance had raised a number of unanswered questions regarding what comprised unique and novel properties.

In the Working Guidance, EPA explicitly states that “size is not considered to be a unique and novel property.”  The Working Guidance differentiates between unique and novel properties and enhanced or continuously scaling properties.  The later are those which do not intrinsically change on the nanoscale and instead scale proportionately with size.  Chemicals that have different functionality at the nanoscale than the form greater than 100 nanometers would be considered substances demonstrating unique and novel properties.

Additional points about “reportable chemical substances” include discussion of discrete chemical substances and coatings.  The Working Guidance notes that some nanoscale materials are engineered to give all the particles a certain morphology or shape.  The change in shape needs to be a specifically engineered change in the shape of particles to be a discrete form of a reportable chemical substances.  EPA explains that coating a nanoscale material results in a nanoscale material with different properties; in other words, by coating a nanoscale material, one has created a reportable chemical substance.

Who is Required to Report.  According to the Working Guidance, each manufacturer and processor in the supply chain must report on the reportable chemical substance.  EPA notes that processors should document the steps they took to determine whether reporting is required.  If processors do not know about specific properties that would allow them to know if they are processing a chemical substance subject to the rule, EPA believes that it would be within the reasonably ascertainable standard to ask their suppliers.

NGOs Challenge Risk Evaluation and Prioritization Rules

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Environmental Defense Fund (EDF), Safer Chemicals Healthy Families, and the Alliance of Nurses for Healthy Environments (ANHE) have filed suit for review of EPA’s Risk Evaluation and Prioritization Rules promulgated under the amended Toxic Substances Control Act (TSCA).  Both rules were required by Section 6 of the amended statute.  The final rules were released by EPA on June 22, 2017.  The Safer Chemicals Healthy Families petitions challenge the Risk Evaluation and Prioritization Rules as arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law; in excess of statutory jurisdiction, authority, or limitations; and without observance of procedure required by law.

EDF filed suit on August 11, 2017 in the U.S. Court of Appeals for the Second Circuit; ANHE et al filed suit on August 11, 2017 in the U.S. Court of Appeals for the Fourth Circuit; and Safer Chemicals Healthy Families et al filed suit on August 10, 2017 in the U.S. Court of Appeals for the Ninth Circuit.  Safer Chemicals Health Families was joined on its petition by a number of groups including Environmental Working Group, Union of Concerned Scientists and AFL-CIO.  ANHE was joined on its petition by the Natural Resources Defense Council (NRDC).  The NGOs did not file a Motion for Stay to prevent EPA from moving forward in implementing the Risk Evaluation and Prioritization Rules while the petitions are under review.

Additional insight into the petitioners’ concerns can be found in their statements regarding the final rules and the litigation.  EDF has said that it believes the final risk evaluation rule improperly narrows conditions of use by not including all conditions of use in the risk evaluation.  NRDC expressed concern that the risk evaluation rule introduces loopholes that could lead to incomplete analysis, which could lead EPA to conclude that a chemical doesn’t pose a health or environmental risk when it actually does.  Regarding the prioritization rule, EDF asserts that the final rule describes an information-gathering process that seeks to minimize and undermine EPA’s use of the new testing authorities available to the agency under section 4.

EPA has not commented on the litigation.

CBI Claims under the Amended TSCA

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EPA recently notified many companies that CBI substantiation statements are due September 19, 2017.  This was a surprise to those unfamiliar with the CBI substantiation requirements imposed by the Lautenberg amendments to TSCA and EPA’s Statement of Interpretation regarding these provisions.  The Statement of Interpretation was issued in the Federal Register January, 19, 2017.

The Lautenberg amendments require upfront substantiation of CBI claims.  EPA data systems were not equipped to accept substantiation statements when the statute was first enacted.  CBI claims made in the months between Lautenberg’s enactment and EPA updating its systems must now be substantiated.  At issue are CBI claims made from June 22, 2016 to March 20, 2017.

The Agency has given companies until September 19, 2017 to substantiate claims made from June 22, 2016 to March 20, 2017.  For CBI submissions made on or after March 21, 2017, all claims must be substantiated at the time the assertion is made to EPA – that is at the time the information claimed as CBI is submitted to EPA.  Where there is no substantiation for a CBI claim, EPA is authorized to make the information public.

Under the amended statute, CBI substantiation must address the following:

  • Identify measures the company has taken to protect the confidentiality of the information,
  • Explain how disclosure of the information would harm to the company’s competitive position, and
  • Determine whether or not the information must be disclosed under any other Federal law;

Some categories of information are generally not subject to substantiation requirements (§14(c)(2)) (e.g., specific information describing the processes used in manufacture or processing, marketing and sales information).  Most information from health and safety studies is classified as “information not protected from disclosure” (§14(b)).

EPA provided some helpful guidance on developing CBI substantiation statements in a July 13, 2017 webinar.  In addition, the has developed substantiation templates that may be used as a starting point in preparing CBI substantiations.  In the templates, the EPA asks questions “to elicit facts that will help the Agency understand the basis for the submitter’s belief that a particular data element claimed as CBI is in fact entitled to this status.”  Detailed responses are necessary to demonstrate the following points:

  • The company’s efforts to protect the confidentiality of the information,
  • How disclosure of the information would harm to the company’s competitive position, and
  • That the information claimed as confidential does not appear in any public documents.

EPA has also developed a webpage to address these issues.  Included are lists of CDR and PMN data elements exempt from CBI substantiation under TSCA section 14(c)(2).

It is critical to be very detailed when developing substantiation statements.  Companies get only one chance to articulate the facts that support their CBI claims.  EPA procedures for reviewing CBI substantiation provide no opportunity for companies to revise or amend the statements.  The only avenue for appeal, when claims are denied, is to file a petition for review in federal district court pursuant to TSCA Section 14(g)(2)(D).  In such cases, the court’s review is likely to be limited to the record that was created for the Agency’s review, and additional legal or factual arguments beyond those presented to EPA are unlikely to be allowed.  To ensure that substantiation statements will withstand EPA’s determination process, we encourage companies to seek legal counsel.

The Court of Appeals for the D.C. Circuit Invalidates Two Key Provisions of the 2015 Amendments to the Definition of Solid Waste

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On July 7, 2017, the U.S. Court of Appeals for the D.C. Circuit issued a decision invalidating two key provisions of the 2015 amendments to the definition of solid waste under the Resource Conservation and Recovery Act (RCRA). American Petroleum Institute v. EPA (D.C. Cir. No. 09-1038). The Court invalidated Factor 4 of the legitimacy determination need for recycling hazardous materials. The Court also found the Verified Recycler Exclusion was unreasonable and reinstated the old Transfer Based Exclusion.

There are four legitimacy factors that must be met to determine when a material is being legitimately recycled, and therefore the material might be excluded from the definition of solid waste. The Court struck down Factor 4, which stated that for recycling to be legitimate, the product of the recycling process must be comparable to a legitimate product or intermediate, that is the material must have comparable hazardous properties as the final product being made with the recycled material. The Court concluded that this factor imposed “draconian” procedures for demonstrating the absence of significant environmental risk. The Court vacated Factor 4, insofar as it applies to all hazardous material under 40 CFR § 261.2(g), but it did not strike down Factor 4 as it applies to specific exclusions, such as the generator-controlled exclusion at 40 CFR § 261.4(a)(23), because the Petitioners did not challenge Factor 4 as it applies to those exclusions.

The Court also struck down the Verified Recycler Exclusion and reinstated the Transfer Based Exclusion, an earlier exclusion that the Agency issued in 2008, except it kept two provisions of the Verified Recycler Exclusion: (1) the requirement that the generator meet certain emergency preparedness standards, and (2) the expanded requirement for the materials to be properly contained.

National Academy of Sciences Releases Strategy on Evaluating Low-Dose Effects of Endocrine Disruptors

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On July 18, 2017, the National Academies of Sciences released a report detailing a strategy for evaluating the evidence of low-dose effects of endocrine disruptors (called endocrine active chemicals (EACs) in the report).  The Academies emphasized the importance of the strategy, noting that even small alterations in hormone concentrations, particularly during embryonic development, can have lasting and significant effects.

EPA asked the Academies to develop the strategy in response to evidence suggesting that some chemicals have effects at doses lower than those studied in traditional toxicity testing.  By commissioning the strategy, the Agency is working to address concerns that its current toxicity-testing protocols might be inadequate to identify all potential hazards to human health.

The strategy presents a three phase approach:

  • Surveillance for evidence that a chemical may cause a health effect or that a health effect may be missed by traditional toxicity-testing methods,
  • Investigation and analysis of the evidence, and
  • Acting on the evidence.

The Academies noted that EPA is already conducting many activities consistent with the proposed strategy.  However, the report notes that the Agency’s current approach does not necessarily use these activities to assess low-dose exposure to EACs.

The Academies made recommendations for EPA’s decision-making about its regulatory toxicity-testing practices to facilitate a greater emphasis on regular consideration of the adequacy of toxicity testing for assessing low-dose exposure to EACs.  Recommendations include:

  • Develop an active surveillance program focused specifically on low-dose exposures to EACs that includes regularly monitoring published research, gathering input from stakeholders, and considering human exposure information. The Academies recommend that the surveillance program periodically identify, scope, and prioritize potential areas of focus related to low-dose effects, such as particular chemicals and end points.
  • Use human environmental exposure or biomonitoring data to define the subset of data that should be considered as reflective of low-dose exposure.

Two examples of the application of this strategy are provided in the report.  These examples demonstrate how the strategy can be applied, and how results from its application can be integrated and considered with other relevant data to draw conclusions about causal associations.  To develop these examples, the Academies reviewed the effects of phthalates, specifically diethylhexyl phthalate (DEHP), on male reproductive-tract development and the effects of  polybrominated diphenyl ethers (PBDEs) in relation to developmental neurotoxicity.

The Academies assessment of DEHP concluded that the available data support the hazard conclusion that in utero exposure is presumed to be associated with decreased androgen production.  However, the Academies found challenges drawing conclusions about dose response.  The report explains that it is difficult to directly compare the effects of different levels of DEHP exposure in animals and humans because animal studies typically report administered doses whereas studies in humans rely on the measurement of DEHP metabolites in body fluids.  The Academies flag this as a situation where current toxicity-testing methods can identify a hazard that is presumed to be of concern to humans, but current methods might not be able to accurately predict exposures at which humans are affected.

The Academies review also identified associations between perinatal PBDE exposure and neurobehavioral outcomes.  Again the Academies found difficulties directly comparing PBDE exposure in animal studies to that occurring in humans.  In addition, the Academies report that estimates of human daily intake suggest that human exposure is several orders of magnitude lower than that used for benchmark doses in animal studies.  The Academies concluded that this is another situation where current toxicity-testing methods can identify a hazard that is presumed to be of concern to humans, but current methods might not be able to accurately predict exposures at which humans are affected.

EPA has not yet announced how it will implement the strategy.  The Agency’s efforts to research EACs are detailed on it’s website.

The full report is available here.

Four Paint Companies Settle with FTC Regarding Unsubstantiated Zero VOC and Zero Emissions Claims

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The four companies, Benjamin Moore & Co., Inc., ICP Construction Inc., YOLO Colorhouse, LLC, and Imperial Paints, LLC, agreed to settle Federal Trade Commission (FTC) allegations that they promoted products as emission-free or containing zero volatile organic compounds (VOCs) during and immediately after painting without having adequate substantiation for making those claims. Some advertisements from the companies also made explicit unsubstantiated safety claims regarding babies, children, pregnant women, and other sensitive populations, such as those suffering from asthma or allergies. The FTC is now taking comment on the Consent Orders for the four companies.

The FTC published Green Guides, which are designed to help marketers ensure that their environmental benefit claims are truthful and non-deceptive in accordance with Section 5 of the FTC Act, 15 U.S.C. §45. The companies failed to meet the FTC’s Green Guides and the FTC’s Enforcement Policy on Zero-VOC claims, and did so at their own peril. The Orders follow the Green Guides and the Enforcement Policy in that the companies cannot make unqualified zero-emission or zero-VOC claims unless the emissions and VOC content is actually zero (which is a difficult standard to meet), or the companies can meet the FTC’s de minimis standard, i.e., emissions and VOC content can be at trace levels.

The FTC’s  Enforcement Policy on Zero-VOC claims describes the “trace level” test a company must meet in order to make unqualified “zero” or “free-of” VOC claims: (1) VOCs have not been intentionally added to the product; (2) the presence of VOCs at that level does not cause material harm that consumers typically associate with VOCs, including but not limited to, harm to the environment or human health; and (3) the presence of VOCs at that level does not result in concentrations higher than would be found at background levels in the ambient air.

The Enforcement Policy’s “trace level” test was changed in the recent Consent Orders. In the Orders, the new “trace level” test is:

  • A VOC has not been intentionally added to the covered product;
  • Emission of the covered product does not cause material harm that consumers typically associate with emission, including harm to the environment or human health; and
  • Emission of the covered product does not result in more than harmless concentrations of any compound higher than would be found under normal conditions in the typical residential home without interior architectural coating.

The emphasis in the “trace level” test now seems to be on “emissions,” which is defined in the Orders as any compound that is emitted or produced during application, curing, or exposure of a covered product. Additionally, it appears that the FTC further refined the third criteria pertaining to background levels by specifying where the background level measurement should be, i.e., in a typical residential home, and how the measurement should be taken, i.e., without interior architectural coating.

Based on the Consent Orders, the four companies promoted products as emission-free or zero-VOC without having adequate substantiation for making those claims. As such, they are barred from doing the following:

  • Making unqualified emission-free and VOC-free claims, unless both content and emissions are actually zero, or emissions are at trace levels, beginning at application and thereafter;
  • Making claims about emission, VOC levels, odor, and other environmental or health benefits, unless they are true and not misleading, and unless the companies have competent and reliable scientific evidence to back them up; and
  • Providing third parties with the means of making false, unsubstantiated, or misleading representations about material facts regarding paints.

In addition, the four companies must send letters to their distributors, instructing them to stop using existing marketing materials, and provide stickers or placards to correct misleading claims appearing on product packaging or labeling in order to correct existing unsubstantiated claims. Benjamin Moore and ICP Construction must also disclose that the environmental seals appearing in their promotional materials are their own in-house designations.

It must be noted that if the FTC Commission finalizes the Orders, it plans to update the 2012 Sherwin-Williams Company and PPG Architectural Finishes Orders previously settled with the FTC over unsubstantiated zero-VOC and environmental benefit claims.

EPA Proposes to Retain Primary NOx NAAQS

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Clean Air Act Section 109(d) requires EPA to review national ambient air quality standards (NAAQS) at least every 5 years, and revise them if newly available information indicates that the existing standards are not adequate to protect public health and welfare. The last EPA review of the primary (health based) NAAQS for nitrogen oxides (NOx) was completed in 2010. In that review, the agency added a new one-hour standard at a level of 100 ppb, while retaining the prior annual standard of 53 ppb, set in 1971.

EPA is now nearing the end of the next review of the primary NOx standards, and recently released a proposal not to revise the standards adopted in 2010. (The NOx secondary standards are being reviewed separately.) With respect to the one-hour standard, the proposal finds that the strongest evidence continues to come from human exposure studies of respiratory effects in asthmatics following short-term exposures (typically minutes to hours). Most of these studies were available in the last review, and an updated meta-analysis continues to show effects in some asthmatics following resting exposures to NOx concentrations from 100 to 530 ppb. However, the current data remain insufficient to calculate a reliable dose-response relationship between exposure and effects, and there is uncertainty regarding the potential adversity of reported responses, particularly at the lower exposure levels. While supporting evidence from epidemiological studies reduces uncertainty from the last review, the newly available studies do not fundamentally alter EPA’s prior understanding.

The annual standard is based on a reported relationship between long-term NOx exposures and asthma development in children. The strongest evidence supporting this conclusion comes from recent epidemiologic studies. While these studies strengthen the evidence for effects from long-term exposures presented in the 2010 review, they are subject to uncertainties resulting from the methods used to calculate exposures, the high correlations between NOx and other traffic-related pollutants, and the lack of information regarding the extent to which reported effects are independently associated with NOx rather than the overall mixture of traffic-related pollutants. Additionally, while  the current evidence reports adverse effects (emergency department visits, hospital admissions, asthma incidence) in locations likely to have violated the current standards, studies do not indicate such associations in locations that would clearly have met those standards.

EPA also considered quantitative analyses estimating the potential for adverse NOx exposures that could be allowed by the current standards. Overall, these analyses indicate that the current standards provide substantial protection against adverse effects even under worst-case conditions across a variety of study areas in the U.S.

On the basis of these findings, EPA proposes to retain the current standards. The proposal is consistent with the advice of EPA staff in the NOx Policy Assessment and with the advice of the agency’s Clean Air Scientific Advisory Committee. Comments on the proposal will be due 60 days after it is published in the Federal Register.

Beyond this NOx review, a couple of these findings may affect the pending reviews of the PM and other NAAQS. These include recognition of the uncertainties in the studies at lower exposure levels, and the inability to separate NOx effects from the rest of the traffic pollution mixture.

EPA Administer Assembles Task Force for Superfund Restructuring

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On May 22, 2017, EPA Administrator Scott Pruitt created a task force to improve the Superfund remediation process. He asked the Superfund task force to find ways to “utilize alternative and non-traditional approaches for financing site cleanups.” The task force’s recommendations were due by June 21, 2017. EPA has not yet announced its recommendations.

Creation of the task force was announced one day before the Trump Administration released its budget proposal for fiscal year 2018. The proposal would cut the EPA’s budget by 31.4 percent. In the proposed budget, Superfund spending is reduced by 25 percent — $330 million. Such drastic cuts may not be approved by Congress.

Future management of the Superfund program may rely on called the “Superfund Alternative Approach” to streamline efforts. Under the Superfund Alternative Approach sites are not added to the National Priorities List. However, the Alternative Approach uses the same standards and investigation process as sites addressed under the conventional approach. The Superfund Alternative Approach can’t be used at every site, just those with a willing, capable potential responsible party who will negotiate and sign an agreement with EPA to perform the investigation or cleanup. In addition, sites managed under the Alternative Approach are not eligible for federal cleanup funds. This process cannot be used to remove sites from the National Priorities List, which may frustrate companies working towards permanent resolution of remediation obligations.

EPA Seeking Nominations for the Clean Air Scientific Advisory Committee

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The Clean Air Scientific Advisory Committee (CASAC) is a chartered Federal Advisory Committee, and was established pursuant to the Clean Air Act (CAA) to provide advice, information, and recommendations to the EPA Administrator on the scientific and technical aspects of air quality criteria and National Ambient Air Quality Standards. Members of the CASAC include non-EPA scientists, engineers, and physicians who are nationally and internationally recognized experts in their respective fields. Members are appointed by the EPA Administrator for a three-year term and serve as Special Government Employees who provide independent expert advice to the agency.

EPA is seeking nominations for the “health chair” of the CASAC. The CAA requires that at least one member be a physician who is a member of the National Academy of Sciences and has expertise in health effects of air pollution. EPA is interested in physicians who have knowledge and experience in air quality relating to criteria pollutants (ozone, particulate matter, carbon monoxide, nitrogen oxides, sulfur oxides, and lead). Nominations are due by July 27.

You can read the Federal Register notice here.

EPA Issues Three Final Rules under New TSCA

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On June 22, 2017, the U.S. Environmental Protection Agency (EPA) released pre-publication Federal Register notices of the final framework actions under the new Toxic Substances Control Act (TSCA), the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The final rules include:

  • The Inventory Reset Rule (AKA the Active-Inactive Rule), which requires industry to report chemicals manufactured, imported, or processed in the U.S. over the past ten years;
  • The Prioritization Process Rule, which establishes EPA’s process and criteria for identifying High-Priority chemicals for risk evaluation and Low-Priority chemicals for which risk evaluation is not warranted at this time; and
  • The Risk Evaluation Process Rule, which establishes EPA’s process for evaluating High-Priority chemicals to determine whether or not they present an unreasonable risk to health or the environment.

EPA also published pre-publication notices concerning the scopes of the risk evaluations to be conducted for the first ten chemical substances under new TSCA, and a guidance document to assist interested persons in developing and submitting draft risk evaluations.