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

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

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

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

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.