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.

Ninth Circuit Vacates EPA Conditional Approval of Nanoscale Silver Antimicrobial

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On May 30, 2017, the Ninth Circuit Court of Appeals vacated EPA’s conditional approval of Nanosilva NSPW-L30SWS, a type of antimicrobial silver registered as a materials preservative for textiles and plastics.  NRDC v. United States EPA, 2017 U.S. App. LEXIS 9360  (9th Cir. 2017).  The active ingredient in the product is nanoscale silver.  The National Resources Defense Council (NRDC), Center for Food Safety (CFS), and the International Center for Technology Assessment (ICTA), appealed the conditional approval. The Ninth Circuit found that EPA had not sufficiently supported its finding that early approval was in the public interest – a requirement for conditional approval under the Federal Insecticide, Fungicide, Rodenticide Act (FIFRA).  EPA granted conditional approval of the product in May 2015.

Under FIFRA, EPA is permitted to issue conditional registration for a pesticide containing an active ingredient not contained in any currently registered pesticide, only where: 1) use of that pesticide will not cause any unreasonable adverse effect on the environment, and 2) use of the pesticide is in the public interest.  7 U.S.C. § 136a(c)(7)(C).  The Ninth Circuit explained that the Agency considers this type of conditional registration when it has not received sufficient data to determine that long-term use of a pesticide is reasonable.  Id.  In its decision to grant conditional approval of NSPW, EPA found that use of the pesticide is in the public interest because it has the “potential” to reduce the amount of silver released into the environment.

NRDC, CFS, and ICTA disputed the factual premises underlying the EPA’s public-interest finding.  Petitioners challenged the Agency’s findings that:

  • NSPW has a lower application rate (e., it uses less silver) than conventional-silver pesticides;
  • NSPW has a lower mobility rate (e., it is less likely to release silver into the environment in detectable quantities); and
  • Current users of conventional-silver pesticides will switch to NSPW and/or that NSPW will not be incorporated into new products (i.e., registration of NSPW will reduce the amount of silver pesticides used).

While the Ninth Circuit found that EPA’s analysis supported finding both lower application rate and lower mobility rate, it also found that the Agency “impermissibly relie[d] on unsubstantiated assumptions” to support the finding that the conditional registration of NSPW will reduce the amount of silver pesticides used.  EPA had concluded that use of NSPW is in the public interest because it has the “potential” to reduce the amount of silver released into the environment. The Ninth Circuit held that EPA’s conclusion requires two interrelated and unstated assumptions.  The Ninth Circuit found that

  • EPA assumed that current users of conventional-silver pesticides will replace those pesticides with NSPW (“the substitution assumption”); and
  • EPA assumed that NSPW will not be incorporated into new products to the extent that such incorporation would actually increase the amount of silver released into the environment (“the no-new-products assumption”).

The Ninth Circuit held that neither assumptions are supported by substantial evidence.[1]  In fact, the Ninth Circuit found that if the EPA’s substitution and no-new-products assumptions are incorrect, NSPW may actually increase the amount of silver released into the environment, which would contravene the identified public interest.  The Ninth Circuit explained that

EPA may not satisfy the [substantial evidence] requirement by simply finding that a pesticide has the “potential” to be in the public interest—especially where the pesticide also has the “potential” to contravene the public interest. Accordingly, where an essential premise of a public-interest finding is only supported by bare assumptions, as in the present case, we will find substantial evidence lacking.

NRDC v. United States EPA, 2017 U.S. App. LEXIS 9360  (9th Cir. 2017).

[1] The Ninth Circuit held EPA to the substantial evidence standard as dictated by FIFRA.  7 U.S.C. § 136n(b).  The Court explained that “[s]ubstantial evidence means more than a mere scintilla but less than a preponderance; it is such relevant evidence as a reasonable mind might accept as adequate to support a conclusion.” Nat. Res. Def. Council v. EPA (NRDC), 735 F.3d 873, 877 (9th Cir. 2013).

NIOSH Actions Threaten Lower Exposure Limits for Carcinogens

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The National Institute for Occupational Safety and Health (NIOSH), the workplace research arm of the federal Centers for Disease Control, recently has taken two actions likely to lead to much lower occupational exposure recommendations for known or suspected carcinogens. First, in December 2016, the agency finalized its new Carcinogen Policy. The new policy provides “that there is no known safe level of exposure to a carcinogen, and therefore that reduction of worker exposure to chemical carcinogens as much as possible through elimination or substitution and engineering controls is the pri¬mary way to prevent occupational cancer.” NIOSH no longer will use the term recommended exposure limit (REL) for chemical carcinogens; rather NIOSH will only rec¬ommend an initial starting point for control, called the Risk Management Limit for Car¬cinogens (RML-CA). For each chemical identified as a carcinogen, the RML-CA will be set at the level deemed necessary to ensure no more than one excess cancer case in 10,000 workers in a 45-year working lifetime. When measurement of the occupational carcinogen at the RML-CA is not analytically feasible at the 1 in 10,000 risk estimate, NIOSH will set the RML-CA at the limit of quantifi¬cation (LOQ) of the analytical method. This is a major change from the prior NIOSH policy, which recognized that acceptable exposure limits can be established for carcinogens and focused on risks of 1/1000 or greater.

Second, in March 2017 NIOSH published draft guidance for using Occupational Exposure Banding (OEB) to evaluate chemical hazards.  The guidance would be used by NIOSH to establish and update RELs and the new carcinogen limits, and also appears intended to allow chemical users and others to set their own internal limits.  It includes formulas for deriving upper and lower limit values (bands) on the basis of available data. The preferred databases for carcinogens include EPA’s IRIS listings and the Cal OSHA database, among others.

These two developments, taken together, are likely to lead to major reductions in NIOSH exposure recommendations for known or suspected carcinogens. While NIOSH has no enforcement authority, the NIOSH recommendations can be enforced by OSHA pursuant to the General Duty Clause of the Occupational Safety and Health Act, and they often are used as internal corporate standards.

The Carcinogen Policy is final; therefore, revision likely would require a petition for reconsideration. Comments on the OEB guidance are due by June 13, and could include arguments that it cannot be used to supersede current RELs and that the new Carcinogen Policy should not be applied.