EPA Issues Second Draft “Eco ISA” for NOx, SOx and PM

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EPA recently released the second draft of an Integrated Science Assessment (ISA) for “ecological effects” from NOx, SOx and PM, which include effects on flora, fauna and water resources.  The ISA will be used to determine the need for revising the current secondary national ambient air quality standards (NAAQS) for these pollutants. Other welfare effects that could be caused by these substances, such as effects on visibility, climate or building materials, will be addressed in the ISAs for the primary (health-based) standards for the substances.

The NOx and SOx ecological effects previously were addressed in a 2008 ISA. The specific effects considered are too numerous to discuss here, but they are listed in a table in the new draft ISA that compares the 2008 conclusions with those presented in the new draft. All of the effects analyzed in the 2008 ISA were determined to be “causal” pursuant to EPA’s classification scheme (meaning that they are caused by the pollutants at issue). However, those determinations did not result in a change in the secondary standards, owing to the uncertainties involved in identifying ambient concentrations necessary to alleviate the effects. EPA took the position that the existing suite of primary and secondary standards also would provide adequate protection against these ecological effects.

In the new draft, all the effects determined to be causal in 2008 retain that classification. However, the new draft addresses the following five effects not classified in 2008:

  1. N deposition and the alteration of the physiology and growth of terrestrial organisms and the productivity of terrestrial ecosystems;
  2. Acidifying N and S deposition and the alteration of the physiology and growth of terrestrial organisms and the productivity of terrestrial ecosystems;
  3. N deposition and increased nutrient-enhanced coastal acidification;
  4. N deposition and changes in biota, including altered physiology, species richness, community composition, and biodiversity due to nutrient-enhanced coastal acidification;
  5. S deposition and changes in biota due to sulfide phytotoxicity, including alteration of growth and productivity, species physiology, species richness, community composition, and biodiversity in wetland and freshwater ecosystems.

All these effects, most of which were discussed in the 2008 ISA but not classified, would now be classified in the new ISA as causal on the basis of more recent information. The general conclusion is that new evidence supports the prior classifications and improves quantification of dose-response relationships. However, there is no clear statement that quantification has improved sufficiently to allow use of ecological effects as a basis for revising the standards, and in many cases the draft ISA finds that quantification remains subject to significant uncertainty.

Unlike the 2008 ISA, the new draft includes ecological effects from ambient PM. EPA’s last discussion of this issue, in the 2009 PM ISA, concluded that there is likely a causal relationship between PM deposition and various ecological effects, but that the specific relationships cannot be quantified as a result of a number of uncertainties. As a result, the PM secondary standards were not revised at the conclusion of the last review.  The new draft ISA draws the same conclusions on the basis of the more recent studies.

The Clean Air Scientific Advisory Committee (CASAC) will review this new draft of the Eco ISA, after which EPA is likely to finalize the ISA and prepare a draft Policy Assessment (PA) that makes recommendations for retaining or revising the current secondary standards based on the science presented in the ISA.

EPA Proposes Revision of AP42 Emission Factors for Liquid Storage Tanks

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As a result of widespread interest EPA recently extended the comment deadline for proposed revisions to AP42 chapter 7, which specifies emission factors for organic liquid storage tanks. The AP42 emission factors are used to estimate emissions from specific industrial facilities and processes when no site-specific emissions data are available. They are used in a wide array of regulatory applications ranging from emissions inventories to permit applicability determinations to compliance and enforcement. The proposed changes for liquid storage tanks, which were prepared by the American Petroleum Institute, are extensive; in effect Chapter 7 is being rewritten. The results are unclear and may vary significantly among different types of tanks and facilities. Anyone who has relied on the AP42 factors for storage tanks, or may need to do so in the future, should evaluate the new emission factors and equations EPA is proposing. Comments are due by November 26.

EPA Proposed Regulations for Scientific Integrity in Contracting

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On September 26, EPA published a proposal addressing scientific integrity in the context of agency contractors who perform scientific research or analyses. It would create a new standard contract clause designed to ensure that all scientific work performed for the Agency is done consistently with the agency’s scientific integrity policy, which dates from 2009. The proposal also includes regulations for addressing loss of scientific integrity, including steps for mitigation or termination in appropriate cases.

Contractors who become aware of “an actual or potential” loss of integrity would be required to report it to the contracting officer, who would ultimately decide on the remedy, if any. Contractors would bear the primary responsibility for prevention and detection of research misconduct and for the inquiry, investigation, and adjudication of research misconduct alleged to have occurred in association with its own institution. However, EPA would retain the ultimate oversight authority for EPA-supported research.

This could be a useful tool in addressing any noncompliance with EPA’s integrity policies that may come to light in research sponsored by EPA. However, there are a couple of apparent holes in the proposal. It does not clearly state that the contractor or contracting officer must investigate a loss (or potential loss) of integrity brought to their attention by a third party, such as a potentially regulated stakeholder. In addition, it focuses on EPA’s 2009 integrity policy but does not mention compliance with the regulations for strengthening integrity in regulatory science that EPA proposed earlier this year. Comments on this proposal are due by November 26.

EPA Publishes Final Reporting Requirements for TSCA Mercury Inventory

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On June 27, 2018, the Environmental Protection Agency (EPA) published the final “Reporting Requirements for the TSCA Mercury Inventory” Rule. As required under section 8(b)(10)(D) of the Toxic Substances Control Act (TSCA), EPA finalized reporting requirements for regulated entities to provide information to assist in the preparation of an “inventory of mercury supply, use, and trade in the United States.”

The requirements apply to any person who manufactures (including imports) mercury or mercury-added products, or otherwise intentionally uses mercury in a manufacturing process. The reporting requirements apply to “mercury” as both “elemental mercury” and “a mercury compound.” EPA provides a list of these compounds in the final rule. Reporting requirements vary based on whether the entity is manufacturing mercury, manufacturing a mercury added product, or intentionally using mercury in a manufacturing process, other than the manufacture of a mercury compound or a mercury-added product. EPA will collect data through the Mercury Electronic Reporting (MER) application of its CDX system.

Based on the inventory of information collected, the Agency is directed to “identify any manufacturing processes or products that intentionally add mercury; and . . . recommend actions, including proposed revisions of Federal law or regulations, to achieve further reductions in mercury use.” EPA stated in the final rule that it is not making such identifications or recommendations at this time.

EPA will use data from the 2018 reporting year for the 2020 mercury inventory. The 2018 reporting year is from January 1, 2018, to December 31, 2018, and the submission deadline for the 2018 reporting year is July 1, 2019.

Sherwin-Williams to Remove Paint-Removal Products Containing Methylene Chloride

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Sherwin-Williams is phasing out the use of paint-removal products containing methylene chloride by the end of this year. Both Lowe’s and Home Depot have also announced they will phase out paint removal products that contain methylene chloride. These actions are likely a response to EPA’s forthcoming rulemaking on the substance.

In January, 2017, EPA proposed prohibiting the consumer and commercial paint stripping used for methylene chloride. On May 10, 2018, EPA announced it was working on sending the finalized rulemaking to Office of Management and Budget “shortly.”

EPA Publishes NAAQS Proposals and Notices

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EPA recently has published a plethora of proposed rules and notices governing or closely related to development of national ambient air quality standards (NAAQS). These include (in order by comment deadline):

Consideration of costs and benefits. On June 13 (83 FR 27524), EPA issued an advance notice of proposed rulemaking (ANPRM) soliciting comment on whether and how EPA should promulgate regulations that provide a consistent and transparent method for weighing costs and benefits in making regulatory decisions in a manner consistent with applicable authorizing statutes. With respect to NAAQS, a major issue will be whether and to what extent EPA can consider costs consistently with Supreme Court decisions holding that economic impacts generally may be considered in NAAQS implementation but not in NAAQS development. Comments are due by July 13.

Retention of SO2 NAAQS. On June 8 (83 FR 26752), EPA proposed to retain the existing standards for sulfur oxides. The proposal is based on findings that the existing standards provide adequate public health and welfare protection. A public hearing will be held July 10 and comments are due by August 9.

Scientific transparency. As we reported last month, EPA has proposed new rules for scientific transparency in rulemaking proceedings. The final rules are likely to be applied in EPA’s upcoming proceedings to review the NAAQS for ozone and particulate matter (PM). Comments on the transparency proposal are due by August 16.

Ozone information call. On June 26 (83 FR 29785), EPA published a notice announcing development of a new Integrated Science Assessment (ISA) for ozone and inviting interested parties to submit information on new ozone research or policy-relevant issues for consideration in the agency’s review of the current standards. When finalized, the ISA will contain the scientific information on which EPA will base its decision whether to revise the current standards. Responses to the information call are due by August 27.

Eco ISA for NOx, SOx and PM. On June 26 (83 FR 29786) EPA announced the availability of the Second External Review Draft Integrated Science Assessment for Oxides of Nitrogen, Oxides of Sulfur, and Particulate Matter—Ecological Criteria. This is a ground-breaking ISA that reviews new evidence of ecological effects from emissions of these three pollutants. Such effects previously have been considered separately in the ISAs for each of the pollutants. This second draft builds on an initial draft that the agency released for public comment last year. This draft will be reviewed by EPA’s Clean Air Scientific Advisory Committee (CASAC) as well as the public. Public comments are due by September 4.

NAAQS implementation strategies. On June 26 (83 FR 29784), EPA published a notice soliciting information to facilitate CASAC consideration of any adverse public health, welfare, social, economic, or energy effects which may result from various strategies for NAAQS attainment and maintenance. Comments are due by October 24.

California Proposal to List Nonylphenol Ethoxylates in Laundry Detergent as a Priority Product

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The California Department of Toxic Substances Control has proposed listing nonylphenol ethoxylates (NPEs) in laundry detergent as a Priority Product. This would require manufacturers to use safer alternatives.  The detergents at issue are used by on-premises industrial laundries like hotels and hospitals.

DTSC is concerned about the hazard traits of NPEs and their degradation products.  NPEs are included on the European Union’s list of Substances of Very High Concern.  Laundry detergents with NPEs are sources of exposure to the environment and aquatic organisms.  In May, DTSC released a technical document Product-Chemical Profile for NPEs in Laundry Detergent, to explain the scientific, regulatory, and policy basis for the proposal.  The Department held a public workshop on June 11, 2018 to discuss its proposal.  DTSC is now preparing to undertake a rulemaking on these products.

Systematic Review for TSCA Risk Evaluations

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On May 31, 2018 EPA released  Application of Systematic Review in TSCA Risk Evaluations.  The document presents a detailed description of EPA’s approach to the Risk Evaluations required by the Lautenberg amendments to TSCA.

The announcement by the Office of Pollution Prevention and Toxics (OPPT) explains that “[it] will guide EPA’s selection and review of studies in addition to providing the public with continued transparency regarding how the Agency plans to evaluate scientific information.”  In the document OPPT explains that the Agency intends to apply systematic review principles in the development of the risk evaluations required by the amended statute. The Application of Systematic Review in TSCA Risk Evaluations will serve as internal guidance for this process.  The document describes OPPT’s plan for identifying, evaluating and integrating evidence for the TSCA risk evaluation process.

The document includes chapters on scoping and problem formulation, integration of systematic review principles into TSCA risk evaluations, and appendices on strategy for assessing the quality of data supporting TSCA risk evaluations and data quality criteria for each of the categories of information considered in the evaluation (e.g., physical/chemical property data, occupational exposure and release data).  The Agency notes that this document is not necessarily applicable to risk assessments developed to support other EPA’s statutes or programs.  EPA invites the public to provide input on this document at www.regulations.gov, docket# EPA-HQ-OPPT-2018-0210.

For the risk evaluations, OPPT will first conduct scoping and problem formulation to develop an analytical framework.   Problem formulation will describe the exposure pathways, receptors and health endpoints that OPPT expects to consider in the risk evaluations.

The Agency will use “systematic review“ for problem formulation and the other stages of the risk evaluation process.  The Application of Systematic Review in TSCA Risk Evaluations explains that the risk evaluation process will rely on the National Academy of Sciences, Institute of Medicine’s definition of systematic review:  “a scientific investigation that focuses on a specific question and uses explicit, pre-specified scientific methods to identify, select, assess, and summarize the findings of similar but separate studies.”  OPPT reports that key elements of systematic review include:

  • A clearly stated set of objectives defining the research question,
  • Developing a protocol that describes the specific criteria and approaches that will be used throughout the process,
  • Applying the search strategy in a literature search,
  • Selecting the relevant papers using predefined criteria,
  • Assessing the quality of the studies using predefined criteria,
  • Analyzing and synthesizing the data using the predefined methodology, and
  • Interpreting the results and presenting a summary of findings.

Following problem formulation, OPPT will develop a protocol to specify the criteria, methods for data collection, data evaluation and data integration.

Data will be collected under a defined literature search strategy designed to collect information to evaluate the full life cycle of the chemical substance including exposure, human health hazard, and environmental hazard.  OPPT will use a comprehensive chemical-specific literature search of the open literature to identify relevant data.  OPPT will also use data that are submitted by the public and peer reviewers.  In addition, OPPT will search its internal databases for relevant data submitted under TSCA.  The Agency notes that data submitted under TSCA will be used in the risk evaluation whether or not they are claimed as confidential business information (CBI).  However, CBI data will be used in a manner that protects the confidentiality of the information.

Factors for inclusion in the evaluation include whether the data contain information on: 

  • Environmental fate, transport, partitioning and degradation behavior across environmental media of interest,
  • Environmental exposure of ecological receptors to the chemical substance and/or its degradation products and metabolites,
  • Environmental exposure of human receptors to the substance and/or its degradation products and metabolites,
  • Scenarios resulting in releases of the substance into the environment that would expose ecological or human receptors,
  • Quantitative estimates of worker exposures and of environmental releases from occupational settings for the substance, and
  • Human health and environmental hazards.

OPPT explains that the evaluation stage will assess the quality of individual studies.   For this process the Agency will use the criteria identified in the data quality criteria appendices to the Application of Systematic Review in TSCA Risk Evaluations.  The appendices specify criteria for evaluating data on:

  • Physical and chemical properties,
  • Occupational exposure and release,
  • Fate,
  • Consumer, general population, and environmental exposure,
  • Ecological hazards,
  • Animal and in vitro toxicity, and
  • Epidemiology.

The data will then be integrated to evaluate and synthesize multiple evidence streams.  Data integration includes analysis and synthesis of the evidence and development of weight of evidence conclusions.  As part of this process OPPT will document any underlying assumptions that are used to support the risk evaluation.

TSCA requires that EPA make decisions about these data based on the weight of the scientific evidence.  OPPT reports that under TSCA, the weight of the scientific evidence is defined as “a systematic review method, applied in a manner suited to the nature of the evidence or decision, that uses a pre-established protocol to comprehensively, objectively, transparently, and consistently identify and evaluate each stream of evidence, including strengths, limitations, and relevance of each study and to integrate evidence as necessary and appropriate based upon strengths, limitations, and relevance.”   This approach presents the significant issues, strengths, and limitations of the data and the uncertainties that require consideration, in addition to highlighting the major points of interpretation.

OPPT explains that the last step of the systematic review process will be to develop a summary of findings.  The findings summarize the evidence, describe the methods used to weigh evidence, and articulate the basis for the conclusion(s), recommendation(s), and any uncertainties.  Both exposure assessment and hazard assessment will be discussed.

EPA Issues Rule Amending RCRA Definition of Solid Waste

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On May 30, 2018, in response to the U.S. Court of Appeals for the District of Columbia Circuit’s July 2017 and March 2018 orders, the Environmental Protection Agency (EPA) issued a final rule revising the Definition of Solid Waste (DSW) under the Resource Conservation and Recovery Act (RCRA). EPA relied upon Section 553 of the Administrative Procedure Act (APA) to make the rule immediately effective and published the rule without notice and public comment. Under APA Section 553, EPA is authorized to forego notice and comment rulemaking when “for good cause” EPA finds that these procedures are “impracticable, unnecessary or contrary to the public interest.” EPA determined that there is good cause for revising these provisions “because these revisions simply undertake the ministerial task of implementing court orders vacating these rules and reinstating the prior versions.”

The orders issued by the United States Court of Appeals for the District of Columbia Circuit on July 7, 2017 and amended on March 6, 2018: (1) vacated the 2015 verified recycler exclusion for hazardous waste that is recycled off-site (except for certain provisions); (2) reinstated the transfer-based exclusion from the 2008 rule to replace the now-vacated 2015 verified recycler exclusion; (3) upheld the containment and emergency preparedness provisions of the 2015 rule; (4) vacated Factor 4 of the 2015 definition of legitimate recycling in its entirety; and (5) reinstated the 2008 version of Factor 4 to replace the now-vacated 2015 version of Factor 4.

FTC Approves Final Consent Orders Against Four Paint Companies Regarding Emission- and VOC-Free Claims

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The Federal Trade Commission (FTC) approved final consent orders against four paint companies — Benjamin Moore & Co., Inc., ICP Construction Inc., YOLO Colorhouse, LLC, and Imperial Paints, LLC — that allegedly misled consumers by claiming their products were free of emissions and volatile organic compounds (VOCs). To clarify to industry that these orders represent the Commission’s current view, the FTC has rescinded its 2013 Enforcement Policy Statement Regarding VOC-Free Claims for Architectural Coatings.

According to the FTC’s complaints, the companies claimed their paints would not emit VOCs and other chemicals, including during and immediately after application. Some promotions also made explicit safety claims regarding babies, children, pregnant women, and other sensitive populations. However, the FTC alleged the companies had no evidence to support these claims.

The final orders settling the FTC’s claims bar the companies from making unqualified emission-free and VOC-free claims unless: 1) at all times during and after application, both content in and emissions from their paints are actually zero, or 2) emissions are at “trace” levels, as defined in the orders. The new “trace level test” outlined within the orders is as follows:

  1.  A VOC has not been intentionally added to the covered product;
  2. 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
  3. 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 final orders also prohibit the companies from making other unsubstantiated health and environmental claims and require Benjamin Moore and ICP Construction to disclose that seals appearing in their promotional materials are their own designations.

The final consent orders can be found here.