Systematic Review for TSCA Risk Evaluations

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

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

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.

EPA Adopts “Back to Basics” Process for NAAQS Review

On May 9, EPA Administrator Pruitt released a memorandum to Assistant Administrators titled “Back to Basics Process for Reviewing National Ambient Air Quality Standards” (NAAQS). Key provisions include:

1. Meeting statutory deadlines. The Administrator has ordered completion of the pending review of the ozone NAAQS by October 2020 and of the pending PM NAAQS review by December 2020. The memorandum directs the agency to ensure that the Clean Air Scientific Advisory Committee (CASAC) will convene panels with the necessary expertise in a manner consistent with the 2017 directive on federal advisory committees. This is part of a larger effort to ensure that EPA completes its NAAQS reviews within the statutory 5-year period, a requirement that the agency seldom has met, often spawning litigation in the past.

2. Addressing all CAA NAAQS review provisions. This provision focuses on implementation of the Clean Air Act’s (CAA) requirements for CASAC advice in two areas that have historically been given short shrift: (1) adverse public health, welfare, social, economic, or energy effects which may result from various strategies for attainment and maintenance of a standard (presumably including the adverse health effects of unemployment resulting from a standard); and (2) consideration of background pollution, attainability and technological feasibility. Questions on these issues will now be presented explicitly to CASAC in its official charge documents. The memorandum notes that the Supreme Court has held that EPA cannot consider implementation costs in establishing NAAQS, but states that the Court also recognized that CASAC’s “advice concerning certain aspects of ‘adverse public health … effects’ from various attainment strategies is unquestionably pertinent” to the NAAQS rulemaking record and relevant to the standard-setting process. The Memorandum indicates that EPA will consider implementation costs in the policy judgment it makes with respect to the standard’s margin of safety, and also in developing implementation rules. It also directs CASAC to provide advice on certain agency actions where the Committee historically has been silent, including review of the Regulatory Impact Analysis for a proposed standard and any resulting implementation rules.

3. Streamlining and standardizing the process. This section requires a number of changes to the NAAQS review process to speed it up and make the various documents involved more useful.

4. Clearly differentiating between science and policy considerations. This provision requires the agency to establish a clear distinction between the purely scientific findings of a NAAQS Integrated Science Assessment (ISA) and the wider range of policy concerns that the Administrator must consider in making judgments about requisite standards and margins of safety. It also directs EPA to request CASAC to distinguish clearly between its scientific and policy advice.

5. Issuing timely implementation of regulations and guidance. When a NAAQS is revised, EPA is directed to issue concurrent implementation regulations and guidance as necessary, and also to issue technical information to assist states in developing approvable plans and demonstrating how any new NAAQS is to be attained and maintained. The rules and guidance should provide information relevant to the submission and consideration of state implementation plans and preconstruction permit applications, and may address potential tools for regulatory relief to address background concentrations and sources of pollution outside of the control of the state.

These new principles will be applied to the pending reviews of the ozone and PM NAAQS, which are to be completed before the 2020 elections, and likely will spawn litigation over both of EPA’s final decisions in reviewing these standards.

New REACH Registration Requirements for Nanomaterials

On April 26, 2018, EU Member States voted to implement new REACH registration requirements for nanomaterials.  The European Commission announced that the draft regulation will be reviewed by Parliament and Council for three months before being adopted.  The requirement to provide more information on nanomaterials under REACH (Regulation No. 1907/2006) would apply from Jan. 1, 2020.

The European Commission reported that the proposed amendments will significantly clarify REACH registration requirements with regard to nanomaterials. According to the Commission, REACH always applied to nanomaterials but did not contain specific provisions for them.  The Commission explained that this meant companies often did not know how to register substances in nanoform.  It noted that the specific requirements will address the current knowledge gap on which substances registered under REACH are placed on the market as nanomaterials and in which quantities.

Under the new requirements, manufacturers and importers will be obligated to assess and document in the chemical safety report that the risks, arising from the identified uses of the substance with nanoforms they manufacture or import, are adequately controlled. To ensure clarity, the chemical safety report should describe whether and which different nanoforms are covered by the assessment and how the information is compiled in the report.  The proposed regulation can be accessed here.

EPA Proposes Rule to Strengthen the Transparency of Regulatory Science

EPA has published a proposed regulation that is “intended to strengthen the transparency of EPA regulatory science.”   Specifically, the proposed regulation limits science used in regulatory actions to data that are publicly available “in a manner sufficient for validation and analysis.”  The Agency argues that the “proposal will help ensure that EPA is pursuing its mission of protecting public health and the environment in a manner that the public can trust and understand.” This proposed regulation is intended to apply prospectively to final regulations that are determined to be “significant regulatory actions” pursuant to E.O. 12866. Comments are due by May 30, 2018.

EPA argues that “enhancing the transparency and validity of the scientific information relied upon by EPA strengthens the integrity of EPA’s regulatory actions and its obligation to ensure the Agency is not arbitrary in its conclusions,”  “will lead to better outcomes, and [will] strengthen public confidence in the health and environmental protections underpinning EPA’s regulatory actions.”  The Agency explained in the Federal Register Notice that the “proposed rule is consistent with the principles underlying the Administrative Procedure Act and programmatic statutes that EPA administers to disclose to the public the bases for agency rules and to rationally execute and adequately explain agency actions.”

The proposed rule includes a provision allowing the Administrator to exempt significant regulatory decisions on a case-by-case basis if he or she determines that compliance is impracticable because it is not feasible to ensure that all dose response data and models underlying pivotal regulatory science are publicly available in a fashion that is consistent with law, protects privacy and confidentiality, and is sensitive to national and homeland security, or in instances where OMB’s Information Quality Bulletin for Peer Review provides for an exemption.

The proposal solicits comments on a number of issues including the following:

  • The effects of this proposed rule on individual EPA programs, including whether certain activities are appropriate to be excepted.
  • Should the proposal apply to other agency actions and promulgations in addition to “significant regulatory actions?”
  • The definitions of “pivotal regulatory science,” and “dose response data and models” and how to implement such definitions.
  • How to incorporate stronger data and model access requirements into the terms and conditions of cooperative agreements and grants.
  • Methodologies and technologies designed to provide protected access to identifiable and sensitive data.
  • How to balance appropriate protection for copyrighted or confidential business information with requirements for increased transparency of pivotal regulatory science.
  • Whether the disclosure requirements applicable to dose response data and models in the proposed rule should be expanded to cover other types of data and information, such as for example economic and environmental impact data.

EPA Updated the Pesticide Label Review Manual

EPA has substantively updated the General Labeling Requirements, Precautionary Statements, and Net Contents/Net Weight Chapters of the Pesticide Label Review Manual, and made minor editorial changes throughout the rest of the manual. This manual is designed to help industry understand the pesticide labeling process and how labels should be drafted under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

The latest updates are as follows:

General Labeling Requirements — Chapter 3:

  • Web-distributed labeling section now includes container label language example;
  • Label submission requirements section now includes e-submission option;
  • Final printed labeling section now reflects current practices;
  • Updated mode of action symbol reference from PR Notice 2001-5 to PR Notice 2017-1; and
  • First aid statement location now reflects requirements of EPA’s guidance document “EPA’s Guidance for Pesticide Registrants on Location of the First Aid Statement per 40 CFR 156.68.”

Precautionary Statements — Chapter 7:

  • Added dermal sensitization to acute toxicity categories table (Table 1);
  • Reinstated first aid statements per PR Notice 2001-1, and updated location of first aid statements per the Feb. 27, 2018, First Aid Guidance Document “EPA’s Guidance for Pesticide Registrants on Location of the First Aid Statement per 40 CFR 156.68”;
  • Added Note to Physician statement for products containing zinc phosphide;
  • Updated National Pesticide Information Center NPIC information in first aid statements example in Table 9;
  •  Changed “Labeling Options” section to “Modified precautionary statements for diluted products (aqueous solutions only)”;
  • Removed redundant section on NPIC and referenced Chapter 15 for details; and
  • Removed “Optional Labeling/Deviations” section and moved directions under their respective sections.

Net Contents/Net Weight — Chapter 17:

  • Updated introduction section to include notes on declaring net contents information on application form 8570-1 and leaving net contents information blank on draft label for refillable containers; and
  • Updated labeling requirements for packages that use Bag on Valve technology to reflect 2018 NIST Handbook 130 regulations for net weight measurements.

TSCA Fees Rule — Release of Supplemental Information and Comment Period Extension

On April 24, 2018, EPA released for public comment a supplemental analysis on the definitions of small business size and their effect on Toxic Substances Control Act (TSCA) user fee collection. In the proposed fees rule EPA released in February, small businesses can quality for reduced fee amounts. For the supplemental analysis, EPA requested comment on:

  • Whether an employee-based size standard (how many people are working there) would be more appropriate than a revenue-based size standard (how much revenue comes in), and what that employee level should be (note: the revenue level standard is already in the proposed rule);
  • Whether either size standard should vary from industry to industry for any reason;
  • What other factors and data sources the Agency should consider, besides inflation, when developing the size standard; and
  • What should the new TSCA section 5 fee amounts be if EPA changes the size standard?

EPA is also extending the comment period for the proposed TSCA fees rule until May 24, 2018. This is meant to give interested parties more time to comment on both the rule and the supplemental analysis.

EPA Issues Draft TSCA Inventory With “Active” Substance Designations

Under the Environmental Protection Agency’s (EPA) Toxic Substances Control Act (TSCA) Inventory Reset Rule, manufacturers and importers were required to report all chemical substances that were active in commerce in the ten year “look-back period” ending June 21, 2016. Based on the information it received, the EPA published a draft version of the TSCA Inventory that contains 38,304 substances with “active” designations.

The draft Inventory designates as active those substances:

  • Substances notified under the 2012 and 2016 Chemical Data Reporting (CDR) rule;
  • Those substances EPA received notices of commencement (NOCs) since June 21, 2006; and
  • Substances reported via notices of activity (NOAs) before the February 7, 2018 Inventory Reset reporting deadline.

Substances listed as “active” in the draft Inventory include 30,972 on the public inventory and 7,332 on the confidential inventory. There are approximately 48,000 substances that have not been reported as active.

“Active” designations may grow in the coming months. The Inventory Reset Rule allows processors to report any substances that did not get reported as active by manufacturers or importers until October 5, 2018. In addition EPA has established a process to “activate” substances that are designated inactive.

Download the draft “active” Inventory here.

EPA Science Advisors Support Current SO2 NAAQS

EPA’s Clean Air Scientific Advisory Committee (CASAC) has now completed its review of the agency’s draft Policy Assessment (PA) for the SO2 NAAQS, and supports the EPA staff recommendation that the current scientific literature does not support revision of the current primary (health based) SO2 NAAQS.

In a draft letter recently released, CASAC notes that “key uncertainties” have emerged since the prior SO2 review, particularly with regard to “at-risk” subgroups such as children who are: obese; of African-American ethnicity; severely asthmatic; and/or live in high density areas near sources of exposure. The Committee believes that while many uncertainties remain in quantifying the sizes of the risks for these groups, they should nonetheless be considered in ensuring that the standard provides an adequate margin of safety. CASAC also recommends that efforts should be made to gather the data necessary to ensure that protection of these groups can be considered with less uncertainty in future reviews of the standard.

According to the draft letter, the Committee believes it possible that the current 75 ppb level may not provide an adequate margin of safety in these groups. However, because there is considerable uncertainty in quantifying the sizes of these higher risk subpopulations and the effect of SO2 on them, the Committee did not recommend reconsideration of the level at this time. CASAC strongly recommends that future assessments better quantify the numbers of individuals expected to be affected at the current (or proposed alternative) standard in these groups so that a more informed judgment about the margin of safety in high risk subgroups can be made. In particular, the Committee suggests that EPA express the size of the at-risk population both in percentage form (which is currently done) and also with numerical estimates, providing the number of people expected to be at risk, given the margin of safety.

The Committee recommended a few changes in the draft PA and stated that with those changes it need not review another draft. We expect that CASAC will finalize its draft letter soon and that EPA will then move to finalize the PA and propose to retain the current standard. We doubt that the current Administration will seize on the “margin of safety” points in the CASAC letter to propose a revised standard (as some prior administrations might have done). However, those issues are likely to be a primary focus of the next review of the SO2 standard.

Apart from SO2, this letter is significant because it is the first official CASAC action under the newly appointed Chair, Anthony Cox, and the other new members appointed by this Administration. It therefore appears that the reported “backlog” of NAAQS reviews caused by CASAC appointment delays will now begin to break.