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.

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.

FDA BPA Study Released

On February 23, 2018, the FDA National Center for Toxicological Research (NCTR) released a draft report on the chronic toxicity of BPA in rats.  NCTR found few significant effects of BPA.  In the press release reporting these findings, FDA announced that “initial review [of the study findings] supports our determination that currently authorized uses of BPA continue to be safe for consumers.” The NCTR study will undergo external peer review April 26, 2018 during a meeting at National Toxicology Program (NTP) offices in Research Triangle Park, North Carolina.

The study evaluated chronic and early life exposure to BPA in rats. Endpoints evaluated include growth; weight; hematology; and tumor development in the liver, kidney, thyroid, parathyroid, uterine, ovary, prostate, and mammary gland. Overall, the study found “minimal effects” in the BPA-dosed rats.  NCTR did report that the study found an increase in mammary gland tumors at 2.5 µg BPA/kg/bw/day dose group.  The findings note that the incidence rate in this group was only marginally higher than historical rates for the strain of rats used for the study.

The study is part of a collaborative effort called the Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA), which was established by the FDA and the National Institute of Environmental Health Sciences of the National Institutes of Health after a 2008 NTP report raised concerns about developmental effects in rodents exposed to relatively low doses of BPA.  In addition to the NCTR study, the effort involves studies of various health endpoints, conducted at academic institutions, using offspring of rodents derived from the core study.

More information on the NTP meeting is available here.  The NTP website also provides information on submitting public comments on the draft report.

New Methylisothiazolinone Labeling Requirement in the European Union

Consumer products containing methylisothiazolinone (MIT) will need to be labeled to indicate that the product contains an allergen  when the substance is present at greater than 0.0015%. This is based on a classification approved by the European Commission’s REACH committee on February 20, 2018.  Product labeling will be required to state, “Contains methylisothiazolinone.  May cause an allergic skin reaction.” These requirements are expected to become binding at the end of 2019.  The proposal must first be reviewed by the European Parliament.

Under existing classification, labeling, and packaging regulations, products containing MIT must be labeled as skin sensitizers when the substance is present at 1.0% or more.  The EU currently bans MIT in “leave on” cosmetic products, limits MIT in “rinse-off” products, and restricts the presence of the substance in toys.

EPA Releases the 2018 Plan for Chemical Risk Evaluations under TSCA

As required under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, EPA has released its annual plan for chemical risk evaluations. The annual plan identifies the next steps for the first 10 chemical reviews currently underway, and describes EPA’s work in 2018 to prepare for future risk evaluations.

EPA was required to initiate ten risk evaluations in 2016, and is required to initiate at least 20 more within 3 years after enactment of the Lautenberg Act, or by December 2019. EPA designated the first ten chemical substances on December 19, 2016. By the end of 2018, the EPA will initiate prioritization for 40 chemicals – at least 20 Low-Priority and 20 High-Priority candidates. By December 22, 2019, EPA will designate 20 substances as Low-Priority and initiated risk evaluations on 20 High-Priority substances.

In order to support these risk evaluations and other key aspects of TSCA implementation, EPA stated that it will be proposing a draft TSCA Fees Rule in early 2018, which will provide estimates of the resources required to undertake risk evaluations.

UK to Publish a new Chemicals Strategy

The UK recently issued A Green Future: Our 25 Year Plan to Improve the Environment.  The document sets out a UK plan “to help the natural world regain and retain good health.”  The plan states that the government will publish a new Chemicals Strategy to tackle chemicals of national concern that will build on existing approaches. This new strategy will set priorities for action and detail how goals will be achieved.  According to A Green Future, the plan will also support collaborative work on human biomonitoring, address combination effects of different chemicals and improve the way the government tracks chemicals across supply chains.

 

A Green Future commits the UK to the following actions:

  • Publish an overarching Chemicals Strategy to set out its approach as the UK leaves the EU.
  • Explore options to consolidate monitoring and horizon-scanning work to develop an early warning system for identifying emerging chemical issues.
  • Consider how to address tracking chemicals in products to reduce barriers to recycling and reuse whilst preventing a risk from harmful chemicals.
  • Work internationally to strengthen the standardization of methods that assess chemical safety to identify and share information on emerging concerns and new approaches to risk assessments.

NRDC Petitions 2nd Circuit to Review EPA’s New Chemicals Decision-Making Framework

On January 5, 2018, the Natural Resources Defense Council (NRDC) filed a petition for review with the United States Court of Appeals for the Second Circuit, asking that the court review “a final rule of the U.S. Environmental Protection Agency (EPA) entitled New Chemicals Decision-Making Framework:  Working Approach to Making Determinations under Section 5 of TSCA.”  A stay was not filed with the petition.

On its website, NRDC asserts that it filed the petition to overturn the Agency’s “Framework” “because it is both unlawful under TSCA and was adopted without the minimum legal requirements for ‘rules.’”

The case is Natural Resources Defense Council v. U.S. Environmental Protection Agency, 2d Cir., No. 18-25

EPA Announces Cross-Agency Effort to Address PFAS

On December 4, 2017, the EPA announced a “a cross-agency effort to address per and polyfluoroalkyl substances (PFAS).”  The press release notes that the PFAS effort will include perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS), as well as GenX, a substance developed as a replacement for the older chemicals.

The Agency pledged to:

  • Identify a set of near-term actions to help support local communities;
  • Enhance coordination with states, tribes and federal partners to provide communities with critical information and tools to address PFAS;
  • Increase ongoing research efforts to identify new methods for measuring PFAS and filling data gaps; and
  • Expand proactive communications efforts regarding PFAS and their health effects.

However, the Agency did not promise to take regulatory action.

The EPA issued Significant New Use Rules (SNURs) for PFOS-related substances in 2002.   It also issued a SNUR for the use of perfluorinated chemicals in carpets and carpet aftercare products in 2013.  In addition, the Agency partnered with manufacturers in the US and globally to reduce or eliminate use of PFASs.  U.S. companies voluntarily phased out producing the chemicals between 2000 and 2002.  Foreign companies achieved a 95 percent reduction in PFOA and PFOA-related chemicals in the emissions from their facilities and in their products.

The EPA has also published drinking water health advisories for PFOA and PFOS.

More information about the Agency’s efforts regarding these substances can be found here.

Irene Hantman and Kurt Blase to Present on New Requirements for Chemicals in Commerce

Tuesday, December 12, 2017 at 2PM ET, Irene Hantman and Kurt Blase will conduct a webinar for the American Chemical Society on New Requirements for Chemicals in Commerce – Chemical Regulation under TSCA Reform.  Register for the webinar here.

The Lautenberg amendments to TSCA impose new reporting requirements on chemicals in commerce through Inventory Reset Reporting.  Inventory Reporting is necessary to keep chemicals in commerce lawfully.  These requirements also have implications for raw materials.  The presentation will address these issues.  It will also address how the amendments require EPA to ensure that new chemicals do not present an unreasonable risk to human health and the environment.  This has significant implications for new chemicals notification – the Premanufacture Notification requirement.  In addition, the webinar will discuss the reporting requirements of the Nanoscale Materials Reporting Rule.  (This rule was not required by the Lautenberg amendments.)