Manufacturer Request for Risk Evaluation of OTNE

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On November 20, 2020, EPA received a manufacturer request for risk evaluation for the chemical substances in the octahydro-tetramethyl-naphthalenyl-ethanone chemical category (OTNE).  These substances are used as fragrance ingredients.  The three manufacturers, International Flavors and Fragrances, Inc., Privi Organics USA Corporation, and DRT America, Inc., sent the request through the OTNE Consortium.

The risk evaluation request applies to four chemicals within OTNE.  The Toxic Substances Control Act (TSCA) considers two of the chemicals to be persistent, bioaccumulative and toxic (PBT) chemicals.  While completing the risk evaluation for the OTNE chemical, EPA is not allowed to consider costs or other non-risk factors (15 U.S.C. 2605(b)(4)(F)(iii)).  The request for evaluation also includes possible conditions of use for EPA to identify.

EPA has until no later than June 5, 2021 to either grant or deny the request to conduct the risk evaluation for the OTNE chemicals.  In order for EPA to grant the request, it must meet all of the requirements listed under 40 CFR 702.37(e)(6)(ii).  These conditions are that the request constitutes conditions of use that warrant inclusion in a risk evaluation, EPA has all the necessary information to conduct the risk evaluation, and all the remaining criteria of 40 CFR 702.37 are met, such as manufacturers paying fees to support the risk evaluations.

EPA Changing Systematic Review Approach

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In February 2021, EPA announced the Agency’s commitment to strengthening science used in chemical risk evaluations.  EPA stated the Agency will continue to update its systematic review approach and its broader efforts to review the first 10 TSCA risk evaluations.  The first 10 TSCA risk evaluations were complete in January 2021.  Following the review of their 2018 systematic review approach by the National Academies of Science, Engineering, and Medicine (NAS), EPA stated they will never use that particular systematic review again.

NAS recommendations included:

  • Engaging in ongoing cross-sector efforts to develop and validate new tools and approaches.
  • Incorporating components of existing hazard assessments approaches.
  • Creating a handbook to assist with incomplete and hard to follow documentation.
  • Using standard descriptors for the strength of evidence.

EPA stressed that the NAS report was based on earlier EPA practices, and part of the reason for updating the systematic review approach is to ensure the review of the first 10 TSCA risk evaluations are done in accordance with Executive Orders and other directives from the Biden Administration.  The Agency’s goals from the review are that:

  • All Agency actions meet statutory obligations,
  • Be guided by the best available science,
  • Ensure the integrity of Federal decision-making, and
  • Protect human health and the environment.

EPA has begun the process of creating a TSCA systematic review protocol in collaboration with the Agency’s Office of Research and Development.  The new review protocol will incorporate approaches from the Integrated Risk Information System (IRIS) Program, as recommended by NAS.  EPA expects to publish and take comments on the new review protocol later this year.

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 Releases the 2018 Plan for Chemical Risk Evaluations under TSCA

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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.

EPA to Hold Public Meeting on Identifying Potential Candidates for Prioritization for Risk Evaluation

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EPA is holding two meetings in December to discuss ongoing implementation activities under the Frank R. Lautenberg Chemical Safety Act, which amended Toxic Substances Control Act (TSCA). On December 11, 2017 EPA is holding the second public meeting on possible approaches for identifying potential candidate chemicals for EPA’s prioritization process under TSCA. The meeting will be held December 11, 2017, 8:30 a.m. to 5:00 p.m. at the Ronald Reagan Building and International Trade Center, Horizon Ballroom, 1300 Pennsylvania Avenue, N.W., Washington, DC 20004.

As amended, TSCA required that EPA establish processes for prioritizing and evaluating risks from existing chemicals. EPA will describe and take comment on a number of possible approaches that could guide the Agency in the identification of potential candidate chemicals for prioritization.

EPA will accept questions from the public in advance of the meeting, and will respond to these questions at the meeting as time allows. To register to attend, submit questions, and learn more follow this link.

NGOs Challenge Risk Evaluation and Prioritization Rules

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Environmental Defense Fund (EDF), Safer Chemicals Healthy Families, and the Alliance of Nurses for Healthy Environments (ANHE) have filed suit for review of EPA’s Risk Evaluation and Prioritization Rules promulgated under the amended Toxic Substances Control Act (TSCA).  Both rules were required by Section 6 of the amended statute.  The final rules were released by EPA on June 22, 2017.  The Safer Chemicals Healthy Families petitions challenge the Risk Evaluation and Prioritization Rules as arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law; in excess of statutory jurisdiction, authority, or limitations; and without observance of procedure required by law.

EDF filed suit on August 11, 2017 in the U.S. Court of Appeals for the Second Circuit; ANHE et al filed suit on August 11, 2017 in the U.S. Court of Appeals for the Fourth Circuit; and Safer Chemicals Healthy Families et al filed suit on August 10, 2017 in the U.S. Court of Appeals for the Ninth Circuit.  Safer Chemicals Health Families was joined on its petition by a number of groups including Environmental Working Group, Union of Concerned Scientists and AFL-CIO.  ANHE was joined on its petition by the Natural Resources Defense Council (NRDC).  The NGOs did not file a Motion for Stay to prevent EPA from moving forward in implementing the Risk Evaluation and Prioritization Rules while the petitions are under review.

Additional insight into the petitioners’ concerns can be found in their statements regarding the final rules and the litigation.  EDF has said that it believes the final risk evaluation rule improperly narrows conditions of use by not including all conditions of use in the risk evaluation.  NRDC expressed concern that the risk evaluation rule introduces loopholes that could lead to incomplete analysis, which could lead EPA to conclude that a chemical doesn’t pose a health or environmental risk when it actually does.  Regarding the prioritization rule, EDF asserts that the final rule describes an information-gathering process that seeks to minimize and undermine EPA’s use of the new testing authorities available to the agency under section 4.

EPA has not commented on the litigation.