EPA Announces Improvements to the TSCA Risk Evaluation Process  

On December 20, 2021, EPA released a draft TSCA Systematic Review Protocol. In its announcement on the new Protocol, the Agency explained that the Protocol will strengthen EPA’s approach to reviewing and selecting the scientific studies that are used to inform TSCA Risk Evaluations and ensure that EPA has the best tools under TSCA to protect human health and the environment.  The draft protocol comprises nearly 700 pages.

The draft Protocol notes that EPA’s Office of Pollution Prevention and Toxics (OPPT) applies systematic review principles in the development of its Risk Evaluations of existing chemicals.  It provides specific systematic review approaches which they use for identifying and evaluating evidence for the hazard and exposure assessments that support Risk Evaluations. OPPT added that the draft Protocol responds to key recommendations received from the National Academies of Sciences, Engineering, and Medicine (NASEM).

The Protocol was developed in response to NASEM’s critique that EPA had not previously documented how TSCA prioritization and problem formulation relate to the TSCA Systematic Review.  The Protocol aligns the TSCA prioritization and scoping processes with the steps of the Protocol.  In addition, the Protocol defines how EPA’s systematic review efforts will identify data gaps and data needs in the Risk Evaluations process.  OPPT explains that identifying these data gaps and data needs will provide the Agency with the information it needs “to strategically exercise TSCA authorities to require testing or information collection for use in TSCA prioritization and Risk Evaluation.”

The Protocol reports that for the 20 high-priority substances currently undergoing Risk Evaluation and substances undergoing manufacturer-requested Risk Evaluation, EPA has implemented a new, unified literature search process.  This process, as described in the Protocol, uses chemical identifiers to maximize the capture of relevant literature, which in turn provides consistency and efficiency to the literature search.  In addition, OPPT announced that the Protocol includes new methods to reduce bias and improve evaluation through the use of calibration exercises and data evaluation training for reviewers.  This is a response to NASEM recommendations, SACC comments, and public comments.

In addition, the Protocol includes a description of the evidence integration process.  A step that was not part of the 2018 TSCA systemic review document. This addition was also made in response to recommendations by the NASEM and the SACC. OPPT explains that the Protocol’s evidence integration approach relies on methods related to those in EPA’s IRIS Handbook.

The draft protocol will undergo peer review by at a meeting of the SACC on April 19-21, 2022.  OPPT noted that the agency will use this feedback to further improve the document. The date, time for the public peer review virtual meeting will be announced on the SACC website.

Ending Inventory Correction for Substances Listed to the Initial TSCA Inventory

On February 24, 2022, EPA announced that is revoking the process for correcting the substance identities of substances that were incorrectly described when they were listed on the initial TSCA Inventory in 1978.  Guidelines for Inventory correction were published in 1980 when the Agency recognized that a number of the substances reported to the initial Inventory had been unintentionally, incorrectly described.  Starting on April 26, 2022, companies will be required to submit a premanufacture notice (PMN) in order to request a change to the chemical identity of a substance listed on the Inventory.  Until that time, EPA will continue to accept correction requests that meet the 1980 guidelines.

In its announcement, EPA noted that the 1980 guidelines did not identify a time period during which corrections to the Inventory could be submitted.  However, EPA stated they never intended for the correction period to be indefinite, noting that companies have had more than 40 years since the 1980 publication of the revised TSCA Inventory to make corrections.

EPA stated they will continue to initiate Inventory corrections for substances that it determines were unintentionally misidentified.  For those cases, EPA may request information from a company to support an Inventory correction in lieu of requiring a PMN.  The announcement noted that the revocation will not affect regular maintenance of the Inventory which does include updates to substance identity nomenclature.

EPA Extends Submission Deadline for Health and Safety Studies on 50 Chemicals

EPA is allowing manufacturers and importers additional time to submit unpublished health and safety studies’ data for 50 chemicals.  The new deadline for 20 of the 50 chemicals is December 1, 2021, updated from September 27, 2021.  The new deadline for the remaining 30 chemicals is January 25, 2022.  The 20 chemicals in the first group fall into the category of high priority for risk evaluation – note that EPA explains that being classified as high priority does not necessarily mean that a chemical is high risk.  These chemicals are currently undergoing Risk Evaluation under TSCA.  The Health and Safety studies will help EPA prepare scoping documents that identify the hazards, exposures, conditions of use of the chemicals, and potential exposures to them.

The 30 chemicals in the second group are organohalogen flame retardants.  These chemicals are being evaluated by the Consumer Product Safety Commission, which is a member of TSCA’s Interagency Testing Committee.

Additional information on the reporting requirements for the 50 chemicals can be found here and additional information on initial addition of the chemicals to the list here.

EPA Releases Final Scope Documents Under New Policy

On August 31, 2021, EPA released Toxic Substance Control Act (TSCA) final scope documents for diisodecyl phthalate (DIDP) and diisononyl phthalate (DINP).  The final scope documents are the first to implement the Agency’s new policy for considering exposure to the chemicals from media that are regulated outside of TSCA including air and water, including drinking water.  In a press release on the path forward for risk evaluations, the Agency noted that the previous administration’s “…approach to exclude certain exposure pathways also resulted in a failure to consistently and comprehensively address potential exposures to potentially exposed or susceptible subpopulations, including fence-line communities (i.e., communities near industrial facilities).”  Both risk evaluations were requested by the manufacturer, ExxonMobil, through the American Chemistry Council’s High Phthalates Panel (ACC HPP).

The scope documents for these risk evaluations includes the following information: the conditions of use, potentially exposed or susceptible subpopulations (PESS), hazards, and exposures that EPA plans to consider, along with a description of the reasonably available information and science approaches EPA plans to use in the risk evaluations, a conceptual model, an analysis plan, and the plan for peer review of the draft risk evaluation for this category of chemical substances.

Some of these conditions of use were identified in the manufacturer request as circumstances on which EPA was requested to conduct a risk evaluation. EPA identified other conditions of use from information reported to EPA through Chemical Data Reporting (CDR), published literature, and consultation with stakeholders for both uses currently in production and uses whose production may have ceased

EPA plans to evaluate releases to the environment as well as human and environmental exposures resulting from the conditions of use of these substances that EPA plans to consider in the risk evaluation.  In addition to including occupational exposure, consumer and bystander exposure, and PESS, the scope of the risk evaluations will include general population exposures.  Specifically, EPA plans to evaluate general population exposure to the substances via the oral route from drinking water, surface water, groundwater, ambient air, soil, fish ingestion, and human breast milk; via the inhalation route from air and drinking water; and via the dermal route from contact with drinking water, surface water, groundwater and soil.

In addition to considering the data and information sources provided by the ACC HPP submissions, EPA conducted a comprehensive search to identify and screen multiple evidence streams (i.e., chemistry, fate, release and engineering, exposure, hazard) to inform the development of these scoping documents.

Confidential Status Change of TSCA Chemicals

The confidential business information status of chemicals on the TSCA Inventory is scheduled for change, removing the confidential chemical identity status for 390 chemicals.  This will move the chemicals to the public portion of the TSCA Inventory.  During the 2012, 2016, and 2020 reporting periods, one or more manufacturers reported these chemicals as non-confidential, which is a result of at least one of these manufacturers not reporting a previous confidential chemical as confidential.

EPA recognizes that some manufacturers may have simply been in error for not reporting their chemicals as confidential.  However, EPA states that for each of the 390 chemicals, there is independent reporting based and EPA validated reasons to include the chemicals on the list.  EPA intends to move these chemicals from the confidential chemical identity status of the TSCA Inventory to the public portion sometime during the summer of 2021.

EPA also recognizes stakeholder interest in the status change for these chemicals and has given June 30, 2021 as a deadline for interest, questions, or concerns regarding the change.

ITC Submits New Priority Testing List

The TSCA Interagency Testing Committee (ITC) submitted a report to EPA on April 13, 2020 listing an additional 39 chemicals on the priority testing list.  Within the 39 chemicals, 15 are already designated as high-priority substances and 24 are organohalogen flame retardants.  The priority testing list currently has five other high-priority substances and six organohalogen flame retardants.  The high-priority substance list contains substances with the most demand for evaluation from a risk-based screening process.

ITC also recommended the 15 high-priority substances be added to TSCA section 8(d) Health and Safety Data Reporting rule in order for EPA to obtain unpublished health and safety studies.  The report states the high-priority substances may present an unreasonable risk for the health of people and/or the environment.  The risk evaluation process has already begun for each of these high-priority substances.

The 24 organohalogen flame retardants were added to the priority testing listing after the Consumer Product Safety Commission (CPSC) voted to ask the ITC to add the chemicals.  In addition, CPSC granted a petition to begin rulemaking for additive, nonpolymeric organohalogen flame retardants under the Federal Hazardous Substances Act

EPA is currently seeking public comments on the revisions to the priority testing list and any information relevant to the listing.  The comment period is open until May 28, 2021.

Manufacturer Request for Risk Evaluation of OTNE

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

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.

Proposed TSCA Fee Rule Changes

On December 18, 2020, EPA signed a proposed rule revision for TSCA fees to defray costs for activities under TSCA sections 4, 5, and 6.  This revision proposes updates to the 2018 fees rule and requires EPA to review the fees every three years with ability to adjust the fees.  This adds three new fee categories of a Bona Fide Intent to Manufacture or Import Notice, a Notice of Commencement of Manufacture or Import, and an additional fee associated with test orders.

The Bona Fide Intent to Manufacture or Import Notice covers EPA costs of reviewing bona fide notices.  The 2018 Fee Rule did not have any fees associated with reviewing the notices.  The cost is proposed as 500 dollars, and 90 dollars for small businesses.

The Notice of Commencement (NOC) of Manufacture or Import requires those who submit premanufacture notices to provide notice to the EPA within 30 days of when the chemical substance is first manufactured or imported.  Unlike the new Bona Fide Fee proposal, the NOC fees already existed under the 2018 Fee Rule, but fell under other categories, such as premanufacture notices.  The new proposal will have NOC fees as their own category and are proposed as 500 dollars, and 90 dollars for small businesses.

The new proposed fee associated with test orders applies to recipients who fail to follow terms or conditions of an original order.  Under the 2018 Fee Rule, the recipient had the option to redo the testing and submit new data without paying additional costs from the original test order.  The proposed fee with require payment for the original test order and any resubmitted data.  The new fee for resubmitted data is proposed to be equal to the cost of reviewing the initial data.

EPA is also proposing exemptions to some fee triggering activities:

  • an exemption for research and development activities on fees for EPA-initiated risk evaluations,
  • an exemption for entities manufacturing less than 2,500 lbs. of a chemical subject to an EPA-initiated risk evaluation fee;
  • an exemption for manufacturers of chemical substances produced as a non-isolated intermediate on fees for EPA-initiated risk evaluations;
  • and exemptions for manufacturers of a chemical substance subject to an EPA-initiated risk evaluation if the chemical substance is imported in an article, produced as a byproduct, or produced or imported as an impurity

Two other notable proposed changes are:

  • EPA proposes a volume-based fee allocation for EPA-initiated risk evaluation fees in any situation that does not involve a consortium.
  • EPA proposes export-only manufacturers to pay fees for EPA-initiated risk evaluations.

EPA Proposes Non-Consent-Order SNURs for 13 Chemical Substances

On October 16, 2018, the Environmental Protection Agency (EPA) issued a proposed rule that would establish Significant New Use Rules (SNURs) under the Toxic Substances Control Act (TSCA) for 13 chemical substances for which premanufacture notices (PMNs) have been approved during the two years since the statute was amended. A total of 6 SNURs were proposed for these 13 substances. Unlike other recent SNURs enacted after TSCA was amended, the 13 chemical substances are not also subject to consent orders. Indeed, all previously proposed and final SNURs for PMNs under amended TSCA were for substances for which EPA had previously negotiated orders under TSCA Section 5(e).

The proposed SNURs would require that persons who intend to manufacture (including import) or process any of the 13 chemical substances for an activity that is designated as a significant new use submit a “Significant New Use Notice” to EPA at least 90 days before commencing that activity. And, consistent with the SNUR regulations at 40 CFR § 721.25, the proposed rule states that persons may not commence the manufacture or processing for the significant new use until EPA has conducted a review of the notice and decided on the notice, and the person has taken any actions as are required as a result of that determination. Comments on the proposed SNURs are due November 15, 2018.