Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency’s (EPA) spring 2022 Unified Agenda, published on June 21, 2022, includes the following rulemakings under the Toxic Substances Control Act (TSCA) or the Toxics Release Inventory (TRI).

Proposed Rule Stage

  • Tiered Data Reporting to Inform Prioritization, Risk Evaluation, and Risk Management under TSCA (2070-AK62): EPA is developing a rulemaking under TSCA Sections 8(a) and (d) to establish reporting requirements based upon a chemical’s status in the Risk Evaluation/Risk Management (RE/RM) Lifecycle and update the reporting requirements under the 40 C.F.R. Part 711 Chemical Data Reporting (CDR) regulation. Specifically, EPA is seeking occupational, environmental, and consumer exposure information. EPA is developing this rule to obtain information about potential hazards and exposure pathways related to certain chemicals, particularly occupational, environmental, and consumer exposure information. According to the Unified Agenda item, EPA needs this information to inform prioritization, risk evaluation, and risk management of chemical substances under TSCA Section 6. EPA intends to issue a notice of proposed rulemaking (NPRM) in May 2023 and a final rule in September 2024. More information on EPA’s July 27, 2021, webinar on development of the proposed rule is available in our July 29, 2021, memorandum.
  • Revisions to the TSCA Fees Rule (2070-AK64): In January 2021, EPA proposed updates and adjustments to the 2018 TSCA fees rule. EPA proposed modifications to the TSCA fees and fee categories for fiscal years (FY) 2022, 2023, and 2024 and explained the methodology by which the proposed TSCA fees were determined. EPA proposed to add three new fee categories: 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. In addition, EPA proposed exemptions for entities subject to certain fee-triggering activities, including an exemption for research and development (R&D) activities; an exemption for entities manufacturing less than 2,500 pounds of a chemical subject to an EPA-initiated risk evaluation fee; an exemption for manufacturers of chemical substances produced as a non-isolated intermediate; 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. EPA updated its cost estimates for administering TSCA, relevant information management activities, and individual fee calculation methodologies. EPA proposed a volume-based fee allocation for EPA-initiated risk evaluation fees in any scenario where a consortium is not formed and is proposing to require export-only manufacturers to pay fees for EPA-initiated risk evaluations. EPA also proposed various changes to the timing of certain activities required throughout the fee payment process. In light of public comments, EPA states that it has decided to issue a supplemental NPRM in October 2022 and seek additional public comment on changes to the January 2021 proposal. More information on the proposed rule is available in our December 30, 2020, memorandum.
  • New Chemicals Procedural Regulations to Reflect the 2016 Amendments to TSCA (2070-AK65): On June 22, 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) was signed into law, amending TSCA and impacting how EPA reviews and makes determinations on new chemical notices under TSCA Section 5. EPA states that as a result of these increased responsibilities, it has become more challenging to complete reviews within 90 days. This rulemaking seeks to revise the new chemicals procedural regulations in 40 C.F.R. Part 720 to improve the efficiency of EPA’s review process and to align its processes and procedures with the new statutory requirements. This rulemaking seeks to increase the quality of information initially submitted in new chemicals notices and improve EPA’s processes to reduce unnecessary rework in the risk assessment and, ultimately, the length of time that new chemicals are under review. EPA intends to publish an NPRM in February 2023.
  • Confidential Business Information (CBI) Claims under TSCA (2070-AK68): EPA is considering proposing new and amended rules concerning the assertion and maintenance of claims of CBI under TSCA. Amendments to TSCA in 2016 included several new provisions concerning the assertion and EPA review and treatment of confidentiality claims. EPA states that it is considering procedures for submitting and supporting such claims in TSCA submissions, including substantiation requirements, exemptions, electronic reporting enhancements, and maintenance or withdrawal of confidentiality claims. EPA is also considering whether the proposed rule should also elaborate on EPA’s procedures for reviewing and communicating with TSCA submitters about confidentiality claims. EPA expects the proposed rule to include new provisions, as well as revisions to existing rules on asserting confidentiality claims to conform to the 2016 amendments to TSCA. As reported in our May 17 and May 18, 2022, memoranda, EPA issued a proposed rule on May 12, 2022. EPA intends to issue a final rule in May 2023.
  • Chemical-Specific Rulemakings under TSCA Section 6(a): TSCA Section 6 requires EPA to address unreasonable risks of injury to health or the environment that the Administrator has determined are presented by a chemical substance under the conditions of use. Following risk evaluations for the following chemicals carried out under the authority of TSCA Section 6, EPA initiated rulemakings to address unreasonable risks of injury to health identified in the final risk evaluations:
    • Methylene Chloride (2070-AK70): EPA’s risk evaluation for methylene chloride, describing the conditions of use and presenting EPA’s determinations of unreasonable risk, is in docket EPA-HQ-OPPT-2019-0437, with additional information in docket EPA-HQ-OPPT-2016-0742. EPA intends to issue an NPRM in February 2023 and a final rule in August 2024. More information on EPA’s draft revision to its risk determination for methylene chloride will be available in a forthcoming memorandum;
    • 1-Bromopropane (2070-AK73): EPA’s risk evaluation for 1-bromopropane, describing the conditions of use and presenting EPA’s determinations of unreasonable risk, is in docket EPA-HQ-OPPT-2019-0235, with additional information in docket EPA-HQ-OPPT-2016-0741. EPA intends to publish an NPRM in May 2023 and a final rule in August 2024;
    • Carbon Tetrachloride (2070-AK82): EPA’s risk evaluation, describing the conditions of use and presenting EPA’s determinations of unreasonable risk, is in docket EPA-HQ-OPPT-2019-0499, with additional information in docket EPA-HQ-OPPT-2016-0733. EPA intends to publish an NPRM in April 2023 and a final rule in August 2024;
    • Trichloroethylene (TCE) (2070-AK83): EPA’s risk evaluation for TCE, describing the conditions of use and presenting EPA’s determinations of unreasonable risk, is in docket EPA-HQ-OPPT-2019-0500, with additional information in docket EPA-HQ-OPPT-2016-0737. EPA intends to publish an NPRM in March 2023 and a final rule in August 2024. More information on EPA’s draft revision to its risk determination for TCE will be available in a forthcoming memorandum;
    • Perchloroethylene (PCE) (2070-AK84): EPA’s risk evaluation for PCE, describing the conditions of use and presenting EPA’s determinations of unreasonable risk, is in docket EPA-HQ-OPPT-2019-0502, with additional information in docket EPA-HQ-OPPT-2016-0732. EPA intends to publish an NPRM in February 2023 and a final rule in August 2024. More information on EPA’s draft revision to its risk determination for PCE will be available in a forthcoming memorandum;
    • N-Methylpyrrolidone (NMP) (2070-AK85): EPA’s risk evaluation for NMP, describing the conditions of use and presenting EPA’s determinations of unreasonable risk, is in docket EPA-HQ-OPPT-2019-0236, with additional information in docket EPA-HQ-OPPT-2016-0743. EPA intends to publish an NPRM in May 2023 and a final rule in August 2024. More information on EPA’s draft revision to its risk determination for NMP will be available in a forthcoming memorandum; and
    • Asbestos (Part 1: Chrysotile Asbestos) (2070-AK86): EPA’s risk evaluation for chrysotile asbestos, describing the conditions of use and presenting EPA’s determinations of unreasonable risk, is in docket EPA-HQ-OPPT-2019-0501, with additional information in docket EPA-HQ-OPPT-2016-0736. More information on EPA’s proposed rule to prohibit ongoing uses of chrysotile asbestos is available in our April 7, 2022, memorandum. EPA intends to publish a final rule in November 2023.
  • Procedures for Chemical Risk Evaluation under TSCA (2070-AK90): As required under TSCA Section 6(b)(4), EPA published a final rule on July 20, 2017, that established a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use. This process incorporates the science requirements of the amended statute, including best available science and weight of the scientific evidence. The final rule established the steps of a risk evaluation process, including: scope, hazard assessment, exposure assessment, risk characterization, and risk determination. EPA states that it is now considering revisions to that final rule and will solicit public comment through an NPRM. EPA intends to publish the NPRM in September 2022. More information on EPA’s 2017 rule is available in our June 26, 2017, memorandum.
  • Asbestos; Reporting and Recordkeeping Requirements under TSCA (2070-AK99): This rulemaking, under the authority of TSCA Section 8(a), would require certain persons that manufactured (including imported) or processed asbestos and asbestos-containing articles (including as an impurity) to report certain exposure-related information, including quantities of asbestos and asbestos-containing articles manufactured (including imported) or processed, types of asbestos used, and employee data. Reported information would be used by EPA and other federal agencies in considering the regulation of asbestos. EPA notes that this rulemaking is the result of a settlement agreement stemming from litigation pursuant to TSCA Section 21. See Asbestos Disease Awareness Organization v. EPA, No. 19-CV-00871; State of California et al. v. EPA, No. 19-CV-03807. More information on EPA’s proposed reporting and recordkeeping requirements is available in our May 6, 2022, memorandum. EPA intends to publish a final rule in November 2022.
  • Other Chemical Substances Undergoing TSCA Section 6 Risk Evaluation; Significant New Use Rule (SNUR) for Certain Non-Ongoing Uses (2070-AL05): EPA is developing TSCA Section 5(a)(2) SNURs on conditions of use identified as not currently ongoing in the final scope documents for the high-priority substances undergoing TSCA Section 6 risk evaluations. EPA states that it will use the SNURs to require notice to EPA before chemical substances and mixtures are used in new ways that might create concerns. Persons subject to a SNUR who intend to manufacture (including import) or process the chemical substance for the significant new use must notify EPA at least 90 days prior to initiating activities via a significant new use notice (SNUN). EPA intends to publish an NPRM in December 2022 and a final rule in May 2024.
  • The Unified Agenda includes the following chemical-specific SNURs for certain non-ongoing uses:
    • Phthalates; SNUR for Certain Non-Ongoing Uses (2070-AL06): EPA intends to publish an NPRM in November 2022 and a final rule in May 2024;
    • Flame Retardants; SNUR for Certain Non-Ongoing Uses (2070-AL07): EPA intends to publish an NPRM in December 2022 and a final rule in November 2023; and
    • Certain Solvents; SNUR for Certain Non-Ongoing Uses (2070-AL08): EPA intends to publish an NPRM in December 2022 and a final rule in May 2024.
  • Inactive Inventory Per- and Polyfluoroalkyl Substances (PFAS) SNUR (2070-AL10): EPA is developing a SNUR under TSCA Section 5(a)(2) for certain uses of Inactive Inventory PFAS. Persons subject to the Inactive Inventory PFAS SNUR would be required to notify EPA at least 90 days before commencing manufacture or processing for any use that EPA has determined is a significant new use. The required notifications would initiate EPA’s evaluation of the intended use within the applicable review period. Manufacture and processing for the significant new use would be unable to commence until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination. EPA intends to publish an NPRM in September 2022 and a final rule in June 2023.
  • TRI; Response to Petition to Add Diisononyl Phthalate (DINP) to the TRI List of Toxic Chemicals (2025-AA17): According to EPA, this action arises from a petition received by EPA to add DINP to the list of toxic chemicals reportable under Section 313 of the Emergency Planning and Community Right to Know Act (EPCRA). In response to the petition, EPA initiated a rulemaking on September 5, 2000, proposing to add DINP to the TRI list. On June 14, 2005, EPA issued a notice of data availability seeking comments on EPA’s revised hazard assessment for DINP in further support of EPA’s proposal to add DINP to the TRI list. EPA states that the addition of DINP to the TRI list would make it subject to all the reporting requirements under the Toxic Chemical Release Reporting Rule. EPA intends to publish a supplemental NPRM in July 2022 and a final rule in May 2023;
  • Changes to Reporting Requirements for PFAS; Community Right-to-Know Toxic Chemical Release Reporting (2070-AK97): EPA is developing a proposal to add PFAS subject to reporting under EPCRA Section 313 and Section 6607 of the Pollution Prevention Act (PPA) to the list of Lower Thresholds for Chemicals of Special Concern (Chemicals of Special Concern). EPA states that the addition of the PFAS to the Chemicals of Special Concern list will eliminate the use of the de minimis exemption, eliminate the option to use Form A, and limit the use of range reporting. In addition, EPA is proposing to eliminate the use of the de minimis exemption under the Supplier Notification Requirements for facilities that manufacture or process all chemicals included on the Chemicals of Special Concern list. According to EPA, Chemicals of Special Concern may be found in products below de minimis levels; this is especially true for PFAS that are used at low concentrations in many products. Because of the widespread use of PFAS and their (or their degradants) persistence in the environment, however, even concentrations below de minimis levels can contribute significantly to environmental loading. The elimination of the de minimis exemption for supplier notification purposes will help facilities to identify potential sources of PFAS and other Chemicals of Special Concern. EPA believes that the elimination of the de minimis exemption under the Supplier Notification Requirements for PFAS and other Chemicals of Special Concern will result in a more complete picture of the releases and waste management quantities for these chemicals. EPA intends to publish an NPRM in September 2022 and a final rule in November 2023.
  • Addition of Certain PFAS to the TRI (2070-AL03): EPA is developing a rulemaking to add certain PFAS to the list of chemicals reportable under EPCRA Section 313. EPA states that the addition of these PFAS is in direct response to a statutory mandate under Section 7321(d) of the National Defense Authorization Act for Fiscal Year 2020 (NDAA). Under Section 7321(d), EPA was required to evaluate whether certain specific PFAS meet the EPCRA Section 313 listing criteria by December 2021 and is required to add any PFAS that EPA determines meet the listing criteria by December 2023. EPA intends to publish an NPRM in February 2023 and a final rule in November 2023.
  • Community Right-to-Know; Adopting 2022 North American Industry Classification System (NAICS) Codes for TRI Reporting (2070-AL09): EPA is developing a proposed rule to incorporate the revised 2022 North American Industry Classification System (NAICS) codes for TRI reporting purposes. According to EPA, the Office of Management and Budget (OMB) updates the NAICS codes every five years. OMB approved the 2022 NAICS codes on December 21, 2021 (86 Fed. Reg. 72277), with an effective date of January 1, 2022. EPA currently uses 2017 NAICS codes, and with this proposed rule would implement the 2022 codes for TRI Reporting Year 2022. Facilities reporting to the TRI would be required to use 2022 NAICS codes on reports that are due to EPA by July 1, 2023. This rule also proposed to update the C.F.R. to clarify the scope of facilities required to report to the TRI. According to EPA, the actual data required by a TRI form would not change as a result of this rulemaking, nor would the rule affect the universe of TRI reporting facilities that are required to submit reports to EPA under EPCRA Section 313. EPA intended to publish an NPRM in June 2022 and a final rule in November 2022.

Final Rule Stage

  • Significant New Uses of Chemical Substances; Updates to the Hazard Communication Program and Regulatory Framework; Minor Amendments to Reporting Requirements for Premanufacture Notices (PMN) (2070-AJ94): In 2016, EPA proposed changes to the existing regulations governing significant new uses of chemical substances under TSCA (40 C.F.R. Part 721, specifically “Protection in the Workplace” (40 C.F.R. Section 721.63) and “Hazard Communication Program” (40 C.F.R. Section 721.72)) to align these regulations with revisions to the Occupational Safety and Health Administration’s (OSHA) Hazard Communications Standard (HCS) (29 C.F.R. Section 1910.1200), which are proposed to be cross referenced, and with changes to the OSHA Respiratory Protection Standard and the National Institute for Occupational Safety and Health (NIOSH) respirator certification requirements pertaining to respiratory protection of workers from exposure to chemicals. EPA also proposed changes to the significant new uses of chemical substance regulations based on issues that have been identified by EPA and issues raised by public commenters for SNURs previously proposed and issued under these regulations. Additionally, EPA proposed a minor change to reporting requirements for PMNs and other TSCA Section 5 notices. EPA states that it expects these changes to have minimal impacts on the costs and burdens of complying, while updating the significant new use reporting requirements to assist in addressing any potential effects to human health and the environment. EPA is reviewing the comments received and is planning to issue a final rule. EPA intends to issue a final rule in October 2022. More information on the proposed rule is available in our July 29, 2016, memorandum.
  • Reporting and Recordkeeping for PFAS under TSCA Section 8(a)(7) (2070-AK67): EPA published a proposed rule on June 28, 2021, addressing reporting and recordkeeping requirements for PFAS under TSCA Section 8(a)(7). In accordance with obligations under TSCA Section 8(a), as amended by NDAA Section 7351, persons that manufacture (including import) or have manufactured these chemical substances in any year since January 1, 2011, would be subject to the reporting and recordkeeping requirements. In addition to fulfilling statutory obligations under TSCA, EPA states that it expects that the proposed rule would enable it to characterize better the sources and quantities of manufactured PFAS in the United States. EPA intends to publish a final rule in December 2022. More information on EPA’s proposed rule is available in our June 11, 2021, memorandum.
  • TRI; Response to Petition from the Toxics Use Reduction Institute (TURI) to Add 25 Chemicals (2070-AK26): The Toxics Use Reduction Institute (TURI) submitted a petition under EPCRA Section 313(e)(1) to add 25 chemicals to the EPCRA Section 313 list of toxic chemicals subject to reporting under the TRI. Three of the 25 chemicals were added to the EPCRA Section 313 list through actions unrelated to the petition. EPA states that it evaluated the remaining 22 chemicals to determine if they met the listing criteria of EPCRA Section 313(d)(2). EPA proposed the addition of 12 of the 22 chemicals that were determined to meet the EPCRA Section 313(d)(2) criteria and for which reports were expected to be filed. EPA is reviewing the comments received and is planning to issue a final rule. EPA intends to issue a final rule in November 2022.
  • Parent Company Definition for TRI Reporting (2070-AK42): In 2021, EPA proposed to codify the definition of “parent company” for purposes of reporting to the TRI. Although the existing regulation requires facilities reporting to the TRI to identify their parent company in annual reporting forms, no codified definition of this data element exists. Among the facilities reporting to the TRI are those with complicated corporate ownership structures. As such, effort is required each year by reporting facilities and EPA to clarify how the parent company data element should be represented on the form. According to EPA, a codified definition of parent company would allow EPA to address various corporate ownership scenarios explicitly and reduce the reporting burden caused by regulatory uncertainty. EPA states that the proposed rule would clarify existing regulations to reporting facilities and add a foreign parent company data element, if applicable, while improving EPA’s data quality. EPA is reviewing the comments received and is determining next steps. EPA intends to publish a final rule in October 2022.
  • NDAA Mandated Addition of Certain PFAS to the TRI for Reporting Year 2022 (2070-AL04): According to EPA, NDAA Section 7321 provides a framework for PFAS to be added automatically to the TRI list on January 1 of the year following certain EPA actions. In December 2021, EPA announced the statutory addition of the PFAS chemicals covered by the NDAA to the list of chemical substances subject to reporting for the TRI. This regulatory action amends the EPCRA regulations in 40 C.F.R. Part 372 to reflect this statutory addition. EPA intended to publish a final rule in June 2022.

 

By Lynn L. Bergeson and Carla N. Hutton

On May 12, 2022, the U.S. Environmental Protection Agency (EPA) published a proposed rule relating to the assertion and maintenance of confidential business information (CBI) claims under the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 29078. EPA states in its May 12, 2022, press release that the proposed rule includes new and amended requirements that, if made final, would increase transparency, modernize reporting and review procedures, and ensure consistency with the 2016 amendments to TSCA. In addition to providing increased clarity for TSCA submitters, EPA expects the changes to allow it to review and make determinations on CBI claims more efficiently, meeting the statutory review deadline in TSCA and more promptly making required notifications to submitters of claims. Comments are due July 11, 2022.

The proposed rule includes:

Provisions Intended to Increase Transparency

  • Changes intended to ensure that the existence and scope of a CBI claim is clear and limited to information the submitter views as confidential;
  • A provision to address inappropriate or overly broad CBI claims in public copies of TSCA submissions, especially health and safety related information, that specifies a process for the submitter to correct promptly those issues early in the CBI review and that EPA would promptly deny any remaining inappropriate claims. These changes are expected to remove ambiguity about the scope or validity of claims, permitting more rapid review of valid CBI claims and public access to non-CBI information.
  • Expanded requirements for electronic reporting and uniform requirements to provide publicly releasable copies of certain documents, such as scientific studies, both of which would make more data available to the public more quickly.
  • Requirements for electronic communication and maintaining current and accurate contact information to ensure more prompt delivery of required notices to submitters of CBI claims, thereby permitting EPA to make information for which CBI claims have been withdrawn, denied, or expired available to the public more quickly.

Provisions Intended to Modernize CBI Procedures and Ensure Consistency with Amended TSCA

  • Clear and uniform guidance on requirements for assertion and maintenance of CBI claims, including a standard set of substantiation questions used to support a CBI claim.
  • Requirements for electronic reporting of virtually all CBI claims, with enhancements to reporting tools that will prevent or mitigate common procedural errors EPA has observed to:
    • Ensure better procedural requirements for asserting a claim are met (with built-in certification and validation features for substantiation and generic names);
    • Articulate better and more narrowly the confidential information that is being claimed; and
    • Clarify CBI provisions that apply to individual data elements, such as where CBI claims are not permitted or where upfront CBI substantiation is not required to support a claim.
  • Establishment of a new section of the TSCA regulations to consolidate and standardize how TSCA CBI claims must be asserted and substantiated.
  • Requirements that health and safety information be submitted using an appropriate Organization for Economic Cooperation and Development (OECD) Harmonized Template (when available), a format that will allow data to be more readily used and shared within EPA while allowing submitters to indicate CBI claims more clearly for EPA consideration.

EPA seeks public comment on all aspects of the proposed rule and the Economic Analysis prepared in support of it. In addition to specific requests for comment included throughout the proposed rule, EPA invites specific comment on:

  • EPA’s interpretation of the coverage of TSCA Section 14(a) (proposed Section 703.1) and how this may impact submitters of information to EPA under other statutes, such as the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA states that it is particularly interested in comments on the treatment of FIFRA studies on inert ingredients under TSCA Section 14(b)(2).
  • The applicability of the proposed new or revised requirements to submissions received before the effective date of the subsequent final rule. Specifically, EPA requests comment on whether each proposed new or revised requirement should apply only to submissions received on or after the effective date of the final rule; to all submissions received on or after the effective date of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) amendments; or to all submissions regardless of submission date.
  • The proposed substantiation questions (proposed Section 703.5(b)), especially the proposal to omit a trade secrets-specific question; on how the patents question might be modified to elicit more pertinent information; and comment on the alternative substantial competitive harm question.
  • The proposed list of information that might be included with health and safety information, but that might be permissible to withhold as confidential (proposed Section 703.5(b)(6)). EPA is also interested in comment on alternatives to the proposal that might better ensure that health and safety information is not inappropriately treated as confidential.
  • The proposed approach to CBI claim deficiencies (proposed Section 703.5(e)) and on alternative approaches.
  • Whether submitting templated data should be required (proposed Section 703.5(g)).
  • The option of requiring TSCA submitters to update their original submission to reflect CBI claims that have been withdrawn or denied (proposed Section 703.5(j)).
  • Selection of the representative subset, including possible alternative representative selection methods (proposed Section 703.7).
  • Whether bona fide or pre-notice inquiries or correspondence should be considered part of a representative subset of TSCA submissions (proposed Section 703.7).
  • On the proposed approach to determining when a TSCA Section 14(g) CBI review period begins and how amendments to the submission are included in the review (proposed Section 703.7).
  • The proposed and alternative possible approaches to efficiently developing an acceptable generic name for purposes of listing on the TSCA Inventory, as described in proposed Sections 720.102 and 725.190.
  • On how to incorporate whether a substance may be readily reverse engineered into EPA’s substantive review criteria in proposed Section 703.7(f).

Our forthcoming memoranda will include a detailed summary of the proposed rule and an insightful commentary.

Tags: CBI

 

By Lynn L. Bergeson and Carla N. Hutton
 
On January 20, 2022, the U.S. Environmental Protection Agency (EPA) submitted a proposed rule to the Office of Management and Budget (OMB) concerning the procedures for submitting information subject to business confidentiality claims under the Toxic Substances Control Act (TSCA). According to an item in the fall 2021 Unified Agenda, EPA is considering proposing new and amended rules concerning the assertion and maintenance of claims of business confidentiality (i.e., confidential business information (CBI)) under TSCA. The 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) amendments included several new provisions concerning the assertion and EPA review and treatment of confidentiality claims. The Unified Agenda item states that EPA is considering procedures for submitting and supporting such claims in TSCA submissions, including substantiation requirements, exemptions, electronic reporting enhancements, and maintenance or withdrawal of confidentiality claims. EPA is also considering whether the proposed rule should also elaborate on its procedures for reviewing and communicating with TSCA submitters about confidentiality claims. EPA expects the proposed rule to include new provisions, as well as revisions to existing rules on asserting confidentiality claims to conform to the 2016 TSCA amendments.


 

By Lynn L. Bergeson and Carla N. Hutton

On April 29, 2021, the U.S. Environmental Protection Agency (EPA) announced the release of a list of 390 chemicals that it states are “expected to lose their confidential status and move to the public portion of the Toxic Substances Control Act (TSCA) Inventory, furthering the agency’s commitment to data transparency.”  According to EPA, the specific identities of these chemicals were reported as non-confidential during Chemical Data Reporting (CDR) cycles from the 2012, 2016, and/or 2020 reporting periods.  In accordance with the CDR rule and with TSCA Sections 8 and 14, EPA intends to update the TSCA Inventory listings for these chemicals to list the specific chemical identities on the public portion of the Inventory.  Stakeholders should check the list of substances and ensure that none of those substances is of critical importance to maintain confidential status.  Stakeholders with interest, questions, or concerns about this change in confidential status may contact the listed EPA staff no later than May 14, 2021.  EPA expects to include the specific chemical identities of these 390 chemicals in the next routine publication of the public TSCA Inventory, anticipated in late summer 2021.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published on February 8, 2021, a periodic update of the Toxic Substances Control Act (TSCA) confidential business information (CBI) review statistics.  TSCA Section 14(g)(1) requires that EPA, within 90 days of receipt of a CBI claim:

  • Review and make determinations on CBI claims for chemical identity after the chemical substance has been offered for commercial distribution; and
  • Review and make determinations on a representative subset of at least 25% of other CBI claims that are not exempt from substantiation and review.

The updated data summarize the number of CBI cases under review and results of completed reviews through December 28, 2020.  In addition, a spreadsheet is available showing the details of completed TSCA CBI determinations through December 28, 2020.
EPA states that making this information publicly available continues to demonstrate its commitment to transparency while fulfilling its responsibilities under TSCA.  EPA notes that it has established numerous new processes, systems, and procedures to enable submitters to provide the information required when making confidentiality claims and to facilitate EPA’s review, and where applicable, determinations on these claims.


 

By Lynn L. Bergeson and Carla N. Hutton

On January 12, 2021, the U.S. Environmental Protection Agency (EPA) and the Occupational Safety and Health Administration (OSHA) announced a memorandum of understanding (MOU) that advances collaboration and communication on EPA’s review of new chemicals under the Toxic Substances Control Act (TSCA).  EPA states that the MOU provides a framework for coordination and communication between the two agencies on exposure to new chemicals in the workplace and will help achieve the agencies’ shared goal of ensuring workers are protected from potential health and environmental risks.  As required by TSCA, EPA and OSHA are collaborating on workplace exposures as part of EPA’s review of new chemicals.  The MOU formalizes coordination efforts that EPA and OSHA have already implemented and provides a framework for additional opportunities for collaboration.  Highlights of the MOU include:

  • Establishing designated staff and management points of contact from each agency to discuss and resolve workplace exposure issues related to EPA’s review of new chemicals;
  • Providing OSHA with regular updates on EPA’s new chemical determinations, including any necessary worker protection identified during EPA’s review; and
  • Documenting EPA’s role in identifying and notifying OSHA of the need for formal consultation on EPA’s review of new chemicals.

More information will be available in a forthcoming memorandum that will be posted on our website.


 

By Lynn L. Bergeson and Carla N. Hutton
 

The U.S. Environmental Protection Agency (EPA) announced on January 5, 2021, that it is reopening the reporting period under the Toxic Substances Control Act (TSCA) Inventory notification active-inactive rule where companies identified chemicals that were manufactured, imported, or processed in the United States during the ten-year time period ending on June 21, 2016.  As reported in our June 26, 2017, memorandum, “EPA Issues Final TSCA Framework Rules,” the final TSCA Inventory notification (active-inactive) rule established a retrospective electronic notification of chemical substances on the TSCA Inventory that were manufactured (including imported) for nonexempt commercial purposes during the ten-year time period ending on June 21, 2016, with provision to also allow notification by processors.  From August 11, 2017, through October 5, 2018, chemical manufacturers and processors provided information on which chemicals were manufactured, imported, or processed in the United States over the past ten years.  The reporting period included an opportunity for submitters to assert claims to retain specific chemical identities as confidential business information (CBI).  In May 2020, EPA posted an interim list of chemicals expected to lose their CBI status and move to the public portion of the TSCA Inventory.  In its January 5, 2021, announcement, EPA states that it since become aware of “submitter confusion and issues regarding CBI claims” during the initial reporting period.  EPA is allowing companies to submit, amend, or withdraw filings under the TSCA Inventory notification (active-inactive) rule to maintain existing CBI claims for specific chemical identity.  The reporting period will reopen 30 days after publication in the Federal Register and run for 60 days after that date.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On October 16, 2020, the U.S. Environmental Protection Agency (EPA) reminded companies that if they filed a retrospective activity notice (Notice of Activity (NOA) Form A) under the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Rule and claimed the specific chemical identity as confidential business information (CBI), they have until November 1, 2020, to submit or amend their CBI substantiations.  Companies that amend, update, or file new CBI substantiations must do so electronically via EPA’s Central Data Exchange.

Background

On March 6, 2020, EPA promulgated a final rule on procedures for review of CBI claims made under TSCA.  The final rule includes the requirements for regulated entities to substantiate certain CBI claims made under TSCA to protect the specific chemical identities of chemical substances on the confidential portion of the TSCA Inventory, and EPA’s plan for reviewing certain CBI claims for specific chemical identities.  The substantiation requirements describe the applicable procedures and provide instructions for regulated entities.  EPA sets out the review criteria and related procedures that it will use to complete the reviews within the five-year timeframe set in TSCA.  More information is available in our February 28, 2020, memorandum, “EPA Releases Final Rule on Procedures for Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory.”

Tags: CBI, NOA, Inventory

 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published on August 11, 2020, its quarterly update of the Toxic Substances Control Act (TSCA) confidential business information (CBI) review statistics.  These data summarize the number of CBI cases under review and results of completed reviews through June 15, 2020:

CBI Review Statistics (cases received between June 22, 2016 and June 15, 2020)
Cases in which the specific chemical identity is subject to CBI review 3,326
Cases in which information other than the specific chemical identity is subject to CBI review 2,523
Cases in which both the specific chemical identity and information other than the specific chemical identity is subject to CBI review 734
Total cases subject to CBI review 6,583

 

Cases resulting in final CBI determinations
Cases with all CBI claims subject to review, approved 882
Cases with all CBI claims subject to review, denied 602
Cases with CBI claims subject to review, approved-in-part/denied-in-part 97
Total cases resulting in final CBI determinations 1,581

 

Cases reviewed with no final CBI determination necessary
Cases with all CBI claims screened and found to be exempt from review 1,078
Cases with all CBI claims withdrawn by submitter 430
Cases identified for CBI review, for which no determination required (e.g., in some instances, older EPA information systems do not specifically identify which information is claimed as CBI and upon review, it is determined that no claims require review) 1,500
Total cases reviewed/screened with no final CBI determination necessary 3,008

 

Cases currently undergoing CBI review
Cases currently undergoing CBI review 1,994

 
In August 2020, EPA published an updated list of cases with completed CBI reviews under TSCA Section 14.  The spreadsheet includes the results of completed CBI determinations and cases with approved claims for specific chemical identity for which unique identifiers have been assigned.


 

By Lynn L. Bergeson and Carla N. Hutton

On May 29, 2020, the U.S. Environmental Protection Agency (EPA) released updated data collected during the 2016 Chemical Data Reporting (CDR) period.  EPA notes that the updated 2016 CDR data now include information that was previously classified as confidential business information (CBI), such as aggregate production volumes and site-specific production volumes.  EPA published an initial release of the 2016 CDR data in May 2017.  The Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) amendments to the Toxic Substances Control Act (TSCA) were signed into law during the 2016 CDR submission period and changed CDR CBI reporting requirements.  EPA states that as a result, it conducted “a thorough substantiation and verification process with companies that submitted 2016 CDR data.”  According to EPA, this process allowed it to determine which claims met the new legal standard and ensure that valid CBI claims remained protected.

Background

On March 17, 2020, EPA announced the availability of a final rule amending the CDR rule.  EPA states that some of the key revisions include simplifying reporting, including allowing manufacturers to use certain processing and use data codes already in use by many chemical manufacturers as part of international codes developed through the Organization for Economic Cooperation and Development (OECD); updating requirements for asserting confidentiality claims to align with the requirements in amended TSCA; and adding reporting exemptions for specific types of byproducts manufactured in certain equipment.  Additionally, EPA is extending the reporting period for CDR data submitters from September 30, 2020, to November 30, 2020, to provide additional time for the regulated community to familiarize themselves with the amendments and to allow time for reporters to familiarize themselves with an updated public version of the reporting tool.  More information is available in our March 19, 2020, memorandum, “EPA Releases Final Amendments to CDR Rule, Extends Reporting Period.”

Our May 13, 2020, blog item, “New Reporting Procedure for Co-Manufacturers under TSCA CDR Rule May Catch Certain Manufacturers Off Guard,” notes that EPA has changed the way that toll manufacturing must be reported.  In this cycle, EPA will not accept reporting from only the contracting manufacturer in situations where a company contracts with another company (i.e., a toll manufacturer) for the production of chemicals.  In 2020, EPA has stated in multiple fora that for the 2020 reporting period, EPA will only accept manufacturing details from the actual producers, even if manufacturing was contracted by another company.  This change may come as a surprise, especially to producing companies that heretofore may not have reported under the CDR rule and instead relied on the contracting company to do so.

Tags: CBI, CDR

 
 1 2 3 >  Last ›