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By Lynn L. Bergeson and Carla N. Hutton

On December 10, 2021, the Biden Administration released its Fall 2021 Unified Agenda of Regulatory and Deregulatory Actions. According to the U.S. Environmental Protection Agency’s (EPA) rule list, the Office of Chemical Safety and Pollution Prevention (OCSPP) is working on the following rulemakings under the Toxic Substances Control Act (TSCA). Rulemakings at the proposed stage include:

  • Tiered Data Reporting to Inform Prioritization, Risk Evaluation, and Risk Management Under TSCA (2070-AK62): 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. EPA states that this information is needed to inform prioritization, risk evaluation, and risk management of the chemical substances under TSCA Section 6. EPA intends to publish a notice of proposed rulemaking (NPRM) in July 2022 and a final rule in March 2023. More information on the rulemaking 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 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 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 proposed a volume-based fee allocation for EPA-initiated risk evaluation fees in any scenario where a consortium is not formed and proposed to require export-only manufacturers to pay fees for EPA-initiated risk evaluations. EPA states that in light of public comments, it has decided to issue a supplemental proposal and seek additional public comment on changes to the January 2021 proposal. EPA intends to issue a supplemental NPRM in February 2022. EPA has not determined when it will issue a final rule. More information on the proposed rule is available in our December 30, 2020, memorandum;
     
  • New Chemicals Procedural Regulations to Reflect Amendments to TSCA (2070-AK65): 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. According to EPA, this rulemaking seeks to increase the quality of information initially submitted in new chemicals notices and improve its 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 September 2022. EPA has not determined when it will issue a final rule;
     
  • Procedures for Submitting Information Subject to Business Confidentiality Claims Under TSCA (2070-AK68): EPA states that it 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 TSCA amendments included several new provisions concerning the assertion and EPA review and treatment of confidentiality claims. 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 elaborate on EPA’s procedures for reviewing and communicating with TSCA submitters about confidentiality claims. According to EPA, it 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. EPA intends to issue an NPRM in April 2022;
     
  • Cyclic Aliphatic Bromide Cluster (HBCD); Rulemaking Under TSCA Section 6(a) (2070-AK71): 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 a TSCA Section 6 risk evaluation for HBCD, EPA initiated rulemaking to address unreasonable risks of injury to health and the environment identified in the final risk evaluation. EPA intends to publish an NPRM by September 2022 and a final rule by April 2024. More information on the final risk evaluation is available in our September 28, 2020, memorandum;
     
  • 1-Bromopropane; Rulemaking Under TSCA Section 6(a) (2070-AK73): 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 a TSCA Section 6 risk evaluation for 1-bromopropane, EPA initiated rulemaking to address unreasonable risks of injury to health identified in the final risk evaluation. EPA intends to issue an NPRM in October 2022 and a final rule in May 2024. More information on the final risk evaluation is available in our August 11, 2020, memorandum;
     
  • Carbon Tetrachloride; Rulemaking Under TSCA Section 6(a) (2070-AK82): 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 a TSCA Section 6 risk evaluation for carbon tetrachloride, EPA initiated rulemaking to address unreasonable risks of injury to health identified in the final risk evaluation. EPA intends to issue an NPRM in October 2022 and a final rule in June 2024. More information on the final risk evaluation is available in our November 4, 2020, memorandum;
     
  • Trichloroethylene (TCE); Rulemaking Under TSCA Section 6(a) (2070-AK83): 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 a TSCA Section 6 risk evaluation for TCE carried out under the authority of TSCA Section 6, EPA initiated rulemaking to address unreasonable risks of injury to health identified in the final risk evaluation. EPA intends to issue an NPRM in October 2022 and a final rule in June 2024. More information on the final risk evaluation is available in our November 24, 2020, memorandum;
     
  • Asbestos (Part 1: Chrysotile Asbestos); Rulemaking under TSCA Section 6(a) (2070-AK86): 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 a TSCA Section 6 risk evaluation for chrysotile asbestos, EPA initiated rulemaking to address unreasonable risks of injury to health identified in the final risk evaluation. EPA intends to issue an NPRM by April 2022 and a final rule by November 2023. More information on the final risk evaluation is available in our January 4, 2021, memorandum;
     
  • Reconsideration of Procedures for Chemical Risk Evaluation Under the Amended TSCA (2070-AK90): 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 in the process of reconsidering the final rule in keeping with new executive orders (EO) concerning the advancement of racial equity and support for underserved communities through the federal government (EO 13985), the protection of public health and the environment and restoring science to tackle the climate crisis (EO 13990), tackling the climate crisis at home and abroad (EO 14008), and other Administration priorities (such as the Presidential memorandum on restoring trust in government through scientific integrity and evidence-based policymaking). If EPA determines to amend the 2017 final rule based on its reconsideration, it will solicit public comment through an NPRM. EPA intends to publish an NPRM in September 2022;
     
  • Regulation of Persistent, Bioaccumulative, and Toxic (PBT) Chemicals Under TSCA Section 6(h); Phenol, Isopropylated Phosphate (3:1) (PIP (3:1)); Further Compliance Date Extension (2070-AK95): EPA proposed in October 2021 to amend the regulations applicable to PIP (3:1) promulgated under TSCA. Specifically, EPA proposes to extend the compliance date applicable to the processing and distribution in commerce of certain PIP (3:1)-containing articles and the PIP (3:1) used to make those articles until October 31, 2024, along with the associated recordkeeping requirements for manufacturers, processors, and distributors of PIP (3:1)-containing articles. EPA notes that the articles covered by the proposed rule include a wide range of key consumer and commercial goods such as cellular telephones, laptop computers, and other electronic and electrical devices and industrial and commercial equipment used in various sectors, including transportation, construction, agriculture, forestry, mining, life sciences, and semiconductor production. The proposed rule follows a recently-issued final rule that extended the compliance date applicable to the processing and distribution in commerce of certain PIP (3:1)-containing articles, and the PIP (3:1) used to make those articles, from March 8, 2021, to March 8, 2022, along with the associated recordkeeping requirements. Comments on the proposed rule are due December 27, 2021. EPA intends to issue a final rule in March 2022. More information on the proposed rule is available in our October 25, 2021, memorandum; and
     
  • TSCA Section 8(a) Reporting and Recordkeeping Requirements for Asbestos (2070-AK99): This rulemaking, under the authority of TSCA Section 8(a), would require the maintenance of records and submission to EPA of reports by manufacturers, importers, and processors of asbestos and mixtures and articles containing asbestos (including as an impurity). EPA states that the information sought includes data on the quantities of asbestos used in making products, employee exposure data, and waste disposal data. Reported information would be used by EPA and other federal agencies in considering the regulation of asbestos. EPA intends to issue an NPRM in March 2022 and a final rule in November 2022.

The Unified Agenda lists the following TSCA rulemaking at the final 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): EPA proposed amending components of the Significant New Uses of Chemical Substances regulations at 40 C.F.R. Part 721, specifically the “Protection in the Workplace” (40 C.F.R. Section 721.63) and “Hazard Communication Program” (40 C.F.R. Section 721.72). 81 Fed. Reg. 49598. The proposed changes are intended to align, where possible, EPA’s regulations with the revised Occupational Safety and Health Administration (OSHA) regulations at 29 C.F.R. Section 1910.1200. OSHA issued a final rule on March 26, 2012, (77 Fed. Reg. 17573) that aligns OSHA’s Hazard Communication Standards with the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). EPA states that it is reviewing the comments received and is planning to issue a final rule. EPA intends to issue a final rule in September 2022. More information on EPA’s 2016 proposed rule is available in our July 29, 2016, memorandum.

 

By Lynn L. Bergeson and Carla N. Hutton
 
On November 13, 2019, at 10:00 a.m. (EST), the House Committee on Science, Space, and Technology will hold a hearing on “Strengthening Transparency or Silencing Science?  The Future of Science in EPA Rulemaking.”  The Committee will hear from the following witnesses:
 
Panel 1

  • Dr. Jennifer Orme-Zavaleta, Principal Deputy Assistant Administrator for Science, U.S. Environmental Protection Agency (EPA) Office of Research and Development (ORD); EPA Science Advisor.

Panel 2

  • Dr. Linda S. Birnbaum, Scientist Emeritus, National Institute of Environmental Health Sciences (NIEHS); Director of NIEHS, 2009-2019;
     
  • Dr. Mary B. Rice, Assistant Professor of Medicine, Harvard Medical School; Pulmonary and Critical Care Physician, Beth Israel Deaconess Medical Center;
     
  • Dr. David Allison, Dean, School of Public Health, Indiana University-Bloomington; Member, “Reproducibility and Replicability in Science” Committee, The National Academies of Sciences, Engineering, and Medicine; and
     
  • Dr. Todd Sherer, Chief Executive Officer (CEO), The Michael J. Fox Foundation for Parkinson’s Research.

 

By Lynn L. Bergeson and Margaret R. Graham

On October 17, 2018, the Trump Administration published its Unified Agenda of Regulatory and Deregulatory Actions (Regulatory Agenda).  There are many interesting entries, some of which are flagged here.

Not surprisingly, the U.S. Environmental Protection Agency (EPA) listed implementing Toxic Substances Control Act (TSCA) amendments to enhance public health and chemical safety as one of its top priorities.  According to EPA, the amendments to TSCA that were enacted in June 2016 require EPA “to evaluate existing chemicals on the basis of the health risks they pose -- including risks to vulnerable groups and to workers who may use chemicals daily as part of their jobs.”  If unreasonable risks are found, EPA must then take steps to eliminate these risks but, “during the risk management phase, EPA must balance the risk management decision with potential disruption based on compliance to the national economy, national security, or critical infrastructure.”  The following TSCA items were included. 

The rules in the proposed rule stage are:

  • Microorganisms: General Exemptions From Reporting Requirements; Revisions of Recipient Organisms Eligible for Tier I and Tier II Exemptions, 2070-AJ65.  The Regulatory Agenda states that EPA is still developing a revised proposal that will address concerns raised by commenters in response to its preliminary determination that certain strains of Trichoderma reesei and Bacillus amyloliquefaciens will not present an unreasonable risk of injury to health or the environment when used as a recipient microorganism, provided that certain criteria for the introduced genetic material and the physical containment conditions are met.  EPA is also considering expanding the earlier proposal to prohibit the inclusion of antibiotic resistance genes in the introduced genetic material in microorganisms qualifying for the TSCA Section 5(h)(4) exemption.  EPA was scheduled to issue a proposed rule by October 2018.
  • Long-Chain Perfluoroalkyl Carboxylate (LCPFAC) and Perfluoroalkyl Sulfonate Chemical Substances; Significant New Use Rule (SNUR), 2070-AJ99.  The Regulatory Agenda states that EPA is developing a supplemental proposal for part of a SNUR under TSCA Section 5(a)(2) for LCPFAC chemical substances to make inapplicable the exemption for persons who import a subset of LCPFAC chemical substances as part of certain articles.  This rule was scheduled to be proposed by October 2018 and issued in final by November 2019.  EPA’s initial proposed rule was issued on January 21, 2015.
  • Procedural Rule:  Review of Confidential Business Information (CBI) Claims for the Identity of Chemicals on the TSCA Inventory -- Amended TSCA Section 8(b)(4)(C), 2070-AK21.  The Regulatory Agenda states that EPA is developing a proposed rule that establishes a plan to review all claims to protect the specific chemical identities of chemical substances on the confidential portion of the active TSCA Inventory.  EPA is scheduled to issue the proposed rule by January 2019 and the final rule by December 2019, as TSCA directs a final rule to be issued by December 16, 2019
  • TSCA Chemical Data Reporting Revisions and Small Manufacturer Definition Update for Reporting and Recordkeeping Requirements Under TSCA Section 8(a), 2070-AK33.  The Regulatory Agenda states that before the next Chemical Data Reporting (CDR) period of 2020, EPA intends to revise the reporting requirements to better align with new statutory requirements resulting from TSCA, as amended, to address submitters' feedback following the 2016 submission period, and may consider reporting requirements for inorganic byproducts.  EPA is also proposing amendments to the size standards for small manufacturers, which impacts certain reporting and recordkeeping requirements for TSCA Section 8(a) rules, including CDR.  EPA is scheduled to issue the proposed rule by December 2018 and the final rule by October 2019.
  • Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h), 2070-AK34.  The Regulatory Agenda states that EPA is developing a proposed rule to implement TSCA Section 6(h), as amended, which directs EPA to issue regulations for certain persistent, bioaccumulative, and toxic (PBT) chemical substances that were identified in the 2014 update of the TSCA Work Plan.  TSCA directs these regulations to be proposed by June 22, 2019, and issued in final form no later than 18 months after proposal.  According to the Regulatory Agenda, EPA will issue a proposed rule by June 2019.
  • Technical Issues; Formaldehyde Emission Standards for Composite Wood Products, 2070-AK47.  EPA is proposing to amend the regulations promulgated in a final rule published on December 12, 2016, concerning formaldehyde emission standards for composite wood products, specifically to address certain technical issues and further align the final rule requirements with the California Air Resources Board (CARB) Airborne Toxic Control Measures (ATCM) Phase II program.  EPA issued the proposed rule on November 1, 2018, in the Federal Register; comments are due by December 3, 2018.  EPA expects to issue a final rule by March 2019.  

The rules in the final rule stage are:

  • Review of Dust-Lead Hazard Standards and the Definition of Lead-Based Paint, 2070-AJ82.  EPA issued a proposed rule on July 2, 2018, that would lower the current dust-lead hazard standards (DLHS) from 40 mg/ft2 and 250 mg/ft2 to 10 mg/ft2 and 100 mg/ft2 on floors and window sills, respectively, per a final decision of the U.S. Court of Appeals for the Ninth Circuit.  The Regulatory Agenda states that while EPA has proposed standards of 10 mg/ft2 and 100 mg/ft2 for floors and window sills respectively, EPA encouraged public comment on the full range of candidate standards analyzed as alternatives to the proposal, including the option not to change the current standard or to reduce the floor dust standard but leave the sill dust standard unchanged, since reducing floor dust lead has the greatest impact on children's health.  EPA is scheduled to issue the final rule by June 2019.  More information on the proposed rule is available in our memorandum “Recent Federal Developments -- July 2018.”
  • SNUR for Toluene Diisocyanates (TDI) and Related Compounds, 2070-AJ91.  The Regulatory Agenda states that EPA is preparing the final version of a proposed SNUR issued on January 15, 2015, under TSCA Section 5(a)(2) for 2,4-toluene diisocyanate, 2,6-toluene diisocyanate, toluene diisocyanate unspecified isomers, and related compounds; and that there are no changes in the chemicals subject to the SNUR between the proposed and final rule.  EPA is scheduled to issue the final rule in November 2018.
  • Significant New Uses of Chemical Substances; Updates to the Hazard Communication Program and Regulatory Framework; Minor Amendments to Reporting Requirements for Premanufacture Notices, 2070-AJ94.  On July 28, 2016, EPA issued a rule proposing changes to the applicable significant new uses of chemical substances regulations at 40 C.F.R. Part 721 to align EPA's regulations, where possible, with the final revisions to the U.S. Occupational Safety and Health Administration (OSHA) Hazard Communications Standard.  The Regulatory Agenda states that EPA is reviewing the comments received and is planning to issue a final rule in February 2019.
  • Certain Nonylphenols and Nonylphenol Ethoxylates; SNUR, 2070-AJ96.  The Regulatory Agenda states that EPA is reviewing the comments received on the proposed SNUR issued on October 1, 2014, for certain chemical substances commonly known as nonylphenols (NP) and nonylphenol ethoxylates (NPE) and is planning to issue a final rule in September 2019.  More information on the proposed SNUR is available in our memorandum “EPA Proposes SNUR for Nonylphenols and Nonylphenol Ethoxylates.”
  • Methylene Chloride; Rulemaking Under TSCA Section 6(a), 2070-AK07.  The Regulatory Agenda states that EPA is scheduled to issue the final rule prohibiting the consumer and commercial paint stripping uses for methylene chloride by December 2018.  In a press release issued on May 10, 2018, EPA stated that it will not re-evaluate the paint stripping uses of methylene chloride and will rely on its previous risk assessments.  See our memorandum “EPA Will Send Final Methylene Chloride Rule to OMB ‘Shortly’” for more information on the proposed rule. 
  • Asbestos; SNUR, 2070-AK45.  The Regulatory Agenda states that EPA’s proposed SNUR under TSCA Section 5(a)(2) for certain uses of asbestos that are no longer in use in the United States is scheduled to be issued in final by January 2019.  The proposed SNUR was issued on June 11, 2018, and the comment period ended on August 10, 2018.  More information on the proposed rule is available in our memorandum “Monthly Update for June 2018.”

The following Long-Term Action was also listed:

  • N-Methylpyrrolidone (NMP); Regulation of Certain Uses Under TSCA Section 6(a), RIN 2070-AK46.  The Regulatory Agenda states that EPA’s two co-proposals for NMP that were proposed on January 19, 2017 (as part of RIN 2070-AK07), will be issued in final with a future date “To Be Determined.”  The first co-proposal would prohibit the manufacture, processing, and distribution in commerce of NMP for all consumer and most commercial paint and coating removal and the use of NMP for most commercial paint and coating removal.  The second co-proposal would require commercial users of NMP for paint and coating removal to establish a worker protection program and not use paint and coating removal products that contain greater than 35 percent NMP by weight, with certain exceptions; and require processors of products containing NMP for paint and coating removal to reformulate products such that they do not exceed 35 percent NMP by weight, to identify gloves that provide effective protection for the formulation, and to provide warnings and instructions on any paint and coating removal products containing NMP.  For more information on the proposed rule, please see our memorandum "Monthly Update for February 2017."

For information on the TSCA items included in the Spring 2018 Regulatory Agenda, please see our blog item “EPA’s Spring 2018 Unified Agenda and Regulatory Plan Includes TSCA Rulemakings.”


 

By Lynn L. Bergeson, Carla N. Hutton, and Jessie Nguyen

On May 9, 2018, the Office of Information and Regulatory Affairs (OIRA) posted the Spring 2018 Unified Agenda and Regulatory Plan.  OIRA states that the semi-annual Unified Agenda and Regulatory Plan “provide uniform reporting of data on regulatory and deregulatory actions under development throughout the Federal government, covering over 60 departments, agencies, and commissions.”  Below are highlights of rulemakings from the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) that are related to the Toxic Substances Control Act (TSCA):

  • Microorganisms:  General Exemptions From Reporting Requirements; Revisions of Recipient Organisms Eligible for Tier I and Tier II Exemptions (RIN 2070-AJ65):  EPA promulgated a final rule under TSCA Section 5 to establish notification procedures for review of certain new microorganisms before they are introduced into commerce.  EPA received petitions to add Trichoderma reesei and Bacillus amyloliquefaciens to the list of microorganisms that may be used as recipient microorganisms to qualify for the exemption from full notification and reporting.  Based on EPA’s evaluation of these petitions, EPA states that it made a preliminary determination that certain strains of both microorganisms will not present an unreasonable risk of injury to health or the environment when used as a recipient microorganism, provided that certain criteria for the introduced genetic material and the physical containment conditions are met, and issued a proposed rule.  EPA is developing a revised proposal that will address concerns raised by commenters, and is considering expanding the earlier proposal to prohibit the inclusion of antibiotic resistance genes in the introduced genetic material in microorganisms qualifying for the TSCA Section 5(h)(4) exemption.  EPA intended to issue a notice of proposed rulemaking (NPRM) in May 2018;
  • Long-Chain Perfluoroalkyl Carboxylate (LCPFAC) and Perfluoroalkyl Sulfonate (PFAS) Chemical Substances; Significant New Use Rule (SNUR) (RIN 2070-AJ99):  EPA is developing a SNUR under TSCA Section 5(a)(2) for LCPFAC chemical substances, and for perfluorooctanoic acid (PFOA) or its salts.  On January 21, 2015, EPA proposed to amend a SNUR for LCPFAC chemical substances by designating as a significant new use manufacturing (including importing) or processing of an identified subset of LCPFAC chemical substances for any use that will not be ongoing after December 31, 2015, and all other LCPFAC chemical substances for which there are currently no ongoing uses.  EPA also proposed to make inapplicable the exemption for persons who import LCPFAC chemical substances as part of articles.  In addition, EPA proposed to amend a SNUR for PFAS chemical substances that would make inapplicable the exemption for persons who import PFAS chemical substances as part of carpets.  EPA intended to issue a supplemental NPRM in May 2018 following changes to TSCA brought about by the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  EPA plans to issue a final rule in July 2019;
  • Procedural Rule:  Review of Confidential Business Information (CBI) Claims for the Identity of Chemicals on the TSCA Inventory -- Amended TSCA Section 8(b)(4)(C) (RIN 2070-AK21):  EPA is developing a proposed rule to implement TSCA Section 8(b)(4)(C), which requires EPA to establish a plan to review all claims to protect the specific chemical identities of chemical substances on the confidential portion of the active  TSCA Inventory.  EPA intends to publish an NPRM in January 2019 and a final rule in December 2019;
  • TSCA Chemical Data Reporting (CDR) Revisions (RIN 2070-AK33):  EPA will revise the reporting requirements to align better with new TSCA requirements.  EPA intends to issue an NPRM in September 2018 and a final rule in September 2019;
  • Significant New Uses of Chemical Substances; Updates to the Hazard Communication Program and Regulatory Framework; Minor Amendments to Reporting Requirements for Premanufacture Notices (RIN 2070-AJ94):  On July 28, 2016, EPA issued a rule proposing changes to the applicable Significant New Uses of Chemical Substances regulations to align EPA’s regulations, where possible, with the final revisions to the Occupational Safety and Health Administration’s (OSHA) Hazard Communications Standards.  EPA intends to issue a final rule in September 2018;
  • Certain Nonylphenols (NP) and Nonylphenol Ethoxylates (NPE); SNUR (RIN 2070-AJ96):  On October 1, 2014, EPA issued a proposed SNUR under TSCA Section 5(a)(2) for certain NPs and NPEs.  EPA intends to issue a final SNUR in December 2018;
  • Mercury; Reporting Requirements for the TSCA Mercury Inventory (RIN 2070-AK22):  On October 26, 2017, EPA issued a rule proposing reporting requirements under TSCA Section 8(b)(10)(D) for applicable persons to provide information to assist in the preparation of an “inventory of mercury supply, use, and trade in the United States,” where mercury is defined as “elemental mercury” and “a mercury compound.”  EPA intends to issue a final rule in June 2018; and
  • Service Fees for the Administration of TSCA (RIN 2070-AK27):  On February 26, 2018, EPA issued a rule proposing to implement TSCA Section 26(b)(1), which authorizes EPA to issue a rule to establish fees to defray the cost of administering Sections 4, 5, and 6, and collecting, processing, reviewing, and providing access to and protecting from disclosure as appropriate under Section 14 information on chemical substances.  EPA intends to issue a final rule in August 2018.

 

By Lynn L. Bergeson and Margaret R. Graham

On April 19, 2018, the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) received the U.S. Environmental Protection Agency’s (EPA) proposed rule entitled “Strengthening Transparency and Validity in Regulatory Science.”  This new proposed rule, item 2080-AA14, has not been published in the regulatory agenda; the only information available concerning the content of this rule is its title.

 On April 11, 2018, OIRA received an advanced notice of proposed rulemaking from EPA entitled “Increasing Consistency and Transparency in Considering Costs and Benefits in the Rulemaking Process.”  The OIRA 2017 Fall Regulatory Agenda for this rulemaking, item RIN 2010-AA12, states that EPA is considering “developing implementing regulations that would increase consistency across EPA divisions and offices, increase reliability to affected stakeholders, and increase transparency during the development of regulatory actions,” and that by developing implementing regulations through a notice-and-comment rulemaking process “it will provide the public with a better understanding on how EPA is evaluating costs when developing a regulatory action and allow the public to provide better feedback to EPA on potential future proposed rules.”

 More information on regulatory agenda items is available on our blog under key phrase regulatory agenda.


 

By Lynn L. Bergeson and Kathleen M. Roberts

On October 12, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice in the Federal Register announcing the cancellation of the fourth meeting of the Negotiated Rulemaking Committee for Chemical Data Reporting (CDR) requirements for inorganic byproducts (Reg Neg Committee) scheduled for October 25-26, 2017.  82 Fed. Reg. 47423. 

During their September 13-14, 2017, meeting, the members of the Reg Neg Committee concluded that further dialogue within the Committee context would be unproductive, and that the fourth meeting was not necessary.  EPA is, however, still providing the public an opportunity to weigh in on the legislative directive to reduce the CDR reporting burden for inorganic substances that are recycled, while maintaining EPA’s access to exposure information needed for risk assessment purposes.  The notice states that the Reg Neg Committee docket will remain open until December 11, 2017, to allow for public comment.

The Reg Neg Committee was established to respond to the legislative mandate under Section 8(a)(6)(A) of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which states:

The [EPA] Administrator shall enter into a negotiated rulemaking … to develop and publish … a proposed rule providing for limiting the reporting requirements, under this subsection, for manufacturers of any inorganic byproducts, when such byproducts, whether by the byproduct manufacturer or by any other person, are subsequently recycled, reused, or reprocessed.

During the first set of Reg Neg Committee meetings, EPA stressed its desire to implement the outcome of the Reg Neg Committee work during the next CDR reporting cycle in 2020.  To achieve this timeline, the Committee would need to reach a consensus on an approach or approaches by the October 2017 meetings.   While several different stakeholder organizations offered proposals for consideration, it became clear to Committee members during the September 14-15, 2017, meeting that those proposals would not have consensus support because they either required considerable further refinement and discussion beyond the October 2017 timeframe; did not provide EPA with appropriate exposure information needed for risk assessment; or did not adequately achieve the mandated goal of limiting reporting requirements. 

It is unclear if EPA will be able to complete the myriad of tasks needed to take a proposal received during the public comment period to final implementation before the 2020 CDR reporting cycle, as this would require EPA to complete a thorough analysis of additional proposals, consider potential impacts to the EPA offices, develop a proposed rulemaking, obtain public review and comment on the proposal, issue a final rulemaking, and provide clear and detailed guidance on the new approaches for reporting on recycled inorganic products prior to the 2020 CDR reporting cycle. 

More information on the negotiated rulemaking process as related to inorganic byproducts is available on our blog under key phrases negotiated rulemaking and inorganic byproducts.


 

By Lynn L. Bergeson and Margaret R. Graham

On August 18, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish a notice in the Federal Register stating that it will be holding the third and fourth committee meetings of the Negotiated Rulemaking Committee (NRC) on September 13, 2017, from 9:00 a.m to 5:00 p.m. (EDT) to September 14, 2017, from 9:00 a.m to 3:00 p.m. (EDT); and on October 25, 2017, from 9:00 a.m. to 5:00 p.m. (EDT) to October 26, 2017, from 9:00 a.m. to 3:00 p.m. (EDT).  The third meeting will take place at the Ronald Reagan Building and International Trade Center, Oceanic Suite, 1300 Pennsylvania Avenue N.W., Washington, D.C. 20004, while the fourth meeting will be held at the William Jefferson Clinton East Building, Room 1153, 1201 Constitution Avenue N.W., Washington, D.C. 20004.  Both meetings are open to the public.

The NRC’s objective is to “negotiate a proposed rule that would limit chemical data reporting requirements under Section 8(a) of the Toxic Substances Control Act (TSCA), [as amended], for manufacturers of any inorganic byproduct chemical substances when such byproduct chemical substances are subsequently recycled, reused, or reprocessed.”  Kathleen M. Roberts, Vice President of B&C® Consortia Management, L.L.C. (BCCM), an affiliate of Bergeson & Campbell, P.C. (B&C®), is on the NRC on behalf of a BCCM client.  EPA states that written comments can be submitted at any time during the negotiated rulemaking process, but is asking for written comments to be e-mailed to .(JavaScript must be enabled to view this email address) no later than one week prior to the meeting dates (September 6, 2017; and October 19, 2017).  Information about attending these meetings and their agendas will be posted to the NRC website.   More information regarding the NRC is available on our blog under key phrase Negotiated Rulemaking


 

By Lynn L. Bergeson and Margaret R. Graham

On June 5, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish in the Federal Register a notice of public meetings and a notice regarding the establishment of the Negotiated Rulemaking Committee (NRC).  The NRC’s objective is to “negotiate a proposed rule that would limit chemical data reporting requirements under Section 8(a) of the Toxic Substances Control Act (TSCA), [as amended], for manufacturers of any inorganic byproduct chemical substances when such byproduct chemical substances are subsequently recycled, reused, or reprocessed.”  The prepublication version is available online.  

EPA’s notice lists the stakeholder groups from which EPA plans to invite representatives to participate as members of the Committee -- all of whom have been “identified as having a definable stake in the outcome of the proposed requirements”: 

  • Inorganic chemical manufacturers and processors, including metal mining and related activities;
  • Recyclers, including scrap recyclers;
  • Industry advocacy groups;
  • Environmental advocacy groups; and
  • Federal, State, and Tribal governments.

The first meeting will be held on June 8, 2017, from 9 a.m. to 5 p.m. (EDT) and on June 9, 2017, from 9 a.m. to 3:00 p.m. (EDT).  The second Committee meeting will be held on August 16, 2017, from 9 a.m. to 5 p.m. (EDT) and on August 17, 2017, from 9 a.m. to 3:00 p.m. (EDT).  Both meetings will be held at EPA’s Headquarters in Washington, D.C.

More information on the NRC is available on our blog under key phrase negotiated rulemaking.


 

By Lynn L. Bergeson and Margaret R. Graham

On May 2, 2017, the U.S. Environmental Protection Agency (EPA) announced it would convene a public meeting to clarify and discuss the process of negotiated rulemaking on changes to Chemical Data Reporting (CDR) requirements for inorganic byproducts.  The meeting will be held on May 9, 2017, from 9:00 a.m. to 5:00 p.m. (EDT) and on May 10, 2017, from 9:00 a.m. to 3:00 p.m. (EDT), in Washington, D.C. at the Capital Hilton, 1001 16th Street, N.W, in the General Session Room (South American AB). 

On December 15, 2017, EPA published a notice in the Federal Register of its intention to establish a Negotiated Rulemaking Committee (NRC) under the Federal Advisory Committee Act (FACA) and the Negotiated Rulemaking Act.  81 Fed. Reg. 90843.  The NRC will implement the amended Toxic Substances Control Act (TSCA) Section 8(a)(6) requirement that EPA “enter into a negotiated rulemaking … to develop and publish, not later than 3 years after the date of enactment … a proposed rule providing for limiting the reporting requirements under this subsection for manufacturers of any inorganic byproducts, if the byproducts, whether by the byproduct manufacturer or by any other person, are subsequently recycled, reused, or reprocessed.”  EPA states that it is holding this public meeting prior to the establishment of that NRC to “exchange information and clarify a number of aspects of inorganic byproduct identification and reporting.”

EPA states that written comments can be submitted at any time during the negotiated rulemaking process, but is asking for written comments to be e-mailed to .(JavaScript must be enabled to view this email address) no later than May 8, 2017.  Parties interested in making an oral presentation at the meeting should submit requests by e-mail to .(JavaScript must be enabled to view this email address) no later than May 8, 2017, to be placed on the list of public speakers.  As there are many questions about the scope of the negotiated rulemaking and the process that the initiative will follow, interested stakeholders are urged to participate.

Information about attending this meeting and its agenda will be posted to the NRC website.  More information on the establishment of the NRC is available in our blog item EPA To Establish Negotiated Rulemaking Committee Under Amended TSCA.


 

By Lynn L. Bergeson and Charles M. Auer

On December 21, 2016, the U.S. Environmental Protection Agency (EPA) published a final rule regarding procedures for rulemaking under Section 6 of the Toxic Substances Control Act (TSCA) in the Federal Register.  Under TSCA Section 6, EPA has the authority to address risks from chemical substances, and Section 6 includes procedures that EPA must follow.  As amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, TSCA no longer mandates certain procedural requirements, and this rulemaking removes the regulations specifying those procedures. The final rule is effective on the date of publication, December 21, 2016.

The final rule appears to amend the Section 6 procedural requirements such that they align with the amended requirements under new TSCA.  While the procedural simplifications in new TSCA were a useful change that should better enable regulatory action on existing chemicals, EPA will need to exercise care in its future rulemaking to meet the procedural requirements that remain in Section 6, as well as satisfy the relevant provisions in Section 26.  More information regarding this final rule is available in our memorandum TSCA:  EPA Amends Procedures for TSCA Section 6 Rulemaking.


 
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