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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 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 Margaret R. Graham

On July 20, 2017, the Trump Administration released its 2017 Unified Regulatory Agenda.  The U.S. Environmental Protection Agency’s (EPA) Agency Rule List included many items under the Toxic Substances Control Act (TSCA), including six in the final rule stage, ten in the proposed rule stage, and one in the prerule stage.  The six items in the final rule stage are:

  1. RIN 2070-AK20:  Procedures for Evaluating Existing Chemical Risks Under the Toxic Substances Control Act.  This final rule has been issued in final and published in the Federal Register.  The effective date is September 18, 2017.  More information on this final rule is available in our memorandum EPA Issues Final TSCA Framework Rules.
  2. RIN 2070-AK23:  Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act.  This final rule has been issued in final and published in the Federal Register.  The effective date is September 18, 2017.  More information on this final rule is available in our memorandum EPA Issues Final TSCA Framework Rules.
  3. RIN 2070-AK24:  TSCA Inventory Notification Active-Inactive Reporting Requirements.  This rule has been issued in final but is still awaiting publication in the Federal Register.  The expected effective date is the date of publication.  More information on this final rule is available in our memorandum EPA Issues Final TSCA Framework Rules.
  4. RIN 2070-AJ54:  The Nanoscale Materials; Chemical Substances When Manufactured, Imported, or Processed as Nanoscale Materials; Reporting and Recordkeeping Requirements.  This final rule has been issued in final and published in the Federal Register.  The effective date listed in the Federal Register was May 12, 2017, but the effective date listed in the agenda is TBD.  More information on this final rule is available in our memorandum EPA Promulgates Final TSCA Reporting and Recordkeeping Rule for Nanoscale Materials
  5. RIN 2070-AJ91:  Significant New Use Rule for Toluene Diisocyanates (TDI) and Related Compounds.  The agenda states that EPA is developing a significant new use rule (SNUR) under Section 5(a)(2) of TSCA for 2,4-toluene diisocyanate, 2,6-toluene diisocyanate, toluene diisocyanate unspecified isomers and related compounds.  This rule is still awaiting issuance in final and publication in the Federal Register.  It was scheduled to be issued in June 2017.
  6. RIN 2070-AJ44:  Formaldehyde Emission Standards for Composite Wood Products.  The agenda states that this final rule implements the Formaldehyde Standards for Composite Wood Products Act, which added Title VI to TSCA, and its purpose is to reduce formaldehyde emissions from composite wood products.  This rule has been issued in final and published in the Federal Register.  Its effective date was delayed per a subsequent Federal Register notice to May 22, 2017, but is listed on the agenda as TBD.

The ten items in the proposed rule stage are:

  1. RIN 2070-AJ65:  Microorganisms: General Exemptions From Reporting Requirements; Revisions of Recipient Organisms Eligible for Tier I and Tier II Exemptions.  The agenda states that EPA is 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 5(h)(4) exemption.  This second proposed rule was scheduled to be issued in June 2017.
  2. RIN 2070-AJ99:  Long-Chain Perfluoroalkyl Carboxylate and Perfluoroalkyl Sulfonate Chemical Substances; Significant New Use Rule.  The agenda states that EPA is re-proposing a significant new use rule (SNUR) under TSCA Section 5(a)(2) for long-chain perfluoroalkyl carboxylate (LCPFAC) chemical substances, and for perfluorooctanoic acid (PFOA) or its salts following changes under amended TSCA.  This second proposed rule is scheduled to be issued in October 2017 and is scheduled to be issued in final in October 2018.
  3. RIN 2070-AK07:  N-Methylpyrrolidone (NMP) and Methylene Chloride; Rulemaking Under TSCA Section 6(a).  The agenda states that EPA is developing a supplemental proposed rulemaking to address the risks from methylene chloride, specifically in commercial furniture refinishing as an industry.  This rulemaking is separate and apart from the proposed rule to ban certain uses of NMP and methylene chloride that was issued in January 2017.  The issuance of this supplemental proposed rule is TBD.
  4. RIN 2070-AK11:  Trichloroethylene (TCE); Rulemaking Under TSCA Section 6(a); Vapor Degreasing.  More information on this rulemaking is available in our blog item EPA Proposes Regulation of TCE Use in Vapor Degreasing under TSCA Section 6(a).  The comment period for this proposed rule ended in May 2017.  The issuance of the final rule is TBD. 
  5. RIN 2070-AK22:  Mercury; Reporting Requirements for the TSCA Mercury Inventory.  The agenda states that under amended TSCA, EPA is developing a proposed rule to implement TSCA Section 8(b)(10)(D) which requires EPA to issue a final rule no later than two years after the enactment of the TSCA amendments to establish reporting deadline(s) and information requirements for the purpose of assisting EPA's statutorily-mandated periodic update and publication of the inventory of mercury supply, use, and trade in the U.S.  This proposed rule is scheduled to be issued in October 2017 and is scheduled to be issued in final in June 2018.
  6. RIN 2070-AK27:  Service Fees for the Administration of the Toxic Substances Control Act.  The agenda states that under amended TSCA, EPA is developing a proposed rule to implement TSCA Section 26(b)(1) which authorizes EPA to issue a rule to establish fees to defray the cost of administering TSCA 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 (including contractor costs incurred by the Agency).  More information on this rulemaking is available in our memoranda TSCA Reform:  An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA.  The proposed rule is scheduled to be issued in August 2017 and the final rule is scheduled to be issued in June 2018
  7. RIN 2070-AK31:  TSCA Chemical Data Reporting; Requirements for Inorganic Byproducts.  The agenda states that under amended TSCA, EPA is developing a proposed rule to implement TSCA Section 8(a)(6)(A) which requires EPA to enter into a negotiated rulemaking and develop and publish a proposed rule within three years of enactment that addressed chemical data reporting requirements 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.  The proposed rule is scheduled to be issued in May 2018.
  8. RIN 2070-AK30:  Labeling Relief; Formaldehyde Emission Standards for Composite Wood Products.  On July 11, 2017, EPA issued a direct final rule and a parallel proposed rule that the agenda states “clarify requirements for labeling composite wood products and finished goods made entirely of composite wood products,” in response to stakeholders’ concerns that certain new requirements resulting from the implementation of the Formaldehyde Standards for Composite Wood Products Act (via final rule issued on December 12, 2016) may give rise to unintended supply chain disruptions as the compliance deadline established approaches.  The direct final rule is scheduled to become effective on August 25, 2017, unless adverse comments are received by July 26, 2017.  Comments on the proposed rule were due on July 26, 2017.
  9. RIN 2070-AK35:  Compliance Date Extension; Formaldehyde Emission Standards for Composite Wood Products.  On May 24, 2017, EPA issued a direct final rule and a parallel proposed rule that intended to extend the Formaldehyde Emission Standards for Composite Wood Products final rule (issued Dec. 12, 2016) compliance dates, and extend the California Air Resources Board Third Party Certifiers transitional period.  On July 6, 2017, EPA withdrew the direct final rule and the proposed rule after it received adverse comment.  The Federal Register notice withdrawing the final rule and the proposed rule states that EPA will proceed with a final rule based on the proposed rule after considering all public comments, but no further updates were provided.
  10. RIN 2070-AK36:  Voluntary Consensus Standards Update; Formaldehyde Emission Standards for Composite Wood Products.  The agenda states that EPA intends to issue a direct final rule and a parallel proposed rule to amend the December 2016 final rule on Formaldehyde Emission Standards for Composite Wood Products to correctly reference the current voluntary consensus standards as some of them have been updated, superseded or withdrawn.  The voluntary consensus standards that were incorporated in the final rule address a variety of topics, including material performance requirements and construction, test methods, and conformity assessments.  This proposed rule and direct final rule were scheduled to be issued in June 2017. 

The one item in the prerule stage is:

  • RIN 2070-AK29:  TSCA Reporting and Recordkeeping Requirements; Standards for Small Manufacturers and Processors.  The agenda states that under amended TSCA, EPA is developing an action to implement TSCA Section 8(a)(3)(C) which requires that EPA, after consultation with the Administrator of the Small Business Administration, to review the adequacy of the standards for determining the manufacturers and processors which qualify as small manufacturers and processors for purposes of TSCA Sections 8(a)(1) and 8(a)(3), and, after providing public notice and an opportunity for comment, make a determination as to whether revision of the standards is warranted.  More information on this action and the initial notice issued in December 2016 is available in our blog item EPA Requests Public Comment on Revision of Current Size Standard Definitions Under TSCA.  A second notice was scheduled to be issued in June 2017.  

 

By Lynn L. Bergeson and Margaret R. Graham

On March 6, 2017, the White House’s Office of Management and Budget (OMB), via the Office of Information and Regulatory Affairs (OIRA), issued Memorandum:  Spring 2017 Data Call for the Unified Agenda of Federal Regulatory and Deregulatory Actions, a memorandum for regulatory policy officers at executive departments and agencies and managing and executive directors of certain agencies and commissions, with the subject:  Spring 2017 Data Call for the Unified Agenda of Federal Regulatory and Deregulatory Actions.  Per EO 12866 (Oct. 4, 1993), federal agencies are directed to prepare a “Regulatory Plan (Plan) of the most important significant regulatory actions that the agency reasonably expects to issue in proposed or final form in that fiscal year or thereafter,” which they usually do semi-annually, in the spring and the fall.  This memo reiterates the directives of past executive orders on the regulatory agendas, but also includes new directives and focus, referring largely to the directives in the January 30, 2017, Executive Order (EO), Reducing Regulation and Controlling Regulatory Costs

The memorandum states that the Unified Agendas should “describe all regulations under development or review during the 12 months following publication.  Agencies should include, at a minimum, any plans to publish or otherwise implement an Advance Notice of Proposed Rulemaking (“ANPRM”), a Notice of Proposed Rulemaking (“NPRM”), or a Final Rule,” but also requests them to reflect attention to the following:

  • The total incremental costs of any new significant regulatory actions issued between noon on January 20, 2017, and September 30, 2017, shall, to the extent permitted by law, be fully offset as of September 30, 2017; and
  • Agencies should, for each new significant regulatory action that imposes costs and that an agency plans to issue on or before September 30, 2017, identify two existing regulatory actions the agency plans to eliminate or propose for elimination on or before September 30, 2017.

In an effort to “facilitate the fiscal year 2018 regulatory budget planning process,” the memorandum requests that spring 2017 submissions also include “a preliminary estimate of the total costs or savings associated with each of your planned fiscal year 2018 significant regulatory actions and offsetting deregulatory actions.”  The memorandum also lists suggested steps that it states will improve an agency’s Unified Agenda, including:

  • Considering whether the listing of “long-term” entries benefits readers, especially for those for which no substantial activity was expected within the coming year;
  • Removing entries that agencies do not realistically intend to take action on over the next 12 months, especially ones that the agency does not have the resources to take action on; and
  • Other more administrative suggestions, such as categorization; consistency of agency data; accuracy of timetable information; and abstract information for the entries that informs readers of the reason the rulemaking is under development and what the agency intends to accomplish.

Agencies must submit all of their Unified Agenda materials by March 31, 2017