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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.