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

By Lynn L. Bergeson, Carla N. Hutton, and Holly M. Williams

On June 30, 2020, the Trump Administration released the Spring 2020 Unified Agenda of Regulatory and Deregulatory Actions for the U.S. Environmental Protection Agency (EPA.)  According to the Unified Agenda, the Office of Chemical Safety and Pollution Prevention (OCSPP) is working on several rulemakings under the Toxic Substances Control Act (TSCA).  Rulemakings at the proposed stage are listed below:

  • Review of Dust-Lead Post-Abatement Clearance Levels.  On June 24, 2020, EPA published a proposed rule that would lower the amount of lead that can remain in dust on floors and windowsills after lead removal activities (dust-lead clearance levels (DLCL)) from 40 micrograms (µg) of lead in dust per square foot (ft2) to 10 µg/ft2 for floor dust and from 250 µg/ft2 to 100 µg/ft2 for window sill dust.  85 Fed. Reg. 37810.  Comments on the proposed rule are due August 24, 2020.  EPA intends to publish a final rule in September 2020.
     
  • Reporting and Recordkeeping for Certain Chemicals under TSCA Section 8(a).  EPA is developing a rulemaking under TSCA Section 8(a) to add certain chemicals that are on the TSCA Work Plan to the Chemical-Specific Reporting and Recordkeeping rules in 40 C.F.R. Part 704, Subpart B.  EPA is developing this rule to obtain information about potential hazards and exposure pathways related to certain chemicals on the TSCA Work Plan, particularly occupational, environmental, and consumer exposure information.  EPA states that this information is needed to inform prioritization and risk evaluation of the chemical substances, as mandated under TSCA Section 6.  EPA intends to issue a notice of proposed rulemaking (NPRM) in November 2020 and a final rule in June 2021.
     
  • Revisions to the Fees Rule under TSCA.  EPA is reviewing its 2018 final rule that established the requirements and procedures for setting and collecting fees from chemical manufacturers (including importers) and, in some cases, processors, submitters of new chemical substances, and others.  TSCA Section 26(b)(4)(F) requires EPA to review and adjust the fees every three years and to consult with parties potentially subject to fees when the fees are reviewed and updated to reflect changes in program costs.  EPA states that in addition to possible revisions resulting from this review, consistent with its announcement in March 2020, it will also consider proposing exemptions to the current rule’s self-identification requirements associated with EPA-initiated risk evaluations for manufacturers that:  (1) import the chemical substance in an article; (2) produce the chemical substance as a byproduct; and (3) produce or import the chemical substance as an impurity.  EPA intends to issue an NPRM in December 2020 and a final rule in October 2021.  More information on EPA’s March 2020 announcement is available in our April 17, 2020, blog item.
     
  • Updates to New Chemicals Procedural Regulations to Reflect the 2016 TSCA Amendments:  EPA states that the 2016 amendments impacted how it reviews and makes determinations on new chemical notices under TSCA Section 5.  EPA acknowledges that as a result of these increased responsibilities, “it has become more challenging for EPA to complete reviews within 90 days.”  This rulemaking seeks to revise the 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.  EPA intends 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 2020 and a final rule in July 2021.

Rulemakings at the final stage include:

  • Significant New Uses of Chemical Substances; Updates to the Hazard Communication Program and Regulatory Framework; Minor Amendments to Reporting Requirements for Premanufacture Notices.  On July 28, 2016, EPA proposed amending components of the Significant New Uses of Chemical Substances regulations at 40 C.F.R. Section 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).  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.  EPA intends to issue a final rule in August 2020.  More information on the proposed rule is available in our July 29, 2016, memorandum, “:  TSCA:  Proposed Revisions to Significant New Use Rules Reflect Current Occupational Safety and Health Standards.”
     
  • Long-Chain Perfluoroalkyl Carboxylate (LCPFAC) and Perfluoroalkyl Sulfonate Chemical Substances (PFAS); Significant New Use Rule (SNUR).  In a January 21, 2015, proposed SNUR for LCPFAC and PFAS chemical substances, EPA proposed to require notification of significant new uses from persons who import a subset of LCPFAC chemical substances as part of any article.  80 Fed. Reg. 2885.  EPA proposed to make the exemption from notification requirements for persons who import the chemical substance as part of an article inapplicable for the import of a subset of LCPFAC chemical substances in all articles.  As reported in our February 28, 2020, memorandum, “Proposed Supplemental SNUR Would Remove Exemption for LCPFAC Chemical Substances Used as Surface Coatings on Articles,” EPA issued a supplemental proposal that would make inapplicable the exemption for persons who import a subset of LCPFAC chemical substances as part of surface coatings on articles.  EPA intended to issue a final rule in June 2020.
     
  • Decabromodiphenyl Ether (DecaBDE); Regulation of Persistent, Bioaccumulative, and Toxic (PBT) Chemicals under TSCA Section 6(h).  TSCA Section 6(h) directs EPA to issue regulations under Section 6(a) for certain PBT chemical substances identified in the 2014 update of the TSCA Work Plan.  EPA states that it is selecting among the available prohibitions and other restrictions in TSCA Section 6(a) to address risks of injury to health or the environment that the Administrator determines are presented by the chemical substances and reduce exposure to the chemical substances to the extent practicable.  Since the statute states that a risk evaluation is not required for these chemical substances under TSCA Section 6(h), EPA developed an exposure and use assessment.  According to the Unified Agenda item, EPA intends to take final action on all of the chemicals that were addressed in the July 29, 2019, proposed rule (i.e., the following PBT chemicals identified in TSCA Section 6(h):  DecaBDE; phenol, isopropylated phosphate  (PIP) (3:1); 2,4,6-tris(tert-butyl)phenol (TTBP); pentachlorothiophenol (PCTP); and hexachlorobutadiene (HCBD).  Although addressed in a single proposed rule, EPA intends to issue separate final rules.  EPA proposed to prohibit the manufacture (including import), processing, and distribution in commerce of DecaBDE, and articles and products to which DecaBDE has been added with several exceptions, and proposed to require affected persons to maintain, for three years from the date the record is generated, ordinary business records that demonstrate compliance with the restrictions, prohibitions, and other requirements.  EPA intends to issue a final rule in December 2020.  More information is available in our June 24, 2019, memorandum, “EPA Publishes Proposed PBT Chemicals Rule under TSCA.”
     
  • PIP (3:1); Regulation of PBT Chemicals under TSCA Section 6(h).  EPA proposed to prohibit the processing and distribution in commerce of PIP (3:1), and products containing the chemical substance with several exceptions; prohibit releases to water from the non-prohibited processing, distribution in commerce, and commercial use activities.  Persons manufacturing, processing, and distributing PIP (3:1), and products containing PIP (3:1), in commerce would be required to notify their customers of these restrictions, and EPA proposed to require affected persons to maintain, for three years from the date the record is generated, ordinary business records that demonstrate compliance with the restrictions, prohibitions, and other requirements.  EPA intends to issue a final rule in December 2020.
     
  • TTBP; Regulation of PBT Chemicals under TSCA Section 6(h.).  EPA proposed to prohibit the distribution in commerce of 2,4,6-TTBP and products containing 2,4,6-TTBP in any container with a volume of less than 55 gallons for any use to prevent the use of 2,4,6-TTBP as a fuel additive or fuel injector cleaner by consumers and small commercial operations (e.g., automotive repair shops, marinas).  The proposed restriction also would prohibit processing and distribution in commerce of 2,4,6-TTBP, and products containing 2,4,6-TTBP, for use as an oil or lubricant additive, regardless of container size.  EPA also proposed to require affected persons to maintain, for three years from the date the record is generated, ordinary business records that demonstrate compliance with the restrictions, prohibitions, and other requirements.  EPA intends to issue a final rule in December 2020.
     
  • PCTP; Regulation of PBT Chemicals under TSCA Section 6(h).  EPA proposed to prohibit the manufacture (including import), processing, and distribution in commerce of PCTP, and products containing PCTP, unless in concentrations at or below one percent by weight; and proposed to require affected persons to maintain, for three years from the date the record is generated, ordinary business records that demonstrate compliance with the restrictions, prohibitions, and other requirements.  EPA intends to issue a final rule in December 2020.
     
  • HCBD; Regulation of PBT Chemicals under TSCA Section 6(h).  For HCBD, EPA proposed no regulatory action.  EPA intends to issue a final rule in December 2020.

 

By Lynn L. Bergeson and Carla N. Hutton
 
On June 28, 2019, a coalition of 11 state attorneys general filed a lawsuit in the U.S. District Court for the Northern District of California against the U.S. Environmental Protection Agency (EPA) for its failure to initiate an asbestos reporting rule under Section 8(a) of the Toxic Substances Control Act (TSCA).  The complaint argues that EPA wrongfully denied the states’ January 31, 2019, petition, filed under TSCA Section 21, to issue a rule for the reporting of the manufacture, import, and processing of asbestos.  More information on the petition is available in our February 1, 2019, blog item, and more information on EPA’s denial is available in our January 4, 2019, blog item.
 
According to the coalition, the rulemaking they requested is necessary under TSCA, and the denial of their petition was arbitrary and capricious and violates EPA’s obligations under TSCA.  The coalition asks the court to compel EPA to initiate a rulemaking and issue a new asbestos reporting rule to:

  • Eliminate “naturally occurring substance” as an exemption for asbestos reporting;
     
  • Require processors of asbestos, as well as manufacturers, including importers, of the chemical substance to adhere to reporting requirements;
     
  • Ensure that the impurities exemption in the Chemical Data Reporting (CDR) rule does not apply to asbestos; and
     
  • Require reporting with respect to imported articles that contain asbestos.

The coalition includes the Attorneys General of California, Connecticut, Hawaii, Maine, Maryland, Massachusetts, Minnesota, New Jersey, Oregon, Washington, and the District of Columbia.


 

By Lynn L. Bergeson and Margaret R. Graham

On November 30, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish in the Federal Register a notice of its final determination on whether revision to the current size standards for small manufacturers and processors, which are used in connection with reporting regulations under the Toxic Substances Control Act (TSCA) Section 8(a), is warranted.

The notice states that EPA has made its final determination that revision is warranted based upon three factors, listed below.

  1. Its preliminary determination.  EPA states in the notice that it preliminarily determined that a revision to the size standards is warranted “because of the magnitude of the increase in the [Producer Price Index (PPI)] since the last revision of the size standards and because the current annual sales standard is comparatively low given current revenue-based size standards developed by [the Small Business Administration (SBA)].”  When EPA reviewed the change in the PPI for Chemicals and Allied Products between 1988 and 2015 it found that the PPI has changed by 129 percent, which far exceeds the 20 percent inflation index specified as a level above which EPA may adjust annual sales levels in the current standard if deemed necessary. 
  2. A review of the comments on the preliminary determination.  EPA states that most commenters agreed with its preliminary determination that an update is warranted and several also provided their opinions on how the standards should be revised.  EPA states the actual changes to the standards were out of the scope of this determination, but it will address those issues in the subsequent proposed rulemaking.
  3. Feedback from consultation with the SBA.  SBA’s Office of Advocacy substantively agreed with EPA’s preliminary determination (that a revision to the current size standards is warranted), but it had requested EPA to consider additional factors in reaching that conclusion which EPA did not.  Specifically, the SBA wanted EPA to consider whether the standard is structured appropriately, and wanted EPA evaluate a broader set of factors related to firm and industry characteristics and percentage of firms impacted by Section 8 rules.

More information on these standards is available on our blog item under key phrase size standards.


 

By Lynn L. Bergeson, Carla N. Hutton, Charles M. Auer, and Richard E. Engler, Ph.D.

The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on May 16, 2017, announcing the availability of and requesting public comment on a draft guidance document entitled “Guidance on EPA’s Section 8(a) Information Gathering Rule on Nanomaterials in Commerce.” 82 Fed. Reg. 22452.  The promised guidance provides answers to questions EPA has received from manufacturers (includes importers) and processors of certain chemical substances when they are manufactured or processed at the nanoscale as described in the January 12, 2017, final Toxic Substances Control Act (TSCA) Section 8(a) rule.  The final rule requires one-time reporting for existing discrete forms of certain nanoscale materials, and a standing one-time reporting requirement for new discrete forms of certain nanoscale materials.  More information regarding the final rule is available in our January 12, 2017, memorandum, “EPA Promulgates Final TSCA Reporting and Recordkeeping Rule for Nanoscale Materials.”  EPA states that it will accept comments regarding the draft guidance, but not regarding the rule itself, “which has already been finalized.”  Comments are due June 15, 2017.

The 14-page draft guidance, in the form of questions and answers, addresses questions within the following categories:  what chemicals are reportable; who is required to report; information that is to be reported; when is reporting required; general questions; and confidentiality.  While the publication of draft guidance within four months of promulgation of the final rule is an achievement, the draft guidance does not significantly expand upon that which is already known, or make the rule clearer or easier with which to comply.  Companies subject to the reporting requirements of the final rule can expect to continue to struggle in sorting out what discrete forms are required to be reported.  More information regarding the draft guidance is available in our May 16, 2017, memorandum, “EPA Seeks Comment on Draft Guidance for Nanoscale Materials Reporting Rule.”


 

By Lynn L. Bergeson and Margaret R. Graham

On May 9, 2017, the U.S. Environmental Protection Agency (EPA) published in the Federal Register a notice stating that it was reopening the comment period regarding whether revision to the current size standards for small manufacturers and processors, which are used in connection with reporting regulations under the Toxic Substances Control Act (TSCA) Section 8(a), is warranted.  82 Fed. Reg. 21542.  EPA is opening the comment period for another 15 days, until May 24, 2017, to provide adequate opportunity for the public to consider the results of EPA’s consultation with the Small Business Administration (SBA).  EPA’s initial request for comments was published on December 15, 2016, and comments on its initial notice were due by January 17, 2017. 

The reopening of the comment period allows for public review and comment on EPA’s December 7, 2016, consultation request to the SBA on the adequacy of the current standards, as well as the SBA Administrator’s April 5, 2017, feedback on EPA’s consultation request.  In the notice, EPA states that it had intended to add SBA’s response to the docket to give the public an opportunity to review the response to inform their comments on EPA’s preliminary determination; EPA is providing that opportunity now. 


 

Monday, September 12, 2016
8:00 a.m. Pacific Daylight Time/11:00 a.m. Eastern Daylight Time/16:00 British Summer Time

Register Today

With passage by unanimous consent voice vote of the U.S. Senate of the Frank R. Lautenberg Chemical Safety for the 21st Century Act on June 7, 2016, this bill, that profoundly alters the regulation of industrial chemicals in the U.S. under TSCA, has cleared all hurdles and was signed into law by President Obama on June 22, 2016.

All chemical stakeholders doing business in the U.S., as well as foreign entities with business interests in the U.S., will need to understand the fundamental shifts in requirements, and the new concepts and approaches that are introduced by the law.

Bergeson & Campbell, P.C. has collaborated with Chemical Watch in assembling an impressive faculty of TSCA experts representing the perspectives of industry, environmental organizations, and U.S. federal and state regulatory authorities to present a series of complimentary webinars titled "'The New TSCA' -- What You Need to Know."

Webinar 3: Inventory, CDR, and CBI (Sections 8 & 14)

Speakers:

  • Charles M. Auer, Charles Auer & Associates, LLC, former Director of the Office of Pollution Prevention and Toxics (OPPT), U.S. Environmental Protection Agency (EPA)
     
  • Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C.
     
  • Richard E. Engler, Ph.D., Senior Chemist, Bergeson & Campbell, P.C., former senior staff scientist in OPPT and leader of EPA's Green Chemistry Program
     
  • Kelly Franklin, Chemical Watch
     
  • Kathleen M. Roberts, Vice President, B&C® Consortia Management, L.L.C.

 

Topics Covered:

  • Section 8 Reporting and Retention of Information
     
    • Small Manufacturer Definition
       
    • Reporting by Processors
       
    • Byproduct Rulemaking and Reporting
       
    • Toxic Substances Control Act (TSCA) Inventory
       
    • Nomenclature
       
  • Section 14 Confidential Business Information (CBI)
     
    • Information Not Protected
       
    • Asserting CBI
       
    • Presumptive CBI
       
    • Requirements for CBI Claims
       
    • Exemptions to Protection from Disclosure
       
    • Review and Resubstantiation
       
    • Duties of Administrator
       
    • Criminal Penalties

Register Online

 

Additional Webinars in "The New TSCA" Series:

 

Webinar 1: Overview and Summary of Major Changes: What to Expect and When to Expect It, presented June 13, 2016.
Webinar 2: Impacts on New Chemical Programs, presented July 14, 2016.
Webinar 4: Other Provisions -- PBTs, Preemption, Green/Sustainable Chemistry -- will be presented on September 26, 2016.