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

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on November 12, 2019, announcing the availability of its response to a petition it received under Section 21 of the Toxic Substances Control Act (TSCA) from Public Employees for Environmental Responsibility (PEER).  84 Fed. Reg. 60986.  As reported in our August 23, 2019, blog item, PEER petitioned EPA under TSCA Section 21 to prohibit the use of hydrofluoric acid in manufacturing processes at oil refineries under TSCA Section 6(a) and under the Administrative Procedure Act (APA) to take the same action pursuant to Section 112 of the Clean Air Act (CAA).  PEER petitioned EPA to prohibit the use of hydrofluoric acid in manufacturing processes at oil refineries and require a phase-out of use at such facilities within two years.  EPA states that after “careful consideration,” it has denied the Section 21 petition.  EPA notes that the Federal Register notice specifically addresses only the TSCA Section 21 petition, not the petition submitted under the APA.  EPA is denying the petition “based on the petition’s lack of sufficient facts establishing that it is necessary for the Agency to issue a rule under TSCA section 6(a).”  According to EPA, to grant a petition for a TSCA Section 6(a) rulemaking, a petition must provide facts establishing that the requested rulemaking is necessary.  Those facts need to be “sufficiently clear and robust for EPA to be able to conclude, within 90 days of filing the petition, that the chemical presents an unreasonable risk of injury to health or the environment and that issuance of a TSCA section 6(a) rule is the appropriate response to the petition.”  To make the threshold finding, EPA needs hazard and exposure data and other information to enable it to assess risk and conclude whether the risk is unreasonable.  In this case, EPA states that PEER’s petition “refers to hazard databases and makes conclusory statements of toxicity but provides little further information that would support granting a TSCA section 6(a) rulemaking request.”  According to EPA, the petition lacks the analysis that would be expected in a TSCA risk evaluation preceding a Section 6(a) rulemaking, such as “discussion of the appropriate hazard threshold, exposure estimates, assessment of risks, or how the facts presented allow EPA to comply with its duties under section 26 or other statutory requirements in making an unreasonable risk determination.”  Absent such information, EPA “cannot make the threshold determinations necessary to substantively assess and grant a petition for a TSCA section 6(a) rulemaking.”  EPA denies PEER’s petition request as facially incomplete.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On October 29, 2019, the U.S. Environmental Protection Agency published a Federal Register notice announcing the availability of the draft Toxic Substances Control Act (TSCA) risk evaluation for methylene chloride (MC).  84 Fed. Reg. 57866.  As reported in our October 26, 2019, blog item, EPA is submitting the same document to the TSCA Science Advisory Committee on Chemicals (SACC) for peer review.  SACC will convene an in-person public meeting to consider and review the draft risk evaluation on December 3-4, 2019.  Preceding the in-person meeting, there will be a preparatory virtual public meeting on November 12, 2019, for SACC to consider the scope and clarity of the draft charge questions for the peer review.  Registration for the preparatory virtual meeting must be completed on or before November 12, 2019, to receive the webcast meeting link and audio teleconference information.  Written comments for the preparatory virtual meeting and requests for time to present oral comments are due by 12:00 p.m. on November 8, 2019.  Written comments on the draft risk evaluation that are submitted to EPA on or before November 26, 2019, will be provided to SACC for review and consideration before the December 3-4, 2019, meeting.  Requests to present oral comments at the in-person meeting are due December 3, 2019.  Comments on the draft risk evaluation are due December 30, 2019.
 
The draft risk evaluation states that EPA’s initial determinations of unreasonable risk for the specific conditions of use of MC listed below are based on health risks to workers, occupational non-users (ONU), consumers, or bystanders from consumer use.  According to the draft risk evaluation, risks to the general population either were not relevant for these conditions of use or were evaluated and not found to be unreasonable.

  • Unreasonable Risk to Workers:  EPA determined that the conditions of use that presented unreasonable risks included processing MC into a formulation or mixture; all but two industrial and commercial uses; and disposal;
     
  • Unreasonable Risks to ONUs:  For ONUs, EPA determined that the conditions of use that presented unreasonable risks included import of MC, processing MC as a reactant in several industrial sectors, some industrial and commercial uses, and disposal.  EPA determined in some cases that a condition of use presented an unreasonable risk not only to workers but also to ONUs; in other cases, EPA determined that a condition of use presented an unreasonable risk only to one or the other.
     
  • Unreasonable Risk to Consumers:  EPA determined that all but two consumer conditions of use present unreasonable risks.
     
  • Unreasonable Risk to Bystanders (from Consumer Uses):  When EPA determined that a condition of use presented risks to consumers, unreasonable risks were often, but not always, identified for bystanders.

A more detailed summary of the draft risk evaluation and commentary will be available in our forthcoming memorandum.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on September 20, 2019, that it will extend the public comment period for its proposed rule intended to reduce exposures to certain chemicals that are persistent, bioaccumulative, and toxic (PBT).  84 Fed. Reg. 36728.  EPA identified five chemicals pursuant to Section 6(h) of the Toxic Substances Control Act (TSCA):  decabromodiphenyl ether (DecaBDE); phenol, isopropylated phosphate (3:1) (PIP (3:1)), also known as tris(4-isopropylphenyl) phosphate; 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP); hexachlorobutadiene (HCBD); and pentachlorothiophenol (PCTP).  The proposed rule would restrict or prohibit manufacture (including import), processing, and distribution in commerce for many uses of all of the chemicals except HCBD, for which EPA is proposing no regulatory action.  For the other four chemicals, the proposed rule includes recordkeeping requirements, as well as additional downstream notification requirements for PIP (3:1).  Comments are now due October 28, 2019.  EPA is required to issue a final rule by December 2020.  Our June 24, 2019, memorandum, “EPA Publishes Proposed PBT Chemicals Rule under TSCA,” provides a detailed review and analysis.

Tags: PBT, Section 6,

 

By Lynn L. Bergeson and Carla N. Hutton
 
On September 4, 2019, the U.S. Environmental Protection Agency (EPA) released new guidance intended to help methylene chloride processors and distributors comply with EPA’s March 2019 rule issued under Section 6(a) of the Toxic Substances Control Act (TSCA) prohibiting the manufacture (including import), processing, or distribution in commerce of methylene chloride for consumer paint and coating removal.  The final rule became effective on May 28, 2019.  Each person who manufactures, processes, or distributes in commerce methylene chloride for any use after August 26, 2019, must comply with the requirements for downstream notification and recordkeeping.  The guidance describes the requirements EPA established to address unreasonable risks from the use of methylene chloride in consumer paint and coating removal.  The guidance also:

  • Defines key terms;
  • Identifies the regulated entities;
  • Describes the required or prohibited activities; and
  • Summarizes the downstream notification and recordkeeping requirements.

EPA notes that the small entities directly regulated by the rule include:

  • Processors (since they formulate paint and coating removers containing methylene chloride);
  • Distributors of methylene chloride;
  • Distributors of paint and coating removers containing methylene chloride; and
  • Retailers.

EPA states that the rule is fully effective on November 22, 2019, when prohibitions on manufacturing (including importing), processing, or distributing methylene chloride for consumer paint and coating removal go into effect.  This ban includes a prohibition on distributing any methylene chloride for paint and coating removal to or by retailers, including e-commerce retailers.  More information on EPA’s final rule is available in our March 20, 2019, memorandum, “EPA Bans Consumer Sales of Methylene Chloride Paint Removers, Seeks Comment on Program for Commercial Uses.”


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) posted an August 7, 2019, petition for rulemaking submitted by the Public Employees for Environmental Responsibility (PEER) under Section 21 of the Toxic Substances Control Act (TSCA).  PEER asks that oil refineries be prohibited from using hydrofluoric acid in their manufacturing processes and that oil refineries be required to phase out the use of hydrofluoric acid within two years.  According to PEER, TSCA and the Clean Air Act (CAA) regulate hydrofluoric acid and provide the statutory authority for EPA to issue a regulation prohibiting the use of hydrofluoric acid in oil refineries.  PEER states that under TSCA, EPA “possesses the power to promulgate rules banning chemicals that pose an unreasonable risk to human health.”  If the EPA Administrator determines that the “manufacture, processing, distribution in commerce, use, or disposal of a chemical substance . . . presents an unreasonable risk of injury to health or the environment,” TSCA Section 6(a) provides EPA the authority to prohibit or otherwise restrict “the manufacture, processing, or distribution in commerce of such substance or mixture for (i) a particular use.”  PEER argues that the EPA Administrator could ban the use of hydrofluoric acid in refineries if the Administrator found that its use in that context presented an unreasonable risk to health or the environment.  PEER maintains that the use of hydrofluoric acid presents such a risk.

EPA sent a letter to PEER on August 16, 2019, confirming receipt of its petition and noting that Section 21 provides the Administrator 90 days to grant or deny the petition.  If the EPA Administrator grants the petition, the Administrator will “promptly commence an appropriate preceding [sic].”  If the Administrator denies the petition, the Administrator will publish the reasons for the denial in the Federal Register.


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on August 16, 2019, that it is opening a public comment period for manufacturer requests for the risk evaluations of diisodecyl phthalate (DIDP) and diisononyl phthalate (DINP), two chemicals used in plastic production.  EPA notes that the manufacturer-requested risk evaluations “are among the first such evaluations of this kind to be requested” under the Toxic Substances Control Act (TSCA).  EPA is also taking public comments on additional conditions of use it identified to include in the risk evaluations.  Upon publication of the Federal Register notices, comments may be submitted to Docket ID EPA-HQ-OPPT-2018-0435 for DIDP and Docket ID EPA-HQ-OPPT-2018-0436 for DINP for 45 days.  EPA encourages comments on any information not included in the manufacturer requests that commenters believe would be needed to conduct a risk evaluation.  EPA also welcomes any other information relevant to the proposed determinations of the conditions of use, including information on other conditions of use of the chemicals than those included in the manufacturer requests or in EPA’s proposed determinations.  After the comment period closes, EPA will review the comments and within 60 days either grant or deny the requests to conduct risk evaluations.  If these requests are granted, the manufacturers would be responsible for half the cost of the risk evaluations.  More information is available in our August 19, 2019, memorandum, "EPA Begins Comment Period on Manufacturer Requests for Risk Evaluation of DIDP and DINP, and Identifies Additional Conditions of Use."


 

By Lynn L. Bergeson and Carla N. Hutton
 
On July 29, 2019, the U.S. Environmental Protection Agency (EPA) published in the Federal Register its proposed rule intended to reduce exposures to certain chemicals that are persistent, bioaccumulative, and toxic (PBT).  84 Fed. Reg. 36728.  EPA identified five chemicals pursuant to Section 6(h) of the Toxic Substances Control Act (TSCA):  decabromodiphenyl ether (DecaBDE); phenol, isopropylated phosphate (3:1) (PIP (3:1)), also known as tris(4-isopropylphenyl) phosphate; 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP); hexachlorobutadiene (HCBD); and pentachlorothiophenol (PCTP).  The proposed rule would restrict or prohibit manufacture (including import), processing, and distribution in commerce for many uses of all of the chemicals except HCBD, for which EPA is proposing no regulatory action.  For the other four chemicals, the proposed rule includes recordkeeping requirements, as well as additional downstream notification requirements for PIP (3:1).  Comments are due September 27, 2019.  Our June 24, 2019, memorandum, “EPA Publishes Proposed PBT Chemicals Rule under TSCA,” provides a detailed review and analysis.


 

Bergeson & Campbell, P.C. (B&C®) is pleased to present the complimentary webinar “New TSCA at 3: Key Implementation Issues.” The webinar will drill down on key implementation challenges facing industry and the U.S. Environmental Protection Agency (EPA) three years into navigating the legal, regulatory, and science policy issues arising under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). Alexandra Dapolito Dunn, Assistant Administrator, EPA Office of Chemical Safety and Pollution Prevention (OCSPP); Lynn L. Bergeson, Managing Partner, B&C; and Richard E. Engler, Ph.D., Director of Chemistry, B&C, will present. Register online now.


 

By Lynn L. Bergeson and Emily A. Scherer
As reported in our June 28, 2019, memorandum, on June 24, 2019, Bergeson & Campbell, P.C.(B&C®), the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health (GWU) presented “TSCA: Three Years Later,” a day-long conference with leading experts exploring the current impacts of the Toxic Substances Control Act (TSCA) on science policies, challenges faced by industry, and the impacts of TSCA on regulatory policies, especially those concerning ensuring compliance and enforcement. A recording of the full conference is available online.  Our memorandum provides details regarding the session topics and presenters, including copies of the presentation where available.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency released on June 21, 2019, a proposed rule intended to reduce exposures to certain chemicals that are persistent, bioaccumulative, and toxic (PBT).  EPA identified five chemicals pursuant to Section 6(h) of the Toxic Substances Control Act (TSCA):  decabromodiphenyl ether (DecaBDE); phenol, isopropylated phosphate (3:1) (PIP (3:1)), also known as tris(4-isopropylphenyl) phosphate; 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP); hexachlorobutadiene (HCBD); and pentachlorothiophenol (PCTP).  The proposed rule would restrict or prohibit manufacture (including import), processing, and distribution in commerce for many uses of all of the chemicals except HCBD, for which EPA is proposing no regulatory action.  For the other four chemicals, the proposed rule includes recordkeeping requirements, as well as additional downstream notification requirements for PIP (3:1).  Publication of the proposed rule in the Federal Register will begin a 60-day comment period.  Our June 24, 2019, memorandum, “EPA Publishes Proposed PBT Chemicals Rule under TSCA,” provides a detailed review and analysis.

Tags: PBT, Section 6

 
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