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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 Margaret R. Graham

On May 25, 2018, the U.S. Environmental Protection Agency (EPA) announced it would host a half-day preparatory meeting for experts selected to serve as letter peer reviewers for EPA’s Exposure and Use Assessment and Human Health and Environmental Hazard Summary for Five Persistent, Bioaccumulative, and Toxic (PBT) chemicals.  Section 6(h) of the Toxic Substances Control Act (TSCA) directs EPA to issue regulations under Section 6(a) for certain PBT chemical substances that were identified in EPA’s TSCA Work Plan for Chemical Assessments: 2014 update.  The selected chemicals are:

  • Decabromodiphenyl ethers (DECA);
  • Hexachlorobutadiene (HCBD);
  • Pentachlorothiophenol (PCTP);
  • Phenol, isopropylated, phosphate (3:1) (PIP3/ITPP); and
  • 2,4,6-Tris(tert-butyl) phenol (2, 4, 6 TRIS).

EPA prepared an Exposure and Use Assessment and a Human Health and Environmental Hazard Summary in response to the requirements under TSCA Section 6(h) to summarize conclusions of toxicity and whether there is likely exposure to these PBT chemicals and EPA organized letter peer reviews for the Exposure and Use Assessment and the Human Health and Environmental Hazard Summary.  The Federal Register notice announcing the meeting states that during the preparatory meeting, “the individual letter peer reviewers will have the opportunity to comment on and ask questions regarding the scope and clarity of the draft charge questions.”  EPA’s background papers, related supporting materials, and charge/questions for these letter peer reviews are now available in Docket No. EPA-HQ-OPPT-2018-0314 on www.regulations.gov

The meeting is scheduled for June 25, 2018, from 1:00 p.m. to 5:00 p.m. (EDT) and will be held via teleconference and webcast only.  Registration is available online.  Those requesting to provide oral comments (approximately five minutes) are asked to register by June 21, 2018.  Though the peer reviewers may not be able to consider fully written comments submitted after July 23, 2018, EPA will consider all comments submitted on or before August 17, 2018

More information, including the list of experts, is available on EPA’s TSCA Peer Review website.