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 Margaret R. Graham

On April 26, 2018, U.S. Environmental Protection Agency (EPA) Administrator Scott Pruitt was grilled by Members of the U.S. House of Representatives Committee on Energy and Commerce, Subcommittee on Environment at a hearing titled The Fiscal Year 2019 U.S. Environmental Protection Agency Budget.  The budget was plainly not the primary topic as the House Committee Members covered a lot of ground.  Pruitt fielded many questions and comments from House Democrats on his alleged ethical lapses regarding spending, security details, retaliation towards EPA employees who reportedly questioned his practices, and concerns about a hostile work environment.  Lawmakers from both sides of the aisle expressed concern over the installation of a secure phone booth in his office.  His opening statement addressed these criticisms only vaguely, stating that they are merely a distraction and an attempt to “attack and derail the President’s agenda and these administration’s priorities.”  There were also questions concerning the delay of the proposed rule banning the use of methylene chloride, and criticism regarding EPA’s recent proposed rule to strengthen transparency in regulatory science (the “secret” Science Rule). 

No attempt is made here to summarize the lengthy hearing.

Pruitt’s testimony statement is available here.  It does not contain information on the Science Rule, but it briefly references the implementation of the Toxic Substances Control Act (TSCA) in a section entitled “Ensuring the Safety of Chemicals in Commerce.”

More information on the many TSCA implementation initiatives is available on our TSCA Reform News & Information webpage, as well as the TSCAblogTM.  A summary of Pruitt’s testimony before the Senate Committee on Environment and Public Works is available in our blog item “Pruitt Addresses Legacy Issues, TSCA Implementation in Oversight Hearing.” 


 

By Lynn L. Bergeson and Margaret R. Graham

On April 24, 2018, the U.S. Environmental Protection Agency (EPA) is scheduled to publish a notice in the Federal Register that it will be adding a supplemental analysis, “Supplemental Analysis of Alternative Small Business Size Standard Definitions and their Effect on TSCA User Fee Collection,” to the rulemaking docket for the User Fees for the Administration of the Toxic Substances Control Act (TSCA) proposed rule published on February 26, 2018.  EPA will also be extending the comment period for the proposed rule for an additional 30 days “to give interested parties the opportunity to consider this additional analysis and prepare meaningful comments.”  Comments will be due within 30 days of publication (by May 24, 2018).  The original comment deadline was April 27, 2018.

Regarding the supplemental analysis, EPA states that it “provides additional estimates for the impact of setting the small business definition based on an employee-based threshold.”  More information on the proposed rule is available in our February 9, 2018, memorandum “Administrator Pruitt Signs TSCA User Fee Proposal.”


 

By Lynn L. Bergeson and Margaret R. Graham

On February 26, 2018, the U.S. Environmental Protection Agency (EPA) published its proposed fees rule entitled User Fees for the Administration of the Toxic Substances Control Act (TSCA), as permissible under TSCA Section 26(b).  83 Fed. Reg. 8212.  The rule as proposed will set user fees applicable to any person required to submit information to EPA under TSCA Section 4 or a notice, including an exemption or other information, to be reviewed by the Administrator under TSCA Section 5, or who manufactures (including imports) a chemical substance that is the subject of a risk evaluation under TSCA Section 6(b).  The notice of proposed rulemaking provides a description of proposed TSCA fees and fee categories for fiscal years 2019, 2020, and 2021, and explains the methodology by which the proposed TSCA user fees were determined and would be determined for subsequent fiscal years.  In proposing these new TSCA user fees, EPA also proposes amending long standing user fee regulations governing the review of premanufacture notices, exemption applications and notices, and significant new use notices.  Comments on the proposed rule are due April 27, 2018.

An in-depth analysis prepared by Bergeson & Campbell, P.C. (B&C®) is available in our memorandum “Administrator Pruitt Signs TSCA User Fee Proposal.”


 

By Lynn L. Bergeson and Margaret R. Graham

 


 

By Lynn L. Bergeson and Margaret R. Graham

On February 8, 2018, the U.S. Environmental Protection Agency (EPA) issued the prepublication version of its long-anticipated fees rule under amended Toxic Substances Control Act (TSCA) Section 26(b) entitled User Fees for the Administration of the Toxic Substances Control Act.  EPA states that the proposed rule will set user fees applicable to any person required to submit information to EPA under TSCA Section 4 or a notice, including an exemption or other information, to be reviewed by the Administrator under TSCA Section 5, or who manufactures (including imports) a chemical substance that is the subject of a risk evaluation under TSCA Section 6(b).  

EPA’s notice of proposed rulemaking provides a description of proposed TSCA fees and fee categories for fiscal years 2019, 2020, and 2021, and explains the methodology by which the proposed TSCA user fees were determined and would be determined for subsequent fiscal years.  In proposing these new TSCA user fees, the Agency also proposes amending long standing user fee regulations governing the review of premanufacture notices, exemption applications and notices, and significant new use notices.  

EPA states the proposed fees on certain chemical manufacturers, including importers, would go towards developing risk evaluations for existing chemicals; collecting and reviewing toxicity and exposure data and information; reviewing Confidential Business Information (CBI); and making determinations regarding the safety of new chemicals before they enter the marketplace.

Comments on the proposed rule will be due 60 days after its publication in the Federal Register.

An in-depth analysis prepared by Bergeson & Campbell, P.C. (B&C®) will soon be available on our Regulatory Developments webpage.


 

By Lynn L. Bergeson, Charles M. Auer, and Margaret R. Graham

On December 21, 2017, the U.S. District Court for the Northern District of California ruled that the U.S. Environmental Protection Agency (EPA) had wrongly dismissed a Toxic Substances Control Act (TSCA) Section 21 petition submitted by Food & Water Watch, Inc. and other citizens seeking the regulation of fluoridation of drinking water supplies under TSCA Section 6(a) on grounds that the ingestion of fluoride poses an unreasonable risk to humans.  Food & Water Watch, Inc. v. EPA, Case No. 17-cv-02162-EMC (N.D. Cal.) (Food & Water Watch).  In 2017, EPA denied the Section 21 petition on the grounds that it failed to address conditions of use other than the fluoridation of drinking water.  82 Fed. Reg. 11878 (Feb. 27, 2017). 

In a fairly scathing rebuke of EPA’s legal positions, the court denied EPA’s motion to dismiss the petitioner’s judicial challenge of EPA’s administrative denial of the Section 21 petition and, in so doing, essentially rejected EPA’s interpretation that a citizen petition must evaluate all conditions of use of a chemical substance in a TSCA Section 6(b) risk evaluation.  While we are hesitant to note that “we told you so” in our March 7, 2017, blog item, the analysis noted there was spot on.

At issue in Food & Water Watch is EPA’s legal position that TSCA Section 6 requires that EPA consider all conditions of use in proceedings under that provision.  The court rejected this view noting that the “argument has no basis in the statutory text,” and there “is no good reason to believe that the term’s [conditions of use] appearance … [in Section 21] … obligates all citizen petitioners to address all conditions of use.”  The court also noted that EPA’s interpretation creates “a disparity between citizen petitions and manufacturer requests” for a Section 6(b) risk evaluation.  Under the rules, a manufacturer’s request may be limited only to those particular conditions of use of interest to the manufacturer, citing 40 C.F.R. Section 702.37(b)(4).  The court also noted EPA’s change of view on this issue between the proposed and final risk evaluation rule.  EPA initially proposed that risk evaluations must consider all conditions of use, but concluded in the final rule that EPA may focus its review on fewer than all conditions of use.

The court’s analysis is clear and well written, and goes into some detail on EPA’s legal reasoning and the problems it identified with it.

Commentary

This ruling raises interesting issues when viewed in the broader context of pending judicial challenges to EPA’s TSCA framework rules.  In those challenges, citizen advocates challenge EPA’s view, as articulated in the final framework rules, that the Agency retains discretion to assess those conditions of use it believes are most relevant for a particular chemical evaluation.  In other words, they challenge EPA’s view that fewer than all conditions of use must be considered in a risk evaluation, the very position the court in Food & Water Watch rejected for purposes of Section 21 petitions challenging EPA’s interpretation of a citizen’s legal burden under TSCA Section 6(a).  Given that the judicial challenge to the risk evaluation final rule is being heard in the U.S. Court of Appeals for the Ninth Circuit, this district court decision is particularly relevant.


 

By Lynn L. Bergeson and Margaret R. Graham

On December 6, 2017, the U.S. Environmental Protection Agency (EPA) announced it was extending the public comment period to receive information on the five persistent, bioaccumulative, and toxic (PBT) chemicals that are subject to Section 6(h) of the Toxic Substances Control Act (TSCA) which requires EPA to take expedited regulatory action to address risks from certain PBT chemicals.  Comments were initially due on December 9, 2017; they are now due on January 12, 2018.  EPA states it is interested in information from the public about these chemicals, including uses, products containing these chemicals, exposed populations, and alternatives to these chemicals.  Very few comments have been filed regarding these chemicals thus far.  The chemicals and corresponding docket numbers are:

More information on the PBTs is available on our blog under keyword PBTs.

 


 

By Lynn L. Bergeson and Margaret R. Graham

On December 9, 2016, the U.S. Environmental Protection Agency (EPA) opened five dockets to collect information on five persistent, bioaccumulative, and toxic (PBT) chemicals.  EPA requested information on uses, products containing these chemicals, exposed populations, and alternatives to these chemicals.  These five chemicals were selected on October 11, 2016, to receive expedited action under Section 6(h) of the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which requires EPA to take expedited regulatory action to address risks from certain PBT chemicals.  The deadline to submit comments is fast approaching:  December 9, 2017.  The five chemicals and their corresponding dockets are:

In August 2017, EPA provided background information for each of the five PBT chemicals in the form of use documents which provide a preliminary summary of available information collected by EPA on the manufacturing (including importing), processing, distribution in commerce, use, and disposal of each chemical.  Amended TSCA gives EPA three years to propose rules to reduce risks and exposures from these PBT chemicals to the extent practicable (until June 22, 2019), and EPA must issue the rules in final within 18 months of when they are proposed. 

More information on the PBTs is available on our blog under keyword PBTs.


 

By Lynn L. Bergeson and Margaret R. Graham

On May 1, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice in the Federal Register stating it was reopening and extending the comment period for two proposed rules:  (1) to prohibit the use of trichloroethylene (TCE) in vapor degreasing; to require manufacturers (including importers), processors, and distributors, except for retailers, of TCE for any use to provide downstream notification of these prohibitions throughout the supply chain; and to require limited recordkeeping (issued January 19, 2017); and (2) to prohibit the manufacture (including import), processing, and distribution in commerce of methylene chloride and N-methylpyrrolidone (NMP) for consumer and most types of commercial paint and coating removal; to prohibit the use of methylene chloride and NMP in these commercial uses; to require manufacturers (including importers), processors, and distributors, except for retailers, of methylene chloride and NMP for any use to provide downstream notification of these prohibitions throughout the supply chain; and to require recordkeeping (issued January 19, 2017).  82 Fed. Reg. 20310.

This is the second extension of the comment period for the proposed rule to ban TCE use in vapor degreasing and the first extension of the comment period for the proposed rule to ban the uses of NMP and methylene chloride for consumer and most types of commercial paint and coating removal.  Comments on both proposed rules are now due on May 19, 2017.  


 

By Lynn L. Bergeson and Margaret R. Graham

On February 9, 2017, the U.S. Environmental Protection Agency (EPA) announced it was extending the comment period for the two recently proposed rules issued under Section 6 of the Toxic Substances Control Act (TSCA) to ban certain uses of trichloroethylene (TCE):  proposed rule to ban certain uses of TCE in aerosol degreasing and as a spot cleaner in dry cleaning facilities (issued December 16, 2017); and proposed rule to regulate the use of TCE in vapor degreasing (issued January 19, 2017).  EPA is extending the comment period for the proposed ban on TCE as an aerosol degreaser and for spot cleaning in dry cleaning facilities from the initial deadline of February 14, 2017, to March 16, 2017, and for the proposed ban on TCE as a commercial vapor degreaser from the initial deadline of March 20, 2017, to April 19, 2017.  EPA did not state any information on why it was extending the deadline, but requests for extensions were filed in both dockets.

More information on the proposed rules is available in our memorandum EPA Proposes Regulation of TCE Use in Vapor Degreasing under TSCA Section 6(a) and in our blog item EPA Proposes Prohibiting Use of TCE.


 
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