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
 
On September 14, 2020, the U.S. Environmental Protection Agency (EPA) released a pre-publication version of a final rule establishing the procedures and requirements for how EPA will manage the issuance of guidance documents consistent with Executive Order (EO) 13891, “Promoting the Rule of Law Through Improved Agency Guidance Documents.”  The final regulation provides a definition of guidance document for the purposes of this rule, establishes general requirements and procedures for certain guidance documents issued by EPA, and incorporates additional requirements for guidance documents determined to be significant guidance.  EPA notes that the regulation, consistent with the EO, also provides procedures for the public to petition for the modification or withdrawal of active guidance documents as defined by the rule or to petition for the reinstatement of a rescinded guidance document.  EPA states that the regulation is intended to increase the transparency of its guidance practices and improve the process used to manage its guidance documents.  The final rule will be effective 30 days after publication in the Federal Register.  More information will be available in a forthcoming memorandum that will be posted on our website.


 

By Lynn L. Bergeson and Carla N. Hutton
 

The Environmental Law Institute (ELI) recently released Environment 2021:  What Comes Next?, a report that looks at the Trump Administration’s impact on environmental law and policy and what lies ahead.  ELI states that the report is “a response to growing demand for analysis of how deregulatory initiatives by the Trump Administration will affect environmental protection, governance, and the rule of law with a focus on what might happen in a second Trump administration or a new administration.”  According to ELI, the report:

  • Assesses the Trump Administration’s steps to remake federal environmental regulation and redefine the relationships among state and federal environmental decisions;
     
  • Identifies key categories of action affecting environmental regulation and examines some possible future outcomes; and
     
  • Helps environmental practitioners, policymakers, and the public at large think about what lies ahead, looking particularly at the nation’s ability to address new problems and confront as yet unsolved challenges, such as environmental justice.
Tags: Trump, ELI, 2021

 

By Lynn L. Bergeson and Carla N. Hutton
 

The U.S. Environmental Protection Agency (EPA) is extending the nomination and public comment periods for the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) to receive additional nominees and input on prospective candidates for membership.  EPA states that it will use public comments to assist it in selecting multiple members of SACC over the next year.  EPA anticipates appointing approximately 15 members to SACC by March 2021.  EPA notes that current members of SACC are eligible for reappointment during this period.  Therefore, the approximately 15 member appointments completed by March 2021 may include a mix of newly appointed and reappointed members.  Biographies of the candidates are available in Docket ID EPA-HQ-OPPT-2020-0135.  Comments are due September 1, 2020.

Tags: SACC

 

By Lynn L. Bergeson and Carla N. Hutton
 
On July 31, 2020, the plaintiffs and EPA filed a joint case management statement in the U.S. District Court for the Northern District of California case seeking a rulemaking under Section 6 of the Toxic Substances Control Act (TSCA) to prohibit the addition of fluoridation chemicals to drinking water supplies.  Food & Water Watch, Inc. v. EPA, Case No. 3:17-cv-02162-EMC.  As reported in our June 12 and June 22, 2020, blog items, the court held a bench trial that concluded on June 17, 2020.  After hearing closing arguments, Judge Chen asked plaintiffs and EPA to consider how to reach an agreement.  According to the joint case management statement, the parties have met and conferred to discuss the potential of EPA considering a new or amended petition so that EPA, inter alia, “could consider the new science that has been published subsequent to the initial petition.”  Plaintiffs offered to submit a new petition to EPA that contains all of the evidence presented at trial, including the expert declarations, expert testimony, and exhibits.  EPA contends that plaintiffs’ proposal to “package” the evidence presented at trial as a new petition under Section 21 of the Toxic Substances Control Act (TSCA) “would be insufficient to reach a finding of unreasonable risk.”  EPA maintains that “meaningful review of a new petition based on the specific evidence-base available for evaluating potential neurotoxic effects from exposure to fluoride from community water fluoridation programs” should include:  (1) a systematic review; (2) raw data for the key studies upon which plaintiffs rely; and (3) the data underlying plaintiffs’ risk calculations, including their benchmark dose (BMD) analysis.  Plaintiffs are willing to provide the data underlying Dr. Grandjean’s risk calculations, but “cannot agree to the other two requirements.”  The joint statement states that first, plaintiffs maintain that they have already presented sufficient evidence to demonstrate an unreasonable risk under TSCA and are unwilling to do a new systematic review above and beyond what their experts have already done.  Second, plaintiffs maintain that they do not have the ability to provide the “raw data” for the key studies upon which they rely because the data are not theirs, and that EPA is thus asking for something that plaintiffs cannot provide.  Finally, plaintiffs do not believe that the raw data are necessary for EPA to evaluate the published peer-reviewed studies, and, indeed, requiring these data is “contrary to the health protective goals of TSCA.”
 
On August 3, 2020, plaintiffs filed a further statement on EPA’s position regarding a new petition.  Plaintiffs state that they “feel compelled to bring to the Court’s attention the broader policy shift that EPA’s raw data demand represents, and the overwhelming criticism this policy has received from virtually all sectors of the public health and scientific communities.”  According to the plaintiffs, EPA articulated this policy shift in its March 18, 2020, supplemental notice of proposed rulemaking (SNPRM) regarding “Strengthening Transparency in Regulatory Science” in which “EPA proposed limiting, or excluding altogether, its reliance on any peer reviewed study -- no matter how relevant or well regarded -- if the underlying raw data [are] not made publicly available.”  Plaintiffs cite a “detailed analysis signed by dozens of Harvard scientists,” which states that “EPA’s new policy ‘is based on a profoundly misguided view of how the scientific process works’ and ‘unnecessarily impedes EPA’s ability to base its internal analyses and regulatory decisions on the best available science.’  Further, the rule ‘adopts a partial and biased approach to transparency that systematically favors industry science over academic science.’”
 
EPA filed a response on August 4, 2020, describing plaintiffs’ further statement as “procedurally inappropriate and substantively untrue.”  According to EPA, by releasing the raw data and a detailed explanation of their statistical methods, the authors of the studies “could satisfy incongruities and ensure the scientific record is clear.”  EPA states that it “takes the position that a meaningful substantive review, as contemplated by the Court, of the evolving scientific evidence published since Plaintiffs submitted their 2016 petition should include raw data for the key studies upon which Plaintiffs rely and, according to Dr. Grandjean’s trial testimony, is forthcoming.”  EPA reiterates that its position “is based on the specific evidence-base available for evaluating potential neurotoxic effects from exposure to fluoride from community water fluoridation programs as necessary to support a potential TSCA section 6(a) rulemaking” and not, as alleged by plaintiffs, “a broader policy shift.”
 
The court held a status conference on August 6, 2020, via Zoom.  The judge suggested that plaintiffs file a new petition and that he is holding the case open to allow them to do so.  The next status hearing will be held November 5, 2020.


 

This week's All Things Chemical™ Podcast will be of interest to readers of the TSCAblog™. A brief description of the episode written by Lynn L. Bergeson is below.

This week I sat down with Richard E. Engler, Ph.D., B&C’s Director of Chemistry, and all-around TSCA savant. Rich is an organic chemist and a 17-year veteran with the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics, where Rich managed the Green Chemistry Program and reviewed some 10,000 new chemical notifications.

Given all that is going on at EPA with implementing the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which extensively amended the Toxic Substances Control Act (TSCA), Rich and I discussed a wide range of ongoing and planned EPA initiatives.  These include EPA’s risk evaluations under TSCA Section 6, progress EPA has made in reviewing new chemicals and work that remains to be done, how EPA has responded to staff and resources challenges, key ongoing litigations challenging various aspects of TSCA implementation, and what to look for as we approach the end of the calendar year and the impact of the pending National election.  Rich’s insights are always fascinating and enlightening, and our conversation is sparkling and entertaining.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.


 
By Lynn L. Bergeson and Carla N. Hutton
 
On August 3, 2020, the U.S. Environmental Protection Agency (EPA) announced $3,980,782 in funding to five academic research teams to develop New Approach Methods (NAM) for evaluating chemical toxicokinetics.  According to EPA, compared to traditional animal testing, NAMs allow researchers better to predict potential hazards for risk assessment purposes without the use of traditional methods that rely on animal testing.  EPA is providing a grant of up to $800,000 to each research team through its Science to Achieve Results (STAR) Program.  EPA states that the projects will address gaps in ways to obtain data for informing chemical toxicokinetics and exposure-related factors not currently considered.  The five recipients include:
  • Purdue University to create an integrated blood brain barrier computer model to help determine if a chemical may cause neurotoxicity;
     
  • Texas A&M University to help integrate different types of chemical safety testing for more robust results;
     
  • University of Nevada to develop better estimations of the bioavailability of chemicals to assess the significance of public exposure;
     
  • Vanderbilt University to work on methods to refine organ-on-chip devices for chemical testing; and
     
  • Woods Hole Oceanographic Institution to determine how zebrafish metabolism can be better correlated to the human metabolism to improve models for chemical toxicity testing.

 

By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our March 23, 2020, memorandum, on March 18, 2020, a coalition of non-governmental organizations (NGO) filed suit in the U.S. District Court for the District of Columbia against the U.S. Environmental Protection Agency (EPA), claiming that EPA fails to disclose information about new chemical substances under the Toxic Substances Control Act (TSCA).  Environmental Defense Fund v. Wheeler, No. 1:20-cv-762.  On July 27, 2020, the parties submitted a joint case management statement.  According to the statement, the parties agree that the case can be resolved by motions for summary judgment and that there is no need for a trial.  The parties state that they disagree about whether administrative records exist and the availability and scope of discovery, however.  Resolving these questions will implicate the timing for any discovery, the appropriate deadline for final amended pleadings, and the appropriate schedule for summary judgment briefing.  The parties note that they are currently discussing options to resolve as many of these questions as possible and that they believe successfully resolving them could reduce the number and complexity of procedural issues before the court.  In particular, according to the statement, the parties are discussing options to narrow the scope of factual and legal issues presented, which may minimize the potential for future disputes over the availability and scope of discovery.  The parties propose to submit an updated case management statement no later than August 31, 2020.


 

By Lynn L. Bergeson and Carla N. Hutton
 

The U.S. Environmental Protection Agency (EPA) is accepting public comments on the experts under consideration for membership on the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC).  Biographies of the candidates are available in Docket ID EPA-HQ-OPPT-2020-0135.  Comments are due August 21, 2020.  EPA states that it will use public comments to assist it in selecting multiple members of SACC over the next year.  EPA expects to appoint approximately 15 members to SACC by March 2021.

Tags: SAAC, Comments

 

This week's All Things Chemical™ Podcast will be of interest to readers of the TSCAblog™. A brief description of the episode written by Lynn L. Bergeson is below.

This week I sat down with Congressman John M. Shimkus, a Member of the United States House of Representatives for the 15th District of Illinois.  As listeners of the podcast know well, Congressman Shimkus is a senior Member of the House Energy and Commerce Committee.  In this capacity, Congressman Shimkus has become a rock star in the industrial chemical community, given his tireless efforts to modernize the Toxic Substances Control Act (TSCA) , which of course resulted in passage four years ago of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg).

Given Congressman Shimkus’s extensive involvement in and personal commitment to reforming TSCA, our conversation focused on the efforts that have been under way since June 2016 to implement the massive and complicated new law.  We address many aspects of Lautenberg’s implementation, not just by the U.S. Environmental Protection Agency (EPA), but also efforts under way by other industrial chemical stakeholders, including industry, non-government organizations (NGOs), states, and the courts.  We discuss the many, many rulemakings EPA has issued since 2016 and survey the next leg of EPA’s journey to implement the new law over the next 12 to 24 months, which will be extremely busy.  Congressman Shimkus is as passionate today as he was four years ago about chemical safety, as you will hear in this recording.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.


 

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.

 
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