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 November 30, 2020, Bloomberg Law Environment & Energy Report published a Practitioner Insight column entitled “The Toxic Substances Control Act Under Biden:  Impact on Tribal, Fenceline Populations” by Jeffery Morris, former Director of the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) and founder of Jeff Morris Solutions LLC.  Morris examines how the Biden Administration could apply the Toxic Substances Control Act’s (TSCA) requirement to consider impacts on subpopulations in the evaluation of chemical risks.  Morris notes that fenceline communities and American Indian and Alaskan Natives (referred to as “tribes” in the article, “recognizing that not all native people are in federally recognized tribes”) have faced significant impacts from chemical exposure and should be priorities.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on November 10, 2020, that the Integrated Risk Information System (IRIS) Program released the ORD Staff Handbook for Developing IRIS Assessments (IRIS Handbook) for public comment.  EPA states that the IRIS Handbook provides operating procedures for developing IRIS assessments, including problem formulation approaches and methods for conducting systematic review, dose response analysis, and developing toxicity values.  The IRIS Handbook notes that it does not supersede existing EPA guidance and does not serve as guidance for other EPA programs.  EPA will publish a Federal Register notice announcing the beginning of a 90-day public comment period on the IRIS Handbook and on the draft charge questions for reviewers in advance of a National Academies of Sciences, Engineering, and Medicine (NASEM) peer review.  EPA will summarize comments received and provide them to the committee conducting the peer review.  EPA has posted a pre-publication version of the Federal Register notice.


 

By Lynn L. Bergeson and Carla N. Hutton

We are pleased to announce that the American Bar Association (ABA) Section of Environment, Energy, and Resources published an article written by Lynn L. Bergeson and Eve C. Gartner entitled “The essentials of TSCA practice” in the November/December 2020 issue of Trends.  According to the authors, legal practitioners should be aware of the commercial, legal, and reputational implications of the Toxic Substances Control Act (TSCA) as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act in 2016.  The authors state that TSCA’s expanded commercial reach “is an important, consequential, and growing practice area.”  The authors note that “[c]ommunity organizations representing populations at greater risk of harm from chemicals should also be aware that TSCA may offer much-needed protections.”


 

By Lynn L. Bergeson , Lisa M. Campbell, and Carla N. Hutton
 
Representatives Frank Pallone, Jr. (D-NJ), Chair of the House Committee on Energy and Commerce, and Jan Schakowsky (D-IL), Chair of the House Energy and Commerce Subcommittee on Consumer Protection and Commerce, wrote to Amazon Chief Executive Officer (CEO) and Chair Jeff Bezos on October 7, 2020, requesting that he launch an investigation into the safety of Amazon’s product line, AmazonBasics, and answer a series of questions pertaining to the company’s product safety and recall practices.  The Committee’s October 7, 2020, press release notes that the request comes after a CNN investigation found that many of AmazonBasics’ electronic products “have exploded, caught fire, sparked, melted, or otherwise created hazardous situations at rates well above comparable products.”  According to the press release, many of these products were never recalled and continue to be sold.
 
In addition to their request that Bezos initiate an investigation into the safety of AmazonBasics products, Pallone and Schakowsky also seek answers to a series of questions, including:

  • What Amazon-owned products are no longer for sale due at least in part to safety concerns?
     
  • What products -- both Amazon-owned and third party -- have been officially recalled?
     
  • What notification does Amazon provide to customers who have purchased products that are later recalled or found to be unsafe?
     
  • In addition to direct notification, what other kinds of consumer or public outreach does Amazon conduct to ensure consumers properly dispose of, repair, or replace an unsafe product?
     
  • How can consumers find information regarding recalled products? If information is not readily available, why not, and what plans exist to make it available?
     
  • How can consumers report product safety issues to Amazon?
     
  • How many staff does Amazon have devoted to ensuring that products sold on its platform follow all applicable laws and regulations, and that Amazon is in compliance with obligations to notify the U.S. Consumer Product Safety Commission (CPSC) when a product is suspected of being unsafe?

The letter requests a response no later than October 21, 2020.
 
The letter and request for answers to the questions noted above are another indication of the pressure certain Members in Congress are putting on Amazon to ensure the safety of the products the platform hosts.  Amazon is under increasing scrutiny by the U.S. Environmental Protection Agency (EPA) in this regard, as reported in our February 16, 2018, and June 17, 2020, blog items, and this Congressional inquiry seems more of the same.  These efforts will almost certainly cause more pressure on product manufacturers to ensure the products they offer for sale on Amazon are compliant.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) published on September 30, 2020, its audit of EPA’s Toxic Substances Control Act (TSCA) Service Fee Fund financial statements for the period from Inception (June 22, 2016) through September 30, 2018.  The Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) requires EPA to prepare and OIG to audit the TSCA Service Fee Fund financial statements each year.  OIG states that its primary objectives were to determine whether the financial statements were fairly stated in all material respects; EPA’s internal controls over financial reporting were in place; and EPA management complied with laws and regulations.  OIG notes that the TSCA Service Fee Fund has been designed to defray up to 25 percent of the costs associated with implementing key TSCA provisions.  According to OIG, EPA overstated expenses from other appropriations by $8.4 million.  OIG states it found that EPA made errors in multiple iterations of its calculation for expenses from other appropriations.  No significant matters involving compliance with applicable laws and regulations, contracts, and grant agreements came to OIG’s attention during the course of the audit.
 
OIG recommends that the chief financial officer:  (1) improve the management review process for calculating expenses from other appropriations to be consistent with EPA component financial statement audits and to ensure that costs support the TSCA Service Fee Fund activities; and (2) establish written policies and procedures so that expenses from other appropriations in component audits reflect actual costs.  According to OIG, EPA concurred with its recommendations and provided “acceptable corrective actions and estimated completion dates.”  OIG states that it considers the recommendations resolved with corrective actions pending.


 

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.


 
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