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

After reading the article below by Jeffery Morris, former Director of the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT), we were inspired to post it.  We appreciate having the opportunity to share his analysis with our audience.

TSCA as a Gap-Filling Statute:  Potentially Exposed and Susceptible Subpopulations

By Jeffery Morris, PhD

In its response to public comments on the scope documents for its next twenty chemical risk evaluations conducted under the Toxic Substances Control Act (TSCA), the US Environmental Protection Agency (EPA) has asserted that TSCA is a “gap-filling statute” for the regulation of chemical substances in the United States (US EPA, Summary of Public Comments Received on the Draft Scopes of the Risk Evaluations for Twenty Chemical Substances Under the Toxic Substances Control Act (TSCA), August 2020, p. 13).  This assertion relates to the regulatory nexus between TSCA and other federal statutes.  At issue regarding regulatory nexus is whether TSCA’s role is to:  (1) fill gaps where issues are not addressed by other laws that regulate chemicals1, (2) serve as the nation’s primary and preeminent statute for chemicals, or (3) operate somewhere between these two positions.  Inherent in the TSCA-as-gap-filler position is the view that federal laws should work together to advance the public welfare, and that different environmental statutes have their own strengths in how they govern the impact of chemicals on people and the environment.

TSCA requires the consideration of potentially exposed or susceptible subpopulations in the EPA’s evaluation of chemicals.  While TSCA is not the only environmental law with provisions for susceptible or vulnerable subpopulations, the direct, repeated emphasis across multiple sections of the law that the EPA consider potentially exposed or susceptible subpopulations may be unique in US environmental law.  Therefore, how the EPA meets this requirement with respect to other laws’ treatment of such populations is an important consideration for regulatory nexus.  Key questions regarding regulatory nexus and TSCA’s role are how to go about identifying whether other statutes leave gaps in this area for TSCA to fill and if they do, how those gaps should be filled in the EPA’s chemical evaluations.

The recently released final scope documents and the accompanying response-to-comments document do not fully answer these questions, including regarding comments that have been raised about how the EPA will apply exposure and susceptibility considerations to people living in communities located near high concentrations of chemicals-related activity.  My hope is that exploring these questions now can help inform a path forward for further addressing comments the EPA has received on potentially exposed or susceptible subpopulations as the twenty draft risk evaluations are developed, as well as in scope documents for future chemicals brought into the TSCA prioritization process.

In its response to scope document comments, the EPA makes two important statements regarding the regulatory nexus issue as applied to potentially exposed or susceptible subpopulations.  The first, on page 13, is that “EPA believes that coordinated action on exposure pathways and risks addressed by other EPA-administered statutes and regulatory programs is consistent with statutory text and legislative history, particularly as they pertain to TSCA’s function as a ‘gap-filling’ statute ….”  In the second statement, also on page 13, the EPA adds that “[t]o the extent that specific exposure pathways are not under the jurisdiction of other EPA-administered statutes and associated regulatory programs, EPA plans to evaluate those exposures in the risk evaluations for the individual substances.”

The first statement’s focus on “coordinated action” between laws and regulations with respect to chemical evaluation and management is a crucial consideration for regulatory nexus.  Coordination by the EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP), which administers TSCA, with other EPA offices that manage statutes that address chemicals, as well as with other federal agencies that implement laws impacting chemicals, is good government practice.  What is missing from the final scope documents, and therefore would be a valuable addition to the chemical-specific dockets, is a detailed description of the type of coordination cited in the response to comments.  Ideally, this description would appear in the scope documents, but for these twenty chemicals an addition to the dockets would be helpful.  For example, the EPA could strengthen its explanation of whether potential exposures or susceptibilities are based on geography (e.g., exposures are higher in a particular location), biology (e.g., a particular population has a genetic or otherwise biologically based predisposition to suffer adverse effects from exposure to a chemical), or cultural/societal factors (e.g., a cultural or community practice results in exposure potential greater than in the general population, or an attribute of the subpopulation’s location in society, such as having low income or poor access to health care, creates susceptibilities to adverse effects from chemical exposure).

Because some comments on community exposures refer specifically to 1,3-butadiene, it is a useful example to illustrate the challenges and opportunities presented by the coordination the EPA is conducting within the regulatory nexus construct; it also can illustrate what I mean by a detailed description of cross-office coordination on potentially exposed or susceptible subpopulations.  This example looks at just one of 1,3-butadiene’s uses:  in the production of tires.  Under its Clean Air Act (CAA) authority, the EPA’s Office of Air and Radiation (OAR) conducted a Residual Risk Assessment for the Rubber Tire Manufacturing Source Category in Support of the 2020 Risk and Technology Review Final Rule (EPA-HQ-OAR-2019-0392-0047, February 2020) that includes 1,3-butadiene within this source category, among numerous other chemical substances designated as hazardous air pollutants (HAP).  This assessment supports a July 24, 2020, final rule, National Emission Standards for Hazardous Air Pollutants: Rubber Tire Manufacturing Residual Risk and Technology Review (EPA-HQ-OAR-2019-0392; FRL 10008-48-OAR, 85 FR 44752, July 24, 2020).

The coordination challenge, therefore, is to crosswalk the CAA review, which covers numerous HAPs within one sector, with a TSCA risk evaluation covering the conditions of use of a single HAP chemical across multiple sectors.  On page 49 of the 1,3-butadiene TSCA scope document, the EPA states that air emission pathways are covered under the CAA (Final Scope of the Risk Evaluation for 1,3-Butadiene, EPA Document # EPA-740-R-20-011, August 2020).  It would be useful for the 1,3-butadiene record to include a table and/or narrative that describes how, for its TSCA coordination on the consideration of potentially exposed or susceptible subpopulations, OCSPP evaluated the 1,3-butadiene conditions of use against the respective source category-based and any other analyses conducted by OAR that included 1,3-butadiene.  Such a crosswalk could serve as a best practice for application of regulatory nexus analysis in the implementation of TSCA.  It would also aid in transparency to the public around a very complex but important concept:  that although different environmental statutes may use different approaches (e.g., sector or source category versus individual chemical analysis), it is possible to coordinate their respective contributions to chemical evaluation and management so that, if gaps exist, TSCA can play its appropriate role in health and environmental protection.

For instance, OAR’s 2020 final rule states that “the percentage of the population potentially impacted by Rubber Tire Manufacturing emissions is greater than its corresponding nationwide percentage for: African Americans (25 percent for the source category compared to 12 percent nationwide) and below the poverty level (21 percent for the source category compared to 14 percent nationwide)” (page 44759).  Strong coordination between TSCA and the CAA would suggest that such information obtained through CAA activities would be helpful to OCSPP in determining how to address the “potentially exposed or susceptible subpopulations” considerations required under TSCA section 6, including as they may apply to TSCA’s gap-filler role in addressing comments to the 1,3-butadiene scope document concerning disproportionate exposure to communities located near high concentrations of chemicals-related activity.

This consideration leads to the EPA’s statement in its response-to-comments document that where there is not overlap with another regulatory jurisdiction, the EPA will evaluate the exposures.  Using the above TSCA-CAA coordination example for 1,3-butadiene, a question for OCSPP could be whether the TSCA requirement that the EPA consider potentially exposed or susceptible subpopulations in its risk evaluations is covered by the work done by OAR on 1,3-butadiene, specifically with respect to commenters’ input on community-based impacts.  One would assume “covered” to mean that this particular aspect of TSCA’s potentially exposed or susceptible subpopulations requirement has been evaluated and addressed in OAR’s CAA activities, and therefore can be excluded from the 1,3-butadiene risk evaluation.  However, if the CAA has not addressed this particular TSCA requirement in a manner or to an extent intended by the best read of TSCA’s language regarding the consideration of those potentially exposed or susceptible subpopulations in a particular chemical risk evaluation, then there exists a gap that TSCA, as a gap-filling statute, should address.

The manner in which a TSCA risk evaluation fills any identified gaps is also important.  This again will require careful and transparent coordination and analysis between statutes.  In its chemical risk evaluations, EPA would presumably want to fill gaps in ways that meet the specific requirements of TSCA for potentially exposed or susceptible subpopulations, without doing so in a manner that is at odds with other statutes’ treatment of a chemical substance under TSCA evaluation.  Not only would this careful gap filling be in general sound government practice, but it also would help avoid difficulties if the risk evaluation identifies unreasonable risks that the EPA determines, under TSCA section 9, should be addressed under a law other than TSCA.

The 1,3-butadiene example shows how greater explanation, preferably in scoping documents, on how the EPA coordinates among its offices and other agencies to make regulatory nexus decisions for TSCA risk evaluations can not only provide greater transparency to the public on individual chemical evaluations, but also can inform broader discussions on regulatory nexus by showing how such coordination can identify gaps that TSCA is best situated to fill.  For some chemicals, it may be the case that other statutes have already adequately assessed the risks to potentially exposed or susceptible subpopulations, obviating the need for additional analysis in a TSCA risk evaluation.  However, the mere existence of another statute with jurisdiction over a particular environmental pathway or human exposure scenario for a chemical substance subject to TSCA review should not lead to an a priori assumption that there is not an evaluation gap for TSCA to fill.  Any assumptions about other statutes’ coverage of TSCA’s chemical evaluation requirements should be explored, tested, and fully described in TSCA chemical scope documents or elsewhere in the risk evaluation record.  This is particularly important with potentially exposed or susceptible subpopulations, given TSCA’s unique approach to requiring their consideration in chemical prioritization, evaluation, and management.  I would argue that a good starting point for articulating TSCA’s gap-filling role is in the application of these requirements to people living near high concentrations of chemicals-related activity.

1  By “chemicals” I refer in this article to chemicals regulated under TSCA, and not to chemicals that are regulated under other federal statutes, such as pesticides, drugs, and food additives.


 

By Christopher R. Blunck and Lynn L. Bergeson

In a letter dated July 28, 2020, the U.S. Environmental Protection Agency (EPA) acknowledged the receipt of a Toxic Substances Control Act (TSCA) Section 21 petition requesting EPA to “initiate a proceeding for the issuance of a risk management procedural rule under TSCA section 6” submitted on behalf of the National Association of Manufacturers, the American Coatings Association, the National Association of Home Builders, the Toy Association, and the U.S. Chamber of Commerce.  In the acknowledgement letter, EPA states that the request is not a valid petition under TSCA Section 21.  EPA goes on to state “[‌u]nder TSCA section 21, as it relates to TSCA section 6, any person may petition EPA to initiate a proceeding for the issuance, amendment, or repeal of a rule under TSCA section 6 imposing chemical-specific regulatory controls for setting forth facts showing such action is ‘necessary’” and that “Section 21 does not provide a means for petitioning EPA to initiate a procedural rule.”  The acknowledgement letter further states that “EPA will, however,  consider your request as a petition under the Administrative Procedure Act (APA) for the issuance of a procedural rule” and that the “petition is under review by the Office of Pollution Prevention and Toxics (OPPT), which is responsible for programs under TSCA.” 

As mentioned in our memorandum addressing the TSCA Section 21 petition, there are requirements under the APA that agencies respond to APA petitions for rulemakings within a reasonable time, that Petitioners are given prompt notice of a denial, and that a brief statement of the grounds for denial be included.  A denial of a petition under the APA may be judicially reviewed and set aside if determined to be “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on September 16, 2020, that it is inviting small businesses, governments, and not-for-profits to participate as Small Entity Representatives (SER) to provide advice and recommendations to two Small Business Advocacy Review (SBAR) Panels.  There will be one Panel for methylene chloride and one Panel for 1-bromopropane (1-BP).  According to EPA, each Panel will focus on EPA’s development of proposed rules to address unreasonable risks identified in EPA’s recently completed Toxic Substances Control Act (TSCA) risk evaluations for these chemicals.  As reported in our June 25, 2020, memorandum, and August 11, 2020, memorandum, EPA’s final risk evaluations showed unreasonable risks to workers and consumers under certain conditions of use.  EPA is now moving to the risk management step in the TSCA process by working to draft regulations to protect public health from the unreasonable risks identified in the final risk evaluations.
 
According to EPA, the Regulatory Flexibility Act requires agencies to establish an SBAR Panel for rules that may have a significant economic impact on a substantial number of small entities.  The SBAR Panels will include federal representatives from the Small Business Administration (SBA), the Office of Management and Budget (OMB), and EPA.  The SBAR Panels will select SERs to provide comments on behalf of their company, community, or organization and advise the Panel on the potential impacts of the proposed rule on small entities.  EPA states that it is seeking self-nominations directly from the small entities that may be subject to the rule requirements.  EPA notes that other representatives, such as trade associations that exclusively or at least primarily represent potentially regulated small entities, may also serve as SERs.  Self-nominations may be submitted online for the methylene chloride and 1-BP SBAR Panels and must be received by September 30, 2020.
 
EPA states that in addition to engaging with small businesses, it “is executing a robust outreach effort on risk management that includes one-on-one meetings with stakeholders and formal consultations with state and local governments, tribes, and environmental justice communities.”  EPA notes that there will also be an open public comment period on any draft risk management regulations.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) posted a September 2, 2020, blog item by Alexandra Dapolito Dunn, Assistant Administrator for the Office of Chemical Safety and Pollution Prevention, entitled “Advancing Chemical Safety by Listening to You.”  Dunn describes how EPA will move from risk evaluation to risk management.  As reported in our September 9, 2020, blog item, EPA will hold webinars on September 16 and September 30, 2020, on its final risk evaluations for methylene chloride and 1-bromopropane, as well as one-on-one meetings with stakeholders and formal consultations with state and local governments, tribes, environmental justice communities, and small businesses.  Dunn states that EPA will use these opportunities “to educate the public and our stakeholders on what we found in our final risk evaluations, the risk management process required by TSCA, which options are available to us for managing unreasonable risk, and what that means for all of you moving forward.”  EPA will also seek input on potential risk management approaches, their effectiveness, and any impacts those approaches might have on businesses.  According to Dunn, EPA will use this feedback to develop proposed regulations “that are both protective and practical.”  Dunn notes that there are several actions EPA can take to address the unreasonable risks it has found, “including banning or phasing out certain uses of a chemical, requiring warning labels and other special instructions on how a chemical can be used, recordkeeping/testing, and requiring manufacturers to notify distributors of any unreasonable risks.”  Dunn encourages stakeholders to take advantage of these engagement opportunities.  EPA is “relying on you to ask questions, raise concerns, bring things to our attention that we may not have considered, and to provide us with information we may not already have.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on September 8, 2020, a “broad public engagement and outreach effort” to discuss how EPA will approach the rulemaking process to address unreasonable risks found in final Toxic Substances Control Act (TSCA) chemical risk evaluations.  After issuing the first two final risk evaluations, methylene chloride and 1-bromopropane, EPA states that it “is moving into the risk management phase and is hosting a robust process to gain important feedback from stakeholders on the options for managing those risks.”  EPA will hold two public webinars to kick off this outreach effort:

  • The first webinar, scheduled for September 16, 2020, will feature a discussion of the findings from the final risk evaluation for methylene chloride.  More information on EPA’s final risk evaluation is available in our June 25, 2020, memorandum; and
  • The second webinar, scheduled for September 30, 2020, will include a discussion of the findings from the final risk evaluation for 1-bromopropane.  More information on EPA’s final risk evaluation is available in our August 11, 2020, memorandum.

According to EPA, each webinar will provide an overview of the TSCA risk management process and the tools available to manage the unreasonable risks.
 
EPA intends to schedule additional public webinars as it begins the risk management process for chemicals with unreasonable risks.  EPA states that it will also begin one-on-one meetings with stakeholders and formal consultations with state and local governments, tribes, environmental justice communities, and small businesses.  EPA notes that there will be an open public comment period on any draft risk management regulation.
 
According to EPA, there are several actions it can take under TSCA to address unreasonable risks, including banning a chemical; restricting the manufacturing, processing, distribution, or use; requiring warning labels/testing; and requiring manufacturers to notify distributors of any unreasonable risks. EPA has up to one year after issuing a final risk evaluation to propose and take public comments on any risk management actions.


 

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) published on August 11, 2020, its quarterly update of the Toxic Substances Control Act (TSCA) confidential business information (CBI) review statistics.  These data summarize the number of CBI cases under review and results of completed reviews through June 15, 2020:

CBI Review Statistics (cases received between June 22, 2016 and June 15, 2020)
Cases in which the specific chemical identity is subject to CBI review 3,326
Cases in which information other than the specific chemical identity is subject to CBI review 2,523
Cases in which both the specific chemical identity and information other than the specific chemical identity is subject to CBI review 734
Total cases subject to CBI review 6,583

 

Cases resulting in final CBI determinations
Cases with all CBI claims subject to review, approved 882
Cases with all CBI claims subject to review, denied 602
Cases with CBI claims subject to review, approved-in-part/denied-in-part 97
Total cases resulting in final CBI determinations 1,581

 

Cases reviewed with no final CBI determination necessary
Cases with all CBI claims screened and found to be exempt from review 1,078
Cases with all CBI claims withdrawn by submitter 430
Cases identified for CBI review, for which no determination required (e.g., in some instances, older EPA information systems do not specifically identify which information is claimed as CBI and upon review, it is determined that no claims require review) 1,500
Total cases reviewed/screened with no final CBI determination necessary 3,008

 

Cases currently undergoing CBI review
Cases currently undergoing CBI review 1,994

 
In August 2020, EPA published an updated list of cases with completed CBI reviews under TSCA Section 14.  The spreadsheet includes the results of completed CBI determinations and cases with approved claims for specific chemical identity for which unique identifiers have been assigned.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On August 12, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of the final risk evaluation for 1-bromopropane (1-BP).  85 Fed. Reg. 48687.  After evaluating 25 conditions of use, EPA determined that 16 present an unreasonable risk to workers, occupational non-users (ONU), consumers, and bystanders.  For those conditions of use for which EPA has found an unreasonable risk, EPA states that it must take regulatory action to address that unreasonable risk through risk management measures enumerated in the Toxic Substances Control Act (TSCA).  EPA has also determined that specific conditions of use do not present unreasonable risk of injury to health or the environment.  EPA notes that for those conditions of use for which EPA has found no unreasonable risk to health or the environment, its determination is a final agency action and is issued via order in the risk evaluation.  A detailed analysis and commentary is available in our August 11, 2020, memorandum, “EPA Publishes Final Risk Evaluation for 1-BP.”


 

By Lynn L. Bergeson, Carla N. Hutton, and Holly M. Williams

During the week of June 15, 2020, the U.S. District Court for the Northern District of California heard from the U.S. Environmental Protection Agency’s (EPA) final three witnesses:  Dr. Joyce Tsuji, Dr. Ellen Chang, and Dr. Tala Henry.  Food & Water Watch, Inc. v. EPA, Case No. 3:17-cv-02162-EMC.  Dr. Tsuji did not dispute that fluoride can be a neurotoxin at “high enough levels.”  Dr. Tsuji contended that the scientific literature remains too limited to establish linkage between fluoride and adverse health outcomes.  Dr. Chang testified on the application of systematic review to chemical usage, a process EPA explored at length with its first witness, Dr. Kris Thayer, as reported in our June 12, 2020, blog item.

Dr. Henry defended the EPA Office of Pollution Prevention and Toxics’ (OPPT) decision to deny plaintiffs’ Section 21 petition.  As Director of EPA's Risk Assessment Division, Dr. Henry expressed the view that “robust science” warranted rejection of the petition.  On June 17, 2020, plaintiffs called back Dr. Kathleen Thiessen as a rebuttal witness, who testified briefly in response to the criticism by EPA’s witnesses of plaintiffs’ methodology in studies mentioned earlier in the trial. After Dr. Thiessen’s testimony, the trial moved to closing arguments.

Plaintiffs’ closing argument asserted that EPA failed to quantify what fluoride levels were dangerous to humans.  District Judge Edward M. Chen interceded to inquire in this regard as tests showing neurotoxicity were well above the level in fluoridation chemicals introduced into water.  Plaintiffs argued the necessity of taking into account inter-species differences from animal testing, as well as human-to-human differences.  Plaintiffs stated that this lack of data seriously hinders determining at what level susceptibility can be found.

EPA responded in its closing that studies relied on by plaintiffs are limited by confounding variables, lack of comparison groups, and double-blind methodologies.  Additionally, EPA noted inconsistencies among the reports plaintiffs cited.  Judge Chen followed up with questions regarding the counter-intuitive findings of effects from fluoride exposure in adult rats but not infants and wanted to confirm if this was a byproduct of the quality of research.  EPA replied that there is insufficient evidence to defend an IQ-urine connection.  Judge Chen also asked if the court could find unreasonable risk from the chemical used by EPA without causation of neurological effects. EPA responded that the only standard provided in the Toxic Substances Control Act (TSCA) regarding unreasonable risk is that which results from an evaluation of that risk, not causation.

After hearing closing arguments, Judge Chen noted that the evidence presented by both parties was not confined to the administrative record and that he allowed both parties to use evidence that was available after plaintiffs filed their petition in 2016 Judge Chen asked plaintiffs and EPA to consider how to reach an agreement, including plaintiffs submitting a new petition or EPA reconsidering its denial of the petition.  Pending Judge Chen's request for additional briefing, there was no ruling on what could potentially be the first half of a bifurcated trial.  A status conference is tentatively scheduled for August 6, 2020, at 10:30 a.m. (PDT).


 

By Lynn L. Bergeson, Carla N. Hutton, and Holly M. Williams

The U.S. District Court for the Northern District of California began hearing oral arguments on June 8, 2020, in a 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.  The plaintiffs filed suit following the U.S. Environmental Protection Agency’s (EPA) denial of a TSCA Section 21 petition requesting it to exercise its Section 6 authority to prohibit the purposeful addition of fluoridation chemicals to U.S. water supplies.  On June 12, 2020, Dr. Kathleen M. Thiessen testified as the final witness for the plaintiffs’ case-in-chief regarding risk analysis to determine a level of fluoride that does not produce adverse effects.  Thiessen also testified about a study that found correlation between fluoride intake and diminished thyroid productivity.  EPA’s first witness, Dr. Kristina Thayer, clarified the types of experimental biases and processes to vet bodies of evidence.  Earlier in the week, plaintiffs’ expert witnesses summarized the scientific literature on the adverse effects of fluoride on children’s development, including lowered IQ.  The experts have cited both animal and human studies.  EPA has questioned them at length regarding the discrepancies between male and female test subjects, especially in relation to prenatal fluoride exposure.  EPA has argued that the data presented by plaintiffs suffers from inconsistencies, flawed methodologies, and biases.  The trial will resume on Monday, June 15, 2020.  Readers interested in watching the trial remotely can find scheduling and Zoom information here.


 
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