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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 Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) granted on October 6, 2020, a manufacturer request for a risk evaluation of octamethylcyclotetra-siloxane (D4), a chemical used to make other silicone chemicals and as an ingredient in some personal care products.  Through the American Chemistry Council’s Silicones Environmental, Health, and Safety Center, Dow Silicones Corporation, Elkem Silicones USA Corporation, Evonik Corporation, Momentive Performance Materials, Shin-Etsu Silicones of America, Inc., and Wacker Chemical Corporation requested a risk evaluation of D4 pursuant to Section 6 of the Toxic Substances Control Act (TSCA).  For manufacturer-requested risk evaluations under TSCA Section 6, the manufacturers requesting the risk evaluation are responsible for payment of the associated fees.  The fee for a manufacturer-requested risk evaluation of a chemical included in the 2014 update to the TSCA Work Plan is 50 percent of total actual costs, with a $1,250,000 initial payment.  D4 is included in the 2014 update to the TSCA Work Plan.  EPA notes that if the request is not withdrawn within 30 days, D4 will enter the TSCA risk evaluation process.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) is accepting public comments for all candidates under consideration for membership on the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC).  Biographies for all candidates are available in Docket ID EPA-HQ-OPPT-2020-0135.  When providing comments, EPA states that stakeholders should not submit electronically any information considered to be confidential business information (CBI) or other information whose disclosure is restricted by statute.  Comments are due October 30, 2020.  EPA will use public comments to assist in selecting multiple members of the SACC over the next year. 
 
EPA anticipates appointing approximately 15 members to the SACC by March 2021.  EPA notes that current SACC members are eligible for reappointment during this period.  Therefore, the appointments completed by March 2021 may include a mix of newly appointed and reappointed members.


 

By Lynn L. Bergeson and Carla N. Hutton

On September 24, 2020, the U.S. Environmental Protection Agency (EPA) published the final risk evaluation for cyclic aliphatic bromide cluster (HBCD).  EPA found unreasonable risks to the environment from six out of 12 conditions of use and unreasonable risks to workers and occupational non-users (ONU) from the use and disposal of HBCD in building and construction materials.  EPA found no unreasonable risks to the general population and no unreasonable risks to consumers.  EPA’s next step in the process required by the Toxic Substances Control Act (TSCA) is to develop a plan to reduce or eliminate the unreasonable risks found in the final risk evaluation.  EPA states that it “is moving immediately to risk management for this chemical and will work as quickly as possible to propose and finalize actions to protect workers, occupational non-users, and the environment.”  EPA states that the action it could take to address these risks includes regulating how HBCD is used or limiting or prohibiting the manufacture, processing, distribution in the marketplace, use, or disposal of HBCD, as applicable.  As with any chemical product, EPA “strongly recommends that users of products containing HBCD continue to carefully follow all instructions on the product’s label and safety data sheet.”  EPA notes that this is the third final risk evaluation that it has issued and that it plans to issue the seven remaining final risk evaluations by the end of 2020.  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 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
 
On August 26, 2020, the U.S. Environmental Protection Agency (EPA) released an interim final list of businesses subject to fees for the 20 chemicals designated as high priority for risk evaluation under the Toxic Substances Control Act (TSCA).  EPA notes that the interim list is an updated version of the preliminary list released in January 2020.  According to EPA, making the interim final list available now gives businesses and other stakeholders an opportunity to review the list for accuracy and provides time for businesses to engage in initial outreach regarding the formation of consortia to share in fee payments.  As reported in our January 29, 2020, blog item, EPA published a Federal Register notice on January 27, 2020, identifying the preliminary lists of manufacturers (including importers) of the 20 chemical substances that EPA designated as high-priority substances for risk evaluation and for which fees will be charged.  85 Fed. Reg. 4661.  During the comment period, manufacturers (including importers) were required to self-identify as manufacturers of a high-priority substance irrespective of whether they are included on the preliminary lists identified by EPA.  EPA used this information, along with feedback received during the public comment period, to develop the interim final list.
 
EPA states that it will publish the final list of businesses subject to fees for the 20 high-priority chemicals concurrently with the release of the final scope documents for these chemicals.  Companies on the final list are subject to a portion of the TSCA fee for these risk evaluations and have 60 days to notify EPA of the formation of consortia.  According to EPA, it plans to begin invoicing for the fees after those 60 days have passed.  Due to the public health emergency, EPA states that it is exploring options for payment flexibilities.  Information on forming a consortium is available in our March 2, 2020, memorandum, “The Essential Value of Forming TSCA Consortia.”


 

By Lynn L. Bergeson and Carla N. Hutton

Jeff Morris, former Director of the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT), wrote a column published on August 18, 2020, by Chemical Watch.  In the column, “Expert Focus:  Community-based exposures and susceptibilities -- a social justice challenge for TSCA implementation,” Morris discusses how risk evaluations conducted under the Toxic Substances Control Act (TSCA) provide an opportunity to address community exposures and susceptibilities that are not otherwise covered in assumptions made about exposures in the general population.  Morris proposes ways that TSCA stakeholders can take “leadership roles in discussion, and action, on understanding potential exposures and susceptibilities of communities near chemical facilities and, where they exist, how they can be incorporated into TSCA risk evaluations.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
On August 17, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) published a report entitled Lack of Planning Risks EPA’s Ability to Meet Toxic Substances Control Act Deadlines.  OIG conducted the audit to determine whether EPA met the deadlines already imposed by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) in 2016, which amended the Toxic Substances Control Act (TSCA), and has the staff, resources, and management controls in place to meet future statutory deadlines.  The Lautenberg Act required EPA to develop new rules for chemical prioritization for risk evaluation and risk evaluation for existing chemicals and to review all new chemical submissions and make a regulatory determination.  OIG found that while EPA met several of its TSCA deadlines, it did not complete all ten required existing chemical risk evaluations by the June 19, 2020, deadline.  OIG notes that because of statutory requirements, the number of required existing chemical risk evaluations doubled at the end of 2019, “risking the EPA’s ability to meet TSCA deadlines.”
 
OIG states that EPA’s ability to assess its TSCA workload -- and subsequently estimate the workforce levels necessary to achieve that workload -- “is critically important.”  OIG notes that the Office of Pollution Prevention and Toxics (OPPT) has not publicly identified the additional staff and resources it needs to accomplish all mandated TSCA requirements.  According to OIG, “OPPT’s resource planning is hindered by not complying with the U.S. Office of Personnel Management regulations, which requires developing a workforce plan to manage current and future workforce needs.”
 
OIG states that EPA’s program offices have not conducted a systematic workload analysis or identified workforce needs for budget justification purposes since 1987 and that this is also true for OPPT, which is responsible for implementing the TSCA amendments.  According to OIG, though OPPT expects to hire more staff members to implement the TSCA amendments in fiscal year (FY) 2020, OPPT “lacks a workforce-and-workload analysis to successfully implement and meet the 2016 TSCA deadlines.”  Additionally, OIG states, EPA’s annual plans for risk evaluations “were neither done in a timely manner nor met the statutory requirements to identify the resources needed to initiate or complete the risk evaluations for the year.”
 
OIG recommends that the assistant administrator for Chemical Safety and Pollution Prevention:  (1) publish the annual existing chemical plan including the anticipated implementation efforts and required resources; (2) conduct a workforce analysis to assess OPPT’s capability to implement the TSCA amendments; and (3) specify what skill gaps must be filled in FY 2021 to meet the TSCA requirements.  According to OIG, EPA “provided acceptable corrective actions and estimated milestone dates for all recommendations.” OIG “consider[s] these recommendations resolved with corrective actions pending.”
 


 

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.”


 
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