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
 
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.”


 

By Lynn L. Bergeson and Carla N. Hutton

On July 16, 2020, a coalition of non-governmental organizations (NGO) filed a petition in the U.S. Court of Appeals for the Ninth Circuit, challenging the U.S. Environmental Protection Agency’s (EPA) final risk evaluation for methylene chloride.  The NGOs seek review of EPA’s determination “that the chemical methylene chloride does not present an unreasonable risk of injury to health or the environment under certain conditions of use” and its decision not to consider “certain uses and pathways through which members of Petitioners are exposed and face risks of exposure to methylene chloride.”  The coalition includes the Neighbors for Environmental Justice; the New Jersey Work Environment Council; Sierra Club; the United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Workers International Union, AFL-CIO; and the Natural Resources Defense Council.  According to Earthjustice’s July 16, 2020, press release, the NGOs “represent workers who manufacture and use methylene chloride and communities that are exposed to methylene chlorid[]e from their air and water.”

As reported in our June 25, 2020, memorandum, “Final Risk Evaluation for Methylene Chloride Is First Completed under Lautenberg Act Amendments,” after evaluating 53 conditions of use of methylene chloride, EPA determined that 47 conditions of use present an unreasonable risk of injury to health, while six do not present an unreasonable risk.  EPA also determined that methylene chloride does not present an unreasonable risk to the environment under any conditions of use.  Release of a final risk evaluation is the last step in the Toxic Substances Control Act (TSCA) Section 6(b) process and will guide EPA’s efforts in applying Section 6(a) to reduce human exposure to methylene chloride “so that the chemical . . . no longer presents such risk.”  EPA “will now begin the process of developing ways to address the unreasonable risks identified and has up to one year to propose and take public comments on any risk management actions.”  EPA could prohibit or limit the manufacture, processing, distribution in commerce, use, or disposal of methylene chloride.  Any regulatory action will include opportunities for public comment.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On June 30, 2020, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) released a report on its audit to determine whether the Safer Choice program effectively meets its goals and whether the program achieves quality standards through its product qualification, renewal, and required audit processes.  OIG states that EPA’s Safer Choice program does not have formal goals included in the fiscal year (FY) 2018-2022 EPA Strategic Plan, and the program has not reported results for FYs 2018-2019.  The program does have internal, non-outcome-oriented goals, however, which it is generally achieving.  The Safer Choice program’s goal is to add 200 Safer Choice products to the program and 25 chemicals to the Safer Chemical Ingredients List each year.  According to OIG, in FY 2019, EPA added 265 products and 24 chemicals.  OIG states that by not including formal goals for the Safer Choice program in EPA reports while continuing to receive Congressional funding and support, EPA limits not only accountability to Congress and the public, but also the extent that the program can use performance management information to make policy, budget, and management decisions.  OIG notes that the Safer Choice program has general controls in place for the required Safer Choice audit process, and EPA reviews audit summaries and corrective actions provided by third-party profilers (TPP).  EPA does not routinely review all supporting documentation, however, relying on TPPs to review and retain these documents.  Additionally, the Safer Choice program does not have procedures in place to conduct any formal performance reviews of TPPs or oversight reviews of TPP partner audits.  According to OIG, without periodic audit oversight, including full reviews of supporting documents and formal performance reviews of TPPs, EPA risks approving products that do not comply with the Safer Choice Standard.  OIG recommends that the Assistant Administrator for Chemical Safety and Pollution Prevention develop and publish adequate Safer Choice program goals and performance measures, establish and implement procedures for formal audit oversight of TPPs, amend its memorandums of understanding with TPPs to require performance reviews conducted by EPA, and collect and document TPP audit supporting information.


 

On June 24, 2020, Bergeson & Campbell, P.C. (B&C®), The Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health presented “TSCA Reform -- Four Years Later.”  A full recording of the seminar, including a keynote address by Alexandra Dapolito Dunn, Assistant Administrator, Office of Chemical Safety and Pollution Prevention, U.S. Environmental Protection Agency (EPA), and comments by the Hon. John Shimkus U.S. Representative, 15th District of Illinois, is available to watch now.
 
This complimentary all-day virtual seminar marked the fourth Toxic Substances Control Act (TSCA) Annual Conference, with top EPA officials and industry leaders reflecting on the accomplishments and challenges since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today. Panelists covered “TSCA Implementation: Where Are We Now?,” “Science Policy Issues,” and “Regulatory and Policy Issues” while offering unique insights into the decision-making process of EPA.
 
Building on the timely information shared during this event, B&C’s All Things Chemical ™ podcast has released an exclusive interview with Alexandra Dunn focusing on the current state of TSCA, “TSCA at Four — A Conversation with Alexandra Dunn, OCSPP AA.” Lynn L. Bergeson and Alexandra Dunn focused their discussion on the implementation of the amendments to TSCA, which Congress enacted in 2016.  As pollution prevention is an integral part of EPA’s mission, this episode also focuses on initiatives under way to introduce safer and greener chemicals.  Finally, the discussion includes a look ahead to what is on EPA’s agenda for the remainder of the year, which promises to be extraordinarily busy.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On June 24, 2020, the U.S. Environmental Protection Agency (EPA) released a New Approach Methods (NAM) Work Plan that will “serve[] as a roadmap for meeting its animal testing reduction goals set forth in Administrator Andrew Wheeler’s 2019 Directive.”  According to EPA’s June 24, 2020, press release, the Work Plan describes how EPA plans to develop, test, and apply chemical safety testing approaches that reduce or replace the use of animals.  EPA states that 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.  The objectives of the Work Plan include:

  • Evaluating regulatory flexibility for the use of NAMs;
     
  • Establishing baselines and metrics for assessing progress;
     
  • Developing NAMs that fill critical information gaps;
     
  • Establishing scientific confidence in NAMs;
     
  • Demonstrating NAMs application to regulatory decisions; and
     
  • Engaging with stakeholders to incorporates their knowledge and address their concerns regarding EPA’s phaseout of mammalian testing.

EPA states that the Work Plan will evolve as EPA’s knowledge and experience grow and as outside experts offer their perspectives and contributions.  EPA will regularly review the Work Plan to ensure that the efforts involved provide the best path to success.  More information on the 2019 directive to prioritize efforts to reduce animal testing is available in our September 11, 2019, blog item, “EPA Administrator Signs Directive Intended to Reduce Animal Testing, Awards $4.25 Million for Research on Alternative Methods to Animal Testing.”
 


 
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