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 July 27, 2021, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) will hold a public meeting to engage with interested stakeholders on the development of a proposed rule for implementing a tiered data collection strategy to help inform EPA’s prioritization, risk evaluation, and risk management activities for chemical substances or mixtures under the Toxic Substances Control Act (TSCA). According to EPA, it currently primarily collects exposure-related data through the TSCA Chemical Data Reporting (CDR) process. EPA is interested in ensuring that data collection strategies provide information to meet better its basic chemical data needs, such as information related to exposure, health, and ecotoxicity. To this end, EPA states that it is exploring a data reporting rule that is tiered to specific stages of the TSCA existing chemicals program: identifying a pool of substances as potential candidates for prioritization; selecting candidate chemicals for and completing the prioritization process; and assessing high-priority substances through a robust risk evaluation, which may be followed by risk management actions (depending on the outcome of the risk evaluation). According to EPA, feedback from the public meeting and comments received will help inform its development of a proposed rule. The meeting will be held virtually via WebEx on July 27, 2021, from 1:00 to 3:00 p.m. (EDT). Those who would like to make a comment during the meeting must register by 6:00 p.m. EDT on July 22, 2021. Those who would like to participate in listen-only mode must register by 6:00 p.m. EDT on July 26, 2021. Written comments are due August 15, 2021.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on May 27, 2021, that it has invited environmental justice communities and stakeholders to participate in environmental justice consultations regarding the development of a proposed risk management action under Section 6(a) of the Toxic Substances Control Act (TSCA) to address unreasonable risks presented by N-methylpyrrolidone (NMP). EPA will hold two identical consultation webinars, one on July 7, 2021, and the other on July 13, 2021. Both sessions will provide an overview of the TSCA risk management requirements, the findings from the final risk evaluation, the tools available to manage the unreasonable risks from NMP, and an opportunity for EPA to obtain input on environmental justice concerns. The consultations are open to the public, and EPA is inviting national, local, and non-governmental organizations, communities, and other interested stakeholders to participate. Comments are due August 27, 2021.
 
EPA states that in addition to these environmental justice consultations, it is executing a “robust” outreach effort that includes consultations with small businesses, state and local governments, and tribes. There will also be an open public comment period on proposed risk management regulations. EPA notes that while outreach and stakeholder engagement on risk management activities for NMP move forward, it is “actively reviewing” the final risk evaluation to ensure it uses the best available science and protects human health and the environment, in accordance with the Executive Orders and other direction provided by the Biden-Harris Administration. EPA will keep stakeholders updated as it makes decisions and determines next steps.
 
More information on EPA’s final risk evaluation of NMP is available in our December 29, 2020, memorandum, “EPA Releases Final Chemical Risk Evaluation for NMP.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
On May 21, 2021, the U.S. Environmental Protection Agency (EPA) published its response to a portion of the petition it received February 8, 2021, from People for Protecting Peace River, Center for Biological Diversity, and 16 other organizations. 86 Fed. Reg. 27546. While the petition requested three actions related to the Toxic Substances Control Act (TSCA), EPA states that it has determined that only one of those actions is an appropriate request: a request to issue a test rule under TSCA requiring testing of phosphogypsum and process wastewater from phosphoric acid production. According to the notice, EPA is treating the other portions of the petition involving TSCA as a petition under the Administrative Procedure Act (APA); those other portions request EPA to initiate the prioritization process for designating phosphogypsum and process wastewater as high-priority substances for risk evaluation and to make a determination by rule under TSCA that the use of phosphogypsum in road construction is a significant new use. Therefore, the notice does not provide EPA’s response to these two TSCA-requested actions. Also, it does not address the petitioners’ requests under the Resource Conservation and Recovery Act (RCRA). EPA states that “[a]fter careful consideration,” it has denied the TSCA Section 21 portion of the petition for the following reasons:

  • Request for prioritization under TSCA Section 6 and related testing under TSCA Section 4(a)(2)(B): Because TSCA Section 21 does not provide an avenue for petitioners to request the initiation of the prioritization process for phosphogypsum and process wastewater, EPA is treating this portion of the request as a petition for action under the APA. Petitioners assert that “should EPA initiate prioritization but find that the development of new information is necessary to finalize a prioritization decision for phosphogypsum and process wastewater, EPA should exercise its authority under section 4(a)(2)(B) to obtain that information and establish priority.” EPA states that because it is not addressing the request for prioritization and has not otherwise initiated prioritization on phosphogypsum or process wastewater, it is not in a position to exercise its authority under TSCA Section 4(a)(2)(B) in the manner and for the reason described by petitioners.
  • Request for significant new use rule (SNUR) under TSCA Section 5: TSCA Section 21 does not provide for the submission of a petition seeking the initiation of a rule under TSCA Section 5. EPA states that SNURs are issued under the authority of TSCA Section 5(a)(2). Since TSCA Section 21 does not provide an avenue for petitioners to request the initiation of a proceeding to make a determination by rule under TSCA Section 5(a), EPA is treating this portion of the request as a petition for action under the APA.
  • Request for issuance of a test rule under TSCA Section 4(a)(1)(A): According to the notice, TSCA Section 21 does provide for the submission of a petition seeking issuance of a test rule under TSCA Section 4(a)(1)(A). EPA states that it finds that the petitioners have not met their burden as defined in TSCA Sections 4(a)(1)(A) and 21(b)(1) because the petitioners have not provided the facts necessary to determine for phosphogypsum and process wastewater that existing information and experience are insufficient and testing with respect to such effects is necessary to develop such information.

More information about the petition is available in our March 12, 2021, memorandum, “EPA Receives Petition Seeking RCRA and TSCA Regulatory Action for Phosphogypsum and Process Wastewater.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
On May 18, 2021, the U.S. Environmental Protection Agency (EPA) invited environmental justice communities and stakeholders to participate in environmental justice consultations regarding the development of proposed risk management actions under Section 6(a) of the Toxic Substances Control Act (TSCA) to address unreasonable risks presented by trichloroethylene (TCE) and perchloroethylene (PCE). EPA will hold two identical consultation webinars, one on June 16, 2021, and the other on July 6, 2021. EPA states that both sessions will provide an overview of the TSCA risk management requirements, the findings from the final risk evaluations, the tools available to manage the unreasonable risks from TCE and PCE, and an opportunity for EPA to obtain input on environmental justice concerns. The consultations are open to the public, and EPA invites national, local, and non-governmental organizations, communities, and other interested stakeholders to participate. Comments are due August 20, 2021.
 
In addition to these environmental justice consultations, EPA states that it is executing a “robust outreach effort” that includes consultations with small businesses, state and local governments, and tribes. There will also be an open public comment period on proposed risk management regulations.
 
While outreach and stakeholder engagement on risk management activities for TCE and PCE will continue to move forward, EPA is actively reviewing final risk evaluations to ensure they use the best available science and protect human health and the environment, in accordance with Executive Orders and other direction provided by the Biden-Harris Administration. EPA states that it will keep stakeholders updated as it makes decisions and determines next steps. More information on EPA’s final risk evaluations for TCE is available in our November 24, 2020, memorandum and on EPA’s final risk evaluation for PCE in our December 17, 2020, memorandum.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on May 7, 2021, that it is partnering with the People for the Ethical Treatment of Animals (PETA) Science Consortium International, Unilever, and Syngenta on a three-part virtual workshop series on “Using In Silico and In Vitro Approaches for Next Generation Risk Assessment of Potential Respiratory Toxicants.”  EPA states that this webinar series supports its commitment “to collaborate with partners and stakeholders to reduce, refine, or replace vertebrate animal testing, as outlined in the Strategic Plan to Promote the Development and Implementation of Alternative Test Methods within the [Toxic Substances Control Act (TSCA)] Program.”  The webinars will take place on May 19, May 26, and June 2, 2021, from 8:00 a.m. to 10:00 a.m. (EDT).  Each webinar will feature three speakers.  The meeting agenda and registration information are available at www.thepsci.eu/inhalation-webinars.  Attendees must register for each of the three webinars individually.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on April 1, 2021, that it is extending the public comment period for a manufacturer-requested risk evaluation of octahydro-tetramethyl-naphthalenyl-ethanone (OTNE), a category of chemical substances consisting of four inseparable individual isomers.  As reported in our February 18, 2021, blog item, EPA notes that two chemicals in the OTNE category are considered persistent, bioaccumulative, and toxic (PBT) chemicals under the Toxic Substances Control Act (TSCA), “meaning they are toxic, can remain in the environment for long periods of time, and can build up or accumulate in the body.”  EPA “welcomes all public comments,” particularly on the following:

  • Any information not included in the manufacturer request that commenters believe EPA would need to conduct a risk evaluation;
  • Additional conditions of use EPA is proposing to include in the risk evaluation; and
  • Information on conditions of use not included in the manufacturer request or in the additional conditions of use EPA proposes to include in the risk evaluation, specifically the inclusion of any additional conditions of use and potentially exposed or susceptible subpopulations.  EPA states that it “is in the process of broadly re-examining how it intends to implement these and other provisions of the amended [TSCA] including determining how new executive orders will be addressed.  This process would benefit greatly from stakeholder feedback.”

Comments were due April 5, 2021, but EPA is extending the comment period an additional 30 days.  After the comment period closes, EPA will review the comments and either grant or deny the request to conduct a risk evaluation within 60 days.  If EPA grants the request, the manufacturers would be responsible for half the cost of the risk evaluation.  International Flavors and Fragrances, Inc., Privi Organics USA Corporation, and DRT America, Inc. formally requested the risk evaluation through the OTNE Consortium managed by B&C® Consortia Management, L.L.C. (BCCM).


 

By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our March 9, 2021, blog item, the U.S. Environmental Protection Agency (EPA) announced on March 8, 2021, that “in accordance with Biden-Harris Administration executive orders and directives,” it is asking for additional public input on five final rules for persistent, bioaccumulative, and toxic (PBT) chemicals issued on January 6, 2021, under the Toxic Substances Control Act (TSCA).  On March 16, 2021, EPA announced that comments on the final rules are due May 17, 202186 Fed. Reg. 14398.  EPA seeks comment on:

  • Whether the rules sufficiently reduce exposure to these chemicals, including exposures to potentially exposed or susceptible subpopulations and the environment;
  • Newly raised compliance issues associated with the final rule on phenol, isopropylated phosphate (3:1) (PIP (3:1)), including the compliance dates for certain regulated articles; and
  • Whether to consider additional or alternative measures or approaches.

EPA will use the feedback received during the comment period to determine the best path forward, which could include amending the final rules to include additional or alternative exposure reduction measures or extending compliance dates for certain regulated products and articles.


 

In the 21st century, we take as given a continuous stream of new and better products. From electronics to building materials to transportation solutions, the flow of new and better products and applications seems unending. New chemical substances play a fundamental role in creating those products and making existing products better. If the pipeline of new chemicals were closed off, the flow of new products and applications would slow to a trickle and eventually dry up. Modern life as we know it would not exist without the continued invention, production and use of new chemicals.

In the US, all new chemicals must be reviewed by the US EPA before they can enter commerce. The agency looks at new chemicals to determine whether their manufacturing, processing and use would adversely affect people or the environment. If the EPA identifies risks that it determines to be unreasonable, then it either prohibits use of the chemical, or requires restrictions on the chemical to control for risks. Since the 1970s, tens of thousands of chemicals have come through the EPA for review and have been allowed into US commerce.

In this article, Richard E. Engler, Ph.D. and Jeffery T. Morris, Ph.D. write that more robust consideration of a new chemical’s potential to prevent pollution and lower risks could help achieve the right balance between safety and innovation. The full article is available at https://chemicalwatch.com/220164/guest-column-why-the-us-epa-can-and-should-evaluate-the-risk-reducing-role-a-new-chemical-may-play-if-allowed-on-the-market (subscription required).


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 19, 2021, that it is inviting small businesses, governments, and not-for-profits to participate as Small Entity Representatives (SER) to provide advice and recommendations to a Small Business Advocacy Review (SBAR) Panel for C.I. Pigment Violet 29 (PV29).  The Panel will focus on EPA’s development of a proposed rule to address unreasonable risks identified in EPA’s recently completed Toxic Substances Control Act (TSCA) risk evaluation for PV29.  As reported in our January 25, 2021, memorandum, EPA reviewed 14 conditions of use for PV29, including as an intermediate for other perylene pigments, as well as a component of paints, coatings, industrial carpeting, and plastic and rubber products used primarily in the automobile industry, in ink used for commercial printing, and in consumer watercolors and artistic paints.  EPA determined that there are unreasonable risks to workers and occupational non-users (ONU) from ten out of 14 conditions of use.  EPA found no unreasonable risks to the environment, consumers, or the general public.  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 evaluation.
 
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 Panel will include federal representatives from the Small Business Administration (SBA), the Office of Management and Budget (OMB), and EPA.  The SBAR Panel 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’s 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 and must be received by March 5, 2021.
 
EPA states that in addition to engaging with small businesses, it “is executing a robust outreach effort on risk management that includes 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 regulation.


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on February 19, 2021, that it is extending the public comment period on proposed updates to the Toxic Substances Control Act (TSCA) fees rule to give stakeholders more time to review and comment.  The current comment period was set to close on February 25, 2021.  EPA is extending the comment period an additional 30 days.  Information on the proposed updates is available in our December 30, 2020, memorandum, “EPA Intends Proposed Rule to Increase Flexibility and Reduce Burdens under TSCA Fees Program.”


 
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