By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced the availability of the Draft Systematic Review Protocol Supporting TSCA Risk Evaluations for Chemical Substances
(Draft Protocol) on December 20, 2021. 86 Fed. Reg. 71891
. According to EPA, the Draft Protocol includes a revised generic approach for Toxic Substances Control Act (TSCA)-related approaches accounting for previous peer review comments from the Science Advisory Committee on Chemicals (SACC) reviews of risk evaluations on the first ten chemical assessments and more recent recommendations from the National Academies of Sciences, Engineering, and Medicine (NASEM) review of the Application of Systematic Review in TSCA Risk Evaluations
. EPA states that in addition to the revised, generic approach, the peer review package will include appendices containing chemical-specific information that is relevant for search strings and screening statements and data evaluation criteria for the next chemical risk evaluations being conducted by the Office of Pollution Prevention and Toxics (OPPT). The Draft Protocol provides specific details of the systematic reviews for the individual chemicals listed below:
1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-benzopyran (HHCB)
4,4'-(1-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA)
Tris(2-chloroethyl) phosphate (TCEP)
Phosphoric acid, triphenyl ester (TPP)
Dibutyl phthalate (DBP) (1,2-Benzene-dicarboxylic acid, 1,2- dibutyl ester)
Butyl benzyl phthalate (BBP) -- 1,2-Benzene-dicarboxylic acid, 1-butyl 2(phenylmethyl) ester
Di-ethylhexyl phthalate (DEHP) -- (1,2-Benzene-dicarboxylic acid, 1,2-bis(2-ethylhexyl) ester)
Di-isobutyl phthalate (DIBP) -- (1,2-Benzene-dicarboxylic acid, 1,2-bis-(2-methylpropyl) ester)
Diisodecyl phthalate (DIDP)
Diisononyl phthalate (DINP)
Octamethylcyclotetra-siloxane (Cyclotetrasiloxane, 2,2,4,4,6,6,8,8-octamethyl-) (D4)
Asbestos 2 (including Libby Amphibole Asbestos [LAA] and its tremolite, winchite, and richterite constituents)
EPA invites the public to provide input on the Draft Protocol via Docket No. EPA-HQ-OPPT-2021-0414
. Comments are due February 18, 2022
SACC will hold a virtual three-day peer review public meeting to consider and review the Draft Protocol on April 19-21, 2022
. Stakeholders must register online to receive the webcast meeting link and audio teleconference information. Registration instructions will be announced on the SACC website
by early March 2022
. After the public meeting, SACC will prepare meeting minutes summarizing its recommendations to EPA. The meeting minutes will be posted on the SACC website and in the relevant docket.
More information and a detailed commentary will be available in a forthcoming memorandum that will be posted on our website
Thursday, September 9, 2021
11:00 a.m. – 12:00 p.m. (EDT)
Bergeson & Campbell, P.C. (B&C®) is pleased to present a complimentary webinar focused on the U.S. Environmental Protection Agency’s (EPA) proposed per- and polyfluoroalkyl substances (PFAS) regulations on September 9, 2021, 11:00 a.m. – 12:00 p.m. (EDT). B&C Managing Partner Lynn L. Bergeson and Director of Chemistry Richard E. Engler, Ph.D., will discuss three actions recently taken by EPA:
- Proposing a rule designed to obtain comprehensive data on more than 1,000 PFAS manufactured in the United States;
- Withdrawing guidance that EPA believes weakened its July 2020 significant new use rule (SNUR) restricting certain long-chain PFAS; and
- Publishing a final rule that incorporates three additional PFAS into the Toxics Release Inventory (TRI) maintained under the Emergency Planning and Community Right-to-Know Act (EPCRA).
The proposed rule intended to obtain comprehensive data on PFAS would require all manufacturers (including importers) of PFAS in any year since 2011 to report information related to chemical identity, categories of use, volumes manufactured and processed, byproducts, environmental and health effects, worker exposure, and disposal.
As a result of these EPA regulatory actions, companies that never expected to need to know the Toxic Substances Control Act (TSCA) are now finding themselves in EPA’s crosshairs. This webinar will explore the full scope of these potential rules, how entities can determine if they will be subject to reporting, and the specific recordkeeping requirements that have been proposed.
Register for the webinar now
By Lynn L. Bergeson and Carla N. Hutton
According to a memorandum posted in Docket ID EPA-HQ-OPPT-2021-0436, the U.S. Environmental Protection Agency (EPA) will not extend the comment period stemming from the July 27, 2021, public webinar on the development of a proposed rule under the Toxic Substances Control Act (TSCA) to implement a tiered data collection strategy intended to inform EPA’s prioritization, risk evaluation, and risk management activities for chemical substances or mixtures. As reported in our July 29, 2021, memorandum, EPA 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 that may be followed by risk management actions (depending on the outcome of the risk evaluation). According to the memorandum posted in the docket, the August 16, 2021, deadline is for EPA’s use in the current stage of its rulemaking development. While EPA will consider later comments as it continues to develop the proposed rule, EPA states that “comments submitted at this point will be especially useful to EPA and stand a greater chance of influencing the rulemaking.” Because there will be other opportunities to comment on the tiered data reporting rule, including during the public comment period following publication of the proposed rule, EPA “do[es] not believe that an extension of the comment period is necessary.”
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) has prepared a strategic plan for the Office of Pollution Prevention and Toxics (OPPT) for fiscal years (FY) 2021-2023. The strategic plan outlines how OPPT intends to fulfill its obligations under the Toxic Substances Control Act (TSCA), the Emergency Planning and Community Right-to-Know Act (EPCRA), the Pollution Prevention Act (PPA), and related EPA policies and procedures “in ways that value science, protect people and the environment, and increase transparency for stakeholders and the general public.” The strategic plan includes new vision, mission, and values statements for OPPT. Priority areas include:
- New Chemicals: The New Chemicals Program manages potential risks to human health and the environment from chemicals new to the marketplace. The program identifies conditions to be placed on the use of new chemicals before they enter into commerce;
- Existing Chemicals: TSCA requires EPA to evaluate the safety of existing chemicals through prioritization, risk evaluation, and risk management. Ensuring the safety of existing chemicals requires collecting and analyzing information about the chemicals, developing additional information, conducting analyses to evaluate risk, and taking regulatory action on proper conditions of use for each chemical;
- Pollution Prevention/Safer Choice/Toxics Release Inventory (TRI): OPPT supports a suite of programs that are intended to reduce, eliminate, or prevent pollution at its source as an alternative to pollution control and waste disposal. Safer Choice helps consumers, businesses, and purchasers find products that contain ingredients that are safer for human health and the environment. The TRI Program collects information to track industry progress in reducing waste generation and moving toward safer waste management alternatives;
- Transparency and Stakeholder Engagement: OPPT is committed to providing the public with the information needed to understand EPA’s chemical evaluations. It continually seeks more productive means of engaging with interested stakeholders through public comment during rulemaking, Federal Advisory Committee Act (FACA) workgroups, and other means;
- Human Capital: OPPT strives to provide a healthy and supportive working environment, support for career development, and communication on issues that are important to its colleagues. It closely collaborates with its partners in the Office of Chemical Safety and Pollution Prevention’s (OCSPP) Office of Program Support to ensure that the basics of being an OPPT employee, such as timekeeping, personnel actions, and equipment, are easy to manage; and
- Efficiency and Enabling Tools: OPPT’s priority areas depend on a wide range of data from manufacturers, researchers, and the public. Its employees need to know how to work with these data and to have access to tools that facilitate access to and analysis of these data. OPPT is committed to increasing its ability to manage projects effectively through a unified approach that ensures timely deliverables, increases its ability to track its work, and simplifies its processes.
By Richard E. Engler, Ph.D. and Margaret R. Graham
As the U.S. Environmental Protection Agency (EPA) is currently closed due to the lapse in appropriations, EPA has ceased all work reviewing new and existing chemicals under the Toxic Substances Control Act (TSCA). Regarding new chemicals, although the Central Data Exchange (CDX) may still accept submissions, EPA will not process any information submitted via CDX until EPA reopens and it is not clear how EPA will set “Day 1” for TSCA Section 5 notices submitted during the shutdown.
We are unaware of EPA publishing a formal notice that it is suspending the review period of new chemical notices, but EPA will not be making any determinations on such notices during the shutdown. Submitters should continue to submit any required information (e.g., Notices of Commencement) even though EPA will not process or review such submissions.
EPA actions on existing chemicals (including risk evaluations and publication of the updated TSCA Inventory with active/inactive status) will be delayed. As previously reported, the first preparatory meeting on the Colour Index (C.I.) Pigment Violet 29 risk evaluation (scheduled for January 8, 2019) will be cancelled if the shutdown continues through January 4, 2019, at 5:00 p.m., which appears probable.
By Kathleen M. Roberts, Richard E. Engler, Ph.D., and Lynn L. Bergeson
On December 11, 2017, the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) convened its public meeting on possible approaches for identifying potential candidates for prioritization under the amended Toxic Substances Control Act (TSCA). Key presenters were Jeffery Morris, Ph.D., Directory of OPPT, as well as several other OPPT staff, Health Canada (HC) and Environmental and Climate Change Canada (ECCC), and Russell S. Thomas with EPA’s Office of Research and Development (ORD).
The presentations from the meeting are listed below and available on EPA's website:
- Identifying Potential Candidates for Prioritization: Background, Goal, Guiding Principles, and Milestones -- Dr. Morris, Director, OPPT
- Overview of TSCA Work Plan Methodology -- Maria Doa, Director, Chemical Control Division, OPPT
- Approaches to Identifying Potential Candidate Chemicals for Prioritization: The TSCA Work Plan as a Tool for Identifying Potential Candidates -- Dan Chang, OPPT
- Approaches to Identifying Potential Candidate Chemicals for Prioritization: Approaches to Prioritization and to Streamlined Assessments -- Canada’s Chemical Management Plan – HC and ECCC
- Approaches to Identifying Potential Candidate Chemicals for Prioritization: EPA’s Safer Chemical Ingredients List (SCIL) -- Clive Davies and Lauren Sweet, OPPT
- Approaches to Identifying Potential Candidate Chemicals for Prioritization: Functional Category Approach Based on Use and Exposure Potential -- Joel Wolf and Ana Corado, OPPT
- Approaches to Identifying Potential Candidate Chemicals for Prioritization: Integration of Traditional and New Approach Methods -- Russell S. Thomas, ORD
Nancy Beck, Ph.D. opened the workshop by welcoming attendees and provided some overview remarks. Dr. Beck noted that the workshop could result in more than one approach being considered, or could result in no process being adopted. Dr. Beck explained why EPA does not wish to prioritize chemicals with poor datasets. Unless EPA has sufficient information to conclude there is no unreasonable risk, EPA must proceed with risk evaluations within the specified timelines with increased uncertainties. This will result in a risk management process that has numerous default assumptions and uncertainty that will be difficult to defend. Such risk management results will likely be subject to litigation, which will be costly in terms of time and resources to both EPA and the stakeholders.
Dr. Morris stated that EPA hopes to implement a pre-prioritization approach by June 2018 to help ensure prioritization can begin in December 2018.
In its review of potential adjustments to the TSCA Work Plan for Chemical Assessments (TSCA Work Plan) approach, EPA staff clarified that there would be no changes to the current TSCA Work Plan chemical list last updated in 2014. It was suggested that EPA could rely on the current TSCA Work Plan approach as an interim method for pre-prioritization as EPA works to refine other approaches. EPA acknowledged that neither the current TSCA Work Plan approach nor the SCIL process included screens for certain criteria articulated in the amended TSCA legislation, including storage near significant sources of drinking water.
Based on comments by presenters at the workshop and references in EPA documentation, it appears that chemical substances of unknown or variable composition, complex reaction products and biological materials (UVCB) will be difficult to screen in the pre-prioritization approaches reviewed.
In response to EPA’s comment that active substances will be the starting point for pre-prioritization screening, one non-governmental organization (NGO) group raised concerns with legacy issues that might be associated with inactive substances (e.g., substances contained in products or materials that have been in use for years). NGO groups also commented that the hurdle for identifying a high priority chemical should be relatively low; whereas the hurdle for identifying a low priority chemical should be very high and could potentially include a required minimum data set.
All stakeholders expressed appreciation to EPA for the presentations and the various approaches reviewed. During the public comments, there did not appear to be specific support for any one approach.
We note that none of the approaches included specifics as to how EPA would assess whether the chemical being reviewed had sufficient data available to initiate prioritization and potential risk evaluation. Given EPA’s clear objective to avoid having data-poor chemicals being prioritized, this issue needs to be clearly and definitively addressed in EPA’s practices. Nor was there consideration as to how other governmental regulatory assessments could be incorporated into a pre-prioritization approach.
EPA will be accepting comments on the approach to prioritizing chemicals until January 25, 2018, in Docket ID EPA-HQ-OPPT-2017-0586. More information on the December 6, 2017, public meeting on EPA’s new chemicals review program is available in our blog under key phrase public meeting.
By Lynn L. Bergeson and Margaret R. Graham
On November 14, 2017, the U.S. Environmental Protection Agency (EPA) released the agenda and meeting materials for its December 11, 2017, Approaches for Identifying Potential Candidates for Prioritization for Existing Chemical Risk Evaluations under the Toxic Substances Control Act (TSCA) meeting. EPA states that during this meeting, it will describe goals, guiding principles, and possible approaches for identifying potential candidate chemicals for prioritization; and take comment on possible approaches. Under amended TSCA, EPA is required to establish processes for prioritizing and evaluating risks from existing chemicals. The meeting materials include:
- Agenda for Public Meeting. The Agenda includes the following topics: identifying potential candidates for prioritization: background, goal, guiding principles, and milestones; overview of TSCA Work Plan methodology; TSCA Work Plan as a tool for identifying potential candidates; Canada’s Chemicals Management Plan; EPA’s Safer Chemicals Ingredients List; Functional Category Approach, based on use and exposure potential; Functional Category Approach, based on chemical structure and function; and systematic integration of traditional and new approaches. Featured speakers are Nancy Beck, Ph.D., Deputy Assistant Administrator for the Office of Chemical Safety and Pollution Prevention (OSCPP) and Jeff Morris, Ph.D., Director of the Office of Pollution Prevention and Toxics (OPPT).
- Discussion Document -- Possible Approaches and Tools for Identifying Potential Candidate Chemicals for Prioritization. EPA states that the discussion document introduces a set of approaches that it is considering to help guide the identification of potential candidates for prioritization, and is intended to be a starting point for a dialogue with stakeholders on best practices for EPA’s activities during this phase. EPA is asking for input on the approaches presented here, as well as any additional recommendations.
By Lynn L. Bergeson and Margaret R. Graham
On November 6, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish a notice in the Federal Register in which it will announce two meetings to discuss implementation activities under the Toxic Substances Control Act (TSCA) as amended by the Frank R. Lautenberg Chemical Safety for the 20th Century Act, as well as request public comments. The meetings are:
- New Chemicals Review Program Implementation Meeting: December 6, 2017, from 9:00 a.m. to 5:00 p.m. (EST). EPA’s first meeting will update and engage with the public on EPA’s progress in implementing changes to the New Chemicals Review Program as a result of the 2016 amendments to TSCA, and will include a discussion of EPA’s draft New Chemicals Decision-Making Framework. EPA will describe its review process for new chemical substances under the amended statute and interested parties will have the opportunity to provide input and to ask questions. EPA states it plans to utilize the feedback it receives from the public meeting and comments received to improve policy and processes relating to the review of new chemicals under TSCA. EPA will be accepting questions from the public in advance of the meeting, and will respond to these questions at the meeting as time allows, if such questions are received by November 20, 2017. Questions and comments can be submitted in Docket No. EPA-HQ-OPPT-2017-0585 on www.regulations.gov. Registration for this meeting is available online.
- Approaches for Identifying Potential Candidates for Prioritization for Existing Chemical Risk Evaluations Meeting: December 11, 2017, from 9:00 a.m. to 5:00 p.m. (EST). EPA’s second meeting will focus on possible approaches for identifying potential candidate chemical substances for EPA’s prioritization process under TSCA. As amended, TSCA required that EPA establish processes for prioritizing and evaluating risks from existing chemical substances. EPA will describe and take comment on a number of possible approaches that could guide it in the identification of potential candidate chemical substances. EPA will be accepting questions from the public in advance of the meeting, and will respond to these questions at the meeting as time allows, if such questions are received by November 20, 2017. Questions and comments can be submitted in Docket No. EPA-HQ-OPPT-2017-0586 on www.regulations.gov. Registration for this meeting is available online.
Online requests to participate in either meeting must be received on or before December 5, 2017. Both meetings will be held at the Ronald Reagan Building and International Trade Center, Horizon Ballroom, 1300 Pennsylvania Avenue, N.W., in Washington, D.C., and will be available by remote access for registered participants. EPA states that more information on the specifics of the meetings will be made available in the dockets and on EPA’s website prior to the meeting.
On July 18, 2016, Bloomberg BNA’s Daily Environmental Report reported on the U.S. Environmental Protection Agency’s (EPA) new chemical notice process, and included insight from industry leaders at Bergeson & Campbell, P.C.’s (B&C®) July 14, 2016, webinar, The New TSCA: Impacts on New and Existing Chemicals Programs.
B&C Managing Partner Lynn L. Bergeson was quoted as saying that premanufacture notifications, or PMNs, that chemical manufacturers must submit before they can produce or import a new chemical, and significant new use notifications, which companies must submit before they can make or use certain chemicals in new ways, “need to be much more strategic, thoughtful and detailed.”
Both the old and newly amended TSCA state the EPA's “authority over chemical substances and mixtures should be exercised in such a manner as to not impede unduly or create unnecessary economic barriers to technological innovation,” Bergeson stated, referring to Section 2601(b)(3). The new law makes “very consequential changes” to the new chemicals provisions of TSCA as EPA will have to balance carefully the requirements imposed by different sections of the law.
Richard A. Denison, Ph.D., Senior Scientist with the Environmental Defense Fund, stated that the changes the amended law makes to EPA's new chemicals program “are not trivial.” Further, the changes will make it easier for the public to understand why EPA concludes that new chemicals may or may not enter commerce, what restrictions it may impose on the uses of those chemicals, and why.
BNA’s article, “Detailed New Chemical Applications Needed to Boost Market Chances: Attorneys,” is available online, through paid subscription.
If you are having trouble understanding basic process flows under the new Toxic Substances Control Act (TSCA), please reference Dr. Richard A. Denison’s flow charts that depict the basic processes applicable to existing chemicals already in commerce, and applicable to new chemicals prior to market entry. Comparisons are shown between the processes under the old and new TSCA. Dr. Denison is a Lead Senior Scientist at the Environmental Defense Fund (EDF). There are three flowcharts available:
- How the Lautenberg Act Works (Existing Chemicals);
- How the Original TSCA Worked (Existing Chemicals); and
- TSCA vs. Lautenberg Act (New Chemicals).
You can access the flow charts in Dr. Denison’s blog post on EDF’s Health webpage: Understanding basic process flows under the new TSCA.