By Lynn L. Bergeson and Carla N. Hutton
On September 17, 2021, the U.S. Environmental Protection Agency (EPA) published a final rule amending the regulations applicable to phenol, isopropylated phosphate (3:1) (PIP (3:1)) promulgated under the Toxic Substances Control Act (TSCA). 86 Fed. Reg. 51823. Specifically, EPA is extending the compliance date applicable to the processing and distribution in commerce of certain PIP (3:1)-containing articles, and the PIP (3:1) used to make those articles, from March 8, 2021, to March 8, 2022. For such articles, EPA states that it is also extending the compliance date for the recordkeeping requirements applicable to manufacturers, processors, and distributors from March 8, 2021, to March 8, 2022. According to EPA, the articles covered by the amendment “include a wide range of key consumer and commercial goods such as cellular telephones, laptop computers, and other electronic and electrical devices and industrial and commercial equipment used in various sectors including transportation, life sciences, and semiconductor production.” The final rule is effective September 17, 2021. More information on the final PIP (3:1) rule and on EPA’s plan for a new rulemaking on persistent, bioaccumulative, and toxic (PBT) chemicals is available in our September 3, 2021, memorandum, “EPA Plans New Rulemaking for PBTs, Extends Compliance Dates for PIP (3:1) Rule.”
By Lynn L. Bergeson and Carla N. Hutton
On August 19, 2021, the U.S. Environmental Protection Agency (EPA) announced a collaborative agreement with Unilever to explore better ways to assess chemical risks associated with consumer products. According to EPA, this agreement builds on prior cooperation between EPA and Unilever regarding New Approach Methods (NAM), “which are a promising alternative to conventional toxicity testing that are intended to reduce reliance on the use of animals.” EPA states that the collaboration aims to establish a framework for the Next Generation of Risk Assessments based on NAMs. The collaboration will bring together more than $2 million in both monetary and in-kind contributions, including scientific expertise and equipment, to develop a comprehensive NAMs dataset for a minimum of 40 chemicals. According to EPA, the chemicals will be selected and grouped such that half will be benign and the other half will have known adverse implications for human health. These chemicals will be tested using a wide variety of NAMs, and the results will be compared between the two groups to determine how well particular NAMs can infer differences in risk. EPA states that these data will be used in case studies to evaluate the potential to use NAMs in regulatory decisions. All data generated through the collaboration will be in the public domain, allowing academic, corporate, government, and nonprofit scientists to use the project results in their own research.
EPA states that in addition to the data generated through the collaboration, EPA and Unilever will use chemical data from EPA’s high-throughput screening efforts and the federal government’s Tox21 consortium, which is a collaboration among EPA, the National Institutes of Health (NIH), and the U.S. Food and Drug Administration (FDA). According to EPA, “[t]hese automated chemical screening technologies rapidly test thousands of chemicals for their effects on human cells or cellular components that are critical to normal function.” EPA notes that data from these technologies are then incorporated into computational models to predict potential adverse health effects and estimate the amount of chemical that may cause these effects.
By Lynn L. Bergeson and Carla N. Hutton
As reported in our January 6, 2021, blog item, the U.S. Environmental Protection Agency (EPA) issued final rules under Section 6(h) of the Toxic Substances Control Act (TSCA) for five persistent, bioaccumulative, and toxic (PBT) chemicals, including phenol, isopropylated phosphate (3:1) (PIP (3:1)) (86 Fed. Reg. 894). The final rules limit or prohibit the manufacture (including import), processing, and/or distribution in commerce of the five PBTs, with certain exceptions. In accordance with Biden-Harris Administration Executive Orders and directives, as well as “[n]ewly-raised compliance issues” associated with the PIP (3:1) rule, EPA announced on March 8, 2021, that it would ask for additional public comment. EPA also issued a temporary 180-day “No Action Assurance” (NAA) indicating that the Agency will exercise its enforcement discretion regarding the prohibitions on processing and distribution of PIP (3:1) for use in articles, and the articles to which PIP (3:1) has been added.
Under the final rule, each person who manufactures PIP (3:1) for any use after March 8, 2021, must, prior to or concurrent with the shipment, notify persons to whom PIP (3:1) is shipped, in writing, of the prohibitions on processing, distribution, and releases to water. 40 C.F.R. § 751.407(e)(1). Each person who processes or distributes in commerce PIP (3:1) or PIP (3:1)-containing products for any use after July 6, 2021, must, prior to or concurrent with the shipment, notify persons to whom PIP (3:1) is shipped, in writing, of the prohibitions on processing, distribution, and releases to water. 40 C.F.R. § 751.407(e)(2). The final rule clarifies that the downstream notification requirement applies only to those scenarios where a product has an accompanying safety data sheet (SDS). EPA also included an alternative method of compliance for downstream notification. If a manufacturer, processor, or distributor chooses, they may include specified text on their label, instead of on their SDS.
EPA’s NAA applies only to the prohibitions on processing and distribution of PIP (3:1) for use in articles, and the articles to which PIP (3:1) has been added. It does not apply to the downstream notification requirements or to the downstream notification requirements for manufacturers that began March 9, 2021. Processors and distributors should review the regulations now to ensure that they are prepared to begin providing downstream notifications on July 7, 2021. Information regarding Bergeson & Campbell, P.C.’s TSCA services is available on our website.
By Christopher R. Blunck, Carla N. Hutton, and Lynn L. Bergeson
On June 11, 2021, the Office and Management and Budget released its “Spring 2021 Unified Agenda of Regulatory and Deregulatory Actions” (Regulatory Agenda). It includes an entry for an interim final rule planned by the U.S. Environmental Protection Agency (EPA) entitled “Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h); Reconsideration and Extension of Certain Compliance Dates.” This action, planned for publication in September 2021, would be in follow-up to EPA’s March 16, 2021, proposed rule that sought additional public comment on final rules published on January 6, 2021, covering five persistent, bioaccumulative, and toxic (PBT) chemicals, i.e., decabromodiphenyl ether; 2,4,6-tris(tert-butyl)phenol; hexachlorobutadiene, pentachlorothiophenol; and phenol, isopropylated phosphate (3:1) (PIP (3:1)).
In the March 16, 2021, proposed rule, EPA stated that it sought additional public comment in “accordance with the January 21, 2021, Executive Order entitled “Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis” and other Biden-Harris Administration Executive orders and other direction.” EPA stated also in the proposed rule that it is “aware of and plans to consider revisions in response to implementation issues that have been raised by a range of stakeholders” and that “[i]n particular, EPA is seeking comment on newly-raised issues associated with the March 8, 2021, compliance date in the PIP (3:1) rule for certain regulated articles.”
Concurrent with EPA’s announcement on March 8, 2021, of the March 16, 2021, proposed rule that opened the PBT rules for comment, EPA issued a temporary 180-day “No Action Assurance” (NAA) indicating that EPA would exercise its enforcement discretion regarding the prohibitions on processing and distribution of PIP (3:1) for use in articles, and the articles to which PIP (3:1) has been added. EPA stated that it “is taking this [NAA] action to ensure that the supply chain of these important articles is not interrupted while EPA continues to collect the information needed to best inform subsequent regulatory efforts and allow for the issuance of a final agency action to extend the March 8, 2021, compliance date as necessary.” EPA stated that the NAA “is to remain in effect until either (1) 11:59 PM ET, September 4, 2021, or (2) the effective date of a final action addressing the compliance date for the prohibition on processing and distributing in commerce of PIP (3:1); including in PIP (3:1)-containing articles, whichever occurs earlier.”
The Regulatory Agenda entry for the interim final rule states that EPA intends to address compliance date issues in the action, and that if it “determines to further amend the recent final [PBT] rules, EPA will address those amendments in one or more future Regulatory Agenda entries.”
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.”
March 31, 2021
1:30 p.m. - 3:00 p.m. EDT
The COVID-19 global pandemic has had far-reaching impacts on business operations. While we are all eager to put the pandemic behind us, other catastrophic events will inevitably occur. To strengthen organizational resilience going forward, we must examine lessons learned and position product stewardship as a key player in business continuity and crisis management.
This complimentary future-focused webinar, hosted by the Product Stewardship Society (PSS), will identify the broad range of complex, unresolved, and evolving issues product stewards have faced and continue to face because of the pandemic.
Tina Armstrong, Ph.D., Principal Scientist and Vice President at the global consultancy firm Arcadis
Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (moderator)
Jon Hellerstein, CIH, CSP, a career environmental health professional
Al Iannuzzi, Ph.D., Vice President, Sustainability, The Estée Lauder Companies
Louise Proud, leader of the Environment, Health, and Safety program for Pfizer Inc.
In addition to receiving 1.5 contact hours, participants will learn:
- How product stewards can integrate product stewardship into business continuity and crisis management.
- What issues a product steward needs to address when a COVID-19 outbreak occurs in a workplace, retail space, or upstream/downstream in the supply chain.
- How to leverage the experiences of the COVID-19 pandemic to influence senior leaders to think differently about product stewardship and environment, health, and safety in general.
Make sure to register now for what promises to be a timely, resourceful, and interesting event!
By Lynn L. Bergeson and Carla N. Hutton
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). EPA states that as a first step in its efforts to review these rules immediately, EPA is opening a 60-day comment period for the public to provide new input 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 states that it 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. Upon publication of the Federal Register notice, EPA will accept public comments for 60 days.
Stakeholders recently informed EPA that the prohibition on processing and distribution of PIP (3:1) could impact articles used in a wide variety of electronics, from cell phones, to robotics used to manufacture semiconductors, to equipment used to move COVID-19 vaccines and keep them at the appropriate temperature. EPA states that stakeholders “note that the complexity of international supply chains makes locating the presence of, and finding alternatives to, PIP (3:1) in components challenging.” According to EPA, stakeholders assert that an extension to the compliance deadline is necessary to avoid significant disruption to the supply chain for a wide variety of articles. EPA states that it was not its intent during the development of the final rule to have such a broad disruptive impact. Thus, EPA “is also announcing its expectation that this specific issue will be addressed as part of the broader re-examination of these rules.” EPA “intends to extend compliance dates as necessary for the prohibitions on processing and distribution of PIP (3:1) for use in some articles, and some of the articles to which PIP (3:1) has been added.”
EPA states that for these same reasons, it is issuing a temporary 180-day “No Action Assurance” indicating that the agency will exercise its enforcement discretion regarding the prohibitions on processing and distribution of PIP (3:1) for use in articles, and the articles to which PIP (3:1) has been added. EPA “is taking this action to ensure that the supply chain of these important articles is not interrupted while EPA continues to collect the information needed to best inform subsequent regulatory efforts and allow for the issuance of a final agency action to extend the March 8, 2021, compliance date as necessary.”
The American Law Institute Continuing Legal Education (ALI CLE) and the Environmental Law Institute’s (ELI) Environmental Law 2021 webcast educates lawyers on key current environmental law issues, including the latest developments in air, water, endangered species, climate change, chemicals, and renewable energy. A national faculty of seasoned private practitioners, governmental officials, law professors, and public interest advocates will cover what to expect from the change of administrations in Washington D.C., with Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®), and Alexandra Dapolito Dunn, former Assistant Administrator for the Office of Chemical Safety and Pollution Prevention, U.S. Environmental Protection Agency, presenting "Chemicals Regulation: Latest Developments" on February 25, 2021. This course will cover:
- Biden-Harris Administration priorities with respect to chemical policy and regulation;
- Potential likelihood of shifts in Toxic Substances Control Act (TSCA) implementation and agricultural chemical policy;
- Key recent European Union (EU) initiatives expected to influence domestic initiatives; and
- Anticipated changes with respect to emerging contaminants and environmental justice policy development.
Register online for the full three-part webcast, or register separately for Part 1 on February 24, Part 2 on February 25, and Part 3 on February 26.
By Lynn L. Bergeson and Carla N. Hutton
On January 22, 2021, the U.S. Environmental Protection Agency (EPA) published the reasons for its denial of a petition requesting it to require health and environmental effects testing on 54 per- and polyfluoroalkyl substances (PFAS). 86 Fed. Reg. 6602. The petition sought issuance of a rule or order under TSCA Section 4 compelling The Chemours Company (Chemours) to fund and carry out this testing under the direction of a panel of independent scientists. EPA states that it finds the petitioners have not provided the facts necessary for it to determine for each of the 54 PFAS that “existing information and experience are insufficient and testing of such substance or mixture with respect to such effects is necessary to develop such information.” After “careful consideration,” EPA denied the TSCA petition for the following reasons:
- Insufficient Information and Experience: According to EPA, the petition does not set forth the facts necessary to demonstrate that there is “insufficient information and experience” for each of the 54 PFAS. The petitioners state, in part, “[f]or the 54 PFAS, the sufficiency of available information should be determined by comparing available data with the known adverse effects of other PFAS. The goal should be to conduct a scientifically sound assessment of each of the 54 chemicals for the critical toxic endpoints that have been identified in studies on [perfluorooctane sulfonate (PFOS)], [perfluorooctanoic acid (PFOA)] and other well-characterized studies.” EPA states that the petitioners do not provide evidence that they conducted an assessment to support a finding of insufficient information and experience, however;
- Testing of Such Substance or Mixture with Respect to Such Effects Is Necessary to Develop Such Information: According to EPA, the petitioners do not demonstrate “testing of such substance or mixture with respect to such effects is necessary to develop such information.” EPA finds that the petitioners failed to address ongoing testing and data collections for some of the 54 PFAS, thereby failing to set forth facts that are necessary to establish there is a need for the testing sought in the petition. According to EPA, this research may provide information that overlaps with testing the petitioners requested, which would render the information unnecessary under TSCA Section 4(a)(1)(A)(i)(III);
- Class-Based Approach to Testing: TSCA Section 4(h)(1)(B)(ii) “encourage[s]” EPA to consider “the grouping of 2 or more chemical substances into scientifically appropriate categories in cases in which testing of a chemical substance would provide scientifically valid and useful information on other chemical substances in the category.” EPA states that it “is currently investigating ways to group similar PFAS by likeness into subcategories for purposes of research, data collection, hazard determinations, and other activities.” EPA notes that it collaborated with the National Toxicology Program (NTP) “to construct a PFAS screening library subset composed of 75 PFAS on a structural category basis and considerations such as structural diversity within a category, data availability, and read-across category-level weight (e.g., value of substance for anchoring read-across trends within a category, serving as an analog); four of the 54 PFAS the petitioners identify are included in this subset.” While the petitioners mention this effort, they “incorrectly state that just two of the 54 PFAS the petitioners cover are included in the EPA testing.”
- Practicability of National Academy of Sciences Oversight: The petitioners also request that the National Academy of Sciences (NAS) oversee all aspects of the proposed testing program. EPA states that it “finds such an oversight arrangement is not within the scope of what a TSCA section 21 petitioner can request when seeking the initiation of a rule or the issuance of an order under TSCA section 4.” Furthermore, according to EPA, projects and studies must meet certain conditions for the NAS to accept private funding. EPA concludes that it is not in a position to require NAS to oversee the testing requested by the petitioners, and the petitioners provide no administrative or organizational procedures for implementation.
- Selection of PFAS for Health and Environmental Effects Testing: The petitioners divide the 54 PFAS at issue into Tier 1 substances “for which there is known human exposure based on detection in blood, food or drinking water,” and Tier 2 substances “for which human exposure is probable based on detection in environmental media.” According to EPA, the petitioners do not set forth facts showing that for all 40 PFAS it ranks as Tier 2 substances “human exposure is probable based on detection in environmental media” or that “a strong inference of exposure can be drawn from their presence in surface water, stormwater, wastewater, sediment, groundwater, soil, private wells, and/or air emissions,” however.
- Scientific Standards: EPA states that it “finds the petitioners have not evaluated the quality of the data they have provided or indicated how they conducted their searches, evaluated the quality of the sources, or indicated what gaps were located and then explained why the specific tests requested, as compared to others, would provide the data being sought.” According to EPA, such an evaluation is necessary for EPA to conduct the considerations under TSCA Section 26(h).
- Vertebrate Testing: TSCA Section 4(h) requires that EPA reduce and replace the use of vertebrate animals in the testing of chemical substances under TSCA Section 4. EPA states that it must consider “as appropriate and to the extent practicable and scientifically justified, reasonably available existing information, including (i) Toxicity information; (ii) Computational toxicology and bioinformatics; and (iii) High-throughput screening methods and the prediction models of those methods.”
More information on the TSCA Section 21 petition is available in our October 29, 2020, memorandum, “TSCA Section 21 Petition Seeks Section 4 Test Rule for 54 PFAS.”
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on November 3, 2020, that it will hold webinars to consult with environmental justice communities on risk management for methylene chloride and 1-bromopropane (1-BP). EPA states that the webinars are open to the public and will focus on the environmental justice impacts of EPA’s development of proposed rules to address the unreasonable risks identified in the final Toxic Substances Control Act (TSCA) risk evaluations for these chemicals. EPA will hold “identical” consultation webinars on November 16, 2020, and November 19, 2020. According to EPA, both sessions will provide an overview of the TSCA risk management requirements, the findings from the final risk evaluations for methylene chloride and 1-BP, the tools available to manage the unreasonable risks from methylene chloride and 1-BP, and discussion of environmental justice concerns. In addition to being open to the public, EPA is inviting national, local, and non-governmental organizations, communities, and other interested stakeholders to participate. EPA states that in addition to environmental justice consultations, it is executing a “robust outreach effort on risk management that includes one-on-one meetings with stakeholders and formal consultations with small businesses, state and local governments, and tribes.” EPA notes that there will also be an open public comment period on proposed risk management regulations.