By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) will hold a webinar on October 13, 2022, on its web-based Interspecies Correlation Estimation (Web-ICE) tool. According to EPA, protecting the diversity of species from the adverse effects of chemicals is a significant environmental challenge. EPA acknowledges that information on the effects of chemicals on species is either very limited or lacking entirely, making management and mitigation of environmental contaminants difficult. EPA developed the Web-ICE tool to allow toxicity extrapolation from standard test organisms to diverse taxa, including endangered species. The publicly-accessible application allows risk assessors and environmental managers from all sectors to estimate chemical toxicity to a diversity of fresh and saltwater invertebrates and fish, birds and mammals, and aquatic plants (algae) that may have limited toxicity data. The training webinar will provide an overview of Web-ICE, including a brief overview of ICE models, demonstration of its application with example case studies, and a tutorial on using the Internet application. Registration is open.
By Lynn L. Bergeson and Carla N. Hutton
On October 1, 2021, the U.S. Environmental Protection Agency (EPA) announced the availability of the Draft FY 2022-2026 EPA Strategic Plan. 86 Fed. Reg. 54448. The draft Strategic Plan communicates EPA’s priorities and provides the roadmap for achieving its mission to protect human health and the environment. The draft Strategic Plan outlines objectives within the following strategic goals:
- Goal 1: Tackle the Climate Crisis;
- Goal 2: Take Decisive Action to Advance Environmental Justice and Civil Rights;
- Goal 3: Enforce Environmental Laws and Ensure Compliance;
- Goal 4: Ensure Clean and Healthy Air for All Communities;
- Goal 5: Ensure Clean and Safe Water for All Communities;
- Goal 6: Safeguard and Revitalize Communities; and
- Goal 7: Ensure Safety of Chemicals for People and the Environment.
Goal 7 includes two objectives. Objective 7.1, “Ensure Chemical and Pesticide Safety,” is intended to protect the health of families, communities, and ecosystems from the risks posed by chemicals and pesticides. It includes the following long-term goals:
- By September 30, 2026, complete at least eight High Priority Substance (HPS) Toxic Substances Control Act (TSCA) risk evaluations annually within statutory timelines compared with the fiscal year (FY) 2020 baseline of one;
- By September 30, 2026, review 90 percent of risk mitigation requirements for TSCA new chemical substances compared to the FY 2021 baseline of none;
- By September 30, 2026, renew 40 percent of expiring lead-based paint Renovation, Repair, and Painting (RRP) firm certifications within 30 days compared to the FY 2021 baseline of 36 percent;
- By September 30, 2026, complete 78 pesticide registration review cases;
- By September 30, 2026, consider the effects determinations or protections of federally threatened and endangered species for new active ingredients in 90 percent of the risk assessments supporting pesticide registration decisions for new active ingredients compared to the FY 2020 baseline of 50 percent;
- By September 30, 2026, consider the effects determinations or protections of federally threatened and endangered species in 50 percent of the risk assessments supporting pesticide registration review decisions compared to the FY 2020 baseline of 25 percent; and
- By September 30, 2026, support Agricultural Worker Protection Standard (WPS) pesticide safety training for 20,000 farmworkers annually compared with the FY 2018-2020 annual average baseline of 11,000.
Objective 7.2, “Promote Pollution Prevention,” is intended to encourage the adoption of pollution prevention and other stewardship practices that conserve natural resources, mitigate climate change, and promote environmental sustainability. It includes the following long-term goals:
- By September 30, 2026, reduce a total of 1.5 million metric tons of carbon dioxide equivalent released attributed to EPA pollution prevention grants; and
- By September 30, 2026, EPA’s Safer Choice program will certify a total of 2,300 products compared to the FY 2021 baseline of 1,950 total certified products.
According to the notice, EPA is seeking comment from individual citizens, states, tribes, local governments, industry, the academic community, non-governmental organizations (NGO), and all other interested parties. Comments are due November 12, 2021. EPA states that it “anticipates the final Strategic Plan will be submitted to Congress in February 2022.”
By Lynn L. Bergeson and Carla N. Hutton
On May 12, 2021, the U.S. Environmental Protection Agency (EPA) began environmental justice consultations regarding the development of risk management actions under Section 6(a) of the Toxic Substances Control Act (TSCA) for Asbestos, Part 1: Chrysotile Asbestos and Pigment Violet 29 (PV29). EPA will hold two identical consultation webinars, on June 1, 2021, and June 9, 2021. EPA states that it is offering these repeated sessions to increase opportunities for participation. 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 Asbestos, Part 1: Chrysotile Asbestos and PV29, and an opportunity for 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. The environmental justice consultation period end August 13, 2021.
EPA states that in addition to these environmental justice consultations, it is implementing a “robust outreach effort” on risk management 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 actions. More information on EPA’s final risk evaluation for Asbestos, Part 1: Chrysotile Asbestos is available in our January 4, 2021, memorandum and on EPA’s final risk evaluation for PV29 in our January 25, 2021, memorandum.
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
The House Energy and Commerce Subcommittee on Environment and Climate Change announced on March 6, 2019, that it will hold a hearing on March 13, 2019, on “Mismanaging Chemical Risks: EPA’s Failure to Protect Workers.” The Subcommittee will address how the U.S. Environmental Protection Agency (EPA) “is systemically ignoring worker risks in its implementation of the Frank R. Lautenberg Chemical Safety Act and other worker protections.” Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ) and Environment and Climate Change Subcommittee Chairman Paul Tonko (D-NY) stated that protecting vulnerable populations is an essential part of EPA’s mission, but under the Trump Administration, EPA “has systematically undervalued or completely overlooked the risks workers face from exposure to chemicals on the job. Workers should not have to choose between their health and their jobs.” Information for the hearing, including the Majority Memorandum, witness list and testimony, and a live webcast, will be posted on the hearing web page as they become available.
By Kathleen M. Roberts, Jason E. Johnston, M.S., Sheryl Lindros Dolan, and Margaret R. Graham
On June 25, 2018, the U.S. Environmental Protection Agency (EPA) held a preparatory meeting for experts selected to serve as letter peer reviewers for EPA's Exposure and Use Assessment and Human Health and Environmental Hazard Summary for five persistent, bioaccumulative, and toxic (PBT) chemicals. A list of those chemicals is available here. Although the meeting was scheduled for four hours, it adjourned after only two hours, as there were only a few questions from peer reviewers and only two outside stakeholders providing oral comments. Below are some highlights/takeaways from the meeting:
- All five PBT chemicals being reviewed scored high for hazard;
- Two PBT chemicals were pulled from EPA action under the Toxic Substances Control Act (TSCA) Section 6 because manufacturers requested risk evaluations for them prior to the September 19, 2016, deadline;
- Four of the PBT chemicals scored high or moderate for exposure; one scored low (pentachlorothiophenol (PCTP));
- For exposure assessment, EPA split up information as “core exposure data” or “supplemental exposure data”: core exposure data would be environmental data, monitoring, biomonitoring, modeled concentrations, or modeled dose; and supplemental exposure data would be environmental fate, engineering data, or other information related to exposure information or pathways;
- EPA identified exposure scenarios -- looking at source/use, environmental pathways, and receptors;
- EPA did not conduct any new modeling on the chemicals but did use modeled data from published literature;
- EPA did not conduct an exhaustive literature search, review, or assessment of hazard data, it used data readily available, as described in the Human Health and Environmental Hazard Summary; the EPA document “Supplemental Information for the Exposure and Use Assessment of Five Persistent, Bioaccumulative and Toxic Chemicals” outlines the literature search process used for exposure data; and
- Exposure scenarios include both quantitative and qualitative information.
No written comments were submitted prior to the peer review webinar. Only three people signed up for oral comments, and one was not present online. The two public commenters noted concerns regarding the likelihood of exposure, including the potential for accidental exposures; the lack of EPA focus on susceptible subpopulations; EPA’s intent not to address exposures that are already regulated under other EPA programs; and the need to assess the risk of bias.
Per the language in amended TSCA, EPA must issue risk management proposals to reduce exposures to the extent practicable by June 19, 2019.
Any public comments submitted by July 23, 2018, will be shared with peer reviewers. Comments submitted between July 23, 2018, and August 17, 2018, will be available to EPA for consideration. All comments are due by August 17, 2018. A recording of the webinar, slides, and other materials from the meeting will be posted in Docket EPA-HQ-OPPT-2018-0314. There are currently six supporting documents posted:
Stay up-to-date on TSCA implementation issues via our Recent Regulatory Developments web page and our TSCAblog.
By Lynn L. Bergeson and Margaret R. Graham
On May 25, 2018, the U.S. Environmental Protection Agency (EPA) announced it would host a half-day preparatory meeting for experts selected to serve as letter peer reviewers for EPA’s Exposure and Use Assessment and Human Health and Environmental Hazard Summary for Five Persistent, Bioaccumulative, and Toxic (PBT) chemicals. Section 6(h) of the Toxic Substances Control Act (TSCA) directs EPA to issue regulations under Section 6(a) for certain PBT chemical substances that were identified in EPA’s TSCA Work Plan for Chemical Assessments: 2014 update. The selected chemicals are:
- Decabromodiphenyl ethers (DECA);
- Hexachlorobutadiene (HCBD);
- Pentachlorothiophenol (PCTP);
- Phenol, isopropylated, phosphate (3:1) (PIP3/ITPP); and
- 2,4,6-Tris(tert-butyl) phenol (2, 4, 6 TRIS).
EPA prepared an Exposure and Use Assessment and a Human Health and Environmental Hazard Summary in response to the requirements under TSCA Section 6(h) to summarize conclusions of toxicity and whether there is likely exposure to these PBT chemicals and EPA organized letter peer reviews for the Exposure and Use Assessment and the Human Health and Environmental Hazard Summary. The Federal Register notice announcing the meeting states that during the preparatory meeting, “the individual letter peer reviewers will have the opportunity to comment on and ask questions regarding the scope and clarity of the draft charge questions.” EPA’s background papers, related supporting materials, and charge/questions for these letter peer reviews are now available in Docket No. EPA-HQ-OPPT-2018-0314 on www.regulations.gov.
The meeting is scheduled for June 25, 2018, from 1:00 p.m. to 5:00 p.m. (EDT) and will be held via teleconference and webcast only. Registration is available online. Those requesting to provide oral comments (approximately five minutes) are asked to register by June 21, 2018. Though the peer reviewers may not be able to consider fully written comments submitted after July 23, 2018, EPA will consider all comments submitted on or before August 17, 2018.
More information, including the list of experts, is available on EPA’s TSCA Peer Review website.
By Lynn L. Bergeson, Susan M. Kirsch, and Margaret R. Graham
On January 30, 2018, the Senate Committee on Environment and Public Works (EPW) convened an Oversight Hearing to Receive Testimony from U.S. Environmental Protection Agency (EPA) Administrator Scott Pruitt. In a written statement submitted in advance of the hearing, Pruitt described implementation of the new Frank R. Lautenberg Chemical Safety for the 21st Century Act, or the “new” Toxic Substances Control Act (TSCA), as being of “significant importance” and a “top priority for ensuring the safety of chemicals in the marketplace.” In opening remarks, Senator Tom Carper (Ranking Member of the EPW Committee) (D-DE)) challenged Pruitt’s record on implementing TSCA reform, stating that EPA has not truly used the authority bestowed on it through TSCA to declare that products being sold on the market are safe, therefore, consumers do not have the confidence that they deserve and that Congress intended in passing TSCA. Pruitt did not respond to this comment, and did not go on to address TSCA implementation in his brief opening remarks. Instead, Pruitt devoted the bulk of his opening statement to highlighting specific areas where EPA’s environmental protection goals dovetail well with opportunities for economic growth. These issues/economic opportunities included: investment in infrastructure to eradicate lead from drinking water within a decade; advancing initiatives that incentivize private companies to take on clean-up projects at abandoned mines; and remediation activities at “Superfund” sites -- hazardous waste sites regulated under the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA).
Senator Jeff Merkley (D-OR) expressed concern that EPA’s chemical reviews under TSCA were only focusing on new “items” (chemicals) being made, but overlooking “legacy” chemicals already in the environment (e.g., asbestos). Merkley cited a report that claimed that review of the ten chemicals on the priority list were being “slow-walked.” In response, Pruitt stated “it is an absolute priority during [EPA’s] first year,” the three TSCA final rules were issued consistent with the implementation schedule in the first year, and the backlog of chemical reviews has been addressed through the addition of resources.
Senator Kirsten Gillibrand (D-NY) expressed her concerns regarding the toxic levels of perfluorooctanesulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) that have been found throughout New York State, stating that EPA was not using its TSCA authority to regulate these chemicals, as the implementation final rules “ignored the public’s exposure to the past uses of chemicals called legacy uses” that could still have the potential to contaminate groundwater. She also stated her concern that due to this oversight, EPA will not likely study the health risks of widespread exposure to chemicals such as PFOS/PFOS. She requested of Pruitt to revise the TSCA implementation rules to address legacy issues, so that “all uses of a chemical, including legacy uses, are studied.” Pruitt stated that as PFOA and PFOS have not been manufactured since early 2000, they are in fact legacy uses, and that EPA was “very much going to focus” on this issue. Gillibrand appeared to be content with his answer, as she did not demand a further commitment from him. In regards to the Hudson River, Gillibrand requested that data from the sediment sampling be integrated into EPA’s five year review plan regarding the effectiveness of dredging for removing polychlorinated biphenyl (PCB) from the Hudson River. Pruitt stated that EPA was reviewing the samples currently and that there is more work to be done to get clarity on this issue. Gillibrand requested Pruitt to personally review the final report to ensure that all issues have been addressed and Pruitt confirmed that he would.
Near the close of the hearing, Senator Carper further stated that EPA has failed to follow through on its proposed ban of three highly toxic chemicals that Congress gave it the authority to ban when it enacted TSCA reform: specifically methylene chloride, tricholoroethylene (TCE), and methylpyrrolidone (NMP), and asked Pruitt to commit to using EPA’s authority to ban them within the next 30 days. Pruitt responded that they are on the priority list and that he will confirm this with the agency (that they are priorities, not that they will be banned in 30 days). EPA’s delay in finalizing the bans was among the failures cited in the Senate EPW Minority Staff report, released January 29, 2018, “Basically Backward: How the Trump Administration is Erasing Decades of Air, Water and Land Protections and Jeopardizing Public Health.”
Several Senators indicated their intention to submit additional questions for the record. Pruitt has until February 13, 2018, to submit written responses, which will be made available on the EPW Committee website. The full hearing is available on the EPW Committee’s website.
On April 14, 2017, Lynn L. Bergeson’s article “TSCA Reform: Key Provisions and Implications,” was published in Volume 26, Issue 2, of Environmental Quality Management. On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act which substantially amended the Toxic Substances Control Act (TSCA), and, in so doing, fundamentally altered the domestic management of industrial chemicals -- the lifeblood of many manufacturing processes. This article summarizes key changes to TSCA and explains their likely impacts on the manufacturing sector.
On August 11, 2016, the Bloomberg BNA Daily Environment Report quoted Kathleen M. Roberts, Vice President of B&C® Consortia Management, L.L.C. (BCCM), an affiliate of Bergeson & Campbell, P.C. (B&C®), on the implication of additional fees created by Toxic Substance Control Act (TSCA) reform.
Companies that pay the costs of generating toxicity, exposure and other data should not be “double billed” through additional fees to review the resulting information, said Walls and Kathleen Roberts, vice president of Bergeson & Campbell Consortia Management, LLC.