Monthly Update for March 2023
B&C Launches PFAS News And Information Site For Industry Stakeholders; Will Hold PFAS Webinar May 17, 2023: Continuing Bergeson & Campbell, P.C.’s (B&C®) tradition of providing reliable information and analysis of the most pressing chemical issues of the day, B&C is pleased to announce the PFAS News and Information web page. This site provides constantly updated resources to help those in the chemicals and chemical products industries understand what they need to know about per- and polyfluoroalkyl substances (PFAS) developments and what it means to their business. View now at www.lawbc.com/pfas-resource-center.
WEBINAR — Extended Producer Responsibility, March 22, 2023, 12:00 p.m. – 1:00 p.m. (EDT), Via Webinar: B&C is pleased to present “Extended Producer Responsibility,” a webinar featuring LeRoy C. Paddock, Associate Dean for Environmental Law Studies at George Washington University Law School; Edith G. Nagy, Regulatory Consultant, B&C; and Lynn L. Bergeson, Managing Partner, B&C, as they explore the history and evolution of Extended Producer Responsibility (EPR) legislation, expected developments that will affect the chemical and chemical product industry, and what companies need to know to prepare for these changes. Register now.
PODCAST — Product Stewardship, Supply Chain, And Downstream User Engagement — A Conversation With Catherine M. Croke, DBA: Lynn L. Bergeson and Catherine M. Croke, DBA, Director of Product Stewardship and Regulatory Affairs, B&C, discuss the expanding role and growing importance of product stewards in corporate America today, what is product stewardship, the value this role offers to companies, and where to begin if your company is without a product steward. Listen now.
ARTICLE — Lynn L. Bergeson and L. Claire Hansen Author “Toxic Substances Law Creating More Confusion for Legal Teams and Public,” For Chemical Processing: This article focuses on one of many abrupt, and in some views, unlawful, U.S. Environmental Protection Agency (EPA) policy shifts frustrating lawyers and confusing the public. EPA moved in 2021 from a “conditions of use” approach to evaluating chemical risk to a “whole chemical” approach. This seemingly modest change is a key reason why lawyers advising chemical stakeholders are struggling and why there may be a lot of Toxic Substances Control Act (TSCA) litigation in EPA’s future.
EPA Updates TSCA Inventory, Plans Next Update In Summer 2023: On February 16, 2023, EPA announced that the latest TSCA Chemical Substance Inventory is now available on its website. The TSCA Inventory is a list of all existing chemical substances manufactured, processed, or imported in the United States. According to EPA, this update to the public TSCA Inventory is part of its biannual posting of non-confidential Inventory data. EPA plans the next regular update of the TSCA Inventory for summer 2023. More information is available in our February 17, 2023, blog item.
EPA Updates Voluntary Consensus Standards In Formaldehyde Emission Standards For Composite Wood Products: On February 21, 2023, EPA published a final rule to update the incorporation by reference of several voluntary consensus standards in the Agency’s formaldehyde standards for composite wood products regulations under TSCA that have since been updated, superseded, or withdrawn by the issuing organizations. 88 Fed. Reg. 10468. EPA states that in addition, it took final action to reflect its interpretation that remote inspections by third-party certifiers (TPC) are allowed in certain circumstances in the event of unsafe conditions such as the on-going COVID-19 pandemic or other unsafe conditions such as natural disasters, outbreaks, political unrest, and epidemics. Finally, EPA made certain technical corrections and conforming changes, including updating standards within the definitions section, clarifying language as it relates to production, and creating greater flexibilities for the third-party certification process. The final rule will be effective March 23, 2023. The incorporation by reference (IBR) of certain material listed in the rule is approved by the Director of the Federal Register as of March 23, 2023. The IBR of certain other material listed in the rule was approved by the Director of the Federal Register on February 10, 2017, and February 7, 2018.
GAO Report Finds Workforce Planning Gaps Contributed To EPA’s Missed TSCA Deadlines: The U.S. Government Accountability Office (GAO) released a report on February 23, 2023, entitled “EPA Chemical Reviews: Workforce Planning Gaps Contributed to Missed Deadlines.” GAO evaluated the extent to which EPA met selected TSCA deadlines for reviewing existing and new chemicals since June 2016, and to which EPA engaged in workforce planning for implementing its chemical review responsibilities. GAO identified five principles with which federal agencies’ strategic workforce planning efforts should align. According to the report, while EPA officials agree that the principles are “relevant and reasonable for its TSCA workforce planning efforts,” they have not yet developed a process or timeline to align fully such efforts with these principles. For more information, please read our February 24, 2023, memorandum.
EPA Releases Proposed Approach For Considering Cumulative Risks Under TSCA: On February 27, 2023, EPA announced the availability of and solicited public comment on two draft documents that are being submitted to the Science Advisory Committee on Chemicals (SACC) for peer review: “Draft Proposed Principles of Cumulative Risk Assessment under the Toxic Substances Control Act” (draft proposed principles) and “Draft Proposed Approach for Cumulative Risk Assessment of High-Priority Phthalates and a Manufacturer-Requested Phthalate under the Toxic Substances Control Act” (draft proposed approach). 88 Fed. Reg. 12354. SACC will consider and review these documents at a four-day virtual public meeting on May 8 to 11, 2023. Comments are due April 28, 2023, for distribution to SACC before the meeting. For more information on next steps and our insightful commentary, please read our March 1, 2023, memorandum.
EPA Holds Third And Final TSCA Engineering Initiative Webinar: On February 28, 2023, EPA’s New Chemicals Program held the third and final webinar in its series on EPA’s process for assessing the potential risks of new chemicals under Section 5 of TSCA and the types of data EPA considers in this assessment. The webinar covered commonly missed information in Section 5 submissions and how EPA evaluates environmental release information for operations that occur at non-submitter sites. The webinar slides are available on EPA’s website. EPA did not record the webinar. For more information on EPA’s responses to questions asked during the webinar and our commentary, please read our March 2, 2023, memorandum.
EPA Issues SNURs For Certain Chemical Substances: On March 6, 2023, EPA issued final significant new use rules (SNUR) under TSCA for chemical substances that were the subject of premanufacture notices (PMN). 88 Fed. Reg. 13696. The SNURs require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA’s evaluation of the use, under the conditions of use for that chemical substance, within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required by that determination. The SNURs will be effective May 5, 2023.
EPA Requests Public Comment On Candidates For Membership On TSCA SACC: On March 8, 2023, EPA opened a 30-day comment period on nominations for candidates to serve on the TSCA SACC. According to EPA, there are currently 17 SACC members, with eight membership terms that will soon expire. Biographies for all candidates under consideration are available online. In addition, biographies for current SACC members are available on the SACC website. Comments on the nominations are due April 7, 2023. EPA states that it will use comments received to assist it in selecting new members of the SACC by June 2023.
EPA Announces P2 Grant For Environmental Justice Through Safer And More Sustainable Products: On March 8, 2023, EPA announced the availability of $16 million for two new grant opportunities to support states and Tribes in providing technical assistance to businesses seeking to develop and adopt pollution prevention (P2) practices that advance environmental justice in underserved communities. The Request for Applications for P2 investments include the Pollution Prevention Grant: Environmental Justice Through Safer and More Sustainable Products. The goal of this grant is to address environmental justice by providing P2 technical assistance to businesses (e.g., information, training, expert advice) to improve human health and the environment in disadvantaged communities by increasing the supply, demand, and use of safer and more sustainable products, such as those that are certified by EPA’s Safer Choice Program, or those that conform to EPA’s Recommendations for Specifications, Standards and Ecolabels for Federal Purchasing (EPA Recommendations). EPA will hold informational webinars on March 21, March 23, March 28, and March 30, 2023. Although EPA’s press release states that applications for the grant are due June 6, 2023, the information on grants.gov states that the closing date for applications is June 20, 2023. More information is available in our March 15, 2023, blog item.
President Biden’s FY 2024 Budget Includes Additional Funding For TSCA And Funding To Address PFAS Pollution: On March 9, 2023, President Biden released his fiscal year (FY) 2024 budget. According to EPA’s March 9, 2023, press release, the budget requests over $12 billion in discretionary budget authority for EPA in FY 2024, a $1.9 billion or 19 percent increase from the FY 2023 enacted level. Highlights of the FY 2024 budget include:
- Ensuring Safety of Chemicals for People and the Environment: The budget provides an investment of $130 million, $49 million more than the 2023 enacted level, to build core capacity to implement TSCA. According to EPA, in FY 2024, it “will focus on evaluating, assessing, and managing risks from exposure to new and existing industrial chemicals to advance human health protection in our communities.” EPA states that “[a]nother priority is to implement FIFRA to ensure pesticides pose no unreasonable risks to human health and the environment.”
- Tackling PFAS Pollution: The budget provides approximately $170 million to combat PFAS pollution. This request allows EPA to continue working toward commitments made under EPA’s 2021 PFAS Strategic Roadmap, including: increasing its knowledge of PFAS impacts on human health and ecological effects; restricting use to prevent PFAS from entering the air, land, and water; and remediating PFAS that have been released into the environment.
EPA Opens Registration For Part Two Of Its Webinar Series On Reviewing MMOs: EPA has opened registration for the second of its two-part webinar series on EPA’s new standardized process to assess risk and apply mitigation measures, as appropriate, for mixed metal oxides (MMO), including new and modified cathode active materials (CAM). The webinar, which will be held March 30, 2023, will give an in-depth look into the standardized risk assessment approach and present various case scenarios and a decision tree for identifying potential hazards and risks. The kickoff webinar, held in November 2022, provided a broad overview of the approach and answered stakeholder questions. A summary of the first webinar is available in our November 23, 2022, memorandum.
EPA Requests Nominations For Drinking Water CCL 6: On February 17, 2023, EPA requested nominations of chemicals, microbes, or other substances that are not currently regulated in drinking water for possible inclusion on the Sixth Contaminant Candidate List (CCL 6). 88 Fed. Reg. 10316. EPA requests that nominations include information showing the nominated contaminant is known or anticipated to occur in public water systems and indicating the nominated contaminant may have an adverse health effect on humans. Nominations are due April 18, 2023.
EPA Reaffirms Scientific, Economic, And Legal Underpinnings Of Limits On Toxic Air Pollution From Power Plants: On February 17, 2023, EPA announced that it is reaffirming the scientific, economic, and legal underpinnings of the 2012 Mercury and Air Toxics Standards (MATS) for power plants, which required significant reductions of mercury, acid gases, and other harmful pollutants. According to EPA, “[c]ontrolling these emissions improves public health by reducing fatal heart attacks, reducing cancer risks, avoiding neurodevelopmental delays in children, and helping protect our environment.” EPA states that the final rule leaves the current emissions standards unchanged and ensures the continuation of public health protections provided by these requirements. When weighing the substantial burden that hazardous air pollutants (HAP), including mercury, impose on public health against the reasonable costs of controlling these emissions, EPA “finds that it is appropriate and necessary to regulate emissions of air toxics from power plants” under the Clean Air Act (CAA). EPA notes that it is also continuing to consider the MATS Risk and Technology Review, as directed by Executive Order 13990, to determine whether more stringent protections for hazardous air pollution from power plants are feasible and warranted and expects to address that review in a separate action.
EPA Completes Technology Review For Miscellaneous Coating Manufacturing Source Category: On February 22, 2023, EPA took final action on the technology review conducted on the Miscellaneous Coating Manufacturing source category regulated under the National Emission Standards for Hazardous Air Pollutants (NESHAP). 88 Fed. Reg. 10842. These final amendments include provisions for inorganic HAP standards for process vessels. The final rule was effective February 22, 2023.
EPA Completes Review Of NSPS For Lead Acid Battery Manufacturing Plants And Technology Review For NESHAP For Lead Acid Battery Manufacturing Area Sources: On February 23, 2023, EPA published the final results of its review of the New Source Performance Standards (NSPS) for Lead Acid Battery Manufacturing Plants and the technology review for the NESHAP for Lead Acid Battery Manufacturing Area Sources. 88 Fed. Reg. 11556. EPA states that it is issuing final revised lead emission limits for grid casting, paste mixing, and lead reclamation operations for both the area source NESHAP and under a new NSPS subpart (for lead acid battery manufacturing facilities that begin construction, reconstruction, or modification after February 23, 2022). In addition, EPA is issuing the following final amendments for both the area source NESHAP and under the new NSPS subpart: performance testing once every five years to demonstrate compliance; work practices to minimize emissions of fugitive lead dust; increased inspection frequency of fabric filters; clarification of activities that are considered to be lead reclamation activities; electronic reporting of performance test results and semiannual compliance reports; and the removal of exemptions for periods of startup, shutdown, and malfunctions (SSM). EPA is revising the applicability provisions in the area source NESHAP such that facilities that make lead-bearing battery parts or process input material, including but not limited to grid casting facilities and lead oxide manufacturing facilities, will be subject to the area source NESHAP. The final rule was effective February 23, 2023. The IBR of certain publications listed in the rule is approved by the Director of the Federal Register as of February 23, 2023.
PHMSA Announces Public Meetings In 2023 For International Standards On The Transport Of Dangerous Goods: The Pipeline and Hazardous Materials Safety Administration (PHMSA) will host four public meetings during 2023 in advance of certain international meetings. 88 Fed. Reg. 11512. For each of these meetings, PHMSA will solicit public input on current proposals. Each public meeting will take place approximately two weeks preceding the following international meetings:
- The International Civil Aviation Organization’s (ICAO) Dangerous Goods Panel (DGP) Working Group 23 (WG/23) scheduled for May 15-19, 2023, in Rio de Janeiro, Brazil.
- The 62nd session of the United Nations Sub-Committee of Experts on the Transport of Dangerous Goods (UNSCOE TDG) scheduled for July 3-July 7, 2023, in Geneva, Switzerland.
- The 29th session of the ICAO DGP (DGP/29) scheduled for November 13-17, 2023, in Montreal, Canada.
- The 63rd session of the UNSCOE TDG scheduled for November 27-December 6, 2023, in Geneva, Switzerland.
EPA Announces $2.4 Billion For Clean Water Infrastructure Upgrades Through The Bipartisan Infrastructure Law: On February 24, 2023, EPA announced over $2.4 billion from President Biden’s Bipartisan Infrastructure Law for states, Tribes, and territories through this year’s Clean Water State Revolving Fund (CWSRF). According to EPA, the funding will support communities in upgrading essential water, wastewater, and stormwater infrastructure that protects public health and treasured water bodies across the nation. EPA states that nearly half of the funding will be available as grants or principal forgiveness loans helping underserved communities across America invest in water infrastructure, while creating good-paying jobs.
EPA Releases 2022 Power Plant Emissions Data: On February 24, 2023, EPA announced the release of its annual data on 2022 emissions from power plants in the lower 48 states. According to EPA, although electricity demand increased by two percent for these power plants (and by three percent for all electric generation in the first 11 months of 2022), emissions decreased from 2021, due primarily to changes in the mix of fuels used in electricity generation. EPA notes that this “reflects the long-standing trend of decreasing annual emissions.” Data from 2022 showed a six percent decrease in coal generation and a seven percent increase in natural gas generation from 2021.
EPA’s OECA Will Hold Listening Sessions On Potential CERCLA Enforcement Discretion Policy For Addressing PFAS Contamination At Superfund Sites: EPA announced on March 2, 2023, that the Office of Enforcement and Compliance Assurance (OECA) will hold two public listening sessions to receive individual input related to concerns about potential liability under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). The listening sessions will focus on an enforcement policy related to responsible parties’ financial obligations under PFAS contamination response actions. According to EPA, it will review and consider the input received in drafting a CERCLA PFAS enforcement discretion and settlement policy “to the extent that PFAS cleanup enforcement efforts occur under CERCLA.” The first session was held March 14, 2023. The second session will be held March 23, 2023. Registration is required. The registration form provides the option for participants to make live verbal remarks or to listen. Information on the opportunity to speak at the session is provided on the registration form. Written comments related to the listening sessions are due March 31, 2023. More information is available in our March 7, 2023, blog item.
EPA Announces Enforcement Actions To Control HFC Imports: On March 2, 2023, EPA announced several enforcement actions that support national and international goals to reduce the use of hydrofluorocarbons (HFC) “in our fight against climate change.” EPA states that the civil penalty actions include three landmark settlements with HFC importers who failed to report their imported quantities in violation of the CAA’s Greenhouse Gas Reporting Program: Artsen Chemical America, LLC ($247,601 penalty), Harp USA, Inc. ($275,000 penalty), and the IGas Companies ($382,473 penalty). EPA is “aggressively pursuing similar actions against several other importers that failed to report their HFCs.”
PHMSA Proposes HMR Amendments: On March 3, 2023, PHMSA proposed to amend the Hazardous Materials Regulations (HMR) to update, clarify, improve the safety of, or streamline various regulatory requirements. 88 Fed. Reg. 13624. According to PHMSA, the rulemaking responds to 18 petitions for rulemaking submitted by the regulated community between May 2018 and October 2020 that request PHMSA address a variety of provisions, including but not limited to those addressing packaging, hazard communication, and the incorporation by reference of certain documents. PHMSA states that the proposed revisions “maintain or enhance the existing high level of safety under the HMR while providing clarity and appropriate regulatory flexibility in the transport of hazardous materials.” Comments are due May 2, 2023. PHMSA notes that it will consider late-filed comments “to the extent possible.”
EPA Corrects Wood Preserving Area Sources NESHAP: On March 8, 2023, EPA issued its final technology review conducted for the Wood Preserving Area Sources NESHAP category. 88 Fed. Reg. 14280. EPA states that while it is making no changes to the existing standards as a result of the technology review, “this action establishes minor editorial and formatting changes to the Wood Preserving Area Sources NESHAP table of applicable general provisions.” In addition, EPA made final technical corrections to the Surface Coating of Wood Building Products NESHAP. The final rule was effective March 8, 2023.
EPA Will Propose Stronger Limits On Water Pollution From Power Plants: EPA announced on March 8, 2023, that it will propose to strengthen wastewater discharge standards that apply to coal-fired power plants. According to EPA, its proposed rule would establish more stringent discharge standards for three types of wastewater generated at coal-fired power plants: flue gas desulfurization wastewater, bottom ash transport water, and combustion residual leachate. The proposed rule also would address wastewater produced by coal-fired power plants that is stored in surface impoundments. The proposal would define these “legacy” wastewaters and will seek comment on whether to develop more stringent discharge standards for these wastewaters. EPA will hold public hearings on the proposed rule on April 20 and 25, 2023. Publication of the proposed rule in the Federal Register will begin a 60-day comment period.
EPA Proposes First-Ever National Drinking Water Standard For Six PFAS: On March 14, 2023, EPA announced that it will propose the first-ever national drinking water standard for six PFAS in the latest action under EPA’s PFAS Strategic Roadmap. The proposed National Primary Drinking Water Regulation (NPDWR) would regulate perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS) as individual contaminants, and would regulate four other PFAS — perfluorononanoic acid (PFNA), perfluorohexane sulfonic acid (PFHxS), perfluorobutane sulfonic acid (PFBS), and hexafluoropropylene oxide dimer acid (GenX Chemicals) — as a mixture. Publication of the proposed rule in the Federal Register will begin a 60-day comment period. EPA has posted a pre-publication version of the proposed rule, as well as additional supporting materials and technical materials, on its web page for the proposed NPDWR. EPA will hold two informational webinars about the proposed PFAS NDPWR on March 16, 2023, and March 29, 2023. EPA notes that the webinars will be similar, with each intended for specific audiences. Registration is required to attend. EPA will hold a public hearing on May 4, 2023. More information will be available in our forthcoming memorandum.
EPA Holds CERCLA PFAS Enforcement Listening Session: On March 14, 2023, EPA held the first of two public listening sessions to receive individual input related to concerns about potential liability under CERCLA. According to EPA’s March 2, 2023, press release, EPA will review and consider the input received in drafting a CERCLA PFAS enforcement discretion and settlement policy to the extent that PFAS cleanup enforcement efforts occur under CERCLA. EPA intends to focus on manufacturers, federal facilities, and other industrial parties whose actions result in the release of significant amounts of PFAS. EPA may choose not to take CERCLA enforcement action against certain entities. EPA will hold another listening session on March 23, 2023. Registration is required. To share remarks verbally, participants must pre-register to speak by 5:00 p.m. (EDT) on March 20, 2023. Registration to listen will close on March 22, 2023, at noon (EDT). Written comments related to the listening sessions are due March 31, 2023. These comments are separate from EPA’s rulemaking process and will not be part of the PFOA/PFOS rulemaking docket. More information will be available in our forthcoming memorandum.
EPA Releases Draft Policy Assessment For Reconsideration Of The Ozone NAAQS: On March 15, 2023, EPA announced the availability of a revised draft document entitled Policy Assessment for the Reconsideration of the Ozone National Ambient Air Quality Standards, External Review Draft Version 2 (Draft PA). 88 Fed. Reg. 15940. EPA states that the Draft PA was prepared as a part of the current reconsideration of the 2020 final decision on the national ambient air quality standards (NAAQS) for ozone. According to EPA, when final, the PA is intended to ‘‘bridge the gap’’ between the scientific and technical information assessed in the 2020 Integrated Science Assessment for Ozone and Related Photochemical Oxidants, as well as any air quality, exposure, and risk analyses available in the reconsideration, and the judgments required of the Administrator. The primary and secondary ozone NAAQS are set to protect the public health and the public welfare from ozone and other photochemical oxidants in ambient air. Comments are due April 14, 2023.
FDA Withdraws “Food Standards; General Principles and Food Standards Modernization” Proposed Rule: On February 28, 2023, the U.S. Food and Drug Administration (FDA) announced withdrawal of its 2005 proposed rule in response to comments received in 2005 and after the FDA reopened the comment period for the proposed rule in 2022. 88 Fed. Reg. 12870. The proposed rule, published jointly with the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (USDA-FSIS), was intended in part to establish a set of general principles for the FDA and USDA-FSIS to use when considering whether to establish, revise, or eliminate a food standard. The withdrawal was effective immediately.
FDA Unveils New Dietary Supplement Ingredient Directory: On March 6, 2023, FDA unveiled a web page enabling the public to look up ingredients used in products marketed as dietary supplements and find quickly what FDA has stated about that ingredient and whether FDA has taken action regarding the ingredient. The directory is in list form and includes links to FDA’s actions and communications for each ingredient on the list. If there is a separate FDA web page for the ingredient, the directory links to that page. The directory is intended to be a one-stop shop of ingredient information that was previously found on different FDA web pages. This directory is intended to help manufacturers, retailers, and consumers stay informed about ingredients that may be found in products marketed as dietary supplements and locate quickly information about such ingredients on FDA’s website.
USDA Proposes New Requirements “Product of USA” Label: On March 13, 2023, USDA released a proposed rule with new regulatory requirements to better align the voluntary “Product of USA” label claim with consumer understanding of what the claim means. 88 Fed. Reg. 15290. The proposed rule allows the voluntary “Product of USA” or “Made in the USA” label claim to be used on meat, poultry, and egg products only when they are derived from animals born, raised, slaughtered, and processed in the United States. The announcement, according to USDA, delivers on one of the key actions in President Biden’s Executive Order on Promoting Competition in the American Economy, and a commitment made in the Biden-Harris Administration’s Action Plan for a Fairer, More Competitive, and More Resilient Meat and Poultry Supply Chain. Comments on the proposed rule are due May 12, 2023.
FDA Summarizes Status Of COVID-19 Guidance Documents: On March 13, 2023, FDA issued a notice explaining how the end of the Public Health Emergency will impact FDA’s COVID-19 guidance documents. 88 Fed. Reg. 15417. Information is provided for the following policies related to Food Safety Modernization Act (FSMA) requirements:
- Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency; and
- Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements During the COVID-19 Public Health Emergency.
FDA Enhances Approach To Food Chemical Safety: According to the FDA website, it is enhancing its approach to food chemical safety in three key areas with corresponding objectives that complement its existing food chemical safety monitoring programs:
- Expanding tools and methods used when conducting safety reviews and assessments of chemicals in food and substances that come into contact with food to keep pace with scientific advances and technological innovations;
- Updating processes to identify, evaluate, prioritize, and communicate new and evolving information to determine if reassessment of a chemical by FDA is warranted; and
- Continuing to monitor the food supply to ensure that chemicals in food are present at levels that are not a risk to public health.
FDA states that as it continues to enhance its approach toward regulating chemicals in food or that come into contact with food, it will also seek additional scientific and other stakeholder perspectives on the activities, processes, and tools in these key areas and improved transparency.
White House OSTP Summarizes Nano4EARTH Kickoff Workshop; Recordings Available Online: The kickoff workshop for Nano4EARTH was held January 24-25, 2023. Nano4EARTH will leverage recent investments in understanding and controlling matter at the nanoscale to develop technologies, industries, and training opportunities that address climate change. On January 26, 2023, the White House Office of Science and Technology Policy (OSTP) issued a press release summarizing the workshop. More information is available in our February 21, 2023, blog item.
OECD Webinar On TG No. 125: Nanomaterial Particle Size And Size Distribution Of Nanomaterials Available For Replay: The Organization for Economic Cooperation and Development (OECD) held a webinar on February 7, 2023, to present the methods described in Test Guideline (TG) No. 125 to determine the size and size distributions of nanomaterial particles and fibers spanning from one nanometer (nm) to 1,000 nm. It also presented the use and limitations of this TG, as well as of the validation exercise that was done to support its development. OECD organized the webinar to increase awareness of the newly adopted TG. The webinar is available for replay, and the presentations are available online.
EC Appeals European General Court Decision Annulling The Harmonized Classification And Labeling Of Titanium Dioxide: On February 14, 2023, the European Commission (EC) appealed the November 23, 2022, decision of the European General Court that annuls the 2019 harmonized classification and labeling of titanium dioxide as a carcinogenic substance by inhalation in certain powder forms. France, which intervened in the court case, filed its appeal of the court’s decision on February 8, 2023. More information is available in our February 27, 2023, blog item.
ECOS And BUND Publish Recommendations For The Testing Of Nano- And Advanced Materials: On February 15, 2023, the Environmental Coalition on Standards (ECOS) and the Bund für Umwelt und Naturschutz Deutschland (BUND), non-governmental organizations in Europe working on both standardization and nanotechnologies, announced the release of a report entitled “Making nano- and advanced materials safe for all: State of play of discussions at the OECD.” According to the organizations, the use of nanomaterials remains underregulated in the European Union (EU). The press release states that the main issue is that there are still many unknowns in the nanomaterial domain. More information is available in our February 16, 2023, blog item.
NIOSH Announces Publication Of Article On The Results Of 2019 Survey Of Engineered Nanomaterial Occupational Health And Safety Practices: The March 2023 issue of the National Institute for Occupational Safety and Health’s (NIOSH) eNews includes an item announcing publication of an article entitled “Results of the 2019 Survey of Engineered Nanomaterial Occupational Health and Safety Practices” in the International Journal of Environmental Research and Public Health. The abstract states that the survey data “are valuable for gauging the reach and influence of the NIOSH NTRC on nano OHS and for informing future outreach, particularly to small businesses.” More information is available in our March 3, 2023, blog item.
NIA Posts Recording Of Antimicrobial Treatment Webinar: The Nanotechnology Industries Association (NIA) has posted a recording of its March 6, 2023, webinar on “Nano in Action: Antimicrobial Treatment.” Subjects covered included the current cleaning and sanitation protocols of public spaces; the kind of nano-based solutions available to meet this need; and how to measure the efficacy of an antimicrobial treatment. B&C is a proud member of the NIA.
Registration Opens For NNI Webinar On “What’s Next In NanoEHS: The Young Professional’s Perspective”: The National Nanotechnology Initiative (NNI) will hold a webinar on “What’s Next in NanoEHS: The Young Professional’s Perspective” on March 28, 2023. Registration is now open. More information is available in our March 7, 2023, blog item.
B&C® Biobased And Sustainable Chemicals Blog: For access to a summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to https://biobasedblog.lawbc.com.
Bipartisan Senate Legislation Would Expand Federal Research To Address PFAS Contamination Effectively: Senator Gary Peters (D-MI) reintroduced bipartisan legislation (S. 466) to help advance the federal government’s understanding of PFAS and better inform plans to address PFAS contamination effectively. According to Peters’s February 23, 2023, press release, the Federal PFAS Research Evaluation Act “would require that federal agencies with expertise related to PFAS work with the National Academies of Sciences, Engineering, and Medicine on a consensus study that would help inform decisions by the federal government, state government, key stakeholders and partners on how to best address PFAS contamination.”
Senate Legislation Would Prevent Future Train Derailment Disasters: On March 1, 2023, Senators Sherrod Brown (D-OH) and JD Vance (R-OH) introduced the bipartisan Railway Safety Act of 2023 (S. 576) to prevent future train disasters like the derailment that devastated East Palestine, Ohio. According to Brown’s March 1, 2023, press release, the bill will take a number of key steps to improve rail safety protocols, such as enhancing safety procedures for trains carrying hazardous materials, establishing requirements for wayside defect detectors, creating a permanent requirement for railroads to operate with at least two-person crews, increasing fines for wrongdoing committed by rail carriers, and more.
House Bill Would Amend FIFRA To Define Biostimulants: On March 8, 2023, Representative Jimmy Panetta (D-CA) introduced a bill (H.R. 1472) that would amend the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to provide for a consistent definition for plant biostimulants. Panetta introduced similar legislation, the Plant Biostimulant Act, in the previous Congress.
House Bill Would Amend CERCLA To Protect Communities From Superfund Sites Vulnerable To Climate Change: Representative Emanuel Cleaver, II (D-MO) introduced legislation (H.R. 1444) on March 8, 2023, that would amend CERCLA to protect communities from toxic waste at Superfund sites that are vulnerable to natural disasters and the effects of climate change. According to Cleaver’s March 8, 2023, press release, the Preparing Superfund for Climate Change Act would enhance protections for communities close to Superfund sites by requiring EPA to account for climate change in their plans for managing Superfund sites.
Maine Congressional Delegation Introduces Bill To Support Farmers Affected By PFAS: On March 9, 2023, Representatives Chellie Pingree (D-ME) and Jared Golden (D-ME) introduced the Relief for Farmers Hit with PFAS Act (H.R. 1517). According to Pingree’s March 10, 2023, press release, funds authorized by the legislation could be used for a variety of purposes at the state level, including:
- Providing financial assistance to affected farmers;
- Building capacity for PFAS testing for soil or water sources;
- Monitoring blood for individuals to make informed decisions about their health;
- Upgrading or purchasing equipment to ensure a farm remains profitable during or after known PFAS contamination;
- Developing alternative production systems or remediation strategies;
- Developing educational programs for farmers experiencing PFAS contamination; and
- Researching soil and water remediation systems, and the viability of those systems for farms.
Pingree’s press release states that Senators Susan Collins (R-ME) and Angus King (I-ME) will introduce companion legislation in the Senate.
Will PFAS Be The End Of “Natural” Product Claims?: On January 27, 2023, plaintiffs in the Southern District of New York announced their displeasure with the inconvenient fact that Tom’s Wicked Fresh! mouthwash contains measurable concentrations of PFAS. They channeled their displeasure by bringing a class action suit against Colgate-Palmolive Company and Tom’s of Maine, Inc. for fraud and unjust enrichment based on several state consumer protection laws, the federal Magnuson-Moss Warranty Act, and common law tort. Plaintiffs assert that “natural” Tom’s Wicked Fresh! mouthwash is anything but natural, in that it contains per- and polyfluoroalkyl substances or “PFAS,” a category of synthetic chemicals are not natural. More information is available in our February 23, 2023, blog item.
Maine Proposes Rule To Clarify Reporting Requirements For PFAS In Products: On February 14, 2023, the Maine Department of Environmental Protection (MDEP) announced a much anticipated proposed rule intended to provide additional guidance on the notification requirements and sales prohibitions for products and product components containing intentionally added PFAS. MDEP will hold a public hearing on April 20, 2023. Comments are due May 19, 2023, by 5:00 p.m. (EDT). The MDEP program could well serve as a template for other states. For more information, please read our February 17, 2023, memorandum.
EPA Announces Availability Of The Protocol For The Ethylbenzene IRIS Assessment: On February 17, 2023, EPA announced a 30-day public comment period associated with release of the Protocol for the Ethylbenzene IRIS Assessment (Preliminary Assessment Materials). 88 Fed. Reg. 10320. EPA states that the document communicates the rationale for conducting the Integrated Risk Information System (IRIS) assessment of ethylbenzene, describes screening criteria to identify relevant literature, outlines the approach for evaluating study quality, and describes the methods for dose-response analysis. Comments are due March 20, 2023.
EPA Announces Both EPA And FDA To Conduct Virtual Public Meeting And Request Comments On Modernizing Their Approach To Oversight Of Certain Products: On February 22, 2023, EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) announced that it will co-host a virtual public meeting with FDA’s Center of Veterinary Medicine (CVM) on March 22, 2023. As stated in our February 17, 2023, blog, EPA and FDA are considering how best to update their respective oversight responsibilities for specific products in an efficient and transparent manner and in alignment with each agency’s expertise. According to EPA, the purpose of the comment period and virtual public meeting is to obtain feedback from stakeholders on ideas for modernizing EPA’s and FDA’s approach to product oversight.
EPA also has opened a docket for the agencies to receive comments on their current approach to the oversight of various products regulated as either pesticides by EPA or new animal drugs by FDA, with a focus on parasite treatment products applied topically to animals and in genetically engineered pest animals for use as pest control tools. EPA posted to the docket, and is requesting comments on, a document entitled “WHITEPAPER: A Modern Approach to EPA and FDA Product Oversight” (Whitepaper) that describes the current challenges and highlights the potential benefits of a modernized approach to oversight of these products. The Whitepaper is available at EPA-HQ-OPP-2023-0103-0002, and comments on the Whitepaper are due on or before April 24, 2023.
EPA announced that registration for the virtual public meeting is available and closes at 11:59 p.m. (EDT) on March 15, 2023. Requests for oral presentations must be made by March 15, 2023. Comments can be submitted in regulations.gov under docket EPA-HQ-OPP-2023-0103 until April 24, 2023. Our commentary is available in our March 6, 2023, blog item.
DOJ Announces New Voluntary Self-Disclosure Policy For U.S. Attorney’s Offices: On February 22, 2023, the U.S. Department of Justice (DOJ) announced the implementation of the new U.S. Attorney’s Offices’ Voluntary Self-Disclosure Policy (VSD). The policy, which is effective immediately, details the circumstances under which a company will be considered to have made a VSD of misconduct to a U.S. Attorney’s Office (USAO). A company is considered to have made a VSD if it becomes aware of misconduct by employees or agents before that misconduct is publicly reported or otherwise known to DOJ, and discloses all relevant facts known to the company about the misconduct to a USAO in a timely fashion prior to an imminent threat of disclosure or government investigation. A company that voluntarily self-discloses and fully meets certain other requirements of the policy, by fully cooperating and timely and appropriately remediating the criminal conduct (including agreeing to pay all disgorgement, forfeiture, and restitution resulting from the misconduct), will receive “significant benefits,” including that the USAO will not seek a guilty plea; may choose not to impose any criminal penalty, and will not impose a criminal penalty that is greater than 50 percent below the low end of the U.S. Sentencing Guidelines (USSG) fine range; and will not seek the imposition of an independent compliance monitor if the company demonstrates that it has implemented and tested an effective compliance program.
OIRA Calls For Feedback On Recommendations To Encourage More Engagement In The Regulatory Process; Hold Listening Session: In February 2023, the Office of Information and Regulatory Affairs (OIRA), within the Office of Management and Budget (OMB), published a summary of learnings and potential recommendations on broadening public engagement in the federal regulatory process. The learnings and recommendations were developed from written submissions and a public engagement session in November 2022 with hundreds of participants. OIRA invited feedback on the recommendations as it continues to consider them, Feedback was due to OIRA on March 10, 2023. OIRA held a virtual listening session on March 7, 2023. More information is available in our March 3, 2023, blog item.
IRIS Program Updates Outlook Document: The IRIS Program announced in February 2023 the release of the February 2023 IRIS Program Outlook. To maintain transparency, the IRIS Program provides an updated outlook of upcoming program activities. The IRIS Program Outlook outlines assessments that are in development and projected public milestone dates. Updates to the IRIS Program Outlook document occur at least three times a year (February, June, and October).
EPA OIG Finds EPA’s January 2021 PFBS Toxicity Assessment Did Not Uphold EPA’s Commitments To Scientific Integrity And Information Quality: EPA Office of Inspector General (OIG) announced on March 7, 2023, that EPA did not follow the typical intra-agency review and clearance process during the development and publication of the January 2021 PFBS toxicity assessment. OIG states that during final clearance, “a political appointee directed that a last-minute review be conducted of the uncertainty factors used to calculate toxicity values, resulting in a scientific disagreement that caused delay, confusion, and significant changes to the near-final, peer-reviewed work product.” While EPA staff expressed scientific integrity concerns about the last-minute review and risks to public health, EPA lacked policies and procedures to address these concerns. According to OIG, without updates to policies and procedures, EPA cannot fulfill its commitment to scientific integrity and information quality. More information is available in our March 10, 2023, blog item.
SAB Biosolids Panel Will Peer Review EPA’s Biosolid Risk Assessment Framework: On March 14, 2023, EPA announced public meetings of the Science Advisory Board (SAB) Biosolids Panel. 88 Fed. Reg. 15715. The purpose of the meetings is to receive a briefing from EPA, review and discuss charge questions, and peer review the EPA’s biosolid risk assessment framework. The SAB Biosolids Panel will meet on the following dates: April 5, 2023; May 2-3, 2023; and May 31, 2023. All meeting materials, including the agendas, will be available on the SAB web page.
White House OSTP Releases State Of Science Report On PFAS: The National Science and Technology Council announced on March 14, 2023, that the White House OSTP released a state of science report on PFAS. The report provides an analysis of the state of the science of PFAS and information that will be used to direct the development of a federal strategic plan. The report focuses on the current science of PFAS as a chemical class, identifies scientific consensus, and portrays uncertainties in the scientific information where consensus is still sought. The report identifies four key strategic areas that, when addressed, will generate actionable information to address PFAS: removal, destruction, or degradation of PFAS; safer and environmentally friendlier alternatives; sources and pathways of exposure; and toxicity.
FTC Will Host May 23, 2023, Workshop On Recyclable Claims And The Green Guides: The Federal Trade Commission (FTC) will host a workshop on May 23, 2023, to examine “recyclable” adverting claims as part of its review of the Guides for the Use of Environmental Marketing Claims (Green Guides). 88 Fed. Reg. 14092. The workshop, “Talking Trash at the FTC: Recyclable Claims and the Green Guides,” is free and open to the public, and pre-registration is not required. The workshop will cover topics including the current state of recycling practices and recycling-related advertising in the United States, consumer perception of current and emerging recycling-related claims, and the need for any updates or other changes to the Green Guides related to recycling claims. Written comments related to the issues to be discussed at the workshop must be received by June 13, 2023. More information is available in our March 1, 2023, blog item.
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