Wrap-Up of Federal and State Chemical Regulatory Developments, August 2024

TSCA/FIFRA/TRI

EPA Releases Draft Risk Evaluation For 1,1-Dichloroethane And Draft Hazard Assessment Of 1,2-Dichloroethane For Public Comment And Peer Review:On July 2, 2024, the U.S. Environmental Protection Agency (EPA) announced the release of the draft risk evaluation for 1,1-dichloroethane (1,1-DCE) and the draft human health hazard assessment supporting the draft risk evaluation for 1,2-dichloroethane (1,2-DCE, also known as ethylene dichloride) prepared under the Toxic Substances Control Act (TSCA). 89 Fed. Reg. 54815. EPA states in its July 1, 2024, press release that it “preliminarily determined 1,1-dichloroethane poses unreasonable risk to human health (of workers) and the environment.” According to EPA, the effects to people from exposure to 1,1-DCE and 1,2-DCE are “kidney and other cancers, as well as harmful non-cancer renal, nasal, immune system, and reproductive effects.” EPA submitted the draft documents to the Science Advisory Committee on Chemicals (SACC) for peer review. On August 27, 2024, SACC will hold a preparatory meeting to consider the scope and clarity of the draft charge questions for the peer review; written comments on the scope and clarity of the charge questions are due on or before noon (12:00 p.m. EDT) on August 23, 2024. On September 17 through 20, 2024, SACC will hold a peer review meeting to consider the draft documents and public comments. Comments on the draft documents are due on or before September 3, 2024. Please consult the Federal Register notice for registration information. For more information, please read the full memorandum.

EPA Publishes Compliance Guide For Final Methylene Chloride Risk Management Rule: On July 10, 2024, EPA published a compliance guide for its final methylene chloride risk management rule issued under TSCA. According to EPA, the compliance guide will help industry, workers, and other interested stakeholders understand and comply with the new regulations to prevent injuries, long-term illnesses, and deaths. EPA also announced that in June 2024, it released a fact sheet on the rule containing information on who is subject to the rule along with a summary of compliance timelines. As reported in our May 17, 2024, memorandum, EPA issued on May 8, 2024, a final rule to address the unreasonable risk of injury to health that EPA identified as caused by methylene chloride under its conditions of use (COU). 89 Fed. Reg. 39254. According to EPA, the final rule will prevent serious illness and death associated with uncontrolled exposures to methylene chloride by preventing consumer access to methylene chloride and by restricting the industrial and commercial use of methylene chloride while also allowing for a reasonable transition period where an industrial and commercial use of methylene chloride is being prohibited, will provide a time-limited exemption for a critical or essential use of methylene chloride for which no technically and economically feasible safer alternative is available, and will protect workers from the unreasonable risk of methylene chloride while on the job. The final rule was effective July 8, 2024. For more information, please read the full memorandum.

EPA Grants TSCA Section 21 Petition Seeking Section 6 Rule Prohibiting Three PFAS Found In Fluorinated Plastic Containers:EPA announced on July 11, 2024, that it granted a petition filed under Section 21 of TSCA requesting that EPA establish regulations under TSCA Section 6 prohibiting the manufacturing, processing, use, distribution in commerce, and disposal of three per- and polyfluoroalkyl substances (PFAS) formed during the fluorination of plastic containers. EPA “will promptly commence an appropriate proceeding under TSCA Section 6.” According to EPA’s announcement, EPA intends to request information, including the number, location, and uses of fluorinated containers in the United States; alternatives to the fluorination process that generates perfluorooctanoic acid (PFOA), perfluorononanoic acid (PFNA), and perfluorodecanoic acid (PFDA); and measures to address risk from PFOA, PFNA, and PFDA formed during the fluorination of plastic containers. The action reflects a growing trend to optimize TSCA’s citizen petition provision, a topic discussed at length at our TSCA Reform — Eight Years Later program held on June 26, 2024. For more information, please read the full memorandum.

EPA Announces Changes To When It Assesses Potential Exposure To Pesticide Spray Drift: On July 15, 2024, EPAannounced it is updating its process when it assesses the potential for exposure to pesticide drift when it reviews new active ingredient pesticide registrations or makes decisions on new use directions for existing pesticide registrations. EPA states it will review potential exposure to drift earlier in the review process. More information is available in our July 25, 2024, blog.

CEH And PEER File Suit Seeking TSCA Section 6 Rule Prohibiting Production Of PFOA During Fluorination Of Plastic Containers: On July 25, 2024, the Center for Environmental Health (CEH) and Public Employees for Environmental Responsibility (PEER) filed suit against EPA in the U.S. District Court for the District of Columbia seeking a rule under Section 6 of TSCA to prohibit the production of PFOA during Inhance Technologies, LLC’s (Inhance) fluorination process. As reported in our May 23, 2024, blog item on their notice of intent to sue (NOI), the petitioners claim that EPA failed to perform non-discretionary duties prescribed by TSCA Section 4(f). Petitioners state that to assure that EPA discharges its duty, the court “should enter an order setting an expeditious deadline for the Agency to propose a rule under TSCA section 6 prohibiting production of PFOA during the Inhance fluorination process.” Petitioners note that under TSCA Section 7(a)(2), “if EPA has not made a section 6(a) rule immediately effective under section 6(d)(3), it ‘shall’ commence a suit for immediate injunctive relief where the substance or mixture subject to the rule is ‘imminently hazardous.’” Accordingly, the court “must therefore order EPA to immediately file an imminent hazard action under TSCA section 7 against Inhance to prohibit the formation of PFOA during the fluorination process or to make its proposed rule under section 6(a) imposing such a ban immediately effective upon publication in the Federal Register.” More information is available in our July 30, 2024, blog item.

EPA Begins 90-Day Comment Period On Proposed High-Priority Substance Designations For Five Chemicals:EPA announced on July 25, 2024, that it is proposing to designate acetaldehyde, acrylonitrile, benzenamine, vinyl chloride, and 4,4-methylene bis(2-chloroaniline) (MBOCA) as high-priority substances (HPS) for risk evaluation under TSCA. 89 Fed. Reg. 60420. EPA is providing a 90-day comment period, during which interested persons may submit comments on the proposed designations of these chemicals as HPSs for risk evaluation. EPA states that it is interested in comments that would inform the exposure and hazard assessments and the identification of COUs for these chemicals. Comments are due October 23, 2024. For more information, please read the full memorandum.

Senate Committee Holds Hearing On Understanding The Potential Environmental Impacts Of 6PPD: The Senate Committee on Environment and Public Works held a hearing on July 31, 2024, on “Understanding the Potential Environmental Impacts of the Chemical 6PPD.” The witnesses included:

• Katrina Lassiter, Program Manager, Hazardous Waste and Toxics Reduction Program, Washington State Department of Ecology (WDOE);

• Tracey Norberg, Executive Vice President and General Counsel, U.S. Tire Manufacturers Association (USTMA); and

• David B. Fischer, MPH, Counsel, Keller and Heckman LLP.

As reported in our November 3, 2023, blog item, on November 2, 2023, EPA granted a petition filed under TSCA Section 21 to address the use of N-(1,3-Dimethylbutyl)-N′-phenyl-p-phenylenediamine (6PPD) in tires. Earthjustice filed the petition on behalf of the Yurok Tribe, the Port Gamble S’Klallam Tribe, and the Puyallup Tribe of Indians and asked EPA to establish regulations prohibiting the manufacturing, processing, use, and distribution of 6PPD for and in tires. As reported in our November 16, 2023, blog item, USTMA announced on November 15, 2023, that it will partner with the U.S. Geological Survey (USGS) on a research project “to assess and refine methods of evaluating potential alternatives to 6PPD for use in tires.”

Registration Opens For August 28, 2024, Webinar On Use Of NAMs: On August 7, 2024, EPA announced that it will hold a webinar on August 28, 2024, on the use of new approach methodologies (NAM). The webinar, “The CATMoS Model for Acute Oral Toxicity and Evaluation of its Potential Use in a Regulatory Context for Pesticide Hazard and Risk Assessment,” is the fifth in a series held in collaboration with PETA Science Consortium International (PSCI), the Institute for In Vitro Sciences (IIVS), and the California Department of Pesticide Regulation (CDPR). More information is available in our August 14, 2024, blog item.

EPA Updates Safer Choice And DfE Standard: On August 8, 2024, EPA announced the availability of the final, updated Safer Choice and Design for the Environment (DfE) Standard (the Standard). 89 Fed. Reg. 64915. According to EPA, the update includes a name change to the title of the Standard, a revision to the packaging criteria, a new certification for cleaning service providers, a new provision allowing for preterm partnership termination under exceptional circumstances, and the addition of several product and functional use class requirements. EPA states that “Safer Choice helps consumers, businesses, and purchasers find products that perform and contain ingredients that are safer for human health and the environment.” DfE is a similar program that helps consumers and commercial buyers identify antimicrobial products that meet the health and safety standards of the normal pesticide registration process required by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as well as other EPA DfE criteria. The Standard was effective August 8, 2024. EPA has posted both the current Standard and a version that reflects the final changes. More information will be available in a forthcoming memorandum.

EPA Issues Proposed 1-BP Risk Management Rule:EPA issued a proposed rule on August 8, 2024, to address the unreasonable risk of injury to human health presented by 1-bromopropane (1-BP) under its COUs as documented in EPA’s August 2020 Risk Evaluation for 1-BP and the December 2022 Revised Risk Determination for 1-BP prepared under TSCA. 89 Fed. Reg. 65066. To address the identified unreasonable risk, EPA proposes requirements to, among other things, prevent consumer access to 1-BP, restrict the industrial and commercial use of 1-BP while also allowing for a reasonable transition period where an industrial and commercial use of 1-BP is being prohibited, and protect workers from the unreasonable risk of 1-BP while on the job. EPA will hold a webinar on August 28, 2024, to provide an overview of the proposed rule. Comments are due September 23, 2024. EPA states that under the Paperwork Reduction Act (PRA), “comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of your comments on or before September 9, 2024.” For more information about the proposed rule, please read the full memorandum.

RCRA/CERCLA/CWA/CAA/PHMSA/SDWA

EPA Amends Lime Manufacturing NESHAP: On July 16, 2024, EPA amended the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Lime Manufacturing Plants. 89 Fed. Reg. 57738. The amendments include final maximum achievable control technology (MACT) standards for hydrogen chloride, mercury, organic hazardous air pollutants (HAP), and dioxin/furans. The final rule will be effective September 16, 2024. The incorporation by reference (IBR) of certain publications listed in the rule is approved by the Director of the Federal Register as of September 16, 2024.

EPA Proposes Amendments To Hazardous Waste Combustors NESHAP: On July 24, 2024, EPA proposed amendments to the NESHAP for Hazardous Waste Combustors (HWC) to remove the exemptions and revise other provisions associated with emission standard exemptions for periods of malfunction, to add electronic reporting provisions, to amend emergency safety vent provisions, and to correct other minor provisions. 89 Fed. Reg. 59867. According to EPA, the removal of the exemption for periods of malfunction is predicated on the previous vacatur of emission standard exemptions for periods of startup, shutdown, and malfunction (SSM) from the applicable general provisions. EPA also proposes to remove or revise some associated requirements that are unnecessary, inappropriate, or redundant in the absence of the malfunction exemption, such as in recordkeeping and reporting. Comments are due September 9, 2024. Under the PRA, comments on the information collection provisions are best assured of consideration if OMB receives a copy of the comments by August 23, 2024.

EPA Announces Results Of Fourth Review Of Existing Drinking Water Standards: The Safe Drinking Water Act (SDWA) requires EPA to conduct a review every six years of existing national primary drinking water regulations (NPDWR) and determine which, if any, are appropriate for revision. The purpose of the Six-Year Review is to evaluate available information for regulated contaminants to determine if any new information on health effects, treatment technologies, analytical methods, occurrence, exposure, implementation, and/or other factors provides a basis to support a regulatory revision that would improve or strengthen public health protection. EPA announced on July 23, 2024, that while it “has recently completed several significant revisions to existing regulations and other regulatory revisions are currently underway, based on this periodic review of all NPDWRs, there are no additional candidates for regulatory revision at this time.” 89 Fed. Reg. 59623.

EPA Publishes Supplemental NPRM For Other Solid Waste Incineration Units Source Category: On July 25, 2024, EPA published a supplemental notice of proposed rulemaking (NPRM) regarding the proposed amendments to the new source performance standards (NSPS) and emission guidelines (EG) for the Other Solid Waste Incineration (OSWI) units source category published in the Federal Register on August 31, 2020. 89 Fed. Reg. 60342. In that action, EPA proposed changes to OSWI subcategories and related MACT floor redeterminations, applicability-related changes, and testing and monitoring flexibilities for certain small OSWI units, among other proposed changes. EPA states that based on its analysis of comments received after proposal and discussions with the state of Alaska and tribes, it proposes to add a definition for a rudimentary combustion device and asks for specific comment on this definition. EPA also proposes to postpone developing standards for such devices. Comments are due September 9, 2024.

PHMSA Will Hold Risk Modeling Public Workshop, Requests Comments: On July 25, 2024, the Pipeline and Hazardous Materials Safety Administration (PHMSA) announced that it will hold a public workshop on risk modeling methodologies and tools for the evaluation of gas, carbon dioxide, and hazardous liquid pipelines. 89 Fed. Reg. 60489. PHMSA requests comment on the topic, including submission of supporting abstracts of relevant engineering and technical modeling considerations to support improvement and advancement in pipeline risk management, such as modeling methods that follow PHMSA’s 2020 report on Pipeline Risk Modeling, Overview of Methods, and Tools for Improved Implementation. The public workshop will be held October 23-24, 2024. Public comments for consideration at the workshop are due October 9, 2024. Abstracts are due August 16, 2024. Registrations to attend the public workshop are due October 1, 2024. Individuals requiring accommodations, such as sign language interpretation or other ancillary aids, should notify Janice Morgan by phone at 202-815-4507 or by e-mail at Janice.Morgan@dot.gov no later than October 1, 2024.

EPA Amends Hazardous Waste Manifest And e-Manifest Regulations: On July 26, 2024, EPA amended the hazardous waste manifest regulations and the hazardous waste electronic manifest (e-Manifest) regulations under the Resource Conservation and Recovery Act (RCRA) to increase utility of the e-Manifest system in delivering benefits to reduce administrative burden and improve tracking of hazardous waste shipments, and to various related regulations. 89 Fed. Reg. 60692. Among other things, the final rule amends the manifest regulations for shipments of hazardous waste that are exported for treatment, storage, and disposal. The final rule also makes regulatory changes to the hazardous waste export and import shipment international movement document-related requirements to link the manifest data more closely with the international movement document data. In addition, the final rule makes regulatory amendments to three manifest-related reports. EPA notes that the final rule also includes conforming regulatory changes to the manifest regulations under TSCA for polychlorinated biphenyls (PCB) wastes to align these requirements better with the RCRA manifest regulations and the e-Manifest program. Lastly, the final rule makes technical corrections to fix typographical errors in the e-Manifest and movement document regulations. The final rule will be effective January 22, 2025.

EPA Will Convene e-Manifest Advisory Board For Meeting On September 17-19, 2024: On August 13, 2024, EPA announced that it will convene the Hazardous Waste Electronic System (e-Manifest) Advisory Board for a three-day virtual public meeting. 89 Fed. Reg. 65878. The purpose of the meeting is for EPA to seek the Board’s consultation and recommendations regarding the e-Manifest system (Meeting Theme: “Meeting the Needs of the User Community: e-Manifest Program Priorities and User Fees for FY 2026 and 2027”). The meeting will be held September 17-19, 2024. To make oral comments during the public meeting and be included on the meeting agenda, registration must be completed by 12:00 p.m. (EDT) on September 10, 2024. Written comments submitted to the public docket by September 10, 2024, will be provided to the e-Manifest Advisory Board for its consideration before the meeting.

FDA

FDA Publishes New Web Page For Microplastics And Nanoplastics In Foods: On July 24, 2024, the U.S. Food and Drug Administration (FDA) published a web page titled Microplastics and Nanoplastics in Foods, which FDA notes, “includes information on what is known about the health effects of microplastics and nanoplastics in foods and presents information about the FDA’s efforts to monitor the research on microplastics and nanoplastics in the food supply while working to advance the science through analysis of testing methodologies…” FDA makes the following “key points” on this web page:

• Some evidence suggests that microplastics and nanoplastics are entering the food supply, primarily through the environment;

• Current scientific evidence does not demonstrate that levels of microplastics or nanoplastics detected in foods pose a risk to human health; and

• FDA continues to monitor the research on microplastics and nanoplastics in foods and is taking steps to advance the science and ensure our food remains safe.

Creation of this web page may signal that FDA views these substances as contaminants of emerging concern and may devote increased scrutiny to this area in the coming years.

FDA Reopens Comment Period For Fluorinated Polyethylene Petition: On July 25, 2024, FDA reopened the comment period for a food additive petition (FAP) originally filed on April 26, 2024, that if approved would revoke the authorized indirect food additive use of fluorinated polyethylene at 21 C.F.R. Section 177.1615. 89 Fed. Reg. 60336. FDA is reopening the comment period for 60 days because the FAP was not uploaded to the docket, which did not allow respondents the ability to view the FAP. FDA is accepting comments until September 23, 2024.

FDA Announces New Features In Cosmetics Direct: On July 29, 2024, FDA announced two new features for cosmetic product manufacturers responsible for facility registration and cosmetic product listing submissions under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Users are now able to note a discontinuation and/or relisting of a cosmetic product within the electronic submission portal, Cosmetics Direct.

FDA Announces User Fees For FSMA Programs: On July 30, 2024, FDA announced user fee rates under the Food Safety Modernization Act (FSMA) for importers approved to participate in the Voluntary Qualified Importer Program (VQIP) and accreditation and certification bodies interested in participating in the Accredited Third-Party Certification Program (TPP) for Fiscal Year (FY) 2025. VQIP and TPP are voluntary fee-based programs that can assist market participants meet FDA’s FSMA regulations.

FDA Will Hold Meeting In September 2024 On Development Of Enhanced Systematic Process For Post-Market Assessment Of Chemicals In Food, Announces Executive Career Opportunities Related To Human Foods Program: On August 1, 2024, FDA announced that it will hold a public meeting on Wednesday, September 25, 2024, from 12:30 to 4:30 pm (EDT), on the development of an enhanced systematic process for its post-market assessment of chemicals in food. FDA states that this includes ingredients considered generally recognized as safe (GRAS), food additives, color additives, food contact substances, and contaminants. According to FDA, this is intended to guide its post-market assessment work going forward and includes a transparent process for identifying and prioritizing food chemicals currently in the market for safety reviews. FDA notes that this project is part of a larger enhanced approach for food chemical safety. During the meeting, FDA will hear stakeholder perspectives on this proposal. This information will help inform its thinking and further the development of the process. Questions for consideration are to be submitted through the registration process. Registration for in-person attendance will remain open through September 20, 2024, and for virtual attendance through September 24, 2024. A Regulations.gov docket (docket number FDA-2024-N-3609) is open for comments related to the event topic. Comments must be submitted on or before December 6, 2024.

On August 1, 2024, FDA also announced executive career opportunities related to its reorganization to create a unified Human Foods Program. FDA anticipates making more announcements as it continues to work toward the reorganized Human Foods Program. According to FDA, the reorganization will allow it to realize more effectively the vision laid out in the FSMA, elevate the importance of nutrition to help reduce diet-related diseases, modernize and strengthen oversight of food chemical safety, strengthen state partnerships, and embrace innovative food and agricultural technologies that will position FDA to regulate more effectively and uphold safety of the nation’s food supply.

NANOTECHNOLOGY

EC Seeks Applications For Newly Established Technology Council For Advanced Materials: On July 5, 2024, the European Commission (EC) launched a call for applications for members of the new Technology Council for Advanced Materials. According to the Directorate General (DG) for Internal Market, Industry, Entrepreneurship and SMEs, “this high-level group will coordinate efforts to meet future needs for advanced materials in Europe, and is key to building a single advanced materials ecosystem.” The Technology Council will comprise representatives from ministries of research and industry from European Union (EU) countries and high-level representatives from academic, research, and technology organizations, as well as representatives from industry and the EC. Applications are due September 9, 2024. More information is available in our July 22, 2024, blog item.

NIOSH NTRC Investigates Explosivity Of Nanomaterials: On August 1, 2024, the National Institute for Occupational Safety and Health (NIOSH) posted a blog item entitled “When Nanoparticles Blow Up — Explosion Hazards of Nanoparticles.” According to the blog item, little is known about the potential explosivity of any material when subdivided down to the nanoscale, prompting the NIOSH Nanotechnology Research Center (NTRC) to study the explosivity of several classes of nanoparticles, including nanocarbons, nanocellulose, and nanometals. More information is available in our August 2, 2024, blog item.

EPA Seeks Applications For Research On Nanosensor Technology To Detect, Monitor, And Degrade PFAS In Drinking Water Sources: EPA is seeking applications for research to develop and demonstrate nanosensor technology with the potential to detect, monitor, and degrade PFAS in groundwater or surface water that may be used as drinking water sources. Applications must address both of the following research areas:

• Develop and demonstrate nanosensor technology to detect and monitor PFAS in drinking water sources; and

• Develop and demonstrate nanosensor technology with functionalized catalysts to degrade PFAS.

EPA will hold an informational webinar on August 29, 2024. Applications are due November 13, 2024.

2024 NIOSH Nanotechnology Health and Safety Summit Will Be Held October 9-10, 2024: The 2024 NIOSH NTRC Nanotechnology Health and Safety Summit will be held October 9-10, 2024. During the conference, industry, academic, and government experts will share the latest advancements in occupational exposure to nanotechnology and advanced materials. The conference will also address critical safety and health challenges and offer valuable insights and foresights on a range of cutting-edge topics. More information is available in our July 30, 2024, blog item.

BIOBASED/RENEWABLE PRODUCTS/SUSTAINABILITY

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://www.lawbc.com/brand/bioblog/.

LEGISLATIVE

Senate Democrats Introduce Legislation To Codify Chevron Doctrine: On July 23, 2024, Senator Elizabeth Warren (D-MA) announced the introduction of the Stop Corporate Capture Act. Introduced with Senators Richard Blumenthal (D-CT), Cory Booker (D-NJ), Mazie Hirono (D-HI), Ben Ray Luján (D-NM), Edward J. Markey (D-MA), Jeff Merkley (D-OR), Bernie Sanders (I-VT), Chris Van Hollen (D-MD), Peter Welch (D-VT), and Ron Wyden (D-OR), the bill would:

Protect Chevron Doctrine

• Codify Chevron deference, allowing expert agencies to conduct rulemaking in line with their reasonable interpretation of their authorizing statutes.

Modernize and Reform the Regulatory Process

• Streamline the White House’s review period for regulations, creating a 120-day time limit for review;

• Authorize agencies to reinstate rules that are rescinded by Congress through the Congressional Review Act; and

• Reform agencies’ cost-benefit analysis to emphasize public benefits of a rule, including non-quantifiable benefits like promoting human dignity, securing child safety, and preventing discrimination.

Empower and Expand Public Participation in Rulemaking

• Create an Office of the Public Advocate to help members of the public participate more effectively in regulatory proceedings;

• Strengthen agency procedures for notifying the public about pending rulemakings;

• Provide the public with greater authority to hold agencies accountable for unreasonable delays in completing rules; and

• Require agencies to respond to citizen petitions for rulemaking that contain 100,000 or more signatures.

Increase Transparency and Protect Independent Expertise in Rulemaking

• Require all rulemaking participants to disclose industry-funded research or other related conflicts of interest;

• Require any submitted scientific or other technical research that raises a specified corporate conflict of interest be made available for independent public review;

• Bring transparency to the White House regulatory review process by requiring disclosure of changes to draft rules during that process and the source of those changes;

• Require agency officials to provide justification when the regulatory review process ends with a rule being withdrawn; and

• Establish financial penalties for corporate special interests that knowingly submit false information during the rulemaking process.

Federal Food Administration Act Would Transfer FDA’s Food Authorities And Establish A Single Food Safety Agency: On July 23, 2024, Representative Rosa DeLauro (D-CT) and Senator Dick Durbin (D-IL) introduced the Federal Food Administration Act (H.R. 9099, S. 4745). According to DeLauro’s July 23, 2024, press release, the legislation would establish the Federal Food Administration, “a single agency responsible for ensuring the safety of our nation’s food supply and promoting good nutrition.” The bill would establish a Federal Food Administration under the Department of Health and Human Services (HHS) by incorporating the existing food programs within FDA into this separate agency: the Center for Food Safety and Applied Nutrition (CFSAN), the Center for Veterinary Medicine (CVM), the Office of Food Policy and Response (OFPR), and the Office of Regulatory Affairs (ORA). The agency would be led by an expert confirmed by the Senate. The press release notes that FDA has undertaken a reorganization of the Human Foods Program to protect better Americans from foodborne illnesses. The press release states that “a unified structure under HHS with a Senate-confirmed Commissioner will strengthen oversight of the food supply, improve the health and well-being of Americans, and enhance the ability of companies to operate effectively,” however.

Bipartisan Legislation Would Help Clinicians Provide Care For Patients Exposed To PFAS: On July 25, 2024, Senators Jeanne Shaheen (D-NH) and Susan Collins (R-ME) introduced the Better Care for PFAS Patients Act (S. 4774), bipartisan legislation to protect better the health of Americans who have been exposed to PFAS. According to Shaheen’s July 25, 2024, press release, the bill would:

• Require the Agency for Toxic Substances and Disease Research (ATSDR) to enter into an agreement with the National Academies of Sciences, Engineering and Medicine (NASEM) to assess the health effects of PFAS and formulate clinical recommendations within two years of enactment;

• Direct NASEM to update its assessment of PFAS health effects and clinical guidance every five years or more frequently as determined by ATSDR; and

• Ensure ATSDR issues its own clinical guidance on addressing the health effects of PFAS within five years of enactment and update that guidance every five years or more frequently as determined by ATSDR.

The press release notes that Representatives Dan Kildee (D-MI) and Mike Lawler (R-NY) introduced a companion bill in the House.

Bipartisan Legislation Would Advance American Production Of Renewable Chemicals: On August 1, 2024, Senators Sherrod Brown (D-OH) and Pete Ricketts (R-NE) introduced the Renewable Chemicals Act of 2024 (S. 4931), bipartisan legislation that would “advance the manufacturing of renewable biochemicals from domestic biomass in the United States by creating a tax credit for the production of these chemicals by American companies.” According to Brown’s August 13, 2024, press release, the legislation would help to build new markets for domestically produced biomass, advance American energy independence, and create American jobs in the chemical industry through a tax credit for either the production of renewable chemicals or investment in renewable chemical production facilities. The press release states that the bill would:

• Create a targeted, short-term production tax credit of 15 percent of the sales price of each pound of a renewable chemical produced and sold for its fair market value at retail by American biochemical producers during the taxable year; and

• In lieu of the production tax credit, producers could elect to take a 30 percent investment tax credit for qualified investments in new renewable chemical production facilities. Taxpayers would be prohibited from electing to take both credits.

The bill was referred to the Senate Committee on Finance.

MISCELLANEOUS

OSHA Will Hold Virtual Public Hearing On Proposed Emergency Response Standard On November 12, 2024: On July 23, 2024, the Occupational Safety and Health Administration (OSHA) announced that it will hold an informal virtual public hearing on its proposed rule “Emergency Response Standard.” 89 Fed. Reg. 59712. The public hearing will begin November 12, 2024, at 9:30 a.m. Eastern Standard Time (EST). To testify or question other witnesses at the hearing, interested persons must electronically submit a Notice of Intention to Appear (NOITA) on or before September 27, 2024. In addition, those who request more than ten minutes for their presentation at the informal hearing and those who intend to submit documentary evidence at the hearing must submit the full text of their testimony, as well as a copy of any documentary evidence, no later than October 18, 2024. OSHA states that it is particularly interested in hearing testimony on the following topics:

• Firefighting services that are not primarily all-hazard/structural, such as wildland, aircraft/airport, and marine, or others. OSHA is particularly interested in hearing testimony related to the appropriate treatment of each of these firefighting categories as related to the current requirements of the proposed rule and whether or not the unique hazards presented by each category of firefighting warrant differential treatment;

• Emergency medical service providers that are not fire department based and those that provide aerial transport;

• Technical search and rescue service providers, particularly those that are not fire department based such as technical water rescue (including some lifeguards), technical wilderness/mountain search and rescue (such as rope/high angle, ski patrol);

• Specific recommendations for reducing the burden(s) on volunteer/non-compensated responders;

• Specific recommendations for excluding volunteer/non-compensated responders;

• Public information on the financial profile of emergency response organizations, particularly those with a substantial volunteer element;

• Public information for estimating the number of employers (and affected employees) who would be classified as Workplace Emergency Response Employers under the proposed standard; and

• Detail on the current practice for various proposed provisions (e.g., medical exams) among emergency response organizations.

Canada Requests Information On 312 PFAS; Responses Due January 29, 2025: On July 27, 2024, Canada’s Minister of the Environment published a Canada Gazette notice announcing a mandatory survey to obtain information on the manufacture, import, and use of 312 specific PFAS. Canada’s “Guidance manual for responding to the: Notice with respect to certain per- and polyfluoroalkyl substances (PFAS)” (Guidance Manual) states that the purpose of the notice is to collect information on certain PFAS substances, either alone, in mixtures, products, or manufactured items in Canadian commerce for the calendar year 2023. Canada will use this information to establish baseline commercial use data and support future activities related to the class of PFAS. The list of specific PFAS “is focused on those substances known, or anticipated to be in Canadian commerce that have not been recently surveyed.” Responses are due January 29, 2025.

The notice applies to PFAS at a concentration equal to or above one ppm in a manufactured item in the following categories:

• That is intended to be used by or for children under the age of 14 years;

• That is intended to come into contact with the mucosa of an individual;

• That is used as intended in a manner such that the substance may be inhaled or come into dermal or oral contact with an individual;

• That is cookware, or a cooking or serving utensil that is intended to come into direct contact with heated food or beverage;

• That is food packaging material, including single-serve and/or disposable bowls, plates, cups, other serving ware, as well as food cans and lid liners, that are intended to or may come into direct contact with food or beverage;

• That is a reusable food or beverage container;

• That is food processing equipment, including conveyor belts, trays, vats, nozzles, molds, and cutters that come into contact with food or beverage prior to packaging and distribution;

• That is clothing or footwear, including life jackets, personal flotation devices, and other safety apparel;

• That is bedding, sleeping bags, or towels;

• That is furniture, mattresses, cushions, or pillows intended to be used by an individual, where the substance is contained in foam or leather or in a textile fiber, yarn, or fabric;

• That is carpet, vinyl, or laminate flooring, or foam underlay for flooring, intended to be used by an individual; and

• Such that the substance is intended to be released from the manufactured item.

While companies located outside of Canada are not subject to the notice, companies importing products must respond to the notice if the criteria are met. In the Guidance Manual, Canada “encourages” foreign suppliers to inform their Canadian customers that they import a reportable substance and may meet the reporting criteria of the notice. More information is available in our July 29, 2024, blog item.

CDPR Announces Pesticide Registration And Renewal Fee Increase: On July 29, 2024, CDPR announced that it will move forward with an emergency rulemaking package to revise the fees for pesticide registrations and renewals in late August with a proposed effective date of no later than October 1, 2024. CDPR states the fee increase is necessary to meet current baseline funding needs and the new positions approved as part of the FY 2024-2025 budget. More information is available in our August 6, 2024, blog.

CPSC Finds Amazon Responsible Under CPSA For Hazardous Products Sold By Third-Party Sellers On Amazon.Com: On July 30, 2024, the U.S. Consumer Product Safety Commission (CPSC) announced that it issued a Decision and Order against Amazon.com, Inc. (Amazon). CPSC states that, in a unanimous vote, it “determined that Amazon was a ‘distributor’ of products that are defective or fail to meet federal consumer product safety standards, and therefore bears legal responsibility for their recall.” According to CPSC, more than 400,000 products are subject to the Order, specifically faulty carbon monoxide detectors, hairdryers without electrocution protection, and children’s sleepwear that violated federal flammability standards. CPSC determined that these products, listed on Amazon.com and sold by third-party sellers using the Fulfilled by Amazon program, pose a “substantial product hazard” under the Consumer Product Safety Act (CPSA). Further, CPSC notes, Amazon failed to notify the public about the hazardous products and did not take adequate steps to encourage its customers to return or destroy them, leaving consumers at substantial risk of injury. Under CPSC’s Decision and Order, Amazon must submit proposed plans to notify consumers and the public about the hazardous products and to remove the products from commerce by incentivizing their return or destruction. CPSC states that it will consider Amazon’s proposed plans and address them in a second order. More information is available in our August 5, 2024, blog item.

Maine Seeks Comments On Concept Draft Language For PFAS In Products Rule:The Maine Department of Environmental Protection (MDEP) announced on August 5, 2024, that its PFAS in Products Program has developed new concept draft language to implement the recently amended Title 38, Section 1614, the section addressing PFAS in products. MDEP has made the concept draft language available for an informal outreach process until August 30, 2024. After the informal outreach process, MDEP plans to proceed with rulemaking in fall 2024. According to MDEP, there will be an opportunity for public comment on a proposed draft rule during the rulemaking process. For more information, please read the full memorandum.

CPSC Proposes Labeling Requirements For Toys Containing Button Cell Or Coin Cell Batteries: On August 13, 2024, CPSC proposed to address the risk of injury and death associated with children ingesting button cell or coin cell batteries obtained from toys by adding performance and labeling requirements for battery-operated toys containing such batteries. 89 Fed. Reg. 65791. To address the risk of injury, CPSC proposes to add performance and labeling requirements for toys containing button cell or coin cell batteries. CPSC proposes to add test requirements for captive fasteners, minimum requirements for threaded fasteners, and sequential use and abuse testing (stress relief, battery replacement, impact, crush, torque, tension, compression, and compliance verification tests), and to update marking and labeling requirements. CPSC notes that the additional requirements are more stringent than the existing requirements in 16 C.F.R. Part 1250 to reduce further the risk of injury from these batteries and “represent the highest level of safety feasible to address child ingestion of button cell or coin cell batteries from toys.” CPSC notes that the additions also are intended to align the requirements for such toys with the requirements for consumer products subject to 16 C.F.R. Part 1263, which could promote design and manufacturing efficiencies. Comments are due October 15, 2024.

IRS Announces Correction To Petition To Add Nylon 6 To List Of Chemical Substances Subject To Superfund Excise Tax: The Internal Revenue Service (IRS) announced on August 14, 2024, a correction to the stoichiometric material consumption equation in the notice of filing for the nylon 6 petition that was published in the February 22, 2024, Federal Register. 89 Fed. Reg. 66175. According to the notice, after the comment period for the original notice closed, an error was discovered in the stoichiometric material consumption equation for nylon 6, and the petitioner subsequently provided a corrected petition. According to the IRS, the other petition information is unchanged from the original notice of filing for nylon 6. The IRS notes that the supplemental notice of filing requests comments on the corrected petition and is not a determination that the list of taxable substances is modified. Written comments and requests for a public hearing are due October 15, 2024.

OIRA Report Highlights Examples Of Agencies Seeking To Strengthen Public Participation And Community Engagement In The Regulatory Process: OMB’s Office of Information and Regulatory Affairs (OIRA) published a blog item on August 14, 2024, announcing the availability of a report highlighting examples of agencies seeking to strengthen public participation and community engagement in the regulatory process. According to OIRA, while agencies have adopted a range of approaches depending on the type of action under consideration and the stakeholders they are seeking to engage, there are four recurring best practices: early engagement; robust public comment process; participation from affected communities, including underserved communities; and how the agency took public input into account. OIRA states that it welcomes ideas from the public about ways to continue to improve public engagement in the regulatory process. Ideas can be shared with OIRA by e-mailing them to publicparticipation@omb.eop.gov. More information is available in our August 15, 2024, blog item.

[View source.]