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Summer 2024 Updates from the Pesticides and Chemicals Committee

James Aidala, Jose Almanzar, Nancy Beck, Lynn L. Bergeson, Erin Lynn Brooks, Lisa Burchi, Julia Casciotti, Barbara Christianson, Meaghan A. Colligan, Heather F Collins, Abigail Contreras, Andrea J Driggs, Mark N Duvall, Amy L Edwards, Richard Engler, Jeffrey Hunter, Carla N Hutton, Elizabeth A Johnson, Merrit M Jones, Dimitios J Karakitsos, Bryan E Keyt, John R Kindschuh, Heidi Knight, Jayni Anita Lanham, Jaclyn Lee, Thomas Simmons Lee, Matthew Zane Leopold, Julie C Michalski, Paul Nyffeler, Dianne R Phillips, Rachel Saltzman, Derek C Smith, Todd Stedeford, Javaneh Tarter, Halley I Townsend, Joo Cha Webb, Malcolm C Weiss, Jasmine Wetherell, Amy O'Brien, Gregory Robert Wall, Kristian Havard, and Molly Broughton

Summary

  • The U.S. Environmental Protection Agency (EPA) has been busy this quarter, issuing Toxic Substances Control Act (TSCA) high-priority designations, risk management rules, and draft risk evaluations, and making improvements to processes. The long arm of the Congressional Review Act may have quickened the pace.
  • Legal cases are challenging EPA TSCA test orders and Amazon’s rights and responsibilities involved in selling hazardous products.
  • The Occupational Safety and Health Administration (OSHA) has amended its Hazard Communication Standard (HCS) for the first time since 2012.
  • EPA’s regulation of per- and polyfluoroalkyl substances (PFAS) shows no signs of slowing down. EPA issued additional reporting requirements, the courts are more engaged, and the states remain hyper-focused on PFAS. The U.S. Food and Drug Administration (FDA) is also active in this space.
  • Pesticide initiatives are also underway at the federal and state level.
Summer 2024 Updates from the Pesticides and Chemicals Committee
SolStock via Getty Images

TSCA Articles

EPA Announces Strengthening the Safer Choice and Design for the Environment Standard for Commercial and Household Cleaning Products

Published August 14, 2024, by Heather F. Collins, M.S., and Barbara A. Christianson

On August 8, 2024, the U.S. Environmental Protection Agency (EPA) announced that it made updates to strengthen the Safer Choice and Design for the Environment (DfE) Standard, which identifies the requirements that products and their ingredients must meet to earn EPA’s Safer Choice label or DfE logo. EPA states these updates strengthen the criteria that products must meet to qualify for the voluntary Safer Choice label, supporting the use of safer chemicals in the marketplace.

Proposed 1-BP Risk Management Rule Would Ban “Numerous” Consumer and Workplace Uses

Published August 13, 2024, by Lynn L. Bergeson, Carla N. Hutton, Todd J. Stedeford, Ph.D., DABT, ERT, ATS, and Richard E. Engler, Ph.D.

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 conditions of use (COU) as documented in EPA’s August 2020 Risk Evaluation for 1-BP and the December 2022 Revised Risk Determination for 1-BP prepared under the Toxic Substances Control Act (TSCA). 89 Fed. Reg. 65,066. 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.

CPSC Finds Amazon Responsible under CPSA for Hazardous Products Sold by Third-Party Sellers on Amazon.com

Published August 5, 2024, by Lynn L. Bergeson and Carla N. Hutton

The U.S. Consumer Product Safety Commission (CPSC) announced on July 30, 2024, 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 (CO) 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.

EPA Publishes Compliance Guide for Final Methylene Chloride Risk Management Rule

Published July 30, 2024, by Lynn L. Bergeson, Carla N. Hutton, and Todd J. Stedeford, Ph.D., DABT, ERT, ATS

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.

EPA Begins 90-Day Comment Period on Proposed High-Priority Substance Designations for Five Chemicals

Published July 29, 2024, by Lynn L. Bergeson, Carla N. Hutton, and Todd J. Stedeford, Ph.D., DABT, ERT, ATS

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. 60,420. 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.

EPA Releases Draft Risk Evaluation for 1,1-Dichloroethane and Draft Hazard Assessment of 1,2-Dichloroethane for Public Comment and Peer Review

Published July 19, 2024, by Lynn L. Bergeson, Carla N. Hutton, Richard E. Engler, Ph.D., and Todd J. Stedeford, Ph.D., DABT, ERT, ATS

On July 1, 2024, 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 TSCA. EPA states 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.” Publication of a notice of availability in the Federal Register will begin a 60-day comment period.

Court Vacates TSCA Section 4 Test Order, Grants Vinyl Institute’s Petition for Review

Published July 10, 2024, by Lynn L. Bergeson and Carla N. Hutton

On July 5, 2024, the U.S. Court of Appeals for the District of Columbia Circuit issued its decision in Vinyl Institute, Inc. v. EPA (No. 22-1089). As reported in our May 31, 2022, blog item, on May 23, 2022, the Vinyl Institute, Inc. (VI) filed suit against EPA, seeking review of EPA’s March 2022 test order for 1,1,2-trichloroethane (1,1,2-TCA) issued under TSCA section 4(a)(2). The court states that “EPA’s non-public part of the administrative record is not part of ‘the record taken as a whole’ subject to our heightened substantial evidence review of TSCA test orders.” According to the court, to the extent EPA relies on nonpublic portions of the administrative record, it “has failed to provide substantial evidence that meets its statutory mandate.” The court vacated the test order, remanding to EPA to satisfy that mandate with “substantial evidence in the record taken as a whole.” The court also denied VI’s motion to supplement the record “with scientific information it could have—and should have—submitted earlier.”

EPA Postpones Proposed Expansion of the Safer Choice and Design for the Environment Programs

Published July 5, 2024, by Lynn L. Bergeson and Carla N. Hutton

As reported in our July 27, 2023, memorandum, in July 2023, EPA proposed an expansion of the Safer Choice and DfE programs to include certification of additional product categories. According to EPA’s website, “EPA thanks the many commenters for their input. EPA reviewed the comments and understands several categories are of interest to stakeholders and Safer Choice partners. With the 2024 decrease in EPA’s funding, however, EPA is not able to pursue expansion at this time. EPA plans to reconsider the expansion in the future as resources allow.” On June 28, 2024, a summary of comments received on EPA’s proposed expansion was posted in the online docket. The Safer Choice program will continue to certify products and is working to ensure current partners and stakeholders do not experience delays in customer service. The program will work to issue final updates to the Safer Choice Standard. More information on the proposed updates to the standard is available in our December 5, 2023, memorandum.

EPA Announces New Initiatives to Improve Efficiency, Worker Protections, and Transparency in New Chemical Reviews

Published June 26, 2024, by Lynn L. Bergeson and Carla N. Hutton

During the June 26, 2024, “TSCA Reform—Eight Years Later” conference, presented by Bergeson & Campbell, P.C. (B&C), the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health, Michal Ilana Freedhoff, Ph.D., assistant administrator of EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP), provided the keynote address. During her remarks, Freedhoff announced four new initiatives in EPA’s review of new chemicals under TSCA.

EPA’s Proposed NMP Risk Management Rule Includes Requirements to Protect Workers and Consumers

Published June 21, 2024, by Lynn L. Bergeson, Carla N. Hutton, and Richard E. Engler, Ph.D.

On June 14, 2024, EPA issued a proposed rule under TSCA section 6(a) that would protect workers and consumers from exposure to N-methylpyrrolidone (NMP). 89 Fed. Reg. 51,134. To address the identified unreasonable risk, EPA proposes to: prohibit the manufacture (including import), processing, distribution in commerce, and use of NMP in several occupational COUs; require worker protections through an NMP workplace chemical protection program (WCPP) or prescriptive controls (including concentration limits) for most of the occupational COUs; require concentration limits on a consumer product; regulate certain consumer products to prevent commercial use; and establish recordkeeping, labeling, and downstream notification requirements.

EPA Announces Peer Review of 1,1-Dichloroethane TSCA Risk Evaluation and 1,2-Dichloroethane Hazard Assessment, Calls for Public Comments on Reviewer Candidates

Published June 14, 2024, by Lynn L. Bergeson and Carla N. Hutton

EPA announced on June 13, 2024, the change in the peer review mechanism from the letter peer review to a Science Advisory Committee on Chemicals (SACC) peer review; the addition of the draft human health hazard assessment for 1,2-DCE for peer review; and the availability of and solicitation of comment on the list of candidates under consideration for selection as ad hoc peer reviewers that will assist SACC with its peer review of EPA’s draft risk evaluation of 1,1-DCE and human health hazard assessment of 1,2-DCE. 89 Fed. Reg. 50,326. The list of candidates provides the names and biographical sketches of all interested and available candidates identified from the responses to the call for nominations and other sources. EPA states that public comments on these candidates will assist it in selecting ad hoc peer reviewers to assist SACC with the identified peer review.

EPA Engaging in “Administrative Deliberations” Regarding TSCA Section 5 Order Challenged by Cherokee Concerned Citizens

Published June 7, 2024, by Lynn L. Bergeson and Carla N. Hutton

Cherokee Concerned Citizens watchers will be interested to know that on June 6, 2024, EPA filed an unopposed motion in the U.S. Court of Appeals for the District of Columbia Circuit to extend the deadlines in Cherokee Concerned Citizens v. EPA (No. 23-1096). As reported in our April 17, 2023, blog item, Cherokee Concerned Citizens filed suit in April 2023 seeking review of an Order for a New Chemical Substance under TSCA section 5 that authorizes Chevron U.S.A. Inc. (Chevron) to manufacture, process, distribute in commerce, use, or dispose of certain new chemical substances. According to EPA’s motion, good cause exists for its filing. EPA states that it “is engaging in further administrative deliberations regarding the order challenged in this petition that may obviate the need for continuance of this litigation.”

EPA Finalizes Risk Management Rules for Asbestos and Methylene Chloride

Published June 5, 2024, by Javaneh S. Tarter, Nancy B. Beck, Ph.D., DABT, Matthew Z. Leopold, Gregory R. Wall, Paul T. Nyffeler, Ph.D., Julia J. Casciotti, and Jaclyn E. Lee

Within the first five months of 2024, EPA finalized two rules under TSCA section 6(a) that would impose extensive bans and restrictions on uses of chrysotile asbestos and methylene chloride. Aside from a 2019 EPA rule prohibiting the manufacturing (including importing), processing, and distributing in commerce of methylene chloride for consumer paint and coating removal, these are the first two broadly applicable risk management rules that EPA has promulgated since Congress amended TSCA in 2016 to manage unreasonable risks to human health or the environment through broad restrictions on existing chemicals. These two rules have already been challenged in the courts. After industry, labor, and environmental groups filed numerous lawsuits across four circuit courts, a federal judiciary panel consolidated all challenges to EPA’s final chrysotile asbestos rule into the Fifth Circuit Court of Appeals. Also, two companies have filed a joint petition for review in the Fifth Circuit challenging EPA’s final methylene chloride rule, and an environmental group has challenged the rule in the Ninth Circuit.

GAO Finds EPA Implemented Three Open Recommendations Related to Assessing and Controlling Toxic Chemicals

Published June 5, 2024, by Lynn L. Bergeson and Carla N. Hutton

On May 28, 2024, the U.S. Government Accountability Office (GAO) publicly released a report entitled Priority Open Recommendations: Environmental Protection Agency. According to the report, since GAO’s May 2023 letter, EPA implemented four of GAO’s 15 open priority recommendations, including three recommendations related to assessing and controlling toxic chemicals. GAO’s report states that in April 2023, it issued its biennial update to its High-Risk List, which identifies government operations with greater vulnerabilities to fraud, waste, abuse, and mismanagement. The High-Risk List also identifies the need for transformation to address economy, efficiency, or effectiveness challenges. GAO states that “[o]ne of our high-risk areas—transforming EPA’s process for assessing and controlling toxic chemicals—centers directly on EPA.”

OSHA Updates Hazard Communication Standard

Published June 5, 2024, by Mark N. Duvall, Jayni A. Lanham, Heidi P. Knight, and Dorje Wu

The Occupational Safety and Health Administration (OSHA) has amended the Hazard Communication Standard (HCS), 29 C.F.R. § 1910.1200, to align with Revision 7 (Rev. 7) of the United Nations’ Globally Harmonized System of Classification and Labelling of Chemicals (GHS). The changes described in 89 Fed. Reg. 44,144 (May 20, 2024) revise criteria for hazard classification, provisions for labeling, and concentrations claimed as trade secrets. Compliance with the new provisions is due in stages between January 19, 2026, and January 19, 2028.

Updated TSCA Inventory Coincides with 2024 CDR Cycle Submission Period

Published May 28, 2024, by Lynn L. Bergeson and Carla N. Hutton

EPA announced on May 23, 2024, that it has updated the TSCA Inventory. EPA states that this biannual update to the public TSCA Inventory is part of its regular posting of nonconfidential TSCA Inventory data. EPA notes that this update coincides with the 2024 Chemical Data Reporting (CDR) cycle submission period beginning June 1, 2024. According to EPA, “[m]anufacturers (including importers) should refer to the latest TSCA Inventory to help them determine what chemicals to report on under the CDR rule.” EPA plans the next regular update of the TSCA Inventory for early 2025.

EPA Releases Draft Risk Evaluation Documents for DIDP and DINP for Public Comment and Peer Review

Published May 24, 2024, by Lynn L. Bergeson and Carla N. Hutton

EPA announced on May 20, 2024, the availability of and solicited public comment on the draft manufacturer-requested risk evaluation (MRRE) for di-isodecyl phthalate (DIDP) and the draft physical chemical, fate, and hazard assessments for di-isononyl phthalate (DINP) prepared under TSCA. 89 Fed. Reg. 43,847. In its May 17, 2024, press release, EPA states that it preliminarily determined that all but one of the uses of DIDP that EPA evaluated under TSCA do not contribute to unreasonable risk to human health. Additionally, EPA preliminarily determined that DINP causes liver damage at lower concentrations than DIDP, and unlike DIDP, could cause cancer at higher levels of exposure.

EPA Announces New Resource Portal and Reporting Tool Improvements Before CDR Reporting Begins on June 1, 2024

Published May 17, 2024, by Lynn L. Bergeson and Carla N. Hutton

The CDR rule requires manufacturers (including importers) to report data to EPA every four years. The 2024 submission period began June 1, 2024, and ends September 30, 2024. On May 16, 2024, EPA announced the creation of CDR GuideME, a new resource portal, and improvements to the reporting tool to make the reporting process easier. Data that must be reported include information concerning the manufacturing, processing, and use of such chemicals, unless exempt from this requirement under the CDR rule. The reporting requirements cover chemicals listed on the TSCA Inventory if manufactured (including imported) above an applicable regulatory threshold. For the 2024 submission period, manufacturers (including importers) are subject to the reporting requirements based on manufacturing (including importing) activities conducted during the calendar years 2020–2023.

EPA Bans Most Uses of Methylene Chloride, Requires Stronger Worker Safety Requirements for Remaining Industrial Uses

Published May 17, 2024, by Lynn L. Bergeson, Carla N. Hutton, and Todd J. Stedeford, Ph.D., DABT, ERT, ATS

EPA issued on May 8, 2024, a final rule to address unreasonable risks of injury to health EPA identified caused by methylene chloride under its COUs. 89 Fed. Reg. 39,254. 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 will be effective July 8, 2024.

FIFRA Articles

Numerous Groups Petition EPA to Suspend and/or Cancel Pesticide Registrations Based on a Class Definition of PFAS Alone

Published August 12, 2024, by Derek C. Smith, Joo Cha Webb, and Julie C. Michalski

Pesticide manufacturers and registrants, like many other companies, are facing increased pressure to remove per- and polyfluoroalkyl substances (PFAS) from their products. This pressure, however, is often focused on how the substances are defined as a class, rather than how science has measured the toxicity of each specific substance within it. Class-wide bans are particularly troubling with respect to PFAS where, depending on how the substances are defined, there are thousands in existence, most of which lack any scientific evidence of an ability to harm humans, animals, or the environment. The latest pressure comes from numerous groups that recently petitioned EPA to suspend registrations for pesticides and cancel all existing registrations for pesticides that contain active and inert ingredients qualifying as “PFAS”—a term the petitioners broadly define as any fluorinated organic chemicals containing “at least one fully fluorinated carbon atom.” The petitioners have also asked EPA to prohibit the use of fluorinated high-density polyethylene (HDPE) and polypropylene storage containers that contain PFAS.

EPA Announces Changes to When It Assesses Potential Exposure to Pesticide Spray Drift

Published July 25, 2024, by James V. Aidala and Barbara A. Christianson

On July 15, 2024, EPA announced 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. Historically, EPA has only conducted a chemical-specific assessment of the potential for people to be exposed to pesticide spray drift during registration review, which happens every 15 years after a pesticide is approved to ensure that it can carry out its intended functions without creating unreasonable adverse effects to human health and the environment. EPA states it will now also complete a chemical-specific spray drift analysis during the initial registration process or the review process for new and amended uses of existing products, to ensure that any needed protections are put in place from the beginning of the pesticide’s use, rather than delaying them for 15 years. According to EPA, this change is consistent with its commitment to address environmental justice concerns from pesticide use in and around farm communities and to comply with the Endangered Species Act (ESA), where EPA is working to improve how it evaluates risk to and protects endangered species.

EPA Announces Final Cancellation Order and Updates to Existing Stocks Provisions for Several Chlorpyrifos Products

Published July 2, 2024, by James V. Aidala and Barbara A. Christianson

On June 25, 2024, EPA announced the issuance of a final cancellation order for Corteva’s chlorpyrifos product “Dursban 50W in Water Soluble Packets” and three Gharda chlorpyrifos products, and an amendment to the existing stocks provisions for two Liberty and three Winfield chlorpyrifos end-use products. EPA also states that it has updated its frequently asked questions about chlorpyrifos. In a final rule issued in August 2021, EPA revoked all tolerances for chlorpyrifos, which stopped the use of chlorpyrifos on all food and animal feed. EPA took this action in response to an April 2021 order from the U.S. Court of Appeals for the Ninth Circuit for EPA to issue a final rule addressing the use of chlorpyrifos in food or feed crops, without taking public comment or engaging in “further factfinding.”

EPA Announces Draft PR Notice to Revise Procedures for Citing Data to Support Pesticide Registrations (EPA Forms 8570-34 and 8570-35)

Published June 17, 2024, by Lisa R. Burchi and Barbara A. Christianson

On June 10, 2024, EPA issued a Federal Register notice announcing the availability of a draft Pesticide Registration Notice entitled Revised Procedures for Citing Data to Support Pesticide Registrations (EPA Forms No. 8570-34 and 8570-35) (Draft PR Notice). 89 Fed. Reg. 48,893. EPA states that this Draft PR Notice will supersede PR Notice 98-5, entitled New Forms for the Certification with Respect to Citation of Data, which was issued on June 12, 1998. EPA states the purpose of this Draft PR Notice is to provide updated guidance to registrants and applicants concerning the submission and public availability of EPA Form No. 8570-35 (Data Matrix) and EPA Form No. 8570-34 (Certification with Respect to Citation of Data).

States Initiatives Articles

California DPR Announces Pesticide Registration and Renewal Fee Increase

Published August 6, 2024, by Barbara A. Christianson

On July 29, 2024, the California Department of Pesticide Regulation (DPR) 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. DPR states the fee increase is necessary to meet current baseline funding needs and the new positions approved as part of the fiscal year (FY) 2024 to 2025 budget.

DPR Announces Modifications to Its Proposed First-of-Its-Kind Pesticide Application Notification System

Published July 23, 2024, by Lisa R. Burchi and Barbara A. Christianson

On July 2, 2024, DPR announced the release of modifications to its proposed pesticide application notification regulation. DPR states this regulation will support the statewide implementation of what it describes to be a “first-of-its-kind” system that would provide information to the public in advance regarding the planned applications of “restricted material pesticides” used in agriculture. DPR initially proposed the regulation on November 3, 2023. DPR requested comments on the proposed modifications through a 30-day public comment period. Comments were due on or before August 1, 2024. Three hearings were held to collect input on the proposed modifications to the notification regulation.

Washington State Becomes First-in-the-Nation to Require Stringent New Restrictions on Lead in Cookware

Published July 8, 2024, by Malcolm C. Weiss, Javaneh S. Tarter, and Abigail Contreras

In March 2024, Washington state became the first in the nation to pass an almost complete ban on the manufacture and sale of cookware containing lead. Starting in January 2026, HB 1551 sets the maximum lead content level for cookware and cookware components at five parts per million (ppm). The law is both broad in scope and stringent in its lead limit, making it important for entities that sell cookware or offer cookware for sale in the state of Washington to begin thinking about compliance now.

California Court Grants Injunction to Stop Prop 65 Warnings for Titanium Dioxide in Cosmetic and Personal Care Product

Published June 20, 2024, by Lynn L. Bergeson and Carla N. Hutton

On June 12, 2024, the U.S. District Court for the Eastern District of California (District Court) issued an Order granting a preliminary injunction brought by the Personal Care Products Council (PCPC), which alleged that the California Office of Environmental Health Hazard Assessment’s (OEHHA) requirement for warnings under Proposition 65 (Prop 65) related to titanium dioxide in cosmetics and personal care products violated the First Amendment. The Personal Care Products Council v. Bonta, No. 2:23-cv-01006-TLN-JDP (E.D. Cal. 2024). In its Order, the District Court enjoined the California Attorney General and any private citizen enforcers from enforcing Prop 65’s warning requirement for “cancer as applied to Listed Titanium Dioxide (i.e., titanium dioxide that consists of airborne, unbound particles of respirable size) in cosmetic and personal care products.” The District Court also denied a motion to intervene by Environmental Health Advocates, Inc. (EHA), which had argued it was “an interested party because it is the primary enforcer of Prop 65.”

California Announces Modifications to Prop 65 Short-Form Warning Regulations

Published June 17, 2024, by Jasmine Wetherell

In response to numerous public comments, California’s OEHHA announced on June 13, 2024, modifications to the proposed amendments to the regulations governing so-called “short-form” warnings under Prop 65. Also known as California’s Safe Drinking Water and Toxic Enforcement Act of 1986, Prop 65 mandates that businesses that sell consumer products notify Californians about certain chemicals that are in those products.

Washington’s Department of Ecology Plans to Ban Formaldehyde Releasers from Cosmetics

Published June 6, 2024, by Mark N. Duvall, Elizabeth A. Johnson, and Jordann Krouse

Washington state’s Toxic-Free Cosmetics Act (TFCA) prohibits the manufacture, sale, and distribution of cosmetic products containing certain added chemicals beginning January 1, 2025. One such chemical that will be prohibited is formaldehyde, but the TFCA does not expressly prohibit specific chemicals that release formaldehyde (known as formaldehyde releasers). Instead, the statute directed Washington’s Department of Ecology (DOE) to identify formaldehyde releasers used in cosmetics. DOE is currently undergoing rulemaking to implement the TFCA. DOE plans to adopt a rule to identify formaldehyde releasers that will be restricted from use in cosmetics once identified.

DPR Issues California Notice 2024-10 Clarification on “Not Registered for Use In CA” and Similar Statements on Pesticide Labels

Published May 29, 2024, by Lisa R. Burchi and Barbara A. Christianson

On May 24, 2024, DPR issued California Notice 2024-10 announcing that EPA and DPR have made recent policy changes regarding state-specific language on pesticide labels intended to reduce delays related to state-specific uses. As part of DPR’s evaluation process when reviewing a new registration application, DPR may determine there are not sufficient data to support registration of a specific use in California. In these instances, DPR allows registrants either to submit data to support the uses or choose to revise their labels to add qualifying statements removing the specific use in California. Historically, if registrants chose to revise their label, it would involve adding the statement “Not for Use in California.” This label revision must first be accepted by EPA before it can be accepted by DPR, and this process often leads to delays in the registration process. With Notice 2024-10, and following recent EPA guidance, DPR states its intention to clarify options to expedite the addition of state-specific label statements.

PFAS Articles

PFAS[t] and Furious: Racing To Comply with the New Reporting Rule

Published August 14, 2024, by Andrea Driggs, Jeffrey L. Hunter, and Jasmine Wetherell

Back in 2023, EPA issued a sweeping information-gathering rule under TSCA requiring manufacturers (including importers) to report on PFAS in their products. The rule requires that manufacturers, including importers of PFAS and PFAS compounds in consumer products in any year from 2011 to 2022, submit detailed information regarding the manufacture, processing, use, disposal, and environmental and health effects of these substances. In our October 2023 Update, we provided an overview of the new TSCA reporting rule. The following is an in-depth analysis of who is required to report, the reporting standard (including the due diligence a manufacturer will need to complete to adequately report), what information can be protected as confidential business information, and potential penalties for failure to report. Under 40 C.F.R. 705, the reporting obligation falls to the “person who manufactured (including imported)” a chemical substance that is a PFAS. This obligation extends to manufacturers who import and use materials containing PFAS in their products. If a company manufactures its product in the United States and then sells the product, it must report. However, in its 2024 Reporting Instructions, EPA suggests that, in the case of chemical substances or products that are manufactured by one person on behalf of another, the manufacturer is the person who actually produces the chemical substance or manufactures the product—not the seller or brand owner of the product.

Maine Seeks Comments on Concept Draft Language for PFAS in Products Rule

Published August 7, 2024, by Lynn L. Bergeson and Carla N. Hutton

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.

PFAS in Cookware: State-by-State Regulations

Published August 7, 2024, by Thomas S. Lee, Bryan E. Keyt, Merrit M. Jones, and John R. Kindschuh

In the absence of comprehensive federal regulation of PFAS in cookware, states are enacting and proposing their own laws. Thus far, eight states have enacted laws addressing PFAS substances in cookware and bakeware (cookware), and seven states introduced bills that are currently pending. The original PFAS cookware laws addressed labeling requirements, and the notification was usually required to appear on the product label as well as the product’s website. Recently, several states have enacted outright bans of intentionally added PFAS in all cookware products. This evolution of these laws underscores how PFAS are being more aggressively regulated in the cookware industry.

CEH and PEER File Suit Seeking TSCA Section 6 Rule Prohibiting Production of PFOA during Fluorination of Plastic Containers

Published July 30, 2024, by Lynn L. Bergeson and Carla N. Hutton

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 TSCA section 6 to prohibit the production of perfluorooctanoic acid (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 nondiscretionary duties prescribed by TSCA section 4(f). According to the petitioners, this obligation arose within 180 days of EPA’s proposed National Primary Drinking Water Regulation (NPDWR) for PFOA and five other PFAS, issued on March 29, 2023, which states: “Following a systematic review of available human epidemiological and animal toxicity studies, EPA has determined that PFOA . . . [is] likely to cause cancer (e.g., kidney and liver cancer) and that there is no dose below which . . . [it] is considered safe.” 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.”

The Summer Heats Up With Five States Enacting New Laws Prohibiting PFAS in Consumer Products

Published July 30, 2024, by Javaneh S. Tarter, Nancy B. Beck, Ph.D., DABT, Gregory R. Wall, Matthew Z. Leopold, Rachel Saltzman, Paul T. Nyffeler, Ph.D., Julia J. Casciotti, and Jaclyn E. Lee

States across the country continue to add to the growing patchwork of restrictions for PFAS in products, posing challenges for those who manufacture, distribute, and sell products in the United States. In 2024 alone, states introduced nearly 250 bills addressing PFAS, including restrictions for PFAS in products. Thirteen states have already enacted laws regulating PFAS in products, including (as previously reported) Minnesota and California. In the past few months, Maine, Colorado, Connecticut, Vermont, and Rhode Island have joined the list, each with its own unique and nuanced set of requirements, deadlines, and exemptions. The variations in these state laws present a complicated compliance matrix, necessitating an informed and strategic approach, particularly for companies navigating the complexities of extensive, global supply chains. We provide our analysis of these new laws that companies selling products in these states should be aware of.

Canada Requests Information on 312 PFAS; Responses Due January 29, 2025

Published July 29, 2024, by Lynn L. Bergeson and Carla N. Hutton

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, either alone or in mixtures, products, or manufactured items in Canadian commerce for 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.

PFAS–What to Know Now, and What to Expect

Published July 22, 2024, by Lynn L. Bergeson and Carla N. Hutton

PFAS are attracting global legal, regulatory, commercial, and litigation attention as no other “emerging contaminant” has. Companies producing, processing, distributing, and/or using these substances must be aware of global legal and scientific developments and take steps now to minimize legal, regulatory, and commercial risk. B&C and its global consulting affiliate The Acta Group (Acta) have prepared this 26-page memorandum for your consideration. It offers a high-level outline of issues, focusing on the most significant bans and restrictions, the most impactful potential legal developments regarding PFAS, and the most important steps chemical product manufacturers should be taking now to identify, diminish, and supplant, as appropriate, PFAS in their supply chains.

2024 Midyear PFAS Regulatory Update: Final Rules Recently Issued by EPA and What’s to Come

Published July 18, 2024, by Dianne R. Phillips, Amy L. Edwards, Meaghan A. Colligan, Jose A. Almanzar, and Molly Broughton

Just past the halfway point of 2024, it’s already been a busy year for those following regulatory developments related to PFAS. Building on its plans in the 2021 PFAS Strategic Roadmap and its 2023 Second Annual Progress Report, EPA continued its fast-paced regulatory activity in anticipation of the Congressional Review Act’s look-back deadline, after which Congress has the right to review and potentially disapprove final regulations. In addition, rules previously promulgated by EPA require significant action in 2024.

EPA Grants TSCA Section 21 Petition Seeking Section 6 Rule Prohibiting Three PFAS Found in Fluorinated Plastic Containers

Published July 16, 2024, by Lynn L. Bergeson, Carla N. Hutton, and Todd J. Stedeford, Ph.D., DABT, ERT, ATS

EPA announced on July 11, 2024, that it granted a petition filed under TSCA section 21 requesting that EPA establish regulations under TSCA section 6 prohibiting the manufacturing, processing, use, distribution in commerce, and disposal of three 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 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.

PFAS in Consumer Products: State-by-State Regulations

Published July 1, 2024, by Thomas S. Lee, Bryan E. Keyt, Merrit M. Jones, and John R. Kindschuh

Manufacturers, distributors, and retailers of consumer products across a broad spectrum of industries are being impacted by laws regulating the presence of PFAS in their products. This area is rapidly developing as states create new laws or amend existing ones, and the penalties and litigation risks for noncompliance can be significant.

Minnesota Department of Health Highlights Recent Publications on PFAS Bioaccumulation and PFAS in Infant Formula

Published June 28, 2024, by Lynn L. Bergeson and Carla N. Hutton

The Minnesota Department of Health (MDH) recently noted that health risk assessment scientists at MDH have published two articles in the Journal of Environmental Exposure Assessment related to PFAS. MDH notes that the work was supported by the Clean Water Fund, funded by the 2008 Clean Water, Land and Legacy Amendment.

Product Importers: Are You Ready for the New PFAS Reporting Requirements Under TSCA?

Published June 26, 2024, by Dianne R. Phillips, Amy L. Edwards, Meaghan A. Colligan, Dimitrios J. Karakitsos, Amy O’Brien, and Halley I. Townsend

EPA published a far-reaching and important final rule (Rule) on Oct. 11, 2023, requiring comprehensive reporting of PFAS manufactured and imported in the United States under TSCA. For background on the Rule, see Holland & Knight’s previous alert, “EPA Publishes Comprehensive PFAS Reporting Rule Under TSCA,” from October 17, 2023. Promulgated under TSCA section 8(a)(7) (15 U.S.C. §2607(a)(7)), the Rule is mandated by section 7351 of FY 2020 National Defense Authorization Act (NDAA) titled “PFAS Data Call.” This simple section amended TSCA section 8(a) to add an entirely new subsection (7). Specifically, Congress ordered EPA to promulgate a rule to collect categories of PFAS data for every year from January 1, 2011, through 2022, corresponding to recordkeeping requirements related to preexisting categories for chemical substances subject to TSCA reporting outlined in subsections (A) through (G) of section 2607(a)(2).

Appellate Court Affirms Decision That TSCA Section 21 Petition Seeking PFAS Testing Is Not Subject to Review

Published June 11, 2024, by Lynn L. Bergeson and Carla N. Hutton

On June 10, 2024, the U.S. Court of Appeals for the Fourth Circuit affirmed the U.S. District Court for the Eastern District of North Carolina’s decision to dismiss a case challenging EPA’s response to a petition seeking a test order for 54 PFAS for lack of jurisdiction. CEH v. EPA, No. 23-1476. The district court granted EPA’s motion to dismiss, finding that EPA granted the petition and that the court lacks jurisdiction to review such a grant. The appellate court affirmed the decision, with one judge concurring in part and dissenting in part.

FAA Reauthorization Act Creates PFAS Replacement Program for Airports

Published June 5, 2024, by Dianne R. Phillips, Kristian L. Havard, and Molly Broughton

President Joe Biden signed the bipartisan, bicameral Federal Aviation Administration [FAA] Reauthorization Act of 2024 into law on May 16, 2024, extending many old provisions as well as creating new policy. One new provision is section 767 of Title VII, Modernizing Airport Infrastructure, setting aside PFAS-related resources for airports. The primary application for PFAS use in airports is in aqueous film-forming foams (AFFF) used to fight fires caused by liquid fuels such as aviation fuels. According to the U.S. Fire Administration, PFAS have been used in such firefighting foams since the 1970s due to their effectiveness at containing flammable vapors.

PEER Files Request for Correction Regarding Verification Analysis for PFAS in Pesticide Products

Published May 31, 2024, by Lynn L. Bergeson and Carla N. Hutton

PEER announced on May 28, 2024, that it filed a request for correction (RFC) under the Information Quality Act (IQA) regarding an EPA research memorandum entitled “Verification Analysis for PFAS in Pesticide Products (ACB Project B23-05b)” dated May 18, 2023, and the accompanying press release. As reported in our June 2, 2023, memorandum, EPA completed a verification analysis of a study published in September 2022 in the Journal of Hazardous Materials entitled “Targeted analysis and Total Oxidizable Precursor assay of several insecticides for PFAS.” The study reported the presence of perfluorooctanesulfonate (PFOS) in six of ten pesticide products tested. EPA released a summary of its laboratory analysis of the same ten pesticide products reported to contain PFAS residues. EPA stated it did not find any PFAS in the tested pesticide products, differing from the results of the published study.

Maine Amends Its PFAS Statute, Exempting Certain Product Categories from the Sales Prohibition and Eliminating the General Notification Requirement

Published May 24, 2024, by Lynn L. Bergeson and Carla N. Hutton

On April 16, 2024, governor Janet Mills signed LD 1537, amending An Act To Stop Perfluoroalkyl and Polyfluoroalkyl Substances Pollution. On May 20, 2024, MDEP updated its “PFAS in Products” web page to reflect the amendments, which include eliminating the general notification requirement that was scheduled to take effect January 1, 2025. The legislation also creates new sales prohibitions for products with intentionally added PFAS with varying effective dates, exempts certain product categories from the prohibitions, and establishes a new reporting program for those product categories that receive a currently unavoidable use (CUU) determination from MDEP.

PEER and CEH File NOI to Sue EPA to Stop Manufacture and Distribution of PFAS in Fluorinated Containers

Published May 23, 2024, by Lynn L. Bergeson and Carla N. Hutton

On May 20, 2024, PEER announced that on May 17, 2024, they filed an NOI against EPA “to stop the manufacture and distribution of hundreds of millions of plastic containers with dangerous levels of a carcinogenic per-and polyfluoroalkyl substance (PFAS) called perfluorooctanoic acid (PFOA).” Filed with CEH, the NOI states that EPA “has failed to perform its non-discretionary duty under TSCA section 4(f), 15 U.S.C. § 2603(f), to initiate applicable action under section 5, 6 or 7 to prevent or reduce the risk posed by [PFOA] formed in the process of fluorinating plastic containers.”

EPA Issues Final Rule Requiring TRI Reporting for Seven Additional PFAS

Published May 22, 2024, by Lynn L. Bergeson and Carla N. Hutton

EPA published a final rule on May 17, 2024, to update the list of chemicals subject to Toxics Release Inventory (TRI) reporting to include seven additional PFAS for Reporting Year 2024 (reporting forms due by July 1, 2025). 89 Fed. Reg. 43,331. The FY 2020 NDAA includes a provision that automatically adds PFAS to the TRI list upon EPA’s adoption of a final toxicity value. As reported in our January 18, 2024, blog item, EPA announced on January 9, 2024, that six PFAS were automatically added for Reporting Year 2024 due to EPA having adopted a final toxicity value during 2023.

EPA Holds Webinar on “Reducing PFAS in Products: Progress and Challenges”

Published May 17, 2024, by Lynn L. Bergeson and Carla N. Hutton

On May 8, 2024, EPA OCSPP held a webinar on “Reducing PFAS in Products: Progress and Challenges.” The webinar was the third in EPA’s series on “Pollution Prevention in Action.” Jennie Romer, EPA deputy assistant administrator for OCSPP’s Pollution Prevention (P2) program, hosts webinars featuring businesses, P2 grantees, and other experts about innovations and successes in implementing source reduction strategies to advance sustainability across sectors. EPA has posted a recording of the May 8, 2024, webinar on its website. Recordings of previous webinars are already available.

Colorado Increases Restrictions on PFAS in Consumer Products

Published May 16, 2024, by Thomas S. Lee, Merrit M. Jones, Erin L. Brooks, and John R. Kindschuh

On May 1, 2024, Colorado governor Jared Polis signed SB-81, a bill entitled the “Perfluoroalkyl and Polyfluoroalkyl Consumer Protection Act.” This bill expands Colorado’s existing restrictions on the use of intentionally added PFAS in certain consumer product categories and revamps the state’s approach to intentionally added PFAS in cookware. The new Colorado law is similar to Maine’s recent legislation, which transitioned away from disclosures and toward PFAS prohibitions in specific product categories.

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