RECORDED WEBINAR ON-DEMAND — “What to Expect in Chemicals Policy and Regulation and on Capitol Hill in 2023”: Bergeson & Campbell, P.C.’s (B&C®) January 31, 2023, webinar “What to Expect in Chemicals Policy and Regulation and on Capitol Hill in 2023” is now available for on-demand viewing. During this one-hour webinar, Lynn L. Bergeson, Managing Partner, B&C; James V. Aidala, Senior Government Affairs Consultant, B&C; Richard E. Engler, Ph.D., Director of Chemistry, B&C; and Dennis R. Deziel, Senior Government Affairs Advisor, B&C, discussed U.S. Environmental Protection Agency (EPA) priorities, leadership, and operating environment in the new year. This includes a review of priorities and challenges that will shape updates that are expected to affect Toxic Substances Control Act (TSCA) and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) implementation in 2023.
WEBINAR — Extended Producer Responsibility, March 22, 2023, 12:00 p.m. – 1:00 p.m. (EDT), Via Webinar: B&C is pleased to present “Extended Producer Responsibility,” a webinar featuring LeRoy Paddock, Associate Dean for Environmental Law Studies at George Washington University Law School; Edith G. Nagy, Regulatory Consultant, B&C; and Lynn L. Bergeson, Managing Partner, B&C, as they discuss the Extended Producer Responsibility (EPR) policy approach of shifting responsibility for a product’s lifecycle upstream, and what that means for producers. Register now.
EVENT — Biocides USA 2023, February 28, 2023, Via Webinar: Chemical Watch’s sixth annual Biocides USA conference will focus on recent developments for antimicrobials in the United States, featuring the Office of Pesticide Programs (OPP) priorities and challenges, updates on federal registration processes, a look at state level developments for per- and polyfluoroalkyl substances (PFAS) regulations, and an update on changes to the regulatory framework for biocides in Canada. Meibao Zhuang, Ph.D., Senior Scientist and Regulatory Consultant, B&C, and Dennis R. Deziel, Senior Government Affairs Advisor, B&C, will present “Emerging FIFRA legal and policy issues and the Congress: Implications for the pesticide community.”
EVENT — TSCA Developments 2023, March 7, 2023, Via Webinar: Chemical Watch presents TSCA Developments 2023, a one-day virtual conference focused on the latest TSCA updates and what they mean for the chemical industry. Lynn L. Bergeson, Managing Partner, B&C, will present on TSCA litigation.
PODCAST – What To Expect In Chemicals Policy And Regulation And On Capitol Hill In 2023: All Things Chemical® is pleased to release two forward looking episodes discussing what the year ahead is expected to hold “What to Expect in Chemicals Policy and Regulation in 2023 — A Conversation with Richard E. Engler, Ph.D.” and “What to Expect on Capitol Hill and at EPA OCSPP in 2023 — A Conversation with Jim Aidala.”
EPA Announces Reinvoicing 2023 Annual Pesticide Registration Maintenance Fee To Meet Statutory Direction: On January 13, 2023, EPA announced it is notifying pesticide registrants that EPA will send supplemental invoices to reflect the new annual pesticide registration maintenance fee for fiscal year (FY) 2023. To meet new statutory requirements in the Pesticide Registration Improvement Act of 2022 (PRIA 5), which was signed into law on December 29, 2022, the revised fee for FY 2023 for each registered pesticide product will be $4,875, increased from the $3,400 level specified in the EPA invoices provided in early December 2022. For more information, please read our January 23, 2023, blog.
EPA Requests Comment On NAMs To Screen For Endocrine Effects: EPA announced on January 19, 2023, the availability of and solicited public comment on a draft white paper entitled “Availability of New Approach Methodologies (NAMs) in the Endocrine Disruptor Screening Program (EDSP).” 88 Fed. Reg. 3406. EPA states that it developed the draft white paper pursuant to the Federal Food, Drug, and Cosmetic Act (FFDCA), which requires EPA to develop a screening program to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen or other endocrine effects. The draft white paper announces that certain NAMs have been validated and may now be accepted by EPA as alternatives for certain EDSP Tier 1 assays, while others are useful for prioritization purposes and for use as other scientifically relevant information, where appropriate, in weight of evidence (WoE) evaluations. Comments on the draft white paper are due March 20, 2023. For more information on the draft white paper, please read the full memorandum.
EPA Announces Stakeholder Engagement Opportunities On IRA Programs To Reduce Embodied GHG Emissions Associated With Construction Materials And Products: On January 26, 2023, EPA announced the first opportunities for public input on new programs focused on lower carbon construction materials made possible by a $350 million investment from the Inflation Reduction Act (IRA). 88 Fed. Reg. 5002. EPA will hold three public webinars and is accepting written feedback on establishing the new grant and technical assistance programs and a carbon labeling program for construction materials with substantially lower levels of embodied carbon. The webinars will be held:
- March 2, 2023, 2:00-3:30 p.m. (EST). Topic: Reducing Embodied Greenhouse Gas (GHG) Emissions: Construction Materials Prioritization and Environmental Data Improvement;
- March 22, 2023, 2:00-3:30 p.m. (EST). Topic: Reducing Embodied GHG Emissions: Grants and Technical Assistance for Environmental Product Declarations; and
- April 19, 2023, 2:00-3:30 p.m. (EST). Topic: Reducing Embodied GHG Emissions: Carbon Labeling.
EPA prepared a Request for Information (RFI) that is intended to facilitate preparation of written comments. Written comments are due May 1, 2023.
EPA Proposes SNUR For PFAS Designated As Inactive On The TSCA Inventory: On January 26, 2023, EPA proposed a significant new use rule (SNUR) for those PFAS that are currently on the TSCA Inventory but that have not been actively manufactured (including imported) or processed in the United States since 2006 and are consequently designated as inactive on the TSCA Inventory. 88 Fed. Reg. 4937. Persons subject to the SNUR would be required to notify EPA at least 90 days before commencing any manufacture (including import) or processing of the chemical substance for a significant new use. Once EPA receives a notification, EPA must review and make an affirmative determination on the notification, and take such action as is required by any such determination before the manufacture (including import) or processing for the significant new use can commence. EPA states that such a review will assess whether the use may present unreasonable risk to health or the environment and ensure that EPA can prevent future unsafe environmental releases of the PFAS subject to this SNUR. Comments on the proposed SNUR are due March 27, 2023. For more information on the proposed SNUR and our Commentary, please read the full memorandum.
EPA Will Hold Third And Final TSCA Engineering Initiative Webinar On February 28, 2023: EPA announced on February 23, 2023, that the New Chemicals Program will hold a webinar on February 28, 2023, on EPA’s process for assessing the potential risks of new chemicals under TSCA Section 5 and the types of data EPA considers in this assessment. EPA states that specifically, the upcoming webinar will cover commonly missed information in Section 5 submissions and how EPA evaluates environmental release information for operations that occur at non-submitter sites. Registration is now open. More information is available in our February 13, 2023, blog item.
EPA Accepting Public Comments On Candidates To Be Ad Hoc Reviewers For Draft Documents Related To Cumulative Risk Assessment Under TSCA: EPA announced on February 13, 2023, that it will accept public comments on candidates under consideration for selection as ad hoc reviewers to assist the Science Advisory Committee on Chemicals (SACC) with peer review of two draft documents related to cumulative risk assessment under TSCA. Biographies of these candidates are available on regulations.gov. If selected, candidates will serve as peer reviewers for two documents, which will be reviewed by the SACC at a public virtual meeting May 8-11, 2023. Comments on the candidates are due February 25, 2023. More information is available in our February 14, 2023, blog item.
EPA Revises Definition Of “Waters Of The United States”: On January 18, 2023, EPA and the Department of the Army published a final rule that defines the scope of waters protected under the Clean Water Act (CWA). 88 Fed. Reg. 3004. In developing this rule, the agencies considered the text of the relevant CWA provisions and the statute as a whole, the scientific record, relevant Supreme Court case law, and the agencies’ experience and technical expertise after more than 45 years of implementing the longstanding pre-2015 regulations defining “waters of the United States” (WOTUS). In the final rule, the agencies interpret WOTUS to include:
- Traditional navigable waters, the territorial seas, and interstate waters (“paragraph (a)(1) waters”);
- Impoundments of WOTUS (“paragraph (a)(2) impoundments”);
- Tributaries to traditional navigable waters, the territorial seas, interstate waters, or paragraph (a)(2) impoundments when the tributaries meet either the relatively permanent standard or the significant nexus standard (“jurisdictional tributaries”);
- Wetlands adjacent to paragraph (a)(1) waters, wetlands adjacent to and with a continuous surface connection to relatively permanent paragraph (a)(2) impoundments, wetlands adjacent to tributaries that meet the relatively permanent standard, and wetlands adjacent to paragraph (a)(2) impoundments or jurisdictional tributaries when the wetlands meet the significant nexus standard (“jurisdictional adjacent wetlands”); and
- Intrastate lakes and ponds, streams, or wetlands not identified in paragraphs (a)(1) through (4) that meet either the relatively permanent standard or the significant nexus standard (“paragraph (a)(5) waters”).
The final rule is effective on March 20, 2023.
EPA Will Convene e-Manifest Advisory Board For Meeting On February 28-March 2, 2023: On January 18, 2023, EPA announced that it will convene the Hazardous Waste Electronic System (e-Manifest) Advisory Board for a three-day virtual public meeting on February 28-March 2, 2023. 88 Fed. Reg. 2910. The purpose of the meeting is for the Board to advise EPA on its proposed program priorities and user fees for the FY 2024/FY 2025 cycle. e-Manifest provides those persons required to use a Resource Conservation and Recovery Act (RCRA) manifest under either federal or state law the option of using electronic manifests to track shipments of hazardous waste and to meet certain RCRA requirements. Under the Hazardous Waste Electronic Manifest Establishment Act of 2012, EPA must collect user fees to offset the costs of developing and operating the e-Manifest system. To make oral comments during the public meeting and be included on the meeting agenda, please register by noon on February 21, 2023. Registration instructions will be posted on the e-Manifest Advisory Board website. Any written comments submitted for the e-Manifest Advisory Board meeting on or before February 21, 2023, should be submitted in the public docket under Docket number EPA-HQ-OLEM-2022-0973 at http://www.regulations.gov. Written comments submitted to the public docket on or before February 21, 2023, will be provided to the e-Manifest Advisory Board for its consideration before the meeting. Anyone who wishes to submit comments after February 21, 2023, must send their written public comments or their oral comment requests directly to the Designated Federal Officer (DFO) listed in the Federal Register notice.
EPA Publishes Final Heavy-Duty Engine And Vehicle Standards: On January 24, 2023, EPA published a final rule intended to reduce air pollution further, including ozone and particulate matter (PM), from heavy-duty engines and vehicles across the United States. 88 Fed. Reg. 4296. According to EPA, the final program includes new emission standards “that are significantly more stringent and that cover a wider range of heavy-duty engine operating conditions compared to today’s standards; further, the final program requires these more stringent emissions standards to be met for a longer period of when these engines operate on the road.” The final rule promulgates new numeric standards and changes key provisions of the existing heavy-duty emission control program, including the test procedures, regulatory useful life, emission-related warranty, and other requirements. EPA also made limited amendments to the regulations that implement its air pollutant emission standards for other sectors (e.g., light-duty vehicles, marine diesel engines, locomotives, and various other types of nonroad engines, vehicles, and equipment). The final rule is effective on March 27, 2023.
EPA Issues Six Proposed Determinations To Deny Facilities’ Requests To Continue “Unsafe Coal Ash Disposal”: On January 25, 2023, EPA announced that it issued six proposed determinations to deny facilities’ requests to continue disposing of coal combustion residuals (CCR) into unlined surface impoundments. For a seventh facility that withdrew its application, EPA states that it issued a letter identifying concerns with deficiencies in its liner components and groundwater monitoring program. According to EPA, it is proposing to deny these applications because the owners and operators of the CCR units failed to demonstrate that the surface impoundments comply with requirements of the CCR regulations. If EPA issues final denials, the facilities will either have to stop sending waste to these unlined impoundments or submit applications to EPA for extensions to the deadline for unlined coal ash surface impoundments to stop receiving waste. EPA is collecting public comments on these proposals for 30 days through dockets in Regulations.gov. For more information on how to submit comments, visit the Part B implementation web page. The comment period end date is March 10, 2023.
EPA Proposes To Strengthen PM2.5 NAAQS: On January 27, 2023, based on its reconsideration of the air quality criteria and the national ambient air quality standards (NAAQS) for PM, EPA proposed to revise the primary annual PM2.5 standard by lowering the level. 88 Fed. Reg. 5558. EPA proposed to retain the current primary 24-hour PM2.5 standard and the primary 24-hour PM10 standard. EPA also proposed not to change the secondary 24-hour PM2.5 standard, secondary annual PM2.5 standard, and secondary 24-hour PM10 standard at this time. EPA also proposed revisions to other key aspects related to the PM NAAQS, including revisions to the Air Quality Index (AQI) and monitoring requirements for the PM NAAQS. Comments are due March 28, 2023.
EPA announced on January 31, 2023, that it will hold a virtual public hearing on February 21, 2023, and February 22, 2023. 88 Fed. Reg. 6215. EPA states that if it receives a high volume of registrations for the public hearing, it may continue the public hearing on February 23, 2023. According to EPA, the public hearing will provide interested parties the opportunity to present data, views, or arguments concerning EPA’s proposed decisions in the reconsideration of the PM NAAQS.
Congressional Democrats Urge EPA To Strengthen Proposed RMP Rule To Protect Americans From Chemical Accidents: On January 27, 2023, Senator Tom Carper (D-DE), Chair of the Senate Committee on Environment and Public Works, and Representative Lisa Blunt Rochester (D-DE), as well as 47 other congressional colleagues, sent a letter to EPA Administrator Michael S. Regan urging the Agency to strengthen protections for workers, environmental justice communities, and first responders under its August 2022 proposed Risk Management Program (RMP) rule. According to the letter, the final RMP rule “should prioritize hazard reduction and prevention measures, including transitioning to inherently safer chemicals and processes and requiring third-party audits to verify compliance.” To ensure adequate protection for those living near RMP facilities, the final rule should improve requirements for outreach to inform the public about RMP facility hazards and emergency response plans before and during incidental releases and require that this information be made available in multiple languages. To foster information access and transparency, EPA should maintain a publicly accessible RMP database and commit to delivering that database on the fastest possible timeline.
EPA Announces Plans For Wastewater Regulations And Studies, Including Limits For PFAS And A New Study For Nutrients: On January 31, 2023, EPA announced the release of its Effluent Guidelines Program Plan 15 (Plan 15), which discusses EPA’s 2021 annual review of effluent limitations guidelines and pretreatment standards, presents the Agency’s preliminary review of certain specific point source categories, provides an update on the analyses and tools that EPA is developing related to effluent limitations guidelines and pretreatment standards, and discusses several new and ongoing rulemaking actions. 88 Fed. Reg. 6258. According to EPA’s January 20, 2023, press release, Plan 15 focuses on evaluating the extent and nature of both nutrient and PFAS discharges. EPA states that Plan 15 announces its determination that revised effluent limitations guidelines and pretreatment standards (ELG) are warranted for reducing PFAS in leachate discharges from landfills. EPA also announced several new and expanded studies, including:
- An expansion of the ongoing study of PFAS discharges from textile manufacturers;
- A new study of publicly owned treatment works (POTW) influents to characterize the PFAS concentrations from industrial dischargers to POTWs and inform implementation of pretreatment programs to address them; and
- A new study on concentrated animal feeding operations (CAFO) to make an informed, reasoned decision on whether to undertake rulemaking to revise the ELGs for CAFOs.
EPA Excludes HFO-1336mzz(E) From Regulatory Definition Of VOC: On February 8, 2023, EPA published a final rule that revises EPA’s regulatory definition of volatile organic compounds (VOC) to exempt trans-1,1,1,4,4,4-hexafluorobut-2-ene (HFO-1336mzz(E)). 88 Fed. Reg. 8226. The final action adds HFO-1336mzz(E) to the list of compounds excluded from the regulatory definition of VOC on the basis that this compound makes a negligible contribution to tropospheric ozone (O3) formation. The final rule will be effective on April 10, 2023.
Biden Administration Announces $2 Billion In Bipartisan Infrastructure Law Funding To States And Territories To Address Emerging Contaminants Like PFAS In Drinking Water: On February 13, 2023, EPA announced the availability of $2 billion from President Biden’s Bipartisan Infrastructure Law to address emerging contaminants like PFAS in drinking water across the country. According to EPA, this investment, which is allocated to states and territories, will be made available to communities as grants through EPA’s Emerging Contaminants in Small or Disadvantaged Communities (EC-SDC) Grant Program and is intended to promote access to safe and clean water in small, rural, and disadvantaged communities while supporting local economies. EPA also released the Emerging Contaminants in Small or Disadvantaged Communities Grant Implementation document. The implementation document provides states and communities with the information necessary to use this funding to address local water quality and public health challenges. These grants will enable communities to improve local water infrastructure and reduce emerging contaminants in drinking water by implementing solutions such as installing necessary treatment solutions.
EPA Publishes Draft Inventory Of U.S. GHG Emissions And Sinks: 1990-2021: EPA announced on February 15, 2023, that the Draft Inventory of U.S. Greenhouse Gas Emissions and Sinks: 1990-2021 is available for public review. 88 Fed. Reg. 9881. EPA requests recommendations for improving the overall quality of the inventory report to be prepared in final in April 2023, as well as subsequent inventory reports. Comments are due March 17, 2023. EPA notes that it will consider comments received after that date for the next edition.
FDA Issues Final FSMA Guidance: On January 11, 2023, the U.S. Food and Drug Administration (FDA) announced the availability of a final guidance for industry titled “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: Guidance for Industry.” 88 Fed. Reg. 1503. The guidance provides FDA’s thinking on how importers of food for humans and animals can comply with the Food Safety Modernization Act (FSMA) regulation on foreign supplier verification programs (FSVP) issued by FDA on November 27, 2015. 80 Fed. Reg. 74225.
FDA Ends Enforcement Discretion Period For Certain Aspects Of Produce Safety Rule: On January 13, 2023, FDA reminded stakeholders that it is ending its intended enforcement discretion period on January 26, 2023, for the harvest and post-harvest agricultural water provisions for covered produce in the Produce Safety Rule.FDA released a fact sheet with questions and answers on the requirements.
FDA Launches “Into The Dataverse” Video Series: On January 13, 2023, FDA released the first video in a series named “Into the Dataverse.” This video provides an overview of 21 Forward, a data analytics tool that makes the food supply chain more transparent to FDA, enabling the agency to anticipate potential problems and manage those risks before they have real-world implications. 21 Forward is a real-world example of data modernization fueling the future of food safety. This platform is part of FDA’s modernization goals through its New Era of Smarter Food Safety initiative.
FDA Posts Translations For FSMA Rule: On January 19, 2023, FDA announced the posting of translated materials for the FSMA final rule on food traceability, which are now available in Indonesian, Simplified Chinese, Spanish, Thai, and Vietnamese.
FDA Re-releases 2022 Edition Of FDA Food Code: On January 20, 2023, FDA announced the posting of the updated 2022 Food Code to include correction of formatting errors. A new job aid was also released for food establishments and regulators.
FDA Reopens Comment Period For Color Certification Fees: On January 24, 2023, FDA reopened the comment period for the proposed rule titled “Color Additive Certification; Increase in Fees for Certification Services.” 88 Fed. Reg. 4117. FDA is taking this action in response to a request from stakeholders to extend the comment period to allow additional time for interested parties to collect, analyze, and incorporate data to develop comments for the proposed rule. Comments are due by March 10, 2023.
FDA Announces 2022 Accomplishments For New Era Of Smarter Food Safety: On January 24, 2023, FDA released a list titled “New Era of Smarter Food Safety Select Accomplishments in 2022,” which highlights FDA activities for the four priority areas of the program. One notable accomplishment for 2022 was the Food Traceability Final Rule, and its list of foods that require additional recordkeeping to enhance tracking and tracing.
FDA Hosts New Era Of Smarter Food Safety Webinar: On January 25, 2023, FDA held its sixth webinar in its ongoing series exploring food safety culture as part of its New Era of Smarter Food Safety. The webinar titled “Food Safety Culture Learning: It’s more than checking the boxes,” featured representatives from major food chains and focused on how food safety culture relates to training and education. The recording of this session will be posted here.
FDA Issues Notice For Front Of Package Labeling: On January 26, 2023, FDA issued a 60-day procedural notice on its plans to conduct a study entitled “Quantitative Research on Front of Package Labeling on Packaged Foods.” 88 Fed. Reg. 5005. FDA “is conducting the consumer research to help it explore the development of a front-of-package labeling scheme, which is part of the national strategy from the White House Conference on Hunger, Nutrition and Health held in September 2022.” FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Electronic or written comments on the collection of information must be submitted by March 27, 2023.
FDA Issues Update To Voluntary Cosmetic Registration Program: On February 1, 2023, FDA released an update to the Voluntary Cosmetic Registration Program (VCRP). This update includes the activity for those cosmetic firms who have voluntarily registered their establishments or product formulations with FDA. The FDA voluntary program may provide a basis for potential rulemaking in the future.
FDA Posts Update To Approved Voluntary Qualified Importer Program Applicant List: On February 7, 2023, FDA posted an update to the list of approved applicants for the Voluntary Qualified Importer Program(VQIP). The application portal is open for FY 2024 benefits through May 31, 2023.
French NGO Claims Certain Everyday Products Contain Unlabeled Nanomaterials: L’association de veille et d’information civique sur les enjeux des nanosciences et nanotechnologies (AVICENN), a French non-governmental organization (NGO), announced on December 15, 2022, publication of a report entitled Searching for [Nanos] in Everyday Products. AVICENN reports that it found nanomaterials in 20 products in the cosmetics, hygiene and health, food, toys, and paint categories. More information is available in our January 20, 2023, blog item.
EUON Publishes Nanopinion On Study Of The EU Market For Nanomaterials: On January 17, 2023, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “EU 2025: Enjoying the Benefits of Nanotechnology and NMS” by Dr. Anastasios Papadiamantis and Dr. Antreas Afantitis, both of NovaMechanics Ltd. The authors report the findings of a study commissioned by EUON on the EU market for nanomaterials, including substances, uses, volumes, and key operators. The authors state that the EU (including the European Economic Area (EEA) countries and Switzerland) nanomaterials market “is expected to have a steady growth led by the medicine and personal care and manufacturing sectors.”
ECHA Provides Updated Guidance On Testing Nanomaterials: The European Chemicals Agency (ECHA) announced in its February 1, 2023, ECHA Weekly that it has released an updated appendix for nanomaterials that provides guidance on how to obtain data under the new information requirements for nanoforms. According to ECHA, this includes information on how to perform environmental testing and advice on preparation methods and testing strategies for physico-chemical testing of nanoforms. More information is available in our February 1, 2023, blog item.
NNI Publishes Supplement To The President’s 2023 Budget Request: On February 3, 2023, the National Nanotechnology Initiative (NNI) announced that it published a supplement to President Biden’s 2023 budget request. The NNI budget represents the sum of the nanotechnology-related investments allocated by each of the participating agencies. Each agency determines its budget for nanotechnology research and development (R&D) in coordination with the Office of Management and Budget (OMB), the White House Office of Science and Technology Policy (OSTP), and Congress. More information is available in our February 6, 2023, blog item.
OECD Holds Webinar On Test Guideline No. 125: Nanomaterial Particle Size And Size Distribution Of Nanomaterials: The Organization for Economic Cooperation and Development (OECD) held a webinar on February 7, 2023, on Test Guideline (TG) No. 125: Nanomaterial Particle Size and Size Distribution of Nanomaterials. OECD presented the methods described in TG No. 125 to determine the size and size distributions of nanomaterial particles and fibers spanning from one nanometer (nm) to 1,000 nm. OECD organized the webinar to increase awareness of this newly adopted TG.
France Appeals European General Court Decision Annulling The Harmonized Classification And Labeling Of Titanium Dioxide: According to a February 13, 2023, press release issued by France’s Ministry of Ecological Transition and Territorial Cohesion and Ministry of Energy Transition, France is appealing the November 23, 2022, decision of the European General Court that annuls the 2019 harmonized classification and labeling of titanium dioxide as a carcinogenic substance by inhalation in certain powder forms. As reported in our December 6, 2022, memorandum, the court concluded that the European Commission (EC) “made a manifest error in its assessment of the reliability and acceptability of the study on which the classification was based and, second, it infringed the criterion according to which that classification can relate only to a substance that has the intrinsic property to cause cancer.” France claims that the court exceeded the limits of its judicial review by conducting its own evaluation and interpretation of the scientific data. France notes that the appeal suspends the court’s decision and that the harmonized classification and labeling will continue to apply until the appeal is decided.
B&C® Biobased And Sustainable Chemicals Blog: For access to a summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to https://biobasedblog.lawbc.com.
Congress Enacts Modernization Of Cosmetics Regulation Act Of 2022, Significantly Strengthening Regulation Of Cosmetics: In a move that some may not have seen coming, Congress enacted the Modernization of Cosmetics Regulation Act of 2022 (MCRA) on December 29, 2022, as part of the Omnibus Appropriations Act. The MCRA significantly strengthens the FDA authority over cosmetic products. Key impacts are summarized in our January 18, 2023, memorandum.
Booker Introduces Package Of Bills To Reform U.S. Food System, Including Protect America’s Children From Toxic Pesticides Act: On February 2, 2023, Senator Cory Booker (D-NJ), a member of the Senate Committee on Agriculture, Nutrition, and Forestry, announced that he reintroduced a package of bills geared towards reforming the country’s agriculture sector:
- The Farm System Reform Act (S. 271): The bill would strengthen the Packers & Stockyards Act “to crack down on the monopolistic practices of meatpackers and corporate integrators,” place a moratorium on CAFOs, and restore mandatory country-of-origin labeling requirements;
- Industrial Agriculture Accountability Act (S. 272): The legislation would place the liability for responsible disaster mitigation on corporations and industrial operators by requiring those entities to register with the U.S. Department of Agriculture (USDA) and submit disaster preparedness plans. The legislation would also ensure that industrial operators do not use inhumane methods in other aspects of the food system;
- Protecting America’s Meatpacking Workers Act (S. 270): The bill would “provide protections for meatpacking workers along with systemic reforms such as creating a fair market that allows independent farmers, ranchers and robust local food systems to thrive and ensuring that consumers can actually identify where their food comes from so that food giants cannot simply shift the burden of their unfair system to others in the supply chain or import more unsustainable meat from other parts of the world”; and
- Protect America’s Children from Toxic Pesticides Act (S. 269): The bill would update FIFRA “by banning the most damaging pesticides that have been scientifically proven to harm the safety of people and our environment,” including organophosphates, neonicotinoids, and paraquat.
Representative Ro Khanna (D-CA) introduced the House companion of the Farm System Reform Act and Protecting America’s Meatpacking Workers Act, and Representatives Jim McGovern (D-MA), Grace Meng (D-NY), and Earl Blumenauer (D-OR) introduced the House companion of the Industrial Agriculture Accountability Act in the House of Representatives.
Republicans Formally Challenge WOTUS Rule Through CRA: On February 2, 2023, Senator Shelley Moore Capito (R-WV), Ranking Member of the Senate Environment and Public Works Committee, led all 48 of Senate Republicans in introducing a formal challenge to the Biden Administration’s WOTUS rule through a Congressional Review Act (CRA) joint resolution of disapproval (S.J. Res. 7). According to Moore Capito’s February 2, 2023, press release, “the Biden administration upended regulatory certainty and placed unnecessary burdens directly on millions of Americans.” Representative Sam Graves (R-MO), Chair of the House Committee on Transportation and Infrastructure, introduced an identical resolution (H.J. Res. 27) in the House on February 2, 2023.
Fischer Introduces CRA Joint Resolution Of Disapproval To Overturn Regulation On Heavy-Duty Vehicle Emissions: On February 9, 2023, Senator Deb Fischer (R-NE) introduced a joint resolution (S.J. Res. 11) to overturn “an excessive Biden Administration regulation on heavy-duty vehicle emissions.” According to Fischer’s February 9, 2023, press release, EPA’s rule “would be challenging to implement and make new, compliant trucks cost prohibitive for small business owners.”
Petition Filed To Add Bisphenol A Epoxy Resin Copolymer To List Of Chemical Substances Subject To Superfund Excise Tax: On January 19, 2023, the Internal Revenue Service (IRS) announced that it received a petition requesting the addition of 4,4′-isopropylidenediphenol-epichlorohydrin copolymer (bisphenol A epoxy resin) to the list of taxable substances under Section 4672(a) of the Internal Revenue Code. 88 Fed. Reg. 3478. The petitioner is Westlake Epoxy Inc., an exporter of 4,4′-isopropylidenediphenol-epichlorohydrin copolymer. According to the petition, “4,4′-Isopropylidenediphenol-Epichlorohydrin Copolymer is a Bisphenol A Epoxy Resin and is used for Epoxide Resin. 4,4′-Isopropylidenediphenol-Epichlorohydrin Copolymer is derived from the taxable chemicals benzene, propylene, chlorine, and sodium hydroxide and produced predominantly from epichlorohydrin and bisphenol-A via a two-step glycidation reaction sequence. Taxable chemicals comprise 92.98 percent of the final product.” Comments and requests for a public hearing are due March 20, 2023.
DOI Seeks Comment On Revising Type A Procedures For Assessing Natural Resource Damages Resulting From Releases Of Hazardous Substances: On January 19, 2023, the Department of the Interior (DOI) requested comment on revising the simplified (Type A) procedures for assessing natural resource damages resulting from releases of hazardous substances. 88 Fed. Reg. 3373. DOI previously developed two types of natural resource damage assessment regulations: standard procedures for simplified assessments requiring minimal field observations (Type A Rule) and site-specific procedures for detailed assessments in individual cases (Type B Rule). The Type A Rule provides two distinct formulas for modeling damages for natural resource injuries caused by hazardous substance releases to coastal and marine environments and Great Lakes environments, respectively. In accordance with the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), damages calculated in accordance with Type A or Type B procedures are entitled to a “rebuttable presumption” of correctness in any administrative or judicial proceeding. The rebuttable presumption for the Type A procedure under the current version of the rule is limited to damages of $100,000 or less. DOI proposes to re-formulate the Type A Rule as a procedural structure for negotiated settlements by using tools tailored to incidents of smaller scale and scope. DOI seeks comment on the appropriate amount of damages eligible for a rebuttable presumption when using a new Type A process, as well as on potential non-monetary limitations for using the Type A Rule. Comments are due March 20, 2023.
OSHA Revises Combustible Dust NEP: On January 27, 2023, the Occupational Safety and Health Administration (OSHA) announced that it issued a revised Combustible Dust National Emphasis Program (NEP). OSHA notes that any combustible material can burn rapidly when in a finely divided form, and if such a dust is suspended in air in the right concentration, under certain conditions, it can become explosible. The purpose of the revised NEP is to continue OSHA inspections of facilities that generate or handle combustible dusts likely to cause fire, flash fire, deflagration, and explosion hazards. According to OSHA, incident reports indicate that the majority of the industries involved in combustible dust hazards are wood processing, agricultural and food production, and lumber production, but others are susceptible as well. OSHA states that it added the following industries to the NEP because they have a higher likelihood of having combustible dust hazards or experienced combustible dust-related fatalities/catastrophes:
- 311812 – Commercial Bakeries;
- 325910 – Printing Ink Manufacturing;
- 321912 – Cut Stock, Resawing Lumber, and Planning;
- 316110 – Leather and Hide Tanning and Finishing;
- 321214 – Truss Manufacturing; and
- 424510 – Grain and Field Bean Merchant Wholesalers.
EPA Requests Nominations For SAB; Members May Be Asked To Participate On CACC: On January 31, 2023, EPA invited nominations of scientific experts from a diverse range of disciplines to be considered for appointment to the EPA Science Advisory Board (SAB). 88 Fed. Reg. 6255. The EPA Administrator appoints members for a two- or three-year term, and the members serve as Special Government Employees who provide independent expert advice to EPA. Nominations are due March 2, 2023. According to the notice, members selected to the chartered SAB may also be asked to participate on the following standing committees of the SAB:
- The Agricultural Science Committee, which provides advice on matters that have been determined to have a significant direct impact on farming and agriculture-related industries;
- The Chemical Assessment Advisory Committee (CACC), which provides advice on EPA guidance documents, methodologies, and assessments that evaluate human health effects resulting from exposure to environmental hazards, as well as selected toxicological reviews of environmental chemicals available on EPA’s Integrated Risk Information System (IRIS);
- The Climate Science Committee, which provides advice on climate change science and the effects of climate change;
- The Drinking Water Committee, which provides advice on the scientific and technical aspects of EPA’s national drinking water program;
- The Economic Analysis Committee, which provides advice on the economic analysis of EPA programs;
- The Environmental Justice Science Committee, which provides advice on the scientific and technical aspects of environmental justice to improve the environment and/or public health in communities disproportionately impacted by environmental health hazards and risks; and
- The Radiation Advisory Committee, which provides advice on radiation protection, radiation science, and radiation risk assessment.
FTC Extends Deadline For Comments On Green Guides To April 24, 2023: On February 6, 2023, the Federal Trade Commission (FTC) extended the deadline for public comment on its Guides for the Use of Environmental Marketing Claims (Green Guides) to April 24, 2023. 88 Fed. Reg. 7656. FTC states in its December 14, 2022, news release that it seeks to update the Green Guides “based on increasing consumer interest in buying environmentally friendly products.” More information and an insightful Commentary are available in our December 16, 2022, memorandum.
EPA Releases Improved Calculators To Measure Impact Of P2 Activities: EPA announced on February 3, 2023, the release of three improved pollution prevention (P2) calculator tools — the P2 Cost Calculator, the P2 Greenhouse Gas Calculator, and the P2 Calculator for Reductions in Hazardous Substances, Pollutants and Contaminants. According to EPA, these tools convert information on P2 activities at a business, such as reductions in energy use, into information on cost savings and pollution reductions. More information is available in our February 7, 2023, blog item.
ATSDR Announces Availability Of Four Draft Toxicological Profiles: The Agency for Toxic Substances and Disease Registry (ATSDR) announced on February 9, 2023, the opening of a docket to obtain comments on drafts of four updated toxicological profiles: cobalt; hexachlorocyclohexanes; 1,1,1-trichloroethane; and vinyl chloride. 88 Fed. Reg. 8427. ATSDR states that it prepared the drafts based on current understanding of the health effects and availability of new studies and other information since their initial release. Comments are due May 10, 2023.
CPCS Proposes Safety Standard And Notification Requirements For Button Cell Or Coin Batteries And Consumer Products Containing Such Batteries: On February 9, 2023, the U.S. Consumer Product Safety Commission (CPSC) proposed to establish performance requirements for battery compartments on consumer products that contain, or are designed to use, one or more button cell or coin batteries. 88 Fed. Reg. 8692. The proposed rule would require warning labels on the packaging of button cell or coin batteries, as well as on the packaging, battery compartments, and accompanying instructions and manuals of consumer products containing button cell or coin batteries. The proposed rule would require manufacturers and importers of button cell or coin batteries, and consumer products containing such batteries, to notify consumers of performance and technical data related to the safety of such batteries at the point of sale, both online and in stores. If CPSC issues a final rule, consumer products subject to the rule must be tested and certified as compliant with the rule. Comments are due March 13, 2023.
Democrats Call On EPA To Address Plastics Crisis: On February 9, 2023, Senator Cory Booker (D-NJ), Representative Jared Huffman (D-CA), and Senator Jeff Merkley (D-OR) led 45 Democrats in the Senate and House in a letter to EPA Administrator Michael Regan “encouraging the agency to expand its current efforts to address the plastic production crisis.” According to Booker’s February 9, 2023, press release, EPA can take the following actions to protect communities, climate, and the environment from plastic production and pollution:
- Create new nationwide targets for single-use plastic source reduction and reuse/refill requirements in the packaging and food service sectors;
- Incentivize the expansion of reusable and refillable systems across the country, prioritizing overburdened communities through agency grant making and public-private partnerships;
- Reject the Trump EPA’s proposal to remove pyrolysis and gasification from the definition of incinerators under Clean Air Act (CAA) Section 129;
- Remove harmful chemical recycling technologies from the National Recycling Strategy;
- Require financial assurance requirements for new or expanded covered facilities (as defined in the Protecting Communities from Plastics Act, Section 4 (a)(3)) as a condition to receiving CAA or CWA permits;
- Initiate a rulemaking under TSCA to review the entire petrochemical industry, from their facilities to specific chemicals used, to understand how these chemicals, alone or mixed, impact human health; and
- Establish and lead a microplastics pilot program to test the efficacy and cost effectiveness of tools, technologies, and techniques to prevent the release of microplastics into the environment and to remove existing microplastics without causing additional harm to the environment.
EPA Will Hold Virtual Listening Sessions On PFAS Strategic Roadmap: EPA Region 7 will hold a virtual listening session on EPA’s PFAS Strategic Roadmap for Region 7 communities on February 28, 2023, and Region 3 will hold a virtual listing session on March 2, 2023. The engagement sessions will provide information about EPA’s ongoing work under the PFAS Strategic Roadmap. Registration is open.
NYS DEC Accepting Comments Until March 20, 2023, On Chemicals Under Consideration For Listing As Toxic Chemicals In Children’s Products: The New York State Department of Environmental Conservation (NYS DEC) will hold a virtual public meeting on February 16, 2023, postponed from January 10, 2023, on the chemicals under consideration for listing as Chemicals of Concern (COC) and High-Priority Chemicals (HPC) for the Toxic Chemicals in Children’s Products (TCCP) program. NYS DEC will present an overview of the enacted TCCP law and discuss the chemicals under consideration for listing as COCs and HPCs that manufacturers will be required to report if present in children’s products. NYS DEC has posted the chemicals under consideration, which are listed in Table 1 (COCs) and Table 2 (HPCs). Comments on the lists are due March 20, 2023. NYS DEC notes that the February 16, 2023, meeting is a pre-rulemaking meeting, and NYS DEC “anticipates releasing a proposed rule with additional public comment opportunities after feedback at this meeting is obtained.” Registration for the February 16, 2023, meeting is required.
PCRM Will Hold Webinar Series On “Tomorrow’s Data Today: Sunsetting The 2-year Carcinogenicity Assay”: The Physicians Committee for Responsible Medicine (PCRM) New Approach Methodologies (NAM) Use for Regulatory Applications (NURA) program is offering a free three-session training series on replacing the traditional two-year bioassay with a more effective, human-relevant carcinogenicity assessment. In “Tomorrow’s Data Today: Sunsetting the 2-year Carcinogenicity Assay,” toxicologists, risk assessors, and scientists will hear directly from other experts on the current progress among working groups, adverse outcome pathways (AOP) and integrated approaches to testing and assessment (IATA), case studies, and promising technologies to use in their WoE carcinogenicity assessments. The webinars will be held February 23, 2023, March 2, 2023, and March 9, 2023. Registration is now open. Maine Proposes Rule To Clarify Reporting Requirements For PFAS In Products: On February 14, 2023, the Maine Department of Environmental Protection (MDEP) proposed a new rule intended to provide additional guidance on the notification requirements and sales prohibitions for products and product components containing intentionally added PFAS. MDEP will hold a public hearing on April 20, 2023. Comments are due May 19, 2023, by 5:00 p.m. (EDT). More information will be available in our forthcoming memorandum.