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Recent Federal Developments for June 17, 2024
Tuesday, June 18, 2024

TSCA/FIFRA/TRI

EPA Announces New Resource Portal And Reporting Tool Improvements Before CDR Reporting Begins On June 1, 2024: On May 16, 2024, the U.S. Environmental Protection Agency (EPA) announced the creation of CDR GuideME, a new resource portal, and improvements to the reporting tool to make the reporting process easier. According to EPA, CDR GuideME is part of its effort to develop “a user-friendly, single location for all CDR guidance documents and other training materials, including the reporting instructions, fact sheets, and selected EPA responses to industry inquiries.” The Chemical Data Reporting (CDR) rule requires all companies to report data electronically using e-CDRweb through EPA’s Central Data Exchange (CDX) system. Updates to CDX include:

  • Incorporating 2024 CDR reporting codes that can be used and the years covered by the reporting period;
  • Providing an updated spreadsheet for uploading chemical information in bulk (available in the resources section of the reporting tool); and
  • Improving the functionality to copy substantiations of confidential business information (CBI) claims between chemicals and for accessing and saving a copy of submitted records.

The CDR website has updated guidance on submitting information to the CDR database, as well as information about prior CDR reporting cycles. EPA notes that stakeholders must register with CDX and be approved by EPA before they can begin submitting forms. The 2024 CDR submission period began June 1, 2024, and will end September 30, 2024. More information is available in our May 17, 2024, blog item.

EPA Issues Final Rule Requiring TRI Reporting For Seven Additional PFAS: 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 per- and polyfluoroalkyl substances (PFAS) for Reporting Year 2024 (reporting forms due by July 1, 2025). 89 Fed. Reg. 43331. 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:

  • Ammonium perfluorohexanoate; Chemical Abstracts Service Registry Number® (CAS RN®) 21615-47-4;
  • Lithium bis[(trifluoromethyl)sulfonyl] azanide; CAS RN 90076-65-6;
  • Perfluorohexanoic acid (PFHxA); CAS RN 307-24-4;
  • Perfluoropropanoic acid (PFPrA); CAS RN 422-64-0;
  • Sodium perfluorohexanoate; CAS RN 2923-26-4; and
  • 1,1,1-Trifluoro-N-[(trifluoromethyl)sulfonyl] methanesulfonamide; CAS RN 82113-65-3.

Because its identity is no longer confidential, EPA added the following chemical to the TRI list:

  • Betaines, dimethyl(.gamma.-.omega.-perfluoro-.gamma.-hydro-C8-18-alkyl); CAS RN 2816091-53-7.

The final rule was effective June 17, 2024. More information is available in our May 22, 2024, blog item.

PEER And CEH File NOI To Sue EPA To Stop Manufacture And Distribution Of PFAS In Fluorinated Containers: On May 20, 2024, the Public Employees for Environmental Responsibility (PEER) announced that on May 17, 2024, it filed a notice of intent (NOI) to sue 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 the Center for Environmental Health (CEH), the NOI states that EPA “has failed to perform its non-discretionary duty under section 4(f) of [the Toxic Substances Control Act (TSCA)], 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.” The NOI asks that EPA take action as soon as possible under TSCA Sections 6 and/or 7 requiring that Inhance Technologies LLC immediately cease all PFOA production during fluorination of plastic containers. More information is available in our May 23, 2024, blog item.

EPA Releases Draft Risk Evaluation Documents For DIDP And DINP For Public Comment And Peer Review: 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. 43847. 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. Comments on the draft documents are due July 19, 2024. EPA will submit the draft documents to its Science Advisory Committee on Chemicals (SACC) for peer review. On July 23, 2024, SACC will consider the scope and clarity of the draft charge questions for the peer review. Written comments on the scope and clarity of the charge questions are due by 12:00 p.m. (EDT) on July 19, 2024. To request time to present oral comments, stakeholders must register by 12:00 p.m. (EDT) on July 19, 2024. For those not making oral comments, registration will remain open through the end of the meeting. On July 30-August 2, 2024, SACC will consider the draft documents and public comments for peer review. To request time to present oral comments, stakeholders must register by 12:00 p.m. (EDT) on July 26, 2024. For those not making oral comments, registration will remain open through the end of the meeting. To allow sufficient time for EPA to process requests for special accommodations, EPA asks that requests be submitted at least ten business days in advance of the meeting. More information is available in our May 24, 2024, memorandum.

Updated TSCA Inventory Coincides With 2024 CDR Cycle Submission Period: EPA announced on May 23, 2024, that it has updated the TSCA Inventory. EPA notes that this update coincides with the 2024 CDR cycle submission period that began 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 states that the TSCA Inventory contains 86,770 chemicals, of which 42,377 are active in U.S commerce. More information is available in our May 28, 2024, blog item.

GAO Finds EPA Implemented Three Open Recommendations Related To Assessing And Controlling Toxic Chemicals: 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:

  • In May 2023, EPA’s chemical assessment program provided information to its program and regional offices about the various chemical assessment products available, how they differ, and the length of time each takes to prepare;
  • In April 2024, EPA’s chemical assessment program completed an analysis to address resource needs; and
  • EPA’s April 2024 analysis also included information on staff specializations, mission critical capabilities, and demand for chemical assessments.

More information is available in our June 5, 2024, blog item.

PEER Files Request For Correction Regarding Verification Analysis For PFAS In Pesticide Products: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. PEER asks that EPA retract the 2023 research memorandum and press release on the grounds that EPA violated its own guidelines for quality science and accuracy. More information is available in our May 31, 2024, blog item.

EPA Engaging In “Administrative Deliberations” Regarding TSCA Section 5 Order Challenged By Cherokee Concerned Citizens: 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 requests that the court alter the July 10, 2024, deadline for its brief to September 9, 2024.

Appellate Court Affirms Decision That TSCA Section 21 Petition Seeking PFAS Testing Is Not Subject To Review: 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. More information is available in our June 11, 2024, blog item.

EPA Proposes Two Batches Of SNURs: On June 11, 2024, EPA proposed two batches of significant new use rules (SNUR) for chemical substances that were the subject of premanufacture notices (PMN) and are also subject to a TSCA Order. 89 Fed. Reg. 4912189 Fed. Reg. 49770. The SNURs would require persons who intend to manufacture (including import) or process a particular chemical substance for an activity that is identified as a significant new use to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA’s evaluation of the conditions of use identified in the notification to EPA. EPA notes that in addition, the manufacture or processing for the significant new use may not commence until EPA has conducted a review of the required notification, made an appropriate determination regarding that notification, and taken such actions as required by that determination. Comments are due July 11, 2024.

EPA Announces Peer Review Of 1,1-Dichloroethane TSCA Risk Evaluation And 1,2-Dichloroethane Hazard Assessment, Calls For Public Comments On Reviewer Candidates: EPA announced on June 13, 2024, the change in the peer review mechanism from the letter peer review to a SACC peer review; the addition of the draft human health hazard assessment for 1,2-dichloroethane 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-dichloroethane and human health hazard assessment of 1,2-dichloroethane. 89 Fed. Reg. 50326. 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. Comments are due June 28, 2024.

In its June 13, 2024, press release, EPA states that it seeks feedback on the draft hazard assessment for 1,2-dichlororethane because the Agency used data on the toxicity of 1,2-dichloroethane to fill gaps in the understanding of the toxicity of 1,1-dichloroethane. EPA notes that “[t]his is a well-established risk assessment practice for chemicals that share structural similarities.” According to EPA, the draft hazard assessment for 1,2-dichloroethane will also help inform the draft risk evaluation for this chemical, which EPA anticipates releasing for public comment and any necessary peer review at a later date. More information is available in our June 14, 2024, blog item.

EPA’s Proposed Risk Management Rule For NMP Includes Requirements To Protect Workers And Consumers: 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. 51134. To address the identified unreasonable risk, EPA proposes to: prohibit the manufacture (including import), processing, and distribution in commerce and use of NMP in several occupational conditions of use; require worker protections through an NMP workplace chemical protection program (WCPP) or prescriptive controls (including concentration limits) for most of the occupational conditions of use; require concentration limits on a consumer product; regulate certain consumer products to prevent commercial use; and establish recordkeeping, labeling, and downstream notification requirements. EPA will host a public webinar on June 20, 2024, to provide an overview of the proposed rule. Participants can register as listeners only or to make prepared remarks. Stakeholders can register to listen up until June 19, 2024, at 12:00 p.m. (EDT). Comments are due July 29, 2024. Under the Paperwork Reduction Act (PRA), comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of the comments on or before July 15, 2024. More information will be available in a forthcoming memorandum.

RCRA/CERCLA/CWA/CAA/PHMSA/SDWA

PHMSA Proposes To Update Registration Fees Under Registration And Fee Assessment Program: The Pipeline and Hazardous Materials Safety Administration (PHMSA) proposed on May 24, 2024, updates to the registration fees under the statutorily mandated registration and fee assessment program for persons who transport, or offer for transportation, certain categories and quantities of hazardous materials. 89 Fed. Reg. 45806. The proposed rule would increase the annual fee to be paid by those registrants qualifying as a small business or not-for-profit organization by $125 to $375 and by those registrants not qualifying as a small business or not-for-profit organization by $425 to $3,000. PHMSA states that “[a]ctions such as fee adjustments are necessary to fund PHMSA’s Hazardous Materials Emergency Preparedness grants program at newly authorized levels in accordance with the Infrastructure Investment and Jobs Act (Pub. L. 117-58).” The proposed rule would also implement an electronic-only registration fee payment process and would revise requirements to clarify that a certificate of registration may be carried in either electronic or paper form for both motor carriers and those who transport hazardous materials by vessel. Comments are due August 22, 2024. PHMSA “will consider late-filed comments to the extent possible,” however.

PHMSA Requests Comment On Tare Weight Marking Policy For Cylinders: PHMSA published a request for information on June 6, 2024, to solicit information pertaining to the current tare weight, mass weight, and water capacity marking requirements for compressed gas cylinders. 89 Fed. Reg. 48482. PHMSA requests comment on the following questions:

  • Does the current language for the marking of U.S. Department of Transportation (DOT) cylinders in Section 178.35(f)(8) lead to confusion between marked tare weight at the time of manufacture and the stamped tare weight for the filling of cylinders?
  • How should PHMSA revise the requirements in Section 178.35(f)(8) for marking of tare weights on DOT 4B, 4BA, 4BW, and 4E cylinders used in liquefied compressed gas service?
  • What impact would PHMSA incorporating the current edition of National Institute of Standards and Technology (NIST) Handbook 44 for scales used to weigh cylinders containing liquefied compressed gases have on ensuring accurate scales in both direct sale applications and for prepackaging liquefied compressed gas cylinders in advance of sale?
  • What would be the impacts of PHMSA adding an “average requirement” to the tare weight regulations in Section 178.35(f)(8) to improve measurement accuracy and production controls, and to ensure a business is not using the allowable differences to disadvantage consumers while at the same time maintaining safety compliance?
  • What would be the impacts of PHMSA reconsidering the allowable differences on stamped tare weight as opposed to actual tare weight and applying a ±0.5 percent tolerance for cylinders 25 pounds or less? How would PHMSA define a requirement to follow “good quality control practices” as suggested in the National Council on Weights and Measurements (NCWM) petition?

Comments are due September 4, 2024. PHMSA will consider comments received after that date to the extent possible.

EPA Publishes Water Quality Screening Values For 6PPD And 6PPD-q: EPA announced on June 10, 2024, that it published water quality screening values under the Clean Water Act (CWA) related to short-term concentrations of N-(1,3-Dimethylbutyl)-N′-phenyl-p-phenylenediamine (6PPD) and 6PPD-quinone (6PPD-q). EPA states that these chemicals have been found in freshwater ecosystems and linked to runoff from automotive tire dust and debris. Once in freshwater, these chemicals are known toxins that can quickly cause fish-kill events. According to EPA, its non-regulatory and non-binding screening values provide information that Tribes, states, and local governments can use to monitor their waterways and help protect aquatic life from these harmful pollutants. As reported in our November 3, 2023, blog item, in November 2023, EPA granted a TSCA Section 21 petition to address the use of 6PPD in tires.

Final Rule Adds Substances To List Of Substitutes Under SNAP Program In Commercial And Industrial Refrigeration: Pursuant to its Significant New Alternatives Policy (SNAP) program, EPA published a final rule on June 13, 2024, listing several substitutes as acceptable, subject to use conditions, for retail food refrigeration, commercial ice machines, industrial process refrigeration, cold storage warehouses, and ice skating rinks. 89 Fed. Reg. 50410. EPA states that through this action, it is incorporating by reference standards that establish requirements for commercial refrigerating appliances and commercial ice machines, safe use of flammable refrigerants, and safe design, construction, installation, and operation of refrigeration systems. EPA notes that the action also exempts propane, in the refrigerated food processing and dispensing end-use, from the prohibition under the Clean Air Act (CAA) on knowingly venting, releasing, or disposing of substitute refrigerants in the course of maintaining, servicing, repairing or disposing of an appliance or industrial process refrigeration, as the Administrator is determining, on the basis of existing evidence, that such venting, release, or disposal of this substance in this end-use does not pose a threat to the environment. The rule is effective July 15, 2024. The incorporation by reference of certain material listed in the rule is approved by the Director of the Federal Register as of July 15, 2024. The incorporation by reference of certain other material listed in the rule was approved by the Director of the Federal Register as of February 21, 2012 (76 Fed. Reg. 78832), May 11, 2015 (79 Fed. Reg. 19454), and January 3, 2017 (81 Fed. Reg. 86778).

FDA

FDA Updates Post-Market Assessment Of Tara Flour: On May 15, 2024, the U.S. Food and Drug Administration (FDA) posted its determination that tara flour does not meet the Generally Recognized as Safe (GRAS) standard and considers it an unapproved food additive. FDA notes that this evaluation “is part of our approach to enhance food chemical safety.” Tara flour was linked to roughly 400 adverse events, including 133 hospitalizations. FDA notes, in its memorandum, that “[o]verall, at this time, the available data are insufficient to support the safety of tara flour for use as a food ingredient that will be consumed by the general public” and that a lack of sufficient data exist to support its classification as GRAS. FDA states that “[m]anufacturers who are considering using tara flour as an ingredient in food are responsible for ensuring that its use is safe and lawful and are encouraged to consult with the FDA.”

FDA Extends Comment Period For Proposed Fee Increase: On May 28, 2024, FDA extended the comment period for a proposed rule titled “Color Additive Certification; Increase in Fees for Certification Services.” 89 Fed. Reg. 46042. The proposed rule, originally published on November 2, 2022, would increase fees to recover FDA’s costs to administer the color certification program. Electronic or written comments must be submitted by June 27, 2024.

FDA Extends Comment Period For Draft Guidance: On May 31, 2024, FDA extended the comment period for revisions to specific sections of its draft guidance entitled “Hazard Analysis and Risk-Based Preventive Controls for Human Food.” 89 Fed. Reg. 47108. The changes address comments from the drafts made available in 2016. FDA originally announced the availability of the revised elements of this draft guidance on February 2, 2024. FDA notes that it received a request to extend the comment period to allow stakeholders more time to “fully evaluate and develop meaningful comments.” Comments are due by August 2, 2024.

FDA Announces Re-Organization And New Structure: On June 3, 2024, FDA announced the approval of its reorganization that, among other changes, establishes the Human Foods Program (HFP) “by realigning the functions of the Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Policy and Response, as well as key functions from the Office of Regulatory Affairs (ORA) including human foods compliance, Human and Animal Food Laboratories, and State Partnerships to this new organization.” 89 Fed. Reg. 47567. The organization was approved on March 5, 2024, and became effective on May 13, 2024. The intent is to modernize FDA by realigning, retitling, abolishing, and establishing a dizzying number of offices in a move that is aimed at resources to strengthen the HFP. FDA notes that it is “transforming its organization structure to be more efficient, nimble, and ready for the future with the ever-changing and complex industries we regulate, including the emergence of new food and medical product technologies, the impacts of globalization, climate change and other factors that require FDA to quickly adapt to a consistently evolving world.”

FDA Hosts Color Certification Program Webinar: FDA hosted a webinar titled “FDA’s Color Certification Program – Regulation and Research” on Thursday, June 13, 2024. Bhakti Petigara Harp, Ph.D., a research chemist with FDA’s Office of Cosmetics and Colors (OCAC) in CFSAN, presented. The webinar recording will be posted on the FDA Grand Rounds web page under Past Grand Rounds.

Modernization Of Cosmetics Regulation Act Of 2022 (MoCRA) Statutory Deadline Approaches: The deadline extension for FDA’s enforcement of the cosmetic product facility registration and cosmetic product listing expires July 1, 2024. FDA extended the deadline by six months to allow industry additional time to comply with the requirements. Facilities that register are expected to renew their registration every two years. The registration includes details on the cosmetic products manufactured or processed at the facility. FDA expects annual updates on the content related to the cosmetic products, including if the product was discontinued. For more details, see FDA’s website

NANOTECHNOLOGY

UBA Concludes REACH Evaluation Of Environmental Aspects Of Nano Zinc Oxide: On April 29, 2024, the German Environment Agency (UBA) posted an item entitled “ZnO nanoforms – REACH substance evaluation: environmental aspects.” According to the item, based on the studies submitted by the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) registrants, UBA has concluded that the tested nanoforms have a comparable aquatic toxicity to other zinc compounds and that the harmonized classification in Annex VI of the Classification, Labeling and Packaging (⁠CLP)⁠ Regulation as acute and chronic aquatic toxicity category 1 also applies to the tested nanoforms. The item states that it cannot be excluded that a nanoparticle-specific effect contributes to the overall toxicity of the tested zinc oxide nanoforms, however. More information is available in our May 20, 2024, blog item.

EC Scientific Committee Publishes Scientific Advice On Titanium Dioxide: On May 23, 2024, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) published a document entitled “Scientific Advice on Titanium dioxide (TiO2).” Having reviewed all of the information, including that evaluated by the European Food Safety Authority (EFSA), SCCS states that the available evidence is not sufficient to exclude the genotoxicity potential of almost all of the types of titanium dioxide grades used in oral cosmetic products. More information is available in our May 24, 2024, blog item.

EC Scientific Committee Begins Public Consultation On Preliminary Opinion On New Coating For Titanium Dioxide (Nano Form): The EC’s SCCS began a public consultation on May 27, 2024, on its preliminary opinion on a new coating for titanium dioxide (nano form). According to the preliminary opinion, SCCS concluded that there are a number of uncertainties and data gaps that do not allow a conclusion on the safety of titanium dioxide (nano) coated with a combination of six percent by weight aluminium hydroxide, 14 percent sodium myristoyl sarcosinate, and ten percent dimethicone (Eclipse 70). Comments are due July 22, 2024. More information is available in our June 3, 2024, blog item.

NIOSH Science Blog Item Reviews NIOSH Risk Assessment Of Engineered Nanomaterials: The National Institute for Occupational Safety and Health (NIOSH) highlights Nanotechnology Research Center (NTRC) activities in the risk assessment of engineered nanomaterials in a June 3, 2024, NIOSH Science blog item entitled “NIOSH Risk Assessment of Engineered Nanomaterials.” The item notes that NTRC researchers “are developing a literature-based dataset as part of its evaluation of approaches to nanomaterials risk assessment.” More information is available in our June 5, 2024, blog item.

EPA Proposes SNUR For Multi-Walled Carbon Nanotubes (Generic) (P-21-216 And P-21-217): On June 11, 2024, EPA published proposed SNURs for certain chemical substances that were the subject of PMNs and are also subject to a TSCA Order, including multi-walled carbon nanotubes (generic) (P-21-216 and P-21-217). 89 Fed. Reg. 49121. The proposed SNUR would designate as a “significant new use” the absence of specified protective measures. Comments are due July 11, 2024. More information is available in our June 11, 2024, blog item.

ECHA Updates Report On Key Areas Of Regulatory Challenge, Addresses Micro- And Nano-Sized Materials: On June 12, 2024, the European Chemicals Agency (ECHA) announced that it updated its report on key areas of regulatory challenge, providing more detailed information on areas, including micro- and nano-size materials, where scientific research is needed to protect human health and the environment from hazardous chemicals. More information is available in our June 17, 2024, blog item.

NNI EHS Research Strategy: 2024 Update Available For Public Comment: The National Nanotechnology Coordination Office (NNCO) requested comments on June 13, 2024, on the “National Nanotechnology Initiative Environmental, Health, and Safety Research Strategy: 2024 Update” (2024 Update). 89 Fed. Reg. 50390. The 2024 Update states that key areas of action could include:

  • Addressing remaining environmental, health, and safety (EHS) knowledge gaps for engineered nanomaterials in commerce;
  • Monitoring and evaluating emerging nanotechnology applications;
  • Investigating emerging nanoscale contaminants of concern;
  • Strengthening the collaborative informatics infrastructure;
  • Engaging the international nanosafety community; and
  • Expanding public engagement in the responsible development of nanotechnology.

Comments are due July 22, 2024. More information is available in our June 14, 2024, blog item.

Registration Opens For June 27, 2024, NNI Webinar On “What’s Next In NanoEHS: Risk Assessment And Risk Management”: The National Nanotechnology Initiative (NNI) will hold a webinar on June 27, 2024, on “What’s Next in NanoEHS: Risk Assessment and Risk Management.” During the webinar, rising nanotechnology environmental, health, and safety (nanoEHS) experts Nathan Drew, NIOSH, and Yueyang “Brian” Zhang, Vireo Advisors, LLC, will share their perspectives on the new tools, approaches, and models that are being developed to assess and manage potential risks. Drew and Zhang will also provide case studies from newer materials (e.g., cellulosic nanomaterials) and modeling advances. Jay Vietas, NIOSH NTRC, will moderate the discussion.

BIOBASED/RENEWABLE PRODUCTS/SUSTAINABILITY

B&C® Biobased And Sustainable Chemicals Blog: For access to a summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to https://www.lawbc.com/brand/bioblog/.

LEGISLATIVE

Bicameral Bill Would Limit Heavy Metals In Baby Food: On May 9, 2024, Senators Amy Klobuchar (D-MN) and Tammy Duckworth (D-IL) introduced legislation to limit the levels of heavy metals allowed in commercial food for infants and toddlers. Klobuchar’s May 9, 2024, press release states that the Baby Food Safety Act of 2024 (S. 4303) would allow FDA to enforce scientifically-established limits on heavy metals in commercial infant and toddler food. The bill would also increase standards for food manufacturer sampling and testing for contaminants in imported and domestic processed food and bring greater transparency to the rate of food facility inspections by FDA in the United States and abroad. Representatives Raja Krishnamoorthi (D-IL) and Tony Cárdenas (D-CA) introduced companion legislation (H.R. 8385) in the House on May 14, 2024.

AUDIT EPA Act Introduced In The House: On May 14, 2024, Representative Cathy McMorris Rodgers (R-WA) introduced the Accounting for the Uses, Disbursements, and Income on our Taxes (AUDIT) at EPA Act (H.R. 8395) that would require EPA to evaluate its CAA programs, conduct an independent and objective audit of them, and report the findings to Congress for accountability and oversight.

House Bill Would Amend OSH Act To Add Language Translation Requirements: On June 13, 2024, Representative Adam Schiff (D-CA) introduced the Language Access for Workers Act (H.R. 8739) to “help alleviate the language barriers many workers face in the workplace that make it difficult for them to receive the critical occupational training, risk assessments, and health services they need to safely do their jobs.” Schiff’s June 13, 2024, press release states that the bill would amend the Occupational Safety and Health (OSH) Act of 1970 to add language translation requirements and introduce a competitive grant program under the Department of Labor (DOL) to allow non-profit and for-profit organizations and government agencies to provide language access and translation services directly to employees.

MISCELLANEOUS

Maine Amends Its PFAS Statute, Exempting Certain Product Categories From The Sales Prohibition And Eliminating The General Notification Requirement: On April 16, 2024, Governor Janet Mills (D) signed LD 1537, amending An Act To Stop Perfluoroalkyl and Polyfluoroalkyl Substances Pollution. On May 20, 2024, the Maine Department of Environmental Protection (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. More information is available in our May 24, 2024, blog item.

OSHA HCS Amendments Primarily Align With GHS Rev 7: The U.S. Occupational Safety and Health Administration (OSHA) issued a final rule on May 20, 2024, that amends the Hazard Communication Standard (HCS) to conform to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS), primarily Revision 7 (Rev 7), address issues that arose during the implementation of the 2012 update to the HCS, and provide better alignment with other U.S. agencies and international trading partners while enhancing the effectiveness of the standard. 89 Fed. Reg. 44144. OSHA states that, consistent with Executive Order 13563 and the Regulatory Flexibility Act, which call for assessment and, where appropriate, modification and improvement of existing rules, OSHA has reviewed the existing HCS. OSHA states that it determined that the revisions in the final rule “will enhance the effectiveness of the HCS by ensuring employees are appropriately apprised of the chemical hazards to which they may be exposed, thus reducing the incidence of chemical-related occupational illnesses and injuries.” The modifications to the HCS include revised criteria for classification of certain health and physical hazards, revised provisions for updating labels, new labeling provisions for small containers, new provisions related to trade secrets, technical amendments related to the contents of safety data sheets (SDS), and related revisions to definitions of terms used in the standard. The final rule will be effective July 19, 2024. The incorporation by reference of certain publications listed in this final rule is approved by the Director of the Federal Register as of July 19, 2024. The incorporation by reference of certain other publications listed in the rule was approved by the Director as of July 15, 2019. More information is available in our May 30, 2024, memorandum.

DPR Issues California Notice 2024-10 Clarification On “Not Registered For Use In CA” And Similar Statements On Pesticide Labels: On May 24, 2024, the California Department of Pesticide Regulation (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. More information is available in our May 29, 2024, blog.

Polyoxymethylene Added To List Of Chemical Substances Subject To Superfund Excise Tax: The Internal Revenue Service (IRS) published a notice of determination on May 31, 2024, that the list of taxable substances is modified to include polyoxymethylene. 89 Fed. Reg. 47238. Celanese Ltd., an exporter of polyoxymethylene, submitted the petition. According to the petition, “the taxable chemical methane constitutes 50.08 percent, by weight, of the materials used to produce polyoxymethylene.” The IRS states that “[a] review of the stoichiometric material consumption equation and other information in the petition shows that methane, a taxable chemical, constitutes more than 20 percent by weight of the materials used in the production of polyoxymethylene, based on the predominant method of production. Therefore, the test in section 4672(a)(2)(B) is satisfied.” The effective date of the modification for tax purposes is October 1, 2024. The effective date of this modification for purposes of refund claims under Section 4662(e) of the Internal Revenue Code is July 1, 2022.

Biden-Harris Administration Announces National Strategy To Reduce Food Loss And Waste And Recycle Organics: EPA, the U.S. Department of Agriculture (USDA), and FDA announced on June 12, 2024, the “National Strategy for Reducing Food Loss and Waste and Recycling Organics” as part of President Biden’s whole-of-government approach to tackle climate change, feed people, address environmental justice, and promote a circular economy. According to EPA, the strategy provides tangible goals that U.S. government partners along with retailers and consumers can work toward to help further prevent the loss and waste of food, increase recycling of food and other organic materials to support a more circular economy for all, reduce greenhouse gas emissions, save households and businesses money, and build cleaner, healthier communities. The strategy highlights four objectives:

  • Objective 1: Prevent food loss;
  • Objective 2: Prevent food waste;
  • Objective 3: Increase the recycling rate for all organic waste; and
  • Objective 4: Support policies that incentivize and encourage the prevention of food loss and waste and organics recycling.

For each objective, the strategy highlights actions that EPA, USDA, or FDA could take.

SAB Inorganic Arsenic Review Panel Will Hold Three Public Meetings: EPA announced on June 14, 2024, that the Science Advisory Board (SAB) Inorganic Arsenic Review Panel will hold three public meetings to review and discuss its draft report on EPA’s draft Integrated Risk Information System (IRIS) Toxicological Review of Inorganic Arsenic. 89 Fed. Reg. 50586. The meetings will be held July 8, 2024, from 1:00 p.m. to 5:30 p.m. (EDT)July 16, 2024, from 1:00 p.m. to 5:00 p.m. (EDT); and July 22, 2024, from 1:00 p.m. to 5:00 p.m. (EDT) (if needed). Written comments submitted by July 1, 2024, will be considered at the July 8, 2024, meeting.

External Peer Review Meeting On Draft IRIS Toxicological Review Of PFNA And Related Salts Will Be Held July 30-August 1, 2024: In March 2024, EPA’s IRIS Program released a draft report entitled IRIS Toxicological Review of Perfluorononanoic Acid (PFNA) and Related Salts for public comment until May 6, 2024. This draft IRIS assessment is now undergoing independent external scientific peer review managed by ERG, a contractor to EPA. ERG is organizing a public peer review meeting that will take place virtually via Zoom over three days: Tuesday, July 30, 2024, from 10:00 a.m. to 4:00 p.m. (EDT)Wednesday, July 31, 2024, from 10:00 a.m. to 4:00 p.m. (EDT); and Thursday, August 1, 2024, from 11:00 a.m. to 2:00 p.m. (EDT). Members of the public may attend as observers. A portion of time will be set aside for oral public comments on the first day of the peer review meeting.

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