Monthly Update for July 2023
WEBINAR — Product Stewardship Practices For Effective Supply Chain Interaction, August 1, 2023, 11:00 a.m. – 12:00 p.m. (EDT): Bergeson & Campbell, P.C. (B&C®) is pleased to present “Product Stewardship Practices for Effective Supply Chain Interaction,” featuring Catherine M. Croke, DBA, Director of Product Stewardship and Regulatory Affairs, B&C; Lee A. Bowers, Vice President, Environmental, Health & Safety, RPM International Inc. (RPM); and Michael J. Ford, President, Tradebridge Consulting. This webinar will explore current and proposed international regulations and restrictions in developed and emerging legislation and provide examples informing and proactively promoting product stewardship practices and regulatory compliance in supply chains. Register now.
TSCA At Seven: As Reasonably Foreseen, ELI And B&C Conclude Another Riveting Conference: On June 29, 2023, B&C, the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health presented “TSCA Reform — Seven Years Later.” This virtual conference marked the seventh Toxic Substances Control Act (TSCA) Annual Conference, reflecting on the accomplishments and challenges since the implementation of the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) and where TSCA stands today. Speakers covered a variety of topics, including risk evaluation, risk management, new chemical review, and per- and polyfluoroalkyl substances (PFAS). The fact that there were more than 800 program registrants demonstrates the continuing, if not growing, interest in the U.S. Environmental Protection Agency’s (EPA) challenging implementation of TSCA. A recording of the conference is available online. ELI members who are logged in to the ELI website can view a recording of the conference and the conference materials on the ELI website. More information is available in our July 10, 2023, memorandum.
EPA’s Spring 2023 Unified Agenda Includes Proposed And Final TSCA And TRI Rules: EPA’s spring 2023 Unified Agenda, published on June 13, 2023, includes a number of proposed and final rulemakings under TSCA or the Toxics Release Inventory (TRI). More information on the rulemakings, including links to our memoranda, will be available in an upcoming blog item.
EPA Proposes To Ban Most Uses Of PCE And Establish A WCPP For Uses Not Prohibited: On June 16, 2023, EPA proposed to ban most uses of perchloroethylene (PCE). 88 Fed. Reg. 39652. According to EPA’s June 8, 2023, press release, the proposed rule “would protect people from these risks by banning all consumer uses while allowing for many industrial/commercial uses to continue only where strict workplace controls could be implemented, including uses related to national security, aviation and other critical infrastructure, and the Agency’s efforts to combat the climate crisis.” EPA states that its proposed risk management rule “would rapidly phase down manufacturing, processing and distribution of PCE for all consumer uses and many industrial and commercial uses, most of which would be fully phased out in 24 months.” EPA notes that the uses subject to the proposed prohibitions represent less than 20 percent of the annual production volume of PCE. For most of the uses of PCE that EPA is proposing to prohibit, EPA’s analysis found that alternative products with similar costs and efficacy to PCE are “reasonably available.” Comments on the proposed rule are due August 15, 2023. EPA notes that under the Paperwork Reduction Act (PRA), “comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of your comments on or before July 17, 2023.” For more information, please read the full memorandum.
NASEM Report Recommends That EPA Develop Framework For Evaluating NAMs For Toxicity Testing: On June 16, 2023, the National Academies of Sciences, Engineering, and Medicine (NASEM) announced the release of a new report providing an overview of new approach methods (NAM) in human health risk assessment of chemicals and calling on EPA to develop a framework for evaluating and building trust in NAMs. According to NASEM, many barriers to the use of NAMs remain. The report calls on EPA to expand its definition of “new approach methods” to encompass the wide range of strategies and approaches available that could address critical human health risk assessments. NASEM states that the report “draws on lessons learned from laboratory mammalian toxicity tests to help inform approaches for building scientific confidence in new approach methods, and offers recommendations to move new approach methods from evaluation in the laboratory to their incorporation into modern, systematic-review-based risk assessments.” More information is available in our July 10, 2023, blog item.
EPA Begins Public Comment Period On CRA Guidelines For Planning And Problem Formulation: EPA announced on June 16, 2023, a 60-day public comment period on the draft Guidelines for Cumulative Risk Assessment Planning and Problem Formulation (draft CRA Guidelines). 88 Fed. Reg. 39424. According to EPA, the draft CRA Guidelines describe steps for the planning and problem formulation of CRAs and offer guidelines for when CRAs could be appropriate. Planning defines both the process for conducting the risk assessment and its general scope, while problem formulation identifies major factors considered in a specific assessment to inform its technical approach. EPA notes that the draft CRA Guidelines “are not final, and do not represent, and should not be construed to represent, Agency policy or views.” Comments are due August 15, 2023. More information is available in our July 11, 2023, memorandum.
EPA Requests Comments For Implementation Of PRIA 5 Bilingual Labeling Requirements For Agricultural Pesticides: On June 20, 2023, EPA announced that it is seeking input from stakeholders on ways to make bilingual pesticide labeling accessible to farmworkers and to implement a plan to ensure that farmworkers have access to the bilingual pesticide labeling by December 2025, as required by the Pesticide Registration Improvement Act of 2022 (PRIA 5). 88 Fed. Reg. 39845. PRIA 5 requires EPA to begin to seek stakeholder input on ways to make bilingual pesticide labeling accessible to farmworkers by June 30, 2023. Comments are to be submitted in docket EPA-HQ-OPP-2023-0270 and are due on or before August 21, 2023.For more information, see our June 29, 2023, blog item.
EPA Announces 2024 CDR Deadlines: On June 22, 2023, EPA announced that the 2024 submission period for the TSCA Chemical Data Reporting (CDR) rule is from June 1, 2024, to September 30, 2024. 88 Fed. Reg. 40816. The CDR rule requires manufacturers (including importers) of chemical substances on the TSCA Inventory above an applicable regulatory threshold to report to EPA, every four years, information concerning the manufacturing, processing, and use of such chemical substances, unless exempt from this requirement under the CDR rule. 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 through 2023. According to EPA’s June 21, 2023, press release, updated guidance documents on submitting information to the CDR database will be available in fall 2023. EPA states that helpful information about prior CDR reporting cycles is available on the CDR website. More information is available in our June 22, 2023, blog item.
EPA Requests Nominations For Experts To Review White Paper To Be Used In The Risk Evaluation For Asbestos Part 2 Under TSCA: On June 22, 2023, EPA called for public nominations of scientific and technical experts to review the “2023 White Paper on the Quantitative Human Health Approach to be Applied in the Risk Evaluation for Asbestos Part 2.” 88 Fed. Reg. 40819. EPA states that it will release the white paper for public review and comment in late July 2023 and subsequently submit it for letter peer review. EPA currently anticipates selecting approximately ten to 15 expert reviewers and plans to make a list of candidates under consideration as prospective letter reviewers for this review available for public comment by early August 2023. Nominations are due July 24, 2023.
EPA Implements Statutory Addition Of Certain PFAS To TRI Beginning With Reporting Year 2023: On June 23, 2023, EPA updated the list of chemicals subject to toxic chemical release reporting under the Emergency Planning and Community Right-to-Know Act (EPCRA) and the Pollution Prevention Act (PPA). 88 Fed. Reg. 41035. Specifically, EPA updated the regulations to identify nine PFAS that must be reported pursuant to the National Defense Authorization Act for Fiscal Year 2020 (NDAA) enacted on December 20, 2019. EPA states that “[a]s this action is being taken to conform the regulations to a Congressional legislative mandate, notice and comment rulemaking is unnecessary.” The final rule will be effective July 24, 2023. For TRI Reporting Year 2023 (reporting forms due by July 1, 2024), reporting is required for nine additional PFAS, bringing the total PFAS subject to TRI reporting to 189. More information is available in our June 26, 2023, blog item.
EPA Announces New Framework Intended To Prevent Unsafe New And New Uses Of PFAS From Entering The Market: EPA announced on June 29, 2023, a new framework (the Framework) for addressing new PFAS and new uses of existing PFAS. The Framework outlines EPA’s planned approach when reviewing new PFAS and new uses of PFAS to ensure that, before these chemicals are allowed to enter into commerce, EPA will undertake an extensive evaluation to ensure they pose no harm to human health and the environment. Under TSCA Section 5, EPA is required to review new chemicals, including new PFAS and new uses of PFAS, within 90 days, assess the potential risks to human health and the environment of the chemical, and make one of five possible risk determinations. When potential risks are identified, EPA must take action to mitigate those risks before the chemical can enter commerce. More information is available in our July 14, 2023, memorandum.
EPA Announces Efforts To Close Out Specific Antimicrobial Notification Actions To Reduce Backlog And Improve Efficiencies: On June 29, 2023, EPA announced a new effort closing out notification actions for minor pesticide label or product formulation changes in an effort to reduce the backlog, which, EPA states, will allow it to focus its limited resources on addressing higher priority actions. EPA announced it has closed out approximately 2,000 antimicrobial actions submitted to EPA prior to October 1, 2022. EPA states that the notification actions do not impact the product’s ability to be used safely according to the approved label instructions and have no impact on human health or the environment. The close out only applies to notification actions, which do not fall under the Pesticide Registration Improvement Act (PRIA). The close out was effective as of June 28, 2023. For more information, see our July 5, 2023, blog item.
EPA Releases Final TSCA Section 8(a) Reporting And Recordkeeping Rule For Asbestos: On July 6, 2023, EPA announced a final rule under TSCA Section 8(a) that will require reporting and recordkeeping requirements for asbestos. The pre-publication version of the final rule states that EPA will require certain persons who manufactured (including imported) or processed asbestos and asbestos-containing articles, including as an impurity, in the four years prior to the date of publication of the final rule to report electronically certain exposure-related information. EPA notes that this action results in a one-time reporting requirement. EPA “emphasizes that this requirement includes asbestos that is a component of a mixture.” The final rule will require that information be reported on presence, types, and quantities of asbestos (including asbestos that is a component of a mixture) and asbestos-containing articles that were manufactured (including imported) or processed, types of use, and employee data. According to EPA, it and other federal agencies will use the reported information in considering potential future actions, including risk evaluation and risk management activities. The final rule will be effective 30 days after publication in the Federal Register. More information is available in our July 12, 2023, memorandum.
Earthjustice Files Notice Of Intent To Sue EPA For Missing TSCA Risk Evaluation Deadlines: On July 7, 2023, Earthjustice, on behalf of its clients, announced that it notified EPA of its intent to sue for missing the statutory deadlines under TSCA for EPA to evaluate the risks to public health posed by 22 toxic chemicals. Earthjustice states that until EPA completes the overdue risk evaluations, “some of the most dangerous and widely used chemicals on the market will remain unregulated under [TSCA].” Earthjustice is representing Louisiana Environmental Action Network (LEAN), Texas Environmental Justice Advocacy Services (t.e.j.a.s.), Sierra Club, Learning Disabilities Association of America, and Community in Power and Development Association (CIDA). According to Earthjustice, TSCA requires EPA to evaluate comprehensively chemicals’ risks and then ban or regulate them to the extent necessary to protect against unreasonable risks to human health and the environment. Earthjustice intends to seek a court order establishing a new timeline to ensure that EPA completes the overdue chemical risk evaluations as quickly as possible.
EPA Releases Draft Supplement To Risk Evaluation For 1,4-Dioxane For Public Comment: On July 10, 2023, EPA announced the availability of the draft supplement to the risk evaluation for 1,4-dioxane for public comment and peer review. 88 Fed. Reg. 43562. EPA states in its July 7, 2023, press release that the draft supplement to the 2020 risk evaluation considers air and water exposure pathways that were excluded from the earlier risk evaluation and exposure to 1,4-dioxane generated as a byproduct. The draft supplement estimates risks to the general population, including to people living in fenceline communities, and aggregate exposures from multiple facilities located in the same area. EPA notes that the draft supplement does not contain its revised draft unreasonable risk determination for 1,4-dioxane, which EPA will release in the coming weeks for public comment. EPA requests public comment on the analysis presented in the draft supplement to the risk evaluation for 1,4-dioxane. Comments on the draft supplement are due September 8, 2023. More information will be available in our forthcoming memorandum.
EPA Announces Availability Of Meeting Minutes And Final Report For May 2023 SACC Meeting For Review Of Draft Documents Related To CRA Under TSCA: EPA announced on July 13, 2023, that the meeting minutes and final report are now available for the May 8-11, 2023, Science Advisory Committee on Chemicals (SACC) virtual meeting regarding the review of two draft documents related to CRA under TSCA. Earlier this year, EPA released for public comment and peer review a set of principles for evaluating cumulative risks under TSCA and an approach for applying those principles to the evaluation of the cumulative risk posed by certain phthalate chemicals undergoing TSCA Section 6 risk evaluation:
- Draft Proposed Principles of Cumulative Risk Assessment under the Toxic Substances Control Act; and
- Draft Proposed Approach for Cumulative Risk Assessment of High-Priority Phthalates and a Manufacturer-Requested Phthalate under the Toxic Substance Control Act.
The meeting minutes state that “[g]iven that the document is not intended to be guidance, and that the intention is not to generate a TSCA-specific methodology document at this time, the committee suggested that the EPA clarify which references are the key guidance/methodologies that would be used to conduct CRAs. It is preferred if these are provided in a hierarchical fashion.” The SACC meeting minutes and final report are available in docket EPA-HQ-OPPT-2021-0918 and on the SACC meeting web page.
EPA Adds DINP Category To TRI Chemical List: On July 14, 2023, EPA added a diisononyl phthalate (DINP) category to the list of toxic chemicals subject to the reporting requirements under EPCRA and PPA. 88 Fed. Reg. 45089. EPA states that in response to a petition, it is adding the DINP category to the toxic chemical list as a category defined to include branched alkyl di-esters of 1,2 benzenedicarboxylic acid in which alkyl ester moieties contain a total of nine carbons. EPA notes that this category includes but is not limited to the chemicals covered by the Chemical Abstracts Service Registry Numbers® (CAS RN®) and names identified by EPA at the time of this rulemaking. According to EPA, the DINP category meets the EPCRA chronic human health effects toxicity criterion “because the members of the category can reasonably be anticipated to cause serious or irreversible reproductive dysfunctions as well as other serious or irreversible chronic health effects in humans, specifically, developmental, kidney, and liver toxicity.” The final rule will be effective September 12, 2023.
EPA Will Hold Webinar On Final CBI Rule: EPA will hold a webinar on July 18, 2023, at 2:00 p.m. (EDT) on its recent final procedural rule for submitting confidential business information (CBI) under TSCA. The final rule increases transparency, modernizes the reporting and review procedures for CBI, and aligns with the 2016 amendments to TSCA. The rule will become effective on August 7, 2023. EPA states that the webinar will be useful for anyone looking for an overview of the new rule and the new requirements for companies that submit data under TSCA. It will include a demonstration of how and where to locate and open time-sensitive notifications from EPA relating to CBI claims and how to update company contact information, and it will show how CBI claim requirements have been further integrated into TSCA reporting applications. Registration for the webinar is open. More information is available in our June 12, 2023, memorandum.
EPA Will Propose Workplace Safety Requirements For Carbon Tetrachloride To Protect Worker Health And Fenceline Communities: EPA announced on July 17, 2023, that it will issue a proposed rule concerning carbon tetrachloride (CTC) that would:
- Prohibit several uses of CTC that have already been phased out;
- Create strict workplace protections to ensure that for the remaining uses, workers will not be harmed by CTC use; and
- Require manufacturers (including importers), processors, and distributors to notify companies to whom CTC is shipped of the prohibitions and to keep records.
EPA states that the workplace chemical protection program (WCPP) would include an existing chemical exposure limit (ECEL) of 0.03 parts per million (ppm) as an eight-hour time-weighted average to address risk from inhalation exposure in combination with direct dermal contact controls for several conditions of use, “which account for essentially all of the production volume of CTC.” For laboratory use, EPA is proposing to require use of a fume hood and personal protective equipment (PPE) to protect skin. According to the pre-publication version of the proposed rule, comments will be due 45 days after the proposed rule is published in the Federal Register. Under the PRA, comments on the information collection provisions are best ensured of consideration if OMB receives 30 days after the proposed rule is published in the Federal Register. More information will be available in our forthcoming memorandum.
EPA Issues Statement On Sackett v. EPA: According to a June 26, 2023, statement issued by EPA, EPA and the U.S. Department of the Army (agencies) are in receipt of the U.S. Supreme Court’s May 25, 2023, decision in the case of Sackett v. EPA. EPA states that “[i]n light of this decision, the agencies are interpreting ‘waters of the United States’ consistent with the Supreme Court’s decision in Sackett.” The agencies are developing a rule to amend the final “Revised Definition of ‘Waters of the United States” rule, published in the Federal Register on January 18, 2023 (88 Fed. Reg. 3004), consistent with the U.S. Supreme Court’s May 25, 2023, decision in the case of Sackett v. EPA. The agencies intend to issue a final rule by September 1, 2023.
EPA Proposes To Add Electronic Reporting Provisions To NESHAP For RICE And NSPSs For Internal Combustion Engines: On June 26, 2023, EPA proposed to amend the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Reciprocating Internal Combustion Engines (RICE), the New Source Performance Standards (NSPS) for Stationary Compression Ignition (CI) Internal Combustion Engines, and the NSPS for Stationary Spark Ignition (SI) Internal Combustion Engines to add electronic reporting provisions. 88 Fed. Reg. 41361. According to EPA, the addition of electronic reporting provisions will provide for simplified reporting by sources and enhance availability of data on sources to EPA and the public. In addition, a small number of clarifications and corrections to these rules are being proposed to correct inadvertent and other minor errors in the C.F.R., particularly related to tables. EPA states that it is soliciting information on the provisions specifying that emergency engines can operate for up to 50 hours per year to mitigate local transmission and/or distribution limitations to avert potential voltage collapse or line overloads that could lead to the interruption of power supply in a local area or region. Comments are due August 25, 2023. Comments on the information collection provisions submitted to OMB under the PRA are best assured of consideration by OMB if OMB receives a copy of the comments by July 26, 2023.
PHMSA Proposes FAST Act Requirements For Real-Time Train Consistent Information: On June 27, 2023, the Pipeline and Hazardous Materials Safety Administration (PHMSA) proposed amendments to its Hazardous Materials Regulations (HMR) to require all railroads to generate in electronic form, maintain, and provide to first responders, emergency response officials, and law enforcement personnel certain information regarding hazardous materials in rail transportation to enhance emergency response and investigative efforts. 88 Fed. Reg. 41541. PHMSA notes that the proposal responds to a safety recommendation of the National Transportation Safety Board and statutory mandates in The Fixing America’s Surface Transportation (FAST) Act, as amended, and complements existing regulatory requirements pertaining to the generation, maintenance, and provision of similar information in hard copy form, as well as other hazard communication requirements. Comments are due August 28, 2023. PHMSA states that to the extent possible, it will consider late-filed comments as it develops a final rule.
PHMSA Seeks Comment On Initiatives To Modernize The HMR: On July 5, 2023, PHMSA published an advance notice of proposed rulemaking (ANPRM) to solicit stakeholder feedback on initiatives PHMSA is considering that may modernize the HMR and improve efficiencies while maintaining or improving a current high level of safety. 88 Fed. Reg. 43016. To engage fully with stakeholders, the ANPRM solicits comments and input on questions related to 46 distinct topics under consideration. PHMSA states that it will use any comments, data, and information received “to evaluate and potentially draft proposed amendments.” Comments are due October 3, 2023. PHMSA notes that it “will consider late-filed comments to the extent possible.”
Our July 13, 2023, memorandum provides more information on several of the topics under consideration: non-bulk packaging, intermediate bulk container (IBC), and large packaging periodic retest extension; aerosol classification alignment; requirements for damaged, defective, or recalled lithium cells and batteries; and 49 C.F.R. Section 173.150 ethyl alcohol exception. It includes highlights of PHMSA’s questions on these topics. Stakeholders should review the notice for the complete list of questions as well as the other topics addressed by the notice.
EPA Adjusts Hydrofluorocarbon Production Baseline: On July 12, 2023, EPA published a final rule correcting the production baseline to reflect corrected calculations for the phasedown of hydrofluorocarbons pursuant to the American Innovation and Manufacturing (AIM) Act. 88 Fed. Reg. 44220. EPA states in its July 11, 2023, press release, that the final rule implements a 40 percent reduction below historic levels from 2024 through 2028. According to EPA, the rule aligns with the bipartisan AIM Act’s goals to reduce the production and consumption of these climate-damaging chemicals by 85 percent by 2036 and help avoid up to 0.5 °C of global warming by 2100. The final rule will be effective September 11, 2023.
EPA Rescinds Rule On Increasing Consistency And Transparency In Considering Benefits And Costs In The CAA Rulemaking Process: On July 13, 2023, EPA rescinded the December 2020 rule entitled “Increasing Consistency and Transparency in Considering Benefits and Costs in the Clean Air Act Rulemaking Process” (the Benefit-Cost Rule). 88 Fed. Reg. 44710. EPA states that it is rescinding the rule because the changes advanced by the rule were inadvisable, untethered to the Clean Air Act (CAA), and not necessary to effectuate the purposes of the CAA. The final rule will be effective August 14, 2023.
FDA Extends Comment Period For “Questions And Answers About Dietary Guidance Statement In Food Labeling”: On June 15, 2023, the U.S. Food and Drug Administration (FDA) extended the comment deadline for the draft guidance entitled ‘‘Questions and Answers About Dietary Guidance Statements in Food Labeling: Draft Guidance for Industry” to allow additional time for interested persons to submit comments. 88 Fed. Reg. 39256. Comments are due by September 25, 2023, and should be identified with docket number FDA-2023-D-1027.
FDA Releases FAQs And Tools For The Food Traceability Rule: FDA on June 26, 2023, posted new frequently asked questions (FAQ) and additional tools to provide industry with more information for the Food Safety Modernization Act (FSMA) Food Traceability Rule. The FAQs, based largely on questions received by FDA from industry, clarify how the rule applies to certain situations. Additional tools, accessible via FDA’s website, include new supply chain examples, fact sheets, and additional foreign language translations.
FDA Provides Update On Proposal For Unified Human Foods Program: On June 27, 2023, FDA updated its proposal to create a unified Human Foods Program (HFP). The update includes a new model for the Office of Regulatory Affairs (ORA) to ensure strategic use of resources.
FDA Extends Comment Period For Titanium Dioxide Color Additive Petition: On June 28, 2023, FDA extended the period to comment on a request by the Environmental Defense Fund to revoke the Color Additive Listing for use of titanium dioxide in food until September 1, 2023. 88 Fed. Reg. 41870. FDA is seeking comments, additional scientific data, and other information related to the issues raised by the petition, which asserts that the intended use of the color additive no longer meets the safety standard under 21 C.F.R. Section 70.3(i), and cites, as evidence, an opinion by the European Food Safety Authority (EFSA). Additional details for the petition are available at the link here.
FDA Releases Update Of Priority Guidance Topics: On July 6, 2023, FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) provided an update to its draft and final guidance priority topics. In this update, CFSAN and OFPR note that several topics have been added to its agenda, including Action Levels for Arsenic and Cadmium for food intended for babies and young children. In addition, the update includes the list of guidance documents released since the February 2023 agenda was issued.
SCHEER Opinion On The Safety Of Titanium Dioxide In Toys Recommends Further Studies: The European Commission’s (EC) Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) announced the release of its final opinion on the safety of titanium dioxide in toys on June 27, 2023. The scientific opinion evaluates whether the uses of pigmentary titanium dioxide in toys and toy materials can be considered to be safe in light of the exposure identified and in light of the classification of titanium dioxide as carcinogenic category 2 after inhalation. According to SCHEER, in view of the uncertainty on the potential genotoxicity of pigmentary fine titanium dioxide, further studies of the genotoxicity of fine titanium dioxide are recommended, including clear demonstration of the absence of an ultrafine fraction in the preparations investigated. SCHEER notes that in view of the lack of data on the release of titanium dioxide from toys and/or toy materials, migration and titanium dioxide release studies are recommended. In view of the uncertainty of the oral hazard characterization of pigmentary titanium dioxide, further toxicity studies after oral exposure are warranted. More information is available in our July 3, 2023, blog item.
Switzerland Updates Precautionary Matrix For Synthetic Nanomaterials: Switzerland’s Federal Office of Public Health (FOPH) has updated its precautionary matrix for synthetic nanomaterials, which is a method for assessing the nano-specific health and environmental risks of nanoproducts. According to FOPH, the precautionary matrix enables the structured assessment of the “nano-specific need for precautions” when handling synthetic nanomaterials. The precautionary matrix is designed “to help industry and trade comply with their due diligence and their duty to exercise self-control opposite employees, consumers and the environment.” More information is available in our July 10, 2023, blog item.
OECD Publishes New, Corrected TGs For Nanomaterials And Workshop Report On How To Prepare TGs For Emerging Technologies: The Organization for Economic Cooperation and Development (OECD) announced on July 4, 2023, that it published a number of new, updated, and corrected Test Guidelines (TG), including the following for nanomaterials:
- TG No. 126: Determination of the Hydrophobicity Index of Nanomaterials through an Affinity Measurement; and
- TG No. 125: Nanomaterial Particle Size and Size Distribution of Nanomaterials.
On July 4, 2023, OECD also released a corrected version of its Report on the WNT Workshop how to prepare the Test Guidelines Programme for emerging technologies. The OECD report summarizes the rationale for organizing the event and the preparatory steps taken in the preceding months, the workshop development, and the outcome of discussions in breakout group and plenary sessions, as well as the workshop conclusions and next steps. More information is available in our July 11, 2023, blog item.
B&C® Biobased And Sustainable Chemicals Blog: For access to a summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to https://biobasedblog.lawbc.com.
Senate Committee Sought Stakeholder Comment On Draft PFAS Legislation By July 3, 2023: The Senate Committee on Environment and Public Works announced on June 22, 2023, that Senators Tom Carper (D-DE), Chair of the Committee, and Shelley Moore Capito (R-WV), Ranking Member of the Committee, have released draft PFAS legislation for stakeholder comment. According to the press release, the bipartisan package seeks to improve the mitigation and remediation of PFAS contamination. The Committee requested stakeholder comments on the draft legislation by July 3, 2023. The press release states that the draft legislation seeks to achieve the following goals:
- Support EPA’s Ability to Address PFAS for Communities through Infrastructure and New Technologies;
- Expand EPA Science Related to PFAS; and
- Assist Communities Dealing with PFAS Contamination.
More information is available in our June 22, 2023, blog item.
Bipartisan Bill Would Ensure Uniformity Of Labeling Standards For Pesticides: On June 22, 2023, Representatives Dusty Johnson (R-SD) and Jim Costa (D-CA) introduced the Agricultural Labeling Uniformity Act (H.R. 4288) to ensure uniformity of labeling standards for pesticides that are backed by sound science and approved by EPA. Johnson’s June 22, 2023, press release, notes that under current law, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) governs pesticide use, sales, and labeling and provides EPA exclusive authority to determine labeling and packaging requirements. States have the ability to regulate the sale or use of pesticides, but are prohibited from imposing their own labeling requirements that are different from EPA’s science-based labels. According to the press release, despite EPA’s explicit authority, some states are adding labeling requirements outside of the EPA-approved label. The legislation would reaffirm that EPA is the single authority on pesticide labeling and packaging requirements. It would ensure EPA does not take any action, including approving label requirements, contradictory to its views.
Bill Introduced To Protect Bees, Birds, And Bats From Harmful Pesticides: On June 22, 2023, Representatives Earl Blumenauer (D-OR) and Jim McGovern (D-MA) introduced the Saving America’s Pollinators Act (H.R. 4277) to protect America’s bees, birds, bats, and other pollinators and secure vital agricultural food production. According to Blumenauer’s June 22, 2023, press release, the bill would suspend the use of neonicotinoids and other pesticides harmful to bees and other pollinators until experts make a science-based determination that they are safe to use.
Senate Bill Would Create “Pollinator-Friendly Plant Labeling Program”: On June 22, 2023, Senator Jeff Merkley (D-OR) introduced the Pollinator-Friendly Plant Labeling Act (S. 2199), which would create the “Pollinator-Friendly Plant Labeling Program,” modeled after the Organic Foods Production Act, which created Organic Labeling. According to Merkley’s June 23, 2023, press release, the program would require the U.S. Department of Agriculture (USDA) to create a certification program for plant producers in order to certify that their plants are not treated with pesticides harmful to monarchs and other pollinators.
House Appropriations Committee Releases FY 2024 Interior, Environment, And Related Agencies Appropriations Bill: On July 12, 2023, the House Appropriations Committee released the fiscal year (FY) 2024 bill for the Interior, Environment, and Related Agencies Subcommittee. The Committee’s bill summary states that the bill would provide $6.173 billion to EPA, which is $3.96 billion (39 percent) below the FY 2023 enacted level and $5.91 billion below the President’s Budget Request:
- Science and Technology: Provides $560.7 million for Science and Technology, which is $241.6 million (30 percent) below the FY 2023 enacted level and $407.1 million below the President’s Budget Request;
- Environmental Programs and Management: Provides $2.429 billion for Environmental Programs and Management, which is $857.4 million (26 percent) below the FY 2023 enacted level and $2.082 billion below the President’s Budget Request. The bill maintains most geographic programs at the FY 2023 enacted level;
- Hazardous Substance Superfund: Provides $355.9 million for the Hazardous Substance Superfund (in addition to fee receipts), which is $926.8 million (72 percent) below the FY 2023 enacted level and equal to the President’s Budget Request; and
- State and Tribal Assistance Grants: Provides $2.584 billion for State and Tribal Assistance Grants, which is $1.897 billion (42 percent) below the FY 2023 enacted level and $3.272 billion below the President’s Budget Request, and in addition to funding already provided by the Infrastructure Investment and Jobs Act (IIJA).
A recording of the Committee’s July 13, 2023, markup is available on the Committee’s website.
Senate Bill Intends To Increase Community Engagement And Transparency Regarding DOD PFAS-Related Activities: On July 12, 2023, Senator Jeanne Shaheen (D-NH), a senior member of the Senate Armed Services Committee, introduced the PFAS Community Engagement and Transparency Act (S. 2271), which would increase the U.S. Department of Defense’s (DOD) transparency regarding PFAS-related activities. According to Shaheen’s July 11, 2023, press release, the bill would:
- Require a U.S. Government Accountability Office (GAO) report assessing ongoing PFAS testing and remediation efforts on military installations;
- Require DOD to provide technical assistance to communities impacted by PFAS contamination and allow DOD to provide an annual grant to an affected community;
- Establish an office for engagement with PFAS-impacted communities at DOD;
- Direct DOD to provide a recurring report on PFAS-related testing and remediation efforts, including timelines for completion and cost; and
- Require DOD to submit a separate budget documenting activities related to PFAS.
Senator Debbie Stabenow (D-MI) introduced the Veterans Exposed to Toxic PFAS Act (VET PFAS Act) (S. 2294), which would require the U.S. Department of Veterans Affairs (VA) to provide health care services and benefits to veterans exposed to PFAS at military installations. According to Stabenow’s July 14, 2023, press release, the bill would ensure that illnesses connected to PFAS exposure are considered a service-connected disability, making veterans exposed to PFAS eligible for disability payments and medical treatment from the VA. Congressman Dan Kildee (D-MI) introduced a companion bill (H.R. 4249) in the House on June 21, 2023.
MDEP Updates PFAS In Products FAQs: The Maine Department of Environmental Protection (MDEP) has updated its FAQs regarding PFAS in products to reflect LD 217, “An Act to Support Manufacturers Whose Products Contain Perfluoroalkyl and Polyfluoroalkyl Substances” (Act). MDEP states that the Act has extended the implementation date for product reporting, requiring manufacturers of products with intentionally added PFAS to report the intentionally added presence of PFAS in those products to MDEP beginning January 1, 2025. According to MDEP, “the Environment and Natural Resources Committee is planning to hold public meetings later this year to discuss additional issues, with the possibility of reporting out another bill with further changes in 2024.” More information is available in our June 21, 2023, blog item.
White House OSTP Publishes Scientific Integrity Policy: On June 22, 2023, the White House Office of Science and Technology Policy (OSTP) published its Scientific Integrity Policy, which was adopted on May 17, 2023. The purpose of the policy “is to provide instruction and guidance to enhance and promote a continuing culture of scientific integrity” at OSTP. The policy aims to ensure the integrity of all aspects of OSTP scientific activities and establishes the expectations and procedures required to maintain scientific integrity at OSTP.
Drawing from the National Science and Technology Council’s (NSTC) 2023 A Framework for Federal Scientific Integrity Policy and Practice, the 2021 Presidential Memorandum on Restoring Trust in Government Through Scientific Integrity and Evidence-Based Policymaking, and the 2009 Presidential Memorandum on Scientific Integrity, the policy states that OSTP will be guided by the following principles:
- Qualified Leadership;
- Policy Implementation;
- Peer Review;
- Public Access:
- Science-Informed Decisions;
- Whole of Government;
- Science at the Policy Table;
- Transparency in Sharing Science;
- Safe and Inclusive Workplaces;
- Responsiveness to New Technologies; and
- Inclusion of Other Modes of Science.
NIOSH Requests Public Comment On Draft IDLH Values For Hydrogen Bromide And Hydrogen Iodide: The National Institute for Occupational Safety and Health (NIOSH) requested public comment and technical review on June 22, 2023, on two draft Immediately Dangerous to Life or Health (IDLH) Value Profiles regarding the chemicals hydrogen bromide and hydrogen iodide. 88 Fed. Reg. 40826. NIOSH bases IDLH values on health effects considerations determined through a critical assessment of the toxicology and human health effects data. According to NIOSH, this approach ensures that the IDLH values reflect an airborne concentration of a substance that represents a high-risk situation that may endanger workers’ lives or health. Comments are due August 21, 2023.
ACGIH® Opens Second Comment Period Of TLV Development Process: The American Conference of Governmental Industrial Hygienists (ACGIH®) announced on July 7, 2023, that the second comment period of the Threshold Limit Value (TLV®) Development Process is open. ACGIH encourages further comment for the second half of the year. The updated list of notice of intended changes (NIC) and adopted substances is available on ACGIH®’s website. Comments are due September 30, 2023, with ratification occurring in November 2023, and updates in December 2023.
Petition Filed To Add Methyl Ethyl Ketoxime To List Of Chemical Substances Subject To Superfund Excise Tax: The Internal Revenue Service (IRS) announced on July 17, 2023, that it received a petition requesting that methyl ethyl ketoxime (MEKO) be added to the list of taxable substances under Section 4672(a) of the Internal Revenue Code. 88 Fed. Reg. 45454. The petitioner is AdvanSix Inc., an exporter of MEKO. Comments and requests for a public hearing are due September 15, 2023. More information is available in our July 17, 2023, blog item.
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