VIRTUAL CONFERENCE — Register Now For “TSCA Reform — Seven Years Later” On June 29, 2023: This essential annual Toxic Substances Control Act (TSCA) event, presented by Bergeson & Campbell, P.C. (B&C®), the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health, will feature speakers from the U.S. Environmental Protection Agency (EPA), non-governmental organizations (NGO), industry stakeholders, and academic leaders providing updates on topics including the interface of science and policy under TSCA, new chemicals, risk evaluation and management, the regulation of articles, and more. The full program and registration are available online.
WEBINAR — Preparing A PFAS Game Plan In The U.S., UK, And EU, July 11, 2023, 10:00 a.m. – 11:00 a.m. (EDT), Via Webinar: Perfluoroalkyl and polyfluoroalkyl substances (PFAS) are attracting global legal, regulatory, commercial, and litigation attention as no other “emerging contaminant” has. B&C affiliate The Acta Group (Acta®) and EPPA are pleased to offer this one-hour complimentary webinar providing companies producing, processing, distributing, and/or using these substances with the information needed to minimize legal, regulatory, and commercial risk. Register now.
WEBINAR — Responsible Land-Based Investments In Agriculture: Latin America, June 21, 2023, 9:30 a.m. – 10:30 a.m. (EDT), Via Webinar: The International Bar Association (IBA) Agriculture and Food Section presents “Responsible land-based investments in agriculture: Latin America.” This webinar will explore the current regulatory framework for sustainable and responsible investment in agriculture, with a focus on Latin America, including how this can contribute to the mitigation of the climate crisis. Panelists will look at how lawyers in the private and public sectors can use a variety of legal tools, including environmental and human rights law, to promote sustainable and responsible investment in agriculture within their national contexts.
ARTICLE — Lynn L. Bergeson, “Toxics Release Inventory Reporting: What is New This Year?,” Chemical Processing, June 9, 2023: Each year about this time, companies are focused on the deadline to submit Toxics Release Inventory (TRI) data to EPA. Companies well acquainted with this reporting ritual have established protocols to collect the data to enable timely reporting. With the July 1, 2023, deadline rapidly approaching, there are a few new reporting features of which to be aware. This column briefly summarizes important new elements.
EPA Releases Draft Guidance For Pesticide Application Submissions That Require Endangered Species Act Reviews And Seeks Public Comment: On May 17, 2023, EPA announced it released, and is seeking public comment on, draft guidance that claims to improve the efficiency of EPA’s Endangered Species Act (ESA) analyses for new pesticide active ingredient applications and active ingredients undergoing registration review. When the guidance is issued in final, EPA states that it will fulfill the requirements outlined in the Pesticide Registration Improvement Act of 2022 (PRIA 5) and extends the goals outlined in EPA’s 2022 ESA Workplan to protect listed species from exposure to pesticides. EPA will accept public comments on the draft guidance document for 30 days in docket EPA-HQ-OPP-2023-0281. Comments are due on or before June 16, 2023. More information is available in our May 22, 2023, blog item.
NGOs Call On EPA To Remove PFAS From Plastic Containers: On May 22, 2023, Public Employees for Environmental Responsibility (PEER) and Center for Environmental Health (CEH) submitted “extensive comments to the U.S. Environmental Protection Agency (EPA) demonstrating serious health risks from Inhance Technologies’ unlawful manufacture of per-and polyfluoroalkyl substances (PFAS) during its fluorination of hundreds of millions of plastic containers.” According to PEER’s press release, the comments call on EPA “to deny the company’s request for approval to continue this dangerous practice and use its authority under the Toxic Substances Control Act (TSCA) to eliminate this unacceptable risk to human health and the environment.” PEER and CEH submitted the comments in response to 18 significant new use notifications (SNUN) submitted by Inhance pursuant to the 2020 significant new use rule (SNUR) for long-chain perfluoroalkyl carboxylate and perfluoroalkyl sulfonate chemical substances. More information is available in our May 25, 2023, blog item.
EPA Region 9 Settles With Watts Regulator Company On Violations Of Product Safety Law: On May 23, 2023, EPA Region 9 announced a settlement with Watts Regulator Company for alleged violations under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) related to the sale or distribution of misbranded water filtration devices and importation of pesticides into the United States. Watts, which is headquartered in Massachusetts, imported devices through a port of entry within EPA Region 9. For more information on the settlement, please read our May 25, 2023, blog item.
EPA Proposes Updates To TSCA New Chemicals Regulations; Comments Due July 25, 2023: On May 26, 2023, EPA proposed amendments to the new chemicals procedural regulations under TSCA. 88 Fed. Reg. 34100. According to EPA, the amendments are “intended to align the regulatory text with the amendments to TSCA’s new chemicals review provisions contained in the  Frank R. Lautenberg Chemical Safety for the 21st Century Act” (Lautenberg Act), improve EPA’s efficiency in the review process, and “update the regulations based on existing policies and experience implementing the New Chemicals Program.” EPA states that the proposed rule includes amendments that would “reduce the need to redo all or part of the risk assessment by improving information initially submitted in new chemicals notices, which should also help reduce the length of time that new chemicals notices are under review.” EPA proposed several amendments to the regulations for low volume exemptions (LVE) and low release and exposure exemptions (LoREX), which include requiring EPA approval of an exemption notice prior to commencement of manufacture, making PFAS categorically ineligible for these exemptions, and providing that certain persistent, bioaccumulative, and toxic (PBT) chemical substances are ineligible for these exemptions, consistent with EPA’s 1999 PBT policy. Comments are due July 25, 2023. More information on the proposed rule is available in our May 24, 2023, memorandum.
EPA Completes Verification Analysis Of PFAS Scientific Testing Of Pesticide Products: On May 30, 2023, EPA announced it has taken additional steps in addressing concerns that PFAS have been found in pesticide products. As part of its ongoing efforts, EPA has completed its verification analysis of a study published in September 2022 in the Journal of Hazardous Materials entitled “Targeted analysis and Total Oxidizable Precursor assay of several insecticides for PFAS.” This study reported the presence of perfluorooctanesulfonate (PFOS) in six of ten pesticide products tested. EPA released a summary of the laboratory analysis of the same ten pesticide products reported to contain PFAS residues. EPA states it did not find any PFAS in the tested pesticide products, differing from the results of the published study in the Journal of Hazardous Materials. In addition to the summary of its findings, EPA also is releasing its newly developed and validated analytical methodology used in the testing process. In its press release, EPA states it is “confident in the results of this newly released method, which is specifically targeted to detect the presence of PFAS in pesticide products formulated with surfactants.” For more information, please read our June 2, 2023, memorandum.
EPA Issues Final Rule To Accelerate Use Of Plant-Incorporated Biotechnologies: On May 31, 2023, EPA released a final rule exempting a class of plant-incorporated protectants (PIP) created using genetic engineering, from registration requirements under FIFRA, and from the food or feed residue tolerance requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA). 88 Fed. Reg. 34756. PIPs are pesticidal substances produced by plants and the genetic material necessary for the plant to produce the substance. According to EPA’s May 25, 2023, press release, this rule will reduce costs for the regulated community and result in increased research and development activities, consistent with Executive Order 14081 on advancing biotechnology. EPA states that the rule also may result in the commercialization of new pest control options and reduced use of conventional pesticides. The final rule will be effective on July 31, 2023. More information is available in our May 31, 2023, blog and our June 2, 2023, memorandum.
EPA Updates TSCA CBI Requirements: EPA published on June 7, 2023, a final rule with new and amended requirements concerning the assertion and treatment of confidential business information (CBI) claims for information reported to or otherwise obtained by EPA under TSCA. 88 Fed. Reg. 37155. The final rule notes that amendments to TSCA in 2016 included many new provisions concerning the assertion, EPA review, and treatment of confidentiality claims. The final rule includes procedures for submitting such claims in TSCA submissions. It addresses issues such as substantiation requirements, exemptions, electronic reporting enhancements (including expanding electronic reporting requirements), maintenance or withdrawal of confidentiality claims, and provisions in current rules that are inconsistent with amended TSCA. The rule also addresses EPA procedures for reviewing and communicating with TSCA submitters about confidentiality claims. The final rule will be effective August 7, 2023. For a more in-depth review of the final rule and our insightful commentary, please read our June 12, 2023, memorandum.
EPA Will Propose To Ban Most Uses Of PCE And Establish A Workplace Chemical Protection Program For Uses Not Prohibited: EPA announced on June 8, 2023, that it will propose to ban most uses of perchloroethylene (PCE), “a chemical known to cause serious health risks such as neurotoxicity and cancer.” According to EPA, 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 will propose to prohibit, EPA’s analysis found that alternative products with similar costs and efficacy to PCE are “reasonably available.” Publication of the proposed rule in the Federal Register will begin a 60-day comment period. EPA has posted a pre-publication version of the proposed rule. More information will be available in a forthcoming memorandum.
EPA Accepting Comments On Candidates To Be Ad Hoc Reviewers For Draft Supplement To 1,4-Dioxane Risk Evaluation Under TSCA: EPA announced on June 14, 2023, that it is accepting public comments on candidates under consideration for selection as ad hoc reviewers to assist the Science Advisory Committee on Chemicals (SACC) with its review of the 2023 draft supplement to the 1,4-dioxane risk evaluation under TSCA. According to EPA, the supplement includes evaluation of additional conditions of use in which 1,4-dioxane is present as a byproduct in industrial processes and commercial products, and it evaluates risks from general population exposures to 1,4-dioxane released to ambient surface water and groundwater, ambient air, and land. EPA notes that to evaluate these additional exposure pathways, it used new methods and novel applications of existing methods. EPA seeks review of these new methods because they have not been the subject of public comment or peer review for applications in TSCA risk evaluations. EPA plans to release the risk evaluation documents for public comment by the end of June 2023. Comments on the candidates are due June 29, 2023. If selected, candidates will serve as peer reviewers for the draft supplement, which SACC plans to review at a four-day virtual public meeting September 12-15, 2023. EPA will post registration instructions for the meeting on the SACC website in mid-August 2023.
EPA Will Propose SNURs For 18 Chemicals Made From Plastic Waste-Derived Feedstocks: EPA announced on June 15, 2023, that it will issue proposed SNURs for 18 chemicals made from plastic waste-derived feedstocks that would ensure they are free from unsafe contaminants before they can be used to make transportation fuels. The proposed SNURs would require notification to and review by EPA before fuels could be made using plastic waste-derived feedstocks that contain impurities like PFAS, heavy metals, dioxins, bisphenols, and flame retardants. Publication of the proposed SNURs in the Federal Register will begin a 30-day comment period. More information will be available in a forthcoming memorandum.
2022 TRI Reporting Deadline Is July 1, 2023 — What Is New This Year?: Each year about this time, companies are focused on the deadline to submit TRI data to EPA. This year is no different as the July 1, 2023, deadline is rapidly approaching. By this date, entities subject to the reporting requirement must submit data for activities that occurred during 2022. Companies are required to report if they meet chemical activity thresholds and are either in a covered industry sector and exceed the employee threshold; or are specifically required to report based on a determination by EPA under the Emergency Planning and Community Right-to-Know Act (EPCRA) Section 313(b)(2). EPA’s TRI Threshold Screening Tool can help companies determine if they are subject to TRI reporting. The tool uses a step-by-step questionnaire to help companies determine whether they meet or exceed the facility, employee, and chemical thresholds established by EPA. For more information, please read our full memorandum.
Proposed Rule Would Address Legacy CCR Surface Impoundments: On May 18, 2023, EPA proposed to establish regulatory requirements for inactive surface impoundments at inactive facilities (legacy coal combustion residuals (CCR) surface impoundments). 88 Fed. Reg. 31982. EPA also proposed to establish groundwater monitoring, corrective action, closure, and post-closure care requirements for all CCR management units (regardless of how or when that CCR was placed) at regulated CCR facilities. EPA also proposed several technical corrections to the existing regulations, such as correcting certain citations and harmonizing definitions. EPA will hold an in-person public hearing on June 28, 2023, and a virtual public hearing on July 12, 2023. Comments are due July 17, 2023.
EPA Proposes To Amend NESHAP For Plywood And Composite Wood Products: On May 18, 2023, EPA proposed amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Plywood and Composite Wood Products (PCWP), as required by the Clean Air Act (CAA). 88 Fed. Reg. 31856. To ensure that all emissions of hazardous air pollutants (HAP) from sources in the source category are regulated, EPA proposed HAP standards for processes currently unregulated for total HAP, non-mercury HAP metals, mercury, hydrogen chloride, polycyclic aromatic hydrocarbons (PAH), dioxin/furan, and methylene diphenyl diisocyanate. The standards EPA proposed include emission limitations and work practices applicable for PCWP process units and lumber kilns located at facilities that are major sources of HAP emissions. Comments are due July 3, 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 the comments by June 20, 2023.
EPA Proposes To Amend GHG Reporting Rule: On May 22, 2023, EPA published a supplemental notice of proposed rulemaking that would amend specific provisions in the Greenhouse Gas (GHG) Reporting Rule to improve the quality and consistency of the rule by providing for the collection of improved data that would better inform and be relevant to a wide variety of CAA provisions that EPA carries out. 88 Fed. Reg. 32852. EPA proposed additional amendments to the GHG Reporting Rule, including updates to the General Provisions to reflect revised global warming potentials, and proposed to require reporting of GHG data from additional sectors — specifically energy consumption; coke calcining; ceramics production; calcium carbide production; and caprolactam, glyoxal, and glyoxylic acid production. Comments are due July 21, 2023. EPA notes that 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 June 21, 2023.
EPA Proposed Rule Would Address GHG Emissions From Fossil Fuel-Fired Electric Generating Units: On May 23, 2023, EPA proposed five separate actions under CAA Section 111 addressing GHG emissions from fossil fuel-fired electric generating units (EGU). 88 Fed. Reg. 33240. EPA proposed revised new source performance standards (NSPS), first for GHG emissions from new fossil fuel-fired stationary combustion turbine EGUs and second for GHG emissions from fossil fuel-fired steam generating units that undertake a large modification, based upon the eight-year review required by the CAA. Third, EPA proposed emission guidelines for GHG emissions from existing fossil fuel-fired steam generating EGUs, which include both coal-fired and oil/gas-fired steam generating EGUs. Fourth, EPA proposed emission guidelines for GHG emissions from the largest, most frequently operated existing stationary combustion turbines and is soliciting comment on approaches for emission guidelines for GHG emissions for the remainder of the existing combustion turbine category. Finally, EPA proposed to repeal the Affordable Clean Energy (ACE) Rule. Comments are due July 24, 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 June 22, 2023.
EPA Proposes To List Substitutes Under The SNAP Program In Commercial And Industrial Refrigeration: On May 24, 2023, pursuant to EPA’s Significant New Alternatives Policy (SNAP) program, EPA proposed to list certain substances in the refrigeration and air conditioning sector. 88 Fed. Reg. 33722. Specifically, EPA proposed to list 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. EPA proposed to incorporate 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 also proposed to exempt propane, in the refrigerated food processing and dispensing end-use, from the prohibition under the CAA on knowingly venting, releasing, or disposing of substitute refrigerants, on the basis of current evidence that the venting, release, or disposal of this substance in this end-use does not pose a threat to the environment. Comments are due July 10, 2023.
Supreme Court Addresses “Waters Of The United States”: On May 25, 2023, the U.S. Supreme Court issued its decision in Sackett v. EPA, finding that the Clean Water Act’s (CWA) use of “waters” in Section 1362(7) refers only to “geographic[al] features that are described in ordinary parlance as ‘streams, oceans, rivers, and lakes’” and to adjacent wetlands that are “indistinguishable” from those bodies of water due to a continuous surface connection. According to the Court, to assert jurisdiction over an adjacent wetland under the CWA, a party must establish “first, that the adjacent [body of water constitutes] . . . ‘water[s] of the United States’ (i.e., a relatively permanent body of water connected to traditional interstate navigable waters); and second, that the wetland has a continuous surface connection with that water, making it difficult to determine where the ‘water’ ends and the ‘wetland’ begins.”
PHMSA Announces Public Meeting On Potential Adjustments To Hazardous Materials Registration And Fee Assessment Program: On May 26, 2023, the Pipeline and Hazardous Materials Safety Administration’s (PHMSA) Office of Hazardous Materials Safety announced that it will hold a public meeting to solicit input on potential adjustments to the statutorily mandated hazardous materials registration and fee assessment program. 88 Fed. Reg. 34227. According to PHMSA, the potential adjustment of fees may be necessary to fund its national emergency preparedness grant programs at the newly authorized level in accordance with the Infrastructure Investment and Jobs Act of 2021. The meeting will be held virtually on June 28, 2023. Requests to attend the meeting must be received by June 21, 2023. Requests for accommodations for a disability must be received by June 21, 2023. Persons requesting to speak during the meeting must submit a written copy of their remarks to the Department of Transportation (DOT) by June 21, 2023. Requests to submit written materials to be reviewed during the meeting must be received no later than June 21, 2023.
PHMSA Proposes To Amend HRM To Maintain Harmonization With International Standards: On May 30, 2023, PHMSA proposed to amend the Hazardous Materials Regulations (HMR) to maintain alignment with international regulations and standards by adopting various amendments, including changes to proper shipping names, hazard classes, packing groups, special provisions, packaging authorizations, air transport quantity limitations, and vessel stowage requirements. 88 Fed. Reg. 34568. Comments are due July 31, 2023.
EPA Requests Comment On Proposed Consent Decree In CAA Citizen Suit: On May 31, 2023, EPA provided notice of a proposed consent decree in California Communities Against Toxics, et al. v. Regan, No. 1:22-cv-03724 (D.D.C.). 88 Fed. Reg. 34853. On December 14, 2022, Plaintiffs California Communities Against Toxics, Clean Power Lake County, Rio Grande International Study Center, Sierra Club, and Union of Concerned Scientists filed a complaint in the U.S. District Court for the District of Columbia alleging that EPA has failed to perform its nondiscretionary duty to “review, and revise as necessary” the Ethylene Oxide Emissions Standards for Sterilization Facilities NESHAP at least every eight years. The proposed consent decree would establish a deadline for EPA to sign a final rule for this action. Comments on the proposed consent decree are due June 30, 2023.
EPA Introduces Clean Air Tracking Tool: On May 31, 2023, EPA announced the release of the Enforcement and Compliance History Online (ECHO) Clean Air Tracking Tool (ECATT), which serves as an interface and repository for CAA data that can be used to evaluate emissions at stationary sources of air pollution and analyze general air quality for the United States. ECATT has two main searches: the Air Monitoring Station (AMS) search and the Emission Screener search. EPA states that the AMS search “can be used to identify areas with high pollutant concentrations and higher potential for health impacts and identify the facilities emitting in those areas.” The Emission Screener search provides data on stationary sources regulated under the CAA, and “[u]sers can analyze the data reported to these emissions inventories to identify top emitters and provide additional information related to the source, quantity and location of the emissions, and the specific pollutants being released.”
FDA Releases Guidance And Report On Trends Related To The Food Traceability Rule: The U.S. Food and Drug Administration (FDA) on May 17, 2023, released the Institute of Food Technologists (IFT) report related to food traceability trends from information it gathered from the FDA 2021 Low- or No- Cost Tech-Enabled Traceability Challenge. The IFT collaboration with FDA is meant to provide guidance for industry in the advancement of concepts under the New Era of Smarter Food Safety. In addition, on May 19, 2023, FDA announced the availability of guidance entitled “Small Entity Compliance Guide: Requirements for Additional Traceability Records for Certain Foods: What You Need to Know About the FDA Regulation.” This question-and-answer type guidance addresses the November 21, 2022, FDA final Food Traceability Rule that places additional requirements for parties that manufacture, process, pack, or hold foods that are listed on the Food Traceability List.
FDA Updates New Approach To Reviewing Food Additives: FDA published an update on May 26, 2023 titled “How FDA’s New Approach to Reviewing Chemicals Added to Food Will Strengthen Food Safety” which discusses FDA’s current approach for reviewing food additives (i.e., pre-market and post-market review). Review of chemicals focused on post-market review will include potential new approaches based on data mining and prioritization based on risk. FDA highlights that increased funding, new staff, expanded regulatory authority, and support from consumer advocacy groups, regulated industry, and Congress will be needed for this expanded regulatory approach. Additional details are provided at the link here.
FDA Provides Updates On PFAS Activities: FDA, on May 31, 2023, provided updates regarding PFAS presence in the food supply based on recent testing results. FDA performed tests on fresh and processed food to estimate dietary exposure from PFAS. Certain PFAS tested resulted in FDA concluding PFAS is not likely to be a health concern for young children or the general population. FDA advises the seafood industry in particular to focus on analytical testing and offered to provide technical assistance in establishing such testing.
FDA Issues Final Guidance On Action Level For Inorganic Arsenic: FDA announced, on June 1, 2023, final guidance regarding the action level for inorganic arsenic in apple juice, with an identified industry action level of ten parts per billion (ppb). FDA expects the action level will encourage industry reduction efforts for inorganic arsenic in apple juice. This guidance supports FDA’s goal to reduce exposure in babies and young children.
FDA Publishes Details For Equivalence Process:, On June 5, 2023, FDA published a web page titled “Equivalence and Food Safety,” which explains how the food safety equivalence process works and lists current equivalence determinations. FDA, in response to a request from a foreign regulatory authority, will conduct an in-depth scientific and regulatory analysis of the authority’s food safety controls, may conduct an onsite audit, and issue a positive or negative determination of equivalence. FDA has been engaged in equivalence discussions on grade A dairy with Canada, the European Union (EU), and New Zealand; and on shellfish with New Zealand.
FDA Celebrates World Food Safety Day: FDA celebrated World Food Safety Day on June 7, 2023, which had the theme “Food Standards Save Lives.” This theme coincides with the 60th anniversary of Codex Alimentarius, a collection of food standards, guidelines and codes of practice adopted by the international Codex Alimentarius Commission (with which FDA participates across many committees) to encourage governments and food safety advocates around the world to focus on the importance of applying safety standards in every aspect of food production.
EUON Posts Nanopinions On Using Single-Walled Carbon Nanotubes To Measure Biochemical Processes And On Experiments Involving Zebrafish To Elicit An Immune Response: The EU Observatory for Nanomaterials (EUON) has posted two Nanopinions:
- “Seeing is believing,” posted on April 11, 2023, by Dr. Chandima Bulumulla, Postdoctoral Fellow at the Janelia Research Campus of the Howard Hughes Medical Institute, and Dr. Abraham G. Beyene, Group Leader at the Janelia Research Campus of the Howard Hughes Medical Institute; and
- “Fishing for novel interactions between nanomaterials and the immune system,” posted on May 14, 2023, by Professor Bengt Fadeel, Full Professor of Medical Inflammation Research at the Institute of Environmental Medicine, Karolinska Institutet.
OECD Tour de Table Includes Information On International Developments Regarding Nanomaterials: The Organization for Cooperation and Development (OECD) has published the latest edition of the Developments in Delegations on the Safety of Manufactured Nanomaterials and Advanced Materials — Tour de Table. The Tour de Table compiles information provided by delegations on the occasion of the 22nd meeting of the OECD Working Party on Manufactured Nanomaterials (WPMN) in June 2022. Highlights on international developments from the Tour de Table are available in our June 9, 2023, blog item.
SCCS Updates Guidance For The Testing Of Cosmetic Ingredients And Their Safety Evaluation: On May 16, 2023, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) published the 12th revision of The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation. The guidance contains information on the different aspects of testing and safety evaluation of cosmetic substances in Europe. The guidance includes a section on “special consideration for certain cosmetic ingredients” that addresses specific ingredients, including nanomaterials. More information is available in our June 1, 2023, blog item.
ANSES Calls For The EC To Adopt A “More Protective” Definition Of Nanomaterials: The French Agency for Food, Environmental and Occupational Health and Safety (ANSES) issued a May 17, 2023, news item stating that it believes that the EC’s revised Recommendation on the definition of nanomaterial, published in June 2022, “is too restrictive and could lead to a regression in the protection of public health and the environment.” ANSES “is therefore urging the French authorities to take a more inclusive definition into account and work towards its integration in the revision of sectoral regulations at [the] European level,” including the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and Classification, Labeling, and Packaging (CLP) regulations. More information is available in our May 31, 2023, blog item.
White House OSTP Extends Comment Period For RFI On NNI EHS Research Strategy: The White House Office of Science and Technology Policy (OSTP) has extended the comment period for its April 5, 2023, request for information (RFI) seeking public input in updating the National Nanotechnology Initiative (NNI) Environmental, Health, and Safety (EHS) Research Strategy. 88 Fed. Reg. 33174. OSTP states that it is interested in public input to inform an updated nanotechnology EHS research strategy, “specifically a strategy that focuses on the use of science-based risk analysis and risk management to protect public health and the environment while also fostering the technological advancements that benefit society.” Comments are due on or before 5:00 p.m. (EDT) on June 16, 2023. More information is available in our May 25, 2023, blog item.
Nano4EARTH Will Hold A Roundtable Discussion On Coatings, Lubricants, Membranes, And Other Interface Technologies On July 6, 2023: On July 6, 2023, Nano4EARTH will hold a roundtable discussion on nanotechnology-enabled coatings, lubricants, membranes, and other interface technologies that aims to identify fundamental knowledge gaps, needs, and opportunities at the interface of materials, technologies, and industrial processes. According to the NNI, “[t]hese needs could have a near-term impact on energy efficiency, sustainable development, and climate change.” The moderated discussion will cover all aspects of the topic — ranging from research and development (R&D) opportunities to commercialization challenges — by featuring a small group of experts from different sectors and backgrounds.
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.
Bicameral Bill Would Establish Consortium To Identify Safer Chemicals: On May 18, 2023, Senator Alex Padilla (D-CA) and Representative Zoe Lofgren (D-CA) introduced the Supercomputing for Safer Chemicals (SUPERSAFE) Act (S. 1685, H.R. 3457). According to Padilla’s May 18, 2023, press release, the legislation would establish a SUPERSAFE Consortium led by EPA “to identify chemicals that are safe to use in commerce through science-backed decision making.” The press release states that the bill would direct the use of supercomputing, machine learning, and other similar capabilities to:
- Establish rapid approaches for large-scale identification of toxic substances and the development of safer alternatives to toxic substances by developing and validating computational toxicology methods;
- Address the need to identify safe chemicals for use in consumer and industrial products and in their manufacture to support the move away from toxic substances and toward safe-by-design alternatives; and
- Make recommendations on how the information produced can be applied in risk assessments and other characterizations for use by EPA and other agencies in regulatory decisions and by industry in identifying toxic and safer chemicals.
More information is available in our June 13, 2023, blog item.
Safer Beauty Bill Package Would Ban Certain Chemicals: On May 24, 2023, Representative Jan Schakowsky (D-IL) announced the reintroduction of the Safer Beauty Bill Package with her Energy and Commerce colleagues, Representatives Lizzie Fletcher (D-TX), Lisa Blunt Rochester (D-DE), and Doris Matsui (D-CA). According to Schakowsky’s May 24, 2023, press release, the package includes four separate bills “that offer progressive updates to an increasingly outdated set of federal cosmetics laws”:
- The Toxic-Free Beauty Act (H.R. 3619): Bans 11 of the most toxic chemicals, including mercury, formaldehyde, parabens, phthalates, and phenylenediamines (hair dye chemicals). The press release states that the EU, California, and Maryland already ban these chemicals, yet they are in cosmetic products sold legally in the United States;
- Cosmetic Safety Protections for Communities of Color and Salon Workers (H.R. 3620): Funds research, resource materials, education and outreach, and the development of safer chemicals to protect the health of women of color and salon workers;
- Cosmetic Fragrance and Flavor Right to Know Act (H.R. 3621): Requires product label and website disclosure of “these secret, unlabeled, and often toxic chemicals in our personal care products”; and
- Cosmetic Supply Chain Transparency Act (H.R. 3622): Requires suppliers of raw materials, ingredients, and private label products to provide full ingredient disclosure and safety data to cosmetic companies so they can make safer products.
Bipartisan Legislation Would Establish National Mercury Monitoring Network: On May 31, 2023, Senators Tom Carper (D-DE), Chair of the Senate Environment and Public Works Committee, and Susan Collins (R-ME) introduced the Comprehensive National Mercury Monitoring Act (S. 1772), bipartisan legislation that would establish a national mercury monitoring network to protect human health and the environment. According to the Committee’s June 1, 2023, press release, the bill would:
- Direct EPA, in conjunction with the Fish and Wildlife Service, the U.S. Geological Survey, the National Park Service, the National Oceanic and Atmospheric Administration, and other appropriate agencies to establish a national mercury monitor program to measure and monitor mercury in watersheds, surface water, fish and wildlife, and the atmosphere;
- Establish a scientific advisory committee to advise on the establishment, site selection, measurement, recording protocols, and operations of the monitoring program;
- Establish a centralized database for existing and newly collected environmental mercury data that can be accessed on the Internet and is comprised of data that are compatible with similar international efforts;
- Require a report to Congress every two years on the program, including trends, and an assessment of the reduction in mercury deposition rates that need to be achieved to prevent adverse human and ecological effects every four years; and
- Authorize $95 million over three years for these purposes.
Food Chemical Reassessment Act Reintroduced In The House: On June 7, 2023, Representatives Jan Schakowsky (D-IL) and Rosa DeLauro (D-CT) reintroduced the Food Chemical Reassessment Act of 2023 (H.R. 3927). According to Schakowsky’s June 7, 2023, press release, the bill would create an Office of Food Safety Assessment within FDA “to ensure that chemicals that have entered the food supply chain through loopholes or that were reviewed by the FDA decades ago are safe to eat.” The Office would study every three years the safety of at least ten chemicals added to food or food packaging, starting with tert-butylhydroquinone (TBHQ), titanium dioxide, potassium bromate, perchlorate, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), brominated vegetable oil (BVO), propyl paraben, sodium nitrite, and sulfuric acid. The bill would also re-establish a Food Advisory Council to advise the FDA on the best methods to review the safety of food chemicals.
Senate Committee Holds Rescheduled Hearing On Impacts Of Plastic Production And Disposal On Environmental Justice Communities: The Senate Environment and Public Works Subcommittee on Chemical Safety, Waste Management, Environmental Justice, and Regulatory Oversight held a hearing on June 15, 2023, on “Impacts of Plastic Production and Disposal on Environmental Justice Communities.” Originally scheduled for April 27, 2023, witnesses included:
- Angelle Bradford, Doctoral student in physiology and medicine at Tulane University School of Medicine, Volunteer Sierra Club Delta Chapter;
- Sharon Lavigne, Founder, Rise St. James;
- Chris Tandazo, Director of Government Affairs, New Jersey Environmental Justice Alliance;
- Kevin Sunday, Director of Government Affairs, Pennsylvania Chamber of Business and Industry; and
- Donna Jackson, Director of Membership Development, Project 21 — National Center for Public Policy and Research.
GAO’s Priority Open Recommendations For EPA Include Recommendations Regarding The IRIS Program: On May 16, 2023, the U.S. Government Accountability Office (GAO) released publicly a report on its priority open recommendations for EPA. GAO’s priority recommendations include three in the area of “assessing and controlling toxic chemicals.” According to GAO, EPA’s ability to protect effectively public health and the environment depends on credible and timely assessments of the risks posed by toxic chemicals, including PFAS. GAO states that implementing the three priority recommendations in this area, such as by establishing an ongoing process to assess the resources required to complete successfully Integrated Risk Information System (IRIS) chemical assessments, would improve EPA’s ability to prepare and issue the assessments. More information is available in our June 6, 2023, blog item.
Public Meetings Wil Be Held In Advance Of 44th Session Of The UNSCEGHS, 62nd Session Of The UNSCETDG: On May 24, 2023, the Occupational Safety and Health Administration (OSHA) announced that it will conduct a hybrid public meeting on June 21, 2023, in advance of the 44th session of the United Nations Sub-Committee of Experts on the Globally Harmonized System of Classification and Labelling of Chemicals (UNSCEGHS) to be held as an in-person meeting July 10-12, 2023, in Geneva, Switzerland. 88 Fed. Reg. 33650. The meeting will occur jointly with DOT’s PHMSA to discuss proposals in preparation for the 62nd session of the United Nations Sub-Committee of Experts on the Transport of Dangerous Goods (UNSCETDG) to be held as an in-person meeting July 3-7, 2023. Advanced meeting registration information for each session will be posted on the PHMSA and OSHA websites. For each of these meetings, OSHA and PHMSA will solicit public input on U.S. government positions regarding proposals submitted by member countries in advance of each meeting.
Minnesota Will Require Manufacturers To Report Intentionally Added PFAS And Will Ban Intentionally Added PFAS In Certain Product Categories Beginning January 1, 2025: Under H.F. 2310, signed into law by Governor Tim Walz (D) as part of the One Minnesota Budget on May 24, 2023, on or before January 1, 2026, a manufacturer of a product sold, offered for sale, or distributed in Minnesota that contains intentionally added PFAS report certain information to the Minnesota Pollution Control Agency (MPCA). Beginning January 1, 2025, a person may not sell, offer for sale, or distribute for sale in Minnesota the following products if the product contains intentionally added PFAS: carpets or rugs; cleaning products; cookware; cosmetics; dental floss; fabric treatments; juvenile products; menstruation products; textile furnishings; ski wax; or upholstered furniture. Beginning January 1, 2032, a person may not sell, offer for sale, or distribute for sale in Minnesota any product that contains intentionally added PFAS, unless MPCA has determined by rule that the use of PFAS in the product is a currently unavoidable use. More information is available in our June 14, 2023, blog item.
Maine Governor Signs Bill Postponing PFAS Reporting Requirement: Governor Janet Mills (D) has signed LD 217, “An Act to Support Manufacturers Whose Products Contain Perfluoroalkyl and Polyfluoroalkyl Substances” (Act). Passed by the House on June 1, 2023, and the Senate on June 6, 2023, the bill extends the January 1, 2023, deadline for reporting the use of PFAS in products for sale to January 1, 2025, and authorizes reporting the amount of total organic fluorine if the amount of each PFAS compound is not known. The bill will allow the amount of PFAS to be reported based on information provided by a supplier rather than testing. It clarifies the packaging exemption under the law regulating PFAS in products, exempts from the reporting requirements manufacturers that employ 25 or fewer people, clarifies that the requirements and prohibitions of PFAS in products do not apply to used products or used product components, and makes other technical clarifications to PFAS reporting requirements. The changes made by the bill to the law regulating PFAS in products will be made retroactive to January 1, 2023.
DPR Issues Notice On Pesticide Program Annual Processing Timelines: On June 8, 2023, the California Department of Pesticide Regulation (DPR) issued Notice 2023-07: Pesticide Registration Program Annual Processing Timelines. Under Notice 2023-07, DPR sets forth its annual report summarizing the past five years of registration and post-registration activities. This includes the number of pesticide product registration and amendment submissions received and processed, and average number of days to complete different types of registration submissions are also provided. For more information, please read our June 12, 2023, blog.
EPA Amends NCP Requirements To Encourage The Development Of Safer Spill Mitigating Products: On June 12, 2023, EPA amended the Subpart J regulatory requirements for the National Oil and Hazardous Substances Pollution Contingency Plan (NCP) Product Schedule in two distinct ways. First, EPA added new listing criteria, revising the efficacy and toxicity testing protocols, and clarified the evaluation criteria for removing products from the NCP Product Schedule. Second, EPA amended requirements for the authorities, notifications, and data reporting when using chemical or biological agents in response to oil discharges to CWA Section 311 jurisdictional waters and adjoining shorelines. EPA states that these requirements “are anticipated to encourage the development of safer and more effective spill mitigating products and better target the use of these products to reduce the risks of oil discharges and response technologies to human health and the environment.” The final rule will be effective December 11, 2023.
EPA Releases June 2023 IRIS Program Outlook: EPA’s IRIS Program has released the June 2023 IRIS Program Outlook. EPA states that to maintain transparency, the IRIS Program provides an updated outlook of upcoming program activities. The IRIS Program Outlook outlines assessments that are in development and projected public milestone dates. According to EPA, updates to the IRIS Program Outlook document occur at least three times a year (February, June, October).
Bipartisan House Committee Leaders Request Information Regarding The Security Of Facilities Handling Certain Chemicals: On June 12, 2023, the House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Committee Ranking Member Frank Pallone, Jr. (D-NJ), Environment, Manufacturing, and Critical Materials Subcommittee Chair Bill Johnson (R-OH), Subcommittee Ranking Member Paul Tonko (D-NY), and Representative August Pfluger (R-TX) sent a letter to Cybersecurity and Infrastructure Security Agency (CISA) Director Jen Easterly regarding the status and renewal of the Chemical Facility Anti-Terrorism Standards (CFATS) program. On July 27, 2023, the statutory authority undergirding the entire CFATS program is scheduled to sunset. In anticipation of any congressional efforts to extend the CFATS program, members requested responses to the following questions:
- What steps has CISA taken to improve transparency of and understanding about the high-risk tiering process among regulated stakeholders? If CISA has taken steps to improve transparency, has CISA conducted outreach to stakeholders and others to determine if those steps improved understanding?
- What steps, if any, has CISA taken in the last three years to change the way it protects chemical-terrorism vulnerability information (CVI)? Does CISA have plans to change the scope or treatment of CVI? What steps is CISA taking to communicate with other federal agencies about use of CVI as part of their programs?
- There are reports that CISA may soon begin a rulemaking that impacts the CFATS program, including changing the risk methodology, the list of chemicals and their thresholds under Appendix A, and cybersecurity. Please confirm whether CISA will be proposing new rules in these areas, the need identified and the precise purpose for each of these proposed changes, and the timeline for action on these rules and whether these timelines will be subject to the Administrative Procedures Act or some other legal set of guidelines.
- Has CISA remedied all deficiencies identified by past GAO reports? Does CISA employ training standards for CFATS inspection and compliance officers, including the use of minimum qualification requirement for inspectors to demonstrate knowledge and understanding of CFATS facilities?
- What action(s) does CISA’s main office in Washington, D.C. take to ensure that the regional offices are uniformly implementing CFATS across the country? Is there an accountability process to prevent one region from operating a very different program from another?
- The issue of drone activity around CFATS regulated facilities is getting increased attention. What actions has CISA taken and what plans does CISA have to address this matter?
- CISA is proposing to reinitiate the statutorily required regulation on the sale of ammonium nitrate. Has CISA taken steps to understand the impact such regulations will have on CFATS-regulated facilities? Has CISA taken steps to understand the impact the absence of such regulation has had on its ability to combat terrorism?
EPA Will Hold External Peer Review Meeting Of Draft IRIS Toxicological Review Of PFDA And Related Salts: In April 2023, EPA’s IRIS Program released a report entitled IRIS Toxicological Review of Perfluorodecanoic Acid (PFDA) and Related Salts for public comment until June 9, 2023. The draft IRIS assessment is now undergoing independent external scientific peer review managed by ERG, a contractor to EPA. ERG is organizing a peer review meeting taking place virtually July 10-13, 2023. Members of the public may attend as observers. A limited amount of time will be set aside for oral public comments during the peer review meeting. Registration is now open