Wrap-Up of Federal and State Chemical Regulatory Developments, January 2022

EPA Reopens Dockets For 20 High-Priority Substances: EPA has reopened the online dockets for 20 high-priority substances. According to the December 9, 2021, memorandum authorizing the re-opening of the dockets, EPA is re-opening these dockets to receive use, hazard, exposure, and any other information that can help inform their risk evaluations under TSCA. Information must be submitted by June 9, 2022, when EPA will close the dockets. Information submitted to the docket should be identified by the docket identification (ID) number associated with the relevant chemical. The 20 high-priority chemicals are:

• p-Dichlorobenzene;
• 1,2-Dichloroethane;
• trans-1,2-Dichloroethylene;
• o-Dichlorobenzene;
• 1,1,2-Trichloroethane;
• 1,2-Dichloropropane;
• 1,1-Dichloroethane;
• Dibutyl phthalate (DBP) (1,2-Benzene-dicarboxylic acid, 1,2-dibutyl ester);
• Butyl benzyl phthalate (BBP) (1,2-Benzene-dicarboxylic acid, 1-butyl 2-(phenylmethyl) ester);
• Di-ethylhexyl phthalate (DEHP) (1,2-Benzene-dicarboxylic acid, 1,2-bis(2-ethylhexyl) ester);
• Di-isobutyl phthalate (DIBP) (1,2-Benzene-dicarboxylic acid, 1,2-bis-(2-methylpropyl) ester);
• Dicyclohexyl phthalate;
• 4,4'-(1-Methylethylidene)bis[2,6-dibromophenol] (TBBPA);
• Tris(2-chloroethyl) phosphate (TCEP);
• Phosphoric acid, triphenyl ester (TPP);
• Ethylene dibromide;
• 1,3-Butadiene;
• 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-benzopyran (HHCB);
• Formaldehyde; and
• Phthalic anhydride.

The docket ID number and contact information for each chemical lead is available in the memorandum.

EPA Submits TSCA Section 6(a) Rulemaking On Asbestos (Part 1: Chrysotile Asbestos) To OMB For Review: On December 16, 2021, EPA submitted to the Office of Management Budget (OMB) a proposed rule under TSCA Section 6(a) on asbestos (part 1: chrysotile asbestos). According to an item in the fall 2021 Unified Agenda, the TSCA Section 6(a) rulemaking is needed to address the unreasonable risks of chrysotile asbestos that were identified in a risk evaluation completed under TSCA Section 6(b). EPA reviewed the exposures and hazards of chrysotile asbestos, the magnitude of risk, exposed populations, severity of the hazard, uncertainties, and other factors.

EPA Intends Draft TSCA Systematic Review Protocol To Strengthen Science Used In Chemical Risk Evaluations: On December 20, 2021, EPA released the Draft Systematic Review Protocol Supporting TSCA Risk Evaluations for Chemical Substances (Draft Protocol) for public comment. 86 Fed. Reg. 71891. According to EPA’s press release, the Draft Protocol will strengthen EPA’s approach to reviewing and selecting the scientific studies that are used to inform TSCA chemical risk evaluations and ensure that EPA has the best tools under TSCA to protect human health and the environment. Comments on the Draft Protocol are due February 18, 2022. For more information, please read the full memorandum.

EPA Expands TRI Reporting Requirements For Ethylene Oxide And Ethylene Glycol By Requiring Reporting For Certain Sterilization Facilities: On December 28, 2021, EPA announced that it is expanding the scope of Toxics Release Inventory (TRI) reporting requirements to include certain contract sterilization facilities that are not currently reporting on ethylene oxide releases. 86 Fed. Reg. 73764. EPA has issued a determination extending TRI reporting requirements to 29 facilities for ethylene oxide and to 16 of those facilities for ethylene glycol. Beginning in January 2022, these 29 facilities should start tracking their activities involving ethylene oxide (and ethylene glycol, if applicable) releases and other waste management quantities as required by the Emergency Planning and Community Right-to-Know Act (EPCRA), similar to any other facility subject to TRI reporting requirements. If reporting thresholds are met, the facilities must submit TRI data beginning in 2023. More information is available in our December 28, 2021, blog item.

EPA Publishes Receipt And Status Information For Certain New Chemicals For November 2021: On December 28, 2021, EPA published the receipt and status reports for the period from November 1, 2021, to November 30, 2021. 86 Fed. Reg. 73760. EPA states that it is providing notice of receipt of premanufacture notices (PMN), significant new use notices (SNUN), and microbial commercial activity notices (MCAN) (including amended notices and test information); an exemption application under 40 C.F.R. Part 725 (Biotech exemption); test marketing exemptions (TME), both pending and/or concluded; notices of commencement (NOC) to manufacture a new chemical substance; and a periodic status report on new chemical substances that are currently under EPA review or have recently concluded review. Comments identified by the specific case number provided by EPA are due January 27, 2022.

EPA Grants TSCA Section 21 Petition To Order Testing On Human Health Hazards Of PFAS: On December 28, 2021, EPA announced it is granting a petition from six North Carolina public health and EJ organizations filed under TSCA Section 21 to compel companies to conduct testing of certain per- and polyfluoroalkyl substances (PFAS). The previous Administration denied the petition on January 22, 2021. 86 Fed. Reg. 6602. As reported in our October 19, 2021, memorandum, EPA published a National PFAS Testing Strategy (Testing Strategy) that identifies priority substances for the first of several described phases of an iterative testing approach based on grouping of chemicals by chemistry features and available toxicity data. EPA states that it has granted the petition and will use its TSCA Section 4 order authority to require PFAS manufacturers to conduct and fund certain studies that will provide toxicity data and information on categories of PFAS. More information is available in our December 29, 2021, blog item.

Draft Revision To Risk Determination For HBCD Retains Finding Of Unreasonable Risk Of Injury: On December 29, 2021, EPA announced the availability of a draft revision to the risk determination for the cyclic aliphatic bromide cluster (HBCD) risk evaluation issued under TSCA. 86 Fed. Reg. 74082. EPA is reconsidering two key aspects of the risk determinations for HBCD. First, EPA proposes that the appropriate approach to these determinations under TSCA and implementing regulations is to make an unreasonable risk determination for HBCD as a whole chemical substance, rather than making unreasonable risk determinations separately on each individual condition of use evaluated in the risk evaluation. Second, EPA proposes that the risk determination should be explicit that it does not rely on assumptions regarding the use of personal protective equipment (PPE) in making the unreasonable risk determination under TSCA Section 6; rather, the use of PPE would be considered during risk management. EPA “finds that HBCD, as a whole chemical substance, presents an unreasonable risk of injury to health and the environment when evaluated under its conditions of use.” Comments are due by February 14, 2022. For more information, please read the full memorandum.

EPA Publishes Draft Scope Of The Risk Evaluation For Asbestos Part 2: Supplemental Evaluation Including Legacy Uses And Associated Disposals Of Asbestos: EPA announced on December 29, 2021, the availability of the Draft Scope of the Risk Evaluation for Asbestos Part 2: Supplemental Evaluation Including Legacy Uses and Associated Disposals of Asbestos (Draft Scope). 86 Fed. Reg. 74088. In the Part 2 risk evaluation, EPA will evaluate the conditions of use of asbestos (including other types of asbestos fibers in addition to chrysotile) that EPA had excluded from Part 1 as legacy uses and associated disposals, as well as any conditions of use of asbestos in talc and talc-containing products. The Draft Scope includes the conditions of use, hazards, exposures, and the potentially exposed or susceptible subpopulations that EPA plans to consider in conducting the risk evaluation for this chemical substance. Comments are due February 14, 2022. For more information, please read the full memorandum.

EPA Rescinds Final Rule For On-site Civil Inspection Procedures: On December 30, 2021, EPA issued a final rule rescinding the March 2, 2020, final rule (2020 inspection rule) regarding EPA’s procedures for conducting on-site civil inspections. 86 Fed. Reg. 74371. This final rule applies to on-site inspections conducted by EPA civil inspectors, federal contractors, and Senior Environmental Employment employees conducting inspections on behalf of EPA. This rule was effective immediately, as EPA states this rulemaking is procedural rather than substantive. For more information, please see our January 6, 2022, blog.

PEER Files Suit Against EPA Seeking TSCA Section 8(e) Reports: On January 5, 2022, Public Employees for Environmental Responsibility (PEER) announced that it filed suit in the U.S. District Court for the District of Columbia to compel EPA to disclose reports submitted pursuant to TSCA Section 8(e). According to the complaint, PEER submitted a Freedom of Information Act (FOIA) request in November 2021 seeking records demonstrating how EPA deals with Section 8(e) reports. PEER states that it requested both Section 8(e) reports submitted to EPA and internal policies regarding publicly posting and using Section 8(e) reports. PEER notes that its FOIA request “built upon information reported in a November 2021 article in The Intercept noting that EPA had only posted one 8(e) report publicly since 2019 and describing disagreement over how the EPA processes 8(e) reports internally.” PEER asks the court to enter an order declaring that EPA wrongfully withheld requested documents and to issue a permanent injunction directing EPA to disclose all wrongfully withheld documents. More information is available in our January 7, 2022, blog item.

OCSPP Accepting Comment On Candidates For Ad Hoc Reviewers For Draft TSCA Screening Level Approach For Assessing Ambient Air And Water Exposures To Fenceline Communities: The EPA Office of Chemical Safety and Pollution Prevention (OCSPP) is accepting public comments on candidates under consideration for selection as ad hoc reviewers assisting the Science Advisory Committee on Chemicals (SACC) with its review of the draft EPA TSCA Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities. EPA will use the comments to assist it in selecting approximately six to eight ad hoc reviewers to assist the SACC with its review. Biographies of the candidates are available online. Comments were due January 5, 2022. EPA states that it is presenting Version 1.0 of a screening level methodology for assessing potential air and water pathway chemical exposures to fenceline communities. Along with presenting this methodology, EPA will also present results of applying the screening methodology (case studies) to 1-bromopropane (air pathway), N-methylpyrrolidone (water pathway), and methylene chloride (air and water pathway). The review will take place during a public meeting anticipated for March 15-17, 2022. Registration instructions will be announced on the SACC website in early February 2022.

EPA Accepting Comments On Candidates To Be Ad Hoc Reviewers For Draft TSCA Systematic Review Protocol: EPA announced on January 13, 2022, that it is accepting public comments on candidates under consideration for selection as ad hoc peer reviewers assisting SACC with its review of the Draft Systematic Review Protocol Supporting TSCA Risk Evaluations for Chemical Substances. This comment period follows a previous 30-day call for nominations that ended on November 17, 2021. EPA will use comments on the potential candidates to assist it in selecting approximately six to eight ad hoc reviewers, depending on a balance of experience, to assist SACC with its review. Biographies of the candidates are available at regulations.gov. Comments are due January 28, 2022, to Docket ID EPA-HQ-OPPT-2021-0414. More information is available in our January 14, 2022, blog item.

EPA Publishes Statements Of Findings For September 2021 For Certain New Chemicals Or Significant New Uses: On January 14, 2022, EPA published its statements of findings made after reviewing notices submitted under TSCA Section 5(a) that certain new chemical substances or significant new uses are not likely to present an unreasonable risk of injury to health or the environment. 87 Fed. Reg. 2430. The notice presents statements of findings made by EPA during the period from September 1, 2021, to September 30, 2021.

EPA Seeks Comment On Modernizing Public Notice For RCRA Hazardous Waste Permitting And Other Actions: On December 16, 2021, EPA provided notice and invited public comment on allowing modern electronic alternatives for public notification in implementing Subtitle C of the Resource Conservation and Recovery Act (RCRA). 86 Fed. Reg. 71482. The notice communicates EPA’s interpretation that the RCRA and EPA regulatory provisions that require newspaper notice for certain actions (e.g., permit issuance) can be satisfied by notice in qualifying online newspapers, as well as print newspapers. EPA requests comment regarding whether online mechanisms that might not typically be viewed as newspapers, such as bulletins or newsletters published online by state environmental agencies, could also satisfy these requirements. The notice further explains EPA’s view that EPA in appropriate cases can authorize state regulations that provide for equivalent notice mechanisms other than newspaper publication for actions other than permit issuance. Finally, the notice requests comment on whether EPA should amend its regulations to allow for more flexibility in providing notice of permit actions and other RCRA actions. Comments are due February 14, 2022.

EPA Allows Lead And Copper Rule Revisions To Take Effect While Proceeding With Rulemaking To Revise Key Sections: On December 17, 2021, EPA published a notification of the conclusion of its review of the National Primary Drinking Water Regulations: Lead and Copper Rule Revisions (LCRR). 86 Fed. Reg. 71574. On June 16, 2021, EPA published its decision to delay the effective and compliance dates of the LCRR, published on January 15, 2021, to allow time for EPA to review the rule in accordance with Presidential directives issued on January 20, 2021, to the heads of federal agencies to review certain regulations and conduct important consultations with affected parties. 86 Fed. Reg. 31939. EPA has completed its review, which included a series of virtual public engagements to hear directly from a diverse set of stakeholders. The notice describes the comments conveyed by stakeholders, EPA's decision to proceed with a proposed rule that would revise certain key sections of the LCRR while allowing the rule to take effect, and other non-regulatory actions that EPA and other federal agencies can take to reduce exposure to lead in drinking water. The effective date of the LCRR published on June 16, 2021, was December 16, 2021, and the compliance date continues to be October 16, 2024. Primacy revision applications are due on December 18, 2023. According to EPA’s December 16, 2021, press release, EPA will also develop a new proposed rule, the Lead and Copper Rule Improvements, that will strengthen the regulatory framework. EPA intends to propose requirements that, along with other actions, would result in the replacement of all lead service lines as quickly as is feasible. EPA also intends to consider opportunities to strengthen tap sampling requirements and explore options to reduce the complexity and confusion associated with the action level and trigger level, with a focus on reducing health risks in more communities. The goal of these potential lead service line replacement regulatory improvements -- coupled with non-regulatory actions -- is to protect public health more equitably.

EPA Will Use Bipartisan Infrastructure Law Funds To Clear Superfund Backlog: On December 17, 2021, EPA announced a $1 billion investment from the Bipartisan Infrastructure Law to initiate cleanup and clear the backlog of 49 previously unfunded Superfund sites and accelerate cleanup at dozens of other sites. EPA states that until this “historic investment,” many of the sites were part of a backlog of hazardous waste sites awaiting funding. Thousands of contaminated sites exist nationally due to hazardous waste being dumped, left out in the open, or otherwise improperly managed. These sites include manufacturing facilities, processing plants, landfills, and mining sites. The $1 billion investment is the first wave of funding from the $3.5 billion in the Bipartisan Infrastructure Law to help clean up polluted Superfund sites in communities. The backlog of previously unfunded sites that will now be receiving funding are in 24 states and territories and all ten EPA regions, including some communities that have been waiting for cleanup for more than four years.

EPA Publishes Proposed RFS Annual Rules: On December 21, 2021, EPA published a proposed rule that would modify the 2021 and 2022 statutory volume targets for cellulosic biofuel, advanced biofuel, and total renewable fuel, as well as to establish the 2022 volume target for biomass-based diesel. 86 Fed. Reg. 72436. The proposed rule would also modify the previously established cellulosic biofuel, advanced biofuel, and total renewable fuel volume requirements for 2020. In addition, EPA proposes the 2020, 2021, and 2022 renewable fuel standards for all four of the above biofuel categories. Finally, EPA also proposes to address the remand of the 2016 standard-setting rulemaking, as well as several regulatory changes to the Renewable Fuel Standard (RFS) program, including regulations for the use of biointermediates to produce qualifying renewable fuel, flexibilities for regulated parties, and clarifications of existing regulations. Comments are due February 4, 2022.

EPA Establishes Nationwide Monitoring For 29 PFAS And Lithium In Drinking Water: On December 27, 2021, EPA published the final Fifth Unregulated Contaminant Monitoring Rule (UCMR 5), which will establish nationwide monitoring for 29 PFAS and lithium in drinking water. 86 Fed. Reg. 73131. Subject to the availability of appropriations, EPA will include all systems serving 3,300 or more people and a representative sample of 800 systems serving 25 to 3,299 people. If EPA does not receive the appropriations needed, it will reduce the number of systems serving 25 to 10,000 people that will be asked to perform monitoring. According to EPA’s December 20, 2021, press release, UCMR 5 will collect new data needed to improve its understanding of the frequency and magnitude at which PFAS are found in drinking water systems. Additionally, expanded monitoring in UCMR 5 will improve EPA’s ability to conduct state and regional assessments of contamination, enabling analyses of potential EJ impacts on disadvantaged communities. These data will also serve as a potential source of information for systems with infrastructure funding needs for emerging contaminant remediation. EPA will hold multiple webinar meetings for stakeholders in 2022. EPA will post dates and times of the upcoming meetings on its website. The final rule will be effective January 26, 2022.

EPA Proposes Amendments To PCE Dry Cleaning NESHAP: On December 27, 2021, EPA proposed amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for dry cleaning facilities using perchloroethylene (PCE) as the cleaning solvent (PCE Dry Cleaning NESHAP). 86 Fed. Reg. 73207. EPA states that the proposed amendments address the results of the technology review for the PCE Dry Cleaning NESHAP, in accordance with Section 112 of the Clean Air Act (CAA). Based on the findings of the technology review, EPA proposes to add provisions to the rule that will require all dry-to-dry machines at existing major and area sources to have both refrigerated condensers and carbon adsorbers as secondary controls. Comments are due February 10, 2022.

EPA Will Hold Workshop On Biofuel GHG Modeling: On December 28, 2021, EPA announced that it will hold a virtual workshop on February 28-March 1, 2022, on biofuel greenhouse gas (GHG) modeling. 86 Fed. Reg. 73756. The purpose of the public workshop is to solicit information on the current scientific understanding of GHG modeling of land-based biofuels used in the transportation sector. EPA states that the workshop seeks to solicit information on the current scientific understanding of GHG modeling of land-based biofuels and how this information can be applied to a range of current and future actions. EPA is explicitly seeking comment on the following questions: (1) what sources of data exist and how can they be used to inform the assumptions that drive GHG estimates; (2) how best to characterize the sources of uncertainty associated with quantifying the GHG emissions associated with biofuels; and (3) what model(s) are available to evaluate the lifecycle GHG emissions of land-based biofuels, and do the model(s) meet the CAA requirements for quantifying the direct and significant indirect emissions from biofuels. Comments are due April 1, 2022.

EPA Will Not Use Negotiated Rulemaking Procedures To Address Petitions Under The AIM Act: On December 29, 2021, EPA announced that it considered the negotiated rulemaking procedure provided for under the Negotiated Rulemaking Act of 1990, and that it decided not to use these procedures for a rulemaking under Subsection (i) of the American Innovation and Manufacturing (AIM) Act of 2020 that will address ten petitions that were granted and one petition that was partially granted by EPA on October 7, 2021. 86 Fed. Reg. 74080. EPA states that for these eleven petitions, it does not think the negotiated rulemaking procedure for identifying, nominating, and taking comment on a relatively limited group of interested parties would be beneficial to reaching consensus given the potential breadth and scope of the rule or rules associated with the eleven petitions. According to EPA, it would be able to reach a broader audience through other means than it would using the negotiated rulemaking procedure. Petitions referenced in this notice were granted by the Administrator via letters signed on October 7, 2021; thus, EPA is required by statute to promulgate a final rule or rules by October 7, 2023.

EPA Revises Light-Duty Vehicle GHG Standards For 2023 And Later Model Years: On December 30, 2021, EPA issued a final rule revising the GHG emissions standards under CAA Section 202(a) for light-duty vehicles for 2023 and later model years to make the standards more stringent. 86 Fed. Reg. 74434. On January 20, 2021, President Biden issued Executive Order 13990 “Protecting Public Health and the Environment and Restoring Science To Tackle the Climate Crisis” directing EPA to consider whether to propose suspending, revising, or rescinding the standards previously revised under “The Safer Affordable Fuel-Efficient (SAFE) Vehicles Rule for Model Years 2021-2026 Passenger Cars and Light Trucks,” promulgated in April 2020. EPA states that it is revising the GHG standards to be more stringent than the SAFE Vehicles Rule standards in each model year from 2023 through 2026. EPA is also including temporary targeted flexibilities to address the lead time of the final standards and to incentivize the production of vehicles with zero and near-zero emissions technology. In addition, EPA is making technical amendments to clarify and streamline the regulations. The final rule will be effective on February 28, 2022.

EPA Releases Draft EJ Action Plan For Land Protection And Cleanup Programs: On January 5, 2022, EPA announced that it released a draft “EJ Action Plan: Building Up Environmental Justice in EPA’s Land Protection and Cleanup Programs” that highlights projects, tools, and practices to be applied to its Office of Land and Emergency Management (OLEM) programs. These programs include Superfund, Brownfields, Emergency Response, Solid Waste Management and Corrective Action, and Underground Storage Tanks. The draft action plan includes four main goals to be carried out in EPA’s land protection and cleanup programs:

• Strengthening compliance with cornerstone environmental statutes and civil rights laws: This includes developing a “Good Governance” process and referral list to help address follow-up actions on communities’ environmental concerns;
• Incorporating EJ considerations during the regulatory development process: This includes assessing impacts to pollution-burdened, underserved, and tribal communities when developing OLEM regulations, while developing tools to identify, track, and consider the implications of potential EJ-related factors throughout the Superfund process;
• Improving community engagement in rulemakings, permitting decisions, and policies: This includes providing earlier and more frequent engagement with pollution-burdened and underserved communities in carrying out OLEM programs, and increasing technical support and risk communication resources for communities through EPA’s Technical Assistance Services for Communities (TASC) program and various grants; and
• Implementing President Biden’s Justice40 Initiative: This includes providing direct and indirect benefits to underserved communities with grant application resources and in making grant award decisions, to the extent allowed by law.

According to the announcement, EPA will provide opportunities for “meaningful public input” at several upcoming virtual and in-person engagement events in 2022.

EPA Adds 1-BP To CAA Section 112 List Of HAPs: On January 5, 2022, EPA amended the list of hazardous air pollutants (HAP) under the CAA to add 1-bromopropane (1-BP) in response to public petitions previously granted by EPA. 87 Fed. Reg. 393. EPA states that once added to the HAP list, 1-BP will become subject to regulation under CAA Section 112 (“EPA has a clear statutory obligation under the statute to set emission standards for each listed HAP.” National Lime Association v. EPA, 233 F.3d 625, 634 (D.C. Cir. 2000)). EPA notes that there is no specific period for promulgating standards for newly listed HAPs under CAA Section 112(b)(1). The final rule will be effective on February 4, 2022.

EPA Proposes New Emissions Standards For Primary Copper Smelters: On January 11, 2022, EPA published the results of its residual risk and technology review (RTR) for the NESHAP for major source Primary Copper Smelters as required under the CAA. 87 Fed. Reg. 1616. EPA also presented the results of its technology review for the Primary Copper Smelting area source NESHAP. EPA proposes new emissions standards in the major source NESHAP. EPA also proposes to remove exemptions for periods of startup, shutdown, and malfunction (SSM) and specify that the emission standards apply at all times and require electronic reporting of performance test results and notification of compliance reports. Comments are due February 25, 2022.

EPA Announces Steps Intended To Protect Groundwater From Coal Ash Contamination: On January 11, 2022, EPA announced that it will take several actions “to protect communities and hold facilities accountable for controlling and cleaning up the contamination created by decades of coal ash disposal.” EPA states that coal combustion residuals (CCR or coal ash), a byproduct of burning coal in coal-fired power plants, contain contaminants like mercury, cadmium, and arsenic that without proper management can pollute waterways, groundwater, drinking water, and the air. EPA’s actions include proposing decisions on requests for extensions to the current deadline for initiating closure of unlined CCR surface impoundments; putting several facilities on notice regarding their obligations to comply with CCR regulations; and laying out plans for future regulatory actions to ensure coal ash impoundments meet strong environmental and safety standards. According to EPA’s web page on its review of the submitted demonstrations, EPA will take public comment on the cease receipt of waste date for four facilities whose applications were determined to be incomplete; the proposed cease receipt of waste date for an ineligible demonstration; and four demonstrations that EPA deemed complete, including a proposed conditional approval and three proposed denials. Comments are due February 23, 2022. Moving forward, EPA states that it will improve the current rules by issuing a final federal permitting program for the disposal of coal ash and establishing regulations for legacy coal ash surface impoundments. EPA will also continue its review of state-level CCR program applications to ensure they are as protective as federal regulations.

FDA Posts Transcripts Of New Era Of Smarter Food Safety Summit On E-Commerce: On December 15, 2021, the U.S. Food and Drug Administration (FDA) posted the transcripts for the E-Commerce Summit on Ensuring the Safety of Foods Ordered Online and Delivered Directly to Consumers. The summit took place virtually on October 19 -21, 2021, and was “designed to help the agency improve its understanding of how human and animal foods are sold through Business to Consumer (or B2C for short) e-commerce models across the U.S. and globally.”

FDA Confirms Color Additive Effective Dates: On December 29, 2021, FDA confirmed that the effective date of the final rule published for the color additive butterfly pea flower extract is October 5, 2021. 86 Fed. Reg. 73969. The amendment to the color additive regulations in 21 C.F.R. Section 73.69 provides for the safe use of this additive in various food categories. FDA separately confirmed that the effective date of the final rule published for the color silver nitrate is November 8, 2021. 86 Fed. Reg. 73969. The amendment to the color additive regulations in 21 C.F.R. Section 73.2550 provides for the safe use of silver nitrate as a color additive in professional-use only cosmetics to color eyebrows and eyelashes.

FDA Publishes Public Dashboard Tool: On January 5, 2022, FDA published a new interactive public data dashboard that displays information collected for the Reportable Food Registry (RFR) program. The tool displays a variety of graphs, charts, and other interactive media that enables users to understand quickly complex food safety information.

FDA Announces Public Meeting: On January 7, 2022, FDA announced a public meeting to discuss the proposed Food Safety Modernization Act (FSMA) rule changes for “Standards for the Growing, Harvesting, Packing, and Holding of Product for Human Consumption Relating to Agricultural Water.” 87 Fed. Reg. 913. The public meeting will be held February 14, 2022, from 11:45 a.m. - 7:45 p.m. (EST) and February 25, 2022, from 8:45 a.m. - 4:45 p.m. (EST). Comments on the proposed rule are due by April 5, 2022. FDA issued the original rule in 2015. The proposed rule modifies the approach for determination of minimum safety standards to allow more flexibility on various approaches.

EC Denies Authorization Of Titanium Dioxide (E171) As A Feed Additive For All Animal Species, Requires Products Be Withdrawn From The Market In 2022: On November 30, 2021, The European Commission (EC) published a regulation in the Official Journal of the European Union that denies the authorization of titanium dioxide (E171) as an additive in animal nutrition, in the additive category “sensory additives,” and in the functional group “colourants: substances that add or restore colour in feedingstuffs.” Under the regulation, existing stocks of the additive must be withdrawn from the market by March 20, 2022. Feed materials and compound feed produced with the additive or premixtures containing it before March 20, 2022, must be withdrawn from the market by June 20, 2022. More information is available in our December 17, 2021, blog item.

Canada Will Publish Draft Framework For Risk Assessment Of Manufactured Nanomaterials For 60-Day Comment Period: On December 17, 2021, Canada published the Chemicals Management Plan implementation table for 2021-2024. The deliverables include:

• Publish a draft Framework for the Risk Assessment of Manufactured Nanomaterials for a 60-day public comment period. According to the implementation table, the framework is targeted for publication in the fourth quarter;
• Continue gathering information on nanoscale substances on the Domestic Substances List (DSL), including by publishing a new survey for nanoscale substances under Section 71 of the Canadian Environmental Protection Act, 1999 (CEPA) (expected in 2023); and
• Continue to conduct assessments, including for titanium dioxide and zinc oxide, between 2021 and 2024.

More information is available in our December 22, 2021, blog item.

EUON Publishes Nanopinion On The Completion Of The Active Phase Of ACEnano: On December 21, 2021, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “ACEnano: Goodbye, Hello” by Dr. Eugenia Valsami-Jones about Project ACEnano, a Horizon2020 project that recently completed its 4.5-year course. The project’s main goal was to strengthen clarity into nanomaterial risk assessment using a tiered approach to the physicochemical characterization of nanomaterials. More information is available in our December 27, 2021, blog item.

SweNanoSafe Publishes Executive Summary For Report On Safe And Sustainable Nanotechnology Innovation: On December 22, 2021, the Swedish National Platform for Nanosafety (SweNanoSafe) announced the availability of the executive summary for a report entitled “Toward Safe and Sustainable Nanotechnology Innovation.” SweNanoSafe and researchers from the Action Research Center for a Resilient Society, Sari Scheinberg and Sverker Alänge, commissioned a study to contribute to knowledge and understanding, to create new ways of meeting, and to gather information on how stakeholders work with nano innovation and nanosafety today. More information is available in our January 5, 2022, blog item.

German Agencies Publish Joint Perspective On Risk Governance Of Advanced Materials: In December 2021, the German Environment Agency (UBA) published a document entitled Risk Governance of Advanced Materials: Considerations from the joint perspective of the German Higher Federal Authorities BAuA, BfR and UBA. The document summarizes the current activities, considerations, and recommendations of UBA, the German Federal Institute for Risk Assessment (BfR), and the Federal Institute for Occupational Safety and Health (BAuA) aiming to establish good governance of advanced materials to ensure their responsible development, use, and recycling considering human and environmental safety. More information is available in our January 12, 2022, blog item.

EC Adopts Ban On Use Of Titanium Dioxide (E171) As A Food Additive: The EC announced on January 14, 2022, that it adopted a ban on the use of titanium dioxide (E171) as a food additive. The ban will apply after a six-month transition period, and beginning summer 2022, this additive should no longer be added to food products. According to the EC, titanium dioxide “is used to impart white colour to many foods, from baked goods and sandwich spreads to soups, sauces, salad dressing and food supplements.” More information is available in the EC’s questions and answers (Q&A).

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 http://blog.braginfo.org.

Legislation Would Exempt Ethylene From New Superfund Excise Taxes: On December 14, 2021, Representatives John Moolenaar (R-MI) and Dan Meuser (R-PA) introduced the Ethylene is Essential for Chemistry and Manufacturing Act (H.R. 6277). The bill would exclude ethylene from taxation under the Superfund excise tax.

Krishnamoorthi Requests FDA Provide Information About Its Regulation Of Phthalates: On January 10, 2022, Representative Raja Krishnamoorthi (D-IL), Chair of the Oversight Subcommittee on Economic and Consumer Policy, sent a letter to FDA requesting information about its regulation of phthalates, “dangerous chemicals commonly found in food packaging and processing materials.” The House Oversight Committee’s press release notes that Congress and federal agencies have taken steps to address the use of phthalates in common goods, but states that “more must be done to eliminate the risk to children and families.” According to the press release, FDA regulations allow 28 different phthalates to be used in food packaging and processing materials, even though eight phthalates are banned at concentrations of more than 0.1 percent in children’s toys and child care articles, and EPA recently designated five phthalates as high-priority substances for risk evaluation. Krishnamoorthi requested that FDA provide information about the steps it has taken to evaluate the dangers posed by phthalates and its efforts to ban phthalates from use in food packaging and processing materials.

House Subcommittee Holds Hearing On Administration Priorities For New Water Resources Development Act For 2022: On January 12, 2022, the House Transportation and Infrastructure Subcommittee on Water Resources and Environment held a hearing on “Proposals for a Water Resources Development Act of 2022: Administration Priorities.” During the hearing, members heard testimony from the U.S. Army Corps of Engineers on the Administration’s priorities for a new water resources development act for 2022. The hearing also provided members with an opportunity to review the 2021 Report to Congress on Future Water Resources Development and several reports of the Chief of Engineers on individual water resources projects that have been submitted to Congress for authorization. The Committee expects to develop and approve a new water resources development act in 2022.

Senate Committee Advances Frey’s Nomination To Be EPA ORD Assistant Administrator: On January 12, 2022, the Senate Committee on Environment and Public Works advanced President Biden’s nomination of Dr. Christopher Frey to be Assistant Administrator for EPA’s Office of Research and Development (ORD). Frey is currently the Deputy Assistant Administrator for Science Policy in ORD as an appointee of the Biden-Harris Administration. According to the White House announcement on Frey’s nomination, at EPA, Frey “is a champion of scientific integrity and the role of science to inform decision-making,” leading scientific and technical research on Administration priorities, including climate change, EJ, PFAS, and lead, as well as promoting the advancement of innovative scientific methods and approaches. The nomination will now head to the full Senate for consideration.

ATSDR Invites Comment On Saint-Gobain PFAS Report: On December 15, 2021, the Agency for Toxic Substances and Disease Registry (ATSDR) announced that it will accept comments on its health consultation report, Evaluation of Per- and Polyfluoroalkyl Substances (PFAS) in Private Wells near the Saint-Gobain Performance Plastics Site in Southern New Hampshire. The health consultation evaluated the public health effects of exposure to PFAS in private drinking water wells near the Saint-Gobain Performance Plastics facility in Merrimack, New Hampshire. Comments are due March 1, 2021.

ITA Solicits Nominations For Membership On Advisory Committee On Supply Chain Competitiveness: On December 16, 2021, The Department of Commerce (DOC) International Trade Administration (ITA) announced that it seeks nominations for immediate consideration to fill positions on the Advisory Committee on Supply Chain Competitiveness. 86 Fed. Reg. 71420. DOC intends for the Committee to play a key role in formulating recommendations to address current global supply chain challenges, including identifying key bottlenecks in supply chains and actionable solutions to address them, advising on the latest advances in supply chain management technology and how to apply them to the current challenges in the economy, and developing long-term recommendations to make supply chains more resilient. DOC seeks members who “bring a track record of effective senior executive leadership on issues impacting the U.S. and global supply chains.” ITA will accept nominations on a rolling basis for membership for the two-year charter term that began on November 10, 2021, and will expire on November 9, 2023. Immediate consideration will be given to applications that were received by December 29, 2021. ITA will accept nominations on an on-going basis during the charter term to fill vacancies as they arise.

NTP Publishes 15th RoC: On December 21, 2021, the National Toxicology Program (NTP) released the 15th Report on Carcinogens (RoC), which includes eight newly reviewed substances, bringing the total list to 256 substances that are known, or reasonably anticipated, to cause cancer in humans. The National Institute of Environmental Health Sciences press release states that in the new RoC, chronic infection with the bacterium Helicobacter pylori (H. pylori) is listed as known to be a human carcinogen. The flame-retardant chemical antimony trioxide, and six haloacetic acids (HAA) found as water disinfection byproducts are listed as reasonably anticipated to be human carcinogens. NTP notes that the RoC does not include estimates of cancer risk because many factors affect whether a person will or will not develop cancer. Those include the carcinogenic potency of the substance, the level and duration of exposure, and an individual’s susceptibility to the carcinogenic action of the substance.

OEHAA Adds PFOS And Its Salts And Transformation And Degradation Precursors And PFNA And Its Salts To Prop 65: On December 22, 2021, the California Office of Environmental Health Hazard Assessment (OEHHA) announced that effective December 24, 2021, it would add perfluorooctane sulfonic acid (PFOS) and its salts and transformation and degradation precursors to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop 65). According to OEHHA, the Carcinogen Identification Committee (CIC), in its official capacity as the “state’s qualified experts,” determined that PFOS and its salts and transformation and degradation precursors were clearly shown to cause cancer. The warning requirement for significant exposures to this chemical will take effect on December 24, 2022.

On December 29, 2021, OEHHA announced that effective December 31, 2021, it would add perfluorononanoic acid (PFNA) and its salts to the list of chemicals known to the state to cause reproductive toxicity (male endpoint) for purposes of Prop 65. OEHHA states that the Developmental and Reproductive Toxicant Identification Committee (DARTIC), in its official capacity as the “state’s qualified experts,” determined that PFNA and its salts were clearly shown to cause reproductive toxicity based on the male endpoint. The warning requirement for significant exposures will take effect on December 31, 2022.

New York Governor Signs Legislation To Regulate Chemicals In Upholstered Furniture, Mattresses, And Electronic Enclosures: On January 2, 2022, New York Governor Kathy Hochul (D) announced the signing of legislation (S.4630-B/A.5418-B) that will prohibit the sale of furniture, mattresses, and electronic displays containing certain flame retardant chemicals linked to “significantly elevated risks of neurological injury, hormone disruption, and cancer.” According to the press release, the bill will regulate chemicals in upholstered furniture, mattresses, and electronic enclosures. It helps to define terms such as halogenated chemical, organophosphorus chemical, and organonitrogen chemical. It prohibits the sale of any furniture that contains identified flame retardant chemicals and establishes a fine of up to $2,500 per day for repeated offenses.

OSTP Releases Report From Scientific Integrity Task Force On Protecting Integrity Of Government Science: On January 11, 2022, the White House Office of Science and Technology Policy (OSTP) released the report of its Scientific Integrity Task Force on protecting the integrity of government science. According to OSTP, the scientific integrity principles and best practices identified in the report “aim to ensure that science is conducted, managed, communicated, and used in ways that preserve its accuracy and objectivity and protect it from suppression, manipulation, and inappropriate influence -- including political interference.” To not only restore, but to strengthen the integrity of federal science beyond the efforts of any previous Administration, the Task Force makes recommendations to guide policymaking and foster a culture of scientific integrity in federal agencies. OSTP states that in the coming months, it will draw upon the findings of the Task Force to develop a plan for the regular assessment and iterative improvement of scientific integrity policies and practices. In addition, agency leadership, working closely with OSTP, will deploy this framework to ensure that their scientific integrity policies are informed by the Task Force report and adhere to scientific integrity principles. More information is available in our January 13, 2022, blog item.

Supreme Court Grants Applications To Stay OSHA’s Vaccine Mandate: The Supreme Court published a decision on January 13, 2022, granting applications for emergency relief and staying the Occupational Safety and Health Administration’s November 5, 2021, COVID-19 vaccination and testing emergency temporary standard (ETS). NFIB v. OSHA (No. 21A244). The ETS applies to employees working for employers with 100 or more employees. Covered employers must “develop, implement, and enforce a mandatory COVID-19 vaccination policy,” and employers must verify the vaccination status of each employee and maintain proof of it. A number of challenges were filed in the federal appellate courts. The Fifth Circuit stayed OSHA’s rule pending further judicial review before the cases were consolidated. After the cases were consolidated in the Sixth Circuit, a three-judge panel dissolved the stay. Various parties filed applications to the Supreme Court requesting that the ETS be stayed. The Court consolidated applications from the National Federal of Independent Business (NFIB) and one from a coalition of states and heard expedited argument on January 7, 2022. The Court disagrees with the Sixth Circuit’s conclusion that a stay was not justified. The Court states that applicants are likely to succeed on the merits of their claim that the Secretary lacked authority to impose the mandate. The Court granted the applications for stays, and the ETS is stayed pending disposition of the applicants’ petitions for review in the Sixth Circuit and disposition of the applicants’ petitions for writs of certiorari, if such writs are timely sought. The Court states that should the petitions for writs of certiorari be denied, its order will terminate automatically. In the event the petitions for writs of certiorari are granted, the order will terminate upon the sending down of the judgment of the Court.

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