Federal Development Update for November 2022


WEBINAR – Registration Is Open For “Articles under TSCA”: Register now to join Richard E. Engler, Ph.D., Eve Gartner, and Lynn L. Bergeson for the Bergeson & Campbell, P.C. (B&C®) webinar “Articles under TSCA.” When the Toxic Substances Control Act (TSCA) was enacted in 1976, the U.S. Environmental Protection Agency (EPA) focused its attention on chemical substances and chemical mixtures, while largely exempting the regulation of chemicals in “articles,” generally meaning finished products or manufactured goods. EPA’s more recent announcement of its intent to regulate chemicals in articles to a much greater extent has caught many in the regulated industries off guard and reflects a significant shift in U.S. chemical regulation policy. This change in policy affects all commercial entities that deal with a physical product, as they must now become familiar with the law, its requirements, and the chemical makeup of their finished goods. This webinar will cover the policy changes that led to the regulation of articles, EPA’s authority to regulate these articles, and what companies need to know to stay in compliance.

WEBINAR -- Recording Available For “Food Safety Issues in the United States”: B&C’s October 26, 2022, webinar “Food Safety Issues in the United States” is now available for on-demand viewing at https://attendee.gotowebinar.com/recording/8196944274166221318. During this one-hour webinar, Thomas J. Dunn, Karin F. Baron, and Lynn L. Bergeson review the seven major rules of the Food Safety Modernization Act (FSMA), discuss food safety over the past decade, and explore what the New Era of Smarter Food Safety means for businesses.

ARTICLE -- Lynn L. Bergeson Authors “Toxics Regulation: A Brave New World Catching Many Off Guard,” For PLI Current: Given the passage of time since TSCA was enacted in 1976, the public’s growing awareness of the potential for exposure from chemicals in “articles,” or finished goods, during use, and greater focus on the implications of end-of-life product disposal, EPA regulation of articles under TSCA has shifted significantly. Historically, EPA elected not to regulate articles for the most part. EPA’s more recent announcement of its intent to regulate chemicals in articles to a much greater extent has caught many off guard and reflects a significant shift in U.S. chemical regulation policy. Read more.

PODCAST -- Keeping Up With CLP Changes — A Conversation With Karin F. Baron: Lynn L. Bergeson and Karin F. Baron discuss the controversial changes proposed by the European Commission (EC) to the regulation on classification, labeling, and packaging (CLP) of substances and mixtures, better known as the CLP regulation. Karin explains why the proposed changes are likely to inject even greater dis-harmonization in the area of the global harmonization of packaging and labeling at a time when global commerce can least afford it. Listen now.

PODCAST -- Biotech’s Emergence In The EU And Globally — A Conversation With Dr. Claire Skentelbery: Lynn L. Bergeson and Claire Skentelbery, Ph.D., Director General, EuropaBio -- The European Association for Bioindustries, discuss evolving perceptions of biotechnology in the European Union (EU), how biotechnology is advancing the EU’s commitment to sustainability and circularity, and what’s next for biotech advocacy in the EU. Listen now.

TSCA/FIFRA/TRI

CSB Recommends EPA Initiate Prioritization Under TSCA To Evaluate Whether Hydrofluoric Acid Is A High-Priority Substance: On October 11, 2022, the U.S. Chemical Safety Board (CSB) released its final investigative report into “a massive fire and explosions” at the Philadelphia Energy Solutions Refinery in Philadelphia, Pennsylvania, that occurred in June 2019. According to CSB, the incident occurred when a corroded pipe elbow ruptured, releasing process fluid into the refinery’s hydrofluoric acid (HF) alkylation unit. In its final report, CSB notes that EPA has not yet prioritized HF or performed a risk evaluation of HF under TSCA, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). According to CSB, HF “is one of the eight most hazardous chemicals regulated by the EPA Risk Management Program (RMP).” CSB states that it concludes that EPA should initiate prioritization to evaluate whether HF is a high-priority substance for risk evaluation under TSCA. If HF is determined to be a high-priority substance, EPA should conduct a risk evaluation of HF and implement any identified corrective actions, as required by TSCA. CSB “recommends to EPA to take such action.” A detailed commentary is available in our October 14, 2022, blog item.

Petition Seeks Revocation Of Approximately 600 PFAS LVEs And LoREXs: On October 13, 2022, Earthjustice, on behalf of a coalition of environmental organizations and community advocates, petitioned EPA to revoke the approval of approximately 600 per- and polyfluoroalkyl substances (PFAS) that were granted through low volume exemptions (LVE) or low release and low exposure exemptions (LoREX) to the TSCA premanufacture notice (PMN) requirements. In its October 13, 2022, press release, Earthjustice states that these exemptions “allow EPA to approve chemicals through lax safety reviews only if it ‘will not present an unreasonable risk’ to humans or the environment.” According to Earthjustice, PFAS do not meet that standard, and EPA must revoke previously granted LVEs and LoREXs for PFAS. More information is available in our October 17, 2022, blog item.

EPA Holds Second Webinar For TSCA New Chemical Engineering Outreach Initiative: On October 18, 2022, EPA’s New Chemicals Program held a webinar on EPA’s process for assessing the potential risks of new chemicals under Section 5 of TSCA and the types of data EPA considers in this assessment. Specifically, the webinar covered examples of data (quantitative and qualitative) that are not likely to be accepted for engineering assessment, considerations EPA makes when evaluating data, and clarifications of common misconceptions in EPA’s new chemical assessments. The webinar was the second in a series of webinars intended to increase the efficiency and transparency of EPA’s new chemical determinations. EPA will hold a third webinar to communicate additional information intended to help submitters of new chemicals supplement complete initial review submissions. EPA will post information on the third webinar as it becomes available. In July 2022, EPA hosted the first webinar, analyzing common issues that cause EPA to have to rework risk assessments. More information on the first webinar is available in our July 28, 2022, memorandum. The slides for the second webinar are available online. For more information on the webinar and our Commentary, please read our October 25, 2022, memorandum.

EPA Announces The Release Of Its Updated Lists Of Disinfectants For Emerging Viral Pathogens, Including Ebola: On October 19, 2022, EPA announced that it activated its emerging viral pathogen (EVP) guidance in support of the Centers for Disease Control and Prevention’s (CDC) response to the Ebola virus cases in western Uganda. With EPA’s EVP guidance, additional disinfectants, for which EVP claims have been approved, can be used against the Ebola virus. More information is available in our October 21, 2022, blog.

EPA Issues Final Rule Regarding Parent Company Definition For TRI Reporting: On October 21, 2022, EPA published a final rule to codify the definition of “parent company” for purposes of reporting to the Toxics Release Inventory (TRI) and to require the reporting of a foreign parent company when applicable. 87 Fed. Reg. 63950. The existing regulation requires facilities reporting to TRI to identify their parent company in annual reporting forms. The final rule adds a codified definition of this data element. According to EPA, among the facilities reporting to TRI are those with complicated corporate ownership structures. As such, effort is required each year by reporting facilities and EPA to clarify how the parent company data element should be represented on the form. A codified definition of parent company will allow EPA to address various corporate ownership scenarios explicitly and will reduce the reporting burden caused by regulatory uncertainty. The rule clarifies existing requirements to reporting facilities and adds a foreign parent company data element, while improving EPA’s data quality. The final rule will be effective December 20, 2022.

EPA Publishes Receipt And Status Information For Certain New Chemicals For September 2022: On October 25, 2022, EPA published the receipt and status reports for the period from September 1, 2022, to September 30, 2022. 87 Fed. Reg. 64477. EPA states that it is providing notice of receipt of PMNs, significant new use notices (SNUN), and microbial commercial activity notices (MCAN) (including amended notices and test information); an exemption application (Biotech exemption); applications for test marketing exemptions (TME), both pending and/or concluded; notices of commencement (NOC) of manufacture (including import) for new chemical substances; 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 November 25, 2022.

EPA Releases Updated Data For 2021 TRI Reporting: On October 26, 2022, EPA announced that it published the updated 2021 TRI data about chemical releases, chemical waste management, and pollution prevention activities that took place between January 1 and December 31, 2021, at more than 20,000 federal and industrial facilities throughout the U.S. and its territories. These data were reported by facilities in certain industry sectors, including federal facilities, that manufactured, processed, or otherwise used the TRI-listed chemicals above certain quantities during 2021. The data include quantities of such chemicals that were released into the environment or otherwise managed as waste. The data also include the pollution prevention activities initiated by individual facilities during 2021. EPA states that it will publish its full analysis of the 2021 data in early 2023 in the 2021 TRI National Analysis. The analysis will examine aspects of the data, including trends in releases, waste management reporting by parent companies, and how facilities are working to reduce pollution.

EPA Held Webinar On October 27 On CompTox Communities Of Practice: Analysis Of High-Throughput Profiling Assays In Chemical Safety Screening: On October 27, 2022, EPA held a webinar in its Computational Toxicology and Exposure Communities of Practice (CompTox Communities of Practice) series on “Analysis of High-Throughput Profiling Assays in Chemical Safety Screening.” The abstract for the webinar states that recent technological advancements have led to the development of new high-throughput profiling methods, such as transcriptomics, that can be used to screen rapidly chemicals for potential hazards. Decreasing costs have made it feasible to profile all protein-coding genes across thousands of samples, allowing for broad evaluation of many target pathways and modes of action in a single screening assay. Similarly, it is now possible to apply high-content imaging across many different chemical exposures to capture a variety of changes in cell morphology. According to the abstract, such methods have been applied to in vitro chemical screening studies, including screening studies at EPA that were recently released on the CompTox Chemicals Dashboard.

EPA Proposes SNURs For Certain Chemicals: On October 31, 2022, EPA proposed significant new use rules (SNUR) under TSCA for chemical substances that were the subject of PMNs and are also subject to Orders issued by EPA pursuant to TSCA. 87 Fed. Reg. 65548. The SNURs require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is proposed as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA’s evaluation of the use, under the conditions of use for that chemical substance, within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required by that determination. Comments are due November 30, 2022.

ORD Publishes Six Strategic Research Action Plans For FYs 2023-2026, Including For Chemical Safety For Sustainability: Research in EPA’s Office of Research and Development (ORD) is organized around six highly integrated and transdisciplinary national research programs that are closely aligned with EPA’s strategic goals and cross-EPA strategies. Each program is guided by a Strategic Research Action Plan (StRAP) developed by EPA with input from its many internal and external partners and stakeholders. In October 2022, EPA published six StRAPs for fiscal years (FY) 2023-2026. EPA states that the StRAP for Chemical Safety for Sustainability (CSS) “is focused on addressing the pressing environmental and health challenge of a lack of sufficient information on chemicals needed to make informed, risk-based decisions.” The StRAP for CSS states that CSS will continue to:

  • Develop the science needed to reduce, refine, and replace vertebrate animal testing consistent with EPA policies;
     
  • Accelerate the pace of chemical assessment to enable our partners to make informed and timely decisions concerning the potential impacts of environmental chemicals on human health and the environment; and
     
  • Provide leadership to transform chemical testing, screening, prioritization, and risk assessment practices.
     

EPA Announces 2022 Safer Choice Partner Of The Year Award Winners: On November 1, 2022, EPA announced 26 Safer Choice Partner of the Year award winners, recognizing their achievements in the design, manufacture, selection, and use of products with safer chemicals. The awardees represent a wide variety of organizations, including small- and medium-sized businesses, women-owned companies, state and local governments, non-governmental organizations (NGO), and trade associations. EPA encouraged applicants for the 2022 awards to show how their work advances environmental justice, bolsters resilience to the impacts of climate change, results in cleaner air or water, or improves drinking water quality. More information is available in our November 3, 2022, blog item.

EPA Will Hold Webinar On Its Approach Reviewing Mixed Metal Oxides, Including New And Modified Cathode Active Materials: On November 4, 2022, EPA announced that it will hold the first of a two-part webinar series on November 17, 2022, on EPA’s new standardized process to assess risk and apply mitigation measures, as appropriate, for mixed metal oxides (MMO), including new and modified cathode active materials (CAM). EPA states that the kickoff webinar will provide statutory and regulatory background, including the related compliance advisory, a broad overview of the approach for risk assessment and risk management, and information on the TSCA Inventory, nomenclature, and the bona fide process for those seeking to find out if their MMOs are already on the Inventory. According to EPA, the second webinar, currently targeted for early 2023, will go into greater detail on the standardized risk assessment approach, present various case scenarios and a decision tree for identifying potential hazards and risks, and provide tips on risk calculators, tools, and models that are used for the risk assessment.

EPA Provides Report To Congress On Its Capacity To Implement Certain Provisions Of The Lautenberg Act: EPA has provided a report to Congress on its capacity to implement certain provisions of the Lautenberg Act. The report provides point-in-time estimates of EPA’s current estimated capacity and resources needed to implement the 2016 Lautenberg Act amendments to TSCA. EPA states that it recognizes its responsibility to identify and implement opportunities to reduce costs as it incorporates lessons learned since the Lautenberg Act was enacted and builds the scientific, regulatory, and other infrastructure needed to implement the program effectively. According to the report, the combination of the resources included in President Joseph Biden’s FY 2023 budget request, an amended Fees rule, and EPA’s ongoing efforts to build and improve the scientific, regulatory, and other infrastructure needed to implement TSCA more efficiently should, over time, reduce the levels of resources needed in the future. More information is available in our November 8, 2022, memorandum.

EPA Awards $7.7 Million For Research Grants To Improve Risk Assessment Of Chemical Mixtures In The Environment: EPA announced on November 9, 2022, that it awarded $7,770,044 in research grant funding to 11 institutions to develop and evaluate innovative methods and approaches to inform its understanding of the human health risks that may result from exposure to chemical mixtures in the environment. EPA states that toxicology studies have traditionally focused on the effects of single chemicals on human health. Chemicals in the environment are often present as mixtures in the air, water, soil, food, and products in commerce, however, and these chemical mixtures include PFAS, phthalates, polycyclic aromatic hydrocarbons (PAH), disinfection byproducts (DBP), and other well-characterized mixtures. According to EPA, there is a need to assess the toxicity of chemical mixtures to understand how their combined effects on human health and the environment differ from what is known about individual chemicals. More information is available in our November 10, 2022, blog item.

EPA Requests Nominations For SACC: EPA announced on November 10, 2022, that it is requesting nominations of prospective candidates for membership on the Science Advisory Committee on Chemicals (SACC) established under TSCA. 87 Fed. Reg. 67898. Any interested person or organization may nominate qualified persons to be considered for appointment to the SACC. Individuals may also self-nominate. Nominations are due December 12, 2022. According to EPA, SACC provides independent scientific advice and recommendations to EPA on the scientific basis for risk assessments, methodologies, and pollution prevention measures and approaches for chemicals regulated under TSCA. Currently, there are 17 SACC members, with eight membership terms that will expire over the next year. More information is available in our November 11, 2022, blog item.

EPA Finds Methylene Chloride, As A Whole Chemical Substance, Presents An Unreasonable Risk To Human Health: EPA announced on November 10, 2022, the availability of the final revision to the risk determination for the methylene chloride risk evaluation issued under TSCA. 87 Fed .Reg. 67901. EPA states that the revision to the methylene chloride risk determination reflects its announced policy changes to ensure the public is protected from unreasonable risks from chemicals in a way that is supported by science and the law. EPA determined that methylene chloride, as a whole chemical substance, presents an unreasonable risk of injury to health when evaluated under its conditions of use. For more information and our Commentary, please read the full memorandum.

Coalition Petitions EPA To Require Health And Environmental Testing And Regulation Of Polyvinyl Alcohol: On November 15, 2022, a coalition petitioned EPA under TSCA Section 21 to require human and environmental health and safety testing for polyvinyl alcohol (PVA/PVOH) as it is used in consumer-packaged goods, “with particular attention to the use of PVA in laundry and dishwasher detergent pods and sheets.” The petitioners request that until such testing is completed, EPA remove PVA/PVOH from its Safer Choice Program “to curb plastic pollution.” More information is available in our November 15, 2022, blog item.

RCRA/CERCLA/CWA/CAA/PHMSA/SDWA

EPA Releases 2021 Data Collected Under GHG Reporting Program: On October 17, 2022, EPA announced the release of the 2021 greenhouse gas (GHG) data collected under its Greenhouse Gas Reporting Program (GHGRP). According to EPA, there has been an overall long-term decreasing trend in industry GHG emissions since 2011, primarily driven by a decrease in emissions from power plants. In 2021, reported emissions from large industrial sources were approximately four percent higher than in 2020, reflecting an increase in economic activity following the economic slowdown and decrease in emissions due to the COVID-19 pandemic. More than 8,100 industrial facilities reported GHG emissions in 2021 to EPA. EPA states that the data show that in 2021:

  • Power plants were the largest stationary source of U.S. GHG emissions, with 1,326 facilities reporting approximately 1.6 billion metric tons of carbon dioxide emissions;
     
  • Petroleum and natural gas systems were the second largest stationary source of emissions, reporting 312 million metric tons of GHG emissions; and
     
  • Reported direct emissions from other large sources in the industrial and waste sectors were a combined 807 million metric tons of GHG emissions in 2021, up 1.8 percent from 2020, and down 7.7 percent since 2011.
     

EPA Proposes Allowance Allocation Methodology For HFC Phasedown For 2024 And Later Years: On November 3, 2022, EPA proposed to amend existing regulations to implement certain provisions of the American Innovation and Manufacturing (AIM) Act, as enacted on December 27, 2020. 87 Fed. Reg. 66372. The rulemaking proposes to establish the methodology for allocating hydrofluorocarbon (HFC) production and consumption allowances for the calendar years of 2024 through 2028. EPA also proposed to amend the consumption baseline to reflect updated data and to make other adjustments based on lessons learned from implementation of the HFC phasedown program thus far, including proposing to: codify the existing approach of how allowances must be expended for import of regulated substances; revise recordkeeping and reporting requirements; and implement other modifications to the existing regulations. Comments are due December 19, 2022. EPA states that under the Paperwork Reduction Act (PRA), “comments on the information collection provisions are best ensured of consideration if the Office of Management and Budget (OMB) receives a copy of your comments on or before December 5, 2022.”

3M Agrees To EPA Order To Sample And Provide Treatment For PFAS Contamination In Drinking Water Near Cordova, Illinois, Facility: On November 3, 2022, EPA announced that the 3M Company agreed to an EPA order to sample and provide treatment to address contamination from PFAS found in drinking water in the vicinity of 3M’s Cordova, Illinois, facility. According to EPA, recent sampling results provided by 3M indicate the “widespread presence” of a mixture of at least 19 different PFAS in drinking water within a three-mile radius of the Cordova facility. As part of the settlement, 3M is required to offer treatment to all private well owners within three miles of the facility and to the Camanche Water Supply in Iowa, in an effort to remove PFAS from the drinking water. 3M is also required to offer drinking water sampling out to four miles from the facility for private well owners and out to ten miles from the facility for public water systems, as well as to the Quad Cities’ public water systems, using EPA protocols and conducted under EPA oversight.

PHMSA Announces December 1 Meeting Of The Research, Development & Technology Forum: On November 4, 2022, the Pipeline and Hazardous Materials Safety Administration (PHMSA) announced that its Office of Hazardous Materials Safety (OHMS) will hold a public Research, Development & Technology Forum on December 1, 2022, virtually on Microsoft Teams (MS Teams). 87 Fed. Reg. 66773. OHMS will present the results of recently completed projects, brief new project plans, and obtain stakeholder input related to new research topics that may be considered for inclusion in its future work. OHMS states that it is “particularly interested” in the research gaps associated with the characterization and transportation of energetic materials (explosives), safe transportation of energy products (e.g., crude oil), safe containment and transportation of compressed gases, and safe packaging and transportation of charge storage devices (e.g., lithium ion batteries), and how these might aid in mitigation of climate change. The forum will also include an opportunity for stakeholder input that identifies other research gaps related to the transportation of hazardous materials. Pre-registration is required.

EPA Amends NESHAP For Paint Stripping And Miscellaneous Surface Coating Operations At Area Sources: On November 10, 2022, EPA published its final decisions and revisions for the paint stripping and miscellaneous surface coating operations area source categories regulated under national emission standards for hazardous air pollutants (NESHAP). 87 Fed. Reg. 67791. The final amendments also address provisions regarding electronic reporting; make miscellaneous clarifying and technical corrections; simplify the petition for exemption process; and clarify requirements for emissions during periods of startup, shutdown, and malfunction (SSM). EPA notes that it is not making any revisions to the numerical emission limits based on the technology review. The final rule was effective November 10, 2022.

EPA Will Strengthen Proposal To Reduce Methane Pollution: EPA announced on November 11, 2022, that it is strengthening its proposed standards to cut methane and other harmful air pollution. EPA states that the updates, which supplement proposed standards released in November 2021, “reflect input and feedback from a broad range of stakeholders and nearly half a million public comments.” According to EPA, the updates would provide more comprehensive requirements to reduce climate and health-harming air pollution, including from hundreds of thousands of existing oil and gas sources nationwide. EPA notes that the new proposal “also includes a ground-breaking ‘Super-Emitter Response Program’ that would require operators to respond to credible third-party reports of high-volume methane leaks.” Comments on the supplemental proposal are due February 13, 2023. EPA will host virtual trainings to provide communities, Tribes, and small businesses information about the supplemental proposal and about participating in the public comment process. Those trainings will be November 17 and 30, 2022. EPA will hold a virtual public hearing January 10 and 11, 2023. Registration for the public hearing will open after the supplemental proposal is published in the Federal Register. EPA states that it intends to issue a final rule in 2023.

Final CCL 5 Includes “Substantial Expansion” Of PFAS: On November 14, 2022, EPA published the final Fifth Contaminant Candidate List (CCL 5), a list of contaminants in drinking water that are currently not subject to any proposed or promulgated national primary drinking water regulations. 87 Fed. Reg. 68060. EPA notes that these contaminants are known or anticipated to occur in public water systems and may require regulation under the Safe Drinking Water Act (SDWA). CCL 5 includes 66 chemicals, three chemical groups (cyanotoxins, disinfection byproducts, and PFAS), and 12 microbial contaminants. According to EPA’s November 2, 2022, press release, CCL 5 includes a “substantial expansion” of PFAS, “an important first step towards identifying additional PFAS that may require regulation” under the SDWA. In developing the final CCL 5, EPA requested public nominations, providing an opportunity for stakeholders to recommend specific contaminants of concern that may disproportionally affect their local community. EPA states that it further enhanced the CCL process based on comments received on this CCL and previous CCLs, including by prioritizing data most relevant to drinking water exposure, improving considerations of sensitive populations including children, and considering the recommendations included in the Science Advisory Board’s review of the draft CCL 5.

FDA

FDA Seeks Comment On Convening Generally Recognized As Safe (GRAS) Panels: On October 27, 2022, the U.S. Food and Drug Administration (FDA) announced a proposed collection of information related to “Substances Generally Recognized as Safe: Best Practices for Convening a Generally Recognized as Safe Panel.” 87 Fed. Reg. 65081. FDA provides estimates -- in terms of number of recordkeepers, number of records, and average burden per recordkeeping -- associated with various aspects of convening GRAS panels. FDA is accepting written comments by November 28, 2022.

FDA Announces Availability Of Recording Of Food Safety Culture Webinar: On October 31, 2022, FDA announced that a webinar recording called “Rewards and Recognition Programs,” recorded by FDA with the non-profit public health organization Stop Foodborne Illness, is available. The recording is available at the link here.

FDA Announces Effective Date For FSMA Rules: On October 31, 2022, FDA announced that the effective date for the requirements related to establishing and implementing supply-chain programs, records documenting supply-chain programs, and onsite audits in two final rules, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals, is October 31, 2022. 87 Fed. Reg. 65527.

FDA Proposes Fee Increase For Color Certification Program: On November 2, 2022, FDA announced a proposed rule to amend the color additive regulation to increase the fee for certification services. 87 Fed. Reg. 66116. The fees for straight colors, including lakes, would be $0.45 per pound ($0.10 per pound increase) with a minimum fee of $288. There would be similar increases in fees for repacks of certified color additives and color additive mixtures. FDA is seeking comments by January 3, 2023.

FDA Provides Update On FSMA Food Traceability Final Rule: On November 7, 2022, FDA provided an update confirming that the FSMA final rule titled “Requirements for Additional Traceability Records for Certain Foods” was sent to the Office of the Federal Register (OFR). Publication is expected in November 2022.

GAO Report States FDA Oversight Of Substances Used In Manufacturing, Packaging, And Transporting Food Could Be Strengthened: The U.S. Government Accountability Office (GAO) published a report on November 8, 2022, entitled FDA Oversight of Substances Used in Manufacturing, Packaging, and Transporting Food Could Be Strengthened. GAO states that since 2000, FDA has helped to stop the use of three types of unsafe substances, such as some PFAS that are used to greaseproof food packages. GAO notes that FDA faces two limitations that impede a risk-informed, postmarket review process for food contact substances, however:

  • FDA does not have specific legal authority to compel companies to provide information and data on substances’ safety and extent of use; and
     
  • FDA staff can search the agency's information system for each food contact substance and find the date of the last premarket review. FDA’s system cannot readily identify all substances that, according to their last review dates, may warrant additional review because new safety information may have emerged, however.
     

GAO made two recommendations to FDA: request from Congress specific legal authority to compel companies to provide the information needed to reassess the safety of substances; and track the dates of the last reviews for all food contact substances to allow FDA to identify readily substances that may warrant postmarket review. According to GAO, FDA neither agreed nor disagreed with the first recommendation and agreed with the second recommendation.

NANOTECHNOLOGY

NanoHarmony And NANOMET Publish Status Report On Development Or Revisions To OECD Test Guidelines And Guidance Documents Applicable To Nanomaterials: NanoHarmony and NANOMET have published a status report summarizing the current status of projects aiming to develop or adapt Organization for Economic Cooperation and Development (OECD) Test Guidelines (TG) and Guidance Documents (GD) for nanomaterials, as well as the outlook for each project as of July 2022. Apart from the projects supported by the OECD Working Group of National Co-ordinators of the TGs program (WNT) or OECD Working Party on Manufactured Nanomaterials (WPMN), an additional number of standardization activities are presented that develop test methodologies for which the initiators foresee an OECD project status in the near future.

EPA Proposes SNUR For Four Multi-Walled Carbon Nanotubes: On October 31, 2022, EPA proposed SNURs under TSCA for a number of chemical substances that were the subject of PMNs and are also subject to Orders issued by EPA pursuant to TSCA. 87 Fed. Reg. 65548. The proposed SNURs include four chemical substances identified as:

  • Multi-walled carbon nanotubes (MWCNT); closed; 4.4-12.8 nanometer (nm) diameter; bundle length 10.6-211.1 micrometer (µm); Grade: Jenotube 6 (PMN P-20-62);
     
  • MWCNTs; closed; 5.1-11.6 nm diameter; bundle length 1.9-552.0 µm; Grade: Jenotube 8 (PMN P-20-63);
     
  • MWCNTs; closed; 7.9-14.2 nm diameter; bundle length 9.4-106.4 µm; Grade: Jenotube 10 (PMN P-20-64); and
     
  • MWCNTs; closed; 17.0-34.7 nm diameter; globular shape; Grade: Jenotube 20 (PMN P-20-65).
     

To protect against identified risks, the Order requires:

  • No domestic manufacture (e., import only);
     
  • No processing or use of the PMN substances in an application method that generates a vapor, mist, dust, or aerosol unless such application method occurs in an enclosed process;
     
  • Use of personal protective equipment where there is a potential for dermal exposure;
     
  • Use of a National Institute for Occupational Safety and Health (NIOSH)-certified respirator with an assigned protection factor (APF) of at least 50 where there is a potential for inhalation exposure;
     
  • No manufacture of the PMN substances with a maximum weight percent of cobalt oxide impurity in exceedance of 2.1%;
     
  • Process and use of the PMN substances only as electrically conductive materials; heat dissipation materials; heat generation materials; additives for weight reduction; additives to improve physical or mechanical properties; additives in batteries, energy storage, and electrode applications; or as additives in field emission applications;
     
  • Establishment of a hazard communication program, including human health precautionary statements on each label and on the safety data sheet (SDS); and
     
  • No release of the PMN substances, or any waste stream containing the PMN substances, into water.
     

The proposed SNURs would designate as a “significant new use” the absence of these protective measures. Comments are due November 30, 2022. More information is available in our October 31, 2022, blog item.

EPA Holds Webinar On November 1 On Research Funding Opportunity To Develop And Demonstrate Nanosensor Technology To Detect, Monitor, And Degrade Pollutants: On November 1, 2022, EPA held a webinar on a new research funding opportunity, “Developing and Demonstrating Nanosensor Technology to Detect, Monitor, and Degrade Pollutants.” During the webinar, EPA provided an overview of the research grant funding opportunity, and attendees had a chance to ask questions. EPA will post a copy of the webinar slides on the funding opportunity’s web page. The solicitation will close December 7, 2022.

OECD Holds Webinar On Safer And Sustainable Innovation Approach For More Sustainable Nanomaterials And Nano-Enabled Products: On November 3, 2022, OECD held a webinar on the safer and sustainable innovation approach (SSIA) for more sustainable nanomaterials and nano-enabled products. According to OECD, SSIA is an approach aiming to boost safer and sustainable innovations by integrating safety and sustainability at an early stage of the design phase of innovative materials, products, applications, and processes. SSIA combines the Safe-and-Sustainable-by-Design (SSbD), Regulatory Preparedness (RP), and Trusted Environment (TE) concepts to identify and minimize sustainability impacts, as well as potential health and environmental risks in the innovation process. OECD organized the webinar to increase awareness of this approach and gather input from potential users, such as innovators and regulators, to ensure its applicability.

EUON Study Predicts Growth In European Nanomaterial Market: On November 7, 2022, the EU Observatory for Nanomaterials (EUON) announced that it published a study on the EU market for nanomaterials, including substances, uses, volumes, and key producers, traders, and users. The study also covers the European Economic Area (EEA) countries and Switzerland. EUON states that according to the study, the European nanomaterial market is expected to grow in the next five years in both volume and value. According to EUON, although Brexit had an impact on this projection, interview participants did not perceive the COVID-19 pandemic to lead to a market slow-down. EUON states that while the largest segment is currently the metal oxides market, “growth is predicted to be driven mainly by nanoclays, nanocellulose and carbon-based nanomaterials.” More information is available in our November 7, 2022, blog item.

BIOBASED/RENEWABLE PRODUCTS/SUSTAINABILITY

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

LEGISLATIVE

Maine Delegation Introduces Bill To Support Farmers Affected By PFAS: On October 11, 2022, Senators Susan Collins (R-ME) and Angus King (I-ME) introduced the Relief for Farmers Hit with PFAS Act (S. 5070), and on October 14, 2022, Representatives Chellie Pingree (D-ME) and Jared Golden (D-ME) introduced identical legislation (H.R. 9186). According to Collins’s October 21, 2022, press release, the bill would authorize grants for states to provide financial assistance to affected farmers, expand monitoring and testing, remediate PFAS, or help farmers relocate. The press release states that funds authorized by the bill could be used for a variety of purposes at the state level, including:

  • More capacity for PFAS testing for soil or water sources;
     
  • Blood monitoring for individuals to make informed decisions about their health;
     
  • Equipment to ensure a farm remains profitable during or after known PFAS contamination;
     
  • Relocation of a commercial farm if the land is no longer viable;
     
  • Alternative cropping systems or remediation strategies;
     
  • Educational programs for farmers experiencing PFAS contamination; and
     
  • Research on soil and water remediation systems, and the viability of those systems for farms.
     

The bill would also create a task force at the U.S. Department of Agriculture (USDA) charged with identifying other USDA programs to which PFAS contamination should be added as an eligible activity. Additionally, the task force would provide technical assistance to states to help them coordinate their responses effectively.

Biden Signs Instrument Of Ratification Of The Kigali Amendment: On October 27, 2022, the White House announced that President Joseph Biden signed the instrument of ratification of the Kigali Amendment to the Montreal Protocol on Substances that Deplete the Ozone Layer. On September 21, 2022, the Senate voted 69 to 27 to ratify the Kigali Amendment, an international agreement to reduce gradually the consumption and production of HFCs, GHGs commonly used in refrigeration and air conditioning. The phase-out of HFCs is expected to avoid a half a degree Celsius of global warming between now and 2100.

MISCELLANEOUS

GAO Recommends EPA Use New Data To Analyze The Demographics Of Communities With PFAS In Their Drinking Water: On October 19, 2022, GAO released a report entitled “Persistent Chemicals: EPA Should Use New Data to Analyze the Demographics of Communities with PFAS in Their Drinking Water.” The Congressional requesters asked GAO to examine PFAS contamination in drinking water and related state actions. GAO’s report examines what recent data from selected states show about the occurrence of PFAS in drinking water; the demographic characteristics of communities in selected states with and without PFAS in their drinking water; and factors that influenced states’ decisions to test and develop standards or guidance for PFAS in drinking water. GAO recommends that EPA conduct a nationwide analysis using comprehensive data to determine the demographic characteristics of communities with PFAS in their drinking water. EPA agreed with the recommendation. More information is available in our October 20, 2022, blog item.

EPA Announces Availability Of Draft IRIS Toxicological Review Of Hexavalent Chromium: On October 20, 2022, EPA announced a 60-day public comment period associated with its release of the draft Integrated Risk Information System (IRIS) Toxicological Review of Hexavalent Chromium. 87 Fed. Reg. 63774. EPA states that it is releasing the draft IRIS assessment for public comment in advance of a Science Advisory Board (SAB) led peer review. SAB will convene a public meeting to discuss the draft report with the public during Step 4 of the IRIS Process. The external peer reviewers will consider public comments submitted to the EPA docket in response to this notice and any others provided at the public meeting when reviewing this document. EPA will consider all comments submitted to the docket when revising the document post-peer review. EPA notes that the draft assessment is not final as described in EPA’s information quality guidelines, and it does not represent, and should not be construed to represent, Agency policy or views. Comments are due December 19, 2022.

OSHA Will Hold Virtual Public Meeting To Prepare For 43rd Session Of UN Sub-Committee Experts On GHS: On October 24, 2022, the Occupational Safety and Health Administration announced that it will conduct a virtual public meeting on November 16, 2022, in advance of the 43rd session of the United Nations (UN) Sub-Committee of Experts on the Globally Harmonized System of Classification and Labelling of Chemicals (UNSCEGHS) to be held as a hybrid (in-person and virtual) meeting on December 7-9, 2022, in Geneva, Switzerland. 87 Fed. Reg. 64256. OSHA, along with the U.S. Interagency Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Coordinating Group, plans to consider the comments and information gathered at this public meeting when developing the U.S. government positions for the UNSCEGHS meeting. The meeting will occur jointly with the Department of Transportation’s (DOT) PHMSA to discuss proposals in preparation for the 61st session of the United Nations Sub-Committee of Experts on the Transport of Dangerous Goods (UNSCETDG), to be held as a hybrid meeting November 28-December 6, 2022.

Biden Administration Expands Public-Private Cybersecurity Partnership To Chemical Sector: On October 26, 2022, the Biden Administration announced that it is expanding the Industrial Control Systems (ICS) Cybersecurity Initiative to the chemical sector. The White House’s fact sheet states that the majority of chemical companies are privately owned, so a collaborative approach is needed between the private sector and government. According to the fact sheet, “[t]he nation’s leading chemical companies and the government’s lead agency for the chemical sector -- the Cybersecurity and Infrastructure Agency (CISA) -- have agreed on a plan to promote a higher standard of cybersecurity across the sector, including capabilities that enable visibility and threat detection for industrial control systems.” The fact sheet states that the Chemical Action Plan will serve as a roadmap to guide the sector’s assessment of its current cybersecurity practices over the next 100 days, building on the lessons learned and best practices of the previously launched action plans for the electric, pipeline, and water sectors to meet the needs for this sector. More information is available in our October 31, 2022, blog item.

EPA Awards Nearly $750,000 To Fund PFAS Exposure Pathways Research: On October 28, 2022, EPA announced that it awarded $748,180 in research grant funding to three institutions for research to improve understanding of how people are exposed to PFAS in several communities throughout the country. EPA states that there is evidence that continued exposure above specific levels to certain PFAS may lead to adverse health effects. According to EPA, more data are needed to measure the nature and levels of PFAS in homes and food to understand pathways for human exposure and risk mitigation. More information is available in our November 1, 2022, blog item.

EPA Announces October 2022 IRIS Program Outlook: On October 28, 2022, EPA’s IRIS Program announced the release of the October 2022 IRIS Program Outlook. 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. Updates to the IRIS Program Outlook occur at least three times a year (February, June, October).

CDTSC Holds Engagement Sessions On A Definition Of Sustainable Chemistry: On November 1 and November 3, 2022, the California Department of Toxic Substances Control (CDTSC) invited stakeholders to two external engagement sessions, to share their perspectives on an actionable definition of sustainable chemistry. CDTSC states that stakeholders’ participation and expertise can help refine a draft, consensus definition and set of criteria for sustainable chemistry. According to CDTSC, the draft definition and criteria were developed over the past six months by a 20-person Expert Committee on Sustainable Chemistry (ECOSChem) that includes representatives from industry, academia, and governmental and non-governmental organizations, including a representative from the Safer Consumer Products Program (SCP). The charge of ECOSChem is to establish “an ambitious, actionable definition and criteria for sustainable chemistry that can enable effective government policy, inform business and investor decision making, enhance chemistry education, and spur the adoption across all supply chains of chemicals that are safer and more sustainable.” More information is available in our October 28, 2022, blog item.

EPA Will Expand Environmental Performance Standard And Ecolabel Recommendations For Federal Purchasing: EPA announced on November 2, 2022, that it launched a new process to expand the Environmentally Preferable Purchasing (EPP) program’s Recommendations of Specifications, Standards and Ecolabels for Federal Purchasing (Recommendations). EPA is inviting managers of standards development organizations, ecolabel programs, and other similar organizations to apply for potential assessment and inclusion in the Recommendations. 87 Fed. Reg. 66176. EPA also hosted a webinar on November 15, 2022, to answer questions about the expansion of the Recommendations and the process for applying. The EPP program’s Recommendations help federal government purchasers use private sector standards and ecolabels to meet sustainable acquisition goals and mandates. According to EPA, they currently include more than 40 private sector environmental performance standards and ecolabels in over 30 purchase categories. Responses to the scoping questions are due January 1, 2023. EPA will use the scoping questions to determine eligibility and scope of the assessment. After the application deadline closes, EPA will issue an estimated timeline for full assessments against the Framework for the Assessment of Environmental Performance Standards and Ecolabels by product/service category within 120 days. For each category being assessed, EPA will provide further notice and instruction to applicable applicants.

DPR Announces Agreement With Amazon To Pay Nearly Five Million Dollars For Illegal Pesticide Sales In California: On November 3, 2022, the California Department of Pesticide Regulation (DPR) announced it reached a settlement agreement with Amazon.com Services, LLC (Amazon) regarding the illegal sale of pesticides in California. According to DPR, its review of Amazon uncovered multiple violations. Among them, Amazon sold unregistered pesticides in California, failed to report and pay required mill assessment fees associated with the sale of registered pesticides in California, and failed to hold a valid pesticide broker’s license. More information is available in our November 7, 2022, blog.

EPA Seeks Public Input On IRA Programs To Fight Climate Change, Protect Health, And Advance Environmental Justice: On November 4, 2022, EPA announced initial public engagement and input opportunities for a subset of new and existing programs funded by President Joseph Biden’s Inflation Reduction Act (IRA). EPA’s engagement strategy for these programs includes:

  • Request for Information (RFI): Issuing a request for public input to inform program design;
     
  • Expert Input: Soliciting expert input on key program design questions from EPA’s Federal Advisory Committees, including the Local Government Advisory Committee, Clean Air Act (CAA) Advisory Committee, and the National Environmental Justice Advisory Committee;
     
  • Listening Sessions: Launching a stakeholder listening session series to enable key stakeholders, including environmental justice communities, state and local governments, clean energy advocates, labor, and others, to provide input directly to EPA staff; and
     
  • New Webpage: Creating a one-stop shop for information on the implementation of IRA programs managed by EPA’s Office of Air and Radiation (OAR).
     

FTC Considering Trade Regulation Rule On The Use Of Reviews And Endorsements: On November 8, 2022, the Federal Trade Commission (FTC) proposed to commence a rulemaking proceeding to address certain deceptive or unfair uses of reviews and endorsements. 87 Fed. Reg. 67424. FTC is soliciting written comment, data, and arguments concerning the need for such a rulemaking to prevent unfair or deceptive marketing utilizing reviews and endorsements. Specifically, FTC proposes addressing the following practices, many of which have been the subject of FTC investigations or law enforcement actions:

  • Reviews or endorsements by people who do not exist, who did not actually use or test the product or service, or who are misrepresenting their experience with it;
     
  • Review of hijacking, where a seller steals or repurposes reviews of another product;
     
  • Marketers offering compensation or other incentives in exchange for, or conditioned on, the writing of positive or negative consumer reviews;
     
  • Owners, officers, or managers of a company: writing reviews or testimonials of their own products or services, or publishing testimonials by their employees or family members, which fail to provide clear and conspicuous disclosures of those relationships; or soliciting reviews from employees or relatives without instructing them to disclose their relationships;
     
  • The creation or operation of websites, organizations, or entities that purportedly provide independent reviews or opinions of products or services but are, in fact, created and controlled by the companies offering the products or services;
     
  • Misrepresenting that the consumer reviews displayed represent most or all of the reviews submitted when, in fact, reviews are being suppressed based upon their negativity;
     
  • The suppression of customer reviews by physical threat or unjustified legal threat; or
     
  • Selling, distributing, or buying followers, subscribers, views, and other indicators of social media influence.
     

FTC hopes that by focusing on practices “most clearly and inarguably deceptive or unfair,” it can streamline its rulemaking, benefit consumers, and not burden legitimate marketers. Comments are due January 9, 2023.

California Sues PFAS Manufacturers: On November 10, 2022, California filed suit in California Superior Court against PFAS manufacturers “for endangering public health, causing irreparable harm to the state’s natural resources, and engaging in a widespread campaign to deceive the public.” According to California Attorney General Rob Bonta’s November 10, 2022, press release, California “alleges that these manufacturers, including 3M and DuPont, knew or should have known that PFAS are toxic and harmful to human health and the environment, yet continued to produce them for mass use and concealed their harms from the public.” The press release states that the lawsuit concerns seven common PFAS that have been detected in drinking water supplies, surface waters, and groundwater in California: perfluorooctanoic acid (PFOA); perfluorooctanesulfonic acid (PFOS); perfluorobutanesulfonic acid (PFBS); perfluorohexanesulfonic acid (PFHxS); perfluorohexanoic acid (PFHxA); perfluoroheptanoic acid (PFHpA); and perfluorononanoic acid (PFNA). California requests statewide treatment and destruction of PFAS, including, but not limited to, the treatment of drinking water by regulated water systems; water drawn from private wells and unregulated systems used for drinking water and irrigation; and water from other wastewater treatment plants and systems. California also seeks payment of funds necessary to mitigate the impacts to human health and the environment through environmental testing, medical monitoring, public noticing, replacement water (for period between testing and installation of treatment), and safe disposal and destruction.

EPA Begins Comment Period On IRIS Assessment Plan And Protocol For Assessing Cancer Risk From Inhalation Exposure To Cobalt And Cobalt Compounds: On November 14, 2022, EPA announced a 30-day comment period on the IRIS Assessment Plan and Systematic Review Protocol for Inhalation Exposure to Cobalt and Compounds (Cancer). 87 Fed. Reg. 68151. According to EPA, this document communicates information on the scoping needs identified by EPA program and regional offices and the IRIS Program’s initial problem formulation activities. The assessment plan outlines the objectives for the IRIS assessment and the type of evidence considered most pertinent to address the scoping needs. The systematic review protocol describes the methodology of how the assessment will be conducted, including dose-response considerations. EPA is releasing this IRIS assessment plan and systematic review protocol in advance of a public science webinar planned for November 30, 2022. EPA “encourages the public to comment on all aspects of the assessment plan and the systematic review protocol, including key science issues and identification of any new or missing studies.” Comments are due December 14, 2022.

This Update is provided as a complimentary service to our clients and is for informational purposes. This Update may be copied or quoted, provided proper attribution is given. The contents are not intended and cannot be considered as legal advice.

 
THE ACTA GROUP
Beijing, China | Brussels, Belgium | Manchester, U.K. | Washington, D.C.
Contact • Twitter
 
Privacy Policy | Terms of Use | Cookie Policy
©2022 The Acta Group All Rights Reserved.