Monthly Update for December 2022


Bergeson & Campbell, P.C. extends its best wishes to our clients and many friends. We wish you and your family a safe and healthy New Year. As we have for many years, the firm has made a contribution to the House of Ruth, a shelter for battered women and their children, in lieu of gifts to our clients, and on our clients’ behalf.

WEBINAR – Registration Is Open For “Two Years Later: How Has the Chemicals Strategy for Sustainability Changed REACH and CLP Regulations?”: Registration is now open to join Meglena Mihova, Managing Partner, EPPA; Thomas Petry, Ph.D., Managing Director, ToxMinds; Jane S. Vergnes, Ph.D., Vice President, The Acta Group (Acta®); and Lynn L. Bergeson, Esquire, President, Acta, as Bergeson & Campbell, P.C. (B&C®) affiliate Acta presents “Two Years Later: How Has the Chemicals Strategy for Sustainability Changed REACH and CLP Regulations?” on January 17, 2023, 10:00 a.m. - 11:00 a.m. (EST). This webinar will explore exactly how the Chemicals Strategy for Sustainability is fundamentally reshaping the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) and the Classification, Labeling and Packaging (CLP) regulations in ways that are resetting the global stage in terms of identifying new hazard classes and New Approach Methodologies (NAM) for identifying them. Register now.

WEBINAR -- Recording Available For “Articles under TSCA” Webinar: B&C’s December 14, 2022, webinar “Articles under TSCA” is now available for on-demand viewing at https://attendee.gotowebinar.com/recording/6939521887005385816. During this one-hour webinar, Richard E. Engler, Ph.D., Eve Gartner, and Lynn L. Bergeson go over the policy changes that led to the regulation of articles under the Toxic Substances Control Act (TSCA), the U.S. Environmental Protection Agency’s (EPA) authority to regulate these articles, and what companies need to know to stay in compliance.

ARTICLE -- Lynn L. Bergeson Authors “Sticker Shock: TSCA Fees Could Soon Be a Lot More Expensive,” For Chemical Processing:On November 16, 2022, EPA published a supplemental proposal modifying its 2021 proposed rule that would amend the 2018 TSCA fees rule. EPA’s Assistant Administrator warned us to be prepared for sticker shock. The proposed increases are significant. This article discusses the new fee structure and what companies need to know.

PODCAST -- TSCA Regulation Of Articles: The Saga Continues — A Conversation With Richard E. Engler, Ph.D.: Lynn L. Bergeson and Richard E. Engler, Ph.D. return to the studio to discuss the stubbornly vexatious problem of TSCA’s regulation of articles, a fancy name for products or finished goods. This EPA Administration has specifically applied TSCA regulations to articles far more than in decades past, a policy pivot that has caused a significant amount of commercial disruption and business uncertainty. This will not abate in the years ahead. Richard Engler explains why this is the case and suggests some steps regulated entities may wish to consider to comply with current regulations and prepare for the future. Listen now.

TSCA/FIFRA/TRI

EPA Announces The Addition Of Chitosan To The List Of Active Ingredients Eligible For Risk Pesticide Exemption: On November 8, 2022, EPA issued a final rule adding chitosan (Poly-D-Glucosamine), a naturally occurring substance found in the cell walls of all crustaceans, many fungi, and the exoskeletons of most insects, to its minimum risk pesticide exemption list. 87 Fed. Reg. 67364. EPA states that the listing also includes those chitosan salts that can be formed when chitosan is mixed with the acids that are listed as active or inert ingredients eligible for use in minimum risk pesticide products. According to EPA’s announcement of the final rule, the purpose of the exemption list is to eliminate the need for EPA to expend significant resources to regulate products deemed to be of minimum risk to human health and the environment. Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 25(b) minimum risk exemption, products that contain only those active and inert ingredients allowed by the exemption and that meet certain requirements are exempt from the normal FIFRA registration requirements. Approximately a decade has passed since a substance was added to the list of ingredients eligible for the minimum risk pesticide exemption. The final rule will be effective on January 9, 2023. For more information on the final rule and our commentary, please see our November 15, 2022, blog item.

EPA Issues SNPRM Modifying And Supplementing 2021 Proposed TSCA Fees Rule: On November 16, 2022, EPA published a much-anticipated supplemental notice of proposed rulemaking (SNPRM) to modify and supplement its 2021 proposed rule that would amend the 2018 TSCA fees rule. 87 Fed. Reg. 68647. EPA states that “[w]ith over five years of experience administering the TSCA amendments of 2016, EPA is publishing this document to ensure that the fees charged accurately reflect the level of effort and resources needed to implement TSCA in the manner envisioned by Congress when it reformed the law.” EPA held a webinar on December 6, 2022, to provide an overview to stakeholders of the SNPRM. Written comments are due by January 17, 2023. More information is available in our November 18, 2022, memorandum.

EPA Holds First Webinar On Approach For Reviewing MMOs, Including New And Modified CAMs: On November 17, 222, EPA held the first of a two-part webinar series 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). Under the TSCA, EPA reviews new chemical substances before they enter the marketplace to ensure they do not present unreasonable risk to human health or the environment. In October 2022, EPA announced an “innovative effort” to help make its review of new MMOs, including new and modified CAMs, more efficient. More information on the initiative is available in our October 11, 2022, memorandum. More information and our commentary on the first webinar is available in our November 23, 2022, memorandum.

EPA Adds Thousands Of Additional TSCA Risk, New Chemical Submissions To ChemView, Commits To “Near Real-Time Publication” Going Forward: On November 21, 2022, EPA announced that it has improved public access to certain reports submitted by chemical companies in ChemView, EPA’s web application for public access to non-confidential business information (non-CBI) on chemicals regulated under TSCA, including new chemical notices and notices of substantial risk. EPA has published previously unpublished new chemical notices received under TSCA Section 5 and notices of substantial risk provided by companies under TSCA Section 8(e). EPA states that going forward, it will continue to identify older, previously submitted unpublished information to make available in ChemView and will publish newly received TSCA Section 5 notices and TSCA Section 8(e) reports on a “near real-time basis.” EPA has also published in ChemView chemical health and safety studies received under TSCA Section 8(d). More information is available in our November 22, 2022, blog item.

EPA Seeks Comment On Initial Regulatory Flexibility Analysis On Proposed PFAS Reporting Rule: On November 25, 2022, EPA announced the availability of and solicited comment on an Initial Regulatory Flexibility Analysis (IRFA) and Updated Economic Analysis following the completion of a Small Business Advocacy Review (SBAR) Panel for the TSCA proposed rule for reporting and recordkeeping requirements for per- and polyfluoroalkyl substances (PFAS). 87 Fed. Reg. 72439. EPA states that it seeks public comment on all aspects of the IRFA and Updated Economic Analysis, including underlying data and assumptions in developing its estimates, as well as on certain items presented in the IRFA for public comment and related to the protection of CBI. Comments are due December 27, 2022. More information is available in our November 29, 2022, memorandum.

EPA Adopts NAICS Codes For TRI Reporting: On November 28, 2022, EPA published a final rule updating the list of North American Industry Classification System (NAICS) codes subject to reporting under the Toxics Release Inventory (TRI) to reflect the Office of Management and Budget (OMB) 2022 NAICS code revision. 87 Fed. Reg. 72891. OMB updates the NAICS codes every five years. EPA is implementing the 2022 codes for TRI Reporting Year 2022 (i.e., facilities reporting to TRI are required to use 2022 NAICS codes on reports that are due by July 1, 2023). EPA notes that the actual data required by a TRI form do not change as a result of this rulemaking, nor does the rule affect the universe of TRI reporting facilities that are required to submit reports under the Emergency Planning and Community Right-to-Know Act (EPCRA). The final rule will be effective December 28, 2022.

EPA’s FY 2023 Top Management Challenges Include Providing For The Safe Use Of Chemicals: Under the Reports Consolidation Act of 2000, each agency’s inspector general must prepare an annual statement summarizing what the inspector general considers to be “the most serious management and performance challenges facing the agency” and to assess briefly the agency’s progress in addressing those challenges. On November 29, 2022, EPA’s Office of Inspector General (OIG) released its report regarding EPA’s fiscal year (FY) 2023 top management challenges. According to the report, the eight top management challenges for EPA in FY 2023 include:

  • Providing for the Safe Use of Chemicals: The public must be able to depend on EPA’s ability to conduct credible and timely assessments of the risks posed by pesticides, toxic chemicals, and other environmental chemicals.
     

More information is available in our November 30, 2022, blog item.

EPA Announces Proposed New Mitigation Measures For Rodenticides, Including Pilot For Protecting Endangered Species: On November 29, 2022, EPA announced proposed new mitigation measures for 11 rodenticides, including measures to reduce potential exposures to three federally listed endangered and threatened species and one critical habitat. The mitigation measures are part of EPA’s goals outlined in its April 2022 Endangered Species Act (ESA) Workplan and one of the ESA pilots described in its November 2022 Workplan Update. More information is available in our December 8, 2022, blog item. See also our November 23, 2022, blog item for more information on the Workplan Update.

EPA Adds 12 Chemicals To List Of Chemicals Subject To TRI Reporting Requirements: On November 30, 2022, EPA published a final rule that adds 12 chemicals to the list of toxic chemicals subject to the reporting requirements under EPCRA and the Pollution Prevention Act (PPA). 87 Fed. Reg. 73475. In response to a petition filed under EPCRA, EPA determined that each of the 12 chemicals meets the EPCRA criteria. EPA’s November 30, 2022, press release states that the 12 chemicals that are now subject to TRI reporting requirements are dibutyltin dichloride; 1,3-dichloro-2-propanol; formamide; 1,3,4,6,7,8-hexahydro-4,6,6,7,8,8-hexamethylcyclopenta[g]-2-benzopyran; n-hydroxyethylethylenediamine; nitrilotriacetic acid trisodium salt; p-(1,1,3,3-tetramethylbutyl)phenol; 1,2,3-trichlorobenzene; triglycidyl isocyanurate; tris(2-chloroethyl) phosphate; tris(1,3-dichloro-2-propyl) phosphate; and tris(dimethylphenol) phosphate. EPA has also classified one of the chemicals, 1,3,4,6,7,8-hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-benzopyran, as a persistent, bioaccumulative, and toxic (PBT) chemical and designated it as a chemical of special concern with a 100-pound reporting threshold. Facilities that are covered by TRI and meet reporting requirements for these chemicals will now be required to report to EPA on quantities of these chemicals that are released into the environment or otherwise managed as waste. The first reports on these chemicals will be due to EPA July 1, 2024, for calendar year 2023 data. The final rule was effective November 30, 2022.

EPA Proposes SNURs For 35 PFAS, Advancing Key Action In PFAS Strategic Roadmap: On December 2, 2022, EPA proposed significant new use rules (SNUR) under TSCA for chemical substances that were the subject of premanufacture notices (PMN) and are also subject to Orders issued by EPA pursuant to TSCA. 87 Fed. Reg. 74072. 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. EPA states that the SNURs advance one of the “key actions” in the PFAS Strategic Roadmap where EPA stated it plans to revisit past regulatory decisions concerning PFAS and address those that are insufficiently protective by imposing additional notification requirements. Comments are due January 3, 2023. More information is available in our December 9, 2022, blog item.

EPA Issues Final SNURs For Certain Chemical Substances: On December 2, 2022, EPA issued final SNURs under TSCA for chemical substances that were the subject of PMNs and a Microbial Commercial Activity Notice (MCAN). 87 Fed. Reg. 73941. 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 designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification will initiate 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 has taken such actions as are required by that determination. The SNURs will be effective January 31, 2023.

EPA Proposes To Add PFAS Subject To TRI Reporting To List Of Chemicals Of Special Concern: EPA proposed on December 5, 2022, to add PFAS subject to reporting under EPCRA and PPA pursuant to the National Defense Authorization Act for Fiscal Year 2020 (NDAA) to the list of Lower Thresholds for Chemicals of Special Concern (chemicals of special concern). 87 Fed. Reg. 74379. EPA notes that these PFAS already have a lower reporting threshold of 100 pounds. Adding these PFAS to the list of chemicals of special concern will cause such PFAS to be subject to the same reporting requirements as other chemicals of special concern (i.e., it would eliminate the use of the de minimis exemption and the option to use Form A and would limit the use of range reporting for PFAS). EPA states that “[r]emoving the availability of these burden-reduction reporting options will result in a more complete picture of the releases and waste management quantities for these PFAS.” In addition, EPA proposes to remove the availability of the de minimis exemption for purposes of the Supplier Notification Requirements for all chemicals on the list of chemicals of special concern. According to EPA, this change will help ensure that purchasers of mixtures and trade name products containing such chemicals are informed of their presence in mixtures and products they purchase. Comments are due February 3, 2023. More information is available in our December 7, 2022, memorandum.

EPA Finds PCE, As A Whole Chemical Substance, Poses An Unreasonable Risk To Human Health: EPA announced on December 14, 2022, the availability of the final revision to the risk determination for perchloroethylene (PCE) risk evaluation issued under TSCA. 87 Fed. Reg. 76481. EPA states that the revision to the PCE 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 PCE, as a whole chemical substance, presents an unreasonable risk of injury to health when evaluated under its conditions of use. More information and a detailed commentary will be available in a forthcoming memorandum that will be posted on our website.

RCRA/CERCLA/CWA/CAA/PHMSA/SDWA

ATSDR Publishes 2022 SPL: In November 2022, the Agency for Toxic Substances and Disease Registry (ATSDR) published its 2022 Substance Priority List (SPL). Section 104(i) of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), as amended by the Superfund Amendments and Reauthorization Act (SARA), requires ATSDR and EPA to prepare a list, in order of priority, of substances that are most commonly found at facilities on the National Priorities List (NPL) and that are determined to pose the most significant potential threat to human health due to their known or suspected toxicity and potential for human exposure at these NPL sites. Each substance on the list is a candidate to become the subject of a Toxicological Profile prepared by ATSDR.

EPA Publishes Fact Sheet On EPCRA Reporting Requirements For Fertilizer Retailers: EPA published a November 2022 fact sheet on “EPCRA Reporting Requirements for Fertilizer Retailers.” EPA developed the fact sheet to help fertilizer retailers comply with their EPCRA reporting requirements by providing its interpretation of the EPCRA Section 311(e)(5) Retail Fertilizer Exemption and an overview of all the EPCRA reporting requirements.

EPA Proposes Amendments To Standards Of Performance For Secondary Lead Smelters: On December 1, EPA proposed amendments to the Standards of Performance for secondary lead smelters per the Agency’s periodic review of the New Source Performance Standards (NSPS) required by the Clean Air Act (CAA). 87 Fed. Reg. 73708. EPA proposes updates to the current NSPS for secondary lead smelters and proposes a new NSPS subpart that applies to affected sources constructed, reconstructed, or modified after the date of this proposed rule. Comments are due January 17, 2023. EPA notes that comments on the information collection provisions submitted to OMB under the Paperwork Reduction Act (PRA) are best assured of consideration by OMB if OMB receives a copy on or before January 3, 2023.

EPA Issues SNPRM For Crude Oil And Natural Gas Source Category, Will Hold Virtual Public Hearing In January 2023: On December 6, 2022, EPA published an SNPRM to update, strengthen, and expand the standards proposed on November 15, 2021, which are intended to reduce significantly emissions of greenhouse gases (GHG) and other harmful air pollutants from the Crude Oil and Natural Gas source category. 87 Fed. Reg. 74702. EPA proposes standards for certain sources that were not addressed in the November 2021 proposal, as well as revisions intended to strengthen standards for sources of leaks, provide greater flexibility to use innovative advanced detection methods, and establish a super emitter response program. EPA also proposes to modify and refine certain elements of the proposed standards in response to information submitted in public comments on the November 2021 proposal. Finally, EPA proposes details of the timelines and other implementation requirements that apply to states to limit methane pollution from existing designated facilities in the source category under the CAA. Comments are due February 13, 2023. EPA notes that under the PRA, OMB is required to make a decision concerning the collections of information contained in the proposed rule between 30 and 60 days after publication and submission to OMB. A comment to OMB is best assured of consideration if received on or before January 5, 2023.

EPA will hold a virtual public hearing on the SNPRM on January 10 and 11, 2023, from 10:00 a.m. to 8:00 p.m. (EST) on each day. Registration to speak at the hearing is open until January 5, 2023. Registration is not necessary to view the hearing. EPA will post a link to the hearing’s YouTube channel prior to the hearing date.

EPA Issues Guidance To States To Reduce PFAS Pollution: On December 6, 2022, EPA announced that it released a memorandum to states that will align wastewater and stormwater National Pollutant Discharge Elimination System (NPDES) permits and pretreatment program implementation activities with the goals in EPA’s PFAS Strategic Roadmap. According to EPA, the memorandum recommends that states use the most current sampling and analysis methods in their NPDES programs to identify known or suspected sources of PFAS and to take actions using their pretreatment and permitting authorities, such as imposing technology-based limits on sources of PFAS discharges. EPA states that the memorandum will also help it obtain comprehensive information through monitoring on the sources and quantities of PFAS discharges, informing other EPA efforts to address PFAS.

EPA Calls For Information On Integrated Science Assessment For Oxides Of Nitrogen-Health Criteria: EPA is preparing an Integrated Science Assessment (ISA) as part of the review of the primary (health-based) National Ambient Air Quality Standards (NAAQS) for oxides of nitrogen. For gaseous oxides of nitrogen (i.e., oxidized nitrogen compounds), which also include nitric oxide (NO) and gases produced from reactions involving NO and nitrogen dioxide (NO2), the primary NAAQS are specified in terms of NO2. According to EPA, when final, the ISA is intended to update the previous Integrated Science Assessment for Oxides of Nitrogen -- Health Criteria (EPA/600/R-15/068, 2016). EPA published a notice on December 9, 2022, asking interested parties to assist in developing and refining the scientific information base for the review of the primary NO2 NAAQS by submitting research studies and data that have been published in the peer-reviewed scientific literature, accepted for publication, or presented at a public scientific meeting since May 15, 2015. 87 Fed. Reg. 75625. Submissions are due February 7, 2023.

PHMSA Publishes First Set Of FAQs Specific To HMR Applicability, Will Address Incident Reporting Requirements Next: On December 9, 2022, the U.S. Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) published a notice responding to comments received on its initiative to convert historical letters of interpretation (LOI) applicable to the Hazardous Materials Regulations (HMR) that have been issued to specific stakeholders into broadly applicable frequently asked questions (FAQ). 87 Fed. Reg. 75694. PHMSA also issued the first set of FAQs in final and announced the topic for further FAQs. The notice includes the final FAQs regarding the applicability of HMR to persons and functions. PHMSA states that it has begun compiling its next set of FAQs, which will pertain to LOIs addressing questions regarding the incident reporting requirements specified in 49 C.F.R. Sections 171.15 and 171.16. In addition, PHMSA will continue concurrent work on future FAQ notices and, in response to the comments received, subsequent topics may include FAQs pertaining to batteries, classification, hazard communication, hazardous substances, hazardous wastes, modal-specific requirements, or packaging. More information is available in our December 12, 2022, memorandum.

EPA Proposes To Restrict The Use Of HFCs In Certain Products And Equipment Where Climate-Safe Alternatives Are Available: On December 15, 2022, EPA issued a proposed rule under the American Innovation and Manufacturing (AIM) Act to restrict the use of hydrofluorocarbons (HFC) in specific sectors or subsectors in which they are used; establish a process for submitting technology transitions petitions; establish recordkeeping and reporting requirements; and address certain other elements related to the effective implementation of the AIM Act. 87 Fed. Reg. 76738. EPA notes that the proposed restrictions on the use of HFCs would, in part, address petitions granted on October 7, 2021, and September 19, 2022. EPA also seeks advance information on certain topics that may be helpful to developing a future proposed rule including on restrictions on the use of HFCs for certain other sectors and subsectors and on a third-party auditing program to verify substances used in products. Comments are due January 30, 2023. Under the PRA, comments on the information collection provisions are best ensured of consideration if OMB receives a copy on or before January 17, 2023. EPA will hold a virtual public hearing on December 30, 2022. The date, time, and other relevant information for the virtual public hearing will be available at https://www.epa.gov/​climate-hfcs-reduction.

FDA

FDA Requests Comments For Threshold Of Regulation: On November 15, 2022, the U.S. Food and Drug Administration (FDA) announced a proposed collection of information related to Threshold of Regulation (TOR) for Substances Used in Food-Contact Articles submissions. 87 Fed. Reg. 68504. FDA estimates only submission of seven TOR submissions per year, each taking 48 hours to prepare. FDA is accepting comments until December 15, 2022.

FDA Issues Final FSMA Rule For Additional Traceability Records: On November 21, 2022, FDA issued a Food Safety Modernization Act (FSMA) final rule titled “Requirements for Additional Traceability Records for Certain Foods” with an effective date of January 20, 2023. 87 Fed. Reg. 70910. The rule establishes additional recordkeeping requirements for persons who manufacture, process, pack, or hold foods FDA has designated for inclusion on the Food Traceability List (FTL).

FDA Announces Filing Of Food Additive Petition For Hydrogen Peroxide: On November 21, 2022, FDA announced the filing of a Food Additive Petition submitted by Cargill, Inc. proposing the use of hydrogen peroxide (Chemical Abstracts Service Registry Number® (CAS RN®) 7722-84-1) as an antimicrobial agent, oxidizing and reducing agent, bleaching agent, and to remove sulfur dioxide. 87 Fed. Reg. 70752. If approved, the food additive regulations in 21 C.F.R. Section 173.356 would be amended to include additional uses. FDA is accepting comments until December 21, 2022.

FDA Extends Comment Period For “Healthy” Claims: On November 28, 2022, FDA extended the comment period for the proposed rule titled “Food Labeling: Nutrient Content Claims; Definition of Term ‘Healthy.’” 87 Fed. Reg. 73267. Comments may be submitted to Regulations.gov for docket number FDA-2016-D-2335 until February 16, 2023.

FDA Issues Food Allergens Draft Guidance: On November 30, 2022, FDA announced the availability of a draft guidance document titled “Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Draft Guidance for Industry.” 87 Fed. Reg. 73561. FDA is accepting comments until January 30, 2023.

NANOTECHNOLOGY

Nano4EARTH Will Hold Kickoff Workshop In January: On November 28, 2022, the National Nanotechnology Coordination Office (NNCO) announced that the kickoff workshop for Nano4EARTH will be held January 24-25, 2023. Nano4EARTH will leverage recent investments in understanding and controlling matter at the nanoscale to develop technologies, industries, and training opportunities that address climate change. The kickoff workshop will serve as an information-gathering exercise to identify key feasible outputs of the challenge and effective ways to measure success.

NNI Reports Its Impact On The U.S. Economy: On November 28, 2022, the National Nanotechnology Initiative (NNI) posted a blog item entitled “Impact of the NNI on the U.S. economy: at least $42 billion in one year!”. According to NNI, participating government agencies and departments have invested more than $38 billion over the past 20 years in nanoscale research and development (R&D). NNI states that data from the 2017 Economic Census reveal that over 3,700 companies -- with over 171,000 employees -- self-identified as primarily being in the business of nanotechnology R&D, reporting $42 billion in revenue and $20 billion in employee salaries. NNI notes that the single-year revenue figure of $42 billion in 2017 exceeds the cumulative 20-year NNI investment of $38 billion.

USDA Scientists Produce Nanobodies In Plant Cells That Block Emerging Pathogens: On November 30, 2022, the U.S. Department of Agriculture’s (USDA) Agricultural Research Service (ARS) announced that its scientists have determined that plants could be used to produce nanobodies that quickly block emerging pathogens in human medicine and agriculture. The nanobodies are small antibody proteins naturally produced in specific animals like camels, alpacas, and llamas. The scientists are now using their newly developed and patented SymbiontTM technology to show that nanobodies can be easily produced in a plant system with broad agricultural and public health applications. More information is available in our November 30, 2022, blog item.

EUON Announces New Study Assessing The Potential Impact Of Graphene On Health And The Environment: On December 7, 2022, the European Union (EU) Observatory for Nanomaterials (EUON) announced publication of a June 2022 report by the European Chemicals Agency (ECHA) entitled Assessment of the potential impact of graphene, graphene oxide and other 2D materials on health, and the environment. Commissioned by EUON, the report provides a systematic review and critical assessment of the health and environmental effects of graphene, graphene oxide, and other two-dimensional (2D) materials, based on existing public information. More information is available in our December 8, 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

Bicameral Legislation Would Address “Plastic Production Crisis”: On December 1, 2022, Senators Cory Booker (D-NJ) and Jeff Merkley (D-OR) introduced the Protecting Communities from Plastics Act (S. 5163). According to Booker’s December 1, 2022, press release, the bill would “directly tackle the plastic pollution crisis by cracking down on the plastic production process.” It would establish stricter rules for petrochemical plants to safeguard the health of American communities and reduce GHG emissions. The bill would also begin to shift the U.S. economy away from its dependence on certain single-use plastics, creating new nationwide targets for plastic source reduction and reuse in the packaging and food service sectors. The press release states that these targets “are paired with federal incentives to spur expansion of reusable and refillable systems, with an emphasis on ensuring benefits are realized in environmental justice communities.” Representative Jared Huffman (D-CA) and Representative Alan Lowenthal (D-CA) introduced companion legislation (H.R. 9388) in the House on December 2, 2022.

House Passes PFAS Act; Bill Will Head To President Biden For Signature: On December 1, 2022, the House passed the Protecting Firefighters from Adverse Substances (PFAS) Act (S. 231). According to Senator Gary Peters’ (D-MI) December 1, 2022, press release, the bipartisan legislation directs federal agencies to develop best practices, training, and educational programs to reduce, limit, and prevent exposure to PFAS. The bill also requires the Department of Homeland Security (DHS) to develop educational resources for firefighters on alternative foams and personal protective equipment (PPE) that do not contain PFAS. The Senate passed the legislation on July 29, 2021. It now heads to President Joseph Biden to be signed into law.

Bicameral Legislation Would Require EPA To Study U.S. Cryptomining Activity And Require GHG Emissions Reporting: On December 7, 2022, Representative Jared Huffman (D-CA) introduced the Crypto-Asset Environmental Transparency Act (H.R. 9457), which would require EPA to conduct a comprehensive impact study of U.S. cryptomining activity and require the reporting of GHG emissions from cryptomining operations that consume more than five megawatts of power. Senator Edward J. Markey (D-MA), Chair of the Senate Environment and Public Works Subcommittee on Clean Air, Climate, and Nuclear Safety, introduced companion legislation (S. 5210) in the Senate on December 7, 2022.

Senate Bill Would Direct EPA To Monitor And Track Methane Emissions: On December 8, 2022, Senators Jeff Merkley (D-OR) and Sheldon Whitehouse (D-RI) introduced the Methane Emissions Research Act of 2022 (S. 5214). According to Merkley’s December 8, 2022, press release, understanding the scale and characteristics of oil and gas methane emissions is crucial to develop effective emission reduction policies, but significant data gaps regarding oil and gas methane emissions exist. The bill would direct EPA to measure and quantify methane emissions from specific oil and gas producing regions and would create a pilot study as an initial one-time program, while requiring EPA to consider how the lessons of the pilot could be used to inform a recurring program on a national scale. The Senate bill is a companion to H.R. 8991, introduced in the House on September 28, 2022.

House And Senate Reach Agreement On Appropriations Framework: On December 13, 2022, the House Committee on Appropriations and the Senate Committee on Appropriations announced that they reached an agreement on a framework to complete an omnibus appropriations bill that can pass the House and Senate and be signed into law by President Biden.

Senate Committee Holds Hearing On Impact Of Plastic Use And Identifying Solutions For Reducing Plastic Waste: On December 15, 2022, the Senate Committee on Environment and Public Works held a hearing on “Examining the Impact of Plastic Use and Identifying Solutions for Reducing Plastic Waste.” The Committee heard from the following witnesses:

  • John Peterson “Pete” Myers, Ph.D., Founder, Chief Executive Officer (CEO) and Chief Scientist, Environmental Health Sciences;
     
  • Judith Enck, President, Beyond Plastics;
     
  • Matt Seaholm, CEO, Plastics Industry Association; and
     
  • Eric Hartz, Co-Founder and President, Nexus Circular.
     
MISCELLANEOUS

California Department Of Pesticide Regulation Issues An Enforcement Action Against TriCal And Announces Proposed Rule On Additional Use Restrictions On 1,3-D: On November 15, 2022, the California Department of Pesticide Regulation (DPR) made two announcements: an enforcement action relating to 1,3-dichloropropene (1,3-D) and chloropicrin and an announcement on a proposed rule on additional use restrictions on 1,3-D. These actions may have significant impacts on registrants and growers who use soil fumigants. For more information, see our November 30, 2022, blog item.

EPA Proposes Revisions To Its FOIA Regulations: On November 17, 2022, EPA proposed revisions to its regulations under the Freedom of Information Act (FOIA). 87 Fed. Reg. 68946. According to EPA, the proposed rule supports its mission by updating the process by which the public may access information about EPA actions and activities. EPA proposes changes to clarify certain provisions and align with FOIA and with EPA and government-wide policy. EPA proposes to modify existing 40 C.F.R. Section 2.102(c) and move it to 40 C.F.R. Section 2.102(b), first, to define more clearly what it means for a FOIA request to describe reasonably the records sought and, second, to clarify how EPA would treat a FOIA request that does not reasonably describe the records sought. EPA proposes 20 calendar days as the time in 40 C.F.R. Section 2.102(c) a requester would be given to respond to EPA's notice that the requester has not reasonably described the records sought. EPA also proposes and seeks comment on several provisions that EPA believes would enhance the readability, clarity, and usability of EPA’s FOIA regulations. Comments are due December 19, 2022.

EPA Postpones Public Science Meeting To Discuss The “IRIS Assessment Plan And Protocol For Assessing Cancer Risk From Inhalation Exposure To Cobalt And Cobalt Compounds”: On December 2, 2022, EPA announced that it is postponing the public science meeting to discuss the “IRIS Assessment Plan and Protocol for Assessing Cancer Risk from Inhalation Exposure to Cobalt and Cobalt Compounds.” 87 Fed. Reg. 74146. The public science webinar originally scheduled for November 30, 2022, is postponed and a new meeting date will be scheduled in early 2023.

CPSC Announces That Further Rulemaking Regarding Phthalates Not Warranted At This Time: On December 5, 2022, the Consumer Product Safety Commission (CPSC) published a notice in response to a federal court decision remanding CPSC’s final phthalates rule, without vacatur, to it to address two procedural deficiencies the court found. 87 Fed. Reg. 74311. The document provides notice of the availability of CPSC staff's memorandum responding to public comments on the justification for the phthalates final rule and on the staff's cost-benefit analysis of continuing the interim prohibition on diisononyl phthalate (DINP). The document also provides CPSC’s finding that further rulemaking is not warranted at this time.

Materials Available From EPA’s NAMs Conference And CompTox Chemicals Dashboard Training: On December 7, 2022, EPA announced that the final video recording, slide deck, and case study worksheets from the CompTox Chemicals Dashboard virtual training are now available. EPA also announced that the Dashboard recently released a new version (v2.1.1). The recordings and slides from the October 12-13, 2022, EPA NAM Conference are available on the conference web page.

CDC And ATSDR Announce Availability Of Final Guidelines For Examining Unusual Patterns Of Cancer And Environmental Concerns: On December 8, 2022, the Centers for Disease Control and Prevention (CDC) and ATSDR announced the availability of the final Guidelines for Examining Unusual Patterns of Cancer and Environmental Concerns (2022 Guidelines). 87 Fed. Reg. 75273. The 2022 Guidelines provide updates to the 2013 publication, Investigating Suspected Cancer Clusters and Responding to Community Concerns: Guidelines from the CDC and the Council of State and Territorial Epidemiologists (CSTE). According to CDC, the updates provide state, Tribal, local, and territorial health departments guidance for a revised and expanded approach to evaluating concerns about unusual patterns of cancer in communities, including those associated with local environmental concerns.

FTC Seeks Public Comment On Potential Updates To The Green Guides, Will Begin 60-Day Comment Period In January 2023: The Federal Trade Commission (FTC) announced on December 14, 2022, that it is seeking public comment on potential updates and changes to the Guides for the Use of Environmental Claims (Green Guides). FTC intends the Green Guides to help marketers avoid making environmental marketing claims that are unfair or deceptive under Section 5 of the FTC Act. FTC requests general comments on the continuing need for the Green Guides, their economic impact, their effect on the accuracy of various environmental claims, and their interaction with other environmental marketing regulations. FTC also seeks consumer survey evidence and consumer perception data regarding environmental claims, including those not in the Green Guides currently. FTC has posted a pre-publication version of the Federal Register notice. Publication of the notice in the Federal Register, which is expected in mid-January 2023, will begin a 60-day comment period. More information and a detailed commentary will be available in a forthcoming memorandum that will be posted on our website.

NYS DEC Will Hold Virtual Public Meeting On January 10 On Chemicals Under Consideration For Listing As Toxic Chemicals In Children’s Products Program: The New York State Department of Environmental Conservation (NYS DEC) will hold a virtual public meeting on January 10, 2023, on the chemicals under consideration for listing as Chemicals of Concern (COC) and High Priority Chemicals (HPC) for the Toxic Chemicals in Children’s Products (TCCP) program. NYS DEC will present an overview of the enacted TCCP law and discuss the chemicals under consideration for listing as COCs and HPCs that manufacturers will be required to report if present in children’s products. NYS DEC asks that stakeholders note that it “is soliciting feedback on these chemicals under consideration and will post them on our website in advance of the meeting. Additionally, please note that this will be a pre-rulemaking meeting and DEC anticipates releasing a proposed rule with additional public comment opportunities after feedback at this meeting is obtained.” Registration for the January 10, 2023, meeting is required.

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.

 
BERGESON & CAMPBELL, P.C.
2200 Pennsylvania Avenue, NW, Suite 100W
Washington, D.C. 20037
202-557-3800 • 202-557-3836 (fax) | lawbc.com
Contact • Twitter
 
Privacy Policy | Terms of Use | Cookie Policy | Attorney Advertising | Trademarks
©2023 Bergeson & Campbell, P.C.
All Rights Reserved.