Federal Development Update for December 2021


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.

A Conversation With Michal Freedhoff, Ph.D., Assistant Administrator, OCSPP: Bergeson & Campbell, P.C.’s (B&C®) podcast All Things Chemical® is pleased to present “A Conversation with Michal Freedhoff, Ph.D., Assistant Administrator, OSCPP.” In this episode, Lynn L. Bergeson, Managing Partner, B&C, sits down with Dr. Michal I. Freedhoff, Assistant Administrator, Office of Chemical Safety and Pollution Prevention (OCSPP), U.S. Environmental Protection Agency (EPA). They engage in a review of OCSPP’s priorities, including new chemical review, industrial chemical testing, EPA’s PFAS Action Plan for per- and polyfluoroalkyl substances (PFAS), and how OCSPP is dealing with a workload that is not matched by existing resources.

Steven P. Brennan, Ph.D., Joins The Acta Group As Senior Manager, REACH: B&C’s consulting affiliate The Acta Group (Acta®) is pleased to announce that Steven P. Brennan, Ph.D., has joined our firm in our Manchester, England, office as Senior Manager, REACH. In his new role, Dr. Brennan will utilize his decade of experience at global manufacturing and consulting firms to help clients plan, execute, routinize, and communicate compliance with European Union (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), EU Restriction of Hazardous Substances (RoHS) Directive, the United Kingdom’s (UK) version of REACH (UK REACH), and EU’s Classification, Labelling and Packaging Regulation (CLP).

Lynn L. Bergeson Authors “Straddling Digital And Environmental Goals: Tips For Investors” For Financier Worldwide: The environmental impacts of the digital economy are increasingly the focus of attention and concern. There is no question the demand for electricity, water, and land have increased sharply in response to the growth in digital activity. Identifying, quantifying, and mitigating environmental and ecological impacts are core to value creation, and investors must be mindful of how a company is positioned to create value while avoiding public rebuke for neglecting to account for the environmental impacts of greatly increased digital activity. This article explores the digital economy, the growing set of metrics used to assess environmental sustainability in a digital economy, the tools companies are using to improve efficiency, lessen environmental impacts, and increase supply chain transparency and traceability, and tips for investors in assessing a company’s environmental awareness of the impacts of greatly increased digital activity.

B&C And Acta To Publish Forecast 2022: Start 2022 with the information you need -- B&C and Acta will publish our Forecast for U.S. Federal and International Chemical Regulatory Policy 2022 the first week of January 2022. In the Forecast, our legal, scientific, and regulatory professionals distill key trends in U.S. and global chemical law and provide their best informed judgment of key developments likely in the coming year.

TSCA/FIFRA/TRI

Lynn L. Bergeson Authors “Supply-Chain Aid — EPA Proposes PIP 3:1 Compliance Extension” For Chemical Processing: EPA announced on October 21 that it intends to move further back the compliance dates related to articles containing phenol, isopropylated phosphate (3:1) (PIP (3:1)) to ensure supply chains for key consumer and commercial goods are not disrupted. The Agency proposed extending the compliance date until October 31, 2024, along with the associated recordkeeping requirements for manufacturers, processors, and distributors of PIP (3:1)-containing articles. This article discusses this important development.

OIG Report Includes Ensuring The Safe Use Of Chemicals Among EPA’s FY 2022 Top Management Challenges: On November 15, 2021, the EPA Office of Inspector General (OIG) announced the availability of its annual report summarizing what OIG considers the “most serious management and performance challenges facing the agency.” According to OIG, EPA’s top management challenges in fiscal year (FY) 2022 include:

  • Mitigating the Causes and Adapting to the Impacts of Climate Change;
     
  • Integrating and Leading Environmental Justice across EPA and the Government;
     
  • Ensuring the Safe Use of Chemicals;
     
  • Safeguarding Scientific Integrity Principles;
     
  • Ensuring Information Technology and Systems Are Protected against Cyberthreats;
     
  • Managing Infrastructure Funding and Business Operations; and
     
  • Enforcing Environmental Laws and Regulations.
     

More information is available in our November 17, 2021, blog item.

EPA Proposes SNURs On Certain Chemical Substances: On November 17, 2021, EPA proposed significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for chemical substances that were the subject of premanufacture notices (PMN). 86 Fed. Reg. 64115. The chemical substances received “not likely to present an unreasonable risk” determinations under TSCA. On November 24, 2021, EPA proposed SNURs for chemical substances that were the subject of PMNs and are also subject to orders issued by EPA pursuant to TSCA. 86 Fed. Reg. 66993. 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 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 has taken such actions as are required by that determination. Comments on the SNURs proposed on November 17, 2021, are due December 17, 2021. Comments on the SNURs proposed on November 24, 2021, are due December 27, 2021.

EPA Denies TSCA Section 21 Petition Seeking The Elimination Of Hazardous Chemicals Used In Mixtures In Cosmetics: On November 17, 2021, EPA announced the availability of its response to an August 16, 2021, petition filed under TSCA Section 21 TSCA. 86 Fed. Reg. 64129. William D. Bush requested that EPA determine that the “chemical mixtures contained within cosmetics present an unreasonable risk of injury to health and the environment,” and issue a rule or order under TSCA to “eliminate the hazardous chemicals used in mixtures [in cosmetics].” EPA states that after “careful consideration,” it has denied the petition. EPA states that to the extent the petition seeks a TSCA Section 6 action on “cosmetics” when manufactured, processed, or distributed in commerce as cosmetics, the requested actions are not within its jurisdiction under TSCA. In addition, according to EPA, to the extent the petition seeks action on “chemical substances” within the TSCA Section 3(2) definition of that term, EPA finds that the petition did not set forth facts establishing that it is necessary for EPA to initiate an appropriate proceeding pursuant to TSCA Section 21.

Petition To Revoke Food Tolerances And Cancel Registrations For Organophosphate Pesticides Filed: On November 18, 2021, the United Farm Workers and several other non-governmental organizations (NGO) filed a petition with EPA to revoke all food tolerances and cancel registrations for organophosphate (OP) pesticides. The petition was filed pursuant to the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. Section 346a(d), the Administrative Procedure Act (APA), 5 U.S.C. Section 551, and the First Amendment Constitutional Right to Petition. The petition seeks final EPA actions to revoke tolerances and cancel registrations for 15 OPs by the registration review deadline of October 1, 2022.

More information on the petition is available in our blog.

EPA Announces Extension Of Emerging Viral Pathogens Guidance For COVID 19: On November 19, 2021, EPA announced that it is extending COVID-19 activation of the emerging viral pathogens (EVP) guidance for antimicrobial pesticides indefinitely. EPA states that its EVP guidance for antimicrobial pesticides is a part of the federal government’s pandemic preparedness, allowing manufacturers to provide EPA with data, even in advance of an outbreak, demonstrating that their products are effective against hard-to-kill viruses. More information is available in our November 24, 2021, blog.

EPA Publishes Receipt And Status Information For Certain New Chemicals For October 2021: On November 22, 2021, EPA published the receipt and status reports for the period from October 1, 2021, to October 31, 2021. 86 Fed. Reg. 66296. 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 under 40 C.F.R. Part 725 (Biotech exemption); test marketing exemptions (TME), both pending and/or concluded; notices of commencement (NOC) to manufacture a new chemical substance; and a periodic status report on new chemical substances that are currently under EPA review or have recently concluded review. Comments identified by the specific case number provided by EPA are due December 22, 2021.

EPA Announces Legally Mandated Changes To TSCA Fees: EPA announced on November 23, 2021, legally mandated changes to the fee requirements under TSCA. This is not the fee adjustment we have been awaiting. It is a routine increase that TSCA directs EPA every three years to adjust the fees. The adjustment will go into effect on January 1, 2022, and will apply to all TSCA fees. The fee adjustment will not be retroactive and will not impact previous fee invoicing. According to EPA, separate from this action, EPA plans to propose additional revisions in 2022 to the 2018 TSCA Fees Rule to supplement its January 2021 proposal to ensure that TSCA fee amounts capture up to 25 percent of the actual costs of TSCA activities, fees are distributed equitably, and fee payers are identified through a transparent process. For more information on EPA’s announcement, please see our November 24, 2021, memorandum.

EPA Adds Natural Gas Processing Facilities To TRI: On November 24, 2021, EPA added natural gas processing (NGP) facilities (also known as natural gas liquid extraction facilities) to the scope of the industrial sectors covered by the reporting requirements of the Emergency Planning and Community Right-to-Know Act (EPCRA), commonly known as the Toxics Release Inventory (TRI), and the Pollution Prevention Act (PPA). 86 Fed. Reg. 66953. EPA states that adding these facilities will meaningfully increase the information available to the public on releases and other waste management of listed chemicals from the NGP sector and further the purposes of EPCRA. In its November 24, 2021, press release, EPA states that the final rule will provide communities with important information about how toxic chemicals are being managed by these facilities in and near their communities. According to EPA, this information can be especially important to fenceline communities, where releases to water, air, or land could be of a greater impact. The final rule will be effective December 27, 2021, and will apply for the reporting year beginning January 1, 2022 (reports due July 1, 2023).

EPA Publishes Updated NAMs Work Plan: On December 2, 2021, EPA published an updated New Approach Methods (NAM) Work Plan. EPA created the work plan to prioritize its efforts and resources toward activities that aim to reduce the use of vertebrate animal testing while continuing to protect human health and the environment. EPA describes its updated roadmap and identifies tangible steps to pursuing and achieving a reduction in the use of vertebrate animals for toxicity testing and related research while ensuring that its regulatory, compliance, and enforcement activities, including chemical and pesticide approvals and EPA research, remain fully protective of human health and the environment. In the updated work plan, EPA discusses the near- and long-term strategies it will deploy through 2024 to accomplish its objectives, working across offices and with stakeholders, and the different deliverables on which it will focus, so the public can track EPA’s progress. More information is available in our December 9, 2021, memorandum.

EPA Announces Updated Registration Review Schedule And Announces Completion Of Safety Assessments And Decisions For Hundreds Of Pesticides: On December 2, 2021, EPA announced it released the registration review schedule for the next four years through FY 2025. While historically this schedule has been updated once each year, EPA states that going forward it will be updated on a quarterly basis. More information is available in our December 7, 2021, blog item.

EPA Issues Final SNURs On Certain Chemical Substances: On December 10, 2021, EPA issued final SNURs under TSCA for chemical substances that were the subject of PMNs. 86 Fed. Reg. 70385. The SNURs require persons to notify EPA at least 90 days before commencing manufacture (defined by statute to include import) or processing of any of these chemical substances for an activity that is designated as a significant new use by the SNURs. The SNURs further require that persons not commence manufacture or processing for the significant new use until they have submitted a SNUN and EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken any risk management actions that are required as a result of that determination. The SNURs will take effect on February 8, 2022.

EPA’s Fall 2021 Unified Agenda Includes TSCA Rulemakings: On December 10, 2021, the Biden Administration released its Fall 2021 Unified Agenda of Regulatory and Deregulatory Actions. According to the EPA rule list, OCSPP is working on a number of TSCA rulemakings. More information is available in our December 14, 2021, blog item.

EPA OIG FY 2022 Oversight Plan Includes Oversight Projects Intended To Ensure The Safe Use Of Chemicals: The EPA OIG announced the availability of its FY 2022 oversight plan on December 14, 2021. According to OIG, the plan reflects the priority work that the OIG believes is necessary to keep EPA, the U.S. Chemical Safety and Hazard Investigation Board (CSB), and Congress fully informed about issues relating to the administration of EPA programs and operations. The planned and ongoing oversight projects include several concerning Ensuring the Safe Use of Chemicals. More information is available in our December 15, 2021, blog item.

EPA Announces Annual Pesticide Maintenance Fee Forms Available To Download From EPA Website -- Deadline For Paying Is January 18, 2022: The January 18, 2022, deadline for payment of EPA’s annual maintenance fee for pesticide registrations is approaching. Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 4(i)(1)(A) requires everyone who holds an active or suspended pesticide registration granted under FIFRA Sections 3 and 24(c) (special local needs) to pay an annual maintenance fee to keep the registration in effect. The maintenance fee requirement does not apply to supplemental registrations of distributors, which are identified by a three-element registration number. The instructions, maintenance fee filing form, fee tables, and product listings grouped by company numbers are available to download on EPA’s website. When completed, the filing submission should be e-mailed to maintfee@epa.gov. A paper copy should not be sent to EPA. More information is available in our December 14, 2021, blog.

RCRA/CERCLA/CWA/CAA/PHMSA/SDWA

EPA Asks SAB To Review Draft Documents On Health Effects Of Certain PFAS, Will Issue Updated Health Advisories For PFOA And PFOS: On November 16, 2021, EPA announced that it is asking its Science Advisory Board (SAB) to review four draft scientific documents regarding the health effects of certain PFAS. EPA states that it is committed to science-based approaches to protect public health from exposure to perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS), “including by quickly updating drinking water health advisories with new peer-reviewed approaches and expeditiously developing National Primary Drinking Water Regulations for these contaminants.” According to EPA, it “will move as quickly as possible to issue updated health advisories for PFOA and PFOS that reflect this new science and input.” Concurrently, EPA will continue to develop a proposed PFAS National Primary Drinking Water Regulation (NPDWR) for publication in fall 2022.

EPA Publishes Final RTR Rules For Certain NESHAP Source Categories: Since November 15, 2021, EPA has published the following final rules regarding residual risk and technology reviews (RTR) for the following national emission standards for hazardous air pollutants (NESHAP) source categories:

  • Flexible Polyurethane Foam Fabrication Operations (86 Fed. Reg. 64385): The November 18, 2021, final rule amends the NESHAP to include adding a numeric emission limit for existing flame lamination units, removing exemptions for periods of startup, shutdown, and malfunction (SSM) and specifying that the emissions standards always apply, requiring periodic performance tests, and requiring electronic reporting of performance test results and compliance reports. EPA is also amending the NESHAP for Flexible Polyurethane Foam Production and Flexible Polyurethane Foam Fabrication area sources to remove references to the provisions of another NESHAP that has been revised and no longer contains the referenced provisions. The final rule was effective November 18, 2021.
     
  • Carbon Black Production and Cyanide Chemicals Manufacturing (86 Fed. Reg. 66096): On November 19, 2021, EPA issued a final rule concerning the RTR conducted for the Carbon Black Production and Cyanide Chemicals Manufacturing major source categories and the technology review conducted for Carbon Black Production area sources. In addition, EPA added new emissions standards for the Carbon Black Production and Cyanide Chemicals Manufacturing major source categories to address hazardous air pollutant (HAP) emissions not previously covered by these NESHAP. EPA also published amendments addressing the SSM provisions of the NESHAP and requiring electronic reporting of certain notifications, performance test results, and semiannual reports. The final rule was effective November 19, 2021.
     
  • Refractory Products Manufacturing (86 Fed. Reg. 66045): According to the November 19, 2021, final rule, EPA found the risks due to emissions of air toxics from this source category to be acceptable and that the standards provide an ample margin of safety to protect public health. As a result, EPA made no revisions to the emission limits for this source category based on the residual risk. In its technology review, after reviewing developments in practices, processes, and control technologies, EPA determined that no revisions to the numeric emission limits is necessary. EPA is revising certain work practice provisions based on the technology review, however. The final amendments include new provisions for certain HAPs and a revision of the alternative fuel provisions. EPA took final action on the proposed amendments for the source category to address emissions during SSM periods; emissions during periods of scheduled maintenance; electronic reporting of notification of compliance status (NOCS) reports, performance test results, and performance evaluation results; the addition of test methods and guidance materials; updates to several test methods; and other miscellaneous clarifying and technical corrections. The final rule was effective November 19, 2021.
     

EPA Proposes Amendments To NESHAP For Paint Stripping And Miscellaneous Surface Coating Operations At Area Sources: On November 19, 2021, EPA published its proposed results of the technology review conducted in accordance with the Clean Air Act (CAA) for the NESHAP for Paint Stripping and Miscellaneous Surface Coating Operations at Area Sources and proposed amendments to the NESHAP. 86 Fed. Reg. 66130. EPA proposes no changes to the NESHAP as a result of the technology review. EPA proposes to amend provisions regarding electronic reporting; make miscellaneous clarifying and technical corrections; simplify the petition for exemption process; and clarify requirements addressing emissions during SSM periods. Comments are due January 3, 2022.

EPA And Army Propose To Re-Establish Pre-2015 Definition Of Waters Of The United States: On December 7, 2021, EPA and the U.S. Department of the Army proposed to re-establish the pre-2015 definition of “waters of the United States,” updated to reflect consideration of Supreme Court decisions. 86 Fed. Reg. 69372. In the proposed rule, the agencies interpret the term “waters of the United States” to include: traditional navigable waters, interstate waters, and the territorial seas, and their adjacent wetlands; most impoundments of “waters of the United States”; tributaries to traditional navigable waters, interstate waters, the territorial seas, and impoundments that meet either the relatively permanent standard or the significant nexus standard; wetlands adjacent to impoundments and tributaries that meet either the relatively permanent standard or the significant nexus standard; and “other waters” that meet either the relatively permanent standard or the significant nexus standard. The “relatively permanent standard” means waters that are relatively permanent, standing, or continuously flowing and waters with a continuous surface connection to such waters. The “significant nexus standard” means waters that either alone or in combination with similarly situated waters in the region, significantly affect the chemical, physical, or biological integrity of traditional navigable waters, interstate waters, or the territorial seas (the “foundational waters”). With these amendments to the 1986 regulations, the proposed rule is within the proper scope of the agencies’ statutory authority and would restore and maintain the chemical, physical, and biological integrity of the nation’s waters. Through the rulemaking process, the agencies will consider all public comments, including changes that improve clarity, implementability, and long-term durability of the definition. According to the notice, “[t]he agencies will also consider changes through a second rulemaking that they anticipate proposing in the future, which would build upon the foundation of this proposed rule.” Comments are due February 7, 2022.

EPA Proposes Comprehensive Set Of Biofuels Program Updates And Improvements: On December 7, 2021, EPA announced that to strengthen the role of the Renewable Fuel Standard (RFS) in advancing greater use of low-carbon renewable fuels, it will propose a package of actions setting biofuels volumes for years 2022, 2021, and 2020, and introducing regulatory changes intended to enhance the program’s objectives. In addition, EPA will seek public comment on a proposed decision to deny petitions to exempt small refineries from their obligations under the RFS on the grounds that petitioners failed to show that EPA has a basis under the CAA and recent federal case law to approve them. EPA states that “[t]ogether, these actions reflect the Biden Administration’s commitment to reset and strengthen the RFS program following years of mismanagement by the previous administration and disruptions to the fuels market stemming from the COVID-19 pandemic.” For 2022, EPA will propose “the highest total volumes in history, putting the program on a stable trajectory that provides for significant growth.” The proposed volumes for 2022 are over 3.5 billion gallons higher than the volume of renewable fuel used in 2020. The proposed volume of advanced biofuel for 2022 is over one billion gallons greater than the volume used in 2020. EPA is also proposing to add a 250-million-gallon “supplemental obligation” to the volumes proposed for 2022 and stating its intent to add another 250 million gallons in 2023.

EPA will hold a virtual public hearing on January 4, 2022, on its proposal. 86 Fed. Reg. 70426. EPA will hold an additional session on January 5, 2022, if necessary, to accommodate the number of testifiers that sign-up to testify. All hearing attendees (including even those who do not intend to provide testimony) should register for the public hearing by December 20, 2021, by sending an e-mail to ASD-Registration@epa.gov.

EPA Announces Grant Competition For Community Air Pollution Monitoring: EPA announced on December 13, 2021, the availability of $20 million in competitive grants through the American Rescue Plan (ARP) to enhance ambient air quality monitoring in communities across the United States, especially in underserved and overburdened communities that often lack access to adequate air quality information. EPA states that it will award funds to support community and local efforts to monitor air quality and to promote air quality monitoring partnerships between communities and Tribal, state, and local governments. To be considered for funding, grant applications must address ambient monitoring for at least one of the following types of air pollution: criteria pollutants (particle pollution, carbon monoxide, lead, nitrogen dioxide, ozone, or sulfur dioxide) and their precursors or HAPs, as defined by the CAA. Community-based nonprofit organizations, Tribes, states, and local governments may apply for the grants.

EPA Requests Nominations For Hazardous Waste Electronic Manifest System Advisory Board: On December 14, 2021, EPA requested nominations of experts to be considered for a three-year appointment to the Hazardous Waste Electronic Manifest System Advisory Board. 86 Fed. Reg. 71060. Pursuant to the Hazardous Waste Electronic Manifest Establishment Act (e-Manifest Act), EPA established the Board to provide practical and independent advice, consultation, and recommendations to the EPA Administrator on the activities, functions, policies, and regulations associated with the Hazardous Waste Electronic Manifest System. In accordance with the e-Manifest Act, the EPA Administrator or designee will serve as Chair of the Board. EPA seeks candidates to serve in the following positions: an expert in information technology (IT); an industry representative member with experience in using or representing users of the manifest system; and a state representative member responsible for processing manifests. Nominations are due January 13, 2022.

IRS Begins Comment Period On Notice Concerning Initial List Of Chemicals Subject To Superfund Tax: On December 13, 2021, the Internal Revenue Service (IRS) began a public comment period on “Superfund; Initial List of Taxable Substances; Registration; Procedural Rules; Request for Comments; Suspension of Notice 89-61” (Notice 2021-66). The notice relates to Section 80201 of the Infrastructure Investment and Jobs Act, Public Law 117-58, that reinstates, effective July 1, 2022, the excise taxes imposed on certain chemical substances by Sections 4661 and 4671 of the Internal Revenue Code (collectively, Superfund chemical taxes) and modifies the applicable rates of tax and other provisions related to those taxes. The notice provides the initial list of taxable substances required to be published by the Secretary of the Treasury or her delegate no later than January 1, 2022. The notice also addresses the registration requirements to exempt certain sales and uses of taxable chemicals from tax, and provides the procedural rules that apply to taxpayers subject to the reinstated Superfund chemical taxes. The notice requests comments on whether any issues related to the reinstated Superfund chemical taxes require clarification or additional guidance. Comments are due January 28, 2022.

SAB Panel Will Review Draft CCL 5 In 2022: The SAB Drinking Water Committee Augmented for Drinking Water Contaminant Candidate List 5 Review Panel will meet on January 11, 2022, to receive a briefing from EPA, discuss the charge to the SAB, and hear oral public comments. 86 Fed. Reg. 69241. The Panel will meet on February 16, 2022, and February 18, 2022, to review the draft Fifth Contaminant Candidate List (CCL 5) and associated support documents. EPA announced the availability of the draft CCL 5 on July 19, 2021. The draft CCL 5 includes 66 chemicals, three chemical groups (PFAS, cyanotoxins, and disinfection byproducts) and 12 microbial contaminants.

FDA

Earthjustice Files Lawsuit Regarding Phthalates In Food Contact Applications: On December 7, 2021, Earthjustice filed a Petition for Writ of Mandamus on behalf of environmental groups seeking a final decision from the U.S. Food and Drug Administration (FDA) for a petition filed in 2016 regarding ortho-phthalate esters (phthalates). The 2016 petition requested that FDA revoke authorizations for 28 phthalates that may be used in food packaging and processing materials based on listings in 21 C.F.R Sections 175.105, 175.300, 175.320, 175.380, 175.390, 176.170, 176.180, 176.210, 176.300, 177.1010, 177.1200, 177.1210, 177.1400, 177.1460, 177.1590, 177.2420, 177.2600, 178.3740, 178.3910, and 181.27.

FDA Proposes Changes To Agricultural Water Provisions: On December 6, 2021, FDA published a notice of proposed rulemaking (NPRM) to amend “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” rule as part of the Food Safety Modernization Act (FSMA). 86 Fed. Reg. 69120. The proposed amendments would revise certain provisions of agricultural water for produce subject to the requirements of 21 C.F.R. Part 112. The revisions would allow impacted parties the option to conduct water assessments to help farms identify potential sources of contamination and effectively manage their waste. Current requirements are viewed as complex and a challenge to implement. Comments can be submitted until April 5, 2022.

FDA Issues Response Plan Regarding Foodborne Outbreak: FDA announced on December 9, 2021, as part of FDA’s New Era of Smarter Food Safety, FDA’s Foodborne Outbreak Response Improvement Plan (FORIP). FDA notes that the intent of FORIP is to “enhance the speed, effectiveness, coordination, and communication” of investigations into outbreaks of foodborne illness. The basis for developing FORIP was to better inform the outbreak-related work under the New Era of Smarter Food Safety Blueprint. The FORIP was based on interviews of key officials at FDA, in addition to the United States Department of Agriculture’s (USDA) Food Safety Inspection Service (FSIS) and the Centers for Disease Control and Prevention (CDC), state health officials, and industry and consumer foodborne outbreak experts. FDA intends to hold a webinar in early 2022 to walk stakeholders through the plan and to respond to questions.

NANOTECHNOLOGY

EUON Releases Study On Product Lifecycles, Waste Recycling, And The Circular Economy For Nanomaterials: On November 15, 2021, the EU Observatory for Nanomaterials (EUON) announced the release of a report that it commissioned entitled “Study on the Product Lifecycles, Waste Recycling and the Circular Economy for Nanomaterials.” More information is available in our November 22, 2021, blog item.

ISO Publishes Standard On Evaluating The Antimicrobial Performance Of Textiles Containing Manufactured Nanomaterials: The International Organization for Standardization (ISO) recently published ISO/TS 23650:2021, “Nanotechnologies -- Evaluation of the antimicrobial performance of textiles containing manufactured nanomaterials.” ISO states that the standard specifies the antimicrobial performance assessment method for textiles containing manufactured (metals/metal oxides) nanomaterials. The textiles in the standard include fabric, yarn, and fiber in which manufactured nanomaterials are used during the production or finishing process. The standard also specifies protocols to determine the quantity of nanomaterials released from the textiles following washing and/or exposure to artificial human body sweat.

NNI Holds Webinar On “What We Know About NanoEHS: Risk Assessment And Risk Management”: On November 16, 2021, the National Nanotechnology Initiative (NNI) held a webinar entitled “What We Know about NanoEHS: Risk Assessment and Risk Management.” The webinar’s speakers explored the impact of advances in risk assessment and risk management on the safe and responsible development of nanotechnology. More information on the webinar is available in our November 18, 2021, blog item.

OECD Publishes Reports Evaluating Tools And Models For Assessing Exposure To Nanomaterials, Hosts Webinar Presenting Key Findings: The Organization for Economic Cooperation and Development (OECD) recently published several reports evaluating the tools and models used for assessing environmental, occupational, and consumer exposures to manufactured nanomaterials. On December 2, 2021, OECD hosted a webinar on how to assess exposure to nanomaterials. During the webinar, the researchers presented the key findings of the reports. More information is available in our November 23, 2021, blog item.

Amendments To Australia’s Industrial Chemicals General And Transitional Rules Include Provisions Concerning Nanoscale Chemicals: On November 22, 2021, the Australian Industrial Chemicals Introduction Scheme (AICIS) announced rules amendments and regulatory changes following amendments to the Industrial Chemicals (General Rules) 2019 and the Industrial Chemicals (Consequential Amendments and Transitional Provisions) Rules 2019. Changes that began on November 23, 2021, that concern nanoscale chemicals include internet content changes to clarify the requirements for chemicals introduced at the nanoscale (items 1-19 in Schedule 1 of the amending rules). Changes that began on December 10, 2021, that concern nanoscale chemicals include an extra requirement for pre-introduction reports that requires introducers to report whether the chemical is at the nanoscale. This applies to introductions of chemicals used only for research and development. More information is available in our November 24, 2021, blog item.

EPA Proposes SNUR For Certain Multi-Walled Carbon Nanotubes: On November 24, 2021, EPA proposed a SNUR for a chemical substance identified generically as multi-walled carbon nanotubes (PMN P-20-72). 86 Fed. Reg. 66993. According to EPA, the PMN states that the generic (non-confidential) use of the substance will be as an additive used to impart specific physiochemical properties to finished articles. Comments on the proposed SNUR are due December 27, 2021. More information is available in our November 29, 2021, blog item.

SCCS Considers HAA299 (Nano) Safe When Used As A UV Filter In Dermally Applied Cosmetic Products Up To Ten Percent: On November 25, 2021, the Scientific Committee on Consumer Safety (SCCS) published its final opinion on HAA299 (nano). According to the final opinion, SCCS considers that HAA299 (nano) as covered within the provided characteristics “is safe when used as a UV-filter in dermally-applied cosmetic products up to a maximum concentration of 10%.” More information is available in our November 30, 2021, blog item.

ISO TC 229 Begins Survey On Advanced And Emergent Materials: The American National Standards Institute (ANSI), which administers the U.S. Technical Advisory Group for the ISO Technical Committee (TC) 229 on Nanotechnologies, announced a survey seeking feedback on the use of terms related to advanced materials as part of its newly launched study group, Advanced and Emerging Materials. The survey seeks comments from subject matter experts, stakeholders, and other interested parties and is aimed at identifying the scientific, technical, and social views of select terms and definitions related to advanced and emergent materials.

Germany Publishes Report On Developing A Specific OECD Test Guideline On Particle Size And Particle Size Distribution Of Nanomaterials: In December 2021, the German Environment Agency (UBA) published a report entitled Development of a specific OECD Test Guideline on Particle Size and Particle Size Distribution of Nanomaterials. The UBA commissioned the Federal Institute for Occupational Safety and Health (BAuA) (project coordinator) and the Federal Institute for Materials Research and Testing (BAM) to develop an OECD⁠ Test Guideline for the determination of particle size and particle size distributions of nanomaterials. More information is available in our December 14, 2021, blog item.

BIOBASED/RENEWABLE PRODUCTS

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

LEGISLATIVE

Coalition Of State Attorneys General Urges Congress To Pass Legislation To Protect Communities From PFAS: On November 15, 2021, a coalition of 19 state attorneys general sent a letter to Congress to urge it to pass the PFAS Action Act (H.R. 2467). According to California Attorney General Rob Bonta’s press release, the coalition expressed support for the following critical priorities:

  • Designating PFAS as “hazardous substances” under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) to promote the clean-up of highly contaminated sites;
     
  • Designating PFAS as HAPs under the CAA and prohibit their unsafe incineration;
     
  • Establishing NPDWRs for PFAS under the Safe Drinking Water Act (SDWA) and controlling PFAS wastewater discharges under the Clean Water Act (CWA);
     
  • Providing funding to drinking water providers to treat contaminated water and to states for PFAS remediation;
     
  • Making medical screenings for PFAS widely available; and
     
  • Prohibiting the use and storage of firefighting foam containing PFAS at federal facilities.
     

Bipartisan Legislation Would Broaden Definition Of PFAS: On November 16, 2021, Representatives Deborah Ross (D-NC) and Nancy Mace (R-SC) introduced the PFAS Definition Improvement Act (H.R. 5987), bipartisan legislation that would amend existing law to ensure that EPA “uses a definition of PFAS that is as broad and protective as others that are already in use.” According to Ross’s press release, EPA’s current definition “requires at least two fully fluorinated carbon atoms, and they must be adjacent.” Numerous states and OECD use definitions of PFAS that require only one fully fluorinated carbon atom, however. As a result, the press release states, “EPA’s narrower definition will produce a rule that fails to capture many PFAS that are already included in other policies.”

Bipartisan Legislation Introduced To Ban PFAS In Food Containers: On November 18, 2021, Representatives Debbie Dingell (D-MI) and Don Young (R-AK) introduced the bipartisan Keep Food Containers Safe from PFAS Act (H.R. 6026), which would prohibit intentionally added PFAS in food packaging. Dingell’s November 18, 2021, press release states that PFAS “are frequently used to greaseproof, waterproof, and give nonstick properties to food containers, cookware, and consumer products. And it has been proven that the PFAS in those containers can contaminate the food, causing liver disease, thyroid dysfunction, and several forms of cancer.” According to the press release, the Environmental Working Group (EWG) “found that as many as 40 percent of fast food wrappers and paper products tested positive for fluorine chemicals.” Senators Maggie Hassan (D-NH) and Lisa Murkowski (R-AK) introduced companion legislation (S. 3169) in the Senate.

Senate Bill Would Amend FIFRA To Prohibit Dangerous Pesticides And Cancel Registrations Of Organophosphates, Neonicotinoids, and Paraquat: On November 23, 2021, Senator Cory Booker (D-NJ) announced his intention to reintroduce the Protect America’s Children from Toxic Pesticides Act of 2021 that would amend FIFRA “to [protect fully] the safety of children and the environment, to remove dangerous pesticides from use, and for other purposes.” Similar legislation was introduced in the House (H.R. 7940) and Senate (S. 4406) in 2020, but the bills did not move out of Committee. For more information on how the bill would amend FIFRA, please see our November 24, 2021, memorandum.

House Subcommittees Hold Hearing On PFAS R&D: On December 7, 2021, the House Science, Space, and Technology Subcommittees on Environment and on Research and Technology held a joint hearing entitled “Forever Chemicals: Research and Development for Addressing the PFAS Problem.” Four witnesses spoke before the Subcommittees on their respective knowledge of the current state of PFAS and where each felt future actions should be focused: Dr. Elsie Sunderland, Gordon McKay Professor of Environmental Chemistry, Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard T.H. Chan School of Public Health; Ms. Abigail Hendershott, Executive Director, Michigan PFAS Action Response Team (MPART); Ms. Amy Dindal, Director of Environmental Research and Development, Battelle Memorial Institute; and Dr. Peter Jaffé, Professor, Department of Civil and Environmental Engineering, Princeton University. For more information on the testimony provided at the hearing, please see our December 8, 2021, memorandum.

MISCELLANEOUS

President Biden Transmits Amendment To The Montreal Protocol To The Senate: On November 16, 2021, President Joseph Biden submitted to the Senate the Amendment to the Montreal Protocol on Substances that Deplete the Ozone Layer (the Montreal Protocol), adopted at Kigali on October 15, 2016, by the Twenty-Eighth Meeting of the Parties to the Montreal Protocol (the Kigali Amendment). The principal features of the Kigali Amendment provide for a gradual phasedown in the production and consumption of hydrofluorocarbons (HFC), which are alternatives to ozone-depleting substances being phased out under the Montreal Protocol, as well as related provisions concerning reporting, licensing, control of trade with non-Parties, and control of certain byproduct emissions. President Biden recommends that the Senate give favorable consideration to the Kigali Amendment and give its advice and consent to ratification at the earliest date.

CDC And ATSDR Release PFAS Exposure Assessment Report For Hampden County, Massachusetts, Site: On November 18, 2021, CDC and the Agency for Toxic Substances and Disease Registry (ATSDR) released the final PFAS exposure assessment report for the area near the Barnes Air National Guard Base site in Westfield, Hampden County, Massachusetts. According to CDC, the exposure assessment found that levels of some PFAS in the blood of Westfield residents were higher than national levels. Elevated levels of PFAS in blood may be linked with past contamination of the city’s drinking water. Tap water samples collected during the 2019 exposure assessment met EPA’s 2016 Health Advisory and Massachusetts Department of Environmental Protection’s public health guidelines. CDC states that ATSDR does not recommend that community members use alternative sources of water.

OSHA Announces New Online Portal For Applying For Voluntary Protection Programs: On November 22, 2021, the Occupational Safety and Health Administration (OSHA) announced that a new online portal for submitting applications to its Voluntary Protection Programs (VPP) is now available. In practice, VPP sets performance-based criteria for a managed safety and health system, invites sites to apply, and then assesses applicants against these criteria. According to OSHA, the new portal modernizes the application process and makes it easier for candidates to start, continue, and get assistance with submitting their applications. The portal allows OSHA to review applications in real time, and help companies correct errors or omissions quickly. Applicants can use the portal to upload electronic versions of supporting documentation, and they can stop and complete their application at a later time without having to restart.

EPA Announces Release Of NASEM Peer Review Of IRIS Handbook: On November 30, 2021, EPA announced the release of the National Academies of Sciences, Engineering, and Medicine’s (NASEM) external peer review report of the Office of Research and Development (ORD) Staff Handbook for Developing Integrated Risk Information System (IRIS) Assessments (IRIS Handbook). The NASEM committee found that the IRIS Handbook “reflects the significant improvements that EPA has made in its IRIS assessment process.” The committee found that the Handbook does not consistently convey the strengths and advances in methodology for the IRIS assessment process in an even and clear manner, however. The report includes the committee’s recommendations to ensure the IRIS Handbook meets its objectives of providing transparency about the IRIS assessment process and providing operational instructions for those conducting the assessments. More information is available in our December 1, 2021, blog item.

NASEM Recommends That The United States Create A National Strategy To Reduce Its Contribution To Global Ocean Plastic Waste: On December 1, 2021, NASEM announced the availability of a new report recommending that the United States create a national strategy by the end of 2022 to reduce its contribution to plastic waste in the ocean, including substantially reducing the amount of solid waste generated in the United States. The report also recommends that the United States establish a nationally coordinated and expanded monitoring system to track plastic pollution to understand the scale and sources of the U.S. plastic waste problem, set reduction and management priorities, and measure progress in addressing it.

OSHA Extends Comment Period On COVID-19 Vaccination And Testing ETS: On December 3, 2021, OSHA extended the comment period on the November 5, 2021, COVID-19 vaccination and testing emergency temporary standard (ETS). 86 Fed. Reg. 68560. Comments on any aspect of the ETS and whether the ETS should be adopted as a permanent standard are due January 19, 2022. On November 12, 2021, the U.S. Court of Appeals for the Fifth Circuit granted petitioners’ motion for a stay pending judicial review.

PFAS Added To TURA Program In Massachusetts: On December 7, 2021, the governing body of the Toxics Use Reduction Act (TURA) program voted to list most PFAS. According to the December 10, 2021, press release issued by the Toxics Use Reduction Institute (TURI), while the listing of PFAS under TURA would not prohibit their use, “it will enhance understanding of the use of these chemicals in industry, and support and encourage prevention by activating Toxics Use Reduction - a successful mechanism for innovation and safer substitution.” The press release states that facilities in Massachusetts that are subject to TURA and use large amounts of PFAS are expected to track use beginning in 2022 and report use of PFAS by July 1, 2023.

EO On Catalyzing Clean Energy Industries And Jobs Through Federal Sustainability Calls For Prioritizing Purchase Of Sustainable Products: On December 8, 2021, President Joseph Biden signed an Executive Order (EO) on Catalyzing Clean Energy Industries and Jobs Through Federal Sustainability. 86 Fed. Reg. 70935. The EO calls for the federal government to achieve a carbon pollution-free electricity sector by 2035 and net-zero emissions economy-wide by no later than 2050. Using a whole-of-government approach, the federal government “will demonstrate how innovation and environmental stewardship can protect our planet, safeguard Federal investments against the effects of climate change, respond to the needs of all of America’s communities, and expand American technologies, industries, and jobs.” The EO directs agencies to “incentivize markets for sustainable products and services by prioritizing products that can be reused, refurbished, or recycled; maximizing environmental benefits and cost savings through use of full lifecycle cost methodologies; purchasing products that contain recycled content, are biobased, or are energy and water efficient, in accordance with relevant statutory requirements; and, to the maximum extent practicable, purchasing sustainable products and services identified or recommended by” EPA. According to the fact sheet, sustainable products include “products without added perfluoroalkyl or polyfluoroalkyl substances (PFAS).”

OEHHA Modifies Proposed Changes to “Short-Form” Warnings: On December 13, 2021, the California Office of Environmental Health Hazard Assessment (OEHHA) issued a notice proposing modifications to the revisions it first proposed on January 8, 2021, to its Proposition 65 (Prop 65) Article 6 “clear and reasonable warnings” regulations for “short-form” warnings (Notice). More information regarding the January 8, 2021, proposal is available in our January 21, 2021, memorandum. OEHHA is requesting comments on its Notice and the modifications to the proposed regulatory text to be submitted no later than January 14, 2022. More information is available in our December 14, 2021, memorandum.

EPA Requests Nominations Of Candidates To Environmental Financial Advisory Board: On December 14, 2021, EPA invited nominations of qualified candidates to be considered for appointment to the Environmental Financial Advisory Board. 86 Fed. Reg. 71058. The Board provides advice to EPA on ways to lower the costs of, and increase investments in, environmental and public health protection. The Bipartisan Infrastructure Law (signed in November 2021) provides funding to EPA that includes more than $50 billion for clean water projects, more than $5 billion for Superfund and brownfields cleanup work, $5 billion for decarbonizing school buses, and $100 million for pollution prevention. Board members will provide recommendations on ways EPA can implement these funds to advance environmental justice, tackle the climate crisis, and protect public health. Appointments will be made by the Administrator and will be announced in June 2022. Nominations are due January 18, 2022.

White House Environmental Justice Advisory Council Will Meet In January: The White House Environmental Justice Advisory Council will meet virtually on January 26-27, 2022. 86 Fed. Reg. 71062. The meeting discussion will focus on several topics. including, but not limited to the discussion and deliberation of draft recommendations to the Chair of the Council on Environmental Quality and the White House Interagency Council on Environmental Justice from the Justice40 Work Group, Climate and Economic Justice Screening Tool Work Group, and the Scorecard Work Group. EPA encourages members of the public to provide comments relevant to the specific issues being considered. Pre-registration 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.

 
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