Wrap-Up of Federal and State Chemical Regulatory Developments, September 2021

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TSCA/FIFRA/TRI

Are You A TSCA Newbie?: If you are among the recently minted class of “TSCA newbies,” help has arrived. The Toxic Substances Control Act (TSCA) has long been relegated to the unique province of industrial chemical manufacturers -- those that make or import industrial chemicals. Not anymore. TSCA now applies to many businesses in the finished product community, perhaps including your company. B&C is pleased to offer you and your company the TSCA Starter Kit to help you understand TSCA and comply with it.

Lynn L. Bergeson Authors “EPA Goes Back To The Drawing Board On Toxic Substances” For Chemical Processing: The implementation of TSCA provisions relating to regulating persistent, bioaccumulative, and toxic (PBT) chemicals has been anything but smooth. On September 3, 2021, EPA announced it intends to initiate new PBT rulemaking and anticipates proposing new rules for five PBT chemicals subject to final risk management rules under TSCA Section 6(h). Additionally, and happily, the Agency extended the compliance dates for the prohibitions on processing and distribution and the associated recordkeeping requirements of one of these PBT chemicals, phenol, isopropylated phosphate (3:1) (PIP (3:1)). The action was imperative as EPA’s earlier-issued “No Action Assurance” (NAA) lapsed on September 4, 2021. This article provides key points related to this complicated area of TSCA regulation. The full article is available to read online.

A Conversation With The NRDC’s Daniel Rosenberg: In the recent All Things Chemical™ episode A Conversation with the NRDC’s Daniel Rosenberg, Lynn L. Bergeson and Daniel Rosenberg, Director, Federal Toxics Policy, Healthy People & Thriving Communities Program, at the Natural Resources Defense Council (NRDC), discuss new TSCA, the EPA’s implementation of the 2016 amendments to TSCA under Lautenberg, several recent regulatory initiatives involving PBT chemicals and PFAS, and much more.

Celebrating 25 Years Of FQPA -- A Personal View: The Food Quality Protection Act (FQPA) was enacted on August 3, 1996. Previous to joining B&C, Jim Aidala was former Assistant Administrator for EPA’s Office of Prevention, Pesticides, and Toxic Substances (OPPTS) (now the Office of Chemical Safety and Pollution Prevention (OCSPP)). As Associate Assistant Administrator for OPPTS, Jim led the team responsible for legislative drafting of FQPA. Please read our blog for Jim’s thoughts on how FQPA came to be.

EPA Announces Electronic Process For Submitting Foreign Purchaser Acknowledgement Statements: On August 17, 2021, EPA announced that it is now accepting official Foreign Purchaser Acknowledgement Statements (FPAS) and FPAS annual summaries through the Central Data Exchange Pesticide Submission Portal (CDX PSP). EPA states this improved process allows for pesticide exporters to submit an FPAS electronically rather than physically mailing them, providing a key flexibility during the COVID-19 public health emergency. According to the Federal Register notice, an FPAS may be submitted using CDX PSP as of August 18, 2021. 86 Fed. Reg. 46246. More information is available in our August 19, 2021, blog.

EPA Issues Final SNURs On Certain Chemical Substances: On August 18, 2021, EPA issued two batches of final significant use rules (SNUR) under TSCA for chemical substances that were the subject of premanufacture notices (PMN). 86 Fed. Reg. 46123, 86 Fed. Reg. 46133. 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 significant new use notice (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 October 18, 2021.

EPA Publishes Statements Of Findings For June 2021 For Certain New Chemicals Or Significant New Uses: On August 18, 2021, EPA published its statements of findings made after reviewing notices submitted under TSCA Section 5(a) that certain new chemical substances or significant new uses are not likely to present an unreasonable risk of injury to health or the environment. 86 Fed. Reg. 46240. The notice presents statements of findings made by EPA during the period from June 1, 2021 to June 30, 2021.

EPA Announces It Will Take Action To Address Risk From Chlorpyrifos: On August 18, 2021, EPA announced that it will stop the use of the pesticide chlorpyrifos on all food. In the Federal Register notice issued on August 30, 2021, EPA is revoking all “tolerances” for chlorpyrifos, which establish an amount of a pesticide that is allowed on food. 86 Fed. Reg. 48315. In addition, EPA states that it will issue a Notice of Intent to Cancel under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to cancel registered food uses of chlorpyrifos associated with the revoked tolerances. EPA has stated the cancellation order will follow in approximately six months after the tolerance revocations. The final rule is effective on October 29, 2021. More information is available in our August 24, 2021, blog.

EPA Collaborates With Unilever To Advance Non-Animal Approaches For Chemical Risk Assessment: On August 19, 2021, EPA announced a collaborative agreement with Unilever to explore better ways to assess chemical risks associated with consumer products. EPA states that the collaboration aims to establish a framework for the Next Generation of Risk Assessments based on New Approach Methods (NAM). The collaboration will bring together more than $2 million in both monetary and in-kind contributions, including scientific expertise and equipment, to develop a comprehensive NAMs dataset for a minimum of 40 chemicals. These chemicals will be tested using a wide variety of NAMs, and the results will be compared between the two groups to determine how well particular NAMs can infer differences in risk. EPA states that these data will be used in case studies to evaluate the potential to use NAMs in regulatory decisions. All data generated through the collaboration will be in the public domain, allowing academic, corporate, government, and nonprofit scientists to use the project results in their own research.

EPA Publishes Receipt And Status Information For July 2021 For Certain New Chemicals: On August 20, 2021, EPA published the receipt and status reports for the period from July 1, 2021, to July 31, 2021. 86 Fed. Reg. 46843. EPA is providing notice of receipt of PMNs, SNUNs, and Microbial Commercial Activity Notices (MCAN) (including amended notices and test information); an exemption application under 40 C.F.R. Part 725 (Biotech exemption); applications for a test marketing exemption (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. EPA also provides information on its website about cases reviewed under the amended TSCA, including the Section 5 PMN/SNUN/MCAN and exemption notices received, the date of receipt, the final EPA determination on the notice, and the effective date of EPA’s determination for PMN/SNUN/MCAN notices on its website. Comments identified by the specific case number provided in the Federal Register notice must be received on or before September 20, 2021.

Comment Period Begins On Draft Guidance On Two TSCA CDR Petition Processes: On August 23, 2021, EPA announced the availability of and solicited public comment on guidance on two petition processes applicable to the TSCA Chemical Data Reporting (CDR) regulations. 86 Fed. Reg. 47102. The guidance covers petitions for full exemption of byproduct substances that are recycled or otherwise used within site-limited, physically enclosed systems and petitions for partial exemption of chemicals for which the CDR processing and use information has been determined to be of “low current interest” by EPA. EPA states that the guidance “is designed to elucidate the process and requirements of CDR-specific petitions and is consistent with both existing regulations and guidance.” The CDR regulations require manufacturers (including importers) of certain chemical substances included on the TSCA Chemical Substance Inventory to report data on the manufacturing, processing, and use of the chemical substances. According to EPA, the guidance identifies and clarifies examples of the types of information submitters can provide to EPA in support of petitions for full or partial exemption from CDR rule requirements. EPA expects the guidance to make the requirements and process of submitting a CDR-specific petition “more comprehensible,” enabling petitioners to determine if a petition is appropriate and to provide better a petition containing the information needed for EPA to reach a determination. Comments on the guidance are due December 21, 2021.

EPA Announces Penalty Issued Against Southern California Company For Selling Illegal Antimicrobial Products: On August 25, 2021, EPA announced that it issued a penalty against Seychelle Environmental Technologies, Inc. (Seychelle), based in Aliso Viejo, California, for violations of FIFRA. The violations, which EPA states that Seychelle has since corrected, involved the sale of unregistered antimicrobial products and the manufacture of products in an unregistered establishment. More information is available in our blog.

EPA Publishes Final Scope Documents For Manufacturer-Requested Risk Evaluations Of Two Phthalates: On August 31, 2021, EPA released the final scope documents for the TSCA risk evaluations of diisodecyl phthalate (DIDP) and diisononyl phthalate (DINP). 86 Fed. Reg. 48695; 86 Fed. Reg. 48693. In its August 31, 2021, press release, EPA notes that both DIDP and DINP “belong to a family of chemicals called phthalates and are commonly used as plasticizers in the production of plastic and plastic coating to increase flexibility.” According to EPA, the final scope documents reflect the policy changes on risk evaluations announced in June 2021. This includes plans to consider exposure pathways that may be regulated outside of TSCA, like air and water, and potential for exposures to fenceline communities (i.e., communities near industrial facilities). EPA states that “[a]ssumptions that personal protective equipment (PPE) in occupational settings will always be properly utilized will not be used as the basis for the risk determination. Use of PPE, and other ways industry protects its workers, will be assessed during the risk evaluation and considered as potential ways to address unreasonable risks during the risk management process.” More information is available in our September 3, 2021, memorandum.

EPA Updates TSCA Inventory: On August 31, 2021, EPA announced the availability of the latest TSCA Inventory. EPA states that the biannual update to the public TSCA Inventory is part of its regular posting of non-confidential TSCA Inventory data. EPA plans the next regular update of the Inventory for winter 2022. According to EPA, the Inventory contains 86,607 chemicals of which 41,953 are active in U.S commerce. Other updates to the TSCA Inventory include new chemical substance additions, commercial activity data and regulatory flags, such as polymer exemptions, TSCA Section 4 test orders, and TSCA Section 5 SNURs.

EPA Plans New Rulemaking For PBTs, Extends Compliance Dates For PIP (3:1) Rule: EPA announced on September 3, 2021, that it intends to initiate a new rulemaking and anticipates proposing new rules for five PBT chemicals that are the subject of final risk management rules under TSCA. Additionally, and importantly, EPA is extending the compliance dates for the prohibitions on processing and distribution and the associated recordkeeping requirements of one of these PBT chemicals, PIP (3:1). For more information on EPA’s announcement, please read the full memorandum.

EPA Publishes Draft Scope Document For D4 For Public Comment: EPA announced on September 8, 2021, the availability of the draft scope of the risk evaluation to be conducted for octamethylcyclotetra-siloxane (D4). 86 Fed. Reg. 50347. The American Chemistry Council’s Silicones Environmental, Health, and Safety Center, Dow Silicones Corporation, Elkem Silicones USA Corporation, Evonik Corporation, Momentive Performance Materials, Shin-Etsu Silicones of America, Inc., and Wacker Chemical Corporation requested a risk evaluation of D4 pursuant to TSCA Section 6. The draft scope document includes the conditions of use, hazards, exposures, and the potentially exposed or susceptible subpopulations that EPA plans to consider in conducting the risk evaluation for this chemical substance. EPA is also opening a 45-calendar day comment period on the draft scope to allow for the public to provide additional data or information that could be useful in preparing the final scope document. Comments are due October 25, 2021.

RCRA/CERCLA/CWA/CAA/PHMSA/SDWA

EPA And Army Issue Memorandum To Address Implementation Challenges With 2020 CWA Section 401 Certification Rule: On August 20, 2021, EPA and the U.S. Department of the Army issued a joint memorandum regarding implementation of the 2020 Clean Water Act (CWA) Section 401 Certification Rule associated with U.S. Army Corps of Engineers (Corps) permits. According to EPA’s August 20, 2021, press release, the joint memorandum directs the Corps to provide the maximum amount of time allowed before issuing in final 41 Nationwide Permits (NWP) that were proposed in September 2020 and have not yet been issued in final. The joint memorandum also addresses multiple implementation challenges with the 2020 Rule associated with Corps-issued permits, including by directing the Corps to work collaboratively with states and Tribes to:

  • Identify factors and circumstances that warrant extending the reasonable period of time;
  • Resolve procedural deficiencies within the reasonable period of time; and
  • Identify and address circumstances that may appropriately require permit modifications.

EPA And Corps Halt Implementation Of Navigable Waters Protection Rule: The U.S. District Court for the District of Arizona issued an order on August 30, 2021, that vacates and remands the Navigable Waters Protection Rule in the case of Pascua Yaqui Tribe v. EPA. EPA states on its website that both it and the Corps (the agencies) are in receipt of the order. According to EPA, in light of the order, the agencies have halted implementation of the Navigable Waters Protection Rule and are interpreting “waters of the United States” consistent with the pre-2015 regulatory regime until further notice. The agencies continue to review the order and consider next steps, including “working expeditiously” to move forward with the rulemakings announced on June 9, 2021, to protect better “our nation’s vital water resources that support public health, environmental protection, agricultural activity, and economic growth.” The agencies “remain committed to crafting a durable definition of ‘waters of the United States’ that is informed by diverse perspectives and based on an inclusive foundation.”

EPA Requests Nominations To SAB Biosolids Chemical Risk Assessment Panel: The EPA Science Advisory Board (SAB) Staff Office requested on September 1, 2021, public nominations of scientific experts to form a panel to review the EPA White Paper: A Standardized Approach to Biosolids Chemical Risk Assessment and a Biosolids Screening Tool with an accompanying User Guide. 86 Fed. Reg. 49021. EPA states that the White Paper, which includes a prioritization method, deterministic screening model, and a probabilistic risk assessment modeling framework, will be used to modernize, standardize, and streamline the risk assessment process to assess risk “efficiently and thoroughly” to chemical pollutants found in biosolids. Nominations are due September 22, 2021.

EPA Announces First Validated Laboratory Method To Test For PFAS In Wastewater, Surface Water, Groundwater, Soils: On September 2, 2021, EPA, in collaboration with the U.S. Department of Defense (DOD), published a draft of the first EPA-validated laboratory analytical method to test for PFAS in eight different environmental media, including wastewater, surface water, groundwater, and soils. Draft Method 1633 is a single-laboratory validated method to test for 40 PFAS compounds in wastewater, surface water, groundwater, soil, biosolids, sediment, landfill leachate, and fish tissue. According to EPA, this method “provides certainty and consistency and advances PFAS monitoring that is essential to protecting public health.”

EPA Requests Nominations Of Candidates For Two CASAC Review Panels: On September 8, 2021, the EPA SAB Staff Office requested public nominations of scientific experts for two ad hoc review panels of the Clean Air Scientific Advisory Committee (CASAC). 86 Fed. Reg. 50345. The review panels will provide advice through the chartered CASAC on the scientific and technical aspects of air quality criteria and the primary and secondary National Ambient Air Quality Standards (NAAQS) for lead and the secondary NAAQS for oxides of nitrogen, oxides of sulfur, and particulate matter (PM). Nominations are due September 29, 2021.

EPA’s Plans For New Wastewater Regulations Include First Limits For PFAS And Updated Limits For Nutrients: EPA announced on September 14, 2021, the availability of the Preliminary Effluent Guidelines Program Plan 15 (Preliminary Plan 15), which identifies opportunities to protect better public health and the environment through regulation of wastewater pollution. 86 Fed. Reg. 51155. EPA will initiate three new rulemakings after concluding several studies that were discussed in Effluent Guidelines Program Plan 14. EPA states that it has determined that revised effluent limitations guidelines (ELG) and pretreatment standards are warranted for the following categories:

  • Meat and Poultry Products point-source category to address nutrient discharges;
  • Organic Chemicals, Plastics and Synthetic Fibers point-source category to address PFAS discharges from facilities manufacturing PFAS; and
  • Metal Finishing point-source category to address PFAS discharges from chromium electroplating facilities.

Preliminary Plan 15 also discusses the Steam Electric Power Generating category rulemaking that EPA announced on July 26, 2021. EPA has initiated the rulemaking process to consider strengthening the effluent limits applicable to certain ELG waste streams from coal power plants that use steam to generate electricity. Comments are due October 14, 2021.

FDA

Color Additive Petition For Iron Oxide Filed: On August 20, 2021, the U.S. Food and Drug Administration (FDA) announced the filing of a Color Additive Petition to permit use of synthetic iron oxide in edible decorative paint. 86 Fed. Reg. 46803. The petition was submitted on July 28, 2021, on behalf of Piotrovska, PTY LTD.

FDA Makes Available Test Results Of PFAS In Food: On August 26, 2021, FDA made available testing results from a survey of nationally distributed processed food, which included several baby foods, collected for the Total Diet Study (TDS). FDA reported measured concentrations for a large number of PFAS -- including perfluorooctanoic acid (PFOA), perfluorooctanesulfonic acid (PFOS), perfluorononanoic acid (PFNA), and perfluorodecanoic acid (PFDA) -- at method detection limits (MDL) ranging from 17 to 344 parts per trillion (ppt). Testing showed that 164 of 167 foods had no detectable levels of PFAS at the MDL. Only three food samples contain detectable levels of PFAS: fish sticks (PFOS and PFNA), canned tuna (PFOS and PFDA), and protein powder (PFOS). Cover text to the survey states that “[b‌]based on the best available current science, the FDA has no scientific evidence that the levels of PFAS found in the TDS samples tested since 2019 indicate a need to avoid any particular foods in the general food supply.”

FDA Issues Final Guidance For Antimicrobial Agents: On September 1, 2021, FDA released a guidance document titled “Microbiological Considerations for Antimicrobial Agents Used in Food Applications: Guidance for Industry,” which is intended to assist submitters of Food Contact Notifications (FCN), generally recognized as safe (GRAS) notices, and other notifications. The guidance addresses questions associated with the information required and testing protocols for notifications made to FDA for antimicrobial agents.

FDA Hosts Two New Era Of Smarter Food Safety Events: Over the past few days, FDA has been hosting the “2021 FDA Retail Food Protection Seminar”; the last day of the seminar is September 16. The virtual event included seminars and breakout sessions focused on foodborne illness, retail food safety initiatives, and risk mitigation efforts. FDA also intends to host a three-day public meeting to discuss the safety of foods sold online and delivered directly to consumers. 86 Fed. Reg. 50130. The “FDA New Era of Smarter Food Safety Summit on E-Commerce: Ensuring the Safety of Foods Ordered Online and Delivered Directly to Consumers” will take place virtually October 19-21, 2021. See the Federal Register notice for more details. Both events are intended to continue FDA efforts on goal setting in FDA’s New Era of Smarter Food Safety blueprint.

NANOTECHNOLOGY

EPA Issues Final SNUR For Certain Multiwalled Carbon Nanotubes: On August 18, 2021, EPA issued several SNURs under TSCA for chemical substances that were the subject of PMNs, including the chemical substance identified generically as multiwalled carbon nanotubes (PMN P-18-182). 86 Fed. Reg. 46133. The SNUR requires persons who intend to manufacture (defined by statute to include import) or process multiwalled carbon nanotubes (PMN P-18-182) for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. The requirements of the SNUR do not apply to quantities of the substance that have been:

  • Embedded or incorporated into a polymer matrix that itself has been reacted (cured);
  • Embedded in a permanent solid/polymer form that is not intended to undergo further processing, except mechanical processing; or
  • Incorporated into an article as defined at 40 C.F.R. Section 720.3(c).

More information is available in our August 18, 2021, blog item.

ASTM Publishes Laboratory Guide For Identifying Nanomaterials: ASTM recently announced that it published a standard, E3275, that seeks to familiarize laboratory scientists with background information and technical content necessary to image and identify engineered nanomaterials in cellular and noncellular samples. According to ASTM, the standard is specific to the use of the darkfield microscopy/hyperspectral imaging analysis technique. ASTM states that in this technique, the resulting sample analysis allows for direct visualization and identification of the nanomaterials based on comparison to the spectral profiles of well-characterized reference nanomaterials.

Proposed Amendments To AICIS General Rules Include Clarifying Criteria For Industrial Chemicals Introduced At The Nanoscale: Australia is proposing targeted amendments to the Industrial Chemicals (General Rules) 2019 and the Industrial Chemicals (Consequential Amendments and Transitional Provisions) Rules 2019 that are intended to clarify the operation of the Ministerial Rules within existing policy. The proposed amendments address several issues, including clarifying the criteria for industrial chemicals introduced at the nanoscale. Comments are due September 17, 2021. More information is available in our August 25, 2021, blog item.

EC Analyzing Responses To Targeted Stakeholder Consultation Concerning Review Of Recommendation On The Definition Of A Nanomaterial: The European Commission (EC) held the consultation to update, test, and verify the preliminary findings of its review of the Recommendation on the definition of a nanomaterial, gathering further evidence and feedback from a wide range of stakeholders who have a role in application of the harmonized regulatory definition of nanomaterial in the European Union (EU). The EC compiled the 136 non-duplicated replies in an XLS spreadsheet. More information is available in our August 30, 2021, blog item.

Registration Opens For Webinar On “What We Know About NanoEHS: Measurement And Characterization”: Registration has opened for a September 22, 2021, webinar held by the National Nanotechnology Coordination Office (NNCO) on “What We Know about NanoEHS: Measurement and Characterization.” The webinar’s speakers will explore the impact of advances in nanomaterial measurement and characterization on the safe and responsible development of nanotechnology. Vincent Hackley, Research Chemist, National Institute of Standards and Technology (NIST), will moderate. The panel will include:

  • Jo Anne Shatkin, President and Founder, Vireo Advisors; and
  • Wendel Wohlleben, Senior Principal Scientist, BASF.

SCHEER Questions Whether Draft EQSs For Silver And Its Compounds Should Address Silver Nanomaterials: On September 7, 2021, the EC Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) posted a preliminary opinion on “Draft Environmental Quality Standards for Priority Substances under the Water Framework Directive” for silver and its compounds. According to SCHEER, the issues that need to be revised include whether silver nanomaterials should “be considered as silver compounds or should nanomaterials, of any origin, be considered as particular compounds to be assessed separately?” Comments on the preliminary opinion are due October 7, 2021. More information is available in our September 10, 2021, blog item.

IRSST Publishes Study On Characterization Of Unintentionally Released Nanometric Particles In Various Workplaces: The Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST) announced on August 9, 2021, publication of a study entitled Characterization of Unintentionally Released Nanometric Particles in Various Workplaces. The study characterizes unintentionally released nanoparticles found in six workplaces -- an underground mine, a truck repair shop, an underground transportation network, a foundry, a machine shop, and a wax casting shop -- on the basis of a broad range of indicators. More information is available in our September 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

House Environment And Commerce Leaders Request Information From EPA About New Chemical Review Program: On August 17, 2021, Representatives Frank Pallone, Jr. (D-NJ), Chair of the House Energy and Commerce Committee, Diana DeGette (D-CO), Chair of the Subcommittee on Oversight and Investigations, and Paul Tonko (D-NY), Chair of the Subcommittee on Environment and Climate Change, sent a letter to EPA Administrator Michael Regan to request information regarding “concerning reported irregularities” in EPA’s chemical review program. The Committee’s August 17, 2021, press release states that “[a]ccording to recent allegations made by four whistleblowers -- each a current or former staffer in EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) -- the OCSPP has for many years downplayed the dangers of new chemicals and inappropriately interfered with risk assessments conducted pursuant to” TSCA. The press release states that additional reports “have described the interference alleging that OCSPP manipulated the review of dozens of chemicals” to make the chemicals appear safer. EPA employees “were reportedly pressured to downplay evidence of chemicals’ potential adverse effects such as cancer, birth defects, and neurological effects,” and “EPA’s scientific staff were subject to retaliation.” More information is available in our August 17, 2021, blog item.

MISCELLANEOUS

Comment Period Begins On Draft IRIS Toxicological Review Of PFBA And Related Compound: On August 23, 2021, EPA announced a 60-day public comment period associated with the release of the Integrated Risk Information System (IRIS) Toxicological Review of Perfluorobutanoic acid (PFBA) and Related Compound Ammonium Perfluorobutanoic Acid. 86 Fed. Reg. 47100. EPA released the draft IRIS assessment for public comment in advance of a contract-led peer review. Eastern Research Group, Inc., a contractor to EPA, will convene a public meeting to discuss the draft report with the public during Step 4 of the IRIS Process. The external peer reviewers will consider public comments submitted in response to this notice and provided at the public meeting when reviewing the draft assessment. EPA will consider all comments received when revising the document post-peer review. Comments are due October 22, 2021.

EPA Requests Nominations Of Experts For Review Of Draft Toxicological Reviews Of PFDA, PFNA, PFHxA, PFHxS, And PFBA: On August 23, 2021, EPA’s Center for Public Health and Environmental Assessment (CPHEA) requested public nominations of scientific experts for the upcoming peer reviews of five IRIS assessments including PFDA, PFNA, perfluorohexanoic acid (PFHxA), perfluorohexanesulfonic acid (PFHxS), PFBA, and their related salts, which are all members of the PFAS group. 86 Fed. Reg. 47101. Each assessment will undergo independent external scientific peer review. A single peer review panel will review all five PFAS IRIS assessments. Nominations for expert reviewers are due September 22, 2021.

APHIS Announces Draft Regulatory Status Review Guide Available For Public Comment: On August 25, 2021, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced its release of a draft guide detailing the information requirements and process for submitting a Regulatory Status Review (RSR) request. Developers of certain genetically modified organisms may use the RSR process to determine the regulatory status of the organisms. The draft guide is open for public comment for 60 days. APHIS also will host a webinar to provide an overview of the draft RSR guide. The draft RSR guide is available on the APHIS website, at the bottom of the tab labeled The Regulatory Status Review Process, and also in the online docket. The public may submit comments at https://www.regulations.gov/docket/APHIS-2021-0062. APHIS states that it will consider all comments received by October 25, 2021, prior to issuing the final RSR guide. Additionally, APHIS will host a technical webinar on September 21, 2021, to discuss the RSR process and guide, and to provide stakeholders the opportunity to ask questions. Registration is available now on the APHIS website. More information is available in our August 31, 2021, blog.

EPA Calls For Nominations For 2022 Green Chemistry Challenge Awards: EPA is now accepting nominations for the 2022 Green Chemistry Challenge Awards from companies or institutions that have developed a new green chemistry process or product that helps protect human health and the environment. EPA states that in support of the Biden-Harris Administration’s commitment to tackle the climate crisis, it is adding a new award category to recognize technology that reduces or eliminates greenhouse gas emissions. EPA will hold a webinar during Pollution Prevention (P2) Week, on Wednesday, September 22, 2021, from 2:00 p.m. - 3:30 p.m. (EDT), to educate stakeholders on the Green Chemistry Challenge Awards and the nomination process. Nominations are due to EPA by December 10, 2021.

EPA Report Shows Disproportionate Impacts Of Climate Change On Socially Vulnerable Populations In The United States: On September 2, 2021, EPA released a new analysis showing that “the most severe harms from climate change fall disproportionately upon underserved communities who are least able to prepare for, and recover from, heat waves, poor air quality, flooding, and other impacts.” EPA states that its analysis indicates that racial and ethnic minority communities are particularly vulnerable to the greatest impacts of climate change. According to EPA, Climate Change and Social Vulnerability in the United States: A Focus on Six Impact Sectors “is one of the most advanced environmental justice studies to date that looks at how projected climate change impacts may be distributed across the American public.”

USDA Publishes ANPR Regarding Labeling Of Meat Or Poultry Products Comprised Of Or Containing Cultured Animal Cells: On September 3, 2021, the USDA Food Safety and Inspection Service (FSIS) published an advance notice of proposed rulemaking (ANPR) to request comments pertaining to the labeling of meat and poultry products comprised of or containing cultured cells derived from animals subject to the Federal Meat Inspection Act or the Poultry Products Inspection Act. 86 Fed. Reg. 49491. FSIS states that issues raised in the comments submitted in response to the ANPR will inform future rulemaking to establish labeling requirements for these products. The ANPR also discusses how FSIS will generally evaluate labels for these products if they are submitted before FSIS completes rulemaking. Comments are due November 2, 2021.

Massachusetts Will Hold Public Hearing On Proposed Amendment Adding PFAS NOL Category To Toxic Or Hazardous Substance List Regulations: The Massachusetts Executive Office of Energy and Environmental Affairs published a notice on September 3, 2021, announcing that it will hold a public hearing on October 15, 2021, on proposed amendments to the Toxic or Hazardous Substance List regulations. The amendments would add a PFAS not otherwise listed (NOL) category, consisting of: PFAS that contain a perfluoroalkyl moiety with three or more carbons or a perfluoroalkylether moiety with two or more carbons that are NOL. The amendments would also add a definition of the word “substance” to clarify usage of the term in the regulations. Written testimony will be accepted until 5:00 p.m. (EDT) on October 15, 2021.

EPA Requests Nominations For SAB IRIS Chloroform (Noncancer; Inhalation) Review Panel: On September 7, 2021, the SAB Staff Office requested public nominations of scientific experts to form a Panel to review the draft EPA IRIS Toxicological Review of Chloroform (Noncancer; Inhalation). 86 Fed. Reg. 50113. The draft assessment includes a hazard identification analysis that summarizes the chemical properties, pharmacokinetics, and health effects associated with environmental or occupational exposure, and dose-response analysis, which characterizes the quantitative relationship between chemical exposure and each credible health hazard. The SAB Chloroform Review Panel will consider whether the conclusions found in the EPA’s draft assessment are “clearly presented and scientifically supported.” The Panel will also be asked to provide recommendations on how the assessment may be strengthened. Nominations are due September 28, 2021.

EPA And UNEP Sign Renewed MOU: On September 8, 2021, EPA and the United Nations Environment Program (UNEP) signed a five-year memorandum of understanding (MOU) that renews cooperation between EPA and UNEP. The agreement addresses key areas of collaboration intended to strengthen environmental governance, create healthy communities, transition towards green economies, and respond to climate change and other global environmental challenges. EPA and UNEP also “committed to lead by using science as the basis to tackle environmental pollution and rising emissions to ensure healthy and productive ecosystems and people.”

EPA Region 9 And CalEPA Sign MOU To Strengthen Environmental Enforcement In Communities Overburdened By Pollution: EPA Region 9 announced on September 10, 2021, that it signed a five-year, “first-of-its-kind,” MOU with the California Environmental Protection Agency (CalEPA) to expand joint activities supporting the agencies’ shared goals of reducing pollution burdens, increasing environmental compliance, and improving public health outcomes in overburdened California communities. Under the MOU, the agencies intend to:

  • Enhance existing collaborations by increasing joint inspections in overburdened communities; sharing or jointly developing metrics for determining pollution burdens and vulnerability; and collaborating on staff training;
  • Promote coordination of enforcement responses, including joint judicial enforcement actions in overburdened communities;
  • Expand engagement with overburdened communities to ensure that targeting of enforcement resources and compliance-related activities are fully informed by the knowledge and lived experience of these communities; and
  • Improve communication and transparency by collaborating on an annual workplan and annual report to highlight achievements under the MOU.

NYSDEC Holds Meeting On Toxic Chemicals In Children’s Products Law: The New York State Department of Environmental Conservation (NYSDEC) held a virtual public meeting on September 15, 2021, on the toxic chemicals in children’s products law. New York’s Environmental Conservation Law (ECL) Article 37 Title 9 establishes an ingredient disclosure program and prohibits certain chemicals in children’s products. ECL Article 37 instructs NYSDEC to promulgate lists of chemicals of concern and high priority chemicals that must be disclosed if present in children’s products by March 1, 2022. ECL Article 37 also prohibits the sale of children’s products containing benzene, asbestos, or tris(1,3-dichloro-2-propyl) phosphate effective January 1, 2023. NYSDEC is in the process of developing a rule to implement portions of the law. According to NYSDEC, the rule is expected to address the specific product categories that are covered, what chemicals and supporting information must be disclosed, details on how to obtain a waiver from reporting or the sales prohibition, and the fees associated with reporting and applying for a waiver. NYSDEC is holding a 30-day public comment period to allow stakeholders to provide written comments on the chemicals under consideration and their practical quantification limits. Comments must be submitted by 5:00 p.m. (EDT) on October 15, 2021

OEHHA Extends Public Comment Period On Draft Technical Support Document For Proposed Public Health Goals For PFOA And PFOS In Drinking Water: The California Office of Environmental Health Hazard Assessment (OEHHA) has extended the comment period on a draft document for public review describing proposed public health goals (PHG) for PFOA and PFOS) in drinking water. The draft technical support document presents the scientific information available on the toxicity of PFOA and PFOS and the calculation of the proposed PHGs. OEHHA will hold a virtual public workshop on September 28, 2021. Comments are due October 28, 2021.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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