Recording Of “TSCA Reform: Five Years Later” Conference And Other Resources Available Now: The “TSCA Reform – Five Years Later” conference held June 30, 2021, featured in-depth discussion, spirited debate, and news-making statements over the course of six virtual panels. A full recording of the event with additional suggested readings and other resources are available on the Environmental Law Institute (ELI) website for members of ELI. A detailed summary of the event with commentary is available in Bergeson & Campbell, P.C.’s (B&C®) July 1, 2021, memorandum, “ELI Concludes Another Successful Annual TSCA Conference.” B&C prepared the resource “TSCA at 5: TSCA Litigation Update” for the conference and has made that document available at the link.
Richard E. Engler, Ph.D., Authors Chapter Of “How to Commercialize Chemical Technologies for a Sustainable Future”: Richard E. Engler, Ph.D., Director of Chemistry, B&C, contributed Chapter 7: Pre-market Approval of Chemical Substances: How New Chemical Products Are Regulated to “How to Commercialize Chemical Technologies for a Sustainable Future,” edited by Timothy J. Clark and Andrew S. Pasternak. This book covers each step of the technology commercialization process, from market landscape analysis and financing to scale-up and strategic partnering, with Dr. Engler’s chapter focusing on legal regulatory requirements for bringing new chemicals to market in several key geographic regions, as well as the impact of public policy on commercialization.
TSCA/FIFRA/TRI
Webinar — “U.S. Chemical Regulation: What’s New, What’s Hot” On July 28, 2021, 11:00 a.m. EDT: Join B&C Managing Partner Lynn L. Bergeson and Director of Chemistry Richard E. Engler, Ph.D. for Mondaq’s “U.S. Chemical Regulation: What’s New, What’s Hot.” During this webinar, they will discuss new topics in U.S. industrial chemical regulation, their implications for chemical stakeholders, and suggested actions for chemical producers, importers, processors, and manufacturers of finished goods containing chemicals. Register now.
Lynn L. Bergeson Publishes “The essential role of evolving technologies in securing a safe and sustainable food supply,” For The Agricultural Law Section Of The International Bar Association: Emerging tools enabled by nanotechnology, synthetic biology, and other innovative technologies are today increasingly supplementing the plows and tractors so emblematic of the agricultural community of the past. These precision farming tools are ensuring a sustainable food supply otherwise threatened by climate change and population growth, among other global challenges, while diminishing worldwide greenhouse gas (GHG) emissions. Genetically modified E coli is being used to produce synthetically-derived pheromones, substances beneficially used in agricultural applications to attract, capture, and eliminate harmful pests. Agricultural stakeholders use nanopesticides and nanofertilizers in drought-stricken regions, minimizing the need for more conventional and environmentally consequential agricultural chemicals. GPS-based auto-steering systems for tractors augment human labor, freeing up effort better spent on other tasks. These technologies enable global agricultural professionals to address the climate change imperatives that threaten an increasingly fragile global food supply. The full article is available online.
Lynn L. Bergeson Publishes “Avoiding costly supply chain disruption: a cautionary tale,” In Financier Worldwide: By any independent standard, the U.S. electronics industry is huge — it was worth over $300 billion in 2019 — and growing annually. Would it surprise you to know that as big, essential, and powerful as it is, a single rule issued in January of this year by the U.S. Environmental Protection Agency (EPA) nearly brought this sector to a halt? To this day, the rule is causing extraordinary disruption as electric and electronic device manufacturers, importers, processors, distributors, and others scramble to adjust in its aftermath. This article tells the cautionary tale of phenol, isopropylated phosphate (3:1) (PIP (3:1)). This sad and largely avoidable tale crystalizes the importance of understanding the long reach of the U.S. industrial chemical control law, the Toxic Substances Control Act (TSCA), and its seemingly limitless potential for disrupting global supply chains. The full article is available online.
EPA Appoints New Members To TSCA SACC: On June 15, 2021, EPA appointed nine new members to serve on the TSCA Science Advisory Committee on Chemicals (SACC). Additionally, EPA appointed a new Chair and reappointed seven existing members. In EPA’s July 13, 2021, announcement, EPA notes that members of the TSCA SACC serve staggered terms of appointment, generally of three years. According to EPA, TSCA SACC serves as a primary scientific peer review mechanism of EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) and is structured to provide independent scientific advice and recommendations to EPA on the scientific basis for risk assessments, methodologies, and pollution prevention measures and approaches for chemicals regulated under TSCA.
EU Regulators Begin Review Of Draft Assessment Of Glyphosate: The European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA) have received a draft assessment of glyphosate carried out by four European Union (EU) member states and have begun to consider the findings. According to ECHA’s June 15, 2021, press release, the national authorities of France, Hungary, the Netherlands, and Sweden — known as the Assessment Group of Glyphosate (AGG) — examined all the evidence submitted by the companies that are seeking renewed approval to market the glyphosate in the EU. Glyphosate is currently authorized for use in the EU until December 2022. ECHA and EFSA will organize parallel consultations on the draft report. These will be open to the public and will be held in the first week of September 2021. Once ECHA adopts its opinion on the classification of glyphosate, EFSA will prepare a final peer review and publish its conclusions, expected in late 2022. Based on this risk assessment, the European Commission (EC) will decide whether to renew glyphosate. More information is available in our June 24, 2021, blog.
Coalition Of Chemical Manufacturers, Brand Owners, NGOs, States, And Municipalities Calls On Congress To Restore Funding For EPA’s Safer Choice Program: On June 24, 2021, a “unique and broad group” of chemical manufacturers, brand owners, environmental non-governmental organizations (NGO), states, and municipalities sent a letter to the leaders of the House and Senate Appropriations Subcommittees on Interior, Environment, and Related Agencies to express their “strong support” for EPA’s Safer Choice Program and to encourage that the program be funded fully. More information is available in our July 7, 2021, blog item.
Comments On Proposed TSCA Reporting And Recordkeeping Requirements For PFAS Due August 27, 2021: On June 28, 2021, EPA proposed reporting and recordkeeping requirements for per- and polyfluoroalkyl substances (PFAS) under TSCA. 86 Fed. Reg. 33926. EPA proposes to require certain persons that manufacture (including import) or have manufactured PFAS in any year since January 1, 2011, to report information electronically regarding PFAS uses, production volumes, disposal, exposures, and hazards. Comments are due August 27, 2021. EPA states that “[u]nder the Paperwork Reduction Act, comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of your comments on or before July 28, 2021.” More information is available in our June 11, 2021, memorandum, “EPA Announces Three PFAS Actions, Including Proposed TSCA Section 8(a) Reporting Rule.”
Data On 20 High-Priority Chemicals And 30 Organohalogen Flame Retardants Due September 27, 2021: On June 29, 2021, EPA published a final rule that requires manufacturers (including importers) of 50 specified chemical substances to report certain lists and copies of unpublished health and safety studies to EPA. 86 Fed. Reg. 34147. The chemical substances subject to the rule consist of the 20 designated by EPA as high-priority substances and the 30 organohalogen flame retardants being evaluated for risks by the Consumer Product Safety Commission (CPSC) under the Federal Hazardous Substances Act (FHSA). EPA will use the submitted information to inform the risk evaluations currently underway for 20 high-priority substances and for future prioritization. The final rule will be effective July 29, 2021. Requests to withdraw a chemical substance from the final rule pursuant to 40 C.F.R. Section 716.105(c) must be received by July 13, 2021. Information specified in the final rule is due to EPA by September 27, 2021. Detailed information about the final rule is available in our June 29, 2021, memorandum, “Manufacturers and Importers of 20 High-Priority Chemicals and 30 Organohalogen Flame Retardants Must Submit Data to EPA.”
NGO Files Suit Against Three Chemical Importers For Alleged CDR Reporting Violations: On June 29, 2021, the Center for Environmental Health (CEH) announced that it filed suit against three companies in the U.S. District Court for the District of Columbia for alleged violations of the Chemical Data Reporting (CDR) rule. According to CEH, an investigation found that four companies imported 65 chemicals that are subject to reporting under the CDR rule. In February 2021, CEH notified the importers of the apparent violations in accordance with TSCA Section 20(b). One of the four companies, Tribute Energy, “approached CEH and entered into an agreement to audit its operations and come into compliance. CEH is not taking legal action against Tribute in recognition of its good faith and commitment to following the law.” CEH filed suit against the other three companies under TSCA Section 20(a). More information is available in our July 9, 2021, blog item.
EPA Announces It Is Taking Action In Response To Supply-Chain Disruptions For Inert Ingredients: On July 2, 2021, EPA announced it is taking action to alleviate a supply-chain issue facing the pesticide industry. EPA stated that it is allowing registrants of non-antimicrobial pesticide products to substitute some combination of pre-approved alternate inert ingredients for inert ingredients derived from propylene oxide feedstocks that are in limited supply due to weather events that occurred in the U.S. Gulf Coast area in February 2021. EPA stated that it is allowing these substitutions even in cases where propylene glycol is added to the formulation or is part of a brand-name mixture in which the full composition is known to the registrant. The pre-approved alternates are glycerin (Chemical Abstracts Service Registry Number (CAS RN) 56-81-5); diethylene glycol (CAS RN 111-46-6); ethylene glycol (CAS RN 107-21-1); and 1,3-propanediol (CAS RN 504-63-2). EPA emphasizes that this action, known as “Propylene Glycol Phase 2 — ‘Not In-Kind’ Substitution Mechanism,” relates only to non-antimicrobial pesticide products and that EPA will handle “not in-kind” substitutions for antimicrobial pesticide products on a case-by-case basis. More information is available in our blog.
EPA Announces Approvals And Denials Of TMEs For Certain New Chemicals Under TSCA: On July 6, 2021, EPA provided notification of its approvals and denials of applications for test marketing exemptions (TME) submitted under TSCA for certain new chemicals. 86 Fed. Reg. 35499. The test marketing conditions are described in the TME applications and in the notice. If EPA determined that test marketing the new chemicals, under the conditions in the TME applications, will not present any unreasonable risk of injury to health or the environment, EPA approved the TMEs. If EPA was unable to determine that test marketing the new chemicals, under the conditions in the TME applications, will not present any unreasonable risk of injury to health or the environment, EPA denied the TMEs.
EPA Orders Allied BioScience To Stop Selling And Distributing SurfaceWise2: On July 8, 2021, EPA announced that it issued a Stop Sale, Use or Removal Order (SSURO) to Allied BioScience for its product SurfaceWise2. SurfaceWise2, a residual antimicrobial surface coating, was previously authorized for emergency use in Arkansas, Oklahoma, and Texas to help address the COVID-19 pandemic. Specific use sites included American Airlines aircraft and airport facilities and two orthopedic facilities in Texas. A discussion of these emergency authorizations can be found here. For more information, please read our blog.
Sustainable Shopping Initiative Highlights EPA’s Safer Choice Program: EPA announced on July 13, 2021, that Amazon’s Climate Pledge Friendly initiative now includes cleaning and other products certified by EPA’s Safer Choice program. Products identified as Climate Pledge Friendly are distinguished on Amazon’s website by an hourglass-with-wings symbol. The company also provides its customers with detailed web pages that include information on how and why products are certified as sustainable.
OCSPP Will Hold Meeting On July 27 On Development Of Tiered Data Reporting To Inform TSCA Prioritization, Risk Evaluation, And Risk Management: On July 27, 2021, OCSPP will hold a public meeting to engage with interested stakeholders on the development of a proposed rule for implementing a tiered data collection strategy to help inform EPA’s prioritization, risk evaluation, and risk management activities for chemical substances or mixtures under TSCA. 86 Fed. Reg. 37152. According to EPA, it currently primarily collects exposure-related data through the CDR process. EPA states that it is exploring a data reporting rule that is tiered to specific stages of the TSCA existing chemicals program: identifying a pool of substances as potential candidates for prioritization; selecting candidate chemicals for and completing the prioritization process; and assessing high-priority substances through a robust risk evaluation, which may be followed by risk management actions (depending on the outcome of the risk evaluation). The meeting will be held virtually via WebEx on July 27, 2021, from 1:00 to 3:00 p.m. (EDT). Those who would like to make a comment during the meeting must register by 6:00 p.m. (EDT) on July 22, 2021. Those who would like to participate in listen-only mode must register by 6:00 p.m. (EDT) on July 26, 2021. Written comments are due August 15, 2021.
EPA Stewardship Program Encourages Voluntary Withdrawal Of PFAS LVEs: On July 14, 2021, EPA announced a stewardship program to encourage the voluntary withdrawal of previously granted low volume exemptions (LVE) for PFAS. According to EPA, the goal of the PFAS LVE Stewardship Program is to stop the ongoing manufacture of PFAS under previously approved LVEs that have not gone through the full premanufacture review process under TSCA. EPA will hold a webinar on July 29, 2021, to provide an overview of the program. To participate in the program, companies with previously granted PFAS LVEs may choose to withdraw voluntarily their LVEs and certify that they will no longer manufacture or import those PFAS. Alternatively, companies may choose to withdraw voluntarily their LVEs following submission and review of a premanufacture notice (PMN), “which will provide for a robust safety review and the imposition of appropriate and enforceable protections for human health and the environment.” Registration for the July 29, 2021, webinar is available here.
EPA OIG Initiating Inquiry Into EPA’s Chemical Risk Assessments Conducted Under TSCA: EPA’s Office of Inspector General (OIG) announced on July 14, 2021, that it plans to initiate an inquiry into a hotline complaint regarding chemical risk assessments conducted under TSCA, including PFAS. The Project Notification states the inquiry will include interviews, data gathering, and analysis of issues, such as adherence to policies and procedures for chemical risk assessments, oversight by EPA management of chemical risk assessments, and resulting information and reports regarding the assessments of such chemicals. OIG may contact officials and managers within OCSPP and across EPA’s offices, programs, laboratories, and work locations.
EPA Publishes Statements Of Findings For Certain New Chemicals Or Significant New Uses For May 2021: On July 15, 2021, EPA published its statements of findings on TSCA notices during the period from May 1, 2021, to May 31, 2021. 86 Fed. Reg. 37325. EPA provides information (to the extent that such information is not claimed as confidential business information (CBI)) on PMNs, microbial commercial activity notices (MCAN), and significant new use notices (SNUN) for which, during this period, EPA has made findings under TSCA Section 5(a)(3)(C) that the new chemical substances or significant new uses are not likely to present an unreasonable risk of injury to health or the environment.
RCRA/CERCLA/CWA/CAA/PHMSA/SDWA
EPA Delays Effective And Compliance Dates For Revisions To Lead And Copper Drinking Water Rule: On June 16, 2021, EPA issued a final rule to delay the effective date of the National Primary Drinking Water Regulations: Lead and Copper Rule Revisions (LCRR), which was published in the Federal Register on January 15, 2021. 86 Fed. Reg. 31939. EPA is also delaying the January 16, 2024, compliance date established in the LCRR to October 16, 2024. EPA states that the delay in the effective date is consistent with presidential directives issued on January 20, 2021, to the heads of federal agencies to review certain regulations, including the LCRR. According to EPA, the delay will allow sufficient time for EPA to complete its review of the rule in accordance with those directives and conduct important consultations with affected parties. EPA notes that the delay in the compliance date of the LCRR ensures that any delay in the effective date will not reduce the time provided for drinking water systems and primacy states to take actions needed to assure compliance with the LCRR. The final rule will be effective December 16, 2021.
EPA Selects CASAC Charter Members And Calls For Nominations For CASAC PM Panel: On June 17, 2021, EPA announced that EPA Administrator Michael S. Regan announced his selections for membership of the Clean Air Scientific Advisory Committee (CASAC). The members “are well-qualified experts with a cross-section of scientific disciplines and experience needed to provide advice on the scientific and technical bases for the National Ambient Air Quality Standards (NAAQS).” On June 25, 2021, EPA requested the nomination of experts for the CASAC Particulate Matter (PM) Panel, which will support the Chartered CASAC in providing advice on the Agency’s reconsideration of the PM NAAQS. 86 Fed. Reg. 33703. Nominations are due July 16, 2021.
EPA To Improve Access, Transparency, And Timeliness Of Air Toxics Data And Risk Information: On June 23, 2021, EPA announced “a move to provide more frequent updates to national air toxics data and risk estimates as part of the agency’s commitment to making high-quality information available on a timely basis to the public.” EPA states that its new approach will provide an annual, more systematic update for all air toxics information, including emissions, ambient concentrations, national screening risk estimates, and monitoring data. Starting later in 2021 and continuing in future years, EPA will make information about the estimated risks of air toxics available to the public using the latest air emissions inventory, beginning with 2017. This information will be incorporated into EPA’s Environmental Justice Screening Tool (EJSCREEN) to help communities screen for potential risks. Ultimately, EPA will start reporting risk information each year in its annual Air Trends Report. This will enable the public to gain more timely air quality information on air toxics, as well as see trends in emissions and risks over time.
EPA Extends Comment Period For LCRR Virtual Engagements: On June 23, 2021, EPA extended the comment period for the LCRR Virtual Engagements. 86 Fed. Reg. 32856. To provide the public with opportunities to submit additional comments to the LCRR Virtual Engagements docket after participating in or viewing the community, tribal, and stakeholder roundtables, EPA is extending the comment period an additional 30 days, from June 30, 2021, to July 30, 2021.
EPA Will Hold Virtual Methane Detection Technology Workshop: On July 1, 2021, EPA announced that it will hold a virtual public workshop August 23 and 24, 2021, to hear perspectives on innovative technologies that could be used to detect methane emissions from the oil and natural gas industry. EPA states that the workshop is part of its public outreach effort to gather stakeholder input on reducing methane and other harmful pollutants from new and existing sources in the oil and natural gas industry. The workshop will focus on methane-sensing technologies that are not currently approved for use in EPA’s New Source Performance Standards for the oil and natural gas industry, and how those applications could be applied in the oil and gas sector. EPA encourages its state, local, and Tribal regulatory partners, along with members of the public, to attend the workshop.
EPA Withdraws Approval For Use Of Phosphogypsum In Road Construction: On July 7, 2021, EPA withdrew its October 14, 2020, approval for use of phosphogypsum in government road projects. 86 Fed. Reg. 35795. Under the Clean Air Act (CAA), EPA may approve a request for other use of phosphogypsum if it includes certain prescribed information. EPA states that upon further review, it has determined that the approval “was premature and should be withdrawn because the request did not contain all of the required information.” With this action, phosphogypsum remains prohibited from use in road construction projects. The effective date of the withdrawal is July 7, 2021.
EPA Announces Additional $50 Million Under ARP To Enhance Air Pollution Monitoring: On July 7, 2021, EPA announced that it will make $50 million in American Rescue Plan (ARP) funding available to improve air quality monitoring in communities across the United States. EPA states that the latest set of funding builds on the Agency’s recent announcement of $50 million for environmental justice (EJ) projects under the ARP, bringing the total to $100 million in EPA funding designated by Congress to address health outcome disparities from pollution and the COVID-19 pandemic. The major components of the plan to enhance air community monitoring include a grants competition that will seek proposals from community groups and state, Tribal, and local government air agencies; direct awards to air agencies for continuous monitoring of small particles (PM with diameters that are generally 2.5 micrometers and smaller (PM2.5) or soot) and other CAA pollutants; enhanced capacity for short-term community monitoring; and support to administer the funding.
EPA Releases Draft CCL 5: On July 12, 2021, EPA released the draft Contaminant Candidate List 5 (CCL 5), which provides the latest list of drinking water contaminants that are known or anticipated to occur in public water systems and are not currently subject to EPA drinking water regulations. EPA states that the draft CCL 5 includes 66 individual chemicals, 12 microbes, and three chemical groups — PFAS, cyanotoxins, and disinfection byproducts (DBP). According to EPA, these contaminants have been identified as Agency priorities and contaminants of concern for drinking water. EPA plans to consult with the Science Advisory Board (SAB) on the draft CCL 5 in Fall 2021. EPA will consider public comments and SAB feedback in developing the final CCL 5, which it expects to publish in July 2022. After EPA publishes the final CCL, it will undertake a separate regulatory determination process to determine whether to regulate contaminants from the CCL. Publication of the draft CCL 5 in the Federal Register will begin a 60-day comment period.
EPA Requests Nominations For SAB CCL 5 Panel: On July 15, 2021, the EPA SAB requested public nominations of scientific experts to form a Panel to review the draft EPA document entitled Contaminant Candidate List 5 — Draft. 86 Fed. Reg. 37327. The draft document presents a list of contaminants that are known or anticipated to occur in public water systems, and that may require future regulation under the Safe Drinking Water Act (SDWA). Nominations are due August 5, 2021.
FDA
FDA-Initiated Threshold Of Regulation Exemption: On June 17, 2021, the U.S. Food and Drug Administration (FDA) issued a Threshold of Regulation (TOR) exemption for the use of metal carbides and metal carbide alloys as a component of ceramic coating in repeat-use applications. Of note, the TOR was initiated by FDA itself — not by an industry submitter — and included the following explanatory text: “Reducing the number of duplicative submissions the agency receives for metal carbide and metal carbide alloy uses is consistent with the FDA’s risk-based approach and conserves the agency’s resources for issues of greater public health significance.” This is the first FDA-initiated TOR in the TOR Database.
FDA Re-opens Comment Period On Environmental Impact Statement For Certain Sunscreens: On June 25, 2021, FDA re-opened the comment period for the public scoping on the environmental impact statement (EIS) for certain sunscreen drug products. 86 Fed. Reg. 33712. FDA published the original notice May 13, 2021 and indicates that this extension was to allow an additional 30 days for interested parties to submit comments without delaying the publication of the draft EIS. The EIS is to address questions raised on the potential environmental effects for sunscreens containing oxybenzone or octinoxate. FDA intends to scope out the relevant issues of the environmental analysis and include potential alternatives. Comments are due by July 14, 2021.
FDA Guidance Under Development: A list of priority topics, of which the FDA Foods Program is either considering development of new guidance or revising existing guidance, was released on June 29, 2021. Topics under consideration include “Best Practices for Convening a GRAS Panel: Guidance for Industry” and a variety of topics related to the Food Safety and Modernization Act (FSMA).
FDA Receives Color Additive Petition For Gardenia Blue Powder: On June 30, 2021, FDA announced the submission of a Color Additive Petition for gardenia blue powder by Gardenia Blue Interest Group (GBIG). 86 Fed. Reg. 34664. Approval of the petition would permit use of the color additive in sports drinks, flavored or enhanced, noncarbonated water, fruit drinks and aides, ready-to-drink tea, hard candy, and soft candy.
FDA Issues Update For PFAS In The Food Supply: On June 30, 2021, FDA issued a Constituent Update covering the occurrence of PFAS in the food supply. The update includes testing results for PFAS in food samples, notice that FDA will conduct a targeted analysis of PFAS in seafood, and a brief explanation of how FDA conducts safety assessments for chemical contaminants in food.
FDA Issues Draft Guidance For Oversight Of Imported Foods: On July 9, 2021, FDA issued draft guidance titled “FDA Oversight of Food Products Covered by Systems Recognition Arrangements.” The guidance elaborates on FDA’s policy regarding Systems Recognition Arrangements, which are agreements between FDA and foreign regulatory counterparts that indicate confidence in each other’s food safety systems and allow leveraging of each other’s regulatory systems to manage the safety of foods. Comments on the draft guidance will be accepted until September 10, 2021.
NANOTECHNOLOGY
EU Survey Seeks Information On Needs For Integration Of Nanofabrication Industrial Ecosystem: The SUSNANOFAB project, funded by the EU’s Horizon 2020 Research and Innovation Program, is conducting a survey on industrial needs. SUSNANOFAB is approaching industrial stakeholders to help identify their immediate industrial needs. SUSNANOFAB states that these are the challenges that industrial stakeholders face in bringing their products or services to market and could include knowledge gaps, financial needs, access to infrastructures, or regulatory compliance. More information is available in our June 18, 2021, blog item.
ISO Publishes Nanotechnologies Standard For 3D Image Reconstruction Of Rod-Supported Nano-Objects Using Transmission Electron Microscopy: The International Organization for Standardization (ISO) has published standard ISO/TS 22292:2021, “Nanotechnologies — 3D image reconstruction of rod-supported nano-objects using transmission electron microscopy.” ISO states that the standard provides guidance for sample preparation, data acquisition by transmission electron microscopy (TEM), data processing, and three-dimensional (3D) image reconstruction to measure size and shape parameters of nano-objects on rod-shaped supports. According to ISO, the method is applicable to samples dispersed on or within an electron-transparent rod-shaped support.
EC Committee States More Data Needed To Assess Safety Of Notified Platinum Nanomaterials: On June 28, 2021, the EC’s Scientific Committee on Consumer Safety (SCCS) published its final opinion on platinum (nano), colloidal platinum (nano), and acetyl tetrapeptide-17 colloidal platinum (nano). The EC asked SCCS whether it considers the nanomaterials A (platinum and colloidal platinum) and B (acetyl tetrapeptide-17 (and) colloidal platinum) safe when used in leave-on cosmetic products according to the maximum concentrations and specifications reported, taking into account reasonably foreseeable exposure conditions. SCCS states that it “is of the opinion that it is not possible to carry out a safety assessment of any of the notified platinum nanomaterials due to limited or missing essential information.” More information is available in our June 29, 2021, blog item.
EC Committee Needs More Data To Assess Safety Of The Nanomaterials Gold, Colloidal Gold, And Surface Modified Gold: On June 28, 2021, the EC’s SCCS published a final opinion on gold (nano), colloidal gold (nano), gold thioethylamino hyaluronic acid (nano), and acetyl heptapeptide-9 colloidal gold (nano). The EC asked SCCS whether the nanomaterials gold, colloidal gold, gold thioethylamino hyaluronic acid, and acetyl heptapeptide-9 colloidal gold are safe when used in leave-on skin cosmetic products according to the maximum concentrations and specifications, taking into account reasonably foreseeable exposure conditions. SCCS states that it considered all the information provided by the notifiers “and is of the opinion that it is not possible to carry out safety assessment of the nanomaterials (Gold, Colloidal Gold and Surface Modified Gold) due to limited or missing essential information.” More information is available in our July 1, 2021, blog item.
EC Requests Scientific Opinion On Fullerenes And Hydroxylated Fullerenes: The EC has requested a scientific opinion from SCCS on fullerenes and hydroxylated fullerenes. The EC asks whether SCCS considers fullerenes and hydroxylated fullerenes safe when used in cosmetic products according to the maximum concentrations and specifications as reported, taking into account reasonably foreseeable exposure conditions. The EC also asks SCCS to assess any further scientific concerns with regard to the use of fullerenes and hydroxylated fullerenes in cosmetic products and whether a potential risk to human health can be identified according to Article 16(6) Reg.1223/2009.
ECHA Begins Consultation On CLH Proposal For Multi-Walled Carbon Tubes, Including Multi-Walled Carbon Nanotubes: ECHA has begun a public consultation on a harmonized classification and labeling (CLH) proposal for multi-walled carbon tubes (synthetic graphite in tubular shape) with a geometric tube diameter range ≥ 30 nanometers (nm) to < 3 micrometers (μm) and a length ≥ 5 μm and aspect ratio > 3:1, including multi-walled carbon nanotubes (MWC(N)T). The hazard classes open for comment are carcinogenicity and specific target organ toxicity — repeated exposure. Comments are due September 3, 2021. More information is available in our July 7, 2021, blog item.
Comment Period Begins On Draft NIOSH Report On Approaches To Developing Occupational Exposure Limits Or Bands For Engineered Nanomaterials: On July 13, 2021, the National Institute for Occupational Safety and Health (NIOSH) announced the availability of a draft technical report entitled Approaches to Developing Occupational Exposure Limits or Bands for Engineered Nanomaterials: User Guide and Technical Report. 86 Fed. Reg. 36748. NIOSH states that the draft report describes an evidence-based approach to evaluate the scientific information available to derive occupational exposure limits, or bands, for engineered nanomaterials. NIOSH seeks comments from individuals, including scientists and representatives from various government agencies, industry, labor, and other stakeholders, and also the public. NIOSH asks that comments note whether there are errors of fact, unsubstantiated claims, evidence of careless experimental work, inclusion of too much information already in the literature, or statements that are inaccurate. More information is available in our July 13, 2021, blog item. Comments are due September 13, 2021.
NanoHarmony Survey Asks Stakeholders About Their Experiences With OECD Test Guidelines And Guidance Documents: NanoHarmony wants to hear from stakeholders about their experiences with Organization for Economic Cooperation and Development (OECD) test guidelines (TG) and guidance documents (GD) by asking people to share their experiences in a short survey. The survey will close September 10, 2021.
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
Toxic Free Food Act Would Expand Federal Oversight Of Chemicals Added To Food: On June 4, 2021, Representative Rosa DeLauro (D-CT) introduced the Toxic Free Food Act of 2021 (H.R. 3699), which would “overhaul” FDA’s process for determining the safety of chemicals used in the food supply. According to DeLauro’s June 4, 2021, press release, an array of chemicals is often added to foods to improve flavor, enhance appearance, or extend shelf life. For decades, FDA has allowed food and chemical manufacturers to designate such chemicals as “generally recognized as safe” (GRAS), without FDA review or public notice. The press release states that consumer advocates “have long criticized the current GRAS notification system due to issues of transparency, effectiveness, and ethics.” The bill would require FDA “to close the so-called GRAS loophole and make the industry’s chemical food additives subject to FDA approval.”
Bill Would Ban PFAS Chemicals In Cosmetics: On June 15, 2021, Senators Susan Collins (R-ME) and Richard Blumenthal (D-CT) introduced the No PFAS in Cosmetics Act (S. 2047), which would ban the inclusion of PFAS chemicals in cosmetics products, such as make-up, moisturizer, and perfume. According to Collins’ June 15, 2021, press release, the bill would direct FDA to issue a proposed rule banning the intentional addition of PFAS in cosmetics, as defined by FDA, within 270 days of enactment, and require a final rule to be issued 90 days thereafter.
House Passes ESG Disclosure Simplification Act Of 2021: The House passed the Environmental, Social, and Governance (ESG) Disclosure Simplification Act of 2021 (H.R. 1187) on June 16, 2021, by a vote of 215 to 214. The bill would require an issuer of securities to disclose annually to shareholders certain ESG metrics and their connection to the long-term business strategy of the issuer. The bill would also establish the Sustainable Finance Advisory Committee that must, among other duties, recommend to the Securities and Exchange Commission (SEC) policies to facilitate the flow of capital towards environmentally sustainable investments.
House Committee Passes PFAS Action Act Of 2021: On June 23, 2021, the House Committee on Energy and Commerce passed the PFAS Action Act of 2021 (H.R. 2467) by a vote of 33 to 20. Introduced on April 13, 2021, by Representatives Fred Upton (R-MI) and Debbie Dingell (D-MI), the legislation would:
- Require EPA to establish a national drinking water standard for perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) within two years that protects public health, including the health of vulnerable subpopulations;
- Designate PFOA and PFOS chemicals as hazardous substances within one year and require EPA to determine whether to list other PFAS within five years;
- Designate PFOA and PFOS as hazardous air pollutants within 180 days and require EPA to determine whether to list other PFAS within five years;
- Require EPA to place discharge limits on industrial releases of PFAS and provide $200 million annually for wastewater treatment;
- Prohibit unsafe incineration of PFAS wastes and place a moratorium on the introduction of new PFAS into commerce;
- Require comprehensive PFAS health testing; and
- Create a voluntary label for PFAS in cookware.
In the previous Congress, the House passed the legislation by a vote of 247 to 159, including 24 Republicans voting in favor.
President Signs Bill Reinstating Methane Regulations: On June 30, 2021, President Joseph Biden signed a resolution of disapproval (S.J.Res. 14) under the Congressional Review Act (CRA) that repeals the Trump Administration’s 2020 Methane Rescission Rule. The resolution reinstates the methane requirements for the oil and gas industry’s production and processing segments and the methane and volatile organic compound (VOC) requirements for the transmission and storage segments.
House Appropriations Committee Approves FY 2022 Interior, Environment, And Related Agencies Funding Bill: On July 1, 2021, the House Appropriations Committee approved the fiscal year (FY) 2022 Interior, Environment, and Related Agencies bill on a 32-24 vote. According to the Committee’s July 1, 2021, press release, the bill includes $43.4 billion in regular appropriations, an increase of $7.3 billion — 20.2 percent — above 2021. There is also an additional $2.45 billion of funding for fire suppression. According to the bill summary, the bill provides a total of $11.34 billion for EPA, an increase of $2.11 billion above the FY 2021 enacted level and $110.8 million above the President’s budget request. Of this amount, the bill includes:
- $4.17 billion for EPA’s core science and environmental program work, an increase of $681 million above the FY 2021 enacted level;
- $5.32 billion for State and Tribal Assistance Grants, an increase of $1.01 billion above the FY 2021 enacted level and $194 million above the President’s budget request;
- $1.54 billion for Superfund, an increase of $331 million above the FY 2021 enacted level and $2.5 million above the President’s request; and
- $248 million for EJ activities, an increase of $235 million above the FY 2021 level.
House Climate Crisis Committee Holds Hearing On Advancing EJ Through Climate Action: The House Select Committee on the Climate Crisis held a hearing on July 15, 2021, on “Advancing Environmental Justice Through Climate Action.” During the hearing, the Committee reviewed opportunities to advance EJ through climate action, including targeting infrastructure investments to EJ communities, understanding the impact of extreme heat on low-income workers and students, and supporting tribal investments in clean energy and climate resilience.
Senate Committee Holds Hearing On Implementing Supply Chain Resiliency: The Senate Committee on Commerce, Science, and Transportation held a hearing on “Implementing Supply Chain Resiliency” on July 15, 2021. According to the Committee, the Department of Commerce (DOC) has an increasingly important role in ensuring the resiliency of the nation’s critical supply chains. These responsibilities stem from directives found in the FY 2021 National Defense Authorization Act, Biden Executive Order 14017 and its 100-day supply chain review, and potentially from the U.S. Innovation and Competition Act. The hearing was intended to inform Committee oversight as DOC executes these responsibilities, highlighting critical supply chains such as in the aerospace and semiconductor sectors.
House Subcommittee Holds Hearing On Whether Toxic Chemicals From Tires And Playground Surfaces Are Killing Endangered Salmon: On July 15, 2021, the House Natural Resources Subcommittee on Oversight and Investigations held a hearing entitled “Are Toxic Chemicals From Tires And Playground Surfaces Killing Endangered Salmon?” Witnesses included Dr. Jenifer McIntyre, Assistant Professor at Washington State University; Ms. Sarah Amick, Senior Counsel at the U.S. Tire Manufacturers Association; Ms. Sue Kuehl Pederson, Fisheries Biologist; and Mr. David Troutt, Director of Natural Resources Nisqually Indian Tribe.
Senate Subcommittee Will Hold Hearing To Examine Current Issues Adversely Affecting EJ Populations: On July 22, 2021, the Senate Committee on Environment and Public Works Subcommittee on Chemical Safety, Waste Management, Environmental Justice, and Regulatory Oversight will hold a hearing to examine current issues that adversely affect EJ communities.
MISCELLANEOUS
EPA Announces $50 Million To Fund EJ Initiatives: On June 25, 2021, EPA announced that it will provide $50 million dollars for EJ initiatives through funds allocated to EPA under the ARP. EPA states that in response to the COVID-19 pandemic, Congress designated this funding for grants, contracts, and other Agency activities that identify and address disproportionate environmental or public health harms and risks in underserved communities through a range of local initiatives. According to EPA, it is assisting under-resourced communities “by quickly getting out ARP funding to leverage important programs that improve air quality, drinking water, revitalization of brownfields, diesel emissions from buses in low income communities and communities of color.”
CPSC Receives Petition Requesting Rulemaking On Duster Aerosol Products: On June 29, 2021, CPSC announced that it has received a petition requesting that it initiate rulemaking to adopt a safety standard for duster aerosol products. 86 Fed. Reg. 34171. According to CPSC, on April 2, 2021, Families United Against Inhalant Abuse (FUAIA) submitted a petition requesting CPSC initiate rulemaking to adopt a mandatory CPSC safety standard to address the hazards associated with “duster” aerosol products used for cleaning electronics and other items and containing the chemical 1,1-difluorethane, or any derivative thereof. The petitioner states that when 1,1-difluoroethane used in duster aerosol products is inhaled from the can, intoxication occurs rapidly, yet is very short-lived (four to five minutes). According to the petitioner, inhalation of this chemical is acutely dangerous and causes immediate brain damage and possible Sudden Sniffing Death (SSD). The petitioner states that 22 percent of first-time duster inhalers die, and the majority of all duster-inhalant deaths are attributed to SSD. CPSC invites written comments concerning the petition. Comments are due August 30, 2021.
President Biden Announces Nominees For CPSC And CPSC Chair: On July 2, 2021, President Joseph Biden announced his intent to nominate Mary Boyle to the CPSC and Alexander Hoehn-Saric for CPSC Chair. Boyle, the current CPSC Executive Director, has spent more than a decade at CPSC in senior positions across the agency and is a member of the Senior Executive Service. Her work has covered a broad range of issues, including policy, administration, legal questions, budgets, product recalls, negotiations, rules and regulations, and agency morale. Hoehn-Saric is Chief Counsel for Communications and Consumer Protection for the House Committee on Energy and Commerce. In this position, he works on legislation and oversight related to product safety, consumer protection, and communications. Hoehn-Saric also served at DOC as the Deputy General Counsel for Strategic Initiatives. Prior to that, he was senior counsel for the Senate Committee on Commerce, Science, and Transportation where he was responsible for product safety and consumer protection matters.
FTC Intends To Initiate Review Of Green Guides In 2022: On July 2, 2021, the Federal Trade Commission (FTC) announced its modified ten-year regulatory review schedule. 86 Fed. Reg. 35239. According to the review schedule, FTC intends to initiate its review of the Guides for the Use of Environmental Marketing Claims (Green Guides) in 2022. As reported in our October 3, 2012, memorandum, FTC last revised the Green Guides in 2012. FTC intends the Green Guides to help marketers ensure that the claims they make about the environmental attributes of their products are “truthful and non-deceptive.” When FTC reviews a rule or guide, it publishes a Federal Register notice seeking public comment on the continuing need for the rule or guide, as well as the rule’s or guide’s costs and benefits to consumers and businesses.
California Will Require Manufacturers Of Carpets And Rugs To Consider Safer Alternatives To PFAS: On July 2, 2021, the California Department of Toxic Substances Control (DTSC) announced that under a new regulation, carpets and rugs containing PFAS are now DTSC’s fourth “Priority Product.” Domestic and foreign carpet and rug manufacturers whose products contain any member of the class of PFAS in their carpets or rugs must submit a Priority Product Notification (PPN) for those products by August 30, 2021. The PPN must name all the products that contain PFAS and are sold in California. After submitting the PPN, manufacturers will have the option to submit one of the following by December 28, 2021:
- Chemical Removal Intent/Confirmation Notification;
- Product Removal Intent/Confirmation Notification;
- Product-Chemical Replacement Intent/Confirmation Notification; or
- Preliminary Alternatives Analysis Report or these alternate reporting options.
Manufacturers of carpets and rugs that do not contain PFAS do not need to take any action. The regulation took effect July 1, 2021.
NIOSH Creates Topic Page For PFAS: On July 7, 2021, NIOSH announced the availability of a topic page for PFAS. The page provides an overview, worker risks, NIOSH research on PFAS, PFAS web resources, and references. According to NIOSH, its research activities include worker exposure and health assessments in manufacturing workers, service sector workers, and firefighters; dermal absorption assessments, sampling and analytical methods, toxicity testing in animals, and high throughput screening in vitro studies; and firefighter turnout gear for PFAS in textiles.
OSHA Extends Period To Submit NOITA At September Hearing On Proposed HCS Rule: On July 8, 2021, the Occupational Safety and Health Administration (OSHA) extended the period to submit a notice of intent to appear (NOITA) at the public hearing on September 21, 2021. 86 Fed. Reg. 36073. NOITAs, along with any submissions and attachments, are due July 22, 2021. More information on OSHA’s proposed amendments to the Hazard Communication Standard (HCS) is available in our February 16, 2021, memorandum.
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