July 24, 2021

Volume XI, Number 205

Advertisement

July 23, 2021

Subscribe to Latest Legal News and Analysis

July 22, 2021

Subscribe to Latest Legal News and Analysis

July 21, 2021

Subscribe to Latest Legal News and Analysis

Recent Federal Developments - June 2021

TSCA/FIFRA/TRI

EPA Begins Environmental Justice Consultations On Risk Management Rulemakings For TCE And PCE: On May 18, 2021, EPA invited environmental justice communities and stakeholders to participate in environmental justice consultations regarding the development of proposed risk management actions under Section 6(a) of TSCA to address unreasonable risks presented by trichloroethylene (TCE) and perchloroethylene (PCE). EPA will hold two identical consultation webinars, one on June 16, 2021, and the other on July 6, 2021. The consultations are open to the public, and EPA invites national, local, and non-governmental organizations (NGO), communities, and other interested stakeholders to participate. Comments are due August 20, 2021. More information is available in our May 18, 2021, blog item.

EPA Publishes Receipt And Status Information For Certain New Chemicals: On May 19, 2021, EPA published the receipt and status reports for TSCA Section 5 submissions for April 2021. 86 Fed. Reg. 27083. EPA published the receipt and status reports for TSCA Section 5 submissions for May 2021 on June 15, 2021. 86 Fed. Reg. 31710. EPA provides notice of receipt of premanufacture notices (PMN), significant new use notices (SNUN), and microbial commercial activity notices (MCAN); an exemption application under 40 C.F.R. Part 725 (Biotech exemption); test marketing exemptions (TME); notices of commencement (NOC); 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 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. Comments identified by the specific case number provided in the May 19, 2021, notice are due June 18, 2021, and comments identified by the specific case number provided in the June 15, 2021, notice are due July 15, 2021.

EPA OPPT Strategic Plan For FYs 2021-2023 Outlines Six Priority Areas: EPA has prepared a strategic plan for the Office of Pollution Prevention and Toxics (OPPT) for fiscal years (FY) 2021-2023. The strategic plan outlines how OPPT intends to fulfill its obligations under TSCA, the Emergency Planning and Community Right-to-Know Act (EPCRA), the Pollution Prevention Act (PPA), and related EPA policies and procedures “in ways that value science, protect people and the environment, and increase transparency for stakeholders and the general public.” The strategic plan includes new vision, mission, and values statements for OPPT. Priority areas include: new chemicals; existing chemicals; pollution prevention/Safer Choice/Toxics Release Inventory (TRI); transparency and stakeholder engagement; human capital; and efficiency and enabling tools. More information is available in our May 20, 2021, blog item.

Yvette T. Collazo Steps Down As Director Of OPPT: Effective May 21, 2021, Yvette T. Collazo has resigned as the Director of OPPT. Collazo began as OPPT Director in March 2020. During her tenure, OPPT’s accomplishments include publishing final risk evaluations for the first ten chemicals reviewed under the amended TSCA and initiating the risk evaluation process for the next 20 high-priority chemicals; beginning risk management activities for the first ten chemicals; issuing final rules to reduce exposures to five persistent, bioaccumulative, and toxic (PBT) chemicals; proposing revisions to the TSCA fees rule; and re-organizing OPPT to align new chemicals, existing chemicals, confidential information/transparency, and “forward-looking” data collection functions structurally. More information is available in our May 24, 2021, blog item.

EPA Responds To Petition Seeking RCRA And TSCA Regulatory Action For Phosphogypsum And Process Wastewater: On May 21, 2021, EPA published its response to a portion of the petition it received February 8, 2021, from People for Protecting Peace River, Center for Biological Diversity, and 16 other organizations. 86 Fed. Reg. 27546. While the petition requested three actions related to TSCA, EPA states that it has determined that only one of those actions is an appropriate request: a request to issue a test rule under TSCA requiring testing of phosphogypsum and process wastewater from phosphoric acid production. According to the notice, EPA is treating the other portions of the petition involving TSCA as a petition under the Administrative Procedure Act (APA); those other portions request EPA to initiate the prioritization process for designating phosphogypsum and process wastewater as high-priority substances for risk evaluation and to make a determination by rule under TSCA that the use of phosphogypsum in road construction is a significant new use. Therefore, the notice does not provide EPA’s response to these two TSCA-requested actions. Also, it does not address the petitioners’ requests under the Resource Conservation and Recovery Act (RCRA). EPA states that “[a]fter careful consideration,” it has denied the TSCA Section 21 portion of the petition. More information is available in our May 25, 2021, blog item.

EPA Begins Environmental Justice Consultation On Risk Management Rulemaking For NMP: On May 27, 2021, EPA announced that it has invited environmental justice communities and stakeholders to participate in environmental justice consultations regarding the development of a proposed risk management action under TSCA Section 6(a) to address unreasonable risks presented by N-methylpyrrolidone (NMP). EPA will hold two identical consultation webinars, one on July 7, 2021, and the other on July 13, 2021. Both sessions will provide an overview of the TSCA risk management requirements, the findings from the final risk evaluation, the tools available to manage the unreasonable risks from NMP, and an opportunity for EPA to obtain input on environmental justice concerns. The consultations are open to the public, and EPA is inviting national, local, and NGOs, communities, and other interested stakeholders to participate. Comments are due August 27, 2021.

EPA Adds Certain PFAS To TRI Beginning With Reporting Year 2021: On June 3, 2021, EPA added three PFAS to the list of chemicals subject to toxic chemical release reporting under EPCRA and PPA. 86 Fed. Reg. 29698. The final rule implements the statutory mandate in the National Defense Authorization Act for Fiscal Year 2020 enacted on December 20, 2019. According to EPA, “[a]s this action is being taken to conform the regulations to a Congressional legislative mandate, notice and comment rulemaking is unnecessary.” The final rule will be effective July 6, 2021.

EPA Amends Certain SNURs To Allow Certain New Uses: On June 7, 2021, EPA published a final rule amending significant new use rules (SNUR) issued under TSCA for certain chemical substances that were the subject of PMNs and SNUNs. 86 Fed. Reg. 30210. The final rule amends the SNURs to allow certain new uses reported in the SNUNs without additional notification requirements and modifies the SNUN requirements based on the actions and determinations for the SNUN submissions. EPA states that it is issuing these amendments based on review of new and existing data for the chemical substances. The final rule will be effective August 6, 2021.

EPA Publishes Three Batches Of Final SNURs: On June 7, 2021, EPA published three batches of final SNURs under TSCA for chemical substances that were the subject of PMNs. 86 Fed. Reg. 3018486 Fed. Reg. 3019086 Fed. Reg. 30196. The final 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 these SNURs. The SNURs further require that persons not commence manufacture or processing for the significant new use until they have submitted a SNUN, EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken any risk management actions as are required as a result of that determination. The final SNURs will be effective August 6, 2021.

EPA Proposes SNURs For Certain Chemical Substances: EPA proposed SNURs on June 11, 2021, for certain chemical substances that were the subject of PMNs and an MCAN, and are also subject to Orders issued by EPA pursuant to TSCA. 86 Fed. Reg. 31239. 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 are due July 12, 2021.

Interim Final Rule To Address PBT Rule Compliance Date Issues Planned For September 2021: On June 11, 2021, the Office of Management and Budget (OMB) released its “Spring 2021 Unified Agenda of Regulatory and Deregulatory Actions” (Regulatory Agenda). It includes an entry for an interim final rule planned by EPA entitled “Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h); Reconsideration and Extension of Certain Compliance Dates.” This action, planned for publication in September 2021, would be in follow-up to EPA’s March 16, 2021, proposed rule that sought additional public comment on final rules published on January 6, 2021, covering five persistent, bioaccumulative, and toxic (PBT) chemicals, i.e., decabromodiphenyl ether2,4,6-tris(tert-butyl)phenolhexachlorobutadienepentachlorothiophenol; and phenol, isopropylated phosphate (3:1) (PIP (3:1)). The Regulatory Agenda entry for the interim final rule states that EPA intends to address compliance date issues in the action, and that if it “determines to further amend the recent final [PBT] rules, EPA will address those amendments in one or more future Regulatory Agenda entries.” More information is available in our June 14, 2021, blog item.

Senate Confirms Michal Freedhoff As EPA Assistant Administrator For Chemical Safety And Pollution Prevention: On June 14, 2021, the Senate confirmed by voice vote Michal Freedhoff to be the Assistant Administrator for OCSPP. As reported in our January 22, 2021, blog item, Freedhoff was onboarded in January 2021 as Principal Deputy Assistant Administrator for OCSPP. On April 14, 2021, President Joseph Biden nominated Freedhoff for Assistant Administrator for OCSPP. More information on Freedhoff’s nomination process is available in our May 12, 2021, memorandum, “Senate Committee Holds Hearing on Nominee for EPA Assistant Administrator for Chemical Safety and Pollution Prevention.”

Electronic Option Available For Export Notifications Required Under TSCA: EPA announced on June 14, 2021, the availability of an electronic option for submitting the export notifications that are required under TSCA. 86 Fed. Reg. 31502. As an alternative to the hardcopy approach, which is still available, EPA states that it is also now accepting the required export notifications electronically using its electronic document submission system, the Central Data Exchange (CDX). According to EPA, use of CDX to prepare and submit the required export notifications will help streamline and reduce the administrative costs and burdens associated with submitting paper-based export notifications for both the submitters and the Agency. TSCA export notifications may be submitted electronically using CDX beginning June 14, 2021.

EPA Hosts Webinar On Electronic Gold Seal Letter Process For Exporting Pesticides: On June 14, 2021, EPA hosted a webinar for pesticide registrants to provide registrants an overview on how to request Certificates of Registration, commonly known as Gold Seal letters, using the Pesticide Submission Portal. Gold Seal letters serve as proof for pesticide exporters that the product is registered with EPA and meets all necessary registration requirements. According to EPA, since launching the digital platform in 2020 in response to the COVID-19 public health emergency, the electronic process has resulted in quicker processing of Gold Seal letters and thorough and complete internal tracking. Due to continuing safety precautions within EPA, it is still unable to produce traditional, paper-based Gold Seal letters. Accordingly, registrants must continue to submit requests through the Pesticide Submission Portal. Information on how to request a Gold Seal certificate letter, including information on how registrants should present the letters to the U.S. Department of State when authentication is needed for business purposes, is available here.

EPA Announces Winners Of The 2021 Green Chemistry Challenge Awards: EPA announced on June 15, 2021, the winners of the 2021 Green Chemistry Challenge Awards. EPA states that “[g]reen chemistry is the design of chemical products and processes that reduce or eliminate the generation and use of hazardous substances.” According to EPA, the 2021 winners “developed new and innovative green chemistry technologies that provide solutions to significant environmental challenges, and spur innovation and economic development.” The 2021 winners are: Professor Srikanth Pilla of Clemson University, South Carolina, for creating the first nonisocyanate polyurethane foam; XploSafe, Oklahoma, for creating PhosRox, a novel sorbent used to make fertilizer; Colonial Chemical, Tennessee, for developing environmentally friendly, high performing Suga®Boost surfactants; Bristol Myers Squibb, New York, for a new class of sustainable reagents -- substances used to cause a chemical reaction; and Merck, New Jersey, for developing a green and sustainable manufacturing process for a drug used to treat chronic coughs. An independent panel of technical experts convened by the American Chemical Society Green Chemistry Institute formally judged the 2021 submissions and made recommendations to EPA for the 2021 winners.

PIP (3:1) Downstream Notifications Will Begin July 7, 2021: Under the January 6, 2021, final PIP (3:1) rule, each person who manufactures PIP (3:1) for any use after March 8, 2021, must notify persons to whom PIP (3:1) is shipped of the prohibitions on processing, distribution, and releases to water. 40 C.F.R. § 751.407(e)(1). Each person who processes or distributes in commerce PIP (3:1) or PIP (3:1)-containing products for any use after July 6, 2021, must notify persons to whom PIP (3:1) is shipped of the prohibitions on processing, distribution, and releases to water. 40 C.F.R. § 751.407(e)(2). The final rule clarifies that the downstream notification requirement applies only to those scenarios where a product has an accompanying safety data sheet (SDS). EPA also included an alternative method of compliance for downstream notification. If a manufacturer, processor, or distributor chooses, they may include specified text on their label, instead of on their SDS. More information is available in our June 15, 2021, blog item.

RCRA/CERCLA/CWA/CAA/PHMSA/SDWA

EPA Announces Public Listening Sessions And Trainings On Upcoming Oil And Natural Gas Methane Rule: On May 14, 2021, EPA announced that it “is taking the first step to develop a proposed rule to reduce methane and other harmful pollutants from new and existing sources in the oil and natural gas industry, beginning with a broad public outreach effort to gather community and stakeholder input.” These activities include holding training sessions on the rulemaking process and how to participate in it, convening listening sessions for stakeholders, and opening a public docket for pre-proposal comments. EPA held training webinars on May 25, 26, and 27, 2021, for communities, Tribes, and small businesses to provide an overview of the oil and natural gas industry and share information to help members of those groups effectively engage in the regulatory process. EPA held a virtual public listening session on June 15, 2021, and will hold other virtual public listening sessions on June 16 and 17, 2021. During the listening sessions, registered members of the public will have the chance to provide their views on the oil and natural gas industry as it relates to climate change, health, and EPA’s upcoming proposed rule. Beginning May 14, 2021, members of the public may submit their perspectives and input to the docket in advance of the September 2021 proposed rulemaking.

EPA Announces Advancements In ENERGY STAR Program: On May 17, 2021, EPA announced advancements in the ENERGY STAR program that “will help set the stage for an economy-wide transition to the types of technology that will be critical in the fight against climate change.” EPA states that as it works toward realizing President Biden’s goal of reducing emissions by over 50 percent by 2030, the announcement “showcase[s] the ability of EPA’s climate partnerships to foster a clean energy future by reducing fossil fuel use, increasing energy efficiency, and creating local jobs.” EPA has updated ENERGY STAR standards for residential water heaters and heating/cooling equipment that advance innovative heat pump technologies as a key component to carbon pollution reduction while also reducing energy use and heating costs. The ENERGY STAR program also expanded to cover electric vehicle (EV) chargers used in commercial settings, known as DC fast chargers. EPA announced a range of new commitments, including:

  • Develop a new ENERGY STAR program offering to accelerate energy efficiency and electrification retrofits in existing homes;

  • Advance the ENERGY STAR Recognition Program for Residential New Construction;

  • Advance public health protections through residential labeling programs for indoor air quality;

  • Support development of building benchmarking policies and building performance standards;

  • Launch EPA Zero-Carbon Building Recognition;

  • Launch a New Greenhouse Gas Emissions Calculator Tool for Commercial Buildings; and

  • Provide technical assistance to state, local, and tribal governments.

EPA Adds New PFAS To Its Drinking Water Treatability Database: On May 19, 2021, EPA announced an update to the Drinking Water Treatability Database with new references and treatment options for PFAS. EPA states that the update will help states, Tribes, local governments, and water utilities make informed decisions to manage PFAS in their communities. The Drinking Water Treatability Database presents an overview of different contaminants and possible treatment processes to remove them from drinking water. With this update, EPA added treatment information for 11 PFAS compounds. According to EPA, this update brings the total number of PFAS with treatment information in the database to 37, including perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS). Researchers have also added 38 new scientific references to the existing PFAS entries, “increas[ing] the depth of scientific knowledge available in the database.”

EPA Publishes Proposed Rule That Would Establish Allowance Allocation And Trading Program For Phasedown Of HFCs: On May 19, 2021, EPA proposed to issue regulations to implement certain provisions of the American Innovation and Manufacturing (AIM) Act, as enacted on December 27, 2020. 86 Fed. Reg. 27150. The rulemaking proposes to establish the hydrofluorocarbon (HFC) production and consumption baselines based on historical data; establish the allowance allocation program to phase down HFC production and consumption; determine an initial methodology to allocating allowances and allowing for the transfer of those allowances; establish provisions for the international transfer of allowances; establish requirements to support compliance with phasing down HFC production and consumption; establish recordkeeping and reporting requirements; release certain data to provide transparency and support implementation of the program; and address certain other elements related to the effective implementation of the AIM Act. In addition to the proposed provisions, EPA seeks advance input on how it may alter its determination of company-specific allocations in later years. EPA is considering these issues, and therefore is seeking public input on them, but is not making any particular proposal in relation to them, and therefore will not issue any final requirements on these topics before issuing a notice of proposed rulemaking and requesting public comment. Comments are due July 6, 2021.

EPA Will Hold Public Listening Session On RMP Rule: EPA will hold two virtual public listening sessions on the Risk Management Plan (RMP) rule, which requires certain industrial facilities to prevent accidental air releases of chemicals that could cause deaths, injuries, property and environmental damage, or require evacuations in surrounding communities. 86 Fed. Reg. 28828. The Occupational Safety and Health Administration (OSHA) will participate in the listening sessions to foster continued coordination with EPA and receive comments on the Process Safety Management (PSM) Standard. The listening sessions are intended to provide interested people the opportunity to present information, and provide comments or views pertaining to revisions made to the RMP rule since 2017. The public listening sessions will be held June 16, 2021, and July 8, 2021. Written comments are due July 15, 2021. Written comments may be submitted independent of attendance or statements at either public listening session.

EPA Publishes Notice Of Data Availability Relevant To Petition Submissions Under AIM Act: On May 25, 2021, EPA published a Notice of Data Availability to alert stakeholders of petitions submitted to EPA under AIM Act Subsection (i) and to provide notice of a new docket where these petitions and others submitted under Subsection (i) will be made publicly available. 86 Fed. Reg. 28099. EPA states that the docket will provide the public the opportunity to view petitions submitted and to submit any supplemental relevant data to the petitions. EPA may consider relevant information submitted to the docket in its determinations of whether to grant or deny Subsection (i) petitions. Supplemental data to be considered in upcoming EPA determinations regarding petitions received on April 13, 2021, were due June 8, 2021.

EPA Selects Ten Communities For Roundtable Discussion On Lead In Drinking Water: On May 26, 2021, EPA announced the ten communities selected for virtual roundtable discussions on EPA’s Lead and Copper Rule (LCR) Revisions. The roundtables are intended to foster dialogue on the experience of communities that are affected by lead in drinking water as EPA reviews the LCR to ensure that it supports EPA’s priorities. The community roundtables began June 3, 2021, in Pittsburgh, Pennsylvania. EPA will also host roundtables in Newark, New Jersey; Washington, D.C.; Milwaukee, Wisconsin; Chicago, Illinois; Benton Harbor and Highland Park, Michigan; Flint and Detroit, Michigan; Malden, Massachusetts; Memphis, Tennessee; and Newburgh, New York. EPA will also host national stakeholder roundtables with drinking water utilities, intergovernmental associations, environmental organizations, environmental justice organizations, public health organizations, and consumer associations. In July 2021, EPA will also host a Tribal roundtable discussion and a national co-regulator meeting with primacy agencies to discuss the feedback received from communities and stakeholders.

EPA Intends To Reconsider And Revise 2020 CWA Section 401 Certification Rule: On June 2, 2021, EPA published a notice of intent announcing its intention to reconsider and revise the Clean Water Act (CWA) Section 401 Certification Rule. 86 Fed. Reg. 29541. In addition, EPA will initiate a series of stakeholder outreach sessions and invite written feedback on how to revise the requirements for water quality certifications under the CWA. EPA states that it intends to revise the CWA Section 401 Certification Rule “in a manner that is well informed by stakeholder input on the rule’s substantive and procedural components; is better aligned with the cooperative federalism principles that have been central to the effective implementation of the Clean Water Act; and is responsive to the national objectives outlined in President Biden's Executive Order 13990.” Under CWA Section 401, a federal agency may not issue a license or permit to conduct any activity that may result in any discharge into navigable waters unless the affected state or Tribe certifies that the discharge is in compliance with the CWA and state law, or waives certification. Written feedback is due August 2, 2021.

EPA And Department Of The Army Intend To Revise WOTUS Definition: EPA and the Department of the Army announced on June 9, 2021, their intent to revise the definition of “waters of the United States” (WOTUS) to protect better vital water resources that support public health, environmental protection, agricultural activity, and economic growth. As described in an EPA declaration requesting remand of the 2020 Navigable Waters Protection Rule, a broad array of stakeholders -- including states, Tribes, local governments, scientists, and NGOs -- “are seeing destructive impacts to critical water bodies under the 2020 rule.” Upon review of the Navigable Waters Protection Rule, the agencies have determined that the rule is significantly reducing clean water protections. According to the announcement, the agencies intend “to initiate a new rulemaking process that restores the protections in place prior to the 2015 WOTUS implementation, and anticipate[] developing a new rule that defines WOTUS and is informed by a robust engagement process as well as the experience of implementing the pre-2015 rule, the Obama-era Clean Water Rule, and the Trump-era Navigable Waters Protection Rule.”

EPA Will Reexamine PM NAAQS That Previous Administration Left Unchanged: EPA announced on June 10, 2021, that it will reconsider the previous Administration’s decision to retain the particulate matter (PM) National Ambient Air Quality Standards (NAAQS), which were last strengthened in 2012. EPA states that it is reconsidering the December 2020 decision “because available scientific evidence and technical information indicate that the current standards may not be adequate to protect public health and welfare,” as required by the Clean Air Act (CAA). As part of the process, EPA will develop a supplement to the 2019 Final Integrated Science Assessment (ISA) that will take into account the most up-to-date science, including new studies in the emerging area of COVID-related research. The supplement will be reviewed at a public meeting by the chartered Clean Air Scientific Advisory Committee (CASAC), supported by a PM review panel of scientific experts on the health and welfare impacts of PM. According to the announcement, EPA expects to issue a proposed rulemaking in Summer 2022 and a final rule in Spring 2023, “following an open, transparent process with opportunities for public review and comment.”

EPA Publishes ANPRM Regarding Adding 1-BP To CAA Section 112 HAP List: Having previously granted a public petition to add 1-bromopropane (1-BP) to the list of hazardous air pollutants (HAP) under the CAA, EPA published an advance notice of proposed rulemaking (ANPRM) on June 11, 2021, soliciting information that will aid in addressing the impacts of the regulatory action. 86 Fed. Reg. 31225. According to EPA, this is the first time that a substance will be added to the HAP list since the initial list was established by the 1990 CAA Amendments. EPA states that the addition of 1-BP to the HAP list “could have immediate regulatory compliance impacts to facilities that emit 1-BP.” EPA is soliciting data and information on 1-BP usage, emission controls, and costs to inform the process to address the implementation of the upcoming listing action and to ensure that the regulatory infrastructure is in place to control effectively and efficiently the emissions of 1-BP. EPA notes that it is not soliciting comments on the decision that granted petitions to list 1-BP as a HAP and has not reopened that decision for comments. Comments are due July 26, 2021.

EPA Publishes Final Denial Of Corrosive Waste Rulemaking Petition: EPA announced on June 15, 2021, its final denial of a rulemaking petition requesting revision of the RCRA corrosivity hazardous waste characteristic regulation. 86 Fed. Reg. 31622. The petition requested that EPA make two changes to the current corrosivity characteristic regulation: revise the regulatory threshold for defining waste as corrosive from the current value of pH 12.5, to pH 11.5; and expand the scope of the RCRA corrosivity definition to include non-aqueous wastes in addition to the aqueous wastes currently regulated. EPA states that it published a tentative denial of the rulemaking petition on April 11, 2016. EPA has concluded that because the available information does not support revision of the RCRA corrosivity characteristic regulations sought by the petitioners, such revisions are unwarranted. The final action is effective immediately.

FDA

FDA Draft Guidance For Elemental Impurities: On May 12, 2021, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance document titled “Q3D(R2) -- Guideline for Elemental Impurities.” 86 Fed. Reg. 26052. The draft guidance, developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), includes Permissible Daily Exposure (PDE) values for elemental impurities (e.g., lead, nickel) in pharmaceuticals via oral, parenteral, and inhalation exposure routes.

New Era Of Smarter Food Safety: On May 18, 2021, FDA, in its continued efforts to address technological advances in food traceability, announced a challenge to stakeholders to develop traceability tools that are scalable and cost-effective mechanisms for food operations of all sizes. The pre-registration web page is available for submissions until July 30, 2021. FDA intends to announce up to 12 winners at the completion of the challenge.

World Food Safety Day 2021:On June 7, 2021, FDA marked the third annual World Food Safety Day, with the theme “Safe Food Today for a Healthy Tomorrow.” Remarks by Frank Yiannas, the FDA Deputy Commissioner for Food Policy and Response, are available here.

FDA’s 2022 Budget For Food Safety And Nutrition: On June 7, 2021, FDA outlined key investments for food safety and nutrition in the President’s 2022 Budget Request. The agency released fact sheets titled, “Overview and Key Accomplishments,” “New Era of Smarter Food Safety,” “Emerging Chemical and Toxicology Issues,” and “Maternal and Infant Health and Nutrition.” The relatively largest increase in funding -- + $44.8 million, equivalent to 46 full-time equivalents in staffing -- is requested for the New Era of Smarter Food Safety initiative.

NANOTECHNOLOGY

ECHA Updating Guidance Concerning REACH Information Requirements For Nanoforms: The European Chemicals Agency (ECHA) is in the process of updating its guidance on the information requirements and chemical safety assessment (IR&CSA) for nanoforms under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. ECHA has developed three appendices concerning information requirements (appendices to IR&CSA Guidance Chapters R.7a, R.7b, and R.7c) to provide advice to registrants for use when preparing REACH registration dossiers that cover nanoforms. ECHA is updating two of the appendices, Appendix R7-1 to Chapter R.7a and Appendix R7-2 to Chapter R.7c. More information is available in our May 19, 2021, blog item.

NIOSH CIB On Health Effect Of Occupational Exposure To Silver Nanomaterials Includes REL For Silver Nanomaterials: The National Institute for Occupational Safety and Health (NIOSH) has published Current Intelligence Bulletin 70: Health Effects of Occupational Exposure to Silver Nanomaterials86 Fed. Reg. 29787. NIOSH derived a recommended exposure limit (REL) for silver nanomaterials (<100 nanometers (nm) primary particle size) of 0.9 micrograms per cubic meter (µg/m3) as an airborne respirable eight-hour time-weighted average (TWA) concentration. The Current Intelligence Bulletin (CIB) notes that NIOSH continues to recommend a REL of 10 µg/m3 as an eight-hour TWA for total silver (metal dust, fume, and soluble compounds, as Ag). More information is available in our May 20, 2021, blog item.

Stakeholder Survey Begins On Nanomaterials Available In EU Market: ECHA, as part of the activities of the EU Observatory for Nanomaterials (EUON), is conducting a stakeholder survey on the substances available as nanomaterials in the EU market. According to EUON’s May 21, 2021, news item, the survey aims to provide an overview of the substances that are available as nanomaterials on the EU market, as well as insight into their main areas of application and approximate volumes.

EUON Publishes Nanopinion On The Need For Updating Language Regarding Nanomaterials: On May 31, 2021, the EUON published a Nanopinion entitled “Updating our language: why we should not paint all nanoforms with the same brush” by Chiara Venturini, Director General of the Nanotechnology Industries Association (NIA). According to Venturini, as explained in a recent NIA position paper, the European Commission’s (EC) transition from nanomaterial to nanoform “is a welcome development: the increased granularity in the information collected on nanoforms supports safe manufacturing; helps build up the knowledge base to identify the safest and most efficient forms of a substance to be used in products; and continuously improves the transparency required to gain end-user trust and foster confidence in nanotechnology.”

NNI Holds Public Webinar On Nanosensors For Food And Agriculture: On June 2, 2021, the U.S. National Nanotechnology Initiative (NNI) held a webinar on nanosensors for food and agriculture. NNI states that nanotechnology-enabled sensors (nanosensors) “are promising tools to advance precision agriculture and support a safe and robust food supply chain, from farm to fork.” Panelists discussed how the development and deployment of nanosensors could transform agriculture and food safety. They highlighted the state of the science, discussed community needs to push the science forward, and explored the challenges associated with bringing these technologies to market. More information is available in our May 21, 2021, blog item.

ANSES Reiterates Recommendation To Restrict Use Of Products Containing Nanomaterials “That Are of Little Benefit to the Population”: On June 3, 2021, the French Agency for Food, Environmental and Occupational Health and Safety (ANSES) published an interview with Aurélie Niaudet, who is in charge of assessing the risks associated with physical agents. More information is available in our June 7, 2021, blog item.

NNI Holds Public Webinar On “What We Know about NanoEHS: Human Health”: On June 8, 2021, NNI held a webinar on “What We Know about NanoEHS: Human Health.” The webinar featured experts from diverse disciplines who shared their perspectives on key findings on the effects of engineered nanomaterials on human health. More information is available in our May 25, 2021, blog item.

Workshop On GRACIOUS Approach To Quality Assessment Of Nanosafety Data Will Be Held June 28: On June 28, 2021, Gov4Nano will hold a workshop on the GRACIOUS approach to the quality assessment of nanosafety data. GRACIOUS, an EU H2020 project, has proposed a methodology to facilitate the evaluation of quality and completeness for sets of nanomaterial physicochemical and (eco)toxicological data based on established criteria, i.e., completeness, reliability, relevance, and adequacy. Gov4Nano is organizing the workshop to present its approach and collect opinions on key aspects of the quality assessment methodology. More information is available in our June 11, 2021, blog item.

LEGISLATIVE

House Committee Leaders Request Information From CSB On Management Challenges: Representatives Frank Pallone, Jr. (D-NJ), Chair of the Energy and Commerce Committee, Cathy McMorris Rodgers (R-WA), Ranking Member, Diana DeGette (D-CO), Chair of the Oversight and Investigations Subcommittee, Morgan Griffith (R-VA), Ranking Member of the Oversight and Investigations Subcommittee, Paul Tonko (D-NY), Chair of the Environment and Climate Change Subcommittee, and David McKinley (R-WV), Ranking Member of the Environment and Climate Change Subcommittee, wrote to the Chemical Safety and Hazard Investigation Board (CSB) “demanding information regarding the ongoing management, resources, and personnel challenges it continues to face.” The House Energy and Commerce Committee’s May 20, 2021, press release states that “[t]he bipartisan Committee leaders express concern over the CSB’s ongoing difficulties meeting its legal authorities related to chemical accident release investigations, as well as its failure to address its investigations backlog.” They note that CSB has 20 open investigations, including one from 2016, and that these delays could result in recommendations being outdated by the time they are complete. According to the letter, CSB did not approve any new recommendations last year.

Legislation Would Reduce PFAS Exposure Among Servicemembers And Military Families: On May 25, 2021, Senators Richard Blumenthal (D-CT) and Jeanne Shaheen (D-NH) introduced legislation intended to reduce exposure of servicemembers and their families to PFAS chemicals. Blumenthal’s May 25, 2021, press release states that the PFAS Free Military Purchasing Act would prohibit the Department of Defense from procuring, purchasing, and selling items that contain PFAS, “dangerous and toxic chemicals commonly found in many everyday items like food service ware, carpets and rugs, clothing, and cosmetics.” According to the press release, “PFAS exposure has been linked to a number of serious health conditions, including cancer, liver damage, decreased fertility, and increased risk of asthma and thyroid disease.”

Senate Committee On Environment And Public Works Holds Hearing On PFAS: The View From Affected Citizens And States: On June 9, 2021, the Senate Committee on Environment and Public Works held a hearing on “PFAS: The View from Affected Citizens and States.” The witnesses included:

  • James Kenney, Cabinet Secretary, New Mexico Environment Department;

  • Joanne Stanton, Co-founder, Buxmont Coalition for Safer Water;

  • Scott Mandirola, Deputy Secretary for External Affairs, West Virginia Department of Environmental Protection; and

  • G. Tracy Mehan III, Executive Director, Government Affairs, American Water Works Association.

MISCELLANEOUS

NGO Claims L.A. Baby Is “Greenwashing,” Files FTC Complaint: On May 13, 2021, the Getting Ready for Baby Campaign, a collaboration of over 100 NGOs, released a report entitled Peeling Back the Green Façade: Calling out “Greenwashing” in the Crib Mattress Market as Lessons on Brand Manipulation of Health and Environmental Claims. Using the research for the report, Clean and Healthy New York (CHNY) filed a complaint with the Federal Trade Commission (FTC) on May 13, 2021, requesting that FTC investigate and take action to enjoin Amwan, Inc., d/b/a L.A. Baby Co. (L.A. Baby), from making false and misleading claims about L.A. Baby’s business practices. According to Getting Ready for Baby Campaign’s May 13, 2021, press release, the report “discloses the use of greenwashing practices from 10 crib mattress companies, ranging from overstating the meaning of certification to misusing terminology like ‘natural,’ ‘nontoxic,’ and ‘organic.’” The complaint states that L.A. Baby “makes numerous representations, implications, and overstatements that lead consumers to believe that it is producing unqualifiedly non-toxic, safe, and organic baby products.”

As reported in our October 3, 2012, memorandum, “FTC Releases Revised Green Guides,” under the revised Green Guides, marketers who claim that their product is non-toxic need competent and reliable scientific evidence that the product is safe for both people and the environment. The Green Guides do not address use of the terms “sustainable,” “natural,” and “organic,” but are intended to ensure that the claims marketers make about the environmental attributes of their products are “truthful and non-deceptive.”

EPA Rescinds Final Rule Establishing Administrative Procedures For Issuing Guidance Documents: On May 18, 2021, EPA rescinded the October 18, 2020, rulemaking that established procedures for issuing, modifying, withdrawing, and using guidance documents. 86 Fed. Reg. 26842. According to the final rule, after consideration and review, “EPA has concluded that the internal rule on guidance deprives the EPA of necessary flexibility in determining when and how best to issue public guidance based on particular facts and circumstances, and unduly restricts the EPA's ability to provide timely guidance on which the public can confidently rely.” EPA states that it will continue to make Agency guidance available to the public at https://www.epa.gov. In addition, EPA will comply with all statutory obligations pertaining to posting documents for public accessibility. EPA will also continue its practice, as appropriate, of soliciting stakeholder input on guidance of significant stakeholder and public interest. EPA notes that consistent with the APA, stakeholders may still petition EPA at any time regarding its regulatory programs, including requests to issue, amend, or repeal EPA guidance. The final rule was effective May 18, 2021.

President Biden Signs EO On Climate-Related Financial Risk: On May 20, 2021, President Joseph Biden signed an Executive Order (EO) on Climate-Related Financial Risk that is intended to “help the American people better understand how climate change can impact their financial security.” According to the White House fact sheet, the EO will strengthen the U.S. financial system and will inform concrete decisions that the federal government can take to mitigate the risks of climate change. The fact sheet states that the EO will:

  • Develop a whole-of-government approach to mitigating climate-related financial risk;

  • Encourage financial regulators to assess climate-related financial risk;

  • Bolster the resilience of life savings and pensions;

  • Modernize federal lending, underwriting, and procurement; and

  • Reduce the risk of climate change to the federal budget.

EPA Announces Availability Of IRIS Assessment Plan For Inhalation Exposure To Vanadium And Compounds, Opens Registration For Public Science Meeting: On May 28, 2021, EPA announced a 30-day public comment period associated with release of the IRIS Assessment Plan for Inhalation Exposure to Vanadium and Compounds (Scoping and Problem Formulation Materials)86 Fed. Reg. 28832. According to the notice, the document communicates information on the scoping needs identified by EPA program and regional offices and the Integrated Risk Information System (IRIS) Program’s initial problem formulation activities. EPA released the IRIS Assessment Plan for a 30-day public comment period in advance of a public science webinar planned for July 14, 2021. EPA states that it will announce the virtual public meeting date and registration details in June 2021 on the EPA IRIS website. Comments are due June 28, 2021. Interested stakeholders may register for the July 14, 2021, public science meeting via the Eventbrite meeting page.

President Biden’s FY 2022 Budget Request Includes $11.2 Billion For EPA: On May 28, 2021, the Biden-Harris Administration submitted President Joseph Biden’s budget for FY 2022 to Congress. According to EPA’s May 28, 2021, press release, the budget request advances “key EPA priorities, including tackling climate change, advancing environmental justice, protecting public health, improving infrastructure, creating jobs, and supporting and rebuilding the EPA workforce.” The President’s FY 2022 budget request supports:

  • Rebuilding Infrastructure and Creating Jobs: The budget provides $882 million for the Superfund Remedial program to clean up some of the nation’s most contaminated land, reduce emissions of toxic substances and greenhouse gases from existing and abandoned infrastructure, and respond to environmental emergencies, oil spills, and natural disasters;

  • Protecting Public Health: The budget includes $75 million to accelerate toxicity studies and fund research to inform the regulatory developments of designating PFAS as hazardous substances while setting enforceable limits for PFAS. In FY 2022, the Agency will advance public health by providing an additional $15 million and 87 FTE employees to build Agency capacity in managing chemical safety and toxic substances under TSCA;

  • Tackling the Climate Crisis with the Urgency Science Demands: The FY 2022 budget request recognizes the opportunity in tackling the climate crisis by developing the technologies and solutions that will drive new markets and create good paying jobs. The budget restores the Air, Climate and Energy Research Program and increases base funding by more than $60 million, including $30 million for break-through research through ARPA-C with the Department of Energy. The budget request provides an additional $6.1 million and 14 FTE employees to implement the recently enacted AIM Act and reduce potent greenhouse gases while supporting new manufacturing in the United States;

  • Advancing Environmental Justice and Civil Rights: The budget request includes over $900 million in investments for environmental justice-related work, collectively known as EPA’s Accelerating Environmental and Economic Justice Initiative, elevating environmental justice as a top priority across the Agency. The budget request also proposes a new national program dedicated to environmental justice to further that goal;

  • Supporting States, Tribes, and Regional Offices: More than half of the total budget request, $5.1 billion, will support states, Tribes, and localities through the State and Tribal Assistance Grants account; and

  • Prioritizing Science and Enhancing the Workforce: The FY 2022 budget request includes an increase of 1,026 FTE employees “to stop the downward slide in the size of EPA’s workforce in recent years to better meet the mission.” Within this increase are 114 FTE employees to propel and expand EPA’s research programs to ensure the Agency has the science programs and communities demand from the EPA. Also included are 86 additional FTE employees to support the criminal and civil enforcement programs to ensure environmental laws are followed.

OSHA Schedules Informal Public Hearing On Proposed Revisions To HCS: OSHA will hold an informal public hearing on its proposed revisions to the Hazard Communication Standard (HCS). 86 Fed. Reg. 27338. The public hearing will begin September 21, 2021, at 10:00 a.m. (EDT). The hearing will be held virtually using WebEx. If necessary, the hearing will continue on subsequent days. Additional information on how to access the informal hearing will be posted when available at https://www.osha.gov/hazcom/rulemaking. To testify or question witnesses at the hearing, interested persons must electronically submit their notice by June 18, 2021. In addition, those who request more than ten minutes for their presentation at the informal hearing and those who intend to submit documentary evidence at the hearing must submit the full text of their testimony, as well as a copy of any documentary evidence, no later than August 21, 2021. OSHA states in its May 20, 2021, press release that OSHA expects the HCS update will increase worker protections and reduce the incidence of chemical-related occupational illnesses and injuries by further improving the information on the labels and SDSs for hazardous chemicals. Proposed modifications will also address issues since implementation of the 2012 standard, and improve alignment with other federal agencies and Canada. Information on the proposed revisions is available in our February 16, 2021, memorandum.

OSHA And PHMSA Will Hold Public Meetings In Advance Of UN Meetings: On May 20, 2021, OSHA advised interested persons that it will conduct a virtual public meeting in advance of certain international meetings. 86 Fed. Reg. 27482. The June 23, 2021, meeting will occur jointly with the Department of Transportation (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) to discuss proposals in preparation for the 58th session of the United Nations Sub-Committee of Experts on the Transport of Dangerous Goods (UNSCETDG) to be held June 28-July 2, 2021, and the 40th session of the United Nations Sub-Committee of Experts on the Globally Harmonized System of Classification and Labeling of Chemicals (UNSCEGHS) to be held July 5-7, 2021. For each of these meetings, OSHA and PHMSA will solicit public input on U.S. government positions regarding proposals submitted by member countries in advance of each meeting. Information on the work of the UNSCEGHS, including meeting agendas, working and informal papers, reports, and documents from previous sessions is available here. Additional information regarding the UNSCETDG and related matters can be found on PHMSA's website here.

EPA Implement Vacatur Of Final Rule On Strengthening Transparency In Science: On June 2, 2021, EPA issued a final rule that effectuated the vacatur of the January 6, 2021, “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information.” 86 Fed. Reg. 29515. The vacatur rule was effective May 28, 2021. As reported in our February 1, 2021, blog item, on February 1, 2021, the U.S. District Court for the District of Montana granted EPA’s January 31, 2021, unopposed motion to vacate and remand its final rule. EDF v. EPA, No. 4:21-cv-03-BMM.

CPSC Concludes Testing And Component Part Testing Regulations Should Be Maintained Without Change: On June 7, 2021, the Consumer Product Safety Commission (CPSC) published a notice of availability announcing the availability of a completed rule review under Section 610 of the Regulatory Flexibility Act (RFA) for the Testing and Labeling Regulations Pertaining to Product Certification of Children’s Products, Including Reliance on Component Part Testing. 86 Fed. Reg. 30288. CPSC states that its regulatory review concludes that the testing and component part testing regulations should be maintained without change. The completed review is available on the CPSC website.

PMRA Issues Interim Order To Regulate Certain UV Radiation-emitting And Ozone-generating Devices Under The Pest Control Products Act: On June 7, 2021, Health Canada’s Pest Management Regulatory Agency (PMRA) announced the issuance of its Interim Order Respecting Ultraviolet Radiation-emitting Devices and Ozone-generating Devices under the Pest Control Products Act (Interim Order), setting forth new requirements for certain devices claiming to control, destroy, make inactive, or reduce the level of bacteria, viruses, and other micro-organisms that are human pathogens. PMRA also issued an “Explanatory Note” and a Questions and Answers document regarding the Interim Order. For more information, please see our June 14, 2021, blog.

White House 100-Day Review Outlines Steps To Strengthen Critical Supply Chains: On June 8, 2021, the Biden-Harris Administration announced key findings from the 100-day supply chain assessments for four critical products: semiconductor manufacturing and advanced packaging; large capacity batteries, like those for EVs; critical minerals and materials; and pharmaceuticals and active pharmaceutical ingredients (API). According to the announcement, the Administration will immediately: support domestic production of critical medicines; secure an end-to-end domestic supply chain for advanced batteries; invest in sustainable domestic and international production and processing of critical minerals; and partner with industry, allies, and partners to address semiconductor shortages. The 100-day review includes recommendations in six categories: rebuilding production and innovation capabilities; supporting the development of markets with high road production models, labor standards, and product quality; leveraging the government’s role as a market actor; strengthening international trade rules, including trade enforcement mechanisms; working with allies and partners to decrease vulnerabilities in the global supply chains; and partnering with industry to take immediate action to address existing shortages.

EPA Revises Permit Appeals Process To Restore Organization And Function Of EAB: EPA published a final rule on June 11, 2021, reversing recent changes to the organization and function of the Environmental Appeals Board (EAB) that altered the appeals process and procedures for EPA decisions that the EAB considers. 86 Fed. Reg. 31172. In addition, according to the notice, “the Administrator reaffirms that the EAB is intended to function as an impartial body that is independent of all EPA components, except the immediate Office of the Administrator, and reaffirms the EAB's ability to carry out the Administrator's delegated authority to adjudicate disputes and issue final Agency decisions.” The final rule was effective June 11, 2021.

Petition Seeks DOJ Rulemaking Regarding Use Of SEPs: On June 14, 2021, the Conservation Law Foundation, Surfrider Foundation, and Sierra Club petitioned the U.S. Department of Justice (DOJ) Environment and Natural Resources Division (ENRD) to initiate a rulemaking proceeding to clarify that DOJ can use Supplemental Environmental Projects (SEP) when settling civil enforcement actions brought under environmental statutes. According to the petition, DOJ had long used SEPs to address the consequences of environmental harm when settling cases involving violations of environmental statutes. The petition notes that in addition to facilitating settlements, SEPs serve an essential environmental justice function. After decades of use by DOJ, the Trump Administration sought to eliminate SEPs through both internal policy memoranda and regulation. While the Biden-Harris Administration has attempted to re-introduce SEPs by withdrawing certain anti-SEP policies, the petition states that “confusion still exists as a result of a Trump-era rule, 28 C.F.R. § 50.28, which appears to prohibit the use of SEPs in ENRD settlements in some circumstances by treating them as ‘third party payments.’”

©2021 Bergeson & Campbell, P.C.National Law Review, Volume XI, Number 167
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement

About this Author

Bergeson & Campbell, P.C. professionals possess legal, scientific, and public communication skills needed to represent effectively client matters before administrative agencies, legislative entities, and public advocacy groups. With our network of affiliates in the United States, Europe, and Asia, we can assemble response teams for matters requiring timely action. With professional backgrounds from relevant regulatory agencies and Capitol Hill, we can develop client-focused strategies to navigate complex regulatory processes.

B&C...

202-557-3812
Advertisement
Advertisement