Federal Development Update for May 2021


Prominent Industry And Agency Veterans Join Bergeson & Campbell, P.C. And The Acta Group: Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®) are pleased to announce that Dennis R. Deziel, former Regional Administrator, Region 1 (New England), U.S. Environmental Protection Agency (EPA), and Todd Stedeford, Ph.D., DABT®, ERT, ATS, former Senior Science Advisor in EPA’s Office of Pollution Prevention and Toxics (OPPT), have joined our firms. Lynn L. Bergeson, B&C Managing Partner and President of Acta, commented regarding these appointments: “Dennis and Todd are exceedingly gifted professionals, both top in their respective fields and perfectly suited for our diverse global practice areas. I have known Dennis and Todd for years and could not be more pleased they are part of our team.” More information is available via our press release.

Registration Opens For TSCA Reform: Five Years Later, June 30, 2021: The Environmental Law Institute (ELI), the George Washington University Milken Institute School of Public Health, and B&C present the fifth annual conference, providing updates and insights regarding the current state of the Toxic Substances Control Act (TSCA) implementation, ongoing and emerging issues, and related developments. Topics will include how EPA is implementing Section 6 risk evaluation provisions, changes in TSCA Section 5’s new chemical review, existing chemical risk management provisions, a TSCA litigation update, and TSCA’s role in achieving environmental justice, among other topics. Register now at https://www.eli.org/events/tsca-reform-five-years-later.

Supply Chain Insight 2021, June 16-17, 2021: Assent Compliance’s Supply Chain Insight conference focuses specifically on helping companies mitigate their supply chain risks and drive sustainable revenue growth across their enterprises. Lynn L. Bergeson, Managing Partner, B&C, will present on TSCA Section 6(h) developments and what may lie ahead. Registration is available at https://www.assentcompliance.com/events/insight/.

PFAS Updates 2021, June 23, 2021: Chemical Watch’s PFAS Updates event will cover the increase in global regulatory action on per- and polyfluoroalkyl substances (PFAS), particularly in the European Union (EU) and North America. Richard E. Engler, Ph.D., Director of Chemistry, B&C, will present “Chemical identity and the EPA process for approving new PFAS chemicals.” Registration is available here.

Lynn L. Bergeson Authors “Don’t Ignore Game-Changing EU Environmental Initiatives,” In Bloomberg Law Insights: EU chemical regulatory and policy initiatives are often influential far beyond their jurisdictional limits. Two such initiatives are noteworthy, and U.S. chemical stakeholders can expect to experience the tremors of these explosive initiatives soon. One initiative restricts certain chemicals to comply with the European Green Deal, while the other amends chemical disclosure requirements. The full article is available here.

TSCA/FIFRA/TRI

EPA Announces Univar Solutions USA Will Pay $165,000 For FIFRA Violations: EPA announced on April 19, 2021, that Univar Solutions USA, Inc. of Portland, Oregon, will pay a $165,000 penalty for violating the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) when it failed to label properly its “Woodlife 111” pesticide, which is used as a wood preservative. EPA notes that under FIFRA, “a pesticide is misbranded if, ‘the labeling accompanying it does not contain directions for use which are necessary … to protect health and the environment’ and if ‘…the label does not contain a warning or caution statement which may be necessary … to protect health and the environment.’” According to the press release, EPA alleged that between approximately January 1, 2017, and December 31, 2018, Woodlife 111 labels “omitted several required sections important for the protection of the handler and for the environment, including user safety requirements, first aid directions, use of personal protective equipment, and portions of the storage and disposal section.” EPA states that it cited the Company for 33 FIFRA violations when Univar sold and distributed the misbranded pesticide via bulk shipments. According to the press release, the case resulted from a March 5, 2019, inspection of the Univar facility by the Oregon Department of Agriculture’s EPA-credentialed inspectors.

EPA Announces Approval Of Supplemental Residual Surface Coating Product: On April 21, 2021, EPA announced the issuance of FIFRA Section 18 emergency exemptions to the states of Georgia, Minnesota, and Utah permitting the use of BiaXamTM B110-V and BiaXamTM B110-P (BiaXam), adhesive film used as supplemental residual surface coating, in Delta Air Lines planes and facilities in those three states. The approved Section 18 emergency requests are effective for one year. Any unexpected adverse effects related to the use of this product must be reported immediately to EPA as required under the terms of the FIFRA Section 18 emergency exemption approval. For more information, see our April 28, 2021, blog.

EPA Likely To Deny Pending And New LVE Submissions For PFAS: On April 27, 2021, EPA announced “important policy shifts in its review of new PFAS before they can enter the market.” According to EPA, although some new PFAS have been allowed to enter the market through low volume exemptions (LVE), EPA’s New Chemicals Program is implementing a new strategy for reviewing and managing LVE requests for PFAS. According to EPA, “[g]iven the complexity of PFAS chemistry, potential health effects, and their longevity and persistence in the environment, an LVE submission for a PFAS is unlikely to be eligible for this kind of exemption under the regulations.” While EPA will consider each LVE application individually, it “generally expects” that it will deny pending and new LVE submissions for PFAS. More information is available in our April 29, 2021, blog item.

EPA Publishes Receipt And Status Information For Certain New Chemicals: On April 27, 2021, EPA published the receipt and status reports for TSCA Section 5 submissions for March 2021. 86 Fed. Reg. 22198. EPA provides notice of receipt of premanufacture notices (PMN), significant new use notices (SNUN), and microbial commercial activity notices (MCAN); exemption applications 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 notice are due May 27, 2021.

EPA Seeks Comment On ITC’s Revisions To TSCA Section 4(e) Priority Testing List: On April 28, 2021, EPA announced that it is accepting comments on the TSCA Interagency Testing Committee’s (ITC) revisions to the Priority Testing List. 86 Fed. Reg. 22414. In the 74th ITC Report, ITC revised the TSCA Section 4(e) Priority Testing List by adding 15 high-priority substances designated pursuant to TSCA Section 6(b) and 24 organohalogen flame retardants. ITC requests that EPA add these chemical substances and the other five high-priority substances and six organohalogen flame retardants currently on the Priority Testing List to 40 C.F.R. Section 716.120(a), the list of substances subject to the TSCA Section 8(d) Health and Safety Data Reporting rule (40 C.F.R. Part 716). The rule requires manufacturers (including importers) of chemical substances and mixtures added to the Health and Safety Data Reporting rule to submit lists and copies of unpublished health and safety studies to EPA. Comments are due May 28, 2021. More information is available in our April 28, 2021, blog item.

EPA Announces Updates To Its Disinfectant Policy To Align With CDC Science: On April 28, 2021, EPA announced that after recent information from the Centers for Disease Control and Prevention (CDC), which stated that the risk of being infected with SARS-CoV-2, the coronavirus that causes COVID-19, by touching contaminated surfaces is considered low, EPA will no longer prioritize public health emergency requests for new products that address surface transmission of SARS-CoV-2. Given this new information, EPA will continue to follow the evolving science of the pandemic by shifting resources to the evaluation of novel products, such as those that kill airborne SARS-CoV-2, and by meeting critical deadlines in the registration and review of all pesticide products within its purview. In addition, in light of the hundreds of EPA-registered products that are already available, EPA will no longer expedite new product registrations, emerging viral pathogen claims, SARS-CoV-2 claims, and electrostatic spraying directions for products intended to kill SARS-CoV-2 on surfaces. EPA states that it will continue to review registration requests for new surface disinfectants for SARS-CoV-2 via the standard registrations process and associated deadlines required by FIFRA and will continue to update List N.

EPA Announces Updates To Confidential Status Of Chemicals On The TSCA Inventory: On April 29, 2021, EPA announced the release of a list of 390 chemicals that it states are “expected to lose their confidential status and move to the public portion of the [TSCA] Inventory, furthering the agency’s commitment to data transparency.” In accordance with the Chemical Data Reporting (CDR) rule and with TSCA Sections 8 and 14, EPA intends to update the TSCA Inventory listings for these chemicals to list the specific chemical identities on the public portion of the Inventory. Stakeholders should check the list of substances and ensure that none of those substances is of critical importance to maintain confidential status. Stakeholders with interest, questions, or concerns about this change in confidential status have until June 30, 2021, to contact the listed EPA staff. EPA expects to include the specific chemical identities of these 390 chemicals in the next routine publication of the public TSCA Inventory, anticipated in summer 2021. More information is available in our May 14, 2021, blog item.

EPA Issues Final SNURs On Certain Chemical Substances: Since April 15, 2021, EPA issued two batches of final significant new use rules (SNUR) under TSCA for chemical substances that were the subject of PMNs and microorganisms that were the subject of an MCAN: 86 Fed. Reg. 22870 (Apr. 30, 2021) and 86 Fed. Reg. 24328 (May 6, 2021). This action requires 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 this rule. This action further requires that persons not commence manufacture or processing for the significant new use until they have submitted a SNUN, and EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken any risk management actions as are required as a result of that determination. The final SNURs will be effective on June 29, 2021 (first batch) and July 6, 2021 (second batch).

EPA Announces Plans To Expand Scope Of TRI Reporting Requirements: EPA announced on April 29, 2021, that it will be “taking important steps under the Toxics Release Inventory (TRI) to advance Environmental Justice, improve transparency, and increase access to environmental information.” EPA plans to expand the scope of TRI reporting requirements to include additional chemicals and facilities, including facilities that are not currently reporting on ethylene oxide (EtO) releases, and provide new tools to make TRI data more accessible to the public. U.S. facilities in different industry sectors must report annually how much of each listed chemical is released to the environment and/or managed through recycling, energy recovery, and treatment. For more information, please read the full memorandum.

EPA Proposes SNURs For Certain Chemical Substances: EPA proposed SNURs on April 30, 2021, for chemical substances that are the subject of PMNs. 86 Fed. Reg. 22924. This action would require persons to notify EPA at least 90 days before commencing manufacture (defined by statute to include import) or processing of any of these chemical substances for an activity that is designated as a significant new use by the proposed SNURs. This action would further require that persons not commence manufacture or processing for the significant new use until they have submitted a SNUN, and EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken any risk management actions as are required as a result of that determination. Comments are due June 1, 2021.

EPA Publishes Statements Of Findings For January 2021 For Certain New Chemicals Or Significant New Uses: On May 4, 2021, EPA published its statements of findings on TSCA notices during the period from January 1, 2021, to January 31, 2021. 86 Fed. Reg. 23722. EPA provides information (to the extent that such information is not claimed as confidential business information (CBI)) on the PMNs, MCANs, and SNUNs 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.

EPA Settles With Sutter County’s Bear River Supply For Selling Misbranded Pesticides: EPA announced on May 6, 2021, that Bear River Supply Inc., based in Rio Oso, California, has agreed to pay a $50,578 penalty to resolve EPA’s findings that the Company produced pesticides in an unregistered establishment, distributed and sold misbranded pesticides, and failed to maintain equipment properly. According to EPA, the California Department of Pesticide Regulation (CDPR) and EPA discovered the violations during a series of inspections conducted at two separate facilities in Rio Oso. Inspectors found that “Vistaspray 440 Spray Oil” and “Roundup PowerMax” were being repackaged and distributed with improper labeling. In addition, EPA states, inspectors determined that Bear River Supply was producing pesticides in a facility that was not registered with EPA. While at the facilities, inspectors also found that a secondary containment unit and loading pad, both used to contain potential spills, were inadequate. The Company has since corrected the violations. More information is available in our May 13, 2021, blog.

EPA Announces Upcoming Webinars On Use Of Non-Animal Test Methods In Chemical Risk Assessment: On May 7, 2021, EPA announced that it is partnering with the People for the Ethical Treatment of Animals (PETA) Science Consortium International, Unilever, and Syngenta on a three-part virtual workshop series on “Using In Silico and In Vitro Approaches for Next Generation Risk Assessment of Potential Respiratory Toxicants.” EPA states that this webinar series supports its commitment “to collaborate with partners and stakeholders to reduce, refine, or replace vertebrate animal testing, as outlined in the Strategic Plan to Promote the Development and Implementation of Alternative Test Methods within the TSCA Program.” The webinars will take place on May 19, May 26, and June 2, 2021, from 8:00 a.m. to 10:00 a.m. (EDT). The meeting agenda and registration information are available at www.thepsci.eu/inhalation-webinars. Attendees must register for each of the three webinars individually.

EPA Announces Launch Of New Electronic Confidential Statement Of Formula Application: On May 10, 2021, EPA announced the launch of an electronic Confidential Statement of Formula application (eCSF builder) to support pesticide registration applications. The new electronic tool is part of EPA’s interest in improving and modernizing the internal processes and digital workflows for pesticide registration submissions. Users can access the eCSF builder in the Central Data Exchange (CDX) under Pre-Submission Tools, Form Builders, by clicking the Create eCSF button. Users can provide feedback to EPA through the CDX. More information is available in our May 14, 2021, blog.

EPA Launches New Paperless Communication Application For TSCA Data In CDX: EPA announced on May 11, 2021, that it has launched a new application in the CDX, EPA’s electronic reporting site, that will allow users to submit electronically certain communications under TSCA. EPA states that the application is located within the Chemical Safety and Pesticide Programs (CSPP) data flow and supports numerous types of communications, including General Confidential Correspondence, Requests for Chemical Information, PMN Corrections for Submissions made Prior to 2016, and Copy of Record Requests. EPA will continue to accept paper documents, but recommends submitting TSCA communications electronically when possible “since paper communications could take longer to process.”

Senate Committee Holds Hearing On Nominee For EPA Assistant Administrator For Chemical Safety And Pollution Prevention: On May 12, 2021, the Senate Committee on Environment and Public Works held a hearing on several Department of the Interior and EPA nominees, including Michal Freedhoff, Ph.D., to be Assistant Administrator for the Office of Chemical Safety and Pollution Prevention (OCSPP). In her opening statement, Dr. Freedhoff stated that during her time working for the legislative branch, she believes that she “earned a reputation for being fair, approachable, substantive, and able to craft consensus by bringing people with disparate viewpoints together to effectively solve problems.” Dr. Freedhoff intends to bring a spirit of collaboration to the role of Assistant Administrator that would include ensuring chemical safety under TSCA, providing safe, effective tools for farmers to protect the food supply under FIFRA, and working to incentivize more sustainable practices and products in pollution prevention programs. For more information on Dr. Freedhoff’s testimony, please read the full memorandum.

EPA Begins Environmental Justice Consultations On Risk Management Rulemakings For Asbestos, Part 1: Chrysotile Asbestos And PV29: On May 12, 2021, EPA began environmental justice consultations regarding the development of risk management actions under TSCA Section 6(a) for Asbestos, Part 1: Chrysotile Asbestos and Pigment Violet 29 (PV29). EPA will hold two identical consultation webinars on June 1, 2021, and June 9, 2021. Both sessions will provide an overview of the TSCA risk management requirements, the findings from the final risk evaluations, the tools available to manage the unreasonable risks from Asbestos, Part 1: Chrysotile Asbestos and PV29, and an opportunity for input on environmental justice concerns. The consultations are open to the public, and EPA is inviting national, local, and non-governmental organizations (NGO), communities, and other interested stakeholders to participate. The environmental justice consultation period ends August 13, 2021.

RCRA/CERCLA/CWA/CAA/PHMSA/SDWA

EPA Reconsiders Withdrawal Of Waiver For California’s Advanced Clean Car Program: On April 28, 2021, EPA announced that it is reconsidering a prior action that withdrew a waiver of preemption for California’s zero emission vehicle (ZEV) mandate and greenhouse gas (GHG) emission standards within California’s Advanced Clean Car (ACC) program for purposes of rescinding that action. 86 Fed. Reg. 22421. Should EPA rescind the prior action, the ACC program waiver, as it pertains to the GHG emission standards and ZEV mandates, will become effective. On September 27, 2019, EPA and the National Highway Transportation Safety Administration (NHTSA) issued an action entitled ”The Safer Affordable Fuel-Efficient Vehicles Rule Part One: One National Program” (SAFE 1) that included, among other matters, EPA’s determination that it had authority to reconsider the ACC program waiver and that elements of the ACC program waiver should be withdrawn due to NHTSA’s action under the Energy Policy & Conservation Act (EPCA) and Clean Air Act (CAA) preemption provisions. Comments are due July 6, 2021. EPA will hold a public hearing on June 2, 2021.

EPA Releases Tools Intended To Help Reduce Nutrients In Water, Improve Public Health, And Support Ecosystems: On April 29, 2021, EPA announced the release of the following new tools and information that states, territories, and authorized Tribes can use to help protect people, animals, and aquatic life from harmful algal blooms and other adverse effects of nutrients in water:

  • N-STEPS Online: EPA’s Nutrient Scientific Technical Exchange Partnership & Support (N-STEPS) program released a new web-based resource, N-STEPS Online, that provides technical assistance to states, territories, and authorized Tribes to help water quality scientists and managers derive numeric nutrient criteria;
     
  • User Perception Surveys Primer: EPA published a new resource to help states and Tribes develop scientific surveys to protect better aesthetic and recreational waterbody uses. States and Tribes can use the Development of User Perception Surveys to Protect Water Quality from Nutrient Pollution: A Primer on Common Practices and Insights to develop numeric nutrient criteria to adopt into their water quality standards under the Clean Water Act (CWA); and
     
  • Hypoxia Task Force Newsletter: The latest issue of the Hypoxia Task Force quarterly newsletter highlights ongoing collaborative efforts within the 12 member states to reduce nutrients in the Mississippi/Atchafalaya River Basin.
     

EPA Proposes Rule To Phase Down Production And Consumption Of HFCs: On May 3 2021, EPA released its first rule under the American Innovation and Manufacturing (AIM) Act of 2020 to phase down the production and consumption of hydrofluorocarbons (HFC), “highly potent greenhouse gases commonly used in refrigerators, air conditioners, and many other applications.” The AIM Act directs EPA to reduce production and consumption sharply of HFCs by using an allowance allocation and trading program. EPA states that this phasedown will decrease the production and import of HFCs in the United States by 85 percent over the next 15 years. According to EPA, a global HFC phasedown is expected to avoid up to 0.5 °C of global warming by 2100. To support the rulemaking, EPA is also collecting data on the production, import, export, and destruction of bulk HFCs, as well as the use of HFCs solely for:

  • A propellant in metered dose inhalers;
     
  • Defense sprays;
     
  • Structural composite preformed polyurethane foam for marine use and trailer use;
     
  • The etching of semiconductor material or wafers and the cleaning of chemical vapor deposition chambers within the semiconductor manufacturing sector; or
     
  • On board aerospace fire suppression.
     

EPA seeks data from companies that produced, imported, exported, and destroyed bulk HFCs, or used HFCs in one of these applications. Publication of the proposed rule in the Federal Register will begin a 45-day public comment period.

EPA Lists Substances In The Refrigeration And Air Conditioning Sector Under SNAP Program: Pursuant to EPA’s Significant New Alternatives Policy (SNAP) program, EPA published a final rule on May 6, 2021, that lists certain substances in the refrigeration and air conditioning sector. 86 Fed. Reg. 24444. For the retail food refrigeration -- medium-temperature stand-alone units (new) end-use, EPA is listing three substitutes as acceptable subject to narrowed use limits. For the residential and light commercial air conditioning and heat pumps (new) end-use, EPA is listing six substitutes as acceptable subject to use conditions. EPA is incorporating by reference the 2019 Underwriters Laboratories (UL) Standard 60335-2-40, 3rd Edition, which establishes requirements for the evaluation of electrical air conditioners, heat pumps, and dehumidifiers, and safe use of flammable refrigerants. The final rule also removes an acceptable substitute subject to use conditions listing for the fire suppression sector because EPA more recently listed the substitute as acceptable with no use restrictions. The final rule will be effective June 7, 2021.

EPA Relaunches Climate Indicators Website: EA announced on May 12, 2021, that for the first time in four years, it is relaunching its Climate Change Indicators in the United States website for the public. EPA states that this “comprehensive resource presents compelling and clear evidence of changes to our climate reflected in rising temperatures, ocean acidity, sea level rise, river flooding, droughts, heat waves, and wildfires, among other indicators.” The site also features interactive data-exploration tools offering a closer look at graphs, maps, and figures, along with an overview of the importance of indicators and how climate change can affect human health and the environment.

EPA Rescinds Rule On Increasing Consistency And Transparency In Considering Benefits And Costs In CAA Rulemaking Process: On May 14, 2021, EPA published an interim final rule rescinding the final rule entitled “Increasing Consistency and Transparency in Considering Benefits and Costs in the Clean Air Act Rulemaking Process” (Benefit-Cost Rule). 86 Fed. Reg. 26406. EPA states that it is rescinding the Benefit-Cost Rule “because the changes advanced by the rule were inadvisable, untethered to the CAA, and not necessary to effectuate the purposes of the Act.” According to the notice, EPA determined, after reviewing each element of the Benefit-Cost Rule, that the additional procedures required under the Rule were not needed, useful, or advisable policy changes. In some cases, the new procedures could hinder EPA’s compliance with the CAA and may not further the Rule’s stated purposes of consistency and transparency. EPA will consider comments on the interim final rule received by June 14, 2021. If a public hearing is requested by May 21, 2021, EPA will hold a virtual public hearing on June 9, 2021. The rule will be effective June 14, 2021. In EPA’s May 13, 2021, press release, EPA states that it will consider public comments submitted on the interim final rule and intends to issue a final rule that responds to comments received, if any, and reflects any accompanying changes to EPA’s approach.

FDA

FDA Launches Food Safety Podcast: On April 16, 2021, the U.S. Food and Drug Administration (FDA) announced the launch of the New Era of Smarter Food Safety TechTalk Podcast. The quarterly podcast will examine various aspects of the New Era of Smarter Food Safety Blueprint. The transcript and recording of the April 29, 2021, episode, which discusses tech-enabled traceability, are available here.

FDA Opens Portal For Foreign Supplier Verification Program: On May 10, 2021, FDA opened the FSVP Importer Portal for FSVP Records Submission. The Portal enables importers of human and animal food to submit records electronically to FDA related to the Foreign Supplier Verification Program (FSVP). The Portal, which is not required, is intended to streamline submissions and improve records management for importers and FDA. Additional information is available at the link here.

NANOTECHNOLOGY

EC Scientific Committee’s Preliminary Opinions For Certain Gold And Platinum Nanomaterials Open For Comment: On April 16, 2021, the European Commission (EC) Scientific Committee on Consumer Safety (SCCS) posted two preliminary opinions for comment: Opinion on Gold (nano), Colloidal Gold (nano), Gold Thioethylamino Hyaluronic Acid (nano) and Acetyl heptapeptide-9 Colloidal gold (nano) and Opinion on Platinum (nano), Colloidal Platinum (nano) and Acetyl tetrapeptide-17 Colloidal Platinum (nano). In the first preliminary opinion, SCCS states that information obtained from the scientific literature indicates that there is a need for further evaluation of the safety of gold nanomaterials when used as cosmetic ingredients. In the absence of sufficient data to allow a safety assessment, SCCS concluded that there is a basis for concern that the use of gold (nano), colloidal gold (nano), and surface modified gold (nano) materials in cosmetic products can pose a risk to the consumer. According to the second preliminary opinion, SCCS “concluded that there is a basis for concern that the use of platinum, colloidal platinum, and acetyl tetrapeptide-17 colloidal platinum (nano) in cosmetic products can pose a risk to the consumer.” Comments on both preliminary opinions are due June 14, 2021. More information is available in our April 19, 2021, blog item.

NIA Publishes Position Paper On Changing Regulatory Landscape And Language For The Nanoscale: The Nanotechnology Industries Association (NIA) has published a March 2021 position paper, A changing regulatory landscape and language for the nanoscale, that examines the transition from “nanomaterial” to “nanoforms” to reflect better the differences in nanomaterial properties both in relation to bulk counterparts and to nanoforms of the same substance. NIA calls “for the use of the term ‘nanoform’ as a way of referring to specific nanomaterials within a given class.” B&C is a proud NIA member.

EUON Publishes Nanopinion On Biotransformation Of Nanomaterials While Transferring In The Food Chain: On April 29, 2021, the EU Observatory for Nanomaterials (EUON) published a Nanopinion entitled “Biotransformation of nanomaterials while transferring in the food chain” by Dr. Fazel A. Monikh. With the help of his collaborators and the support of the EU’s Horizon 2020, Monikh developed “a sensitive workflow to trace and characterize nanomaterials in organisms’ bodies.” Monikh states that the aim of his research is to support designing safe nanomaterials by understanding the possible effects of these materials in the environment and in organisms.

SweNanoSafe Publishes English Translation Of Report From Workshop Series With Education Network And Roadmap For 2021: In fall 2020, the Swedish National Platform for Nanosafety (SweNanoSafe) organized three workshops on education within nanosafety, with the goal of starting and consolidating an education network. On May 5, 2021, SweNanoSafe published Nanosafety and education: Report from workshop series with SweNanoSafe’s education network and Roadmap for 2021, an English translation of its report summarizing the presentations and discussions conducted in the three workshops and presenting a work plan for the education network in the form of a Roadmap for 2021. More information is available in our May 6, 2021, blog item.

EC Review Of Its Recommendation On The Definition Of Nanomaterial Includes Targeted Stakeholder Consultation: The EC has launched a targeted stakeholder consultation to update, test, and verify the preliminary findings of its comprehensive review of its 2011 Recommendation on the definition of a nanomaterial, gathering further evidence and feedback from a wide range of stakeholders who have a role in application of the harmonized regulatory definition of nanomaterial in the EU. The consultation includes a summary of the interim findings and links to relevant documents and reports, and provides a short rationale with every question. The online consultation is open until June 30, 2021. more information is available in our May 7, 2021, blog item.

EFSA Panel Concludes That Titanium Dioxide Cannot Be Considered Safe As A Food Additive: On May 6, 2021, the European Food Safety Association (EFSA) announced that E171 is no longer considered safe when used as a food additive. The EC asked EFSA to update its safety assessment of the food additive titanium dioxide (E171). EFSA states: “Taking into account all available scientific studies and data, the Panel [on Food Additives and Flavorings] concluded that titanium dioxide can no longer be considered safe as a food additive.” Any legislative or regulation decisions on the authorizations of food additives are the responsibility of the EC and member states, who will now “reflect on EFSA’s scientific advice and decide upon any appropriate regulatory measures or advice for consumers.”

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

Republican Slate Of “Pro-Innovation” Agriculture Bills Intends To Address Climate Change: On April 16, 2021, Representative Glenn Thompson (R-PA), Ranking Member of the House Agriculture Committee, announced five pieces of legislation to address climate change through natural solutions. The Sponsoring USDA Sustainability Targets in Agriculture to Incentivize Natural Solutions (SUSTAINS) Act is intended to encourage private-sector partnerships for agriculture sustainability by allowing businesses to invest in conservation practices in geographic regions of their choice. The bill also would allow the U.S. Department of Agriculture (USDA) to match these funds. The other bills include the Restoring Environments, Soils, Trees and Operations to develop the Rural Economy (RESTORE) Act; the Naturally Offsetting Emissions by Managing and Implementing Tillage Strategies (NO EMITS) Act; the Forestry Improvements to Restore the Environment (FIRE) Act; and the Producing Responsible Energy and Conservation Incentives and Solutions for the Environment (PRECISE) Act.

Capito Requests Update On Biden Administration Efforts To Address PFAS: On April 19, 2021, Senator Shelley Moore Capito (R-WV), Ranking Member of the Senate Environment and Public Works Committee, sent a letter to EPA Administrator Michael Regan requesting a “detailed update and briefing” on the status of EPA’s ongoing activities related to PFAS. According to the Committee minority’s press release, “[t]he letter highlights EPA’s overdue PFAS research and development activities and the need for EPA to continue placing a strong emphasis on scientific research to support any potential regulatory actions.”

House Bill Would Reinstate Superfund Taxes: On April 20, 2021, Representative Earl Blumenauer (D-OR) introduced the Superfund Reinvestment Act (H.R. 4088) to require polluters to pay for the cleanup of toxic and hazardous waste sites throughout the United States. Blumenauer’s press release states that the Superfund Reinvestment Act would, among other things:

  • Restore Superfund taxes at inflation adjusted rates, including excise taxes on crude oil or refined oil products, excise taxes on certain chemicals that have hazardous characteristics or may generate hazardous wastes, and a tax based on a corporation’s taxable income if it exceeds $4.7 million;
     
  • Expand the definition of crude oil to include unconventional crude, such as tar sands and oil shale; and
     
  • Ensure that money from the Trust Fund is spent only on Superfund cleanup.
     

According to the press release, a 2010 estimate found that revenue garnered from these taxes would be about $1.7 billion per year and $18.9 billion over ten years.

Bill Would Amend TSCA To Create Federal Cause Of Action For Victims Of PFAS Exposure: On April 22, 2021, Senator Kirsten Gillibrand (D-NY) and Representatives Madeleine Dean (D-PA) and Dan Kildee (D-MI) introduced the PFAS Accountability Act (S. 1334, H.R. 2751). The bill would amend TSCA to create a federal cause of action intended to help courts award medical monitoring for victims of PFAS exposure and bolster PFAS research. Gillibrand’s press release states that the bill would create legal pathways to medical monitoring for PFAS contamination victims to prevent against premature morbidity, disability, or mortality; establish a federal cause of action for victims of significant PFAS exposure to bring claims against manufacturers of PFAS; and incentivize industry to fund PFAS safety research.

Bipartisan Bill Would Establish National Mercury Monitoring Network: On April 22, 2021, Senators Tom Carper (D-DE), Chair of the Senate Committee on Environment and Public Works, and Susan Collins (R-ME) introduced the Comprehensive National Mercury Monitoring Act, bipartisan legislation that would establish a national mercury monitoring network to protect human health and the environment. According to the Committee’s press release, the bill would direct EPA, in conjunction with other agencies, to establish a national mercury monitoring program to measure and monitor mercury in watersheds, surface water, fish and wildlife, and the atmosphere. The bill would establish a centralized database for existing and newly collected environmental mercury data and require a report to Congress every two years on the program, including trends, and an assessment of the reduction in mercury deposition rates that need to be achieved to prevent adverse human and ecological effects every four years.

Senate Votes To Reinstate Methane Regulations: On April 28, 2021, the Senate passed 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 industry’s production and processing segments and the methane and volatile organic compound (VOC) requirements for the transmission and storage segments. The resolution is now before the House.

Senate Passes Drinking Water And Wastewater Infrastructure Act: The Senate passed the Drinking Water and Wastewater Infrastructure Act (S. 914) by a vote of 89 to 2 on April 29, 2021. The bill would authorize more than $35 billion for water resource development projects, with a focus on upgrading aging infrastructure, addressing the threat of climate change, investing in new technologies, and providing assistance to marginalized communities. Of that $35 billion, more than 40 percent can be used directly to benefit small, disadvantaged, rural, and tribal communities through additional subsidization from the State Revolving Loan Funds or direct grant programs.

MISCELLANEOUS

President Biden Sets 2030 GHG Reduction Target: On April 22, 2021, President Joseph Biden announced a new target for the United States to achieve a 50-52 percent reduction from 2005 levels in economy-wide net GHG pollution in 2030. The announcement was made during the Leaders Summit on Climate that President Biden held to “challenge the world on increased ambition in combatting climate change.” According to President Biden, meeting the 2030 emissions target will create “millions of good-paying, middle class, union jobs,” including line workers who will lay thousands of miles of transmission lines for a clean, modern, resilient grid; workers capping abandoned wells and reclaiming mines and stopping methane leaks; autoworkers building modern, efficient, electric vehicles and the charging infrastructure to support them; engineers and construction workers expanding carbon capture and green hydrogen to forge cleaner steel and cement; and farmers using cutting-edge tools to make American soil the next frontier of carbon innovation.

EPA Administrator Announces New Initiatives Intended To Support Environmental Justice And Climate Action: On April 23, 2021, EPA Administrator Michael Regan announced three initiatives intended to reduce GHG pollution while also providing economic opportunities, creating good jobs, and advancing environmental justice. EPA will resume and strengthen its commitment to the United Nations Foundation’s Clean Cooking Alliance, working to reduce emissions from home cooking and heating that contribute to climate change and directly affect the health and livelihoods of almost 40 percent of the world’s population. The Black Carbon Health Assessment in Indigenous Arctic Communities project will be implemented by the Aleut International Association, providing needed tools to understand their exposure to black carbon emissions, identify significant local sources, and share best practices for preventing and mitigating the health impacts of air pollution and climate. With its North American partners in Canada and Mexico, EPA will support an initial allocation of $1 million for an Environmental Justice and Climate Resilience Initiative. Through the North American Commission on Environmental Cooperation (CEC), this initiative will support underserved and vulnerable communities, including Indigenous communities in Canada, Mexico, and the United States, helping to build resilience in the face of climate-related impacts.

Comment Period Begins On Systematic Review Protocol For Vanadium And Compounds (Oral Exposure) IRIS Assessment: On April 26, 2021, EPA announced a 30-day public comment period associated with the release of the Systematic Review Protocol for the Vanadium and Compounds (Oral Exposure) Integrated Risk Information System (IRIS) Assessment. 86 Fed. Reg. 22047. The Systematic Review Protocol communicates the rationale for conducting the oral assessment of vanadium and compounds, describes screening criteria to identify relevant literature, outlines the approach for evaluating study quality, and describes the methods for dose-response analysis. Comments are due May 26, 2021.

EPA Establishes New Council On PFAS: On April 27, 2021, EPA announced that EPA Administrator Michael Regan issued a memorandum to EPA's senior leadership calling for the creation of a new “EPA Council on PFAS” charged with building on EPA’s ongoing work to understand better and reduce the potential risks caused by these chemicals. Regan is directing the EPA Council on PFAS (ECP) to:

  • Develop “PFAS 2021-2025 -- Safeguarding America’s Waters, Air and Land,” a multi-year strategy to deliver critical public health protections to the American public. To develop the strategy, the ECP will review all ongoing actions, propose any necessary modifications, and identify new strategies and priorities. The ECP shall make initial recommendations within 100 days of its establishment;
     
  • Continue close interagency coordination on regional specific and cross-media issues to assist states, Tribes, and local communities faced with significant and complex PFAS challenges;
     
  • Work with all national program offices and regions to maximize the impact of EPA’s funding and financing programs and leverage federal and state funds to support cleanup of PFAS pollution, particularly in underserved communities; and
     
  • Expand engagement opportunities with federal, state, and tribal partners to ensure consistent communications, exchange information, and identify collaborative solutions.
     

CDTSC Announces Final 2021-2023 Priority Product Work Plan: On April 28, 2021, the California Department of Toxic Substances Control (CDTSC) announced that the Safer Consumer Products Program has released its final 2021-2023 Priority Product Work Plan. The Work Plan describes the product categories that the program intends to evaluate to identify Priority Products containing one or more Chemicals of Concern. Manufacturers of products that CDTSC designates as Priority Products must conduct an Alternatives Analysis to determine if there are safer alternatives to the use of Chemicals of Concern. CDTSC states that the Work Plan retains the personal care products, cleaning products, food packaging, and building products categories from the 2018-2020 Priority Product Work Plan. The program is in the process of listing some products from these categories as Priority Products, and will also continue working to evaluate additional products in these categories. New children’s products and motor vehicle tire categories were added to the Work Plan. The building products category was also expanded to allow for the evaluation of artificial turf.

EPA Administrator Issues Statement On First 100 Days Of Biden-Harris Administration: On April 29, 2021, EPA Administrator Michael Regan issued a statement on the 100th day of the Biden-Harris Administration. Regan noted the following highlights of EPA accomplishments in that time:

  • Acted to Combat Climate Change: EPA recently took a major step toward restoring California’s waiver to enforce stringent GHG pollution standards for vehicles. Additionally, EPA relaunched its climate change website after the prior Administration had it removed. EPA also awarded approximately $10.5 million to replace older diesel school buses with cleaner buses, including for the first time, alt-fuel and electric buses, through its Diesel Emissions Reduction Act funding;
     
  • Restored Scientific Integrity: Regan issued a scientific integrity directive to all employees. He also reset key science advisory boards, the Science Advisory Board (SAB), and the Clean Air Scientific Advisory Committee (CASAC) to return to the standard process of incorporating a balanced group of expert advisors. Additionally, EPA is in the process of vacating the prior Administration’s exclusionary science rule, which placed inappropriate restrictions on the types of scientific studies that EPA could consider in its regulatory processes;
     
  • Advanced Environmental Justice: After meeting with leaders from the National Environmental Justice Advisory Council, Regan issued an Agency-wide message directing EPA offices to take specific actions to ensure environmental justice is incorporated across the Agency’s work in communities overburdened by pollution. These directives include: strengthening enforcement of environmental laws, increasing engagement, building environmental justice considerations into regulations, and incorporating President Biden’s Justice 40 directive to consider and prioritize direct and indirect benefits to underserved communities;
     
  • Funded Job-Creating Water Infrastructure: EPA has closed more than $1.3 billion in job-creating Water Infrastructure Finance and Innovation Act (WIFIA) loans to multiple communities. These investments will generate nearly 9,000 jobs and improve water quality and safety for nearly four million people. Additionally, EPA announced the availability of $6.5 billion in water infrastructure funding under the WIFIA and state infrastructure financing authority WIFIA (SWIFIA) program, which is estimated to create an additional 40,000 jobs. EPA also announced the availability of $2.7 billion for State Revolving Funds (SRF) to assist states, Tribes, and territories; and
     
  • Moved to Address PFAS Contamination: Regan issued a memorandum to EPA’s senior leadership creating a new council charged with building on the Agency’s ongoing work to understand better and reduce the potential risks caused by these chemicals and to present recommendations to the Administrator within 100 days. EPA is also moving forward to establish a drinking water standard for perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), and reissued the final Human Health Toxicity assessment for Perfluorobutane Sulfonic Acid (PFBS) that had been compromised by political interference during the prior Administration.
     

Janet McCabe Sworn In As EPA Deputy Administrator: On April 29, 2021, Janet McCabe was sworn in as EPA Deputy Administrator. According to EPA’s April 29, 2021, press release, McCabe committed to fulfilling EPA’s mission of protecting human health and the environment and supporting the work of its scientists, program staff, regional teams, environmental justice leaders, and all the individuals who support the Agency’s operations. McCabe returns to EPA after spending seven years working as Acting Assistant Administrator and Principal Deputy to the Assistant Administrator in the Office of Air and Radiation under President Barack Obama. Prior to rejoining EPA, McCabe was a Professor of Practice at the Indiana University McKinney School of Law and Director of the IU Environmental Resilience Institute, where she started as Assistant Director for Policy and Implementation in 2017. Her work at Indiana University centered on establishing innovative, research-informed, and actionable solutions to reduce environmental risks and help protect the health of communities and families.

EPA Awards Cooperative Agreement To Support States And Territories In Advancing Environmental Health: On May 3, 2021, EPA announced that it awarded a cooperative agreement to the Association of State and Territorial Health Officials (ASTHO) to support the work of states and territories in addressing environmental health challenges. Under the formal agreement, EPA and ASTHO reaffirmed their commitment to work as partners to advance shared priorities, including water quality, children’s environmental health, resilience to pollutants, air quality, lead, emerging contaminants of concern, and COVID-19. EPA states that outcomes of the agreement will include increased communication and collaboration, enhanced state and territorial capacity to address environmental health challenges, technical assistance from EPA scientists and engineers, and the exchange of information through regular webinars, face-to-face meetings, and technical training. The agreement will also “facilitate seamless EPA support in the event of an emergency, increasing the resilience capacity of state and territorial partners.”

ATSDR Publishes Final Toxicological Profile For Perfluoroalkyls: In May 2021, the Agency for Toxic Substances and Disease Registry (ATSDR) published the Toxicological Profile for Perfluoroalkyls. ATSDR states that Toxicological Profiles “succinctly characterize[] the toxicology and adverse health effects information for the toxic substance described therein. Each peer-reviewed profile identifies and reviews the key literature that describes a substance’s toxicological properties.” The ToxFAQsTM for Perfluoroalkyls states that perfluoroalkyls “are a group of man-made chemicals that are not found naturally in the environment. Some chemicals that are in this group include: perfluorooctanoic acid (PFOA), perfluorooctane sulfonic acid (PFOS), perfluorononanoic acid (PFNA), perfluorohexane sulfonic acid (PFHxS), and perfluorodecanoic acid (PFDA).”

EPA Rescinds Rule On Guidance Documents: EPA announced on May 12, 2021, that it issued a final rule rescinding an October 18, 2020, rulemaking that established procedures for issuing, modifying, withdrawing, and using guidance documents. The final rule restores EPA’s ability to provide timely guidance on which the public can confidently rely. EPA states that it “has historically employed procedures for public transparency and involvement in the development of all agency actions, including guidance, and will continue these practices.” Specifically:

  • EPA will continue its practice of soliciting stakeholder input on guidance of significant stakeholder and public interest, as appropriate;
     
  • Stakeholders may submit a request to EPA at any time to issue, amend, or repeal EPA guidance;
     
  • Guidance continues to be non-binding and does not have the force and effect of law; and
     
  • EPA will continue to make Agency guidance available to the public. More information is available at https://epa.gov/guidance.
     

The final rule will be effective when it is published in the Federal Register.

EPA OIG Reports That Resource Constraints, Leadership Decisions, And Workforce Culture Led To Decline In Federal Enforcement: The EPA Office of Inspector General (OIG) issued a report on May 13, 2021, entitled Resource Constraints, Leadership Decisions, and Workforce Culture Led to a Decline in Federal Enforcement. OIG conducted the audit to identify the trends, as well as the key factors contributing to these trends, in EPA-led enforcement actions and results from fiscal years (FY) 2006 through 2018. According to OIG, EPA-led compliance monitoring activities, enforcement actions, monetary enforcement results, and environmental benefits generally declined from FYs 2007 through 2018 nationwide. This downward trend also occurred at the regional level and on a statute-by-statute basis. While annual enforcement measures, such as penalty dollars assessed or commitments to clean up pollution, declined, the results varied year-to-year based on the conclusion of large cases. OIG states that the decline in enforcement resources was a primary driver behind the observed declining enforcement trends, resulting in fewer compliance monitoring activities and concluded enforcement actions. EPA leadership also made strategic decisions that affected enforcement trends, such as focusing limited resources on the most serious cases and, in 2017, emphasizing deference to state enforcement programs and compliance assistance. According to OIG, from 2006 through 2018, growth in the domestic economy and new laws increased the size and level of activity in key sectors regulated by EPA, but EPA’s capacity to meet that need decreased. OIG recommends that the EPA Assistant Administrator for Enforcement and Compliance Assurance complete a workforce analysis to assess EPA’s capacity to maintain a strong enforcement field presence that protects human health and the environment and to integrate the results of this analysis into the Office of Enforcement and Compliance Assurance’s (OECA) strategic and annual planning processes.

New York Will Hold Public Meeting On Toxic Chemicals In Children’s Products Law: The New York State Department of Environmental Conservation (NYSDEC) will hold a virtual public meeting on May 26, 2021, at 1:00 p.m. (EDT). NYSDEC will present topics for discussion related to implementation of the recently enacted law, which created ingredient disclosure requirements for children’s products. NYSDEC states that it is in the process of developing a rule to implement portions of the law. NYSDEC expects the rule to address the specific product categories that are covered, what chemicals and supporting information must be disclosed, details on how to obtain a waiver from reporting or the sales prohibition, and the fees associated with reporting and applying for a waiver. Stakeholders must register to attend the virtual public meeting. More information is available in our May 12, 2021, blog item.

This Update is provided as a complimentary service to our clients and is for informational purposes. This Update may be copied or quoted, provided proper attribution is given. The contents are not intended and cannot be considered as legal advice.

 
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