Monthly Update for October 2021


All Things Chemical Celebrates Three Years Of Great Conversations: Bergeson & Campbell, P.C.’s (B&C®) All Things Chemical® podcast is celebrating three years of great conversations by offering listeners a chance to win audio-technica headphones, a wireless charging pad from Anker, books authored by us, and regulatory training courses. Help us celebrate this milestone by sending your dream guest or topic choices to podcast@lawbc.com, with the subject line “All Things Chemical,” and we may use them for future episodes! Submit your suggestions by October 31, 2021 -- all e-mails received will be entered into the prize drawing. Visit our sweepstakes announcement for more information about All Things Chemical and giveaway details.

Recording Of The First International Conference On Agricultural Law Available Now: The First International Conference on Agricultural Law was held jointly by the Agricultural Law Section of the International Bar Association (IBA), Project Pravo-Justice, and Ukrainian Bar Association (UBA) on September, 23-24 2021. A complimentary recording of this informative event is now available to stream. B&C Managing Partner Lynn L. Bergeson is the Senior Vice Chair of the IBA’s Agricultural Law Section.

Lynn L. Bergeson Authors “Extended producer responsibility for packaging: and so it begins in the US” For Financier Worldwide: On July 13, 2021, Maine became the first state in the United States to enact extended producer responsibility (EPR) legislation for packaging. Quickly thereafter, on August 6, 2021, Oregon became the second state to enact a similar EPR law applicable to packaging. Other states are poised to enact similar legislation, following trends more mature in the European Union (EU) and elsewhere around the world. The full article is available to read online.

IBA Global Showcase, October 25-29, 2021, Via Webinar: The IBA Global Showcase is a complimentary event highlighting the diverse work and achievements of the IBA’s membership in many key areas of policy and practice. There will be a series of high-profile expert sessions discussing some of the biggest issues and challenges facing the global legal profession, with speakers sharing ideas and solutions.

TSCA/FIFRA/TRI

TSCA Reform Reform? — A Conversation With Dennis Deziel: In the recent All Things Chemical® episode TSCA Reform Reform? — A Conversation with Dennis Deziel, Lynn L. Bergeson and Dennis R. Deziel, Senior Government Affairs Advisor at B&C, discuss Mr. Deziel’s time serving as Director of Federal Government Affairs for the Dow Chemical Company when the Toxic Substances Control Act (TSCA) amendments were considered and eventually enacted by Congress in 2016. Lynn and Dennis then discuss his time as a Senate-confirmed political appointee, after TSCA reform was enacted and he was part of the team implementing the new law.

EPA And PBTs: A New Normal? — A Conversation With Richard E. Engler, Ph.D.: Lynn L. Bergeson and Richard E. Engler, Ph.D., Director of Chemistry, B&C, sat down for another episode of All Things Chemical, this time discussing EPA and PBTs: A New Normal? During this episode Dr. Engler explains the U.S. Environmental Protection Agency’s (EPA) continuing struggle to regulate certain persistent, bioaccumulative, and toxic (PBT) chemicals, especially those found in finished products, what EPA refers to as “articles.”

EPA Receives TSCA Section 21 Petitions Regarding Chemical Mixtures In Cigarettes And Cosmetics: On August 2, 2021, EPA received a petition under Section 21 of TSCA seeking a rule requiring cigarette manufacturers to eliminate the hazardous chemicals used and to develop new product designs that eliminate or reduce the cigarette butt disposal risks to the environment. EPA acknowledged receipt of Bush’s petition on September 9, 2021, stating that it will grant or deny the petition by October 31, 2021. EPA received a second TSCA Section 21 petition from Bush on August 16, 2021, seeking a determination that the chemical mixtures contained within cosmetics present an unreasonable risk of injury to public health and the environment. EPA acknowledged receipt of Bush’s second petition on September 20, 2021, stating that it will grant or deny the petition by November 14, 2021. More information is available in our October 5, 2021, blog item.

EPA Issues Final SNURs On Certain Chemical Substances: Since September 15, 2021, EPA has issued three batches of final significant use rules (SNUR) under TSCA for chemical substances that were the subject of premanufacture notices (PMN). 86 Fed. Reg. 51616 (Sept. 16, 2021), 86 Fed. Reg. 51620 (Sept. 16, 2021), 86 Fed. Reg. 55704 (Oct. 7, 2021). The SNURs require persons to notify EPA at least 90 days before commencing manufacture (defined by statute to include import) or processing of any of these chemical substances for an activity that is designated as a significant new use by the SNURs. The SNURs further require that persons not commence manufacture or processing for the significant new use until they have submitted a significant new use notice (SNUN) and EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken any risk management actions that are required as a result of that determination. The SNURs issued on September 16, 2021, will take effect on November 15, 2021, and the SNURs issued on October 7, 2021, will take effect on December 6, 2021.

EPA Publishes Final Rule Extending PIP (3:1) Compliance Dates: On September 17, 2021, EPA published a final rule amending the regulations applicable to phenol, isopropylated phosphate (3:1) (PIP (3:1)) promulgated under TSCA. 86 Fed. Reg. 51823. Specifically, EPA is extending the compliance date applicable to the processing and distribution in commerce of certain PIP (3:1)-containing articles, and the PIP (3:1) used to make those articles, from March 8, 2021, to March 8, 2022. For such articles, EPA states that it is also extending the compliance date for the recordkeeping requirements applicable to manufacturers, processors, and distributors from March 8, 2021, to March 8, 2022. The final rule was effective September 17, 2021. More information on the final PIP (3:1) rule and on EPA’s plan for a new rulemaking on PBT chemicals is available in our September 3, 2021, memorandum, “EPA Plans New Rulemaking for PBTs, Extends Compliance Dates for PIP (3:1) Rule.”

EPA Publishes Statements Of Findings For July 2021 For Certain New Chemicals Or Significant New Uses: On September 21, 2021, EPA published its statements of findings made after reviewing notices submitted under TSCA Section 5(a) that certain new chemical substances or significant new uses are not likely to present an unreasonable risk of injury to health or the environment. 86 Fed. Reg. 52459. The notice presents statements of findings made by EPA during the period from July 1, 2021, to July 31, 2021.

EPA Announces 2021 Safer Choice Partner Of The Year Awards: On September 22, 2021, EPA recognized 33 Safer Choice Partner of the Year award winners across 16 states and the District of Columbia for achievement in the design, manufacture, selection, and use of products with safer chemicals. EPA states that in the coming year, it hopes to expand the Safer Choice program to make products containing safer chemicals increasingly available to underserved communities, including communities of color and low-income communities. More information is available in our September 28, 2021, blog item.

EPA Publishes Receipt And Status Information For August 2021 For Certain New Chemicals: On September 23, 2021, EPA published the receipt and status reports for the period from August 1, 2021, to August 31, 2021. 86 Fed. Reg. 52899. EPA is providing notice of receipt of PMNs, SNUNs, and Microbial Commercial Activity Notices (MCAN) (including amended notices and test information); an exemption application under 40 C.F.R. Part 725 (Biotech exemption); applications for a test marketing exemption (TME), both pending and/or concluded; notices of commencement (NOC) to manufacture (including import) a new chemical substance; and a periodic status report on new chemical substances that are currently under EPA review or have recently concluded review. EPA also provides information on its website about cases reviewed under the amended TSCA, including the Section 5 PMN/SNUN/MCAN and exemption notices received, the date of receipt, the final EPA determination on the notice, and the effective date of EPA’s determination for PMN/SNUN/MCAN notices on its website. Comments identified by the specific case number provided in the Federal Register notice must be received by October 25, 2021.

EPA Proposes To Codify Parent Company Definition For TRI Reporting: On September 28, 2021, EPA published a proposed rule that would codify the definition of “parent company” for purposes of reporting to the Toxics Release Inventory (TRI). 86 Fed. Reg. 53577. Although the existing regulation requires a facility reporting to TRI to identify its parent company in annual reporting forms, no codified definition of this data element exists. The proposed rule addresses the following ownership scenarios:

  • A facility is owned by a single company that is not owned by another company;
     
  • A facility is owned by a single company that is owned by another company;
     
  • A facility is owned by multiple companies, including companies that are themselves owned by other entities;
     
  • A facility is owned by a joint venture or cooperative;
     
  • A facility is owned, at least in part, by a foreign company; and
     
  • A facility is owned by the federal government, or a state, tribal, or municipal government.
     

EPA also proposes to require facilities reporting to TRI to use standardized naming conventions for parent company reporting, as provided in the annual TRI Reporting Forms and Instructions, available as a downloadable Excel file (“Standardized Parent Company Names”) at http://www.epa.gov/tri/rfi. Comments are due November 29, 2021. According to the notice, under the Paperwork Reduction Act (PRA), comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of comments by October 28, 2021.

EPA Extends Submission Deadline For Health And Safety Studies On High-Priority Chemicals And Organohalogen Flame Retardants: On October 1, 2021, EPA extended the submission deadline for manufacturers (including importers) of 50 chemicals to report data from certain unpublished health and safety studies. 86 Fed. Reg. 54386. The 50 chemicals include:

  • Twenty chemicals designated by EPA as high-priority substances and currently undergoing risk evaluation under TSCA. The deadline for manufacturers to submit studies on these chemicals will be December 1, 2021. EPA states that this deadline “ensures that health and safety studies will be received in time for use in risk evaluations on these chemical substances.”
     
  • Thirty organohalogen flame retardants being evaluated for health risks by the Consumer Product Safety Commission (CPSC) under the Federal Hazardous Substances Act (FHSA). The deadline for manufacturers to submit studies on these chemicals will be January 25, 2022.
     

GAO Asks Whether Chemical Recycling Can Reduce Plastic Pollution: On October 5, 2021, the U.S. Government Accountability Office (GAO) posted a WatchBlog item entitled “Can Chemical Recycling Reduce Plastic Pollution?”. The item looks at GAO’s September 2021 Science & Tech Spotlight: Advanced Plastic Recycling. According to GAO, chemical recycling could reduce the amount of plastic that ends up in landfills, potentially reducing the release of chemicals into the environment. Chemical recycling can produce high-quality raw materials, decreasing the demand for fossil fuels and other natural resources. GAO states that the obstacles to using chemical recycling include process and technology challenges, high startup and operating costs, and limited incentives for recycling innovation and investment. GAO notes that new plastics produced from fossil fuels are typically cheaper to produce than recycled plastics, in part due to transportation costs and limited recycling infrastructure, making recycled plastics less marketable. More information is available in our October 7, 2021, blog item.

OIRA Completes Review Of Proposed Rule Concerning Further Compliance Date Extension For PIP (3:1): On October 7, 2021, OMB’s Office of Information and Regulatory Affairs (OIRA) completed its review of a proposed rule on “Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h); Phenol, Isopropylated Phosphate (3:1); Further Compliance Date Extension.” The proposed rule reviewed by OIRA is expected to propose further extensions to certain article-related compliance dates. More information on EPA’s September 3, 2021, announcement is available in our memorandum, “EPA Plans New Rulemaking for PBTs, Extends Compliance Dates for PIP (3:1) Rule.”

EPA Region 2 Settles With Reckitt Benckiser On Violations Related To Sales Of Mislabeled Rodenticides: On October 7, 2021, EPA Region 2 announced a settlement with Reckitt Benckiser, LLC (Reckitt Benckiser) regarding alleged violations under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The specific alleged violations relate to 239 sales and distributions of two rodenticide products in the United States that EPA asserts had misleading advertising claims on the packaging. Reckitt Benckiser has agreed to pay a civil penalty of $458,000 under the settlement to resolve these violations. More information is available in our October 12, 2021, blog.

EPA Proposes SNURs For Certain Chemicals: On October 12, 2021, EPA proposed SNURs under TSCA for chemical substances that were the subject of PMNs. 86 Fed. Reg. 56664. The chemical substances received “not likely to present an unreasonable risk” determinations under TSCA. 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 November 12, 2021.

EPA Announces Next Step To Broaden TRI Reporting Requirements For Ethylene Oxide: EPA announced on October 13, 2021, that it is taking a “critical first step forward” to expand the scope of TRI reporting requirements to include certain contract sterilization facilities that are not currently reporting on ethylene oxide releases. EPA states that under the Emergency Planning and Community Right-to-Know Act (EPCRA), it has discretionary authority to extend TRI reporting requirements to specific facilities based on a chemical’s toxicity, the facility’s proximity to other facilities that release the chemical or to population centers, any history of releases of the chemical at the facility, or other factors that the Administrator deems appropriate. According to EPA, it has sent letters to 31 facilities providing notice that it is considering requiring those facilities to report ethylene oxide releases to TRI under this discretionary authority. EPA notes that some facilities will receive notice that they may also be required to report ethylene glycol releases. Ethylene glycol is produced using ethylene oxide; thus, EPA states, both chemicals may co-occur at facilities.

EPA Announces Steps Intended To Enhance Scientific Integrity And Strengthen New Chemical Safety Reviews: EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) announced on October 14, 2021, several actions intended to enhance scientific integrity, including establishing two internal science policy advisory councils, creating a new senior-level career position to serve as a science policy advisor to the Assistant Administrator, and making further improvements to policies and procedures. The announcement includes the following actions:

  • New OCSPP Science Policy Council and New Science Policy Advisor Position;
     
  • Strengthening New Chemical Safety Reviews:
     
    • New Chemicals Advisory Committee;
       
    • Human Health Risk Assessment Process Improvements; and
       
    • Enhanced Recordkeeping Requirements; and
       
  • Workplace Climate Assessment.
     

More information is available in our October 14, 2021, blog item.

EPA Updates Confidential Status Of Chemicals On TSCA Inventory: EPA announced on October 15, 2021, that it is updating the confidential status of 377 chemical identities and will include these chemical identities on the next update of the TSCA Inventory, planned for winter 2022. The TSCA Inventory is a list of all existing chemical substances manufactured, processed, or imported in the United States. According to EPA, the Inventory contains 86,607 chemicals, of which 41,953 are active in U.S commerce. More information is available in our October 15, 2021, blog item.

EPA Will Hold Webinar On Real-World Applications Of TRI: On October 20, 2021, EPA will hold a webinar on “Data in Action: Real-World Applications of the Toxics Release Inventory.” Participants will hear from three researchers about how they have used TRI in their work in the fields of environmental justice (EJ), public health equity, corporate environmental performance, and more.

Registration Open For Meeting To Discuss IRIS Assessment Plan For Naphthalene: EPA will hold a meeting on November 9, 2021, to discuss the Integrated Risk Information System (IRIS) Assessment Plan associated with the unsuspended naphthalene assessment. Registration is required for stakeholders who wish to attend the meeting and/or provide oral public comment. EPA has posted program materials, including the Assessment Plan.

RCRA/CERCLA/CWA/CAA/PHMSA/SDWA

EPA Rescinds Trump Administration’s Guidance On CWA Permit Requirements: On September 15, 2021, EPA issued a memorandum rescinding a guidance document entitled “Applying the Supreme Court’s County of Maui v. Hawaii Wildlife Fund Decision in the Clean Water Act Section 402 National Pollutant Discharge Elimination System Permit Program” that was issued by the Trump Administration on January 14, 2021. 86 Fed. Reg. 53653. According to EPA’s September 16, 2021, announcement, the previous Administration’s Maui guidance “reduced clean water protections by creating a new factor for determining if a discharge of pollution from a point source through groundwater that reaches a water of the United States is the ‘functional equivalent’ of a direct discharge to such water.” EPA states that the addition of that factor “skewed the ‘functional equivalent’ analysis in a way that could reduce the number of discharges requiring a National Pollutant Discharge Elimination System (NPDES) permit.” EPA is rescinding the guidance upon determining that this additional factor is inconsistent with the Clean Water Act (CWA) and the Supreme Court decision in County of Maui v. Hawaii Wildlife Fund.

EPA Proposes To Amend National VOC Emission Standards For Aerosol Coatings: On September 17, 2021, EPA issued a proposed rule that would amend the National Volatile Organic Compound (VOC) Emission Standards for Aerosol Coatings, which establish reactivity-based emission standards for the aerosol coatings category (aerosol spray paints) under the Clean Air Act (CAA). 86 Fed. Reg. 51851. EPA proposes to update the coating category product-weighted reactivity limits for aerosol coatings categories; add new compounds and reactivity factors (RF); update existing reactivity values; revise the default RF; amend the thresholds for compounds regulated by this document; and add electronic reporting provisions. Comments are due November 16, 2021. The notice states that under the PRA, comments on the information collection provisions “are best assured of consideration if the [OMB] receives a copy of your comments on or before October 18, 2021.”

EPA Proposes To Require Control, Capture, And/Or Destruction Of Hydrofluorocarbons (HFC) That Would Otherwise Be Emitted From Manufacture Of HCFCs: On September 29, 2021, EPA published a proposed rule to require companies to control, capture, and destroy HFC-23 byproduct generated at plants that manufacture class II ozone-depleting substances regulated under current CAA regulations, such as HCFC-22. 86 Fed. Reg. 53916. According to EPA, HFC-23 is a very potent greenhouse gas (GHG) that is generated as a byproduct during the manufacture of certain class II ozone-depleting substances, including HCFC-22. Under the CAA and the implementing regulations, the production and consumption of class II ozone-depleting substances, including HCFC-22, are restricted with limited exceptions. One such exception is production for use in transformation, or as a feedstock, which is allowed indefinitely. EPA proposes to limit emissions of HFC-23 from plants manufacturing hydrochlorofluorocarbons (HCFC). The HFC-23 must be captured and employed for a commercial use or destroyed using a technology approved by EPA, thereby ensuring it is not directly emitted. Comments are due November 15, 2021.

EPA Will Host Virtual Public Meetings On How To Increase Adoption Of e-Manifest: EPA will host two virtual public meetings to discuss how to increase industry adoption of electronic manifests and solicit feedback from stakeholders. 86 Fed. Reg. 54188. EPA launched the e-Manifest system on June 30, 2018. e-Manifest provides those persons required to use a Resource Conservation and Recovery Act (RCRA) manifest under either federal or state law the option of using electronic manifests to track shipments of hazardous waste and to meet certain RCRA requirements. The meetings will be held on October 27, 2021, and November 3, 2021, from approximately 1:00 p.m. to 5:00 p.m. (EDT). Additional public meetings may be added. According to EPA, the agenda for both meetings will be identical. EPA encourages all stakeholders to attend one of the meetings. Registration is required. EPA will accept oral comments during the public meetings and will accept written comments prior to and after the public meetings. Any written comments should be submitted by December 30, 2021.

EPA Publishes Review Drafts Of Supplement To 2019 Integrated Science Assessment For PM, Policy Assessment For Reconsideration Of NAAQS For PM: On September 30, 2021, EPA announced the availability of a draft document entitled “Supplement to the 2019 Integrated Science Assessment for Particulate Matter (External Review Draft)” (EPA/600/R-21/198). 86 Fed. Reg. 54186. The Center for Public Health and Environmental Assessment within EPA's Office of Research and Development (ORD) prepared the document as part of the reconsideration of the 2020 National Ambient Air Quality Standard (NAAQS) for particulate matter (PM). According to EPA, the Supplement represents a targeted review of peer-reviewed studies published since the literature cutoff date (i.e., ~January 2018) of the 2019 Integrated Science Assessment for PM. EPA is releasing the draft document to seek review by the Clean Air Scientific Advisory Committee (CASAC) and the public. Comments are due November 29, 2021.

EPA announced on October 8, 2021, that it will make available for public comment a draft document entitled “Policy Assessment for Reconsideration of the National Ambient Air Quality Standards for Particulate Matter, External Review Draft” (Draft PA). 86 Fed. Reg. 56263. The draft document was prepared as a part of the current reconsideration of the 2020 final decision on the PM NAAQS. When final, the document is intended to “bridge the gap” between the scientific and technical information assessed in the 2019 Integrated Science Assessment for Particulate Matter and Supplement to the 2019 Integrated Science Assessment for Particulate Matter and the judgments required of the Administrator in determining whether to retain or revise the existing PM NAAQS. Comments are due December 14, 2021.

EPA Withdraws Guidance Memorandum Addressing SSM In SIPs And Implementation Of Prior Policy: On September 30, 2021, EPA announced that it is returning to its 2015 policy explaining that State Implementation Plan (SIP) provisions that provide exemptions from air emissions limits during periods of startup, shutdown, and malfunction (SSM) or that provide affirmative defense provisions are not consistent with the CAA and would not generally be approvable. According to EPA, the reinstated 2015 Policy will ensure that all modes of source operation, including periods of SSM, have emissions limitations in place that can be appropriately enforced in all communities and populations across the affected states, including minority, low-income, and indigenous populations overburdened by pollution. In addition, EPA plans to revisit the three related state-specific SIP actions that were issued in final in 2020 that withdrew the SIP calls previously issued to Texas, North Carolina, and Iowa. Through notice-and-comment rulemaking actions, EPA plans to reconsider whether any of the findings underlying those actions should be retained in light of its change in policy.

EPA Publishes Final Rule To Cap And Phase Down Production And Consumption Of HFCs: On October 5, 2021, EPA issued a final rule that will establish a comprehensive program to cap and phase down the production and consumption of climate-damaging HFCs in the United States. 86 Fed. Reg. 55116. According to EPA’s September 23, 2021, announcement, “HFCs are potent greenhouse gases commonly used in refrigeration and air conditioning equipment, as well as foams and many other applications.” The final rule will phase down the U.S. production and consumption of HFCs by 85 percent over the next 15 years, as mandated by the American Innovation and Manufacturing (AIM) Act that was enacted in December 2020. EPA states that in addition to implementing the phasedown program, the Biden-Harris Administration is marshalling a whole-of-government approach to prevent the illegal trade, production, use, or sale of HFCs; support the transition to HFC alternatives through research and purchasing; and encourage the reclamation and recycling of HFCs from retired equipment, thus reducing further HFC production. In addition to establishing a general HFC allowance pool and a set aside pool (e.g., for new market entrants), the rule outlines how EPA is issuing allowances for specific applications listed in the AIM Act, such as mission-critical military applications. The rule will be effective November 4, 2021, except for amendatory instruction 3 adding 40 C.F.R. Part 84, which was effective October 5, 2021. On October 7, 2021, EPA announced that it issued calendar year 2022 allowances for the production and consumption of HFCs in accordance with its regulations. 86 Fed. Reg. 55841.

EPA Proposes Listing Of Substitutes Under SNAP Program: On October 6, 2021, EPA published a supplemental notice of proposed rulemaking, that supplements its June 12, 2020, proposal with respect to the proposed listings in the foam-blowing sector, taking into consideration public comments and information received since issuance of the initial proposal. 86 Fed. Reg. 55549. In the June 12, 2020, proposal, EPA proposed to list three foam-blowing agent blends as acceptable pursuant to the Significant New Alternatives Policy (SNAP) program. In the supplemental proposal, EPA is proposing an additional approach to list these blends as acceptable, subject to narrowed use limits, in the foam-blowing sector, extruded polystyrene: boardstock and billet end-use, from the effective date of a final rule based on this supplemental proposal until January 1, 2023. EPA is providing an opportunity for public comment on the additional approach for the listings in the foam-blowing sector, as well as reopening the public comment period for the proposed listings in the foam-blowing sector in the June 12, 2020, proposal. EPA states that it is not reopening for comment those other portions of the June 12, 2020, proposal that are addressed in a separate final rule issued May 6, 2021. Comments are due November 22, 2021.

EPA Releases 2020 Data Collected Under GHG Reporting Program: On October 6, 2021, EPA announced that it released the 2020 GHG data collected under its Greenhouse Gas Reporting Program (GHGRP). In 2020, reported emissions from large industrial sources were approximately nine percent lower than in 2019, “reflecting both the economic slowdown due to the COVID-19 pandemic, and ongoing, long-term industry trends.” More than 8,100 large facilities reported GHG emissions in 2020 to EPA. The data show that in 2020:

  • Power plants were the largest stationary source of U.S. GHG emissions reporting to the GHGRP, with 1,339 facilities emitting approximately 1.5 billion metric tons of carbon dioxide. Reported power plant emissions in 2020 declined by ten percent between 2019 and 2020, and nearly 33 percent since 2011 reflecting both changes in electricity use during the COVID-19 pandemic, as well long-term shifts in power sector fuel-stock from coal to natural gas;
     
  • Petroleum and natural gas systems were the second largest stationary source of emissions, reporting 316 million metric tons of GHG emissions. Reported emissions for 2020 were nine percent lower than in 2019, but 11.6 percent higher than 2016; and
     
  • Reported emissions from other large sources in the industrial and waste sectors were a combined 2,286 million metric tons of GHG emissions in 2020, down 8.9 percent from 2019, and down 26 percent since 2011. All sectors reported emissions reductions, with the largest reductions in the metals, oil and gas, and refineries sectors, reflecting the reduced demand for automobiles and gasoline due to the COVID-19 pandemic.
     

EPA And Army Will Hold Regional Roundtables On WOTUS: EPA and the U.S. Department of the Army have asked communities to propose roundtables to provide input on the regional implications of “waters of the United States” (WOTUS). According to EPA’s October 13, 2021, press release, the regional roundtables are intended to “engage stakeholders representing diverse perspectives in meaningful dialogue to help inform the agencies’ work to develop an enduring definition of WOTUS that supports public health, environmental protection, agricultural activity, and economic growth.” The agencies invite stakeholders to organize a targeted set of interested parties and regional representatives to participate in these discrete roundtables. The agencies request that organizers submit their self-nomination letter via e-mail not later than November 3, 2021.

EPA Acts On Petitions To Cut HFCs, Will Begin AIM Act Rulemaking Process: On October 14, 2021, EPA announced that it granted or partially granted 11 petitions that were submitted under the AIM Act to restrict the use of HFCs in the refrigeration and air conditioning, aerosols, and foam sectors. 86 Fed. Reg. 57141. EPA states in its October 8, 2021, press release that it will now have two years to propose and issue final rulemakings addressing these petitions and expects the forthcoming rules will provide a clear regulatory landscape that will help the transition to more climate friendly alternatives. After reviewing the petitions and considering a number of factors as specified in the AIM Act, including the availability of substitutes, overall economic costs, and environmental impacts, the Administrator is granting ten petitions and partially granting one petition. According to EPA, it is continuing to evaluate the other petitions it has received and plans to respond to those petitions separately. EPA intends to move swiftly to develop a proposal responding to the petitions and will continue to engage with stakeholders as we proceed. EPA notes that granting a petition does not mean it will propose or issue final requirements identical to those requested in the petition.

FDA

Food Traceability Challenge Winners Announced: On September 13, 2021, the U.S. Food and Drug Administration (FDA) announced the winners of the New Era of Smarter Food Safety Low- or No-Cost Tech-Enabled Traceability Challenge, which is an initiative intended to promote affordable and effective methods for food traceability. Examples of traceability hardware, software, and data analytics platforms identified by the winning teams include:

  • Item-level and batch-tracking traceability utilizing blockchain technology, cloud storage, collaborative open data networks, mobile apps, machine learning, and Internet of Things technologies; and
     
  • Free software that helps small and mid-size farmers manage records for traceability and other farm-related metrics.
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A recording of a webinar with presentations from the winners is available at the link here.

Withdrawal Of Temporary Guidance For Hand Sanitizer Products: On October 13, 2021, FDA announced the withdrawal of the following three guidance documents:

  • “Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)”;
     
  • "Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency”; and
     
  • “Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19).”
     

86 Fed. Reg. 56960. FDA is withdrawing these temporary guidance documents because current data indicate that consumers and healthcare personnel are no longer experiencing difficulties accessing alcohol-based hand sanitizer products. The withdrawal date is December 31, 2021, and firms must cease distribution by March 31, 2022, of any remaining products (i.e., those that were prepared before or on December 31, 2021, under the temporary policies).

NANOTECHNOLOGY

OSTP Requests Input On Development Of A National Strategic Plan For Advanced Manufacturing: On October 5, 2021, The White House Office of Science and Technology Policy (OSTP) published a request for information (RFI) requesting input on the development of a National Strategic Plan for Advanced Manufacturing. 86 Fed. Reg. 55022. According to the RFI, advanced manufacturing is a family of activities that: depend on the use and coordination of information, automation, computation, software, sensing, and networking; and/or make use of cutting-edge materials and emerging capabilities enabled by the physical and biological sciences, for example, nanotechnology, chemistry, and biology. Responses are due December 17, 2021. More information is available in our October 5, 2021, blog item.

NIOSH Highlights Its Work In Blog Item On National Nanotechnology Day: In honor of National Nanotechnology Day, and as part of a series for its 50th anniversary, the National Institute for Occupational Safety and Health (NIOSH) has posted a blog item entitled “National Nanotechnology Day: A big day for small things.” NIOSH states that it has been at the forefront of efforts to characterize the potential hazards for those working with engineered nanomaterials and to ensure safe workplaces since the early 2000s. More information is available in our October 7, 2021, blog item.

ECHA Posts New Set Of Q&As For Downstream Users Of Nanoforms: The European Chemicals Agency (ECHA) has posted a new set of questions and answers (Q&A) for downstream users of nanoforms. More information is available in our October 9, 2021, blog item.

NNCO Releases 2021 NNI Strategic Plan: On October 8, 2021, the National Nanotechnology Coordination Office (NNCO) announced the release of the 2021 National Nanotechnology Initiative Strategic Plan, which outlines the goals, objectives, and actions for National Nanotechnology Initiative (NNI) over the next five years:

  • Goal 1. Ensure that the United States remains a world leader in nanotechnology research and development (R&D);
     
  • Goal 2. Promote commercialization of nanotechnology R&D;
     
  • Goal 3. Provide the infrastructure to support sustainably nanotechnology research, development, and deployment;
     
  • Goal 4. Engage the public and expand the nanotechnology workforce; and
     
  • Goal 5. Ensure the responsible development of nanotechnology.
     

More information is available in our October 12, 2021, blog item.

EC Standing Committee Approves EC Proposal To Ban Use Of Titanium Dioxide (E171) As A Food Additive: The European Commission (EC) announced on October 8, 2021, that the Standing Committee on Plants, Animals, Food and Feed approved the EC’s proposal to ban the use of titanium dioxide (E171) as a food additive. The EC states that its proposal “is based on a scientific opinion by the European Food Safety Authority, which concluded that E171 could no longer be considered as safe when used as a food additive, in particular due to the fact that concerns regarding genotoxicity cannot be ruled out.” According to the EC, unless an objection is adopted by the end of 2021 by either the Council or the European Parliament, the text will enter into force in early 2022. This will begin a six-month phasing out period after which a full ban will apply in food products. The EC has posted Q&As regarding its proposal.

SweNanoSafe Will Hold Workshop On Safe And Sustainable By Design: A Prerequisite For Achieving A Circular Economy: The Swedish National Platform for Nanosafety (SweNanoSafe) will hold a workshop on November 29, 2021, on “Safe and Sustainable by Design: a prerequisite for achieving a circular economy.” The workshop aims to orient Swedish authorities in the ongoing development and implementation of the Safe and Sustainable by Design concept to face regulatory challenges related to nano- (and advanced) materials with the purpose of advancing circular economy.

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

Senate Committee Holds Hearing On EPA Nominees For Assistant Administrator For Mission Support And Assistant Administrator For Enforcement And Compliance Assurance: On September 15, 2021, the Senate Committee on Environment and Public Works (EPW) held a hearing on several EPA nominees, including Amanda Howe, nominated for Assistant Administrator for Mission Support, and David Uhlmann, nominated for Assistant Administrator for Enforcement and Compliance Assurance. For more information on the hearing, please read the full memorandum.

White House Opposes NDAA Provision Prohibiting DOD From Procuring Certain Items Containing PFAS: On September 21, 2021, the White House published a Statement of Administration Policy concerning the National Defense Authorization Act for Fiscal Year 2022 (NDAA) (H.R. 4350). The Statement addresses a number of provisions in the legislation, including Section 317, which would prohibit the Department of Defense (DOD) “from procuring a wide range of items” that may contain per- and polyfluoroalkyl substances (PFAS). According to the Statement, it would not be feasible for DOD to test all of the items to determine if they contain PFAS. In addition, some of these products may not have PFAS-free alternatives available. The Biden-Harris Administration “will continue to work with Congress to both address PFAS contamination and find alternative products and solutions.” On September 23, 2021, the House passed the bill by a vote of 316-113.

Senate EPW Committee Approves Jeffrey Prieto’s Nomination As EPA General Counsel: On September 22, 2021, the Senate EPW Committee voted to approve Jeffrey Prieto’s nomination to be EPA General Counsel. Prieto is currently the General Counsel of the Los Angeles Community College District. His prior federal government service includes nearly 20 years across various agencies, including serving as an Attorney-Advisor at EPA’s Office of Water. He also served as a Trial Attorney, Counsel to the Assistant Attorney General, Deputy Executive Officer, and General Counsel in the Environment and Natural Resources Division (ENRD). Under the Obama-Biden Administration, he served as the Senate-confirmed General Counsel of the U.S. Department of Agriculture (USDA).

Senate Committee Will Hold Hearing On Evaluating Federal Response To Persistence And Impacts Of PFAS On The Environment: The Senate EPW Committee will hold a hearing on October 20, 2021, on “Evaluating the Federal Response to the Persistence and Impacts of PFAS Chemicals on our Environment.” The Committee intends to assess EPA’s ongoing and proposed responses to the presence of PFAS in the environment, particularly in the nation’s waters. Radhika Fox, Assistant Administrator for EPA’s Office of Water, will testify.

MISCELLANEOUS

Ninth Edition Of GHS Includes Revisions To Chapter 2.1 (Explosives) And Decision Logic: On September 14, 2021, the United Nations (UN) published an electronic version of the ninth revised edition (Rev 9) of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) available for free for consultation purposes. The amendments to the eighth revision of the GHS (Rev 8) include extensive revision of Chapter 2.1 (explosives) to address explosion hazard determination better when explosives are not in transit; the revision of decision logic; the revision of the classification and labeling summary tables in Annex 1; the revision and further rationalization of precautionary statements; and the updating of references to Organization for Economic Cooperation and Development (OECD) test guidelines for the testing of chemicals in Annexes 9 and 10. In addition, several format changes to decision logic are noted throughout. The decision logic provides clarification on the process for how to arrive at the appropriate classification. For more information, please read the full memorandum.

OSHA Holds Public Hearing On Proposed Amendments To The Hazard Communication Standard: The Occupational Safety and Health Administration (OSHA) concluded a three-day informal public hearing on its February 16, 2021, notice of proposed rulemaking (NPRM) to amend the Hazard Communication Standard (HCS). The NPRM was open for comment until May 19, 2021. OSHA stated that it would schedule an informal public hearing on the NPRM if a request was made during the comment period. A request was made, and OSHA scheduled the public hearing for September 21-23, 2021. More information is available in our September 28, 2021, memorandum.

Biden Nominates Dr. Christopher Frey As ORD Assistant Administrator: On September 22, 2021, President Biden announced several nominations, including Dr. Christopher Frey for Assistant Administrator of EPA’s ORD. Frey is currently the Deputy Assistant Administrator for Science Policy in ORD as an appointee of the Biden-Harris Administration. According to the announcement, at EPA, Frey “is a champion of scientific integrity and the role of science to inform decision-making,” leading scientific and technical research on Administration priorities, including climate change, EJ, PFAS, and lead, as well as promoting the advancement of innovative scientific methods and approaches. Prior to joining EPA, Frey was the Glenn E. and Phyllis J. Futrell Distinguished University Professor at North Carolina State University, where he served on the faculty since 1994. His research includes measurement and modeling of human exposure to air pollution, measurement and modeling of vehicle emissions, and applications of probabilistic and sensitivity analysis methods to emissions estimation, risk assessment, and technology assessment.

President Biden Announces PCAST Members: On September 22, 2021, President Biden announced “30 of America’s most distinguished leaders in science and technology” who will serve as members of the President’s Council of Advisors on Science and Technology (PCAST). PCAST is the sole body of external advisors charged with making science, technology, and innovation policy recommendations to the President and the White House. The 30 members include 20 elected members of the National Academies of Sciences, Engineering, and Medicine, five MacArthur “Genius” Fellows, two former Cabinet secretaries, and two Nobel laureates. The White House notes that the members represent the most diverse PCAST to date, with women making up half of PCAST, and people of color and immigrants making up more than one-third of PCAST.

EPA Hosting Biweekly National EJ Community Engagement Calls: On September 27, 2021, EPA invited EJ advocates and the public to participate in its National EJ Community Engagement Calls, now happening biweekly, to discuss and receive feedback on all aspects of EJ at EPA with partners and communities. According to EPA, the meetings not only serve as an opportunity to give an update on EPA’s EJ work and its resources, but also to listen and learn from communities, partners, and stakeholders. Additionally, the biweekly community engagement calls speak to EPA’s commitment to Justice40, an initiative announced by President Biden, to deliver 40 percent of the overall benefits of relevant federal investments to disadvantaged communities.

EPA Draft FY 2022-2026 Strategic Plan Includes Ambitious Goals To Protect Human Health And The Environment: On October 1, 2021, EPA announced the availability of the Draft FY 2022-2026 EPA Strategic Plan. 86 Fed. Reg. 54448. The draft Strategic Plan communicates EPA’s priorities and provides the roadmap for achieving its mission to protect human health and the environment. The draft Strategic Plan outlines objectives within the following strategic goals:

  • Goal 1: Tackle the Climate Crisis;
     
  • Goal 2: Take Decisive Action to Advance EJ and Civil Rights;
     
  • Goal 3: Enforce Environmental Laws and Ensure Compliance;
     
  • Goal 4: Ensure Clean and Healthy Air for All Communities;
     
  • Goal 5: Ensure Clean and Safe Water for All Communities;
     
  • Goal 6: Safeguard and Revitalize Communities; and
     
  • Goal 7: Ensure Safety of Chemicals for People and the Environment.
     

According to the notice, EPA is seeking comment from individual citizens, states, tribes, local governments, industry, the academic community, non-governmental organizations (NGO), and all other interested parties. Comments are due November 12, 2021. EPA states that it “anticipates the final Strategic Plan will be submitted to Congress in February 2022.”

California Governor Signs Bills Banning PFAS In Products For Children And In Disposable Food Packaging: On October 5, 2021, California Governor Gavin Newsom (D) signed A.B. 652, which bans the use of PFAS in products for children, and A.B. 1200, which prohibits their use in disposable food packaging. According to Newsom’s press release, A.B. 1200 prohibits disposable food packaging from containing intentionally added PFAS and requires cookware manufacturers to disclose the presence of hazardous chemicals such as PFAS on product labels and online. A.B. 652 bans the use of PFAS in products for children, such as car seats and cribs, beginning July 1, 2023.

EPA Publishes 2021 Climate Adaptation Action Plan: On October 7, 2021, EPA released its Climate Adaptation Action Plan, which describes steps EPA will take to address the impacts of climate change on communities across the United States, as part of President Biden’s whole-of-government approach to confronting the climate crisis. EPA also launched a new Climate Adaptation web page that will act as a hub for climate adaptation resources from across EPA. The 2021 Climate Adaptation Action Plan lays out several priorities for EPA to implement in the coming months and years, including:

  • Integrating climate adaptation and consideration of climate impacts into EPA programs, policies, rulemaking processes, and enforcement activities;
     
  • Consulting and partnering with Tribes; state, local, and territorial governments, and other federal agencies; community groups; scientists and adaptation experts; businesses; and other stakeholders to increase the resilience of the nation, with a particular focus on advancing EJ; and
     
  • Implementing measures to protect the Agency’s workforce, facilities, critical infrastructure, supply chains, and procurement processes from the risks posed by climate change.
     

Rod Snyder Appointed As EPA Agriculture Advisor: On October 7, 2021, EPA announced the appointment of Rod Snyder to become EPA’s Agriculture Advisor. Snyder will lead outreach and engagement efforts with the agricultural community for EPA, working to advance the Biden Administration’s environmental agenda for farmers and rural communities. EPA states that Snyder is nationally recognized for his leadership at the intersection of agricultural and environmental policy, and joins EPA after serving as president of Field to Market: The Alliance for Sustainable Agriculture, the largest multi-stakeholder initiative working to advance the sustainability of commodity crop farming in the United States. In that role, he forged science-based consensus among stakeholders across the food and agriculture value chain on issues such as climate change, water quality, biodiversity, and pest management. More information is available in our October 13, 2021, blog.

CEQ Proposes To Revise NEPA Implementing Regulations: On October 7, 2021, the Council on Environmental Quality (CEQ) proposed to modify certain aspects of its regulations for implementing the procedural provisions of the National Environmental Policy Act (NEPA) to restore generally regulatory provisions “that were in effect for decades before being modified in 2020.” 86 Fed. Reg. 55757. The proposed rule would restore provisions addressing the purpose and need of a proposed action, agency NEPA procedures for implementing CEQ’s NEPA regulations, and the definition of “effects.” CEQ will conduct two online public meetings for the proposed rule on October 19, 2021, from 1:00 p.m. to 4:00 p.m. (EDT) and October 21, 2021, from 5:00 p.m. to 8:00 p.m. (EDT). Comments are due November 22, 2021.

OSHA Submits Final COVID-19 Vaccination And Testing Emergency Temporary Standard Rulemaking To OIRA For Review: On October 12, 2021, OSHA submitted to OIRA a final rule entitled “COVID-19 Vaccination and Testing Emergency Temporary Standard Rulemaking.” President Biden’s COVID-19 Action Plan states that OSHA “is developing a rule that will require all employers with 100 or more employees to ensure their workforce is fully vaccinated or require any workers who remain unvaccinated to produce a negative test result on at least a weekly basis before coming to work.” According to the Action Plan, OSHA will issue an Emergency Temporary Standard to implement this requirement.

EPA Local Government And Small Communities Advisory Committees Meet Virtually: The Local Government Advisory Committee (LGAC) and the Small Communities Advisory Subcommittee (SCAS) met on October 15, 2021. During the meeting, EPA shared its vision for the agency over the next several years, including providing clean and safe water to all, safeguarding and revitalizing communities, addressing climate change, advancing EJ, and ensuring the safety of chemicals for people and the environment. LGAC and SCAS members discussed workgroups and future plans to address EPA’s priorities. The meeting was open to the public.

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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