ABA SEER And CropLife America Present New Developments In Pesticide Law And Policy: Registration is now open for the American Bar Association (ABA) Section of Environment, Energy, and Resources (SEER) and CropLife America virtual conference entitled New Developments in Pesticide Law and Policyon November 18, 2020. The program provides important updates on U.S. pesticide law and policy issues with Lisa M. Campbell, Partner, Bergeson & Campbell, P.C. (B&C®), moderating the “Potential Impacts of California’s Rodenticide Restrictions on Urban Pest Management” panel. It is important to note that registration is divided in a morning session from 11:00 a.m. – 1:20 p.m. (EST) and an afternoon session from 2:00 p.m. – 4:05 p.m. (EST), with CLE credits available for both.
CDR Cross-CheckTM: The Chemical Data Reporting (CDR) deadline of November 30, 2020, is swiftly approaching. Let The Acta Group (Acta®) assist with determining whether a particular Toxic Substances Control Act (TSCA) action changes a reporting exemption or the reporting threshold. To get started using CDR Cross-Check, simply go to https://cdr-cross-check.actagroup.com/ and follow the instructions.
Edith G. Nagy Joins B&C And Acta: We are pleased to announce that Edith G. Nagy has joined our firms as Of Counsel (B&C) and Regulatory Consultant (Acta) and will assist clients with environmental, health, and safety (EHS) compliance in the United States and internationally. Ms. Nagy received law degrees from Universitatea de Vest Timisoara, Romania, and Arizona State University, Sandra Day O’Connor College of Law, from which she also earned a Certificate in Law, Science and Technology. Ms. Nagy’s international experience and extensive language skills (English, Romanian, Hungarian, German, Spanish, French, and Italian) are a valuable asset to clients pursuing and maintaining commercialization in multiple global markets.
EPA At 50 Celebration: The U.S. Environmental Protection Agency (EPA) turns 50 this year and the Agency is celebrating the milestone with a number of highlights and remembrances from 1970 to today. B&C’s James V. Aidala, former Assistant Administrator of EPA’s Office of Prevention, Pesticides, and Toxic Substances (OPPTS) (now the Office of Chemical Safety and Pollution Prevention), was asked to contribute a few remarks regarding his years of public service at the Agency. Jim’s thoughtful and very interesting remarks can be viewed here.
2021 Forecast — Hitting Inboxes The First Week Of January: B&C and Acta professionals are hard at work reporting and interpreting the many developments that will shape the agenda for chemicals and chemical products under a new Administration in the coming year. Our perennially anticipated Forecast document will be sent to clients and friends in the first week of January 2021.
TSCA/FIFRA/TRI
ABA SEER Article — “The Essentials Of TSCA Practice”: We are pleased to announce that the ABA SEER published an article written by Lynn L. Bergeson and Eve C. Gartner entitled “The essentials of TSCA practice” in the November/December 2020 issue of Trends. According to the authors, legal practitioners should be aware of the commercial, legal, and reputational implications of TSCA as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) in 2016. The authors state that TSCA’s expanded commercial reach “is an important, consequential, and growing practice area.” The authors note that “[c]ommunity organizations representing populations at greater risk of harm from chemicals should also be aware that TSCA may offer much-needed protections.”
NGOs Petition EPA For TSCA Section 4 Testing Of 54 PFAS: On October 14, 2020, a coalition of North Carolina non-governmental organizations (NGO) EPA for a TSCA Section 4 test rule for 54 per- and polyfluoroalkyl substances (PFAS) manufactured by The Chemours Company (Chemours) at its chemical production facility in Fayetteville, North Carolina. The petition, filed under TSCA Section 21, seeks issuance of a rule or order under TSCA Section 4 compelling Chemours to fund and carry out testing under the direction of a panel of independent scientists. EPA states in its letter acknowledging receipt of the petition that under TSCA Section 21, it has 90 days after the date the petition is filed to grant or deny the petition (January 11, 2021, in this case). If the Administrator grants the petition, the Administrator shall promptly commence an appropriate proceeding. If the Administrator denies the petition, the Administrator shall publish the reasons for such a denial in the Federal Register. The petition was filed by Center for Environmental Health, Cape Fear River Watch, Clean Cape Fear, Democracy Green, the NC Black Alliance, and Toxic Free NC. More information is available in our October 29, 2020, memorandum.
EPA Announces Settlement With Electrolux For Importing Air Filter Products With Nanosilver: On October 15, 2020, EPA announced a settlement with Electrolux Home Products, Inc. (Electrolux) to resolve alleged violations of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for importing air filter products that contain nanosilver. Specifically, the settlement resolves EPA’s claims that Electrolux imported unregistered pesticides in violation of FIFRA Section 12(a)(1)(A) and failed to file the required Notices of Arrival in violation of FIFRA Section 12(a)(2)(N). As part of the settlement, Electrolux will pay a civil penalty in the amount of $6,991,400. The Consent Agreement and Final Order (CAFO) is available here. More information is available in our October 22, 2020, blog.
EPA Proposes SNURs For Certain Chemical Substances: Since October 15, 2020, EPA has published two batches of proposed significant new use rules (SNUR) for certain chemical substances that are the subject of premanufacture notices (PMN): 85 Fed. Reg. 65782 (Oct. 16, 2020) and 85 Fed. Reg. 66506 (Oct. 20, 2020). The proposed SNURs 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. The proposed SNURs would 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 under TSCA, and has taken any risk management actions as are required as a result of that determination. Comments are due November 16, 2020, (first batch) and November 19, 2020 (second batch).
EPA Seeks Comment On Its Interim Guidance On Residual Efficacy Claims: On October 26, 2020, EPA announced that it is soliciting public comment on the interim guidance on registering products that claim to have “residual” or “long-lasting” effectiveness against viruses. This announcement follows up on EPA’s October 14, 2020, announcement that it would begin expediting its review of products with residual efficacy intended for use against SARS-CoV-2, the coronavirus that causes COVID-19. While traditional disinfectants only kill viruses and bacteria that are on the surface at the time they are used, surfaces treated with residual antimicrobial products kill pathogens that come into contact with the surface days, weeks, or years after the product is applied. EPA announced in an October 26, 2020, memorandum that it is seeking feedback from the public on the expedited process, design elements for evaluating residual product claims, and the test methods associated with this initiative. All comments on the interim guidance must be submitted to Docket Number EPA-HQ-OPP-2020-0529 on or before January 4, 2021. The interim guidance documents — Interim Method for Evaluating the Efficacy of Antimicrobial Surface Coatings, Interim Guidance – Expedited Review for Products Adding Residual Efficacy Claims, and Interim Method for the Evaluation of Bacterial Activity of Hard, Non-Porous Copper-Containing Surface Products — are available in Docket Number EPA-HQ-OPP-2020-0529. More information on the interim guidance is available on our blog and in our memorandum.
EPA Releases Updated 2019 TRI Data: On October 27, 2020, EPA released updated 2019 Toxics Release Inventory (TRI) data. EPA states that the data set builds upon the preliminary data released in July 2020, including revised submissions and additional data quality checks, and will be used to develop the 2019 TRI National Analysis. The 2019 data set contains data about chemical releases and other waste management practices and pollution prevention activities that took place during 2019 at more than 21,000 federal and industrial facilities. EPA notes that this data publication includes summary and trend information but does not include its full analysis of the 2019 data. EPA will publish that analysis in early 2021 in the TRI National Analysis, and will examine different aspects of the data, including trends in releases, other waste management practices, and pollution prevention (P2) activities.
EPA Amends Final SNURs For Certain Chemical Substances: On October 27, 2020, EPA amended final SNURs for certain chemical substances that were the subject of PMNs and SNUNs. 85 Fed. Reg. 67996. EPA states that as a result of its review of SNUNs for these chemical substances and based on new and existing data, EPA is amending the identified SNURs to allow certain new uses reported in the SNUNs without additional notification requirements and modify the significant new use notification requirements based on the actions and determinations for the SNUN submissions. The amendments will take effect December 28, 2020.
EPA Issues Annual Progress Report On Pesticide Reregistration Performance Measures And Goals: On October 28, 2020, EPA published a notice in the Federal Register announcing the availability of its progress report in meeting its performance measures and goals for pesticide reregistration during fiscal year (FY) 2018 (2018 Report). 85 Fed. Reg. 68327. Section 4(l) of FIFRA requires EPA to publish information about EPA’s annual achievements in this area. The 2018 Report discusses the completion of tolerance reassessment and describes the status of various regulatory activities associated with reregistration. The 2018 Report also provides the total number of products reregistered and products registered under the “fast-track” provisions of FIFRA. The report is available at EPA-HQ-OPP-2014-0125. Comments can be submitted on or before December 28, 2020. More information is available in our October 30, 2020, blog.
EPA Releases Revised Draft TSCA Risk Evaluation For PV29 For Comment: On October 29, 2020, EPA announced that it is releasing a revised draft risk evaluation for C.I. Pigment Violet 29 (PV29) for public comment and peer review. According to EPA, new data led it to revise its analytical approach for evaluating the potential exposure and health effects of PV29. EPA’s updated analysis, reflected in the revised draft risk evaluation, now shows unreasonable risk to workers for 11 out of 14 conditions of use. EPA published a Federal Register notice on October 30, 2020, beginning a 30-day comment period. 85 Fed. Reg. 68873. During the public comment period, EPA states that it will also conduct a letter peer review of the revised draft risk evaluation using independent scientists, including one who has served as a member and several who have served as ad hoc peer reviewers for the TSCA Science Advisory Committee on Chemicals (SACC). The peer review will focus on charge questions supplied by EPA, and EPA states that “the public is encouraged to focus their comments on those issues as well.” Comments are due November 30, 2020.
EPA Announces The Issuance Of An Advisory On UV Lights That Claim To Kill Or Be Effective Against Viruses And Bacteria: On October 30, 2020, EPA’s Office of Enforcement and Compliance Assurance (OECA) announced that it issued a Compliance Advisory on ultraviolet (UV) lights claiming to kill or be effective against viruses and bacteria. EPA states that the Advisory was issued to provide an explanation to the UV light industry that UV lights are regulated under FIFRA as pesticide devices when sold or distributed with claims to kill or be otherwise effective against viruses and/or bacteria, unless an exception applies, and must comply with certain statutory and regulatory requirements. This is the second Compliance Advisory issued by EPA relating to UV light devices, as an Advisory issued in May 2020 entitled “What You Need to Know Regarding Products Making Claims to Kill the Coronavirus Causing COVID-19” also addressed in part whether UV light devices could make claims against the coronavirus. More information is available in our November 2, 2020, blog.
EPA Announces Improvements To Pesticide Application Exclusion Zone Requirements: On October 30, 2020, EPA issued a final rule on the Agricultural Worker Protection Standard (WPS) regulation that revises the requirements on the pesticide application exclusion zone (AEZ), defined as an “area surrounding the point(s) of pesticide discharge from the application equipment that must generally be free of all persons during pesticide applications.” 85 Fed. Reg. 68760. According to EPA, the targeted changes improve the enforceability and workability of the AEZ requirements, decrease regulatory burdens for farmers, and maintain critical worker protections. EPA also states the revisions made to the AEZ are consistent with the 2018 Pesticide Registration Improvement Extension Act of 2018 (PRIA 4). The final AEZ requirements will go into effect on December 29, 2020. More information is available in our blog.
EPA Requests Comments On Its Proposal To Add Chitosan To Minimum Risk Pesticide Active Ingredient List: On November 2, 2020, EPA published a notice in the Federal Register announcing the proposed rule to add chitosan (Poly-D-Glucosamine) to its list of active ingredients eligible for EPA’s minimum risk pesticide exemption under FIFRA Section 25(b). 85 Fed. Reg. 69307. The proposed rule is in response to a petition submitted to EPA on October 10, 2018, requesting that chitosan be added to the list of active ingredients eligible for EPA’s minimum risk exemption, followed by an April 4 2019, amended petition seeking also to add chitosan to the list of inert ingredients eligible for the minimum risk exemption. Comments on EPA’s proposal to add chitosan to its list of active ingredients for use on minimum risk pesticides are due on or before January 4, 2021, in Docket EPA-HQ-OPP-2019-0701. EPA states that it is currently deferring a decision regarding the amended petition to add chitosan to the list of inert ingredients permitted in minimum risk pesticides. Additional information on chitosan is available here and here.
EPA Announces Environmental Justice Consultations On Risk Management Rulemakings For Methylene Chloride And 1-BP: On November 3, 2020, EPA announced that it will hold webinars to consult with environmental justice communities on risk management for methylene chloride and 1-bromopropane (1-BP). EPA states that the webinars are open to the public and will focus on the environmental justice impacts of EPA’s development of proposed rules to address the unreasonable risks identified in the final TSCA risk evaluations for these chemicals. EPA will hold “identical” consultation webinars on November 16, 2020, and November 19, 2020. According to EPA, both sessions will provide an overview of the TSCA risk management requirements, the findings from the final risk evaluations for methylene chloride and 1-BP, the tools available to manage the unreasonable risks from methylene chloride and 1-BP, and discussion of environmental justice concerns. In addition to being open to the public, EPA is inviting national, local, and NGOs, communities, and other interested stakeholders to participate. EPA states that in addition to environmental justice consultations, it is executing a “robust outreach effort on risk management that includes one-on-one meetings with stakeholders and formal consultations with small businesses, state and local governments, and tribes.” EPA notes that there will also be an open public comment period on proposed risk management regulations.
Final Risk Evaluation For Carbon Tetrachloride Finds Unreasonable Risks To Workers And Occupational Non-Users: On November 4, 2020, EPA published the final risk evaluation for carbon tetrachloride. 85 Fed. Reg. 70147. EPA states that it reviewed 15 conditions of use, “all of which are associated with industrial and commercial work and primarily involve the manufacturing of other chemicals.” EPA found unreasonable risks to workers and occupational non-users (ONU) for 13 of the 15 conditions of use. EPA found no unreasonable risks to the environment. According to EPA, there are no consumer uses of this chemical. For more information on the fourth final risk evaluation, please read the full memorandum.
EPA Announces Proposed Updates To List Of Pests Of Significant Health Importance: On November 4, 2020, EPA published a notice in the Federal Register announcing the release of an updated list of pests of significant health importance for public review and comment. 85 Fed. Reg. 70146. EPA, in coordination with the Centers for Disease Control and Prevention (CDC) and the U.S. Department of Agriculture (USDA), identifies pests of significant public health importance, and in coordination with the Public Health Service, develops and implements programs to improve and facilitate the safe and necessary use of chemical, biological, and other methods to combat and control such pests of public health importance. According to EPA, the list serves as a tool for private and public organizations, including local or state governments, departments of public health, pesticide registrants, and NGOs, when making decisions and plans about future public health actions. EPA states in the notice that the draft Pesticide Registration (PR) Notice 2020-X more precisely describes both the pests and expected public health impacts and adds several new pests (the brown dog tick) and public health impacts (Zika fever and coronaviruses like SARS-CoV-2), and that other pests have been renamed or grouped with similar species or removed altogether (hobo spider). More information is available in our blog. Comments on the draft PR Notice are due on or before January 4, 2021, in Docket EPA-HQ-OPP-2020-0260.
EPA Proposes Revised Crop Groups For Herbs And Spices: On November 6, 2020, EPA published a final rule in the Federal Register that makes several changes to “Crop Group 19: Herbs and Spices Group.” 85 Fed. Reg. 70976. The original proposed rule, which was published on August 27, 2019 (84 Fed. Reg. 44804), was created in response to a petition developed by the International Crop Grouping Consulting Committee (ICGCC) workgroup that was submitted by the Interregional Research Project Number 4 (IR-4). EPA received comments from eight entities and revised the original proposed rule in response to those comments. The major components of the new rule are a revision of the commodity definition for marjoram; the addition of three new commodity definitions for basil, edible flowers, and mint; and replacement of the existing “Crop Group 19: Herbs and Spices Group” with two new expanded crop groups, “Crop Group 25: Herb Group” and “Crop Group 26: Spice Group.” Recognizing that the existing combined Crop Group 19: Herbs and Spices limited the establishment of crop group tolerances, EPA created the two new separate crop groups to benefit herb and spice growers. EPA states that the anticipated economic benefit of the new crop groups is estimated to be a cost savings of $51.8 million annually. The crop groups in the final rule include even more commodities than those listed in the proposal. Crop Group 25 includes 418 herb commodities directly and 25 indirectly through the modification of the definition of edible flowers in 40 C.F.R. Section 180.1. Crop Group 26 includes 205 spice commodities. The final rule specifies all commodities in the new crop groups and the subgroups therein (i.e., 25A and 25B for fresh herbs and dried herbs) and provides updated representative commodities for each crop group and subgroup. The effective date of the final rule is January 5, 2021.
EPA Seeks Participants For Small Business Review Panel On HBCD Risk Management Rulemaking: On November 9, 2020, EPA announced that it is inviting small businesses, governments, and not-for-profits to participate as Small Entity Representatives (SER) to provide advice and recommendations to a Small Business Advocacy Review (SBAR) Panel for the cyclic aliphatic bromide cluster (HBCD). The Panel will focus on EPA’s development of a proposed rule to address unreasonable risks identified in EPA’s recently completed TSCA risk evaluation for HBCD. The SBAR Panel will select SERs to provide comments on behalf of their company, community, or organization and advise the Panel on the potential impacts of the proposed rule on small entities. EPA states that it is seeking self-nominations directly from the small entities that may be subject to the rule’s requirements. EPA notes that other representatives, such as trade associations that exclusively or at least primarily represent potentially regulated small entities, may also serve as SERs. Self-nominations may be submitted online and must be received by November 23, 2020.
COVID-19
OSHA Publishes FAQs Confirming N95 Respirators Protect Against The Coronavirus: On October 19, 2020, the Occupational Safety and Health Administration (OSHA) released a set of frequently asked questions (FAQ) on how N95 respirators effectively protect wearers from coronavirus exposure. OSHA states that it is aware of incorrect claims stating that the N95 respirators filter does not capture particles as small as the virus that causes the coronavirus. OSHA’s new FAQs explain why an N95 respirator is effective at protecting users from the virus.
FDA Podcast: Hand Hygiene During COVID-19: The U.S. Food and Drug Administration (FDA) posted, on November 10, 2020, a recent podcast episode on hygiene that includes guidance for the safe use of hand sanitizers for consumers. The podcast includes details on best practices for hand hygiene and tips for consumers for avoiding potentially dangerous issues with hand sanitizers when conventional methods of washing hands with soap and water are not available.
RCRA/CERCLA/CWA/CAA/PHMSA/SDWA
EPA Publishes Final Integrated Science Assessment For Oxides Of Nitrogen, Oxides Of Sulfur, And Particulate Matter — Ecological Criteria: On October 19, 2020, EPA announced the availability of a document entitled Integrated Science Assessment for Oxides of Nitrogen, Oxides of Sulfur, and Particulate Matter — Ecological Criteria (Final) (EPA/600/R-20/278). 85 Fed. Reg. 66327. The document was prepared as part of the review of the secondary (welfare-based) national ambient air quality standards (NAAQS) for oxides of nitrogen, oxides of sulfur, and particulate matter. According to EPA, the Integrated Science Assessment (ISA) represents an update of the 2008 Integrated Science Assessment for Oxides of Nitrogen and Sulfur — Ecological Criteria (EPA/600/R-08/082F) and the 2009 Integrated Science Assessment for Particulate Matter (EPA/600/AR-08/139F). EPA states that the ISA, in conjunction with additional technical and policy assessments, provides the basis for EPA’s decisions on the adequacy of the current NAAQS and the appropriateness of possible alternative standards.
EPA Intends Final Rule To Improve And Clarify NSR Permitting Process: On October 22, 2020, EPA announced that it is releasing a final rule that will clarify the process for evaluating whether a New Source Review (NSR) preconstruction permit is needed when an existing major-emitting facility plans to make changes to its facility. In a March 2018 memorandum, the EPA Administrator explained that EPA interprets current NSR regulations to allow emissions decreases as well as increases from a project to be considered at Step 1 of the NSR applicability process. EPA states that it expects that allowing project emissions accounting will reduce regulatory burden — saving time and money without sacrificing environmental protection. According to EPA, where a review of both the emissions increases and the emissions decreases associated with a proposed project indicates that the project will not result in a significant emissions increase, the review would end the applicability evaluation. In general, the project could then proceed under a minor source permit as applicable. EPA notes that state and local air agencies that implement the NSR program through EPA-approved State Implementation Plans (SIP) need not allow for project emissions accounting nor are they required to submit SIP revisions or stringency determinations to EPA as a result of this action. A pre-publication version of the final rule is available online. The rule will be effective 30 days after publication in the Federal Register.
EPA Postpones Compliance Deadlines For Phase 2 Of NPDES eRule: On November 2, 2020, EPA published a final rule that postpones the compliance deadlines for implementation of Phase 2 of the National Pollutant Discharge Elimination System (NPDES) Electronic Reporting Rule (NPDES eRule). 85 Fed. Reg. 69189. The NPDES eRule requires EPA and states to modernize Clean Water Act (CWA) reporting. The November 2, 2020, final rule provides states with additional flexibility to request additional time as needed, promulgates clarifying changes to the NPDES eRule, and eliminates some duplicative or outdated reporting requirements. The final rule will be effective January 4, 2021. The start dates for electronic reporting are provided in 40 C.F.R. Section 127.16.
EPA Amends NESHAP For Phosphoric Acid Manufacturing Source Category: On November 3, 2020, EPA published a final rule that amends the national emission standards for hazardous air pollutants (NESHAP) for the Phosphoric Acid Manufacturing source category. 85 Fed. Reg. 69508. EPA states that the final amendment is in response to a petition for rulemaking on the mercury emission limit for existing phosphate rock calciners that was issued on August 19, 2015. EPA based the emission limit on the maximum achievable control technology (MACT) floor for existing sources. According to EPA, all six of the existing calciners used to set this MACT floor are located at the PCS Phosphate Company, Inc. (PCS Phosphate) facility in Aurora, North Carolina. PCS Phosphate asserted that data received since the rule’s promulgation indicate that the MACT floor did not accurately reflect the average emission limitation achieved by the units used to set the standard. EPA states that based on these new data, it is revising the mercury MACT floor for existing calciners. The final rule was effective on November 3, 2020.
EPA Amends NESHAP For Chemical Recovery Combustion Sources At Kraft, Soda, Sulfite, And Stand-Alone Semichemical Pulp Mills, And NSPS For Kraft Pulp Mills: On November 5, 2020, EPA published a final rule that amends the NESHAP for Chemical Recovery Combustion Sources at Kraft, Soda, Sulfite, and Stand-alone Semichemical Pulp Mills, and the New Source Performance Standards (NSPS) for Kraft Pulp Mills constructed, reconstructed, or modified after May 23, 2013. 85 Fed. Reg. 70487. The final rule clarifies how to set operating limits for smelt dissolving tank scrubbers used at these mills and corrects cross-reference errors in both rules. The final rule was effective on November 5, 2020.
EPA Proposes Revisions To NESHAP For PVC Production: On November 9, 2020, EPA published a proposed rule that would revise the emission limits in the 2012 NESHAP for Polyvinyl Chloride and Copolymers (PVC) Production major source rule for process vents and process wastewater. 85 Fed. Reg. 71490. EPA states that although it is not proposing revisions to the emission limits in the 2012 area source rule, it is proposing other amendments that affect both rules, including technical corrections and clarifications related to the standards for stripped resin, storage vessels (including the use of vapor balancing), equipment leaks, and closed vent systems. EPA is also proposing to clarify text and correct typographical errors, grammatical errors, and cross-reference errors in both rules. In addition, EPA is proposing to remove the affirmative defense provisions. If requested, EPA will hold a virtual hearing on November 24, 2020. Comments are due January 8, 2021.
EPA Releases 2019 GHG Data: On November 9, 2020, EPA released 2019 greenhouse gas (GHG) data collected under the GHG Gas Reporting Program. EPA states that the data show that between 2018 and 2019, total reported GHG emissions from large facilities fell nearly five percent. According to EPA, these most recent data are consistent with the decade-long trend in which total reported GHG emissions from large facilities decreased by more than 14 percent from 2011 to 2019. With respect to power plant emissions specifically, GHG emissions from this sector decreased by 25 percent between 2011 and 2019.
EPA Issues Final Procedures For Alternate Liner Demonstrations, Allows For More Site-Specific Management Of Coal Ash: On November 12, 2020, EPA published the final alternate liner demonstration procedures for unlined surface impoundments of coal combustion residuals (CCR), commonly known as coal ash. 85 Fed. Reg. 72506. The final rule includes a two-step process to allow coal-fired facilities to demonstrate to EPA or a Participating State Director that, based on ongoing groundwater monitoring data, the impoundment has had no negative impact on groundwater. Additionally, facilities must demonstrate that the design of a particular surface impoundment unit will continue to have no reasonable probability of adverse effects to human health and the environment. The final rule will be effective on December 14, 2020.
FDA
FDA Draft Guidance For Disclosing Sesame As An Allergen: FDA, on November 12, 2020, announced the availability of a draft guidance document titled “Voluntary Disclosure of Sesame as an Allergen,” which includes FDA’s views on sesame as an allergen and recommendations regarding voluntary disclosure (e.g., labelling) for use scenarios where disclosure is not mandatory. 85 Fed. Reg. 71920. The guidance, when final, would recommend “that manufacturers voluntarily declare sesame in the ingredient list when it is used in foods as a “flavor” or “spice” in a parenthetical following the spice or flavor, such as, “spice (sesame),” “spices (including sesame),” “flavor (sesame),” or “flavors (including sesame).”” Comments on the draft guidance are due January 11, 2021.
FDA Pilot Program For Third-Party Food Safety Standards: FDA has requested that members of the public, particularly owners of third-party human food safety standards, consider participating in a voluntary pilot program for evaluating third-party food safety standards. 85 Fed. Reg. 67744. FDA, under the pilot program, will assess third-party food safety standards for alignment with certain food safety regulations. Written and electronic requests to participate in the program must be submitted by November 25, 2020.
NANOTECHNOLOGY
TURI Calls For Information On Carbon Nanotubes And Carbon Nanofibers: According to the Toxics Use Reduction Institute’s (TURI) website, the Toxics Use Reduction Act (TURA) Program in Massachusetts has received a petition to list carbon nanotubes (both single-walled and multi-walled) and carbon nanofibers. The TURA Science Advisory Board (SAB) is beginning the process of reviewing these substances and seeks additional information from stakeholders. More information is available in our October 28, 2020, blog item.
NNI Publishes Supplement To President’s 2021 Budget Request: On October 27, 2020, the U.S. National Nanotechnology Initiative (NNI) published the National Nanotechnology Initiative Supplement to the President’s 2021 Budget (Supplement), which serves as the annual report for NNI, called for under the provisions of the 21st Century Nanotechnology Research and Development Act. According to the Supplement, the President’s 2021 budget requests more than $1.7 billion for NNI, with an increased investment in the foundational research intended to lead to discoveries that will advance a wide range of areas. More information is available in our October 27, 2020, blog item.
NNI Strategic Planning Stakeholder Workshop Will Be Held In January 2021: NNI will hold a virtual stakeholder workshop January 11-13, 2021. As NNI enters its third decade, conversations at the January 2021 workshop will identify effective mechanisms to advance research and development, strategies for communication, and priority topics to shape future directions. The workshop will take place virtually, and registration information will be available soon.
EC Requests Scientific Opinion On UV-Filter HAA299 (Nano): On November 2, 2020, the European Commission (EC) requested a scientific opinion from the Scientific Committee on Consumer Safety (SCCS) on the UV filter HAA299 (nano) (chemical name “2-(4-(2-(4-Diethylamino-2 hydroxy-benzoyl)-benzoyl)-piperazine-1-carbonyl)-phenyl)-(4-diethylamino-2-hydroxyphenyl)-methanone”). According to the EC’s request, the applicant seeks to assess the safety of HAA299 (nano) for use as a UV filter up to a maximum concentration of ten percent. The deadline for the scientific opinion is nine months.
EC Committee Preliminary Opinions On Hydroxyapatite (Nano) And Copper (Nano) And Colloidal Copper (Nano) Available For Comment: On November 9, 2020, SCCS published two draft opinions for public comment. In the preliminary opinion on hydroxyapatite (nano), SCCS considered whether the nanomaterial hydroxyapatite is safe when used in leave-on and rinse-off dermal and oral cosmetic products according to the reported maximum concentrations and specifications, taking into account reasonably foreseeable exposure conditions. In the preliminary opinion for copper (nano) and colloidal copper (nano), SCCS states that it is unable to carry out a safety assessment of the nanomaterials copper and colloidal copper when used in leave-on and rinse-off dermal and oral cosmetic products, including skin, nail and cuticle, hair and scalp, and oral hygiene products, at a maximum concentration of one percent. Comments on both preliminary opinions are due January 4, 2021. More information is available in our November 10, 2020, blog item.
BIOBASED/RENEWABLE PRODUCTS
BRAG Biobased Products News And Policy Report: B&C consulting affiliate, B&C® Consortia Management, L.L.C. (BCCM), manages the Biobased and Renewable Products Advocacy Group (BRAG®). For access to a summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to http://www.braginfo.org.
LEGISLATIVE
House Bill Intends To Address Ocean Impacts Of Climate Change: On October 20, 2020, Representative Raúl M. Grijalva (D-AZ), Chair of the House Natural Resources Committee, introduced the Ocean-Based Climate Solutions Act with his co-lead, House Select Committee on the Climate Crisis Chair Kathy Castor (D-FL), original cosponsors, and a range of bill endorsers. The legislation is intended to reduce GHG emissions; increase carbon storage in blue carbon ecosystems; promote coastal resiliency and adaptation; improve ocean protection; support climate-ready fisheries; tackle ocean health challenges; and restore U.S. leadership in international ocean governance.
Zero-Emission Vehicles Act Would Create Federal Zero-Emissions Vehicle Standard: On October 20, 2020, Representative Mike Levin (D-CA) announced that he introduced the Zero-Emission Vehicles (ZEV) Act of 2020 (H.R. 8635, S. 4823) with Representative Joe Neguse (D-CO) and Senator Jeff Merkley (D-OR). According to Levin, the bill would position the United States to lead the world in vehicle innovation, combat the climate crisis, and reduce premature deaths caused by the pollution that gasoline engines produce. Levin’s press release states that legislation would replace a patchwork of state-level policies by establishing a federal ZEV standard intended to boost the market for battery electric vehicles and hydrogen fuel cell vehicles. The standard would require that by 2025, 50 percent of sales for new passenger vehicles are ZEVs, and ramp up five percent each year to 100 percent by 2035. The ZEV standard would be applied only to the sale of new cars.
Senate Bill Intended To Improve Soil Health, Crop Resilience And Address The Climate Crisis: On October 23, 2020, Senator Ron Wyden (D-OR) introduced the Healthy Soils Healthy Climate Act of 2020 (S. 4850). According to Wyden’s press release, the bill builds on a 2018 Farm Bill provision authored by Wyden by creating a permanent soil health program through the Environmental Quality Incentives Program (EQIP) at USDA. The program would provide $100 million to producers who adopt practices designed to improve soil health through increasing carbon levels in soil. The press release states that by promoting farming practices that capture carbon in soil, producers will improve soil health and crop resilience, while lowering the amount of carbon in the atmosphere.
UNSHACKLE Act Would Reform NEPA: On October 26, 2020, Senator Mike Lee (R-UT) announced the introduction of the Undoing NEPA’s Substantial Harm by Advancing Concepts that Kickstart the Liberation of the Economy (UNSHACKLE) Act (S.4862). The legislation would comprehensively reform the National Environmental Policy Act (NEPA). According to Lee, NEPA “has become a weapon used by special interests to make much-needed infrastructure and maintenance projects throughout our country prohibitively expensive.” The legislation is intended to reform the NEPA process so that federal agencies and state and local governments “are better empowered to carry out NEPA’s original process while also making our nation’s infrastructure and maintenance project affordable again.” The UNSHACKLE Act combines five other previously introduced NEPA reform acts into one bill. Those other bills are: the NEPA Data Transparency and Accountability Act (S. 4625); the NEPA State Assignment Expansion Act (S. 4312); the NEPA Agency Process Accountability Act (S. 4590); the NEPA Accountability and Enforcement Act (S. 4619); and the NEPA Legal Reform Act (S. 4829).
House Energy And Commerce Committee Releases Report Detailing Trump Administration Environmental Rollbacks: On October 28, 2020, the House Energy and Commerce Committee released a staff report “on the Trump Administration’s four-year assault on environmental and public health protections.” The report examines some of the Trump EPA’s “most egregious and dangerous rollbacks” in five areas — climate change, scientific integrity, environmental justice, clean air, and clean water — and highlights the impacts these rollbacks could have on public health. The report also underscores some of the Committee’s efforts to hold the Trump Administration accountable for these actions.
President Signs ACE Act: On October 30, 2020, President Trump signed America’s Conservation Enhancement (ACE) Act (S. 3051), a bipartisan bill that is intended to help conserve wildlife and wildlife habitat, including by reauthorizing the North American Wetlands Conservation Act and the National Fish and Wildlife Foundation Establishment Act. The ACE Act also addresses the threats of emerging wildlife diseases like Chronic Wasting Disease, protects livestock from predators, and combats invasive species. The bill received support from a broad group of stakeholders.
Senate Committee Releases 12 FY 2021 Appropriations Bills: On November 10, 2020, the Senate Committee on Appropriations released all twelve of its FY 2021 funding measures and the FY 2021 Subcommittee allocations. The bill text and explanatory statements released are funding measures for the Appropriations Subcommittees on Agriculture, Rural Development, FDA, and Related Agencies; Commerce, Justice, Science, and Related Agencies; Defense; Energy and Water Development; Financial Services and General Government; Homeland Security; Interior, Environment, and Related Agencies; Labor, Health and Human Services, Education, and Related Agencies; Legislative Branch; Military Construction, Veterans Affairs, and Related Agencies; State, Foreign Operations, and Related Programs; and Transportation, Housing and Urban Development, and Related Agencies. The bill for Interior, Environment, and Related Agencies would provide $9.085 billion for EPA, including $64.5 million for EPA to continue to take action on PFAS, including addressing contamination, conducting research, and undertaking needed regulatory actions. The bill includes language that will enable EPA to collect and spend fees to conduct additional chemical reviews, consistent with the Lautenberg Act. According to the explanatory statement, those fees are expected to be $27 million per year once the program is fully implemented. The Congressional Budget Office estimates that in FY 2021, fee collections will total $5 million. The explanatory statement notes that the appropriations bill includes language intended to ensure that the new fee collections supplement, not supplant, appropriated resources for these activities. The explanatory statement also directs the EPA Administrator to involve FDA in research regarding the environment, health, and safety of nanomaterials (nanoEHS), including participation in EPA-funded research.
MISCELLANEOUS
Final Rule Intended To Promote Transparency In Developing EPA Regulatory Guidance Documents Will Take Effect In November: On October 19, 2020, EPA published a final rule establishing the procedures and requirements for how EPA will manage the issuance of guidance documents consistent with Executive Order (EO) 13891, “Promoting the Rule of Law Through Improved Agency Guidance Documents.” 85 Fed. Reg. 66230. The final regulation provides a definition of guidance document for the purposes of this rule, establishes general requirements and procedures for certain guidance documents issued by EPA, and incorporates additional requirements for guidance documents determined to be significant guidance. EPA notes that the regulation, consistent with the EO, also provides procedures for the public to petition for the modification or withdrawal of active guidance documents as defined by the rule or to petition for the reinstatement of a rescinded guidance document. EPA states that the regulation is intended to increase the transparency of its guidance practices and improve the process used to manage its guidance documents. The final rule will be effective November 18, 2020. More information is available in our October 21, 2020, memorandum.
Final Rule Applies Scientific Integrity Requirements To EPA Contractors: On October 19, 2020, EPA issued a final rule to address scientific integrity requirements in the creation of a contract clause for inclusion in solicitations and contracts when the Contractor may be required to perform, communicate, or supervise scientific activities or use scientific information to perform advisory and assistance services. 85 Fed. Reg. 66266. EPA states that this clause will complement its Scientific Integrity Policy “to ensure all scientific work developed and used by the Government is accomplished with scientific integrity.” The final rule was effective on October 19, 2020.
EPA Administrator Releases Federal Strategy For Addressing Global Marine Litter: On October 19, 2020, EPA announced that EPA’s Administrator Andrew Wheeler released the United States Federal Strategy for Addressing the Global Issue of Marine Litter. According to EPA, the strategy highlights the federal government’s four pillars for tackling the issue of marine litter: building capacity; incentivizing the global recycling market; promoting research and development; and promoting marine litter removal. It also identifies existing U.S. legal authorities and federal programs already underway, such as EPA’s Trash Free Waters program.
OSHA Will Hold Public Meeting In Advance Of Session Of UN Subcommittee Of Experts On GHS: On October 22, 2020, OSHA announced that it will conduct a virtual meeting on November 19, 2020, in advance of the official 39th session of the United Nations (UN) Subcommittee of Experts on the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) to be held December 9-11, 2020, in Geneva, Switzerland. 85 Fed. Reg. 67378. According to the notice, OSHA, along with the U.S. Interagency GHS Coordinating Group, plans to consider the comments and information gathered at this public meeting when developing the U.S. government positions for the UN meeting.
Tongass National Forest Exempted From Roadless Area Conservation Rule: On October 29, 2020, USDA published a final rule exempting the Tongass National Forest from the 2001 Roadless Area Conservation Rule (2001 Roadless Rule), which prohibits timber harvest and road construction/reconstruction with limited exceptions within designated inventoried roadless areas. 85 Fed. Reg. 68688. In addition, the rule directs an administrative change to the timber suitability of lands deemed unsuitable, solely due to the application of the 2001 Roadless Rule, in the 2016 Tongass National Forest Land and Resource Management Plan, Appendix A. The rule does not authorize any ground-disturbing activities, nor does it increase the overall amount of timber harvested from the Tongass National Forest. The rule was effective October 29, 2020.
Trump Issues Memorandum Directing Administration To Assess Effects Of Bans On Fracking: On October 31, 2020, President Trump issued a memorandum on “Protecting Jobs, Economic Opportunities, and National Security for All Americans by Ensuring Appropriate Support of Innovative Technologies for Using Our Domestic Natural Resources.” According to the fact sheet on the memorandum, Trump is “fighting misguided attacks on hydraulic fracturing (“fracking”) and other innovative energy and natural-resources technologies.” Due to public calls to ban or restrict such technologies, Trump has directed his Administration to assess the potential effects of such bans or restrictions on American citizens. The fact sheet states that the Administration will assess the potential consequences of fracking bans, such as job losses, on Americans who are directly or indirectly benefiting from the energy industry and other industries, including mining for sand and other minerals.
EPA Signs MOU With Innovation Center For U.S. Dairy To Advance Engagement With Agriculture Community: On November 9, 2020, EPA announced that EPA Administrator Andrew Wheeler signed a first-time Memorandum of Understanding (MOU) with the Innovation Center for U.S. Dairy (Innovation Center) that is intended to support better environmental outcomes. According to EPA, the MOU “signals a commitment to collaborate and coordinate in areas of mutual interest related to environmental stewardship in the dairy industry.” Highlights in the MOU include:
- Outreach and education tied to dairy community access to technical, financial, and educational support related to adoption of environmentally beneficial practices and technologies across farms of all sizes, regions, and designs;
- Contribution of EPA expert input and feedback on Innovation Center initiatives to help advance environmental stewardship; and
- EPA membership in the Innovation Center’s Dairy Sustainability Alliance.
EPA Accepting Comment On IRIS Handbook, Draft Charge Questions For Reviewers: On November 10, 2020, EPA announced that the Integrated Risk Information System (IRIS) Program released the ORD Staff Handbook for Developing IRIS Assessments (IRIS Handbook) for public comment. EPA states that the IRIS Handbook provides operating procedures for developing IRIS assessments, including problem formulation approaches and methods for conducting systematic review, dose response analysis, and developing toxicity values. The IRIS Handbook notes that it does not supersede existing EPA guidance and does not serve as guidance for other EPA programs. EPA will publish a Federal Register notice announcing the beginning of a 90-day public comment period on the IRIS Handbook and on the draft charge questions for reviewers in advance of a National Academies of Sciences, Engineering, and Medicine (NASEM) peer review. EPA will summarize comments received and provide them to the committee conducting the peer review. EPA has posted a pre-publication version of the Federal Register notice.
EPA Nears Full Implementation Of Lean Management System: On November 10, 2020, EPA announced that it has implemented the EPA Lean Management System (ELMS) to 83 percent of the Agency across the U.S. EPA states that ELMS is an Agency-wide systematic approach to continuous process improvement, based on lean principles used for years by the private sector. ELMS is comprised of six components: visual management; standard process; cascading performance measures; problem solving; business reviews and huddles; and leader behaviors. According to EPA, some of the most notable process improvements include reducing the backlog of Freedom of Information Act (FOIA) requests by almost 45 percent, increasing the number of inspection reports that are completed on-time and communicated to the regulated entity from around 49 percent to 82 percent, and reducing the number of backlogged new permit applications by almost 150.