Federal Development Update for October 2020


Lynn L. Bergeson To Present During The Agricultural Law Section Of IBA 2020’s Virtual Conference: The International Bar Association’s (IBA) 2020 Virtually Together conference, occurring November 2-27, 2020, provides an exciting new way to bring the IBA and the world’s legal community together. Lynn L. Bergeson, Managing Partner at Bergeson & Campbell, P.C. (B&C®), and Vice Chair of the IBA’s Agricultural Law Section, will present during, “Opting out of climate unfriendly food? Consumer action or regulatory restrictions?,” on November 5, 2020.

Register Now For Four-Part “TSCA Fundamentals” Course: B&C is pleased to join Chemical Watch to provide in-depth training on the very latest Toxic Substances Control Act (TSCA) regulatory and policy developments, their impact, and how to anticipate their requirements. Staying on top of TSCA changes is critically important, and training on current regulatory requirements is vital for a company to comply with the law and remain commercially competitive. Lynn L. Bergeson, Managing Partner; Richard E. Engler, Ph.D., Director of Chemistry; and Kathleen M. Roberts, Senior Regulatory Consultant, will teach the courses over four two-hour live virtual training sessions on October 19, 21, 26, and 29, 2020. Register now!

CDR Cross-CheckTM: As you gather your company’s information for Chemical Data Reporting (CDR), let The Acta Group (Acta®) assist with the search of the TSCA Inventory and particular TSCA actions. CDR Cross-Check is a low-cost, straightforward way to have Acta search Chemical Abstracts Service (CAS) Registry Numbers (RN) and TSCA Accession Numbers and provide the output that you need to know whether a particular TSCA action changes a reporting exemption or the reporting threshold.

You do not have to be a current Acta client, simply go to https://cdr-cross-check.actagroup.com/, follow the instructions to upload your list of CAS RNs, and pay the search fee.

You have enough to worry about in CDR reporting, let Acta help with the database searching!

TSCA/FIFRA/TRI

EPA States TSCA Section 21 Petition For Risk Management Rule Not Valid, Treats It As An APA Petition: In a letter dated July 28, 2020, the U.S. Environmental Protection Agency (EPA) acknowledged the receipt of a TSCA Section 21 petition requesting EPA to “initiate a proceeding for the issuance of a risk management procedural rule under TSCA section 6” submitted on behalf of the National Association of Manufacturers, the American Coatings Association, the National Association of Home Builders, the Toy Association, and the U.S. Chamber of Commerce. In the acknowledgement letter, EPA states that the request is not a valid petition under TSCA Section 21. EPA goes on to state “[u‌]nder TSCA section 21, as it relates to TSCA section 6, any person may petition EPA to initiate a proceeding for the issuance, amendment, or repeal of a rule under TSCA section 6 imposing chemical-specific regulatory controls for setting forth facts showing such action is ‘necessary’” and that “Section 21 does not provide a means for petitioning EPA to initiate a procedural rule.” The acknowledgement letter further states that “EPA will, however, consider your request as a petition under the Administrative Procedure Act (APA) for the issuance of a procedural rule” and that the “petition is under review by the Office of Pollution Prevention and Toxics (OPPT), which is responsible for programs under TSCA.” More information is available in our October 1, 2020, blog item.

EPA Seeks Participants For Small Business Advocacy Review Panels On Methylene Chloride And 1-BP Risk Management Rulemakings: On September 16, 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 two Small Business Advocacy Review (SBAR) Panels. There will be one Panel for methylene chloride and one Panel for 1-bromopropane (1-BP). According to EPA, each Panel will focus on EPA’s development of proposed rules to address unreasonable risks identified in EPA’s recently completed TSCA risk evaluations for these chemicals. The SBAR Panels will include federal representatives from the Small Business Administration (SBA), the Office of Management and Budget (OMB), and EPA. The SBAR Panels 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. Self-nominations were due September 30, 2020.

EPA Issues Final SNURs For Certain Chemical Substances: On September 17, 2020, EPA published final significant new use rules (SNUR) for certain chemical substances that were the subject of premanufacture notices (PMN) and are subject to Orders issued by EPA pursuant to TSCA. 85 Fed. Reg. 57968. The final SNURs require persons to notify EPA at least 90 days before commencing manufacture (defined by statute to include import) or processing of any of these chemical substances for an activity that is designated as a significant new use. The required notification initiates EPA’s evaluation of the chemical under the conditions of use 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 as a result of that determination. The SNURs will be effective on November 16, 2020.

EPA Publishes Final Risk Evaluation For HBCD: On September 24, 2020, EPA published the final risk evaluation for cyclic aliphatic bromide cluster (HBCD). EPA found unreasonable risks to the environment from six out of 12 conditions of use and unreasonable risks to workers and occupational non-users (ONU) from the processing, use, and disposal of HBCD, largely from building and construction materials. EPA’s website states “EPA did not find unreasonable risks to the general population or consumers.” Nevertheless, in the risk evaluation document, EPA did find unreasonable risk from fish ingestion at the high-end exposure in one scenario. The unreasonable risk determinations in HBCD’s final risk evaluation represent a substantial change in response to public comments and peer review compared to the draft assessment in which EPA did not make unreasonable risk findings to health or the environment for any of the conditions of use evaluated. EPA’s next step in the process required by TSCA is to develop a plan to reduce or eliminate the unreasonable risks found in the final risk evaluation. For B&C’s commentary, please read the full memorandum.

EPA OIG Finds TSCA Service Fee Fund Financial Statements To Be “Fairly Presented And Free Of Material Misstatement”: On September 30, 2020, EPA’s Office of Inspector General (OIG) published its audit of EPA’s TSCA Service Fee Fund financial statements for the period from Inception (June 22, 2016) through September 30, 2018. OIG states that its primary objectives were to determine whether the financial statements were fairly stated in all material respects; EPA’s internal controls over financial reporting were in place; and EPA management complied with laws and regulations. According to OIG, EPA overstated expenses from other appropriations by $8.4 million. OIG states it found that EPA made errors in multiple iterations of its calculation for expenses from other appropriations. OIG recommends that the chief financial officer: (1) improve the management review process for calculating expenses from other appropriations to be consistent with EPA component financial statement audits and to ensure that costs support the TSCA Service Fee Fund activities; and (2) establish written policies and procedures so that expenses from other appropriations in component audits reflect actual costs. According to OIG, EPA concurred with its recommendations and provided “acceptable corrective actions and estimated completion dates.” OIG states that it considers the recommendations resolved with corrective actions pending.

EPA Holds Webinar On Proposed Nomination Form To Add New Approach Methodologies (NAM) To TSCA Section 4(h)(2)(C): On September 30, 2020, EPA held a webinar on “Identification of NAMs for Placement on the TSCA Section 4(h)(2)(C) List: A Proposed NAM Nomination Form.” The Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) amended TSCA Section 4(h)(2)(C) to require EPA to develop a list of alternative test methods or strategies that are “scientifically reliable, relevant, and capable of providing information of equivalent or better scientific reliability and quality to that which would be obtained from vertebrate animal testing.” The current TSCA Section 4(h)(2)(C) List is available on the EPA website. More information is available in our September 23, 2020, blog item.

EPA Accepting Public Comments For Candidates Under Consideration For TSCA SACC Membership: EPA is accepting public comments for all candidates under consideration for membership on the TSCA Science Advisory Committee on Chemicals (SACC). Biographies for all candidates are available in Docket ID EPA-HQ-OPPT-2020-0135. When providing comments, EPA states that stakeholders should not submit electronically any information considered to be confidential business information (CBI) or other information whose disclosure is restricted by statute. Comments are due October 30, 2020. EPA will use public comments to assist in selecting multiple members of the SACC over the next year.

EPA Grants Manufacturer Request For Risk Evaluation Of D4: EPA granted on October 6, 2020, a manufacturer request for a risk evaluation of octamethylcyclotetra-siloxane (D4), a chemical used to make other silicone chemicals and as an ingredient in some personal care products. Through the American Chemistry Council’s Silicones Environmental, Health, and Safety Center, Dow Silicones Corporation, Elkem Silicones USA Corporation, Evonik Corporation, Momentive Performance Materials, Shin-Etsu Silicones of America, Inc., and Wacker Chemical Corporation requested a risk evaluation of D4 pursuant to TSCA Section 6. More information is available in our October 7, 2020, blog item.

EPA Announces Guidance To Waive Toxicity Tests On Animal Skin: On October 7, 2020, EPA announced that it is requesting comments on its draft guidance that would allow registrants, in certain circumstances, to forgo testing chemicals on animal skin to determine whether a pesticide would lead to adverse effects. This new draft guidance is part of EPA’s continued efforts to reduce animal testing and achieve its goal of eliminating all EPA requests for studies and EPA funding of studies on mammals by 2035. Comments on the draft guidance are due on or before November 9, 2020, and can be submitted at http://www.regulations.gov under Docket ID No. EPA-HQ-OPP-2016-0093. EPA also announced the launch of its new web page that provides metrics and strategies for reducing and replacing animal testing, including links and resources to all pertinent guidance and work plans tied to the larger Toxicology in the 21st Century Initiative across the federal government. The directive, issued by EPA Administrator Andrew Wheeler in September 2019, calls for EPA to reduce animal testing and to reduce funding 30 percent by 2025 and eliminate it by 2035. Finally, EPA will host its Second Annual Conference on the State of Science on Development and Use of NAMs for Chemical Safety Testing virtually on October 19 and 20, 2020. Additional information on EPA’s efforts to reduce animal testing is available in our blog and on EPA’s website.

EPA Proposes SNURs For Certain Chemical Substances: On October 9, 2020, EPA proposed SNURs under TSCA for chemical substances that are the subject of PMNs. 85 Fed. Reg. 64280. This action would require persons to notify EPA at least 90 days before commencing manufacture (defined by statute to include import) or processing of any of these chemical substances for an activity that is designated as a significant new use by this proposed rule. This action 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, and has taken any risk management actions as are required as a result of that determination. Comments are due November 9, 2020.

Jeffery Morris, Former OPPT Director, Examines TSCA As A Gap-Filling Statute: On October 13, 2020, we published an article by Jeffery Morris, former Director of EPA’s OPPT, entitled “TSCA as a Gap-Filling Statute: Potentially Exposed and Susceptible Subpopulations.” The article is available in our October 13, 2020, blog item.

COVID-19

FDA Hosts Webinar Series: The U.S. Food and Drug Administration (FDA), along with the Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH) and the Occupational Safety and Health Administration (OSHA), announced on September 29, 2020, that they would host a one-hour webinar entitled “Respirators and Other Personal Protective Equipment (PPE) for Health Care and Personnel Use during the COVID-19 Pandemic.” This is part of an ongoing series of webinars FDA has been hosting every two weeks to share information and address questions. The last webinar was held on October 13, 2020. Previous webinars are available here.

OSHA Publishes FAQs About Reporting Work-Related Cases Of Coronavirus: On September 30, 2020, OSHA announced that it published additional frequently asked questions (FAQ) regarding the need to report employees’ in-patient hospitalizations and fatalities resulting from work-related cases of the coronavirus. According to OSHA, the new FAQs provide information to help employers apply the agency’s existing injury and illness recording and reporting requirements to the coronavirus. In particular, the FAQs provide guidance on how to calculate reporting deadlines for in-patient hospitalizations and fatalities, and clarify the meaning of the term “incident” as it relates to work-related coronavirus in-patient hospitalizations and fatalities.

EPA Announces Expedited Pathway For Companies To Claim “Long-Lasting” Efficacy For Antiviral Products: On October 14, 2020, EPA released a much-anticipated draft guidance that will allow companies to demonstrate that their products have “long-lasting” or “residual” effectiveness on surfaces against viruses like SARS-CoV-2, the coronavirus that causes COVID-19. As most know, EPA has not before now provided guidance on how stakeholders can demonstrate to EPA’s satisfaction that their product remains efficacious for periods of time, given the broad diversity of contact opportunities and scenarios. Importantly, EPA states that pursuant to Title VII of the Coronavirus Aid, Relief, and Economic Security (CARES) Act, it is providing notice of its intention to expedite reviews for addition of residual (i.e., extended or long-lasting) efficacy claims for currently registered or new product registrations that are on EPA’s Disinfectant List N, that would qualify for List N, or products that can be used as a residual supplement to disinfectants on List N. The guidance specifies scientific testing requirements for two different types of products, supplemental residual antimicrobial products and residual disinfectants. According to EPA, supplemental residual antimicrobial products work within two hours of a virus or bacteria coming into contact with a surface and can remain effective for weeks to years. EPA notes that these products can supplement, but do not replace, routine cleaning and disinfection using products from EPA’s List N: Disinfectants for Use Against SARS-CoV-2 (COVID-19). Approved supplemental residual antimicrobial products are not eligible for inclusion on List N, but EPA will add them to a separate List N appendix. In addition to releasing the draft residual efficacy protocols, EPA has also released an updated draft testing protocol for evaluating a copper surface’s ability to kill bacteria and a draft protocol for evaluating the efficacy of antimicrobial surface coatings. According to EPA, “[t]hese laboratory testing methods act as a foundation for EPA’s interim guidance to registrants regarding residual effectiveness.”

RCRA/CERCLA/CWA/CAA/PHMSA/SDWA

EPA Announces $5 Million In Community-Scale Air Toxics Monitoring Grant Winners: On September 28, 2020, EPA announced the selection of 11 air toxics monitoring projects to receive $5 million in funding under the Community-Scale Air Toxics Ambient Monitoring grants program. According to EPA, the grants will help monitor and provide important information to communities on air toxics, including ethylene oxide, chloroprene, benzene, 1,3-butadiene, and toxic metals. The 11 state and local agencies selected to receive grants will conduct projects in characterizing the impacts of air toxics in a community (community-scale monitoring); assessing the impacts of air toxics emissions from specific sources (near-source monitoring); and evaluating new and emerging testing methods for air toxics. Once all legal and administrative requirements are satisfied by the grantees, EPA states that it anticipates providing selected agencies funding for their work in fiscal years (FY) 2021 and 2022.

EPA Releases Final Rule Allowing Major Source Of HAPs To Reclassify As Area Source After Acting To Limit Emissions: On October 1, 2020, EPA released a final rule that will “implement the clear language of the Clean Air Act that allows a ‘major source’ of hazardous air pollutants (HAP) to reclassify as an ‘area source’ at any time after acting to limit emissions.” According to EPA, the final rule will encourage facilities to pursue innovations in pollution-reduction technologies and relieve regulatory requirements intended for much larger emitters. EPA states that the “once in, always in” policy discouraged facilities from modernizing and implementing voluntary pollution abatement and prevention efforts. States and stakeholders voiced concern that the “once in, always in” policy discouraged voluntary pollution abatement and prevention efforts. By removing unnecessary monitoring, recordkeeping, and reporting associated with being a major source, EPA states that the final rule will relieve unnecessary compliance and financial burdens from regulated entities and encourage other sources to reduce emissions. EPA notes that emissions requirements will not change for existing major sources that choose not to reclassify. Sources that choose to reclassify will be subject to any applicable “area source” requirements. The final rule will be effective 60 days after publication in the Federal Register.

EPA Seeks Data On Inactive CCR Surface Impoundments At Inactive Facilities: EPA published an advance notice of proposed rulemaking (ANPRM) on October 14, 2020, seeking comments and data on inactive coal combustion residuals (CCR) surface impoundments at inactive facilities to assist in the development of future regulations for these CCR units. 85 Fed. Reg. 65015. The ANPRM also discusses the related research conducted to date, describes EPA’s preliminary analysis of that research, and seeks additional data and public input on issues that may inform a future proposed rule. Comments are due December 14, 2020.

FDA

FDA Proposes Rule For Traceability Of Certain Foods: FDA, on September 23, 2020, proposed a rule in accordance with the Food Safety Modernization Act (FSMA) that would impose additional traceability recordkeeping requirements for persons that manufacture, process, pack, or hold foods FDA has designated for inclusion on the Food Traceability List. 85 Fed. Reg. 59984. The additional requirements are designed to improve the traceability information available during foodborne illness outbreaks and to increase the speed and precision of investigations for recall events. The proposed rule includes a “Tentative Food Traceability List” that was developed based on FDA’s “Methodological Approach to Developing a Risk-Ranking Model for Food Tracing FSMA Section 204 (21 U.S.C. 2223)” and input from various subject matter experts. Comments are due by January 21, 2021.

Online Biennial Registration Renewal Of Food Facilities Began October 1, 2020: All FDA food facilities registrations are required to review and renew registrations on even numbered years. The renewal period is now open from October 1 to December 31, 2020. FDA notes that a food facility registration is considered invalid or canceled if not renewed within the specified timeframe. For more details and guidance, see the “Food Facility Registration User Guide: Biennial Registration Renewal” web page.

NANOTECHNOLOGY

NSF Will Invest $84 Million In National Nanotechnology Coordinated Infrastructure: On August 24, 2020, the National Science Foundation (NSF) announced that it will invest a total of $84 million over five years in a renewal of the National Nanotechnology Coordinated Infrastructure (NNCI). According to NSF, “NNCI’s 16 sites and coordinating office provide researchers from academia, large and small businesses, and government with access to leading-edge fabrication and characterization tools, instrumentation, and expertise across all disciplines of nanoscale science, engineering and technology.” NSF states that NNCI sites are in 15 states and involve 26 university and partner institutions. The new NSF awards range from $600,000 to $1.5 million per year for up to five years.

EFSA Calls For Grant Proposals On The Use Of NAMs For The Hazard Assessment Of Cellulose Nanofibers: On September 15, 2020, the European Food Safety Authority (EFSA) called for grant proposals on the use of NAMs for the hazard assessment of cellulose nanofibers. The main objective of the call is to design and conduct a set of NAM-based studies for addressing the current data gaps and to offer a proposal for including the results in the regulatory hazard assessment of nanocellulose for consumers exposed via food. More information is available in our September 18, 2020, blog item.

EPA Publishes Final SNUR For Carbon Nanotubes (Generic) (PMN P-15-54): On September 17, 2020, EPA published final SNURs under TSCA for chemical substances that were the subject of PMNs and are subject to Orders issued by EPA pursuant to TSCA. 85 Fed. Reg. 57968. 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 final SNURs include one for carbon nanotubes (generic) (PMN P-15-54). The SNUR requirements do not apply to quantities of the PMN substance that have been embedded or incorporated into a polymer matrix that itself has been reacted (cured) or embedded in a permanent solid polymer form that is not intended to undergo further processing, except mechanical processing. The SNUR will be effective on November 16, 2020. More information is available in our September 24, 2020, blog item.

EAASM Report On Patient Safety And Nanomedicines Calls For Centralized Regulatory Procedure: On September 17, 2020, the European Alliance for Access to Safe Medicines (EAASM) announced the availability of a report entitled Patient Safety and Nanomedicines: The need for a centralised regulatory procedure. According to EAASM, “[n]anomedicines and their follow-on products, also referred to as nanosimilars, are complex molecules and so regulatory oversight must be scientifically fit for purpose.” The report makes recommendations intended to ensure patient safety and enable the European Union (EU) to harness fully the potential of this technology. More information is available in our September 29, 2020, blog item.

Mandatory Naming Of Nanoforms For REACH Registration Will Begin November 2, 2020: Beginning November 2, 2020, following the next release of the International Uniform Chemical Information Database (IUCLID), companies will be required to provide a name for the nanoforms or sets of nanoforms of their substance when registering nanomaterials under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. According to an item in the European Chemicals Agency’s (ECHA) September 30, 2020, weekly news, companies that have already registered their nanoforms do not need to take any immediate action, but will be required to provide a name in the next update of their registration dossier. More information is available in our October 2, 2020, blog item.

OEHHA’s DARTIC Will Discuss Titanium Dioxide Nanoparticles At December Meeting: The Developmental and Reproductive Toxicant Identification Committee (DARTIC) of California’s Office of Environmental Health Hazard Assessment (OEHHA) will meet on December 10, 2020, to discuss the prioritization of 22 chemicals or chemical groups, including titanium dioxide nanoparticles. No listing decisions will be made at the meeting. Interested parties may provide comments on the potential for exposure in California and the extent of the scientific evidence pertaining to the selection of any of the 22 chemicals or chemical groups for possible preparation of hazard identification materials. Written comments and any supporting documentation are due November 16, 2020. More information is available in our October 5, 2020, blog item.

Public Consultation Begins On SCCS Scientific Advice On Safety Of Nanomaterials In Cosmetics: The European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) began a public consultation on October 5, 2020, on a preliminary opinion entitled Scientific Advice on the Safety of Nanomaterials in Cosmetics. Comments on the preliminary opinion are due November 2, 2020. More information is available in our October 7, 2020, blog item.

European Parliament Calls On EC To Ban Titanium Dioxide (E171) In Food: The European Parliament (EP) announced on October 8, 2020, that it objected to an EC proposal to amend the specification for the use of titanium dioxide (E171) in food products. The EP rejected the EC’s proposal to reduce the amount of titanium dioxide (E171), instead calling on the EC “to apply the precautionary principle and to remove E171 from the EU list of permitted food additives that are currently used mainly to colour confectionery, bakery and pastry products as well as chewing gum, candies, chocolates, and ice cream.” More information is available in our October 8, 2020, blog item.

NSET Subcommittee Seeks Input On 2021 NNI Strategic Plan: On October 13, 2020, the Nanoscale Science, Engineering and Technology (NSET) Subcommittee published a request for information to inform the development of the 2021 National Nanotechnology Initiative (NNI) Strategic Plan. 85 Fed. Reg. 64535. According to the Subcommittee, a restructuring of the NNI is under consideration. The Subcommittee seeks response to questions to identify effective mechanisms, strategies for communication, and priority topics to inform the future directions of the NNI. Responses are due November 9, 2020. More information is available in our October 13, 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

Senate Bill Intended To Modernize And Strengthen ESA: On September 16, 2020, Senator John Barrasso (R-WY), Chair of the Senate Committee on Environment and Public Works, introduced the Endangered Species Act Amendments of 2020. According to the Committee’s press release, the legislation would reauthorize the Endangered Species Act (ESA) for the first time since 1992, elevate the role of states, and increase transparency in the implementation of the ESA. It would also prioritize resources to help meet conservation goals, while providing regulatory certainty to promote recovery activities. The Committee held a legislative hearing on September 23, 2020, on the bill. Witnesses included Wyoming Governor Mark Gordon (R); Aliese “Liesa” Priddy, Owner and Operator, JB Ranch; and Jamie Rappaport Clark, President and Chief Executive Officer (CEO), Defenders of Wildlife.

Senate Passes Bipartisan Wildlife Conservation Legislation: On September 17, 2020, the Senate unanimously passed America’s Conservation Enhancement (ACE) Act (S. 3051). According to the September 17, 2020, press release issued by the Senate Committee on Environment and Public Works, the ACE Act will help conserve wildlife and wildlife habitat, including by reauthorizing the North American Wetlands Conservation Act and the National Fish and Wildlife Foundation Establishment Act. It also addresses the threats of emerging wildlife diseases like Chronic Wasting Disease, protects livestock from predators, and combats invasive species. The press release states that the legislation has received support from a broad group of stakeholders. The ACE Act language passed the Senate in the form of a substitute amendment that was negotiated with the House of Representatives. The House passed the legislation on October 1, 2020. The bill has been sent to President Trump to be signed into law.

House Passes Clean Economy Jobs And Innovation Act, Trump Administration Opposes Bill: The House passed the Clean Economy Jobs and Innovation Act (H.R. 4447) on September 24, 2020. The legislation includes programs to develop and deploy renewable and distributed energy resources; improve the efficiency of homes and businesses; electrify the transportation sector; modernize the grid and enhance its resiliency; prioritize the needs of environmental justice communities; reduce carbon pollution from industrial and traditional sources; and develop advanced nuclear energy technologies. A fact sheet lists provisions addressing clean energy; energy efficiency; grid modernization, cybersecurity, and supply chain security; clean transportation; modernizing the federal approach to innovation; reducing carbon pollution and enhancing industrial innovation; environmental justice; workforce development and labor protections; and scientific integrity. OMB issued a Statement of Administration Policy on September 21, 2020, stating that the Trump Administration opposes passage of the bill. According to the Statement, the bill “would implement a top-down approach that would undermine the Administration’s deregulatory agenda and empower the government to select favored solutions while reinstating big-government policies and programs.”

House Subcommittee Holds Hearing On Climate Change: On September 24, 2020, the House Oversight and Reform Subcommittee on Environment held a hearing on “Climate Change, Part IV: Moving Towards a Sustainable Future.” The hearing explored solutions to the climate crisis, including actions that can be taken by the federal government to support the transition to a green economy and increase competitiveness in the global marketplace. The Subcommittee heard testimony from Robert C. Orr, Ph.D, Dean of the University of Maryland School of Public Policy; Rachel Cleetus, Ph.D, Policy Director, Climate and Energy Program at the Union of Concerned Scientists; Christopher Castro, Senior Advisor to Orlando Mayor Buddy Dyer and Director of Sustainability & Resilience at the City of Orlando; Reed Schuler, Senior Policy Advisor at the Office of the Governor for Governor Jay Inslee; and minority witness Kevin Dayaratna, Ph.D. Principal Statistician, Data Scientist, and Research Fellow at the Heritage Foundation. Members and witnesses discussed innovative strategies to transition to a green economy and the economic opportunities and health benefits of doing so.

Bicameral Legislation Would Build Climate Change Preparedness: On September 25, 2020, Senator Amy Klobuchar (D-MN) and Representative Carolyn Maloney (D-NY), Chair of the House Committee on Oversight and Reform, introduced the Climate Planning, Resilience, and Enhanced Preparedness (Climate PREP) Act. The bill would require each agency of the federal government to create a climate change adaptation plan that includes: assessments of climate change-related risks to agency missions, operations, and programs; efforts to manage these risks and build resilience with future milestones in mind; strategies for addressing risks that threaten vital missions and operations; alternatives for agency actions that may exacerbate climate change threats; and opportunities to address the disproportionate effect of climate change on frontline communities and vulnerable populations. The Climate PREP Act would also establish the Council on Climate Preparedness and Resilience, an interagency council that would guide, coordinate, and track implementation of federal actions on climate change preparedness and resilience.

House Fails To Pass Bill Banning Asbestos: Although the House was expected to pass the Alan Reinstein Ban Asbestos Now Act (H.R. 1603) easily, the bill was pulled from the floor on October 1, 2020. The bill would amend TSCA to prohibit the manufacturing, processing, and distribution of asbestos or any mixture or article containing asbestos. Representatives Frank Pallone, Jr. (D-NJ), Chair of the House Energy and Commerce Committee, Paul Tonko (D-NY), Chair of the House Energy and Commerce Subcommittee on Environment and Climate Change, and Representative Suzanne Bonamici (D-OR) issued an October 1, 2020, statement “condemning House Republicans for blocking the long-awaited, previously bipartisan Alan Reinstein Ban Asbestos Now Act from being passed.” On October 1, 2020, Representatives Greg Walden (R-OR), Ranking Member of the House Energy and Commerce Committee, and John Shimkus (R-IL), Ranking Member of the House Energy and Commerce Subcommittee on Energy and Climate Change, issued a statement to “set the record straight” on the bill. According to the statement, after an agreement was reached in Committee, House Democrats added language written “by trial lawyers.” The language at issue states that the bill would have no effect on the definition of asbestos for purposes of regulating cosmetics under the Federal Food, Drug, and Cosmetic Act (FFDCA) and for determining whether a cosmetic contains asbestos either as an ingredient or as an accessory mineral to an ingredient such as talc.

House Natural Resources Committee Chair Releases Draft Bill Providing Climate Solution For U.S. Territories, Seeks Stakeholder Input: On October 5, 2020, Representative Raúl M. Grijalva (D-AZ), Chair of the House Natural Resources Committee, released a discussion draft of legislation to reduce climate crisis impacts on U.S. territories and freely associated states. The Committee’s October 5, 2020, press release, lists the following key features:

  • The creation within the Department of Energy (DOE) of an Office of Insular Area Energy Policy and Programs to direct energy management, planning, delivery, and conservation programs in the U.S. territories;
     
  • The establishment within the Office of Insular Area Energy Policy and Programs of an Energy Efficient Appliance Rebate Program to provide funding allocations to reduce energy demand in the U.S. territories;
     
  • The creation within the National Oceanic and Atmospheric Administration of a Climate Change Insular Research Grant Programto provide grants to institutions of higher education for monitoring, collecting, synthesizing, analyzing, and publishing local climate change data; and
     
  • A waiver of non-federal share funding requirements associated with disaster relief and long-term recovery funding made available to U.S. territories and freely associated states pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act.
     

Grijalva encourages local government officials, organizations, and communities to provide feedback on the discussion draft by November 13, 2020.

MISCELLANEOUS

China Tariffs: Court Of International Trade Lawsuit Challenges Section 301 Tariffs: A recent legal challenge may be of interest to some of our clients. The challenge involves a case filed in the U.S. Court of International Trade (CIT) challenging President Trump’s authority to impose supplemental tariffs on goods from China identified on Lists 3 and 4A and seeking refunds. As our clients know well, some pesticides and cleaning products are listed on List 3 and thus subject to 25% China tariffs. There are two prongs to the argument. One prong is that the List 3 and List 4A retaliations were not related to the original purpose for which retaliation was recommended by the U.S. Trade Representative (USTR), i.e., China’s Intellectual Property Rights practices. The second prong is that these retaliations were untimely because they occurred more than 12 months after the USTR issued its report. We believe that the challenge has merit. It would be prudent for any importer who has paid the Section 301 tariffs on List 3 or List 4A goods to file a protective action in the CIT. We offer a memorandum prepared by our long-time customs and trade counsel, Michael K. Tomenga of Neville Peterson LLP, which provides additional information.

OIRA Memorandum Directs Agencies To Consider Principles Of Fairness In Administrative Enforcement And Adjudication: The OMB’s Office of Information and Regulatory Affairs (OIRA) issued memorandum M-20-31 on August 31, 2020, on the implementation of Section 6 of Executive Order (EO) 13924, “Executive Order on Regulatory Relief to Support Economic Recovery.” Section 6 of the EO directs the “heads of all agencies” to “consider the principles of fairness in administrative enforcement and adjudication” enumerated in the EO and to “revise their procedures and practices in light of them, consistent with applicable law and as they deem appropriate in the context of particular statutory and regulatory programs and the policy considerations identified in section 1 of this order.” The memorandum requests that agencies coordinate with OIRA staff to issue any needed final rules by November 26, 2020 (absent a waiver granted by the Administrator), with a request for public comment that agencies may consider in any future revisions. More information is available in our September 29, 2020, memorandum.

EPA Announces More Than $6 Million In Funding To Research How To Control And Prevent Harmful Algal Blooms: On September 17, 2020, EPA announced that it is providing $6,487,188 in funding to seven institutions to research how to prevent and control harmful algal blooms (HAB) using current and new technologies. EPA states that “[a]s part of Administrator Wheeler’s focus on addressing our nation’s pressing water issues, preventing and mitigating excess nutrients in our waters, and the HABs that they can create is one of EPA’s highest water quality priorities.” According to EPA, the award marks the largest research grant to date to support a nation-wide effort to prevent and control HABs.

SEC Adopts Amendments To Modernize Shareholder Proposal Rule: On September 23, 2020, the Securities and Exchange Commission (SEC) voted to adopt amendments intended to modernize its shareholder proposal rule, which governs the process for a shareholder to have its proposal included in a company’s proxy statement for consideration by all of the company’s shareholders. According to SEC’s September 23, 2020, press release, the amendments will facilitate engagement among shareholder-proponents, companies, and other shareholders, including preserving the ability of smaller shareholders to access the proxy statements of the companies in which they have demonstrated a continuing interest. Under the rules, any shareholder may submit an initial proposal after having held $2,000 of company stock for at least three years, or higher amounts for shorter periods of time. The rules also provide for a transition period so that shareholders who are currently eligible at the $2,000 threshold will remain eligible to submit a proposal for inclusion in the company’s proxy statement so long as they continue to maintain at least their current holdings through the date of submission (and through the date of the relevant meeting). The amendments will be effective 60 days after publication in the Federal Register, and the final amendments will apply to any proposal submitted for an annual or special meeting to be held on or after January 1, 2022. The final rules also provide for a transition period with respect to the ownership thresholds that will allow shareholders meeting specified conditions to rely on the $2,000/one-year ownership threshold for proposals submitted for an annual or special meeting to be held prior to January 1, 2023.

EPA Announces 2020 Safer Choice Partner Of The Year Award Winners: On September 24, 2020, EPA announced the 2020 Safer Choice Partner of the Year award winners. EPA recognized 18 Safer Choice Partner of the Year award winners across ten states and the District of Columbia for achievement in the design, manufacture, selection, and use of products with safer chemicals that furthers outstanding or innovative source reduction. EPA states that the Safer Choice program helps consumers and purchasers for facilities, such as schools and office buildings, find products that perform and are safer for human health and the environment. According to EPA, the 2020 Partner of the Year award winners represent businesses, including woman-owned and small- and medium-sized; federal and local governments; and associations. More information is available in our September 25, 2020, blog item.

California Enacts Menstrual Products Right To Know Act: California Governor Gavin Newsom signed the Menstrual Products Right to Know Act of 2020 (A.B. 1989) on September 29, 2020. Under the Act, a package or box containing menstrual products that is manufactured on or after January 1, 2023, must have printed on the label a “plain and conspicuous list of all ingredients in the product.” Ingredients must be listed in order of predominance by weight in the menstrual product using a standardized nomenclature. Beginning January 1, 2023, a manufacturer of a menstrual product that is manufactured for sale or distribution in the state shall post on an Internet website the ingredient information that is required to be disclosed on a package or box containing menstrual products.

ATSDR Seeks Comments On Draft Toxicological Profile For Ethylene Oxide: On September 30, 2020, the Agency for Toxic Substances and Disease Registry (ATSDR) announced the opening of a docket to obtain comments on the Draft Toxicological Profile for Ethylene Oxide. 85 Fed. Reg. 61749. ATSDR states that it is seeking public comments and additional information or reports on studies about the health effects of ethylene oxide for review and potential inclusion in the profile. ATSDR considers key studies for these substances during the profile development process. ATSDR will evaluate the quality and relevance of such data or studies for possible inclusion in the profile. Comments are due December 29, 2020.

OSHA And American Chemistry Council Renew Alliance Intended To Protect Workers From Hazardous Chemicals Exposure: On September 30, 2020, OSHA announced that it renewed its alliance with the American Chemistry Council to protect the safety and health of workers handling diisocyanates, a compound used to make polyurethane. According to OSHA, during the five-year agreement, the alliance will focus on workplace practices to reduce and prevent exposure to aliphatic and aromatic diisocyanates; promoting guidance and information that addresses the health and safety issues affecting workers within the polyurethanes value chain, as well as the broader chemical industry; and helping employers and workers understand their rights and responsibilities under the Occupational Safety and Health Act (OSH Act). OSHA states that the American Chemistry Council entities participating in the alliance include the Center for the Polyurethanes Industry and the Diisocyanates and Aliphatic Diisocyanates panels. Members of these groups include manufacturers and distributors of chemicals and equipment used to make polyurethane.

President Signs EO On Addressing The Threat To The Domestic Supply Chain From Reliance On Critical Minerals From Foreign Adversaries: On September 30, 2020, President Trump signed an Executive Order (EO) and declared a National Emergency to expand the domestic mining industry, support mining jobs, alleviate unnecessary permitting delays, and reduce U.S. dependence on China for critical minerals. 85 Fed. Reg. 62539. According to a White House fact sheet on the EO, the EO begins the process for the U.S. Department of the Interior (DOI) to develop a program to use its authorities under the Defense Production Act to fund mineral processing that protects U.S. national security. The fact sheet states that the action will cut down on unnecessary delays in permitting actions, providing opportunities for jobs, and improving economic and national security. Through the EO, federal agencies will use their authorities to investigate and work to decrease U.S. reliance on mineral imports.

USDA Publishes Screening Method For PFAS In Biological Matrices: The U.S. Department of Agriculture (USDA) Food Safety and Inspection Service, Office of Public Health Science, published a method titled “Screening, Determination and Confirmation of PFAS by UPLC-MS-MS” that became effective on September 30, 2020. The method is suitable for identifying select per- and poly-fluorinated compounds in tissue and plasma matrices at levels as low as 0.5 nanograms per- and polyfluorinated alkyl substances (PFAS) per gram of matrix. Analysis is performed by Ultra Performance Liquid Chromatrography tandem mass spectrometry (UPLC/MS/MS) on a triple quadruple mass spectrometer in negative electrospray ionization (ESI) mode.

California Enacts Toxic-Free Cosmetics Act: On September 30, 2020, Governor Gavin Newsom (D) signed the Toxic-Free Cosmetics Act (A.B. 2762). Under the Toxic-Free Cosmetics Act, as of January 1, 2025, the manufacture, sale, and delivery of any cosmetic product that contains any of the following intentionally added ingredients will be prohibited:

Dibutyl phthalate

Diethylhexyl phthalate

Formaldehyde

Paraformaldehyde

Methylene glycol

Quaternium-15

Mercury

Isobutylparaben

Isopropylparaben

m-Phenylenediamine and its salts

o-Phenylenediamine and its salts

Certain PFAS and their salts

EPA Begins Public Comment Period On Draft National Recycling Strategy: On October 5, 2020, EPA announced the release of the draft National Recycling Strategy, which “identifies strategic objectives and actions needed to create a stronger, more resilient, and cost-effective U.S. municipal solid waste recycling system.” According to EPA, challenges faced by the U.S. recycling system include confusion about what materials can be recycled, recycling infrastructure that has not kept pace with today’s diverse and changing waste stream, reduced markets for recycled materials, and varying methodologies to measure recycling system performance. The draft strategy identifies actions to address these challenges that build on the collaborative efforts by stakeholders from across the recycling system that began under the National Framework for Advancing the U.S. Recycling System, which are organized under three strategic objectives: reduce contamination in the recycling stream; increase processing efficiency; and improve markets. When issued in final, the Strategy will align with and support implementation of the national recycling goals that EPA intends to announce in November 2020. Comments on the draft National Recycling Strategy are due December 4, 2020.

Pallone And Schakowsky Request Amazon Investigate Safety Of Its Product Line And Answer Questions Pertaining To Company’s Product Safety And Recall Practices: Representatives Frank Pallone, Jr. (D-NJ), Chair of the House Committee on Energy and Commerce, and Jan Schakowsky (D-IL), Chair of the House Energy and Commerce Subcommittee on Consumer Protection and Commerce, wrote to Amazon CEO and Chair Jeff Bezos on October 7, 2020, requesting that he launch an investigation into the safety of Amazon’s product line, AmazonBasics, and answer a series of questions pertaining to the company’s product safety and recall practices. The Committee’s October 7, 2020, press release notes that the request comes after a CNN investigation found that many of AmazonBasics’ electronic products “have exploded, caught fire, sparked, melted, or otherwise created hazardous situations at rates well above comparable products.” According to the press release, many of these products were never recalled and continue to be sold. For more information, see our October 9, 2020, blog.

EO Establishes One Trillion Trees Interagency Council: On October 13, 2020, President Trump signed an EO on Establishing the One Trillion Trees Interagency Council. The Council will be charged with developing, coordinating, and promoting federal government interactions with the World Economic Forum’s One Trillion Trees initiative with respect to tree growing, restoration, and conservation, and with coordinating with key stakeholders to help advance the Initiative.

EO On Modernizing Water Resource Management And Water Infrastructure Creates Interagency Water Subcabinet: On October 13, 2020, President Trump signed an EO on Modernizing America’s Water Resource Management and Water Infrastructure. The EO creates an Interagency Water Subcabinet that will be co-chaired by DOI Secretary David Bernhardt and EPA Administrator Andrew Wheeler, and will include senior officials from USDA, the Department of Commerce, DOE, and the Department of the Army. According to EPA’s October 13, 2020, press release, the Water Subcabinet will work in close coordination with senior officials from the White House Council on Environmental Quality, OMB, and the Office of Science and Technology Policy (OSTP), and other federal agencies as appropriate. Under the EO, the Water Subcabinet will promote effective and efficient water resources management by reducing duplication between federal agencies developing water policy; develop a national water strategy to ensure the reliability of water supplies, water quality, water systems, and water forecasting; protect taxpayer investments and improve water infrastructure planning by promoting integrated planning and coordination for drinking water, wastewater, water reuse, water storage and delivery, and water resource management; and support and enhance workforce development to recruit, train, and retain water sector professionals.

EPA Appoints New Members To SAB And Subcommittees: EPA announced on October 14, 2020, the selection of Dr. John Graham as the new Chair of the Science Advisory Board (SAB) and Dr. Barbara Beck as SAB Vice-Chair. EPA also announced the appointment of members who will serve on the SAB and four subcommittees, including the Agricultural Science Committee (ASC), the Chemical Assessment Advisory Committee (CAAC), the Drinking Water Committee (DWC), and the Radiation Advisory Committee (RAC).

NASEM Will Hold Workshop On Federal Government Human Health PFAS Research: The National Academies of Sciences, Engineering, and Medicine (NASEM) will hold a workshop on October 26-27, 2020, to review federal government human health research on PFAS and to identify research and data gaps. NASEM will address the state of the science and ongoing federal research regarding human exposure to PFAS; experimental toxicology studies to identify human risks from PFAS; human health outcomes from PFAS exposures; and cross cutting issues, such as mixtures and class-based approaches. The event is free to attend via Zoom. Those who register will also have the opportunity to submit suggested research needs or data gaps for consideration as input to the workshop.

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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