Lynn L. Bergeson Publishes “The importance of regulatory diligence in funding,” In Financier Worldwide, April 2021: Lawyers counselling companies in the biotechnology, biopesticide, and related crop protection and industrial biotechnology areas appreciate the critically important role federal agencies play in ensuring the success of start-up businesses. Federal agencies, including EPA and the U.S. Food and Drug Administration (FDA), among others, wield enormous power over businesses that require premarket product approval. While we product approval practitioners know this, it comes as a bit of a surprise when investors, poised to make multimillion-dollar investments in start-up businesses, neglect to focus on the regulatory integrity of the start-up. This lack of focus invites costly mistakes. This article explains why, and how to avoid making these mistakes.
EPA Announces Settlement Resolving Alleged TSCA Reporting Violations: On March 15, 2021, EPA announced a settlement requiring Western Reserve Chemical Corporation (WRCC) in Stow, Ohio, to pay a $357,000 civil penalty for violations of chemical data reporting (CDR) regulations under TSCA. EPA claims that from 2012 to 2015, WRCC failed to submit data reports for 18 chemical substances as required by TSCA. According to EPA, WRCC imports various chemicals for businesses that formulate rubber, plastics, adhesives, sealants, and coatings. EPA states that the alleged violations “presented a potential harm to the Agency’s ability to maintain accurate and updated information regarding commercially-produced chemicals.” EPA’s consent agreement and final order with WRCC resolves the alleged violations and requires the payment of a $357,000 civil penalty in installments within 18 months.
Comments On Final PBT Rules Due May 17, 2021: On March 16, 2021, EPA announced that comments on its five final rules for persistent, bioaccumulative, and toxic (PBT) chemicals are due May 17, 2021. 86 Fed. Reg. 14398. EPA seeks comment on whether the rules sufficiently reduce exposure to these chemicals, including exposures to potentially exposed or susceptible subpopulations and the environment; newly raised compliance issues associated with the final rule on phenol, isopropylated phosphate (3:1) (PIP (3:1)), including the compliance dates for certain regulated articles; and whether to consider additional or alternative measures or approaches.
EPA Issues Final Guidance For Waiving Acute Dermal Toxicity Testing: On March 17, 2021, EPA announced the issuance of the final guidance document entitled “Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Technical Chemicals & Supporting Retrospective Analysis” (EPA 705-G-2020-3722; Docket ID: EPA-HQ-OPP-2016-0093) that expands the potential for data waivers for acute dermal studies to single technical active ingredients (AI) used to formulate end-use products. 86 Fed. Reg. 14625. This new guidance builds upon the final guidance for waiving acute dermal toxicity tests for pesticide formulations published by EPA on November 9, 2016, and is an example 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. EPA states that this guidance is expected to reduce the number of test animals used annually by approximately 750, as well as save EPA, industry, and laboratory resources. More information is available in our March 22, 2021, blog.
EPA Publishes Final SNURs On Certain Chemical Substances: On March 22, 2021, EPA issued final significant new use rules (SNUR) for chemical substances that were the subject of premanufacture notices (PMN). 86 Fed. Reg. 15096. The final SNURs require persons to notify EPA at least 90 days before commencing manufacture (defined by statute to include import) or processing of any of these chemical substances for an activity that is designated as a significant new use by the SNURs The SNURs further require that persons not commence manufacture or processing for a 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. The final SNURs will be effective on May 21, 2021.
EPA Publishes Receipt And Status Information For Certain New Chemicals: On March 23, 2021, EPA published the receipt and status reports for TSCA Section 5 submissions for February 2021. 86 Fed. Reg. 15478. EPA provides notice of receipt of PMNs, SNUNs, and microbial commercial activity notices (MCAN) (including amended notices and test information); an exemption application under 40 C.F.R. Part 725 (Biotech exemption); test marketing exemptions (TME), both pending and/or concluded; notices of commencement (NOC) to manufacture a new chemical substance; and a periodic status report on new chemical substances that are currently under EPA review or have recently concluded review. EPA also provides information on its website about cases reviewed under the amended TSCA, including the Section 5 PMN/SNUN/MCAN and exemption notices received, the date of receipt, the final EPA determination on the notice, and the effective date of EPA’s determination for PMN/SNUN/MCAN notices. Comments identified by the specific case number provided in the notice must be received on or before April 22, 2021.
EPA Calls For Nominations For 2021 Safer Choice Partner Of The Year Awards: On March 24, 2021, EPA announced that it is now accepting nominations for the 2021 Safer Choice Partner of the Year Awards. 86 Fed. Reg. 15668. According to the Federal Register notice, the awards will recognize the leadership contributions of Safer Choice partners and stakeholders who, over the past year, have shown achievement in the design, manufacture, selection, and use of products with safer chemicals that further outstanding or innovative source reduction. EPA “especially encourages” award applications that show how the applicant’s work in the design, manufacture, selection, and use of those products promotes environmental justice, bolsters resilience to the impacts of climate change, results in cleaner air or water, or improves drinking water quality. Interested parties should submit to EPA information about their accomplishments and contributions during 2020. Submissions are due May 31, 2021. EPA will recognize award winners at a ceremony in fall 2021.
EPA Announces Updates To TSCA New Chemicals Program: On March 29, 2021, EPA announced that it is evaluating its policies, guidance, templates, and regulations under the TSCA new chemicals program to ensure they “adhere to statutory requirements,” the Biden-Harris Administration’s executive orders, and other directives. EPA states that it will stop issuing determinations of “not likely to present an unreasonable risk” based on the existence of proposed SNURs. Going forward, when EPA concludes that one or more uses may present an unreasonable risk, or when EPA believes that it lacks the information needed to make a safety finding, EPA will issue an order to address those potential risks. EPA intends to continue issuing SNURs following TSCA Section 5(e) and 5(f) orders for new chemicals to ensure the requirements imposed on the submitter via an order apply to any person who manufactures or processes the chemical in the future. According to the announcement, where EPA identifies a potential unreasonable risk to workers that could be addressed with appropriate personal protective equipment (PPE) and hazard communication, EPA will no longer assume that workers are protected adequately under the Occupational Safety and Health Administration’s (OSHA) worker protection standards and updated safety data sheets (SDS). Instead, EPA will identify the absence of worker safeguards as “reasonably foreseen” conditions of use, and mandate necessary protections through a TSCA Section 5(e) order, as appropriate. More information is available in our March 29, 2021, blog item.
EPA Issues SSURO Against ViaClean Technologies For Making Inaccurate Health Claims About Its Pesticide Product: On March 31, 2021, EPA issued a Stop Sale, Use or Removal Order (SSURO) to ViaClean Technologies (ViaClean), operating in Philadelphia, regarding the sales, distribution, and marketing of the pesticide BioProtect RTU with claims that it is effective against surfaces from public health-related pathogens such as SARS-CoV-2, the virus that causes COVID-19. This case is another example of EPA’s enforcement priorities and vigilance over the past year to identify products making claims to act against the coronavirus and taking action to prevent further sales when such products are not approved by EPA to make such claims. For more information on this case, see our April 12, 2021, blog.
EPA Extends Public Comment Period For Manufacturer-Requested Risk Evaluation Of OTNE: On April 5, 2021, EPA extended the public comment period for a manufacturer-requested risk evaluation of octahydro-tetramethyl-naphthalenyl-ethanone (OTNE), a category of chemical substances consisting of four inseparable individual isomers. 86 Fed. Reg. 17592. As reported in our February 18, 2021, blog item, EPA notes that two chemicals in the OTNE category are considered PBT chemicals under TSCA, “meaning they are toxic, can remain in the environment for long periods of time, and can build up or accumulate in the body.” Comments are due May 5, 2021. More information is available in our April 2, 2021, blog item.
EPA Releases Updated PFBS Toxicity Assessment: On April 8, 2021, EPA announced that it is releasing an updated toxicity assessment for perfluorobutane sulfonic acid (PFBS), which is a member of the group of per- and polyfluoroalkyl substances (PFAS). According to EPA’s announcement, “EPA, federal agencies, states, tribes, and local communities can use the PFBS toxicity assessment, along with specific exposure and other relevant information, to determine if and when it is necessary to take action to address potential health risks associated with human exposures to PFBS under appropriate regulations and statutes.” EPA notes that the updated assessment “has gone through all appropriate reviews, includes input EPA received from external peer review, upholds the tenants of scientific integrity, was authored by expert career scientists in EPA’s Office of Research and Development, and has not been compromised by political staff -- these were all issues with a version of the assessment that was posted during the previous administration.” More information is available in our April 9, 2021, blog item.
EPA Announces Request For Public Input On The Current Pesticide Exemption Provision Process: On April 8, 2021, EPA issued an Advance Notice of Proposed Rulemaking (ANPRM) to solicit information on the current pesticide exemption provision process. 86 Fed. Reg. 18232. EPA announced its intent to issue this ANPRM on January 19, 2021, as discussed here. The issuance of the ANPRM was paused following the Biden Administration’s Executive Orders requiring agencies to review their rules and policies to ensure consistency with the current Administration’s environmental policies. EPA states that it is soliciting comments and suggestions to determine whether regulatory and policy changes are needed to improve the exemption provisions for pesticides that may be considered minimum risk under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA states that changes to the current process could make the implementation and evaluation of the exemption provisions more efficient. Comments on the ANPRM are due on or before July 7, 2021. More information is available in our April 12, 2021, blog.
ANPRM Regarding CWA Effluent Limitations Guidances And Standards For OCPSF Point Source Category Would Address PFAS Discharges From Manufacturers: On March 17, 2021, EPA published an ANPRM, stating that it is initiating further data collection and analysis to support potential future rulemaking, under the Clean Water Act (CWA), relating to the effluent limitations guidelines, pretreatment standards, and new source performance standards applicable to the Organic Chemicals, Plastics and Synthetic Fibers (OCPSF) point source category to address discharges from manufacturers of PFAS and is considering revising the same for formulators of PFAS. 86 Fed. Reg. 14560. EPA states that analysis of animal studies and human epidemiological research suggest that exposure above certain levels to some PFAS may be associated with adverse human health effects. According to the ANPRM, EPA has identified several industries with facilities that are likely to be discharging PFAS in their wastewater, including OCPSF manufacturers and formulators. The ANPRM provides for public review and comment on the information and data regarding PFAS manufacturers and formulators that EPA has collected to date. EPA requests public comment on the information and data presented in the ANPRM. EPA is also soliciting additional information and data regarding discharges of PFAS from these facilities to inform future revisions to the wastewater discharge requirements that apply to the OCPSF point source category. Comments are due May 17, 2021.
EPA Reboots Climate Change Website: On March 18, 2021, EPA announced, that as part of the Biden-Harris Administration’s commitment to action on climate change and restoring science, EPA is taking the first step in a relaunch of its climate change website. EPA states that for the first time in four years, it now has a web page to guide the public to a range of information, including greenhouse gas (GHG) emissions data, climate change impacts, scientific reports, and existing climate programs within EPA and across the federal government.
EPA Will Host Brownfields Stakeholder Discussion And Listening Session With Nonprofit Organizations And Community Foundations: On March 24, 2021, EPA announced that it will host an open discussion and listening session with nonprofit organizations to hear about nonprofit leadership in brownfields assessment, cleanup, and redevelopment projects. 86 Fed. Reg. 15666. The virtual event will be held April 23, 2021. The purpose of the meeting is to hear from representatives of nonprofits, using the following questions to guide the discussion: how does your nonprofit organization view its role in brownfields cleanup and redevelopment; what benefits and barriers exist to nonprofits leading brownfields cleanup and redevelopment projects; and how can EPA best engage with nonprofit organizations that are most interested in leading brownfields cleanup and redevelopment. Stakeholders may respond in writing to these questions. Comments are due April 23, 2021.
EPA And Environment And Climate Change Canada Release Joint Statement On Environment And Climate Change: On April 1, 2021, EPA and Environment and Climate Change Canada (ECCC) released a joint statement “reaffirming their shared commitment to a partnership focused on renewed and strengthened actions to address our mutual priorities, with a strong emphasis on climate change and environmental justice.” In support of the Roadmap for a Renewed U.S.-Canada Partnership announced by President Biden and Prime Minister Trudeau and building on the long-standing environmental agreements on air quality, waste management, and water quality, the United States and Canada “will work together to accelerate policy actions based on science and evidence that support a healthy and just world for all.” With the Climate Summit on April 22, 2021, approaching, the United States and Canada have agreed to target three areas: reductions in methane emission from oil and gas operations and potentially other sectors; emission reductions from the transportation sector, and opportunities for a cleaner electricity sector.
EPA Will Hold Public Listening Sessions And Roundtables On Lead And Copper Rule Revisions: On April 5, 2021, EPA announced that it will hold public listening sessions on April 28, 2021, and May 5, 2021, to obtain further public input on EPA’s revision to the Lead and Copper rule (LCRR), particularly from individuals and communities that are most at-risk of exposure to lead in drinking water. 86 Fed. Reg. 17571. Those interested in speaking can sign up for a three-minute time slot by submitting a registration form. Registration for April 28, 2021, will close on April 26, 2021, at 5:00 p.m. EDT and registration for May 5, 2021, will close on May 3, 2021, at 5:00 p.m. EDT. EPA intends to make each session available for viewing to those who are not participating but are interested in listening. Starting in May 2021, EPA intends to host community virtual roundtables during which local organizations can participate in a discussion of LCRR-related topics and provide their unique perspective to EPA. The roundtables will focus on communities disproportionately impacted by the challenges of lead in drinking water. Beginning June 2021, EPA intends to host stakeholder roundtables where representatives of national organizations (e.g., environmental, industry, consumer, intergovernmental) can participate in a discussion of LCRR-related topics and provide their perspective to EPA. EPA requests that communities and organizations that would like to be considered for a roundtable submit their nomination letter to EPA via e-mail to LCRR@epa.gov no later than April 23, 2021.
FDA Closer To Zero Action Plan: On April 8, 2021, FDA announced an action plan named “Closer to Zero” that aims to reduce exposure to toxic elements, including lead, arsenic, cadmium, and mercury, from foods for babies and young children. FDA proposes making continual improvement by following a phased approach that includes research, regulatory, and outreach activities. Additional information is available at the link here.
Fees For Over-The-Counter Drug Program Announced: On March, 26, 2021, FDA announced the fiscal year (FY) 2021 fees for the Over-the-Counter (OTC) Monograph Drug user fee program. 86 Fed. Reg. 16223. The announcement includes a clarification regarding entities that registered with FDA during the COVID-19 pandemic whose sole activity with respect to OTC monograph drugs during the pandemic consists (or had consisted) of manufacturing OTC hand sanitizer products.
Extension For Food Facility DUNS Number: On March 30, 2021, FDA communicated an extension to when domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States are required to submit a unique facility identifier (UFI) with their registration submission (e.g., a Dun & Bradstreet (DUNS) number). To avoid unnecessary cancellations of registrations due to difficulties registrants may have with obtaining a valid DUNS number, FDA is further extending the time period to obtain and submit a UFI until December 31, 2022.
Gov4Nano Conducting “Data Sharing And FAIR Data Use Survey”: Gov4Nano is conducting a “Data Sharing and FAIR Data Use Survey” to obtain views and opinions from data users and producers on data availability and sharing and how these can be improved. Gov4Nano seeks to determine how barriers to data availability can be lowered and incentives for data sharing can be raised. Gov4Nano “want[s] to hear from all data users and producers, whatever your role.” The questionnaire can be answered anonymously.
EUON Seeks Topic Suggestions For Future Studies On Nanomaterials: On March 19, 2021, the European Union (EU) Observatory for Nanomaterials (EUON) announced that it is looking for topic suggestions that could be addressed in its upcoming studies. According to EUON, up to three studies are conducted annually to address knowledge gaps on nanomaterials that are of interest to the general public and the research community. EUON states that it seeks studies that address: questions relating to the health and safety of nanomaterials, including hazard and risk assessment, exposure to nanomaterials, or worker safety and protection; specific issues surrounding the uses of nanomaterials; or information about markets for nanomaterials (g., the market for specific materials, such as graphene, or specific market sectors). Proposals are due April 19, 2021.
EUON Publishes Nanopinion On NanoApp Developed By ECETOC Task Force On Nanomaterials: On March 19, 2021, EUON published a Nanopinion entitled “ECETOC task force ensures society benefits from safe nanomaterials via efficient safety assessments that require minimal animal testing” by authors from BASF and the Center for Chemical Safety Assessment (ECETOC). The column reviews ways to assess the safety of nanomaterials while minimizing animal testing. According to the authors, the NanoApp developed by the ECETOC Task Force on Nanomaterials helps users group similar nanoforms, which can be useful when registering nanoforms via sets of similar nanoforms, or when doing read-across between nanoforms for particular information requirements.
NanoHarmony Posts Recording And Slides For Webinar On Identification And Solving Barriers For Translating Science To Regulation And Standards: On March 17, 2021, NanoHarmony held a webinar on “Identification and solving barriers for translating science to regulation and standards.” According to NanoHarmony, the webinar focused on helping to identify the obstacles faced by stakeholders in developing new test methods and having them introduced as new test guidelines and guidance documents. A recording of the webinar is now available online. More information is available in our March 25, 2021, blog item.
EC Requests Committee Opinion On Safety Of Titanium Dioxide In Toys; Committee Calls For Scientific Information: The European Commission (EC) has requested a scientific opinion from the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) on the safety of titanium dioxide in toys with regard to a possible derogation from its prohibition. The Toy Safety Directive 2009/48/EC prohibits the use of substances in toys if those substances are classified as carcinogenic, mutagenic, or toxic for reproduction (CMR). The use of such substances may be permitted under certain conditions, however. SCHEER has called for scientific information on: the chemical and physical specifications of titanium dioxide used in toys; the size distribution of pigment grade titanium dioxide used in toys; the migration or release of titanium dioxide from toys; and exposure measurements on titanium dioxide used in toys. Submissions are due April 28, 2021. More information is available in our April 1, 2021, blog item.
ISO Updates Series Of Standards For Nanotechnology: On April 1, 2021, The International Organization for Standardization (ISO) published a news item entitled “The Science of Tiny Little Things.” According to the item, ISO has recently made some revisions and updates to its comprehensive 13-part series of International Standards for nanotechnology. Updated standards include ISO/TS 80004-3, Nanotechnologies – Vocabulary – Part 3: Carbon nano-objects, which defines terms and concepts for carbon nano-objects, ISO/TS 80004-6, Nanotechnologies – Vocabulary – Part 6: Nano-object characterization, and ISO/TS 80004-8, Nanotechnologies – Vocabulary – Part 8: Nanomanufacturing processes. The item states that work is underway “to develop a standard that will consolidate some of the most fundamental terminology in the series.” More information is available in our April 5, 2021, blog item.
SOT FDA Colloquia Series Includes Webcast On The Toxicology Of Nanoparticles: The Society of Toxicology (SOT) in conjunction with the FDA Center for Food Safety and Applied Nutrition (CFSAN) have partnered to provide a colloquia series on Emerging Toxicological Science: Challenges in Food and Ingredient Safety. On April 8, 2021, there was a live webcast on the toxicology of nanoparticles. Richard Canady, Ph.D., and Kapal Dewan, MS, CLSp(CG), are Colloquium Co-Chairs. More information is available in our March 30, 2021, blog item.
EC Committee Concludes Hydroxyapatite (Nano) In Cosmetic Products Can Pose A Risk To Consumers: On April 12, 2021, the EC Scientific Committee on Consumer Safety (SCCS) published its final opinion on hydroxyapatite (nano). The EC asked whether SCCS considers the nanomaterial hydroxyapatite safe when used in leave-on and rinse-off dermal and oral cosmetic products according to the maximum concentrations and specifications reported, taking into account reasonably foreseeable exposure conditions. SCCS concluded that there is a basis for concern that the use of hydroxyapatite (nano) in cosmetic products “can pose a risk to the consumer.” More information is available in our April 13, 2021, blog item.
Registration Open For April 27 NNI Webinar On “What We Know About NanoEHS: Environment”: Registration is open for the U.S. National Nanotechnology Initiative’s (NNI) April 27, 2021, webinar on “What We Know about NanoEHS: Environment.” The webinar will feature experts from diverse disciplines to share their perspectives on key findings on the effects of engineered nanomaterials in the environment. More information is available in our April 6, 2021, blog item.
B&C® Biobased And Sustainable Chemicals Blog: For access to a summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to http://blog.braginfo.org.
Republicans On House Committee Release Agenda For Securing Cleaner American Energy: On March 15, 2021, Republicans on the House Energy and Commerce Committee released an agenda for Securing Cleaner American Energy. According to the press release, the legislative package will address climate change risks and spur the development and deployment of clean energy infrastructure. The press release states that the package will modernize and improve the nation’s energy infrastructure and promote an all-the-above energy strategy across the board, including solutions to unleash innovation in hydropower, nuclear, clean coal, and natural gas. These are “real, workable solutions to make energy cleaner, reduce emissions, prioritize energy security, and keep energy costs low.”
Bipartisan Legislation To Help Communities Upgrade Wastewater Infrastructure And Address Local Water Quality Challenges Introduced In The House: On March 16, 2021, Representatives Peter DeFazio (D-OR), Chair of the House Committee on Transportation and Infrastructure, Grace F. Napolitano (D-CA), Chair of the Subcommittee on Water Resources and Environment, and Brian Fitzpatrick (R-PA), Ranking Member of the Aviation Subcommittee, introduced the Water Quality Protection and Job Creation Act of 2021 (H.R. 1915). According to the Committee’s press release, the bill would authorize $50 billion in direct infrastructure investment over the next five years to address wastewater infrastructure and local water quality challenges. The bill would also significantly increase the amount of federal assistance made available to states and communities through the Clean Water State Revolving Fund (SRF) program, which has not been reauthorized by Congress since 1987.
Bill Would Improve Transparency Of Federal Advisory Committee Act Committees: On March 16, 2021, Representatives Carolyn B. Maloney (D-NY) and James Comer (R-KY), the Chair and Ranking Member of the House Committee on Oversight and Reform, along with Senator Rob Portman (R-OH), Ranking Member of the Senate Committee on Homeland Security and Governmental Affairs, and Senator Maggie Hassan (D-NH), Chair of the Subcommittee on Emerging Threats and Spending Oversight, introduced the Federal Advisory Committee Transparency Act (H.R. 1930, S. 790). According to the House Committee’s March 16, 2021, press release, the bill would require that agencies inform committee members of any applicable ethics requirements; ensure the disclosure of detailed minutes from advisory committee meetings; and clarify that the law applies to subcommittees and to committees set up by a contractor. The House passed similar legislation in the 114th, 115th, and 116th Congress.
House Subcommittee Holds Hearing On “Brain Drain: Rebuilding The Federal Scientific Workforce”: On March 17, 2021, The House Science, Space, and Technology Subcommittee on Investigations and Oversight held a hearing on “Brain Drain: Rebuilding the Federal Scientific Workforce.” During the hearing, Subcommittee Chair Bill Foster (D-IL) submitted a Majority staff report into the record. The staff report, “Scientific Brain Drain: Quantifying the Decline of the Federal Scientific Workforce,” evaluates how Science, Technology, Engineering and Mathematics (STEM) civil service employment has expanded or contracted over the past decade at several federal agencies, including EPA. More information is available in our March 19, 2021, blog item.
Senate Committee Approves Bipartisan Bill Intended To Protect Firefighters From PFAS: On March 17, 2021, the Senate Committee on Homeland Security and Governmental Affairs approved the Protecting Firefighters from Adverse Substances (PFAS) Act (S. 231). The bill would direct federal agencies to develop best practices, training, and educational programs to reduce, limit, and prevent exposure to PFAS. The bill would also require guidance to be issued on alternative foams and PPE that do not contain PFAS. The bill has now moved to the full Senate.
Water Rights Protection Act Would Protect Private Water Rights: On March 18, 2021, Republicans on the Senate Committee on Energy and Natural Resources introduced the Water Rights Protection Act (S. 855). According to the Republicans’ press release, the bill would protect privately owned waters from being seized by the federal government. The press release states that the legislation would forbid the Departments of the Interior and Agriculture from mandating water users transfer water rights to the United States or purchase water rights in the name of the United States as a condition of any permit, lease, or other use agreement; prevent unlawful seizures of groundwater; and recognize state water law and require coordination with states.
Bipartisan Infrastructure Bill Would Rebuild Water Infrastructure: On March 23, 2021, the Senate Committee on Environment and Public Works announced the introduction of the Drinking Water and Wastewater Infrastructure Act of 2021 (S. 914). The bill would authorize more than $35 billion for water resource development projects with a focus on upgrading aging infrastructure, addressing the threat of climate change, investing in new technologies, and providing assistance to marginalized communities. According to the Committee’s press release, the bill would:
- Invest significantly in small, disadvantaged, rural, and tribal communities through grant programs that promote environmental justice;
- Provide states with increased funding and program flexibilities to invest in community water projects that address aging infrastructure and improve water quality through the State Revolving Loan Funds;
- Connect households to public water and wastewater services, decentralized wastewater services, and improve sanitation in Alaskan rural and native villages;
- Increase investments in lead abatement through grant programs and assistance;
- Promote resiliency projects to address the impacts of climate change;
- Increase investment to address recruitment, training, and retention challenges facing the water and wastewater utility workforce;
- Invest in the drinking water and wastewater needs of tribal communities; and
- Provide significant investments in technical assistance and new and emerging technologies that result in cleaner, safer, and more reliable water.
Senate Bill Would Introduce Tax Relief Bill To Aid Clean Energy’s Recovery: On March 25, 2021, the Senate Committee on Environment and Public Works announced the introduction of the Save America’s Clean Energy Jobs Act, which would “help the clean energy industry create good-paying jobs and recover from the COVID-driven economic downturn.” The bill would allow for temporary refundability of Section 45, 45Q, and 48 investment and production tax credits, which incentivize private development of renewable energy projects such as solar, wind, fuel cells, and carbon capture and sequestration. The press release states that this “will enable clean energy companies to bypass frozen tax equity markets and access these tax credits directly, which in turn will help get stalled projects off the ground and people back to work.”
Senate Bill Intends To Spur Investments In Clean Vehicle Charging And Refueling Stations: On March 25, 2021, the Senate Committee on Environment and Public Works announced the introduction of the Securing America’s Clean Fuels Infrastructure Act, which is intended to promote investments in clean vehicle infrastructure, such as electric vehicle charging stations and hydrogen refueling stations for fuel cell vehicles. According to the press release, the bill would improve and expand the Alternative Fuel Vehicle Refueling Property Investment Tax Credit (ITC), commonly referred to as “30C,” lowering costs for clean vehicle infrastructure deployment. The press release states that by providing incentives to build the needed infrastructure to support clean vehicles, the legislation will support consumers as they move towards more electric and clean energy vehicles.
Bicameral Bill Would Address “Plastic Pollution Crisis”: On March 25, 2021, Senator Jeff Merkley (D-OR) and Representative Alan Lowenthal (D-CA) introduced the bicameral Break Free from Plastic Pollution Act. According to Merkley’s press release, the bill is “the most comprehensive plan ever introduced in Congress to address the plastic pollution crisis that is poisoning our air, water, and land, and disproportionately impacting communities of color and low-income Americans.” The legislation would reduce plastic production, increase recycling, and protect frontline and fenceline communities from emissions from plastic waste by changing the incentives of the industry. The press release states that the bill would “shift the burden of cleanup to the corporations that produced the plastics so they have financial motivation to end the burning and dumping”; strengthen environmental justice protections; eliminate waste export loopholes; and extend existing laws that have been proven to work on the state and local level.
Carbon Capture Legislation Would Use Changes To Tax Credits To Reduce GHG Emissions: On March 25, 2021, Senators Shelley Moore Capito (R-WV), Ranking Member of the Senate Committee on Environment and Public Works, and Joe Manchin (D-WV), Chair of the Senate Committee on Energy and Natural Resources, introduced legislation to reduce GHG emissions. The Carbon Capture, Utilization, and Storage (CCUS) Tax Credit Amendments Act is intended to make tax credits that encourage carbon capture projects more available and easier to use.
House Science Committee Leaders Introduce NSF For The Future Act: On March 26, 2021, Representatives Eddie Bernice Johnson (D-TX), Chair of the House Committee on Science, Space, and Technology, and Frank Lucas (R-OK), Ranking Member, introduced the National Science Foundation (NSF) for the Future Act. According to the Committee’s press release, the legislation increases the funding for more research; advances research and development to address persistent challenges in STEM education across all education levels; addresses challenges for data access and accountability, as well as security threats that undermine the integrity of federally-funded research; and creates a new Directorate for Science and Engineering Solutions (SES) that will enable NSF “to take big risks and experiment with new approaches to accelerating the translation of science and technology into solutions to society’s major challenges.”
Biden-Harris Administration FY 2022 Discretionary Funding Request Includes $11.2 Billion For EPA: According to an April 9, 2021, EPA press release, the Biden-Harris Administration submitted President Joseph Biden’s priorities for FY 2022 discretionary spending to Congress on April 9, 2021. The press release highlights the following provisions of the request:
- Tackling Climate Change with the Urgency Science Demands: In line with the urgency needed to address this crisis, the discretionary request invests $1.8 billion in programs that will help reduce GHG emissions, while also delivering environmental justice to marginalized and over-burdened communities;
- Delivering Environmental Justice for Overburdened and Marginalized Communities: For decades, low-income and marginalized communities have been overburdened with air pollution and other environmental hazards. The discretionary request directs more than $900 million towards a new Accelerating Environmental and Economic Justice initiative that will help create jobs, clean up pollution, and secure environmental justice for communities who too often have been left behind, including rural and Tribal communities;
- Investing in Critical Water Infrastructure and Creating Jobs: The discretionary request provides a total of $3.6 billion for water infrastructure, an increase of $625 million over the FY 2021 enacted level;
- Protecting Communities from Hazardous Waste and Environmental Damage: Preventing and cleaning up environmental damage that harms communities and poses a risk to public health and safety is both an economic and moral imperative. The discretionary request provides $882 million for the Superfund Remedial program to clean up some of the nation’s most contaminated land, reduce emissions of toxic substances and GHGs from existing and abandoned infrastructure, and respond to environmental emergencies, oil spills, and natural disasters;
- Addressing PFAS Pollution: The discretionary request provides approximately $75 million to accelerate toxicity studies and research to inform the regulatory developments of designating PFAS as hazardous substances and setting enforceable limits for PFAS under the Safe Drinking Water Act (SDWA), and for grants for technical assistance as state and local governments deal with PFAS contamination; and
- Restores Critical Capacity to Carry Out EPA’s Core Mission: EPA has lost nearly 1,000 staff over the past four years, impacting the Agency’s ability to carry out effectively its core duties and functions to protect public health and the environment. The discretionary request invests in restoring EPA’s critical staff capacity and programmatic capabilities that focus on protecting clean air, land, and water.
The press release states that in the coming months, the Administration will release the President’s Budget, “which will present a unified, comprehensive plan to address the overlapping crises we face in a fiscally and economically responsible way.”
Bipartisan PFAS Action Act Is Intended To Protect Air, Land, And Water From PFAS Contamination: On April 13, 2021, Representatives Fred Upton (R-MI) and Debbie Dingell (D-MI) introduced the PFAS Action Act. According to Upton’s April 13, 2021, press release, the legislation would:
- Require EPA to establish a national drinking water standard for perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) within two years that protects public health, including the health of vulnerable subpopulations;
- Designate PFOA and PFOS chemicals as hazardous substances within one year and require EPA to determine whether to list other PFAS within five years;
- Designate PFOA and PFOS as hazardous air pollutants within 180 days and require EPA to determine whether to list other PFAS within five years;
- Require EPA to place discharge limits on industrial releases of PFAS and provide $200 million annually for wastewater treatment;
- Prohibit unsafe incineration of PFAS wastes and place a moratorium on the introduction of new PFAS into commerce;
- Require comprehensive PFAS health testing; and
- Create a voluntary label for PFAS in cookware.
House Subcommittee Holds Legislative Hearing On Environmental Justice Bills And CLEAN Future Act: On April 15, 2021, the House Energy and Commerce Subcommittee on Environment and Climate Change held a legislative hearing on “The CLEAN Future Act and Environmental Justice: Protecting Frontline Communities.” The legislation discussed during the hearing included several environmental justice proposals, including the provisions within the Climate Leadership and Environmental Action for our Nation’s (CLEAN) Future Act.
House Climate Crisis Committee Holds Hearing On Growing Risks And Costs Of Inaction: On April 15, 2021, the House Select Committee on the Climate Crisis held a hearing entitled “Making the Case for Climate Action: The Growing Risks and Costs of Inaction.” The hearing explored the changes seen in climate, the efforts underway to study those changes, and the economic risks and impacts the climate crisis poses to labor supply, human health, and the American economy. It also explored the disparate impacts of the climate crisis on low-income communities and communities of color.
NGOs Claim Chevron Misled Consumers On Climate Action In Violation Of FTC Green Guides: On March 16, 2021, Earthworks, Global Witness, and Greenpeace USA jointly filed a Federal Trade Commission (FTC) complaint against Chevron for “unlawfully deceptive advertisements which overstate investment in renewable energy and its commitment to reducing fossil fuel pollution.” According to Earthworks’ March 16, 2021, press release, the complaint claims that Chevron “is consistently misrepresenting its image to appear climate-friendly and racial justice-oriented, while its business operations overwhelmingly rely on climate-polluting fossil fuels, which disproportionately harm communities of color.” The press release notes that the complaint is the first to petition FTC to use its Guides for the Use of Environmental Marketing Claims (Green Guides) against a fossil fuel company for misleading consumers on the climate and environmental impact of its operations. The complaint requests that Chevron remove the misleading marketing claims and disseminate corrective statements, and that FTC assess appropriate relief according to the law. More information is available in our April 14, 2021, memorandum.
EPA Announces External Expert Peer Review And Public Comment For EPA MPPD Model Software And Documentation: On March 23, 2021, EPA announced an external expert peer review and public comment for the EPA Multiple-Path Particle Dosimetry (MPPD) Model Software (MPPD EPA 2021 v. 1.01) and its associated “Technical Support Documentation and User’s Guide (External Review Draft)” ([EPA/600/R-20/406]). 86 Fed. Reg. 15476. EPA is releasing this draft model software version and associated document to seek review by external experts and the public. EPA notes that the external review draft document and model software (MPPD EPA 2021 v. 1.01) are not final and do not represent, and should not be construed to represent, any final Agency policy or views. When revising the document and the model software, EPA will consider any peer or public comments submitted during the public comment period specified in this document. Comments are due April 22, 2021. The peer review will be open to the public. The peer review will take place over three days: May 4, 2021, 12:00 p.m. - 4:30 p.m. EDT; May 6, 2021, 11:30 a.m. - 5:00 p.m. EDT; and May 10, 2021, 11:30 a.m. - 5:00 p.m. EDT. Registration is available here.
White House Announces Environmental Justice Advisory Council Members: On March 29, 2021, The White House announced the members of the White House Environmental Justice Advisory Council (WHEJAC). The WHEJAC will provide advice and recommendations to the Chair of the Council on Environmental Quality (CEQ) and the White House Environmental Justice Interagency Council on how to address current and historic environmental injustices, including recommendations for updating Executive Order (EO) 12898, Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations, signed by former President William J. Clinton in 1994. The WHEJAC was established by President Biden’s EO on Tackling the Climate Crisis at Home and Abroad to fulfill his and Vice President Harris’s commitment to “confronting longstanding environmental injustices and to ensuring that historically marginalized and polluted, overburdened communities have greater input on federal policies and decisions.”
EPA Administrator Directs EPA To Reset “Critical Science-Focused Federal Advisory Committees”: On March 31, 2021, EPA Administrator Michael Regan announced his decision to reestablish the membership of the Science Advisory Board (SAB) and the Clean Air Scientific Advisory Committee (CASAC) and reorient the SAB standing committees. EPA staff is now tasked with reconfiguring the independent committees in a way that returns the Agency “to its standard process of incorporating a balanced group of experts.” The announcement states that Regan’s decision to reset these federal advisory committees “emphasizes the importance of the SAB and the CASAC to EPA’s mission of protecting human health and the environment, and seeks to reverse deficiencies caused by decisions made in recent years.” The SAB staff office will initiate the release of current SAB and CASAC members; reconstitute, restore, and create new committees to address better EPA priorities; and augment both SAB and CASAC with specialized panels. EPA published Federal Register notices on April 1, 2021, to solicit nominations from all qualified experts in a variety of disciplines to SAB and its standing committees (86 Fed. Reg. 17148) and CASAC (86 Fed. Reg. 17146). Nominations are due May 3, 2021. EPA states that it “is grateful for the dedicated service of its current members and encourages all who are interested to reapply for consideration.”
International Trade Administration Will Hold Advisory Committee Meeting On Supply Chain Competitiveness: On April 2, 2021, the International Trade Administration announced that the Advisory Committee on Supply Chain Competitiveness will meet on April 22, 2021. 86 Fed. Reg. 17363. According to the notice, Committee members are expected to continue discussing the major competitiveness-related topics raised at the previous Committee meetings, including trade and competitiveness; freight movement and policy; trade innovation; regulatory issues; finance and infrastructure; and workforce development. The Committee’s subcommittees will report on the status of their work regarding these topics. The agenda may change to accommodate other Committee business. The Office of Supply Chain, Professional & Business Services will post the final detailed agenda on its website, https://www.trade.gov/acscc, at least one week prior to the meeting.
PHMSA Will Hold Public Meetings For International Standards On Transport Of Dangerous Goods: On April 2, 2021, the Pipeline and Hazardous Materials Safety Administration (PHMSA) announced that its Office of Hazardous Materials Safety will host four public meetings during 2021 in advance of certain international meetings. 86 Fed. Reg. 17453. The first meeting will be held in preparation of the International Civil Aviation Organization’s (ICAO) Dangerous Goods Panel (DGP) Working Group 21 (WG/21) virtual meeting scheduled for May 24-28, 2021. The second meeting will be held in preparation of the 58th session of the United Nations Sub-Committee of Experts on the Transport of Dangerous Goods (UNSCOE TDG) scheduled for June 28 - July 2, 2021, in Geneva, Switzerland. The third meeting will be held in preparation of the ICAO DGP 28 Meeting (DGP/28) scheduled for September 27 - October 1, 2021. The fourth meeting will be held in preparation of the 59th session of the UNSCOE TDG scheduled for November 29 - December 8, 2021. For each of these meetings, PHMSA will solicit public input on current proposals. Each public meeting will take place virtually approximately two weeks preceding the international meeting.
EPA Administrator Announces Agency Actions To Advance Environmental Justice: On April 7, 2021, EPA Administrator Michael Regan announced that he directed all EPA offices to integrate clearly environmental justice considerations into their plans and actions. Regan called on all EPA offices to take the following steps: strengthen enforcement of violations of cornerstone environmental statutes and civil rights laws in communities overburdened by pollution; take immediate and affirmative steps to incorporate environmental justice considerations into their work, including assessing impacts to pollution-burdened, underserved, and Tribal communities in regulatory development processes and to consider regulatory options to maximize benefits to these communities; take immediate and affirmative steps to improve early and more frequent engagement with pollution-burdened and underserved communities affected by Agency rulemakings, permitting and enforcement decisions, and policies; and consistent with the Administration’s Justice 40 initiative, consider and prioritize direct and indirect benefits to underserved communities in the development of requests for grant applications and in making grant award decisions, to the extent allowed by law.
OSHA Extends Comment Period On Proposed Updates To HCS: On April 12, 2021, OSHA published a Federal Register notice to extend the comment period of the notice of proposed rulemaking (NPRM) to amend the Hazard Communication Standard (HCS) by one month. 86 Fed. Reg. 18924. The HCS is the federal-level legislation that sets forth the classification, labeling, SDS, and training requirements for hazardous chemicals intended to be used, handled, or stored in workplaces. The current HCS is based on the third revised edition (Rev 3) of the United Nations (UN) Globally Harmonized System of Classification and Labeling of Chemicals (GHS). The proposed changes include updating the HCS to align with the seventh revised edition (Rev 7) of GHS. The transition period proposed is one year for chemical manufacturers, importers, and distributors of substances and two years for chemical manufacturers, importers, and distributors of mixtures after the effective final rule is published. The notice was open for comments until April 19, 2021. OSHA states in the Federal Register that it will extend the comment period to May 19, 2021, and that it intends to schedule an informal public hearing. For more information, see our April 13, 2021, memorandum.
CPSC Will Hold Webinar On Improvements To SaferProducts.gov: The U.S. Consumer Product Safety Commission (CPSC) announced on April 12, 2021, that it will hold a public webinar on April 28, 2021, to receive information from interested parties about updates CPSC is making to www.SaferProducts.gov/Business for reports filed electronically under Section 15(b) of the Consumer Product Safety Act (CPSA). 86 Fed. Reg. 18966. The presentation will focus on Section 15(b) reporting for the purposes of entering the Fast Track Recall Program. Webinar participants will have an opportunity to see the improvements to www.SaferProducts.gov/Business and provide feedback to CPSC through a moderated discussion. More information is available in our April 13, 2021, blog item.