By Lynn L. Bergeson and Carla N. Hutton
On September 1, 2022, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the availability of two new resources to answer stakeholder questions regarding the revised biotechnology regulations under 7 C.F.R. Part 340:
By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.
On May 27, 2022, EPA announced that it is seeking nominations for technical experts to serve as Special Government Employees (SGE) to participate in the review of the New Chemicals Collaborative Research Program with the Board of Scientific Counselors (BOSC), a federal advisory committee to the Office of Research and Development (ORD). EPA will consider nominees from industry, business, public and private research institutes or organizations, academia, government (federal, state, local, and Tribal), non-governmental organizations, and other relevant interest areas. EPA notes that it values and welcomes diversity. EPA encourages all qualified candidates to apply regardless of gender, race, disability, or ethnicity. The deadline to submit nominations is June 30, 2022, and submissions should be made via the BOSC website. More information on EPA’s Draft Document on “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA” is available in Bergeson & Campbell, P.C.’s (B&C®) March 14, 2022, memorandum.
By Lynn L. Bergeson and Carla N. Hutton
On June 6, 2022, the U.S. Environmental Protection Agency (EPA) announced the winners of the 2022 Green Chemistry Challenge Awards. EPA states that green chemistry “is the design of chemical products and processes that reduce or eliminate the generation and use of hazardous substances.” According to EPA, the winners “have developed new and innovative green chemistry technologies that provide solutions to significant environmental challenges and spur innovation and economic development.” In support of the Biden Administration’s commitment to tackle the climate crisis, EPA added a new award category recognizing technology that reduces or eliminates greenhouse gas (GHG) emissions. The 2022 winners include:
- Professor Song Lin of Cornell University, Ithaca, New York, for developing a new, more efficient process to create large and complicated molecules that are widely used in the pharmaceutical industry. EPA states that the new technology avoids using hazardous materials and has the potential to reduce both energy use and wasteful byproducts.
- Merck, Rahway, New Jersey, for developing a greener way to make LAGEVRIO™ (molnupiravir), an antiviral treatment for COVID-19. According to EPA, Merck significantly improved the manufacturing process for this antiviral drug in a short time, producing ingredients more efficiently and greatly reducing solvent waste and energy use.
- Amgen, Thousand Oaks, California, for an improved manufacturing process for LUMAKRAS™ (sotorasib), a novel drug for the treatment of certain non-small cell lung cancers. EPA states that Amgen’s innovation decreased manufacturing time, lowered the amount of solvent waste generated, and established a recycling process for a high-value waste stream.
- Provivi, Santa Monica, California, for creating ProviviFAW®, a biological pheromone-based product that controls the fall armyworm, a destructive pest of corn. The product’s pheromone active ingredients are produced through innovative green chemistry using renewable plant oils. According to EPA, ProviviFAW™ can reduce the need for conventional pesticides, which can be harmful to beneficial insects, such as pollinators.
- Professor Mark Mascal of the University of California, Davis, California, in partnership with Origin Materials, for a technology that reduces GHG emissions by producing chemicals for making polyethylene terephthalate (PET) plastic from biomass derived from sugar fructose rather than petroleum. EPA states that this novel chemistry could have significant climate impacts by replacing fossil-based products with carbon-neutral, biobased products, especially when the technology is scaled to an entire industry.
EPA recognized the winners during the American Chemical Society Green Chemistry & Engineering Conference. EPA states that since 1996, EPA and the American Chemical Society, which co-sponsor the awards, have received more than 1,800 nominations and presented awards to 133 technologies that decrease hazardous chemicals and resources, reduce costs, protect public health, and spur economic growth. According to EPA, winning technologies are responsible for reducing the use or generation of nearly one billion pounds of hazardous chemicals, saving over 20 billion gallons of water, and eliminating nearly eight billion pounds of carbon dioxide equivalents released to the air.
By Lynn L. Bergeson
The Senate Committee on Environment and Public Works held a hearing on April 6, 2022, on the U.S. Environmental Protection Agency’s (EPA) proposed fiscal year (FY) 2023 budget. The only witness was EPA Administrator Michael S. Regan. In his written testimony, Regan states that EPA has significant responsibilities under amendments to the Toxic Substances Control Act (TSCA) to ensure the safety of chemicals in or entering commerce and addressing unreasonable risks to human health or the environment. President Biden’s proposed budget would provide $124 million and 449 full-time equivalents (FTE) to implement TSCA, an increase of more than $60 million. According to Regan, these resources will support EPA-initiated chemical risk evaluations, issue protective regulations in accordance with statutory timelines, and establish a pipeline of priority chemicals for risk evaluation. EPA “also has significant responsibility under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to screen new pesticides before they reach the market and ensure pesticides already in commerce are safe.” Regan notes that in addition, EPA is responsible for complying with the Endangered Species Act (ESA) and ensuring that federally endangered and threatened species are not harmed when EPA registers pesticides. The FY 2023 budget includes an additional $4.9 million to enable EPA’s pesticide program to integrate ESA requirements in conducting risk assessments and making risk management decisions that protect federally threatened and endangered species from exposure to new active ingredients.
After Regan gave his opening statement, the Committee asked questions. Committee Chair Tom Carper (D-DE) stated that President Biden requested $124 million and hiring of about 450 FTEs to implement the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). According to Carper, despite the previous Administration’s failure to request funds to support implementation of the Lautenberg Act, EPA professionals have worked hard to meet the aspirations and mandates of the Act. Carper asked Regan to describe the resource challenges that the TSCA program is currently facing and how EPA plans to fulfill its obligations under the Lautenberg Act if Congress appropriates the increase in resources requested by the Biden Administration. Regan stated that the previous Administration missed nine of ten deadlines for chemical risk review evaluations. Meanwhile, the workload for the Biden EPA has doubled, with 20 high-priority risk evaluations to do and ten risk management rules to write, but EPA is still working with the same budget that it had before the Lautenberg Act. As a result, EPA has only about 50 percent of the resources that it thinks it needs to review the safety of new chemicals quickly and in the way that the law requires. The proposed FY 2023 budget reflects what EPA thinks it will actually take to implement the Lautenberg Act in the way that Congress and stakeholders expect and deserve. According to Regan, EPA would put those resources to good use. EPA wants to keep pace with what Congress requested.
According to Senator Kevin Cramer (R-ND), the North Dakota Agricultural Commissioner sent a letter to EPA’s Office of Pesticide Programs (OPP) (still waiting for a response) about unused stocks of chlorpyrifos. In August 2021, EPA issued a final rule revoking all tolerances for chlorpyrifos. Cramer stated that under the final rule, farmers and retailers have six months to dispose of it. To date, there has been very little to no guidance on how to dispose of it, and without guidance from EPA, there is worry about improper disposal or illegal use. Cramer asked Regan if he could provide some assurance that EPA is not going to seek to punish growers that currently have product in their possession. Regan responded that in this case, like others, EPA found itself in a situation where, because of inaction over decades, the court put it on a timeline to take action. Regan stated that he can commit that the EPA regional office is working with North Dakota now to think about how to address the situation.
As Regan noted in his testimony before the Committee, the Lautenberg Act includes statutory deadlines that EPA must meet as it evaluates existing chemicals. In addition to these mandates, after reviewing the risk evaluations completed by the previous Administration, the Biden EPA announced June 30, 2021, its plans to review and address certain issues. The Biden EPA is working to complete its revisions to the final risk evaluations and move to the risk management rulemaking stage. Under the previous Administration, EPA, in 2020 and 2021, directed significant energy to developing risk evaluations for the “Next 20” chemicals designated as high priority for risk evaluations through the TSCA prioritization process, completing scoping documents in September 2020. In light of the Biden Administration’s revised approach to risk evaluations, however, those scoping documents will need to be revisited and revised as appropriate, and work is expected to continue through 2022 and probably much of 2023. EPA also now has received four manufacturer-requested risk evaluations, three of which have been granted as of mid-December 2021, and one of which is pending. Without significant resources, the Biden EPA will struggle to meet the ambitious goals of the Lautenberg Act.
By Lynn L. Bergeson
On February 24, 2022, EPA announced the selection of 11 organizations to receive a total of approximately $2 million in funding to divert food waste from landfills by expanding anaerobic digester capacity nationwide. Anaerobic digestion (AD) produces biogas that can be captured and used for energy production and digestate (a fertilizer product) by using microorganisms to break down organic materials, such as food scraps and manure, in the absence of oxygen. By reducing the amount of wasted food in landfills and consequently methane emissions, AD may reduce significantly the impacts of climate change. EPA’s food recovery hierarchy includes AD as a strategy that is preferable to landfilling and incineration, because it contributes to building a circular economy. Each of the selected organizations will receive between $150,000 and $200,000 over two years. A list of the selected projects is available here.
By Lynn L. Bergeson
On January 10, 2022, the Massachusetts Institute of Technology (MIT) announced that a team of its researchers has developed a promising approach to control methane emissions and remove methane from the air using zeolite clay. Zeolite clay is inexpensive and abundant. The MIT team found that, when treated with copper, the material is very effective at absorbing methane from the air even at low concentrations. According to researcher and Associate Professor of Civil and Environmental Engineering, Desiree Plata, Ph.D., this process is advantageous over other approaches to removing methane from the air, as other methods tend to use more expensive catalysts that require high temperatures. The method converts methane into carbon dioxide that, according to Plata, is much less impactful in the atmosphere than methane. Methane is about 80 times stronger as a greenhouse gas (GHG) over the first 20 years, and approximately 25 times stronger for the first century.
MIT researchers still have outstanding engineering details to address in this process. To do so, the U.S. Department of Energy (DOE) awarded a $2 million grant for MIT to continue to develop specific equipment for methane removal in places with concentrated sources of methane, such as dairy barns and coal mines. Plata reported that the next phase of the project will focus largely on ways to structure the clay material in a multiscale, hierarchical configuration to demonstrate a proof of concept that this method can work in the field.
By Lynn L. Bergeson
On December 28, 2021, EPA announced that it will hold a public virtual meeting to discuss biofuel greenhouse gas (GHG) modeling. EPA is soliciting information on the current scientific understanding of GHG modeling of land-based biofuels used in the transportation sector. According to EPA, the information gathered during this meeting will be used to inform current and future EPA actions, including the method for quantifying GHG emissions under RFS. Of particular interest to EPA, is input on:
- How to incorporate the best available science into an update of EPA’s biofuels lifecycle analysis (LCA); and
- The next steps EPA should take in this work area.
Hosted by EPA’s Office of Transportation and Air Quality in consultation with USDA and DOE, the virtual public meeting is scheduled for February 28, 2022, and March 1, 2022, from 12:00 p.m. to 4:00 p.m. (EST). EPA will also be accepting comments on these topics until April 1, 2022.
By Lynn L. Bergeson
On June 7, 2021, Secretary of Energy Jennifer M. Granholm launched the U.S. Department of Energy’s (DOE) Energy Earthshots Initiative. Designed to accelerate innovation of abundant, affordable, and reliable clean energy solutions within the next ten years. Secretary Granholm stated that the first Energy Earthshot will be the Hydrogen Shot, which sets an ambitious yet achievable cost target to accelerate innovations and spur demand of clean hydrogen.” The Hydrogen Shot aims to reduce the cost of clean hydrogen by 80 percent to $1 per kilogram (kg) while also creating more clean energy jobs. Currently, clean hydrogen costs approximately $5 per kg. This initiative will drive program development across DOE’s science and applied energy offices, and the Advanced Research Projects Agency-Energy (ARPA-E).
DOE’s Hydrogen Program issued a Request for Information (RFI) on viable hydrogen demonstrations that can help to lower the cost of hydrogen, reduce carbon emissions, create jobs, and provide benefits to disadvantaged communities. Topics for the RFI include:
- Hydrogen Production, Resources, and Infrastructure;
- End Users for Hydrogen Based on Specific Regions, Cost, and Value Propositions;
- Greenhouse Gas and Other Pollutant Emissions Reduction Potential;
- Diversity, Equity, and Inclusion (DEI), Jobs, and Environmental Justice; and
- Science and Innovation Needs and Challenges.
RFI responses are due on July 7, 2021, by 5:00 p.m. (EDT). Additional information about the RFI is available here.
By Lynn L. Bergeson
On May 28, 2021, the Biden-Harris Administration submitted President Joseph Biden’s budget for fiscal year 2022 (FY 2022) to Congress. According to EPA’s May 28, 2021, press release, the budget request advances “key EPA priorities, including tackling climate change, advancing environmental justice, protecting public health, improving infrastructure, creating jobs, and supporting and rebuilding the EPA workforce.” The President’s FY 2022 budget request supports:
- Rebuilding Infrastructure and Creating Jobs: The budget 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 greenhouse gases (GHG) from existing and abandoned infrastructure, and respond to environmental emergencies, oil spills, and natural disasters;
- Protecting Public Health: The budget includes $75 million to accelerate toxicity studies and fund research to inform the regulatory developments of designating per- and polyfluoroalkyl substances (PFAS) as hazardous substances while setting enforceable limits for PFAS. In FY 2022, EPA will advance public health by providing an additional $15 million and 87 full-time equivalent employees (FTE) to build agency capacity in managing chemical safety and toxic substances under the Toxic Substances Control Act (TSCA);
- Tackling the Climate Crisis with the Urgency Science Demands: The FY 2022 budget recognizes the opportunity in tackling the climate crisis by developing the technologies and solutions that will drive new markets and create good paying jobs. The budget restores the Air, Climate, and Energy Research Program and increases base funding by more than $60 million, including $30 million for breakthrough research through the Advanced Research Projects Agency-Climate (ARPA-C) with DOE. The budget provides an additional $6.1 million and 14 FTEs to implement the recently enacted American Innovation and Manufacturing (AIM) Act and reduce potent GHGs while supporting new manufacturing in the United States;
- Advancing Environmental Justice and Civil Rights: The budget includes more than $900 million in investments for environmental justice-related work, collectively known as EPA’s Accelerating Environmental and Economic Justice Initiative, elevating environmental justice as a top priority across the agency. The budget also proposes a new national program dedicated to environmental justice to further that goal;
- Supporting States, Tribes, and Regional Offices: Almost half of the total budget, $5.1 billion, will support states, tribes, and localities through the State and Tribal Assistance Grants account;
- Prioritizing Science and Enhancing the Workforce: The FY 2022 budget includes an increase of 1,026 FTEs “to stop the downward slide in the size of EPA’s workforce in recent years to better meet the mission.” Within this increase are 114 FTEs to propel and expand EPA’s research programs to ensure the agency has the science programs that communities demand from EPA. Also included are 86 additional FTEs to support the criminal and civil enforcement programs to ensure that environmental laws are followed.
By Lynn L. Bergeson
On June 3, 2021, from 2:00 p.m. to 3:00 p.m. (EDT), the U.S. Department of Energy’s (DOE) Office of Energy Efficiency & Renewable Energy (EERE) Acting Assistant Secretary Kelly Speakes-Backman and the Deputy Assistant Secretaries (DAS) for EERE’s three technology pillars and Operations will host a webinar to discuss EERE’s fiscal year 2022 (FY 2022) budget request. DOE EERE’s three technology pillars are: Energy Efficiency, Renewable Power, and Sustainable Transportation. EERE has requested $4.7 billion in an effort to lead the transition of the national economy into a 100 percent clean energy economy. The budget request includes more than $1 billion in new funding to deploy clean energy technologies. The one-hour webinar will cover activities, programs, and initiatives proposed in EERE’s budget request. EERE’s main goals include the decarbonization of the electricity, industrial, and transportation sectors. Registration is available at https://www.zoomgov.com/webinar/register/WN_80xUPhvCQOmKaId8TNUJ7Q.