Federal
National Academies Publishes Proceedings Of Workshop On Successes And Challenges In Biomanufacturing: The National Academies of Sciences, Engineering, and Medicine (NASEM) hosted an October 2022 workshop on successes and challenges in biomanufacturing. The workshop brought together biomanufacturing stakeholders across industry, academia, and government with expertise across diverse fields, including United States-based and international speakers. According to NASEM, discussions spanned the breadth of biomanufacturing contexts and applications, including bioindustrial and biopharmaceutical manufacturing. NASEM’s Proceedings of a Workshop-in Brief provides a high-level summary of the topics addressed at the workshop. NASEM notes that the summary should not be viewed as consensus conclusions or recommendations of NASEM.
EPA Announces P2 Grant For Environmental Justice Through Safer And More Sustainable Products: On March 8, 2023, the U.S. Environmental Protection Agency (EPA) announced the availability of $16 million for two new grant opportunities to support states and Tribes in providing technical assistance to businesses seeking to develop and adopt pollution prevention (P2) practices that advance environmental justice in underserved communities. The Request for Applications for P2 investments include the Pollution Prevention Grant: Environmental Justice Through Safer and More Sustainable Products. The goal of this grant is to address environmental justice by providing P2 technical assistance to businesses (e.g., information, training, expert advice) to improve human health and the environment in disadvantaged communities by increasing the supply, demand, and use of safer and more sustainable products, such as those that are certified by EPA’s Safer Choice Program, or those that conform to EPA’s Recommendations for Specifications, Standards and Ecolabels for Federal Purchasing. Eligible entities include the 50 states, the District of Columbia, the U.S. Virgin Islands, the Commonwealth of Puerto Rico, any territory or possession of the United States, any agency or instrumentality of a state or Tribe, including colleges and universities, and federally recognized Tribes and intertribal consortia. EPA “strongly” encourages applicants to develop partnerships where they can strengthen their ability to provide P2 technical assistance to businesses in disadvantaged communities. The closing date for applications is June 20, 2023.
USDA Celebrates Inaugural National Biobased Products Day, Announces 2022 Award Winners For BioPreferred® Program “Excellence In Procurement”: On March 8, 2023, the U.S. Department of Agriculture (USDA) announced the kickoff of the inaugural National Biobased Products Day and highlighted the accomplishments of people and organizations working to improve sustainability within the federal government. A key component of federal sustainability efforts is USDA’s BioPreferred® Program, the federal government’s “official advocate and market accelerator for biobased products.” USDA congratulates the four winners of the BioPreferred® Program’s “Excellence in Procurement Award” for 2022 for reducing their respective agencies’ environmental impact by using biobased products and championing farmers in rural America:
- The U.S. Department of Energy’s (DOE) Y-12 National Security Complex in Oak Ridge, Tennessee;
- Christina Graves with USDA’s Forest Service;
- Brian McCabe with the National Park Service (NPS); and
- Brooke Siegel with the Federal Bureau of Investigation (FBI).
APHIS Accepting Public Comments On Draft Guide For Submitting Permit Applications For Microorganisms Developed Using Genetic Engineering: USDA’s Animal and Plant Health Inspection Service (APHIS) announced on March 23, 2023, the availability of a draft guide detailing the information requirements and process for submitting permit applications for microorganisms developed using genetic engineering. The draft Guide for Submitting Permit Applications for Microorganisms Developed Using Genetic Engineering under 7 CFR Part 340 is intended to assist developers with preparing a permit application for movement activities with modified microorganisms under 7 C.F.R. Part 340 (Movement of Organisms Modified or Produced through Genetic Engineering). Comments on the draft guide are due May 22, 2023. APHIS states that it will consider all comments received by May 22, 2023, prior to issuing the final version of the guide.
EPA’s Congressional Justification For FY 2024 Budget Includes Information On Safer Choice, EPP, And Green Chemistry Programs: EPA has posted the justification for its fiscal year (FY) 2024 appropriation estimates for the Committee on Appropriations (Congressional Justification (CJ)). According to the CJ, work in the P2 Program supports Objective 7.2: Promote Pollution Prevention under Goal 7: Ensure Safety of Chemicals for People and the Environment. The FY 2024 budget includes $29 million and 69.2 full-time equivalents (FTE) to support the P2 Program in the Environmental Program and Management (EPM) appropriation, an increase of $16 million and 18 FTEs above the FY 2023 enacted budget. The CJ states that FY 2024 funding will continue to support the following P2 programs:
- Safer Choice Program: In FY 2024, EPA will continue its Partner of the Year Awards Program, recognizing organizations and companies for their leadership in formulating products made with safer ingredients and making them available to communities. In FY 2024, Safer Choice will integrate and address environmental justice concerns through outreach and partnership activities. According to the CJ, Safer Choice will work with retailers and product manufacturers to help them develop more products containing safer chemical ingredients that are easy to identify and purchase.
- Environmentally Preferable Purchasing (EPP) Program: Beginning in FY 2023, the EPP Program is expanding the EPA Recommendations of Specifications, Standards, and Ecolabels for Federal Purchasing in new categories to support the Biden Administration’s environmental and human health goals and mandates, including net-zero emissions procurement, low embodied carbon construction materials, and products that do not contain per- and polyfluoroalkyl substances (PFAS). In FY 2024, EPA will enhance public protection from potential effects of PFAS through recommendations of additional standards/ecolabels to help purchasers identify products that meet specific environmental performance criteria.
- Green Chemistry Program: In FY 2024, the Green Chemistry Program will begin to work with Green Chemistry Challenge awardees and nominees to pursue the goal of market-oriented environmental and economic progress through increased adoption of these innovations. The CJ notes that EPA will support and lead portions of EPA’s responsibilities for implementation of the Sustainable Chemistry Research and Development Act of 2020. More information on the Sustainable Chemistry Research and Development Act of 2020 is available in our January 19, 2021, memorandum.
More information is available in our March 24, 2023, blog item.
Biden Administration Announces New Goals And Priorities To Advance Biotechnology And Biomanufacturing: As reported in our September 13, 2022, blog item, President Joseph Biden signed an Executive Order (EO) on September 12, 2022, creating a National Biotechnology and Biomanufacturing Initiative “that will ensure we can make in the United States all that we invent in the United States.” On March 22, 2023, the White House Office of Science and Technology Policy (OSTP) published a fact sheet announcing “new bold goals and priorities that will catalyze action inside and outside of government to advance American biotechnology and biomanufacturing.”
- Harnessing Biotechnology and Biomanufacturing Research and Development (R&D) to Further Societal Goals: On March 22, 2023, OSTP released a new report, Bold Goals for U.S. Biotechnology and Biomanufacturing: Harnessing Research and Development to Further Societal Goals, outlining a vision for what is possible with the power of biotechnology and biomanufacturing and the R&D needs to achieve this ambitious vision. More information on OSTP’s report is available in our April 3, 2023, blog item.
- Establishing Biomanufacturing Priorities for DOD: As part of the National Biotechnology and Biomanufacturing Initiative, the Department of Defense (DOD) announced in September 2022 an investment of $1.2 billion in bioindustrial domestic manufacturing infrastructure to catalyze the establishment of a domestic bioindustrial manufacturing base accessible to U.S. innovators. On March 22, 2023, DOD released its Biomanufacturing Strategy to guide these investments, and its broader efforts in this critical technology field. In support of the strategy, DOD issued a formal request for information (RFI) on biomanufactured products and process capabilities that could help address defense needs and whose development and commercialization could be addressed by DOD investment. Comments on the RFI are due by April 19, 2023, at 12:00 p.m. (EDT). More information on DOD’s Biomanufacturing Strategy and RFI is available in our April 5, 2023, blog item.
- Assessing the Economic Value of the Nation’s Bioeconomy: The Department of Commerce’s (DOC) Bureau of Economic Analysis (BEA) released a new report that assesses the feasibility of measuring the economic contributions of the U.S. bioeconomy. More information on BEA’s report is available in our April 6, 2023, blog item.
ASTM International Publishes Case Study On Standards For Biodegradable Plastic: To celebrate its 125th anniversary, ASTM International invited case study submissions from committee members to highlight standards that have made a significant impact in society. One of the winning entries is on a set of standards for biodegradable plastic from Committee D20 on Plastics. According to ASTM International’s article, standard test methods for determining the biobased content of solid, liquid, and gaseous samples using radiocarbon analysis (D6866) allows industry, regulators, and government to determine experimentally the percent biobased carbon present in a product or fuel. The article states that there are two companion specification standards for compostable plastics and paper coatings, “redesigning plastic polymers for biodegradability in industrial composting for an environmentally responsible, managed end-of-life”:
- Standard specification for labeling of plastics designed to be aerobically composted in municipal or industrial facilities (D6400); and
- Standard specification for labeling of end items that incorporate plastics and polymers as coatings or additives with paper and other substrates designed to be aerobically composted in municipal or industrial facilities (D6868).
More information is available in our March 31, 2023, blog item.
BETO Announces 2023 Multi-Year Program Plan: On March 23, 2023, DOE’s Bioenergy Technologies Office (BETO) announced the release of its 2023 Multi-Year Program Plan (MYPP). The MYPP is used as an operational guide, setting forth BETO’s mission, goals, and strategic approach. It also serves as a resource to help manage and coordinate BETO’s activities and communicate its strategy to stakeholders and the public. The new plan identifies BETO’s forthcoming research, development, and demonstration (RD&D) plans and activities and outlines why these undertakings are critical to meeting the energy and sustainability challenges facing our nation. According to BETO, due to the urgency of reducing greenhouse gases (GHG) across all modes of transportation, BETO has shifted its focus to low-carbon and net-zero carbon fuels for the aviation, marine, rail, and heavy-duty, long-haul industries, which have fewer options for reducing carbon impact. The MYPP prioritizes strategies to enable the decarbonization of the industrial sector via the advancement of renewable chemicals and materials, recognizing the potential for bioenergy technologies to decarbonize communities and other economic sectors through sustainable agriculture, improved waste management, and additional beneficial uses of biomass.
EPA Accepting Applications For The 2023 Safer Choice Partner Of The Year Awards: On March 27, 2023, EPA announced that its Safer Choice program is accepting submissions for its 2023 Safer Choice Partner of the Year Awards. 88 Fed. Reg. 18135. The Safer Choice program certifies products containing ingredients that have met the program’s specific and rigorous human health and environmental toxicological criteria. EPA states that it developed the Partner of the Year Awards to recognize the leadership contributions of Safer Choice partners and stakeholders who have shown achievement in the design, manufacture, selection, and use of products with safer chemicals that further outstanding or innovative source reduction. Similar achievement in the design, manufacture, selection, and use of Design for the Environment (DfE)-certified products will also make an organization eligible for the Partner of the Year Awards. The DfE program is a companion program to Safer Choice and certifies antimicrobial products. Submissions are due May 31, 2023. More information on the 2023 Safer Choice Partner of the Year Awards, including the application form, submission process, and past winners, is available on EPA’s website.
GAO Recommends Agencies Track Progress Toward Federal Sustainable Aviation Fuel Goals: The U.S. Government Accountability Office (GAO) publicly released a report on March 27, 2023, entitled Sustainable Aviation Fuel: Agencies Should Track Progress toward Ambitious Federal Goals. GAO was asked to review the federal role in sustainable aviation fuel (SAF). GAO’s report discusses the state of SAF production and use for the U.S. commercial aviation industry and factors shaping this market, identifies how federal agencies have supported SAF, and assesses how they will monitor progress toward SAF Grand Challenge goals. According to GAO, the roadmap published by the U.S. Department of Transportation (DOT), DOE, and USDA does not establish performance measures to monitor, evaluate, and report the results of these actions. GAO states that without performance measures, the agencies are not well positioned to evaluate the effectiveness of federal government actions to meet the Grand Challenge goals. In contrast, according to GAO, establishing and using such measures can help identify progress on the extent to which SAF is contributing to emission reductions.
GAO recommended that DOT, DOE, and USDA develop and incorporate performance measures into the Grand Challenge roadmap. According to GAO, DOT and USDA concurred. DOE indicated the recommendation is completed and that planned roadmap activities will enable progress to be measured. GAO notes that as discussed in its report, it disagrees that the recommendation is completed.
Events
“EPA GenRA Training” On May 23, 2023
EPA will hold training on May 23, 2023, on Generalized Read-Across (GenRA), a publicly available tool that uses an automated approach to make reproducible read-across predictions of toxicity. According to EPA, while read-across sometimes relies on subjective or expert judgement, use of the GenRA tool could provide more objective and reproducible read-across predictions. EPA has divided the training into two parts to accommodate a variety of interests and schedules. Registration for one or both sessions is free but required.
- Session 1 (Presentation and Questions and Answers (Q&A)) 11:00 a.m. – 12:30 p.m. (EDT)
This session will provide an overview of GenRA content and function with opportunities for participation and Q&A.
- Session 2 (Breakout Sessions) 12:30 – 1:30 p.m. (EDT)
This session will break participants into breakout rooms to work on exercises in small groups, aided by facilitators.
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