Federal
APHIS Seeks Comment On Draft Environmental Documents For Deregulation Of Corn Developed Using Genetic Engineering: The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on April 10, 2023, that it is inviting public comment on a draft Environmental Assessment (EA) and draft Plant Pest Risk Assessment (PPRA). 88 Fed. Reg. 21602. APHIS states that it produced these documents in response to a petition from Pioneer Hi-Bred International, Inc. seeking deregulation of a corn variety developed using genetic engineering to resist corn rootworm and tolerate glufosinate herbicides. Comments are due May 11, 2023.
Bipartisan Group Of Legislators Call For Strengthened RFS: On April 11, 2023, a bipartisan group of legislators led by Senators Amy Klobuchar (D-MN) and Chuck Grassley (R-IA) sent a letter to the U.S. Environmental Protection Agency (EPA), urging it to strengthen the Renewable Fuel Standard (RFS) by maintaining the blending requirements for 2023; denying all pending Small Refinery Exemptions (SRE); eliminating proposed retroactive cuts to the renewable volume obligations (RVO); and setting RFS volumes at the statutory levels. According to Klobuchar’s April 14, 2023, press release, by taking the suggested steps, EPA “can set the RFS on a path that provides stability and growth for the U.S. biofuel sector.”
USDA Researchers Develop Natural, Washable, Antimicrobial Cleaning Wipes Using Nanocomposite Raw Cotton Fiber: USDA announced on April 11, 2023, that its Agricultural Research Service (ARS) recently developed sustainable, machine-washable antimicrobial wipes that can be used at least 30 times for cleaning hard and nonporous surfaces. According to USDA, ARS researchers developed the antimicrobial wipes “by using raw cotton fiber that naturally produced silver nanoparticles inside the fiber in the presence of a silver precursor.” USDA states that the embedded silver nanoparticles then release silver ions that act as antibacterial agents and kill harmful bacteria. USDA notes that in their research, scientists found that the wipes killed 99.9 percent of harmful bacteria S. aureus and P. aeruginosa on surfaces. More information on the antimicrobial wipes is available in an article in Molecules entitled “Washable Antimicrobial Wipes Fabricated from a Blend of Nanocomposite Raw Cotton Fiber.”
CSU Announces Redesigned “Dream” Biodegradable Plastics: Colorado State University (CSU) announced on April 11, 2023, that its chemists, led by Eugene Chen, University Distinguished Professor in the Department of Chemistry, have created a synthetic polyhydroxyalkanoate (PHA) platform. CSU states that PHAs are a class of polymers naturally created by living microorganisms or synthetically produced from biorenewable feedstocks. While they are biodegradable in the ambient environment, they are brittle and cannot easily be melt-processed and recycled. According to CSU, the synthetic PHA platform addresses each of these problems, “paving the way for a future in which PHAs can take off in the marketplace as truly sustainable plastics.” The work was supported by the U.S. Department of Energy’s (DOE) Bio-Optimized Technologies to keep Thermoplastics out of Landfills and the Environment (BOTTLE™), a DOE multi-organization consortium “focused on developing new chemical upcycling strategies for today’s plastics and redesigning tomorrow’s plastics to be recyclable-by-design.” More information is available in a Science article entitled “Chemically circular, mechanically tough, and melt-processable polyhydroxyalkanoates.”
GAO Science And Tech Spotlight Describes Benefits Of Synthetic Biology And Challenges Ahead: The U.S. Government Accountability Office (GAO) published a “Science & Tech Spotlight” on synthetic biology on April 17, 2023. GAO defines synthetic biology as “a multidisciplinary field of biotechnology that involves engineering the genetic material of organisms — such as viruses, bacteria, yeast, plants, or animals — to have new characteristics.” According to GAO, scientists are currently exploring the use of synthetic biology to address environmental challenges by engineering organisms to use carbon dioxide, produce biofuels for vehicles, and transform methane into biodegradable plastics. GAO notes that the synthetic biology market could grow from about $10 billion in 2021 to between $37 billion and $100 billion dollars by 2030. GAO concludes the “Science & Tech Spotlight” with the following policy context and questions:
- Do policymakers have adequate access to expertise and resources to evaluate the societal effects and public policy implications of synthetic biology research and development?
- How effective is the coordination among 1) domestic and 2) global stakeholders for monitoring and assessing the risks associated with advances in synthetic biology research and applications?
- Is the current regulatory framework sufficient to address ongoing and future applications and their effects without unnecessarily hindering U.S. competitiveness in synthetic biology?
More information is available in our April 24, 2023, blog item.
APHIS Releases New Strategic Plan For 2023-2027, Includes Biotechnology Objectives: On April 25, 2023, USDA’s APHIS announced that it published a new five-year strategic plan. According to APHIS, it incorporates input it received from stakeholders on the strategic framework, a summarized version of the plan that it published in June 2022. The plan includes six strategic goals that focus on working to:
- Protect agriculture from plant and animal diseases and pests. Objective 5 is “Ensure the development of safe agricultural biotechnology products using a science-based regulatory framework”;
- Cultivate a talented, diverse, and public service-focused workforce where employees are supported, valued, and engaged;
- Reduce the impacts of zoonotic and emerging diseases and climate change;
- Maintain and expand the safe trade of agricultural products nationally and internationally. Objective 2, “Maintain and expand the Agency’s leadership role through international standard setting and collaboration,” includes promoting engagement, collaboration, and harmonization of agricultural biotechnology regulation with trading partners, the Organization for Economic Cooperation and Development (OECD), and other international and regional organizations. Objective 3, “Create safe export opportunities,” includes:
- Communicating to international stakeholders about APHIS’ processes and share outcomes of biotechnology product evaluations;
- Working with trade agencies on technical aspects of trade in biotechnology products; and
- Working with the regulatory authorities of U.S. trading partners to harmonize further regulatory frameworks for biotechnology products;
- Communicating to international stakeholders about APHIS’ processes and share outcomes of biotechnology product evaluations;
- Manage wildlife damage and threats to agriculture, natural resources, property, and people; and
- Promote the welfare of animals.
More information is available in our May 3, 2023, blog item.
OMB Seeks Input On Bioeconomy-Related Industries And Products: The Office of Management and Budget (OMB) published a request for information (RFI) on April 27, 2023, seeking public input on existing or potential bioeconomy-related industries and products that are established, emerging, or currently embedded in existing industry/manufacturing processes. 88 Fed. Reg. 25711. Under President Joseph Biden’s September 12, 2022, Executive Order (EO) creating a National Biotechnology and Biomanufacturing Initiative, the Chief Statistician of the United States (CSOTUS) in OMB’s Office of Information and Regulatory Affairs (OIRA) was charged with improving and enhancing federal statistical data collection designed to characterize and measure the economic value of the U.S. bioeconomy. The CSOTUS was also charged with establishing an Interagency Technical Working Group (Working Group) to recommend bioeconomy-related revisions for the North American Industry Classification System (NAICS) and the North American Product Classification System (NAPCS). To ensure consideration of comments on potential bioeconomy-related industries and products solicited in the RFI, OMB asked that all comments be submitted “as soon as possible,” but no later than June 12, 2023. More information is available in our May 1, 2023, blog item.
EPA Issues Emergency Fuel Waiver For E15 Sales: EPA announced on April 28, 2023, that it issued an emergency fuel waiver to allow E15 gasoline — gasoline blended with 15 percent ethanol — to be sold “during the summer driving season.” EPA states that this action will provide relief from ongoing market supply issues “created by Russia’s unprovoked war in Ukraine by increasing fuel supply and offering consumers more choices at the pump.” According to EPA, the waiver will help protect Americans from fuel supply crises by reducing reliance on imported fossil fuels, building U.S. energy independence, and supporting American agriculture and manufacturing. EPA notes that current estimates indicate that, on average, E15 is about 25 cents a gallon cheaper than E10.
International
FAO And WHO Issue Publication On Food-Safety Aspects Of Cell-Based Food: On April 5, 2023, the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) issued a report on the food safety aspects of cell-based food, which is animal agricultural products grown directly from cell cultures. FAO, in collaboration with WHO, developed the report to engage with respective members and relevant stakeholders “by proactively sharing the current knowledge to identify concrete ways to inform consumers and all other stakeholders about the food safety considerations for cell-based food products.” The report includes a literature synthesis of relevant terminology issues, principles of cell-based food production processes, and the global landscape of regulatory frameworks for cell-based food production. More information is available in our April 20, 2023, blog item.
Council Of The EU Approves Conclusions On The Opportunities Of The Bioeconomy: On April 25, 2023, the Council of the European Union (EU) announced that it approved the conclusions on the opportunities of the bioeconomy in light of current challenges, with special emphasis on rural areas. Using biomass to produce food, materials, and energy can help boost rural communities, increase competitiveness, and combat many of the challenges facing the EU. According to the press release, in their conclusions, ministers “highlighted the key role that the bioeconomy could play in achieving the environmental and climate goals under the European Green Deal, while also making the EU more competitive, helping it transition away from fossil-fuel dependency, and strengthening food security in the wake of Russia’s war of aggression against Ukraine.” The ministers also stressed the importance of promoting research and innovation and improving alignment between scientific advances and industry policy. The press release states that the conclusions will provide political guidance for the European Commission (EC) and EU member states on developing the potential of the bioeconomy in Europe. While the Council of the EU welcomed the EC’s progress report on the implementation of the EU Bioeconomy Strategy, ministers put forward a number of recommendations intended to help boost the potential of the bioeconomy in Europe. Ministers also noted that the bioeconomy was an integral aspect of the reformed Common Agricultural Policy (CAP) and invited the EC to follow up on how EU member states had incorporated it into their national strategic plans. More information is available in our April 27, 2023, blog item.
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