Posted on March 23, 2023 by Lynn L BergesonBy Lynn L. Bergeson and Carla N. Hutton
The U.S. Department of Agriculture’s (USDA) 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). The draft guide states that genetic engineering is defined in 7 C.F.R. Section 340.3 as “techniques that use recombinant, synthesized, or amplified nucleic acids to modify or create a genome.” According to the draft guide, regulated microorganisms include plant pests and other modified microorganisms that could pose a plant pest risk. Developers require a permit for regulated activities involving any modified microorganism that:
- Meets the definition of a plant pest in Section 340.3; or
- Is not a plant but has received deoxyribonucleic acid (DNA) from a plant pest, as defined in Section 340.3, and the DNA from the donor organism is either capable of producing an infectious agent that causes plant disease or encodes a compound that is capable of causing plant disease; or
- Is a microorganism used to control plant pests and could pose a plant pest risk.
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.
Posted on March 09, 2023 by Lynn L BergesonBy Lynn L. Bergeson and Carla N. Hutton
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. USDA notes that its ongoing work includes the National Institute of Food and Agriculture’s (NIFA) Agriculture and Food Research Initiative programs, which fund research that advances climate-smart agriculture and forestry and strengthens the bioeconomy. USDA states that in line with President Biden’s September 12, 2022, Executive Order (EO) on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy, “these programs develop sources of clean energy and power, biomass systems and high-value biobased products from agricultural feedstocks to foster economic development.” The Bipartisan Infrastructure Law funded innovative new USDA programs such as NIFA’s $9.5 million Bioproduct Pilot Program, which supports research into the benefits of using materials derived from agricultural commodities to manufacture construction and consumer products. USDA notes that the projects have special emphasis on benefits to underserved communities.
USDA states that National Biobased Products Day is an annual celebration on March 8 to raise awareness of the benefits of biobased products. The day recognizes the Biden Administration’s commitment to use the vast array of federal resources to combat climate change and help rural communities address its impacts. The day also aligns with President Biden’s Federal Sustainability Plan and EO Number 14057, which focuses on making the federal government carbon-neutral by 2050 and reducing planet-warming greenhouse gas emissions by 65 percent by 2030.
A key component of these 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).
According to USDA, all of these efforts support President Biden’s EO to advance U.S. biotechnology and biomanufacturing. USDA states that it is supporting this effort by providing tools, resources, and scientific research to ensure American farmers and producers remain globally competitive.
Posted on March 02, 2023 by Lynn L BergesonBy Lynn L. Bergeson and Carla N. Hutton
On February 16, 2023, Representative Randy Feenstra (R-IA) introduced a legislative package that includes bills regarding researching the potential of biofuels to power jet engines and developing a commercially viable fuel cell system for cars and trucks powered exclusively by biofuels. The package includes:
- The Comparison of Sustainable Transportation (COST) Act would direct the Comptroller General of the U.S. Government Accountability Office (GAO) and the U.S. Secretary of Energy to compare the financial and environmental costs between replacing the entire federal gasoline-powered fleet with either electric vehicles or E-85 capable flex-fuel cars and trucks;
- The Biojet Fuel Research Act would direct the Federal Aviation Administration (FAA) to establish a working group focused on identifying research and development needs to produce biojet fuel. The working group would consist of the Bioenergy Technologies Office of the U.S. Department of Energy (DOE), the U.S. Department of Agriculture (USDA), biorefinery stakeholders, agriculture research universities, and others; and
- The Biofuel Cell Research Act would direct the DOE Secretary to establish a research, development, and demonstration program for a commercially viable fuel cell system that uses biofuels as the main fuel source.
Feenstra introduced similar legislation in the 117th Congress.
Posted on February 22, 2023 by Lynn L BergesonBy Lynn L. Bergeson and Carla N. Hutton
As reported in our January 4, 2023, blog item, on January 3, 2023, the U.S. Environmental Protection Agency (EPA) announced the release of a draft document entitled “Biofuels and the Environment: Third Triennial Report to Congress (External Review Draft)” for public comment. 88 Fed. Reg. 72. EPA’s Office of Research and Development (ORD) and Office of Air and Radiation (OAR), in consultation with the U.S. Departments of Agriculture (USDA) and Energy (DOE), prepared the document. The purpose of the report is to examine the effects of the Renewable Fuel Standard (RFS) Program on the environment, including the impacts to date and likely future impacts to the nation’s air, land, and water resources. The draft report focuses on the dominant biofuel sources in the United States: (1) domestic corn ethanol from corn starch; (2) domestic biodiesel from soybean oil; (3) domestic biodiesel from fats, oils, and greases (FOG); and (4) imported ethanol from Brazilian sugarcane.
ERG, an EPA contractor, is organizing an independent external peer review of the draft report. The peer review meetings are open to anyone who would like to attend as an observer and will include a brief public comment period on the first day (February 24, 2023). Registration is required. Panel peer review meetings will be held:
- February 24, 2023, 11:00 a.m.-6:45 p.m. (EST);
- February 27, 2023, 11:00 a.m.-6:30 p.m. (EST); and
- February 28, 2023, 1:00 p.m.-3:40 p.m. (EST).
Comments on the draft report are due March 6, 2023.
Posted on January 09, 2023 by Lynn L BergesonBy Lynn L. Bergeson and Carla N. Hutton
The U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) announced on December 22, 2022, that it posted its final Regulatory Status Review (RSR) guide. The RSR guide details the information requirements and process for submitting an RSR request under the revised biotechnology regulations at 7 C.F.R. Part 340. Under the revised regulations, developers may request a permit and/or an RSR of a plant developed using genetic engineering that APHIS has not previously reviewed. Developers may submit a request for an RSR when they believe a modified plant is not subject to regulation. APHIS will review the modified plant and consider whether it might pose an increased plant pest risk compared to a nonregulated plant. If its review finds a plant is unlikely to pose an increased plant pest risk relative to the comparator plant, APHIS will post the request, its response letter, the plant, trait, and a general description of the Mechanism of Action (MOA) on its website. The posting of plant, trait, and MOA combinations provides a growing range of modifications that are eligible for exemption from regulation. Alternatively, if APHIS is unable to make such a finding, the modified plant is subject to regulation.
Posted on December 05, 2022 by Lynn L Bergeson By Lynn L. Bergeson and Carla N. Hutton
On November 30, 2022, the U.S. Department of Agriculture’s (USDA) Agricultural Research Service (ARS) announced that its scientists have determined that plants could be used to produce nanobodies that quickly block emerging pathogens in human medicine and agriculture. The nanobodies are small antibody proteins naturally produced in specific animals like camels, alpacas, and llamas. ARS researchers evaluated nanobodies to prevent and treat citrus greening disease in citrus trees. The scientists are now using their newly developed and patented SymbiontTM technology to show that nanobodies can be easily produced in a plant system with broad agricultural and public health applications. According to ARS, as a proof-of-concept, researchers showed that nanobodies targeting the SARS-CoV-2 virus could be made in plant cells and remain functional in blocking the binding of the SARS-CoV-2 spike protein to its receptor protein: the process responsible for initiating viral infection in human cells.
AgroSource, Inc. collaborated with ARS to develop the plant-based production system. According to ARS, they are currently taking the necessary steps to see how they can move this advancement into the commercial sector. ARS notes that this research collaboration is in response to the White House’s Executive Order on advancing biotechnology and biomanufacturing innovation for a sustainable, safe, and secure American bioeconomy.
Posted on November 01, 2022 by Lynn L BergesonBy Lynn L. Bergeson and Carla N. Hutton
On October 28, 2022, the U.S. Department of Agriculture’s (USDA) Rural Business-Cooperative Service (RBCS) and Rural Utilities Service (RUS) announced a request for information (RFI) and notice of public listening sessions on how to implement newly allocated funding opportunities under the Inflation Reduction Act (IRA). 87 Fed. Reg. 65188. It is anticipated that these funds will support new projects related to rural electric system resiliency, biofuels, renewable energy technologies, and more. USDA requests comments on specific questions in the RFI, as well as on any other topics relevant to implementation. Written comments are due November 28, 2022. USDA will also host two public listening sessions:
- November 3, 2022, focused on IRA Sections 22001, 22002, and 22003. The two-hour listening session is aimed at renewable energy generation providers, distribution utilities, transportation fueling facilities, fuel distribution facilities, environmental advocates and other environmental groups, and other federal agencies; and
- November 4, 2022, focused on IRA Section 22004. The two-hour listening session is aimed at electric cooperatives, environmental advocates, and other environmental groups.
Registration is required.
Posted on October 24, 2022 by Lynn L BergesonBy Lynn L. Bergeson and Carla N. Hutton
The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on October 21, 2022, that it recently reviewed a corn plant and a potato plant that were modified using genetic engineering to determine whether they present an increased pest risk as compared to unmodified plants. APHIS has posted its Regulatory Status Review (RSR) responses on its website, as required under 7 C.F.R. Part 340. According to APHIS, the corn plant, from Infinite Enzymes, Inc., was modified to produce the enzyme manganese peroxidase in corn seed and to make it resistant to the herbicide glufosinate. The potato plant, from J.R. Simplot Company, was modified to make it resistant to potato late blight and potato virus Y and to alter the potato tuber’s sugar profile and quality.
According to APHIS, in both cases, it “found these plants unlikely to pose an increased plant pest risk compared to other cultivated corn and potato plants.” As a result, they are not subject to regulation under 7 C.F.R. Part 340. From a plant pest risk perspective, these plants may be safely grown and used in breeding in the United States. APHIS notes that its responses are based on information from the developers and its own:
- Familiarity with plant varieties;
- Knowledge of the traits; and
- Understanding of the modifications.
Under 7 C.F.R. Part 340, developers may request an RSR when they believe a modified plant is not subject to regulation. APHIS reviews the modified plant and considers whether it might pose an increased plant pest risk compared to a nonregulated plant. If its review finds a plant is unlikely to pose an increased plant pest risk relative to the comparator plant, APHIS issues a response indicating the plant is not subject to the regulations.
Posted on October 14, 2022 by Lynn L BergesonBy Lynn L. Bergeson and Carla N. Hutton
The U.S. Department of Agriculture’s (USDA) Biotechnology Risk Assessment Research Grants (BRAG) program supports the generation of new information that will assist federal regulatory agencies in making science-based decisions about the environmental effects of introducing genetically engineered organisms. In an October 27, 2022, technical assistance webinar, staff will provide an overview of the program, which is jointly administered by USDA’s National Institute of Food and Agriculture (NIFA) and Agricultural Research Service (ARS), and discuss details included in the fiscal year (FY) 2023 Request for Applications (RFA). NIFA plans to invest $5.5 million in this funding opportunity, which supports applied and/or fundamental research relevant to environmental risk assessment, including biological risk, and the federal regulatory process. Applications may be submitted by any U.S. public or private research or educational institution or organization. The closing date for grant applications is January 19, 2023. Registration for the webinar is required.
Posted on October 11, 2022 by Lynn L BergesonBy Lynn L. Bergeson and Carla N. Hutton
On September 7, 2022, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that it reviewed a new tomato from Norfolk Plant Sciences. The tomato was modified to alter its color and enhance its nutritional quality. APHIS found the plant is unlikely to pose an increased plant pest risk compared to other cultivated tomatoes and is not subject to regulation under 7 C.F.R. Part 340. That means, from a plant pest risk perspective, the plant may be safely grown and used in breeding in the United States.
APHIS announced on September 30, 2022, that it reviewed a modified corn plant from Agrivida, Inc. The corn was modified using genetic engineering to alter animal feed quality for improved digestion. APHIS also reviewed a modified potato from Toolgen, Inc. This potato was modified using genetic engineering to alter tuber quality by reducing browning. APHIS states that it found these plants are unlikely to pose an increased plant pest risk compared to other cultivated corn and potato and, thus, they are not subject to regulation under 7 C.F.R. Part 340.
APHIS’s Regulatory Status Review (RSR) responses under the revised biotechnology regulations at 7 C.F.R. Part 340 are available online. In each case, APHIS based its responses on information from the developers and its:
- Familiarity with plant varieties;
- Knowledge of the traits; and
- Understanding of the modifications.
Under 7 C.F.R. Part 340, developers may submit a request to APHIS for an RSR when they believe a modified plant is not subject to regulation. APHIS reviews the modified plant and considers whether it might pose an increased plant pest risk compared to a nonregulated plant. If APHIS’s review finds a plant is unlikely to pose an increased plant pest risk relative to the comparator plant, it will issue a response indicating the plant is not subject to the regulations.
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