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.
Posted on October 07, 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) Biotechnology Regulatory Services (BRS) will hold its annual Stakeholder Meeting on December 8, 2022. BRS will offer in-person, at the USDA Center at Riverside, 4700 River Road, Riverdale, Maryland 20737, and virtual options for attendance. Attendees will hear updates about BRS’s implementation of the revised biotechnology regulations, including the new Regulatory Status Review and Confirmation Request processes, and other 2022 activities.
BRS seeks feedback on discussion topics for the meeting. Comments or suggestions on potential topics of interest are due October 14, 2022, to .(JavaScript must be enabled to view this email address). BRS will send out further meeting details and registration information. BRS states that stakeholders should check the BRS website for future meeting updates.
Posted on September 01, 2022 by Lynn L BergesonBy 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:
These resources, along with other information on the revised biotechnology regulations, are available on the APHIS website. For additional questions regarding the regulation of modified microorganisms, contact APHIS at .(JavaScript must be enabled to view this email address). For questions regarding confirmation requests, contact APHIS at .(JavaScript must be enabled to view this email address).
Posted on August 26, 2022 by Lynn L BergesonBy Lynn L. Bergeson and Carla N. Hutton
The U.S. Department of Agriculture (USDA) announced on August 23, 2022, that USDA is accepting applications for $100 million in grants to increase the sale and use of biofuels derived from U.S. agricultural products. 87 Fed. Reg. 51641. The funding is available through the Higher Blends Infrastructure Incentive Program (HBIIP). The program seeks to market higher blends of ethanol and biodiesel by sharing the costs to build and retrofit biofuel-related infrastructure such as pumps, dispensers, and storage tanks. Applications are due by 4:30 p.m. (EST) on November 21, 2022.
Under HBIIP, USDA provides grants to transportation fueling and distribution facilities. These grants lower the out-of-pocket costs for businesses to install and upgrade infrastructure and related equipment. The $100 million will support a variety of fueling operations, including filling stations, convenience stores, and larger retail stores that also sell fuel. The funds will also support fleet facilities, including rail and marine, and fuel distribution facilities, such as fuel terminal operations, midstream operations, and distribution facilities, as well as home heating oil distribution centers.
The grants will cover up to 50 percent of total eligible project costs -- but not more than $5 million -- to help owners of transportation fueling and fuel distribution facilities convert to higher blends of ethanol and biodiesel. These higher-blend fuels must be greater than ten percent for ethanol and greater than five percent for biodiesel.
Posted on August 05, 2022 by Lynn L BergesonBy Lynn L. Bergeson and Carla N. Hutton
According to an item in the U.S. Department of Agriculture’s (USDA) Unified Agenda, which was published on June 21, 2022, USDA intended to publish in June 2022 a proposed rule that would codify BioPreferred Program guidance. According to the item, USDA expects this action to reduce burden on both it and the applicants by reducing requirements, clarifying requirements, streamlining the application and certification process, and increasing efficiencies in program delivery. The item states that codification for all Program guidance “will ensure consistency in how programs are administered.” Improvements will also “facilitate the sales of the business using the labeling program.”
The BioPreferred Program is intended to spur economic development, create new jobs, and provide new markets for farm commodities. The two major parts of the Program are:
- Mandatory purchasing requirements for federal agencies and their contractors; and
- A voluntary labeling initiative for biobased products.
Posted on July 13, 2022 by Lynn L BergesonBy Lynn L. Bergeson
The U.S. Department of Agriculture’s (USDA) National Institute of Food and Agriculture (NIFA) announced recently a new program that directs USDA to partner with at least one qualified institution to support the scale-up of sustainable bioproduct manufacturing. Up to $5 million is available for each of the fiscal years (FY) 2022 and 2023. NIFA will work in collaboration with USDA Rural Development’s BioPreferred program to seek research proposals that explore the benefits of bioproducts in relation to:
- “Cost savings relative to other commonly used alternative materials;
- Greenhouse gas emission reductions and other environmental benefits relative to their commonly used alternative materials;
- Lifecycle and longevity-extending characteristics relative to other commonly used alternative materials;
- Lifecycle and longevity-reducing characteristics relative to other commonly used alternative materials;
- Landfill quantity and waste management cost reductions;
- Product development and production scale-up; and
- Any other benefits that the Secretary determines to be appropriate.”
Information on how to apply for the Bioproduct Pilot Program is available here, and NIFA will hold a webinar on July 14, 2022, at 3:00 p.m. (EDT) to discuss the program and answer questions. Registration for the webinar is required.
Posted on May 17, 2022 by Lynn L BergesonBy Lynn L. Bergeson and Ligia Duarte Botelho, M.A.
On April 12, 2022, U.S. Department of Agriculture’s (USDA) Tom Vilsack, Agriculture Secretary, announced steps that USDA is taking to implement President Biden’s plan to enable energy independence by boosting homegrown biofuels. President Biden’s plan aims to reduce energy prices and tackle the rising consumer prices caused by “Putin’s Price Hike.” As part of USDA’s measures to help the Biden Administration to achieve its goals, USDA is making the following investments:
- $5.6 million in funding for seven states to build infrastructure for renewable fuels through the Higher Blends Infrastructure Incentive Program;
- $700 million for biofuels producers through USDA’s new Biofuel Producer Program;
- $100 million for biofuels infrastructure grants; and
- Billions of dollars to support a new market in sustainable aviation fuels by partnering with the federal government to advance the use of cleaner and more sustainable fuels in the United States.
According to USDA, these investments will assist in the development, transportation, and distribution of low-carbon fuels, more affordable and cleaner fuels for consumers, and better market access for producers.
Posted on March 08, 2022 by Lynn L BergesonBy Lynn L. Bergeson and Ligia Duarte Botelho, M.A.
On February 22, 2022, U.S. Senator and Chairwoman of the U.S. Senate Committee on Agriculture, Nutrition, and Forestry, Debbie Stabenow (D-MI), and U.S. Senator and Committee member, Amy Klobuchar (D-MN), sent a letter to the U.S. Secretary of Agriculture, Tom Vilsack, requesting improvements to the United States’ biobased economy. Senators Stabenow and Klobuchar’s request focuses particularly on the U.S. Department of Agriculture (USDA) BioPreferred® Program (Program), urging that USDA leverage its long-standing expertise in biobased products to strengthen the Program.
Managed by USDA, the Program aims to increase the purchase and use of biobased products, spur economic development, create new jobs, and provide new markets for farm commodities. The Program has two major parts:
- Mandatory purchasing requirements for federal agencies and their contractors; and
- A voluntary labeling initiative for biobased products.
According to Senators Stabenow and Klobuchar, federal procurement for BioPreferred® products has failed to increase, despite significant product innovations in recent years. The two U.S. Senators encourage the U.S. Office of Management and Budget (OMB) and USDA to educate procurement officers on the benefits of BioPreferred® products and routinely to measure progress of the Program. They also request that Secretary Vilsack and the U.S. Secretary of Commerce complete swiftly creation of North American Product Classification System (NAPCS) codes, correlating them to North American Industry Classification System (NAICS) codes to capture the multiple industries into which each product is sold.
Posted on January 06, 2022 by Lynn L BergesonBy Lynn L. Bergeson and Ligia Duarte Botelho, M.A.
On December 7, 2021, the U.S. Department of Agriculture (USDA) Secretary Tom Vilsack announced that USDA is making $800 million available to support biofuel producers and improve infrastructure affected negatively by the COVID-19 pandemic. Funds will become available through USDA’s new Biofuel Producer Program authorized by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). USDA hopes that $100 million of the total amount available will increase significantly the sales and use of higher bioethanol and biodiesel blends through the expansion of the infrastructure for renewable fuels derived from U.S. agricultural products. Secretary Vilsack stated that [u]nder the leadership of President Biden and Vice President Harris, USDA is providing direct relief to the people of rural America who are still reeling from the economic impacts of the pandemic.” He also reported that USDA is targeting resources and investments to improve the strength and resiliency of America’s sustainable fuel markets.
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