All Knowledge & Insights By Date

By Lynn L. Bergeson and Carla N. Hutton   As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order (EO) 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.” The White House hosted a Summit on Biotechnology and Biomanufacturing on September 14, 2022. According to the White House fact sheet on the summit, federal...

October 26, 202212:00 p.m. - 1:00 p.m. (EDT)Register Now  The U.S. Food and Drug Administration (FDA) reports that 48 million people in the United States (1 in 6) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases. In 2011, President Obama signed into law the Food Safety Modernization Act (FSMA) in part to address this significant public health issue. FSMA is a comprehensive law intended to shift the focus of foodborne illness management from responding to...

By Lynn L. Bergeson and Carla N. Hutton   The Congressional Research Service (CRS) published a CRS report, updated on September 19, 2022, entitled The Bioeconomy: A Primer. The report provides an overview of the bioeconomy, details the efforts of the United States and other selected nations pertaining to the bioeconomy, and offers policy considerations for strengthening the role of the United States in the global bioeconomy. The report does not examine the policies and programs of...

On September 2, 2022, the U.S. Department of Agriculture (USDA) Agricultural Marketing Service (AMS) published an advance notice of proposed rulemaking (ANPR) seeking input from stakeholders about how to update its organic regulations on inert ingredients in pesticides used in organic production. 87 Fed. Reg. 54173. AMS seeks comments on alternatives to its existing regulations that would align with the Organic Foods Production Act of 1990 (OFPA) and the U.S. Environmental Protection...

By Lynn L. Bergeson and Carla N. Hutton   On September 12, 2022, President Joseph Biden signed an Executive Order 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 September 14, 2022, the White House will host a Summit on the National Biotechnology and Biomanufacturing Initiative during which cabinet agencies will announce a wide range of new investments and resources...

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: “Questions & Answers -- Working with Microorganisms Developed Using Genetic Engineering Under 7 CFR part 340”: The questions and answers (Q&A) cover topics such as what microorganisms are regulated, permit...

 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: “Questions & Answers -- Working with Microorganisms Developed Using Genetic Engineering Under 7 CFR part 340”: The questions and answers (Q&A) cover topics such as what microorganisms are regulated, permit...

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: “Questions & Answers -- Working with Microorganisms Developed Using Genetic Engineering Under 7 CFR part 340”: The questions and answers (Q&A) cover topics...

By 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...

By 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...

By 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...

By 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...

 On May 6, 2022, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of, and requesting comments on, data related to aquatic toxicity of chitosan salts. 87 Fed. Reg. 27059. Specifically, EPA is seeking comments on the following two aquatic toxicity reports submitted by Tidal Vision Products, LLC (Tidal Vision), the company that submitted a petition to EPA on October 10, 2018, requesting that EPA add chitosan to...

On March 16, 2022, the House Science, Space, and Technology Subcommittee on Energy held a hearing on “Bioenergy Research and Development for the Fuels and Chemicals of Tomorrow.” According to the hearing charter, the purpose of the hearing was to examine the status of bioenergy research, development, and demonstration (RD&D) activities carried out by the U.S. Department of Energy (DOE). The hearing also considered advancements in bioenergy research and the potential role of this...

By 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....

By 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....

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...

By 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...

Click here for a PDF brochure of the memorandum. Bergeson & Campbell, P.C. (B&C®) and its consulting affiliate The Acta Group (Acta®) and consortia management affiliate B&C® Consortia Management, L.L.C. (BCCM) are pleased to offer you our Forecast 2022. The extraordinary diversity and complexity of global industrial, agricultural, and biocidal chemical initiatives in which our clients engage are reflected in the detailed summary that follows, prepared by the legal,...

On November 8, 2021, the Infrastructure Investment and Jobs Act (H.R. 3684) was presented to President Joseph Biden (D) for signature. The House passed the bill on November 5, 2021, by a vote of 228 to 206, and the Senate passed the bill on August 10, 2021, by a vote of 69 to 30. The bill contains many important provisions. We highlight below some of the provisions in the 1,039-page bill that we believe our clients and friends may find interesting. Pesticides Under the bill, the...

On November 3, 2021, the U.S. Environmental Protection Agency (EPA), the White House Council on Environmental Quality (CEQ), the U.S. Department of Agriculture (USDA), the U.S. Department of Commerce, and the U.S. Department of the Interior “reaffirm[ed] their commitment to working together and with stakeholders to protect endangered species, provide effective pest control tools, and regulate pesticide use in a fair, transparent, and predictable manner.” According to EPA’s November 3,...

On October 18, 2021, the Biden Administration announced a multi-agency plan to address per- and polyfluoroalkyl substances (PFAS) contamination nationwide. According to the White House, agencies, including the U.S. Environmental Protection Agency (EPA), the Department of Defense (DOD), the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), the Department of Homeland Security (DHS), and the Department of Health and Human Services (DHHS), will take actions to...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. As part of a White House roundtable to launch the Sustainable Aviation Fuels (SAF) Grand Challenge to decarbonize the aviation sector by 2050, on September 9, 2021, the U.S. Department of Energy (DOE) announced the availability of $64.7 million in funding for projects focused on the production of cost-effective and low-carbon biofuels. DOE aims to advance technologies to replace petroleum fuels used in heavy-duty forms of...

In early July 1996, I was returning on a flight from Amman, Jordan, wondering what kind of negotiation we in the Clinton Administration faced in completing the legislative text of what became the Food Quality Protection Act (FQPA). (I had been asked to go to Jordan to visit the Jordanian pesticide regulatory program by a friend who was a senior official at the State Department. The result of my visit may have played a very, very small role in the Middle East peace process -- but that is another...

On August 25, 2021, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced its release of a draft guide detailing the information requirements and process for submitting a Regulatory Status Review (RSR) request. Developers of certain genetically modified organisms may use the RSR process to determine the regulatory status of the organisms. The draft guide is open for public comment for 60 days. APHIS also will host a webinar to...

The U.S. National Nanotechnology Initiative (NNI) will hold a webinar on June 2, 2021, on nanosensors for food and agriculture. NNI states that nanotechnology-enabled sensors (nanosensors) “are promising tools to advance precision agriculture and support a safe and robust food supply chain, from farm to fork.” Panelists will discuss how the development and deployment of nanosensors could transform agriculture and food safety. They will highlight the state of the science,...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On March 3, 2021, the co-chairs of the House Biofuels Caucus, U.S. Representatives Cindy Axne (D-IA) and Rodney Davis (R-IL), introduced the Renewable Fuels Infrastructure Investment and Market Expansion Act, which would expand access to higher biofuel blends. Building off the U.S. Department of Agriculture’s (USDA) Higher Blends Infrastructure Inventive Program, this bill intends to provide consistent federal investment...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On January 27, 2021, U.S. President Biden signed an “Executive Order on Tackling the Climate Crisis at Home and Abroad,” which established a National Climate Task Force (Task Force) and puts the climate crisis at the forefront of U.S. domestic and foreign policy. Highlighting the urgency in addressing the climate crisis, this EO requires short-term global reductions of greenhouse gas (GHG) emissions and net-zero...

Having created an impressive legacy of regulatory and policy success for biobased and renewable chemicals and chemical products, the Biobased and Renewable Products Advocacy Group (BRAG®) will sunset at the end of 2020. BRAG was formed in 2013 to give biobased chemical stakeholders the expertise and collective voice necessary to educate legislative and administrative decision-makers during the negotiations occurring at that time regarding reform of the Toxic Substances Control Act...

On November 4, 2020, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the release of an updated list of pests of significant health importance for public review and comment.  85 Fed. Reg. 70146. EPA, in coordination with the Centers for Disease Control and Prevention (CDC) and the U.S. Department of Agriculture (USDA), identifies pests of significant public health importance, and in coordination with the Public Health Service,...

By Lynn L. Bergeson On October 8, 2020, Secretary of Agriculture, Sonny Perdue, announced that the U.S. Department of Agriculture (USDA) has made $22 million available in grants to increase sales of ethanol and biodiesel. The funds are coming out of the $100 million in grants available through the Higher Blends Infrastructure Incentive Program (HBIIP) and have been disbursed to 14 states. USDA predicts that the investments will increase ethanol demand by approximately 150 million gallons...

On November 2, 2020, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the proposed rule to add chitosan (Poly-D-Glucosamine) to its list of active ingredients eligible for EPA’s minimum risk pesticide exemption under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 25(b).  85 Fed. Reg. 69307. The proposed rule is in response to a petition submitted to EPA on October 10, 2018, requesting...

By Lynn L. Bergeson On September 21, 2020, the U.S. Department of Agriculture (USDA) Rural Business-Cooperative Service announced that it is soliciting applications for funds available under the Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program (the Program) to provide guaranteed loans to fund the construction, development, and retrofitting of commercial-scale biorefineries and of biobased product manufacturing facilities. Biorefineries applying must use...

The U.S. Department of Agriculture (USDA) held a forum on its Agriculture Innovation Agenda (AIA) on August 16, 2020. The forum focused on science-informed policies and programs from government agencies with the shared aim of supporting environmentalism and enhanced productivity. AIA seeks to spur developments in biotechnology and support accessibility in response to modern industry challenges. Stakeholders were given a chance to hear from representatives and participate in a question and answer...

On August 20, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is seeking to add chitosan to the list of active ingredients allowed for in minimum risk pesticides exempted from pesticide registration requirements under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 25(b).  A minimum risk product must meet six specific conditions to be exempted from pesticide registration.  One of those conditions is that the active ingredient in the minimum...

On August 20, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is seeking to add chitosan to the list of active ingredients allowed for in minimum risk pesticides exempted from pesticide registration requirements under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 25(b).  A minimum risk product must meet six specific conditions to be exempted from pesticide registration.  One of those conditions is that the active ingredient in the minimum...

By Lynn L. Bergeson  On July 24, 2020, the U.S. Department of Agriculture (USDA) Agricultural Marketing Service (AMS) announced its solicitation for comments and feedback on recommendations to update the List of Bioengineered Foods as it pertains to the National Bioengineered Food Disclosure Standard. Comments are due by August 24, 2020.

Federal U.S. Senators Vote Against Deputy Secretary Of Energy Nominee On August 4, 2020, U.S. Senators Joni Ernst (R-IA) and Chuck Grassley (R-IA) voted against Mark Menezes, who is nominated to become Deputy Secretary of Energy. In a statement, both Senators said that “[g]iven the uncertainty with the ‘gap year’ small refinery waivers, the wasted time and resources to score the waivers again, the lack of transparency in the entire process, and most importantly, the toll this has...

By Lynn L. Bergeson On June 4, 2020, the Missouri Agricultural and Small Business Development Authority (MASBDA) announced the creation of the Biofuel Infrastructure Program (BIP). Designed to increase the availability of higher blends of ethanol and biodiesel in Missouri, BIP partners with private entities to support biofuel producers in applying for U.S. Department of Agriculture (USDA) Rural Development’s Higher Blends Infrastructure Investment Program (HBIIP) funding. The MASBDA Board...

By Lynn L. Bergeson On May 21, 2020, U.S. Senators Amy Klobuchar (D-MN) and Chuck Grassley (R-IA) introduced a bill directing the U.S. Department of Agriculture (USDA) Secretary to establish a renewable feedstock reimbursement program. Aiming to support biofuel producers that have been negatively affected by the COVID-19 pandemic, this bill can be cited as the Renewable Fuel Feedstock Reimbursement Act of 2020. Under the reimbursement program, biofuel producers will be reimbursed for their...

By Lynn L. Bergeson On May 18, 2020, USDA issued its final rule for the Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program (9003 Program), which incorporates the statutory definition changes as required in the Agricultural Act of 2018 (Farm Bill) and adopts the interim rule published on June 14, 2015. The 9003 Program replaces the Biorefinery Assistance Program (BAP), which guaranteed loans to fund the development, construction, and retrofitting of...

By Lynn L. Bergeson On May 18, 2020, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) issued the much-anticipated final Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule. 85 Fed. Reg. 29790. The rule is intended to update and modernize USDA’s biotechnology regulations under the Plant Protection Act. The final rule amends the regulations regarding the movement (importation, interstate movement, and...

On May 18, 2020, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) issued the much-anticipated final Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule. 85 Fed. Reg. 29790. The rule is intended to update and modernize USDA’s biotechnology regulations under the Plant Protection Act. The final rule amends the regulations regarding the movement (importation, interstate movement, and environmental release) of...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On April 17, 2020, U.S. Department of Agriculture (USDA) Secretary, Sonny Perdue, announced $19 billion to farmers and ranchers as part of its COVID-19 relief program. Aimed at providing critical support in maintaining the integrity of the U.S. food supply chain and ensuring that every American has access to the food needed, the funds will be used not only to directly support farmers and ranchers, but also for USDA purchase and distribution. The...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On April 9, 2020, the U.S. Department of Agriculture (USDA) published a report titled “Agricultural Biotechnology Annual,” which argues that under any scenario, the United Kingdom’s (U.K.) separation from the EU (Brexit) is unlikely to change policy or trade in genetically engineered (GE) industries. According to the report prepared by USDA’s Jennifer Wilson, given the fact that the EU is the U.K.’s trading partner...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On April 6, 2020, 15 United States Senators submitted a bipartisan letter to the U.S. Department of Agriculture (USDA) Secretary, Sonny Perdue, requesting the use of its authority to assist the biofuels industry’s economic circumstances brought by the COVID-19 pandemic. Highlighting the negative impacts of the pandemic on farmers and producers who will bear the impact of the decrease in consumption, in the letter, the Senators have also...

By Lynn L. Bergeson On April 1, 2020, the U.S. Department of Agriculture (USDA) requested written stakeholder input on objectives and opportunities leading to research goals and informed product goals to facilitate transformative breakthroughs that enable U.S. agriculture to meet its goal of increasing agricultural production by 40 percent by 2050.

By Lynn L. Bergeson On March 4, 2020, USDA announced that it is now accepting comments on its technical guidelines and science-based methods to quantify greenhouse gas (GHG) sources and sinks from the agriculture and forest sectors at the entity-scale. USDA intends to update the technical guidelines based on newly available data and methodologies within the next three years. Interested parties must submit comments on or prior to April 20, 2020.

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On March 4, 2020, the U.S. Food and Drug Administration (FDA), in collaboration with EPA and the U.S. Department of Agriculture (USDA), launched a new initiative called “Feed Your Mind” to help consumers better understand genetically engineered (GE) foods. Consisting of science-based information, the initiative’s features include a wide range of resources designed to teach consumers, health care professionals, and students...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On January 30, 2020, the National Biodiesel Board (NBB) submitted comments to USDA in response to its request for information (RFI) on the Higher Blends Infrastructure Incentive Program (HBIIP). A new USDA Rural Development project, HBIIP is designed to expand the availability of domestic ethanol and biodiesel by incentivizing the expansion of sales of renewable fuels. USDA’s RFI solicited information on options for fuel ethanol and...