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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 that will allow the United States to harness the full potential of biotechnology and biomanufacturing and advance the President’s Executive Order.
 
According to a White House fact sheet, the initiative will accelerate biotechnology innovation and grow America’s bioeconomy across multiple sectors in industries such as health, agriculture, and energy. It will “drive advances in biomanufacturing that substitute fragile supply chains from abroad with strong chains at home, anchored by well-paying jobs in communities all across America.” It will improve food and energy security, and promote agricultural innovation while mitigating the impacts of climate change.
 
Specifically, the initiative will:

  • Grow Domestic Biomanufacturing Capacity: The initiative will build, revitalize, and secure national infrastructure for biomanufacturing across America, including through investments in regional innovation and enhanced bio-education, while strengthening the U.S. supply chain that produces domestic fuels, chemicals, and materials.
     
  • Expand Market Opportunities for Biobased Products: The fact sheet notes that the U.S. Department of Agriculture’s (USDA) BioPreferred Program “is the standard for sustainable procurement by government agencies, both providing an alternative to petroleum-based products and supporting good-paying jobs for American workers.” The initiative will increase mandatory biobased purchasing by federal agencies and ensure that the Office of Management and Budget (OMB) and USDA regularly publish progress assessments. The fact sheet states that doing so “will provide specific directions to industry about gaps in biobased product options, leading to the creation of new products and new markets.” Together, the initiative will grow and strengthen the BioPreferred Program, increase the use of renewable agricultural materials, and “position American companies to continue to lead the world in bio-innovation.”
     
  • Drive Research and Development (R&D) to Solve Our Greatest Challenges: According to the fact sheet, focused government support for biotechnology can quickly produce solutions, “as seen with the first-of-their-kind mRNA vaccines during the COVID-19 pandemic.” This initiative directs federal agencies to identify priority R&D needs to translate bioscience and biotechnology discoveries into medical breakthroughs, climate change solutions, food and agricultural innovation, and stronger U.S. supply chains.
     
  • Improve Access to Quality Federal Data: Combining biotechnology with massive computing power and artificial intelligence can produce significant breakthroughs for health, energy, agriculture, and the environment. The Data for the Bioeconomy Initiative will ensure that biotechnology developers have streamlined access to high-quality, secure, and wide-ranging biological data sets that can drive solutions to urgent societal and global problems.
     
  • Train a Diverse Skilled Workforce: The United States is facing a shortage of relevant talent spanning all levels, from community college to graduate school. The initiative will expand training and education opportunities for all Americans in biotechnology and biomanufacturing, with a focus on advancing racial and gender equity and support for talent development in underserved communities.
     
  • Streamline Regulations for Products of Biotechnology: Advances in biotechnology are rapidly altering the agricultural, industrial, technological, and medical products landscape, which can create challenges for developers and innovators. The initiative will improve the clarity and efficiency of the regulatory process for products of biotechnology so that valuable inventions and products can come to market faster without sacrificing safety.
     
  • Advance Biosafety and Biosecurity to Reduce Risk: The initiative will prioritize investments in applied biosafety research and incentivize innovations in biosecurity to reduce risk throughout the biotechnology R&D lifecycles.
     
  • Protect the U.S. Biotechnology Ecosystem: The initiative will protect the U.S. biotechnology ecosystem by advancing privacy standards and practices for human biological data, cybersecurity practices for biological data, standards development for bio-related software, and mitigation measures for risks posed by foreign adversary involvement in the biomanufacturing supply chain.
     
  • Build a Thriving, Secure Global Bioeconomy with Partners and Allies: According to the fact sheet, the initiative advances international cooperation to leverage biotechnology and biomanufacturing to tackle the most urgent global challenges -- from climate change to health security -- and to work together to ensure that biotechnology product development and use aligns with our shared democratic ethics and values, and that biotechnology breakthroughs benefit all citizens.

The White House has posted a transcript of the press call announcing the Executive Order.


 

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 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.

 

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 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.


 

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. 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.
 


 

 

By Lynn L. Bergeson

On June 4, 2018, Proctor & Gamble (P&G) announced the launch of Downy’s first plant-based line of fabric conditioner. In addition to powering the manufacturing process completely with renewable wind powered electricity at a zero-manufacturing waste to landfill facility, the product formula includes 70 percent biobased ingredients and the bottles are made from 25 percent post-consumer recycled content.  The 70 percent claim has been certified through the U.S. Department of Agriculture (USDA) BioPreferred program, which provides third-party verification of a product’s biobased content. This program was created by the 2002 Farm Bill and expanded by the 2014 Farm Bill to increase the development, purchase, and use of biobased products.


 

By Lynn L. Bergeson

On May 9, 2018, Tremco Roofing and Building Maintenance announced that its POWERply® Endure™ BIO Adhesive had earned the Certified Biobased Product label from the USDA BioPreferred Program. Tremco’s adhesive is made of 71 percent biobased material with ultra-low levels of Volatile Organic Compounds (VOC) that meet California VOC limits. Four other Tremco Roofing products have the USDA Certified Biobased Product Label, including AlphaGuard™ BIO Base Coat, AlphaGuard BIO Top Coat, Rock-It® WB, and Low Rise Foam Insulation Adhesive Green. The USDA BioPreferred Program was created by the 2002 Farm Bill and expanded by the 2014 Farm Bill, and provides third-party verification of a product’s biobased content. This program was created to increase the development, purchase, and use of biobased products.


 

By Lynn L. Bergeson

On May 3, 2018, Jacor, LLC announced that five of its EcoBioClean® products earned the U.S. Department of Agriculture (USDA) Certified Biobased Product label:

  • EcoBioClean® 100 COSW with 95% biobased content;
  • EcoBioClean® Pipes/Tanks 103 CE with 95% biobased content;
  • EcoBioClean® Fresh Water 101 COFW with 95% biobased content;
  • EcoBioClean® Land 102 COL with 95% biobased content; and
  • EcoBioClean® Biological Waste 105 BW with 95% biobased content.

These products provide contamination cleanup solutions for crude oil spills and leaks, as well as lubricants, dispersants, cleaning solutions, tar, human waste, and more, in a variety of environments and temperatures. The USDA BioPreferred Program was created by the 2002 Farm Bill and expanded by the 2014 Farm Bill, and provides third-party verification of a product’s biobased content. This program was created to increase the development, purchase, and use of biobased products.


 

By Lynn L. Bergeson

On March 20, 2018, BioLogiQ, Inc. announced that its NuPlastiQ® GP biopolymer received certification under the USDA BioPreferred program.  NuPlastiQ is a 100 percent renewably-resourced, plant-based resin that is blended with traditional plastics to reduce fossil-based plastic use and greenhouse gas emissions.  The thermoplastic resin is produced using BioLogiQ’s proprietary process for converting high crystalline starch into a low crystalline (mostly amorphous) plastic.  The starch is derived from potato waste following processing to produce potato chips and French fries. 
 
The BioPreferred program is a USDA initiative to increase the purchase and use of biobased products through mandatory purchasing requirements for federal agencies and contractors, and voluntary product certification and labeling.  The USDA Certified Biobased Product label is designed to help consumers identify biobased products containing a verified amount of renewable biological ingredients.


 

On November 29, 2016, Green Biologics, Inc. (Green Biologics) announced that its high purity biobased n-butanol and acetone received certification under the U.S. Department of Agriculture’s (USDA) BioPreferred® program.  Both products, which are produced through the fermentation of sugars from renewable feedstocks, were certified as 100 percent biobased.  In the early stages of its first commercial production facility, Green Biologics aims to produce commercial n-butanol and acetone by late 2016.  Additionally, Green Biologics states that the production of its renewable n-butanol results in 85 percent lower carbon emissions than alternative petroleum-based sources.
 
The BioPreferred program is a USDA initiative to increase the purchase and use of biobased products through mandatory purchasing requirements for federal agencies and contractors, and voluntary product certification and labeling.  The USDA Certified Biobased Product label is designed to help consumers identify biobased products containing a verified amount of renewable biological ingredients.


 
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