The Biobased and Renewable Products Advocacy Group (BRAG) helps members develop and bring to market their innovative biobased and renewable chemical products through insightful policy and regulatory advocacy. BRAG is managed by B&C® Consortia Management, L.L.C., an affiliate of Bergeson & Campbell, P.C.

By Lynn L. Bergeson

On May 22, 2020, EPA’s Office of Pesticide Programs (OPP) announced the opening of a 15-day comment period on its proposal to register a new active ingredient and biopesticide product. The biopesticide product, PHC-91398, would contain Ea peptide 91398, the new active ingredient that was derived from naturally occurring bacterium and induces natural plant defenses. The plant’s reaction to the peptide “activates a hypersensitive response in treated plants, which enables resistance to bacterial and fungal infection, as well as suppression of nematode egg production.” PHC-91398, the biopesticide product, is intended for use on a wide range of agricultural crops and home and garden uses. There will be three product applications:

  • Pre-plant foliar or root dip;
  • Foliar application in greenhouses and fields through a conventional spray, drip, or aerial equipment; and
  • Seed treatment.

Upon review of the data submitted in support of Ea peptide 91398, EPA states that toxicity, allergenicity to humans, and/or adverse effects on non-target organisms is not expected.

EPA is seeking comments, particularly from pesticide users, registrants, public interest organizations, and state, tribal, and local governments. Comments are due on or prior to June 5, 2020.


 

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 commercial-scale biorefineries using eligible technology. The final rule makes several specific changes to BAP, including:

  • Renames the program as the 9003 Program;
  • Revises the purpose statement for the program to include renewable chemicals and biobased product manufacturing;
  • Expands the program to include biobased product manufacturing facilities;
  • Adds definitions for “renewable chemicals” and “biobased product manufacturing”; and
  • Ensures diversity in the types of projects approved by the program.

The final rule became effective on May 18, 2020.


 

By Lynn L. Bergeson

The U.S. Air Force (USAF) Research Laboratory is sponsoring a $1 million challenge for synthetic biology solutions to reduce the cost and improve the quality for aerospace thermosets. This scientific challenge is focused on the use of biotechnology to create products or product precursors required by USAF. Interested parties must submit white papers on the viability of the approach to bio-synthesize two molecules A and B needed for aerospace thermosets. This is the first of three challenges and consists of three phases. Phase One is the white paper submission as previously described. Phase Two is when submitted white papers will be down-selected from the viable entrees. Potential awardees selected will then have two weeks to enter into a subsequent agreement with a company that can scale up their production concept and demonstrate capability to manufacture testable amounts with a United States company (if the awardees cannot manufacture the product themselves). In the third and final phase, semi-finalist teams will have one hour to pitch their concept and scale up strategy with their manufacturing partner (if needed) to the evaluation team.

The winner of the third phase will be awarded half of the prize ($500,000) based on their total cost estimate to complete the challenge. The team will then have to demonstrate that they can biosynthesize molecules A and B. Upon completion of this demonstration, the team will be given one-third of the prize award to demonstrate the viability of the concept to manufacture one gram each of A and B to test for purity. Interested parties must submit applications here on or prior to June 15, 2020.


 

By Lynn L. Bergeson

On May 14, 2020, the American Cleaning Institute (ACI), a BRAG member, announced that the U.S. Environmental Protection Agency (EPA) approved eight cleaning product ingredients submitted by ACI for inclusion in EPA’s Safer Chemical Ingredients List (SCIL). EPA’s Safer Choice Program focuses on assisting consumers, businesses, and purchasers to find products that perform and contain ingredients that are safer for human health and the environment. SCIL is a list of chemical ingredients that have been evaluated and determined by the Safer Choice Program to be safer than traditional chemical ingredients. This is the first time that the Safer Choice Program has approved a SCIL submission by a non-manufacturer. Kathleen Stanton, ACI Associate Vice President of Technical and International Affairs and BRAG company representative, commented on ACI’s achievement stating that “[a]dding chemicals to the SCIL encourages innovation and growth in safer products, increases markets for manufacturers and helps protect people and the environment.” The following chemical surfactants were added to SCIL:

  • Octadecanoic acid, 2-ethylhexyl ester;
  • Alcohols, C12-15;
  • Octadecanoic acid, 12-hydroxy-;
  • Fatty acids, C8-18 and C18-unsaturated, sodium salts;
  • Fatty acids, C14-18 and C16-18-unsaturated, sodium salts;
  • Potassium oleate;
  • Fatty acids, palm-oil; and
  • Sulfuric acid, mono-C14-18-alkyl esters, sodium salts.

 

By Lynn L. Bergeson

On May 12, 2020, the U.S. Food and Drug Administration (FDA) announced the release of an update to its Purple Book: Database of FDA-Licensed Biological Products (Purple Book). The update adds all FDA-licensed biological products, including products approved in the new drug applications (NDAs) that were deemed to be licenses (transition biological products). This update also includes a new feature allowing users to download reports. Historical reports now include highlighted sections reflecting changes made in the previous month. This is the second phase of FDA’s Purple Book planned improvements.

As reported in B&C’s biobased products blog on February 28, 2020, FDA is working to expand the Purple Book by transitioning from its current table list format to a searchable online database for all approved biosimilar products and their reference products. The first phase of the upgrade included information about a product’s proprietary and proper names, the full product label, dosage form, route of administration, strength, and marketing status, among other information. Subsequent phases will include the expansion of the number of FDA-licensed biological products included in the Purple Book online database until the final release, which will include information about all FDA-licensed biological products.


 

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

In March 2020, a paper by master’s degree student Anastasia Prosina titled “Algae-Based Printer Ink as the Way to Foster In-Situ Resource Utilization in Habitation Structures” was published in ResearchGate. Prosina’s paper, submitted to Sasakawa International Center for Space Architecture (SICSA), proposes that the most feasible long-term habitat off-Earth will consist of a 3D printed mixture of algae and regolith, the layer of unconsolidated rocky material covering bedrock. Proposed as an alternative to building structures in space that require intensive mining and sifting, the 3D printed mixture can be cultivated in a lab controlled by biological media. In addition, “[t]he utilization of algae off-Earth is not limited to a singular application and its cultivation would allow for a substantial yield of products, and local micro and macro environmental benefits.” According to Prosina, because of the high protein in and natural thermostatic qualities of algae biomass, this new printing mixture would allow for easier and safer production of everyday consumables, including clothes. Prosina’s paper outlines the benefits and complications of algae production and utilization processes, concluding that algae has the best potential for establishing long-term habitation on the Moon and Mars.


 

Register now for the American Bar Association (ABA) webinar “Navigating the Jurisdictional Tightrope Between Biopesticides, Biostimulants, and Related Emerging Technologies” with Bergeson & Campbell P.C. (B&C®) professionals deconstructing the jurisdictional boundaries distinguishing pesticides, biopesticides, plant regulators, biostimulants, and related technologies. The webinar will focus on draft EPA guidance intended to clarify the lines between and among those products that are subject to FIFRA registration as plant regulators and those biostimulant products not subject to FIFRA registration. The webinar also will focus on new and evolving chemistry and technology issues that may blur some jurisdictional lines or potentially move products from one category to another.  Lynn L. Bergeson, Managing Partner, B&C; Lisa R. Burchi, Of Counsel, B&C; and Sheryl Dolan, Senior Regulatory Consultant, B&C, will present.


 

By Lynn L. Bergeson

On March 16, 2020, DOE EERE’s Advanced Manufacturing Office and Bioenergy Technologies Office used a joint funding opportunity announcement (FOA) of up to $25 million for plastics recycling R&D. As part of the Department’s Plastics Innovation Challenge, this FOA has been titled “BOTTLE: Bio-Optimized Technologies to Keep Thermoplastics Out of Landfills and the Environment.” The BOTTLE FOA will support the development of new plastics capable of efficient recyclability and improvement of recycling strategies that can break existing plastics into chemical building blocks that can be used in other products.

Also as part of the Plastics Innovation Challenge, DOE has launched a new BOTTLE Consortium, which will be led by three of DOE’s national laboratories. The Consortium will work with stakeholders in industry and academia to focus on BOTTLE’s core mission. The three national laboratories in the Consortium currently are the National Renewable Energy Laboratory, Oak Ridge National Laboratory, and Los Alamos National Laboratory.

This BOTTLE FOA includes three topic areas:

  • Highly recyclable or biodegradable plastics;
     
  • Novel methods for deconstructing and upcycling existing plastics; and
     
  • BOTTLE Consortium collaborations to tackle challenges in plastic waste.

Concept papers for the BOTTLE FOA are due on April 22, 2020, and full applications are due on June 18, 2020. Information on how to submit concept papers and applications can be found here.


 

By Lynn L. Bergeson

The Product Stewardship Society is now accepting nominations for officials from member companies to serve on its Board of Directors. The Board establishes the organization’s strategic direction and goals, and monitors progress toward reaching those goals. Nominees must be members in good standing; self-nominations are allowed.

“Our Board members are leaders in a diverse range of business sectors. We are looking for leaders who have a passion for the Society and who wish to work with like-minded professionals to grow the profession and make a difference,” stated Lynn Bergeson, President of the Product Stewardship Society.

Deadline for the nominations is April 15, 2020. More information is available in the full press release.

Tags: PSS, Board

 

By Lynn L. Bergeson

The Iowa Economic Development Authority (IEDA) is offering the first Renewable Chemicals Production (RCP) Tax Credit in the United States. What does this mean? It means that the program provides an opportunity for industry stakeholders to advance Iowa’s economy through a focus on biomass as a feedstock for the production of renewable chemicals. As an attempt to incentivize the production of 30 high-value chemicals derived from biomass feedstocks, IEDA developed the RCP Tax Credit program to “capitalize on its resources and infrastructure and to capture the renewable chemical manufacturing industry.” IEDA is offering tax credit of $0.05 per pound of renewable chemical produced. Start-ups can receive up to $1 million in credit, and established businesses can earn up to $500,000. Applications are open until March 15, 2020, for chemicals produced in 2019.


 
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