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 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

On March 2, 2020, the U.S. Department of Energy (DOE) Office of Energy Efficiency and Renewable Energy (EERE) announced open meetings of the Biomass Research and Development (R&D) Technical Advisory Committee. Occurring on March 24, 2020, from 8:00 a.m. to 5:00 p.m. (EDT) and March 25, 2020, from 1:00 p.m. to 4:30 p.m. (EDT), both meetings will take place in Arlington, VA. The purpose of the meetings is to develop advice and guidance that promotes R&D leading to the production of biobased fuels and biobased products. Parties interested in participating in the meeting and/or making oral statements must contact .(JavaScript must be enabled to view this email address) five days prior to the meetings.

Tags: DOE, EERE, Biofuel

 

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

On March 4, 2020, FDA announced that it has issued in final a guidance for industry titled “The ‘Deemed to be a License’ Provision of the BPCI Act: Questions and Answers,” which addresses FDA’s “transition” provision of the BPCI Act. Established in 2009, the Biologics Price Competition and Innovation Act (BPCI Act) deemed applications for an approved biological product under Section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to be a license for the biological product under Section 351 of the Public Health Service Act (PHS Act) as of March 23, 2020. Aiming to make the BPCI Act implementation process smoother, FDA has published the guidance for industry as part of the “transition” provision of the Act. The transition of biological products currently regulated under the FD&C Act to the PHS Act will allow for the submission and approval of marketing applications for new biosimilar or interchangeable biological products. The guidance follows FDA’s recent issue of the new definition of the term “biological product,” announced on February 21, 2020, per Bergeson & Campbell, P.C.’s (B&C®) February 28, 2020, blog item.


 

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

On March 5, 2020, FDA opened a public docket for comments on its enhancement of the Purple Book, which is otherwise known as FDA’s “Database of FDA-Licensed Biological Products.” 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. These upgrades will be released in multiple phases. FDA has now completed phase I, which consists of the full search functionality of the database. 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.

The first phase of the upgrade includes 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. Given its completion, FDA is now requesting comments from stakeholders until May 4, 2020.


 

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.


 

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

On February 26, 2020, the city of Helsinki announced the opening of applications for the Helsinki Energy Challenge (HEC), which aims to address challenges associated with urban heating produced with coal. According to its press release, Helsinki is one of the leading cities in the transition toward a sustainable future. Its aim is to achieve carbon neutrality by 2035. Currently, however, Helsinki needs solutions to meet its heat demand. Given Finland’s coal ban starting in 2029, Helsinki is seeking heating solutions that go beyond coal and beyond burning biomass. Helsinki Mayor, Jan Vapaavuori, stated that “[s]olving the urban heating challenge is crucial to reach global climate goals. Cities have a key role to play in the transition to a low carbon economy, and Helsinki is now taking an initiative to lead the way.” The city is inviting innovators from around the world to use Helsinki as a test bed to develop fossil-free and sustainable solutions in the fight against global warming.

Proposed solutions will be evaluated based on:

  • Climate impact;
  • Impact on natural resources;
  • Implementation schedule and feasibility;
  • Reliability and security of supply; and
  • Capacity.

HEC is open globally to consortiums, start-ups, established companies, research institutions, universities, research groups, and individual experts. Applications will be accepted until May 31, 2020. Finalists will be invited to a co-creation phase in early July 2020, which will include a 3-day boot camp, where they will be provided support to develop their proposals. After the boot camp, finalists will present their proposals to an international jury of experts, who will name the winner or winners. To be presented in November 2020, the winning solution will be awarded one million euros.


 

By Lynn L. Bergeson

On February 24, 2020, FDA Commissioner Stephen M. Hahn, M.D., announced that FDA is upgrading its Purple Book, which is otherwise known as its “Database of FDA-Licensed Biological Products.” According to Dr. Hahn, FDA is working to expand the Purple Book by transitioning from its current list format to a searchable online database for all approved biosimilar products and their reference products. An upgrade planned to be released in multiple phases, the full search functionality is the first step. 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. The aim is to grow the data set to include data and information about all Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) regulated products.

The first phase of the upgrade includes 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. FDA plans to open a public docket to gather feedback from stakeholders on the new database with its enhanced functionality. In the announcement, Dr. Hahn stated that “[t]his expansion and digitization of the Purple Book will make more information about FDA-licensed biological products more accessible, increasing transparency for patients, industry users and other stakeholders.”


 

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

On February 25, 2020, DOE’s Oak Ridge National Laboratory (ORNL) announced that its scientists have developed a novel technique to closely observe the nanostructure of biomaterials without damaging the sample. Using a nonintrusive soft mechanical nanoablation (sMNA) technique can confirm structural features in starch, which is an important carbohydrate in the production of biofuels. ORNL’s chief scientist for systems biology and biotechnology, Brian Davison, highlighted the importance of plant cell wall structures in the next generation of biofuels, stating that the “study used starch as an example of how this technique can start to access some of these nanomechanical structure materials” that currently cannot be observed. ORNL’s study was published on February 6, 2020. ORNL scientists believe the novel technique can also be applied to nonliving materials and used on synthetic polymers or even three-dimensional-printed materials.


 

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

The international standards organization, ASTM International, is seeking additional task group members to further develop the current terminology standard in industrial biotechnology (E3072-19). ASTM International develops and publishes voluntary consensus technical standards for a wide range of materials, products, systems, and services. Its sub-committee, E62.91 for Terminology in Industrial Biotechnology, is responsible for suggesting new terms and definitions to be added to the current standard and for revising existing terms and definitions as needed. The meanings and explanations of the technical terms have been written for both non-expert and expert users and is updated annually to include editorially any terms approved in the committees of technical standards. This standard, however, does not purport to address all of the safety concerns, if any, associated with the use of biotechnology products, materials, systems, or services. Interested parties should contact the sub-committee chair, .(JavaScript must be enabled to view this email address), or the E62 staff manager, .(JavaScript must be enabled to view this email address), directly.


 

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

On February 19, 2020, the University of Oulu, Finland, announced that scientists from its Research Unit of Sustainable Chemistry have developed a new synthetic bioplastic that provides protection from ultraviolet (UV) radiation. In addition to its UV-light blocking capacity, the transparent bioplastic made from a biomass-based copolymer with bisfuran structure, the new bioplastic also has airtightness capabilities three to four times higher than polyethylene terephthalate (PET) plastic. The raw materials used in the production of this entirely biomass-based plastic are hydroxymethylfurfural (HMF) and furfural, which are biorefinery products derived from cellulose and hemicellulose. University of Oulu researchers chemically linked the two chemicals to create copolymer parts with bisfuran and furan-like structures. The research results have been published, and a patent application for the bioplastic has been filed for the new method developed.


 
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