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 October 30, 2018, the U.S. Food and Drug Administration (FDA) published a statement by FDA Commissioner Scott Gottlieb, M.D., and FDA Deputy Commissioner Anna Abram regarding FDA’s new action plan to advance plant and animal biotechnology innovation.  Aimed at ensuring the safety of plant and animal biotechnology products and avoiding unnecessary barriers to future innovation, the Action Plan focuses on three key priorities:

  1. Advancing public health by promoting innovation;
  2. Strengthening public outreach and communication; and
  3. Increasing engagement with domestic and international partners.

The statement includes an indication that FDA will be seeking public input in the coming year.  Once input is received, the first step in implementing the new action plan will be the adoption of “a comprehensive policy framework for the development and regulatory oversight of animal biotechnology products, including for intentionally genetically altered animals and the food and drug products derived from them.”  According to their statement, this policy framework will be modern and flexible, accompanied by two guidance documents in 2019.  The guidance documents are intended to provide greater clarity on how FDA will be applying regulatory oversight in evaluating risk profiles of various products.  In addition to these elements, the Action Plan also highlights FDA’s commitment to efforts with both national and international partners in fostering efficiency and cooperation.


 

By Lynn L. Bergeson

The European Commission (EC) announced on October 16, 2018, the launch of a new web-based tool called BioWatch. Developed by BIOWAYS, a project funded by the European Union (EU), this new tool expands BIOWAYS’ efforts in raising awareness of biobased products and their social, economic, and environmental benefits. BioWatch consists of “an interactive online platform that provides projects in the bioeconomy sector with a free service to position themselves alongside one another and provide direct access to industry, political stakeholders, the media, and the general public.” Essentially, this tool serves as an “e-library” for biobased research and projects for its members. BIOWAYS is currently recruiting biobased industry research projects to begin building its “e-library.” More information is available on its website.


 

 

By Lynn L. Bergeson

On October 11, 2018, the European Commission (EC) released a statement announcing its new action plan for a sustainable bioeconomy in Europe. The new action plan, originally announced by President Juncker and First Vice-President Timmermans in their letter of intent, aims to “improve and scale up the sustainable use of renewable sources to address global and local challenges such as climate change and sustainable development.” In his remarks, EC Vice-President for Jobs, Growth, Investment and Competitiveness, Jyrki Katainen, emphasized the need for systemic changes as key drivers of change for the bioeconomy sector. Renewable and sustainable solutions depend on collaborative efforts by governments and industry stakeholders. Based on this premise, EC’s new strategy focuses on three key objectives that include 14 measures to be taken as early as 2019.  The three objectives are to:

  1. Scale up and strengthen the biobased sectors;
  2. Rapidly deploy bioeconomies across Europe; and
  3. Protect the ecosystem and understand the ecological limitations of the bioeconomy.

‚ÄčThese long- and short-term objectives focus on modernizing the European biobased economy and call for systemic changes that will reduce the large underused biomass and waste potential. The action plan will be further discussed and outlined during a conference with stakeholders, hosted by the EC on October 22, 2018, in Brussels.


 

By Lynn L. Bergeson

The 5th Biotechnology World Congress has been scheduled to take place in Bangkok, Thailand, from February 13-15, 2019.  The Welcome Letter states that the conference will “feature a variety of lectures in a number of key sessions in biotechnology, including a commercial exhibition and poster sessions” and the sessions given will include “strategic alliances in biotechnology, pharmaceutical biotechnology, medical biotechnology, plant and environmental biotechnology, bioprocess engineering, and industrial biotechnology.”  A list of the speakers and presentations that have already been scheduled is posted.  The event has put out a call for speakers and posters.  The deadline of abstract submissions for lecture and poster presentation is December 31, 2018; more information on how to apply is available online.


 

By Lynn L. Bergeson

On August 2, 2018, the Trump Administration’s Principal Deputy Director of the U.S. Fish and Wildlife Service, Gregory J. Sheehan, reversed an Obama era 2014 policy on the use of biotechnology on wildlife refuges. On July 17, 2014, the Obama Administration issued a memorandum prohibiting the use of genetically modified biotechnology crops to feed wildlife and the use of neonicotinoid pesticides in agricultural practices. This ban was issued in response to lawsuits that claimed the use of toxic pesticides and genetically engineered crops violated environmental laws. The 2014 memorandum declared that the use of these products should be phased out by 2016. In his 2018 memorandum, Sheehan argued that genetically modified crops and bee-killing pesticides are necessary to promulgate maximum production of farming practices in refuges.


 

 

By Lynn L. Bergeson

On August 1, 2018, the U.S. Department of Energy (DOE) announced an open meeting of the Biomass Research and Development Technical Advisory Committee under the Food, Conservation, and Energy Act of 2008.  83 Fed. Reg. 37490.  The Committee will meet on August 22, 2018, from 8:30 a.m. to 5:30 p.m. (EDT) and on August 23, 2018, from 8:00 a.m. to 1:30 p.m. (EDT).  The purpose of these meetings is to promote research and development (R&D) that leads to the production of biobased fuels and products.  Agenda items include updates on biomass R&D from the U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA).  National laboratories and federal agencies will also be presenting their work on the Bioeconomy Initiative and on prospects and hurdles in the biobased plastics R&D field.  The meeting is open to the public for observation or oral statements on any agenda items.  Written statements will be accepted by the Committee any time before or after the meeting takes place.  To attend the meetings, contact Dr. Mark Elless at 202-568-6501, or via e-mail at .(JavaScript must be enabled to view this email address) at least five business days prior to the meeting.


 

By Lynn L. Bergeson

On July 16, 2018, Anellotech and Suntory announced that a new milestone had been reached in developing a 100 percent biobased plastic bottle. Anellotech is using a thermal catalytic process called Bio-TCatTM to confirm non-food based feedstocks into BTX aromatics, renewable chemicals that are structurally identical to traditional plastic components.  The BTX is now undergoing purification studies to make bio-paraxylene, a key chemical for the renewable bottles. David Sudolsky, President & CEO of Anellotech, stated “[f]ollowing our announcements earlier this year on process development and continuous operation, we are glad that significant progress continues at our TCat-8® pilot plant. We continue to move the technology towards commercialization, and shipping the pilot plant’s product for downstream evaluation is another major milestone.  Having collaborated with Suntory since 2012 to advance development of cost-competitive bio-aromatics, we hope bio-based plastics made from our Bio-TCatTM process and a 100% bio-based bottle soon become a reality.”


 

By Lynn L. Bergeson

On June 18, 2018, DOE’s Bioenergy Technologies Office (BETO)-funded Algae Technology Educational Consortium (ATEC) announced its first graduates from the algal certificate program at Santa Fe Community College in Santa Fe, New Mexico.  DOE states that these first ATEC graduates “received their Associate Applied Science Degree in Controlled Environment Agriculture with a certificate in Algae Cultivation” on May 12, 2018. The program was conceptualized and designed by ATEC members, including professors, algal commercial leaders, community college instructors, and the National Renewable Energy Lab (NREL).  The announcement states that the ATEC curriculum was designed “with inputs from America’s leading algal companies to include education and training in specific job skills, thus allowing students’ skills to transfer immediately into professional careers.”

Tags: DOE, BETO, ATEC, Algae

 
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