"Legal, Regulatory & Political Considerations In Commercializing Algal Products" Panel Presented At ABO, October 1, 2015
Hear BRAG's Richard E. Engler, Ph.D., and other panelists on Thursday, October 1, at the Algae Biomass Summit, which runs September 29 - October 2, 2015, in Washington, D.C. This is where leading producers of algae products go to network with industry suppliers and technology providers, where project developers converse with utility executives, and where researchers and technology developers rub elbows with venture capitalists. Bergeson & Campbell, P.C. is a proud sponsor. Register online.
On August 25, 2015, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing a Public Meeting and Opportunity for Public Comment on Considerations for Risk Assessment of Genetically Engineered Algae. The public meeting, entitled "Workshop for Public Input on Considerations for Risk Assessment of Genetically Engineered Algae," is intended to receive public input and comments on the data needs of EPA to support risk assessments of biotechnology products using genetically engineered algae and cyanobacteria under the Toxic Substances Control Act (TSCA). Feedback from the workshop will also be used to update the EPA guidance document "Points to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms."
The public workshop will be held on September 30, 2015, from 8:00 a.m. to noon (EDT) in Washington D.C., and will also be available online for registered participants. Advance registration will close on September 25, 2015, and written comments are due by October 31, 2015. More information regarding the workshop is available in Bergeson & Campbell, P.C.'s (B&C®) memorandum EPA Schedules Workshop on Considerations for Risk Assessment of Biotechnology Algae.
The Expert Workshop focusing on technical questions for the U.S. Environmental Protection Agency's (EPA) development of a biotechnology algae considerations document is drawing near. The workshop will be open to the public and is scheduled for September 30, 2015, from 8:00 a.m. to noon. More details, including instructions on how to register for the workshop, will be made available in a Federal Register notice. More information regarding the biotechnology algae project is available in Bergeson & Campbell, P.C.'s (B&C®) memorandum EPA Posts Information on Biotechnology Algae Project.
On August 12, 2015, the U.S. Environmental Protection Agency (EPA) announced three webinars to review the new features of the updated online Premanufacture Notifications (PMN) Submission System. The new web-based submission system for the Toxic Substances Control Act (TSCA) Section 5 submissions is replacing the ePMN reporting software that is currently in use. The first webinar is on August 26, 2015, from 1:00 p.m. - 4:00 p.m., and will cover the process of registering with the Central Data Exchange (CDX) and user roles. The second webinar is on September 16, 2015, from 1:00 p.m. - 4:00 p.m., and will review the PMN form, support form, and joint submissions. The final webinar will occur on September 30, 2015, from 1:00 p.m. - 4:00 p.m., and will include a discussion of Notice of Commencement (NOC), biotech, "bona fide," and Significant New Use Rules (SNUR) Alternate Control Measures electronic submissions.
The inclusion of biotechnology algae in the third and final webinars was previously mentioned in the announcement of the "US Environmental Protection Agency Biotechnology Algae Project." The biotechnology algae project will result in the development of a stand-alone document that will assist innovators who are developing new microbial technology applications under TSCA. EPA will develop the algae guidance in conjunction with the update of the Points to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms (Points to Consider) document. The webinar will allow the public to submit questions on both technical issues relating to the development of a biotechnology algae considerations document, as well as on the societal implications of the development of biotechnology algae. This invitation for stakeholder input is a key opportunity to explain the steps that are being taken to ensure responsible development and use of biotechnology, and to provide comment on how EPA can improve and update the Points to Consider document. More information regarding the biotechnology algae project is available in Bergeson & Campbell, P.C.'s (B&C®) memorandum EPA Posts Information on Biotechnology Algae Project.
The U.S. Environmental Protection Agency (EPA) announced last week that it is developing a project intended to support public dialog concerning the development and use of synthetic biology (Synbio) algae. EPA has oversight responsibility for the production and use of intergeneric microorganisms, including cyanobacteria, eukaryotic microalgae (genetically modified (GM) algae), and their products by application of genetic engineering approaches, including those called Synbio. EPA's recently posted document, US Environmental Protection Agency GM/Synbio Algae Project, states that it is focusing its project around GM/Synbio algae applications.
EPA intends to facilitate the development of the GM/Synbio algae project by holding an expert workshop, open to the public on September 30, 2015. While the workshop will focus on the technical questions that EPA believes are important to its development of a GM/Synbio algae considerations document, EPA states that it will also provide an opportunity to stakeholders and the general public to comment on any aspects of GM/Synbio algae that they believe are relevant to EPA's mission.
EPA's posting of the GM/Synbio algae project is hugely important for the industrial biotechnology and synthetic biology communities. EPA's announcement suggests a broader Agency initiative is underway, and is best read in the context of other relevant developments. Full details on this announcement and related developments are available in Biobased and Renewable Products Advocacy Group (BRAG®) affiliate Bergeson & Campbell P.C. (B&C®)'s memorandum EPA Posts Information on GM/Synbio Algae Project.
On July 9, 2015, the U.S. Department of Energy (DOE) announced $18 million in funding for six projects to develop bioproducts and biofuels from algae. The funding is intended to reduce the cost of algae-based biofuels to less than $5 per gasoline gallon equivalent (gge) by 2019 to help reach DOE's target of $3 per gge for advanced algal biofuels by 2030. The projects that were selected for the funding are run by Producing Algae and Co-Products for Energy (PACE), Marine Algae Industrialization Consortium (MAGIC), Global Algae Innovations, Arizona State University, the University of California, and the Lawrence Livermore National Laboratory. The projects aim to increase algal biofuel efficiency and sustainability by maximizing the productivity and recovery of materials used in fuel production, as well as researching ways to protect algae production ponds and ensure crop health by developing probiotic bacteria to fight pond infections and infestations.
The U.S. Department of Energy (DOE) announced up to $25 million in funding to reduce the cost of algal biofuels to less than $5 per gasoline gallon equivalent (gge) by 2019. On behalf of the Bioenergy Technologies Office (BETO), the DOE Office of Energy Efficiency and Renewable Energy posted a notice of a funding opportunity, entitled "Targeted Algal Biofuels and Bioproducts" (TABB). The TABB Funding Opportunity Announcement (FOA) looks for pathways to overcome the key barriers to commercializing algal biofuels: the high cost of producing algal biomass and the low yield of target biofuel and bioproduct feedstocks produced from algae. Specifically, the TABB FOA will support: (1) the development of algae cultures that produce valuable bioproducts alongside fuels to increase the overall value of the biomass; and (2) the development of crop protection and carbon dioxide utilization technologies to boost culture productivity and yield to reduce the cost of the biomass. There will be an information webinar on October 8, 2014. Information on the webinar is available online.
More information on the TABB FOA and applications is available online.
On August 20, 2014, the U.S. Department of Energy (DOE) announced that it intends to issue a Funding Opportunity Announcement (FOA) sometime in September to help reduce the cost of algae biofuels and bioproducts. DOE explains in the announcement that the Agency's Bioenergy Technologies Office's (BETO) "2019 projected state of technology for the cost of algal biofuels is modeled at about $7 per gallon gasoline gallon equivalent, without valuable co-products such as animal feed or commodity chemicals. This FOA seeks to improve the value proposition for algal biofuels by employing multi-disciplinary consortia to produce algae bioproduct precursors (alongside fuel components), as well as single-investigator or small-team technology development projects focused on crop protection and CO2 utilization technologies for improving biomass productivity. BETO hopes these strategies will enable a 30-50% cost reduction for algal biofuels." The FOA will be available online. Currently, the formal notice of intent to issue this FOA is available via this link.
A copy of DOE's announcement is available online.
On July 28, 2014, Sapphire Energy (Sapphire) announced that James Levine would replace CJ Warner as the Company's President and CEO. Mr. Levine had been the CEO of Verenium Corporation (Verenium). San Diego-based Sapphire focuses on the production of green crude made from algae. Verenium is an industrial biotechnology company developing commercial-scale enzyme solutions. Sapphire's press release with more information is available online.
On June 23, 2014, U.S. algae developer Cellana, Inc. announced that it has entered into a letter of intent with Galil Algae Cooperative Agriculture Society Limited of Israel for the production of high-value algae products for aquaculture applications. The primary objective of this effort is to identify, cultivate, develop, and scale-up algae strains with immediate commercial value, emphasizing the high-value components for existing aquaculture, mariculture, nutraceuticals, pharmaceuticals, and/or cosmetic applications. A copy of Cellana's press release is available online.