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.

On September 30, 2015, the U.S. Environmental Protection Agency (EPA) held a workshop on genetically engineered (GE) algae to give stakeholders an opportunity to hear about EPA's plans for improving its risk assessments of GE algae under the Toxic Substances Control Act (TSCA). Dr. Jeff Morris, Deputy Director of Programs for the Office of Pollution Prevention and Toxics (OPPT), welcomed participants and laid out the scope of the meeting: to assist EPA in understanding the questions it needs to ask and answer when it receives a Microbial Commercial Activity Notice (MCAN) for GE algae. Dr. Morris discussed how this workshop will contribute to EPA's broader effort to update the Points to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms document that relates to other GE microorganisms, as well as the update to the federal Coordinated Framework on the Regulation of Products of Biotechnology. While updating the framework will assist EPA in handling risk assessments for GE algae, regulation will continue to be risk-based and determined on a case-by-case basis.

Members of EPA's biotech review team discussed aspects of MCAN review and pointed out particular areas where EPA seeks input, in particular:

  • Taxonomy of algae;
     
  • Propensity to transfer genetic material to other species;
     
  • Ability to produce toxins or allergenic effects;
     
  • How the growth rate and forms (unicellular or filamentous) might relate to exposure;
     
  • Survivability of GE algae in the wild; and
     
  • Propensity to out-compete wild populations of algae, and organismal control mechanisms.

The panel, as well as stakeholders, commented on how algae are different than traditional industrial microbes in some significant ways:

  • The organisms are not as well studied, largely because, unlike bacteria and fungi, they have only recently been used for industrial production.
     
  • Inactivation methods are quite different because of the protective cell walls that algae have, that most microbes lack.

Dr. Morris also made it clear that this meeting is just the beginning of the conversation. EPA continues to seek input from stakeholders on algae, in particular, and other GE organisms as part of EPA's effort to update the regulatory framework for GE organisms. Draft Charge questions are available on the workshop website, speaker presentations can be accessed through the meeting agenda webpage, and the deadline for written comments is October 31, 2015. More information on EPA's development and use of biotechnology is available in B&C's memorandum EPA Posts Information on Biotechnology Algae Project.


 

Stakeholders working with algae to produce chemicals and fuels should take note of these upcoming opportunities:

Tags: algae

 

On September 3, 2015, the U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy’s Bioenergy Technologies Office (BETO) released a Request for Information (RFI) titled “High Yields through Productivity and Integration Research.”  BETO is seeking input from industry, academia, and other stakeholders regarding supply systems and services for the cultivation, logistics, and preprocessing of algal feedstocks.

This RFI provides algae stakeholders with an opportunity to contribute their views on the requirements necessary to develop reliable and sustainable supplies of algal biomass, algal intermediates, and metabolites. Multiple types of algae, including microalgae, cyanobacteria, and macroalgae are of interest.

The request is only for information that may be used by DOE to support program planning and is not a funding opportunity announcement. To respond to the request for information, e-mail attachments to .(JavaScript must be enabled to view this email address) by 5:00 p.m. (EDT) on September 30, 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.


 

"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.


 
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