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

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 July 16, 2018, the National Science Foundation (NSF) announced a $12 million investment in the Semiconductor Synthetic Biology for Information Processing and Storage Technologies (SemiSynBio) program, a partnership between NSF and Semiconductor Research Corporation (SRC).  Researches expect that integrating biological structures with semiconductor technology could increase current data storage capabilities by 1,000 times, while using less energy than current technology.  "While today's data storage devices are smaller and more powerful than ever before, we have the potential to catalyze a new wave of innovation that will push the boundaries for the future," stated Erwin Gianchandani, acting NSF assistant director for Computer and Information Science and Engineering (CISE).  Further, "[t]his research will pave the way for devices with much greater storage capacity and much lower power usage. Imagine, for example, having the entire contents of the Library of Congress on a device the size of your fingernail."   The funded projects include:

  • DNA-based electrically readable memories:  Joshua Hihath, University of California-Davis; Manjeri Anantram, University of Washington; Yonggang Ke, Emory University.
  • An on-chip nanoscale storage system using chimeric DNA:  Olgica Milenkovic, University of Illinois at Urbana-Champaign.
  • Highly scalable random access DNA data storage with nanopore-based reading:  Hanlee Ji, Stanford University. 
  • Nucleic Acid Memory: William Hughes, Boise State University.
  • Very large-scale genetic circuit design automation:  Christopher Voigt, Massachusetts Institute of Technology; Kate Adamala, University of Minnesota-Twin Cities; Eduardo Sontag, Northeastern University.
  • Redox-enabled Bio-Electronics for Molecular Communication and Memory (RE-BIONICS):  William Bentley, University of Maryland College Park.
  • YeastOns:  Neural Networks Implemented in Communicating Yeast Cells: Rebecca Schulman, Johns Hopkins University; Eric Klavins, University of Washington; Andrew Ellington, University of Texas at Austin.
  • Cardiac Muscle-Cell-Based Coupled Oscillator Networks for Collective Computing:  Pinar Zorlutuna, University of Notre Dame.

 

By Lynn L. Bergeson

On June 19, 2018, the National Academies of Sciences, Engineering, and Medicine (National Academies) published a press release announcing the availability of a final report entitled Biodefense in the Age of Synthetic Biology.  According to the National Academies, the final report concludes that “[s]ynthetic biology expands the possibilities for creating new weapons -- including making existing bacteria and viruses more harmful -- while decreasing the time required to engineer such organisms.”  Some malicious applications of synthetic biology that may not seem plausible right now could become achievable with future advances.

The final report, which builds on and supersedes an interim report released in August 2017, explores and envisions potential misuses of synthetic biology, including concepts that are regularly discussed in open meetings.  In the interim report, the Committee on Strategies for Identifying and Addressing Potential Biodefense Vulnerabilities Posed by Synthetic Biology proposed a strategic framework intended to identify and prioritize potential areas of concern associated with the field and to help biodefense analysts as they consider the current and future synthetic biology capabilities.  The Committee designed the framework for analyzing existing biotechnology tools to evaluate the dangers at present, understand how various technologies compare with and complement each other, and assess the implications of new experimental outcomes.  More information is available in Bergeson & Campbell, P.C.’s (B&C®) memorandum.


 

By Lauren M. Graham, Ph.D.

On November 7, 2017, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) issued a notice in the Federal Register announcing that it was withdrawing its proposed rule that would have revised the importation, interstate movement, and environmental release of certain genetically engineered (GE) organisms.  The proposed rule, which was issued on January 19, 2017, aimed to “update the regulations in response to advances in genetic engineering and understanding of the plant pest and noxious weed risk posed by [GE] organisms, thereby reducing burden for regulated entities whose organisms pose no plant pest or noxious weed risks.”  After reviewing public comments on the proposed rule, USDA decided to re-engage with stakeholders and explore alternative policy approaches.  More specific comments from USDA and the reasons supporting its decision are set forth in the notice.
 
While it appears that some in industry may welcome the withdrawal, most would agree that all stakeholders should work collaboratively and quickly to develop a new framework to speed the process to market, and to ensure the regulatory landscape is more efficient and clearer than it currently is.  USDA and pertinent others should immediately begin another process to enable the regrouping to begin.


 

By Lauren M. Graham, Ph.D.

On August 21, 2017, the National Academies of Sciences, Engineering, and Medicine (NAS) released their interim report titled A Proposed Framework for Identifying Potential Biodefense Vulnerabilities Posed by Synthetic Biology.  The U.S. Department of Defense (DOD) asked NAS to develop the framework to:

  • Guide an assessment of the security concerns related to advances in synthetic biology;
  • Assess the level of concern warranted for various advances and identify areas of vulnerability; and
  • Prioritize options to address these vulnerabilities.
The report provides an overview of the categories of synthetic biology and a set of initial questions aimed at guiding the assessment of concern related to the technologies and applications of the field.  The framework outlines factors for assessing the levels of concern that each technology and application presents in terms of malicious use, as well as factors for assessing the capability for mitigation.  The final report will use the framework to provide DOD with an assessment of concerns and mitigation options by developing informed answers to the questions posed in the interim report.

 

By Lauren M. Graham, Ph.D.

On June 19, 2017, Synthetic Genomics Inc. announced a breakthrough in its collaboration with ExxonMobil involving the modification of an algae strain that more than doubled its oil content to 40 percent without significantly inhibiting the strain’s growth.  Synthetic Genomics researchers identified a genetic switch that could be fine-tuned to regulate the conversion of carbon to oil in the algae species, Nannochloropsis gaditana, and established a proof-of-concept approach for the new process.  The achievement is a key milestone in the partnership that aims to demonstrate that algae can be incredibly productive as a renewable energy source with a corresponding positive contribution to our environment.  Additional research, testing, and analysis is required to ensure the process is commercially viable. 


 

On November 9, 2016, Inside EPA published “ New TSCA Requirements Raise Challenges To EPA Biotech Review Staff” (subscription required), outlining what EPA has done to adapt to revised Toxic Substances Control Act (TSCA) requirements for engineered microorganisms.   Richard E. Engler, Ph.D., Senior Chemist with Bergeson & Campbell, P.C. (B&C®), was quoted in the article discussing what to expect from approaching biotechnology regulations:  

Richard Engler, a former EPA toxics official now a senior chemist with environmental law firm Bergeson & Campbell, attended the [Second Public Meeting and Opportunity for Public Comment on EPA's Draft Algae Guidance for the Preparation of TSCA Biotech Submissions] and said in a Nov. 3 interview with Risk Policy Report, "I think EPA's still figuring out what 'reasonably foreseeable' means.  It's a challenge for chemicals as well as microorganisms.
 
Noting that the Lautenberg Chemical Safety Act, which reformed TSCA, "is silent on microorganisms," Engler adds that the "effect of Lautenberg is parallel for chemicals and microorganisms."  A key change in the updated law, Engler says, is the new requirement that EPA make an affirmative decision on whether new chemicals or microorganisms meet TSCA's risk standard of "will not present an unreasonable risk of injury to health or the environment," which is "true for chemicals and microorganisms."
 
One difference that Engler notes is that if a newly submitted chemical "is a new microbe, it increases the data need for EPA to show not likely to present" unreasonable risk.
 
[…]
 
Engler said that what Segal described is "what [significant new use rules (SNURs)] do.  They limit releases of substances or an organism so the commercial activity in the notice is permitted but if another company wanted to use [it] in a different manner a significant new use notice is required."
 
As an example, Engler said that "if a [microbial commercial activity notices (MCAN)] submitter had a contained use [of a microorganism] with complete destruction of the organism but if EPA was unsure . . . they might place a SNUR on the microorganism that the submitter or anyone else would have to abide by."
 
In this example, as in other cases, Engler said, EPA would treat a new organism and the decision on whether to place a SNUR on other uses of that microorganism as it would a new chemical.  "It's the same rules," he said.  "The hazards are different, there are other risks because they're living organisms.  There are concerns about gene transfer between the MCAN organism and whatever's in the wild.  But the criteria is the same and the regulatory tools they use to contain are the same."
 
One change that Engler noticed is that all SNURs will now be accompanied by a consent order.  "EPA said that their interpretation of Lautenberg is that if they make a 'may present' finding, they must also impose a Section 5(e) consent order.  In the past we could do a non 5(e) SNUR."
 
"Their new interpretation is they have to do a consent order" with a SNUR," Engler said.  "The effect depends on what the consent order says.  It may say, 'SNUR is in effect until the SNUR is published'" once the commercial activity commences.  "In the past, [5e orders] were typically used to impose testing" requirements.
 
Like other elements of changes to TSCA, Engler said that the consent order changes will apply equally to chemicals and microorganisms.  "With TSCA reform in place, I'm not sure what consent orders will look like," he said.  "But that will be the same for chemicals and microbes."

 

On October 17, 2016, the Industrial Biotechnology Innovation Centre (IBioIC) announced over £3 million in investments over six synthetic biology projects.  IBioIC was founded by Ingenza Ltd, GlaxoSmithKline plc (GSK), and INEOS to connect academic expertise in synthetic biology with industrial capabilities from businesses in the area.  IBioIC focuses on biotechnology in health, industrial, agriculture, and marine areas.  Recipients of the £3 million in funding are:
 


 
“Synpromics with University of Edinburgh to enable better gene therapy;
 

 
Lucite International with University of St Andrews to increase the sustainability of acrylic glass;
 

 
Unilever with University of Edinburgh to create “greener” skin cleansers;
 

 
Ingenza Ltd with University of Glasgow to develop advanced metrology (measurements) for biotechnology;
 

 
Twist Bioscience with University of Edinburgh to develop tools to engineer yeast strains for fuels and pharmaceuticals; and
 
Nissan Chemicals with University of Glasgow for new tools for bio-production of pharmaceuticals, nutraceuticals, cosmetics.

 

On June 22, 2016, DOE released the detailed agenda for the Biotechnology for Clean Vehicles: Harnessing Synthetic Biology To Enable Next-Generation Biomaterials And Biofuels session at the Sustainable Transportation Summit. The session is hosted by DOE's Office of Energy Efficiency and Renewable Energy (EERE) and will focus on how novel biomaterials and renewable fuels can be used to improve vehicle efficiency and sustainability. The session will also discus the role of synthetic biology in enabling renewable fuels and materials. The Biotechnology for Clean Vehicles session will be held from 8:00 a.m. to 12:00 p.m. (ET) on July 12, 2016, during the Sustainable Transportation Summit in Washington D.C.


 

On March 22, 2016, a team visited Malmstrom Air Force Base to test a new biobased synthetic oil in the base's vehicles. The testing is sponsored by the Defense Logistics Agency (DLA) and the Office of the Secretary of Defense, with four bases chosen to use the plant based synthetic oil in vehicles. The Department of Homeland Security's Law Enforcement Training Center has also begun testing the oil and will be monitoring the impacts on vehicle performance and engine quality over the next 12-18 months. George Handy, the project manager, stated that the use of biobased oil is not expected to result in "any change in the performance of any of the vehicles because they are already running on synthetic fuels." If the testing goes well, the biobased oil will be available to purchase through normal channels, improving national security through the use of a domestically produced sustainable product.


 
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