EPA Approves First Applications for Outdoor Testing of Modified Algae

A few weeks ago, I posted two entries having to do with the possible open-pond use of genetically modified algae for fuel or chemical production, and how such uses would be regulated by the US EPA through the use of TSCA Experimental Release Applications (TERAs). These posts were (unknowingly) quite timely, since EPA just recently (December 6, 2013) posted on their website that they had approved the first TERAs submitted for the experimental outdoor use of genetically modified algae. These are a series of applications submitted by Sapphire Energy, Inc., the well-known San Diego company that is a leader in the algae biofuels field, for open-pond testing of five intergeneric strains of the photosynthetic green algae Scenedesmus dimorphus. Sapphire submitted these TERAs on August 1, 2013, and EPA approved them on September 25, 2013, within the 60-day review period allotted under the regulations.

As I described in the earlier post, small-scale, research uses of genetically modified algae or other microorganisms in an open-pond or other minimally contained reactor would not be eligible for the “contained structure” R&D exemption under EPA’s TSCA biotechnology rules, and would instead require EPA review before the research can be conducted, through the filing of a TERA. The TERA process provides an expedited review procedure for small-scale field tests and other outdoor R&D uses of new organisms. Applicants proposing such uses must file a TERA with the EPA at least 60 days in advance of the proposed activity. The data requirements for TERAs are outlined in §§725.255 and 725.260 of the regulations, and were also summarized in my earlier post. EPA would review the submitted information and decide whether or not to approve the proposed outdoor R&D activity within 60 days, although the agency could extend the review by an additional 60 days. If EPA determines that the proposed activity does not present an unreasonable risk of injury to health or the environment, it will notify the applicant in writing that the TERA has been approved, but EPA can also approve a TERA with limitations or conditions, such as a requirement to conduct certain monitoring of the experiments.

Prior to Sapphire’s filings, there had only been 25 TERAs submitted for field use of engineered microorganisms, almost exclusively for agricultural microorganisms, or for microbes to be used for bioremediation or for detection of hazardous contaminants in soil. None of these TERAs proposed the use of GM algae or any use related to biofuels. So the Sapphire applications and approvals represent a true “first” in the industrial biotechnology regulatory world.

As mentioned above, the Sapphire TERAs  proposed the testing of five different intergeneric strains of Scenedesmus dimorphus in open ponds. The stated purpose of this testing, as summarized on the EPA website, is to (1) evaluate the translatability of the genetically modified strains from the laboratory to an outdoor setting, and (2) to characterize the potential ecological impact (dispersion and invasion) of the genetically-modified microalgae. The introduced intergeneric DNA sequences include certain “metabolism genes” and a marker gene that enables detection of the microorganism from environmental samples, and different genetic regulatory sequences were used as well. Although the details of the genetic engineering have been claimed as confidential (as allowed under the regulations), it appears that the so-called metabolism genes enable or enhance the ability of the strains to synthesize the mixture of compounds Sapphire refers to as “green crude”. The field trials were proposed to be conducted at the University of California San Diego Biology Field Station (BFS) in La Jolla, CA.

Further details of the proposed testing can be seen from the non-confidential version of the TERA submission, which can be obtained from EPA’s TSCA docket office (Sapphire filed a single document describing all five strains, which EPA treated as five individual TERA applications). The intergeneric genes have been integrated into the algae chloroplast, so that the encoded proteins are expressed within that organelle. Although the identity of these genes has not been made public, the application document indicates that they are codon-optimized versions of genes identified from public databases. Although all the details of the genetic construction are claimed as confidential, it is clear from the public version of the document that Sapphire submitted a great deal of information describing and characterizing the five modified strains it will be testing. The TERA notes that the wild type (non-modified) strain of the algal species that has been modified, Scenedesmus dimorphus, has been cultivated at Sapphire’s facilities for several years, both in closed reactors and outdoor ponds, and the TERA includes data and an extensive discussion to support the company’s belief that the use of these modified organisms in open-pond reactors will not pose unreasonable risks to human health or the environment. In particular, Sapphire performed and submitted studies in both soil and water to show that the strains showed poor survival (i.e., zero or negative growth) in these environments.

As required by the regulations, the TERA also included a detailed description of the proposed outdoor experimentation and the procedures that will be followed to minimize and monitor the potential release of the organism from the test plots. In the main portion of the experiment, the five modified algal strains will be grown semi-continuously in six to eight 1,200 liter capacity “miniponds” operating with volumes of 600-800 liters. To provide secondary containment, the miniponds are located in a sand/soil berm that has been lined with a puncture-resistant liner. This is the portion of the testing to determine how well the laboratory performance of the strains (presumably for green crude production) translates to performance in the open environment. The experiment also includes a number of “trap ponds” that will be filled with tap water and nutrients that might enable algal growth, and these ponds will be monitored on a periodic basis to determine if the experimental strains have spread in detectable numbers from the miniponds. Conducting such monitoring during a small-scale outdoor field trial of a GMO is a very important way of obtaining data on the potential for environmental dispersal that will be crucial in future regulatory reviews to assess the impacts of larger-scale testing and use.

From my brief review of the TERA document, I can say that Sapphire did a really nice job in preparing the submission, documenting how they’ve created and characterized the strains, and describing in detail how the outdoor testing would be conducted and monitored. It also seems that a great deal of care has gone into the design of the experiment, knowing that they would be the first to test the waters of the TERA process and the EPA biotech regulations with genetically modified algae. There has been some reluctance within the algae community to take this first step, and some uncertainty about how the open-pond uses of modified algae would be treated under the EPA regulations, and so it is good to see that the first TERA to be submitted was prepared so thoroughly and was approved, seemingly without issue, by EPA.

As I said in my earlier post, the TERA process is well-suited to allow outdoor uses of modified microorganisms to take place under appropriate agency oversight and risk assessments. Most importantly, the TERA process allows outdoor uses of GMOs to take place in a stepwise fashion, to enable environmental risk assessment questions to be addressed with data from actual small-scale environmental use, thus facilitating subsequent risk assessments for larger-scale uses. Although there is no doubt that outdoor uses of genetically modified algae and other microorganisms will receive greater regulatory scrutiny than uses in contained manufacturing, EPA’s TERA process should allow such uses to proceed through the normal phases of scaled testing in an orderly and responsible manner. I hope that other companies and research institutions follow Sapphire’s lead, to begin to establish a track record and publicly-available data to show that modified algae can be used in the open environment without adverse environmental effects.

D. Glass Associates, Inc. is a consulting company specializing in government and regulatory affairs support for renewable fuels and industrial biotechnology. David Glass, Ph.D. is a veteran of over thirty years in the biotechnology industry, with expertise in industrial biotechnology regulatory affairs, U.S. and international renewable fuels regulation, patents, technology licensing, and market and technology assessments. Dr. Glass also serves as director of regulatory affairs for Joule Unlimited Technologies, Inc. More information on D. Glass Associates’ regulatory affairs consulting capabilities, and copies of some of Dr. Glass’s prior presentations on biofuels and biotechnology regulation, are available at www.slideshare.net/djglass99 and at www.dglassassociates.com. The views expressed in this blog are those of Dr. Glass and D. Glass Associates and do not represent the views of Joule Unlimited Technologies, Inc. or any other organization with which Dr. Glass is affiliated. Please visit our other blog, Biofuel Policy Watch.

European food approval still elusive for Enogen corn

In a decision last month that seems to have gone a bit under-reported in the trade press, the European Food Safety Authority (EFSA) announced that it could not reach a conclusion on an application from Syngenta Crop Protection AG for the approval of the use of Syngenta’s Enogen® corn in food and feed. While fully in line with the reluctance of the EU and its member states to allow commercial growth and food uses of transgenic plants and their products, this represents another setback in the long saga of Syngenta’s development of this modified corn variety.

I’ve described Enogen corn in earlier blog entries, including a post on February 14, 2011 when the corn variety was approved by the U.S. Department of Agriculture for commercial cultivation in the U.S. As described in my earlier posts, Enogen, originally known as “Corn [Maize] event 3272”, is a variety of corn expressing two heterologous genes: the amy797E gene and the pmi gene. The amy797E gene is derived from three naturally-occurring genes and encodes a thermostable alpha-amylase which catalyses the hydrolysis of starch by cleaving the internal alpha-1,4-glucosidic bonds into dextrins, maltose and glucose. The pmi gene from Escherichia coli encodes the phosphomannose isomerase (PMI) enzyme, which allows the plant to utilize mannose as a carbon source. The expression of thermostable alpha-amylase directly in plant tissue can potentially lead to significant yield increases in production of corn-based ethanol.

To my knowledge, Enogen is the only genetically modified plant variety that has achieved commercial approval in any industrialized country for use as a biofuel feedstock, and it has been approved for use in the U.S. and in a number of other countries. It appears to be doing well in the market – although sales figures are not readily available, Syngenta announced in June 2013 that Enogen is now grown by 300 growers covering more than 64,000 acres in the U.S., and is being used as a feedstock at eleven U.S. ethanol facilities. In addition to its USDA regulatory approval in February 2011, the company says that the U.S. Food and Drug Administration concluded its review of the food safety of the corn in 2007, which would clear U.S. use in animal feed (e.g., distillers grains) of corn residues remaining after ethanol fermentation.

The ultimate (although time-consuming) success of the U.S. regulatory process is in contrast to the situation in the European Union, a region that has long been suspicious, if not downright hostile, towards proposals to use transgenic plants in agriculture and food. Enogen has not been approved for cultivation in the EU, and the recent regulatory action arises from an application first filed by Syngenta in 2006 to obtain approval to import Enogen corn grown elsewhere and allow it to be processed and used in human food or animal feed in the EU. Syngenta’s application was made to the European Food Safety Authority (EFSA) pursuant to EC Regulation Number 1829/2003, which governs the placing on the market of genetically modified organisms (GMOs) and foodstuffs containing GMOs, both for human and animal food purposes (click here for a summary of this regulation). EFSA is the agency that is responsible for evaluating the food safety of GMO plants proposed for use in Europe.

On June 20, 2013, EFSA announced that it could not reach a conclusion on the safety of Enogen (variety 3272) corn, because Syngenta had not provided “key information to allow a full risk assessment to take place”.  The primary data deficiency appeared to be that the company’s choice of a conventional corn species as the “comparator” was inadequate due to lack of data and because that species did not have a history of safe use. The scientific report of EFSA’s Panel on Genetically Modified Organisms can be found here. Among its findings and other comments, as summarized in the published abstract, are the following:

In delivering its scientific opinion, the EFSA GMO Panel considered the application EFSA-GMO-UK-2006-34, additional information provided by the applicant (Syngenta Crop Protection AG) and the scientific comments submitted by the Member States. The scope of application EFSA-GMO-UK-2006-34 is for food and feed uses and import and processing of maize 3272 and all derived products, but excludes cultivation in the European Union (EU).

The EFSA GMO Panel could not conclude on the comparative assessment of the compositional, agronomic and phenotypic characteristics of maize 3272, on the basis of the data provided. In the absence of an appropriately performed comparative assessment, the safety assessment could not be completed and has focused mainly on the newly expressed proteins AMY797E and PMI.

The AMY797E and PMI proteins did not show significant similarity to known toxins in bioinformatic analyses. The EFSA GMO Panel concluded that administration of the AMY797E protein to rats for 28 days did not induce adverse effects up to the highest dose tested. Based on all the available information, the EFSA GMO Panel considers that there are no indications that the newly expressed PMI protein in maize 3272 may be allergenic. In relation to the AMY797E protein, the EFSA GMO Panel could not conclude on the de novo sensitisation potential of the protein.

[T]here is no requirement for scientific information on possible environmental effects associated with the cultivation of maize 3272. …  However, … the EFSA GMO Panel concluded that there is very little likelihood of any adverse environmental impacts as a result of the accidental release into the environment of viable grains from maize 3272. In the case of accidental release into the environment of viable grains of maize 3272, there are no indications of an increased likelihood of spread and establishment of feral maize 3272 plants.

In the absence of an appropriately performed comparative assessment by the applicant, the EFSA GMO Panel was not in the position to complete its risk assessment on maize 3272 and therefore does not conclude on the safety of maize 3272 compared with its conventional counterpart with respect to potential effects on human and animal health. However, the EFSA GMO Panel concluded that maize event 3272 is unlikely to have any adverse effect on the environment in the context of its intended uses.

So, the panel reached favorable conclusions on the lack of toxicity of the introduced gene products, and for one of the gene products was able to conclude that there were no allergenicity concerns. And while not within the panel’s formal remit, it found no evidence that use of Enogen corn would have any adverse environmental effects. In spite of these favorable rulings, the panel could not reach an ultimate conclusion on food safety and has apparently asked Syngenta for additional data. This is apparently not an unusual outcome: EFSA’s own press release says that it has requested more data for 98% of the GMO applications it has received to date.

In its public statement, Syngenta has said that it was “disappointed with the EFSA response,” but that it “remains committed to working with EFSA, including providing information based on sound science to allow EFSA to conclude the risk assessment.” Syngenta also noted that EFSA’s opinion was not related to the safety of the product.

This decision, while no doubt disconcerting for the company, is in the abstract not surprising, given the extreme skepticism that European governments and the public have expressed towards any use of GMO plants on the continent. It comes on the heels of the recent disclosure by agbiotech giant Monsanto that it will no longer seek regulatory approvals for any genetically modified crop plants in Europe (with the apparent exception of one pending application), a decision which itself arises from many years of frustration with the EU regulatory system for transgenic plants and the many obstacles the system has placed in the pathway for commercial approvals.

The impact of this decision on Syngenta’s business and on the overall ethanol industry is far from clear. As noted above, Enogen seems to be selling well and making significant inroads into ethanol markets in the U.S. And while there is certainly a substantial market for ethanol in Europe, especially as mandated under the EU Renewable Energy Directive (RED), long-term prospects do not look good for the use of cornstarch-derived ethanol on the continent. There is significant public and governmental sentiment developing against the use of food crops for the production of fuels, as evidenced by the recent proposals to place limits on the volume of food crop derived fuels that could count towards the mandated targets under the RED (these proposed amendments were described in a January post on Biofuel Policy Watch,  and the most recent developments were described in a post earlier this week).  By the time Enogen is approved for use in Europe (if that decision ever comes), regulatory pressures against corn-derived ethanol may severely limit the product’s market potential.

With regard to the bigger picture, I’m not aware of any other GMO plant variety that is close to commercialization, for which the current European regulatory situation would pose an imminent problem. However, this won’t always be the case, and as transgenic plants, particularly non-food energy crops, become available in the U.S. and elsewhere for fuel production, the European Union risks shutting itself off from such technological innovations. On the other hand, GMO plants of nonfood species would by definition not require EFSA approval for use in Europe and may therefore face an easier regulatory path, although approvals under the biotechnology directives would be needed for growth or importation of such plants in Europe, which might also prove controversial.

D. Glass Associates, Inc. is a consulting company specializing in government and regulatory affairs support for renewable fuels and industrial biotechnology. David Glass, Ph.D. is a veteran of over thirty years in the biotechnology industry, with expertise in industrial biotechnology regulatory affairs, U.S. and international renewable fuels regulation, patents, technology licensing, and market and technology assessments. Dr. Glass also serves as director of regulatory affairs for Joule Unlimited Technologies, Inc. More information on D. Glass Associates’ regulatory affairs consulting capabilities, and copies of some of Dr. Glass’s prior presentations on biofuels and biotechnology regulation, are available at www.slideshare.net/djglass99 and at www.dglassassociates.com. The views expressed in this blog are those of Dr. Glass and D. Glass Associates and do not represent the views of Joule Unlimited Technologies, Inc. or any other organization with which Dr. Glass is affiliated. Please visit our other blog, Biofuel Policy Watch.

BIO World Congress on Industrial Biotechnology — Part 2

Earlier this week, I attended the 10th Annual BIO World Congress on Industrial Biotechnology in Montreal. Overall, I found it to be a great show, with over 1,000 attendees from all segments of the renewable fuels and industrial biotech space. The topics presented at the breakout sessions ranged all over the breadth of the field, and included technical talks as well as business and policy talks.

I’ve now written a summary of another of the breakout sessions I attended. This was the second of two panels that discussed the current status of efforts to commercialize cellulosic ethanol. This session, held on Wednesday, June 19, the last day of the conference, featured speakers from Enerkem, Mascoma, DuPont and Abengoa. You can once again find my summary on the Advanced Biofuels USA website.

Earlier this week, I posted a summary of the first cellulosic ethanol panel from the World Congress, that was held on Monday, June 17. That session featured speakers from Clariant, Praj, DSM and Beta Renewables, and you can find that summary on the Advanced Biofuels USA website as well.  My thanks to Joanne Ivancic for giving me the opportunity to contribute these stories to her very useful and informative site. I’d also mention that two previous posts on this blog, from February 21 and February 25, provide additional information on the companies who are commercializing, or are close to commercializing, cellulosic ethanol in the U.S. and elsewhere in the world.

As you’ll see in these two stories, there were a number of common trends in business models and technical approaches that were evident from the different company presentations at these two panels. But overall, it was good to see evidence that this will finally be the year in which cellulosic ethanol is commercially produced in significant volumes.

D. Glass Associates, Inc. is a consulting company specializing in government and regulatory affairs support for renewable fuels and industrial biotechnology. David Glass, Ph.D. is a veteran of over thirty years in the biotechnology industry, with expertise in industrial biotechnology regulatory affairs, U.S. and international renewable fuels regulation, patents, technology licensing, and market and technology assessments. More information on D. Glass Associates’ regulatory affairs consulting capabilities is available at www.dglassassociates.com.

BIO World Congress on Industrial Biotechnology

This week, I’ve been attending the 10th Annual BIO World Congress on Industrial Biotechnology in Montreal. So far, it’s been a great show, reportedly with over 1,000 attendees from all segments of the renewable fuels and industrial biotech space.

I’ve written a summary of one of the breakout sessions I attended, the first of two sessions presenting the current status of efforts to commercialize cellulosic ethanol. The session featured speakers from Clariant, Praj, DSM and Beta Renewables. You can find my summary on the Advanced Biofuels USA website: for the next few days it will be the lead story you’ll see on the site’s main page, but later you can find the story at  http://advancedbiofuelsusa.info/bio-world-congress-cellulosic-ethanol-panel-the-latest-on-commercialization-progress.  My thanks to Joanne Ivancic for giving me the opportunity to contribute this story to her very useful and informative site. I’d also mention that two previous posts on this blog, from February 21 and February 25, provide additional information on the companies who are commercializing, or are close to commercializing, cellulosic ethanol in the U.S. and elsewhere in the world.

The World Congress is ending today, but I hope to post a summary of a second session on cellulosic fuels, perhaps as well as other topics, either here or on the Advanced Biofuels USA website.

D. Glass Associates, Inc. is a consulting company specializing in government and regulatory affairs support for renewable fuels and industrial biotechnology. David Glass, Ph.D. is a veteran of over thirty years in the biotechnology industry, with expertise in industrial biotechnology regulatory affairs, U.S. and international renewable fuels regulation, patents, technology licensing, and market and technology assessments. More information on D. Glass Associates’ regulatory affairs consulting capabilities is available at www.dglassassociates.com.

Commercial Cellulosic Ethanol Projects: Brazil and Europe

In the previous post, I listed the companies that are operating, or which have begun construction of, demonstration-scale or commercial-scale cellulosic ethanol plants in the U.S. and Canada, along with brief descriptions of these projects and the companies’ activities in producing cellulosic ethanol. In this post I’ll summarize similar projects in Brazil and Europe for the production of cellulosic ethanol, which is ethanol produced without the use of the use of food crops as the starting biomass, but instead utilizing feedstocks like wood, agricultural waste products, or municipal solid waste. For each geographical sector, the summary is organized alphabetically by company name. It is important to note that, unlike most other entries in this blog, the focus here is not the use of advanced biotechnology – although many of these companies are using genetically modified yeast strains or cellulloytic enzymes produced through biotechnology, that is not universally the case, and these posts should not be construed to imply that any company is using genetically engineered material unless explicitly stated. I’ll use the abbreviations MGY for million gallons per year, GPY for gallons per year, and MSW for municipal solid waste.

The information presented here is all derived from publicly available sources. In particular, I’ve attempted to synthesize in a single location information about cellulosic ethanol plants beginning operations or under construction that has recently been published in a number of very useful summaries or online sources. Citations for these sources can be found at the end of each post: in some cases my write-up quotes or paraphrases information presented in these sources. I believe this is a comprehensive list of demo and commercial scale projects, although I’d appreciate hearing from any commenters of any omissions.

Brazilian projects

Brazil has seen a flurry of recently-announced activity in planning and construction of cellulosic ethanol facilities. This reflects the significant role that ethanol plays in the motor vehicle fuel market in Brazil, but also represents a departure from the country’s historical near-exclusive reliance on sugar cane derived ethanol, in favor of  a growing interest in using byproducts of sugar cane milling, particularly bagasse, the fibrous cane stalk matter resulting from processing, in cellulosic ethanol production technologies. The following are the projects of which I’m aware that are underway or planned for Brazil.

Andritz AG, the world’s second- biggest maker of hydropower turbines, will furnish equipment to Brazilian sugar-cane research agency Centro de Tecnologia Canavieira for an 80 million-real ($40 million) plant that will produce cellulosic ethanol fuel from sugar-cane waste. The process will use steam to expose cellulose in fibrous biomass to enzymes that will degrade it into fermentable sugars. Discussions are reportedly underway with biotechnology companies such as Novozymes and Codexis to supply enzymes for the plant, which will be built by the Finnish engineering company Poyry Oyj. Construction is expected to begin in July 2013 and the demonstration plant will start producing fuel in the middle of 2014, at an existing mill in the city of Sao Manoel.

Beta Renewables plans to build a cellulosic ethanol plant in Brazil with Brazilian company GraalBio. The first 21.6 million gallon facility in Alagoas that will use sugarcane bagasse as feedstock is expected to come online in 2014. At the Alagoas plant, the suppliers of the enzymes and genetically modified industrial yeasts are Novozymes and DSM, respectively.

Cobalt Biofuels. In June 2012, Cobalt signed an agreement with Solvay-Rhodia to build a demonstration plant in Brazil for Cobalt’s process to produce n-butanol utilizing sugarcane bagasse as feedstock, which is expected to be fully operational in mid-2013. The companies expect to later form a joint venture to build a commercial plant, with a decision expected by October 2013, and plant operations targeted for the second quarter of 2015. Target capacity is up to 100,000 metric tonnes per year, or 35 MGY. Bunge Limited (through Bunge Global Innovation, LLC) has agreed to work with Cobalt and Solvay-Rhodia on a pilot plant, with additional collaboration on a demonstration scale facility and a commercial-scale biorefinery possible, to be co-located at a Bunge sugarcane mill.

Edeniq, a U.S. biofuel company, announced in November 2012 that it began construction of a demo-scale cellulosic ethanol operation at a sugar cane ethanol plant owned by Usina Vale in São Paulo, Brazil. Edeniq’s process will utilize up to 20 tons per day of sugarcane bagasse, and the ethanol produced at the demo plant will be added to Usina Vale’s production at their existing plant.

Inbicon recently announced a collaboration with ETH Bioenergia in Brazil that could result in a demonstration cellulosic ethanol plant in Brazil as early as 2015, with an expected capacity of several million liters per year. The plant would be co-located with one of ETH’s existing mills.

Iogen is building a plant in Brazil with Raizen, which has apparently demonstrated production of ethanol from sugarcane bagasse. The plant will be co-located with Raizen’s existing factory in Piracicaba, São Paulo, but otherwise the companies have released few details about the size or timing of the plant.

European Projects

Although to date there has been relatively less activity in Europe directed at cellulosic ethanol production, this is expected to change in the coming years, as pressure intensifies within the European Union to move away from corn and other food crops as biofuel feedstocks. This is exemplified by the Fall 2012 European Commission proposal to cap the amounts of food-derived fuels that can be counted against the renewable fuel targets under the EU Renewable Energy Directive. The following are European projects of which I’m aware.

Abengoa. Abengoa is providing its proprietary process technology and the process engineering design for a Demonstration Plant in Salamanca, Spain. The plant was completed in December 2008 and has been fully operational since September 2009. The plant capacity is 70 tonnes per day of lignocellulosic feedstock such as wheat or barley straw, with a reported capacity of 1.3 MGY of ethanol.

Chempolis, a Finnish company, is operating a biorefinery to produce cellulosic ethanol and other products from a variety of non-food biomass, particularly straw and bagasse. The biorefinery, located in Oulu in Northern Finland, was opened by the Finnish Prime Minister, Matti Vanhanen on May 4, 2010. The plant can process 25,000 tonnes per year of raw material, and will also be used for testing raw materials and producing samples of bioethanol. The process is designed to be carbon neutral and low in water consumption The Chemopolis formicobio™ technology combines selective fractionation and efficient enzymatic hydrolysis followed by rapid fermentation.

Clariant/ Sud-Chemie. On July 20, 2012, the company officially commissioned its Sunliquid® demonstration plant in Straubing (Lower Bavaria), Germany. The plant incorporates the entire process chain on an industrial scale, from pre-treatment to ethanol purification. It is an integrated process where a portion of the feedstock is used to grow microorganisms which overproduce enzymes which are then used to digest the rest of the feedstock. The plant, which is expected to have a 1,000 tonne/year (330,000 GPY) capacity, produced its first volumes of ethanol in July 2012. The company is currently choosing sites for first commercial plant, looking at possible locations in US, EU, Brazil and Canada, with construction planned to start in 2014 and production to begin in 2015.

Inbicon. In Autumn 2009, Inbicon, a subsidiary of DONG Energy, started the construction of a demonstration plant in Kalundborg, Denmark to showcase the company’s technology for large-scale production of ethanol from straw. This plant also serves to demonstrate the ability to integrate energy with a co-localized power station. The facility uses enzymes from Dupont Danisco and Novozymes, and is operational at a capacity of 1.5 MGY ethanol. The company is also planning a commercial facility in Maabjerg, Denmark, expected to be completed in 2016, which would have a 20 MGY capacity and also use wheat straw as a feedstock.

Mossi & Ghisolfi (Chemtex). In April 2011, Mossi & Ghisolfi Group (M&G) (Chemtex) commenced construction of a commercial-scale cellulosic ethanol production facility in Crescentino, Italy. This facility, which began operations in the fourth quarter of 2012, is designed to produce approximately 20 MGY of cellulosic ethanol. The plant uses an enzymatic hydrolysis process, using Novozymes enzyme technology, to convert a range of cellulosic feedstocks (such as wheat straw, rice straw, bagasse, poplar and Arundo donax) to ethanol.

St1 Biofuels (Finland). ST1’s Bionolix™ plant in Hämeenlinna is the first second-generation waste-to-ethanol plant based on the company’s proprietary technology. Commissioned in 2010, the plant uses municipal and commercial biowaste as its feedstock to produce approx. 1 million litres a year of bioethanol for motor vehicle fuel use.

Sources:

U.S. EPA, proposed rule for 2013 Renewable Fuels volume mandates

Biofuels International, “Cellulosic Ethanol Becoming a Reality

Ethanol Producer Magazine map of ethanol facilities, November 2012, and accompanying online articles “Milestones Reached” and “Making Cellulosic Ethanol a Reality

Advanced Ethanol Council, Cellulosic Biofuels Industry Progress Report, 2012-2013

European Biofuels Technology Platform: Cellulosic Ethanol page

Biofuels Digest, “12 Bellwether Biofuels Projects for 2013

D. Glass Associates, Inc. is a consulting company specializing in government and regulatory affairs support for renewable fuels and industrial biotechnology. David Glass, Ph.D. is a veteran of over thirty years in the biotechnology industry, with expertise in industrial biotechnology regulatory affairs, U.S. and international renewable fuels regulation, patents, technology licensing, and market and technology assessments. Dr. Glass also serves as director of regulatory affairs for Joule Unlimited Technologies, Inc. More information on D. Glass Associates’ regulatory affairs consulting capabilities, and copies of some of Dr. Glass’s prior presentations on biofuels and biotechnology regulation, are available at www.slideshare.net/djglass99 and at www.dglassassociates.com. The views expressed in this blog are those of Dr. Glass and D. Glass Associates and do not represent the views of Joule Unlimited Technologies, Inc. or any other organization with which Dr. Glass is affiliated. Please visit our other blog, Biofuel Policy Watch. 

Commercial Cellulosic Ethanol Projects: U.S. and Canada

Back in 2010 when I first began this blog, I posted lists of companies that were applying advanced biotechnology in various sectors of the biofuels industry. Now that I’ve returned to the blog three years later, my intention is to update those lists, perhaps utilizing somewhat different categories with which to group the companies in the industry. So, I thought I would begin that effort by focusing on one of the most important, or at least most highly anticipated, categories of companies, those who are developing or implementing technologies for cellulosic ethanol: that is, methods of producing fuel ethanol that do not depend on the use of food crops as the starting biomass, but which instead utilize feedstocks like wood, agricultural waste products, or municipal solid waste. As readers of my Biofuel Policy Watch blog are aware, much of the controversy over ethanol mandates in the U.S. and around the world centers on the fact that there is much interest in getting away from the use of corn or other food crops to produce ethanol, but the technologies to produce it from non-food biomass have been slower to develop than originally expected. So, there are lots of people waiting with baited breath for cellulosic ethanol plants to come on line and begin producing significant amounts of fuel ethanol and generating Renewable Identification Numbers (RINs) that can be used for compliance with EPA’s volume mandates under the Renewable Fuel Standard.

In this entry and the one that follows, I’ll list the companies that are operating, or which have begun construction of, demonstration-scale or commercial-scale cellulosic ethanol plants in the U.S., Canada, Brazil and Europe. Rather than present company profiles (as I did in my 2010 posts), for each company I’ll briefly summarize its activities in building pilot, demonstration and commercial plants. It is also important to note that, unlike most other entries in this blog, the focus here is not the use of advanced biotechnology – although many of these companies are using genetically modified yeast strains or cellulloytic enzymes produced through biotechnology, that is not universally the case, and these posts should not be construed to imply that any company is using genetically engineered material unless explicitly stated.

The information presented here is all derived from publicly available sources. In particular, I’ve attempted to synthesize in a single location information about cellulosic ethanol plants beginning operations or under construction that has recently been published in a number of very useful summaries or online sources. Citations for these sources can be found at the end of each post: in some cases my write-up quotes or paraphrases information presented in these sources. I believe this is a comprehensive list of demo and commercial scale projects, although I’d appreciate hearing from any commenters of any omissions.

In this first post, I’ll list companies operating or building plants in North America and in a second post I’ll list projects in Europe and Brazil. Each summary is organized alphabetically by company name. I’ll use the abbreviations MGY for million gallons per year, GPY for gallons per year, and MSW for municipal solid waste.

Projects in the United States and Canada

Abengoa BioEnergy. Abengoa has previously demonstrated its technology at a pilot plant in York, Nebraska and at a demo plant in Salamanca, Spain. The company is currently completing its first commercial plant in Hugoton, Kansas. Construction at this facility began in September 2011 and is expected to take 24 months and be completed in the fourth quarter of 2013. This facility is being partially funded by a $132 million Department of Energy (DOE) loan guarantee. When completed, the Hugoton plant have an expected capacity of approximately 24 MGY. Abengoa plans to begin production in late 2013 and to be producing fuel at rates near capacity by the second quarter of 2014. Feedstocks are expected to include agricultural residues, dedicated energy crops and prairie grasses. Abengoa plans to construct additional similar cellulosic ethanol production facilities at other sites, including some sites co-located with Abengoa cornstarch ethanol plants.

American Process Inc. American Process Inc. (API) is developing a project in Alpena, Michigan capable of producing up to 900,000 GPY of cellulosic ethanol from woody biomass (mixed hardwood). The technology extracts the hemicellulose portion of woody biomass using hot water and hydrolyzes it into sugars. API began commissioning operations in the summer of 2012 and production start-up is expected to begin in 2013. It has been reported that API’s technology partners include GreenTech America (yeast strains), Novozymes (enzymes) and ArborGen (purpose-grown energy crops).

Beta Renewables. Beta Renewables is a joint venture between Gruppo Mossi and Chemtex. The company completed construction on its first commercial-scale facility in Crescentino, Italy in the summer of 2012. Beta Renewables is planning a U.S. commercial facility in Sampson County, North Carolina, that is expected to have a 2014 start-up at 20 MGY capacity. Beta Renewables also plans to build a 21.6 MGY cellulosic ethanol plant in Brazil with Brazilian company GraalBio which is expected to come online in 2014.

Blue Sugars Corporation. Blue Sugars, formerly KL Energy, has developed a process to convert cellulose and hemicellulose into sugars and ethanol using a combined chemical/thermal-mechanical pretreatment process followed by enzymatic hydrolysis and co-fermentation of C5 and C6 sugars. The process can be used with a wide variety of cellulosic feedstocks, including woody biomass and sugarcane bagasse. Blue Sugars has a joint development agreement with Petrobras America Inc., under which Petrobras has invested $11 million to modify Blue Sugars’ 1.5 MGY demonstration facility in Upton, Wyoming to allow it to process bagasse and other biomass feedstocks. In April 2012 Blue Sugars generated approximately 20,000 cellulosic biofuel RINs, the first such RINs generated under the RFS program, but these were exported to Brazil and not used in the U.S. market. However, it was just announced in February 2013 that this facility had filed for Chapter 11 bankruptcy in October 2012, with a restructuring planned.

BlueFire Renewables Inc. BlueFire operates a demo facility in Anaheim, California, and is building a commercial plant in Fulton, Mississippi. Construction of the commercial plant is expected to be complete in 2014, with an expected capacity of 19 MGY. The technology uses agricultural residues, wood residues, municipal solid wastes and purpose grown energy crops.

Dupont Biofuel Solutions. Dupont has been operating a pilot plant in Vonore, Tennessee and broke ground on a commercial cellulosic ethanol facility in Nevada, Iowa, on Nov. 30, 2012. This facility, costing more than $200 million, is expected to be completed in mid-2014, and will be among the first and largest commercial-scale cellulosic biorefineries in the world. This new facility is expected to generate 30 MGY cellulosic biofuel produced from corn stover residues (i.e. corn stalks and leaves).

Enerkem Inc. Enerkerm is operating a 1.3 MGY demo plant in Westbury, Quebec. The company is in the process of building its first commercial-scale facility in Edmonton, Alberta and plans to begin operations in early 2013. Enerkem’s facility will use a thermochemical process to produce syngas from municipal solid waste (MSW) and then catalytically convert the syngas to methanol. The methanol can then be sold directly or upgraded to ethanol or other chemical products. At full capacity this facility will be capable of producing 10 MGY ethanol. The company is also planning a U.S. commercial site in Pontotoc, Mississippi, with construction to begin in 2013 and be complete in 2015.

Fiberight Inc. A plant for conversion of MSW to ethanol is in operation at Lawrenceville, Virginia (1 MGY capacity) with a larger plant planned by modifying  an idled corn ethanol plant in Blairstown, Iowa to allow for the production of 6 MGY of cellulosic ethanol from separated MSW and industrial waste streams. Construction is expected to begin in early spring 2013 and the company expects that it will take approximately 6 months to complete The British company TMO Renewables is supplying fermentation technology. Fiberight uses an enzymatic hydrolysis process to convert the biogenic portion of separated MSW and other waste feedstocks into ethanol. In January 2012 Fiberight was offered a $25 million loan guarantee from USDA. Additional plants are planned for 2014 and 2015.

Fulcrum BioEnergy. Fulcrum operates a demonstration plant in Durham, North Carolina. The technology involves conversion of syngas to ethanol. A commercial cellulosic ethanol facility is planned for McCarran, Nevada (near Reno), which will use MSW to produce ethanol. The estimated capacity of this plant is 10 MGY, with operations scheduled to begin in 2014. Fulcrum received a $105 million conditional loan guarantee from the USDA for the construction of this plant.

Inbicon. Inbicon uses steam, enzymes (from Novozymes and DuPont Danisco) and yeast to convert soft lignocellulose (e.g. wheat straw, corn stalks, energy grasses) into ethanol. A demonstration facility in Denmark (1.5 MGY ethanol) has been operational since 2009. A U.S. commercial facility (10+ MGY capacity) is planned for Spiritwood, North Dakota, with estimated completion in the third quarter of 2015, as well as a commercial plant in Denmark which would begin operations in early 2016. Inbicon also recently announced a collaboration with ETH in Brazil that could result in a cellulosic ethanol plant in Brazil as early as 2015.

INEOS Bio. INEOS Bio has developed a process for producing cellulosic ethanol by first gasifying cellulosic feedstocks into a syngas and then using naturally occurring bacteria to ferment the syngas into ethanol. The project has received funding or loan guarantees from DOE and USDA. INEOS has a pilot plant in Fayetteville, Arkansas, and completed construction on a Vero Beach, Florida facility in June 2012. The company entered the start-up phase of cellulosic ethanol production at this facility in November 2012, and expects to be producing cellulosic ethanol at levels near the facility’s capacity of 8 MGY throughout 2013.

Iogen. Iogen has had a 1 MGY capacity demo plant in Ottawa, Ontario operating since 2005. Iogen is also building a plant in Brazil, with Raizen, which has reportedly demonstrated production of ethanol from sugarcane bagasse.

KiOR. This company is not producing ethanol, but instead is producing cellulosic gasoline,  diesel and jet fuel at an 11 MGY commercial-scale facility in Columbus, Mississippi, using a catalytic cracking technology. It is one of the companies that the U.S. EPA is counting on to produce cellulosic biofuels under the RFS in 2013, and to be issuing RINs as early as the first quarter of the year.

LanzaTech. The company’s technology combines microbial fermentation with other physicochemical processing, and uses agricultural or forestry wastes as well as MSW. The company operates a pilot plant in Auckland, New Zealand (15,000 GPY), and two demo plants in China (each 100,000 GPY). LanzaTech is planning to build a commercial facility, the Freedom Pines Biorefinery, at the old Range Fuels site in Soperton, Georgia. This plant is expected to be in operation by 2014, with a 4 MGY capacity.

Lignol. This Canadian company is using a delignification process first developed for the pulping industry to produce a cellulose/hemicellulose wood pulp that can be used to produce ethanol. The company has operated what it calls a pilot plant in Burnaby, British Columbia, which reportedly has a capacity of 100,000 liters per year (26,417 GPY).

Mascoma Corporation. Currently operating a demo plant in Rome, New York (200,000 GPY capacity). Mascoma is developing a commercial plant in Kinross, Michigan, in partnership with Valero, with a capacity of 20 MGY, using consolidated bioprocessing with its proprietary microorganisms. Groundbreaking is expected in 2013, with construction complete 2014-15. The company is also planning a second plant in Drayton Valley, Alberta, expected completion 2015-16.

POET-DSM. POET has been operating a 20,000 GPY pilot plant in Scotland, South Dakota since 2008. The POET-DSM joint venture is building a 20-25 MGY plant in Emmetsburg, Iowa that will utilize corn stover as feedstock. The technology features acid pretreatment followed by the use of DSM enzymes and yeast for fermentation. The plant is expected to be complete by the end of 2013 but not producing commercial ethanol until 2014. POET reportedly plans to build cellulosic facilities at all their existing corn ethanol plants.

Woodland Biofuels Inc. The company has completed construction of a Sarnia, Ontario demonstration plant. The plant is now in the initial stages of commissioning, with ethanol production expected in the first quarter of 2013. The company says that it is also exploring possible commercial sites. The technology uses gasification to convert biomass into syngas, followed by chemical catalysis to ethanol. The Sarnia demo facility will be capable of handling 7.2 metric tons per day of wood waste, or about 2,400 metric tons per year.

World Ethanol Institute LLC. This company, an affiliate of World Paulownia Institute LLC, reportedly has a 20 MGY plant under construction in Lenox, Georgia. The company is planning the use of its proprietary lines of a purpose-grown tree, Paulownia, in a process combining steam explosion and acid hydrolysis, followed by standard fermentation, reportedly using a modified yeast from another company. Construction is expected to be completed by the end of 2013.

ZeaChem Inc. ZeaChem is operating a 250,000 GPY demo plant in Boardman, Oregon. The company is building a larger biorefinery at same site in Oregon, with a USDA grant. The plant will have an expected capacity of 25 MGY, but is not expected to be producing cellulosic ethanol until 2014 or 2015. The company’s technology is hybrid biochemical fermentation and thermochemical gasification, using the termite gut microorganism Morella thermoacetica in the fermentation. ZeaChem claims that its process is feedstock agnostic.

Sources:

U.S. EPA, proposed rule for 2013 Renewable Fuels volume mandates

Biofuels International, “Cellulosic Ethanol Becoming a Reality

Ethanol Producer Magazine map of ethanol facilities, November 2012, and accompanying online articles “Milestones Reached” and “Making Cellulosic Ethanol a Reality

Advanced Ethanol Council, Cellulosic Biofuels Industry Progress Report, 2012-2013

European Biofuels Technology Platform: Cellulosic Ethanol page

Biofuels Digest, “12 Bellwether Biofuels Projects for 2013

D. Glass Associates, Inc. is a consulting company specializing in government and regulatory affairs support for renewable fuels and industrial biotechnology. David Glass, Ph.D. is a veteran of over thirty years in the biotechnology industry, with expertise in industrial biotechnology regulatory affairs, U.S. and international renewable fuels regulation, patents, technology licensing, and market and technology assessments. Dr. Glass also serves as director of regulatory affairs for Joule Unlimited Technologies, Inc. More information on D. Glass Associates’ regulatory affairs consulting capabilities, and copies of some of Dr. Glass’s prior presentations on biofuels and biotechnology regulation, are available at www.slideshare.net/djglass99 and at www.dglassassociates.com. The views expressed in this blog are those of Dr. Glass and D. Glass Associates and do not represent the views of Joule Unlimited Technologies, Inc. or any other organization with which Dr. Glass is affiliated. Please visit our other blog, Biofuel Policy Watch.

Syngenta Gains Approval of Corn Modified for Ethanol Production

This past Friday, February 11, 2011, the U.S. Department of Agriculture issued its decision to grant full deregulation of Syngenta’s genetically engineered corn expressing a thermostable alpha-amylase for use in ethanol processing. This decision means that the company can now sell this new maize variety, trade named EnogenTM, to growers in the U.S. beginning with the 2011 growing season. This decision is noteworthy for several reasons, mostly because it is the first U.S. regulatory approval for commercial use of a genetically engineered plant designed and dedicated for use as an improved biofuel feedstock. 

I’ve briefly described this product in an earlier entry in this blog. Originally known by the internal product name “Corn [Maize] event 3272”, this line was developed using recombinant DNA technology to introduce into corn the amy797E gene and the pmi marker gene. The amy797E gene is derived from alpha-amylase genes from three hyperthermophilic microorganisms of the archaeal order Thermococcales, and it encodes a thermostable AMY797E alpha-amylase enzyme which catalyses the hydrolysis of starch by cleaving the internal alpha-1,4-glucosidic bonds into dextrins, maltose and glucose. The pmi gene from Escherichia coli encodes the phosphomannose isomerase (PMI) enzyme, which allows the plant to utilize mannose as a carbon source. The company’s press release announcing the approval describes the product and its importance as follows:

By enabling expression of an optimized alpha-amylase enzyme directly in corn, dry grind ethanol production can be improved in a way that can be easily integrated into existing infrastructure.  “Enogen corn seed offers growers an opportunity to cultivate a premium specialty crop. It is a breakthrough product that provides U.S. ethanol producers with a proven means to generate more gallons of ethanol from their existing facilities,” said Davor Pisk, Chief Operating Officer. “Enogen corn also reduces the energy and water consumed in the production process while substantially reducing carbon emissions.”

This action has important implications for several reasons. As mentioned above, it is the first U.S. approval for commercial use of a genetically engineered plant variety specifically designed for biofuel production (although in May 2010 USDA did grant the biotechnology company Arborgen a significant permit for expanded field testing of transgenic Eucalyptus varieties as improved energy crops, but that permit was only for experimental field testing, not commercial use and sale). Although, as noted in Syngenta’s press release, the corn amylase trait in Enogen had already been approved for import into Australia, Canada, Japan, Mexico, New Zealand, Philippines, Russia and Taiwan, and for cultivation in Canada, the U.S. regulatory approval had been pending since 2005, and followed multiple years of field testing at numerous plots around the country and the world. I’ve described this long history and USDA’s environmental assessment of Enogen corn in an earlier blog entry. The history of agricultural biotechnology regulation is replete with examples where pioneering applicants proposing the first of a new type of product have often been subjected to long regulatory review times and some amount of regulatory uncertainty, but where after the initial approval the path was cleared for subsequent applicants of similar products. As I’ve described in prior entries in the blog, there are a good number of companies developing transgenic plants as improved biofuel feedstocks, including several other efforts to develop energy crops expressing biodegradative enzymes in planta to improve the efficiency and economics of feedstock processing, and it is good to know that developers of such products can now see the roadmap to regulatory approval in the U.S. 

USDA’s decision on the Syngenta decision comes hard on the heels of two other long-awaited biotechnology regulatory decisions, the January 27, 2011 decision to fully deregulate Roundup® Ready alfalfa and the February 4, 2011 decision to partially deregulate Roundup® Ready sugar beets, both of which had been the subject of protracted legal action. Over the past two or more years, it has seemed that the Biotechnology Regulatory Services (BRS) branch of USDA’s Animal and Plant Health Inspection Service (APHIS) has been (understandably) paralyzed by these ongoing legal challenges, and had seemed to put on hold deregulation petitions for numerous biotech crops as well as the agency’s effort first proposed in 2007 to rewrite the biotechnology regulations. Although each of these recent decisions may yet be subject to further legal challenge, it is good to see the logjam breaking somewhat with these three decisions being issued early enough in the year to apply to the 2011 growing season. 

Finally, the Enogen approval is noteworthy for its several commercial implications. It will be the first transgenic plant variety to be sold in the U.S. as a dedicated energy crop, which will make its ultimate commercial success a bellwether for other companies developing similar products. Perhaps more importantly are the conditions that Syngenta will place on its use in 2011. According to the company’s press release, production of Enogen corn will be managed using a contracted, closed production system, through which the company plans to sell the seeds to only a small number of corn growers in close proximity to the ethanol production facilities that will process the corn, in preparation for larger scale commercial introduction in 2012.  Such a “closed loop” system serves two purposes. It addresses the concern expressed by many biotech opponents as well as corn millers and others in the food industry over the disruption to food supplies that could arise if the amylase corn is inadvertently found in food supplies. As reported in the New York Times on February 11, 2011, Syngenta’s own data has apparently indicated that as little as one amylase corn kernel mixed with 10,000 conventional kernels could be enough to weaken the corn starch and disrupt food processing operations. Syngenta’s response is that the enzyme is not active when the kernel is intact and is most active at higher temperatures and at certain levels of acidity and moisture found in ethanol factories but rarely in factories that make corn starch, corn syrup or corn chips. Having a closed loop arrangement where growers are contracted to grow the corn and sell it to ethanol producers puts in place a system where the transgenic corn is segregated and kept separate from corn grain that will be used for animal feed or human food processing, to try to avoid as best as possible any inadvertent contamination of food corn with the amylase-expressing corn (although, as noted in the New York Times article, the alpha-amylase expressed in Enogen corn has already been approved for food use by the U.S. Food and Drug Administration, and this should to some extent lessen the concern over inadvertent contamination). 

But the closed loop system is also important for other commercial reasons. Presumably, Enogen corn seed will be sold at a premium over other, traditional corn varieties, but the harvested corn should command a higher price than traditional corn when sold to ethanol producers. In order for growers to be sure of getting that higher price for their crop in return for paying the higher price for seed, some guaranteed form of segregation would be needed. In fact, such a model seems to be critical for the future success of all plant species (conventional or transgenic) that are being developed as dedicated energy crops – in most cases the developer will need to sell seed at a premium (e.g. to recoup R&D costs) and so the grower must be guaranteed of being able to sell the crop to the fuel producers at a higher cost.  So, Syngenta’s experience with its closed loop system may be an indicator of the success that similar such models will face in the coming years. 

Although it has been a long, hard path for Syngenta to win this approval, and although roadblocks may yet lie ahead, this can only be a positive development for the many other companies developing transgenic plants as improved biofuel feedstocks. I’ll be watching and commenting on future regulatory developments as they may arise. 

D. Glass Associates, Inc. is a consulting company specializing in several fields of biotechnology. David Glass, Ph.D. is a veteran of nearly thirty years in the biotech industry, with expertise in industrial biotechnology regulatory affairs, patents, technology licensing, and market and technology assessments. This blog provides back-up and expanded content to complement a presentation Dr. Glass made at the EUEC 2010 conference on February 2, 2010 entitled “Prospects for the Use of Genetic Engineering in Biofuel Production,” and will also complement Dr. Glass’s upcoming presentation on uses of biotechnology to improve the plant species used as feedstocks for biofuel production, at the “Energy Crops” session  at the World Biofuels Market conference in Rotterdam, the Netherlands, on March 22, 2011. Slides from Dr. Glass’s presentations, along with more information on D. Glass Associates’ regulatory affairs consulting capabilities, are available at www.slideshare.net/djglass99 or at www.dglassassociates.com.

Companies Developing Modified Plant Varieties as Improved Biofuel Feedstocks

Earlier this year, I completed several blog entries that provided brief profiles of companies developing modified microorganisms, plants or algae for improved biofuel production. The field has, of course, continued to develop in the several months since those entries, and not only have the originally-profiled companies announced new business and scientific developments, but other companies have announced their presence or have otherwise come to my attention. In view of the dozens of companies profiled in the earlier entries, it really isn’t feasible to continually update their profiles, particularly since links to company websites are included in each profile, but in this and the next several entries I will profile some of the additional companies that have entered the field or whose activities I’ve recently learned about.

Today’s posting will focus on companies developing modified plant varieties for use as biofuel feedstocks. This is a topic I may revisit in the blog in the coming months, because I have been asked to chair a session on “Energy Crops” at the 2011 World Biofuels Market Conference in Rotterdam in March. So far it is shaping up as a diverse, interesting set of presentations, and for my own talk, I’m planning to present an overview of the plant biotechnology strategies that are being used to improve energy feedstocks.  I welcome comments and suggestions about this topic in the months leading up to the March 22, 2011 session.

A large number of companies are using advanced biotechnology to improve the plant varieties that are, or might be, used as feedstocks to produce renewable fuels like ethanol or biodiesel. Many of these companies were profiled in a series of earlier blog entries, beginning at http://wp.me/pKTxe-1p.  The following are profiles of additional companies in this sector. The profiles have been adapted or excerpted from company websites and/or other publicly available information, and I don’t assume any liability for the accuracy, comprehensiveness or use of the information.

Abba Gaia is a Spanish company formed on April 2, 2008 to use biotechnology to help improve the environment.  Abba Gaia’s main business is using Nicotiana glauca for phytoremediation, and has R&D programs directed at genetic engineering to improve the plant’s ability to remove heavy metals and other contaminants from soil, water and sludge. According to the company’s website it is active in several other industrial sectors, including “renewable energy”, but the website offers no specifics about activities in the energy sector. However, in 2010, in a notification submitted to the EU, the company proposed a field test in Spain of Nicotiana glauca genetically modified as an energy crop (Notification B/ES/10/50, Spain, published 24 June 2010). According to this notification, the genetic material inserted into Nicotiana glauca is the wheat phytochelatin synthase gene under the control of the 35S promoter of cauliflower mosaic virus, to provide phytochelatin synthase and phytochelatins overexpression in the plant, along with a gene conferring resistance to the antibiotic kanamycin for selection of transformed plants. The goal of this field test is to evaluate the genetically modified line for biomass production under different cultivation situations .

Catchlight Energy is a joint venture between Chevron and Weyerhaeuser, formed in February 2008 to commercialize large scale production of liquid transportation fuels from sustainable forest-based resources. The plan was to leverage the strengths of both companies: Weyerhaeuser’s expertise in innovative land stewardship, resource management and capacity to deliver sustainable cellulose-based feedstocks at scale, and Chevron’s technology capabilities in molecular conversion, product engineering, advanced fuel manufacturing and fuels distribution. The joint venture reflects the parent companies’ shared view that cellulosic biofuels can fill an important role in diversifying the nation’s energy sources and addressing global climate change by providing a source of low-carbon transportation fuel.

Catchlight Energy’s vision is to become a major integrated producer of biofuels derived from non-food sources and to deliver renewable transportation products produced from biomass in a manner that is scalable and sustainable — both environmentally and economically. By focusing on researching and commercializing technology, Catchlight Energy hopes to help the U.S. make the move to the next generation of biofuels. The company’s research addresses a range of products including ethanol as well as gasoline and diesel hydrocarbons, and its commercial business model is expected to involve multiple pathways based on combinations of biological, chemical and thermochemical process steps.

Building on the strengths and core competencies of its parent companies, Catchlight’s R&D program is aimed at discovering, developing and/or licensing third party developed technology solutions for converting forest-based feedstocks to liquid transportation fuels. This strategy will likely involve cooperation with key technology partners having complementary interests and technology. The company says there are two main thrusts to its current research efforts: a near term focus on early commercialization opportunities for producing ethanol and a longer term focus on direct conversion of biomass to hydrocarbons. While there is a large and ready market for ethanol today, the company thinks it will be important for longer term success to expand its product portfolio to include hydrocarbons like gasoline and diesel, fuels that are fully compatible with the existing infrastructure.

Catchlight Energy intends to utilize the potential of forests to produce biomass in a sustainable manner while still maintaining supply for traditional forest products. Specifically, perennials, short rotation trees, understory crops and residuals to supplement high-value timber can be used for emerging biofuels markets, and such purpose-grown energy crops can be grown in conjunction with high-value timber. The plan is to grow alternating strips of trees and energy crops. The energy crops can be harvested annually while the trees are managed for wood products and fiber. The company will develop large-scale production capability by leveraging Weyerhaeuser’s strengths in managing large-scale ecosystems, its experience with harvest, handling and transport infrastructure, and its expertise in genetic improvement (e.g. to improve yield, product quality). The company will also aim to scale up their processes so that cellulosic ethanol can be produced in a manner that is scalable and sustainable — both environmentally and economically. In this regard, the company will capitalize on Weyerhaeuser’s vast land holdings, Chevron’s large fuel infrastructure, and the development of a cost-effective end-to-end business model, to enable the company to produce significant quantities of cellulosic biofuels.

Idén Biotechnology was founded in 2005 by members of the Carbohydrate Metabolism Research Group at the Agrobiotechnology Institute of the Spanish National Research Council. The company’s goal has been the generation, transfer, exploitation and marketing of innovative agricultural biotechnology knowledge. The company’s founding scientific team has expertise in plant and bacterial carbohydrate metabolism knowledge at a physiological, biochemical and molecular level, and have used this expertise to develop new industrial raw materials which the company says are applicable to the energy, paper, biomaterials and pharmaceutical sectors. Specific areas of research focus as the development of new plant-derived raw materials based on manipulation of carbohydrate metabolism, with applications in bioenergy, food, feed and biomaterials, or through modifications in secondary metabolism to address markets including agriculture, food, feed and biomaterials.

Among the company’s activities in the energy sector, Iden submitted a notification to EU regulatory authorities for a field test in Spain of maize plants engineered for modified lignification with the goal of improving digestibility for bioethanol production. According to Notification  B/ES/10/40, published 23 March 2010, the company planned a small field test of corn in which the gene encoding cinnamyl alcohol dehydrogenase (CAD), an enzyme which is involved in lignin production in the plant, was knocked down using RNA interference. In CAD-RNAi expressing plants, the enzyme CAD was shown to be inactivated. In greenhouse experiments, CAD-RNAi expressing plants showed altered lignin production and an increase in degradability for the production of ethanol in vitro as compared with wild type corn plants. The company hopes that field tests will establish that residual biomass of these plants could be of great agronomic value for more efficient ethanol fermentation.

Naturally Scientific plans to use waste CO2 to bio-manufacture fermentable sugars and pure vegetable oil from plant cell cultures to provide sustainable feedstock for bio-diesel, ethanol and “drop-in” synthetic fuel producers. In April 2010, Naturally Scientific CEO Geoff Dixon said that his company had signed its first five commercial installations, a series of five $50 million projects that would be erected in China over the next five years. In May 2010, the company announced further details about its patented solution for converting waste CO2, water and light in a photosynthetic reaction to grow palisade layer plant cell culture to produce low-cost sugar – glucose and sucrose. This natural sugar can be sold in crystallized or concentrated liquid syrup form or alternatively it is used in a second process as the necessary carbon source for vacuole cells of rapeseed (or other oil seeds) to produce pure vegetable oils and their valuable derivatives. Naturally Scientific says that its technology absorbs and fixes between 90% and 100% of the CO2 passed through it, and in using plant cell cultures, the resulting products can be produced in a safe and sustainable way that results in no indirect land use change or deforestation. Naturally Scientific has constructed a demonstration plant in Nottingham, UK which it expected to be fully operational by the end of May 2010, producing both sugars and oils. The plant is a scaled down version of a 500,000 gallon plant proving the technology, automated process control systems, yields and unit economics at commercial-scale. The company is planning a business model based on out-licensing its technology to other companies.

D. Glass Associates, Inc. is a consulting company specializing in several fields of biotechnology. David Glass, Ph.D. is a veteran of nearly thirty years in the biotech industry, with expertise in industrial biotechnology regulatory affairs, patents, technology licensing, and market and technology assessments. This blog provides back-up and expanded content to complement a presentation Dr. Glass made at the EUEC 2010 conference on February 2, 2010 entitled “Prospects for the Use of Genetic Engineering in Biofuel Production.” The slides from that presentation and Dr. Glass’ September 2010 talk on biotechnology regulations from the Algae Biomass Summit, along with more information on D. Glass Associates’ regulatory affairs consulting capabilities, are available at www.slideshare.net/djglass99 or at www.dglassassociates.com.

Companies Developing Modified Algae for Biofuel Production

Earlier this year, I completed several blog entries that provided brief profiles of companies developing modified microorganisms, plants or algae for improved biofuel production. The field has, of course, continued to develop in the several months since those entries, and not only have the originally-profiled companies announced new business and scientific developments, but other companies have announced their presence or have otherwise come to my attention. In view of the dozens of companies profiled in the earlier entries, it really isn’t feasible to continually update their profiles, particularly since links to company websites are included in each profile, but in this and the next several entries I will profile some of the additional companies that have entered the field or whose activities I’ve recently learned about. 

A number of companies are reported to be using advanced biotechnology to improve the algal strains that are, or might be, used to produce renewable fuels like biodiesel, jet biofuel, or ethanol. Many of these companies were profiled in an earlier blog entry. The following are profiles of three additional companies in this sector, which have been adapted or excerpted from company websites and/or other publicly available information, and I don’t assume any liability for the accuracy, comprehensiveness or use of the information. 

Photon8 is a Brownsville, Texas based company that is utilizing what it calls a “financials-first” strategy, to enable technology developments capable of 100-fold reductions in capital and operating expenses for the production of fuels from algae. Locating in Brownsville gives the company access to optimal algal growth conditions and a partnership with the University of Texas-Brownsville, where the company operates its offices and labs in the university’s “International Innovation Center”.  The company has not said much publicly about its technology strategies, but it has said that it is using genetic technologies to enhance the ability of algae to produce lipids; it is developing a Parallel Film Reactor (PFRsm), with “Traveling Wave Technology” that will offer closed-system performance at lesser cost than an open system and which makes full use of injected CO2; and that it is developing strategies to remove lipids from the algae without dewatering and without killing the cell, and thereby allowing reuse of algal cells.

In October 2010, the company announced that it has succeeded in producing “drop-in” fuel components from its genetically improved algae, as determined by an outside laboratory using gas chromatography analysis for determining carbon chain length and degree of saturation. The company’s president and CEO, Brad Bartilson, has been quoted as saying “the process is simpler than those who propose producing ‘green crude’ and sending it through an oil refinery hydrotreating system. We have already achieved the productivity of 5600 gal/acre/year, and most importantly, within our confines of under $10/m2, leading to a cost of jet fuel components of less than $1.50/gallon.”

TransAlgae was founded in 2008 to commercialize biotechnologies based on development and breeding of transgenic algae to enable its cost-effective conversion into oil, protein and other co-products. TransAlgae is a registered USA company, with a research center located at the Weizmann Science Park in Rehovot, Israel. TransAlgae believes that undomesticated algae are incapable of providing cost-effective production solutions to the world’s needs, just as wild plants cannot produce foods. The company believes that meeting  feed and fossil fuel needs for both the long term and short term can only come by domesticating algae with the requisite genes by genetic engineering, to enable algae to fix large amounts of carbon dioxide into biological molecules, such as carbohydrates, protein and oil with favorable economics.

TransAlgae hopes to build the framework for algal biofuel and animal feed using genetic engineering combined with practical agricultural, industrial and economic approaches. The company’s scientific team has completed its first generation of transgenic algae, and is further developing its marine algae platform to be resistant to contamination by other algae and other organisms, reducing downtime in production facilities, as well introducing genetic failsafe mechanisms that preclude the transgenic algae from reproducing in natural ecosystems. In addition to higher productivity, the company says that genetic approach enables rapid growth, and the production of multiple high-quality products.

TransAlgae has developed novel technologies for gene insertion, has introduced into algae genes encoding resistance to herbicides that can be used to control wild algae and cyanobacteria using sub micromolar levels, and is introducing genes that control other contaminants as well as genes that prevent establishment of the transgenic algae in natural environments. On top of this platform TransAlgae is adding genes for improved protein content as well as genes encoding expensive feed additives, while modifying the algae to increase digestibility. TransAlgae is developing strains that are appropriate for different environments and system designs. By developing strains for a matrix of climates, resources and co-products, the company hopes to be able to rapidly deploy stocks worldwide, allowing its partners to meet demand and respond to changing market conditions.

In November 2009, TransAlgae announced that it had  signed a Memorandum of Understanding with Endicott Biofuels, LLC, a Houston-based, next-generation biodiesel producer, for the development of algae as a potential transportation fuel and renewable chemical feedstock source.

Viral Genetics is a biotechnology company whose primary business is the discovery and development of  immune-based therapies for HIV and AIDS using a proprietary thymus nuclear protein compound. Founded in 2000, the biotech company is researching treatments for HIV/AIDS, Lyme Disease, Strep, Staph and drug resistant tumors. The company has recently announced an expansion of its efforts to encompass work in algal biofuels. Company advisor Dr. M. Karen Newell originally of the University of Colorado and now at the Texas AgriLife Research Blacklands campus, has discovered a trigger that increases oil or lipid production in plant cells, which leads to the possibility that plant or algal cells can be manipulated to produce more oil. Viral Genetics has licensed the right to develop commercial applications for Newell’s biofuel discoveries. Newell recently received a $750,000 grant from the Texas Emerging Technology Fund to expand research into developing plant-based fuels. Viral Genetics has the exclusive right to develop commercial applications for this technology.  The company’s CEO Haig Keledjian was quoted as saying, “this grant validates an exciting line of research into increasing yields of plant oils including algae bio-fuel and agricultural oils such as palm or corn oil,” and company advisor John Sheehan has said, “Viral Genetics is in the right place at the right time with this technology. Identifying and controlling the trigger for lipid production in algae has long been the holy grail of algal biofuels technology. Many big players are working in this field, and whoever is first to translate such a discovery into an economic process will leap frog to the front of the pack.”  

Breaking News: On December 7, 2010, just a day after I originally posted this blog entry, Viral Genetics announced that it has launched a subsidiary called VG Energy, Inc. to market the biofuel technology that I’ve described above. This subsidiary is majority-owned by Viral Genetics and its current shareholders, and Viral Genetics’ CEO Haig Keledjian will serve as CEO of the new subsidiary. According to the company’s press release, VG Energy will be marketing an algae-enhancing technology (described above) which the company says has been shown to increase the yield of oil production from algae by as much as 300%. Dr. Newell-Rogers said, “Our research seems to indicate that we can trigger plant cells to increase their fat stores. We can manipulate plant cells so that they store oil and eventually release those reserves instead of burning the fat for fuel when glucose stores are low. The end result is more oil is available for processing into a biofuel.”

According to the new company’s website, their technology is embodied in a portfolio of patents and patent applications relating to what it calls “Metabolic Disruption Technology” (“MDT”) in non-human cells. MDT encompasses the use of combinations of certain proprietary compounds and processes to change how cells use fat and sugar for energy. The MDT technology led to the yields in oil production described above, and the company says it also has the ability to increase oil storage in seeds for increased production of edible oils. VG Energy will be focusing on scaling-up the technology and seeking industry partnerships and licensing deals.

D. Glass Associates, Inc. is a consulting company specializing in several fields of biotechnology. David Glass, Ph.D. is a veteran of nearly thirty years in the biotech industry, with expertise in industrial biotechnology regulatory affairs, patents, technology licensing, and market and technology assessments. This blog provides back-up and expanded content to complement a presentation Dr. Glass made at the EUEC 2010 conference on February 2, 2010 entitled “Prospects for the Use of Genetic Engineering in Biofuel Production.” The slides from that presentation and Dr. Glass’ September 2010 talk on biotechnology regulations from the Algae Biomass Summit, along with more information on D. Glass Associates’ regulatory affairs consulting capabilities, are available at www.slideshare.net/djglass99 or at www.dglassassociates.com.

Companies Developing Modified Microorganisms for Production of Ethanol and Other Biofuels

Earlier this year, I completed several blog entries that provided brief profiles of companies developing modified microorganisms, plants or algae for improved biofuel production. The field has, of course, continued to develop in the several months since those entries, and not only have the originally-profiled companies announced new business and scientific developments, but other companies have announced their presence or have otherwise come to my attention. In view of the dozens of companies profiled in the earlier entries, it really isn’t feasible to continually update their profiles, particularly since links to company websites are included in each profile, but in this and the next several entries I will profile some of the additional companies that have entered the field or whose activities I’ve recently learned about. 

This entry will profile several additional companies developing altered microorganisms or yeast for the production of ethanol, higher alcohols and other fuels. Future postings will discuss companies developing modified algae or plants for fuel manufacture. The following profiles have been adapted or excerpted from company websites and/or other publicly available information, and I don’t assume any liability for the accuracy, comprehensiveness or use of the information. 

Companies Developing Modified Microorganisms for Ethanol Production

A large number of companies are using advanced biotechnology to improve the bacterial and yeast strains that are used to produce ethanol from traditional sugar or starch based feedstocks or from cellulosic feedstocks. These were profiled in my earlier entries, beginning at http//wp.me/pKTxe-I. The following are profiles of some additional companies in this sector. 

iDiverse, Inc. is developing high-performance cell lines for the biological manufacture of fuel ethanol, industrial enzymes, and pharmaceutical products, and is also working on creating transgenic plants that are resistant to a broad spectrum of diseases and environmental stresses. The company says that its proprietary technology includes genetic sequences which, when introduced into cells, allows the resulting transformed cells to be able to resist a variety of stresses that occur in the bioproduction process. The company believes that cell lines incorporating this proprietary ProTectAll™ transgenic technology will have enhanced resistance to the stresses of the bioproduction process, that will enable these cells to produce more product at higher concentrations, using less nutrients, and under more extreme conditions, thus resulting in higher production efficiencies at lower costs. 

The company is targeting the production of fuel ethanol as the first application of this technology. Fuel ethanol is ordinarily produced by the fermentation of a carbohydrate substrate by yeast cells, but yeast can be inhibited from reaching its optimum production efficiency by a variety of stresses including rising alcohol concentration, low pH, high temperature, bacterial contamination, and dissolved chemicals. The changes iDiverse is engineering into yeast strains are designed to overcome these problems. In October 2010 iDiverse announced that it had successfully modified yeast to be highly resistant to a number of lethal stresses normally encountered in the bioproduction of fuel ethanol, and in doing so enabled the yeast to generate significantly more ethanol. In its press release, the company said “Our technology is applicable to current fuel ethanol manufacturing processes using corn and sugar cane as starting materials and also to those being developed to use cellulosic biomass”. The company’s CEO also says that, “if its technology is effective at large-scale, it could increase the efficiency of installed fuel ethanol plants, enhance yields from corn and sugar cane feed stocks, and help manufacturers bridge the fuel ethanol production gap until the next generation biomass plants come on-line. Also, our technology is ready to be used in applications beyond fuel ethanol. Those include the bioproduction of industrial enzymes, research reagents, and pharmaceuticals. Our technology will provide benefits to biomanufacturing cell types beyond yeast, such as CHO, insect, fungal, and algal cells.” 

iDiverse is also developing genetically modified plants incorporating its ProTectAll™ transgenic technology that are expected to be resistant to a wide range of fungi and viruses. Such plants will require less pesticide, fertilizer, and water to achieve better yields and will be able to be grown on less than optimal land under adverse conditions. These plant varieties are expected to be less costly to grow, provide higher yields, and be friendlier to the environment. 

LanzaTech is a New Zealand-based company founded in early 2005 to develop and commercialize proprietary technologies for the conversion of industrial waste gases into fuels (including ethanol) and chemicals using bacteria. LanzaTech says that its process can use gases from any source, including carbon monoxide produced in high volumes by the steel industry, other industrial waste gases that contain elevated concentrations of carbon monoxide and little or no hydrogen, as well as syngas. Syngas can be produced from any biomass resource, municipal waste or other organic wastestream, using a gasification process that breaks down the chemical bonds in the biomass making up to 80% of the energy available for fermentation. In the LanzaTech process, the gas feedstock is scrubbed, cooled and sent to a bioreactor. The carbon component is used as a food source for proprietary LanzaTech microbes during a biofermentation process, which produce ethanol as a liquid biofuel. 

After several years of fund-raising and internal growth, the company says it is now ready to undertake the next stage on its critical path, the pilot-scale demonstration of its fuel ethanol production from both biomass syngas and industrial waste gas feedstocks. A pilot plant design has been developed that will allow ethanol production from each of these feedstocks to be demonstrated at scale over the next 12 months (i.e. 2010-11). 

LanzaTech recently announced two alliances with Chinese companies: a memorandum of understanding with one of the largest coal producers in China, Henan Coal and Chemical Industrial Corporation (HNCC), for the production of fuels and chemicals using the LanzaTech Process and synthesis gas derived from the gasification of coal; and a partnership with China’s largest steel and iron conglomerate, Baosteel, and the prestigious Chinese Academy of Sciences (CAS) to commercialize its technologies for producing fuel ethanol from steel mill off gases. 

Xylogenics, Inc. is a start-up company spun off from the Indiana University Medical School.  Dr. Mark Goebl of IU and his colleagues identified a particular strain of yeast that was particularly efficient at producing ethanol from cellulosic feedstocks. The company says that this yeast strain is able to increase ethanol production from cellulose by at least 30%, while also allowing producers to use feedstocks such as corn kernels, corn stover, wheat straw, barley straw, grasses, wood waste and municipal waste. 

In August  2010, Xylogenics and Lallemand Ethanol Technology, a global provider of yeast to the fuel ethanol industry, announced that they signed an exclusive agreement to develop and commercialize genetically enhanced ethanol producing yeasts for first generation fuel ethanol production. Xylogenics will use its extensive knowledge of yeast genomics in cooperation with Lallemand to engineer a new class of industrial ethanol yeast strains. These enhanced yeasts will increase fermentation yield, reduce fermentation costs and potentially increase ethanol plant fermentation capacity compared with current commercial strains. Lallemand will be responsible for process development, manufacturing and commercialization of the new yeast. Under the terms of the agreement, Xylogenics will receive patent license fees and royalty payments. 

Companies Developing Modified Microorganisms for Production of Other Fuels

In earlier blog entries, I profiled several companies using biotechnology to improve organisms used to produce butanol or isobutanol, or other renewable fuels such as biodiesel or jet biofuel. Here are profiles of two additional companies active in these sectors. 

EASEL Biotechnologies, LLC is a UCLA spinoff company that is developing strategies for biosynthesis of chemicals and fuels from renewable resources such as CO2. Ethanol made by fermentation can be used as a fuel additive, but its use is limited by its low energy content. “Higher” alcohols (those with more than two carbons in the molecule) have higher energy content, but naturally occurring microorganisms do not produce them. UCLA Professor James Liao has genetically engineered microorganisms to make higher alcohols from glucose or directly from carbon dioxide, and the company was founded to develop such organisms to enable manufacture of renewable higher alcohols for use as chemical building blocks or as fuel. Liao’s work makes use of genetically engineered E. coli or cyanobacteria, modified to enable use of photosynthesis to directly convert carbon dioxide into higher alcohols having between three and eight carbon atoms. Those alcohols can then be further processed to produce green fuels. 

In June 2010, EASEL Biotechnologies was named a winner of the 2010 Presidential Green Chemistry Challenge Award for Recycled Fuel Breakthroughs. The company won this award, given by the U.S. Environmental Protection Agency, with support from the American Chemical Society Green Chemistry Institute, for Dr. Liao’s work in developing what it calls the world’s first biofuels derived from recycled carbon dioxide.  In receiving the award, Liao was quoted as saying “The first practical application [of this technology] will probably be to hook up to power plants and recycle some of the CO2 and make it into fuel,” Liao also said that, while the technology has the potential for multiple uses, he anticipates that the first goal would be to use it as a gasoline replacement. However, Liao estimated that it will probably take five to 10 years before the technology is ready for commercial use. 

Ginkgo BioWorks is a synthetic biology company founded by five MIT Ph.D. scientists, that is developing strategies for engineered biological solutions to address challenges in energy and chemicals. The company has developed a proprietary set of synthetic biology tools and technologies that allow it to design and build new organisms. Although much of the company is devoted to these basic “tool” products, the company has embarked on one biofuel-related project. Ginkgo, along with collaborators Jay Keasling of UC Berkeley and Mary Lidstrom and David Baker of the University of Washington, was awarded a $6.7M grant from the U.S. Department of Energy’s Advanced Research Projects Agency – Energy (DOE ARPA-E) to engineer E. coli to produce liquid transportation fuels from electricity and carbon dioxide. The goal of the project is  use synthetic biology to re-engineer the bacteria to fix carbon dioxide into liquid transportation fuels, such as gasoline, using energy from electricity. The project was scheduled to begin in the summer of 2010 and last for three years. 

D. Glass Associates, Inc. is a consulting company specializing in several fields of biotechnology. David Glass, Ph.D. is a veteran of nearly thirty years in the biotech industry, with expertise in industrial biotechnology regulatory affairs, patents, technology licensing, and market and technology assessments. This blog provides back-up and expanded content to complement a presentation Dr. Glass made at the EUEC 2010 conference on February 2, 2010 entitled “Prospects for the Use of Genetic Engineering in Biofuel Production.” The slides from that presentation and from Dr. Glass’ September 2010 talk on biotechnology regulations from the Algae Biomass Summit, along with more information on D. Glass Associates’ regulatory affairs consulting capabilities, are available at www.slideshare.net/djglass99 or at www.dglassassociates.com.