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.