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.

FDA Regulation of Biofuel Production Microorganisms Used in Animal Feed

In a previous post on this blog, back in June 2010, I posted a brief discussion of the regulations of the U.S. Food and Drug Administration governing animal feed and feed additives, as they may impact the use of spent microbial biomass from biofuel fermentations in animal feed. It has been frequent practice for years to use such microbial biomass (which most often comprised common yeast strains) as a component of dried distillers grains or other products used as animal feed, and many companies developing genetically modified yeast strains or other microorganisms for use in ethanol fermentations are investigating how their strains, once inactivated after fermentation, can be used for this purpose. In this post, I’d like to go into a little more detail about the FDA regulatory structure under which such uses would be reviewed and approved in the United States.

The use of spent biomass in animal feed, or to produce a substance to be used in animal feed, would be regulated in the U.S. by the Food and Drug Administration. FDA regulation of animal feed is not much different from its regulation of human food, especially for feed intended for use in food-producing animals. Specifically (and contrary to popular belief), FDA does not regulate “food” per se: whole food products are presumed to be safe for consumption, but FDA has enforcement powers to be sure marketed food products are not adulterated. So, FDA regulation is largely directed at new substances proposed for use as human food additives or as animal feed additives. Under the Federal Food, Drug and Cosmetic Act, most such new substances that are intended to be components of food or to affect components of food are considered to be “food additives” and must be approved through the submission of a Food Additive Petition or, in the case of products for animal consumption, “feed additives” requiring Feed Additive Petitions. Food or Feed Additive Petitions generally rely on manufacturer-generated data on the manufacture, composition and safety of the additive, and usually include toxicology testing.  FDA must undertake formal rulemaking to grant approval of a food additive petition.

The law further provides that “substances that are generally recognized, among experts qualified by scientific training and experience to evaluate their safety as having been adequately shown …  to be safe under the conditions of their intended use,” are not considered as food additives. This created the category of substances known as GRAS: “generally recognized as safe”. Certain substances were “grandfathered” in as GRAS at the time of the legislation based on common prior safe use in foods, other GRAS substances were later affirmed by FDA to be GRAS, often in response to manufacturer petitions, under a petition process established in the regulations (21 CFR Part 170.35 for human food and Part 570.35 for animals). These GRAS affirmations were generally based on scientific information in the public domain. It is important to point out that GRAS determinations are not made for the substance per se, but for the substance in its intended use, so that a substance might be GRAS for one food use but not for another.

By 1997 FDA concluded that it could no longer devote substantial resources to the GRAS affirmation petition process. On April 17, 1997, the agency published a proposed rule outlining a GRAS notification process for both human and animal foods to replace the petition process.  Under the new proposal, applicants would submit notifications containing data that supports their own determination that a substance should be considered as GRAS. The FDA would review the notification and either accept the determination based on the applicant’s data, or request further data. The agency also announced that its Office of Food Additive Safety would immediately institute the human food notification scheme as a pilot program, and that it would accept and administer GRAS notices as described in the proposed rule until a final rule was published. To date, a final rule has not yet been issued, but FDA has been operating the human food notification program as an interim policy since 1997. The FDA website describes the pilot program for human GRAS notifications.

The 1997 notice did not originally extend the pilot program to animal feed substances, but on June 4, 2010, the Agency announced the creation of an animal feed GRAS pilot program, to be administered by the FDA’s Center for Veterinary Medicine (CVM). The program for animal feeds is described on the website, and like the human program, it now allows applicants (called “notifiers”) to submit notifications in which they inform the Agency that they believe an animal feed substance qualifies for GRAS status. The website gives the following guidance for the information that should be included in the notification.

[Notifications should provide] a succinct description of the substance, the applicable conditions of use, and the basis for the GRAS determination (scientific procedures or common use in food). The applicable conditions of use of the substance include the foods in which the substance is to be used, levels of use in such foods, the purposes for which the substance is used, and the specific animal species intended to consume the substance. If the intended use of the substance includes administration to food-producing animals, a human food safety component must be included.  The notice should also include information about the identity and properties of the substance and a discussion of the notifier’s reasons for concluding that the substance is GRAS for its intended use. The information about the substance generally is chemical, toxicological, and, if applicable, microbiological in nature. The notifier should discuss information supporting the GRAS determination, as well as any information that would appear to be inconsistent with a GRAS determination, and explain why, in light of the totality of the information, the notifier concludes the substance is GRAS under the intended conditions of use.

In the animal feed GRAS program, FDA CVM evaluates whether the notice provides a sufficient basis to support a GRAS determination or instead whether information in the notice, or information otherwise available, raises issues that might question the GRAS status of the proposed use. The Agency issues an opinion letter at the end of its review, and for those notifications that it clears for commercialization, the Agency’s letter says it has “no questions” about the applicant’s determination of GRAS status but states that FDA is not making its own determination. Alternatively, the letter may state the Agency’s conclusion that the notice does not provide a sufficient basis for a GRAS determination (e.g., because the notice does not include appropriate data and information, or because the available data and information raise questions about the safety of the substance).

Since implementing these policies, FDA has maintained inventories of received and pending GRAS notices. The human product inventory includes well over 400 entries (about two dozen of which appear to be pending at any given time). The inventory for animal feed GRAS notices is much smaller, since it lists only those notices received since the pilot program began in 2010. At this writing, there are 14 entries on the animal product inventory, and only 3 of these have been approved (i.e. these applications received FDA’s determination that they had “no questions”). Of the ones not approved, a few were withdrawn by the submitter while others bear the notation “Notice does not provide a basis for a GRAS determination”. Two of the rejected notices and the one that is still pending appear to cover products derived from recombinant microorganisms. Nonconfidential versions of the non-withdrawn notices, and FDA’s decision letters for each, can be downloaded from the inventory site.

Because, historically, the microorganisms used to produce fuel ethanol have been yeasts or other well-known species, companies seeking approval to sell the spent biomass for animal feed have contemplated the GRAS route, but in principle the feed additive process could also apply. The GRAS process is usually considered to be less burdensome than the food or feed additive petition process (this is certainly the case for human food additives) and so that is another reason the GRAS route might be favored.

Although the law and regulations give FDA the ultimate authority to make decisions on food or feed additive petitions and GRAS determinations, in practice CVM operates in cooperation with the Association of American Feed Control Officials (AAFCO), which is composed of state, federal, and international regulatory officials who are responsible for the enforcement of state laws regulating the safe production and labeling of animal feed. According to FDA’s website, FDA and AAFCO work together on animal feed regulation, particularly in the establishment of definitions to describe new feed ingredients. Each year AAFCO publishes its Official Publication which includes a model feed bill for states to adopt in regulating feed products and a list of accepted feed ingredients. Most states have adopted all or part of the model feed bill and allow feed ingredients listed in the publication to be used in their respective territories.

FDA and AAFCO entered into a memorandum of understanding in 2007, which was renewed in 2012, which specifies how these organizations would work together on animal feed regulation, allows FDA to formally recognize AAFCO’s list of feed ingredients, and defines the role FDA can play in deciding on the suitability of feed ingredients proposed for addition to the list. In practice, CVM assigns scientists to work with AAFCO in reviewing petitions for new feed ingredients, and this cooperation includes both GRAS petitions and feed additive petitions. AAFCO uses a “New and Modified Feed Ingredient Definitions Process” to determine the suitability of feed ingredients and to establish standard ingredient names, which FDA considers the common or usual name, used on feed labels as required by state and federal law. In addition, before it adopts a new feed ingredient definition or amends an existing one, AAFCO will ask CVM for advice and a letter of concurrence.

There appears to only be one genetically modified biofuel production microorganism that has cleared the FDA/AAFCO process to achieve GRAS status, although it is not listed on the FDA website inventory. This is a genetically modified yeast strain developed by Mascoma Corporation. Mascoma announced in February 2012 that FDA CVM, after completing a scientific review, supported the use of this strain, the Mascoma Grain Technology (MGTTM) yeast product, as a processing aid in the production of animal feed, resulting as a byproduct of the corn ethanol conversion process (presentations made at the time of product launch in June 2012 identified the strain as S. cerevisiae expressing a glucoamylase gene). The February press release further said that CVM sent a letter to AAFCO supporting inclusion of the product as a feed ingredient on the AAFCO Official Publication. Mascoma later announced that the MGTTM yeast product would be jointly marketed with Lallemand Ethanol Technology under the commercial name TransFermTM for use by the fuel ethanol industry, and this product was officially launched at the June 2012 Fuel Ethanol Workshop.

Although this product is not listed on CVM’s online inventory, Mascoma’s 2011 SEC filings from a planned IPO make clear that the company submitted a data package to CVM after obtaining the opinion of an outside expert panel that the MGTTM yeast product qualified for GRAS status. And the February 2012 press release and subsequent marketing documents indicate CVM’s support was achieved. In any event, it appears that Mascoma’s claim is correct that this is “the first bioengineered yeast that has gained the FDA’s acceptance for use in corn ethanol production of distillers co-products for animal feed.”

The path for new applicants to submit notifications to CVM for new GRAS determinations appears straightforward. The data requirements seem to be clear from the regulations and the various pages on the FDA CVM website. As with any regulatory matter, prior consultation with the Agency would be highly advisable, which is particularly true in this instance, where CVM officials would be able to provide specific guidance on how the process works, and how FDA and AAFCO work together. The fact that 10 of the 14 notifications submitted to CVM since the pilot program began in 2010 were not successful may imply that the standards and data requirements of the AAFCO are somewhat high, or it may simply reflect the fact that the notification program is new and may have been unfamiliar to applicants (the success rates for the human GRAS notification program seem much higher). Nevertheless, with proper advance planning, guidance from outside experts, and consultation with the Agency, GRAS status should be achievable for many modified biofuel production organisms intended for use in animal feed.

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.

Low-Carbon Fuel Standards in Other States and Regions

The previous blog entry described the “Low Carbon Fuel Standard” (LCFS) regulations that have been adopted by the State of California. In this entry, I’ll describe LCFS laws on the books or proposed in other states or regions, as well as a proposal to establish a national LCFS that would replace or modify the existing RFS. The website of the National LCFS Project at the University of California Davis is a useful resource on both the status of state regulations and the prospects for a national law, and that website was the source for a lot of the information presented below.

Oregon

Oregon appears to be the only U.S. state other than California to make a definitive move to adopt its own Low Carbon Fuel Standard, in proposed regulations that in the process of being finalized. In 2009, the Oregon legislature set a goal of reducing the average carbon intensity of Oregon’s transportation fuels by 10% over a 10-year period, and it authorized the state’s Environmental Quality Commission to develop low carbon fuel standards to achieve this goal. However, it appears that it was not until April 2012 that the state’s governor, John Kitzhaber, asked the Department of Environmental Quality (DEQ) to begin the rulemaking process for this program. DEQ solicited the input of potential regulated parties and other interested stakeholders on the design of the program and its estimated fiscal impacts, and the agency accepted formal written comments on the proposed rules. for review by the Environmental Quality Commission in December 2012.

The approach embodied in the draft rules focuses on decreasing the greenhouse gas emissions from fuels over time, through a two-stage program that would be phased in over a several-year timeframe. During an initial two-year period, fuel producers and importers would simply be required to report the lifecycle greenhouse gas emissions from the fuels they supply in Oregon, to allow DEQ to gather data and refine the program. Progressing to a second phase where fuel producers and importers would be required to take action to reduce GHG emissions would require approval by the legislature and the Environmental Quality Commission to take effect.

The draft rules were presented in a public meeting held December 6-7, 2012. At this meeting, the Environmental Quality Commission voted to move forward with the first phase, and require gasoline and diesel suppliers to begin reporting the carbon intensity of their fuels beginning in 2013. The state legislature would then have to decide whether to move to the second phase, which would be to require fuel producers and importers to achieve a 10% reduction in carbon intensity by 2025. However, the legislation as adopted in 2009 included a sunset date of 2015 for the program, and Governor Kitzhaber has reportedly decided that the state won’t implement these reductions unless the Legislature lifts the sunset date in its 2013 session. It has been reported that proponents of the legislation will make a lobbying effort in 2013 in favor of extending the program past this sunset date.

There is opposition to this program within the state. A group known as Oregonians for Sound Fuel Policy, a group of associations, businesses and organizations that represent heavy fuel-users, was formed shortly before the December 2012 EQB meeting, with the goal of opposing the LCFS policy. The members of this group are concerned that the policy will cause volatile fuel prices and create unnecessary government regulation, especially burdening small businesses. Other industry groups have been reported in the press to oppose the legislation as well.

Washington State

In May 2009, Washington Governor Christine Gregoire issued an Executive Order that directs the Washington Department of Ecology to assess whether the California LCFS or some variation would best meet Washington’s greenhouse gas emissions reduction targets. After a series of meetings in 2009 and 2010, a final report was released in February 2011. The LCFS considered in the report would be based on the goal of reducing transportation fuel carbon intensity 10% from 2007 levels by 2023, with reductions beginning in 2014. The report recommended that the program require only minimal reductions in the early years, followed by more aggressive goals as 2023 approached. No LCFS policy has been implemented, and the state has not yet decided how to proceed.

Northeast States for Coordinated Air Use Management

In 2009, the governors of 11 states (Delaware, Connecticut, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island and Vermont) signed a memorandum of understanding aimed at creating a regional LCFS plan to reduce the carbon intensity of transportation fuels by as much as 15% percent over a 10 to 15 year period. These states then formed a consortium, the Northeast States for Coordinated Air Use Management (NESCAUM), to lead the effort to develop a draft plan, including solicitation of stakeholder comments. NESCAUM issued a draft final report in August 2011, in which it considered adopting a plan similar to the California LCFS program. This draft plan says the states are considering a reduction target of between 5 and 15 percent over a period of 10 or 15 years, although the baseline for measuring reduction was still under consideration. The plan would also create a credit system for companies that produce or import fuels below the carbon intensity targets, which could include some liquid biofuels, electricity, hydrogen or natural gas. The calculation of carbon intensity would include upstream and indirect emissions as calculated by the GREET model, similar to the California program. However, there is nothing on the group’s website that is more recent than November 2011, and it is not clear whether this plan will progress in the near future.

Midwestern States

In December 2010, the Midwestern Governors Association (MGA) Low Carbon Fuel Policy (LCFP) Advisory Group issued a policy paper outlining what a possible Midwestern state low-carbon fuel standard could look like. The advisory group included participants from the oil industry, environmental community, biofuels industry, utility industry, and auto industry, and represented a wide spectrum of views on the direction Midwestern fuel policy should take. The MGA report recommended a federal LCFP as opposed to a patchwork of state policies, but given uncertainty with federal policy, a regional approach was viewed as the next best option. This policy paper did not propose the adoption of an LCFP per se, and the report made clear that some members of the Advisory Group did not favor such a regional policy. It appears that the MGA did not pursue such an approach, and instead the group issued a report in February 2012 with more traditional policy recommendations for promoting biofuel development and use in the region (e.g. supporting the federal RFS, promoting the use of E15 ethanol, etc.). No low-carbon fuel policy has been implemented in the Midwest region, and it is up to member states to determine what action to take next.

LCFS Explored for Minnesota

A study recently published by the Political Economy Research Institute at UMass Amherst examines some of the economic impacts of establishing a low carbon fuel standard (LCFS) in Minnesota. The study, titled “The Employment Impacts of a Low-Carbon Fuel Standard for Minnesota,” found that enacting a LCFS in Minnesota could create nearly 32,500 jobs when analyzed through 2025, and that this was the best of the three options analyzed for job creation in the state’s ethanol and biodiesel industries. The LCFS option was projected to lead to creation of 6 new corn ethanol plants and 10 cellulosic ethanol plants in the state by 2025. I don’t know whether this report has led to any significant interest within the Minnesota state government in adopting a state LCFS.

British Columbia, Canada

British Columbia is the only Canadian province to adopt a low carbon fuel regulation. The Renewable and Low Carbon Fuel Requirements Regulation (RLCFRR), which took effect in January 2010, is intended to reduce British Columbia’s reliance on non-renewable fuels, help reduce the environmental impact of transportation fuels and contribute to a low-carbon economy. The RLCFRR provides a regulatory framework to enable the province to set benchmarks for the amount of renewable fuel in B.C.’s transportation fuel blends, reduce the carbon intensity of transportation fuels and meet its commitment to adopt a low-carbon fuel standard. The province’s overall goal is to lower provincial greenhouse gas (GHG) emissions by 33% by 2020. The RLCFRR has two major requirements: the Renewable Fuel Requirement, requiring 5% renewable content in gasoline beginning in 2010 and 4% renewable content for diesel in 2012 onward (originally 5% but revised downward in February 2012); and the Low Carbon Fuel Requirement, which requires a 10% reduction in carbon intensity by 2020.

A National LCFS?

In 2010, the National LCFS Project was launched to study the potential implementation of a national Low Carbon Fuel Standard for the United States. The project was funded by the Energy Foundation and the William and Flora Hewlett Foundation. The participating researchers were from Oak Ridge National Laboratory, University of California, University of Illinois, University of Maine, Carnegie Mellon University, and the International Food Policy Research Institute. This group published two final reports in July 2012, one analyzing policy aspects of a national LCFS, the other focusing on technical aspects.

The group distinguished a national LCFS from provisions now in place under the RFS. Most importantly, rather than having the limited number of rigidly defined categories under the RFS, an LCFS system would resemble the California regulations in establishing carbon intensity values for all fuels, and basing the target GHG reductions on this continuum of carbon intensities rather than on mandates for the specified categories of fuel. Another advantage of an LCFS is that unlike the RFS it could apply to all transportation fuels, not simply biofuels, and therefore promote overall GHG reductions across the entire transportation sector, possibly promoting innovation in reducing carbon intensity of fossil fuels. Among the group’s recommendations was the option of amending the RFS to incorporate principles of an LCFS, rather than replacing the RFS wholesale.

It is too early to assess or predict the possible impact of this group’s recommendations so soon after release of its reports, but it is hard to see the necessary consensus develop in Congress in the near future to adopt a new regulatory framework such as this, particularly in view of the significant concerns about the RFS and its approach to promoting renewable fuels that are developing in Congress.

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.