Upcoming Conferences

I’ve been invited to speak at the Sixth Annual Biofuels Law and Regulation Conference in Champaign, Illinois on May 2, 2014. I’ll be part of a panel addressing legal and policy issues affecting the commercial development of biofuels. The conference is sponsored by the Energy Biosciences Institute, and the conference is intended to focus on “exploring new ways that biofuel policies can be re-imagined in order to continue promoting growth in the developing biofuel industry.” The conference aims to involve leading academic, scientific, government, and industry experts, with opportunities for in-depth discussion between and among speakers and audience members, and the organizers expect the program will appeal to a variety of stakeholders, from various industry sectors. You can find more information and links for registration at http://www.biofuellawconference.org.

Later in May, I’ll be attending BIO’s World Congress on Industrial Biotechnology, May 12-15, 2014 in Philadelphia. I’ll be presenting a poster on “International Regulation of Industrial Biotechnology”. The BIO World Congress is billed as the world’s largest industrial biotechnology event for business leaders, investors, and policy makers in biofuels, biobased products, and renewable chemicals. If you’re attending the conference and would like to meet, please let me know.

Details are also being finalized for another invited talk at a biofuels conference later this spring — I’ll report on that when everything has been worked out. I’ll be reporting on any newsworthy developments or interesting discussions that take place at these meetings, and I’ll certainly be posting my slides and a copy of my poster after each conference.

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, 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 any other organization with which Dr. Glass is affiliated. Please visit our other blog, Biofuel Policy Watch.

EPA seeks to improve its review of RFS pathway petitions

In a blog post several months ago, I commented on a recently-published study by two researchers at the University of Illinois Energy Biosciences Institute, James S.N. McCubbins and A. Bryan Endres, regarding the length of time the Environmental Protection Agency is taking to review petitions submitted from industry for approval of new fuel pathways under the Renewable Fuel Standard (RFS) (I have described the RFS pathway petition process in an earlier blog post.) The authors’ analysis of data from EPA’s website confirmed what many in the industry have been saying for some time — that EPA has a large backlog of pathway petitions, which may potentially be hindering the growth of the renewable fuels industry. EPA’s Office of Transportation and Air Quality was clearly listening, as shown in an announcement posted on their website earlier this month.

In a Program Announcement dated March 2014, EPA announced that it was initiating activities to improve the petition process for new fuel pathways under the RFS.  EPA said that it found “that improvements should be made to the petition process to enable more timely and efficient decision-making” in the RFS program. There are several components of this effort, including:

  • Undertaking what EPA calls a “lean government exercise” to improve their internal review process and to make it more transparent.
  • Developing improve guidance for companies seeking to prepare and file petitions, possibly including development of step-by-step instructions and application templates.
  • Trying to “automate” the more routine pathway petitions – those involving previously-approved feedstocks and well-understood production processes, but which (apparently) differed sufficiently from approved pathways as to require submission of a new pathway petition.

EPA expects this process to take about 6 months, and they have asked that companies considering the filing of new pathway petitions to consider deferring submittal until after EPA has completed its internal reviews. EPA will continue to review already-submitted petitions during the 6-month period, but will attempt to prioritize their reviews based on the importance of the proposed pathways to the most important goals of the RFS (e.g. contributing to the cellulosic biofuel mandate), and to the closeness of the pathway to commercialization.

EPA is also seeking stakeholder input of ideas for improving the petition process. Any submissions can be sent to support@epamts-support.com, with the phrase “Petition Process Input” in the subject line.

I think most industry observers will find this to be a positive development. There is no doubt that there is a substantial backlog of petitions – at this writing, there are 36 pending petitions listed on EPA’s website.  Although EPA staff has been encouraging companies to submit petitions as early as possible to get into the queue, no doubt many of these petitions represent pathways that are very close to commercialization, but are requests that have been pending for a long time. This is a state of affairs that could place some companies in a real hardship, to be close to commercialization but to still be uncertain that the process will be approved and therefore qualified to issue RINs.

Furthermore, I know from personal experience that there has been a lack of sufficient guidance from the Agency (particularly on its website), telling applicants how best to prepare petitions. In my consultations with Agency staff, I’ve found them to be very helpful, and they’ve indicated that, as long as the most important information, such as mass and energy balances, are submitted, the actual narrative content of the petitions was not that critical. This advice was useful, and it turned out (in my case) not to be too difficult to draft a petition working from the bare-bones requirements of the regulations. However, it is also likely that, due to the vague guidance, EPA found that many petitions lacked the needed information, while others contained a great deal of extraneous information that EPA staff had to wade through to get to the “good stuff”.

So, overall, I think this is a positive development, and I look forward to seeing the result of EPA’s hard work during this 6-month period.

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, 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 any other organization with which Dr. Glass is affiliated. Please visit our other blog, Biofuel Policy Watch.

Oilseed crops for biodiesel and animal feed

Back in the early days of this blog, I posted some general information about the variety of crops and other plant species that were being used, or contemplated for use, in producing biofuels, and about some of the companies known at that time to be developing genetically modified plants for this purpose.  Generally speaking, these plant species can be divided into two categories – plants that are primarily used as a source of carbohydrates like sugar or cellulose for the production of ethanol, butanol and other fuels; and plants that are used as a source of oils (fatty acids) which can be extracted and chemically converted into biodiesel via transesterification. Included in these two categories are plant species such as the following:

Traditional Species New Species
Sugar/Cellulose sources corn, sugarcane, beets, forestry wastes, other cellulosic materials such as corn stover, bagasse, etc. sorghum, switchgrass, Miscanthus, energy cane, Arundo donax, woody trees like Eucalyptus
Oilseed crops soybean, canola (rapeseed), cotton, palm, vegetable oil Camelina, Jatropha, castor beans

What’s notable from an economic standpoint is that, for just about all of these crop species, the potential exists to derive additional value from materials that are left over after the harvested crop material has served its purpose in biofuel production. Many of the plants used as carbohydrate sources can be used in animal feed, in the form of distillers grains (often combined with the spent biomass of the yeast or other microorganism used to ferment the sugars); and the protein-rich portion of oilseed crops can also be used in animal feed as oilseed meal after the fatty acids have been extracted for biodiesel production.  These are both longstanding uses for such plant-derived materials, which may play a significant role in improving the economics of biofuel production processes by creating byproducts having tangible economic value.

The market for dried distillers grains (DDGs) is significant: U.S. production alone is reportedly about 35 million metric tons per year, with a value of somewhere around US $10 billion, depending on the somewhat volatile market price; with over 9 million metric tons of U.S. production exported in 2013. Many companies developing novel microorganisms to produce biofuels by fermentation of these feedstocks are hoping to have their microbial strains approved for inclusion in DDGs that are fed to animals. I hope to devote a future blog entry to discussing the DDG market in more detail, but for today I’d like to discuss the markets for the oilseed crops that can be used for biodiesel production and as a source of seed meal for animal feed.

The term biodiesel refers to an automotive fuel that can be used in place of petroleum-derived diesel, which is produced from any of several renewable sources of fats or oils. Although several methods are used, biodiesel is generally produced by chemical transesterification of the fatty acids to produce mono-alkyl esters. In addition to vegetable oils and animal fats, oils extracted from several oilseed crops are commonly used to produce diesel. Historically, these include soybean, canola (rapeseed), palm and sunflower, but other oil-rich seed crops are being developed or have begun being used for biodiesel production, particularly including Camelina and Jatropha. Under the U.S. EPA Renewable Fuel Standard (RFS), there are approved pathways to produce renewable diesel from most of these sources, including soybean, canola, and Camelina, while pathway petitions for use of Jatropha are pending; biodiesel produced according to any approved pathway (at a facility registered with EPA) would be qualified to issue Renewable Identification Numbers (RINs) to take advantage of economic benefits under the RFS. Under the EU Renewable Energy Directive (RED), biodiesel made from these plants would qualify as a “renewable fuel” if the production process met the specified greenhouse gas emission reduction (currently 35%) and satisfied the other sustainability criteria in Article 17 of the Directive.

According to a 2012 publication of the Food and Agriculture Organization, there were almost 18 million metric tons (5.34 billion gallons) of biodiesel produced in the world in 2010. This amount is expected to rise dramatically due to incentives and mandates around the world such as the U.S. RFS and the EU RED, and one estimate by the FAO and the Organization for Economic Cooperation and Development is that by 2022 world production will rise to 41 billion liters (approximately 10 billion gallons) per year. The 2012 FAO report (citing an estimate from F.O. Licht) says that in 2010, most of the biodiesel produced globally was derived from rapeseed oil (5.75 million metric tons), soybean oil (5.70 million MT), and palm oil (2.44 million MT), followed by animal fats (2.23 million MT) (See Figure below, from FAO 2012). Among other sources, 211,000 MT of sunflower oil was used to produce biodiesel, and from these figures it appears that about 12 million MT of oils derived from oilseed crops were used in 2010 to make biodiesel. Based on approximate figures for the percentage of oil in the oilseed mass this amount of oil would have been produced by approximately 68 million MT of oilseed crops.

Feedstock2

Feedstock Usage for Bioideisel. Source: FAO 2012

However, this amount of oilseed used for biodiesel production represents only a small percentage of oilseed crops grown around the world. Recent estimates by the USDA Foreign Agriculture Service (downloadable from here) are that the world produces around 500 million metric tons of all oilseed crops combined, with soybean alone accounting for over half this amount with approximately 286 million MT, and rapeseed a distant second at around 70 million MT.

Oilseed crops are used for a variety of purposes, including the creation of oilseed meal, a protein-rich material that can be used in human foods and animal feed. The USDA FAS estimated at the end of 2013 that total worldwide oilseed meal production in that year was about 281 million MT, the great majority of which was attributed to soybean (190 million MT). Using these figures and the approximate market prices for oilseed meals at the end of 2013, I’ve estimated that the overall world market for oilseed meal (i.e. the economic value of the 281 MMT of production) was about US $123 billion.

Animal feed represents only a portion of the market for oilseed meal. One published estimate (apparently from 2009) was that about 22 MMT of oilseed meal was used in animal feed in Europe, about 68% of which was soybean meal. The European Union represents about 20% of the world market for all compound animal feed, and using this figure to extrapolate, world usage of oilseed meal in animal feed might be approximately 110 MMT. Using approximate percentages attributing this amount of production to the 3 or 4 major crop species, and applying the approximate 2013 commodity prices to the result, gives an estimate that the world market for oilseed meal used in animal feed might be as high as US $50 billion, with about $10 billion in the EU. These are very rough approximations, but they are consistent with other figures I’ve found – for example, from figures published by the U.S. Soybean Board, about 27 MMT of soybean meal was used in the 2011/12 growing season in animal feed in the U.S., giving an estimated U.S. market size for soybean meal in animal feed of US $14 billion, which is consistent with my calculated value for soybean meal used in the EU (15 MMT for a value of US $7.7 billion).

These calculations combine published estimates from different sources and different years, and embody a number of assumptions, and so the figure of a $50 billion world market for oilseed meal in animal feed should be considered as an approximation. The market is currently dominated by soybean and canola, and no doubt includes some amount of the oilseed meal derived from crops already used for biodiesel production. But this figure represents a significant market for developers of biodiesel crops – even gaining an 0.1% market share for these byproducts of biodiesel production would represent perhaps US $50 million in annual sales.

The animal feed market is segmented in several ways, notably by target animal. According to published data (Alltech’s survey of the amounts of compound feed produced globally in 2012), the overall market breaks down as 44% poultry, 26% ruminants (primarily cattle), 23% pigs, 4% aquaculture, 2% companion animals and 1% horses (Alltech’s more recent survey of 2013 production gives similar results, although poultry’s share has risen and ruminants’ has decreased). Other published estimates provide similar percentages. Different mixes of oilseed meals are preferred for different target animals, and so crop-by-crop percentages within the different sectors differ, but it is clear that the market is dominated by soybean meal, which tends to have a protein content, amino acid balance, and other features that make it well suited for most animal diets. However, each of the other oilseed meals used in animal feed supplement the nutritional value of soybean meal in certain ways, and each type of meal makes up a specific portion of the diet for each target animal species.

It is worth noting that most oilseed meal has achieved regulatory approval for use in animal feed. Traditional oilseed meals like soy, cotton, and palm have long been used in animal feed and are considered to be generally recognized as safe (GRAS) in the U.S. and elsewhere in the world. However, because naturally occurring rapeseed contains potentially toxic levels of erucic acid, GRAS status for canola and other artificially-bred low-erucic acid varieties of rapeseed had to be achieved through appropriate testing, with approvals around the world coming in the 1980s. More recently, the oilseed crop Camelina has achieved approval for use in certain animal feeds, in the U.S. and elsewhere, but the potential use of Jatropha meal in feed likely faces the same challenge as did rapeseed, since Jatropha seeds contain high levels of toxic materials such as phorbol esters. Methods to detoxify Jatropha or to breed nontoxic varieties are under development but have yet to gain regulatory approval for use in feed.

While the focus of oilseed crop strain development is clearly on improving oil yield or other traits important for diesel production, developers should keep in mind the potential value of the oilseed meal as an animal feed ingredient. For most oilseed meals, markets and marketing channels exist and regulatory approvals to enable market access; while for some of the newer crops some work remains to be done to establish regulatory approvals and gain market entry. However, the animal feed market remains an important opportunity for biofuel feedstock developers to improve the economics of their products.

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, 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 any other organization with which Dr. Glass is affiliated. Please visit our other blog, Biofuel Policy Watch.

Regulation of Genetically Modified Microorganisms: Recent Developments in Brazil

Last fall on the blog, I posted some information about laws and regulations in Brazil that might affect the use of microorganisms and algae, particularly ones with genetic modifications, for production of biofuels or bio-based chemicals. That post was one of a series of entries serving as background information for a poster I presented at the 2013 Algae Biomass Summit, and so like the others in the series, it primarily focused on uses of algae and cyanobacteria, although much of the information was relevant to potential uses of other genetically modified microorganisms for industrial purposes. In today’s post, I’d like to briefly update the situation in Brazil, particularly in view of two new approvals that were granted near the end of last year for uses of modified microorganisms for contained industrial manufacturing in the country.

To summarize the regulatory landscape in Brazil, the country has ratified the Cartagena Protocol and has adopted a national biosafety law (Law No. 11,105 of March 24, 2005, available here in either English or Portuguese). The law creates a national regulatory framework administered by the Biosafety National Technical Committee (Comissão Técnica Nacional de Biossegurança, known by its Portuguese acronym CTNBio), and the National Biosafety Council (CNBS), with the involvement of the Ministries of Health, Environment and Agriculture, the Special Secretariat of Agriculture and Fishery, and other agencies. CTNBio is a 27-member committee comprised of technical representatives from across the Brazilian government. The CTNBio website, in Portuguese but with some links to English pages, can be found here.

Regulations implementing Law No. 11,105 were put in place by Decree No. 5591 of November 22, 2005. The Law and its regulations require that companies wishing to conduct commercial activities using genetically modified organisms (GMOs) or to test or use modified plants in the environment must seek the approval of CTNBio. Specifically, the Law requires approval for any activities involving the “cultivation, production, handling, transport, transfer, commercialization, import, export, storage, consumption, release and disposal of GMOs and their derivatives for commercial purposes.” It is therefore likely that proposed uses of modified microorganisms, even in contained manufacturing, would require multiple approvals under the regulations, not only for the proposed use itself, but possibly also for the importation of the GMO into the country and an approval or registration requirement for the laboratory or manufacturing facilities to be used within Brazil.

My post from last fall briefly mentioned that CTNBio had approved two applications from Amyris for the use of genetically modified microorganisms for the production of farnesene. There have now been two other, more recent, CTNBio approvals of other uses of GMOs in contained manufacturing. Summaries of all four approvals follow, along with links to the detailed online summaries of the CTNBio decisions (these links are all to pages in Portuguese except where noted). Please note that, although the CTNBio website has a menu tab for the English language page “Commercial Approvals”, followed by a page for “Microorganisms”, those links lead to only one English translation of a CTNBio microorganism approval – in order to locate all four approvals, it’s necessary to click on the Portuguese language tab “Aprovações Comerciais” and then to go to the “Microorganismsos” page.

The approved microorganism decisions, in chronological order, are as follows (translations courtesy of Google Translate, edited for grammar and content):

Amyris: February 2010
Case No. 01200.003590/2009-85
Applicant: Amyris Brazil S.A. (English translation available here)
Subject: Request for Opinion on the commercial release of yeast (Saccharomyces cerevisiae) strain Y1979 genetically modified to produce farnesene.
Decision: GRANTED
Amyris Brazil SA requested CTNBio’s technical opinion on the biosafety of genetically modified Saccharomyces cerevisiae yeast strain Y1979, engineered to produce farnesene by expression of the farnesene synthase gene from the nonpathogenic medicinal plant Artemisia annua L. CTNBio decided that the information provided by the company supported the safety of the product and the proposed use of the modified microorganism for the industrial production of farnesene.

Amyris: May 2012
Case No.: No. 01200.003977/2011-56
Applicant: Amyris Brazil SA
Protocol Date: 03/11/11
Subject: Request for Advice for the commercial release of yeast (Saccharomyces cerevisiae) strain Y5056 genetically modified to produce farnesene
Meeting: Regular Meeting of the 152nd CTNBio held on May 17, 2012
Decision: GRANTED
Amyris Brazil SA requested CTNBio’s technical opinion on the biosafety of genetically modified Saccharomyces cerevisiae yeast strain Y5056, engineered to produce farnesene by expression of the farnesene synthase gene from the plant Artemisia annua L. CTNBio decided that the information provided by the company supported the safety of the product and the proposed use of the modified microorganism.

Solazyme: October 2013
Case No.: 01200.001052/2013-32
Applicant: Solazyme Renewable Oils and Bioproducts Brazil Ltda.
Subject: Request for Opinion on the commercial release of genetically modified Class I biohazard microorganism.
Meeting: 166th Ordinary meeting held on October 17, 2013.
Decision: Granted
Solazyme requested CTNBio’s advice on the proposed use of the genetically modified microorganism Prototheca moriformis strain S2014, for the commercial production of triglycerides and bioproducts marketing. The microalgae species Prototheca moriformis is a single-celled non-chlorophyll-containing obligatory heterotroph, which reproduces asexually and does not produce spores. CTNBio approved the commercial release of the genetically modified Prototheca moriformis, strain S2014, for the production of triglyceride oils and other bioproducts.

Bio Celere Agroindustrial: December 2013
Case No.: 01200.001454/2013-37
Applicant: Bio Celere Agroindustrial Ltda.
Subject: Request for Opinion of Trade Liberalization with confidential information
Meeting: 168th Annual Meeting of CTNBio, held on December 5, 2013
Decision: GRANTED
Bio Celere Agroindustrial Ltda. requested CTNBio’s review of its proposal to import modified S. cerevisiae into Brazil for the purpose of ethanol production. The strain, RN1016, is a yeast of the species S. cerevisiae genetically modified to express the xylA gene encoding xylose isomerase from the nonpathogenic fungus Piromyces sp., which also features increased expression of natural yeast genes XKS1, TAL1, TKL1, RPE1 and RKI1 and deletion of the gene GRE3. CTNBio’s reviewers determined that, based on the information presented, there were no clear risks to the environment or health if used under the conditions proposed by the company.

It’s hard to tell from the website listings how difficult or time consuming these applications were. Each of the decision documents lists a date on which some information about the case was published in Brazil’s Official Gazette, and although it’s not clear how closely those dates correspond to each company’s actual application date, for three of the cases the elapsed time between the publication date and the approval date was about 4-6 months. However, the gap for the second Amyris approval is about 14 months, which may indicate that that application was not as easily approved as the first. In any event, given the importance of Brazil for the commercial plans of so many companies developing technologies for ethanol production, it is good to see that commercial applications are being processed and approved by CTNBio under reasonable timelines.

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, 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 any other organization with which Dr. Glass is affiliated. Please visit our other blog, Biofuel Policy Watch.

Recap of New Pathways Added to the Renewable Fuel Standard in 2013

This is the week that public comments are due on EPA’s controversial proposed rule that would scale back certain of the 2014 volume mandates under the Renewable Fuel Standard, which I’ve more fully described in a post on Biofuel Policy Watch. EPA has (rightly) taken a lot of flak from the biofuels industry for rolling back the target volumes for cellulosic and advanced biofuels and the overall target for all renewable fuels, and we’ll see in the coming weeks whether the torrent of negative comments EPA will no doubt receive will have any impact on the final 2014 volume mandates. At any rate, I felt it would be good to take a “time out” from all the criticism over EPA’s 2014 proposal to look back at other EPA actions under the RFS in the past year, which have generally been more favorable to the industry and which have also significantly expanded the scope of the program.

I’d like to focus primarily on EPA’s rulemaking activities relating to new fuel pathways. As I described in a post last year, the original legislation that established the RFS set up the four broad categories of renewable fuels (renewable fuels, advanced biofuels, cellulosic biofuels, and biomass-based diesel), and EPA’s implementing regulations specified certain fuels and feedstock production pathways that were originally qualified for inclusion within these categories. The regulations further provided that fuel pathways not included within the original rule would need to be reviewed and approved by EPA to be considered as renewable fuels under the RFS. New pathways can be added to the regulations as generic pathways, applicable to any manufacturer using a specified feedstock as long as the specified conditions are met. These actions usually arise as a result of reviews initiated by EPA staff and are accomplished through formal rulemaking procedures. Other pathways are added in response to petitions submitted by a manufacturer, and approval of such pathways may be more narrowly applicable to the submitter’s proprietary pathway. Last year’s post described the petition process in more detail, with additional information on the process available on EPA’s website.

EPA’s RFS website contains a great deal of information on the RFS program and specifically on the approved pathways and those that are currently under review. Specifically, the complete list of all the approved pathways can be found on this page on the EPA website. This page includes the list of pathways that appears in the formal RFS regulations in Table 1 within 40 CFR Part 80.1426, and also includes a list of company-specific pathways that have been approved.

The most notable 2013 rulemaking actions adding generic pathways to the list in Part 80.1426 are the following:

  • In February 2013, EPA issued a final rule creating pathways for biofuels produced from camelina oil and energy cane, as well as renewable gasoline and renewable gasoline blendstock made from certain qualifying feedstocks such as crop residue, pre-commercial thinnings, and separated components of certain waste materials.
  • In June 2013, EPA approved new pathways for the production of renewable fuel from giant reed (Arundo donax) and napier grass (Pennisetum purpureum) as feedstocks for cellulosic biofuel. As I described in a blog post last year, these approvals included specific requirements for management techniques for the growth of these crops, which have the potential to behave as invasive species.
  • In September 2013, the agency issued a final rule that expanded the definition of the heating oils that would qualify for generation of Renewable Identification Numbers (RINs) under the RFS, an action taken in response to industry comments that the definitions in the original legislation were too narrow.

Also on this page on the EPA website is a listing of the manufacturer-specific petitions that have been approved. My January 2013 post included a chart listing those pathways that had been approved through the end of 2012. To update that listing, the following are the new pathways that EPA approved in 2013 – although all of these represent manufacturer-filed petitions, some of these correspond to the new generic pathways described above.

Company Fuel Feedstock Determination
Marquis Renewable Energy-Wisconsin Ethanol Corn Starch Approved,
November 2013
Valero Fort Dodge Ethanol Corn Starch Approved,
November 2013
Guardian Energy Ethanol Corn Starch Approved,
November 2013
Diamond Green Diesel, LLC Naphtha, LPG Non-food grade corn oil Approved,
October2013
Valero Welcome Ethanol Corn Starch Approved,
July 2013
Hankinson Renewable Energy, LLC Ethanol Corn Starch Approved,
July 2013
Chemtex Group Cellulosic Biofuel New (Arundo donax) Approved,
July 2013
BP Biofuels North America, LLC Ethanol, cellulosic diesel, jet fuel and heating oil; naphtha Energy cane and Napier grass Approved,
March 2013
Kior, Inc. Renewable gasoline and renewable gasoline blendstock Cellulosic biomass** Approved,
March 2013
Sundrop Fuels, Inc. Renewable gasoline and renewable gasoline blendstock Cellulosic biomass** Approved,
March 2013
Terrabon, Inc. Renewable gasoline and renewable gasoline blendstock Cellulosic biomass** Approved,
March 2013
Sustainable Oils Biodiesel, renewable diesel, jet fuel, heating oil, naphtha, LPG Camelina sativa oil Approved,
March 2013
Dakota Spirit AgEnergy, LLC Ethanol Corn starch Approved,
February 2013
Absolute Energy,
LLC
Ethanol Corn starch Approved,
February 2013
Western Plains Ethanol Grain sorghum Approved,
January 2013

**In these approvals, the term “cellulosic biomass” includes biomass from crop residue, slash, pre-commercial thinnings, tree residue, annual cover crops; cellulosic components of separated yard waste; cellulosic components of separated food waste; and cellulosic components of separated municipal solid waste.

As you can see, EPA approved 15 petitions during calendar year 2013, bringing the overall total approvals to 22, although it should be noted that in some cases groups of two or more individual petitions were likely reviewed as a unit due to commonalities in the pathways, or as part of EPA’s development of a generic pathway. Nevertheless, this is still reasonably good productivity for an agency that has come under fire for its backlog of petition reviews, over and above the criticism over the scaled-back 2014 volume mandates.

In a post last summer, I commented on a study from the University of Illinois Energy Biosciences Institute that analyzed EPA’s response time for new RFS petition reviews, and which found that overall, EPA’s average review time for all approved and pending petitions was 500 days, and that the ten petitions successful as of the time of their analysis had an average wait time of 290 days. I haven’t attempted to try to recalculate any of the figures in the Illinois study to see if review times had changed at all, but it seems to me that EPA is moving a bit faster in processing pathway petitions. On the other hand, as of today the EPA website lists 34 petitions still undergoing or awaiting review at the agency, so a substantial backlog still remains. It’s not clear to what extent these delays in approving pathways are affecting the petitioning companies, because in my experience I know that EPA staff encourages companies to submit petitions as early as possible; and companies can’t be fully approved to issue RINs until their first production facilities are operational and are registered with EPA under the RFS regulations. While I’m sure there are several among the 34 pending petitions whose ability to issue RINs is being held up by EPA’s backlog, it may be that many of the companies having pending petitions are earlier in the development process and are not being unduly disadvantaged by the delays. Here’s hoping that EPA is able to continue to work through this backlog, so that more and more companies and pathways are qualified for the issuance of RINs to help meet the annual volume obligations under the RFS.

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, 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 any other organization with which Dr. Glass is affiliated. Please visit our other blog, Biofuel Policy Watch.

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.

Presenting a regulatory case study at BIO Pacific Rim Conference

Next week, I’ll be speaking and moderating a panel at the BIO Pacific Rim Conference on Industrial Biotechnology and Bioenergy in San Diego.  The panel is entitled “Overcoming Challenges in Regulation and Intellectual Property”, and I’ll be presenting an overview of U.S. and international regulations affecting industrial biotechnology along with a case study of my work for Joule Unlimited in its recent successful interactions with the EPA for review of a Microbial Commercial Activity Notice (MCAN) for a modified cyanobacterium for ethanol production.

The other speakers on the panel will be Kevin Wenger of Mascoma, speaking about his company’s experience in gaining regulatory approval for genetically modified yeast strains for ethanol production and use as animal feed ingredients, Konrad Sechley, of the Canadian patent law firm Gowling Lafleur Henderson, LLP, who will discuss the scope of patent protection available for biotechnology in view of recent legal developments, and Kathleen Roberts, of Bergeson & Campbell Consortia Management, LLC, who will discuss the impact of the Toxic Substances Control Act on the manufacture of bio-based chemicals.

The conference is taking place December 8-11, 2013, and you can find more information on the conference website. This is the 8th annual Pacific Rim Summit organized by the Biotechnology Industry Organization, and is the original conference dedicated solely to the growth of the industrial biotechnology and bioenergy sectors in North America and the Asia-Pacific region. In addition to four plenary sessions, the meeting will feature 30 breakout panels covering topics including algae, advanced biofuels, bioplastics, dedicated energy crops, renewable chemicals, marine bio-resources and synthetic biology.

Please let me know if you’re attending the conference and would like to meet, or if you’d like a copy of my presentation, which I expect to make available after the meeting. I also hope to blog about the conference and some of the sessions I attend, time permitting.

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.