Comments on Recent Articles on Regulation of Genetically Modified Algae for Biofuels

Two articles appeared over the past week that have described the growing interest in using genetic engineering to improve algal strains for enhanced biofuel production, as well as the apparently-increasing debate over the possible need for regulation and government assessment of the potential environmental risks of such strains. These articles, “The Race to Make Fuel Out of Algae Poses Risks as Well as Benefits”, by Dina Fine Maron of ClimateWire, appearing on nytimes.com on July 22, and “Exploring Algae as Fuel”, by Andrew Pollack, appearing in print and web editions of the New York Times on July 26, both present thoughtful, accurate, and balanced presentations of the issues, even though the discussions were eerily reminiscent of the original debates in the 1980s over risk and regulation of agricultural biotechnology.  These articles touch on many of the same issues discussed in earlier entries of my blog (see postings of June 9, 2010 and June 16, 2010), and so I wanted to offer the following comments about these two excellent articles (full disclosure: I was interviewed by both writers, primarily for background, although I was not quoted in either article). 

Both articles present a fair, balanced view not only of the potential risks that some envision for the use of engineered algae, but also the potential benefits and the likelihood that we’ll need to make use of tools such as genetic engineering and advanced biotechnology to achieve cost-effective fuel production from algae at commercial scale. Both articles also correctly state that the most plausible environmental concerns are raised by the possibility that engineered algae might be used in the kind of open-pond reactors that are common in many current commercial applications of algae, rather than the better-contained fermentation vessels that are standard for industrial use of microorganisms, yeasts and fungi, and that such open-pond use of engineered algae at commercial scale is likely to be years away. 

I’ve always been among those who have acknowledged that, as a general proposition, the use of novel microorganisms (and algae) in the environment pose certain potential risks, and that it is entirely appropriate to evaluate those risks. Where I and most industry observers differ from the critics is in the belief that these risks are in most cases minimal, and in many cases easy to manage, and that the appropriate way to address risk is on a case-by-case basis. (I’d also say that I’ve never been a proponent of the kind of “suicide gene” strategies discussed in both articles, feeling that the potential risks are minimal enough so as not to require such extreme strategies, but that’s just my personal opinion). Both articles, I thought, gave a balanced presentation of the two sides of the discussion, but it is too early to know if the concerns expressed by some of the scientists quoted in the articles represents anything more than isolated opinions. In other words, I don’t yet know if presenting both sides of the debate in articles like these gives the impression that equal numbers of scientists are on both sides of the discussion, thus overstating the depth of the opposition (like the current situation with the so-called debate on climate change). 

Both articles touched on what could be the battle lines of the forthcoming debate – whether the potential environmental issues posed by GM algae are so significant and pervasive that the U.S. government should conduct a full-blown environmental assessment (EA) or environmental impact statement (EIS); or whether the existing framework of laws and regulations are sufficient to manage risks on a case-by-case basis. Although I didn’t touch on this issue in my earlier blog entries, I’m firmly in the “case-by-case” camp, and I don’t see the need or the statutory basis for an EA or EIS. Historically, U.S. government agencies have been mandated by the National Environmental Policy Act of 1969 (NEPA) to perform environmental assessments for certain regulatory decisions or actions – originally intended to cover only “major federal actions”, but more recently applied to many projects, federal, state or local, that involve federal funding or work performed by the federal government, or other federal regulatory decisions. Many federal actions trigger the compiling of an EA, leading to a finding of “no significant impact”, which if properly done is sufficient to meet the requirements of the law, but some EAs identify potential risks that justify or require the preparation of the more comprehensive EIS. 

The current proponents of an EA or EIS for engineered algae base their position on the fact that the U.S. government, particularly the Department of Energy, has funded hundreds of research projects, and tens of millions of dollars, in research into fuel uses of algae, including research involving genetic engineering, and that this government investment should trigger the need for an EA under NEPA. While there is some legitimacy in such a position, it ignores the fact that the great majority of this research has been basic, often academic, research conducted in laboratories and greenhouses, under conditions where any genetically engineered algae are reasonably contained. The environmental impacts of such small-scale, contained research projects are certainly minimal, and in my view it would be somewhat extraordinary and certainly premature to conduct an EA, much less an EIS, for the government’s decision to fund a laboratory project that might, someday, hypothetically be used at a scale large enough to have an environmental impact. 

However, the NEPA debate is one that is not going to go away, because it is consistent with other trends in regulatory law, particularly the regulation of biotechnology: the past several years have seen considerable discussion and several lawsuits over the adequacy of USDA’s biotechnology regulations for granting approval for engineered crop plants to be sold and used commercially, and whether the agency must prepare EISs before granting any such approvals. Recent momentum appears to be on the side of the NEPA proponents, with most court decisions requiring USDA to prepare an EIS for each new product approval. Interestingly, because the mission of the Environmental Protection Agency is the protection of the environment, many of its actions have been held not to be subject to many of the procedural requirements other agencies face under NEPA. According to the EPA’s website, many EPA actions under the Clean Water Act and Clean Air Act are exempt from the requirements of NEPA, and  “EPA is also exempted from the procedural requirements of environmental laws, including NEPA, for comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) [i.e. Superfund] response actions. Courts also consistently have recognized that EPA procedures or environmental reviews under enabling legislation are functionally equivalent to the NEPA process and thus exempt from the procedural requirements in NEPA”. This may imply that GMO projects regulated under EPA’s TSCA biotechnology regulations may not face any statutory requirement for a formal EA or EIS, although EPA review of Microbial Commercial Activity Notices under TSCA would address the same risk and benefit issues that would be covered in an EA. 

So this brings me to the final point about the issues raised in the two recent articles. I strongly believe that the appropriate time for review of environmental impacts is the case-by-case regulatory process that would take place when any particular engineered algal strain is proposed to be used commercially, or in some other manner that would trigger the applicable biotechnology regulations. Generally speaking, this would be when a company reaches the point of wanting to use such a strain in a manner not limited to R&D use, particularly a point in time when commercial use is intended. But it is worth noting that the TSCA biotech regulations include provisions to ensure that there is adequate regulation of R&D uses of engineered microorganisms if they are used in the open environment or under conditions where “containment” cannot be assured. I mentioned this only briefly in my earlier blog entries, but any proposed outdoor (i.e. non-contained) research use of a “new microorganism” for an application falling under TSCA jurisdiction would require reporting to EPA 60 days prior to the proposed use, using a procedure known as a TSCA Environmental Release Application, or TERA. Although I don’t believe there have yet been any specific examples, it is likely that the proposed use of an engineered algal strain for biofuel production in an open-pond reactor, even at the research or pilot level, would require the filing of a TERA regardless of the scale, and this would require EPA to assess the possible environmental impact of the proposal. 

At whatever time the regulations are triggered, rather than focus on broad, abstract, hypothetical risks, the relevant agency can conduct a risk assessment of a specific strain that has actually been constructed and tested, using available data obtained by the applicant or other entities, while also taking into account the possible benefits of the proposed use. Several commenters in the two articles, including spokespersons of the Biotechnology Industry Organization and the Algal Biomass Organization, expressed support for reliance on the existing framework of biotech regulations, and the case-by-case, product-specific approach it embodies, and I strongly agree with that sentiment. I know that responsible parties within the industry are prepared to work within the regulations to develop data and other relevant information to ensure governmental and public acceptance of what could be an important new technology for renewable energy production. 

So, I was glad to see both articles appear this week, and to see that they both featured responsible, balanced presentations of the issues.  It appears that the time has indeed come for the debate or discussion over the possible impacts of engineered algae as they begin to see broader commercial use for biofuel production or other purposes, and I felt both articles made a positive contribution towards an informed public debate on this topic. 

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

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European Regulations Affecting the Use of Modified Organisms in Biofuel Production

Previous entries in this blog have focused on U.S. government biotechnology regulations that might affect the use of genetically modified organisms in biofuel production, and the entry immediately preceding this one discussed the regulatory framework in Canada for such proposed industrial applications. Today’s entry will discuss applicable European Union regulations that might affect the use of modified microorganisms or plants for biofuel purposes. 

The European Union (EU) has grappled with issues relating to genetically modified organisms (GMOs) since the 1908s, and to this day there remains a great deal of controversy over the growth of GMOs, principally plants) and their use in food. Today there are two primary pieces of EU legislation that might affect the use of modified plants or microorganisms in biofuel production. These are in the form of “Directives”, which are adopted by the European Commission and which are binding upon all EU member states, which must then adopt national laws that conform with the provisions of the directive. These two principal biotechnology directives have been adopted by the European Commission’s Environmental Directorate, DGXI, and they are as follows: 

• Directive 98/81/EC, which amended Directive 90/219/EEC, on the contained use of genetically modified microorganisms (GMMs). This Directive regulates research and industrial activities involving GMMs under conditions of containment. 
• Directive 2001/18/EC, which replaced Directive 90/220EEC, on the deliberate release into the environment of GMOs, which applies to two types of activities:  the experimental release of GMOs into the environment, such as in connection with field tests; and the placing on the market of GMOs, for example the cultivation, importation or transformation of GMOs into industrial products, such as the sale of seed to grow GMO plants or the use of products of genetically modified plants in food.

European regulation of modified microorganisms for biofuel production 

The Directive on the contained use of GMMs might be applicable to the use of modified microorganisms, yeast and algae for production of biofuel in Europe. However, the focus of this directive is to ensure that appropriate facilities, procedures and controls are used with GMMs in both the laboratory and in industrial practice to prevent or minimize the release of the organisms from the contained facility and to protect worker safety. The requirements of this Directive are similar to the U.S. NIH Guidelines and other international biosafety guidelines. For example, Annex IV, Table II of this Directive lists “minimum requirements for activities other than laboratory activities [i.e. industrial activities] using GMMs”, and lists procedures for handling, inactivating and disposing biomass from GMMs. Although the Directive would be implemented on the national level by the relevant government agency, its focus really is on the appropriate procedures or controls for use of the microorganisms, and the Directive does not speak at all to how the commercial product of, say, a microbial fermentation, would be regulated. 

Therefore, unless covered by any specific national law, it would not appear that the EU has any specific regulations that might require product-specific approvals for microbial strains used to produce biofuels, or to produce the enzymes used in biofuel manufacture, unless regulated for another reason (e.g. the use of enzymes as feed additives would need to be approved by the European Food Safety Authority). The Directive also does not require that GMO-produced enzymes be labeled in any special manner. Industrial enzymes produced by modified microbes would be subject to the same registration or inventory procedures that might be required for all industrial enzyme products, such as the European Inventory of Chemical Substances or the European List of New Chemical Substances. According to one Internet source, there are quite a number of industrial enzymes on the market in Europe produced from modified microbes, including enzymes with biofuel uses such as cellulases, hemicellulases, and xylanases.

European regulation of genetically modified plants 

The “Deliberate Release” Directive is applicable to the possible growth and use of transgenic plants as biofuel feedstocks.  This Directive requires each EU member state to appoint a regulatory agency with the authority to review and approve environmental introductions within its jurisdiction. Proposals for R&D field tests must be made to the competent authority of the EU member within whose territory the experimental release is to take place, and the review of such proposals would address similar environmental issues as are considered in the United States (e.g. under the USDA regulations). Member states have sole authority to approve R&D uses within their jurisdiction, after European Commission notification and a 90 day review period. Although approvals are strictly up to each national government, other EU member states as well as the Commission itself may contribute observations and comments to the national authority considering any specific field test proposal. In spite of widespread public concern over GMO plants in Europe, there have been a large number of experimental field trials approved of transgenic plants over the past two decades. 

Proposals for marketing or commercial use of a GMO must first be made to a single member state, although the decision to authorize the commercial use will involve all member states, and any approvals granted would (in theory) allow commercial use throughout the EU. The application (called a “notification”) must include a full evaluation of the environmental risks of the GMO, based on data from prior experimental use. After its review, the national authority must issue an opinion which will take the form of an “assessment report”, which may be favorable or unfavorable. If the national authority issues a favorable report, it will notify the other member states via the European Commission. The other member states and the Commission are entitled to provide their observations and objections to the report. If there are no objections, the original national authority can authorize the commercial use of the product, although the agency can place restrictions on the approval, and all product approvals are limited to a ten year duration. The Directive includes procedures for resolving disputes, e.g. if one member state lodges an objection to a proposed commercial use. 

In practice, the European Commission’s decisions regarding commercial approval for GMOs (all for modified crops that would be destined for food use) have been controversial. There have been frequent deadlocks between different member states regarding approvals for specific products, and even for those products that have been approved by the Commission, there are a number of individual nations, including Ireland, France, Austria and others, that have imposed either a product-specific ban or an overall ban on the growth of GMOs. However, it has been reported that the European Commission is planning to formally propose modifying the approval procedures for GMO crops, so that decisions can be made on a nation-by-nation basis rather than requiring one decision that would cover the whole European Union. Although most of the controversy has arisen over concerns about the food use of the products of these modified plant varieties, there is no doubt that the political and public relations situation in Europe may make it quite difficult to commercialize transgenic energy crops, even non-food crops, in the near future. 

A database of notifications of proposed field uses of GMO plants can be found here. This database is hard to search, but I found the following proposed field tests which seemed to involve plants engineered for improved biofuel production. There may well be others, where the plant phenotype was identified in a way that was not picked up by the keywords I searched. 

Notification B/FR/03/02/07, France, published 03 March 2003, Biogemma
Field experiment of genetically modified hypolignified tall fescue

Notification B/FR/03/03/05, France, published 31March 2003, Biogemma
Field experiment of corn genetically modified for the lignin biosynthesis pathway

Notification B/FR/07/06/01, France, published 02 July 2007, INRA
Field trial of genetically modified poplars for wood properties and bio energy production. Agronomical and environmental assessment

Notification B/ES/10/40, Spain, published 23 March 2010, Idén Biotechnology S.L.
Study of maize lignification for the improvement of digestibility and bioethanol production.

Notification B/ES/10/50, Spain, published 24 June 2010, ABBA Gaia, S.L.
Field test of Nicotiana glauca genetically modified as an energy crop

Finally, I would note that the European Union also maintains regulations affecting the importation and international movement of GMOs. These rules are largely in conformance with the requirements of the Cartagena Protocol on Biosafety. The Cartagena Protocol was annexed to UNEP’s Convention on Biological Diversity, which took effect on September 11, 2003, and the purpose of this agreement was to set common rules for all nations to follow regarding the transboundary movements of GMOs. Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms was explicitly adopted (as a modification to the EU’s previously-adopted Directive on “deliberate releases”) to conform with the provisions of the Cartagena Protocol. The Protocol and its implementing regulations are intended to ensure that national authorities are notified of proposed deliberate releases or transboundary movement of GMOs in their countries, that information is provided to the public and to other countries regarding on EU practices, legislation and decisions on GMOs, as well as on accidental releases of GMOs, and that rules are in place for the export of GMOs, particularly those to be used for food or feed. 

There appears to be a great deal of interest in Europe in developing novel technologies for biofuel production, and many of the companies I profiled in earlier entries in the blog are located in the European Union. EU regulations don’t appear to pose too significant a barrier for possible use of genetically modified microorganisms for biofuel manufacture, but the outlook is far more unclear for the possible use of transgenic plants. Presumably, however, a well-prepared, well-thought-out proposal to use an engineered non-food species as a biofuel feedstock could win governmental and public acceptance at some point in the near future. 

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

Canadian Regulations Affecting the Use of Modified Organisms in Biofuel Production

Previous entries in this blog have focused on U.S. government biotechnology regulations that might affect the use of genetically modified organisms in biofuel production. In this entry and the next I’ll focus on regulations outside the U.S. In this entry, I’ll briefly discuss the regulatory framework in Canada which may affect such proposed industrial applications, and I’ll discuss the handful of proposals which have, to date, been subject to these regulations. The next entry will discuss applicable European Union regulations. 

Canadian regulation of microorganisms used for industrial purposes  

Canada’s regulatory approach resembles that of the U.S., in that existing laws and regulations are used to regulate biotechnology in a product-specific way. Therefore, many products of biotechnology would be regulated in Canada under federal laws such as the Pest Control Products Act (pesticides), the Seeds Act (plants) and the Fertilizers Act (nitrogen fixing microbes). In November 1997, Environment Canada (EC) issued biotechnology regulations under the Canadian Environmental Protection Act (CEPA), that are similar in scope and approach to the U.S. EPA’s TSCA biotechnology regulations. EC has been using CEPA to conduct risk assessments of certain biotechnology products that are new to commerce in Canada and which are not regulated by other federal agencies. Among products that could fall under this law’s scope would be microbial strains used for biofuel production, or for manufacture of enzymes for use in biofuel production. 

EC considers microorganisms as being potentially subject to these “New Substance Notification” (NSN) regulations if they meet the definition of “new substance”. Unlike, the U.S. EPA, however, EC did not create a specific definition of  “new microorganism” using scientific criteria, but instead is relying on the definition in the law that a “new substance” is one intended for introduction into commerce that is not on the Domestic Substance List as having been used in commerce between January 1, 1984 and December 31, 1986. Thus, if a microorganism was used in commerce in this time period in a way such that “its entry into the environment was unrestricted”, it is exempt from reporting; but all other microorganisms, regardless of make-up, are subject to reporting. In this way, the Canadian CEPA regulations are broader than those of the U.S. EPA, in subjecting a larger class of microorganisms to regulation, and it is important to note that the regulations are broad enough to include naturally occurring or classically mutated strains, if such strains had never previously been used in commerce. 

Under the NSN regulations, any person who manufactures or imports substances subject to notification must provide a notification package to EC, which contains certain information specified in the regulations. EC uses this information to conduct a risk assessment prior to entry into commerce. These requirements are generally similar to those used by the U.S. EPA, which I’ve discussed in previous blog entries.  Information on the Canadian biotechnology rule is available at the biotechnology home page, and the New Substance regulations themselves can be found at http://www.gazette.gc.ca/archives/p2/2005/2005-09-21/html/sor-dors248-eng.html. A Guidelines document that is similar to EPA’s “Points to Consider document” can be accessed at  http://www.ec.gc.ca/subsnouvelles-newsubs/default.asp?lang=En&xml=42A1CC66-BCCA-CF00-5C87-C57E1D9D25B0.  

According to the EC website, the following New Substance Notifications have been received and risk assessment decisions made for new microorganisms since the regulations were put into place: 

• EAU-313: Carnobacterium maltaromaticum strain CB1
• EAU-308, 309, 310, 311, 312: Rotavirus strains W179-9 (G1), SC2-9 (G2), 178-9 (G3), BrB-9 (G4), 179-4 (P1)
• EAU-288: Saccharomyces cerevisiae strain ECMo01
• EAU-224: Saccharomyces cerevisiae strain ML01
• NSN 11017: Trichoderma reesei 1391A IOGEN
• NSN 10642: Pseudomonas putida CR30RNSLL(pADPTel)
• NSN 6823: Trichoderma longibrachiatum RM4-100 
• NSN # 11909: Trichoderma reesei P59G
• NSN # 12961: Trichoderma reesei P210A
• NSN # 13912: Trichoderma reesei P345A

Interestingly, although not related to biofuels use, the two notifications for novel S. cerevisiae strains (third and fourth bullet points) are the same modified yeast strains that have been reviewed by the U.S. FDA for GRAS status for use in wine-making (see the blog entry immediately preceding this one for more information). Of these ten risk assessments, five have involved modified microbial strains for the manufacture of enzymes for use in biofuels, and these have all been submitted by the Canadian company Iogen Corporation. More information about these five notifications are as follows (note that the hyperlinks provided have all been obtained from the EC website, but as of today’s writing some or all of these links may not be operational). 

• NSN #6823: Commercial production of a novel thermophilic xylanase enzyme by the genetically engineered strain Trichoderma longibrachiatum RM4-100.
• NSN# 11017: Trichoderma reesei 1391A, expressing of a novel xylanase II enzyme with enhanced thermal stability and a selectable marker.
• NSN # 11909: Commercial production of a β-glucosidase enzyme by genetically engineered Trichoderma reesei P59G.
• NSN # 12961: Commercial production of a novel thermophilic and alkalophilic xylanase II (xln2) enzyme by genetically engineered Trichoderma reesei P210A.
• NSN # 13912: Commercial production of a thermophilic/ alkalophilic xylanase II enzyme by genetically engineered strain Trichoderma reesei P345A.

Canadian regulation of microorganisms used for animal feed 

Interestingly, Canada appears to have regulations specific for the review and approval of modified microorganisms intended for use in animal feed, and these regulations might affect the use of spent biomass from biofuel fermentations as an animal feed or feed additive. As part of the Feeds Regulations, the Canadian Food Inspection Agency (CFIA) regulates “Novel Feeds from Microbial Sources”.  The agency defines “microbial feeds” as “microbial products [which] are routinely used in livestock feed and are composed of or derived from microorganisms (bacteria, yeast, moulds)”. They are classified into one of two categories: “viable microorganisms” or “nonviable microbial products”,  and all microbial feeds, whether composed of live microorganisms, fermentation products or residuals, must be evaluated, approved and registered prior to being used in livestock feeds. Ingredients previously approved are listed in Schedules IV and V of the regulations. The regulations also specify that “novel microbial feeds” are “feeds composed of or derived from microorganisms that are not approved as livestock feed in Canada (not listed in Schedules IV or V of the Feeds Regulations) and/or contain a novel trait developed by mutagenesis or by recombinant DNA (rDNA) techniques”. According to the Agency’s website, “a novel trait is an intentional genetic modification that results in a feed that is not substantially equivalent in terms of use and safety to an approved feed ingredient derived from microbial sources set out in Schedules IV or V of the Feeds Regulations”.  Note that it is the presence of a novel trait in the microorganism that triggers regulatory oversight, not the method used to introduce the trait, so the regulations potentially cover strains modified not only using recombinant DNA techniques, but also by other methods such as mutagenesis and cell fusion. 

Canadian regulation of genetically modified plants  

Canada’s CFIA maintains regulations governing the field testing (“confined release”) and commercialization (“unconfined release”) of plants with novel traits (“PNTs”). These regulations are conceptually similar to the regulations of the U.S. Department of Agriculture. According to the Agency’s website, a PNT is “a plant that contains a trait which is both new to the Canadian environment and has the potential to affect the specific use and safety of the plant with respect to the environment and human health, … [which has been] introduced using biotechnology, mutagenesis, or conventional breeding techniques”. CFIA is responsible for regulating the environmental release of PNTs, including the approval of unconfined release of PNTs, the approval and inspection of confined research field trials of PNTs, the assessment of import applications for PNTs, the development of domestic regulatory policies related to the environmental release of PNTs, and the development of internationally aligned regulatory policies through participation in various international forums. 

The regulations administered by CFIA, “Regulations Respecting the Quality of Seeds Including Seed Potatoes, and the Testing, Inspection, and Sale Thereof (C.R.C., c. 1400)”, were created under the authority of the Seeds Act, and it is Part V of these regulations that specifically govern the field use and commercialization of PNTs. The regulations require applicants to notify CFIA prior to carrying out a field test of a PNT, and to provide information of a similar nature to that required under the USDA regulations in the U.S., and CFIA approval is needed before the field test can begin. PNTs approved for confined release cannot be used in food or livestock feed. A separate process is required to have a PNT approved for unconfined use, including possible use in food or livestock feed. CFIA has developed a guidance document for applications to conduct field tests of plants with novel traits,  known as “Directive Dir2000-07: Conducting Confined Research Field Trials of Plant with Novel Traits in Canada”. 

The CFIA website includes a listing of PNTs that have been cleared in recent years for confined field trials. This list can be accessed at http://www.inspection.gc.ca/english/plaveg/bio/confine.shtml. This database listing is not as convenient to search as are the databases available for U.S. field tests, but it appears that only two companies have conducted field tests of transgenic plants intended for biofuel use. Agrisoma conducted its first field tests in 2009 of engineered Brassica and soybean that have been improved in oil quality, content and seed size.  And for at least the past several years, Targeted Growth has field tested engineered Camelina and soybean varieties at numerous locations in Canada, including varieties modified for improved performance as biofuel feedstocks. 

There is one transgenic biofuel crop that has been approved for unconfined release and commercial use in Canada, and that is Syngenta Seeds’s Event 3272 corn, engineered to express a thermostable alpha-amylase (described in more detail in a previous blog entry). On March 11, 2008, in Decision Document DD2008-70, CFIA approved this variety for “production of grain for use in the dry-grind ethanol process”, and to allow by-products of the dry-grind ethanol process to be used as livestock feed. As I’ve noted in my previous blog entry, this corn variety has been awaiting approval by the U.S. Department of Agriculture for several years. 

In summary, the situation in Canada resembles that of the United States, both in the nature of the regulatory framework and also in the overall tenor of the political and public relations climate. Although pockets of opposition to GMOs remain in both the U.S. and Canada, for the most part these countries are both reasonably hospitable to biotechnology innovations, particularly industrial applications, and particularly for applications not involving any proposed food use of the modified organism.

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