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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3 thoughts on “Comments on Recent Articles on Regulation of Genetically Modified Algae for Biofuels

  1. Comments on Recent Articles on Regulation of Genetically Modified … | Biotechnology News

  2. Thanks for your balanced commentary.

    My issue with the case-by-case approach is that it leaves the door open to lax regulatory action at the agency under ultra pro-business administrations.

    I also wonder if we have fully exhausted the search for natural or hybridized species. Have we run complete, high throughput assays of known (or recently discovered) species, as is done for other bioresources? Are we sure that GM is the only possible answer? If the answer is yes then I’d like to see the meta-data showing the known species that have been vetted and found to be inadequate.

    Best wishes to you.

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