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Regulations on the Use of Genetically Modified Algae 37

" This is very important to our club. This article too goes over my head. Not as much as second law of thermodynamics.
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.? "

Impact of Biotechnology Regulations on the Use of Genetically Modified Algae for Biofuel Production
By dglassassociates

In the preceding entry of the blog, I discussed how the regulatory programs of the U.S. Environmental Protection Agency and U.S Department of Agriculture might affect the use of genetically modified algae for biofuel uses. It would appear that the EPA Biotechnology Rule under the Toxic Substances Control Act (TSCA) was more likely to be applicable than the USDA?s biotechnology rules under the Plant Protection Act. But I?ll briefly comment on how algal programs might be handled under each of these programs, and discuss the need to develop a common understanding between regulators and the industry about how these regulations would affect companies developing modified algae for biofuel production and other uses.

Possible Requirements under EPA Regulations

As is described in more detail elsewhere in this blog, under the TSCA Biotech Rule, EPA regulates certain industrial uses of ?new microorganisms?, which are defined as those that contain coding nucleic acids from more than one taxonomic genus. Although most R&D uses are exempt from reporting under TSCA provided the microorganism is used in a ?contained facility?, the use of a new microorganism for a commercial purpose (in an industrial field subject to TSCA) would require the filing of a Microbial Commercial Activity Notification (MCAN) 90 days before the intended commencement of commercial use. (Please refer to that earlier blog entry for a great deal more detail on this regulatory program).

It is likely that any regulatory review of engineered algae would be subject to the same data and procedural requirements as has been the case for modified bacteria that have so far been subject to TSCA regulation. Specifically, this would include the need to submit a detailed description of the construction of the modified organism, a description of the manufacturing process in which it is intended to be used, description of the controls that would be put into place to minimize possible dissemination of the microbe outside the facility, and whatever data is in the applicant?s possession regarding the possible health or environmental effects of the organism. EPA?s review would focus on balancing the potential risks of the project against the potential benefits, and although one wouldn?t expect most algal strains to pose unusual environmental risks, the issues EPA addresses may be different for algae than they have been for the modified bacteria and fungi that have been the subject of all prior MCANs submitted to date.

For any algae projects subject to EPA authority under these rules, one potential area of concern would be the design of the bioreactors to be used with the algae. In current practice, algae are often grown in open-air reactors, or in other reactor designs that may differ considerably from traditional bacterial fermentation set-ups. If a reactor was judged by EPA not to be sufficiently ?contained? as defined in the regulations, EPA would consider any use of such reactor with live algae to be an outdoor use, triggering the need for regulatory oversight (e.g. requiring submission of a TSCA Environmental Release Application) at the research level and possibly a greater level of scrutiny at commercial scale. Aside from such possible heightened concerns about issues like containment, controlled access to the facility, handling and inactivation of spent biomass and other wastes, one could expect that EPA review and handling of an MCAN for an engineered algae under the TSCA regulations would proceed in much the same way as prior reviews of MCANs for engineered bacteria. With proper planning, advance consultation with the Agency, and given sufficient time to develop the needed data package, algae projects that might fall subject to TSCA should not encounter too much difficulty in being cleared for commercialization.


Comments - 5

  • Veronica wrote:
    Fri June 18 2010 04:33:43 AM

    All that algae to fuel enethlusiasts would want from Craing Venter.

    Vote Up! 10 Vote Down! 0

  • Fri July 02 2010 04:25:24 AM

    Regulation is a must .

    Vote Up! 0 Vote Down! 0

  • Pitts wrote:
    Wed October 06 2010 12:23:34 AM

    Thanks for the post on Dr Glass.
    Thanks to Veronica, she is always very useful.
    The url that she reminded is one of the best I have read on this matter.

    Now, can we have something like what has been done for Aviation fuel
    done by one Parkavi

    done for

    Gene modification of algae for biofuel.

    Can we have the list of companies doing this.
    Can we have a list of Universitites doing this.

    Can we also have the directions that various companies are taking in modifiying the gene/ or for that matter in the strain selection itself.

    We can also have the names of Profs in the universities who are doing some work on this.

    I understand that there over 100 universitites the world over doing research on algae strain selection and modification for biofuel.

    So that will be a great compendium.

    I know that lots of information is confidential and many profs or their Research scholars will be reluctant to disclose anything about their research.

    But they sure can talk about what others are doing and give their views.


    Vote Up! 2 Vote Down! 0

  • Shankar wrote:
    Wed October 06 2010 12:25:30 AM

    GREAT IDEA ! Pitts ! I welcome and second your proposal. If someone can sell this information, I am waiting for it.

    Vote Up! 0 Vote Down! 0

  • Shankar wrote:
    Wed October 06 2010 09:18:56 AM

    Thanks to parkavi and Pitts. good info. useful to many.

    Vote Up! 0 Vote Down! 0

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