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Government Regulation of the Uses of Genetically Modified Algae and Other Microorganisms in Biofuel and Bio-based Chemical Production

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Book cover Algal Biorefineries

Abstract

Recent years have seen an increased interest in developing genetically modified algae and other microorganisms for use in biofuel and bio-based chemical production. However, this comes at a time when there is uncertainty within the industry and the academic community about how such uses will be regulated by governments in the U.S. and elsewhere in the world, as well as concerns by some observers over the adequacy of existing regulations to cover organisms created using techniques known as synthetic biology. However, a reasonable road map is emerging of a regulatory regime that can allow pilot, demonstration and commercial stage uses of modified microorganisms. In the U.S., regulations of the U.S. Environmental Protection Agency and possibly of the U.S. Department of Agriculture might govern the industrial use of microorganisms in contained photobioreactors or algae in open ponds, and these regulations generally require conducting assessments of the potential environmental risks of such large-scale uses. The EPA regulations include a mechanism by which outdoor experimentation of modified microorganisms can take place in a stepwise approach, with risks assessed as the scale of experimentation increases, which provides an accessible path to exploration of the use of modified algae in open ponds. Such risk assessments will address legitimate questions of potential ecological impact, such as the potential survival and dissemination of the production organism, the potential for heterologous genes to horizontally transfer to indigenous microorganisms, and the chance for other unintended effects on nontarget species. Numerous companies have successfully navigated these regulations, including some recent project approvals in the U.S. and elsewhere in the world.

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Notes

  1. 1.

    This is in contrast to most other countries in the world, which have generally created a single national biotechnology (“biosafety”) law, often in compliance with the Cartagena Protocol on Biosafety (see below).

  2. 2.

    EPA developed regulations under the U.S. pesticide law (the Federal Insecticide, Fungicide and Rodenticide act; FIFRA) to regulate proposed uses of modified and unmodified microorganisms as biopesticides. These regulations encompass risk assessments similar to those discussed in this chapter, but pesticides and other agricultural uses of microorganisms are outside this chapter’s focus on fuels and chemicals. See references such as Glass (2003) or Wozniak et al. (2012) for more details on FIFRA biopesticide regulation.

  3. 3.

    USDA now has potentially broader regulatory ability. In 2000, the Plant Pest Act, the law on which the Part 340 regulations was based, was combined with other statutes to create a new law, the Agriculture Risk Protection Act, which includes language that could give USDA the ability to regulate modified organisms based on potential invasiveness or weediness. In 2008, USDA published some possible options to amend the regulations to accomplish this, but to date the Department has never proposed any specific regulations for this purpose.

  4. 4.

    The author has consulted for Mascoma in the past, but at this writing has no financial interest in this company.

  5. 5.

    The author coordinated the preparation of Joule’s MCAN and handled all interactions with EPA during its review of the filing, while employed by Joule Unlimited. The author also declares a financial interest in this company.

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Author information

Authors and Affiliations

  1. D. Glass Associates, Inc., 124 Bird Street, Needham, MA, 02492, USA

    David J. Glass

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  1. David J. Glass
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Editor information

Editors and Affiliations

  1. Department of Chemical and Biological Engineering, Vanderbilt University, Nashville, Tennessee, USA

    Aleš Prokop

  2. Department of Chemical Engineering, University of Louisiana at Lafayette, Lafayette, Louisiana, USA

    Rakesh K. Bajpai

  3. Department of Chemical Engineering, University of Louisiana at Lafayette, Lafayette, Louisiana, USA

    Mark E. Zappi

List of Acronyms

List of Acronyms

EPA:

U.S. Environmental Protection Agency

FDA:

U.S. Food and Drug Administration

GMM:

Genetically Modified Microorganism

GMO:

Genetically Modified Organism

LMO:

Living Modified Organism

MCAN:

Microbial Commercial Activity Notice

PMN:

Premanufacture Notice

TERA:

TSCA Experimental Release Application

TSCA:

Toxic Substances Control Act

USDA:

U.S. Department of Agriculture

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Glass, D.J. (2015). Government Regulation of the Uses of Genetically Modified Algae and Other Microorganisms in Biofuel and Bio-based Chemical Production. In: Prokop, A., Bajpai, R., Zappi, M. (eds) Algal Biorefineries. Springer, Cham. https://doi.org/10.1007/978-3-319-20200-6_2

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