Poster scheduled for presentation at the 2013 Algae Biomass Summit, September 30, 2013, describing international regulations that might affect the use of native or modified algae or cyanobacteria in the production of renewable fuels. Includes discussion of applicable biotechnology regulation, aquaculture regulation, and renewable fuels standards.

1. International Regulations Governing the Use of Algae or Cyanobacteria in Fuel Production
David J. Glass, Ph.D., D. Glass Associates, Inc.
International regulations that may cover the use of naturally‐occurring or genetically modified algae in fuel
production include: biotechnology or biosafety regulations, aquaculture regulations, and renewable fuel
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standards or volume mandates.
Biotechnology Regulation: Many national biotechnology laws are based on the principles of the Cartagena
Protocol on Biosafety, part of the Convention on Biological Diversity, which was adopted in January 2000.
Under such laws, government approvals are generally needed for importation of Living Modified Organisms
(LMOs) into countries, and for many industrial activities including “contained uses” or “environmental uses”.
Such approvals may often require a risk assessment of the LMO and its proposed use.
Canada
Biotechnology: Industrial uses of modified algae may fall
under the New Substances Notification regulations under
the Canadian Environmental Protection Act.
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Aquaculture: Algal culture may fall within federal or
provincial aquaculture regulations.
Fuels: Fuel must meet definition of “renewable fuels”
under the Renewable Fuels Regulation, and producers
must register with Environment Canada.
United States
Biotechnology: Contained uses of modified algae would
likely be regulated by EPA under the TSCA biotechnology
regulations (40 CFR Part 725). Open‐pond uses might be
covered by EPA or by USDA biotechnology regulations (7
CFR Part 340).
Aquaculture: Individual state regulations may apply.
Fuels: Fuels must be certified by EPA (40 CFR Part 79) and
must meet the requirements of the Renewable Fuels
Standard (40 CFR Part 80) to be able to issue RINs and
qualify as renewable fuels.
Brazil
Biotechnology: Under the National Biosafety Law, both
contained and open‐pond uses of LMO algae would require
approval from the Biosafety National Technical Committee
(CTNBio) and the applicable Ministry. These regulations are
well established, and there have been approvals for
contained industrial uses of GMOs.
Aquaculture: Algal culture may require permitting and
environmental assessment under the national Fisheries
Code, and possibly under state regulation as well.
Fuels: Brazil, a major market for ethanol fuels, has blending
mandates of E25 ethanol and B5 diesel.
Canada
Europe
U.S.A.
China
Japan
Brazil
Australia
Aquaculture Regulation: In many countries and
jurisdictions, the industrial use of algae, particularly
nonnative strains, may fall under laws governing safe
practice of aquaculture, and permits may be required.
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Fuel Regulation: Algae‐produced fuels may need to be
registered or certified before sale in certain countries,
and may also be subject to blending mandates or laws
requiring documentation of sustainable production.
Please visit the Advanced Biotechnology for Biofuels blog
for a more detailed discussion of these and other
international regulations. (http://wp.me/pKTxe‐8a)
David Glass is an independent consultant with over thirty years
experience in industrial biotechnology regulation.
D. Glass Associates, Inc.
(617) 653‐9945
124 Bird Street
dglass@dglassassociates.com
Needham, MA 02492
www.dglassassociates.com
European Union
Biotechnology: Contained uses of modified algae would
likely require national government approval under EU
Directive 2009/41/EC. Open‐pond uses would be covered
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by EU Directive 2001/18/EC on “Environmental Release”
and would also require approval by appropriate national
agency.
Aquaculture: Use of algae might be covered by EU
Directive 2007/708/EC on Alien and Locally Absent
Species in Aquaculture.
Fuels: New fuels must meet the requirements of the
Renewable Energy Directive 2009/28/EC and the Fuel
Quality Directive 2009/30/EC to count towards EU
renewable target volumes.
Japan
Biotechnology: Under national biotechnology laws,
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contained uses of LMOs are regulated as “Type 2” uses,
while open‐pond applications would be regulated more
stringently as “Type 1” uses. The Ministry of Agriculture,
Forestry and Fisheries would likely have jurisdiction for
uses of algae.
Aquaculture: The national Fisheries Law may apply.
Aquaculture: The national Fisheries Law may apply.
China
Biotechnology: Under national biotechnology regulations,
open‐pond use of LMO algae would likely require approval
from the Agriculture Ministry. Jurisdiction over contained
uses is less certain, although approval would likely be
needed to import LMOs into China for any purpose.
needed to import LMOs into China for any purpose
Aquaculture: The national Fisheries Law may apply.
Australia
Biotechnology: Under the Gene Technology Act and its
regulations, both contained and non‐contained uses of
LMOs would require a license from the government.
Contained uses (“Dealings not involving release”) would
face a shorter, easier approval process.
Aquaculture: Algal culture may fall within aquaculture
regulations of individual Australian states.
Fuels: Individual states have blending mandates.