david glass poster presentation 2013 algae biomass summit
DESCRIPTION
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.TRANSCRIPT
International Regulations Governing the Use of Algae or Cyanobacteria in Fuel ProductionDavid J. Glass, Ph.D., D. Glass Associates, Inc.International regulations that may cover the use of naturally‐occurring or genetically modified algae in fuel
d i i l d bi h l bi f l i l l i d bl f l
European UnionBiotechnology: Contained uses of modified algae would likely require national government approval under EU Di i 2009/41/EC O d ld b d
production include: biotechnology or biosafety regulations, aquaculture regulations, and renewable fuel 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
Directive 2009/41/EC. Open‐pond uses would be covered 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.
(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.
CanadaBiotechnology: Industrial uses of modified algae may fall under the New Substances Notification regulations under h C di E i l P i A
CanadaEurope Japan 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.
JapanBi h l U d i l bi h l l
the Canadian Environmental Protection Act. 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.
U.S.A.
Brazil
Europe JapanChina
AustraliaBiotechnology: Under national biotechnology laws, 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 Lawmay apply.
United StatesBiotechnology: 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 Regulation: In many countries and jurisdictions, the industrial use of algae, particularly nonnative strains, may fall under laws governing safe
ti f lt d it b i d Aquaculture: The national Fisheries Law may apply.
ChinaBiotechnology: 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
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
practice of aquaculture, and permits may be required.
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. needed to import LMOs into China for any purpose.
Aquaculture: The national Fisheries Law may apply.
AustraliaBiotechnology: Under the Gene Technology Act and its regulations, both contained and non‐contained uses of LMOs would require a license from the government.
BrazilBiotechnology: 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.
Please visit the Advanced Biotechnology for Biofuels blog for a more detailed discussion of these and other international regulations. (http://wp.me/pKTxe‐8a)
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.
David Glass is an independent consultant with over thirty years experience in industrial biotechnology regulation.D. Glass Associates, Inc. (617) 653‐9945124 Bird Street [email protected], MA 02492 www.dglassassociates.com
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.