1. International Regulation of Industrial Biotechnology
David J. Glass, Ph.D., D. Glass Associates, Inc.
European Union
Oversight under national laws adopted by EU member
states based on binding EU Directives.
Contained manufacturing: Contained uses of LMO
microorganisms require national government notification
under EU “Contained Use” Directive 2009/41/EC.
Open Ponds and Transgenic Plants: Uses of LMOs in the
open environment would be covered by EU Directive
2001/18/EC on “Environmental Release”.
International regulations may cover the use of genetically modified microorganisms or
plants to produce fuels or chemicals. Such regulations will be described for several
important countries or regions.
Japan
Contained manufacturing: Under the biotechnology laws,
contained uses of LMOs are regulated as “Type 2” uses: the
Ministry having jurisdiction may vary.
Open Ponds and Transgenic Plants: are regulated more
stringently by the Agriculture Ministry as “Type 1” uses.
China
Contained manufacturing and open ponds: Open-pond use
of LMO microorganisms would likely require approval from
the Agriculture Ministry. Jurisdiction over contained uses is
less certain, although approval would be needed to import
LMOs into China for any purpose.
Novel Plant Feedstocks: Approval for field tests and
commercial uses are needed from the Agriculture Ministry.
Australia
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. Numerous transgenic plant field tests
have been approved.
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
Canada
Contained or Open Pond uses of modified microorganisms
may require Environment Canada approval under the New
Substances Notification regulations under the Canadian
Environmental Protection Act.
Novel Plant Feedstocks: The Canadian Food Inspection
Agency regulates “confined” and “unconfined” releases of
plants with novel traits.
United States
Contained manufacturing: Most contained uses of
modified microorganisms would be regulated by EPA under
TSCA (40 CFR Part 725) and would require MCAN filings.
Open Pond uses of GM algae would require TERA approval
and later MCAN filings under the TSCA regulations.
Novel Plant Feedstocks: Field testing and use of transgenic
plants as biofuel feedstocks would be subject to USDA
biotechnology regulations (7 CFR Part 340).
Brazil
Under the National Biosafety Law, all proposed uses of
LMOs would require approval from the Biosafety National
Technical Committee (CTNBio) and the applicable Ministry.
There have been previous approvals for contained
industrial uses of LMOs and transgenic plant field testing.
Canada
U.S.A.
Brazil
Europe Japan
China
AustraliaSouth Africa
Indonesia
Contained manufacturing: Under Government Law 21,
government notification and a risk assessment are needed.
Open Ponds and Transgenic Plants: Outdoor uses of LMOs
require approval by the National Biosafety Commission on
Genetically Engineered Products (KKH).
Mexico
CIBIOGEM, an Inter-Ministerial commission, coordinates
oversight activities under Mexico’s Biosafety Law.
Contained manufacturing: Uses of LMO microorganisms
require review and approval, likely by the Environment
Ministry SEMARNAT.
Open Ponds and Transgenic Plants: Outdoor uses of LMOs
must be approved by the Agriculture Ministry SEGARPA.
Regulatory regimes are described for three industrial approaches: contained use of microorganisms in fuel or
chemical manufacture; open-pond use of algae or photosynthetic bacteria to produce fuels or chemicals; and the
field testing and commercial cultivation of transgenic plants as feedstocks.
Other areas of regulation not discussed here are the requirements for certification of renewable fuels and the
regulations governing the use of spent microbial biomass in animal feed (e.g., in dried distillers grains).
Malaysia
Contained manufacturing: Under the Biosafety Law, the
National Biosafety Board must be notified before using or
importing LMOs in contained manufacturing.
Open Ponds and Transgenic Plants: The Biosafety Board’s
Genetic Modification Advisory Committee must approve
releases of LMO plants and microorganisms into the
environment.
Malaysia
Indonesia
Mexico
Many national 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.
South Africa
Under the Genetically Modified Organisms Act, permits are needed
from the Agriculture Ministry for importation, contained use, and
environmental use of LMOs. An Advisory Committee conducts risk
assessments, and an Executive Council makes final decisions.
Please visit the Advanced Biotechnology for Biofuels blog for a more
detailed discussion of these and other international regulations.
(http://wp.me/pKTxe-a4)