Environmental Assessment of
Living Organisms developed
via biotechnology in Canada
and AHTEG on SB impressions
Jim Louter, PhD
Environment and Climate Change Canada
Overview
– Canada’s shared federal approach to protecting the environment
and human health
– Canadian Environmental Protection Act 1999 (CEPA, 1999)
▪ Regulations (New Substances Notification – Organisms)
– Ad hoc Technical Expert Group on Synthetic Biology (AHTEG)
Page 2 – March 17, 2016
Canadian Federal Partners
Canadian Food Inspection Agency (now part of Health
Canada) – novel plants, feeds, fertilizers, veterinary
biologics
Health Canada (for CEPA, for food, for pest control
products) – indirect human health, novel foods, pesticides
Environment and Climate Change Canada (for CEPA) –
environmental assessment
Fisheries and Oceans Canada – fish specific advice
Agriculture and Agri-Food Canada – agricultural trade
Page 3 – March 17, 2016
Canadian Federal Regulation of organism
products of biotechnology
Feeds Act
Feeds
Seeds Act
Seeds
Fertilizers Act
Fertilizers
Health of Animals Act
Vet.
biologics
Pest Control Products Act
Pesticides
Novel Foods
Food and Drugs Act
Drugs and
biologics
Medical
instruments
CEPA 1999 and the
NSNR(Organisms)
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All the
rest
Vet. Drugs
The Act and the Regulations:
• Canadian Environmental Protection Act, 1999
– New Substances Notification Regulations (Organisms)
• Not commodity based – generic
• Not technology based
• Regulates activities (import or ‘manufacture’)
using ‘new’ living organisms
– Micro-organisms in containment or bioremediation
(any non-agricultural, non-pesticide use)
– Animals (from insects to mice/fish/livestock)
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The Act and the Regulations:
• Canadian Environmental Protection Act, 1999
– pollution prevention and the protection of the
environment and human health
– New Substances Notification Regulations (Organisms)
• 2 Ministers; 2 Departments
• Risk Assessment Process
Environment Canada &
Health Canada
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Canadian Environmental Protection Act, 1999
(CEPA 1999)
Environment Canada
Health Canada
Determine the risk for environment
and/or its biological diversity
Determine the risk to human life
or health*
• Collaborative effort on the risk assessment
• Conclusion and proposed measure, if needed
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Examples of New Organisms Covered
Transgenic
grain for processing
Transgenic salmon
overexpressing a
growth hormone
GFP-expressing
transgenic pig
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Naturally occurring
or
Genetically Modified
micro-organisms
Cartagena Protocol on Biosafety:
Role of Canada
1. Canada has singed and ratified the Convention
on Biological Diversity and was involved in the
AHTEG on synthetic biology (as Party).
2. Canada has signed but not ratified the
Cartagena Protocol but is involved in the AHTEG
on RA and RM of LMOs (as non-Party).
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Canada’s regulation of LMOs
Even if not a Party to the Cartagena Protocol,
Canada is a ‘model non-party’.
LMO’s are regulated as are many other products
regardless of technology used.
‘technology independent’ scope that covers ‘living’
products of synthetic biology well
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Impressions of AHTEG on SB
The report of the AHTEG was representative of
discussion.
LMOs covers all known products of synthetic
biology but may not cover all future ones
Convention includes also ‘components’ and
‘products’ that are non-living and therefore not
under CPB
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Impressions of AHTEG on SB
However, non-living products of SB are (or should
be) covered by existing domestic regulations in
most countries
Ex. new drugs, new foods produced from new
technologies, new chemicals, new pesticide, new
breed of cattle
If ‘identical’….
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Impressions of AHTEG on SB
There are not enough real-world examples of living
organisms that are products of SB that are not
LMOs to justify a new protocol.
Even if such living organisms were created,
existing RA and RM framework in CPB provide
flexibility.
Page 13 – March 17, 2016