Environmental Assessment of Animals Developed Via Biotechnology in Canada (Jim Louter)

Environmental Assessment of
Animals developed via

biotechnology in Canada
Jim Louter, PhD
Environment and Climate Change Canada
Overview
Canadas shared federal approach to protecting the environment

and human health
Canadian Environmental Protection Act 1999 (CEPA, 1999)
Regulations (New Substances Notification Organisms)
Pigs and fish
Page 2 December-16-15
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)
All the
rest
Vet. Drugs
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
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)
The Act and the Regulations:

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

(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
Examples of New Organisms Covered
Transgenic
grain for processing
Transgenic salmon
overexpressing a
growth hormone
GFP-expressing
transgenic pig
Naturally occurring
or
Genetically Modified
micro-organisms
Assessment of New Substances under NSNR(O)
Schedule
Type of Organism
Description
Assessment
Period (days)
Micro-organism
Introduction anywhere in Canada
120
Micro-organism
Contained facility OR export only
30
Micro-organism
Micro-organism
Experimental field trials

Introduction at the same site where
isolated and manufactured
Other than microAll

organism
90
30
120
Transparency vs Confidential
Business Information
Some risk assessments decisions are published
http://www.ec.gc.ca/subsnouvellesnewsubs/default.asp?lang=En&n=8AD6A8C1-1
No public comment period as part of the assessment

process
Proponent indicates elements that should be considered

as confidential business information
Action to be Taken after Risk Assessment
Risk Assessment
Not Toxic
Not Toxic for the

proposed use
Manufacture or
import
proceeds
Significant New
Activity Notice
(SNAc)
NB.
-Not a permitting system
-No labeling required
Suspicion of Toxic or
Capable of becoming Toxic
Manufacture or import
with condition; OR
Prohibit; OR
Prohibition pending
additional information
Examples of Biotech Notifications
Higher Organisms
Schedule 5 (full release*):
E.g. Enviropig, Aquabounty GM Atlantic Salmon
*Risk assessment conclusion: not toxic for proposed use, SNAc
notice issued (must be raised in building, containment, etc.)
Challenges
Heightened sensitivity
Public perception
Technology (gene editing)
Communications
Inquiries
The Substances Information Line

Environment and Climate Change Canada
Place Vincent Massey 6th floor
351 St Joseph Blvd.
Gatineau, QC K1A 0H3
Telephone:
(800) 567-1999 (Toll Free in Canada)
(819) 953-7156 (Outside of Canada)
E-mail: substances@canada.ca
Web site: http://www.ec.gc.ca/subsnouvellesnewsubs/
14

Environmental Assessment of Animals Developed Via Biotechnology in Canada (Jim Louter)

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Environmental Assessment of Animals Developed Via Biotechnology in Canada (Jim Louter)

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Copyright:

Environmental Assessment of

Animals developed via

Canadas shared federal approach to protecting the environment

Canadian Federal Regulation of organism

Health of Animals Act

Pest Control Products Act

Food and Drugs Act

CEPA 1999 and the

Canadian Federal Partners

The Act and the Regulations:

Canadian Environmental Protection Act, 1999

Not commodity based generic

The Act and the Regulations:

Canadian Environmental Protection Act, 1999

Canadian Environmental Protection Act, 1999

Determine the risk for environment

Determine the risk to human life

Collaborative effort on the risk assessment

Examples of New Organisms Covered

Assessment of New Substances under NSNR(O)

Introduction anywhere in Canada

Contained facility OR export only

Experimental field trials

Other than microAll

No public comment period as part of the assessment

Proponent indicates elements that should be considered

Action to be Taken after Risk Assessment

Not Toxic for the

Examples of Biotech Notifications

The Substances Information Line

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