Advisory Note
DFO 2006-01
Importing or Manufacturing
Aquatic Organisms that are
Animate Products of
Biotechnology
New Substances Notification
Regulations (Organisms)
Office of Aquatic Biotechnology
Fisheries and Oceans
Canada
This Advisory Note is to inform
manufacturers and importers of aquatic organisms[1]
that are animate products of biotechnology[2]
of their regulatory obligations under the New Substances Notification
Regulations (Organisms), a regulation made under the Canadian
Environmental Protection Act, 1999.
________________________________________________________________
Background
The Canadian Environmental Protection
Act, 1999 (CEPA 1999) and its New Substances Notification Regulations
(Organisms) [NSNR (Organisms)] apply to new living organisms, including
aquatic organisms, which are manufactured (e.g. developed, produced or bred)
in or imported into Canada. For the purposes of
CEPA 1999, a “living organism” is an animate product of biotechnology and is
“new” if it is not listed on the Domestic Substances List (DSL).
Manufacturers and importers of new living organisms other than
micro-organisms are required to provide the information prescribed in
Schedule 5 of the NSNR (Organisms) a minimum of 120 days before the intended
date of manufacture or import. This information is used in the conduct of a
risk assessment to determine if the living organism may pose a risk (i.e. is
“toxic” as per the criteria set out in CEPA 1999[3])
to the environment or to the health of Canadians. Living organisms
determined or suspected to pose a risk may be controlled as necessary,
including by prohibiting or imposing conditions on their manufacture or
import.
Examples of aquatic
living organisms that could be subject to the NSNR (Organisms) include:
- Genetically modified plants and animals (including vertebrates and
invertebrates)
- Interspecies hybrids
- Naturally occurring, exotic plants and animals used in biotechnology
applications such as bio-remediation and industrial enzyme production.
Aquatic
animal strains that are indigenous to Canada including Canadian wildlife
species and their progeny produced through traditional breeding, artificial
insemination or surrogate hosting are
not subject to the NSNR (Organisms). Aquatic living organisms that are
research and development organisms[4]
and that meet the containment criteria specified in subsection 2(4) of the
NSNR (Organisms) are not subject to the NSNR (Organisms).
The Departments of Fisheries and Oceans
Canada (DFO), Environment Canada and Health Canada have signed a Memorandum
of Understanding respecting the implementation of the NSNR (Organisms) for
certain new aquatic living organisms. As such, DFO
will assist in administering the NSNR (Organisms), which will include
conducting risk assessments and compliance promotion for these organisms.
All decision-making, including the application of any necessary risk
management measures and the enforcement of the NSNR (Organisms), remains the
statutory responsibility of the Ministers of the Environment and of Health.
Legal Obligations
and Responsibilities
Under section 106 of
CEPA 1999, any person intending to manufacture or import a new living
organism, including an aquatic living organism, must provide the information
prescribed in section 8 and Schedule 5 of the NSNR (Organisms) at least 120
days prior to the intended date of manufacture or import. The text of the
regulations is available at:
http://canadagazette.gc.ca/partII/2005/20050921/html/sor248-e.html
The information must be
provided in duplicate to the:
Minister of the
Environment,
c/o Director
New Substances
Division,
Department of the
Environment,
Ottawa, Ontario,
K1A 0H3
For a new aquatic living organism, notifiers
are also encouraged to advise the Office of Aquatic Biotechnology, DFO, that
a regulatory submission in respect of an aquatic organism has been made to
the Minister of the Environment. This can be done by providing a copy of the
New Substances Notification form to:
Office of Aquatic
Biotechnology
Fisheries and Oceans
Canada
200 Kent St., 12S029
Ottawa, ON
K1A 0E6
Canada
Facsimile: (613)
990-6199 (non secure)
Telephone:
(866)
633-6676 (toll free within Canada)
(613)
990-0258 (outside Canada)
Email: aquabiotech@dfo-mpo.gc.ca
Website:
www.dfo-mpo.gc.ca/biotech
Contacts for More
Information
Further information
regarding the applicability of CEPA 1999 and of the NSNR (Organisms) to
aquatic living organisms, and the process for making a notification, can be
obtained by contacting the New Substances Notification Information Line of
Environment Canada at the address listed below, and by obtaining the
document entitled Guidelines for the Notification and Testing of New
Substances: Organisms that explains the technical information
requirements prescribed in Schedule 5 of the NSNR (Organisms), available at
the website listed below:
New Substances
Notification Information Line
New Substances Division
Environment Canada
Ottawa, ON
K1A 0H3.
Telephone:
(800) 567-1999 (toll
free within Canada)
(819) 953-7156 (outside Canada)
Facsimile: (819)
953-7155
E-mail:
nsn-infoline@ec.gc.ca
Website: http://www.ec.gc.ca/substances/nsb/eng/biotech_e.shtml
[1]
“Aquatic
organisms” are fresh water and marine organisms, including fish* as
defined in the Fisheries Act.
* “Fish” as defined
in the Fisheries Act, includes (a) parts of fish, (b) shellfish,
crustaceans, marine animals and any parts of shellfish, crustaceans or
marine animals, and (c) the eggs, sperm, spawn, larvae, spat and
juvenile stages of fish, shellfish, crustaceans and marine animals.
[2]
“biotechnology” means the
application of science and engineering in the direct or indirect use of
living organisms or parts or products of living organisms in their
natural or modified forms.
[3]
Under section 64 of
CEPA 1999, a substance is toxic if it is entering or may enter
the environment in a quantity or concentration or under conditions that
(a) have or may have an immediate or long-term harmful effect on the
environment or its biological diversity; (b) constitute or may
constitute a danger to the environment on which life depends; or (c)
constitute or may constitute a danger in Canada to human life or health.
[4]
research and
development organism" means an organism that is undergoing systematic
investigation or research, by means of experimentation or analysis other
than test marketing, whose primary objective is any of the following:
(a) to create or improve
a product or process;
(b) to determine the
technical viability or performance characteristics of a product or
process; or
(c) to evaluate the
organism prior to its commercialization, by pilot plant trials,
production trials, including scale-up, or customer plant trials so that
technical specifications can be modified in response to the performance
requirements of potential customers.
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