New Substances Notification:
a Federal Regulatory
Perspective on Organisms
used in the Bioeconomy
Track 7: Advanced Biofuels and Biorefinery Platforms
Session 1: Biofuels and Federal Regulation. The
Roadmap to Regulatory Approval
Monday July 20 – 8:30 am -10:00 am
Heather Shearer
Evaluator, Biotechnology Section
Environment Canada
Overview
• Overview of the Canadian Environmental
Protection Act, 1999 (CEPA 1999)
• Overview of the New Substances Notification
Regulations (NSNR) (Chemical and Polymers and
NSNR (Organisms)
• Linkage to biofuels production
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Canadian Environmental Protection
Act, 1999 (CEPA 1999)
Key Principles
– pollution prevention / sustainable development
– application of the precautionary principle
– protection of the environment and human
health
Purpose of Parts 5 and 6
– Part 5: Controlling Toxic Substances
– Part 6: Animate Products of Biotechnology
– To ensure that “new substances” are not
introduced into Canada before an assessment to
determine whether they are “toxic” or capable
of becoming “toxic” has been made
Definition of toxic under CEPA 1999
Section 64 of the Act states that a substance is
“toxic” if it is entering or may enter the
environment in a quantity or concentration or
under conditions that:
• have or may have an immediate or long-term
harmful effect on the environment or its
biological diversity; or
• constitute or may constitute a danger to the
environment on which life depends; or
• constitute or may constitute a danger in
Canada to human life or health.
New Substances (NS) Program
Environment Canada
New Substances Division
Notification &
Client Services
Innovation &
Program
Coordination
New Chemical
Evaluation
Section
Biotechnology
Section
Health Canada
New Substances Assessment and Control Bureau
New Chemicals 1
New Chemicals 2
Biotechnology
Section
New Chemicals 3
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Environmental
Assessment Unit
In-Commerce
Substances Unit
What is a Substance?
•
•
Substance
– Any distinguishable kind of organic or inorganic matter,
whether animate or inanimate.
– Includes living organisms that are micro-organisms and
organisms other than micro-organisms, and their
metabolites
Exclusions from the definition of a substance
– Mixtures (can contain notifiable substances)
– Manufactured items
What’s a “New” Substance?
• Substances listed on the Domestic Substances
List (DSL) are considered existing substances
• Substances not listed on the DSL are
considered new substances
• All new substances are regulated by someone,
somewhere in federal government (i.e.
including other Acts/Regulations listed in CEPA
Schedules 2 and 4). Examples – Pest Control
Products Act, Seeds Act, Feeds Act, Fertilizers
Act, Health of Animals Act
Domestic Substances List (DSL)
• Currently approximately 23 000 substances
listed, 71 are microorganisms
• Based on substances proven to be in Canadian
commerce between January 1, 1984 to
December 31, 1986, and those that have been
added to the DSL following assessment
• Substances listed on the DSL are considered to
exist in Canadian commerce and do not require
notification under the NSNR
• Search the DSL on the internet
http://www.ec.gc.ca/subsnouvelles-newsubs/
Regulation of Substances under
CEPA 1999
Substance (Chemical, Polymer, Living
On the Domestic Substances List (DSL)
(Existing)
• Were in commerce in Canada between
1984 – 1986 i.e. “grandfathered”
or
• Were added to DSL after a comprehensive
assessment – for example, Schedule 1 (full
release) under NSNR-O
Search the DSL on the internet
http://www.ec.gc.ca/subsnouvelles-newsubs/
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Organism,
)
New to Canada
• Assessed under NSNR
prior to manufacture and/or
import
Notification may
be required
The New Substances Notification Process
Pre-Notification
Consultation
(voluntary /
recommended)
NSN Submission
Review of NSN for Completeness
(Regulatory and Scientific)
Risk Assessment
Environment Canada
Health Canada
Determine the risk for environment
and/or its biological diversity
Determine the risk to human life
or health
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Science-Based Risk Assessment
Determination of potential human health and/or environmental hazards
and likelihood that an exposure event will have adverse effects
on human health and/or the environment
Main elements of risk assessment:
Assessment of Hazard
Assessment of Exposure
Risk Characterization (Hazard x Exposure)
• Some R&D activities may be exempted from notification
if certain criteria are met (reporting, containment,
volume of material). Consult the NSP for details.
If the assessment determines a risk, then risk
management conditions will be put in place
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Assessment of New Substances under NSNR(O)
Schedule
Type of
Organism
Description
Assessment
Period (days)
1
Micro-organism Introduction anywhere in Canada
120
2
Micro-organism
30
3
Micro-organism Experimental field trials
4
Micro-organism
5
Other than
All
micro-organism
Contained facility OR export only
Introduction at the same site
where isolated and manufactured
12
90
30
120
Assessment of New Substances
under NSNR(C&P)
Schedule
Description
1
R&D substances, contained site-limited intermediate substances, or contained
export-only substances
2
Biochemicals and biopolymers
3
Polymers and biopolymers that are R&D substances, contained site-limited
intermediate substances, or contained export-only substances
4
Other chemicals and biochemicals not on the NDSL (100 kg), or on the NDSL
(1000 kg)
5
Other chemicals and biochemicals not on the NDSL (1000 kg), or on the NDSL
(10000 kg)
6
Other chemicals and biochemicals not on the NDSL (10000 kg)
9
Reduced regulatory requirement for polymers and other polymers and biopolymers
(1000 kg)
10
Other polymers and biopolymers on the NDSL or all of whose reactants are on the
DSL or NDSL (10000kg)
11
Other polymers13and biopolymers not on the NDSL (10000kg)
This and other flowcharts can be viewed in the NSNR
(C&P) at:
http://laws-lois.justice.gc.ca/eng/regulations/SOR-2005-247/FullText.html
Possible Outcomes of ‘new’ substances
assessment
Not Toxic for the
Proposed Activity
Not Toxic

No further action
Significant New
Activity Notice (SNAc),
 Can be added to the
meaning that any new
DSL
use will require a
notification

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Suspicion of Toxic
or
Capable of becoming Toxic
Manufacture or import
with condition; or
 Prohibition; or
 Prohibition pending
additional information

So What Does This Mean?
If you intend to manufacture (produce, grow, develop)
or import a new substance (eg. chemical, polymer,
organism) , you must ensure that this new substance
has been assessed for the potential risk to the
environment and human health as required by the
Canadian Environmental Protection Act, 1999 (CEPA
1999), prior to import or manufacture.
Substances used in Biofuel Production
Chemicals, biochemicals, polymers and
biopolymers used in the following
substances and activities may be subject to
the NSNR (Chemicals and Polymers):
 ‘new’ enzymes used for biofuel production
 other ‘new’ catalysts, feedstocks or other reagents
used for biofuel production
Substances used in Biofuel Production
Micro-organisms and organisms other than
microorganisms used in biofuel production
may be subject to the NSNR (Organisms):
 ‘new’ bacteria or fungi (including yeasts) used to
ferment sugars to produce ethanol or solubilize
hemicellulose
 ‘new’ bacteria or fungi used to produce enzymes for use
in biofuel production
 GM seeds imported for direct use as biomass/feedstock
Linkage to Biofuels
• The NSNR are targeted to importers and
‘manufacturers’ of ‘new’ chemicals, polymers
and micro-organisms
• NOT targeting end-users buying their product
in Canada
To sum up
 ‘New’ chemicals or polymers
• ‘New’ micro-organisms and
‘organisms other than
microorganisms’
used in biofuel production may be
subject to the NSNR (Chemicals
and Polymers) and/or NSNR
(Organisms)
For further information
• Visit us at table 2 in the exhibition hall or request a
meeting during BIOWC2015
• http://www.ec.gc.ca/subsnouvelles-newsubs/
• [email protected]
• (800) 567-1999 (Toll Free in Canada)
(819) 938-3232 (Outside of Canada)
• New Substances Division
Science and Technology Branch
Environment Canada
Place Vincent Massey, 6th Floor
Gatineau QC K1A 0H3
QUESTIONS ?
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