Directive 94-08 (Dir94-08)
Assessment Criteria for Determining Environmental
Safety of Plants With Novel Traits
This document updates Directive 94-08
(Dir94-08),
"Assessment Criteria for Determining Environmental Safety of
Plants with Novel Traits."
The original Dir94-08 was first published
December 16, 1994, revised September 15, 2000, and then again on October 29, 2004.
PDF (210kb)
Table of Contents
Directive 94-08, entitled "Assessment Criteria for Determining
Environmental Safety of Plant with Novel Traits", has been prepared to
provide guidance regarding the submission of an application for the
authorization of the unconfined release of a plant with a novel trait (PNT) in Canada, as may be required
under Part V of the Seed Regulations. Due to the broad range
of PNTs that may be developed
and submitted for approval in Canada , the information provided in these
guidelines should not be considered as exhaustive and will be updated as
appropriate to reflect current scientific knowledge and acquired field
experience. For further clarification, applicants are strongly recommended to
consult with the Canadian Food Inspection Agency's Plant Biosafety Office.
For all purposes of interpreting and applying the law, applicants are invited
to consult the official versions of the relevant Acts and Regulations.
The scope of this Directive covers all plants (excluding aquatic plants)
containing a novel trait that has been intentionally selected, created, or
introduced into a distinct, stable population of the cultivated plant species
through a specific genetic change, including agricultural and horticultural
crop plants and forest trees.
The purpose of this Directive is to (i) provide
guidance on what constitutes a PNT, (ii) define
the criteria and information relevant to an environmental safety assessment of
a PNT under consideration for
release and (iii) describe the steps leading to the
unconfined release of a PNT.
This includes identification of potential concerns, relevant information, and
procedures to assess potential environmental effects associated with the
unconfined release of PNTs.
It should be noted that the definitions provided in Appendix 1 have been
adapted from multiple sources to reflect the context of this Directive.
The Plant Biosafety Office (PBO) of the Canadian Food Inspection Agency
(CFIA) is
responsible for the administration of regulatory provisions regarding
notification and authorization of the release of plants with novel traits
(PNTs) into the Canadian
environment.
By definition:
A PNT is a plant containing a
trait not present in plants of the same species already existing as stable,
cultivated populations in Canada, or is present at a level significantly
outside the range of that trait in stable, cultivated populations of that plant
species in Canada. All PNTs
are subject to an environmental safety assessment.
Substantial equivalence is used in the comparative assessment of a PNT relative to its counterpart to
assess its relative and acceptable risk:
i) A PNT that is substantially equivalent, in
terms of its specific use and safety for the environment, as well as for human
and animal health, to plants currently cultivated in Canada, having regards to
its potential changes in weediness/invasiveness, gene flow, plant pest
properties, impacts on other organisms and impact on biodiversity, should pose
no greater risk to the Canadian environment compared with its counterpart. A
plant that is substantially equivalent to its counterpart and is derived from
seed authorized for unconfined release may be exempted from the
notification and authorization requirements under the Seeds
Regulations.
ii) A PNT that is not substantially equivalent, in
terms of its specific use and safety for the environment as well as for human
and animal health, to plants currently cultivated in Canada, having regards to
their potential changes in weediness/invasiveness, gene flow, plant pest
properties, impacts on other organisms and impact on biodiversity, may be
authorized for release into the Canadian environment with appropriate
environmental risk management and risk mitigation measures.
Before a PNT can be
released into the environment, a determination of the associated risk to the
environment, including to human health, is required.
The PBO is responsible for
the authorization of release, whether it is confined or unconfined, of PNTs into the Canadian environment.
The confined release, which may be considered to be a release for research
purposes, involves imposing conditions such as reproductive isolation as well
as restrictions on the use of harvested material and the field plot in
subsequent growing seasons. Information relevant for the purpose of submitting
an application for an authorization of confined research field trials is
detailed in Directive 2000-07 (Dir2000-07),
entitled "Directive for the Environmental Release of Plants with Novel
Traits Within Confined Research Field Trials in Canada."
An unconfined release involves the release of a PNT into the environment with no
restrictions, with a view towards commercialization. In general, a PNT will proceed from the research
stage in a laboratory, growth chamber or greenhouse, to a confined field
trial-based environmental release, and finally, to an unconfined release.
Information gathered over several years regarding the agronomic/silvicultural
and environmental characteristics of the PNT during its confined release stage will
generally contribute to a developer's determination as to whether or not to
proceed to the next stage of development, which is the unconfined environmental
release. Particular PNTs,
such as those intended for the production of pharmaceutical or industrial
compounds, may be required to grow under conditions that provide for physical
and reproductive confinement, even during its commercialization.
2.1 Determination of Novelty
Prior to the introduction of a new plant into the Canadian market, it is
necessary to consider whether or not it would be classified as novel under the
provisions of the Feeds Act, the Food and Drugs Act, the
Seeds Act, as well as under the provisions of the respective
regulations of these Acts.
A new variety of a species is subject to the notification and authorization
requirements of the Seeds Regulations when it possesses trait(s) novel
to that species in Canada, i.e.,
i) the new trait is not present in stable,
cultivated populations of the plant species in Canada, or
ii) the trait in the plant species is present at a
level significantly outside the range of that trait in stable, cultivated
populations of that plant species in Canada.
Canada has a product-based regulatory system for plants with novel traits.
It is the presence of a novel trait in a plant, irrespective of the
method used to introduce it, which will trigger the notification and
authorization requirements under the Seeds Regulations. PNTs may be developed through
mutagenesis, somaclonal variation, intra-specific and inter-specific crosses,
protoplast fusion, recombinant DNA technology, or other techniques.
Conventional breeding may produce a plant with a novel trait requiring
notification and authorization of its release, depending on the selected
trait's level of expression in comparison with similar existing traits
present in stable, cultivated populations of the plant species in Canada. For
example, an increase in yield in a new wheat line, similar to increases seen
historically in wheat lines cultivated in Canada, may not be considered to be a
PNT. However, a new
sclerotinia resistant canola line exhibiting a resistance many folds higher
than that currently grown in Canada would likely be considered a PNT. The introduction of a trait from
wild biotypes or from germplasm originating outside of Canada, is more likely
to produce a PNT than
conventional breeding with germplasm already in use in the Canadian
environment.
It is the responsibility of proponents (e.g., plant breeders, product developers, etc.) based both on their expertise and relevant scientific
literature reviews, to determine the range of the selected trait in cultivated
populations of the plant species in Canada. i.e. it is the proponent's responsibility to
determine if they have produced a PNT. Thus, the PNT status of a new plant variety is
determined on a case-by-case basis. The requirement for
notification and authorization under the Seeds Regulations is
triggered by the presence of a novel trait in a plant. Certain information
detailed in this directive may be waived by the CFIA if it determines, based on
valid, scientific rationale (supported by appropriate data and/or literature
references) submitted by the proponent, that the information in question is not
relevant to a particular PNT's environmental safety assessment,
and as such, is not required for the CFIA's decision as to whether
or not to authorize the environmental release of the PNT.
When a proponent contacts the PBO, CFIA, the Feed Section, CFIA, and/or the Novel Foods
Section, regarding the determination of their plant's novelty status, as
well as the novelty status of food and feed products derived therefrom, a
meeting may be organized among all three groups to review the case to analyze
the factors contributing to its status and to provide guidance to the proponent
on applicable requirements.
Where a plant variety has been determined by the proponent to be a PNT, the food and feed products
derived therefrom will usually be considered to be novel as well. However, in
some cases, a plant variety will be determined not to be a PNT, but the food and feed products derived
therefrom will be considered as novel. In other instances, a plant will be
considered to be a PNT, but
the food and feed products derived therefrom will not considered novel because
of their history of safe use in the marketplace. In order to respond to a
proponent's request for guidance on the novelty of their plant product,
additional information may be required necessary in order to reach a
decision.
2.2 Intra-specific Crosses
Once a PNT is authorized
for unconfined release, all its progeny and sister lines which have been
derived from the original transformation and their respective progenies, are
also authorized for unconfined release provided that the proponent has
determined that:
- no inter-specific crosses are performed;
- the intended uses are similar;
- based on characterization, these plants do not display any additional novel
traits and are substantially equivalent, in terms of their specific use and
safety for the environment and for human and animal health, to plants currently
being cultivated; and
- the novel genes are expressed at a level similar to that of the authorized
line.
The CFIA may ask
the proponent to provide scientific evidence supporting these conclusions.
2.3 Inter-specific Crosses
Once a plant is authorized for unconfined release, an environmental safety
assessment of the plant created from the first interspecific cross may be
necessary. Subsequent to an unconfined release authorization for an
interspecific cross, the proponent may not need to apply for unconfined release
authorization of further lines, provided that the proponent has determined:
- there is no new transformation event;
- the intended uses are similar;
- based on characterization, these plants do not display any additional novel
traits and are substantially equivalent, in terms of their specific use and
safety for the environment and for human and animal health, to plants currently
being cultivated; and
- the novel genes are expressed at a level similar to that of the authorized
line.
The CFIA may ask
the proponent to provide scientific evidence supporting these conclusions.
2.4 Intentional Trait Stacking
Proponents are asked to advise the PBO at least 60 days prior to the
anticipated environmental release of plants having stacked traits and resulting
from either intentional intra-specific or inter-specific crosses between
PNTs already authorized for
unconfined environmental release. Following notification, the PBO may issue a letter (within 60 days of
notification) informing the proponent of any concerns the it may have regarding
the unconfined environmental release. The PBO may request and review data to support
the safe use of the modified plant in the environment. Stacking of traits with
potential incompatible management requirements, possible negative synergistic
effects, or where production of the plant may be extended to a new area of the
country, may elicit an environmental safety assessment. Until all environmental
safety concerns have been resolved, the modified plant should not be released
in the environment.
2.5 Re-transformation and
Re-mutation
A re-transformation/re-mutation, i.e.,
- transformation of a plant, with the identical construct(s) as a previously
authorized plant of the same species
- mutation of the same gene in a plant as a previously authorized plant of
the same species
which conveys the same novel trait to a plant as a transformation/mutation
in a previously authorized plant may not trigger the notification and
authorization requirements under the Seed Regulations, provided
that:
- the method is identical to that used previously;
- the intended uses are similar;
- it is known based on characterization, that the plant does not display any
additional novel traits and is substantially equivalent, in terms its specific
use and safety for the environment and for human and animal health, to plants
currently cultivated; and
- the novel genes are expressed at similar levels as that of the authorized
line.
The PBO may ask the
proponent to provide scientific evidence supporting these conclusions. For
further guidance, consultation with the PBO, CFIA, the Feed Section, CFIA, and the Novel Food
Section, Health Canada, is recommended.
Proponents are encouraged to consult with the PBO in the early stages of development of
their new plant variety in order to receive guidance regarding the
determination of their plant variety's novelty status and, where
appropriate, for clarification on what specific information is necessary for
the PNT's environmental
safety assessment. Applications that are complete and of acceptable quality and
legibility will allow for timely assessments with a minimum of correspondence
requesting further information.
3.1 Where to Apply
Please address your application for unconfined environmental release
authorization of a PNT
to:
Plant Biosafety Office
Plant Products Directorate
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, Ontario
K1A 0Y9
Telephone: (613) 225-2342
3.2 When to Apply
The developer of a PNT is
strongly encouraged to apply for unconfined environmental release authorization
well in advance of the anticipated time of commercialization. Applications for
authorization will be processed on a first-come-first-served
basis. Degree of completeness of the application will also be a factor
in the length of the review period required.
3.3 How to Apply and Number of Copies
Requested
Applicants are asked to send a covering letter along with their application,
summarizing their request for an unconfined environmental release authorization
for their plant product and an explanation as to why their new variety is
subject to regulatory oversight. A description of the plant species, the novel
traits, and the potential geographic scope of the release should be included in
this summary. Two copies of the application should be submitted to the PBO for review.
3.4 Information Considered to be
Confidential
In formation submitted to the PBO for the purposes of obtaining an
authorization for the environmental release of a PNT may be protected under the federal
Access to Information Act, Section 20.
All requests for such information are subject to the federal Access to
Information and Privacy Acts . Please consult with CFIA's ATIP service, at (613) 225-2342,
for further information.
3.5 Fees
The application fee should be included with the application for the review
to be initiated. Please see Appendix 2 for a schedule of fees for the review of
applications and authorization for the environmental release of PNTs. Once review of an application has been
initiated, the application fee will not be refunded. Please make cheques
payable to the Receiver General of Canada.
3.6 Submission to Feed Section and Health
Canada
The Feed Section, CFIA, is responsible for the
administration of regulatory provisions with respect to the authorization of
the release of novel feeds. The Novel Foods Section, Health Canada, is
responsible for the administration of regulatory provisions with respect to the
authorization of the release of novel foods intended for human consumption. The
unconfined environmental release of a PNT in Canada intended for feed and/or food
use, or that could reasonably be expected to be used as feed or food, may
require:
- a determination of environmental safety by the PBO (CFIA),
- a determination of product safety as a novel livestock feed by the Feed
Section (CFIA),
and
- a determination of product safety as a novel food by the Novel Foods
Section (Health Canada).
Please note that it is the responsibility of the applicant
to contact these offices.
Where registration of a pest control product is mandatory, it is the
applicant's responsibility to meet all the requirements of the Pest
Control Products Act, an act which is administered by Health Canada's
Pest Management Regulatory Agency (PMRA). PMRA is the federal agency
responsible for conducting the appropriate risk and value assessments of pest
control products in Canada. Applicants may wish to refer to the
Registration Handbook for Pest Control Products as a detailed
reference for the registration process.
3.7 Submissions to PNT Authorities
Applicants seeking authorization for the unconfined environmental release in
Canada of plants that may be regulated in the United States are encouraged to
seek authorization for the environmental release of their product in the United
States simultaneously. Obtaining such authorizations may minimize the movement
of unauthorized material across the border of a product released in one country
but whose release is not authorized in the other. It is recommended that
applicants advise the CFIA of any notification to foreign
governments of the intended unconfined environmental release within their
respective foreign borders of a PNT under review in Canada. Where
appropriate, the CFIA may try to coordinate its
activities and work with foreign governments to minimize the presence of
unauthorized products in each country's respective environment.
For the regulation of PNTs
in confined research field trials and unconfined release:
The Seeds Act, R.S., c. S-8
The Seeds Regulations, C.R.C., c. 1400, Part V
For the importation of plant materials, including PNTs:
The Plant Protection Act, S.C. 1990, c.22
The Plant Protection Regulations, SOR/95-212
For the collection of fees:
Canadian Food Inspection Agency Fees Notice, Canada Gazette,
Part 1 (05/13/2000)
A seed (which covers plants under the Seeds Act) is not subject to
Part V of the Seeds Regulations if
one of the following applies:
i) the seed was grown in Canada outside of
containment before the coming into force of Part V of the Seeds
Regulations (i.e., prior to December
1996),
ii) the seed is derived from seed referred to in
paragraph i), or from seed in respect of which an
unconfined release has been already authorized, or
iii) the seed is grown in containment in such
manner that there is no release into the environment of any genetic materials
from the plants derived from the seed.
6.1 Environmental Safety Assessment
Criteria
- The PBO assesses the
environmental safety of PNTs
based on the five criteria:
- potential of the PNT to
become a weed of agriculture or be invasive of natural habitats,
- potential for gene-flow to wild relatives whose hybrid offspring may become
more weedy or more invasive,
- potential for the PNT to
become a plant pest,
- potential impact of the PNT or its gene products on non-target
species, including humans,
- potential impact on biodiversity.
6.2 Environmental Safety Assessment
The PBO performs
environmental safety assessments of PNTs based on the five criteria listed
above, primarily using two sets of information. The first set is a companion
biology document, which provides baseline information for the plant species of
the PNT under review (Please see Section 7.2 for details).
The second set of information is submitted by the applicant as part of a
complete application for the unconfined release authorization of the PNT is question and consists of
appropriate data and relevant scientific information describing the
environmental risk of the PNT
relative to its counterpart(s) already present in the Canadian environment (Please see Section 7, entitled "Authorization for
Environmental Release of a PNT"). This data should be
collected through testing and analysis, and during confined research field
trials conducted either in Canada (Please refer to Dir2000-07 for further details), or in foreign environments
similar to that of Canada's. Based on the information provided in the
biology document, field experiments can be carefully designed to generate data
demonstrating the agronomic/silvicultural and environmental characteristics of
the PNT relative to its
counterpart.
The PBO may also use other
peer-reviewed scientific literature, as appropriate, to guide their safety
assessments.
6.3 Consultation with Experts
During its evaluation of an application for the authorization of the
environmental release of a PNT, the PBO may consult relevant scientific experts
on specific issues with regards to the environmental safety of a PNT. For example, the PBO may solicit the scientific expertise of
Health Canada' PMRA with respect to the
environmental safety of a PNT
expressing altered pesticidal tolerance or altered pesticidal properties.
Information considered as confidential business information (CBI) will not be shared without
prior written authorization from the applicant. Solicited advice, given by
either PMRA or
other consulted scientific experts, will be considered by the PBO in the final evaluation of the PNT for unconfined environmental
release.
7.1 Specific Information
To enable the PBO to
assess the environmental safety of a PNT, the applicant must address the
following issues:
- the identity and origin of the PNT;
- the properties of the novel gene and gene products;
- the relative phenotypic expression of the PNT compared to a similar counterpart, where
differences are anticipated; and,
- anticipated or known relative effects on the environment resulting
from the release.
The specific information relevant for the purposes of conducting
environmental safety assessments can be found in Appendix 3, entitled
"Relevant Information Regarding the PNT" , and Appendix 4, entitled
"Information on the Biology and Interactions of the PNT" . Specific information will vary
with the species, characteristics of the novel trait, and the PNT's end use. All other supporting
information and test data that are relevant to environmental and human health
exposure and hazard identification, and which are in the applicant's
possession or to which the applicant should reasonably have access to, must be
included in the application. For further guidance, the applicant is encouraged
to consult with the PBO.
In addition to data generated by the applicant through research and testing
in laboratory, growth chamber, and/or greenhouse, as well as during confined
research field trials, further information can also be submitted in an
application based on available scientific literature and any other recent
research. The PBO may also
refer to data generated from CFIA's own research on specific
key environmental areas.
The PBO may decide to
waive the requirement for certain information if it determines, based on
written scientific rationale submitted by the applicant, that the information
is not relevant to a particular PNT's environmental safety assessment,
and as such, is not required for the PBO's decision as to whether or not to
authorize the environmental release of the PNT.
7.2 Biology Documents of the Plant
Species
The biology of certain plant species is described in a series of species-specific biology documents,
which are published on the PBO web site at the following address:
http://www.inspection.gc.ca/english/plaveg/bio/dir/biodoce.shtml.
These documents describe the characteristics of the plant species in
question, such as habitat, fertility, dispersal, and endogenous toxins, as well
as include information about the plant species'major interactions with
other life forms in its production range in Canada (e.g., predators, grazers, parasites, pathogens,
competitors, symbionts and beneficial organisms, including humans, where
appropriate). This information will help identify potential risks associated
with a PNT under review
relative to its counterpart(s) of the same species already present in the
Canadian environment. These documents act as references for comparative
data.
Where a biology document is not available for a particular PNT's plant species, one should be
provided to the PBO with a
proponent's application for unconfined environmental release authorization.
Once a biology document is submitted, it will be reviewed by the PBO as well as peer-reviewed. Comments
received from the peer review will be incorporated into the biology document as
appropriate. Based on comments received from the peer review, an applicant may
need to submit further information and test data for the PNT's environmental safety
assessment.
The format of the new biology document should follow that of the existing
biology documents. The Organisation for Economic Cooperation and Development
(OECD)
Consensus Documents may be used as a reference tool to help applicants in the
preparation of biology documents.
7.3 Quality of Data Submitted
The quality of information in the data package should be equivalent to that
provided for peer reviewed publications. Applicants should clearly describe the
test procedures followed in developing the test data, including test methods,
reference products, quality control, quality assurances procedures, appropriate
statistical analysis, together with bibliographic references, including
numbered patents, where these are appropriate. The generation of field trial
data should be produced using statistically valid experimental designs and
protocols. Field trials should be conducted in a manner consistent with the
proposed farming practices of the PNT's plant species. The applicant may
be asked to submit details of field trial protocols, including experimental
designs and sampling procedures.
A guide to the expected quality for some types of submitted analytical data
can be found in the reviewer's checklist. This guide has been developed jointly
with Health Canada and the United States Department of Agriculture's Animal
and Plant Health Inspection Service (
USDA-APHIS), and is available at
http://www.inspection.gc.ca/english/plaveg/bio/usda/usda04e.shtml.
7.4 Detection and Identification
Requirements
Along with all other data, relevant to the environmental safety assessment
of a PNT, the following
should also be submitted to the CFIA:
- appropriate test methodologies for the detection and identification of
PNTs;
- written agreement to provide the CFIA with reference material
suitable to support these methods.
Certain information regarding the detection and identification of a PNT, which is provided to the CFIA for the purposes of
conducting an environmental safety assessment, may be protected under the
provisions of the Access to Information Act. All requests for such
information are not only subject to the Access to Information Act but
to the Privacy Act as well.
CFIA's criteria regarding
acceptable detection and identification methods can be found on the
PBO web site at the following
address: http://www.inspection.gc.ca/english/plaveg/bio/detecte.shtml
Consultation with the CFIA is recommended prior to the
submission of an application for authorization of environmental release for
guidance in the determination of appropriate test methodologies and reference
materials.
7.5 Stewardship Plan Requirements
As part of the PBO's
assessment of a PNT's
environmental safety, in particular, of its assessment of longer term
environmental effects, the PBO's decision with regards to
authorizing the release of a PNT expressing either a novel herbicide
tolerance or a novel insect resistance will take into consideration whether or
not the applicant has provided a stewardship plan addressing the need for the
responsible deployment of the novel crop into the environment.
Stewardship plans should include appropriate strategies that will allow for
the environmentally safe and sustainable deployment of such novel plants
(Please see Sections 7.5.1 and 7.5.2 for specific information). In addition, communication to
growers and an efficient mechanism allowing growers to report problems to the
applicant are all integral parts of a stewardship plan.
7.5.1 Insect Resistance Management (IRM)
The CFIA strongly
recommends that an IRM
plan be implemented for all plants expressing novel insect resistance
(including those expressing Bacillus thuringiensis (Bt) endotoxins) grown in fields of
greater than one hectare in size. IRM strategies are intended to delay
the development of resistance in the insect to the active compound(s) and
thereby prolong the lifespan and usefulness of the technology. The development
of resistance in insects to these active novel compounds due to the
non-adoption of effective IRM plans could also have significant
implications on sustainable agriculture.
The IRM plans
currently in place for Bt
corn and Bt potatoes
consist of planting refugia, areas of non-Bt crops which provide a population of
insects which have not been exposed to the Bt toxin and are available to breed with
potentially resistant insects which could be emerging from the cultivation of a
Bt crop.
The IRM plan should
take into consideration the most recent available scientific evidence on, among
other factors, the following:
- the reproductive biology and behaviour of the insect pest;
- the mobility of the larvae;
- the ability of adults to disperse from the natal field before and after
mating;
- an estimate of resistance allele frequency in the insect population;
- the impact of management practices such as insecticide use in the
refuge;
- the targeted life cycle stage of the insect pest, and;
- any history of insect resistance to the active compound(s).
The IRM plan
submitted in an application for unconfined environmental release authorization
is specific to the target insect species and is based on field/laboratory
research and computer models.
Communication to growers, the monitoring of the effectiveness of the plan,
and an efficient mechanism allowing growers to report problems to the
applicant, are all integral parts of an IRM stewardship plan.
7.5.2 Herbicide Tolerance Management (HTM)
The development of an HTM plan is the applicant's
responsibility and should contain elements that address:
- the control of volunteers, more specifically, any changes in usual
agronomic practices that may arise from the novel herbicide tolerance and which
could result in reduced sustainability or have significant impacts on soil
conservation;
- the selection of herbicide tolerance in weeds resulting from the potential
continued application of the same herbicide in subsequent rotations;
- the introgression of novel trait into related species;
- the management of the herbicide tolerant crop during the growing season,
particularly where multiple herbicide tolerances, due to cross pollination,
could arise in subsequent growing seasons;
- communication to growers as well as an efficient mechanism allowing growers
to report problems to developer;
- the monitoring of effectiveness of the stewardship plan.
A PNT with a novel
herbicide tolerance that could be introgressed to related species, resulting in
hybrids that have no effective or sustainable control options, will not be
authorized.
The PBO also cooperates
with the PMRA on
strategies for the safe and effective use of herbicides and herbicide tolerant
crops in Canada. Safety issues concerning the application of herbicides on
plants expressing novel herbicide tolerance(s) are assessed in collaboration
with the PMRA.
7.6 Post-release Monitoring Plan
A general post-release monitoring plan to monitor for unintended or
unexpected environmental effects of an authorized product should also be an
integral part of a complete application and will be reviewed during the
environmental safety assessment of the novel plant in question. The use of
appropriate indicators to evaluate these effects should be based on the
characteristics of the PNT. A
stewardship plan (Please see Section 7.5) may be
considered acceptable for post-release monitoring purposes.
The applicant must inform the PBO of any new information regarding the
risks to the environment or to human health resulting from worker exposure to
the PNT that could result
from the unconfined release of the PNT (Please see Section 9 for
further details).
The PBO will consider the
information provided by the applicant to determine if the PNT poses risks to the environment. The
PBO may authorize or refuse
to authorize the release of a PNT based on its environmental safety
assessment.
8.1 Regulatory Decision
Where the proposed release of a PNT poses a minimal
apparent risk to the environment, the PBO may authorize the unconfined release of
the PNT, and may, where
necessary, impose conditions for the management of the apparent risk.
Conditions will be imposed on an indeterminate basis.
Where the proposed release of a PNT has been assessed to pose unacceptable
risk to the environment, the PBO may refuse to authorize the unconfined
environmental release of the PNT, and will provide reasons for the
refusal.
8.2 Harmonization of Approvals under Other Federal
Acts and Regulations
A PNT that could
reasonably be expected to be used as feed and food, will not be authorized for
unconfined environmental release by the PBO, among other requirements, until:
- the Feed Section of the CFIA is ready to authorize the
novel feed for livestock feed use under the authority of the Feeds Act and
Regulations, and/or
- the Novel Foods Section, Health Canada, is ready to provide notification of
no objection for human food use under the authority of the Novel Food
Regulations.
Where products are intended for exclusive use as either food, feed or
molecular farming (use of plants to produce industrial or therapeutic
products), consultations among regulatory authorities will be required to
assess any potential risks associated with the release of the product in an
unintended commodity stream. For these products, an identity preservation
system or alternative will be essential to minimize the likelihood of such an
event.
Please note that once the safety assessments have been completed, the
applicant is notified in writing by the CFIA and Health Canada (separate
letters) on their respective decisions regarding the application.
8.3 PNTs Carrying Antibiotic Resistance
Markers
While the presence of antibiotic resistance marker genes in transgenic
plants may not pose a significant environmental risk, developers of transgenic
plants are encouraged to consider alternative selection systems. The presence
of an antibiotic resistance marker, to which no significant environmental risk
has been associated, will not be considered as grounds for denying
authorization for the environmental release of the PNT in question.
8.4 Web Site Summaries of PNTs authorized for unconfined
release
A list of all authorized
PNTs and novel feeds
derived therefrom, as well as their accompanying decision documents, is
available on the CFIA PBO's web site at the following address: http://active.inspection.gc.ca/eng/plaveg/bio/pntvcne.asp.
The PBO will update its list of authorized PNTs and post related decision
documents on its web site within 15 days after authorizing a PNT.
A list
of approved novel foods in Canada derived from PNTs whose environmental release has been
authorized, as well as their accompanying decision documents, is available
onHealth Canada's web site at the following address:
http://www.hc-sc.gc.ca/food-aliment/mh-dm/ofb-bba/nfi-ani/e_nf_dec.html
The decision documents explain the decision reached by the CFIA's PBO and the Feed Section and Health
Canada's Novel Food Section following their safety assessments.
The PBO also submits
information on the environmental release of PNTs to the Organization for Economic
Cooperation and Development (OECD) publicly available Biotrack database
at: http://www.oecd.org/ehs/service.htm and to the Canadian Node of the Biosafety Clearing-House under
the Cartagena Protocol on Biosafety (http://www.bch.gc.ca). It is therefore
important that CBI
be clearly identified.
Where, at any time after providing notification of the proposed unconfined
release or receiving authorization for the unconfined release of a particular
PNT, the applicant becomes
aware of any new information regarding the environmental safety of the PNT (e.g., enhanced weediness characteristics),
including the risk to human health (e.g.,
exposure to allergens) that could result from the release, the applicant must
immediately provide the PBO
with the new information. On the basis of the new information, the PBO will re-evaluate the potential
effect on, and risk to the environment, including the potential effect on, and
risk to human health posed by the release. The PBO may maintain, change, or remove existing
conditions respecting the release; impose additional conditions; or refuse or
cancel the authorization and require the applicant to stop the release and take
any appropriate action necessary to eliminate from, or minimize the risk to,
the environment.
This document is published by the Plant Biosafety Office. For further
information, please contact:
Plant Biosafety Office,
Plant Products Directorate,
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, Ontario K1A 0Y9
Telephone: (613) 225-2342
Facsimile: (613) 228-6140
http://www.inspection.gc.ca/english/plaveg/bio/pbobbve.shtml
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