Directive 94-08 (Dir 94-08)
Assessment Criteria for Determining Environmental Safety of Plants With Novel Traits

Appendices

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 and revised September 15, 2000.

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Appendix 1 Definitions

Biodiversity

The variety of life and its processes. Biodiversity includes all life forms, from one-celled fungi, protozoa and bacteria to complex organisms such as plants, insects, fishes and mammals. It includes processes, pathways and cycles that link living organisms into populations, ecosystems and landscapes. This variety of life is dynamic and constantly changing and evolving. It is sensitive to perturbations that may result from human activity. Biodiversity is generally recognized on three levels:

• genetic diversity - the variety of genetic building blocks found among individual representatives of a species;
• species diversity - the variety of living organisms found in a particular place; and
• ecosystem diversity - the variety of species and ecological functions and processes, both their kind and number, that occur in different physical settings.

Biology Document

A CFIA species-specific companion document that describes the biology, related species and interactions with other life forms of the plant.

Carrier DNA

DNA used to expedite the preparation or the transformation of genetic material into a plant but which is itself not part of the construct.

Coding Region

A DNA sequence which can be translated to produce a protein.

Confined Research Field Trials

A confined research field trial is the release of a PNT, for research purposes, under terms and conditions of confinement designed to minimize any impact the PNT may have on the environment. These terms and conditions include, but are not limited to, reproductive isolation, site-monitoring and post-harvest land use restriction. See Regulatory Directive 2000-07.

Construct

An engineered DNA fragment (e.g. plasmid) which contains, but is not limited to, the DNA sequences to be integrated into a target plant's genome.

Counterpart

The chosen counterpart should, if possible, be the host plant already existing as stable, cultivated populations in Canada. In the case of an F1 hybrid, the counterpart must be a similar genotype/phenotype of the same species. Consideration may also be given to the use of several counterparts. Since there will be a range of characteristics among varieties within a species, comparison with several counterparts may show that the PNT has characteristics within the normal range exhibited by that species.

Cultivate

To produce or grow in an agricultural system. For the purpose of this Directive, cultivate also means to produce or grow in a managed system, e.g., a forest plantation.

Database Citations

Publicly accessible sources of nucleotide or protein sequence information. Five commonly used databases and their website addresses are:

• GenBank: An annotated collection of all publicly available DNA sequences maintained by the National Institute of Health (NIH). http://www.ncbi.nlm.nih.gov/Genbank/
  GenbankOverview.html
• DNA Data Bank of Japan: The officially certified DNA bank of Japan, which collects DNA sequences from researchers. http://www.ddbj.nig.ac.jp/fromddbj-e.html
• EMBL Nucleotide Sequence: A database of DNA and RNA sequences collected from the scientific literature, patent applications, and directly submitted from researchers and sequencing groups. http://www.ebi.ac.uk/embl/
• The SWISS-PROT Protein Sequence Data Bank: A database of protein sequences produced collaboratively by Amos Bairoch (University of Geneva) and the EBI. http://www.ebi.ac.uk/swissprot/
• The FARRP Allergen Database: A database containing a list of unique known and putative allergens that were identified by searching publicly available protein databases. http://www.allergenonline.com

  Please note: The CFIA is not responsible for the accuracy, currency or the reliability or the content of these databases. Please be aware that information from these databases may not be available in both official languages.

Environment

Components of the earth including air, land, water; all layers of the atmosphere; all organic and inorganic matter and living organisms; and all interacting natural systems that include components referred to above (Canadian Environmental Protection Act, Section 3). This includes the natural and managed ecosystems which includes agricultural ecosystems.

Environmental Risk

Possibility of causing harm to the environment.

Environmental Safety Assessment

The qualitative and/or quantitative estimation of the likelihood of adverse environmental impacts that may result from the release of the PNT into the environment.

Gene Flow

The transfer of genetic material by interbreeding from one population of a species to another population (same or related species), thereby changing the composition of the gene pool of the receiving population.

Genotype

The sum total of the genes of an organism, latent or expressed.

Insert

That part of a construct (see above) which is integrated into the recipient plant's genome.

Invasive Plant

Any plant that is successful in colonizing natural "un-managed" ecosystems and in the process displaces other species and disrupts those ecosystems.

Irritant

Any agent capable of eliciting an abnormally excited or sensitive condition in a body part of a human or other animal.

Microfauna

Microscopic animals.

Microflora

Microscopic plants, bacteria and fungi.

Natural Ecosystem

A non-agricultural area not subject to significant human manipulation such as mowing, pesticide application, planting, etc.

Non-coding Region

DNA sequences which lie outside of an open reading frame and which are not translated to become part of a protein. These include scaffold attachment regions, promoters, leader sequences, enhancers, introns, terminators, and any other sequences that are used for gene expression either in the plant or other hosts, such as origins of replication, transposable elements, T-DNA borders, lox sequences, etc.

Non-target Organisms

An organism (including humans) that may be unintentionally affected due to the presence of the PNT in the environment.

OECD Consensus Documents

Reports published by the Organisation for Economic Cooperation and Development (OECD) that contain technical information for use in the regulatory assessment of products of biotechnology (http://www.oecd.org).

Outcrossing

Sexual reproduction involving other individuals of the same or related species.

Outcrossing Frequency

The percentage of total progeny produced by a plant as a result of outcrossing.

Parthenocarpy

Production of fruit without fertilization.

Phenotype

The observable characteristics of an organism (including physical, biochemical or other traits) which may result from the interaction of the organism with its environment.

Plant Pest

Any plant that is injurious or potentially injurious, whether directly or indirectly, to plants or to products or by-products of plants.

Seed

Any plant part of any species belonging to the plant kingdom, represented, sold or used to grow a plant (Seeds Act).

Stability

The ability of the trait to be expressed in the modified plant line and plant lines derived therefrom in a consistent, reliable, and predictable manner.

Stable population

A population is deemed stable if its relevant trait remains unchanged throughout the continuous, repeated propagation of the plant species.

Substantial equivalence

The equivalence of a novel trait within a particular plant species, in terms of its specific use and safety to the environment and human health, to those in that same species, that are in use and generally considered as safe in Canada, based on valid scientific rationale.

Threatened and Endangered Species

Organisms listed as such by Federal authorities: in Canada the Species At Risk Act (SARA) is administered by Environment Canada, and endangered species are officially listed by the Committee on the Status of Endangered Wildlife in Canada (COSEWIC) (http://www.cosewic.gc.ca/index.htm); in the U.S. Departments of Interior or Commerce who jointly administer under the authority of the Federal Endangered Species Act.

Trait(s)

The phenotypic characteristic(s) conferred to the recipient plant by specific genetic changes.

Transgenic Plant

A plant in which one or more genes, genetic constructs, or traits have been introduced using recombinant DNA techniques, including the insertion of genetic material from the same or different species.

Unconfined Release

A release into an environment of a plant with novel trait(s) that is not isolated either reproductively or physically from managed or natural environments, but may be subject to certain conditions.

Vector

An autonomously replicating DNA molecule into which foreign DNA is inserted and then propagated in a host cell.

Weed

A plant species that is a nuisance to humankind in that it occurs in "managed" ecosystems where it is unwanted. Weeds tend to spread easily in disturbed areas or among crops. Whereas it can be considered that any "plant out of place" is a weed, the emphasis of an environmental safety assessment is to determine whether a PNT could be successful in colonizing managed ecosystems at the expense of other species, in particular cultivated crop plants.

Appendix 2 Plant Biosafety Office Fee Schedule

(http://www.inspection.gc.ca/english/plaveg/bio/feepaie.shtml)

Appendix 3 Information Regarding the PNT

1. Personnel involved and status of the PNT in the application

1.1 Applicant:

1. Name
2. Address
3. Telephone Number
4. Facsimile Number

1.2 Canadian representative, if different from above:

1. Name
2. Address
3. Telephone Number
4. Facsimile Number

1.3 Is the plant material imported? If yes, was an import permit applied for under the Plant Protection Act? Was it granted? If yes, provide the permit number if known.

1.4 Was the plant material previously tested/grown/released in Canada? If yes, in what years?

1.5 If the PNT was derived through recombinant DNA techniques, were the gene constructs previously tested in Canada? If yes, in what plant species and in what years?

1.6 Were other government agencies, either foreign or within Canada, notified of the development of the PNT or its importation? What was the purpose of such notification?

2. Description of the PNT

2.1 Description of taxonomy

2.2 Designation given to the PNT, including all synonyms

2.3 Pedigree information of the PNT (including any relationship to a previously assessed PNT)

2.4 For transgenic PNTs, provide a unique identifier for each line designated according to the "OECD Guidance for the Designation of a Unique Identifier for Transgenic Plants" (ENV/JM/MONO(2002)7) (http://www.olis.oecd.org/olis/2002doc.nsf/LinkTo/env-jm-mono(2002)7)

2.5 Give details of the use of the PNT (e.g., to be grown as a field crop for grain production; to be grown as field crop for grain production on lands contaminated with persistent herbicide; to reclaim lands contaminated with heavy metals).

3. Description of the modification of the PNT

3.1 Novel gene products conferring the novel traits

3.2 Methods used to introduce the novel traits (briefly describe the techniques, if not through recombinant DNA)

3.3 Identify the objective of the modification, e.g., novel herbicide tolerance, male sterility/restoration, etc.

4. Description of the modification of the PNT through recombinant DNA technology

Please address the information requirements listed in this section if the PNT was derived through recombinant DNA technology.

4.1 Transformation method:

4.1.1 Describe and provide references for the transformation method, e.g. Agrobacterium- mediated transformation or direct transformation by methods such as particle bombardment, electroporation, polyethylene glycol transformation of protoplasts, etc.

4.1.2 For direct transformation methods, describe the nature and source of any carrier DNA used.

4.1.3 For Agrobacterium-mediated transformation, provide the strain designation of the Agrobacterium used during the transformation process, and indicate if tumor-inducing genes were present on the plasmid-based vector, and whether Agrobacterium was cleared from the transformed tissue. Briefly describe or provide reference(s) describing the construction of the vector.

4.1.4 For transformation systems other than Agrobacterium, provide the following information:

1. Does the system utilize a pathogenic organism or nucleic acid sequences from a pathogen?
2. How were any pathogenesis-related sequences removed prior to transformation?
3. Did the transformation process involve the use of helper plasmids or a mixture of plasmids? If so, describe these in detail.

4.2 Description of the genetic material potentially delivered to the recipient plant material (the modification/constructs):

4.2.1 Provide a summary of all genetic components which comprise the vector including coding regions, and non-coding sequences of known function. Example of a table describing the DNA components of a vector (from APHIS petition #94-257-01P) is available at http://www.inspection.gc.ca/english/plaveg/
bio/usda/usda03e.shtml#table1. For each genetic component provide a citation where these functional sequences were described, isolated, and characterized (publicly available database citations are acceptable) and indicate:

1. The portion and size of the sequence inserted.
2. The location, order, and orientation in the vector.
3. The function in the plant.
4. The source (scientific and common, or trade name, of the donor organism).
5. If the genetic component is responsible for disease or injury to plants or other organisms, and is a known toxicant, allergen, pathogenicity factor, or irritant.
6. If the donor organism is responsible for any disease or injury to plants or other organisms, produces toxicants, allergens or irritants or is related to organisms that do.
7. If there is a history of safe use of the source organism or components thereof.

4.2.2 If there has been a modification in the transgene relative to the native gene that affects the amino acid sequence of the protein designed to be expressed in the plant, provide the citation. If the modified amino acid sequence has not been published, provide the complete deduced sequence highlighting the modifications. Indicate whether the modifications are known or expected to result in changes in post-translational modifications or sites critical to the structure or function of the gene product. An example of such modifications might include the addition of new glycosylation sites.

4.2.3 Provide a detailed map of the vector with the location of sequences described above that is sufficient to be used in the analysis of data supporting the characterization of the DNA, including as appropriate the location of restriction sites and/or primers used for PCR and regions used as probes. Example of a detailed map of a plasmid vector (from APHIS petition #94-257-01P) is available at the following address: http://www.inspection.gc.ca/english/plaveg/
bio/usda/usda03e.shtml#figure

4.3 Characterization of the DNA inserted in the plant:

4.3.1 For all coding regions, provide data that demonstrate if complete or partial copies are inserted into the plant's genome. Coding regions may include truncated sense constructs, sequences engineered to be nontranslatable, antisense constructs, and constructs containing ribozymes, regardless of whether or not the coding region is designed or expected to be expressed in the transgenic plant. For allopolyploid plants, information may be required indicating into which parental genome insertion has occurred.

4.3.2 For noncoding regions associated with the expression of coding regions:

1. Data should demonstrate whether or not plant promoters are inserted intact with the coding regions whose expression they are designed to regulate. This data is relevant to consideration of points 4.4.1 and 4.4.2 below.
2. DNA analysis may be necessary for introns, leader sequences, terminators, and enhancers of plant-expressible cassettes. DNA analyses may be presented in the form of Southern analyses, DNA sequencing, PCR analyses, or other appropriate information.
3. DNA analysis may be necessary for promoters and other regulatory regions associated with bacteria-expressible cassettes.

4.3.3 For non-coding regions which have no known plant function and are not associated with expression of coding regions:

1. DNA analysis may be required for some sequences of known function (e.g., ori V and ori-322, bom, T-DNA borders of Agrobacterium, and bacterial transposable elements).
2. DNA analysis is not necessary for any remaining sequences of the plasmid backbone when the plasmid is well characterized.

4.3.4 Where appropriate, provide sequence data of the inserted material and of the surrounding regions (sequencing information may be informative in some cases, i.e., to fully characterize a partial or rearranged DNA insert).

4.4 Protein and RNA characterization and expression:

4.4.1 For all complete coding regions inserted, provide data that demonstrates whether the protein is or is not produced as expected in the appropriate tissues consistent with the associated regulatory sequences driving its expression (e.g., if the gene is inducible, determine if the gene is expressed in the appropriate tissues under induction conditions). For virus resistant plants where the transgenes are derived from a viral genome, in addition to transgene protein analysis, determine transgene RNA levels in tissues consistent with the associated regulatory regions driving expression of the transgene. The following exceptions also apply:

1. If the protein concentration is below the limits of detection, mRNA data may be substituted.
2. Protein analysis for products of genes used only as selectable markers may be waived under certain circumstances, e.g. when there is at least one complete copy of a selectable marker gene present and the effective expression of the selectable marker gene is verified by the process used to select the transformed tissue.
3. For plants modified to express non-translatable mRNA, truncated sense constructs, antisense constructs, or constructs containing ribozymes, since the function of these genetic constructs is to specifically alter the accumulation of a specific mRNA or protein present in the transgenic plant, provide data on the level of the target protein only (e.g. native tomato fruit polygalacturonase would be the target protein of antisense polygalacturonase to achieve altered fruit ripening). If the target protein levels are below levels of detection, determine target mRNA levels.

4.4.2 When a fragment of a coding region designed to be expressed in a plant is detected, determine whether a fusion protein could be produced and in which tissues it may be located.

4.4.3 Protein or RNA characterization may not be required for fragments of genetic constructs not expected to be functional in the plant (e.g., fragments of selectable marker genes driven by bacterial promoters.)

5. Description of the inheritance and stability of introduced traits which are functional in the plant

5.1 For plants which are either male or female fertile or both, provide data that demonstrates the pattern and stability of inheritance and expression of the novel traits. If the new trait can not be directly measured by an assay, it may be necessary to examine the inheritance of the novel DNA sequences directly, and expression of the RNA.

5.2 For plants which are either infertile or for which it is difficult to produce seed (such as vegetatively propagated male-sterile potatoes), provide data to demonstrate that the novel trait is stably maintained and expressed during vegetative propagation over a number of cycles that is appropriate to the plant.

6. Description of the parental genome

In the case of an allopolyploid PNT, in which parental genome is the genetic modification?

7. Number of generations removed from the original modification

8. Description of the novel traits

8.1 Where applicable, characterize in detail the novel gene products, breakdown products, by-products and their metabolic pathways.

8.2 Is the novel trait expressed in a tissue-specific manner?

8.3 Is the novel trait expressed in a developmental stage-specific manner?

8.4 Is expression of the novel trait induced? If yes, what are the inducing agents?

8.5 Where applicable, describe the activity of the gene products, breakdown products and by-products in the host plant. Describe any changes to existing metabolic pathways (including altered accumulation and storage patterns), including those that might not be intended.

8.6 Where applicable, the toxicity of the novel gene products, breakdown products and by-products in the environment must be established. Describe:

1. potential toxigenicity to known or potential predators, grazers, parasites, pathogens, competitors and symbionts;
2. potential for adverse human health effects, e.g., exposure to toxins, irritants and antigens. Include estimated level and most likely route of human exposure to the gene products, breakdown products and by-products.

Appendix 4 Information on the Biology and Interactions of the PNT

1. Description of the biology of the plant species prior to modification

1.1 Provide common name(s) and currently accepted scientific nomenclature.

1.2 A biology document describing the biology of the plant species must be submitted with the application if it is not available in the biology document series, unless the PBO confirms that such a document has previously been submitted.

2. Selection of Counterpart

Generally the most suitable counterpart for comparative studies is the isogenic line closest to the PNT, provided that the PNT is intended to be cultivated in the same region as this line. The counterpart may be a previously authorized PNT that has been in large-scale commercial production for several years. Developers are encouraged to consult with the PBO where there are questions regarding selection of an appropriate counterpart.

3. Phenotype of the PNT

The applicant must provide information on the intended phenotype and any known unintended or unanticipated traits. The PNT should be compared to its counterpart(s) and related cultivated varieties as appropriate. If differences are detected, the applicant should address these findings in the application.

Typically, observations are made when the plants are grown in multiple sites and over more than one growing season. Confined research field trials of PNTs should take place in the intended growing region of the PNT in Canada. Data collected from field studies outside Canada can be used if the applicant demonstrates that the environment for testing the PNT is similar to the Canadian environment. In some cases, such as where there may be a potential for increased weed characteristics or if the plant is an outcrossing species, it may be appropriate to evaluate the plants outside of managed ecosystems. Depending upon the results, additional studies may be warranted to provide the required information. Applicants may provide valid scientific rationale why certain information is unnecessary or inappropriate.

3.1 Describe the breeding history of the PNT population being evaluated starting at the point of trait introduction.

3.2 Compare the PNT to its counterpart with respect to the following characteristics which influence reproductive and survival biology:

1. Habit - Note any changes in basic morphology of the plant including any abnormalities, e.g., changes in overall growth habit, pollen characteristics (such as stickiness, size), seed shattering dormancy characteristics, symbionic associations (e.g., with vesicular-arbuscular mycorrhizal fungi, rhizobia) etc.
2. Life cycle - e.g., plants are categorized as annual, biennial, perennial. Would the presence of the introduced trait produce a change?
3. Life history characteristics such as:
   1. plant height, biomass (dry/wet weight) 
   2. number of flowers produced/plant
   3. number of fruits produced/plant
   4. number of pollen grains/anther
   5. percentage of viable pollen
   6. time to maturity (e.g., time to flowering)
   7. number of viable seeds produced/fruit
   8. percentage of seed germination
   9. percentage of germinated seeds surviving to maturation
   10. number of flowering days
4. Outcrossing frequency (within species) and/or cross fertilization frequency (between species).
5. Impact on pollinator species - this may be addressed through information on whether the same pollinator species have been seen in the field or have there been changes in the pollinators that visit the flowers (requires previous familiarity with pollinators on non PNT species).
6. Stress adaptations (specifically note which stresses were observed):
   1. Biotic stress factors: Examples might include parasites or pathogens, competitors (e.g., weeds), and herbivores.
   2. Abiotic stress factors: Examples might include response to drought stress, nutrient deficiency or other stresses common to that plant.
7. Ability to overwinter (or overseason).

3.3 Compare the compositional analysis of the PNT to its counterpart(s) including, protein, lipids, fiber, and other parameters as appropriate. This data is used to assess secondary or pleiotropic effects and may indicate environmental impacts (e.g., changes in nutritional quality of seeds affecting birds).

3.4 Compare the PNT and its counterpart(s) with respect to levels of known naturally expressed toxicants, antinutrients and allergens known for that species.

4. Cultivation of the PNT

4.1 Description of area of cultivation

1. Describe the regions in Canada where the species is currently cultivated
2. Will the modification permit cultivation of the species in regions in Canada outside the area of current cultivation? If so, in what new regions might the PNT be cultivated? Describe the ecosystems in the new regions.

4.2 Description of cultivation practices

1. Describe the cultivation practices for the PNT, including land preparation, fertilizer usage, weed and pest control, harvest, post-harvest protocols, and other cultivation practices. Compare and contrast these practices from those traditionally used for this species. Discuss how such practices might influence agro-ecosystem sustainability, crop rotations, pesticide use, frequency of tillage, soil erosion and consequential changes in energy and soil conservation. Discuss in what ways any volunteer plants of the PNT may dictate altered management practices for succeeding crops?
2. Describe any specific deployment strategies recommended for this PNT? Deployment strategies might include geographic or temporal factors or integration with other practices.
   1. Insect Resistance Management - In the case of insect resistant PNTs, describe strategies intended to delay the development of resistance in target insect populations (see Section 7.5.1 within the Directive text for details).
   2. Herbicide Tolerance Management - In the case of PNTs developed for tolerance to a herbicide or class of herbicides, describe appropriate strategies that are intended to delay the development of herbicide tolerance weeds and avoid significant changes in weed biotypes (see Section 7.5.2 within the Directive text for details).

5. Interactions of the PNT with sexually compatible species

Determine whether there are any sexually compatible species in areas where the PNTs will be grown. If there are, then this section is applicable and the following questions should be considered.

5.1 Which sexually compatible species, if any, are found in areas where the plant will be cultivated, including any new areas of cultivation?

5.2 Characterize the compatible wild relative(s) with respect to weediness in managed ecosystems and/or establishment and spread into natural ecosystems

5.3 In what ways would the introduced trait itself be likely to change the ability of the PNT to interbreed with other plant species?

5.4 In cases in which there is a potential for gene flow from the PNT into sexually compatible species (e.g. same or related species as appropriate), describe the consequences for the offspring of such crosses. Characterization of the crosses between wild relatives and PNTs should be considered using the criteria described in Section 1 above for PNTs in order to address questions 5.4.1) and 5.4.2) below.

1. Is the introduced trait similar to a trait found currently in natural populations of the compatible wild relatives?
2. Does the introduced trait have the potential to increase the reproductive fitness or confer a selective advantage on the wild relative? If so would the introduced trait have a significant impact on the establishment and spread of populations of wild relatives? Consider the presence or absence of selection pressures.
   1. Is the potential for the trait to increase reproductive fitness or confer a selective advantage different than the potential for this to occur from a similar trait that may already exist for the same plant?

6. Residual effects and toxicity on non-target organisms

6.1 Characterize the extent to which the gene product has been a part of the human or animal diet.

6.2 Where applicable, characterize to what extent the introduced DNA directly or indirectly leads to the expression or altered expression of a toxin or other product that is known to affect metabolism, growth, development, or reproduction of animals, plants, or microbes?

6.3 Consider potential physiological and behavioral effects to other organisms including insect, avian, aquatic, or mammalian species in the areas where the plant will be cultivated, including any new area of cultivation.

Consideration may be given to:

• threatened and endangered species in the area where the plant is to be grown.
• beneficial organisms (pollinators, predators, parasites, biological control organisms, soil microbes)
• other appropriate non-target organisms

Consider levels and routes of exposure to all plant parts that express the gene, i.e., direct feeding or other exposure to the plant or plant part, dispersed plant parts, secretion, degradation, or leaching of the novel gene product, gene introgression, or organisms that have fed on the plant.

To address the possibility of persistent toxins in the environment or persistent changes in soil ecosystem function, applicants are encouraged to undertake residual effects studies. The residual effects of the PNT in comparison to the counterpart may be assessed by crop rotation studies or other techniques. Direct measurements in soil microbial communities may be indicated if microbial toxins are expected in root exudates.

6.4 Characterize potential adverse effects on the health of humans (including workers, adults, and children) which may arise through physical contact with or use of the PNT or its parts or its raw or processed products, other than for uses for which other authorizations or reviews are required (e.g. food, feed, pharmaceuticals). The analysis might include a comparison of the transgenic and non-transgenic counterpart(s) with respect to the likely exposure to toxins, irritants, and allergens.

7. Other environmental interactions

In the case of PNTs developed using plant viral coding regions, address synergy, facilitated movement, transcapsidation, and viral recombination. For a description of these terms, see the OECD "Consensus Document on General Information concerning the Biosafety of Crop Plants Made Virus Resistant through Coat Protein Gene-Mediated Protection" No. 5, 1996, OCDE/GD(96)162 (http://www.olis.oecd.org/olis/1996doc.nsf/LinkTo/ocde-gd(96)162).

Appendix 5 Application Package Checklist

Biology Document
Have you confirmed with the PBO that a biology document has been prepared for your species? (Note that biology documents used by the PBO are posted at  http://www.inspection.gc.ca/english/plaveg/bio/dir/biodoce.shtml as they are finalized). If not, have you enclosed a draft biology document for your species, following those on the PBO web site as an example? (See Section 7.2 of the Directive).

Core Characterization
Have you considered all the questions in Appendix 3?

Environmental Characterization
Have you considered all the questions in Appendix 4? Note that data from at least two seasons of trials in multiple locations in Canada or in a similar environment are normally required to address these questions.

Detection and Identification
Have you provided a detection method capable of distinguishing your PNT from other commercial cultivars of the same species? (See Section 7.4 of the Directive).

Food and Feed Use Approvals
If your PNT is intended for food and/or feed use, have you applied to the Novel Foods Section, Health Canada and/or the Feed Section, CFIA for food and/or feed use approval as appropriate? (See Section 8.2 of the Directive).

Special Crop Management Considerations
If your PNT carries a novel insect resistance, have you provided an appropriate Insect Resistance Management (IRM) plan (Please see Section 7.5.1 of this Directive)? If your PNT carries a novel herbicide tolerance, have you provided an appropriate Herbicide Tolerance Management (HTM) plan? You are encouraged to work with seed distributors, extension personnel and growers to develop and implement an appropriate HTM plan for your PNT (Please see Section 7.5.2 of this Directive).

Please note that the PBO's decision with regards to authorizing the environmental release of a PNT expressing either a novel insect resistance or a novel herbicide tolerance, 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 in question into the environment.

Post-Release Monitoring Plan
You must provide a general plan for post-release monitoring of environmental effects of your PNT (see Section 7.6 of the Directive).

Payment
Have you enclosed the application fee, according to the guidelines provided in http://www.inspection.gc.ca/english/plaveg/bio/feepaie.shtml? Please note that review of your application may not begin until your payment has been received.