Government of Canada
Symbol of the Government of Canada
Skip to content | Skip to institutional links

Common menu bar links

Animals > Veterinary Biologics > Guidelines / Forms

Institutional links

Veterinary Biologics Guideline 3.2E
Guideline for the Regulation of Veterinary Biologics
produced by Biotechnology

Table of Contents

  • 1.0 Regulation of Veterinary Biologics
    • 1.1 Manufacturing Protocols
    • 1.2 Importation of Veterinary Biologics
    • 1.3 Exportation of Veterinary Biologics
    • 1.4 Confidentiality of Proprietary Information
  • 2.0 Guidelines for the Licensing of Biotechnological Veterinary Biologics
    • 2.1 General Comments
    • 2.2 Classification of Biotechnological Veterinary Biologics
    • 2.3 Procedures for Licensing of Biotechnological Veterinary Biologics
    • 2.4 Laboratory Monitoring of Veterinary Biologics\
    • 2.5 Environmental Release of Live Genetically Engineered Veterinary Biologics
      • 2.5.1 Regulatory Requirements for Development, Field Testing and Licensing of Live Genetically Engineered Veterinary Biologics
      • 2.5.2 General Information on the Application for Field Testing of Live Genetically Engineered Animal Pathogens
      • 2.5.3 Environmental Assessment Requirements for Field Testing and Licensure
      • 2.5.4 Requirements for Field Testing and Licensure
        • 2.5.4.1 Physical Requirements of the Facility
        • 2.5.4.2 Sanitation and Security
  • 3.0 Literature Consulted

1.0 Regulation of Veterinary Biologics

The Health of Animals (HofA) Act and the Regulations administered by the Canadian Food Inspection Agency (CFIA) gives authority to the Canadian Centre for Veterinary Biologics (CCVB) of the Animal Health and Production Division (AHPD), to regulate the production, evaluation, importation and registration of veterinary biologics in Canada. The Health of Animals (HofA) Act, Section 2, provides the following definition: veterinary biologic means

  1. a helminth, protozoa or micro-organism,
  2. a substance or mixture of substances derived from animals, helminths, protozoa or micro-organisms, or
  3. a substance of synthetic origin that is manufactured, sold or represented for use in restoring, correcting or modifying organic functions in animals or for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state, or the symptoms thereof, in animals;

This definition provides the mandate to regulate any product claiming to be a veterinary biologic, produced by modern techniques of biotechnology or by conventional methods.

In Section 2 of the Regulations a number of definitions relating to Veterinary Biologics such as "establishment license "and "manufacture" are included. Of particular interest on this subject is the description of product outline:

"product outline" means a detailed description of

  1. the process followed in preparing a veterinary biologic and any diluent to be used therewith,
  2. the methods and procedures to be employed in handling, storing, administering, and testing a veterinary biologic and any diluent to be used therewith, and
  3. the tests used to establish the purity, safety, potency, and efficacy of a veterinary biologic, and the purity and safety of any diluent to be used therewith, and the results of all such tests.

The detailed description of the process followed in preparing a veterinary biologic would indicate whether the product is derived from traditional processes or from new methods of biotechnology.

Paragraph (c) mentions the need for tests that are used to establish purity, safety, potency and efficacy of conventional products. It will be necessary to specify tests to establish the purity, safety and potency of genetically engineered products. The definition of safety for live genetically engineered products, includes the assessment of both animal and human health risks as well as environmental impact. A detailed Environmental Assessment will be required to establish the safety of the live genetically engineered products. After the product has passed the different criteria established for purity, safety and potency, field trials may be authorized in order to collect information that may be used to support full licensure. The conditions of the field trial will be assessed on a case-by-case basis. Since the guidelines proposed for the evaluation and release of biotechnology products can only be general in nature, specific needs for each product will be determined by CCVB staff in consultation with the manufacturer or the researcher.

Section 64.1 (s) of the Act provides the regulation making authority to the Governor in Council for prohibiting or regulating the importation, preparation, manufacturing, preserving, packing, labelling, storing, testing, transportation, sale, conditions of sale, advertising for sale, use and disposal of veterinary biologics and regulating their purity, potency, efficacy and safety.

In order to expedite the licensing procedures the manufacturers are encouraged to start communicating with the CCVB staff as early as practical during the developmental stage. Manufacturers from the United States of America (USA) must submit a copy of their United States (US) Veterinary Biologics Establishment License and a copy of the US Veterinary Biological Product License. Manufacturers from other countries must submit a copy of the documentation appropriate to their country.

1.1 Manufacturing Protocols

Canadian and foreign manufacturers must provide data to license a veterinary biologic for sale in Canada.

A current Outline of Production, with Special Outlines for all testing procedures and labels should be submitted for approval. The master seeds used for the preparation of veterinary biologics must be demonstrated to be pure, safe and immunogenic by accepted test methods. Cell lines, or primary cells if used, must provide evidence of being pure and safe. Serum, media or any other ingredients used in the preparation of the veterinary biologic must be demonstrated to be free of contaminants by accepted test protocols.

Before licensing the product, test results obtained from 3 pre-licensing serials for purity, potency, safety and efficacy are to be submitted. After licensing, each serial of final product is tested for sterility, potency and safety according to accepted methods including, analysis for preservatives and moisture content, if applicable. The format in which data is presented is described in other guidelines on the CCVB website.

Data must be provided to demonstrate and support the safety, purity, potency, efficacy and stability of the product and support label and advertising claims. This is usually provided as research and development data (including laboratory and animal studies) and field trial data. If needed, field trial data maybe generated in Canada.

1.2 Importation of Veterinary Biologics

For the importation of veterinary biologics, a Canadian importer must be designated by the foreign manufacturer and inspected and approved by CFIA. Similarly, the foreign manufacturers and their manufacturing premises are to be inspected and approved.

A Single entry permit is issued for one shipment of the product described on the permit and expires when that shipment has cleared customs. A Temporary permit is issued for those products that require pre-clearance, for example, vaccines that require a blue tongue virus exclusion test. The permit is valid throughout the expiration period for the serial(s) of the product(s) designated on the permit and multiple shipments may be made on the original permit. An Annual permit is issued for the majority of products which have been found acceptable for importation and which do not require special tests or pre-clearance.

The results of tests on each lot or serial must be provided for single entry and temporary permits prior to issuance of the import permit and for annual permits at the time of shipment. For products produced in the US, this would include but not necessarily be limited to, information provided on APHIS Form 2008. A copy of the invoice from the Canada Border Services Agency for all products imported into Canada (on single entry, temporary or annual permit) must be provided. This information is for statistical purposes only and is kept strictly confidential. Canadian manufacturers must provide data on amount of product produced for the same reason.

1.3 Exportation of Veterinary Biologics

The requirements that apply to all veterinary biologics manufactured, distributed or sold in Canada, also apply to products intended for export.  On a case by case basis, a product may be licensed "For Export Only" provided that it meets the requirements of the destination country's regulatory agency.  For example, confirmatory serial release testing by the Biologics Evaluation Laboratory (BEL) of CFIA could be waived, if the manufacturer provides a letter from the regulatory agency of the importing country stating that the manufacturer's testing is sufficient to meet their licensing requirements.

If required by the importing country, CCVB will issue a Veterinary Biologics Export Certificate stating that the manufacturer is registered to manufacture and sell a particular product under the Health of Animals Act and Regulations.

1.4 Confidentiality of Proprietary Information

The CFIA is subject to Canadian legislation including the Access to Information Act and Privacy Act, as well as administrative procedures and court orders. The CFIA will treat all information that it may receive from manufacturers of veterinary biologics in accordance to such legislation, administrative procedures and court orders.

All information provided by the manufacturer is for the regulatory use by CCVB, and is held in strict confidence.

2.0 Guidelines for the Licensing of Biotechnological Veterinary Biologics

2.1 General Comments

It is recommended that the focus for licensing veterinary biologics including genetically engineered products should be on the product to be regulated and not on the process. This approach is consistent with that taken by the USA and internationally by the World Organisation for Animal Health (OIE).

Veterinary biologics include animal vaccines, diagnostic kits antibody used in the diagnosis, treatment, mitigation or prevention of infectious diseases of animals. It is generally recognized that the new biotechnology products do not differ significantly from products produced by conventional methods. Although the methods used in the production of biologics or in the construction of recombinant organisms or other products are carefully assessed in the regulatory process, the emphasis of regulation is on the product and its intended use, rather than on the methods used in its development. It has been resolved that the definition of veterinary biologics as included in the HofA Act covers products produced by conventional and new techniques of biotechnology. Therefore, the regulation of the products will be conducted under the current legislation. However, an amendment in the regulations may be needed to determine that the vaccines containing genetically manipulated living organisms are safe not only to animals but also for humans and the environment. If additional reviews are needed for environmental and human safety, CFIA will approach Environment Canada and Health Canada.

The majority of the veterinary biologics sold in Canada are imported from the USA. It is likely that for a Canadian licensed product, the biggest share of the export market will be in the USA. For the veterinary biologics to move freely, it is desirable that our guidelines for licensing of veterinary biologics be in harmony, especially with those, of the USA, and other trading partners namely, the United Kingdom, other European Union countries, Australia and New Zealand.

Veterinary biologics produced by new techniques are now being evaluated on a case-by-case basis using the same standards for product safety, purity, potency and efficacy required for licensing of conventionally produced products.

It is important that the regulatory procedure be based on scientific knowledge, and that the procedures used, be sensible and flexible but not restrictive. It is recognized by regulators and the scientific community that there is limited risk if the release of a biotechnology product is properly planned. Risks can be further minimized if they are evaluated and carefully considered at the outset. A genetically manipulated microorganism may not always exhibit the expected characteristics, however, early laboratory studies and contained animal trials are usually used to reveal such unplanned outcomes.

It is imperative that the public have confidence in federal regulations and the safety of biotechnology products especially the live genetically engineered products released into the environment. Depending on the complexity of the genetically engineered product, it may be necessary that the proposal be forwarded to a committee of experts. The membership of the committee would be flexible and could change according to the expertise required for the evaluation of a particular product. The final approval for field trials and licensing of the product will be the responsibility of the Animal Health and Production Division.

As mentioned earlier, veterinary biologics produced by biotechnology must be shown to be pure, safe, potent and efficacious. Assurance of safety for all products will include a requirement that the products do not have adverse effects upon the environment and do not harm animal or human health. Accordingly, information that must be provided by manufacturers and researchers includes data on molecular and biological properties of the master seed, including data from parental organisms, data to support the safety of genetically engineered products inapplicable species of target and non-target animals, information on purity (including genetic and phenotypic stability), immunogenicity studies to demonstrate efficacy, and results to support the potency of the product. The genetic information to be added or deleted must consist of well-characterized DNA segments. Information required regarding molecular properties may include sequence information from recipient, donor and recombinant organisms; description of the cloning site and genetic markers if present; genetic modification procedures used to construct genetically engineered including information on intermediate cloning vectors as well as phenotypic characterization of the altered organism. Biological characterization will include information on comparisons between the engineered organism and its parent strain with respect to biochemical pathways, virulence traits, host range, tissue distribution and other factors affecting pathogenicity. In addition, data on the environmental distribution, survival and spread, and potential to recombine with other organisms must be provided. Concerns for the safety to humans and animals, and the impact on the environment, must be addressed during the Environmental Assessment before live products can be considered for limited field trials or licensing. Input from the public in the form of expert committee consultations may also be required to complete the licensing process.

2.2 Classification of Biotechnological Veterinary Biologics

Veterinary biologics produced by new biotechnological techniques (genetically engineered products or hybridomas) are classified into the following two broad classes (Table I); depending on the biological characteristics of the new products and on safety aspects.

Table I. Classification of Biotechnology Veterinary Biologics

Class I

Inactivated genetically engineered viral vaccines.
Inactivated genetically engineered bacterial vaccines.
Viral, bacterial or other sub-units, cytokines.
Monoclonal antibody (hybridoma) products.
Vaccines containing live organisms modified by gene insertion or deletion (No introduction of foreign DNA)

Class II

Vaccines using a live vector to carry recombinant derived foreign genes.
Vaccines containing live organisms modified by gene insertion or deletion (introduction of "foreign" DNA).

Class I includes products prepared from recombinant derived inactivated organisms such as viruses, bacteria, bacterin-toxoids, viral  sub-units or bacterial sub-units, cytokines; and monoclonal antibody products that are used prophylactically, therapeutically or as components of diagnostic kits. The non viable products in Class I pose little risk to the environment and present no new or unusual safety concerns. Live products in this class contain organisms resulting from deletions, single base changes, and rearrangements within a single gene. In these cases data may be needed to establish environmental safety. These products are similar to modified live vaccines which have been used without any unexpected risks for decades. However, this type of product could be subjected to the same licensing process as used for the live products of Class II.

Class II includes products containing live microorganisms that have been modified and involve introduction of DNA from different organisms or different strains of the same organism. This Class consists of products using live vectors to carry one or more foreign genes that code for immunizing antigens and/or immune stimulants, and are capable of efficiently infecting and immunizing host animals. Deleted genes in Class I or Class II live products may code for virulence, oncogenicity, enzyme activity, or other biochemical functions. Added genes may result in the expression of unique marker antigens or the production of novel biochemical byproducts. Precautions must be taken to ensure that this addition or deletion of specific genetic information does not impart increased virulence, pathogenically, or survival advantages in these organisms, greater than those found in natural or wild-type forms. Modification must not impart undesirable new or increased adhesive or invasive factors, colonization properties, different survival within the host, oncogenic properties or other deleterious effects. It is important that genes added or deleted do not compromise the safety characteristics of these organisms. In most cases their safety characteristics are improved, so that they do not pose any new threat to humans, or other animal species, or to the environment.

Additional information required by CCVB for licensing live genetically engineered products may include (but is not necessarily limited to) detailed descriptions of the molecular and biological properties of parental and recombinant organisms; methods used in the construction of recombinant organisms and screening techniques for identification; in vitro and in vivo data to demonstrate the genetic and phenotypic stability of the construct; information on the potential for horizontal gene transfer or recombination and data from animal experiments to demonstrate safety of the product. Safety data required may include studies documenting non-pathogenically and non-reversion to virulence by a number of back passages in the host animal, studies to determine the fate of the microorganism when injected into the host, and the ability of the organism to multiply, shed, transmit and maintain itself in target and non-target animal populations. Manufacturers may also be requested to define the stability and survival of the organism in the environment and to provide information on the environmental and geographic distribution of parental organisms. The organism's host range, specificity and tissue tropism, as well as it stability to adapt and to affect other species will also be investigated. Potential human health and safety risks will be assessed in collaboration with Health Canada, on the basis of known molecular and biological properties of parental organisms and by safety studies conducted in animals including those in non-human primates. A similar collaborative approach to regulation involving Environment Canada will be used in the evaluation of environmental impact of live genetically engineered products.

2.3 Procedures for Licensing of Biotechnological Veterinary Biologics

The general requirements for licensing biotechnology products are similar to those for conventional products. See the CCVB web site.

Veterinary biologics produced by new techniques of biotechnology such as genetic engineering, chemical synthesis, hybridoma technology may require special assays for potency and stability determinations. Additional tests may be required to assure safety, especially when live microorganisms are present.

In order to maintain uniformity of production, manufacturers are required to obtain seed materials for production from a lot of seed material which is defined as the Master Seed. Master seed and final product are tested to assure purity, safety, identity and immunogenicity.

Genetically engineered Master Seeds from both Class I and Class II categories will be fully characterized by the criteria listed in section 2.5.3. which requires the submission of detailed descriptions of the molecular and biological properties, and data to evaluate the target and non-target animal safety, potential human safety risks and environmental impacts. Immunogenicity of vaccines must be supported by statistically valid host animal immunization and challenge studies.

The manufacturer must prepare "Outlines of Production" that include procedures to ensure consistency and recovery of specific antigenic material. Recovery procedures must include removal of excessive antibiotic levels and undesirable fermentation by-products such as excessive bacterial endotoxins. Some in-process test procedures which might be used for monitoring purposes are (but not necessarily limited to): gel electrophoretic profiles; immunoassays such as western blotting or radio-immunoassays; molecular biological techniques such as polymerase chain reaction and southern blotting; and determination of characteristics such as antibiotic resistance, metabolic markers, molecular weight, biological activity, growth rate and percent protein. Specific techniques to be used for monitoring biotechnology products will be determined on a case by case basis.

For each serial release of the final biotechnology product testing for purity, safety and potency will be required. Standard procedures will be applicable for purity, potency and efficacy. Safety procedures may entail expanded laboratory and field testing programs. In addition to these tests, product characterization will be required to demonstrate gene expression. Some examples of the techniques that can be used are: partial sequence analysis, immuno-screening, high performance liquid chromatography, peptide mapping, poly-acrylamide gel analysis and molecular weight determination.

2.4 Laboratory Monitoring of Veterinary Biologics

The BEL, located at the CFIA-Ottawa Laboratory (Fallowfield), Ottawa, Ontario, was established in 1986. Its mandate is to develop and conduct quality assurance monitoring tests for animal biologicals including vaccines and diagnostic test kits. It monitors manufacturers quality assurance programs for purity, potency, safety, and efficacy through an active laboratory testing program and the review and monitoring of animal trials.

BEL describes its test methods in Quality Assurance Monitoring Protocols (QAMPs). Because BEL is at arms length from actual licensing, it advises its client group, CCVB. It often works collaboratively with industry at the technical level to develop more meaningful quality assurance tests. The intent is to support the regulation of products of biotechnology in an efficient and scientifically contemporary fashion.

2.5 Environmental Release of Live Genetically Engineered Veterinary Biologics

The movement of live biotechnological veterinary products of Class I and Class II from contained laboratory research to a fully licensed product for unrestricted distribution can be accomplished in four stages:

  1. Laboratory research and development.
  2. Controlled containment experiments using target and non-targeted animal species.
  3. Limited field trials using target species.
  4. Licensing of the product.

The regulatory conditions to be met for each stage are summarized in Section 2.5.1.

The authorization of protocols proposed for experiments at stages II-IV will be evaluated on a case-by-case basis by the CCVB.

The movement of the live-recombinant DNA product from Stage II to Stage III for limited field trials outside the controlled containment facilities will require a complete submission on the product including safety data from stage I and stage II experiments. At this stage, an Environmental Impact Assessment Statement (EIAS) will be prepared by CCVB based on the information provided by the manufacturer/researcher before authorization of the field trial. CCVB may request BEL to conduct assurance tests on the product before finalizing the EIAS.

The specific details needed for the environmental assessment can be provided in the format described under section 2.5.3. This format is comparable to that used by the Biotechnology Regulatory Services of USDA. Additional information required by CCVB for the preparation of EIAS will be determined on a case by case basis and communicated to manufacturers or researchers.

2.5.1 Regulatory Requirements for Development, Field Testing and Licensing of Live Genetically Engineered Veterinary Biologics

Stage I : Laboratory Research and Development under contained conditions.

  1. Follow Public Health Agency of Canada's Laboratory Biosafety Guidelines, 2004.
  2. Follow Guide to the Care and Use of Experimental Animals current version, developed by the Canadian Council for Animal Care.

The research and development work in the first stage will be conducted entirely under the control of the Institutional Biohazard/Biosafety Committee following the above guidelines.

Containment is a condition under which the movement of an organism is limited by one or more of the following mechanisms.

  1. A set of standard practices that are generally used in microbiological laboratories.
  2. Special procedures, equipment and laboratory installations that provide physical and other barriers which are applied in various degrees according to the estimated biohazard.
  3. Biological barriers that limit either (a) the infectivity of a vector or vehicle (plasmid or virus) for specific hosts or (b) its dissemination and survival in the environment (NIH guidelines for research involving Recombinant DNA molecules).

Stage II Controlled containment experiments using target and non target animal species.

The physical containment facilities for the second stage will be almost equivalent to those for Stage I but the conditions can be negotiated upon review of the data generated at Stage I.

Stage III Limited field testing on target species under confined conditions or large scale field trials.

  1. Evaluation on case-by-case basis.
  2. Submit the data to the CCVB for review in the format suggested in Sections 2.5.2 and 2.5.3.
  3. Laboratory evaluation may be sought through the BEL, CFIA.
  4. Preparation of Environmental Assessment Statement by CCVB.
  5. Consultation with other federal departments, technical experts and other stakeholders as needed.

Confinement is a condition under which the movement of experimental animals is confined within a designated outdoor environmental zone of control with designated borders or limits. Recommended Codes of Practice for the Care and Handling of Farm Animals should be consulted. These Codes of Practice are available from AHPD, CFIA.

Field testing: Under the HofA Act and the Regulations, it is proposed to write separate guidelines to regulate the field testing of veterinary biologics.

Experiments involving the release of Class I, i.e. live gene deleted organisms or Class II veterinary biologics from laboratory physical containment to confined field conditions requires AHPD approval.

On receipt of a submission made by a manufacturer/researcher for permission to conduct a field test (i.e. in a confined area), the AHPD determines the action that needs to be taken at this stage. This involves a comprehensive consideration of the environmental effects of the proposed activity and the risks associated with human and animal health.

In addition to the information required under Sections 2.5.2, 2.5.3 and 2.5.4 for the Environmental Assessment Impact Statement, the manufacturer must submit the following information with each submission:

  1. A description of the product, serial numbers of product to be used, recommendations for use, and results of preliminary research conducted in containment, including satisfactory purity and safety test results for each serial of product to be used.
  2. A proposed general plan covering the methods and procedures for evaluating the products and for maintaining records of the quantity of the experimental product prepared, shipped, and used. The plan should identify proposed methods of biological or physical control and retrieval.
  3. A tentative list of the names and addresses of the proposed recipients and the quantity of experimental product which is to be shipped to each individual.
  4. Copies of labels or label sketches with the statement "Notice! For Experimental Use Only - Not For Sale" or equivalent.

The CCVB will provide necessary information to the provincial authorities in which the trial is going to be conducted for their evaluation. In case where there is overlap of jurisdiction, necessary recommendations and approval will be sought from the appropriate federal regulatory agency. Confined field trials will be conducted under quarantine conditions acceptable to the CCVB where there is adequate evidence of biological and/or physical control of the genetically engineered organism. Facilities shall be maintained and operated in an appropriate way to prevent the dissemination of any communicable disease. Test facilities may be inspected by an officer of the CCVB to determine whether they comply with the following guidelines.

The application for the field trial will be evaluated and a decision to approve or reject the acceptance of the trial will be made within 90 days after the submission of the complete information. A field trial can be initiated 30 days following approval.

Stage IV Complete Submission including field trial results for product license.

The product is registered and is licensed for sale in Canada when all requirements of the HofA Act are fulfilled.

For the fourth Stage of granting the license for the manufacture and sale of the live recombinant product, the applicant must submit all necessary information including test results of the limited field trial for stage III. The data must demonstrate that the product is safe, potent and efficacious. Once the product is licensed, it can be released for distribution, either with or without restrictions and can be used in the target species according to the approved label instructions.

2.5.2 General Information on the Application for Field Testing of Live Genetically Engineered Animal Pathogens

  1. CCVB Reference Number.
  2. Name and Address of the Organization/Institution/Commercial Company:
  3. Project Title:
  4. Supervising Institutional Biosafety/Biohazard Committee (IBC).
  5. Project Supervisor/Principal Investigator:
  6. Location of trial site (complete address and map).
  7. Date of field trial.
  8. Tentative date of completion of trial.
  9. Indicate scale of field test (animals involved).
  10. What is the size, scale and timing of anticipated future trials.
  11. Detailed assessment of the IBC. -- This should include a detailed evaluation of the proposal, the adequacy of the experimental design, site selection and contingency plans.
  12. Communication plan.
  13. Federal funding used in the research and development of the genetically modified animal pathogen.
  14. Signature of the Principal Investigator.
  15. Signature of the Chairperson of the IBC.
  16. Signature of Regulatory Affairs Manager of manufacturer/Veterinary Biologics company.

2.5.3 Environmental Assessment Requirements for Field Testing and Licensure

  1. Introduction:
    • Proposed action: objectives, location and protocols.
    • Background: provide information on problem/action.
  2. Purpose and need for proposed action:
    • Significance: agricultural, scientific.
    • Background: provide rationale for action.
  3. Alternatives:
    • Available choices and their relative scientific merits.
    • Discuss selection criteria and weight given to each alternative.
    • Justify selection of proposed action.
  4. Molecular and biological characteristics of parental and recombinant organisms:
    • Identification, sources, and strains of parental organism.
    • Source, description, and function of foreign genetic material.
    • Method of accomplishing genetic modification.
    • Genetic stability, phenotypic stability, and potential for recombination. Host range/specificity, tissue tropism and shed/spread capabilities.
    • Comparison of the modified organisms to parental properties.
    • Route of administration/transmission.
  5. Human Safety:
    • previous safe use.
    • Probability of human exposure.
    • Possible outcomes of human exposures.
    • Pathogenicity of parent microorganisms in man.
    • Effect of gene manipulation on pathogenicity in man.
    • Risk associated with widespread use of the vaccine.
  6. Animal Safety:
    • Previous safe use.
    • Fate of the vaccine in target and non-target species.
    • Potential for shed and/or spread from vaccinate to contact target and non-target animals.
    • Reversion to virulence resulting from back passage in animals.
    • Effect of overdose in target and potential non-target species.
    • Relative safety when compared to conventional vaccines.
    • The extent of the host range and the degree of mobility of the vector.
    • Safety in pregnant animals and to offspring nursing vaccinated animals.
  7. Affected Environment:
    • Identify site.
    • Discuss effects of alternatives on each aspect of the environment.
    • Ecological concerns.
    • Extent of release into the environment.
    • Persistence of the vector in the environment /cumulative impacts.
    • Extent of exposure to non-target species.
    • Behavior of parent microorganisms and vector in non-target species.
    • Potential of vector to infect non vertebrate organisms.
    • Physical and chemical factors which can affect survival, reproduction and dispersal of the vector.
  8. Environmental Consequences:
    • Discuss program action problems/benefits/potential hazards.
    • compare benefits and problems of the experimental vaccine with licensed products
  9. Mitigative measures:
    • Worker safety.
    • Non-worker human safety.
    • Handling of vaccine.
    • Handling vaccinated or exposed animals.
    • Other.
  10. Monitoring:
    • General.
    • Human.
    • Animal.
  11. Consultation and coordination with other agencies, organizations, and persons:
    • List all contacts.
    • Identify comments, if any.
  12. Conclusion and Summary
    • List all references cited or relied upon.
    • Include personal communications.
  13. References:
    • List all references cited or relied upon.
    • Include personal communications.
  14. Appendices:
    • Tables, figures and maps.
    • Reports.

2.5.4 Requirements for Field Testing and Licensure

2.5.4.1 Physical Requirements of the Facility

Generally the facility should be located and constructed so as to prevent test animals from having physical contact with other animals outside the facility. The holding area should be of sufficient size to prevent overcrowding of animals in quarantine.

The facilities should be constructed with materials which can withstand cleaning and disinfecting. Doors, windows and other openings should be provided with screens to prevent birds and insects from entering. A safe and effective program will be required to control insects, ectoparasites, and avian and mammalian pests. Facility specifications shall comply with applicable federal, provincial and local laws, and regulations relating to pollution control and the protection of the environment.

2.5.4.2 Sanitation and Security

The applicant shall arrange for a water supply adequate for use in cleaning and disinfecting the facility. All feed and bedding used in the approved quarantine facility shall originate from an area not under quarantine and shall be stored in the test facility in a vermin-proof storage area. If needed, facilities must be adequately equipped to incinerate, or effectively disinfect bedding and solid waste at the conclusion of the study.

3.0 Literature Consulted

  1. Access to Information Act and Privacy Act.
  2. The Health of Animals (HofA) Act.
  3. Code of Federal Regulations 9, parts 1 to 199. Animal and Animal Products. Office of the Federal Register, National Archives & Records Administration. USA.
  4. Laboratory Biosafety Guidelines, 2004. Office of Laboratory Security, Public Health Agency of Canada, Ottawa, Ontario, K1A 0K9.
  5. Proceedings of the Workshop on the Regulation of Agricultural Products of Biotechnology, 1988. Canadian Agriculture Research Council, Ottawa, Ontario.
  6. Recommended Codes of Practice for the Care and Handling of Farm Animals. Originally published by Agriculture and Agri-Food Canada and the Canadian Agri-Food Research Council.

Top of Page
Important Notices