Environmental assessment

Summary

Identify the veterinary biologic, its indication for use, and intended species.

1. Introduction

  • 1.1 Proposed action

    Introduce the reason and objectives behind the environmental assessment for a biotechnology-derived veterinary biologic (VB).

  • 1.2 Background

    Provide background information on the infectious disease, affected population, and the proposed action. For use of an unlicensed VB in a confined field trial, describe the study, identify the study location, and summarize the protocol. Append the study protocol.

2. Purpose and need for proposed action

  • 2.1 Significance

    What is the agricultural, animal health, and/or scientific significance of the biotechnology-derived VB?

  • 2.2 Rationale

    Summarize the rationale and criteria followed by the Canadian Centre for Veterinary Biologics to arrive at the final decision.

3. Alternatives

Discuss the available, alternative VB options and their relative scientific merits. What are the selection criteria and weight given to each alternative option? For proposed confined field trials, what are the implications if permission is not given? Justify the proposed action.

4. Molecular and biological characteristics of parental and recombinant organisms

Instructions to the evaluator: For sections 4 through 9 below provide information under each subsection heading for each topic. Use submitted information from the manufacturer's or researcher's licensing dossier and studies, peer-reviewed scientific publications, and expert opinions as the basis for this section. If applicable, reference past environmental assessments for similar biotechnology-derived VB.

  • 4.1 Identification, sources, and strains of parental organisms
  • 4.2 Source, description, and function of foreign genetic material
  • 4.3 Method of accomplishing genetic modification
  • 4.4 Genetic and phenotypic stability of vaccine organism
  • 4.5 Potential for recombination and horizontal gene transfer
  • 4.6 Host range/specificity, tissue tropism and shed/spread capabilities
  • 4.7 Comparison of the modified organism to parental properties
  • 4.8 Route of administration/transmission

5. Human safety

  • 5.1 Previous safe use
  • 5.2 Probability of human exposure
  • 5.3 Possible outcomes of human exposures
  • 5.4 Pathogenicity of parent microorganisms in humans
  • 5.5 Effect of gene manipulation on pathogenicity in humans
  • 5.6 Risk associated with widespread use of the vaccine

6. Animal safety

  • 6.1 Previous safe use
  • 6.2 Fate of the vaccine in target and non-target species
  • 6.3 Potential for shed and/or spread from vaccinate to contact target and non-target animals
  • 6.4 Reversion to virulence resulting from back passage in animals
  • 6.5 Effect of overdose in target and potential non-target species
  • 6.6 The extent of the host range and the degree of mobility of the vector
  • 6.7 Relative safety when compared to conventional vaccines
  • 6.8 Safety in pregnant animals and to offspring nursing vaccinated animals

7. Affected environment

  • 7.1 Extent of release into the environment and identification of study site
  • 7.2 Persistence of the vector in the environment/cumulative impacts
  • 7.3 Extent of exposure to non-target species
  • 7.4 Behaviour of parent microorganisms and vector in non-target species
  • 7.5 Physical and chemical factors which can affect survival, reproduction and dispersal of the vector

8. Environmental consequences

  • 8.1 Risks and benefits

    Compare and analyze the potential risks compared to benefits of proposed action, study or licensing of the biotechnology-derived VB.

  • 8.2 Relative safety compared to other vaccines

9. Mitigative measures

  • 9.1 Worker safety
  • 9.2 Non-worker human safety (hazards to public health and safety)
  • 9.3 Handling of vaccine
  • 9.4 Handling vaccinated or exposed animals (shed, spread of vaccine)
  • 9.5 Environment

10. Monitoring and record keeping

Indicate the permission to be issued and summarize specific conditions of VB use and record keeping for manufacturing, production, quality control (QC) testing, storage, distribution, use, and disposal of the VB, as applicable.

11. Consultation and contacts

Provide names and contact information for the VB manufacturer, researcher and/or importer, government departments, and topic experts consulted during the preparation of this environmental assessment.

12. Conclusion and actions

Summarize the decision and recommendations for use of the biotechnology-derived VB.

13. References

List of all references cited or relied upon, including peer-reviewed scientific publications, expert websites, and personal communications.

14. Appendices

  • Append tables, figures and maps of study sites, if applicable.
  • Append study protocols, final reports, and study deviations, if applicable.
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