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Applications of Biotechnology for Livestock and Animal Health Products (Technical Item II) Anne A. MacKenzie Canadian Food Inspection Agency 73 rd General.

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Presentation on theme: "Applications of Biotechnology for Livestock and Animal Health Products (Technical Item II) Anne A. MacKenzie Canadian Food Inspection Agency 73 rd General."— Presentation transcript:

1 Applications of Biotechnology for Livestock and Animal Health Products (Technical Item II) Anne A. MacKenzie Canadian Food Inspection Agency 73 rd General Session – International Committee World Organisation for Animal Health May 23, 2005

2 Outline Introduction Introduction Techniques Techniques Applications Applications Risk Assessment Risk Assessment Regulatory Framework Regulatory Framework Questionnaire Responses Questionnaire Responses Conclusion Conclusion

3 Techniques Four Generations of reproductive biotechnologies Four Generations of reproductive biotechnologies Artificial insemination Artificial insemination In-vivo derived embryos In-vivo derived embryos In-Vitro fertilised embryos, sorting, ovum, pickup, cloning In-Vitro fertilised embryos, sorting, ovum, pickup, cloning Functional deletion and addition of specific genes Functional deletion and addition of specific genes Combinations of Trangenesis Combinations of Trangenesis Propagation by somatic cell nuclear transfer Propagation by somatic cell nuclear transfer

4 Techniques Cloning Cloning Inefficient – success rate 6-10% Inefficient – success rate 6-10% Concerns Concerns Higher losses in pregnancy Higher losses in pregnancy Placental dysfunction Placental dysfunction Incorrect epigenetic reprogramming Incorrect epigenetic reprogramming Post natal complications Post natal complications Transgenesis Transgenesis Rapidly improving techniques Rapidly improving techniques Uses Uses Human medicine Human medicine Donors – xenotransplantation Donors – xenotransplantation Research Research

5 Applications 1. Embryo Transfer North America – 190,000 Anually North America – 190,000 AnuallyBenefits Disease Control Disease Control Transboundary Movement of Livestock Transboundary Movement of Livestock Sexed Sperm and Sexed Embryos Sexed Sperm and Sexed Embryos

6 Applications 2. Nuclear transfer Cloning Benefits Multiplication of desired traits Multiplication of desired traits Conservation of animal germplasm Conservation of animal germplasm Research models Research models Association with transgenic applications Association with transgenic applications

7 Applications 3. Transgenesis Disease resistant animals Disease resistant animals Improved meat-milk-wool Improved meat-milk-wool Biopharm animals Biopharm animals 4. Xenotransplantation Alternative to human donors for transplanted organs Alternative to human donors for transplanted organs

8 Applications 5. Vaccines 3 considerations, both advantages and disadvantages depending on product Efficacy: may be improved over killed vaccines, may be more thermostable antigens (eg. Plant) Efficacy: may be improved over killed vaccines, may be more thermostable antigens (eg. Plant) Purity: may be less risk of contamination in ingredients, may be able to eliminate toxins Purity: may be less risk of contamination in ingredients, may be able to eliminate toxins Safety: Safety: the most important potential advantage the most important potential advantage may be safer than attenuated live vaccines, but could other human or environmental safety issues with novel products may be safer than attenuated live vaccines, but could other human or environmental safety issues with novel products

9 Risk Assessment Conventional Identification of hazards: infectious disease. Release assessment Release assessment Exposure assessment Exposure assessment Consequence assessment Consequence assessment Risk estimations Risk estimations Genetically Engineered Identification of hazards- associated with infectious pathogens ALSO Identification of hazards related to the impact of the genetic modification ON ANIMAL HEALTH Identification of hazards related to the impact of the genetic modification ON ANIMAL HEALTHAND RA, EA, CA, RE. RA, EA, CA, RE.

10 Risk Assessment Questions: 1. How would subtle genetic hazards from genetically-engineered animals differ from the gene dysregulation arising in conventional animals? 2. How frequent do they occur compared to conventional animals? 3. Would these genetic hazards pose a risk? 4. Should they pose a risk, how to measure risks if they happen?

11 Regulatory Framework ISSUES TO CONSIDER: Environmental Impact Environmental Impact Food Safety Food Safety Animal Health and Welfare Animal Health and Welfare Trade Trade Ethics Ethics

12 Regulatory Framework Considerations: 1. High standards for human and animal health and welfare 2. Development of clear standards and guidelines for assessments 3. Provision of sound scientific basis to evaluate associated risks 4. Consultation and involvement of stakeholders in the development of regulations 5. Maintenance of genetic diversity and conservation of environment 6. Building upon existing regulations

13 Nanotechnology What is Nanotechnology? (NNI definition) “research and development (R&D) aimed at understanding and working with - seeing, measuring and manipulating- matter at the atomic, molecular and supramolecular levels. This correlates to length scales of roughly 1 to 100 nanometers. At this scale, the physical, chemical and biological properties of materials differ fundamentally and often unexpectedly from those of the corresponding bulk materials.” “research and development (R&D) aimed at understanding and working with - seeing, measuring and manipulating- matter at the atomic, molecular and supramolecular levels. This correlates to length scales of roughly 1 to 100 nanometers. At this scale, the physical, chemical and biological properties of materials differ fundamentally and often unexpectedly from those of the corresponding bulk materials.” Virus: nm Virus: nm Protein: 5-50 nm Protein: 5-50 nm DNA (width): ~2nm DNA (width): ~2nm

14 Nanotechnology Nanotechnology and Animal Health: Possible Applications “Smart” Drug Delivery Systems: targeted drug delivery targeted drug delivery monitoring effects of the delivery of pharmaceuticals, nutraceuticals, nutrients, food supplements, etc. monitoring effects of the delivery of pharmaceuticals, nutraceuticals, nutrients, food supplements, etc. Early disease diagnosis and treatment Early disease diagnosis and treatment Identity Preservation Identity Preservation Animal Breeding: e.g., real-time measurement of blood estradiol changes Animal Breeding: e.g., real-time measurement of blood estradiol changes

15 Ethics “the qualities that characterize and motivate a good scientist do not necessarily have any bearing on the ethical or sociological sequelae of discovery.” - Dr. Anfinsen “the qualities that characterize and motivate a good scientist do not necessarily have any bearing on the ethical or sociological sequelae of discovery.” - Dr. Anfinsen “A practical framework for ethical assessment of GM-animals,” – Dr. Kaiser “A practical framework for ethical assessment of GM-animals,” – Dr. Kaiser

16 Questionnaire Member Countries Responses Received Global16591 Africa4924 America2817 Asia2614 Europe4934 Middle East 132

17 Overall Questionnaire Response Total number of questionnaires sent = 167 Total number of questionnaires sent = 167 Total number of responses = 91 Total number of responses = 91 Response rate = 54.5% Response rate = 54.5%

18 Definitions 81 / 91 Agreed 81 / 91 Agreed Alternate Definitions: Alternate Definitions: Cartegena Protocol on Biosafety to the convention on Biodivesity Cartegena Protocol on Biosafety to the convention on Biodivesity Codex Alimentarius – Principles for the Risk Analysis of Foods Derived from modern biotechnology (CAC/gc ) Codex Alimentarius – Principles for the Risk Analysis of Foods Derived from modern biotechnology (CAC/gc )

19

20 Question 2: Key Considerations P L = proportion of respondents rating 1 or 2 P H = proportion of respondents rating 4 or 5 * = Comparison is statistically significant at the 5% level of significance.

21 Risk Analysis: Question 3 Respondents (n=91) Yes=40%, No=58% Respondents (n=91) Yes=40%, No=58% Do the animal health regulatory administrations and/or agencies in your country have the capability to conduct risk analysis (risk assessment, risk communication, risk management) on biotechnology derived livestock and biotechnology products?

22 Risk Analysis: Question 3 ( continued ) Respondents (n=36) Yes=64%, No=33% Respondents (n=36) Yes=64%, No=33% Yes: National FrameworkNo: Reasons Respondents (n=84) LK=26%, Tr=53% Respondents (n=84) LK=26%, Tr=53%

23 Risk Analysis: Question 4 Do the animal health authorities in your country have a dedicated unit that conducts risk analysis pertaining to biotechnology-derived livestock and biotechnology products? Respondents (n=91) Yes=15%, No=83% Respondents (n=91) Yes=15%, No=83% No Respondents (n=75) Risk Analysis Unit [82 responses] No Respondents (n=75) Risk Analysis Unit [82 responses]

24 Risk Analysis: Question 6 Respondents (n=91) Yes=25%, No=73% Respondents (n=91) Yes=25%, No=73% Have the animal health authorities conducted (or received a request to conduct) a risk analysis on biotechnology derived livestock or biotechnology products?

25 Risk Analysis: Question 7 Respondents (n=91) Yes=27%, No=66% Respondents (n=91) Yes=27%, No=66% Do the animal health authorities in your country make their risk analysis document available for peer review or for public consultation?

26 Risk Analysis: Question 7 ( continued ) Yes Respondents (n=25) OGP=38%, EV=27% Yes Respondents (n=25) OGP=38%, EV=27% Dissemination Method Peer Review Yes Respondents (n=25) IVS=45%, ER=25% Yes Respondents (n=25) IVS=45%, ER=25%

27 Risk Analysis: Question 8 Respondents (n=91) Yes=69%, No=20% Respondents (n=91) Yes=69%, No=20% Do you consider the “Guidelines for risk analysis” contained in the OIE Terrestrial Animal Health Code, adequate to help carry out an import risk analysis on biotechnology-derived animals or biotechnology-derived products?

28 Risk Analysis: Question 8 (continued)

29 Regulatory : Question 9 Respondents (n=91) Yes=34%, No=64% Respondents (n=91) Yes=34%, No=64% Has your country produced biotechnology-derived animals or biotechnology- derived products for use on animals?

30 Regulatory : Question 11 Respondents (n=91) Yes=48%, No=50% Respondents (n=91) Yes=48%, No=50% Do you have a regulatory framework in place to govern the use of the above?

31 Research : Question 12 Respondents (n=91) Yes=47%, No=51% Respondents (n=91) Yes=47%, No=51% Is research being conducted in your country into biotechnology-derived animals and products including vaccines and drugs?

32 Animal Vaccines : Question 13 Respondents (n=91) Yes=44%, No=54% Respondents (n=91) Yes=44%, No=54% Do you produce or use any animal vaccines in your country that are biotechnology-derived?

33 Animal Vaccines / Technologies: Questions 14 / 20

34 Technologies : Question 17 Respondents (n=91) Yes=12%, No=79% Respondents (n=91) Yes=12%, No=79% Is there a public support for cloning of animals?

35 Technologies : Question 18 Respondents (n=91) Yes=24%, No=74% Respondents (n=91) Yes=24%, No=74% Are there transgenic animals present in your country?

36 Technologies : Question 19 Respondents (n=91) Yes=42%, No=56% Respondents (n=91) Yes=42%, No=56% Does your country have the laboratory capacity to identify and detect transgenes in the food/feed supply?

37 Animal Vaccines / Technologies: Questions 14 / 20

38 Conclusion 1. Development of a definition for Biotechnology which can be agreed by OIE Member Countries. 2. Development of standards and guidelines for research on containment and environmental release of live attenuated vaccines in animal health. 3. Development of recommendations and guidelines for use of DNA vaccines in food animals. 4. Development of guidelines and recommendations for somatic cell nuclear transfer cloning – guidance for interspecies cloning, recognising that this process has the potential to increase the possibility for transmission of diseases between species. 5. Develop objective criteria for assessing the health of embryos and animals derived from cloning, and associated safety of cloned livestock and their products.

39 Conclusion 6. Develop policy guidelines for exclusion of unapproved animals and products from the livestock population, and segregation from the feed and food supply. 7. Develop identification, testing, and certification guidelines for international trade in livestock animals and their products for which biotechnology procedures have been employed to confer disease resistance. 8. Incorporate standards into relevant OIE documentation such as the Terrestrial Manual and the Terrestrial Code, as well as the companion standards for aquatic animals. 9. Development of guidelines relevant to the application of Nanoscience/Nanotechnology as it relates to animal health


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