Animal Cloning: A Draft Risk Assessment - Biotechnologie.de

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2. Evaluations Performed......................................................................................E8 3. CVM’s Analysis of Cyagra Data: Method........................................................E9 4. CVM’s Analysis of Cyagra Data: Results ......................................................E11 a. Comprehensive Veterinary Examinations ..................................................E11 b. Conclusions from Veterinary Examinations...............................................E13 c. Laboratory Values: Selection of Most Appropriate Comparator................E13 d. Conclusions Regarding Clone and Comparator Population Cohorts in Aggregate............................................................................................................E15 e. Animal and Analyte Specific Analyses ......................................................E16 i. Growth-Related Phenomena ...................................................................E18 f. Animals with Measurements at Different Developmental Nodes ..............E20 i. Age Range within 24 hours of birth (Charts E101 and E111)................E21 (a) Analyte Evaluation..........................................................................E22 (b) Animal Evaluation ..........................................................................E24 (c) Conclusions for Perinatal Period: Animal Safety ...........................E25 (d) Food Safety .....................................................................................E25 ii. Age Range 1 to 6 months (Charts E201 and E211)................................E26 (a) Analyte Review...............................................................................E26 (b) Animal Evaluation (1 to 6 months Age Group)..............................E27 (c) Conclusion for 1 to 6 month old group: Animal Safety..................E29 (d) Conclusion for 1 to 6 month old group: Food Safety .....................E29 iii. Age Range: 6-18 Months (Charts E301 and E311) ............................E30 (a) Analyte Analysis.............................................................................E30 (b) Animal Analysis..............................................................................E32 (c) Conclusions for 6-18 Month Group: Animal Safety.......................E33 (d) Conclusions for 6-18 Month Group: Food Safety ..........................E33 5. Charts and Tables............................................................................................E34 Appendix F: The Viagen Dataset ..............................................................F3 A. Background........................................................................................................... F3 B. Experimental Design............................................................................................. F3 1. Study 1: Clones vs. Comparators...................................................................... F5 a. Animal Health, Hematology, Clinical Chemistry, and Urinalysis................ F6 b. Boar Semen Evaluation................................................................................. F6 c. Farrowing Rate.............................................................................................. F6 2. Study 2: Progeny of Clone Boars vs. Progeny of Conventional Boars ............ F7 a. Statistical Analysis........................................................................................ F7 i. Methodology............................................................................................. F7 ii. Utility of Statistical Analysis as a Tool for Assessment of Outcomes ..... F9 b. Specific Methods for the Analysis of Animal Health, Hematology, Clinical Chemistry, and Urinalysis Data .................................................................. F10 c. Meat Composition, Carcass Characteristics, and Meat Quality Assessments for Clones, Comparators, and Progeny....................................................... F10 C. Results................................................................................................................. F11 1. Study 1 ............................................................................................................ F11 a. Survival....................................................................................................... F11
. Animal Health, Growth, Blood Clinical Chemistry, Hematology, and Urinalysis .................................................................................................... F12 c. Carcass Characteristics ............................................................................... F20 d. Meat Composition Analysis for Clones and Comparators ......................... F21 e. Semen and Breeding Evaluation................................................................. F23 f. Farrowing Rate............................................................................................ F24 2. Study 2: Progeny of Clones vs. Comparators ................................................. F26 a. Survival....................................................................................................... F26 b. Growth, Hematology, Clinical Chemistry, and Urinalysis......................... F32 i. Growth .................................................................................................... F32 ii. Hematology, Clinical Chemistry, and Urinalysis ................................... F34 c. Carcass Characteristics ............................................................................... F40 d. Meat Composition from the Progeny of Clones and Comparators............. F41 D. Conclusions from the Viagen Dataset................................................................. F46 1. Study 1: Clones vs. Comparators.................................................................... F46 a. Animal Health............................................................................................. F46 b. Food Safety ................................................................................................. F47 2. Progeny of Clone Boars vs. Progeny of Comparator Boars ........................... F47 a. Animal Health............................................................................................. F47 b. Food Safety ................................................................................................. F48 E. Addendum........................................................................................................... F49 Appendix G: Investigation on Attribues of Cloned Bovine Products: A Study Performed by the Ministry of Health of Japan........................ G3 A. Project Report of an Investigation of the Properties of Products from Cloned Cattle.................................................................................................................... G7 B. English language summary of the report “Investigation on the Attributes of Cloned Bovine Products”................................................................................... G11 C. Results of a 28-day feeding study in rats fed diets containing freeze dried milk or beef from ordinary cattle and clone cattle............................................. G21 Appendix H: The Comprehensive Veterinary Examination................. H3 A. Introduction to the Comprehensive Veterinary Examination .............................. H3 B. The Importance of Species-Specific Standards ................................................... H4 C. How a Veterinarian Performs a Comprehensive Veterinary Examination.......... H4 1. Specific Considerations for Neonatal CVEs.................................................... H6 2. Specific Considerations for Juvenile CVEs..................................................... H7 3. Specific Considerations for Mature Animal CVEs.......................................... H7 4. Specific Consideration for Reproductive Stage Examinations........................ H7 a. Males............................................................................................................ H7 b. Females ........................................................................................................ H8 D. Interpreting the Comprehensive Veterinary Examination for Animal Clones .... H9 E. Parameters Evaluated in the Comprehensive Veterinary Exam for a Risk Assessment........................................................................................................... H9
Page 1: Animal Cloning: A Draft Risk Assess
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Page 6 and 7: i. Peer-reviewed literature........
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Page 15 and 16: Preface
Page 17 and 18: Preface The following Draft Risk As
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Chapter III: Developing the Risk As
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Chapter IV: The Implications of Epi
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Chapter IV: Epigenetic Reprogrammin
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Chapter V: Animal Health Risks
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Chapter V: Animal Health Risks A. P
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Chapter V: Animal Health Risks 95 f
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Chapter V: Animal Health Risks 97 n
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Chapter V: Animal Health Risks 99 o
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Chapter V: Animal Health Risks 101
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Chapter VI: Food Consumption Risks
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Chapter VII: Summary and Conclusion
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Chapter VII Summary and Conclusions
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Glossary The following terms are de
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Glossary 313 chromosome(s) A struct
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Glossary 315 ectoderm The outermost
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Glossary 317 reprogramming cell’s
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Glossary 319 ketonuria Ketone bodie
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Glossary 321 nucleus The most consp
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Glossary 323 promoter A segment of
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Glossary 325 translation The second
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References Agca Y, Monson RL, North
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References 329 Bishop MD (2000) Clo
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References 331 CHANG MC (1959) Fert
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References 333 alpha(1,3)galactosyl
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References 335 Farin PW, Farin CE (
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References 337 Hajkova P, Erhardt S
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References 339 Ideta A, Urakawa M,
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References 341 King KK, Seidel GE,
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References 343 Li E (2002) Chromati
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References 345 National Academy of
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References 347 Pearson, H. Adult cl
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References 349 Reimers TJ, Lamb SV,
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References 351 Sebastiano V, Gentil
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References 353 Tamashiro KL, Wakaya
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References 355 Vonnahme KA, Wilson
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References 357 Wilmut I, Young L, D
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Appendix A: Risk and Safety Assessm
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Appendix B: Overall Reproductive Ef
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Appendix B :Overall Reproductive Ef
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Appendix C: Comparison of Outcomes
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Appendix C: Comparisons of Outcomes
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Appendix D: Transgenic Clones Anima
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A. Issues Appendix D Transgenic Clo
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Appendix D: Transgenic Clones D-5 o
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Appendix D: Transgenic Clones D-7 a
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Appendix D: Transgenic Clones D-9 w
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Appendix D: Transgenic Clones D-11
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Appendix D: Transgenic Clones D-13
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Appendix E: The Cyagra Dataset Anim
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Appendix E: The Cyagra Dataset A. R
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Appendix E: The Cyagra Dataset E-5
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Cyagra Inc. Table E-5: Cloned Birth
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Cyagra Inc. Table E-5: Cloned Birth
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Table E-100a: Individual Animal Cli
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Table E-100b: Individual Animal Hem
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Table E-200b: Individual Animal Cli
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Table E-300b: Individual Animal Hem
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Appendix F: The Viagen Dataset Anim
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A. Background Appendix F: The Viage
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Appendix F: The Viagen Dataset F-5
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Chart F-1 (Page 1): Summary of Clin
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Chart F-1 (Page 11): Summary of Cli
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Chart F-2 (Page 1): Summary of Hema
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Chart F-7 (Page 1): Summary of Urin
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Chart F-7 (Page 11): Summary of Uri
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Appendix G Investigation on the Att
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Appendix G Investigation on the Att
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Appendix G: The Comprehensive Veter
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A project aided by the Agriculture
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- Contents - Results of an investig
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Press Release 1 August 13, 2002 Liv
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(Material and method) The general c
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Table 1. General components (1) Mil
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Table 5. Feed study of milk and mea
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Table 1 Analyzed nutrient compositi
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Table 3 Body weights of male rats f
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Table 7 Urinary findings of male ra
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Table 11 Blood biochemical 6ndings
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TaUe 14 Absduw and rehtiw arm weigh
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Appendix 3 Individual food consumpt
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Appendix 7 Individual hematological
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Appendix 9 - 1 Individual blood bio
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Appsndix 11 Ahrdute -weights of ind
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Table 1 Analyzed nutrient compositi
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4 ! Table 3 Body velghts of male ra
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Table 9 Hematolo 'cal Kndin a of ma
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Tlble 13-1 Absolute md relativa arm
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Appendix 2 lndivldnal body weights
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Appendix 6 - 1 Individual urinary f
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~p - ~p -- Cons. in Animal B.W. Bnl
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