Benefits and Uses of Cloning and Other Animal Biotechnologies:

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1 Benefits and Uses of Cloning and Other Animal Biotechnologies: U.S. Perspective Diane Wray-Cahen, PhD Senior Science Advisor New Technologies and Production Methods Division Office of Agreements and Scientific Affairs United States Department of Agriculture Washington, DC, USA May 2015, Prague

2 Animal Biotechnologies in Context Assisted Reproductive Technologies Artificial insemination (1890s s) Embryo transfer (1950s) In vitro fertilization (1980s) Sex selection Embryo splitting Somatic cell nuclear transfer (Cloning; 1990s) Increase Distribution C O N T I N U U M Genetic Modification Mass selection Pedigree selection Progeny selection Marker-assisted selection Transgenics (1980s) (GE Animals) Genome-wide selection Gene Editing (2000s) Change Genetic Makeup

3 Best selection of tools in the toolbox... for efficient progress towards sustainable goals

4 Public misperception of Cloning Uses Perfect Dairy Cow C L O N I N G

5 Expansion of Elite Breeding Stock (clones are for breeding, not eating)

6 Why Clone? Conserve and Resuscitate Genetics Insurance against loss - Deceased animals - Disease outbreaks Steers, geldings (polo ponies), mules Endangered species, rare breeds Increase Genetic Diversity Superior production animals Disease resistance Rare breeds or animals Increase rate of introduction of traits into herds Reduce generation time for genetic progress

7 Saving Superior Genetics (Man-O-Man2) MAN-O-MAN MAN-O-MAN2 Top dairy sire (produced #1 genomic bull in world) Respiratory infection and sick in early life Never produced enough semen Died young Produced many more semen doses than Man-O-Man Excellent health Superior quality semen Semen in high demand globally

8 From Beef to Breeding Stock (Alpha and the Gammas) Angus bull named Alpha Prime, Yield Grade 1 carcass: Pinnacle of genetic success for beef industry Occurs 0.03% of the time - Prime, Yield Grade 1 carcasses identified at slaughter - Muscle tissue collected (dam and sire likely unknown) - Bulls and heifers cloned from muscle to produce breeding stock - Used increase animals producing highest quality meat

9 Case Study: Curly Calf Syndrome (Arthrogryposis Multiplex Congenita) Precision descendant with curly calf syndrome 2008 GAR Precision 1680 Leading Angus sire Father of another top sire Highly desirable traits Natural mutation identified Fatal recessive gene (Not a clone) Solution: Cloning used as tool to help eliminate genetic defect from US Angus herds N Bar Primrose 2424 Clones Leading dam of registered Angus cattle Does not carry 4 genetic recessives Positive traits, without lethal recessive 20 clones

10 What are the Barriers?

11 Risk Assessments of Animal Clones by Country Risk Assessments Conducted (year) US (FDA) Japan (FSC) Australia & NZ (FSANZ) NZ (NZFSA) Australia Argentina China EU (EFSA) France UK Clones Food Safety: safe as food from conventionally bred animals ? 2008 (x 4) yes yes yes yes yes yes yes yes not accessed yes Labeling: none voluntary none none none none? N/A Tracing: Moratorium for food: Offspring are not clones Food Safety: Tracing: same as other sexually reproduced animals none Voluntary (industry) yes none National registry none none? yes Voluntary (industry) none none yes yes yes yes yes yes yes yes yes yes yes none none none none none none? none

12 No Food Safety Concerns Concensus: Food products from animal clones (and their offspring) are as safe as food products from conventionally bred animals.

13 Challenges and Barriers US Perspective Science-based risk assessments... non-science-based regulatory decisions Focus on production processes, rather than safety of products Public uncertainty and concern Mis-information campaigns

14 Animal Genetics Trade is Global 34% 49% 51% EU:12% EU: World s Largest importer of Bovine Semen 1% 1% 1% 2% Flow of genetics to the EU Flow of genetics from USA (>$1M in trade) Estimated Global Market Share for Bovine Semen (%) Livestock cloning reported * Data compiled from FAS-PSD, FAOSTAT, Global Trade Atlas, EuroStat

15 Risks to Animal Health and Welfare? No unique risks (similar to other ARTs); Increased frequency of adverse outcomes Most losses in early embryonic period (as with other ARTs) Embryonic loss is NOT a welfare issue No increased health risks after early neonatal period Adult clones as healthy as conventionally-bred animals Risks for Offspring are same as for other sexually reproduced animals (no increased risks or frequency)

16 Addressing Welfare Issues Surrogate dams and fetuses monitored throughout pregnancy by veterinarian (including ultrasound) Not all species have increased animal health risks Efficiency is not a measure of animal welfare Cloning efficiencies improve with experience and skill

17 Skill and Experience Matters Skill/Practice = Success Rates Other factors: Cell lines (DNA) Ova (egg) Media choice Embryo selection Environmental conditions, etc. Efficiencies for cloning can be comparable to other reproductive technologies like ET and IVF

18 Effects of Technician on Embryo Transfer (ET) Efficiency Data: Individual ET technicians, who transferred 250 or more embryos in Brazil 32 (Marquezini et al., 2005)

19 Animal Biotechnology Advancing Livestock Genomes Mapped Identify sequences associated with valued traits Genomic selection of sires Combine with cloning to reduce generation time Gene editing Easy, efficient and inexpensive Animals not distinguishable from natural breeding

20 Editing Genes to Improve Animal Welfare All female chicks for laying hens Polled Dehorning

21 Editing Genes to Produce More Meat with Fewer Resources, Less Waste Gene Deletion (China) Increased muscling (myostatin deletion)

22 Traits Targeted to Region of Need

23 Encourage development of new ideas and innovations... Opportunity to utilize and/or combine the most appropriate and targeted tools to meet the challenges of the future

24 Next Generation... More Options, Not Fewer

25 Thank you!