1. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 1 Animal Biotechnology: Innovation Stifled by Inaction Dave Edwards, PhD Biotechnology Industry Organization April 2, 2014

2. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 2 Ames, IA

3. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 3 Needs for technology in animal agriculture Regulatory challenges Animal biotechnology opportunities Opponents to biotechnology Inaction as a reaction What are we doing about it Conversation Today

4. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 4 Food Security Animal Health Animal Welfare Environmental Footprint Challenges to Address

5. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 5 Working to Heal, Fuel, and Feed the World World’s largest biotechnology trade association –1100 companies, academic centers, state and regional affiliates, and related organizations R&D of technologies –Human Health –Industrial & Environmental –Food and Agriculture BIO is…

6. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 6 Technology is Crucial Over the next 50 years, the world’s farmers and ranchers will be called upon to produce more food than has been produced in the past 10,000 years combined, and to do so in environmentally sustainable ways. -Jacques Diouf, FAO Director General, 2007

7. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 7 Images courtesy of Elanco Animal Health Technology is Crucial Seventy percent of the world’s additional food needs can be produced only with new and existing agricultural technologies. -United Nations FAO, 2002

8. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 8 Corn Yield (Bushels/Acre) Open Pollination N2 Fertilizers Herbicides Insecticides Fungicides Hybridization Biotech Crops USDA, National Agricultural Statistics Service: http://www.nass.usda.gov/ Impact of Technologies

9. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 9 MONTH XX, 2012

10. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 10 Worldwide Biotech Acreage: 420 million acres in 28 countries U.S. Biotech Crops –90 percent of corn –90 percent of cotton –90+ percent of papaya –93 percent of soybeans –95 percent of sugar beets 2012 Crop Acreage

11. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 11 Federal “Safety Net” All products subject to science-based regulation under existing, product-based statutes Individual products or categories eligible for exemption over time based on experience and data Same “precautionary approach” applied under other health, safety and environmental statutes Coordinated Framework

12. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 12 Current U.S. Regulatory Context The Coordinated Framework Plants and seeds Animal biologics Meat and poultry Three regulatory agencies have oversight for biotechnology products under existing legislation USDA FDAEPA Shipping Public Health ‘ Pesticidal’ Substances Plant/Animal Protection ActsFood Drug Cosmetic Act NEPA FIFRA Food and feed Human biologics Drugs GE animals Medical devices Plant Pesticides (PIPs) Herbicides Chemicals and microbials

13. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 13 BIO and its members support the science-based regulatory process in the US as laid out by FDA Guidance for Industry 187 Political interference in the process means that these innovations in food and medicine cannot help public health, the environment, or with sustainability Process should allow innovative products to come to market once approved for safety and efficacy through a scientific review Market should decide acceptance of technology U.S. Regulatory Process

14. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 14 Genomics Cloning Genetic Engineering Vaccines Animal Biotechnology

15. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 15 Animal Biotechnology Applications Genomics –Improved Livestock Breeds –Faster Breeding Decisions –Quality/Trait Certification –Animal Identification

16. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 16 Cloning –Risk Assessments-Safe as non-cloned food US FDA (2008), EFSA (2008, 2009, 2010, 2012) Japan, New Zealand, Argentina, China –Utilized as a vital tool in development of genetically engineered animals –Like-minded agreement to not restrict trade Argentina, Brazil, New Zealand, U.S., Uruguay Animal Biotechnology Applications

17. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 17 Cloning Applications Genetically elite animals

18. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 18 Current EU Commission proposal –Ban cloning for food production for next 5 years –Label food from clones –Further analysis of labeling beef from clone offspring –Not restrict embryos and semen from clones EU Parliament statements –Full ban on clones and offspring –Ban imported clones and offspring, or at least label Precautionary Principle at play –EU wants ban so cloning process can improve-counterintuitive –EFSA reports food is safe (2008, 2009, 2010, and 2012) –Some have issue with ethics, welfare of cloning EU Impact on Cloning

19. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 19 Opportunities to impact –Food availability, cost, & production –Biomedical research, treatments, & production BIO report, “Genetically Engineered Animals and Public Health” available from http://www.bio.org/articles/genetically- engineered-animals-frequently-asked- questions Animal Biotechnology Applications

20. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 20 AquAdvantage Salmon: An Atlantic salmon that is genetically engineered to grow more rapidly Aquaculture Biotechnology Cohorts of the same age Image courtesy of AquaBounty Environmental Impact of Importing Salmon Fly halfway around world 1847 fully loaded 747’s = 66,359,178 gallons of fuel = 94,799 cars per year

21. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 21 Do not make prion, but remain healthy $4.7 billion in losses to U.S. beef industry in 2004 from BSE case Prion and antibody free bovine sera and reagents for cell culture development BSE Resistant Cows

22. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 22 Mastitis costs $2 billion/year Cows that do not require antibiotics for mastitis USDA project Mastitis Resistant Cows

23. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 23 The Enviropig TM Image courtesy of University of Guelph

24. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 24 Gene editing –Make single changes to DNA –Turn horned cattle gene to polled RNA interference –Small segments of RNA keep genes from being expressed –2006 Nobel Prize Newer Technologies

25. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 25 RNAi for Disease-Resistant Livestock FMD resistant cattle Influenza resistant pigs Influenza resistant chickens Disease-resistant fish Slide courtesy of CSIRO $6.5 billion lost in China alone on H7N9 outbreak $13 billion lost in 2001 FMD outbreak in Britain 59 million human cases of H1N1 in U.S. in 2009 ISA found in salmon worldwide, decimated Chilean industry for several years

26. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 26 Silk produced in milk can be used in high-value industrial products –Medical applications Sutures Replacement tendons or ligaments –Manufacturing Seat belts Bulletproof vests Spider Silk Goats

27. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 27 GE Livestock Models Current Models –Cystic Fibrosis –Liver Disease –Heart Disease –Cardiac Arrhythmia –Cancer –Neurological –Muscular Dystrophy EU, US, and worldwide Slide courtesy of Exemplar Genetics

28. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 28 Microchromosome with human antibody genes in cow cell Calves carrying human antibody genes. Calves produce specific human antibody after immunization. Images courtesy of Sanford Applied Biosciences Human Antibody Production System

29. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 29 $600 million to build/operate $3 million to build/operate This protein can be produced at either of these facilities in the same amounts. It represents a $200 million/year product in the pharmaceutical industry Financial Advantage of Genetically Engineered Animals

30. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 30 Animal biotechnology developers are small No predictability in regulatory system Public perception Trade questions Well funded opponents of technology Technology at a Crossroads

31. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 31

32. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 32 …”The burning question for us all then becomes how- and how quickly-can we move healthy, organic products from a 4.2% market niche, to the dominant force in American food and farming? The first step is to change our labeling laws…” OCA 08/02/12 “We are going to force them to label this food. If we have it labeled, then we can organize people not to buy it.” Center for Food Safety “Personally, I believe GM foods must be banned entirely, but labeling is the most efficient way to achieve this.” Mercola.com Proponent Industry Perspective

33. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 33 Eliminate/prejudice biotech food Undermine consumer confidence in food safety Undermine value chain confidence in demand for GE ingredients Increase market share organic/non-GM, $ Opposition intention to change market conditions through legislation

34. IN AK HI CA OR WA ID MT WI NV UT AZ NM CO ND SD NE KS OK TX MN IA MO AR LA WI IL KY MI OH TN MSAL FL GA SC NC VA WV MD DE NJ PA NY ME NH VT MA RI CT As of 2/7/14 2014 Biotech Food Labeling Activity IN

35. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 35 Stalled Innovation in Animal Agriculture Image courtesy of Elanco Animal Health

36. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 36 Regulatory Inaction YearEvent 1989Founder AquAdvantage ® fish produced in Canada 1995FDA review of AquAdvantage ® salmon begins 2001First regulatory study submitted by Aqua Bounty Technologies to U.S. FDA for a New Animal Drug Application 2009 FDA guidance on how GE animals will be regulated FDA approval of first GE animal pharmaceutical Final AquAdvantage ® regulatory study submitted to FDA 2010FDA VMAC meeting on AquAdvantage ® salmon (9/20/10)-’as safe as food from conventional Atlantic salmon’ 2011-2014 Political efforts to prevent FDA from regulating GE salmon, ban GE salmon, delay regulatory approval 2012 FDA released finding of no significant impact “FONSI” environmental assessment 2014Still waiting for regulatory decision on AquAdvantage® salmon [1] [1] Chart from Alison van Eenennaam, University of California-Davis It has been 1291 days since VMAC meeting

37. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 37 China-investing $12 billion in agriculture biotechnology –Over 50 different animal lines developed Brazil-recruiting U.S. researchers –Supportive environment for development and deployment EU-biomedical research on livestock growing –Have put together a regulatory regime for GE animals Technology Moving Overseas

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42. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 42 Innovations from biotechnology will positively impact the future of food production The biotechnology industry seeks to work in partnership with the value chain –Providing timely and useful information –Working for public understanding and confidence –Overcome inaction from overabundance of precaution Conclusions

43. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 43 “Not one person has suffered negative effects from innovations like GMOs, yet 25,000 people die every day from malnutrition.” - Dr. Norman Borlaug, 2009 Limiting innovation due to imagined possibilities and the Precautionary Principle has negative ramifications for us all.

44. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 44 Dave Edwards, PhD –Director, Animal Biotechnology –dedwards@bio.org –P: +1(202)962-9200 http://www.bio.org/livestockbiotechsummit Contact Information September 16-18, 2014 in Sioux Falls, SD

45. BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014 45