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

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

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

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

BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 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…

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, $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

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

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

BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, …”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

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

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/ Biotech Food Labeling Activity IN

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

BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 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’ 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

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

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

BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, Dave Edwards, PhD –Director, Animal Biotechnology –P: +1(202) Contact Information September 16-18, 2014 in Sioux Falls, SD

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