Animal Biotechnology: Innovation Stifled by Inaction

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Animal Biotechnology: Innovation Stifled by InactionDave Edwards, PhDBiotechnology Industry OrganizationApril 2, 2014BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014#1

Ames, IABIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014#Needs for technology in animal agricultureRegulatory challengesAnimal biotechnology opportunitiesOpponents to biotechnologyInaction as a reactionWhat are we doing about it

Conversation TodayBIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014#Food SecurityAnimal HealthAnimal WelfareEnvironmental Footprint

Challenges to AddressBIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014#Working to Heal, Fuel, and Feed the World

Worlds largest biotechnology trade association1100 companies, academic centers, state and regional affiliates, and related organizations

R&D of technologiesHuman HealthIndustrial & EnvironmentalFood and AgricultureBIO isBIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014#5Technology is CrucialOver the next 50 years, the worlds 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, 2014#

Images courtesy of Elanco Animal HealthTechnology is CrucialSeventy percent of the worlds additional food needs can be produced only with new and existing agricultural technologies. -United Nations FAO, 2002


Corn Yield (Bushels/Acre)Open PollinationN2 FertilizersHerbicidesInsecticidesFungicidesHybridizationBiotech Crops

USDA, National Agricultural Statistics Service: http://www.nass.usda.gov/ Impact of TechnologiesBIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014#

MONTH XX, 2012BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014#Worldwide Biotech Acreage: 420 million acres in 28 countriesU.S. Biotech Crops90 percent of corn90 percent of cotton 90+ percent of papaya93 percent of soybeans95 percent of sugar beets

2012 Crop AcreageBIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014#Federal Safety NetAll 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 statutesCoordinated FrameworkBIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014#Current U.S. Regulatory ContextThe Coordinated FrameworkPlants and seedsAnimal biologicsMeat and poultry

Three regulatory agencies have oversight for biotechnology products under existing legislationUSDAFDAEPAShippingPublic HealthPesticidal SubstancesPlant/Animal Protection ActsFood Drug Cosmetic ActNEPAFIFRA Food and feedHuman biologicsDrugsGE animalsMedical devicesPlant Pesticides (PIPs)HerbicidesChemicals and microbialsBIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014#EPA EPA regulates GE plants that produce pesticidal substances (e.g., Bt crops)EPA also regulates herbicidesFFDCA and TSCA responsibilities as well.Registrations 3 -9 years with terms and conditions, including monitoring, providing annual reports, {and other requirements} that must be fulfilled to maintain authorization.Data protection for 10 yearsMandatory reporting of any information which draws decision into questionFDA:Developer provides FDA with data and other information justifying a conclusion that a food derived from a GE plant is as safe as a comparable non-GE food. Voluntary consultation process.No time limit on authorization.Mandatory reporting of any information which draws decision into questionUSDARegulated Products: Importation, Movement, Field TrialsAll conducted under very clear, authorized performance standardsNotifications: Plants only; Familiar crops; GE traits must present no plant pest risksPermits: Any organism or trait; Details of biological containment are stipulatedFor both: State review; Sites inspected; Field data reports submitted

(Next slide segway into USDA deregulation)

12BIO and its members support the science-based regulatory process in the US as laid out by FDA Guidance for Industry 187Political 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 reviewMarket should decide acceptance of technologyU.S. Regulatory ProcessBIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014#GenomicsCloningGenetic EngineeringVaccinesAnimal Biotechnology

BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014#14Animal Biotechnology ApplicationsGenomicsImproved Livestock BreedsFaster Breeding DecisionsQuality/Trait CertificationAnimal Identification

BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014#15CloningRisk Assessments-Safe as non-cloned foodUS 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 tradeArgentina, Brazil, New Zealand, U.S., UruguayAnimal Biotechnology ApplicationsBIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014#16Cloning Applications

Genetically elite animals

BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014#17Current EU Commission proposalBan cloning for food production for next 5 yearsLabel food from clonesFurther analysis of labeling beef from clone offspringNot restrict embryos and semen from clonesEU Parliament statementsFull ban on clones and offspringBan imported clones and offspring, or at least labelPrecautionary Principle at playEU wants ban so cloning process can improve-counterintuitiveEFSA reports food is safe (2008, 2009, 2010, and 2012)Some have issue with ethics, welfare of cloningEU Impact on CloningBIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014#Opportunities to impactFood availability, cost, & productionBiomedical research, treatments, & production

BIO report, Genetically Engineered Animals and Public Health available from http://www.bio.org/articles/genetically-engineered-animals-frequently-asked-questionsAnimal Biotechnology ApplicationsBIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014#19AquAdvantage Salmon: An Atlantic salmon that is genetically engineered to grow more rapidlyAquaculture BiotechnologyCohorts of the same age

Image courtesy of AquaBountyEnvironmental Impact of Importing SalmonFly halfway around world 1847 fully loaded 747s=66,359,178 gallons of fuel=94,799 cars per year BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014#20Do not make prion, but remain healthy$4.7 billion in losses to U.S. beef industry in 2004 from BSE casePrion 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, 2014#Mastitis costs $2 billion/yearCows that do not require antibiotics for mastitisUSDA project

Mastitis Resistant Cows

FrozenFrozenBIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014#The EnviropigTM

Image courtesy of University of GuelphFrozenBIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014#Gene editingMake single changes to DNATurn horned cattle gene to polledRNA interferenceSmall segments of RNA keep genes from being expressed2006 Nobel Prize

Newer Technologies

BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014#RNAi for Disease-Resistant LivestockFMD resistant cattle

Influenza resistant pigsInfluenza resistant chickens

Disease-resistant fishSlide courtesy of CSIRO$6.5 billion lost in China alone on H7N9 outbreak$13 billion lost in 2001 FMD outbreak in Britain59 million human cases of H1N1 in U.S. in 2009ISA found in salmon worldwide, decimated Chilean industry for several yearsBIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014#25Silk produced in milk can be used in high-value industrial productsMedical applicationsSuturesReplacement tendons or ligamentsManufacturingSeat beltsBulletproof vests

Spider Silk Goats

BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014#GE Livestock ModelsCurrent ModelsCystic FibrosisLiver DiseaseHeart DiseaseCardiac ArrhythmiaCancerNeurologicalMuscular DystrophyEU, US, and worldwide

Slide courtesy of Exemplar GeneticsBIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014#Exemplars first model of human disease, the CF model, has been an excellent model for the research community. The expected introduction of the gut corrected model in 2013 should expand the utility and demand for this model. In addition to the CF model, Exemplar Genetics has developed a model of liver disease, a model of heart disease, and cardiac arrhythmia model, a cancer susceptible model, a rare disease model and a model of muscular dystrophy. All of these models have mimicked the human disease that they are intended to model. We have been working with MAYO and are waiting the birth of homozygous animals to determine the utility of the liver disease model. For the heart disease model, we believe both the heterozygous and homozygous animals will have utility and have started the characterization of both of these models. Data collected in 2012 should drive sales in 2013. We are working with NYUMC with the cardiac arrhythmia model and will be sending the first animals to NYC in September for a full analysis.

Microchromosome with humanantibody genes in cow cellCalves carrying human antibody genes. Calves produce specific human antibody after immunization.Images courtesy of Sanford Applied BiosciencesHuman Antibody Production SystemBIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014#28

$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 industryFinancial Advantage of Genetically Engineered AnimalsBIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014#Animal biotechnology developers are smallNo predictability in regulatory systemPublic perceptionTrade questionsWell funded opponents of technology

Technology at a CrossroadsBIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014#

BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014#31The 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 08/02/12We 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, 2014#32Eliminate/prejudice biotech foodUndermine consumer confidence in food safetyUndermine value chain confidence in demand for GE ingredientsIncrease market share organic/non-GM, $

Opposition intention to change market conditions through legislation

BIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014#33 INAK HI CA ORWA ID MT WI NV UT

AZ NM CO ND SD NE KS OK TXMN IA MO ARLA WI IL KYMI OH TNMSAL

FL

GASC NC VA WV MD DENJ PA NYMENH

VT MARI CTAs of 2/7/142014 Biotech Food Labeling Activity INBIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014#Stalled Innovation in Animal Agriculture

Image courtesy of Elanco Animal HealthBIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014#Regulatory InactionYearEvent1989Founder AquAdvantage fish produced in Canada1995FDA review of AquAdvantage salmon begins2001 First regulatory study submitted by Aqua Bounty Technologies to U.S. FDA for a New Animal Drug Application 2009FDA guidance on how GE animals will be regulatedFDA approval of first GE animal pharmaceuticalFinal AquAdvantage regulatory study submitted to FDA 2010FDA VMAC meeting on AquAdvantage salmon (9/20/10)-as safe as food from conventional Atlantic salmon2011-2014Political efforts to prevent FDA from regulating GE salmon, ban GE salmon, delay regulatory approval2012FDA released finding of no significant impact FONSI environmental assessment2014Still waiting for regulatory decision on AquAdvantage salmon

[1] Chart from Alison van Eenennaam, University of California-DavisIt has been 1291 days since VMAC meetingBIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014#China-investing $12 billion in agriculture biotechnologyOver 50 different animal lines developed

Brazil-recruiting U.S. researchersSupportive environment for development and deployment

EU-biomedical research on livestock growingHave put together a regulatory regime for GE animalsTechnology Moving OverseasBIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014#

Acknowledge Current Business Climate/Skepticism

We have great stories that are not being heard because we are not believed Instead of repeating these messages, we committed to showing our audiences that we have nothing to hide Only when our audiences understand we are listening to them will they begin to listen to us38

www.gmoanswers.com

Strong digital and social presence in which people hang out and engage

Website TrafficFacebook and Twitter top drivers

More than 150,000 visits and 600,000 page viewsCurrently 25,000 visitors /monthAverage duration of visit is 5 minutes35% are returning visitors

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More balanced media coverage in which our stories are told accurately

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41Innovations from biotechnology will positively impact the future of food production

The biotechnology industry seeks to work in partnership with the value chainProviding timely and useful informationWorking for public understanding and confidenceOvercome inaction from overabundance of precautionConclusionsBIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014#42

Not one person has suffered negative effects from innovations like GMOs, yet 25,000 people die every day from malnutrition.- Dr. Norman Borlaug, 2009Limiting 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, 2014#Dave Edwards, PhDDirector, Animal [email protected]: +1(202)962-9200http://www.bio.org/livestockbiotechsummit

Contact Information

September 16-18, 2014 in Sioux Falls, SDBIOTECHNOLOGY INDUSTRY ORGANIZATION ANIMAL BIOTECHNOLOGY: INNOVATION STIFLED BY INACTION APRIL 2, 2014#44


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Animal Biotechnology: Innovation Stifled by Inaction