Presentation Transcript

1. Animal Biotechnology: Innovation Stifled by Inaction

   Dave Edwards, PhD Biotechnology Industry Organization April 2, 2014
2. Ames, IA
3. Conversation Today Needs for technology in animal agriculture Regulatory challenges Animal biotechnology opportunities Opponents to biotechnology Inaction as a reaction What are we doing about it
4. Challenges to Address Food Security Animal Health Animal Welfare Environmental Footprint
5. BIO is… 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
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. 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 Images courtesy of Elanco Animal Health
8. Impact of Technologies Biotech Crops Fungicides Corn Yield (Bushels/Acre) Insecticides Herbicides N2 Fertilizers Hybridization Open Pollination USDA, National Agricultural Statistics Service: http://www.nass.usda.gov/
9. Coordinated Framework 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
10. Plants and seeds Animal biologics Meat and poultry Current U.S. Regulatory ContextThe Coordinated Framework Three regulatory agencies have oversight for biotechnology products under existing legislation USDA FDA EPA Food and feed Human biologics Drugs GE animals Medical devices Plant Pesticides (PIPs) Herbicides Chemicals and microbials Shipping Public Health ‘Pesticidal’ Substances Plant/Animal Protection Acts FIFRA Food Drug Cosmetic Act NEPA
11. U.S. Regulatory Process 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
12. Animal Biotechnology Genomics Cloning Genetic Engineering Vaccines
13. Animal Biotechnology Applications Genomics Improved Livestock Breeds Faster Breeding Decisions Quality/Trait Certification Animal Identification
14. Animal Biotechnology Applications 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
15. Cloning Applications Genetically elite animals
16. EU Impact on Cloning 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
17. Animal Biotechnology Applications 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
18. Aquaculture Biotechnology AquAdvantage Salmon: An Atlantic salmon that is genetically engineered to grow more rapidly 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 Cohorts of the same age Image courtesy of AquaBounty
19. BSE Resistant Cows 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
20. Mastitis Resistant Cows Mastitis costs $2 billion/year Cows that do not require antibiotics for mastitis USDA project Frozen Frozen
21. The EnviropigTM Frozen Image courtesy of University of Guelph
22. Newer Technologies 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
23. FMD resistant cattle Influenza resistant chickens RNAi for Disease-Resistant Livestock $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 Disease-resistant fish Influenza resistant pigs Slide courtesy of CSIRO
24. Spider Silk Goats Silk produced in milk can be used in high-value industrial products Medical applications Sutures Replacement tendons or ligaments Manufacturing Seat belts Bulletproof vests
25. Current Models Cystic Fibrosis Liver Disease Heart Disease Cardiac Arrhythmia Cancer Neurological Muscular Dystrophy EU, US, and worldwide GE Livestock Models Slide courtesy of Exemplar Genetics
26. Microchromosome with human antibody genes in cow cell Human Antibody Production System Calves carrying human antibody genes. Calves produce specific human antibody after immunization. Images courtesy of Sanford Applied Biosciences
27. Financial Advantage of Genetically Engineered Animals $3 million to build/operate $600 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
28. Technology at a Crossroads Animal biotechnology developers are small No predictability in regulatory system Public perception Trade questions Well funded opponents of technology
29. Proponent Industry Perspective …”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
30. Opposition intention to change market conditions through legislation 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, $
31. 2014 Biotech Food Labeling Activity As of 2/7/14 NH VT WA ME MT MA ND MN OR MI WI NY ID SD RI WI PA IA CT NE IN OH CA NV IL IN NJ WV UT CO VA MO DE KS KY NC TN MD OK SC AK AZ NM AR GA MS AL TX LA FL HI
32. Stalled Innovation in Animal Agriculture Image courtesy of Elanco Animal Health
33. Regulatory Inaction It has been 1291 days since VMAC meeting [1] Chart from Alison van Eenennaam, University of California-Davis
34. Technology Moving Overseas 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
35. 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 us
36. www.gmoanswers.com
37. Strong digital and social presence in which people hang out and engage Website Traffic Facebook and Twitter top drivers More than 150,000 visits and 600,000 page views Currently 25,000 visitors /month Average duration of visit is 5 minutes 35% are returning visitors
38. More balanced media coverage in which our stories are told accurately
39. Conclusions 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
40. “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.
41. Contact Information Dave Edwards, PhD Director, Animal Biotechnology dedwards@bio.org P: +1(202)962-9200 http://www.bio.org/livestockbiotechsummit September 16-18, 2014 in Sioux Falls, SD