1 / 44

Animal Biotechnology: Innovation Stifled by Inaction

Animal Biotechnology: Innovation Stifled by Inaction. Dave Edwards, PhD Biotechnology Industry Organization. April 2, 2014. Ames, IA. Conversation Today. Needs for technology in animal agriculture Regulatory challenges Animal biotechnology opportunities Opponents to biotechnology

viet
Télécharger la présentation

Animal Biotechnology: Innovation Stifled by Inaction

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

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

More Related