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Assessing the Changing Landscape of Genetically Engineered Crops and Foods
Assessing the Changing Landscape of Genetically Engineered Crops and Foods
Jack BoboU.S. Department of State
Alison Van EenennaamUniversity of California, Davis
Mark KriegerDow AgroSciences
Matthew O’MaraBiotechnology Industry Organization
John Mandler, ModeratorFaegre Baker Daniels
Mark KriegerGlobal Leader, Biotechnology Registration and OperationsDow AgroSciences
Mark Krieger, PhDGlobal Leader, Biotechnology Registration and Operations
Faster Crop Innovation x Slower Regulatory Systems = More Trade Disruption
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Innovation is Accelerating
Why Continued rapid advancements in genomics
Continued development of genetic editing tools (“New Breeding Techniques”)
Diffusion of practical knowledge on how to move from lab-scale research to field-scale development
Expiration of patents on first generation tools and products
Results New GM crops
New GM phenotypes
More “events” in current commercialized GM crops
Exponential increase in number of products requiring regulatory approvals─ Combined event (“stacked”) products require separate regulatory approval in
many countries
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Innovation is Coming from New Developers and Countries
Arcadia Biosciences Salt-tolerant, water-efficient &
nitrogen-use efficient rice
Del Monte Pink Pineapple, higher lycopene
levels
Okanagan Specialty Fruits Arctic Apples, prevent browning
after slicing
J.R. Simplot Innate Potatoes, prevent bruising
and browning
Rothamsted Research Institute (UK) Aphid-resistant wheat
China Public Pipeline Sweet pepper, tomato, papaya,
soybeans, maize, rice, potatoes
India Public Pipeline Brinjal, tomato, cabbage,
cauliflower, okra, mustard, wheat, chili, peanuts, maize, cotton, rice, potatoes
African Agricultural Technology Foundation Pest control and drought tolerance
in maize, cowpea, rice & bananas
Public Sector Developers Private Sector Developers
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Developing Countries Export Agricultural Products
http://faostat.fao.org/DesktopModules/Faostat/WATFDetailed2/watf.aspx
Exports of Potatoes from Egypt
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Regulatory System Performance is Decreasing
China
Korea Japan
0
10
20
30
40
50
60
70
2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014
Reg
ulat
ory
Rev
iew
(Mon
ths)
Year
Time to obtain regulatory approvals up substantially in past decade
Regulatory costs now estimated to average $35 million
New countries are implementing regulatory systems
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Possible OutcomesGood
● Trade protecting processes developed (e.g., LLP thresholds)
● Regulators speed up
● Regulators synchronize and harmonize globally
Bad
● Innovators slow down
● Trade disruptions increase─ Zero benefits, zero winners─ Business As Usual scenario
Process the Backlog• Regulatory
systems function as designed
LLP• Thresholds• Minimize short-
term trade disruption
Regulatory Reform• Predictable
regulatory system
• Compress timelines
Synchronous Approvals• Concurrent
multilateral submissions
Harmonization • Harmonize food
and feed approvals
Matthew O’MaraDirector, International AffairsBiotechnology Industry Organization (BIO)
50
Trade and Technology Policy Critical to Meeting Global Challenges
Matthew O’Mara
Managing Director, Food and Agriculture
51
Within next 36 years, the global population will grow by over 2 billion requiring agricultural output to double
Climate change will place greater stress on agricultural systems globally, requiring crops to be adapted for agronomic stress, such as drought, salinity, etc.
Our ability to meet these challenges will depend a number of factors, including trade and technology policies
Context
52
Historically, trade agreements have focused on opening markets, removing traditional barriers to trade
The Uruguay Round brought rules to agricultural trade and significantly reduced tariff rates and subsidies
Doha Round has ambitions to further reduce tariffs and subsidies, but after 13 years, no clear path to agreement
US has recently embarked on an aggressive trade agenda with Europe and Asia
Very little progress on harmonization of regulatory systems
Trade policy past and present
53
Greater need for trade policy to focus on regulatory harmonization, equivalence, mutual recognition…
The WTO Sanitary and Phytosanitary (SPS) Agreement, established obligations with regard to basing measures on science based risk assessment, and called on members to harmonize and to accept others SPS measures as equivalent– A number of WTO challenges have resulted (41
consultations/panels since 1995; 16 resolved)US-EC biotech remains unresolved
Shall we litigate or negotiate?
Trade policy of the future
54
United States– First crop commercialized in the United States in 1996– Biotech soy, corn, cotton acreage -- 90% – Pace of U.S. regulatory system is slowing
Ex. United States– Most growth in ag biotech acreage is in developing countries
Brazil/Argentina leading the wayHave significantly reduced approval timelinesSouth Americans actively discussing regional harmonization of policies
Global leadership in ag biotech changing
55http://www.isaaa.org/
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United States, Brazil and Argentina account for:– Nearly 70% of global corn exports– 87% of global soy exports– 83% of soy meal exports
These three countries must lead the way towards addressing barriers to trade for products derived from agricultural biotechnology
Six countries* signed a “like-minded” statement, but we need to aspire for a like-minded agreement that paves the way for science-based, risk proportionate regulation for ag biotech
*Argentina, Australia, Brazil, Canada, Paraguay and the United States
Need for a like-minded approach
57
Great deal of attention on GMOs in the TTIP– Long standing issues between US and EU over biotech– WTO case remains unresolved
Industry views the TTIP as an opportunity to help facilitate trade and forge a new relationship, keeping in mind biotech innovation has spread and the balance is tipping to developed countries
Focus is on increasing predictability, facilitating trade and working within existing laws and regulations– Not seeking to address cultivation– Not seeking to change EU labeling laws– Improved dialogue & increased accountability
Ag Biotech in the TTIP
58
Landscape is changing– Developing countries are beginning to take a more active
leadership role– Not a U.S.-only issue anymoreNeed to align “Like Minded” CountriesNeed to take better advantage of trade agreements and explore opportunities for mutual recognitionBut we cannot take consumers for granted, we must do a better job of communicating, particularly listening and answering questions…
Conclusion
www.gmoanswers.com
Alison Van EenennaamCooperative Extension Specialist,Animal Genomics and BiotechnologyDepartment of Animal Science | University of California, Davis
rDNA vaccines rBST
GMO feed
GE rennet, and other food processing aids
GMO food & ingredients
Currently no GM animals in market
Where is GE used in Animal Agriculture?GE products are used in animal feed, vaccines (chickens, pigs, horses, dogs, cats), pharmaceuticals, food processing aids, and food
Van Eenennaam 5/14/2014
70-90% of harvested GE biomass is fed to food producing animals
Flachowsky G, Schafft H, Meyer U: 2012 Animal feeding studies for nutritional and safety assessments of feeds from genetically modified plants: a review. (Journal of Consumer Protection and Food Safety) :179–194.
Global livestock populations have been eating predominately GE feed for well over a decade
Van Eenennaam 5/14/2014
GE and conventional corn and soy produced (MMT) by selected countries 2012 – hatch marked slices
represent GE, solid are conventional
Van Eenennaam 5/14/2014
81% (80.7 million hectares) of the 100 million hectares of the soybean
planted globally were GE
35% (55.1 million hectares) of the 159 million hectares of the corn planted globally were GE
CORN SOYBEANS
Van Eenennaam and Young. 2014. J. Anim. Sci. In preparation
Corn Production Imports, Export, Feed by Country 2013
Van Eenennaam 5/14/2014 Van Eenennaam and Young. 2014. J. Anim. Sci. In preparation
Soybean ProductionImports, Exports and Crush by Country 2013
Van Eenennaam 5/14/2014 Van Eenennaam and Young. 2014. J. Anim. Sci. In preparation
Van Eenennaam 5/14/2014 Van Eenennaam and Young. 2014. J. Anim. Sci. In preparation
Value of imports of organic soybeans into US 2011-2013
Van Eenennaam 5/14/2014 Van Eenennaam and Young. 2014. J. Anim. Sci. In preparation
Jack BoboSenior Advisor on BiotechnologyU.S. Department of State