assessing the changing landscape of genetically engineered … · 2018-05-29 · assessing the...

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/

56

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


GE and conventional corn and soy produced (MMT) by selected countries 2012 – hatch marked slices

represent GE, solid are conventional


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


Value of imports of organic soybeans into US 2011-2013


Jack BoboSenior Advisor on BiotechnologyU.S. Department of State

assessing the changing landscape of genetically engineered … · 2018-05-29 · assessing the...

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