Program for Biosafety Systems – http://pbs.ifpri.info/

Global policy and economic issues associated with the development and use of genetically engineering crops

José Falck ZepedaSenior Research Fellow

International Food Policy Research Institute – Program for Biosafety Systems (IFPRI - PBS)

Presented at the AAAS Annual Meeting in Boston, February 19, 2017.

The “New” Evolving Global Food System

• Global agricultural growth driven by changes in productivity– But unequal changes in productivity

• Facing long term vulnerability and short term productivity shocks– Climate change– Population growth, urbanization, income inequality and conflict– Increasing environmental and biodiversity protection challenges– Declining investments in R&D and science and technology in

some countries

• Challenging context that requires embracing complexity and broader approaches to address new development landscape

A new, knowledge-based global food system focused on ensuring equity

• Departing from a focus on a narrow set of objectives – think innovation convergence

• Advancing scientific frontiers—investing in R&D

• Designing better policies—evidence-based decision-making

• Integrating gender and ensuring equity—in both policy and technology design

• Linking to health and nutrition—yield gain is not enough

• Ensuring sustainability—synergies in agriculture and environment

Genetically Engineering: A story of contrast and a cautionary tale about

the future

Science and Technology Achievement• An elegant and ingenious

innovation that solved specific agricultural production and productivity problems

• Rapid uptake leading to 187 million hectares adopted, roughly 13% of total area planted

• Four crops (maize, soybeans, cotton and canola) and two traits (insect resistance and herbicide tolerance) but situation changing…

Consumer Acceptance and Social Context Issues• “Frankenfoods”• Unsafe products• Imposed by developed countries• Need to be subjected to

regulatory scrutiny• Questions about corporate

control of agriculture, access to seeds by smallholder farmers

• Competing with “more acceptable” agricultural production systems or technologies such as organics or fair trade or biologics….

Genetic Engineering is product of innovative convergence

• Convergence at different levels

– Knowledge /disciplinary

– Organizational /collaboration

– Product

• Along value chains

– Input side

– Market

– Industry (Input + Market)

Source: Brӧring, 2010; Allarakhia, 2011

Genetic Engineering as a convergent innovation – knowledge/input side

Biology

Information science

Plant breeding

Molecular engineering

• Social

• Economic

• Legal

• Regulatory

• Ethical

Development context

GE technology transfer: Insect resistant / Herbicide tolerant maize in Honduras

Seed innovator

Breeding/Agronomy

Capacity and R&D

Asgrow / Dekalb A5753

Gene innovator

Biotechnology Capacity and

R&D

Monsanto

MON810 & NK 603

Biosafety

analysis

Bt / RR maize hybrid

A5753BT/RR

Intellectual

Property

Farmers /

Households

+

Socio-Economic

Impact

Assessment?

Dir

ect

seed

tra

nsf

erUSA, South

Africa, Chile

Honduras

Seed SystemSustainable

livelihoods and

gender analysis

Public Private

Partnerships and

strategic alliances

Innovation System

Five takeaways from the NAS GE crops report

1. The best evidence suggests current GM crops are just as safe to eat as regular crops

2. Current GM crops have proven valuable to many farmers — but context matters

3. Beware of simplistic arguments over whether GM crops can "feed the world“

4. Some GM crops have had positive environmental effects — but watch out for unintended effects

5. Genetic engineering is changing radically — and regulations need to adjust

Source:

based on

Broad Portfolio of Technologies in the Regulatory Pipeline

“The Global Pipeline of GM Crops to 2020” Parisi, Tillie and Rodriguez-Cerezo (2016) published in Nature Biotechnology shows:

• Doubling of GM events at advanced regulatory to commercialization stages has doubled from 2008-2014

• Still relatively few crops and traits but this is changing rapidly especially number of stacked traits

• Increase in number of traits will represent an issue for international trade – adventitious and low level presence

Not only GE approaches in the pipeline, but also upcoming New Plant Breeding

TechniquesTechniques Examples Applications

Nuclear genome transformation

Agrobacterium mediated Gene gun mediated

Most commercially available technologies

Plastome transformation Not widely usedGene silencing techniques Antisense silencing FLAVR SAVR tomato delayed fruit ripening and enhanced fruit quality

RNA Interference(RNAi) Yellow/Golden mosaic virus resistant bean produced by EMBRAPA

Transformation methods that do not rely on tissue culture

Floral dip For example, certain members of the Brassicaceae family such as Arabidopsis thaliana and Camelina sativa can be transformed using the floral dip method (Clough and Bent, 1998; Liu et al., 2012) in which Agrobacterium tumefaciens delivers the transgene directly into the genome of egg cells, thereby permitting production of transgenic plants directly from seed. Used to avoid somaclonal variation

Genome editing Meganucleases Not widely usedZinc finger nucleases (ZFNs) Not used yet for commercial application

transcription activator-like effector nucleases (TALENs)

Not used yet for commercial application

Clustered regularly interspaced palindromic repeats (CRISPR)/Cas9 nuclease system

Release approvals for waxy corn and disease resistant mushrooms in the US

Artificial and synthethic chromosomes

Not used yet for commercial application

Targeted epigenetic modifications

Not used yet for commercial application

Source: Based on data presented in the NAS Report 2016

Regulatory and the innovation policy environment related to GE crops development and delivery

• R&D investments• Public-private, public-public, private-private

collaborations and the challenges especially in developing countries to deliver technology to farmers

• Intellectual Property• Biosafety• Seed registration• Trade• Policy and regulatory environment outside agriculture

having an impact on agriculture – CO2 mitigation…• Consumer acceptance

Timeline and estimated R&D and regulatory costs for a GE crop

Year Early

Discovery

Late

Discovery

Construct

optimisati

on

Commercial event

production &

selection

Introgression

breeding & wide

area testing

Regulatory

science

Registration

& Regulatory

affairs

R&D Total Regulatory science

+ Registration and

Regulatory Affairs

Total

1 15.9 0.0

2 13.9 0.0

3 8.8 0.0

4 10.4 0.0

5 14.4 4.2

6 8.8 4.6

7 12.8 4.6

8 8.0 6.0

9 8.0 3.2

10 0.0 3.2

11 0.0 3.2

12 0.0 3.2

13 0.0 3.2

Total 17.6 13.4 28.3 13.6 28.0 17.9 17.2 100.9 35.1

Source: Based upon Phillips McDougal 2011

The future

• Technology change with a focus on equity and equity access

• Focusing on a knowledge based food production system – smart agriculture with respect to climate change, energy and fossil fuel use, sustainable and stronger connection with changes in consumer demand

• Need for increased convergence and intensification

Main messages

• Need to resolve regulatory, policy and legal issues which are currently hurdles for deployment

• Need to consider science, technology and innovation within the broader social, economic and ethical context

• Otherwise… innovation flows will decrease to unacceptable levels that will not keep up with human development needs

José Benjamin Falck-Zepeda

Senior Research FellowIFPRI

2033 K Street NWWashington, DC 20006-1002

USAj.falck-zepeda@cgiar.org

Brief bio/pubs: http://www.ifpri.org/staffprofile/jose-falck-zepeda

Blog: http://socioeconomicbiosafety.wordpress.com/

Follow me on Twitter: @josefalck