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    Socio-Economics Considerations, Biosafety and Decision Making

    Jos Falck ZepedaResearch Fellow / Leader Policy Team Program for Biosafety Systems (PBS)

    IFPRI

    Presentation made at the Michigan State University Short Course Environmental Biosafety August

    2011

    From left to rigth: a) Damage by Asia corn borer and b) Bt maize plot in Barangay Conel, Mindanao, The Philippines, c) Bt/RR maize Isabelaprovince, North Luzon

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    Outline1. Introduction and

    Background2. Economics of GE

    biotechnologies andbiosafety

    3. Experiences with socio-economic assessments

    4. Cost of compliance withbiosafety regulations

    5. Practical socio-economic

    assessmentsimplementation

    6. Concluding comments

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    Limits to resources and other trade-offs

    We have limited Resources Capacity for risk and risk

    taking

    Technical capacity We learn over time

    Trade-offs and alternativesStatus quo is not

    necessary risk-lessTechnology deployment

    and precautionaryapproaches to regulation

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    Why Genetically Engineered cropsand other biotechnologies?

    Embodied technologies Address specific productivity

    constraints not easilyaddressed by conventional

    means Can be deployed in low

    resource use productionsystems

    Flexible fit with otherproduction systems

    Impacts can be non-monetary,indirect, and scale neutral

    Scalable

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    2. Economics of GE

    biotechnologies and biosafety

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    The basic decision making rule ineconomic impact assessment of anynew technologies

    Sum ofAllBenefits

    Sum ofAllCosts

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    Several issues with the basic rule

    We may have winners and losers at

    the same time

    Costs/benefits may not be monetary

    Quantification issues

    Externalities => persons benefitingfrom intervention may not endure allcosts

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    What are socio-economicconsiderations (SEC) assessments?

    Diverse research focus

    Household, Farm, Communities,Industry, Consumer, Trade

    Gender, health, age, institutionalissues

    May be done before(ex ante) or

    after adoption of the technology(ex post)

    Contrast effects of interventionagainst an alternative

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    Impact assessment is a scientificprocess that significantly incorporates artin its implementation

    The practitioner has to in many casessubjectively address many problems

    with data, assumptions, models anduncertainties

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    A paper by Gruere and Pal suggests

    Well conducted socio-economicassessments can

    Objectively weigh benefits and cost for better

    decisions Provide useful lessons that may avoid costly

    mistakes

    Suggest management practices to increasebenefits from use

    Support economically beneficial applicationsand pave the way for promising new tech

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    What drives SEC inclusion?

    Knowledge creation

    Understanding role oftechnology

    Regional considerations

    National laws and regulations

    International agreements Other political, institutional and

    stakeholder interests

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    Socio economic considerations and Article 26.1of the Cartagena Protocol on Biosafety

    1 . The Parties, in reaching a decision on import under thisProtocol or under its domestic measures implementing the

    Protocol,

    may take into account,

    consistent with their international obligations,

    socio-economic considerations arising from the impactof living modified organisms on the conservation andsustainable use of biological diversity,

    especially with regard to the value of biological diversityto indigenous and local communities

    Applies to decisionon import only

    National measures

    Voluntary NOTmandatory

    Especially WTO

    Strictly a specificfocus and targetgroup

    Explicit impact

    indicator

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    Objective driving socio-economicconsideration assessments

    For biosafety regulatory processes one needs to

    understand: the impact of the inclusion of socio-economic issues in

    decision making

    The relationship / interaction with the risk assessmentprocess

    Technologyassessments

    Technology assessmentwithin biosafety regulatoryprocesses that lead to an

    approval or rejection

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    Consider impacts on

    innovation,opportunities lost

    due to additional regulatory hurdles

    andwho

    is impacted more by regulatory

    actions and technology decisions

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    Biosafety regulatory design impliesestablishing a balance between

    Democratic societies right to know

    vs.Freedom to operate

    vs.

    Freedom to choose

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    Important distinction

    What are the goal and objectives for socio-economic assessments as related tobiosafety or technology decision making?

    An impact assessmentduring the biosafetyregulatory stage needsto be ex ante

    For monitoring orstandard technologyevaluation purposes this

    is a conventional ex-post assessment

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    Specific questions about potential socio-economic consideration inclusion

    Feasibility Can all socio-economicconsiderations be assessed exante and/or ex post?

    Fit with decision making

    process

    How are assessment outputs

    going to be used in a decisionmaking process?

    Utility Does inclusion of socio-economic considerationsimprove societys welfare?

    Regulatory impacts Are we considering allbenefits, costs, risks andpotential outcome from theinclusion of socio-economicconsiderations

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    3. Experiences with socio-

    economic assessments

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    What do we know from the economic impactassessment literature to date?

    A review of 137 peerreviewed studies

    Examined studies with a

    focus on: Farmers, household and

    community

    Industry and markets

    Consumers

    Trade

    Citation: Smale, Melinda; Zambrano, Patricia; Grure, Guillaume; Falck-Zepeda, Jos; Matuschke, Ira; Horna, Daniela; Nagarajan, Latha;Yerramareddy, Indira; Jones, Hannah. 2009. Measuring the economic impacts of transgenic crops in developing agriculture during the first

    decade: Approaches, findings, and future directions. (Food policy review 10) Washington, D.C.: International Food Policy Research Institute(IFPRI) 107 pages

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    Food Policy Review 10 conclusions

    On average profitable but averages maskvariability by agro-climate,

    host cultivar, trait, farmer Too few traits, too few

    cases/authorsgeneralizations should notbe drawn yet...need moretime to describe adoption

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    Food Policy Review 10 conclusions

    Next decade

    Cross cutting issues forfurther study including

    impacts of poverty,gender, public health,generational

    Need improved

    methods to examinebroader issues

    R l i hi b d

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    Relationship between genderdifferentiated adoption and impact

    Farmers

    Technology

    developers

    Regulators

    Attitudes

    Perceived and actual risk

    Social norms

    Gender roles

    Access and control

    Time

    AssetsInputs

    Credit

    Market

    Prices

    Technolo cost

    Knowledge

    Crop and trait

    Economic

    Health

    Nutrition

    Labor

    Farming practices

    Impacts

    By crop- trait

    Economic

    Health

    Nutrition

    Labor

    Social norms

    Policy

    Regulations

    Governance

    Institutions

    A joint study onthe Bt/RR maizein the Philippinesdone by UP-LBand IFPRIexaminingrelationshipbetween gender

    andbiotechnologyadoption andimpact

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    Impact on Farmers / Household / Community

    Value of biodiversity to indigenous communities

    Value of biodiversity to individual farmers, households, and communities

    Profits and benefit/cost ratios

    Net income

    Use of productive inputs (pesticides,)

    Production practices

    Gender differentiated access and control, knowledge and/or attitudesHealth impacts

    Safety first, downside risk, minimum production for survival

    Irreversible costs and benefits

    Freedom of choice and freedom to operate

    Potential issues for a socio-economic assessment

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    Lists of potential issues should not beviewed as check lists

    Prudent to carefully choose whichissues are relevant to the technologydecision making process

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    How does a producer benefit? Insectresistance and herbicide tolerant traits

    The case of Bt/RR maize

    Impacts on:

    Producer Profit

    Producer Surplus

    Cost to Benefit

    LivelihoodsAdditional

    cost ofusing the

    Technology

    Tech fee

    0

    +

    -

    Decrease

    pesticide

    application

    cost-Insecticide

    -Machinery &

    Equipment

    Increase

    Yield

    -Timing

    applications-Reduced

    damage bolls

    Price change

    due to increase

    in supply

    Additional

    cost of

    controllingsecondary

    pests

    Amenable to

    IPM and/or

    controlled

    easily

    Labor

    Labor

    The

    management

    conveniencefactor

    Allow use of

    alternative

    productiontechnologies

    - No-till low-till

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    A bit of historyThe case of Bt

    cotton in the U.S.

    -22 -12 -14

    58 37 37

    141

    80

    97

    63

    8593

    -50

    0

    50

    100

    150

    200

    250

    300

    1996

    Industry

    US Farmers

    Consumers

    Foreign Farmers

    1997 1998

    Industry

    36%

    Consumers19%

    US Farmers

    45%

    Total benefit estimates(Millions US $)

    Falck-Zepeda, Traxler & Nelson 1999, 2000

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    Black Sigatoka Resistant Bananas in Uganda:An ex antestudy

    One year delay foregopotential annual (social)benefits of +/- US$200million

    A GM banana with tangiblebenefits to consumersincreases their acceptancefor 58% of the population

    Photos credits: Kikulwe 2009 and Edmeades 2008

    Citations:Kikulwe, E., J. Wesseler and J. Falck-Zepeda. 2008. Introducing a Genetically Modified Bananain Uganda: Social Benefits, Costs, and Consumer Perceptions. IFPRI Discussion Paper 767,Environment and Production Technology Division, International Food Policy Research Institute,Washington, D. C. USA.

    Kikulwe, E.M., E. Birol, J. Wesseler, J. Falck-Zepeda. A latent class approach to investigating

    demand for genetically modified banana in Uganda Agricultural Economics. 2011.

    http://www.gmo-compass.org/features/zoomimage.php?image=/data/imagescontent/grocery_shopping/017_banana-blacksigatoka_zoom.jpg&width=500&height=332
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    Bt cotton in West Africa: An ex antestudy

    Impact of adoption in Burkina Faso, Benin, Mali,Senegal and Togo

    Conclusions

    West African countries are worse off by not adopting

    Bt cotton

    Smaller Net Benefits than other studies

    Negotiating downward the technology fee is key

    Larger share of benefits tends to be captured by

    developers based on conservative assumptionsused in the model

    Citation: Falck-Zepeda, Horna and Smale, African Journal of

    Agricultural and Resource Economics, 2008

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    Bt maize in the Philippines: An Ex poststudy

    Growing Bt maizesignificantly increasesprofits and yields

    Significant insecticide usereductions

    Adopters tend to: Cultivate larger areas

    Use hired labor

    More educated

    have more positive perceptionsof current and future status

    Change in economic surplus

    (mill pesos)

    Producer Surplus 7906

    Seed Innovator 703

    Total Surplus 8609

    Producer Share (%) 92

    Innovator Share (%) 8Bt maize studies in Philippines led by Dr. Jose Yorobe Jr. with 466 farmers in16 villages Isabela Province, Luzon, South Cotabato Province, Mindanao

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    Bt maize in Honduras: Ex post study

    Excellent insect control

    Bt yield advantage 893-1136 Kg ha-1 yield (24-33%)

    Bt maize yieldspreferred even by riskaverse producers

    100% higher seed costthan conventional hybrid

    Institutional issuesimportant

    Photos credit: Sanders and Trabanino 2008

    Small Resource-Poor Countries Taking Advantage of the New Bioeconomyand Innovation: The Case of Insect Protected/Herbicide Tolerant Maize inHonduras. Jose Falck Zepeda, Arie Sanders, Rogelio Trabanino, Oswaldo

    Medina and Rolando Batallas-Huacon. Paper presented at the 13th ICABRConference The Emerging Bio-Economy, Ravello, Italy June 17-20, 2009.

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    4. Cost of compliance with

    biosafety regulations

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    Tension between safety andinnovation

    Innovation as a path to address poverty andpromote sustainable growth

    How precautionary an approach is

    necessary/sufficient for society to accept atechnology?

    All biosafety processes/regulations are bydefinitionprecautionary

    Precaution is really a matter of degree Need clear bounds, decision making rules, time

    limitations

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    Biosafety as a process

    Contained Use

    Experiments

    Confined

    Field Trials

    Deliberate

    Release

    Post

    Release Deregulation

    Regulatory decision points

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    R&D and product development lifecycle

    1 3 years 1 3 years 1 3 years

    Product

    Concept

    Discovery Early Product

    Testing &Development

    Integration

    & ProductSelection

    Product

    Ramp Up

    Market

    Introduction

    1 2 3 4 5 6

    Confined Field Trials

    Author: Ramaeker-Zahn

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    Why study the cost of compliance?

    Focus is to explore balance between a country-defined acceptable level of safety and thenecessary cost to achieve it

    Critical to include all direct and opportunity

    benefits and costs of adopting and not adoptingbiotechnologies and alternatives

    Identify which areas contribute more overall tosafety and net benefits in order to focusinvestments

    Avoid investing (good) money in issues that

    are trivial, manageable or irrelevant

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    An (old) compilation of cost studies

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    Cost of Compliance with Biosafety Regulationsin Indonesia and the Philippines: A PBS study

    Citation: Falck Zepeda et al. 2007

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    Opportunity and direct costs ofregulation are important to society

    Direct and indirect effects High costs are a special concern

    for Public sector

    Small private (domestic) firms Crops and traits of interest to

    developing countries

    Countries without significantinnovative capacity

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    5. Practical socio-economic

    assessments implementationissues and implications

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    Considerations for regulatory design

    Issues OptionsType of inclusion No inclusion vs. Mandatory vs. Voluntary

    Scope Narrow interpretation article 26.1 Narrow set of socio-economic issues Broader set of assessments (SIA or SL)

    Approach Concurrent but separate vs. Sequential vs. Embedded Implementation entity

    Assessment trigger Each submission vs. Event-by-event

    When Laboratory/greenhouse vs. CFTs vs. Commercialization For post release monitoring At all stages?

    How? Choice of methods for ex anteassessments is much more limitedthan for ex post Decision making rules and standards Method integration, standards, tolerance to errors

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    My blogSocio-economics, biosafetyand Decision Making

    http://socioeconomicbiosafety.wordpress.com/

    P i l i li i f SEC

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    Potential implications from SECinclusion into decision making

    Potential for introducing uncertainty that canlead to an unworkable system if rules andstandards are not clear

    Gain more and/or better information abouttechnology impacts for decision making

    Balance gains in information, additional costs &

    effort, and innovation What to do with SEA results?

    What can a decision maker do with the results

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    What can a decision maker do with the resultsa socio-economic assessment?

    ASSESSMENT

    OUTCOME

    Negative SocioEconomic

    Assessment dueto institutional

    issues

    Biosafety rendersproduct to be

    safe

    Not approve

    Require moreinformation

    SEC assessment

    Approve afterresolving

    institutional issues

    Biosafety assessment(environmental and

    food/feed safety)

    REGULATORY

    DECISION

    ?

    ?

    ?

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    Potential implications from SECinclusion into decision making (cont..)

    Cost of compliance will increase

    Time to completion may increase

    Reduction in the ability for the country toinnovate

    Consider impacts on public sector and crops

    and traits of interest to developing countries Difficulties for private and public sector

    investments

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    Contrasting benefit levels from GE crop adoption withhigher costs and regulatory lags in the Philippines

    Bt eggplant MVR tomato Bt rice PRSV resistantpapaya

    Net Benefitsbaseline (NPVUS$)

    20,466,196 16,748,347 220,373,603 90,765,793

    Impact on net benefits due to an increase in the cost of compliance with biosafety

    75% higher 0% -1% 0% 0%

    200% higher -2% -3% 0% 0%

    400% higher -5% -7% -1% -1%

    Impact on net benefit due to an Increase regulatory time lag

    1 year longer -28% -36% -12% -27%

    2 years longer -56% -71% -23% -49%

    3 years longer -79% -93% -34% -67%

    Notes: 1) Source: Bayer, Norton and Falck Zepeda (2008), 2) Discount rate for the estimation of NPV = 5%, 3) Changein Net benefits defined as the total benefits estimated using the economic surplus minus total regulatory costs.

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    6. Some concluding reflections

    Adoption of GE biotechnologies has beenoverall positive, but not in each and everycase

    Benefit variability a function of institutionalissues rather than the technology itself

    Prudent to judge technology by its own merits

    Think about crops and traits of interest todeveloping countries

    N d t ffi i t d t ti

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    Need smart, efficient and protectiveregulatory systems

    Match the level of regulation to the level ofrisk

    Introduce and promote system flexibility

    Innovative approaches to assessmentsPerformance rather than prescriptive

    regulations

    Rationalize and streamline application and

    decision making processes

    Ensure understanding of regulatory impacts

    Pursue regional approaches

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    Jos Falck-ZepedaResearch Fellow / Leader PolicyTeam PBS

    IFPRI2033 K Street NWWashington, DC 20006-1002USA

    [email protected]

    Tel. +1.202.862.8158Fax. +1.202.467.4439Skype: josefalck

    Honduras

    mailto:[email protected]:[email protected]:[email protected]:[email protected]