Post on 11-May-2015
description
Program for Biosafety Systems – http://pbs.ifpri.info/
“Experiences with Genetically Modified Crops, Socioeconomic Assessments,
Biosafety and Decision Making”
José Falck ZepedaSenior Research Fellow
International Food Policy Research Institute
Leader Policy Team for the Program for Biosafety Systems (IFPRI - PBS)
Photos: Bt/RR maize Isabela province, Northern Luzon, Philippines, 2012
Presentation made at USDA-FAS, Washington DC, February 25, 2014.
Program for Biosafety Systems – http://pbs.ifpri.info/
Content
• Background
• What we know
• Approaches –Brazil & Argentina
• Potential implications from SEC inclusion
Program for Biosafety Systems – http://pbs.ifpri.info/
Socioeconomic Considerations (SEC) Definition
• Slight paraphrase of International Association of Impact Assessment (IAIA)“All the issues of interest to humans that may be affected by an intervention or natural phenomena following a line of causality, that is, from cause to effect. The characterization of socioeconomics considerations may include all the potential ways by which people and communities interact with their socio-cultural, economic and biophysical surroundings and the impact that such intervention or causal agent may have on them.”
• Simplified version (author to be revealed someday…)"Socioeconomic assessment can include examination of a variety of social and economic factors with the objective to better understand the potential impacts of relevant interventions on people and communities."
Program for Biosafety Systems – http://pbs.ifpri.info/
The Netherlands Commission on Genetic Modification (COGEM 2009) proposal on SECs
Benefits to society – e.g. yield increase or food quality improvement
Economics and prosperity – such as increased employment and productivity
Health and welfare – for workers, the local population and consumers
Local and general food supply – these should remain at the same level or improve
Cultural heritage – if desired, specific elements of cultural heritage or local customs should be preserved
Freedom of choice – both consumers and producers should be able to choose between GMO and GMO-free products
Safety – in terms of bother personal and the environment
Biodiversity
Environmental quality
Program for Biosafety Systems – http://pbs.ifpri.info/
What drives SEC inclusion in decision making
• International agreements
• Regional considerations
• National laws and regulations
– National Biosafety Frameworks
– Implementing regulations, directives, administrative acts
• Stakeholder interests
Program for Biosafety Systems – http://pbs.ifpri.info/
Article 26.1 of the Cartagena Protocol on Biosafety1 . The Parties, in reaching a decision on import under
this Protocol or under its domestic measures implementing the Protocol,
may take into account,
consistent with their international obligations,
socio-economic considerations arising from the impact of living modified organisms on the conservation and
sustainable use of biological diversity,
especially with regard to the value of biological diversity to indigenous and local communities
• Applies to decision on import only, or
• National measures
• Voluntary – NOTmandatory
• Especially –not limited to - WTO
• Strictly a specific focus and line of causality
• Explicit impact indicator and emphasis on one target group
Program for Biosafety Systems – http://pbs.ifpri.info/
Assessments as tools/inputs for decision making
Biosafety assessments
Socio-Economic
Assessments
Decision Making
Biosafety regulatory processes are:
• Time and budget constrained
• Mandated to render a decision as an outcome
• Decisions and options tradeoffs
Program for Biosafety Systems – http://pbs.ifpri.info/
Socio-economics and biosafety & biotechnology decision making
BEFORE RELEASE
An impact assessment during the biosafety regulatory stage to decide on the approval of a technology needs to be ex ante
AFTER RELEASE
For monitoring purposes or for standard technology evaluation purposes this is a conventional ex-post assessment
Program for Biosafety Systems – http://pbs.ifpri.info/
What can a decision maker do with the results a socio-economic assessment?
ASSESSMENT OUTCOME
Negative Socio – Economic Assessment
due to institutional
issues
Biosafety renders
product to be “safe”
Not approve?
Require more information?
SEC
assessment
Approve after resolving
institutional issues?
DECISION MAKING
Biosafety
assessment
Program for Biosafety Systems – http://pbs.ifpri.info/
SEC and regulatory design and implementation issues
Issues Options
Type of inclusion? • No inclusion vs. Mandatory vs. Voluntary
Who? • Developer vs. dedicated government unit vs. third party experts
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 vs. class of events
When? • Laboratory/greenhouse vs. CFTs vs. Commercialization• For post release monitoring
How? • Will the assessment require a de novo study? • Choice of methods limited• Decision making rules and standards• Method integration, standards, tolerance to errors
Program for Biosafety Systems – http://pbs.ifpri.info/
2. What do we know about the socio-economic impact of GE technologies?
Program for Biosafety Systems – http://pbs.ifpri.info/
What do we know from the economic impact assessment literature to date?
• A review of 187 peer reviewed studies
• Examined studies with a focus on:
– Farmers, household and community
– Industry and markets
– Consumers
– TradeCitation: Smale, Melinda; Zambrano, Patricia; Gruère, Guillaume; Falck-Zepeda, José; 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
Program for Biosafety Systems – http://pbs.ifpri.info/
Food Policy Review 10 conclusions
• On average GM crops have a higher economic performance — averages do not reflect agro-climate, host cultivar, trait, and farmer variability
• Too few traits, too few cases/authors—generalizations should not be drawn yet...need more time to describe adoption
These conclusions are no different than those for most technologies released to date…
Program for Biosafety Systems – http://pbs.ifpri.info/
Food Policy Review 10 conclusions
• Address cross cutting issues for further study including impacts of poverty, gender, public health, generational, cross links with environmental and health issues
• Develop improved methods and multi-disciplinary collaborations to examine broader issues
Program for Biosafety Systems – http://pbs.ifpri.info/
Black Sigatoka Resistant Bananas in Uganda
Consider irreversible and reversible cost and benefits
With one year delay, forego potential annual (social) benefits of +/- US$200 million
A GM banana with tangible benefits to consumers increases their acceptance for 58% of the population
Photos credits: Kikulwe 2009 and Edmeades 2008
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.
Program for Biosafety Systems – http://pbs.ifpri.info/
Bt cotton in Uganda Positive yield impacts and
net benefits
Smaller rate of return probably explained due to low base yields Need to improve overall
cotton productivity
Probability of a negative return can be as high as 38% with a technology fee as charged elsewhere
Photos credit: © Horna 2009
Horna, et al. (2013) . “Economic Considerations in the Approval
Process of GM Cotton in Uganda: Designing an Ex-ante
Assessment to Support Decision-making. “IFPRI Monoograph
Program for Biosafety Systems – http://pbs.ifpri.info/
Bt maize in the Philippines
• Growing Bt maize significantly increases profits and yields
• Significant insecticide use reductions
• Adopters tend to be– Cultivate larger areas
– Use hired labor
– More educated
– have more positive perceptions of current and future status
Change in economic surplus
(mill pesos)
Producer Surplus 7906
Seed Innovator 703
Total Surplus 8609
Producer Share (%) 92
Innovator Share (%) 8
Bt maize studies in Philippines led by Dr. Jose Yorobe Jr. with 466 farmers in
16 villages Isabela Province, Luzon, South Cotabato Province, Mindanao
Program for Biosafety Systems – http://pbs.ifpri.info/
Bt/RR maize in Honduras
Excellent target pest control
Bt yield advantage 893-1136 Kg ha-1 yield (24-33%)
Bt maize yields preferred even by risk averse producers
100% higher seed cost than conventional hybrid
Institutional issues important
Photos credit: © Sanders and Trabanino 2008
Source: Falck-Zepeda, J., A. Sanders, C. Rogelio Trabanino, & R. Batallas-
Huacon. Caught Between Scylla and Charybdis: Impact Estimation Issues from
the Early Adoption of GM Maize in Honduras. AgBioForum, 15(2), 138-151.
Available on the World Wide Web: http://www.agbioforum.org.
Program for Biosafety Systems – http://pbs.ifpri.info/
A meta-analysis paper by Areal, Riesgo and Rodriguez-Cerezo (2012)
“GM crops perform better than their conventional counterparts in agronomic and economic (gross margin) terms”
“GM crops tend to perform better in developing countries than in developed countries, with Bt cotton being the most profitable crop grown”
Program for Biosafety Systems – http://pbs.ifpri.info/
3. How are socioeconomics included in decision making ….or not…
Program for Biosafety Systems – http://pbs.ifpri.info/
In Brazil, Law 11.105, of 2005, an several normative resolutions from CTNBio –
National Technical Commision on Biosafety regulate the processes for the evaluation,
import authorization, transport, research and deliberate release (limited or
commerical) of LMOs
CNBS
CTNBio
ANVISA (Health)IBAMA (Environment)
Proponent(legal entity)
CIBio
Ministries of Health, Agriculture,
and EnvironmentSociety
Source: Paulo Paes de Andrade, 2012
The case of Brazil
Program for Biosafety Systems – http://pbs.ifpri.info/
Comercialization
Risk Assessment
Biological Aspects
Risk
management
CTNBioMultidisciplinary
body with 54 members
Publicconsultation
Federal monitoring entities –Ministries Agriculture and Health
CIBiosResearch institutions,
universities, private and public companies
CNBS11 Ministries
ResearchProponent
Risk
communication
Source: Paulo
Paes de Andrade,
2012
Program for Biosafety Systems – http://pbs.ifpri.info/
Issue Brazil
Type of inclusion Only if an SEC identified during the scientific biosafety assessment
Scope / What Not clear / open
Who • Three separate bodies Institutional Biosafety Committee, CTNBio = biosafety assessments, CNBS (National Biosafety Council): decision making body.
• CNBS commissions a third party
When Commercialization
Comments • Rationale for dual bodies was to separate technical assessment from the “political” decision making
• Mexico has a similar approach
Source: based on Falck Zepeda, Wesseler and Smyth, 2010 and Pray, 2010
Program for Biosafety Systems – http://pbs.ifpri.info/
Permits for GM crops in Brazil (cultivation,
importation, export)
Source: Paulo Paes de Andrade, 2012
Num
ber
of app
roved e
vents
Year of approval
Old regulatory framework New regulatory framework
Beans
Cotton
Maize
Soybeans
Simple majority voting
Program for Biosafety Systems – http://pbs.ifpri.info/
Argentina – Key regulatory steps
• CONABIA: Evaluates agricultural and environmental impacts through trials
• SENASA: Food safety evaluation
• DNMA: Evaluates potential commercial impact focusing on export markets
• CONABIA makes final report
Program for Biosafety Systems – http://pbs.ifpri.info/
Regulatory activity
• Number of evaluated applications 1991-2011
– Soybeans: 703
– Cotton: 123
• Basic biosafety measures
– Isolation distances• Soybeans: 3-30 meters
• Cotton: 800 meters
– Year post release monitoring• Soybean: 1
• Cotton: 3
Program for Biosafety Systems – http://pbs.ifpri.info/
Issue Argentina
Type of inclusion Mandatory
Scope / What? Economic impacts on trade and/orcompetitiveness. Other impacts being considered.
Who? Minister of Finance and Trade – special unit
When? Commercialization
Comments For a while..policy of only approving those already approved in trade sensitive markets
Source: based on Falck Zepeda, Wesseler and Smyth, 2010 and Pray, 2010
Program for Biosafety Systems – http://pbs.ifpri.info/
3. Potential implications
Photos: KARI –Kenya glasshouse, KARI-Thika confined field trial of Bt cotton, IRRI conventional rice trials Los Baños, Philippines
Program for Biosafety Systems – http://pbs.ifpri.info/
Potential implications from SEC inclusion into decision making
• Gain more and/or better information about technology impacts for decision making - may support valuable technologies
• Balance gains in information, additional costs & effort, and impacts on innovation
• Potential for introducing uncertainty that can lead to an unworkable system if rules and standards are not clear
Program for Biosafety Systems – http://pbs.ifpri.info/
Potential implications from SEC inclusion into decision making
• Cost of compliance costs will increase
• Potential regulatory delays
– Reduction in the number of technologies especially those released by the public sector and crops/traits of a public good nature
– Some public sector institutions may not be able to deploy technologies due to fixed costs necessary to enter market
Program for Biosafety Systems – http://pbs.ifpri.info/
Contrasting baseline net benefit levels from GE crop adoption with higher costs in the Philippines
Notes: 1) Source: Bayer, Norton and Falck Zepeda (2008), 2) Baseline values for each technology expressed in millions US$ using a discount rate for
the estimation of Net Present Value = 5%, 3) Change in Net benefits defined as the total benefits estimated using the economic surplus minus total
regulatory costs.
Program for Biosafety Systems – http://pbs.ifpri.info/
Contrasting benefit levels from GE crop adoption with larger regulatory lags in the Philippines
Notes: 1) Source: Bayer, Norton and Falck Zepeda (2008), 2) Baseline values for each technology expressed in millions US$ using a discount rate for
the estimation of Net Present Value = 5%, 3) Change in Net benefits defined as the total benefits estimated using the economic surplus minus total
regulatory costs.
Program for Biosafety Systems – http://pbs.ifpri.info/
Risk impacts and the stream of benefits
-120
-100
-80
-60
-40
-20
0
20
40
1 2 3 4 5 6 7 8
Valu
es
in M
illio
ns
Years after the onset of benefits5% - 95% +/- 1 Std. Dev. Mean
• Regulatory delays have a negative
impact on returns to investments
• With a 20% rate of return, expect
year 6 of regulatory delay to be the
trigger point for suspending
investment in new R&D
• Investment risk increases over time
• Likelihood that investments will not
be made increases with no
information about probability of
success
Source: Smyth, McDonald and Falck-Zepeda, 2013
Program for Biosafety Systems – http://pbs.ifpri.info/
Program for Biosafety Systems – http://pbs.ifpri.info/
Summarizing
• Socioeconomic consideration inclusion in decision making is not mandatory
• Inclusion of socioeconomics in decision making
– Can have positive and negative impacts linked significantly to implementation
– Increase the cost of compliance
– Time delays are significant
– Investment risk can increase
• GM crop adoption impacts have been mostly positive with some caveats
• There are feasible approaches for implementation but need to focus on options and processes
• Prudent for countries to consider carefully whether the gains in information and assurance are actually outweighed by the cost and other implications from the inclusion of socioeconomics
Program for Biosafety Systems – http://pbs.ifpri.info/
José Benjamin Falck-Zepeda, Ph.D.Senior Research Fellow / Leader Policy Team Program for
Biosafety SystemsIFPRI
2033 K Street NWWashington, DC 20006-1002
USAj.falck-zepeda@cgiar.org
Brief bio/pubs: http://www.ifpri.org/staffprofile/jose-falck-zepedaBlog: http://socioeconomicbiosafety.wordpress.com/
Follow me on Twitter: @josefalck