international seed trade and phytosanitary issues: a seed industry ... · international seed trade...
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A Complicated Trade Model
1.Breeding parental lines: Europe State 1
2.Production of basic seeds: Europe State 2
3. Treatment and manufacture of basic seeds: Europe state 1
4. Production of hybrid seeds: China
5. Treatment and manufacture of commercial seeds: Europe state 1
6. Commercial packaging: USA
7. Final market: Mexico
*Adapted from a presentation by Ric Dunkle, PPQ Seed Summit, 2014
The Dilemma with Regulating Seed Movements • International seed trade is continuing to rise!
• Research/breeder seed: needed to support development of new varieties that are better adapted
• More hybrid varieties are being developed: parents are often produced in different countries
• Stock seed production
• Counter season production to meet market needs more rapidly
• Movement of commercial products
• Movements often based on “just in time” concept
• Re-export in the seed industry is a business practice
The Dilemma with Regulating Seeds
• Over 300 different seed species and 65,000 different varieties representing all seed types (vegetable, flower, forage and row crop, grasses)
• Thousands of pests potentially involved; mainly plant/seed pathogens
• Hundreds of thousands, if not millions of shipments globally per year!
• For a given pest, is seed a pathway? If so, what is the appropriate phytosanitary measure?
The Seed Regulation Dilemma • The current solution for many (most) NPPOs is to add
phytosanitary requirements for individual pests or pathogens on individual seed species, often for all origins
Focus is on regulation of individual shipments
Many countries re-test at the POE
• These individual actions add up!
• The impact for seed companies is the need to respond to an increasing patchwork of phytosanitary requirements often for the same seed species
Many pests are technically unjustified-seed often not a pathway (example: tomato seed – over 200 requirements globally; 75% of them are not justified)
The Seed Regulation Dilemma
• NPPOs are having difficulty keeping up: • Too many PRAs to get done – severe backlogs
• Not enough resources for inspections and testing needed for timely export certifications
• Lab capacities for testing at or beyond capacity
• Pushing the problem off shore – onto the industry
• High reliance on seed testing but few standardized international methods have been developed
• Lots of re-testing at POEs; non-harmonized methods often lead to discrepancies in test results
• Low risk pests are treated the same as high risk pests
New Approaches to Regulate Seed Movements Are Needed
•New guidance from the IPPC seed standard
•Pathway analysis/PRA
•Re-export certification
• Seed industry practices that reduce phytosanitary risk
New Approaches to Regulate Seed Movements Are Needed • Evolution away from regulation of individual consignments
toward regulation of seed companies themselves • Focus on recognition of practices that reduce overall risk
• NPPOs would develop non-prescriptive “standards” for phytosanitary security (zero risk is impossible!)
• Companies would present proposals based on their specific (often proprietary) practices (promotes innovation)
• Develop accreditation programs that rely on audit approaches
• NPPOs and industry would direct specific activities/requirements on any significant remaining risk
• To remain competitive, companies will develop improved production and post harvest practices
What is NSHAPP?
• National Seed Health Accreditation Pilot Program (NSHAPP)
• Testing a new model for mitigating risk of imported seed
• Coordinated effort between the Iowa State University and APHIS
• Industry participants voluntarily self-test imported seed and report results to APHIS
• Initial target – CGMMV in cucumbers, melons, watermelon
NSHAPP Successes
• Detected and destroyed positive seed lots
• Increased collaboration with industry
• Increased knowledge of seed business models within APHIS
• Creating ideas for future seed work
A New APHIS Approach
• Regulatory Framework for Seed Health (ReFreSH)
• Risk-, science-based systems approach
• Work within current seed trade model
• Leverage industry best practices
• Promote global adoption of seed trade framework
ReFreSH-Clean Seed “Passport” • Participating company will be issued a clean seed
document
• Company will be able to move seed among participating countries without phytosanitary certificates for each consignment
• Production process will be certified/accredited at each stage; practices will be audited
• Industry required to report pests
• Goal: Facilitate safer global movement of clean seed
Developing the Framework: ReFreSH Workshop, January 27, 2017 • Joint APHIS-seed industry workshop
• Purpose: understand current industry practices • Pest management
• Post-harvest processing
• Quality management
• Evaluate risk
• Determine available risk mitigation tools
• Identify gaps
• Industry collaboration is critical!
Information Needs
• Seed production practices
•Global production areas and typical movement patterns
•Pests of high concern
•Differences between small and large producers
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Risk Characterization
•Pathway analysis
•Pest risk assessment of high profile crops
•Determine critical quarantine pests that follow the seed pathway
EFFECTS OF SEED QUALITY MANAGEMENT PRACTICES ON PHYTOSANITARY RISK REDUCTION
José Laborde (Postdoc - Biostatistics) NCSU-CIPM/USDA-ARS
Stephen Ippolito (Postdoc - Mathematics) ASTA/USDA-ARS
Gary Munkvold (Professor and Chair, Seed Technology & Business Graduate Program) ISU
Alissa Kriss (Math-Stats-Pathology Consultant - Liaison) Syngenta
Tim Gottwald (Epidemiologist/Research Leader) USDA-ARS
2017
Goal
• “To develop a probabilistic risk-based model to assess the efficacy of seed quality management practices in reducing phytosanitary risks as well as enhancing disease control”
• Initially, the main focus is CMM (Clavibacter michiganensis subsp. Michiganensis) as a model system.
Photo: http://www.posgradoeinvestigacion.uadec.mx/CienciaCierta/CC33/1.html#.VmnjBk2FNaQ
Motivation for our modeling approach Module 1 Module 2 - 4 Module 5 & 6 Module 7 Module 8
• The seed goes through a pathway which has several components. • Some components introduce risk and some others are mitigation measures of that risk.
• Each component may have different outcomes associated with a probability. • Not every component can readily generate data to populate a model. • Hence, this problem can not be solved by simple data collection and later
performing logistic regression since not every covariate is or can be measured.
Technical Needs
•Develop validated testing methods for pathogens of concern
•Resolve sampling question
•What do we do with small lots of seeds?
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Leading a Global Conversation
• APHIS is working with other NPPOs to establish widely accepted global seed movement system that promotes a managed risk approach
• APHIS has had initial conversations with QUADs countries (CA, AUS, NZ) and Netherlands
• Initial discussions for an international NPPO meeting this year on seeds
ReFreSH Contacts APHIS: Angela McMellen-Brannigan
Email: [email protected] Phone 1-301-851-2314
Industry: Ric Dunkle Email: [email protected]
Phone 1 703-226-9275
Regulation of Small Seed Lots
• Huge problem for the seed industry
• Problem occurs when a sample needs to be taken for seed testing – molecular testing methods often require sample sizes that can deplete the consignment
U.S. System and Philosophy Regarding Seed • Seed is generally considered low risk (except for certain
seed transmitted pests)
• The market place dictates what seed varieties are marketed • No mandatory variety registration in the U.S.
• Seed performance is regulated according to the label (FSA)
• Poor performing varieties do not compete well in the market place
• Intellectual property protected through PVP and patents
• APHIS makes no distinction based on intended use of seed • Seed lots must only meet phytosanitary import requirements,
whether the intend use is for breeding, research, seed increase, seed commercialization
• No distinctions made on size of the seed consignment
U.S. Regulatory Structure for Seeds
• Seed that is prohibited entry can still be imported for research purposes • Import permit required; permit conditions customized based on
nature of risk
• High risk seed must enter into Federal quarantine (Beltsville quarantine facility): seed is inspected/tested, grown under quarantine conditions, and progeny seed is released (sometimes into PEQ).
• APHIS has special requirements for importation of seed packets (e.g. garden seed packets that are for commercial sale)
Are There other Options for Phytosanitary Certification of Small Seed Lots?
• Inspection/testing of mother plants rather than the seeds prior to shipment(?)
• Produce a generation of seeds in quarantine (at origin or in Brazil), inspect and release progeny seed(?)
• Adjust measures to the risk of the seed species(?)
• In general, find ways to reduce reliance on seed testing for small seed lots