Revolutionizing Seed Trade Regulations: The ReFreSH Approach

 
R
E
F
RE
SH
 
Ric Dunkle
V/F Emerging Issues Working Group
January 27, 2018
 
Regulating Seed Trade (U.S.)
 
Traditionally seed regarded by regulators as a
relatively low risk pathway so seed moved in trade
with minimal import requirements
Currently, most seed for planting imported into the
United States requires only a phytosanitary
certificate from the country of origin and port of
entry inspection
Phytosanitary certification on consignment by
consignment basis
 
Why The Recent  Concern About Seeds?
 
2013:  Detection of CGMMV in
California
2014:  National Seed Health
Summit
 
Source:
CDFA
 
Challenges of Regulating Seed Trade
 
Increasingly global nature of seed
industry
Trend to increasing demand for
documents and declarations that
specific pests are absent in
imported seed
Providing those certifications on a
consignment basis straining NPPO
resources
 
Source: Good Fruits & Vegetables
 
NSHAPP
 
National Seed Health Accreditation Pilot Program
Implemented 2015
Program administered through Iowa State University
Voluntary program
Participating seed companies voluntarily test imported seed
lots
Focus on testing cucumbers, melons and watermelon for
CGMMV
10K lots tested; 22 positive lots detected
 
A New Approach- 
Re
gulatory 
Fr
am
e
work for 
S
eed 
H
ealth
(ReFreSH)
 
Risk-, science-based systems approach
Aims to develop a more effective and efficient
program for managing phytosanitary risk
associated with international seed
movements.
Leverage industry best practices
Promote global adoption of same system
 
 
A New Approach- 
Re
gulatory 
Fr
am
e
work for 
S
eed 
H
ealth
(ReFreSH)
 
Goals:
Shift the current focus of consignment by
consignment inspection and testing to a
system where accreditation of producers
and production processes forms the basis
for phytosanitary certification
Accommodate all seed sectors (vegetable,
cereal, row crop, farm and lawn, flower) and
all sizes of companies
 
 
ReFreSH- How it could work
 
Companies producing and exporting seed become
accredited by their NPPO
NPPOs of importing countries accept accreditations
as equivalent to phytosanitary certification of
individual seed consignments
Accreditation is basis for issuing phytosanitary
certificates
Compliance assured by quality management
systems/audits
ISF Systems Approach WG VISION
9
One globally accepted Systems Approach that serves
as an alternative to existing pest risk management
options to secure phytosanitary certification for the
international movement of seed
 
Global acceptance via
IPPC
 
How do we get there?
 
Where are we now?
 
ReFreSH Working Group
APHIS, Industry, Academia, NPB
Draft ReFreSH Concept paper
Leveraging existing
systems/practices
Seed production site visits to Iowa and
California
QMS/BMP comparison document
PRAs
Spinach, Melon
 
 
Where are we now
 
Buckets (aka Critical Control Points)
 
 
A Closer Look
 
 
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Sources
 
Review of existing QMS and industry BMPs
Guidance from international standards
ISPM 11: 
Pest risk analysis
ISPM
 
14: 
Systems approaches
ISPM
 
36: 
Integrated measures for plants for
planting
ISPM 38: 
International movement of seed
RSPM 40: 
Risk management
 
Overall Seed Production Model
Field Production Variables - A
Lab Testing Variables - A
Plant
Operations
Outcome
Plant Operations Variables - B
Seed Health Test
Lab Testing Variables - B
ISHI
Protocol
Seed Production Outcome
Trade Operations
Variables
Seed Health
Test
Disease
Endemnicity
Variables
Seed Test Accuracy
Disease Endemic
Location
Control
Parameters
Seed Test Accuracy
Plant
Operations
Variables -A
Trade
Conditions
 
Next Steps
 
Complete identifying mitigations and corresponding
regulatory oversight activities
Develop accreditation criteria for ReFreSH
Complete description of ReFReSH by September 30, 2018
April 12-13: meeting with 6 countries (Chatham House
rules) in Rome, Italy to discuss/promote se of systems
approach internationally (USA, AUS, FR, NL, RSA, Chile)
Bring NSHAPP under umbrella of ReFreSH
Explore creation of pilot projects
ReFreSH is still a work in progress!
 
 
 
 
What’s in  it for me?
 
To justify the ReFreSH effort there must be a
demonstrated benefit to industry and regulators
For industry:
Faster release of product at import
Reduced operational cost
Harmonized import requirements
For regulators:
Greater phytosanitary security
Greater efficiency and transparency
 
QUESTIONS & ANSWERS
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A new approach, ReFreSH, aims to enhance the efficiency of managing phytosanitary risks in international seed movements by shifting focus towards accrediting producers and production processes. This system seeks to accommodate all seed sectors and company sizes while promoting global adoption of best practices.


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  1. REFRESH Ric Dunkle V/F Emerging Issues Working Group January 27, 2018

  2. Regulating Seed Trade (U.S.) Traditionally seed regarded by regulators as a relatively low risk pathway so seed moved in trade with minimal import requirements Currently, most seed for planting imported into the United States requires only a phytosanitary certificate from the country of origin and port of entry inspection Phytosanitary certification on consignment by consignment basis

  3. Why The Recent Concern About Seeds? 2013: Detection of CGMMV in California 2014: National Seed Health Summit Source: CDFA

  4. Challenges of Regulating Seed Trade Increasingly global nature of seed industry Trend to increasing demand for documents and declarations that specific pests are absent in imported seed Providing those certifications on a consignment basis straining NPPO resources Source: Good Fruits & Vegetables

  5. NSHAPP National Seed Health Accreditation Pilot Program Implemented 2015 Program administered through Iowa State University Voluntary program Participating seed companies voluntarily test imported seed lots Focus on testing cucumbers, melons and watermelon for CGMMV 10K lots tested; 22 positive lots detected

  6. A New Approach- Regulatory Framework for Seed Health (ReFreSH) Risk-, science-based systems approach Aims to develop a more effective and efficient program for managing phytosanitary risk associated with international seed movements. Leverage industry best practices Promote global adoption of same system

  7. A New Approach- Regulatory Framework for Seed Health (ReFreSH) Goals: Shift the current focus of consignment by consignment inspection and testing to a system where accreditation of producers and production processes forms the basis for phytosanitary certification Accommodate all seed sectors (vegetable, cereal, row crop, farm and lawn, flower) and all sizes of companies

  8. ReFreSH- How it could work Companies producing and exporting seed become accredited by their NPPO NPPOs of importing countries accept accreditations as equivalent to phytosanitary certification of individual seed consignments Accreditation is basis for issuing phytosanitary certificates Compliance assured by quality management systems/audits

  9. ISF Systems Approach WG VISION One globally accepted Systems Approach that serves as an alternative to existing pest risk management options to secure phytosanitary certification for the international movement of seed Global acceptance via IPPC 9

  10. How do we get there? Conduct commodity PRAs Inventory current systems Establish accreditatio n criteria ReFreSH Identify mitigation measures Identify BMPs Validate via pilot(s)

  11. Where are we now? ReFreSH Working Group APHIS, Industry, Academia, NPB Draft ReFreSH Concept paper Leveraging existing systems/practices Seed production site visits to Iowa and California QMS/BMP comparison document PRAs Spinach, Melon

  12. Where are we now Conduct commodity PRAs Inventory current systems Establish accreditation criteria ReFreSH Identify mitigation measures Identify BMPs Validate via pilot(s)

  13. Buckets (aka Critical Control Points) Pre-planting: Site Selection & Preparation Pre-planting: Plant & Seed Inputs Production: Pre-harvest Production: Seed Harvest Postharvest : Handling & Storage Postharvest: Conditioning & Treatment Postharvest: Seed Quality Testing Distribution & Transport

  14. A Closer Look Accredit testing facilities/ certification programs Certify transplant facilities Pre- planting: Plant & Seed Inputs Use tested/ certified seed Transplant sanitation Use resistant or less susceptible cultivars Seed treatments Documentation

  15. Sources Review of existing QMS and industry BMPs Guidance from international standards ISPM 11: Pest risk analysis ISPM14: Systems approaches ISPM36: Integrated measures for plants for planting ISPM 38: International movement of seed RSPM 40: Risk management

  16. Overall Seed Production Model Lab Testing Variables - A Seed Health Test Seed Test Accuracy Lab Testing Variables - B Field Production Variables - A Seed Production Outcome Control Parameters ISHI Protocol Seed Test Accuracy Plant Operations Outcome Seed Health Test Trade Conditions Plant Operations Variables -A Trade Operations Variables Plant Operations Variables - B Disease Endemic Location Disease Endemnicity Variables

  17. Next Steps Complete identifying mitigations and corresponding regulatory oversight activities Develop accreditation criteria for ReFreSH Complete description of ReFReSH by September 30, 2018 April 12-13: meeting with 6 countries (Chatham House rules) in Rome, Italy to discuss/promote se of systems approach internationally (USA, AUS, FR, NL, RSA, Chile) Bring NSHAPP under umbrella of ReFreSH Explore creation of pilot projects ReFreSH is still a work in progress!

  18. Whats in it for me? To justify the ReFreSH effort there must be a demonstrated benefit to industry and regulators For industry: Faster release of product at import Reduced operational cost Harmonized import requirements For regulators: Greater phytosanitary security Greater efficiency and transparency

  19. QUESTIONS & ANSWERS

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