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USDA Irradiation Rules
Inder P.S. Gadh, Ph.D.Senior Risk Manager - Treatments
USDA APHIS PPQ RPM
4700 River Road, Unit 133
Riverdale, MD 20737
(301) 851-2141
United States Department of Agriculture
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I will talk about
• Three rules on irradiation
• Requirements for southern facilities
• Steps to follow
United States Department of Agriculture
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Relevance to exportsWhen it comes to irradiation:
• Harmonization of requirements required
• US import requirements closely followed
• Pest-free trade means greater credibility
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Irradiation as a Phytosanitary Treatment
Some unique features/advantages of IR:
• Commodity non-specific
• Wider range of pests covered
• Pest mortality not necessary
• Relatively less toxic to commodity
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Three Irradiation Rules – Landmark rules
• October 23, 2002 – Sets the ground work
• January 27, 2006 – Provides generic doses
• July 20, 2012 – Allows facilities in southern U.S.
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The October 23, 2002 Rule established
• Treatment requirements
• Monitoring
• Inspection
• Safeguards
• Facility certification
• Dosages for 12 pests
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The January 27, 2006 Rule expanded pest list
Anastrepha ludens 70 Cryptophlebia illepida 250
Anastrepha obliqua 70 Cylas formicarius
Anastrepha serpentina 100 elegantulus 150
Anastrepha suspensa 70 Cydia pomonella 200
Bactrocera jarvisi 100 Euscepes postfasciatus 150
Bactrocera tryoni 100 Grapholita molesta 200
Brevipalpus chilensis 300 Omphisa anastomosalis 150
Conotrachelus nenuphar 92 Rhagoletis pomonella 60
Croptophlebia ombrodelta 250 Sternochetus mangiferae 300
ALL Fruit Flies of Tephritidae family not listed above 150
ALL Insects except Lepidoptera pupae and adults 400
Three more pests with specific doses added later
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The January 27, 2006 Rule
Generic Doses
• 150 Gy – Neutralizes all fruit flies
• 400 Gy – Neutralizes all insects
(excluding Lepidoptera adults & pupae )
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Irradiation facilities in the southern United States
• Earlier many States of the U.S.
were prohibited to have irradiation
facilities
• After July 20, 2012, a rule allowed
to have facilities in the southern
U.S.
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Approved US Locations Prior to July 2012
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Irradiation facilities in the southern United States … cont’d
• In 1994, APHIS conducted a study that
determined areas where fruit flies may or
may not overwinter
• Thus certain area in northeast was
considered safe and movement of FF hosts
and facilities were allowed
• Certain areas considered unsafe required to
have additional measures to allow such
movement or have facilities
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Key requirements for southern facilities
• Location to be operationally feasible
• State concurrence in writing
• Facility to provide map of crops
around
• Facility certification required
• Pest proof boxes & fruits stay in them
until treated
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Key requirements for south … cont’d
• Refrigerated or A/C conveyance
• Pre-arrangement with the facility
(Time/Route/Conveyance)
• Facility under compliance agreement
• Pest trapping or monitoring
• Secured devanning of fruit ensured
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Key requirements for south … cont’d
• Treated commodities kept separated
• Facility is locked during non-business hours
• Back up CT/MB fumigation required
• Contingency destruction plan required
• Only pre-approved admissible articles
allowed
• Other requirements if necessary per CA
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So where you go from here ? (next steps)
Check FAVIR to determine admissibility http://www.aphis.usda.gov/https://epermits.aphis.usda.gov/manual/index.cfm?ACTION=pubHome
If admissible (work on operational issues):
– Work thru NPPO to finalize agreements (FEWP, OWP, CA, Trust Fund, etc),
– Have facility certified; Apply for import permit, set up funds for preclearance etc
If not admissible – have NPPO initiate the approval process
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Commodity Approval – Two ways
• Rulemaking Process – to change
the regulations (CFR)
• Notice Based Process – to
change the manual (FAVIR) –
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Yes
Develop Regulatory Workplan
•Get OMB Designation
•Apply NAPA
•Submit to RAD
Write the Proposed Rule
•Go through Clearance Chain
•Provide a period for Comments
Make a Decision
•Review Comments
•Decide if to go for or not
No
Draft Final Rule•Address Comments
•Write Final Rule
•Send for Clearance
Rule
Cleared without
comments
?
Trigger
(Initiating Event)
Develop Supporting
Documents•PRA, RMD
•TED
•Other Analyses
Federal
Register
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Agreements Required for use of IR • FEWP (Framework Equivalency Work Plan)
• OWP or Operational Work Plan
Includes:
– Detailed procedures for IR application
– Facility Certification
– Safeguards needed
• Compliance Agreement with Facility, Importer
• Trust Fund to pay APHIS’ preclearance activities abroad
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Thank you
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Currently 9 countries have signed the FEWP with the U.S.
India Philippines Laos South Africa Malaysia Thailand Mexico VietnamPakistan Peru[United States]
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Series1
Series2
0
1000000
2000000
3000000
4000000
5000000
6000000
Mexico Viet Nam Thailand India Pakistan(US)
Kg
Imports of irradiated fruit into the U.S. in 2011
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Imports of irradiated fruits 2008-2012
0
1000000
2000000
3000000
4000000
5000000
6000000
2007 2008 2009 2010 2011 2012 2013
Mexico
Viet Nam
Thailand
India
Pakistan (US)
South Africa
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Pests where irradiation still not approved
• Mites
• Mollusks
• Nematodes
• Weeds & weed seeds
• Lepidoptera adults & pupae
• Pathogens
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Code of Federal Regulations (CFR)
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Commodity Approval - Rulemaking (RM) vs. Notice Based Process (NBP)
• RM is a time consuming process, takes years
• In 2007, APHIS approved NBP, a streamlined
process
• NBP takes only months as opposed to years
• NBP applicable to pre-approved Designated
Measures only
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Commodity Approval - Notice Based Process …
Five Designated Measures
- as Conditions of entry
• Commercial consignment only
• From Pest free area
• Inspection (External pests)
• PC declares shipment as free of pests
• Treatment (High risk internal pests)
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Treatment Types
• Chemical Treatment e.g. MB
fumigation
• Heat Treatments – By Hot Air, Water
or Steam
• Cold Treatment or Refrigeration
• Freezing
• Irradiation – potentially an alternative
to methyl bromide fumigations
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Relative Tolerance of commodities
• High tolerance
Apple, cherry date, guava, longan, cantaloupe, nectarine, papaya, rambutan, raspberry, strawberry, tomato
• Medium tolerance
Apricot, banana, cherimoya, fig, grapefruit, kumquat, loquat, litchi, orange, passion fruit, pear, pineapple, plum, tangelo, tangerine
• Low tolerance
Avocado, cucumber, grape, green bean, lemon
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Some Challenges
• Public misperception – Education helps
• Initial capital required high
• Relative costs of treatment an issue
• No way to validate treatment at POE
• Many pest groups still not mitigated
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Some quarantine significant pathogens• Citrus canker
• Citrus black spot
• Citrus greening
• Citrus scab
• Karnal Bunt
• Fusarium spp
• Puccinia rusts
• Xanthomonas spp
• Ralstonia spp
• Chrysanthimum white rust (& others)
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