Irradiation as a Quarantine
Treatment:
I. USDA Regulations
ALAN GREEN
IAEA FORUM
LIMA, PERU
NOVEMBER 27-30, 2012
Irradiation as a Commodity
Treatment
Background:
•
Over 50 countries using food irradiation
•
Hawaii irradiating fruit and vegetables
1995
•
Increased interest to find MB alternative
since
Irradiation as a Commodity
Treatment
• Endorsed by International Standards:
– International Plant Protection Convention (ISPM 18, April
2003)
– North American Plant Protection Organization (April 1997)
APHIS Irradiation Regulations
• October 23, 2002: Overall
requirements for irradiation as a
quarantine treatment
(Closely followed ISPM 18)
• January 27, 2006: Establishes
generic doses for insects and
specifically for fruit flies
USDA Rule
October 23, 2002
• Follows ISPM section for section
• Allows for irradiation of fruit and
vegetables as a quarantine
treatment
• Code of Federal Regulations:
Parts 305 and 319
Objective of Irradiation
• Prevent establishment of
pests
 Mortality is NOT necessary
 Preventing reproduction IS
necessary
USDA Rule and ISPM 18
Require:
• Establish Dose to Neutralize
Pest
• Ensure Minimum Dose is
delivered
• Establish Safeguards to
identify treated product and
Establish Dose to Neutralize
Pest
• Based on Probit 9
– 99.9968% effective
– 95% level of confidence
• Consideration about changes to:
– commodity
– color
– texture
Ensure Delivery of Minimum
Dose
• Dosimetry mapping that ensures all of commodity
receives minimum dose
• Accurate dosimetry system that ensures dose is
met on each treatment
• Meets guidelines of American Society for Testing
and Materials (ASTM) or equivalent
Packaging
• Prevent infestation after irradiation treatment
•
•
•
•
•
Insect-proof cartons
Storage in room secure to insect infestation
Polyethylene shrink warp
Net wrapping
Strapping
• Preserve identity of treated lots with
appropriate labeling
Records
• Irradiator must maintain
records for 1 year
• Must be available for
inspection
• Must contain treatment
specifics
USDA Also Requires-Compliance Agreements:
Outside U.S., the facility signs an agreement—
1. With SENASA to monitor &
comply with regulations; AND
2. With USDA
Operational Work plan
• Describes Irradiation Program requirements and
responsibilities
• Treatment facility Certification
• Compliance Agreements
• Safeguarding, post-treatment
• Record keeping
• Corrective Actions
Other Agreements
Required by USDA Rule
• Irradiation treatment framework
equivalency work plan
• Provides for reciprocal trade in irradiated
products
• Operational (preclearance) work
plan
• Verifies facility compliance
• Trust fund agreement
• Covers all APHIS costs
Regulation
January 27, 2006
• Establishes a generic
minimum dose of 400
Gray for all insects (other
than Lepidoptera adult
and pupae)
New Regulation
January 27, 2006
• Establishes a generic
minimum dose of 150
gray for all fruit flies of
the Family Tephritidae
(Ceratitis, Bactrocera,
Anastrepha, Rhagoletis,
etc.)
Regulation
January 27, 2006
Does NOT include:
• Mites
• Mollusks
• Nematodes
• Plant pathogens
Doses for Peruvian Commodities
• Asparagus – Probably 400 GY for Copitarsia and
other moth species
• Pomegranates, figs, cherimoya – Minimum of 150
Gy for fruit flies. If other pests are identified in risk
analysis as requiring treatment, up to 400 Gy may
be needed.
Specific Dosages Established
Scientific name
Common name
Dose
(Gy)
•
•
•
•
•
•
•
•
•
Brevipalpus chilensis
False red spider mite
300
Cydia pomonella
Codling moth
200
Cryptophlebia illepida
Koa seedworm
250
Cryptophlebia ombrodelta
Litchi fruit moth
250
Grapholita molesta
Oriental fruit moth
200
Conotrachelus nenuphar
Plum curculio
92
Cylas formicarius elegantulus Sweetpotato weevil
165
Rhagoletis pomonella
Apple maggot
60
Coccus viridis
Green scale
400
Irradiation as a Quarantine Treatment:
II. Operational Work Plan
Alan Green
IAEA Forum
Lima, Peru
November 27-30, 2012
Operational Work plan
Participants
• USDA, APHIS, PPQ
• SENASA
• Cooperator
• Packinghouses
• Growers
• Treatment facilities
USDAU
APHIS Responsibilities
• Oversight and Monitoring of
all preclearance activities
• Sampling, cutting and
inspection of commodity at
treatment facility
• Operational guidance
SENASA Responsibilities
• Register packinghouses and production units
• Monitor production Units (best agricultural
practices)
• Pest identification services
• Sampling, cutting, inspection of commodity (with
APHIS)
• Ensure pallets are strapped and wrapped, and
boxes marked
Cooperator Responsibilities
• Organize and arrange
funding
• Request services of
APHIS and SENASA,
starting and closing
dates.
Growers Responsibilities
• Register with SENASA
and get Production Unit
Code
• Comply with best
agricultural practices
Packing House responsibilites
• Document Standard operating Procedures for
handling and packing program commodities
• For export, pack only fruit from registered
production units.
• Pack in approved pest-proof boxes, adequately
marked
Treatment Facility
• Get Certification from USDA/ APHIS
• Enter Compliance Agreements with SENASA and
USDA
• Document standard operating procedures,
including safeguarding treated fruit and record
keeping
• Treat fruit in boxes for export
Irradiation as a Quarantine Treatment:
III. Facility Certification
Alan Green
IAEA Forum
Lima, Peru
November 27-30, 2012
Facility Certification
• Submit request in writing to
APHIS
• Capable of administering
and verifying proper dose
• Capable of keeping the
treated and untreated
product physically separate
Certification Prerequisites
• Facility is certified by national nuclear regulatory
agency
• All agreements are signed:
– Framework Equivalency Agreement
– Operational Workplan
– Financial Agreements
30
Plan Approval
• Prior to the site visit, APHIS reviews the facility
plans to verify that they meet requirements for
certification
• Plans must be submitted using the “Plan Approval
Application for Irradiation Facilities“
• Plan Approval Application is designed to collect
specific information APHIS needs to determine if
the facility meets the regulations
• Plan Approval Application is in PDF format with
fillable fields
31
Plan Approval Application
•
After the Plan Approval Application is complete,
the facility must send it to APHIS, via SENASA
and APHIS/International Services.
•
Review may take as long as 60 days.
•
After the review is complete, APHIS will send an
approval or rejection letter through IS and
SENASA.
32
Certification Site Inspection
•
APHIS staff will visit the facility to verify that it
meets all requirements.
•
Inspection must take place when articles are
available for treatment.
33
Certification Site Inspection
•
During the site visit, APHIS staff will:
– Review all SOPs and verify that they are being followed.
Make any modifications to the SOPs.
– Inspect segregation structures (how irradiated and nonirradiated commodity is separated)
– Verify that data management procedures are adequate to
secure the required data.
34
Certification Site Inspection
•
Irradiate National Institute of Standards and
technology (NIST) dosimeters and compare results
to facility dosimeters.
– APHIS uses NIST alanine dosimeters to verify the dose
reported by the facility’ dosimeters.
– NIST dosimeters will be sent to NIST in Washington, DC
for analysis.
35
Certification Site Inspection
•
Monitor and approve dose mapping of process
configurations.
– APHIS will monitor dose mapping for all process
configurations at the facility.
– Box type, stacking arrangement, target dose, and other
process specifications will be set and recorded.
36
Recertification
•
Recertification will only be performed when:
– There is a change in management of the facility.
– There are operational or structural changes at the facility.
– The radiation producing source is replenished or
reconfigured.
•
Annual recertifications will NOT be performed
37
On-line access to APHIS Rules
and documents
http://www.aphis.usda.gov/
http://www.regulations.gov/fdmspublic/
component/main