ALAN GREEN IAEA FORUM LIMA, PERU NOVEMBER 27-30, 2012 Irradiation as a Quarantine Treatment: I. USDA Regulations.

ALAN GREENIAEA FORUMLIMA, PERUNOVEMBER 27-30, 2012

Irradiation as a Quarantine Treatment:I. USDA Regulations

Irradiation as a Commodity Irradiation as a Commodity TreatmentTreatmentBackground:• Over 50 countries using food irradiation

• Hawaii irradiating fruit and vegetables since 1995

• Increased interest to find MB alternative

Irradiation as a Commodity Irradiation as a Commodity TreatmentTreatment• 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 RuleUSDA Rule October 23, 2002 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 IrradiationObjective 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 prevent infestation

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

PackagingPackaging

• 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

RegulationJanuary 27, 2006• Establishes a generic

minimum dose of 400 Gray for all insects (other than Lepidoptera adult and pupae)

New RegulationJanuary 27, 2006• Establishes a generic

minimum dose of 150 gray for all fruit flies of the Family Tephritidae (Ceratitis, Bactrocera, Anastrepha, Rhagoletis, etc.)

RegulationJanuary 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 EstablishedScientific 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 GreenIAEA ForumLima, Peru

November 27-30, 2012

Participants

• USDA, APHIS, PPQ

• SENASA

• Cooperator

• Packinghouses

• Growers

• Treatment facilitiesUSDAU

Operational Work plan

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 GreenIAEA ForumLima, 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

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Certification Prerequisites

• Facility is certified by national nuclear regulatory agency

• All agreements are signed:– Framework Equivalency Agreement

– Operational Workplan

– Financial Agreements

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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

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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.

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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.

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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 non-irradiated commodity is separated)

– Verify that data management procedures are adequate to secure the required data.

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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.

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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.

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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

On-line access to APHIS Rules and documents

http://www.aphis.usda.gov/

http://www.regulations.gov/fdmspublic/component/main