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

2. Irradiation as a Commodity Treatment Background: Over 50 countries using food irradiation Hawaii irradiating fruit and vegetables since 1995 Increased interest to find MB alternative

3. Irradiation as a Commodity Treatment Endorsed by International Standards: –International Plant Protection Convention (ISPM 18, April 2003) –North American Plant Protection Organization (April 1997)

4. 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

5. 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

6. Objective of Irradiation Prevent establishment of pests  Mortality is NOT necessary  Preventing reproduction IS necessary

7. 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

8. Establish Dose to Neutralize Pest Based on Probit 9 –99.9968% effective –95% level of confidence Consideration about changes to: –commodity –color –texture

9. 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

10. 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

11. Records Irradiator must maintain records for 1 year Must be available for inspection Must contain treatment specifics

12. 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

13. Operational Work plan Describes Irradiation Program requirements and responsibilities Treatment facility Certification Compliance Agreements Safeguarding, post-treatment Record keeping Corrective Actions

14. 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

15. Regulation January 27, 2006 Establishes a generic minimum dose of 400 Gray for all insects (other than Lepidoptera adult and pupae)

16. 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.)

17. Regulation January 27, 2006 Does NOT include: Mites Mollusks Nematodes Plant pathogens

18. 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.

19. Specific Dosages Established Scientific name Common name Dose (Gy) Brevipalpus chilensisFalse red spider mite 300 Cydia pomonellaCodling moth 200 Cryptophlebia illepidaKoa seedworm 250 Cryptophlebia ombrodeltaLitchi fruit moth 250 Grapholita molestaOriental fruit moth 200 Conotrachelus nenupharPlum curculio 92 Cylas formicarius elegantulus Sweetpotato weevil 165 Rhagoletis pomonellaApple maggot 60 Coccus viridisGreen scale 400

20. Irradiation as a Quarantine Treatment: II. Operational Work Plan Alan Green IAEA Forum Lima, Peru November 27-30, 2012

21. Participants USDA, APHIS, PPQ SENASA Cooperator Packinghouses Growers Treatment facilities USDAU Operational Work plan

22. APHIS Responsibilities Oversight and Monitoring of all preclearance activities Sampling, cutting and inspection of commodity at treatment facility Operational guidance

23. 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

24. Cooperator Responsibilities Organize and arrange funding Request services of APHIS and SENASA, starting and closing dates.

25. Growers Responsibilities Register with SENASA and get Production Unit Code Comply with best agricultural practices

26. 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

27. 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

28. Irradiation as a Quarantine Treatment: III. Facility Certification Alan Green IAEA Forum Lima, Peru November 27-30, 2012

29. 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

30. 30 Certification Prerequisites Facility is certified by national nuclear regulatory agency All agreements are signed: –Framework Equivalency Agreement –Operational Workplan –Financial Agreements

31. 31 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

32. 32 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.

33. 33 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.

34. 34 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.

35. 35 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.

36. 36 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.

37. 37 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

38. On-line access to APHIS Rules and documents http://www.aphis.usda.gov/ http://www.regulations.gov/fdmspublic/ component/main