2. Food and Agriculture Organization of the United NationsInternational Atomic Energy Agency By: Gary Luckman IAEA Expert Cairns, July 2009 Auditing of Irradiation Facilities - Australia

3. Food and Agriculture Organization of the United NationsInternational Atomic Energy Agency Introduction Food Irradiation treatment is becoming increasing viewed as an alternate treatments for food and agricultural goods in the Asia and Pacific region. The Introduction of ISPM 18 and the Codex Recommended International Code of Practice for Radiation Processing of Food in 2003 resulted in Australia basing its new auditing requirements for gamma radiation facilities on these new guidelines and the existing IAEA Codes of practice for radiation treatment facilities. The Australia and New Zealand Standard (A-17) for Food Irradiation incorporates harmonised regulations principles from Codex and IPPC.

4. Food and Agriculture Organization of the United NationsInternational Atomic Energy Agency Australian Regulatory Agencies Responsible for Radiation Department of Health and Aging & NZ Health Minister(ANZFA only) (policy and standards ratification) Food Standards, Australia New Zealand (food standards & policy development) State Environmental Protection Agencies (Safety and operations) Biosecurity Australia (Import risk assessment for plants and animal products) Australian Radiation Protection and Nuclear Safety Agency (Safety and Operations) Department of Agriculture, Fisheries and Forestry-Australia Australian Nuclear Science and Technology Organisation (Research and dosimetry) Australian Quarantine and inspection Service (AQIS) (Auditing and Import and Export Certification role)

5. Food and Agriculture Organization of the United NationsInternational Atomic Energy Agency Imports of foods and quarantine risk materials must meet Australian Biosecurity and Food Safety requirements, be appropriately labelled and treated in approved facilities. Exports from Australia must meet importing country requirements, be appropriately labelled, identified and treated in approved facilities. Australian Requirements for Irradiation Treatments

6. Food and Agriculture Organization of the United NationsInternational Atomic Energy Agency Irradiation treatment facilities need to be registered. Registered facilities are inspected regularly. Foods treated for sanitary reasons become prescribed and require export permits. Fit and proper person requirements fro treatment facilities. Penal provisions for illegal exports or false declarations. Labelling/trade description are required.(Based on Codex) Export certificates are issued by AQIS for importing countries that require certification. Eventual electronic issuing of export sanitary certificates for irradiated foods (EXDOC system) Food Irradiation Domestic Treatment Issues

7. Food and Agriculture Organization of the United NationsInternational Atomic Energy Agency (1) Basic product information consisting of: Product type code Pack type, and Method of preservation: Gamma Irradiation (2) Type of packaging and number of packages. (3) Description of the goods. (4) Where and when the product was produced: Dates of production Registered number of irradiation processor (5) Basic Transport Information: Destination country Destination city Port of loading Port of discharge Mode of transport (post, sea or air) Vessel name or flight details, and Date of departure (6) Dosage Information: Min or Max Food Irradiation Certification Requirements

8. Food and Agriculture Organization of the United NationsInternational Atomic Energy Agency Export Certification: Example

9. Food and Agriculture Organization of the United NationsInternational Atomic Energy Agency The Australian Quarantine and Inspection Service (AQIS) accepts offshore gamma irradiation treatment for a number of commodities in accordance with the requirements outlined in the AQIS Import Conditions Database (ICON). Applications to register with the Gamma Irradiation Offshore Treatment Providers Scheme (the Scheme) –See notes, are subject to approval by AQIS (Canberra Office) and will be assessed on their individual merits with consideration being given to the quarantine risk. Application evaluations include two main factors: - an assessment of the applicant’s capacity to operate in accordance with relevant AQIS requirements, based on supporting documentary evidence; and - an assessment of the physical structures and operational procedures used by the applicant with a view to determining their effectiveness in addressing quarantine risks. Australia’s Off Shore Treatment Providers Scheme

10. Food and Agriculture Organization of the United NationsInternational Atomic Energy Agency Gamma Radiation Off shore Treatment Providers Scheme- Auditing Requirements 2-3 year audit frequency depending on risk assessment. Audit contracts entered into between the facility and the Australian Government. Pre-payment and full cost recovery of audit costs from the treatment facility or commercial partner. Verification requirements after arrival of treated goods in Australia. Applications to register with the Scheme must be accompanied with documentary evidence of the applicant’s ability to meet International Codes of Practice and Standards relevant to performing a gamma irradiation treatment, including but not limited to: Codex Recommended International Code of Practice for Radiation Processing of Food (cac/rcp 19-1979, rev. 2-2003); Food Standard A17: Irradiation of Food – (Food Standards Australia)

11. Food and Agriculture Organization of the United NationsInternational Atomic Energy Agency Currently there are AQIS approved facilities under the off shore scheme in Germany, the Netherlands, South Africa, UK, Israel and India. Assessments of applications generally take 2-3 months to process. On shore (after arrival) verification programs are being developed to improve the scheme. Australian on-shore gamma radiation treatment facilities have been inspected and assessed by several RCA member country authorities, including New Zealand and Malaysia. Australia is building up a team of qualified auditors for the on and off shore gamma schemes via industry and IAEA training opportunities. Gamma Radiation Schemes- Current