Operational procedure: Control response plan for the detection of radiation positive marine shipping containers housing imported food

On this page

• 1. Purpose
• 2. Authorities
• 3. Reference documents
• 4. Definitions
• 5. Acronyms
• 6. Operational procedure
  • 6.1 Conduct preliminary assessment
  • 6.2 Conduct an incident response investigation
  • 6.3 Assess risk
  • 6.4 Request risk opinion
  • 6.5 Mitigate risk
  • 6.6 Follow-up
• 7. Appendices
  • Appendix 1 – Roles and responsibilities
  • Appendix 2 – Example of RADNET marine container referral form
  • Appendix 3 – Certificates of analysis – criteria

1. Purpose

The purpose of this document is to provide guidance to Canadian Food Inspection Agency (CFIA) inspection staff to evaluate and control potential food safety risks associated with the detection of radiation positive marine shipping containers housing imported food.

This document is intended to be used in conjunction with other guidance documents as referenced in section 3.0.

The guidance below should be used when imported food commodities, housed in marine shipping containers analysed as radiation-positive for radioisotopes, are cleared by the Canada Border Services Agency (CBSA) and referred to the CFIA.

2. Authorities

• Safe Food for Canadians Act (SFCA)
• Safe Food for Canadians Regulations (SFCR)
• Food and Drugs Act (FDA)
• Food and Drug Regulations (FDR)

The inspection powers, control actions and enforcement actions authorized by the above legislation are identified and explained in the Operational guideline – Food regulatory response guidelines.

A list of the roles and responsibilities of all parties involved in this control response plan is found in Appendix 1.

3. Reference documents

• Operational guideline – Food regulatory response guidelines
• Standard regulatory response process
• Standard inspection process
• Radiation-positive shipping container datasheet (accessible only on the Government of Canada network – RDIMS 7991520)
• Nuclear Substances and Radiation Devices Regulations
• Operational procedure – Procedure for seizure and detention, authorizing movement and disposition

4. Definitions

Definitions are located in either the:

• Safe Food for Canadians Regulations: Glossary of key terms
• My CFIA glossary of terms

Radioisotope: an isotope that undergoes spontaneous decay and emits radiation. (radio-isotope)^Footnote 1.

5. Acronyms

Acronyms are spelled out the first time they are used in this document and are consolidated in the Food business line acronyms list.

6. Operational procedure

All questions regarding human exposure to radioisotopes including the handling and transportation of food samples are to be directed to:

Radiation Safety Officer
c/o Occupational Health and Safety (OHS) and Prevention Team (cfia.osh-sst.acia@inspection.gc.ca)

For questions on applying this procedure in specific scenarios, the Operational Guidance and Expertise (OGE) Division may be contacted to obtain subject matter expertise.

6.1 Conduct preliminary assessment

6.1.1 Determine jurisdiction and validity

Note on in-transit shipments: In-transit shipments are outside the scope of this operational procedure. If an in-transit shipment is found radiation positive by the CBSA and refused entry by the destination country, the CBSA, and if appropriate the CFIA, must contact the importer. In-transit shipments are not entering Canada and are not destined for sale in the Canadian market. SFCA and SFCR do not apply in this situation (SFCR (24)) and inspection powers are limited.

This guidance is initiated when the CBSA clears a radiation-positive shipping container housing food at the port of entry and provides the CFIA Area designated contact (see Appendix 1) with the Radiation Detection Network (RADNET) marine container referral form (see Appendix 2).

The CFIA area designated contact gathers the following additional information from CBSA:

• the transaction number
• the current location of the container
• the seal number of the container
• any accompanying documents that may demonstrate the safety of the food such as results of analysis for radiation (radioisotopes)

The CFIA area designated contact provides the appropriate CFIA office with the CBSA RADNET marine container referral form and the above-noted information. The inspector responsible carries out the remainder of this control response plan.

6.1.2 Determine next steps

When a RADNET marine container referral form is received, complete the following actions:

• inform the importer that the food products housed in the container are being held for secondary inspection at the location on their import declaration and in accordance with SFCR 14(1)
• provide the importer with a copy of the RADNET marine container referral form
• confirm the identity of the food(s) housed in the container and the corresponding amounts
• request any documentation demonstrating the safety of the food(s) such as results of analysis for radiation
• request any documentation required by the SFCR for that specific imported commodity

Pre-import off-shore lab certificates of analysis are for reference use only. They cannot be used to determine safety or compliance.

If the container houses food products from multiple importers, this step should be conducted for each importer.

6.2 Conduct an incident response investigation

6.2.1 Prepare for the incident response investigation

Review the information received from CBSA and the importer while considering the following information:

• the shipping container itself may be contaminated with radiation while the food itself may or may not be
• the radiation measurement taken on the outside of the shipping container cannot be used on its own to determine the safety of the food housed inside
• the food must be sampled from its current state and location using an accredited lab
• the Radiation-positive shipping container datasheet (accessible only on the Government of Canada network – RDIMS 7991520) contains historical information on CFIA responses to the detection of radiation in food products and this information is used to determine the need for a health risk opinion in step 6.4

6.2.2 Collect and record additional information

1. Gather information concerning the shipping container and its contents and record it in the Radiation-positive shipping container datasheet (accessible only on the Government of Canada network – RDIMS 7991520). Examples of types of information an inspector can consider include:

• valid private domestic or foreign laboratory certificates of analysis submitted by the importer for the food or food ingredients (refer to Appendix 3: Certificates of Analysis – Criteria to determine validity)
• previously reported results of analysis for the same lot code of food
• responsible importer's history of compliance
• responsible importer's willingness to cooperate
• evidence of fraudulent documentation or reporting
• history of compliance of the same ingredients originating from the same or approximate geographic location

Note: Pre-import off-shore lab certificates of analysis are for reference use only. They cannot be used to determine safety or compliance. Secondary sampling must be collected from its current state and location using an accredited lab. For assistance inspectors can contact Lab Coordination / Coordination des laboratoires (CFIA/ACIA) (Refer to Appendix 3: Certificates of Analysis – Criteria to determine validity)

2. Open a file in the Issues Management System (IMS). To support future trend analysis, ensure the following fields are completed as follows:

• the "Subject Line" must include the word "Radiation"
• the "Trigger Type" = Customs Referral
• the "Area of Concern" = Environmental Hazard (Radioactivity)

6.3 Assess risk

The safety of the food housed inside the marine shipping container is assessed using the results of samples collected by the CFIA. The responsible importer should be given the option to collect and analyse samples. If the importer wishes to sample, they should be made aware of considerations in section 6.3.1. If the CFIA will conduct the sampling, follow the procedure in 6.3.2.

6.3.1 Food sampling conducted by or on behalf of the responsible importer

If the responsible importer indicates they will conduct testing of the product, inform them of the following considerations:

• the responsible importer or the 3rd party laboratory must follow the applicable procedures as set out in section 6.3.2 to obtain the recommended sample size, packaging and maintenance instructions as well as the isotopes to be analysed
• the responsible importer must use an accredited laboratory
• samples must be taken from the food in its current state and location
• pre-import off-shore laboratory results are not acceptable
• the responsible importer must obtain and follow any applicable procedures from the accredited laboratory
• the laboratory used does not need to be a Canadian laboratory (it can be offshore) but importers must be aware of Canadian laboratory accreditation and time windows (48 hrs for perishables) (see appendix 3 for information on accredited labs)
• The responsible importer must communicate to the responsible inspector:
  • the name and contact information of the lab to which the samples are being submitted
  • the date the samples were submitted
  • the sample results

The CFIA does not need to be present during sampling.

6.3.2 Food sampling conducted by the CFIA

All questions regarding human exposure to radioisotopes including the handling and transportation of food samples are to be directed to:

Radiation Safety Officer
c/o Occupational Health and Safety (OHS) and Prevention Team (cfia.osh-sst.acia@inspection.gc.ca)

If the responsible importer will not sample the product, a CFIA sample is required to determine compliance to SFCA and FDA by applying the following process:

1. Collect a sample

• Collect only 1 sample per lot
• To ensure enough sample size to perform testing, 1 kg of the edible portion is required
• For "high value low weight" crops, a sample size of 350 grams of the edible portion is adequate to perform testing (Examples of high value low weight crops include blackberries, blueberries, raspberries, cherries, strawberries, currants and fine herbs such as basil, parsley and dill)
• Package, store and transport the food in a leak proof container to maintain the current physical state
• Ship samples to the Health Canada laboratory with sufficient time to be received no later than 4 p.m. on Fridays
• Request an analysis for the types of isotopes detected by the CBSA on the exterior of the shipping container(s) (for example, if the CBSA report states a measurement of 0.5 µSv/hr of Cs-137 and nil for Cs-134, the analyses must include Cs-137 but does not need to include Cs-134)

2. Notify Health Canada of the intent to submit samples

Once the samples have been collected, send an e-mail to Health Canada at the following address rpb-brp@hc-sc.gc.ca to notify the laboratory of the sample submission. Include the following information:

• "Radiation Analysis – Notification of submission of samples to Health Canada" in the subject line
• IMS number
• RADNET marine container referral form
• number of samples being submitted
• food description(s) including the physical state, for example, fresh, frozen
• proposed end use of the food(s)
• size of each lot and number of lots per food
• name of the importer
• name of the food producer/supplier
• where the food was produced/harvested (nearest city or GPS coordinates)
• amount of food contained in the shipping container
• location of the container at the time of sampling
• date of collection
• CFIA inspector's signature block with phone number

3. Submit the sample(s)

Courier the samples to the following address:

National Monitoring Section | Section de la surveillance nationale
Radiation Surveillance Division | Division de la surveillance du rayonnement
Radiation Protection Bureau | Bureau de la Radioprotection
Health Canada | Santé Canada
775 Brookfield Road, Ottawa, Ontario K1A 1C1

Enclose the following documents with the samples to the Health Canada laboratory:

• a copy of the e-mail "Notification of intent to submit samples to Health Canada"
• the RADNET marine container referral form
• any documentation provided by the responsible importer that may contribute to the health risk opinion, for example, a certificate of analysis for radiation provided by an accredited lab in the country of origin of the last processor of the food

When disclosing the contents of the package to the courier, consider Schedule 1 of the Nuclear Substances and Radiation Devices Regulations (NSRDR) for the quantities of a specific isotope used to determine radioactive vs. non-radioactive with respect to packaging, transportation and labelling.

Store the sample in a manner that maintains the physical state of the food.

4. Communication

Notify the following persons when samples of the food have been submitted to Health Canada for analysis:

• National Manager, Chemistry, Food Safety Science Services Division
• Chief, Special Surveys, Chemistry, Food Safety Science Services Division
• National Manager, Food Imports, Food Import Export Division (FIED)

Notify the designated CFIA area contact in writing of the decision to sample the product. The CFIA area designated contact will forward the information in writing to the CBSA.

6.3.3 Food sample results

CFIA sample results from Health Canada

Health Canada's laboratory provides the CFIA inspector with the Record of Analysis (ROA). When the results are received, refer to section 6.4 to determine whether or not to request a health risk opinion from Health Canada.

Results provided by the responsible importer or 3rd party and analysed by an accredited laboratory

Assess the laboratory result provided by the responsible importer using Table 1 in section 6.4.1 and Appendix 3: Certificates of Analysis – Criteria.

6.4 Request risk opinion

6.4.1 Evaluate need for a risk opinion

Use the data contained in the Radiation-positive shipping container datasheet (accessible only on the Government of Canada network – RDIMS 7991520) and Table 1 below to determine if a Health Canada risk opinion is required.

6.4.2 Obtain risk opinion

If a health risk opinion is required, provide the National Manager, Food Imports, Food Import Export Division (FIED) with the following documents:

• the ROA
• a copy of the e-mail "Notification of to submit samples to Health Canada"
• the RADNET marine container referral form
• any documentation provided by the responsible importer that may contribute to the health risk opinion, for example, a certificate of analysis for radiation provided by an accredited lab in the country of origin of the last processor of the food

The National Manager, Food Imports, will liaise with Technical Expertise and Advice to obtain a health risk opinion from Health Canada. FIED will notify the inspector of the health risk opinion.

6.5 Mitigate risk

6.5.1 Communicate and initiate the risk mitigation plan

When the health risk opinion is obtained from Health Canada, take the following action:

• notify the responsible importer of the conclusion regarding the health risk of the food(s)
• inform the responsible importer that secondary inspection has been completed and compliant lots may now be moved, provided all other legislated requirements are met
• complete and issue an inspection report for each lot analysed that reflects if the lot was compliant or non-compliant to SFCR 8(1)(a) or FDA 4(1)(a)
• if necessary, seize and detain any lots that are non-compliant to prevent them from being further distributed (Refer to the Operational procedure – Procedure for seizure and detention, authorizing movement and disposition)
• notify the CFIA departments/branches identified in section 6.3.2, step 4 of the Health Canada health risk opinion

6.5.2 Documentation and recording

1. Complete the Radiation-positive shipping container datasheet (accessible only on the Government of Canada network – RDIMS 7991520) for every lot of food housed in a radiation-positive shipping container regardless of the type of action taken on the food.

The purpose of the Radiation-positive shipping container datasheet (accessible only on the Government of Canada network – RDIMS 7991520) is to capture all of the data in a manner that will support the inspectorate in determining:

• the type of action(s) to be taken
• sampling requirements, if any
• the validity of a foreign certificate of analysis
• whether or not a health risk opinion is needed
• trends

2. Update the IMS file with information on the decisions made, the health risk opinion and final disposition of the product (release or seizure).

6.6 Follow-up

If any lots are found to be non-compliant, verify compliance of the licence holder to SFCR 82 (investigation, notification and mitigation). For commodities or activities inspected using the Standard Inspection Process (SIP), this can be assessed by including Preventive Control Plan (PCP) Element 7: Traceability, Control and Complaints in the scope of a PCP inspection.

7. Appendices

• Appendix 1 – Roles and responsibilities
• Appendix 2 – Example of RADNET marine container referral form
• Appendix 3 – Certificates of analysis – criteria

For general inquiries related to this operational guidance document, please follow established communication channels, including submitting an electronic Request for Action Form (e-RAF).

Appendix 1: Roles and responsibilities

Canada Border Services Agency (CBSA)

• notifies the CFIA Area designated contact of any radiation-positive shipping containers that will be cleared at the border and are reported to contain food
• puts the affected shipping containers on hold until otherwise notified by the CFIA Area designated contact
• provides the CFIA inspector with the associated incident documents including the Radiation Detection Network (RADNET) marine container referral form (Appendix 2)
• takes the lead on in-transit shipments with support from CFIA if required

Importer

• submits applicable documentation for importation
• submits applicable documentation to the CFIA inspector upon request
• may collect and submit samples for analysis
• communicates with inspector regarding sampling and results if required

CFIA area designated contact

• is the single contact with CBSA
• provides the local CFIA office with the CBSA contact information for the specific incident
• the CFIA area designated contacts are the individuals assigned to the duties of the Area Import Coordinator

CFIA lead investigator/assigned inspector (referred to as the CFIA inspector)

• notifies the importer of the radiation results found outside of the shipping container(s)
• gathers appropriate information
• takes the appropriate action on the food such as:
  • seizes and detains affected food
  • collects and submits samples for analysis
  • provides FIED with results of analysis submitted by the importer
  • notifies the CFIA Area designated contact of the status of the food housed inside the container(s)
• records information gathered during the investigation

Supervisors, individuals with technical expertise within the areas (for example Area Operational Specialists, Regional Program Officers, inspectors who have been involved in similar issues)

• provide technical assistance as required

Food Import Export Division (FIED)

• liaises with Health Canada to obtain a health risk opinion when applicable

Health Canada

• provides advice on sampling requirements
• conducts radiation analysis of food samples submitted by the CFIA
• provides a health risk opinion

Appendix 2: Example of RADNET marine container referral form

Refer to RDIMS 10653788 (accessible only on the Government of Canada network) to see an example of the Radiation Detection Network (RADNET) marine container referral form that will be provided by the CBSA upon referral (available from CBSA in English only).

Appendix 3: Certificates of analysis – criteria