Sampling and testing protocol for bulk shipments of flaxseed exported to the European Union

Producer delivery samples

A sample will be taken by grain handling company personnel from each producer delivery into the commercial handling system. Samples will be retained for a period of no less than 6 months from the date of delivery. The Canadian Grain Commission provides guidance on sampling methods to the Canadian grain industry in its official Sampling Systems Handbook and Approval Guide.

Composite railcar samples and testing

All flaxseed moves from primary elevators to port position by railcars. At time of loading, each railcar will be sampled, and composite samples representing not more than 5 railcars will be prepared. The Canadian Grain Commission provides guidance on sampling methods to the Canadian grain industry in its official Sampling Systems Handbook and Approval Guide. These composite samples will be tested for the presence of FP967 by a laboratory on the list of laboratories approved for testing flaxseed shipments to the European Union and Brazil using the approved method.

Commercial segregation and quality management

All Canadian grain handling companies exporting bulk flaxseed to the European Union are either ISO or HACCP certified. Companies will employ internal quality management systems and practices to guard against cross contamination of positive flaxseed and negative flaxseed lots.

Prior to railcar unloading

Grain handling company personnel will:

• seal all silos in the elevator containing flaxseed not tested under this protocol or that has tested positive using a uniquely numbered seal, and record the silo and seal numbers
• provide to the Canadian Grain Commission a list of silos in the elevator designated for negative flaxseed destined to the EU and confirm those silos are empty prior to use

Unloading railcars, sealing silos, sampling and testing

Grain handling companies will provide a list of the rail cars that test negative to the Canadian Grain Commission and the Canadian Grain Commission will compile and maintain that list.

Grain handling company personnel will sample all railcars unloading flaxseed destined for export to the EU with an approved automatic diverter-type sampler in accordance with the official Sampling Systems Handbook and Approval Guide.

For lots of flaxseed exceeding 500 metric tons, a minimum sample size of 50 kilograms will be taken. For lots between 50 metric tons and 500 metric tons, a sample equal to 0.01% of the lot size will be taken. For lots less than 50 metric tons, a minimum sample size of 5 kilograms will be taken. These sample sizes are in accordance with European Commission Recommendation 2004/787/EC (OJ L 348, 24/11/2004, p 0018- 0026).

Grain handling company personnel will monitor grain flow from each railcar unload to each designated silo. Grain handling company personnel will seal full silos with a uniquely numbered seal and record the silo and seal number.

Grain handling company personnel will prepare two 2.5-kilogram composite samples for each silo. One sample will be forwarded to an ISO 17025-accredited laboratory on the list of laboratories approved for testing flaxseed shipments to the European Union and Brazil.

Approved laboratories will test the sample in accordance with the procedures outlined in this protocol, and notify the grain handling company whether each silo tests positive or negative for the presence of FP967. Any silo for which the composite sample tests positive will be diverted from the EU flaxseed supply.

Loading lake vessels

At the time of loading:

• grain handling company personnel will provide the lake vessel name to the Canadian Grain Commission Canadian Grain Commission personnel will confirm that this vessel has not been used to transport untested or positive tested flax in the prior twelve months
• Canadian Grain Commission will confirm that this vessel has not been used to transport untested or positive tested flax in the prior twelve months
• grain handling company personnel will provide to the Canadian Grain Commission a list of silos to be loaded to lake vessels and confirm that they have tested negative and that the seals remain intact
  
• grain handling company personnel will break the seal on each negative silo, monitor the grain flow paths and confirm to the Canadian Grain Commission that only flaxseed from designated silos is loaded to the lake vessel during the loading of the lake vessel
• grain handling company personnel will confirm to the Canadian Grain Commission that seals on positive or non-protocol flaxseed are intact prior, during and after lake vessel loading

Prior to unloading lake vessels

Grain handling company personnel will seal all silos in the elevator containing flaxseed not tested under this protocol or that tested positive using a uniquely numbered seal. Grain handling company personnel will record the silo and seal numbers.

Grain handling company personnel will provide to the Canadian Grain Commission a list of silos in the elevator designated for negative flaxseed destined to the EU and confirm those silos are empty prior to use.

Unloading of lake vessels

Grain handling company personnel will monitor grain flow from each lake vessel, to each designated silo. Grain handling company personnel will seal full silos with a uniquely numbered seal and record the silo and seal number.

Loading ocean vessels

Grain handling company personnel will:

• provide to the Canadian Grain Commission a list of silos to be loaded to EU ocean vessels and confirm that they tested negative and that the seals remain intact
• break the seal on each negative silo, monitor grain flow paths and confirm to the Canadian Grain Commission that only flaxseed from designated silos is loaded to the ocean vessel during the loading of the ocean vessel
• confirm to the Canadian Grain Commission that seals on positive or non-protocol flaxseed are intact prior, during, and after ocean vessel loading

Testing preparation

Laboratory personnel will draw four 60-gram sub-samples from the single 2.5-kilogram laboratory sample. Each 60-gram sub-sample represents approximately 10,000 individual flax seeds, which is capable of achieving a level of detection of 0.01%.

Testing procedures

Laboratory personnel will test four 60-gram sub-samples taken from the single 2.5-kilogram laboratory sample. One DNA extraction will be made from each sub-sample using a DNA extraction kit that meets the performance criteria laid down in section 2.1 and 2.2 of the JRC Technical report Definition of Minimum Performance Requirements for Analytical Methods of GMO Testing. Two PCR analyses will be carried out for each DNA extraction. The construct-specific method, verified by the European Union Reference Laboratory, will be used for the qualitative PCR assay.

• European Union Reference Laboratory method for detection of flax CDC Triffid (FP967)

Testing results

A lot shall be considered negative when all four 60-gram sub-samples test negative.