Directive 14-01: Procedure for follow-up on positive chemical residue results in organic products
On this page
- 1.0 Purpose and scope
- 2.0 Authority
- 3.0 Background
- 4.0 CB follow-up actions on chemical residue results received from the CFIA
- 5.0 Fees
- 6.0 CVB responsibilities
Date: November 5, 2020
Canadian Food Inspection Agency
Canada Organic Regime
1400 Merivale Road
Ottawa, Ontario, Canada, K1A 0Y9
1.0 Purpose and scope
This directive specifies how the certification bodies (CBs) accredited by the Canadian Food Inspection Agency (CFIA) shall follow up on positive chemical residue results submitted to them by the CFIA, and the timeline for reporting their findings to CFIA.
- Conformity Assessment – Requirements for Bodies Certifying Products, Processes and Services (ISO/IEC 17065)
- Organic Production Systems: General Principles and Management Standards (CAN/CGSB-32.310)
- Organic Production Systems: Permitted substances lists (CAN/CGSB-32.311)
- Pest Control Products Act (PCPA) (S.C. 2002, c. 28)
- The Canada Organic Regime (COR) Operating Manual
- The Safe Food for Canadians Regulations (SFCR)
Under Part 13 of the SFCR, CFIA accredited certification bodies (CBs) must suspend a product's certification when the substances used in the production and processing of organic products are other than those set out in the Permitted Substances Lists (PSL), or if the organic product comes in contact with substances other than those set out in the PSL.
Compliance in regards to prohibited substances must be verified through sampling and testing when there is a reason to suspect the presence of a prohibited substance as outlined in Part C of the COR Operating Manual.
The CFIA also samples and test organic products as part of its monitoring and surveillance programs for chemical residues. Through these programs the CFIA monitors the food supply for chemical residues and contaminants, and evaluates compliance with maximum residue limits (MRLs), tolerances and maximum levels established by Health Canada.
Health Canada's Pest Management Regulatory Agency (PMRA) is responsible for the registration and regulation of pesticides in Canada including the establishment of Maximum Residue Limits (MRLs) under the PCPA.
4.0 CB follow-up actions on chemical residue results received from the CFIA
The CFIA forwards all chemical residue results from its monitoring and surveillance programs to the CBs for follow-up through the conformity verification bodies (CVB).
Detections of chemical residues below the MRL are sent to the CB to follow up with the organic operator and to investigate the cause of the contamination. Based on the investigation, the CB is required to take enforcement actions as per Part 13 of the SFCR.
Depending on the level of detection, CBs are required to follow-up on the results of the chemical residues in accordance with the guidelines listed below, where applicable.
If residues are detected in excess of the MRL, CFIA inspection staff will also follow-up on the violation.
4.1 CB actions when chemical residues are detected below 0.01 ppm
The CB shall
- inform the operator that chemical residues are present
- assess why chemical residues are present and
- follow up with the operator as appropriate
4.2 CB actions when chemical residues are detected:
Between 0.01 ppm and 5% of an applicable MRL (inclusive)
Between 0.01 ppm and 0.1 ppm if no MRL is specified (inclusive)
- the CB shall inform the operator of the detection of chemical residues and request the results of the operator’s investigation into the source of the contamination.
- to follow up, the CB may decide to:
- conduct an inspection
- sample products currently available at the operation or production site for chemical residues. If the affected lot is not available, a different lot should be sampled. If the affected product is not available, a similar product should be sampled
- issue a non-conformity (NC) and request corrective action within a specified time frame
- if the follow up activities indicate that the presence of prohibited chemicals is not due to deliberate use, the CB shall notify the operator that the product(s) remain in compliance with the Canadian Organic Regime.
- if the follow up activities indicate deliberate use of prohibited chemicals by an operator, the CB shall initiate suspension/cancellation of the operation as per Part 13 of the SFCR.
- Upon request by the CFIA the CB shall report their findings to the CFIA through their CVB using the CFIA standardized reporting template.
4.3 CB actions when chemical residues are detected:
Above 5% of an applicable MRL
Above 0.1 ppm if no MRL is specified
- the CB shall immediately initiate an investigation to determine why chemical residues are present and inform the operator of the detection.
- the CB shall inform the operator that the contaminated product shall remain on hold during the course of the investigation. In the case of perishable products, the operator may request permission from the CB to downgrade the product for conventional sale.
- the CB shall schedule an inspection and conduct additional sampling of products currently available at the operation or production site as part of the investigation. If the affected lot is not available, a different lot shall be sampled. If the affected product is not available, a similar product shall be sampled.
- if the results of the investigation indicate presence of prohibited chemicals which is not due to deliberate use, the CB shall issue a non-conformity (NC) and request corrective action within a specified time frame. Products shall lose their organic certification status as per section 7.11.1 (b) of ISO/IEC 17065 if chemical residues are detected above 5% of an applicable MRL OR above 0.1 ppm if no MRL is specified.
- if the results of the investigation indicate deliberate use of prohibited chemicals by an operator, the CB shall initiate suspension/cancellation of the operator as per Part 13 of the SFCR.
The Operator is responsible for ensuring that their products meet the Organic Production Systems General Principles and Management Standards. A sample testing positive for one or more chemical residues may result in further testing or an inspection of the operator facilities/premises to determine their ability to be in compliance with the Organic Production Systems General Principles and Management Standards. In these cases, the certification body may recover from the applicant the fee payable for each inspection.
6.0 CVB responsibilities
CVBs shall verify how the CBs comply with this Directive during the on-site audit of the CBs.
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