Directive 14-01: Procedure for follow-up on positive chemical residue results in organic products

Effective date: November 5, 2020

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1. Purpose and scope

This directive specifies how the certification bodies 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.

2. Authority

3. Background

Under Part 13 of the SFCR, CFIA accredited certification bodies 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, or if the organic product comes in contact with substances other than those set out in these lists.

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 Canada Organic Regime 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 is responsible for the registration and regulation of pesticides in Canada including the establishment of MRLs under the Pest Control Products Act.

4. Follow-up actions by the certification body after receiving chemical residue results from the CFIA

The CFIA forwards positive chemical residue results from its monitoring and surveillance programs to the certification bodies (CBs) of the implicated operators for follow-up through the conformity verification bodies.

Depending on the levels of chemical residues detected, CBs are required to follow-up with the operator in accordance with the guidelines listed below, as applicable.

When residues are detected in excess of the MRL, CFIA inspection staff will also follow-up on the violation.

4.1 When chemical residues are detected at levels below 0.01 ppm

The certification body shall:

  • inform the operator that chemical residues are present in their product(s),
  • assess why chemical residues are present, and
  • follow up with the operator as appropriate.

4.2 When chemical residues are detected at levels between 0.01 ppm and either 5% of an applicable MRL or 0.1 ppm if no MRL is specified

The certification body shall:

  • inform the operator of the results of chemical residue testing
  • request that the operator investigate the source of the contamination and report their findings.
  • follow up on the actions and findings of the operator, by choosing to, as applicable:
    • conduct an inspection
    • sample products currently available at the operation or production site for chemical residue testing.
      • 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:

  • the presence of prohibited chemicals which is not due to deliberate use, the CB shall notify the operator that the product(s) remain in compliance with the Canadian Organic Regime.
  • 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 conformity verification body using the CFIA standardized reporting template.

4.3 When chemical residues are detected at levels above 5% of an applicable MRL or 0.1 ppm if no MRL is specified

The certification body shall:

  • immediately inform the operator of the detection and initiate an investigation to determine why chemical residues are present.
  • 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.
  • 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:

  • the 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.
  • 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 CB shall report its findings to the CFIA, through its CVB, using the CFIA standardized reporting template within 60 working days following the conclusion of the investigation.

5. Fees

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. Responsibilities of the conformity verification bodies

Conformity verification bodies shall verify how the certification bodies comply with this directive during their on-site audit.

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