Operational procedures: Official food sample collection

1.0 Purpose

The purpose of this document is to provide guidance to Canadian Food Inspection Agency (CFIA) inspection staff on the procedures for sample collection of official samples under the Food Business Line (FBL).

This guidance is written with the assumption that inspection staff have been trained in the Standard Inspection Process (SIP) and Digital Service Delivery Platform (DSDP).

This document is intended to be used in conjunction with the Operational guideline: Food sample collection.

Official sample collection requires more complex procedures for sample collection, preparation, submission, and laboratory testing compared to routine product sample collection. In order to ensure that testing results are admissible in court, official sampling procedures must be strictly followed.

2.0 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.

3.0 Reference documents

Common inspection references

Food inspection references

CFIA Sampling Information (accessible only on the Government of Canada network)
- Food sample collection plan (accessible only on Government of Canada network)
- National Sampling Plans Assessment Criteria – Imported and Manufactured Food (IMF) (accessible only on the Government of Canada network - RDIMS 4276478)
Food inspection guidance: sample collection
Food inspection guidance: incident response
- Food incident response process (FIRP)
- Responding to food complaints (accessible only on the Government of Canada network - RDIMS 13899359)
Food inspection guidance: regulatory response
- Operational Procedure: Procedure for seizure and detention, authorizing movement and disposition
Food inspection guidance: operational directives and special projects
- Food misrepresentation direction (accessible only on the Government of Canada network - RDIMS 13862494)
Canadian Food Inspection Agency – Health Canada Food sampling and testing terminology
Standard Operating Procedure (SOP) for Data and Documentation Gathering During Inspection (accessible only on the Government of Canada network)

DSDP sample collection specific references

4.0 Definitions

Definitions are located in the documents listed below:

5.0 Acronyms

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

6.0 Operational procedure

This operational procedure provides guidance to be used by CFIA inspection staff when collecting official samples of food.

An inspector may collect official samples when referral to Enforcement and Investigation Services (EIS) may follow. Legal samples and evidentiary samples are other terms that may be used interchangeably with official samples.

Certain projects (for example, Food misrepresentation direction (accessible only on the Government of Canada network - RDIMS 13862494)) recommend taking a directed sample for screening and an official sample at the same time.

6.1 Prepare for the inspection

Refer to SIP, Section 3, Step 1 and Operational guideline: Food sample collection, Section 6.1. In addition to the general guidance provided in these documents, the following guidance applies to official sample collection.

Prior to taking an official sample, an inspector should consult with their Supervisor and Regional Program Officer (if applicable). The Food Inspection Response Operational Guidance and Expertise (OGE) team may be consulted by submitting an electronic Request for Action Form (e-RAF) (accessible only on the Government of Canada network). Consultation with legal services may also be required.

When the inspector is ready to proceed with the official sample collection, they should contact the appropriate laboratory prior to collecting the official sample to ensure that the laboratory:

has the resources to receive, store and analyze the sample
knows when the sample will arrive
knows the number of samples that will be shipped
knows the analyses to be performed

6.1.1 Official sample collection forms

The inspector will require the following CFIA forms for collecting, preparing, and shipping of official samples for analysis.

Sample Portion Form for official samples (CFIA/ACIA 0072)

When collecting official samples, inspectors must use the Sample Portion Form. Each form has a unique, pre-printed number on the upper right hand corner, and includes quadruplicate copies: 1 – Sample portion, 2 – Duplicate Sample portion, 3 – Owner's portion, 4 – Inspector's copy. Once completed, the appropriate sheets must be attached to the sample portions using the Label - Official Seal (CFIA/ACIA 5112).

Note that the form is not available through Desktop e-Forms (accessible only on the Government of Canada network), and must be ordered through the Forms Catalogue (accessible only on the Government of Canada network) on Merlin. Different versions of this form exist and any version can be used by inspectors when collecting official samples. Figure 1 shows two versions of the form that are being used by inspection staff.

Figure 1. Sample Portion Form for official samples (CFIA/ACIA 0072); two different versions shown here both of which can be used

Receipt for Sample(s) Taken (CFIA/ACIA 4168)

This form is used by inspectors when collecting product samples (including official samples) without payment from an establishment for the purpose of CFIA laboratory analysis. A copy of the completed form, which serves as a receipt for samples taken, should be given to the owner or representative of the company. The form is available through Desktop e-Forms (accessible only on the Government of Canada network). Refer to the Operational guideline: Food sample collection, Appendix 17, for more details on using and completing this form.

Food Product Sample Submission Form (CFIA/ACIA 5164)

This form is available through the Laboratory Sample Tracking System (LSTS) and must be completed by the inspector prior to submitting a sample to the CFIA laboratory for analysis. In addition, inspectors must ensure that a copy of the completed form accompanies the shipment of the official sample to the laboratory.

Chain of Custody (CFIA/ACIA 5428)

This form is used to track the possession of the official sample during shipping and can be ordered through the Forms Catalogue (accessible only on the Government of Canada network).

Label - Official Seal (CFIA/ACIA 5112)

This form can be ordered through the Forms Catalogue (accessible only on the Government of Canada network). The inspector must complete the information on the Label - Official Seal and attach it to each official sample. The Label - Official Seal is also used to attach the Sample Portion form to the official sample.

Yellow Tape - Official Seal (CFIA/ACIA 4561)

This tape can be ordered through the Forms Catalogue (accessible only on the Government of Canada network). This yellow tape is used to provide tamper evidence to the official sample and the shipping container.

6.2 Conduct the inspection

Refer to SIP, Section 4, Step 2 and Operational guideline: Food sample collection, Section 6.2. In addition to the general guidance provided in these documents, the following guidance applies to official sample collection.

Official samples must be collected in accordance with the Food and Drug Regulations (FDR) subsection A.01.050.

When collecting an official sample, more than one inspector should be present to assist in collecting information and documenting all the information relating to the sample. All steps of the sample collection procedure should be documented and should include times, dates, places, full names, positions, what happened, what was said and by whom, etc. Photographs should be taken throughout the process and of all completed samples. Note taking, report writing and filing are all important activities necessary to support regulatory compliance work. These activities must be done in a complete and accurate manner. Refer to the Operational guideline: Food sample collection, Section 6.2.3 and the Standard Operating Procedure (SOP) for Data and Documentation Gathering During Inspection (accessible only on the Government of Canada network) for more information on documenting and photographing inspection details.

In addition to taking notes during sample collection, inspectors should also obtain and make certified true copies of all available supporting documentation relating to the sample, including invoices, specification sheets, certificates of analysis, and any other information the regulated party has for the product. The Standard Operating Procedure (SOP) for Data and Documentation Gathering During Inspection (accessible only on the Government of Canada network) provides guidance on information relating to the purchase and sale of sampled products that need to be obtained to establish that the contravention of the Act or Regulations has occurred.

Possession of the official sample must be traceable and documented from the time the samples are collected until the completion of the inspection or the EIS investigation. Track possession of official samples during sample collection by taking inspection notes of the time, location, unique identifiers, and any other information about the sample. Between the time the sample is taken and the time it is shipped to the laboratory, the inspector must take all the necessary precautions to ensure that the sample and the duplicate sample are kept in a controlled environment under lock and key. The Chain of Custody Form (CFIA/ACIA 5428) is used to track possession of the sample during shipping and upon receipt of the sample at the laboratory.

6.2.1 Select the sample

6.2.1.1 Determine the number of units and the size of sub-samples

Table 1. Number and size of sub-samples
Type of analysis	Number of sub-samples and sub-sample size
FEN0 official samples	Sample numbers and sizes vary for most FEN0 sampling plans. Refer to Section 7: FEN0 Samples in the National Sampling Plans and Assessment Criteria - Imported and Manufactured Food (IMF) (accessible only on the Government of Canada network – RDIMS 4276478). See details for the specific FEN0 plan.
Extraneous material	24 individual consumer sized packages or 250 grams (g) or milliliter (mL) per container. Refer to Section 3: Extraneous Matter in the National Sampling Plans and Assessment Criteria - Imported and Manufactured Food (IMF) (accessible only on the Government of Canada network – RDIMS 4276478)
All other types of analysis	For the number and size of official samples associated with the national Food Sample Collection plan (accessible only on the Government of Canada network), refer to the plan. If the sample number and size are not defined in the Food Sample Collection plan, contact the Science Branch using the Lab Coordination / Coordination des laboratoires (CFIA/ACIA) email account for guidance.

6.2.1.2 Ensure sample portions are representative of the lot

Refer to Operational guideline: Food sample collection, Appendix 4, to ensure that sub-samples are chosen randomly from the same production lot and are representative of the lot.

Official samples must be selected by the inspector. A company representative must not be permitted to select CFIA's official samples.

An official sample requires three portions: the official sample, the duplicate sample, and the owner's sample. Use an appropriate random sampling procedure to select locations within a lot and ensure that three portions are collected at each location so that the portions are equally representative of the lot. If the unique product identifier includes a timestamp, try to keep the production time of the three portions as close to each other as possible. Refer to Table 2 for a visual illustration for selecting the sub-samples for the three portions.

Table 2. Sample collection of the three portions to ensure they are equally representative of the production lot
Sub-sample	3 Portions of sample
Sub-sample	(1) Sample	(2) Duplicate	(3) Owner
a	Location / Timestamp A	Location / Timestamp A	Location / Timestamp A
b	Location / Timestamp B	Location / Timestamp B	Location / Timestamp B
c	Location / Timestamp C	Location / Timestamp C	Location / Timestamp C
d	Location / Timestamp D	Location / Timestamp D	Location / Timestamp D
e	Location / Timestamp E	Location / Timestamp E	Location / Timestamp E

6.2.1.3 Product control

Detain the lot of product from which the sample is collected. If the results are reported as satisfactory, the product can be released from detention. Refer to the Operational Procedure: Procedure for seizure and detention, authorizing movement and disposition for more details on product detention.

6.2.2 Collect the official sample

When taking an official sample under paragraph 23(1)(a) of the Food and Drugs Act (FDA), an inspector must inform the owner or the person from whom the sample is taken of their intention to submit the sample or a part thereof to an analyst for analysis or examination, and:

(1) where the division of the procured quantity would not interfere with analysis or examination:
- (a) obtain a sufficient quantity of product for a triplicate sample
- (b) divide the quantity into three portions
- (c) identify the three parts as the sample, the duplicate sample, the owner's sample; and in the situation where only one part bears the label, that part must be identified as the sample (Figure 5)
- (d) complete the Sample Portion Form to identify each portion. Only one Sample Portion Form is required per official sample, even if multiple sub-samples make up that sample.
- (e) use the Label - Official Seal and Yellow Tape - Official Seal to prepare samples:
  1. seal the lid of each sample with Yellow Tape - Official Seal in such a manner that it cannot be opened without breaking the seal
  2. for each sub-sample collected, complete the following information on a Label - Official Seal:
    1. Date: the date of sample collection
    2. Initials: the inspector's initials
    3. No.: the unique pre-printed number of the Sample Portion Form
  3. using the Label - Official Seal and Yellow Tape - Official Seal, attach each of the 3 pages from the Sample Portion Form to the corresponding sample portion
  4. for the remainder of the sub-samples, attach a completed Label - Official Seal to each sub-sample
  5. avoid obscuring information on the label that is required for determining compliance or identifying the product, such as the list of ingredients, label claim statements, product and brand name, or lot code
  6. using a permanent marker, write the inspector's initials in the following locations on each sample, ensuring the initials cover all overlapping pieces of tape / seal / form / package surface:
    1. initial where separate pieces of Yellow Tape - Official Seal overlap
    2. initial where a piece of Yellow Tape - Official Seal creases to fit around corners (box) or rounded surfaces (neck / cap of a bottle)
    3. initial where a piece of Yellow Tape - Official Seal overlaps an Label - Official Seal
- (f) deliver the owner's portion to the owner or the person from whom the sample was obtained. Send both the sample portion and the duplicate sample portion to an analyst for analysis or examination (refer to section 6.2.4); or
(2) where, in the opinion of the inspector, division of the procured quantity would interfere with analysis or examination:
- (a) identify the entire quantity as the sample,
- (b) seal the sample in such a manner that it cannot be opened without breaking the seal, (refer to section 6.2.2 (1)(e) above), and
- (c) forward the sample to an analyst for analysis or examination (refer to section 6.2.4 below)

Refer to Operational guideline: Food sample collection, Appendix 17, for guidance on issuing a Receipt for Sample(s) Taken for the collection of official samples.

Figure 5. The three portions of an official sample

6.2.3 Record information in LSTS

LSTS is the primary system for tracking sample information and the resulting laboratory assessments.

Refer to the LSTS User Services User Guide (accessible only on the Government of Canada network – RDIMS 3495373) for instructions on how to record sample collection data in LSTS.

In the section "Display comments on Report of Analysis", select "Yes".

In the LSTS "Comments" field, enter the following information:

the DSDP case number
the Sample Portion Form number
the CFIA Detention number

6.2.4 Prepare the shipping box for delivery to the laboratory

Each set of official samples must be packaged by itself and not mixed with other samples.

For samples that may leak during transit (for example, olive or vegetable oil), place them into a clear plastic bag before putting them in the box for shipment. Write the number of the Sample Portion Form on the bag and seal it with the Yellow Tape - Official Seal. Initial places where the Yellow Tape - Official Seal meets the plastic bag and where the yellow tape overlaps other pieces of yellow tape.

Include a signed copy of Food Product Sample Collection Form in the shipping box.

For samples that may leak during transit, place the Food Product Sample Collection Form in a sealed plastic bag inside the shipping box. The inspector, at their discretion, can also include a copy of the Food Product Sample Collection Form when they email the laboratory to notify them that the sample has been shipped.

Pack shipments in such a way as to minimize the potential for damage in transit.

Clearly write "OFFICIAL SAMPLE" on the outside of the box to ensure that receiving staff at the laboratory are aware and take proper precaution to protect the sample and ensure its validity in court.

The completed Chain of Custody Form can either be placed inside the shipping box, or attached, in a sealed envelope, to the outside of the shipping box.

Using a permanent marker, write the inspector's initials in the following places of the shipping box, ensuring initials cover all overlapping pieces of tape and shipping box surface:

a) initial where separate pieces of Yellow Tape - Official Seal overlap
b) initial where a piece of Yellow Tape - Official Seal creases to fit around corners of the box

For perishable samples, courier shipments should be sent on Mondays or Tuesdays. Avoid shipments having to spend the weekend in transit. Use a courier service that guarantees next-day delivery.

When an official sample is taken at the same time as a directed sample, submit the directed sample to the laboratory first and keep the official sample secured at the inspection office. If the directed sample is determined to be non-compliant, submit the official sample for laboratory analysis. If required, consult with the supervisor and/or the OGE Food Inspection Response.

Figure 6. Official samples prepared for distribution to the laboratory (sample and duplicate) and owner

Figure 7. Shipping box containing official samples prepared for submission to the laboratory (Note: Chain of Custody form is not visible.)

6.2.5 Record sample information in DSDP

DSDP is used to capture official sample information for the following purposes:

Sample collection: Work planning, tracking of time and tracking of samples
Sample results: Documenting the sample results and the communication of sample results to the regulated party

Task time entries are recorded in DSDP for the time associated with sample collection only. The time taken to enter the sample information into LSTS or to ship the samples is not included in DSDP.

When an inspector collects an official sample that is not associated with an existing Preventive Control (PC) inspection, commodity inspection or sample collection case, (for example, a consumer or industry complaint) they must create a new inspection case in DSDP. Refer to SOP Creating an Inspection Request (accessible only on the Government of Canada network – RDIMS 9852034) for instructions on how to document official sample collection data in a new DSDP inspection case. Refer to Table 3 for inspection case details for "Trigger" and "Inspection task type". After creating a DSDP inspection case, the inspector can add a DSDP inspection task. Refer to SOP Creating an Inspection Request (accessible only on the Government of Canada network (accessible only on the Government of Canada network – RDIMS 9852034) for instructions on how to add a DSDP inspection task and SOP Manage Samples in an Inspection Case (accessible only on the Government of Canada network – RDIMS 9852138) for instructions on how to complete the information in the inspection task. Refer to Table 3 for inspection task details for Inspection task levels 1, 2, and 3 and Table 4 for additional task data.

If official samples are collected as part of a PC inspection, commodity inspection, or sample collection activity, the inspector is not required to create a new DSPD inspection case. The inspector can add a DSDP inspection task for the official sample to the existing DSDP inspection case. Refer to Table 3 for inspection task details for Inspection task levels 1, 2, and 3 and Table 4 for additional task data.

When the DSDP inspection case contains more than one sample collection task, the inspector can customize the name of each sample task to distinguish one from the others by first completing and saving the DSDP inspection task data, then entering a new name in the "Customizable Name" field (for example, Official Sample), and once again saving the DSDP inspection task data.

Table 3. DSDP case data
Trigger	Incident Response
Inspection task type	Sample Collection
Inspection task level 1	Food Sample Collection Plan
Inspection task level 2	Select the appropriate analysis type: Microbiological Misrepresentation – Composition Extraneous Material Chemical Residue Other
Inspection task level 3	Sample plan code

Table 4. Additional DSDP task data
DSDP data field	DSDP task data entry
Special instructions	For planned samples, the Sample plan code is automatically pre-populated in this field. For as required samples, this field will be empty.
Inspection task details	Official sample
Sample Description (information in this field appears in the DSDP inspection report)	Enter the following information in this field for it to appear on the DSDP inspection report: LSTS generated System ID Sample Portion Form number CFIA Detention form number Issues Management System (IMS) number (if applicable)

Important Note: The first part of the sample collection task is now complete; the sample has been collected and sent to the lab for analysis. The second part of the sample collection task will be initiated once the sample results are received.

6.2.6 Determine if immediate control action is required

Once sample results are received, review the results. If sample results indicate the need to control a potential risk, inspectors will follow the Food Incident Response Process (FIRP). Refer to SIP, Section 4.5 for additional information.

6.2.7 Determine compliance

Refer to the following guidance to support the determination of compliance, as applicable:

Inspectors will evaluate the sample results against regulatory requirements to:

determine compliance of the product, for example
- Food and Drugs Act (FDA) 4(1), 5(1)
- Safe Food for Canadians Act (SFCA) 6(1)
- Safe Food for Canadians Regulations (SFCR) 8(1)
determine compliance of the regulated party's PC and/or preventive control plan (PCP), for example SFCR 47

For a sample result that is reported as investigative, the inspector will collect supplementary inspection findings to support the determination of compliance. Refer to the SIP, Section 4.6 for more information.

6.2.8 Categorize non-compliance

For a non-compliance that will be referred to EIS, categorization of non-compliance is not required. The purpose for categorizing a non-compliance is to determine the time frame for the regulated party to complete corrective actions. If the non-compliance is being referred to EIS, the detained product must remain under detention and changes to the product cannot be made unless instructed by EIS.

If the inspector, in consultation with the supervisor and/or the OGE Food Inspection Response, decides not to refer the non-compliance to EIS, then the inspector should categorize the non-compliance as per SIP, Section 4.7 to determine the time frame for the completion of corrective actions.

6.2.9 Record sample results in DSDP

For official samples, all sample results, including satisfactory results, must be documented in the DSDP inspection case.

Refer to Step 6 of Annex B: Food Sample Collection Plan DSDP data entry – CFIA sampled – results other than satisfactory (accessible only on the Government of Canada network – RDIMS 14996797) for instructions on how to document official sample collection results in the DSDP by:

recording the sample result
creating a non-compliance record (if required)
issuing the inspection report

6.3 Communicate the sample results

Refer to SIP, Section 5, Step 3 and Operational guideline: Food sample collection, Section 6.3. In addition to the general guidance provided in these documents, the following guidance applies to official sample collection.

6.3.1 Communicate the sample results to the regulated party

All compliance decisions based on official sample results should be communicated to the regulated party. This information may impact the regulated party's decision to test the owner's portion of the official sample.

When communicating official sample results and compliance decision to the regulated party, provide the following documents to the regulated party:

inspection letter
- for non-compliant official sample results, use the letter template in Appendix 1. This letter must be sent to the regulated party by registered mail.
- for compliant official sample results, use letter template in Appendix 2
DSDP inspection report
LSTS external Report of Analysis (ROA)

The inspection letters provided in Appendix 1 and Appendix 2 are only intended for communicating results of official samples to regulated parties. These letters should not be used to communicate sample results that are not official samples.

6.3.2 Communicate the sample results to EIS

To refer the non-compliance to EIS, complete an Inspector's Non-Compliance Report (INCR) (accessible only on the Government of Canada network) and submit the report along with inspection notes, photos, document, sample results, etc. to the Area or National EIS Office. Questions regarding the completion of an INCR should be directed to an OGE Food Inspection Response specialist.

6.4 Conduct the follow-up inspection

After a non-compliance is referred to EIS, the product that is under detention must remain under detention and should not be altered (for example, label correction). If the regulated party requests changes or movement to the product, the inspector should consult with an OGE Food Inspection Response specialist and/or EIS. Also, the inspector should not conduct a follow-up inspection until the EIS investigation is complete. EIS will advise the inspector what can or must be done with the product.

7.0 Appendix

Appendix 1: Letter template for non-compliant official samples

CFIA Letter Head

Canadian Food Inspection Agency
[Program]
[CFIA Office Address]
[CFIA Office telephone number]

[Date]

[Name of Licence Holder / Regulated Party]
[Full address of Licence Holder / Regulated Party]

Attention: [Name and Title of company representative]

RE: [Product Brand, Description, Common Name, Lot code or Unique identifier]

Dear [Name of company representative],

This refers to the above product from which we had taken official samples for analysis of [product] for [reason for sample collection]. The samples were obtained on [Date], and the "owner's sample" was left with [name of person sample left with] on [date / that day].

This is to advise you that the results of the Canadian Food Inspection Agency's (CFIA) analysis of [Product] for [reason for sample collection] conducted on the official sample was reported as unsatisfactory. The results indicated the following:

[Provide lab results]

Summary of Results:
[Provide an explanation of the lab results from LSTS report of analysis (if applicable)]

The above results are specific to [the number of (one, two)] lot code(s) of your product which is currently under detention. This product has been deemed to be [describe non-compliance (eg. misrepresented on the package labelled as "100% Pure Extra Virgin Olive Oil)].

You are hereby advised of section [number] of the [Name of Act (for example, Food and Drugs Act and/or Safe Food for Canadians Act, as applicable)] which states:

[Quote section]

Currently the product is detained under [FDA 23(2)(l) or SFCA 25] and must not be moved without written authorization from CFIA. The file is under review and the CFIA will contact you on the next steps once a decision has been made.

Sincerely,

[Name of inspector]

[Name of program (optional)]

Appendix 2: Letter template for compliant official samples