Imported and Manufactured Food Program Inspection Manual

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Table of Contents

Preface

Objective of the Manual

The primary objective of this manual is to provide Imported and Manufactured Food Program (IMFP) inspectors with a comprehensive reference tool aimed at improving uniformity of food safety, composition and labelling inspection delivery in non-federally registered establishments. In addition, this manual is intended to assist in training new IMFP inspectors on their functions related to establishment and product inspections.

The current version of the manual is focussed on food safety inspections. Work is underway to add information on labelling, composition and retail food inspections to the manual. This manual will be updated regularly to remain current with the design and delivery of the IMFP. Any changes to the manual will be recorded on the Document Revision History table on the following page.

Users of this manual should be aware that it has no precedence over any federal regulations. For legal requirements, you may consult the appropriate set of regulations.

Headquarter Contact Information:
Compliance and Enforcement Section
Imported and Manufactured Food Program
Canadian Food Inspection Agency
1400 Merivale Rd., Ottawa, ON K1A 0Y9

Document Revision History

Note: RDIMS is a document management tool for internal use only
RDIMS/Version NumberRevision DatePages RevisedDescription
2137508v8 April 2010 Original document
2137508v11 April 2012 All Entire manual updated to improve flow, remove repetition and correct errors.
Chapters 2 and 3 were combined
Instructions on ratings were moved from Chapter 5 to Chapter 6
2137508v12 September 2013 Pages 152 and 159 Convert 5 WordPerfect documents to Word documents links.

Chapter 1: Introduction

1.0 Scope

Chapter 1 of the Inspection Manual describes the scope and activities of the Imported and Manufactured Food Program (IMFP) and outlines the roles and responsibilities of the CFIA and other government departments involved in the regulation of food. The responsibilities of the food industry with respect to food safety are also outlined here.

1.1 The Imported and Manufactured Food Program

The focus of the Imported and Manufactured Food Program (IMFP) is the non-federally registered sector (NFRS) which represents approximately 70 per cent of food products available for sale in Canada. The regulatory authority for the IMFP is derived from the Food and Drugs Act, the Food and Drug Regulations, the Consumer Packaging and Labelling Act and Regulations and the Organic Regulations under the Canada Agricultural Products Act.

There are several large general categories of food that fall under the exclusive jurisdiction of the IMFP. These for the most part include, but are not limited to:

  • Grains and grain-based products such as breads, biscuits, pastas and cereals, rice
  • Bakery products such as cookies, crackers, muffins and cakes
  • Most beverages including tea, coffee, most carbonated drinks, pre-packaged water and alcoholic beverages, juice blends/cocktails
  • Confectionary/chocolate
  • Snack foods that do not contain fish and/or contain less than 2 per cent meat
  • Food chemicals, such as additives and colours, vitamins and minerals
  • Biological additives, such as bakers' and brewers' yeasts
  • Spices, seasonings, salt and dried herbs
  • Vegetable fats and oils
  • Infant formula, meal replacements and formulated liquid diets
  • All retail-prepared food, such as meat that is cut and packaged at retail, or items that are manufactured and sold at retail (e.g. baked goods produced by in-store bakeries)
  • Intra-provincially traded foodFootnote 1

To facilitate decision-making regarding the jurisdiction of a food product, the Imported and Manufactured Food Division (IMFD) developed and published Products Regulated under the Imported and Manufactured Food Program (This document is intended for internal use. CFIA staff can access this document using RDIMS number 2580416). This document is intended as a guide for use by all CFIA personnel, including inspectors and program officers, to determine which products are within the jurisdiction of the Imported and Manufactured Food Program.

1.1.1 Activities of the IMFP

The IMFP contributes to food safety and consumer protection through the administration of a national food program for non-federally registered foods at all levels of trade. This includes domestic manufacturers, importers, and distributors as well as retailers who manufacture/package foods on-site. The program is based upon the safety, nutrition, composition and labelling provisions of the federal FDA/R and the CPLA/R and the organic requirements in the CAPA/R. Some of the Program's activities include:

  • Designing and developing a food safety control program which encompasses assessment standards, verification procedures and training.
  • Compliance verification and enforcement actions related to food safety, labelling and fraud.
  • Developing and implementing policies and procedures for the non-federally registered sector.
  • Liaising with the provinces, territories and foreign governments to facilitate the formation of MOUs and other agreements
  • Providing input into legislative changes aimed at strengthening Canada's food safety system.
Figure 1: Imported and Manufactured Food Program Risk Pathway Decision Model
Figure 1. Description follows.
Description for Figure 1

This image describes the key activities under the seven phases of the Risk Pathway Decision Model. The Imported and Manufactured Food Program follows this model to develop risk management options.

Phase 1 is called Risk Identification. In this phase the CFIA's Science Committee conducts environmental scans, identifies and prioritizes food safety issues, identifies research needs, and recommends risk management options. Risk is also identified through other means such as field issues, international referrals, complaints, and intergovernmental initiatives.

Phase 2 is called Risk Mitigation. In the phase, the CFIA obtains data regarding the activities of stakeholders that can mitigate the risk. Stakeholders can be provincial/territorial governments, industry, associations, etc.

Phase 3 is called Gap and Options Analysis. In this phase the CFIA compiles and analyses the data, and develops risk management options to address any gaps where the risks are not mitigated.

Phase 4 is called Design and Development. In this phase the CFIA decides, designs and develops appropriate risk management options that are a best fit for the Imported and Manufactured Food Program.

Phase 5 is called Delivery. In this phase the CFIA implements the risk management option.

Phase 6 is called Review and Re-design. In this phase the CFIA reviews the effectiveness of the risk management option and re-designs the Program based on the results of Phase 3.

Phase 7 is called On-going Activities. This phase includes ongoing monitoring and hibernation of the risk management option.

The Risk Pathway Decision Model (as seen above) outlines some of the activities carried out by the IMFP. While the Food Safety Division (FSD) is primarily responsible for phases 1, 2 and 3 of this model (risk identification, risk mitigation and gap analysis), the IMFP may collaborate with the FSD to conduct activities under these phases. Based on the results of these first three phases, the IMFP will develop risk management options which may include inspection and sampling strategies and development of policies, procedures, and standards. The effectiveness of the risk management options will be assessed and the activities will be redesigned or retired as required.

As a means to facilitate and standardize establishment inspections, the IMFP developed two voluntary Codes of Practice – General Principles of Food Hygiene, Composition and Labelling (GPFHCL) and Good Importing Practices for Food (GIP). These Codes of Practice provide guidance to inspectors in assessing an establishment's compliance with the regulatory provisions. In addition, they serve as voluntary guidelines to the food industry in Canada for good manufacturing and importing practices.

As an on-going risk management strategy, the IMFP develops work specifications to target commodities and hazards that pose the highest potential risk to public health and safety. Work specifications are designed to provide commodity-specific inspection and sampling guidelines for inspectors.

1.2 Roles and Responsibilities

The CFIA delivers its mandate in many areas of shared jurisdiction and responsibility. Strong partnerships with other federal government departments, as well as provincial, territorial and municipal authorities are imperative to the Program's success. Specifically, in the area of food safety, Health Canada and the CFIA share unique and complementary roles and responsibilities. Health Canada is responsible for food safety policies, standards and regulations, while the CFIA is responsible for all food inspection activities, as well as the development of regulations and policies related to food labelling and compositional standards.

1.2.1 The Canadian Food Inspection Agency

The Canadian Food Inspection Agency (CFIA) is mandated to safeguard Canada's food supply and the plants and animals upon which safe and high quality food depends. In carrying out its mandate, it provides all federal inspection services related to food safety, economic fraud, trade-related requirements, and animal and plant health programs. The consolidation of responsibilities into a single agency was designed to enhance food safety systems by integrating the delivery of inspection and quarantine services that had previously been provided by other departments such as Agriculture and Agri-Food Canada, Health Canada, and Fisheries and Oceans Canada.

The CFIA is responsible for the administration and/or enforcement of 13 federal acts and their respective regulations. In carrying out its food safety mandate, in particular, the CFIA enforces the FDA/R as it relates to food.

1.2.1.1 CFIA Inspectors

CFIA inspectors are tasked to deliver thorough, unbiased inspections in accordance with the established design of the program.

As a public servant, inspectors are responsible for respecting certain ethical guidelines designed to protect his or her reputation as an honest and impartial public service employee, and the image of the public service.

As an employee of the CFIA, inspectors are also expected to act in a reasonable manner that will not compromise his or her job or the Agency. They are expected to uphold the CFIA values.

1.2.2 Health Canada

Although Health Canada is no longer directly involved in the inspection of food, it has the responsibility of establishing national health, safety and nutritional standards for food, and for assessing the CFIA's food safety activities. Among other roles, the Health Products and Food Branch of Health Canada:

  • Administers the food safety provisions of the FDA/R;
  • Develops regulations and guidelines for food safety;
  • Sets standards for food safety and nutritional content of food;
  • Conducts health risk assessments and evaluations concerning physical, chemical and microbial contaminants, natural toxicants, food additives, allergens, etc.;
  • Conducts safety assessments on novel and genetically modified food;
  • Approves the use of food additives;
  • Approves the use of veterinary drugs for food-producing animals and sets residue tolerances; and
  • Serves as the national authority for food safety issues at the international level in the development of international standards, guidelines, recommendations, etc. (e.g. WHO, FAO, CODEX).

1.2.3 The Public Health Agency of Canada

The Public Health Agency of Canada (PHAC) mandate is focused on preventing chronic diseases, and responding to public health emergencies and infectious disease outbreaks in collaboration with the provinces and territories.

The PHAC maintains linkages with the CFIA during the course of a foodborne illness outbreak investigation, and advises the CFIA, upon confirmation, of the epidemiological link of an outbreak with a food product.

Information or intelligence shared by the PHAC with the CFIA may be used in developing risk management strategies, such as inspection and sampling programs, for targeting higher risk commodities.

1.2.4 The Canada Border Services Agency

The Canada Border Services Agency (CBSA) ensures the security and prosperity of Canada by managing the access of people and goods to and from Canada. CBSA officers are present at strategic border points and undertake activities to protect the safety of imported goods, including food.

The CFIA liaises with the CBSA during border blitzes and takes advantage of the CBSA border lookout process to identify high-risk goods as they enter the country. The two Agencies also share intelligence and information when developing risk management options to address specific situations.

1.2.5 Provincial/Territorial/Municipal Governments

Constitutionally, the Provinces and Territories have prime jurisdiction for foods manufactured and sold within their province/territory. However, given that the FDA/R and CPLA/R are federal in scope and that most of the provinces/territories do not have parallel legislative requirements, the CFIA and the provinces/territories share jurisdiction for the over-sight of the intra-provincial part of the non-federally registered sector. Hence, the IMFP often consults with its provincial and territorial counterparts as part of the design and development of risk management strategies.

Among the provinces and territories, different levels of food industry oversight exist due to differences in priorities, regulations and resource capacity. For example, some provinces and territories may require certain establishments (e.g., meat and dairy) to be registered provincially or territorially, while others carryout regular establishment inspections and sampling of specific, high risk commodities. Some territories or provinces may not have manufacturers or producers of particular commodities and consequently do not engage in oversight activities related to those commodities. In order to maximize resources, the CFIA focuses on areas where potential risk is high, and oversight is not available or limited at some or all levels of government.

1.2.6 Industry

The food industry plays an important role in safeguarding the Canadian food supply. In general, food establishments are responsible for:

  • The safety and quality of food products offered for sale.
  • Ensuring compliance of imported or manufactured food products with appropriate government regulations.

Industry is expected to develop and implement their own food safety control program or system (e.g., quality assurance system) to minimize the risk of exposure by consumers to products which may have health and safety implications. They are also encouraged to establish and implement their own internal audit program and self-monitor their food safety control system on an ongoing basis. Further, industry is expected to cooperate with the CFIA during inspections and other regulatory activities.

Chapter 2: Legal Authorities

2.0 Scope

Chapter 2 of the Inspection Manual outlines the legislation and the legislative authorities that are available to officially designated inspectors of the Canadian Food Inspection Agency (CFIA).

2.1 Overview of Legislation

2.1.1 Canadian Food Inspection Agency Act

The CFIA Act established the creation of the Canadian Food Inspection Agency on April 1st, 1997 and describes the responsibilities, organization, resources, powers, and reporting framework of the Agency.

The CFIA is responsible for the administration and enforcement of 13 Federal Acts (listed below) and their respective regulations:

  • Agriculture and Agri-Food Administrative Monetary Penalties Act,
  • Canada Agricultural Products Act,
  • Canadian Food Inspection Agency Act,
  • Consumer Packaging and Labelling Act (as it pertains to food),
  • Feeds Act,
  • Fertilizers Act,
  • Fish Inspection Act,
  • Food and Drugs Act (as it pertains to food),
  • Health of Animals Act,
  • Meat Inspection Act,
  • Plant Breeders' Rights Act,
  • Plant Protection Act and
  • Seeds Act.

2.1.2 Food and Drugs Act

The Food and Drugs Act (FDA) applies to all foods sold in Canada, both imported and domestically manufactured products. The FDA establishes minimum health and safety provisions as well as other requirements to prevent fraud and deception.

The FDA is designed, in part, to protect Canadians from foods which may be harmful to their health, aesthetically unacceptable, or contaminated with filth. The Act also prohibits the labelling, packaging, treatment, processing, selling or advertising of any food in a manner that is false, misleading, and deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety.

The FDA derives its authority from the criminal law and trade and commerce powers of parliament defined in the Constitution Act, 1867. Offences under the FDA are considered strict liability offences, meaning that individuals or companies are held responsible for the consequences of their actions, or their employees' actions, committed in contravention to the FDA even if they did not intentionally commit the violation. This also means that the company can use due diligence1 as a defence in a court of law.

2.1.3 Food and Drug Regulations

The Food and Drug Regulations (FDR) establishes the minimum requirements and provisions for foods sold in Canada. The FDR prescribes, among other requirements, the compositional standards, conditions of sale and uses of ingredients. The health and safety provisions in the FDR apply to all foods sold in Canada, based on the criminal law powers of parliament. The non-health and safety aspects of the compositional standards set in the FDR are based on the trade and commerce powers of parliament and thus, apply only to foods that are imported or traded inter-provincially. Note that intra-provincially traded foods which do not meet the compositional standards may be considered to be misleading and may be in violation of the FDA (Section 5(1)).

2.1.4 Consumer Packaging and Labelling Act and Regulations

The Consumer Packaging and Labelling Act and Regulations (CPLA/R) provides for a uniform method of labelling and packaging of pre-packaged consumer goods (products sold at retail). It contains provisions regarding prevention of fraud and provides for mandatory label information with which consumers can make informed choices. It also requires the use of metric units of measurement and bilingual labelling.

2.1.5 Relationship between Acts and Regulations

Although Acts and regulations are made separately, they are linked in several ways:

  • Parliament creates Acts and through them authorizes regulations;
  • A regulation must strictly conform to the limits established by the Act that authorizes it; and
  • Most legislative schemes depend on regulations to make them work, so an Act and the regulations should be developed together to ensure a good match.

2.2 The Food and Drugs Act

Although we generally refer to the document in use in our day to day work as the Food and Drugs Act and Regulations, what we actually use is more correctly entitled the Departmental Consolidation of the Food and Drugs Act and Food and Drug Regulations. It has been assembled for easy reading and includes explanatory notes, indices, etc. which are not present in the actual Act and Regulations. This is a document of convenience and has no official sanction. The letter of the law is found in the Statutes and in the regulations as published in the Canada Gazette.

Although once offered in paper format to all CFIA employees and new revision pages were distributed every 12 to 18 months so these versions would remain current with any new amendments, this service is no longer offered. Instead, the most up-to-date version of the FDA and the FDR is found on the government Justice Department website (see reference section of this chapter). Both are in HTML and PDF format for ease of readability and searchability. The PDF version is easier to use as the Adobe Acrobat program used to open the PDF document provides a variety of search options that will allow you to find key words and sections of the Act or Regulations quickly. As well, the print and format of the PDF version resembles the paper version making it easier to read. Finally, the PDF format can be saved to your computer or memory stick so that it can be accessed outside of the office and when internet access is not available. In preparation for an establishment inspection, you may wish to print relevant pages of the Act and Regulations (e.g. the powers of inspectors described in the Act) to bring with you.

2.2.1 A Brief History

The present Food and Drugs Act had its beginnings in the nineteenth century when adulterated liquor was a health hazard. The Inland Revenue Act of 1875 was the earliest Canadian law to protect the public against adulteration of drinks, food and drugs. Amended in 1884, it became known as the Adulteration Act. Liquor was said to be adulterated if it contained certain specified substances such as common table salt, Indian hemp, or salts of zinc or lead.

Foods were considered adulterated if they included a deleterious ingredient or any material of less value than understood by name. The Government later devised food standards within the Adulteration Act and by 1910, standards for milk and milk products, meat and meat products, grain and grain products, maple products and beverages came into being. Other standards followed.

With the establishment of the Health Department and its Food and Drug Division in Ottawa in 1919, the Adulteration Act was replaced by the 1920 Food and Drugs Act. The Food and Drugs Act and Regulations were completely revised in 1949 and given Royal Assent in 1953. The Act with amendments came into force in Canada on July 1, 1954. It was last revised by Statutes of Canada in 1985.

2.2.2 Definitions

The FDA contains definitions that the inspector should be familiar with. Some of these are listed below:

Food
"Includes any article manufactured, sold or represented for use as food or drink for human beings, chewing gum, and any ingredient that may be mixed with food for any purpose whatever"
Inspector
"Means any person designated as an inspector for the purpose of the enforcement of this Act under subsection 22(1) or under section 13 of the Canadian Food Inspection Agency Act"
Sell
"Includes offer for sale, expose for sale, have in possession for sale and distribute, whether or not the distribution is made for consideration"
Unsanitary conditions
"Means such conditions or circumstances as might contaminate with dirt or filth, or render injurious to health, a food, drug or cosmetic."

The FDR also contains many definitions which are too numerous to list in this manual. Inspectors are encouraged to become familiar with the definitions in the FDA and the FDR.

2.2.3 Authorities in the FDA

The FDA provides several authorities to the CFIA including:

  • Inspector designation
  • Powers of inspectors
  • Prohibitions regarding the sale of food
  • Deceptions regarding food
  • Importation/inter-provincial movement of food
  • Unsanitary manufacture of food
2.2.3.1 Inspector Designation

The CFIA Act provides the authority for the President of the CFIA to designate any person as an inspector for the purposes of enforcement and administration of the FDA (CFIA Act Section 13(3)). The President has delegated this authority to the CFIA Executive Vice-President, all Vice-Presidents and Executive Directors, including Area Executive Directors. Each inspector must be personally designated under the FDA in order to enforce it.

Certificates of Designation are maintained in employee's personnel file. Proof of an employee's designation is found on the CFIA-issued ID Card. The Acts for which an employee is designated are listed on the back of the ID Card. An inspector's ID Card must be presented as proof of designation, when requested, upon entering any food premise for the purpose of enforcing the FDA.

2.2.3.2 Inspector Powers and Authorities

Section 23 of the FDA confers powers to CFIA inspectors that are extensive, wide-ranging and extraordinary, particularly in the areas of entry, search and seizure. These powers should be exercised in accordance with the statutory authority provided in section 23 and may only be used for the purpose of administering or enforcing activities that are prohibited or regulated under the FDA/R.

The powers provided by Section 23 can be exercised only on the basis that the inspector believes, on reasonable grounds, that an article to which the FDA/R applies is manufactured, prepared, packaged or stored. Facts or circumstances to demonstrate that the conditions to exercise the power must exist and the belief should be beyond mere suspicion. Inspectors must act in good faith and with due care within the scope and intent of the Act.

Inspectors are under an obligation to exercise reasonable care and diligence in the exercise of powers provided under the FDA. Where inspectors, in bad faith or though negligence, exceed their powers or use their powers for an unauthorized purpose, they may be civilly liable for any loss of damage resulting from their actions.

Powers like those enumerated under Section 23 of the FDA have been found by the Courts of Canada to be reasonable within the meaning of Section 8 of the Charter of Rights and Freedoms when they are exercised solely for an inspection and compliance purpose and not for the purpose of investigation and the securing of evidence for potential prosecution.

2.2.3.2.1 Direct Powers

Table 1 (below) outlines the direct powers afforded to a designated inspector under Section 23 of the FDA.

Table 1: Direct Powers of Inspectors
PowerSectionExplanation
Enter 23(1) Inspectors have the power to enter an establishment where, under reasonable grounds, any article to which the FDA/R applies is manufactured, prepared, preserved, packaged or stored (see below for the definition of 'article').
Sample (at import) A01.041 An inspector may examine and sample a food to which the FDA or FDR apply, prior to its entry into Canada, if the food is intended to be imported into Canada. The food must be physically present in Canada but may be examined prior to customs clearance.
Sample (in general) 23(1)(a) Inspectors can examine and take samples of any food/article to which the FDA/R applies.
Open Containers 23 (1)(b) Inspectors can open any container, receptacle or package that they believe contains any food/article to which the FDA/R applies.
Examine/Copy Records 23(1)(c)

Any record (book, document, etc.) that is examined or copied must be relevant to the enforcement of the Act with respect to any article to which the Act or the regulations apply, and must be found where the "article" is "manufactured, prepared, preserved, packaged or stored".

If records are kept at a location other than where the articles are manufactured, prepared, preserved, packaged, or stored, and the owner of the records has not given consent to the inspector to enter that facility, the inspector does not have the power to enter that place except under a search warrant.

Seize and detain 23(1)(d)

Seizure is the act of taking possession of property by legal right or process. Seizure action achieves the objective of obtaining maximum control of a violative product. It also meets the requirements of gathering and securing evidence for the purpose of initiating a prosecution under the FDA and the FDR.

Detention is the custody of property. An article detained by the CFIA remains the possession of the owner but may not be moved or otherwise altered without the consent of the CFIA.

Depending on the purpose for seizure/detention, an inspector may choose either to leave the article in the facility where it was seized /detained or to remove it to a place appropriate for controlling the product.

In practice, seizure and detention are not differentiated. Seizure and detention can be seen as actions taken in sequence: an article is seized and then kept under detention. In the IMFP and all other CFIA programs (with the exception of the Fish Program), seizure and detention are not performed separately (i.e. a product is always both seized and detained, not one or the other). See Chapter 6, section 6.8.2.1 for further details.

Photographs A.01.026 The photograph must not encompass more than what is relevant for the purpose of enforcing the FDA or the FDR. Personnel are not to be included in photographs.

For the purposes of the FDA, an article is defined as:

  1. any food, drug, cosmetic or device;
  2. anything used for the manufacture, preparation, preservation, packaging or storing thereof; and
  3. any labelling or advertising material.

The definition of "article" is broadly defined as inclusive, which means that "article" is not limited to those things listed above; there may be other items that fall within the meaning of "article" as, for example, magazines or other publications (such as the internet) in which foods are advertised.

Note: Dwelling house

Where the establishment or business is located in a dwelling-house, an inspector may not enter that dwelling-house without the consent of the occupant except under the authority of a warrant issued by a Justice of the Peace under the conditions outlined in Section 23(1.2) of the FDA.

2.2.3.2.2 Indirect powers

Table 2 below outlines the indirect powers afforded to designated inspectors

Table 2: Indirect Powers of Inspectors
PowerSectionExplanation
Assistance 23(3) Any person in a facility in which a food is manufactured, prepared, preserved, packaged or stored is required to provide assistance and information, within reason, when requested by an inspector.
Obstruction 24(1)

It is an offence to obstruct or hinder an inspector engaged in carrying out his duties.

Obstruction includes any actions by non-CFIA persons that prevent the completion of an inspection, including failure to provide assistance, refusing to cooperate with an inspection, or refusing an inspector access to premises, records, etc.

Obstruction does not include insults, rude comments, jokes or complaints. Inspectors should provide proper identification and copies of relevant powers and authorities to industry to clarify requirements and encourage cooperation.

2.2.3.3 Prohibitions Regarding the Sale of Food

Section 4(1) of the FDA deals with the sale of an article of food that contains an unacceptable substance or has been subjected to unsanitary conditions during manufacturing. Table 3 below outlines the requirements of Section 4(1).

Table 3: Section 4(1), FDA - 4. (1) No person shall sell an article of food that
Sub-sectionExamples
(a) has in or on it any poisonous or harmful substance
  • harmful extraneous materials (glass in infant foods)
  • pathogens (Salmonella and E. coli O157:H7)
  • harmful levels of chemicals and natural toxins (mycotoxins)
(b) is unfit for human consumption
  • non-harmful, objectionable, extraneous matter (paper, wood, sand, hair)
  • spoiled or rancid food products
(c) consists in whole or in part of any filthy, putrid, disgusting, rotten, decomposed or diseased animal or vegetable substance
  • rotten foods
  • parts of field animals in foods
(d) is adulterated
  • as defined in section B.01.046 and in Division 15 of the FDR
(e) was manufactured, prepared, preserved, packaged or stored under unsanitary conditions Table Note 2
  • high non-pathogenic microbiological count (e.g. high aerobic CFU, yeast, mould)

Table Note

Table Note 2

"Unsanitary conditions" means such conditions or circumstances as might contaminate with dirt or filth, or render injurious to health, a food, drug or cosmetic

Return to table note 2  referrer

2.2.3.4 Deception Regarding Food

5(1) No person shall label, package, treat, process, sell or advertise any food in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety.

Section 5 of the FDA deals with the element of deception which may lead the consumer to believe something about the food which is not true. An example would be a product containing sodium but has a "sodium-free" claim on the label. This section covers foods that are misleading as to their composition, meaning foods that contain an undeclared, and often unacceptable, ingredient that has been added to the food for economic purposes (e.g. spices cut with flour or melamine added to milk). The sale of pre-packaged foods with undeclared allergens violates this section when a health risk is identified and the food is considered misleading as to its safety. Unacceptable health claims on foods may also violate this section of the Act.

2.2.3.5 Importation/inter-provincial Movement of Food

Section 6 of the FDA covers the requirement that foods that are imported or traded inter-provincially must meet the standards that are prescribed in the FDR. (e.g. flour must be fortified as prescribed)

"6.(1) Where a standard for a food has been prescribed, no person shall

  1. import into Canada,
  2. send, convey or receive for conveyance from one province to another, or
  3. have in possession for the purpose of sending or conveying from one province to another any article that is intended for sale and that is likely to be mistaken for that food unless the article complies with the prescribed standard."

Note that this section does not apply to foods that are manufactured and sold within a province (intra-provincial trade). However, if an intra-provincially traded food does not meet the standard of identity, it may be considered in violation of Section 5(1) of the FDA.

2.2.3.6 Unsanitary Conditions

7. No person shall manufacture, prepare, preserve, package or store for sale any food under unsanitary conditions

Section 7 deals with foods that are processed under unsanitary conditions that are intended to be sold in Canada. This section typically applies to the environmental conditions in which the food is manufactured, packaged and stored for sale (i.e. are circumstances observed which could contaminate the product?). For this reason, this section is not typically applied to imported products.

2.3 The Food and Drug Regulations

2.3.1 Parts of the Food and Drug Regulations

The FDR is divided into large Parts (and sections) as follows:

  • Part A – Administration
  • Part B – Food
  • Part C – Drugs
  • Part D – Vitamins, Minerals and Amino Acids
  • Part E – Cyclamate and Saccharin Sweeteners
  • Part G – Controlled Drugs
  • Part J – Restricted Drugs
  • Schedule F
  • Cosmetic Regulations
  • Processing and Distribution of Semen for Assisted Conception Regulations
  • Medical Devises Regulations
  • Natural Health Products Regulations
  • Marihuana Exemption Regulations
  • Index (Food Additives)
  • Appendix III – Forms

Part A covers a few definitions and discusses the following subjects among others: "Analysts", "Inspectors", "Importations", "Exports" and "Sampling".

Part B of the Regulations is divided into 28 Divisions. This Part deals specifically with foods and contains the following Divisions:

DivisionName
1 General
2 Alcoholic Beverages
3 Baking Powder
4 Cocoa and Chocolate Products
5 Coffee
6 Food Colours
7 Spices, Dressings and Seasonings
8 Dairy Products
9 Fats and Oils
10 Flavouring Preparations
11 Fruits, Vegetables, their Products and Substitutes
12 Pre-packaged Water and Ice
13 Grain and Bakery Products
14 Meat, its Preparation and Products
15 Adulteration of Food
16 Food Additives
17 Salt
18 Sweetening Agents
19 Vinegar
20 Tea
21 Marine and Fresh Water Animal Products
22 Poultry, Poultry Meat, their Preparations and Products
23 Food Packaging Materials
24 Foods for Special Dietary Use
25 Infant Foods
26 Food Irradiation
27 Low-Acid Foods Packaged in Hermetically Sealed Containers
28 Novel Foods

Division 1 contains many important definitions, such as "common name", "ingredient", etc., and labelling provisions. Divisions 2 to 28 of Part B are commodity/process-specific.

Divisions are further divided into units called sections. Each section of the regulations is identified by letter and number so that there can be no duplication of identifying mark and so that the mark itself clearly designates the position of each section in relation to all other sections. This is done by using a six character mark consisting in order of a single letter, a two-figure number, and a three-figure number, separated by periods. The single letter refers to one of the Parts into which the whole regulations are first divided (for example, Part B refers only to Foods). The two numbers following the letter denote subject Divisions into which the Parts are subdivided. For example, "B.08" means Division 8 of Part B.

Each Division is further broken down into the actual Sections of the regulations. For example, in B.08.041, the number "041" refers to "Processed (naming the variety) Cheese with (naming the added ingredients)". The zeros in the identifying marks are significant and may not be omitted. To speak or write about any section, it is only necessary to quote the number.

In Division 8 (Dairy Products), the six character mark has grown to a seven character mark, in the case of several processed cheese products, because enough space had originally not been left in the numbering system to accommodate so many products. Rather than renumber the whole division, the decimal system was initiated.

Example:

  • B.08.041 Processed (naming the variety) Cheese with (naming the added ingredients)
  • B.08.041.1 Processed Cheese Food
  • B.08.041.2 Processed Cheese Food with (naming the added ingredients)
  • B.08.041.3 Processed Cheese Spread

A regulation can also be broken down into several components which are illustrated in the following example for Processed (naming the variety) Cheese with (naming the added ingredients) in section B.08.041:

  • B.08.041 (1)(a)(ii)(A)
  • B Part
  • 08 Division
  • 041 Section
  • (1) Subsection
  • (a) Paragraph
  • (ii) Subparagraph
  • (A) Clause

2.3.2 Standardized vs. Unstandardized Foods

A standardized food is one that has a standard of identity (compositional standard) prescribed by the regulations (see B.01.002 FDR). A standard of identity refers to a standard of composition, strength, potency, purity, quality or other property of that food and may include a definition, a recipe (e.g., shall contain, may contain), and/or analytical requirements. If the section refers to a standard of identity, the letter "S" will appear in square brackets, immediately after the number. A food so described is generally known as a "standardized" food. The name in bold face type beside the letter "S" is the prescribed common name and is the only one permitted to be used to describe the food. Sometime, more than one common name is prescribed for the same food which means that all common names shown in bold face type are regarded as synonyms and any one of the names may be used. When a food deviates from the prescribed standard, a modified common name that describes the deviation may be acceptable.

As an example, Section B.02.100 in the FDR describes the standard for "Wine". The [S] indicates that "wine" is a standardized food. Wine is defined in paragraph (a), as: "shall be an alcoholic beverage that is produced by the complete or partial alcoholic fermentation of fresh grapes, grape must, products derived solely from fresh grapes, or any combination of them". The optional recipe ingredients for wine are given in paragraph (b): "may have added to it during the course of manufacture (i) yeast, (ii) concentrated grape juice" and so on.

Section B.02.090 is where the alcoholic beverage "Tequila" is described. "Tequila" is not a standardized food and, therefore, there is no [S] beside it.

Section B.01.042 of the FDR, states that:

"When a standard is prescribed for a food:

  1. the food shall contain only the ingredients included in the standard for the food;
  2. each ingredient shall be incorporated in the food in a quantity within any limits prescribed for that ingredient; and
  3. if the standard includes an ingredient to be used as a food additive for a specified purpose, that ingredient shall be a food additive set out in one of the Tables to section B.16.100 for use as an additive to that food for that purpose."

The section of the FDR above describes how a food must meet its prescribed standard and this and Section 6 of the FDA are the key pieces of legislation describing how food standards are applied.

For unstandardized foods, Section B.01.043 of the FDR states that:

"when a standard is not prescribed for a food:

  1. the food shall not contain any food additives except food additives set out in a Table section B.16.100 for use as additives to that food for the purpose set out in that Table; and
  2. each such food additive shall be incorporated in the food in a quantity within any limits prescribed for that food and food additive in that Table."

It is important to become familiar with the concepts of "standardized" and "unstandardized" foods as this knowledge is important when dealing with food additives in Division 16. The Regulations specify whether an additive is permitted to be added to either unstandardized foods or to specific standardized products.

The CFIA training course "Introduction to Food Labelling" discusses standardized and unstandardized foods in greater detail.

2.3.3 Microbiological Standards

The FDR has specific microbiological standards for some products. The following table (Table 4) show examples of the different products for which microbiological standards are set in the Regulations. Health Canada's document Standards and Guidelines for Microbiological Safety of Food – An Interpretive Summary includes all the microbiological guidelines that have been set for foods and can be referred to when the microbiological standards for a food are not prescribed in the Regulations.

Table 4: Microbiological standards for foods
Table 4a: Salmonella
ProductSection of the FDR
Cocoa and Chocolate Products B.04.012
Powdered Milk Products B.08.014A
Frog legs B.21.031
Egg Products B.22.033
Table 4b: S. aureus and E. coli
ProductSection of the FDR
Cheese (Pasteurized Source) B.08.048 (1a)
Cheese (Unpasteurized Source) B.08.048 (2a)
Table 4c: Coliform
ProductSection of the FDR
Cottage Cheese B.08.054
Ice Cream B.08.062 (d) (ii)
Ice Milk B.08.072 (d) (ii)
Mineral or Spring Water B.12.001 (b)
Other Bottled Water B.12.004 (a)
Prepackaged Ice B.12.005 (1) (a)
Water Used to Make Prepackaged Ice B.12.005 (2) (a)

2.3.4 Nutrient Enrichment or Fortification

The World Health Organization (WHO) and Food and Agriculture Organization of the United Nations (FAO) Guidelines on Food Fortification with Micronutrients describe food fortification and enrichment as synonymous terms and define them as follows:

Fortification is the practice of deliberately increasing the content of an essential micronutrient, i.e. vitamins and minerals (including trace elements) in a food, so as to improve the nutritional quality of the food supply and provide a public health benefit with minimal risk to health.

Enrichment is synonymous with fortification and refers to the addition of micronutrients to a food irrespective of whether the nutrients were originally in the food before processing or not.

Health Canada agrees with these definitions and uses the term fortification to describe the addition of nutrients to food. In Canada, addition of these nutrients to food is regulated under the FDR. Regulating the addition of vitamins, minerals and amino acids to food is one way to help ensure that consumers receive adequate but not excessive amounts of nutrients.

The limits for the amount of vitamins and minerals that may be added to the products are specified in the appropriate section of the Regulations for a specific product, e.g., sole source of nutrition, infant food/formula, food for special dietary use, simulated meat products, etc. Nutrient requirements may also be prescribed in a food standard in the FDR.

For example, Grain and Bakery Products:

B.13.001 Flour, White Flour, Enriched Flour or Enriched White Flour

(d) shall contain in 100 grams of flour:

  • (i) 0.64 milligram of thiamine,
  • (ii) 0.40 milligram of riboflavin,
  • (iii) 5.30 milligrams of niacin or niacinamide,
  • (iv) 0.15 milligram of folic acid, and
  • (v) 4.4 milligrams of iron;

Part D of the FDR also contains requirements for nutrient addition to specific foods. The table in D.03.002 contains a positive listing of which nutrients can be added to which foods. If the food/nutrient combination is not listed, that particular nutrient cannot be added to that food.

2.3.5 Food Additives

A food additive is defined in Part B Division 1 of the FDR as:

"any substance the use of which results, or may reasonably be expected to result, in it or its by-products becoming a part of or affecting the characteristics of a food, but does not include

  1. any nutritive material that is used, recognized or commonly sold as an article or ingredient of food;
  2. vitamins, mineral nutrients and amino acids, other than those listed in the tables to Division 16,
  3. spices, seasonings, flavouring preparations, essential oils, oleoresins and natural extractives;
  4. agricultural chemicals, other than those listed in the tables to Division 16,
  5. food packaging materials and components thereof; and
  6. drugs recommended for administration to animals that may be consumed as food"

Division 16 and sections B.01.042 to B.01.045 of the FDR describe the regulations pertaining to food additives. Division 16 contains a positive listing of all the permitted food additives, which foods they can be added to as well as levels and purpose. If the food additive/food combination is not listed, that particular additive cannot be added to that food.

2.3.6 Adulterated Foods

The circumstance under which a food is considered adulterated and, therefore, in violation of the Section 4.1(d) of the FDA is defined specifically in the FDR, sections B.01.046 and Division 15.

Section B.01.046 defines certain substances which are considered adulterants, including aflatoxin in nuts. Division 15 also defines adulterants, namely heavy metals (arsenic, fluoride, lead, tin), agricultural chemicals, veterinary drugs. In some cases, there are limits set for adulterants in specific foods however, for agricultural chemicals and veterinary drugs, a limit of 0.1ppm is set where no limit exists.

2.4 Citing the Act or the Regulations

During the course of an inspection or investigation, it is often useful or necessary to cite which section of the FDA or FDR a non-compliant practice or product may be violating. In truth, only a judge, through a judicial process, can make the final decision as to whether or not the practice or product is indeed violating a certain section of the FDA or FDR but non-compliant issues within IMFP are rarely elevated to this level of review.

Since regulations are often more detailed and specific than the Act, it is preferable to cite a section of the FDR, rather than the FDA, for the violation. However, there are situations where a specific regulation does not exist or does not cover the element of sale and a section from the Act or from the Act and the Regulations will need to be cited for the violation. Figure 1 below is a decision making tree that can be used when deciding whether to cite the Act, the Regulations or both for a violation.

Figure 2: Decision tree: When to cite the Act or the Regulations or both.
Figure 2. Description follows.
Description for Figure 2

This image is a decision making tree that can be used when deciding whether to cite the Act, the Regulations, or both for a violation.

It begins with the question, "Is there a Regulation for the Commodity or Issue?"

If the answer is 'no', use the Act.

If the answer is 'yes', does the Regulation cover the element of sale and/or contain a prescribed standard and/or prohibit sale under certain conditions? If the answer is 'yes', use the Regulation. If the answer is 'no', use the Regulation and the Act.

2.4.1 Examples

Table 5 below describes particular situations and the section(s) of the FDA and/or FDR to be cited for the violation.

Table 5: FDA or FDR?
SituationFDA/FDR
Glass in beer 4.1(a) FDA
Mouldy spices 4.1(e) or 7 FDA
Undeclared peanuts in a snack bar 5(1) FDA
Imported flour that is not fortified 6(1) FDA
20ppm aflatoxin in nuts 4.1(d) FDA with B.01.046(n) FDR
Inadequate fortification of infant formula B25.054(1) FDR
Salmonella in chocolate 4.1(a) FDA
High aerobic colony count in bottled water B.12.004 FDR
Synthetic caffeine added to tea B.16.007 FDR

2.5 Legal Opinions

The CFIA Legal Services employs lawyers and other legal experts who can offer support on the interpretation of legislation and regulations and on court and litigation procedures. Their responses to CFIA internal inquiries are often referred to as legal opinions. The aid of Legal Services should be sought in circumstances such as:

  • Interpretation of the law or legal principles
  • Legal issues are raised
  • When contacted by a lawyer (only lawyers should speak to lawyers)
  • When there is a possibility of litigation against the CFIA

Inspectors should consult with their supervisor and Area Specialist prior to contacting Legal Services. In cases where a legal opinion is needed, the Area Specialist may need to contact other Areas and Headquarters to be sure that an opinion has not already been received for the same question/scenario.

Legal opinions are subject to solicitor-client privileges and are not to be shared with persons outside of the CFIA without the permission of the client, represented by the President of the CFIA. Sharing includes providing the written opinion or discussing its contents.

Chapter 3: Occupational Safety and Health

3.0 Scope

Chapter 3 of the Inspection Manual covers safety and health matters related to delivery of inspection duties. This chapter also provides information on employee rights as they relate to occupational safety and health, and aims to increase awareness on prevention of accidents and hazardous occurrences related to inspection activities. The latter section of this chapter provides information on general safety guidelines for Inspectors.

The bulk of the sections of this chapter have been derived directly from the CFIA's Occupational Safety and Health (OSH) website.

3.1 Rights of Employees

The Canada Labour Code - Part II is intended to prevent accidents and injury related to employment. The Code is based on three fundamental rights of employees:

The right to know

Inspectors have the right to be informed of known or foreseeable hazards in the workplace and to be provided with the information, instruction, training and supervision necessary to protect their health and safety.

The right to participate

Through the Regional, Area and local OSH workplace committees and representatives - (Internal access only), inspectors have the right, and the responsibility, to participate in identifying and recommending corrective and preventive measures regarding job-related health and safety concerns.

The right to refuse dangerous work

An employee, at work, has the right to refuse dangerous work, if he or she has reasonable cause to believe that:

  • a condition exists at work that presents a danger to himself or herself;
  • the use or operation of a machine or thing presents a danger to the employee or a co-worker; or
  • the performance of an activity constitutes a danger to the employee or to another employee.

Section 128 (1), 129 and 130 of the Canada Labour Code – Part II describes the inspectors right to refuse dangerous work in detail.

3.2 Duties of Employees

Section 126 (1) of the Canada Labour Code - Part II outlines the duties of employees with respect to occupational health and safety. In summary, employees should:

  • use any safety materials, equipment, devices and clothing that are intended for the employee's protection and furnished to the employee by the employer
  • follow prescribed procedures with respect to the health and safety of employees
  • take all reasonable and necessary precautions to ensure the health and safety of themselves, other employees and any person likely to be affected by the employee's acts or omissions
  • comply with all instructions from the employer concerning health and safety
  • cooperate with the policy and work place committees or the health and safety representative
  • report to the employer any circumstance in a work place that is likely to be hazardous to the health or safety of the employee
  • report every accident or other occurrence arising in the course of or in connection with the employee's work that has caused injury to the employee or to any other person
  • comply with oral or written direction of a health and safety officer
  • report any situation that the employee believes to be a contravention the Code

3.3 Duties of the Employer

Section 125 (1) of the Canada Labour Code - Part II outlines the duties of employers with respect to occupational health and safety. In summary, employers should:

  • investigate, record and report in the manner and to the authorities as prescribed all accidents, occupational diseases and other hazardous occurrences known to the employer
  • post at a place accessible to every employee and at every place directed by a health and safety officer
    • a copy of the Code
    • a statement of the employer's general policy concerning the health and safety at work of employees, and
    • any other printed material related to health and safety that may be directed by a health and safety officer
  • keep and maintain in prescribed form and manner prescribed health and safety records
  • provide
    • first-aid facilities and health services
    • sanitary and personal facilities
    • potable water
  • ensure that the vehicles and mobile equipment used by the employees in the course of their employment meet prescribed standards
  • provide every person granted access to the work place with prescribed safety materials, equipment, devices and clothing
  • ensure that the levels of ventilation, lighting, temperature, humidity, sound and vibration are in accordance with prescribed standards
  • comply with prescribed standards relating to fire safety and emergency measures
  • ensure that employees have safe entry to, exit from and occupancy of the work place
  • provide each employee with the information, instruction, training and supervision necessary to ensure their health and safety at work
  • ensure that each employee is made aware of every known or foreseeable health or safety hazard in the area where the employee works
  • ensure that the work place, work spaces and procedures meet prescribed ergonomic standards
  • comply with every oral or written direction given to the employer by an appeals officer or a health and safety officer concerning the health and safety of employees
  • ensure that employees who have supervisory or managerial responsibilities are adequately trained in health and safety and are informed of the responsibilities they have under the Code
  • respond, as soon as possible, to reports made by employees
  • develop health and safety policies
  • ensure that the work place committee or the health and safety representative inspects each month all or part of the work place, so that every part of the work place is inspected at least once each year
  • when necessary, develop, implement and monitor a program for the provision of personal protective equipment, clothing, devices or materials

3.4 Preventing Accidents/Hazardous Occurrences

The Canada Labour Code - Part II and its Regulations, and CFIA occupational safety and health (OSH) policies, directives, and guidelines provide directional advice in preventing accidents, injury and occupation-related illness.

3.4.1 Job Hazard Analysis

A Job Hazard Analysis (JHA) is a process of identifying potential hazards related to a job for the purpose of reducing or eliminating hazards, developing safe work practices and implementing control measures.

Human Resources Skills Development Canada (HRSDC) is currently developing regulations to provide inspectors with directional advice on JHAs.

3.4.2 Personal Protective Equipment (PPE) and Clothing

The use of Personal Protective Equipment (PPE) is an important component in accident prevention and inspectors should use PPE or wear protective clothing when it is not possible to eliminate a health or safety hazard at their work site. Inspectors should consult their supervisor to find out what types of PPE is required for a specific inspection activity.

3.4.2.1 General Requirements for PPE

All personal protective equipment must:

  • provide effective protection,
  • not create a hazard itself,
  • be regularly inspected and tested by a qualified person, and
  • be kept in a clean and sanitary condition.

A "qualified person" means, a person who, because of his or her knowledge, training and experience, is qualified to perform that duty safely and properly.

Annex 1 provides a list of personal protective equipment, materials and clothing provided by the CFIA to Inspectors conducting food safety inspections.

3.5 Ergonomics

Ergonomics is the study of designing equipment and devices that fit the human body and its movements. The main purpose of using ergonomic equipment is to prevent musculoskeletal problems resulting in aching, numbness, tingling, weakness or pain usually in the fingers, wrists, arms, shoulders, neck, back and feet. Other concerns include fatigue, headache and eye strain. These problems are common among employees working in an office, a laboratory, and in slaughter environments.

The main causes of these injuries are:

Posture:
Sitting or standing in a stationary position for extended periods of time, poor body alignment, excessive reaching or twisting.
Repetition:
Repetitive motion such as mousing, keyboarding, or inspecting samples for extended periods of time.
Force or Pressure:
Sitting for extended periods of time, handling knives, lifting objects (especially when lifting outside of neutral position).
Poor workstation design:
Improper positioning of the monitor, keyboard or mouse, rack and table height, incorrect lighting, poor layout of tools and accessories on the working surface, and poor design of tools and equipment.
Work Habits:
Working for long periods without breaks or stretching, or using poor lifting techniques.

Inspectors should report any symptoms to their supervisor and should take time to examine their work station design to see if improvements can be made.

3.5.1 Safe Work Practices – Office Environment

Listed below are some tips to follow in order to maximize comfort when working in an office environment

  • Stretch or change your position every half hour.
  • Maintain good posture.
  • Blink often and look into the distance.
  • Adjust your armrests to support your forearms.
  • Position the keyboard and mouse beside each other, allowing for your wrist and forearm to be straight.
  • Keep the monitor at arm's distance and placed so that your eyes can sweep the screen without head movement.
  • Reduce glare that you see on your monitor.
  • Keep ambient lighting low and use task lighting for work surface or document.
  • Adjust your chair to support your lower and upper back and most of your thigh.
  • Avoid resting your wrist.
  • Use a headset if you are on the phone regularly.
  • Use hotkeys (such as control S for Save).
  • Organize your workstation efficiently to avoid twisting, bending, or reaching.
  • Have your glasses set appropriately for computer distance.

3.5.2 Precautionary Measures for Safe Lifting

If you lift or carry more than 10 kg, you must be trained in safe lifting and must follow safe work procedures. Here are some guidelines:

  • Size up the load and get help or equipment when necessary.
  • Check to see if the movement pathway is clear.
  • Get a firm footing with feet apart for a stable base close to the load.
  • Bend your knees.
  • Tighten abdominal muscles to support your spine.
  • Keep the load close to your body.
  • Keep your back straight and avoid twisting.
  • Lift with your legs.

3.6 Hazardous Substances

Inspectors may sometimes work in an environment where there may be a risk of exposure to hazardous materials. The inspectors must have the appropriate level of Workplace Hazardous Materials Information System (WHMIS) training if they are exposed to hazardous substances.

3.6.1 Workplace Hazardous Materials Information System

The Workplace Hazardous Materials Information System (WHMIS) is Canada's hazard communication standard. The key elements of the system are cautionary labelling of containers of WHMIS "controlled products", the provision of Material Safety Data Sheets - (Internal access only) (MSDSs) and worker education programs.

The employer is responsible for ensuring that controlled products are properly labelled and that inspectors are provided with appropriate MSDSs and any required training if they are expected to be exposed to hazardous substances.

WHMIS covers any product, material or substance found in the classes listed in Schedule II of the Hazardous Products Act. It includes compressed gas, flammable, combustible, oxidizing, corrosive, bio-hazardous and dangerous materials and materials causing toxic and corrosive effects.

3.6.1.1 Material Safety Data Sheets

Before undertaking any task or while performing these tasks, inspectors should be aware of all risks of exposure to hazardous materials. Always review the Material Safety Data Sheets before using or handling new products or chemicals in the workplace or at an establishment. The potential dangers may include:

  • explosion hazards
  • fire hazards,
  • incompatibility hazards,
  • toxic hazards,
  • dangers of bio-hazardous and infectious substances,
  • corrosive hazards,
  • radiation hazards,
  • unknown substances.

The degree of severity for exposure to any hazardous material varies with:

  • the substances or materials involved,
  • concentrations,
  • the length of exposure,
  • the route of entry into the body,
  • the individual's health and physical condition,
  • the length of time before treatment is administered,
  • whether the correct first-aid measures are taken,
  • environmental considerations (e.g. humidity, temperature).
3.6.1.2 General Preventative Measures

Listed below are some general precautions to take when dealing with hazardous substances:

Look
Look for labelling, placarding or any other symbol that indicates presence of hazardous wastes and that can identify the material belonging to one of the 9 classes; symbols or words that indicate the contents are from a lab; signs of corrosion or leakage; and swelling or bulging of the container.
Handling
Keep all handling to a minimum.
Preventive Guidelines
Follow the preventive guidelines of the 8 classes of dangerous goods.
PPE
Wear personal protective equipment as prescribed by the Job Hazard Analysis
Skin Contact
Never allow direct skin contact with the surfaces of containers or their contents.
Precision Tools
Use precision tools to open and sample hazardous substances

3.7 Reporting Accidents and Hazardous Occurrences

Under the Canada Labour Code - Part II, inspectors are required to report every accident in the course of work that has or is likely to cause an injury to the employer.

Guidelines were developed to ensure reporting and recording consistency and to gather information for trends analysis. They contain:

  • explanations about the responsibilities of employees, supervisors and managers;
  • information about applicable forms, such as the Hazardous Occurrence Investigation Report - (Internal access only) ; and
  • details on what to report – the different categories of incidents, such as near misses, minor injuries, recurrences – and how to send the information.

3.7.1 Responsibilities

3.7.1.1 Employee's Responsibilities

Employees have a responsibility to take all reasonable and necessary precautions (use and maintenance of Personal Protective Equipment, safe work and hygiene practices) to ensure their health and safety and that of anyone else who may be affected by their work or activities:

  • by reporting to the manager/supervisor any accident even if they seem minor;
  • by reporting to the manager/supervisor any thing or circumstance that is likely to be hazardous to employees or any other person in the work place;
  • by reporting to the manager/supervisor, all work related accidents, occupational diseases or other hazardous occurrences that have caused injury to the employee or any other person.
3.7.1.2 Manager's/Supervisor's Responsibilities

Managers/supervisors must be thoroughly aware of all applicable legislation, regulations and departmental policies. Occupational safety and health issues should be considered in all activities they carry out.

When notified of a hazardous occurrence, managers/supervisors must:

  • determine the severity and type of occurrence;
  • ensure that the situation is contained and that no further hazard exists;
  • ensure that appropriate treatment (first aid and/or medical care) is provided, as required;
  • ensure that the affected area is left undisturbed for investigation purposes;
  • notify a member of the OSH committee or the OSH representative;
  • advise the Director(s) responsible for the affected employee(s);
  • advise the Area OSH Advisor;
  • advise the National Laboratory Safety Coordinator (NLSC) if the accident/hazardous occurrence occurred in a lab;
  • ensure that the situation is promptly and properly investigated and the Hazardous Occurrence Investigation Report completed; and
  • ensure that corrective actions, follow-up and record-keeping are completed.
3.7.1.3 OSH Committee's/Representative's Responsibilities
  • Participate in the accident/hazardous occurrence investigations and reporting;
  • Monitor implementation of recommendations;
  • Review and keep records on accidents/hazardous occurrences and recommend corrective measures to avoid reoccurrence.

3.7.2 Reporting

3.7.2.1 What to Report

Employees and employers are required to promptly report:

  • all injuries incurred in the workplace that require first aid or medical treatment;
  • any disease or illness contracted or incurred in the course of employment; and
  • all hazards, near misses, events or situations that may jeopardize the safety and health of employees and outsiders.
3.7.2.2 When to Report

All accidents, hazardous occurrences or occupational diseases should be reported promptly to the manager/ supervisor, as soon as possible and/or upon becoming aware that a hazardous condition may be work-related.

3.7.2.3 How to report

The manager/supervisor must complete The Hazardous Occurrence Investigation Report (HOIR)

3.8 Inspector Safety

3.8.1 Safe Work Practices

All inspection staff must be aware of the potential hazards present in their immediate work environment. When unsafe conditions or situations are identified at third-party premises during the course of an inspection, they must be corrected first before continuing inspection activities. Safe work practices should always be observed by inspectors when performing their tasks to avoid or reduce the risk of injury or harm.

Inspectors always have the right to refuse to perform an inspection for occupational safety and health reasons. If they have doubts about their safety or a co-worker's safety, they must notify their supervisor and identify safety issues. Safety issues must be addressed and resolved before inspectors can carry out their activities.

3.8.2 Personal Safety and Protection

Personal safety of Inspectors is paramount, and should not be taken for granted. The following are some information on Inspector's personal safety and protection related to inspection activities.

3.8.2.1 Personal Protective Equipment

PPE should always be used/worn to prevent accidents and to protect the inspector from hazardous conditions. See Section 3.4.2 for more information on PPE.

3.8.2.2 Dealing with Aggressive Persons

Inspectors are tasked to enforce the regulations as necessary. In carrying out their activities, they have to deal directly with the parties that the Agency regulates – manufacturers, importers, legal agents, etc. Sometimes, conflict may arise between inspectors and the management or representative of a company. When such situations arise, inspectors have a responsibility to report the incident to their supervisor and Security Services.

Listed below are a few guidelines on dealing with hostile or defensive clients:

  • Properly prepare to conduct an inspection. Wear clean, comfortable, suitable clothing and practical shoes which allow you to leave the premises quickly, if necessary.
  • Always wear your identity badge or carry it with you.
  • The supervisor should inform employees about regulated parties who are known to be aggressive or hostile. By the same token, inspectors should report to their supervisor any regulated party that have shown him or her any form of aggressive or threatening behaviour during an inspection.
  • Inspectors should work in pairs or teams in potentially high-risk situations.
  • Arrange to meet with regulated parties in a safe location.
  • Carry only the items that are strictly necessary (basic kit).
  • Remain vigilant and take note of the layout of the premises during your first visit.
  • When dealing with an emotional or aggressive person, remain calm and focused on objective while negotiating a resolution.
  • If you receive physical resistance or threat, disengage from the confrontation, get to safety, and inform your supervisor immediately.
3.8.2.3 Slip and Fall Prevention

The risk of slipping, tripping and falling can be reduced by:

  • wearing CSA-approved protective footwear;
  • keeping footwear tread in good condition; and
  • following safe work practices.

Inspectors must not climb on skids, equipment or materials. Further, inspectors must not stand on platforms being hoisted by a lift truck or on the lift truck forks. They must always ask a company representative for assistance when obtaining samples or items beyond their reach.

3.8.3 Emergency Preparedness

During inspections, inspectors should be aware of the company's emergency plan or procedures. If such a plan does not exist, inspectors should ask the company management to establish an interim evacuation plan in case of an emergency. Be aware of the emergency exits in your immediate work area, and ensure that these exits are unlocked and unobstructed.

In the event of an emergency (e.g., fire) where evacuation of the building is necessary, the following guidelines should be followed:

  • Calmly proceed to the nearest exit. Do not use elevators. Use handrails in stairways.
  • Move away from the building quickly, and watch for falling debris and other hazards.
  • Follow instructions from the company's emergency personnel.
  • Never re-enter the building until the company's emergency personnel has given instructions that it is safe to do so.

3.8.4 Road Safety

Inspectors are sometimes required to travel long distances or through heavy traffic to get to an establishment. The establishment may be located in a remote area, and driving on country or back roads through rural or sparsely populated areas may be necessary. In any event, whether driving long or short distances, inspectors should always exercise and observe road safety.

Before driving a fleet vehicle for duty travel, make sure it is maintained according to the CFIA Fleet Policy:

  • Perform a quick vehicle safety check (tires, lights, windshield wiper fluid, etc.)
  • Check for any fluid leaks (e.g., brake fluid, oil or gasoline).

Inspectors are recommended to complete a Defensive Driving Course to enhance driving skills and gain knowledge on road safety.

3.8.4.1 Winter Driving

Winter driving is a challenge not only to novices but also for experienced drivers. Factors that affect driving in winter include: shorter daylight, poor or limited visibility during white-outs or with blowing snow, poor road conditions due to snow accumulation on roads, and cold temperatures. Some winter driving tips are listed below:

  • Check local weather and road conditions before leaving.
  • If possible, tell someone where you are going and when you expect to arrive.
  • Plan properly and allow yourself extra time for travel.
  • Bring a map and be prepared to take an alternative route.
  • Dress properly – wear warm clothing.
  • Clear the vehicle completely of snow so that you can see and be seen.
  • Wait until the windows are defrosted before you start driving.
  • Always keep the gas tank at least half full, and add gasoline antifreeze to every second tank.
  • Top up antifreeze, transmission, brake and windshield-washer fluids.
  • Use a matching set of all-season or snow tires that meet standards.
  • Make sure that tire valves are equipped with caps to keep out snow and ice.
  • Bring a charged cell phone, and a cell phone charger, as appropriate.
  • Stick to the main roads whenever possible.
  • Stay alert, slow down, be aware and follow road signs and driving speed limits. Watch out for black ice.
  • Drive with low-beam headlamps on.

In the event that the vehicle gets stuck in snow, do not panic. Stay with the vehicle for safety and warmth. Call for help using a cellular phone if you are in an area with cellular phone service. Otherwise, draw attention to the vehicle using emergency flashers, flares or a "Call Police" sign.

3.8.4.2 Emergency Kits

Emergency situations are often unforeseeable. Therefore, inspectors should always be prepared in the event an emergency situation is encountered. Having essential supplies can provide some safety and comfort. Before venturing out to conduct an inspection, especially during inclement weather, always check that the vehicle, be it a fleet or personal vehicle, is equipped with an emergency kit.

3.8.4.3 In Case of an Accident

In the unlikely event of a vehicular accident, the following guidelines should be followed:

  • Remain on the scene.
  • Turn on your four-way flashers and set out safety triangles to prevent further damage as necessary.
  • Call the police.
  • Obtain the following information: name, address, telephone number and drivers' license number of the other driver(s) involved; make, model and license plate number of the vehicles, and the name of the insurance company; names and addresses of the witnesses; name of the police officer dispatched to the scene, his/her badge number and unit.
  • Take note of the time, location, date, weather conditions and light.
  • Do not admit guilt.
  • Notify your supervisor.
  • Fill out an accident report form.

Annex I

Scales of Entitlement
Personal Protective Equipment, Materials and Clothing

Legend:

Note: This document is provided as a guide to assist managers in the provision of personal protective equipment, materials and clothing. This guideline does not preclude management from taking into account unique situations and thereby providing acceptable alternate items. This document will be updated, modified and amended as required with changes in standards, regulations, directives and as dictated through job hazard analysis (JHA). In determining the requirements for PPE, in addition to this guide, managers should refer to relevant standards, regulations and directives listed. Contact Area OSH Advisors for assistance in selecting appropriate PPE or acceptable alternate items.

II. Inspections In Processing Plants, Manufactured Plants, Egg Stations, Storage (Fish Inspection, Meat Hygiene, Food Safety, Fair Labelling Practices, Dairy Products, Eggs, Honey, Fresh Fruits and Vegetables, Processed Products)

ItemFreq. of Repl.COSH Reg.CSA Std.TBS/NJC
Directive
Comments
1. CSA Approved Rubber Boots (Steel toe) As required Part XII (12.5(1)(2)) CAN/CSA-Z195-02 & Z195.1-02 Protective Footwear Paragraphs 12.9,12.10,12.11PPE & Clothing Provided. Check tread regularly Fish inspection: includes sanitary zone boots
2. CSA Approved Leather Boots (Steel toe and/or Steel sole) and Rubber Overboots As required Part XII (12.5(1)(2)) CAN/CSA-Z195-02 & Z195.1-02 Protective Footwear Paragraphs 12.9,12.10,12.11PPE & Clothing Provided. Fish inspection: includes sanitary zone boots
3. Freezer Coat / Insulated Vest As required Part XII (12.9) Paragraphs 12.4,12.6 PPE & Clothing Pooled clothing
4. Protective gloves As required Part XII (12.9) Paragraphs 12.3 Appendix PPE & Clothing Leather / Rubber / Insulated / Cotton Provided
5. Disposable Gloves As required Part XII (12.9) Paragraphs 12.3 PPE & Clothing Provided
6. CSA Approved Hearing Protection As required Part VII (7.7(1)) Z94-2-02 Hearing Protection Appendix Noise Control and Hearing Conservation Provided
7. Lab Coats/Long-Short Coat/Vest/ Coveralls/ Insulated Coveralls As required Part XII (12.9) Paragraph 12.3PPE & Clothing Pooled. Insulated coveralls only for work in cold storage for extended periods.
8. CSA Approved Headwear As required Part XII (12.4) CAN/CSAZ94.1-05 Industrial protective Headwear - Performance, selection, care and use Paragraph 12.7PPE & Clothing Provided
9. Hair / Beard Net As required Part XII(12.12) Appendix PPE & Clothing Provided
10. Half face-piece air purifying respirator, disposable As required Part XII (12.7) Must be in NIOSH Certified Equipment List Paragraph 12.3PPE & Clothing Provided
11. CSA Approved Eye Protection As required Part XII (12.6) Z94.3-02 & Z94.3-1-02 Industrial Eye & Face Protection Paragraph 12.8PPE & Clothing Provided
12. CSA Approved Flashlight As required Part XII (12.1) Paragraph 12.1PPE & Clothing Provided
13. Rubber Pants/Jacket/Apron As required Part XII (12.9) Paragraph 12.3PPE & Clothing Provided - For pickled / salted fish inspection
14. Raincoat or Rain suit As required Part XII (12.9) Paragraph 12.3PPE & Clothing Provided - For Fish Inspection only.
15. Parkas/Pants/ Exterior Footwear/Ski glasses As required Part XII (12.9) Paragraphs 12.4, 12.6 PPE & Clothing Pooled - For Coastal Labrador inspections - Arctic Wear. For other programs than fish, winter parkas/coats should be provided only to staff working outside or in hazardous weather condition.
16. Felt Boots - Long Underwear - Mittens - Socks - Tuque As required Part XII (12.9) Paragraph 12.4PPE & Clothing Individual - For Coastal Labrador inspections - Arctic wear
17. Fall Protection Systems As required Part XII(12.10)

Z259.1-95

Safety Belts and Lanyards

Z259.2-M1979 Fall Arresting Devices, Personnel Lowering Devices and Life Lines

Z259.3-M1978 Lineman's Body Belt and Lineman's Safety Strap.

Paragraph 12.3PPE & Clothing

Fall Arrest Kit

The fall-arresting system must respect the CSA/ANSI standards for all items - i.e. harness, lines, safety hooks, belts and rope grabs.

Provided, only if required.

Chapter 4: Food Safety Hazards

4.0 Scope

Chapter 4 of this Manual is intended to provide inspectors with information on the various types of hazards as they relate to food safety.

A food safety hazard refers to any agent with the potential to cause adverse health consequences for consumers. Food safety hazards occur when food is exposed to hazardous agents which result in contamination of that food. Food hazards may be biological, chemical, physical, allergenic, nutritional and/or biotechnology-related.

Hazards may be introduced into the food supply any time during harvesting, formulation and processing, packaging and labelling, transportation, storage, preparation, and serving.

For more information on Food Hazards, see the Reference Database for Hazard Identification (This document is intended for internal use. CFIA staff can access this document using RDIMS number 974917).

4.1 Biological Hazards

Biological hazards occur when hazardous or pathogenic organisms are introduced to food and thus pose a food safety concern to consumers. Biological hazards include bacteria, viruses and parasites of public health significance.

Biological hazards can be introduced to food from the environment (e.g. soil bacteria, agricultural run-off) or from inadequate sanitation practices and cross contamination during transportation, handling, processing, and storage (e.g., poor food hygiene practices). The type and magnitude of microbial growth is determined in part by the nature of the food, package conditions and storage environment.

Reference: Food-related Illness (Health Canada)

4.1.1 Bacteria

Bacteria are single-celled microorganisms that exist in a range of habitats and can be free-living (e.g. in soil, air, water) or symbiotic (e.g. in intestinal tract or mucous membranes of animals and humans) and have a broad range of enzymatic, biochemical and/or pathogenic properties. The principal bacteria associated with food borne illnesses include:

  • Bacillus cereus
  • Campylobacter jejuni
  • Clostridium botulinum
  • Clostridium perfringens
  • Escherichia coli 0157:H7
  • Escherichia coli 0104:H4
  • Listeria monocytogenes
  • Salmonella spp.
  • Shigella spp.
  • Staphylococcus aureus
  • Vibrio cholerae
  • Vibrio parahaemolyticus
  • Vibrio vulnificus
  • Yersinia enterocolitica
  • Cronobacter sakazakii

Ingesting food contaminated with pathogenic microorganisms and/or their toxic by-products can lead to food-borne illness. These illnesses can take the form of infection or intoxication, or both. Infectious microorganisms are detrimental to their host through mechanisms which crowd out beneficial microorganisms, use up host resources, and destroy host tissue. A food-borne illness caused by an infection can take days or weeks to manifest which often makes it difficult to identify the causative agent. On the other hand, illness caused by intoxication often occurs within hours of consuming the suspect food. Intoxications are caused by toxins that are produced by the microorganism, either in the food itself or after ingestion.

4.1.2 Viruses

In contrast to other microorganisms, active viruses consist of unique sections of DNA or RNA enclosed in a thin coat of protein, and cannot exist independently of their living hosts. Depending on the combination of DNA/RNA and the protein coating, viruses can be very infectious and often pathogenic. They reproduce by inserting themselves into a host cell and altering the function of that cell to replicate the component pieces that make up the virus. Viruses commonly associated with food safety issues include:

  • Bacteriophage
  • Enteric Virus (other than Hepatitis A and Noroviruses)
  • Hepatitis A virus
  • Norovirus
  • Norwalk virus
  • Rota virus

Viruses are typically introduced into food either through poor handling practices by people infected with the virus (i.e. poor personal hygiene practices) or via contaminated food ingredients (i.e. water).

4.1.3 Parasites

A parasite is any organism which obtains nourishment from its host organism in order to grow and reproduce. Unlike symbiotic organisms, which reciprocate by supplying their hosts with other resources the host would not otherwise be able to find, parasites do not supply the host with any resources, usually to the detriment of the host. Parasites commonly associated with food-borne illnesses include:

  • Cryptosporidium parvum
  • Giardia duodenalis or intestinalis
  • Taenia spp.
  • Toxoplasma gondii
  • Trichinella spiralis
  • Entamoeba histolytica
  • Entamoeba coli

Parasites enter food through similar means as viruses (i.e., poor personal hygiene practices and contaminated ingredients).

4.1.4 Other Biological Hazards - Prions

Other biological food safety hazards not belonging to the above mentioned categories include prions, also known as proteinaceous infectious particles, which are infectious agents made of protein. They are known to cause a number of diseases that affect both humans and animals. BSE or "Mad Cow Disease" is a progressive, fatal disease of the nervous system of cattle. It is also known as a transmissible spongiform encephalopathy (TSE). Other TSEs include scrapie in sheep and chronic wasting disease in deer and elk. Creutzfeldt-Jakob disease in humans is thought to be caused by consuming cattle infected with BSE. Although the exact cause of BSE is unknown, it is associated with the presence of prions. There is no treatment or vaccine currently available for the disease.

4.2 Chemical Hazards

Chemical hazards occur when chemicals are present in foods at levels that can be hazardous to humans. Contamination may occur through various pathways:

  • The environment (air, soil, water),
  • Intentional use of chemicals, such as pesticides and veterinary drugs,
  • Manufacturing processes,
  • Addition of food additives.

In the food industry, there are various types of chemical hazards, some notable ones include:

  • Mycotoxins
  • Natural Toxins
  • Marine Toxins
  • Environmental Contaminants
  • Food Additives
  • Processing-induced chemicals
  • Pesticides/Agricultural Products and
  • Veterinary Drug Residues

4.2.1 Mycotoxins

Mycotoxins are natural toxins which are produced by fungi and can be toxic to humans and animals. They are formed by moulds which grow on crops and foods under certain conditions. There are number of mycotoxins present in the environment but only a few are found in foods and they are usually associated with particular field crops like corn. The most prominent mycotoxins which cause health concerns in humans are aflatoxin, deoxynivalenol, ochratoxin, fumonisin and patulin.

Some of the general characteristics of mycotoxins are listed below.

  • resistant to heat
  • produced by fungi as secondary metabolites in response to competitive pressures from other fungi/bacteria
  • can have antibiotic properties
  • can cause toxic damage to cells of humans and animals
  • can cause chronic effects such as various cancers, immunosuppression, growth retardation, birth defects, renal dysfunction
  • can have serious long-term effects even at small concentrations
  • usually associated with particular crops (i.e. corn, cereal crops, apples)

Reference: Natural Toxins – Health Canada

4.2.1.1 Aflatoxin

Aflatoxin is produced by the mould Aspergillus flavus. Commodities which have a high potential for contamination with aflatoxin include tree nuts, peanuts, peanut butter, figs and corn. It should be noted that contaminated feed can lead to elevated levels in milk as well. The proliferation of Aspergillus and the corresponding production of aflatoxin are affected by drought during the growing season and high humidity during storage.

Aflatoxin is a potential carcinogen associated with the development of liver cancer.

4.2.1.2 Deoxynivalenol (Vomitoxin)

Deoxynivalenol (DON) is produced by various species of mould, most notably, Fusarium graminearum and F. sporotrichioide. Fusarium species are widely dispersed and their toxins reportedly occur in a wide variety of cereals, grains and in animal feeds. DON is classified in the trichothecene family of mycotoxins, a metabolite most commonly found in crops, such as wheat, barley and corn.

DON is not known to be carcinogenic. However it is a potent inhibitor of protein and DNA synthesis and is known to have immunosuppressive and cytotoxic effects. Symptoms observed as a result of human exposure to these toxins are vomiting, dermatitis, cough and rhinitis.

4.2.1.3 Ochratoxin A

Ochratoxin A (OTA) is a toxic metabolite formed by Aspergillus ochraceus, Penicillium verrucosum and other mould species. It is one of the most commonly occurring mycotoxins in improperly stored food.

OTA has been found in corn, peanuts and decaying vegetation. It has also been found in mouldy cereals such as wheat, rye, barley, oats, and other commodities, including bread, flour, beans, peas, rice, and coffee and in samples of meat where the slaughtered animal may have consumed feed contaminated with OTA.

Ochratoxin A is a human carcinogen which has also been found to cause lesions as well as teratogenic and neurotoxic effects.

4.2.1.4 Fumonisin

Fumonisin is a toxin produced by various species of mould, most notably Fusarium verticilloides and Fusarium proliferatum. Fumonisin is one of the most frequent mycotoxins found in corn. High levels of fumonisin are associated with hot and dry weather, followed by a period of high humidity.

Fumonisin causes two animal diseases: porcine (pig) pulmonary edema and leukoencephalomalacia in horses. This mycotoxin is a concern for humans as there is evidence to suggest it may be carcinogenic, causing oesophageal and liver cancers, and may contribute to neural tube defects in babies.

4.2.1.5 Patulin

Patulin is a toxic chemical produced by various mould species including Penicillium spp., Aspergillus spp. and Byssochlamys spp. It is heat stable at a pH<6 and will survive thermal processing. Patulin can be found in mouldy fruits (i.e. apples, pears, peaches, grapes), as well as mouldy vegetables and grains; however the major source of patulin contamination is from apples and apple products. The use of mouldy fruit increases the likelihood of patulin contamination in juices or ciders.

Patulin is known to be genotoxic, causing damage to DNA and chromosomes, which has led to theories that it may be carcinogenic.

4.2.2 Natural toxins

Natural toxins are biochemical compounds produced by plants in response to certain conditions or stressors.

Reference: Natural Toxins – Health Canada

4.2.2.1 Glycoalkaloids

Potatoes can contain natural toxins called glycoalkaloids. The major ones found in potatoes are α-solanine and α-chaconine. These toxins are formed in response to stresses such as UV light and damage (such as bruising), and cannot be destroyed by cooking. Toxin concentrations are highest in the peel and sprout of the potatoes and can be seen as a characteristic green color on those parts.

Exposure to glycoalkaloids can cause acute toxic effects such as burning in the mouth, diarrhoea, severe stomach ache, vomiting and gastrointestinal irritation. Death from glycoalkaloid poisoning is rare.

4.2.2.2 Other Natural Toxins

Other natural toxins are listed in the Table 1 below.

Table 1: Some Natural Toxins in Food Plants
Food commodityToxin
Ackee fruit hypoglycin
Cassa root, bamboo shoots, stone fruit cyanogenic glycoside
Fiddlehead unidentified
Green beans, red kidney beans, white kidney beans lectin
Wild mushrooms amanitins, gyromitrin, muscarine, phallotoxins
Parsnip furocoumarins
Rhubarb oxalic acid
Cabbage, cauliflower, broccoli, mustard, turnip goitrogens

4.2.3 Marine Toxins

Marine toxins are a group of toxins that sometimes accumulate in fish and shellfish. There are two sources of marine toxins:

  • decomposition
  • microscopic marine algae (phytoplankton, including diatoms and dinoflagellates)
4.2.3.1 Decomposition

When certain fish, especially scombroid fish (i.e. tuna, bonito and mackerel), start to decompose, histamine is formed. Histidine, a naturally-occurring amino acid, is converted into histamine by an enzyme produced by certain bacteria during decomposition. Histamine, in small doses, is necessary for the proper functioning of the human immune system. However, histamine in higher does may trigger severe reactions when consumed similar to those seen in allergic reactions such as rash, nausea, vomiting, diarrhoea, headache, dizziness, burning throat, stomach pain and itchy skin. The presence of high levels of histamine indicates that decomposition has occurred, even if the decomposition is not obvious. Toxic amounts of histamine can form before a fish smells or tastes bad. As this typically only occurs in scombroid fish, this is called Scombroid Poisoning.

4.2.3.2 Microscopic Marine Algae

Many marine toxins are produced by and can accumulate in fish and shellfish if they ingest certain types of algae.

Table 2 lists some common marine toxins and the seafood they are commonly associated with.

Table 2: Common Marine Toxins
IllnessToxinSeafood
Paralytic shellfish poisoning (PSP) Saxitoxin Oysters, clams, scallops, mussels, cockles, whelks
Amnesic shellfish poisoning (ASP) Domoic acid Bivalve molluscan shellfish, clams, mussels, oysters, scallops
Ciguatera poisoning Ciguatoxin Tropical fish such as barracuda, amberjack, red snapper, grouper
Diarrhetic shellfish poisoning (DSP) Okadaic acid Various shellfish, cockles, mussels, oysters
Tetrodotoxin poisoning Tetrodotoxin Pufferfish, California newt, parrotfish, octopus, starfish, angelfish, and xanthid crabs
Neurotoxic Shellfish Poisoning Brevetoxin oysters, clams, and mussels

4.2.4 Environmental Contaminants

Environmental contaminants are chemicals that accidentally or deliberately enter the environment, often, but not always, as a result of human activities. Some of these contaminants may have been manufactured for industrial use and because they are very stable, they do not break down easily. If released to the environment, these contaminants may enter the food chain. Other environmental contaminants are naturally-occurring chemicals, but industrial activity may increase their mobility or increase the amount available to circulate in the environment, allowing them to enter the food chain at higher levels than would otherwise occur.

Some examples of environmental contaminants include lead, arsenic, bromates, dioxins, furans, mercury and polychlorinated biphenols (PCBs). Division 15 (Table 1) of the FDA contains maximum limits for some environmental contaminants in specific commodities.

Reference: Environmental Contaminants – Health Canada

4.2.4.1 Arsenic

Arsenic is a naturally occurring element widely distributed in the earth's crust and is generally found in trace quantities in soil, rock, water and air. Arsenic can take two forms – organic and inorganic. Organic arsenic can be found in fish and shellfish and is the much less harmful form of arsenic. Inorganic arsenic compounds are found throughout the environment and can be released into the air through various processes such as volcanic action, mining of arsenic-containing minerals and ores and by industrial and commercial processes such as copper or lead smelting, wood treatment and pesticide application.

Inorganic arsenic is a carcinogen, and long-term exposure increases the risk of cancers of the skin, lungs, bladder, liver, kidney and prostate.

4.2.4.2 Cadmium

Cadmium is a rare element and is usually not found in nature in its pure state, but exists in combination with other elements, forming compounds such as cadmium oxide, cadmium chloride and cadmium sulphide. Cadmium is used in the manufacture of batteries, pigments, coatings, plating, stabilizers for plastics, ore processing and smelting, thus it finds its way into the environment through waste, waste water and soil uptake.

Most of the cadmium which enters the body is directly from plants grown in contaminated soil, or indirectly, from meat-producing animals which have eaten plants grown in contaminated soil. Cadmium and its compounds are highly toxic and are also suspected carcinogens.

4.2.4.3 Lead

Lead is a toxic heavy metal and is found in the environment in sources such as dust and soil. It can also be found in water and some food products (i.e. maple syrup and honey), that may have come into contact with older plumbing and cookware that contains lead-based solder. Lead may be found in older paint products as well.

Lead has been shown to cause neurological disorders, reproductive problems and diminished intelligence. Infants and young children are particularly at risk because they absorb a higher proportion of lead from food than adults, as they are still growing and developing. Pregnant women are also susceptible. Other effects are impaired mental function, visual motor performance and anaemia. Symptoms of exposure to lead may also be subtle, such as irritability, headaches, insomnia, gastrointestinal upsets, learning, behavioural and kidney problems.

For more information on lead, see Health Canada's website on Lead and Human Health.

4.2.4.4 Mercury

Mercury is a heavy metal which occurs naturally in rocks and soils and can be found in lakes, streams and oceans. Combustion of fossil fuels, mining, pulp and paper industries and burning garbage can also release mercury into the environment.

There are traces of mercury in almost all foods, with very low levels in vegetables and fruits, and high levels in certain types of fish such as shark, swordfish, marlin, escolar and orange roughly, which absorb the mercury from the organisms they consume as well as the surrounding water in which they live.

Mercury exists in several chemical forms. Two types are 'inorganic' and 'organic' mercury. Methyl mercury ('organic' mercury) is the most common form of mercury found in the aquatic environment and most fish have trace amounts present. It has been found that larger and older fish tend to have the highest levels of mercury, due to bioaccumulation. Methyl mercury is suspected to be a human carcinogen.

Exposure to mercury may cause several health effects: damage to the nervous system, kidneys, and the developing foetus. Other effects include brain damage, irritability, tremors, memory problems, changes in vision and hearing. Children are more sensitive to mercury than adults.

For more information see Health Canada's website: Human Health Risk Assessment of Mercury in Fish and Health Benefits of Fish Consumption as well as the information sheet on Mercury in Fish.

4.2.5 Food Additives

A food additive is any chemical substance that is added to food during preparation or storage and either becomes a part of the food or affects its characteristics for the purpose of achieving a particular technical effect (See B.01.001 of the FDR for a definition of 'food additive').

Substances that are used in food to maintain its nutritive quality, enhance its keeping quality and make it attractive or to aid in its processing, packaging or storage are all considered to be food additives. However, some substances that aid in the processing of food, under certain conditions, are considered to be food processing aids, not food additives. Examples of food additives include:

  • food colours (natural and synthetic)
  • pH adjusting agents
  • preservatives
  • bleaching agents
  • food enzymes
  • glazing and polishing agents
  • emulsifiers
  • gelling agents

Division 16 of the FDR contains a positive listing of all of the food additives that are permitted in food in Canada as well as the purpose, the level and the specific commodities.

Note:

A processing aid is product that is used in the manufacturing process of food products, but is not present in the finished food product, i.e. there is no residue present at the end. A processing aid is not considered to be a food additive.

A flavour enhancer is considered to be a food ingredient under the Food and Drug Regulations and is not currently regulated as a food additive in Canada for a number of reasons; the level of use of these substances is small, the history of use is well established and many international compendiums exist to substantiate their safe use.

Sometimes, food additives are found in food for which there is no provision in the FDR or at levels which exceed the prescribed levels. In these situations, the food may pose a risk to the consumer. Some examples of this type of situation include non-permitted synthetic colours (Sudan, Rhodamine and Gardenia Yellow).

Reference: Food Additives – Health Canada

4.2.6 Processing-induced Chemicals

Undesirable chemicals can be formed in certain foods during processing as a result of reactions between compounds that are natural components of the food. In some cases an undesirable chemical may be formed as a result of a food additive being intentionally added to food and then reacting with another compound in the food. When foods are heat-processed (baked, deep-fried, etc.), reactions occur between components of the food, resulting in the desired flavour, appearance and texture of the food. However, some of these reactions can lead to the production of undesirable compounds. Similarly, certain storage or processing conditions may allow reactions to occur that could generate potentially harmful compounds. Such chemicals can be collectively referred to as processing-induced chemicals. Some of these chemical reactions involve naturally-occurring components in the food, while other reactions may involve food additives, ingredients, or food packaging materials that were intentionally used. For these reasons, the presence of processing-induced chemicals in food cannot always be avoided.

Examples of processing-induced chemicals include:

  • acrylamide
  • ethyl carbamate
  • furan

Reference: Processing-induced Chemicals – Health Canada

4.2.6.1 Acrylamide

Acrylamide is a chemical that naturally forms in certain foods, particularly plant-based foods that are rich in carbohydrates and low in protein, during processing or cooking at high temperatures Asparagine (a natural amino acid) reacts with naturally occurring sugar (glucose) in the food and acrylamide is formed, but only if the temperature during the cooking process is high enough. The highest concentrations of acrylamide have been detected in potato chips and french fries, although it has been found in other foods as well including baked and roasted foods.

Acrylamide is a health concern as, based on studies, it is a probable human carcinogen.

For more information, refer to Health Canada's Acrylamide and Food

4.2.6.2 Ethyl Carbamate (Urethane)

Ethyl carbamate (urethane) is a chemical naturally formed during food processing especially in alcoholic beverages such as wine, beer, whisky, fruit brandies, and fermented foods such as bread and yogurt. Its presence was first identified in 1985.

Ethyl carbamate is formed by the spontaneous reaction of urea and ethanol. Urea is either added to increase fermentation rates, or is excreted by yeast when the wine yeast metabolises. Ethyl carbamate formation builds up over time and is exponentially accelerated at elevated temperatures. Fermented products that are also heated during processing (such as sherry "baking"), increases ethyl carbamate levels.

Ethyl carbamate is a health concern as it has been classified as a probable human carcinogen.

For allowable levels of ethyl carbamate, see the Canadian Standards] ("Maximum Limits") for various chemical contaminants in Foods, at Health Canada's website. The levels range from 30 ppb in wines to 400 ppb in fruit brandies and liquors.

4.2.6.3 Furan

Furan is a colourless, volatile organic compound that is used in some chemical manufacturing industries and may also be found in low levels in some heat-treated foods, such as canned or jarred foods. Furan in foods can form through multiple pathways that involve different naturally-present starting compounds that undergo thermal degradation or chemical rearrangement during food processing. The presence of furan in food is a potential concern because of indications of liver toxicity, including carcinogenicity, in experimental animals that were exposed to furan in their diet over a lifetime.

Note:

The chemical "furan" is different from "furans". "Furans" is an abbreviation of chlorinated dibenzofurans and are chemically related to a group of chemicals called dioxins. Dioxins and furans are environmental contaminants, not processing-induced food contaminants, and have distinctly different chemical structures and behaviours than furan.

4.2.7 Pesticides/Agricultural Products

A pesticide is any substance or organism (including organisms derived through biotechnology) that is used to control, destroy, repel or attract a pest or to mitigate the effects of a pest. A pest is defined as an animal, plant or other organism that is directly or indirectly injurious, noxious or troublesome (Pest Control Products Act, 2002)

Pesticides consist of insecticides, fungicides and herbicides. The following are examples of pesticides on certain crop groups:

  • Azoxystrobin on peaches
  • Captan on cherries
  • Clethodim on beans
  • Thiocarbamate on apples

Pesticides play an important role in Canada's food supply by protecting food from pests and diseases. When pesticides are used on food crops or when animals eat crops treated with pesticides, residues may remain on or in the food. Health Canada's Pest Management Regulatory Agency (PMRA) assesses the likelihood of health and environmental risks associated with each pesticide before it is allowed to be used in Canada. The PMRA also determines whether the ingestion of the pesticide residues that are most likely to remain on or in the food poses an unacceptable health risk, and establishes a maximum residue limit (MRL).

An MRL is an acceptable amount of the pesticide allowed to remain on food when sold in Canada. The Pest Control Products Act (PCPA) defines a pest control product and describes the maximum residue limits (MRLs) for many of these products. The complete list of Health Canada's MRLs regulated under the PCPA can be found on their website.

A major issue associated with pesticides is that they can accumulate in the food chain and may contaminate the environment. A classic example is dichloro-diphenyl-trichloroethane or DDT. This is one of the best known synthetic pesticides which has prevented many deaths by helping control the insect vector that spread malaria, but at the same time, its use was controversial. It was banned in 1972 due to the damage it caused to wildlife, especially birds, as it builds up in plants and in the fatty tissues of birds and other animals. DDT is believed to be carcinogenic to humans, and still remains in the environment today.

4.2.8 Veterinary Drugs

Veterinary drugs are often used in food-producing animals to control and/or prevent illness in the animal. If these drugs are used inappropriately or the withdrawal time prior to slaughter is not respected, residues from these drugs can be present in the food. These residues can be the drug itself or metabolites that are produced by the drug as it is digested by the animal and can be considered harmful to the consumer.

Veterinary drug residues are regulated under the Food and Drug Regulations. Table III in Division 15 lists the maximum residue limits (MRLs) of veterinary drugs for various foods. The MRLs are the maximum residue levels tolerated in food products and tissues of animals that have been treated with veterinary drugs. This residue level is considered to pose no adverse health effects if ingested daily by consumers over their lifetime.

Reference: Veterinary Drugs – Health Canada

4.3 Physical/Extraneous Material Hazards

Extraneous material covers all materials (excluding bacteria and their by-products (toxins), viruses and parasites) which may be found in a food that are foreign to that particular food. These materials are usually non-toxic but are associated with unsanitary conditions of production, processing, handling, storage and distribution of food. Some examples of extraneous materials that may be found in food are insects, hair, metal fragments, pieces of plastic, wood chips and glass.

Extraneous material can be considered hazardous due to its hardness, sharpness, size or shape. It may cause lacerations, perforations and wounds or may become a choking hazard. The sale of food contaminated with injurious extraneous material may be considered to be a violation of Section 4(1) (a) and/or Section 7 of the Food and Drugs Act.

The document Guidelines for the General Cleanliness of Food – An Overview outlines the current guidelines and associated methods used by the CFIA for determining the general cleanliness of foods. It can be found on Health Canada's website in Volume 1 of the Compendium of Analytical Methods.

Health Canada evaluates injurious extraneous material in food and it considers 2.0 mm or greater as the threshold size for consideration as a health risk. For infant food, any size of injurious extraneous material may be considered a risk. Besides size, the risk associated with extraneous material is further evaluated through an assessment of shape, hardness, material, source, target consumer groups, etc.

Extraneous materials can be differentiated into two categories: unavoidable and avoidable

Unavoidable extraneous material may occur in food as a by-product of the processing system or as something inherent to the product itself. Items such as stems in blueberries, microscopic airborne debris, dirt on potatoes, or minute insect fragments in figs are common examples of unavoidable extraneous matter.

Avoidable extraneous material is generally less tolerated than unavoidable because it is preventable. It consists of foreign matter which should not be present if proper GMPs are followed. Avoidable extraneous material may come in many different forms such as small glass fragments, pieces of plastic, chunks of rubber, pieces of jewellery, feather barbules, animal debris or any other unrelated foreign material.

Crystals, which appear to be glass, can sometimes form in certain food products such as tuna (struvite), processed cheese, soya sauce and fish sauce. These are not glass; they are mineral crystals. This can be verified by dissolving the crystals in heated vinegar or lemon juice.

4.4 Allergenic Hazards

An allergen is any protein that is capable of producing an abnormal immune response in sensitive segments of the population. Allergic reactions to food usually involve IgE antibodies. Symptoms of an allergic reaction can range in severity from a skin rash or slight itching of the mouth, to migraine headaches, to anaphylactic shock and death. The type and severity of an allergic response is determined by many factors, including dosage, route of administration, frequency of exposure, and genetic factors. This is not to be confused with a food intolerance which is an abnormal physiological response to a specific food. Symptoms of food intolerance may include cramps, diarrhoea and bloating.

Anaphylactic shock is the most severe adverse reaction to food and can be fatal if left untreated. It generally occurs within minutes of consumption, but occasionally the reaction may be delayed, with symptoms appearing several hours after the initial exposure. Initial symptoms of an IgE mediated allergic reaction are characterized by itching, hives, and/or swelling of the lips, palate, tongue, and throat. Once the food enters the stomach and intestine, symptoms may include cramping, nausea, pain, and diarrhoea. Subsequent systemic symptoms generally affect the pulmonary and cardiovascular system. The most dangerous symptoms include breathing difficulties and a drop in blood pressure or shock.

Health Canada has defined the foods that represent 95% of allergic reactions in Canada. These are termed 'priority allergens'.

  • Peanuts
  • Tree nuts (almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts, pistachio nuts, and walnuts)
  • Sesame seeds
  • Milk
  • Eggs
  • Seafood (fish, crustaceans, and shellfish)
  • Soy
  • Wheat
  • Sulphites
  • MustardFootnote 3

Other adverse reactions to food are not IgE mediated, but can also be severe. For example, Celiac disease is an autoimmune disease in which the body produces antibodies that attack its own tissues in the presence of gluten, which results in inflammation of the gut. The inflammation and consequent damage to the gut result in a decreased ability to absorb nutrients. Individuals with celiac disease can be nutrient deficient and have a wide range of digestive symptoms. Consumption of certain grains containing gluten put these individuals at increased risk of lymphoma and osteoporosis.

Reactions to sulphites are also non IgE mediated, but can be severe. Sulphite sensitive individuals generally have asthma or other allergies and exposure to sulphite can trigger an asthma attack.

There is no cure for food allergies (and Celiac Disease) and the only successful method for sensitive individuals to manage food allergy is to practice complete avoidance of the specific allergen. These individuals therefore rely on accurate information (e.g. ingredient list) on food labels to manage food allergy. Inaccurate, undeclared or hidden allergens on food labels can pose a significant health hazard to these individuals. Cross contamination during processing, packaging, and storage can inadvertently produce products that contain allergens which may not be reflected in the ingredients list on the food label. Strict adherence to good manufacturing practices (GMP), Hazard Analysis Critical Control Points (HACCP), and allergen prevention plans will reduce the likelihood of cross contamination.

Reference: Food Allergies – Health Canada

4.5 Nutritional Hazards

Nutrients are essential to maintain good health and pertain to a group of substances which includes carbohydrates, proteins, fats, vitamins and minerals.

Food fortification refers to the addition of one or more nutrients (vitamins, minerals, and amino acids) to a food product and plays an important role in ensuring the health of Canadians. Adding vitamins and minerals to food helps:

  • protect Canadians against nutritional deficiencies - for example, requiring all milk to be fortified with vitamin D virtually eliminated childhood rickets since the 1970s;
  • maintain and improve the nutritional quality of the Canadian food supply - for example, enriching flour with B vitamins and iron replaces those same nutrients lost in processing;
  • reduce the risk of diet-related chronic diseases - for example, fortification contributes to adequate intakes of calcium and vitamin D which help build strong bones and may reduce the risk of osteoporosis.

In Canada, addition of these nutrients to food is regulated under the FDR. Where a nutrient has not been added to the prescribed amounts, i.e., overage or underage, as permitted by the FDR, or where the nutrient is not present at the required amount at the end of the expected shelf-life of the product, the impact may be classified as low, medium or high (e.g., from no impact to weakness and slight skin discoloration to rickets, Carotenosis, and brain abnormalities), depending on the quantity of the nutrient, the nature and type of deficiency or excess. The health effects related to under-fortification are generally well understood, however, over-fortification can be equally hazardous. For example, if women consume high amounts of vitamin A shortly before or during pregnancy, it can lead to birth defects.

The current Food and Drug Regulations permit food fortification to:

  • replace nutrients lost in the manufacturing process;
  • act as a public health intervention;
  • ensure the nutritional equivalence of substitute foods; or
  • ensure the appropriate vitamin and mineral nutrient composition of foods for special dietary purposes.

4.6 Biotechnology-related Hazards/Novel Foods

The definition of biotechnology used by CFIA is:
"The application of science and engineering to the direct or indirect use of living organisms or parts or products of living organisms in their natural or modified forms"

This definition of biotechnology takes into account that genetic modification refers to both:

  1. indirect scientific processes that induce spontaneous mutations through, chemical mutagenesis and other processes involving the indirect modification of the organisms' original genome, and;
  2. direct genetic manipulation via methods of inserting genes from the same, or from different species and/or organisms.

The genetically modified (GM) food may cause hazard in developing allergenicity, transfer of genes from GM food to cells of the body or to bacteria in the in gastrointestinal tract.

Typically it is understood that referring to products of biotechnology encompasses products that have been, or are derived from, genetic modification and/or engineering. However, there are instances where genetic modification or engineering is not used, but the process and/or resulting product could be identified as a novel food. The term novel foods means:

  • Foods resulting from a process not previously used for food.
  • Products that do not have a history of safe use as a food.
  • Foods that have been modified by genetic manipulation, also known as GM foods, genetically engineered foods or biotechnology-derived foods.

Division 28 of the FDA/R requires that novel foods be pre-approved for sale in Canada. Once approved, novel foods (including products of biotechnology) are considered no different from their conventional counterparts and labelling is voluntary. Although biotechnology is not new, its subsequent practical applications in producing and manufacturing foods are a relatively new phenomenon. Consequently, it is difficult to identify products of biotechnology in the Canadian marketplace other than by identifying any label claims or physical characteristics that are unusual to the product, and identify it as being novel

There have been several situations in the past whereby unapproved products of biotechnology have entered into the Canadian marketplace. This can be the result of improperly labelled source seed, misidentified field research trials, or the 'escape' of the genetic material into other crops or the environment. Consequently, the volume of unapproved material that inadvertently becomes intermingled with the conventional food supply is usually present in relatively small amounts and is termed adventitious presence (AP). In this scenario, HC provides an opinion on the relative risk of the AP, and the resulting compliance and enforcement program is implemented by inspectors with specific instructions as to how to identify, test and/or sample the product Two recent examples of AP are:

  1. Corn that was approved for feed, but not food in the US, and not approved for any use in Canada (Starlink corn). This corn was imported into Canada in the form of flour and used to make taco shells and tortilla chips.
  2. Rice crops became contaminated with GM rice that was in the trial phase and entered into the food supply (LLrice601).

In these instances, the primary concerns were associated with potential allergenicity and/or toxicity arising from proteins or other products arising from unintended effects from genetic insertion or from the inserted gene itself. All genetically modified products must undergo a rigorous science-based safety assessment by Health Canada before they can be considered as safe as their conventional counterparts for human consumption in the Canadian food supply. Without completing the safety assessment, the relative risks associated with the product cannot be accurately measured, and the product becomes a liability as its potential hazards are unknown.

Reference: Biotechnology and Foods – Health Canada

Chapter 5: Codes of Practice

5.0 Scope

This chapter provides a brief introduction and overview of the generic codes of practice and other tools that IMFP inspectors use as assessment tools when inspecting a non-federally registered food establishment.

5.1 Generic Codes of Practice

The General Principles of Food Hygiene, Composition and Labelling (GPFHCL) and the Good Importing Practices for Food (GIP) are generic codes of practice that were developed by the Imported and Manufactured Food Program (IMFP) in consultation with other food programs within the Agency, as well as with industry. While the GPFHCL and the GIP serve as guidance to industry in the development of their food safety systems, IMFP inspectors use these two codes of practice to assess a manufacturers' or importers' compliance with the Food and Drugs Act and Food and Drug Regulations and the Consumer Packaging and Labelling Act and Regulations.

Each chapter of the codes of practice describes specific criteria and procedures for the control of the safety, labelling and composition of food during the manufacture, processing, storage, and distribution of food in Canada. The chapters are divided into sub-sections which are further comprised of a principle statement (generic outcome-based statements of the objective of the particular sub-section), rationale, and assessment criteria. Inspectors can subsequently estimate the potential health risk associated with any non-conformity to the criteria.

Example:

Figure 3: General Principles of Food Hygiene, Composition and Labelling
Figure 3. Description follows.
Description for Figure 3
Chapter:
3.0 Premises
Sub-section:
3.1 Building Exterior
Sub-sub-section:
3.1.1 Outside Property and Buildings
Principle Statement:
Buildings and surrounding areas are designed, constructed and maintained in a manner which prevents conditions that may result in the contamination of food.

Assessment Criteria

Grounds, roadways and drainage

The surrounding land is maintained to minimize sources of contamination such as debris and pest harbourage areas.

The building is not located in close proximity to any environmental contaminants.

Roadways are properly graded, compacted, dust proofed and drained.

The surrounding property is adequately drained.

Exterior building structure

The building exterior is designed, constructed and maintained to prevent entry of contaminants and pests (e.g. the exterior has no unprotected openings; air intakes are appropriately located; the roof, walls and foundation are maintained to prevent leakage).

It is essential that inspectors familiarize themselves with the chapters, sub-sections and assessment criteria of the GPFHCL and the GIP for Food . Both documents are available publicly and can be found on the CFIA website.

The Guide to Food Safety was also developed by the IMFP, in consultations with other food programs, other federal, provincial and territorial government and industry and is a voluntary tool that provides the Canadian food industry with generic guidance on how to design, develop and implement effective preventive food safety control systems. This will help to enhance food safety and prevent foodborne illness, injury and food spoilage.

5.2 Commodity-specific Codes of Practice, Inspection Guidelines, and HACCP Models

The list below outlines additional tools that have been developed to assist industry in meeting their regulatory requirements and inspectors in assessing compliance with regulatory requirements. These tools are generally more specific than the GPFHCL and the GIP.

Code of Practice

Inspection Guidelines

  • Assessing Allergen Controls in Processing and Importing Establishments – Food Allergy Reference Manual (Chapter 7). (This document is intended for internal use. CFIA staff can access this document using RDIMS number 1358753.)
  • Risk Management Strategy: Precautionary Labelling Regarding Milk on Chocolate Products. (This document is intended for internal use. CFIA staff can access this document using RDIMS number 1111827.)

Generic HACCP Model for…

Chapter 6: Establishment Inspection

6.0 Scope

Chapter 6 outlines the procedures to be followed when conducting inspections of establishments that fall within the jurisdiction of the IMFP.

An establishment inspection is an assessment of a manufacturer's or importer's compliance with the requirements of the Food and Drugs Act and Regulations, the Consumer Packaging and Labelling Act and Regulations, and the Organic Regulations under the Canada Agricultural Products Act. Inspections are conducted using the General Principles of Food Hygiene, Composition and Labelling (GPFHCL) and/or the Good Importing Practices for Food (GIP) as a guideline. During an inspection, the inspector identifies any deviations from regulatory requirements and guidelines.

Note that this chapter does not cover food safety investigations. During an inspection, situations may arise where an inspector will need to stop his/her inspection to conduct a food safety investigation or take enforcement action in response to an observed food safety hazard. If this occurs, inspectors should reference the Food Safety Investigation Manual.

6.1 Types of Inspections

6.1.1 Full Inspection

In a full inspection, the establishment should be assessed against all subsections of the GIP or GPFHCL. Because of the breadth and depth of a full inspection, and depending on the size and the complexity of an establishment, it may require several days to complete a full inspection.

Inspectors, at the discretion of their supervisor or manager, may decide to conduct a full inspection of an establishment for a variety of reasons. For example, a full inspection may be carried out in cases where the CFIA is in receipt of a number of complaints of varying concerns (both quality and potential food safety concerns) related to a particular company. An increase in the number of complaints may indicate a potential lack or loss of food safety control(s) in an establishment, and warrants a full inspection.

6.1.2 Focused Inspection

A focused inspection assesses a specific area or process of concern. It may be conducted in response to a complaint or as a follow-up to a previous inspection or unsatisfactory sampling result. The goal is to identify the possible root cause or source of an issue, or to verify if the company has put appropriate controls in place to address a minor, major or critical rating. Inspectors assess against the appropriate sections of the GIP or GPFHCL, as necessary.

Inspections conducted as part of Work Specifications are also considered focussed inspections. Work Specifications are developed by the Imported and Manufactured Food Program (IMFP) as a proactive approach to addressing potential risks associated with high-risk commodities or sectors. They provide guidance to inspectors on what commodities to inspect and how to conduct inspections and sampling.

All Work Specifications can be found on the IMFP Merlin web page - (Internal access only).

6.2 Inspector Conduct and Personal Hygiene

6.2.1 Professionalism

An inspector is an official representative of the Agency and must project a professional image when dealing with establishment officials. He/she must, therefore, be appropriately dressed and well groomed, respect the rules that establishment employees are required to follow, and have good interpersonal skills. Courteous and professional language must be used when dealing with the industry and public.

6.2.2 Confidentiality

All information discussed and obtained from a specific company must remain confidential. Other companies' systems, processes or inspection findings should not be discussed while conducting an inspection. This does not preclude government inspection reports being made available under the Access to Information Act.

6.2.3 Personal Cleanliness

Good personal hygiene includes proper care and cleanliness of hands, fingernails, hair and beards. Nail polish and perfume are not appropriate during inspections. Watches and jewellery, such as rings, chains, etc. must be removed before entering food processing areas. Plain wedding bands may be worn, provided that they are covered by sanitary gloves. Band aids must be covered by sanitary gloves if on hands or fingers. Loose items of clothing (ties, scarves, etc.) must be secured.

Inspectors should bring a lab coat with them to the inspection. The lab coat must be clean when put on, i.e. previously washed by a commercial cleaner. Inspectors may be asked to wear the establishment's lab coat during the inspection, rather than their own personal lab coat. Shoes and/or boots must have been thoroughly washed and disinfected, including the sole, before inspection and transported in a clean disposable bag. The hair and beard net must be new when put on and discarded after each inspection. The protective safety hat must be clean. Consult the manufacturer for appropriate cleaning and disinfection methods that will not affect the integrity of the hard hat.

6.2.4 Hand Washing

Before entering a food-handling area, inspectors must wash their hands properly, and disinfect them if necessary. This practice must be repeated as often as necessary, for example when an inspector has handled material likely to be contaminated.

6.2.5 Cleanliness of Inspection Equipment

All inspection material must be clean and sanitized before each inspection. Do not bring any equipment into the plant that may contaminate food directly. For example, a pen cap could come loose and fall into a food or ingredient; only use click pens during inspections. Refer to Appendix 1 of this chapter for procedures to clean and sanitize inspection equipment.

6.2.6 Inspector Conduct

All non-hygienic practices such as eating, smoking or chewing gum are prohibited in food-handling areas. Inspectors must follow all industry-standard precautionary measures (e.g.: foot bath, hand sanitizer, etc.) while in a food establishment. They must wash and disinfect their hands after every break, after using the toilet, after meals, at the end of an inspection and every time they touch a potential source of contamination (drains, dirty equipment, etc.).

6.2.7 Compliance with Establishment Policies

In general the inspector should abide by and respect establishment policies and procedures, for example, the use of foot baths, hair nets and protective clothing. In the event of a conflict, regulations supersede any establishment policies or procedures.

6.2.8 Contagious Diseases

An inspector known, or suspected, to be suffering from or to be a carrier of a disease or illness likely to be transmitted through food, must not conduct an inspection in a food establishment.

Examples include: jaundice, diarrhoea, vomiting, fever, sore throat with fever, discharges from the ear, eye or nose, hepatitis or any open cuts or wounds. Always notify your supervisor if you are experiencing any of these symptoms.

6.3 Preparation

An inspection involves much more than simply going to an establishment and inspecting the premises. The foundation of a complete and comprehensive inspection is sound preparation. This involves several steps as outlined below.

  • Frequency and timing
  • Team/joint inspections
  • File review
  • Process/product review
  • Inspection kit
  • Notifying the establishment

6.3.1 Inspection Frequency and Timing

The prioritization of work is a challenge for inspectors working in the IMFP, as responding to complaints and conducting food safety investigations and recalls may consume much of the inspectors' time and are impossible to predict in advance. Inspectors should work with their supervisor to balance the requirement to respond effectively to this work and the activities of the planned work specifications.

Work specifications define the timing and number of inspections. The inspection date must take into account the period scheduled for each work specification, and in some cases, the seasonal availability of the product. For example, maple syrup producers may only be operational in the spring, while apple cider processors may only press in the fall. Also, some imported products are more readily available at certain times of the year. Every effort should be made to ensure that the establishments are fully operational, and products are available to sample (should sampling be necessary), at the time of the inspection.

6.3.2 Inspection Team and Joint Inspections

Inspections may be conducted individually or in teams, as dictated by the requirements of the work specifications and available resources. A team approach may also be used for the following reasons: to improve uniformity, to increase the depth of the inspection by building on the strengths of two or more inspectors, to coach and mentor a new inspector, for safety reasons or to facilitate the inspection of a large or complex establishment.

In some cases, inspections may be conducted in conjunction with provincial inspectors or inspectors from other food programs. In most cases, this will be indicated in the work specification or discussed with the inspector's supervisor. Always consult with your supervisor prior to agreeing to conduct a joint inspection to ensure that it is within your legal authority to do so.

6.3.3 Establishment File

The establishment's file contains the firm's Establishment Profile, the most recent inspection reports and any communications, complaints, legal actions, seizures, infractions or recalls associated with this company. A file for each establishment/facility that the CFIA has inspected should be stored at the appropriate district office. Inspections should not be conducted without first consulting this file. The file should not leave the office; inspectors should review the file in advance of the inspection. Prior to an inspection the inspector should review and note:

  • The name of the establishment manager and key personnel.
  • Previous inspection reports, action plans and follow-up measures.
  • The size and age of the establishment as well as the products packaged or processed.
  • Unique features of the establishment, such as equipment, processing schedules, size or product lines.
  • Determine if there are any outstanding issues by reviewing: follow-up inspection summaries, consumer and industry complaints, recalls, laboratory reports, etc.
  • Review Incident Management System (IMS) reports.
  • Review the establishment's flow diagram showing the general movement of raw, in-process and finished product within the establishment.

This information is a useful tool for identifying the sources of concern during previous inspections and noting possible trends. It provides guidance as to what should be given priority during an inspection. If necessary, the inspector should consult with his/her supervisor, colleagues and the program officers.

6.3.4 Process /Product Review

Planning for inspections should also include a review of any available technical and scientific information on the products being processed or imported, the manufacturing methods and the equipment being used in the establishment. This information is essential for any inspector who is not familiar with the type of company to be inspected or for any inspector who needs an update. Program files, web sites, work specifications and scientific journals may be helpful.

6.3.5 Inspection Materials and Equipment (Kit)

Each inspector must have the proper equipment to conduct an inspection and must use or wear it where appropriate. If more than one plant is to be visited during the day or during a trip, the inspector must bring along a sufficient supply of equipment so as to have clean equipment for each visit. Since the CFIA is often scrutinized by industry, it is important to lead by example and ensure that all equipment is cleaned and disinfected as necessary.

6.3.5.1 Protective Clothing

The following protective clothing should be included in the inspection kit:

  • Safety hat - clean, CSA approved (Canadian Standards Association), white, marked "CFIA" or CFIA logo
  • Hair net and beard net (if applicable) - in good condition, disposable, white and individually wrapped
  • Dust mask
  • Eye and hearing protection – CSA approved
  • Lab coat (or equivalent, e.g. coveralls) - clean, white, front snap or velcro fasteners, no pockets above the waist.
  • Coat - for protection from the cold.
  • Sterile gloves – several pairs
  • Safety shoes - clean, CSA-approved, sanitized, steel-toed, non-slip
  • Safety boots - clean, CSA-approved, steel-toed, non-slip

Following the inspection, dirty clothing and footwear must be placed in a plastic bag in order to avoid contaminating the carrying case or vehicle.

6.3.5.2 Inspection Equipment and Tools

The equipment and tools needed to conduct an inspection depend on the product and establishment; however each inspector should have a kit that includes the following:

  • Carrying case
  • Calculator
  • Camera
  • Flashlight (in good working order)
  • An accurate thermometer with a steel shaft (not mercury in glass)
  • Containers and equipment for sampling, sterile or non-sterile as required (e.g.: bags, plastic containers, spoon, spatula, etc.)
  • Bags for taking official samples
  • Box or heavy duty plastic or cloth bag for transporting samples
  • Pen (without cap)
  • Clipboard that can be easily sanitized and that closes to protect documents from splashes
  • A notebook – with bound and lined pages (not spiral or perforated)
  • Disinfectants; inspectors should carry a disinfectant (e.g.: Dettol, 70% ethyl alcohol) so that they can sanitize their equipment between inspections as necessary.
  • Coolers and ice packs
  • Sterile gloves
6.3.5.3 Reference Materials and Documents

An inspector should carry the following materials or documents on the inspection:

  • Establishment Profile
  • GPFHCL or GIP worksheet
  • Notice of Detention and Notice of Release from Detention forms which includes the detention labels (CFIA 3256)
  • Sealing tape (CFIA 4561)
  • A copy of the Food and Drugs Act and Food and Drug Regulations, specifically sections 23 and 24 dealing with the powers of inspectors and sections 4 and 7 of the FDA, which are the sections under which the inspection is conducted.
  • A copy of the GPFHCL and the GIP
  • A copy of the recall plan
  • Any other relevant guidelines or information letters
6.3.5.4 Identification

Each inspector must carry and be prepared to show his/her CFIA inspector identity card (with appropriate delegated authorities), CFIA inspector's badge and business card. The identity card provides proof of the inspectors' delegated legal authority and is required to conduct an inspection.

6.3.6 Prepare for Reporting

Before an inspection, information regarding the establishment should be entered into MCAP. Open a new inspection and choose the appropriate assessment criteria (GIP or GPFHCL) and work specification. The subsections of the GPFHCL or the GIP relevant to the inspection will be pre-populated in the task list. The task list may be printed for easier record-keeping and on-site reporting. The assessment criteria should be reviewed before the inspection.

6.3.7 Notifying the Establishment

In most cases, notification should be given to the establishment's management of an upcoming inspection. This ensures that the appropriate establishment officials are available on the inspection date. Notification should be considered in cases where the establishment does not operate regularly or the CFIA has a need to see a specific process. However, there may be circumstances which warrant an unannounced inspection. The inspector must first check with his/her supervisor to determine whether notification is necessary.

An establishment may be informed of an upcoming inspection by telephone, letter or e-mail. It is recommended that all documentary evidence of notification be placed in the establishment file.

6.4 On-site Inspection

6.4.1 Opening Meeting

The purpose of the opening meeting is to introduce the inspector (or inspection team) to the management at the establishment and to set out the expectations for the duration of the inspection.

When meeting with the establishment's management, the inspector should demonstrate courtesy and professionalism. This helps to establish a working partnership.

  • Ask for the establishment's manager or person in charge.
  • Show your badge, identity card or business card.
  • Explain what the inspection will involve and agree on an inspection schedule and time frame.
  • Inform management that the results will be discussed once the inspection has been completed, and arrange a time to meet and discuss the results.
  • Inquire about any special requirements of the establishment concerning protective equipment and safety measures or changes to processes or products.
  • Provide the appropriate documentation if necessary (e.g. Codes of Practice, Letters to Industry, Facts Sheets, etc.)

During the opening meeting, complete or update the Food Establishment Profile. A copy of this form is available at RDIMS #834877 or on the Imported and Manufactured Food Program page on Merlin. The last page of the Food Establishment Profile includes the compliance history, which must be updated following any activity involving the company. At the very least, the region in which the company is located must retain a paper copy of the Food Establishment Profile. Include the establishment Record Number from the Client Management System (CMS) in the activities table at the end of the profile.

6.4.2 Conducting the Inspection

When conducting an inspection, the inspector assesses the establishment's controls against the assessment criteria in the sub-sections of the GIP or GPFHCL. These assessment criteria are not exhaustive and it may be necessary to include other criteria to fully assess the subsection. It is important for the inspector to follow the plan created while at the same time knowing when to stop and respond to serious food safety hazards, if observed.

It is preferable to have a representative (establishment's manager, foreman or quality assurance person) accompany the inspector as it allows for questions to be asked on the spot and serious deficiencies to be pointed out as observed; this way, immediate action can be taken. At a minimum the inspector has the authority to ask for assistance in reviewing records and programs and dismantling equipment.

Inspectors must not allow accompanying plant personnel to rush the inspection or to lead them away from infractions.

If the company suggests that their lawyer be present during the inspection, the inspector should stop the inspection and contact their supervisor. Their supervisor should contact CFIA legal services who will provide guidance on how to proceed. They may advise to proceed with the inspection with the company lawyer present.

For plants producing high-risk foods, inspections should be conducted following the reverse order of the production sequence. To minimize the risk of cross-contamination, begin the inspection in the cleanest areas (from a microbiological standpoint) and end the inspection in the least clean areas. For example, begin with the finished product packaging section and end with the inspection of raw materials. If the inspector must return to the finished products section, he must disinfect his equipment again before returning to this area.

Ideally, production steps should be evaluated during operations. This approach makes it possible to provide a realistic inspection of the establishment. If certain production steps (including cleaning and sanitizing) are not currently being carried out, consideration must be given to the possibility of returning to complete the inspection at the appropriate time.

6.4.2.1 Information Gathering Tools

Information can be gathered using three basic tools: observation, interviews, and examination of records and documents.

Figure 4: Observation
Figure 4 shows a set of eyes looking up, down, and all around.

Be thorough when observing processes, products and equipment. Remember to look up, look down and all around. Observations include product and process inspection. Observe employees to verify if a procedure is being followed.

Interviews

Conduct interviews face to face and try to create a bond between you and the person being interviewed. Ask questions in a normal conversational tone. Open ended questions elicit more information than closed questions. For example, ask: "How do you conduct this procedure?" rather than "Did you do XYZ?" Wherever possible, verify the information gained from an interview with observations and review of documents.

Records

Examine all relevant documents and records. Documents and records should also be used to verify the validity of interviews and observations. Records should be legible, permanent, an accurate reflection of what happened at a specific time, signed and dated. If the record looks "too perfect," that is, the writing all the same and the overall appearance too much the same, there is a possibility that the records are being completed all at one time and do not reflect true data. Errors and/or changes should be clearly identified, i.e., no use of white out. Critical records should be signed by a qualified person. All pertinent records should be available to the inspector upon request. While conducting a work specification-based inspection, it is generally appropriate to examine documents and make notes about them in the inspector's notebook. If a food safety hazard is identified during the inspection, or as part of a complaint follow-up, it may be more appropriate to obtain copies of relevant records. Inspectors have the authority to obtain copies under paragraph 23(1)(c) of the Food and Drugs Act.

6.4.2.2 Communication during the Inspection

The inspector should direct questions to the establishment's management rather than to the employees, except when the inspector wants to determine whether an employee understands what he/she is doing or what procedures he/she has been directed to follow during regular production, or when there is a problem or deviation. Employees should be addressed in the presence of management.

6.4.3 Sampling Products During or After the Inspection

Product samples may be collected during or after an inspection of an establishment, to verify inspection findings. Samples should always be collected in the presence of a company official. Always notify the establishment's management of the exact nature of the samples collected and the purpose of sampling. Collect samples as outlined in the work specifications and Chapter 7: Sampling of this manual.

6.4.4 Recording Observations

Inspection findings can be recorded on an MCAP inspection worksheet or in a notebook referencing the worksheet. Notes should be relevant, factual and accurate. When interviewing people, note their name and position in the company, and quote what was said and their actions. Do not make judgements on what they said or their actions. Notes on observations should include how the observation was made. If working in teams, take turns asking questions with one asking the question while the other records the answer.

6.4.5 Addressing Non-conformance/Non-compliance during the Inspection

In some cases, a non-conformance or non-compliance may be rectified immediately, during the inspection. These findings should be documented and assessed even if they are addressed immediately. Always note observations even if the situation is immediately rectified.

Note:
Compliance is defined as 'the state of adherence to regulatory requirements' while conformance is defined as 'the state of adherence to a regulated party's written programs or the assessment criteria in the GPFHCL and/or the GIP'.

6.5 Assessment of Findings

All non-conformances/non-compliances found during the inspection must be indicated in writing on the worksheet or notebook. The inspector must review the deficiencies in private, assign the appropriate ratings (critical, major, minor) and determine the priority of the items to be corrected. In some cases, the inspector may need to consult with his supervisor or program specialist before assigning a rating but in most cases, the inspector should be able to identify critical and major deviations and communicate these immediately to the establishment's management.

When it is difficult to determine a rating, the inspector may need to probe deeper and re-examine the situation to gather additional information that will make it possible to rate the observation.

6.5.1 Estimating Health Risk and the Rating System

The process of estimating health risk is not an exact science. Inspectors in the IMFP should use the following procedures in estimating health risk related to non-conformities which are noted during routine inspections.

6.5.1.1 The Rating System

There are two levels of rating during an inspection:

  • The potential health risk resulting from a non-conformity at the subsection level of the Code of Practice (Critical, Major, Minor or Satisfactory) and
  • An overall inspection rating (1, 2, 3 or 4).

The first rating is assigned by the inspector based on inspection findings and the second is automatically assigned by MCAP.

6.5.1.2 Assigning a Rating at the Subsection level

Using the Health Risk Estimation Model in Figure 1, estimate the potential risk of non-conformity as follows:

  1. Identify the hazard created by the non-conformity (physical, chemical, microbiological, allergen or nutrition)
  2. Identify the severity of consequences (high, medium or low). See section 6.5.1.2.1 below.
  3. Assess the controls in place, and any other relevant information gathered during the inspection
  4. Determine the likelihood of occurrence/exposure to the hazard (high, medium, low or remote). See section 6.2.1.2.2 below
  5. Apply the health risk estimation model below to determine the overall rating of the non-conformity (critical, major, minor or satisfactory)
Figure 5: Health Risk Estimation Model
Figure 5. Description follows.
Description for Figure 5

This image is a graph of the Health Risk Estimation Model. The y-axis is the likelihood of occurrence (remote, low, medium or high). The x-axis is the severity of consequences (low, medium or high). The graph assigns a health risk rating of Satisfactory, Minor, Major or Critical for specific combinations of x and y parameters.

The following combinations having a Health Risk Rating of 'Satisfactory':

  • Likelihood of Occurrence is Remote and Severity of Consequences is Low
  • Likelihood of Occurrence is Remote and Severity of Consequences is Medium
  • Likelihood of Occurrence is Remote and Severity of Consequences is High
  • Likelihood of Occurrence is Low and Severity of Consequences is Low
  • Likelihood of Occurrence is Medium and Severity of Consequences is Low
  • Likelihood of Occurrence is High and Severity of Consequences is Low

The following combinations having a Health Risk Rating of 'Minor':

  • Likelihood of Occurrence is Low and Severity of Consequences is Low
  • Likelihood of Occurrence is Low and Severity of Consequences is Medium
  • Likelihood of Occurrence is Low and Severity of Consequences is High
  • Likelihood of Occurrence is Medium and Severity of Consequences is Low
  • Likelihood of Occurrence is High and Severity of Consequences is Low

The following combinations having a Health Risk Rating of 'Major':

  • Likelihood of Occurrence is Medium and Severity of Consequences is Medium
  • Likelihood of Occurrence is Medium and Severity of Consequences is High
  • Likelihood of Occurrence is High and Severity of Consequences is Medium

The following combinations having a Health Risk Rating of 'Critical':

  • Likelihood of Occurrence is High and Severity of Consequences is High

Health Risk Rating Definitions

The non-conformity represents:

  • Satisfactory (Sa): a remote health risk
  • Minor (Mi): a low health risk
  • Major (Ma): a moderate health risk
  • Critical (Cr): a high heath risk
6.5.1.2.1 Severity of Consequences

The severity of consequences (low, medium or high) defines the seriousness of the hazard. It is usually predetermined as a result of scientific knowledge. The three levels of severity of consequences are defined as:

  • Low: exposure to the hazard is not likely to cause any adverse health consequences
  • Medium: exposure to the hazard could result in temporary or non life-threatening health consequences
  • High: exposure to the hazard could cause permanent disability or death

    If there is not enough information to determine the severity of consequences, always assume that it is high until further information proves otherwise.

Microbial Hazards

With respect to microbiological hazards, the severity of consequences of the most common pathogens and natural toxins known to be associated with foods are classified as outlined in Table 1 below.

Chemical Hazards

The severity of consequence for some chemical hazards is determined on a case-by-case basis. Information on various chemical hazards can be found on the CFIA and Health Canada websites. Table 1 below indicates the severity of consequences for some toxins.

Table 1: Severity of Consequences of Common Food Pathogens and Natural Toxins
Severity of ConsequencesPathogen/Disease
High
  • Clostridium botulinum
  • Salmonella typhi
  • Listeria monocytogenes
  • Escherichia coli O157:H7
  • Vibrio cholerae
  • Vibrio vulnificus
  • paralytic shellfish poisoning
  • amnesic shellfish poisoning
Medium
  • Brucella spp.
  • Campylobacter spp.
  • Salmonella spp.
  • Shigella spp.
  • Streptococcus type A
  • Yersinia enterolitica
  • hepatitis A virus
  • mycotoxins
  • ciguatera toxin
Low
  • Bacillus spp.
  • Clostridium perfringens
  • Staphylococcus aureus
  • Norwalk virus
  • most parasites
  • histamine-like substances

Source: Food Quality and Safety Systems - A training manual on food hygiene and the Hazard Analysis and Critical Control Point (HACCP) system, Food and Agriculture Organization of the United Nations, Rome, 1998

Extraneous Material Hazards

For extraneous materials hazards, use the Injury Risk of Extraneous Materials found in Table 2 below as a guide to determining the severity of consequences. Note that in addition to size, the risk associated with extraneous material is further evaluated through an assessment of elements such as shape, hardness, nature of the extraneous material, source, visual appearance (e.g. colour, visibility in the product), method of consumption/preparation, target population, quantity, etc.

Table 2: Severity of Consequences for Extraneous Material
Severity of ConsequencesCommodityMaterial
High Infant Foods Any size
High Beverages
Medium All other foods 2mm or larger in any one dimension
Low All other foods Less than 2mm in any one dimension

Nutrition Hazards

The severity of consequences of nutrition hazards is determined on a case-by-case basis. In general, the severity of consequence for nutritional hazards is medium to low however, it can be higher in foods that are targeted to very young consumers or those consumers with special dietary needs.

Allergen Hazards

Allergen hazards are also evaluated on a case-by-case basis. However, sulphites at <10ppm and gluten at <20ppm are not considered hazardous.

6.5.1.2.2 Likelihood of Occurrence of Exposure to the Hazard

The likelihood of occurrence of exposure to the hazard refers to the probability that the consumer may be exposed to a hazard. It is assessed by the inspector to be: remote, low, medium or high based on the inspectors' findings of the controls in place by the manufacturer or importer, all other relevant information, and inspector judgement.

It is important to note that it is the likelihood of the consumers' exposure to the hazard that should be assessed, not the likelihood that the non-conformity to specific assessment criteria will occur.

Consider the following example:

Finding:
While at a large juice processor, an inspector determines that the temperature recording device for the pasteurizer was not properly calibrated and the actual temperature of the product was potentially several degrees lower than indicated. This occurred twice in the last month and the product that was manufactured during that time is in national distribution.

Assessment:
The hazard identified would be 'pathogen survival' and would be rated as a high severity of consequences since the juice did not reach the temperature required to destroy the pathogens of concern. As the product is in national distribution, there is consumer exposure and the likelihood of occurrence is also high. This would result in a critical rating.

In this same example, however, if it is later observed that the temperature of the product in the holding tank of the pasteurizer was also recorded manually and these records indicate that the minimum temperature required to pasteurize the juice was achieved during the period of time in question. This would indicate that the product did achieve the required temperature to destroy any pathogens and the severity of consequences would be changed to remote. The likelihood of occurrence remains the same and the resulting rating is satisfactory.

In general, there is an inverse relationship between the likelihood of occurrence and the degrees of control over the hazard i.e., if there are inadequate process controls in place, the likelihood that the hazard may occur increases.

When a rating of major or critical is assigned to a subsection, inspectors should review their findings in consultation with their Area Program Specialist in order to verify their conclusions.

Note: Use caution when rating deficiencies related to record-keeping. These will typically be rated as minor. On some occasions, a major rating may be assigned where absent or incomplete records are associated with a deviation which is directly related to a health and safety concern e.g. records associated with a critical control point (CPP).

6.5.1.3 Assigning an Inspection Rating to an Inspection

The inspection rating (ranked from 1 to 4) is determined by the relative potential health risk represented by the overall inspection findings, as shown in Table 3. A rating of 1 (the most severe rating; a rating of 4 being the least severe) means that there is a high risk that the deviations noted during the inspection could result in exposure to a hazard which could cause permanent disability or death. Consequently, inspections rated as 1 receive the highest priority for follow-up activities.

The MCAP reporting system will automatically assign a rating to a completed inspection according to the rating scheme in Table 3.

Table 3: The Inspection Rating Scheme
Inspection RatingCriteria
1 At least one subsection rated Cr
2 At least one subsection rated Ma, but no Cr
3 At least one subsection rated Mi, but no Ma or Cr
4 No subsection rated Mi, Ma or Cr

6.6 Closing Meeting

The closing meeting should take place with the appropriate plant management representatives (those who are responsible or accountable for taking corrective action) as soon as possible after the inspection. A quiet location, preferably in the establishment, should be chosen for holding the meeting.

During this meeting, the inspector should begin by pointing out any positive comments that are appropriate and then communicate the critical and/or major non-conformances/non-compliances observed during the inspection. The inspector and the establishment should negotiate a reasonable time frame for the establishment to provide the inspector with their Corrective Action Plan (CAP) for all sections rated critical, major or minor. The due date for the CAP should be noted on the inspection report and/or cover letter (see Reporting below). The inspector should highlight the importance of a CAP and indicate essential items for the establishment to include in order to correct all deviations identified. If the inspector does not receive the CAP in the agreed to time frame, they should contact the establishment for clarification and to urge them to provide the plan. Should a CAP not be received by the end of the time frame allowed for CAP implementation and CFIA follow-up (for example; 6 months for a minor non-conformance), then the inspector should return to the establishment. All identified deficiencies should be re-inspected to make sure they are corrected and have not become more serious.

When negotiating these time frames the inspector should keep in mind and ensure that the firm understands that critical non-conformances/non-compliances must be addressed immediately, majors within one month, and minors within approximately six months as per Table 5 in this chapter.

It is important that the management understand the inspection findings. Explain clearly the reason certain assessment criteria were not met and that these items require correction or improvement. Remember to thank the management for their cooperation.

6.7 Reporting

The proper reporting of the results of an inspection is integral to the success of any program. A report should be clearly written, contain all pertinent information and be accessible to everyone involved in the design and implementation of the program. The information in the report is important for tracking and monitoring trends over time and for identifying gaps and/or areas for improvement with regards to further program development.

Once the inspection is completed, the inspector or team writes the inspection report. All inspection findings are reported in MCAP, including comments for each subsection rated minor, major or critical. Comments are optional for subsections rated Satisfactory, but may be useful for documenting changes in ratings from a previous minor, major or critical to a satisfactory rating.

Focus comments on objective evidence, observations and inspector judgement. Use clear and concise statements. State the facts and avoid stating inspector opinions. Write non-conformities/non-compliances in the past tense, in the third person. State the objective evidence, state the non-conformity and quote the appropriate subsection.

Print the inspection report and send it with a cover letter to the establishment within two weeks of completing the inspection. The cover letter will confirm the inspection and any samples taken, communicate inspection findings, confirm any enforcement actions taken and request a CAP for any outstanding non-conformance/non-compliance issues. Indicate the results of the sample analysis if available. If not available, indicate that the results will be forwarded when they are completed. A sample cover letter is available in Appendix 2 at the end of this chapter.

Ensure that all applicable fields in MCAP are completed, and assess your findings to determine whether any additional CAPs and/or other follow-ups are needed before closing the inspection report. All relevant LSTS sample numbers and IMS numbers should be entered into MCAP.

Any critical deviations requiring immediate action to protect the health and safety of the public (e.g. Health Risk Assessments, Recalls) are to be reported in IMS and to the Area Recall Coordinator and Area Program Specialist immediately. For reporting complaint follow-up and/or recalls the inspector may refer to the Food Investigation Response Manual (FIRM) (This document is intended for internal use. CFIA staff can access this document using RDIMS number 4052577.).

6.8 Inspection and Sample Follow-up

Non-conforming/non-compliant samples and establishment inspection results require follow-up action. This section outlines the time frames, procedures, enforcement actions and reporting procedures to follow for non-conforming/non-compliant sample results and establishment inspections. Following these procedures facilitates the national consistency of enforcement actions in the non-federally registered sector.

6.8.1 Procedure

Figure 2 (Sample and Inspection Follow-up), is a flow chart that outlines the procedures to follow for samples and inspection results. The flow chart begins with receipt of inspection or sample results and ends with no further action required or a referral to Enforcement and Investigation Services.

Consultation between Operations, Programs, including the Office of Food Safety and Recall (OFSR), laboratories and others during the enforcement decision making process is essential. This consultation process must consider the available resources, the health risk assessment, program and policy advice and other Agency priorities. The dotted lines in the flow chart indicate when to consult and the colours indicate who to consult and where they are located (blue represents the Areas, and purple represents the Headquarters activities).

Figure 6: Flow Chart for Sample and Inspection Follow-up
Figure 6. Description follows.
Description for Figure 6

This image is a flow diagram that outlines the steps for follow up of sample and inspection results by CFIA inspectors.

Boxes shaded in blue are the responsibility of the Area. Boxes shaded in pink are the responsibility of Headquarters. Boxes joined with a dotted line indicate a consultation step. Boxes inside the red outline are the Food Safety Investigation.

The first object is blue and is titled 'Sample or Inspection Results'. It goes to each of the following six blue boxes:

  1. Satisfactory sample
  2. Inspection rated 4
  3. Inspection rated 3
  4. Samples rated No Decision
  5. Inspections rated 1 or 2
  6. Samples rated Unsatisfactory or Investigative

Option 1 (Satisfactory sample) goes to the white box 'No further action'.

Option 2 (Inspection rated 4) goes to the blue box 'Advise Firm, send letter and report' and then to the white box 'No further action'.

Option 3 (Inspection rated 3) goes to the blue decision box 'Violation'. The answer 'No violation' goes to the blue box 'Advise Firm, send letter and report', then to the blue box 'Follow-up with firm', then to the blue decision box 'Satisfactory'. The answer 'Yes violation' goes to the blue box 'Enforcement Actions, e.g. detain'. The 'Enforcement Actions, e.g. detain' box is joined by a dotted line (meaning consultation) to the pink box 'Technical/Commodity Specialist' and the blue box 'Area Specialist', and goes to the blue box 'Advise Firm, send letter and report', then to the blue box 'Follow-up with firm', then to the blue decision box 'Satisfactory'. The answer 'Yes satisfactory' goes to the white box 'No further action'. The answer 'No satisfactory' goes to the blue box 'Complete Inspectors Non-Compliance Report' then to the white box 'Enforcement and Compliance Policy'.

Option 4 (Samples rated No Decision) goes to the blue box 'Area Specialist' which butts up against the pink box 'Technical/Commodity Specialist'. The 'Technical/Commodity Specialist' box is joined by a dotted line to the blue box 'Enforcement Actions e.g. detain', then to the blue box 'Advise Firm, send letter and report', then to the blue box 'Follow-up with firm', then to the blue decision box 'Satisfactory'. The answer 'Yes satisfactory' goes to the white box 'No further action'. The answer 'No satisfactory' goes to the blue box 'Complete Inspectors Non-Compliance Report' then to the white box 'Enforcement and Compliance Policy'.

Option 5 (Inspections rated 1 or 2) goes to the blue box 'Enforcement Actions, e.g. detain', then to the boxes separated by a red border to indicate 'Food Safety Investigation'.

'Food Safety Investigation' begins with a blue decision box 'Potential Health and Safety Issue'. The 'Potential Health and Safety Issue' decision box is joined by a dotted line (meaning consultation) to the blue box 'Area Recall Co-ordinator, Inspection Supervisor, Inspection Manager, Area Program Specialist, others', which is joined by a dotted line to the pink box 'Program Specialist (Program Advice). This box butts up against the pink box 'Technical Specialist (Risk Assessment), Commodity Specialist', however this latter box is outside of the red border. It is joined by a dotted line to the pink box 'Health Canada Health Risk Assessment' and to the pink box 'Office of Food Safety and Recall (Risk Management)' which is inside the red border.

The answer 'No potential health and safety issue' goes to the blue box 'Advise Firm, send letter and report', then to the blue box 'Follow-up with firm', then to the blue decision box 'Satisfactory'. The answer 'Yes satisfactory' goes to the white box 'No further action'. The answer 'No satisfactory' goes to the blue box 'Complete Inspectors Non-Compliance Report' then to the white box 'Enforcement and Compliance Policy'.

The answer 'Yes potential health and safety issue' goes to the blue box 'Area Recall Co-ordinator', then to the pink box 'Office of Food Safety and Recall (Risk Management)' then to the pink decision box 'Recall'.

The answer 'No recall' goes to the blue box 'Advise Firm, send letter and report', then to the blue box 'Follow-up with firm', then to the blue decision box 'Satisfactory'. The answer 'Yes satisfactory' goes to the white box 'No further action'. The answer 'No satisfactory' goes to the blue box 'Complete Inspectors Non-Compliance Report' then to the white box 'Enforcement and Compliance Policy.

The answer 'Yes recall' goes to the blue box 'Recall Implementation', which has a white box 'Food Emergency Response Manual' also pointing to it. The 'Recall Implementation' box goes to the white box 'SOP-FS1.8 Recall Follow-up', then to the blue box 'Follow-up with firm', then to the blue decision box 'Satisfactory'. The answer 'Yes satisfactory' goes to the white box 'No further action'. The answer 'No satisfactory' goes to the blue box 'Complete Inspectors Non-Compliance Report' then to the white box 'Enforcement and Compliance Policy.

Option 6 (Samples rated Unsatisfactory or Investigative) goes to the blue box 'Open Issue Management System for sample', then follows the same path as Option 5 (Inspections rated 1 or 2).

Acronyms for Figure 5

Acronym:

  • ND = No Decision
  • IMS = Issues Management System
  • INCR = Inspectors Non-Compliance Report
  • FERM = Food Emergency Response Manual
  • IS/IM = Inspection Supervisor, Inspection Manager
  • H&S = Health and Safety
  • ARC = Area Recall Co-ordinator
  • OFSR = Office of Food Safety and Recall
  • FDA/R = Food and Drugs Act and Regulations
6.8.1.1 Establishment Inspections rated 1 or 2/Samples judged I or U

For inspections rated 1 or 2 and samples judged investigative or unsatisfactory, the inspector must evaluate the results and determine if there is a violation and/or a potential health and safety concern with respect to product on the market. In other words, "is the consumer at risk?" The inspector should consult with CFIA stakeholders at the Area level to evaluate non-conforming/non-compliant establishment inspections and sampling results to develop appropriate enforcement options and strategies. The CFIA Area stakeholders include the relevant Area Program Specialist, the Area Recall Coordinator (ARC), the Inspection Supervisor or Manager (IS/IM) or designate, and any others as appropriate for resolution of the issue. The degree of consultation between stakeholders may vary depending upon the issue, from notification by e-mail to conference calls and meetings.

A food safety investigation should be conducted to ensure all aspects of the potential health and safety issue are addressed. Follow the guidance in the Food Safety Investigation Manual.

When a potential health and safety issue is identified, the inspector must take immediate enforcement action (e.g. detention) to limit the exposure to the potential health risk or to prevent further violation(s) of the FDA/R. If product(s) on the market pose a potential health and safety concern, the ARC should notify the OFSR. The OFSR coordinates the risk assessment and development of risk management options between Programs and Health Canada at Headquarters.

After consultation with Programs, consideration of the risk assessment and the program/policy advice, the OFSR will determine the need for a recall, and decide on the classification, depth and level of communication of the recall. Recall implementation is described in the FIRM.

When a potential health and safety issue is not identified or a recall is not warranted other enforcement actions may be required to address non-conforming/non-compliant inspections or sample results. See section 6.8.2 for guidance.

6.8.1.2 Establishment Inspections rated 3

For inspections rated 3, the inspector should evaluate the results of the inspection to determine if a potential violation of the FDA/R exists. If a potential violation is identified, appropriate enforcement action should be implemented. The inspector should consult with CFIA stakeholders at the Area level to evaluate non-compliant establishment inspections and develop appropriate enforcement options and strategies. The CFIA Area stakeholders include the relevant Area Program Specialist, the ARC, the IS/IM or designate, and any others as appropriate for resolution of the issue. The degree of consultation between stakeholders varies depending upon the issue, from notification by e-mail to conference calls and/or meetings. See Section 6.8.2 for guidance on enforcement action.

If it is determined that a violation does not exist, the firm should be informed of the reason for the rating and appropriate follow-up should be carried out with the establishment to resolve the non-conformance(s) to the assessment criteria. See section 6.8.3 for guidance.

6.8.1.3 Establishment Inspections rated 4

Send a letter to the firm with the inspection report. No further action is required.

6.8.1.4 Samples Judged Satisfactory

The establishment should be notified, however, no further action is required.

6.8.1.5 Samples Judged as No Decision

For samples judged as no decision, the inspector should discuss the results with the Area Program Specialist who will review the issue with the National Managers, Laboratory Services, if necessary.

6.8.2 Enforcement Actions

Enforcement action should be taken whenever a potential violation of the FDA/R is identified. The type of enforcement action will vary depending on the following factors;

  1. the seriousness of the violation,
  2. the seriousness of the health risk, and
  3. the compliance history of the regulated party.

Other factors may also be taken into consideration depending on the situation. Consultation between Operations, Programs, laboratories and others is essential in developing and implementing appropriate enforcement strategies for non-conforming or non-compliant samples and inspections.

Enforcement actions that may be taken include, but are not limited to:

  1. letter of non-compliance (see Appendix 3 of this Chapter for a template)
  2. seizure/detention
  3. prosecution

There is a direct relationship between the inspection rating and enforcement as shown in Table 4. Note that when establishments are assigned an inspection rating of 3, there may or may not be a violation of the FDA/R, and the health risk is always low. Where an establishment is assigned an inspection rating of 3 and there is a violation of the FDA/R, enforcement action must be initiated by the CFIA and corrective action must be undertaken by the establishment.

Table 4: Comparison of Inspection Ratings and Enforcement Action
Inspection Rating 1Inspection Rating 2Inspection Rating 3Inspection Rating 4
Violation of FDA/R? Yes Yes Yes or No No
Health Risk? High Moderate Low Remote
Enforcement Action Required? Yes Yes Yes or No No
6.8.2.1 Seizure and Detention

An inspector has the power to seize and detain food products pursuant to subsection 23 (1)(d) of the Food and Drugs Act. Seizure and detention is carried out in order to control the disposition of non-compliant products. However, seizure and detention is not mandatory. An inspector has the discretion as to when to apply this enforcement action. Regardless, it is recommended that inspectors detain products which they believe on reasonable grounds have contravened a provision of an Act or Regulations enforced by the CFIA.

SeizureFootnote 4 is the act or an instance of taking possession of property by legal right or process. Seizure action achieves the objective of obtaining maximum control of a violative product. It also meets the requirements of gathering and securing evidence for the purpose of initiating a prosecution under the FDA and the FDR. (Note that once an investigation is initiated, a warrant is required.)

DetentionFootnote 5 is the custody of property. An article detained by the CFIA remains the possession of the owner but may not be moved or otherwise altered without the consent of the CFIA. Depending on the purpose for seizure/detention, an inspector may choose either to leave the article in the facility where it was seized/detained or to remove it to a place appropriate for controlling the product (FDA section 25).

In practice, seizure and detention are not differentiated. Seizure and detention can be seen as actions taken in sequence: an article is seized and then kept under detention. In the IMFP and all other CFIA programs (with the exception of the Fish Program), seizure and detention are not performed separately (i.e. a product is always both seized and detained, not one or the other).

The power to seize and detain goods without referral to a Court is unusual and must be used with discretion. For the power of seizure and detention of any article under paragraph 23(1)(d), an inspector must believe on reasonable grounds that a provision of the Act or regulations has been contravened. Reasonable grounds to believe that a provision of the Act or regulations has been contravened may take the form of, but is not limited to, the receipt of a credible complaint, the results from inspecting a particular product, the review of documentation, or the test results of a particular product.

There is no prescribed expiry of seizure/detention under the Food and Drugs Act; however, an inspector who has seized /detained any article under the Act has an obligation to release it, in writing, once they are satisfied that the article complies with all the provisions of the FDA and regulations (FDA section 26). As well, although there is no prescribed expiry of seizure/detention, articles may only be seized/detained for what can be considered a reasonable length of time and should not continue indefinitely. Throughout the entire length of time the product is under seizure/detention, the CFIA has the obligation to continue to monitor the product and to impose on industry the requirement to deal with the detained article within a reasonable length of time.

In order to affect a seizure/detention, it is necessary to complete a detention form (see 8.4.1 for more details on this form). If a company wishes to move or destroy the detained products, the owner or representative must first seek approval from a designated CFIA inspector in order to do so and the form must be modified to reflect the authorized movement/destruction.

According to section 26 of the Food and Drugs Act, "an inspector who has seized any article under this Part shall release it when he is satisfied that all the provisions of this Act and the regulations with respect thereto have been complied with."

In order for a product to be released from detention, the owner has the following options:

  • bringing the non-compliant product into compliance by re-labelling or modification where possible,
  • exporting the non-compliant product out of Canada,
  • consenting to the CFIA inspector's request to forfeit ownership of the non-compliant product to the CFIA for destruction or disposal,
  • voluntarily destroying the product, where a CFIA inspector must witness the destruction of the product and make a note of this destruction in CFIA records (i.e., IMS).

Note that if and when the owner decides to voluntarily destroy or dispose of the affected product, a voluntary destruction form (see Chapter 8, Section 8.5) must be completed by the owner and submitted to the CFIA inspector.

6.8.3 Time Frames

Table 5 below summarizes the time frame required for corrective action related to the inspection rating. The inspection rating for an establishment always reflects the health risk, for example, a rating of 1 is always associated with a high health risk. The table also shows the criteria used to determine the inspection rating of an establishment.

The inspection rating ranges from 1 to 4, with 1 being the least conforming/compliant and 4 being the most conforming/compliant inspection. The colours in Table 5 match the health risk ratings in the Health Risk Estimation Model in Figure 1 of this Chapter. An inspection rating of 1 is red and matches the Critical health risk, which is also red, in the Model. Where the inspection rating is red ("1"), corrective action must be taken immediately.

Table 5: Timeframe for follow-up actions
Inspection RatingCriteriaFollow-up
1 at least one subsection rated Cr immediate
2 at least one subsection rated Ma, but no Cr within one month
3 at least one subsection rated Mi, but no Ma or Cr within six months
4 no subsection rated Mi, Ma or Cr not applicable

For cases of recurring minor non-conformances with the assessment standard, continue to follow-up with the regulated party. Consult with your IS/IM to develop a follow-up strategy.

Where a firm is unwilling or unable to achieve compliance with the food safety provisions of the FDA/R, refer to the Compliance and Enforcement Operational Policy for guidance on enforcement.

6.8.4 Review and Evaluation of a Corrective Action Plan

6.8.4.1 Purpose of a Corrective Action Plan

During their normal duties, such as inspections and follow-ups to recalls and complaints, inspectors identify non-conformities to the GPFHCL and/or the GIP. To address these non-conformities, the regulated party submits a CAP to the CFIA. The purpose of the CAP is to identify the root cause of the non-conformity, and to implement activities to address the root cause and prevent recurrence of the non-conformity.

If the non-conformity could result in a food safety hazard, the inspector must take immediate action to protect the consumer. This action may include a food safety investigation, product seizure/detention, sampling, or recall.

6.8.4.2 Contents of a CAP

The establishment should include the following items in the CAP:

  • A description of the non-conformity to be addressed.
  • The root cause of the non-conformity.
  • Action to be taken to address the root cause and prevent recurrence of the non-conformity.
  • The responsible person(s).
  • Timelines.
  • Activities that the establishment will take to ensure that the action taken addressed and corrected the root cause (verification).
  • A requirement for record-keeping.
6.8.4.3 Evaluation of a CAP
6.8.4.3.1 Description of the non-conformity

The establishment should fully describe the non-conformity and link it to the relevant sub-section(s) of the GPFHCL or the GIP. The description should clearly indicate a full understanding of the importance and potential repercussions of the issue and the reason for the non-conformity.

Example: During the cooking process, the temperature readings on the indicating and recording thermometers did not correlate. Corrective action was not taken to address the potential for undercooked product. This occurred because the thermometers were not calibrated at the required intervals. This issue relates to GPFHCL 2.1.4 Instrument Maintenance and Calibration Program.

6.8.4.3.2 Root Cause

The establishment should identify the root cause of the non-conformity by conducting an investigation. The root cause should be plausible and related to the non-conformity.

Example: The root cause of the non-conformity (from the example above) was inadequate operator training. The regular operator was absent for an extended period of time and the replacement was not trained on calibration. The supervisor was not monitoring thermometer calibration and deviation procedures at the required frequency.

6.8.4.3.3 Prevent recurrence

The establishment should identify action(s) that will fully address the root cause and prevent recurrence of the non-conformity. These actions may include process re-design, training, re-formulation, a new procedure or any combination of actions that will achieve the intended result.

Example: The operator will be re-trained on calibration procedures including deviations and documentation. The supervisor will be re-trained on verification and documentation.

6.8.4.3.4 Responsible Person(s)

The establishment will identify person(s) who are responsible to ensure that the CAP is implemented as intended. These persons should be in a position to take action if the CAP is not implemented.

Example: The plant manager is responsible to ensure that this CAP is implemented and verified and has full authority to take action if it is not.

6.8.4.3.5 Timelines

The inspector should review the timelines to ensure that they are realistic. For potential food safety issues, the timelines should be short.

Example: This CAP will be fully implemented within one week.

6.8.4.3.6 Verification of CAP

The establishment should describe the verification procedures taken to ensure that the CAP was implemented as intended and addressed the root cause of the non-conformity.

Example: The Plant Manager will verify that this CAP was implemented and that it addresses the root cause of the non-conformity by signing and dating this CAP.

6.8.4.4 Records

The establishment should maintain records related to the non-conformity, the development of the CAP and the verification and follow-up of the CAP. The records should be signed and dated by the responsible person and maintained on file.

6.8.4.5 CFIA Verification of the CAP

The inspector will conduct an on-site inspection to verify that the CAP was implemented as written and that it is effective in preventing recurrence of the non-conformity. This inspection should be conducted as soon as possible after the date of implementation of the CAP and within one month of the date of implementation. The inspection should include record review, on-site observations and interviews.

6.8.4.6 CFIA Reporting

If the CAP is the result of a MCAP inspection, the inspector will record the contents of the CAP in the corrective action request section of MCAP. The inspector will use the CAP section of MCAP to record the action detail on the CAP and the activities taken by the CFIA to verify the CAP. The inspector will also record on-site verification in this section of MCAP.

If the CAP is a result of a non-conformity identified through another activity (complaint follow-up, recall follow-up), the inspector will record the CAP and verification activities in IMS.

6.8.4.7 Sample of an Acceptable CAP
Inspection finding:

A manufacturer uses a preservative in their bottled oil with garlic and herbs. There is no other barrier in this product against bacterial growth. While observing the operator mixing the ingredients during an inspection on June 10, 2007, the inspector noted that the operator did not measure the amount of added preservative. He used a big scoop, sprinkled some preservative into the mixture and recorded the required amount on the formulation sheet. The company has a written procedure for addition of the preservative and a requirement for proper record keeping. When questioned, the operator explained that he has been making this product for so long that he instinctively knows how much preservative to add. The inspector measured the amount that the employee scoops five times and the results were inconsistent and did not meet formulation requirements.

The inspector took immediate action to address the food safety hazard and requested a CAP from the company to prevent recurrence of this food safety issue.

Company's CAP:

Non-conformity: Inconsistent level of preservative. Preservative level is a CCP. Section of GPFHCL: 1.6.1 Control of Preparation, Composition and Blending.

Root Cause: Employee formulating and mixing product was not adding a consistent or correct amount of preservative. Supervisor was not monitoring employee and verifying the addition of preservative. Preservative levels were not being monitored by analysis.

Corrective Actions: The employee will be retrained on the correct procedures for preservative addition including recording. The supervisor will be re-trained on employee monitoring and verification of CCPs. QC will sample and analyze product monthly to ensure that the correct amount of preservative is being added and will complete an analysis report that will be verified by the Plant Manager.

Date of completion: June 24, 2007

Responsible person: Sam Jones, QA Manager

Records: A training record will be created and verified by the QA Manager. Analysis reports will be created and verified by the Plant Manager.

Appendix 1: Inspection Equipment Cleaning and Sanitizing Procedures

Note: These procedures can be used as a guide. Check with manufacturer's instructions, your IS/IM, and OSH representatives for instructions specific to your equipment.

A) Cleaning and Sanitizing Procedure - Boots and Shoes

  • Thoroughly rinse boots or shoes.
  • Wash with an industrial liquid detergent according to package instructions, taking care to scrub the sole thoroughly to remove any encrusted dirt.
  • Rinse thoroughly with clean water.
  • Dry with paper towels.
  • Spray the boots or shoes with an industrial sanitizer according to package instructions.
  • Shoes: Let air dry.
  • Boots: Rinse with water to prevent yellowing.
  • Place in a clean plastic bag.

B) Cleaning and Sanitizing Procedure - Safety Hats

  • Rinse the safety hat with water.
  • Wipe with a paper towel.
  • Spray with a sanitizer (e.g.: 70% ethyl alcohol, etc.).
  • Let air dry.
  • Store in a plastic bag.

C) Cleaning and Sanitizing Procedure - Pocket Thermometers

  • Using a clean paper towel, wipe the thermometer clean of any traces of grease, protein or dirt.
  • Wipe the handle of the probe with a sanitizer.
  • Completely immerse the stainless steel portion of the probe in a cup containing the sanitizer.
  • After a few minutes, wipe with a paper towel or let air dry.
  • Store in a Whirl-Pak® sterile bag .
  • After use, rinse with water to remove any residues.

D) Cleaning and Sanitizing Procedure - Coolers and Ice Packs

Coolers may become a source of contamination if they are not properly cleaned and sanitized before use. Each inspector who borrows coolers is responsible for them. The coolers must be free of all foreign bodies (hair, dust, liquid, etc.).

  • Wash with an industrial liquid detergent according to package instructions, taking care to scrub thoroughly to remove any encrusted dirt.
  • Rinse the cooler (inside and outside) and the ice packs with water.
  • Spray with a sanitizer.
  • Wipe with a paper towel.

Appendix 2: Sample Cover Letter for Inspection Report

Canadian Food Inspection Agency
123 Address
City, Province
Postal Code

Date

Name of Establishment
123 Address
City, Province
Postal Code

Attention: Name of Establishment Contact, Title of Position

Re: Facility Inspection (date)

Para 1: Confirm inspection, location and date.

Para 2: Indicate report of inspection is attached and how to read the report.

Para 2: Outline any major or critical non-conformance/non-compliance issues and any actions taken during the inspection to address these issues.

Para 3: Request a corrective action plan for any subsections rated minor, major or critical and indicate a time frame for receipt.

Para 4: Advise the establishment that if any further information is required to contact you at your telephone number.

Yours truly,
Inspector's Name
Inspector's Title
Imported & Manufactured Food Program
Canadian Food Inspection Agency

Appendix 3: Example Letter Outlining Non-Compliance

Canadian Food Inspection Agency
123 Address
City, Province
Postal Code

Date
Name of Establishment
123 Address
City, Province
Postal Code

Attention: Name of Establishment Contact, Title of Position

Re: Non-compliant Sample or Inspection

Para 1: Describe the date that sampling occurred and the product(s) sampled and/or the date that the inspection occurred. State that the sampling/inspection was conducted under the authority of the Food and Drugs Act and Regulations.

Para 2: Describe the non-compliance and section of the Act or Regulations that it violates. Outline the responsibility of the establishment to ensure that the food offered for sale in Canada complies with the requirements of the Food and Drugs Act and Regulations.

Para 3: Describe any enforcement action that has been taken or summarize any corrective action that the establishment has agreed to take and the date by which it will be taken. If corrective action has not been discussed yet, a corrective action plan should be requested by a specific date. Note: the time frame given should be consistent with those in Table 1 in Section 7.9.2.

Para 4: Advise the establishment that if any further information is required to contact you at your telephone number.

Yours truly,
Inspector's Name
Inspector's Title
Imported & Manufactured Food Program
Canadian Food Inspection Agency

Chapter 7: Sampling

7.0 Scope

Product sampling and testing are part of CFIA's routine activities and are performed to identify potential hazards that may affect the quality and safety of food products that are available to consumers. Sampling may be conducted to assess human exposure to food-related risks, to monitor trends, and to support creation of standards and guidelines. Sampling is a means to validate compliance with the regulations, and can be used to support enforcement actions.

In the Imported and Manufactured Food Program, inspection-driven sampling, as described in the Work Specifications, is undertaken to support inspection findings. This means that samples may be taken at the inspector's discretion to verify inspection observations. Inspectors should follow the sampling instructions in the Work Specification with regards to sample size and number and samples should be submitted to the lab under the appropriate sample plan (FS Code). These sampling plans have been negotiated with the labs so it is important for inspectors to follow the directions for the number and timing of the sampling, if specified.

An inspector may also decide to sample a product to validate inspection findings related to the effectiveness of a company's food safety controls (outside the scope of the Work Specification) or to follow up on a specific food safety issue. Before taking an unplanned sample, an inspector should ask themselves 'what is the purpose for taking the sample?'. Is it to verify that an issue exists? Is it to link the product to an issue? Inspectors should consult with their Supervisor, the Area Program Specialist or the Laboratory to determine the necessity of analysis, and laboratory capability and capacity

7.1 Authority to Take Samples

An inspector's regulatory authority to carry out sampling functions is provided in the Food and Drugs Act (section 23(1)(a.1)). Prior to collecting a sample, the inspector should provide appropriate identification (e.g. badge, identification card, business card) to establish his/her authority to collect samples.

7.2 Protective Equipment

Protective items, when worn, serve to protect the inspector as well as minimize the potential for contamination of the sample, the product being sampled and the environment. Prior to entering an establishment, ensure that the protective items are clean and in suitable condition. The analysis, the type of sample collected and the environment in which the sample will be collected, will determine the protective items that will be required. Prior to collecting samples, the inspector should consult with his/her supervisor for the specific occupational health and safety (OSH) requirements. When collecting a sample, the following protective items (see table below) should be used as appropriate.

Protective Equipment

  • Protective footwear
  • Hard hat
  • Ear protection
  • Safety glasses
  • Lab coats/disposable coveralls
  • Sterile gloves
  • Hair/Beard restraints
  • Dust mask

Inspectors are expected to follow principles of good personal hygiene. This includes keeping hands, fingernails, hair, beard, clothing, and shoes/boots thoroughly clean. Prior to collecting a sample, personal effects and jewellery should be removed. Those that cannot be removed should be well secured (under clothes or gloves).

7.3 Sampling Equipment/Materials

Table 2 below outlines sampling equipment/materials that may be necessary for the collection, preparation, storage and transportation of a sample. Inspectors should ensure that these tools are part of their inspection kit and that they carry these tools with them to all inspections.

Sampling equipment/material

  • Sample Containers
    Sampling containers should be sterile, clean, dry and leak-proof. The capacity of the container should be adequate for the desired sample unit. (e.g., Whirl-Pak® bags, sterile cups, etc.)
  • Instruments for Opening Food Containers
    Instruments should be clean, dry and sterile. (e.g. Scissors, knives, box cutters, etc.)
  • Sampling Devices
    Sampling devices should be clean, dry and sterile. (e.g., Scoops, triers, forks, etc.) Pre-moistened sterile swabs, RODAC plates and/or Petrifilm™ plates may be required for environmental sampling.
  • Disposable Gloves
    Pre-packaged, non-latex sterile disposable gloves. Gloves with talcum powder should not be used since it may interfere with laboratory testing.
  • Shipping Containers
    Insulated container (e.g. Styrofoam cooler) of sufficient capacity should be used, when appropriate. Samples of foods normally stored at ambient temperature may be shipped in cardboard boxes
  • Packing Material
    • Suitable material should be used to secure samples within the shipping container.
      (e.g., crumpled newspaper, shredded paper, styrofoam nuggets, bubble wrap, etc.)
  • Coolants
    Plastic containers filled with refrigerant or well-frozen ice packs in re-sealable airtight plastic bags should be used. Dry ice may be used to keep frozen samples in a frozen state.

    Note:

    • 1. Exercise caution when handling dry ice
    • 2. Do not use ice as melting ice can result in sample contamination
  • Other equipment
    Document holders, notebooks, pencils/pens, sanitized thermometers, sanitizing agents (e.g. alcohol swabs), flashlights, markers, labels/tags, rubber bands and sealing tape, etc..

7.4 Aseptic Sampling

Accurate and defendable analytical results depend on proper sampling. If the samples are not obtained in a manner that ensures and protects the integrity of the sample, the results may become irrelevant.

It is always preferable to take intact, pre-packaged samples. However, if this is not possible, it is essential to use aseptic techniques, especially for microbiological and allergen analysis. This means using sterile tools and techniques and clean disposable gloves. If the units to be sampled are in an unclean area of the establishment, it may be necessary to take the units and move to a cleaner area to obtain the samples.

For aseptic sampling, use pre-sterilized plastic or metal tools. If pre-sterilized plastic or metal tools are unavailable, metal tools can be sterilized immediately before use with a propane torch. The metal tool should be cooled inside a sterile container before being used to collect samples. Soaking the metal tool with 70% alcohol and flaming off is also an acceptable method of sterilization.

If it is necessary to drill, saw, or cut the item being sampled (such as large frozen fish, cheese wheels, frozen fruit, etc.), use pre-sterilized stainless steel bits, blades, knives, etc. Sampling instruments with wooden handles are particularly susceptible to bacterial contamination and are difficult to sterilize. These types of instruments should be avoided.

7.5 Finished Product Sample Collection

7.5.1 Choosing the Sample Unit

When sampling finished product, choose consumer-ready packages whenever possible. In general, the sample should represent the product as it is purchased by the consumer. Take random samples, representative of the lot, from various locations (e.g., top, middle and bottom of pallet). Do not sample open, broken or damaged containers.

Do not sample products that are past the "use by" date or the "best before" date and collect samples so that they can be tested before the "use by" or "best before" date. This ensures that the samples collected represent an accurate profile of the product, as product should not be sold past the "best before" or "use by" date.

7.5.2 Number and Size of Sample Unit

The number and minimum size of each sample unit is indicated in the specification for each sampling plan and depends on the laboratory tests to be performed. Collect the sufficient number and size of each sample unit to enable the Laboratory to perform all analytical tests required. Consult the appropriate work specification for the required sample number and size. For samples taken due to a consumer complaint or investigation, consult the appropriate Area Program Specialist to determine the size and number of units to be taken.

7.5.3 General Principles of End Product Sample Collection

  • Wash and dry hands prior to sampling.
  • Conduct sampling aseptically for microbiological or allergen testing (i.e., in a manner to avoid contaminating the sample, the product, the environment and the inspector).
  • Wear sterile gloves, when necessary.
  • Take samples randomly, i.e., top, middle and bottom.
  • When sampling from master containers, choose the master containers at random; and from these, choose sample units at random.
  • Whenever practical, sample product in the original unopened container. Submit pre-packaged product as one, intact, sample unit.
  • When sampling containers are used, choose the appropriate size and avoid damage to the integrity of the sampling container.
  • Securely seal sample containers after filling so that they cannot leak or become contaminated during further handling.
  • Immediately label each sample unit with adequate information so that the unit can be matched to the sampling submission form. The markings must be legible and permanent.

7.6 In-line Sample Collection

7.6.1 Choosing the In-line Sample

The purpose of in-line product sampling is to determine the characteristics of the product at a specific point in the production process (e.g. a Critical Control Point). Collect in-line samples randomly by using a random number system (e.g., Random Number Table) to develop a selection system for the product that will be sampled. Choose each unit based on this predetermined frequency until the required number of sample units are collected. Do not intentionally sample a product that has been observed to have unsatisfactory characteristics.

7.6.2 Number and Size of In-Line Sample Unit

The number and minimum size of each in-line sample unit are indicated in the specification for each sampling plan and depend on the laboratory test to be performed. Collect a sufficient number and size of in-line sample units to enable the Laboratory to perform all analytical tests required. For samples taken due to a consumer complaint or investigation, consult the appropriate Area Program Specialist to determine the size and number of units to be taken.

7.6.3 General Principles of In-line Sample Collection

  • Wash and dry hands prior to sampling.
  • Conduct sampling aseptically (i.e., in a manner to avoid contaminating the sample, the product, the environment and the inspector).
  • Wear sterile gloves.
  • Sample randomly.
  • Whenever possible, have an assistant prepare the sterile container and /or bag to receive the in-line sample unit.
  • Securely seal in-line sampling containers after filling so that they cannot leak or become contaminated during further handling.
  • Immediately label each in-line sample unit with adequate information so that the unit can be matched to the sampling submission form. The markings must be legible and permanent.

7.7 Environmental Sampling

Environmental sampling is conducted to ensure that food products are not exposed to harmful environmental hazards during processing. A product can be contaminated by physical, chemical or biological hazards in its surrounding environment, which in turn may pose a health and safety risk to consumers.

Environmental sampling for the detection of microorganism(s) is employed to determine the presence of pathogens or other organisms on equipment and food contact surfaces. Depending on the microorganism(s) identified, its presence may indicate poor sanitation or microbial growth niches in a food establishment. Results of environmental sampling are important as they can be used by inspectors to identify potential deviations from good manufacturing practices for enforcement purposes and as an educational tool to inform establishment management where corrective measures are neededFootnote 6.

This section outlines techniques used to collect environmental surface samples for microbiological analysis. Similar techniques may also be used to determine the presence of allergens, chemical or physical hazards on surfaces. Other types of environmental sampling (e.g. water, air) may be useful under some circumstances. Specialized equipment may be required (e.g. air sampler). Consult with your Inspection Supervisor/Inspection Manager (IS/IM), Area Program Specialist, and laboratory personnel to determine the feasibility of these types of samples.

7.7.1 Preparation Prior to Taking the Sample

Take the following steps prior to sampling (where possible):

  • Draw a process flow chart, including the employee and product traffic patterns, and identify the location of the critical control point(s) (CPPs)
  • Identify sampling sites and target microorganisms or hazards and supplies needed for sampling. Sampling sites may include walls, floors, drains, equipment, food contact surfaces, etc.
  • Define the purpose for sampling, and plan sampling times accordingly; if information is needed regarding cleaning and sanitation conditions in the facility, it is recommended that samples be taken immediately after cleaning and sanitation, but before production. If information is needed regarding the microbiological conditions during production, then samples should be taken during production.
  • Arrange to have all necessary sterile equipment, supplies, clothing, etc., ready before going to sample.

7.7.2 General Principles of Environmental Sample Collection

  • Wash and dry hands prior to sampling.
  • Begin the sampling sequence in the finished product area first (least contaminated) and proceed through the potentially contaminated areas, finishing at the raw materials and receiving areas.
  • Conduct environmental sample collection aseptically (i.e., in a manner to avoid contaminating the sample, the product, the environment and the inspector).
  • Wear sterile gloves during environmental sample collection.
  • Label each environmental sample unit with adequate information so that the unit can be matched to the sampling submission form. The markings must be legible and permanent.

7.7.3 Environmental Sampling Techniques

The type of environmental sample will determine which method to use.

7.7.3.1 Surface Contact Sampling: Swab Method
  • Used to sample any surface up to 1 metre squared (m2).
  • Swab walls and floors (1 m2) using cloths.
  • Swab small food contact surfaces (100 cm2) using fabric-tipped swabs or sponges.
  • Wash and dry hands.
  • Aseptically open the container (Nalgene jar or Whirl-Pak® bag) containing the pre-moistened sterile swab. (Note: Each container should only have one sterile pre-moistened swab, cloth or sponge.)
  • Aseptically remove the pre-moistened sterile swab from the container using sterile gloves or tongs
  • Rub the swab firmly and thoroughly over the surface to be sampled.
  • For surfaces that are easy to swab (i.e., flat surface), rub five times (5x) from top to bottom and five times (5x) from left to right.
  • For surfaces that are difficult to swab (i.e., contour surfaces), rub as thoroughly as possible.
  • When collecting environmental samples from inside large equipment (e.g., milk drier), dress entirely in sterile clothing (e.g., head cover, facial hair cover, disposable overalls and overshoes).
  • Change sterile forceps and/or gloves after each environmental sample is collected.
  • Aseptically remove the sample and place it into a sterile Whirl-Pak® bag or sterilized bottle/container. Avoid touching the outside of the container with the swab.
  • The sample should be well marked, e.g. site location, conditions, etc.
  • Place the sample into your carry bag/cooler.
7.7.3.2 Dried Material Sampling
  • The sample size will be determined by the analysis required and/or the amount of sample available (e.g. dried material on food contact surface).
  • Select the environmental site for sampling.
  • Determine what sterile materials/tools will be needed to collect the sample, e.g., scraper, sweeper, tongs, forceps, spoons, etc.
  • Wash and dry hands.
  • Put on sterile gloves.
  • Aseptically remove the sample using sterile tools and place it into a sterile Whirl-Pak® bag or sterilized bottle/container.
  • The sample should be well marked, e.g. site location, conditions, etc.
  • When collecting environmental samples from inside large equipment (e.g., milk drier), dress entirely in sterile clothing (e.g., head cover, facial hair cover, disposable overalls and overshoes, etc.).
  • Change sterile tools (e.g. forceps, etc.) and gloves after each environmental sample is collected.
  • Place the sample into your carry bag/cooler.
7.7.3.3 Surface Contact Sampling: Replicate Organism Direct Agar Contact (RODAC) Plate method (for flat impervious surfaces)
  • Wash and dry hands.
  • While wearing sterile gloves, open the bag containing the RODAC plates and only remove the plate that will be used.
  • Remove the plastic cover and carefully press the agar surface to the surface being sampled.
  • Apply uniform pressure on the back of the plate so that the entire agar surface contacts the area being sampled.
  • Remove the RODAC plate from the surface being sampled and replace the cover onto the RODAC plate.
  • Using a new RODAC plate each time, repeat the above procedure until all environmental surfaces are sampled.
  • Immediately label each RODAC plate with adequate information so that the plate can be matched to the sampling submission form. The markings must be legible and permanent.
  • Stack the plates (e.g., 5 - 10) on top of each other and secure them with masking tape.
  • Put the piled RODAC plates in Whirl-Pak® bags or other suitable containers.
  • Seal bag tightly.
  • The sample should be well marked, e.g. site location, conditions, etc.
  • Place the sample into your carry bag/cooler.
  • Before going to the next sampling site, wipe off the surface that was sampled with a sterile wet cloth or sanitizer (e.g., Rocal, 70% ethanol).
7.7.3.4 Surface Contact Sampling: Petrifilm™ method (used for sampling irregular surfaces)
  • Wash and dry hands.
  • While wearing sterile gloves, open the bag containing the Petrifilm™ plates.
  • Remove as many plates as required, and hydrate them following the manufacturer's instructions.
  • Peel back the top film of the Petrifilm™ (gel will adhere to top film). Note: On occasion the gel may split (adhering to both the top and bottom of the Petrifilm™ when the top film is lifted). This splitting of the gel will not affect the performance of the product.
  • Contact the top film of the gel, not the bottom, to the surface being tested.
    Note: Avoid touching the growth area and bottom cardboard of the Petrifilm™ plate with any surface, including your hands, that is not being sampled.
  • Firmly rub fingers over the entire film side of the gelled area of the Petrifilm™ to ensure good contact with surface.
  • Lift the film from surface and rejoin the top and bottom sheets of the Petrifilm™.
  • Before going to the next sampling site, wipe off the surface that was sampled with a sterile wet cloth or sanitizer (e.g., Rocal, 70% ethanol)
  • Label each Petrifilm™ plate with adequate information so that the plate can be matched to the sampling submission form. The markings must be legible and permanent.
  • Put the Petrifilm™ plates in a Whirl-Pak® bag and handle with care.
  • Place the sample into your carry bag/cooler.

7.8 Post-sampling Procedures

7.8.1 Disposal of Garbage

Place used gloves and sampling material in a large plastic bag and dispose of them at the facility or take them with you. Collect multiple used tools (spoons, tongs, etc.) in a plastic bag and return them to the office or laboratory.

7.8.2 Transportation and Storage

Samples should be transported back to the office or laboratory as soon as possible after sampling. Transport samples in clean, dry containers. Refrigerated or frozen samples should be transported in coolers with a sufficient quantity of ice packs or dry ice to maintain sample integrity. If samples are not shipped immediately, store them in a secure location in the office. Refrigerated or frozen samples should be stored in either a refrigerator or freezer, as appropriate. Whenever possible, plan sampling activities so that samples are not stored or shipped over the weekend. In some cases, the laboratory will accept samples for analysis on the weekend. Contact the laboratory in advance to determine availability.

7.8.3 Completion of the Sample Submission Form (LSTS)

Inspectors should contact the laboratory in advance before submitting samples. Laboratory personnel will need to determine whether the requested testing is available, and which lab can accept the sample(s). The correct laboratory information is required to complete the sample submission form (LSTS).

It is critical that the information entered into the LSTS Sample Submission Form is accurate and complete. Directions for completing the sample submission form can be found at RDIMS 1857345 or in Section 8.3 of this Manual.

Refer to the work specifications for the appropriate LSTS sampling plan codes. For unscheduled or ad hoc samples, please contact your Area Program Specialist for sample plan codes.

7.8.4 Shipping

7.8.4.1 General shipping guidelines
  • Use clean, sturdy materials and containers for each sample or group of samples being shipped.
  • Choose transport coolers and containers that are appropriate for your sample size, the number of samples being sent (do not squeeze too many samples into one container) and are dry, leak-proof and sealable.
  • Do not ship different analytical product/sample types in the same transport cooler/container.
  • If more than one shipping container is required (due to sample size/weight), clearly indicate the container number and total number of containers on each box/cooler, courier waybill, and LSTS form. A copy of the LSTS form should be placed in each container.
  • Pack samples tightly to prevent shifting within the shipping container but not so tight that the samples may be compromised during transport. To achieve properly secured samples, use shredded paper, styrofoam nuggets, bubble wrap, or other suitable packaging material.
  • Before sealing the transport container, be sure that all completed submission documents are included. Pack LSTS submission forms in a plastic bag to protect them from moisture.
  • Tightly close and secure the transport coolers/containers.
  • After the samples have been picked up by the shipper, contact the lab to advise them that the samples are now in transit. Request that the lab contact you if the samples should not arrive within a specified period of time.
7.8.4.2 Temperature Control

Temperature abuse of samples is a serious problem that can result in sample rejection before testing. Refer to the following guidelines for refrigerated and frozen samples:

  • Transport frozen or refrigerated samples in insulated shipping containers of rigid construction.
  • Prior to packaging the sample units into the shipping container, measure the temperature of the sample and record it on the sample submission form.
  • For refrigerated samples, pack the shipping container with suitable coolant material to maintain the samples at a temperature between 0 - 7°C.
  • Do not allow coolant material, e.g. ice packs, to directly touch the samples. Use a layer of packaging material to avoid direct contact between the samples and the coolant material in order to prevent freezing.
  • For very large coolers, ice packs around the sides of the cooler or in between samples may be necessary to ensure consistent and adequate temperature.
  • During warmer months, prior to use, place shipping containers in a freezer long enough to chill them thoroughly. Include more ice packs in hot weather.
  • When dry ice is used to ship frozen samples, avoid direct contact with the samples. Use sufficient dry ice to keep the product frozen.
  • Dry ice should be handled subject to the Transportation of Dangerous Goods Act.

7.9 Official or Legal Sampling

7.9.1 What is Official Sampling?

An inspector may perform legal or official sampling when legal action is the anticipated follow-up action. It demands more complex procedures for sample collection, submission and laboratory testing compared to regular product sampling.

In order to ensure that testing results are admissible in court, official sampling procedures, as directed in subsection A.01.050 of the Food and Drug Regulations, must be strictly followed. Inspectors should seek legal advice prior to initiating official sampling.

7.9.2 Sample Number and Size

Consult with the Area Program Specialist prior to taking official samples. Generally, for extraneous material testing, select 24 individual containers with a minimum of 250 g or mL per container. For all other analyses, select 5 sub-samples with a minimum of 250 g or mL per sub-sample.

7.9.3 Obtaining the Sample

Refer to Subsection A.01.050 of the Food and Drug Regulations for complete details.

Where, in the opinion of the inspector, division of the product to be sampled would not interfere with analysis or examination, obtain a sufficient quantity of product for a triplicate sample and

  1. divide the quantity into three parts,
  2. identify the three parts as the owner's portion, the sample, and the duplicate sample and where only one part bears the label, that part shall be identified as the sample,
  3. seal each part in such a manner that it cannot be opened without breaking the seal, and
  4. deliver the part identified as the owner's portion to the owner or the person from whom the sample was obtained and forward the sample and the duplicate sample to an analyst for analysis or examination.

Where, in the opinion of the inspector, division of the procured quantity would interfere with analysis or examination

  1. identify the entire quantity as the sample,
  2. seal the sample in such a manner that it cannot be opened without breaking the seal, and
  3. forward the sample to an analyst for analysis or examination.

Always choose sub-samples randomly from the same lot. At no time should the inspector allow a company representative to choose the samples.

7.9.4 Sample Identification

Write the sample number on all containers/packages of samples submitted to the laboratory. Avoid obscuring portions of the labels that are significant, such as the list of ingredients, label claim statements, product and brand name, lot code, etc.

7.9.5 Shipping

  • Use a courier service that guarantees next-day delivery.
  • Ship samples at the beginning of the week.
  • Do not ship official samples with planned or ad hoc samples or other official samples.
  • Pack shipments in such a way as to minimize the potential for damage occurring in transit

7.9.6 Security

  • Between the time the sample is taken and the time it is shipped to the laboratory, take all the necessary precautions to ensure that the sample is kept in a controlled environment under lock and key.
  • Seal the sample with yellow CFIA Official Seal tape in a manner that it cannot be opened without breaking the seal.
  • Clearly write "Official Samples" on the box to ensure that receiving laboratory staff take proper precautions to protect the samples and ensure validity in court.

7.9.7 Documentation

Complete the sample submission form and include a signed copy of the form in the shipping box.

7.9.8 Laboratory Contact Information

Consult the appropriate laboratory contact prior to taking official samples, to ensure that the laboratory is able to handle the samples. It is important to let the laboratory contact know when the samples will arrive, the number of samples that will be shipped, and the analyses to be performed.

7.10 Analysis and Interpretation of Results

When testing is completed, the laboratory analyst enters the final results with comments into LSTS. Once authorization is complete, a notification of the report of analyses is automatically sent via e-mail to the inspector who sent the sample.

Table 1 below outlines the four possible sample test result outcomes: Satisfactory (S), Unsatisfactory (U), Investigative (I) and No Decision (ND). It is important to remember that the sample assessment is not directly related to compliance.

Table 1: Sample Assessments
AssessmentCommentsFollow-up Action
Satisfactory N
Investigative Determine if there is a potential health and safety issue and/or a violation Y/N
Unsatisfactory Determine if there is a potential health and safety issue and/or a violation Y
No Decision Can be a result of the sample being unfit for analysis, no assessment criteria, pre-determined decision Y/N

In most cases, consultation with the Area Program Specialist can assist the inspector in determining the most appropriate follow-up action. See Chapter 6, Section 6.8 for further instructions.

7.11 Instructions for Tracking Sample Follow-up in IMS

7.11.1 Creating an Issue

The following fields are mandatory:

  • Subject Line: Enter the "Year-Project Code-Sample" with no spaces (e.g."2012 WS_CONF-Sample"). Note: Correct coding is very important to enable tracking of non-compliance.
  • Area of Concern: There can be multiple areas of concern. Select all that apply.
  • Illness/Allergic Reaction/Injury Reported: Select "Yes" or "No"
  • Priority: Usually "urgent" would be selected.
  • Trigger Type: MCAP Inspection
  • Occurred On: Enter the date that the sample result was received.
  • Area/Region/District: Enter the Area/Region/District in which the manufacturer/importer is located.

7.11.2 Product Screen

The following fields are mandatory to be able to save a product: Commodity Group/Class, Commodity Subclass, Product, Brand Name, Common Name, Source, Country of Origin, Size, UPC, Code on Product. Enter complete and accurate information.

If information such as the UPC is not available, enter N/A in the field.

7.11.3 Client Screen

  • Enter the name of the establishment/facility that manufactured/imported the sample.
  • If the establishment is not in the client data base, add the establishment.
  • If the client data base is incorrect, update the information.
    • Note: do not make any changes to registered establishments in the database.
  • Select the product associated with the client.

7.11.4 Samples Screen

  • Use this screen to link the LSTS report for the sample to the IMS.
  • Go to the 'Samples' tab and click 'Add'.
  • Under 'Type' choose 'CFIA'.
  • Click on 'Search LSTS' on the left side of the screen.
  • Enter the LSTS number under 'System ID'. For other query types, see the IMS User Manual.
  • Click on 'Search'. Select the LSTS report from the table and click 'OK'.
  • Click on 'Save' to link the LSTS to the IMS.

7.11.5 Task Activity Log Screen

  • Enter all activities taken to address the issue.
  • This is to be a summary of the actions taken and should offer the reader a complete picture of the issue.
  • After a Task/Activity record is added to the issue it cannot be modified or deleted, therefore, it is important to carefully consider the information being captured.
  • Do not cut and paste the LSTS report into a Task Activity. Use the Samples screen as directed above.

7.11.6 Corrective Actions Screen

  • Document all compliance actions taken with a facility and/or product on this screen.
  • If the investigation results in a recall, use the same issue to record actions taken regarding the recall.
  • Note: This section must be completed even if no corrective action was required.

7.11.7 Completing the Issue

  • Prior to closing your assignment and completing the issue, review the information to ensure that it is complete and accurate.
  • Enter a deviation and a conclusion on the main screen. The conclusion should be brief, accurate and complete.

Chapter 8: Forms

8.0 Scope

Documentation plays an important role in carrying out the CFIA's various activities. The CFIA has a various forms to collect information on regulated parties or on products. These forms facilitate inspection, sampling and enforcement activities. Filling out these forms properly provides structure and consistency in the way the Agency conducts its business.

A story illustrating the importance of properly filling out forms:

"An inspector conducted an inspection at a medium-size maple syrup establishment that caters to local clients and grocery stores. As part of the inspection, he collected a sample and sent it to a CFIA lab for lead testing. The sample result came back unsatisfactory, prompting the inspector to put the remaining lot of maple syrup under detention. A few weeks went by without hearing from the company with an action plan proposal, and so the Inspector decided to visit the establishment to follow up on the detained product. Upon arriving at the establishment he found that the company had broken the detention by continuing to sell the affected product. The inspector decided to complete an INCR and submit the completed form and other relevant documents (e.g., copy of detention form, etc.) to the area EIS for possible prosecution. EIS reviewed the documents, but decided against pursuing a legal action due to technical errors on the detention form. The inspector misquoted the section of the Act related to the power of an inspector to detain the product. Instead of citing section 23(1)d, the inspector wrote 23(d). Further, not all copies of the completed form had original signatures. EIS indicated that the case would only be dismissed by court due to these seemingly trivial errors."

This chapter outlines the different forms that IMFP inspectors may use related to inspection activities and provides information on how and in which situations these different forms are used.

Table 1 at the end of this chapter provides information and links on where to find each individual form.

8.1 Food Establishment Profile

The Food Establishment Profile is the form used by IMFP inspectors to gather key information about an establishment. The form is used to gather information on a new company, or to update an existing profile of a company where there have been changes in their organizational structure or operations. This form is usually completed or updated at the beginning of the inspection process, during the opening meeting.

The Food Establishment Profile form captures the following information: establishment name, address and contact information; major officers or resource persons; hours of operation; products (production per annum and type of product) and area of distribution; product coding; operations and processing; quality control; and compliance history.

Inspectors should keep updated company profiles on file at their respective CFIA office to be used a tool for inspection planning. For instance, prior to conducting an inspection, an inspector should review the establishment profile so that he or she becomes familiar with the company's management and operations.

Inspectors must be aware of and protect the confidentiality of the information gathered on this form. Because the profile contains significant, third-party information, care must be taken to keep this information secured.

8.2 Inspection Worksheets

Before conducting inspections, inspectors should print the appropriate inspection worksheet, either the General Principles of Food Hygiene Composition and Labelling (GPFHCL) or Good Importing Practices for Food (GIP) worksheet, using the MCAP system. These worksheets serve as a tool that inspectors can use to record observations or findings during the course of an inspection.

In the event that the MCAP system is down, and a form is needed to conduct an inspection, inspectors may use the Word version of the worksheets. Links to both the GPFHCL and GIP inspection worksheets are available in Table 1.

Inspection findings gathered on these worksheets are to be entered into the MCAP system within two weeks of completing an inspection.

8.3 Sampling Forms

8.3.1 Official Sample Form (CFIA/ACIA 0072)

Official or legal sampling applies to specific conditions where legal action is the anticipated follow up action. It demands more complex procedures for sample collection, submission, and laboratory testing to ensure that testing results are admissible in court. It is important that inspectors seek legal advice prior to initiating official sampling.

When collecting official samples, inspectors must use form CFIA/ACIA 0072, Sample Portion. Each form has a unique, pre-printed number on the upper right hand corner of the form, and comprises of 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 samples using CFIA/ACIA 5112 Official Seal (i.e., CFIA tape).

Note that the form is not available through Desktop e-Forms, and must be ordered through the Forms Catalogue on Merlin.

For more information on official sampling, refer to Chapter 7 of this manual.

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

The Receipt for Sample Taken form, or form CFIA/ACIA 4168, is used by inspectors when collecting product samples (including official samples) from an establishment for the purpose of CFIA laboratory analysis. This form is required for any food item or products that are actually removed from the premises. 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.

8.3.3 Food Product Sampling Submission Form (CFIA/ACIA 5164)

The Food Product Sampling Submission form is available through the Laboratory Sample Tracking System (LSTS). Inspectors must complete this form prior to submitting a sample to the CFIA laboratory for analysis. In addition, inspectors must ensure that a copy of the completed form accompany the shipment of the sample to the laboratory. Refer to section 9.3 of this Manual for more information on LSTS.

8.4 Detention and Release Forms

8.4.1 Notice of Detention Form (CFIA/ACIA 3256)

When detaining a product, an inspector must use form CFIA/ACIA 3256, Notice of Detention (see 6.8.2.1 for more details on seizures and detentions). The form has a unique, pre-determined number located on the upper right hand corner and comprises of quadruplicate copies and a pink detention tag.

Once the form is completed, both the inspector and owner or representative of the company must sign the form. Note that all copies (4 copies) require original signatures. An inspector must then hand a copy of the notice to the person in charge of the product, and explain its contents. Emphasis should be given to the warning statement on the form which states:

"Except with written permission of an inspector, no person shall move, sell, alter or dispose of any thing under detention or remove or alter the detention tag."

It is important that the detained products be properly labelled and identified using the "Under Detention" tag and official CFIA tape, and be segregated from other products.

The Notice of Detention form is available through Desktop e-Forms. When using Desktop e-Forms, the form must be printed in four (4) copies. In order to print the "Under Detention" tag which is to be attached to the detained product(s), an inspector must insert the form CFIA/ACIA 3256L into the printer prior to printing that page. CFIA/ACIA 256L may be ordered also through the Forms Catalogue. 3256L is a special label paper designed for use with this form.

Alternatively, an inspector may order the form in a book format through Forms Catalogue on Merlin.

8.4.2 Release from Detention Form (CFIA/ACIA 3257)

According to Section 26 of the FDA, an inspector must release the product when it has been brought into compliance and issue form CFIA/ACIA 3257, Release from Detention Form. The inspector must obtain the owner's signature on the Release from Detention form before releasing the product.

Note: Do not release the product from detention if it must be kept for any reason (e.g. for on-going investigations, for evidence, etc.).

8.5 Voluntary Destruction Form

CFIA inspectors have traditionally employed voluntary destruction or disposal as an enforcement option to deal with products that are not compliant with the Food and Drugs Act and Food and Drug Regulations. Regardless of whether or not a non-compliant product is under seizure and detention, the owner or legal agent may opt to destroy the product. The owner must decide to take this option voluntarily, without the prompting or coercion by the CFIA inspector.

If and when the owner decides to voluntarily destroy or dispose of the affected product, the CFIA inspector should obtain a letter (i.e., using voluntary destruction form) from the owner stating that he or she is destroying the product on his or her own accord. Further, an inspector must supervise/witness the destruction of the product in question.

The voluntary destruction form can be found in Annex 1 at the end of this Chapter.

8.6 Inspector's Non-compliance Report

The purpose of the Inspector's Non Compliance Report (INCR), or form CFIA/ACIA 5046 (long form) and form CFIA/ACIA 5393 (short form), is to standardize enforcement reporting and serve as an investigative tool to assist Inspectors in identifying relevant information and evidence that should be collected when reporting incidents of non-compliance.

When conducting inspections, inspectors should carry hard copies of the INCR form so that it is available when needed. The INCR report should be used to report significant incidents of non-compliance and should be forwarded to your Inspection Manager or Supervisor and a copy should also be sent to your area Enforcement and Investigation Services (EIS) office. EIS will use the report to open files and store the information in the National Enforcement Tracking System (NETS).

8.7 Forms Catalogue

The Forms Management Section of the CFIA has developed a Forms Catalogue on Merlin to allow Agency staff to obtain a listing of all forms, or to search for a form by its title or number. Further, the catalogue allows staff to place an order for that form, if it is available in either a Print-on-Demand (POD) or as a Stocked Form. Instruction on how to use the catalogue is available in Annex XII or at the following link: Forms Catalogue - (Internal access only)

Table 1: Where to find a form
Form NameLocation
Food Establishment Profile RDIMS 4048816
GPFHCL Inspection Worksheet RDIMS 4117382
GIP Inspection Worksheet RDIMS 4116915
Official Sample Form (0072) Forms Catalogue
Receipt for Samples Taken (4168) Desktop e-Forms
Food Product Sampling Submission Form (5247) Desktop e-Forms
Notice of Detention Form (3256) Desktop e-Forms
Release from Detention Form (3257) Desktop e-Forms
Voluntary Destruction Form Inspection Manual, Chapter 8, Annex 1
Inspector's Non-compliance Report (5393) Desktop e-Forms

Most forms can also be accessed via the Forms section on the IMFP Merlin page.

Annex 1: Template Letter for Voluntary Destruction of Product

Owner's Letterhead
Address
City, Province
Postal Code

Attention: CFIA

This is to certify that the undersigned duly authorized officer has decided to voluntarily dispose of the following merchandise, situated at:

Le soussigné représentant dûment autorisé certifie par la présente qu'il a pris la décision de disposer volontairement de la marchandise suivante, située à:

image - information to fill of the Letter for Voluntary Destruction of Product. Description follows
Description of the fillable part

List and description of articles

  • Name and title
  • Signature
  • Date
  • Act or regulation, section(s) violated
  • Reason
  • Site and method of disposal
    • Date

Chapter 9: Reporting, Tracking and Reference Systems

9.0 Scope

Chapter 9 of this manual covers the reporting, tracking and reference systems used by Imported and Manufactured Food Program (IMFP) Inspectors that are related to inspection activities. This chapter provides information on the following systems:

  • Multi-Commodity Activities Program (MCAP)
  • Self-Contained Personal Reporting and Inspection Tool (SPRINT)
  • Laboratory Sample Tracking System (LSTS)
  • Issues Management System (IMS)
  • Import Retrieval System (IRS)
  • Automated Import Reference System (AIRS)
  • Client Management System (CMS)
  • Records/Documents Information Management System (RDIMS)

These systems are important tools in capturing and storing pertinent information related to the Agency's various activities. The data collected by some of these systems may be manipulated to generate useful reports from which valuable information can be derived. Information may be useful in determining the effectiveness of program strategies, and may influence the future direction of the program activities and of the Canadian Food Inspection Agency (CFIA) as a whole.

It is worth mentioning that the quality of information being captured and stored in these systems dictates its usefulness and value. For instance, inaccurate or incomplete data may skew results or conclusions that are derived from that data. Inspectors should keep in mind the following key elements that influence the quality of not only the information stored in, but also of the reports derived from, any of these systems.

Accuracy – information must be factual, accurate, substantiated and not be influenced by personal bias.

Completeness/ Thoroughness – information must be complete, providing all pertinent details or elements.

Clarity – information is written and presented in a manner that is clear, logical and easy to understand.

Timeliness – data should be entered into a reporting system in a timely manner. Whenever possible, information should be entered into a system as soon as an activity is completed.

9.1 Multi-Commodity Activities Program

The CFIA's Multi-Commodity Activities Program (MCAP) is a computerized inspection reporting system used by the IMFP to record and report on inspection data for inspections related to food safety issues. IMFP Inspectors use this system as a tool to plan for, record and report on inspections and to assist them during inspections and related follow-up activities for food safety. Inspectors may generate an inspection overview report, an inspection history report, inspection worksheets, an inspection report and a corrective action plan (CAP) report for the purposes of planning, reporting and conducting inspections.

In case of planning and reporting:

From the Overview screen, Program and Operations Staff can search, review and print out information about inspections that have been done by area. An Inspection Overview Report can be printed. This report will show the search results by company name, name of inspectors, inspection numbers, start date, close date, inspection rating, status, work specification, level of trade, inspection standard and inspection reason.

From the Inspection screen, an Inspection History can also be printed. This report contains information about any past inspections conducted at a given firm. This includes the company name, address, inspection numbers, start date, close date, inspection rating, status and name of inspectors.

For conducting inspections:

From the MCAP screen, the Inspection Worksheet can be printed by inspectors for guidance and note-taking during the inspection. The Inspection Worksheet contains the principle statement and inspection criteria for each selected sub-section of the standard chosen for the inspection, dates, establishment name , address, a space for writing inspection comments, area(s) of concern and rating(s). When an inspection is completed, findings should be entered into MCAP within two weeks of the inspection date. An Inspection Report is then generated and delivered to the company in person or by mail. Any follow-up action related to areas or subsections where corrective action is required is also captured in the MCAP system.

For follow-up action:

From the MCAP screen, a Corrective Action Plan (CAP) Report can be printed by inspectors. This document contains general information about the inspection, as seen in the Inspection Report and all information on all CAPs associated to a given inspection. This report can be used internally by the inspector or can be sent to the manufacturer or importer.

Inspectors must use MCAP for all IMFP inspection activities related to food safety.

IMFP HQ uses the MCAP system as a tool to produce Inspection Summary Reports on a quarterly and annual basis for all IMFP inspections recorded in MCAP, and to respond to Access to Information Privacy (ATIP) requests, Media Queries, requests from the Minister's office (MinO), Auditor General, and other parliamentary requests.

For information on how to use the MCAP system, please refer to the MCAP User Manual. (This document is intended for internal use. CFIA staff can access this document using RDIMS number 3318547.) This manual is also available on the IMFP Merlin page.

9.2 Self-contained Personal Reporting and Inspection Tool

The Self-contained Personal Reporting and Inspection Tool (SPRINT) is a computerized inspection system which permits both positive and negative reporting of inspection findings for labelling inspection activities, in order to produce reliable data and trending information related to a specific work specification.

IMFP Inspectors use the SPRINT system to view and input detailed inspection information regarding the labelling of both manufactured and retail foods. Managers also use the system to view up-to-date information on inspections and employee time to help plan their budgets and schedules and track progress; while specialists/program officers use this system to view up-to-date compliance information to help develop National and Regional work plans and to respond to Access to Information and Privacy (ATIP) requests, Media Queries, minister office (MinO), Auditor General, and other parliamentary requests.

For information on how to use the SPRINT system, please refer to the SPRINT User Manual. (This document is intended for internal use. CFIA staff can access this document using RDIMS number 2417913.) This manual is also available on the IMFP Merlin page.

9.3 Laboratory Sample Tracking System

The Laboratory Sample Tracking System (LSTS) is another computerized system which the Agency uses for tracking its sampling and analysis activities. It serves as a repository for sample submissions and their corresponding analytical results.

Prior to submitting samples to CFIA laboratories, inspectors must complete the sample submission form using LSTS. Inspectors are required to provide information on the sample, the source of the sample and the name of the submitter/inspector. A copy of the completed form must accompany the sample during shipment to the lab.

The LSTS User Services User Guide is available at RDIMS 1857345 (This document is intended for internal use).

Inspectors have three (3) ways of obtaining laboratory testing results. They are described below.

9.3.1 Reports of Analysis (ROA)

9.3.1.1 Default e-mail Notification

The Inspector who submitted the sample and the laboratory analyst who "authorized" the results of the analysis will receive an automatic default e-mail notification when results are finalized.

9.3.1.2 LSTS User Services Report of Analysis Utility

The Report of Analysis (ROA) Utility is a customized, web-based application used to retrieve laboratory results. In order to use the ROA Utility, an inspector must have one of the following pieces of information available: System ID, Reference No., or Laboratory No.

Information on using LSTS ROA Utility is available on Merlin in the LSTS User Services User Guide under "Using the Reports of Analysis (ROA) Utility".

9.3.2 LSTS User Services Personal E-mail Notification Management (PENMAN)

PENMAN is a web-based application that allows registered users of LSTS to subscribe to an e-mail notification process for obtaining results of laboratory testing as soon as they become available.

Once an inspector is registered with PENMAN, any time that lab results that match the chosen criteria (e.g., sampling plan, province, etc.) are "authorized", he or she will receive an e-mail notifying that the results are available, with a link to LSTS User Services and a number identifying the Report of Analysis. Note that an e-mail notifying that results are available is automatically sent to the inspector who took the sample, the person who submitted the sample (if this is someone other than the inspector), and the laboratory person who authorized the results, regardless of whether these people are registered with PENMAN or not.

Information on registering and using PENMAN is available on Merlin in the LSTS User Services Guide under "Using Personal E-mail Notification Management (PENMAN)".

9.3.3 Submission Status Inquiry (SSI)

Inspectors may check the status of a sample submission any time after a sample has been submitted, using the LSTS Submission Status Inquiry tool. Inspectors may use this tool to search for sample submissions by selecting one of the search options provided (e.g., Sampling Plan, Country of Origin, Submitter, LSTS etc.). With the exception of Laboratory No., System ID and Reference No., searches using other parameters are limited by the date selection field (i.e., up to 12 months).

Note: All LSTS user services can be accessed through the LSTS User Services Login Screen on Merlin.

9.4 Issue Management System

The Issue Management System (IMS) is a centralized, national database system used by Agency staff to document, track, and communicate information relating to the investigation and resolution of food related issues including food recalls. The system allows users to determine the status and progress of an issue from initiation to final conclusion. IMS facilitates informed and effective decision making, and allows Agency staff to identify trends in food issues.

Although IMS is not directly related to inspection activities, a link between the two exists. An inspector may identify a potential food safety issue or concern during the course of an inspection, which may initiate a food safety investigation. Further, an unsatisfactory laboratory result for a food sample collected during an inspection may require an investigation. In both cases, the use of IMS would be necessary to keep track of any follow up investigation or activities related to an issue. Conversely, a complaint or recall reported in IMS may require a follow-up involving an inspection.

For information on how to use the IMS, please refer to the IMS User Manual, RDIMS 1599661 (This file must be viewed in native format. Due to large document size, the time to load may be lengthy) or Issues Management System User Manual RDIMS 1599661 | PDF (1,473 kb) - (Internal access only). This manual is also available on the IMFP page of Merlin.

9.5 Import Retrieval System

The Import Retrieval System (IRS) is a computer program which sorts information and produces and prints reports from data which the CFIA receives on a weekly basis from the Canada Border Services Agency (CBSA).

This database is a listing of every shipment imported into Canada for all commodities regulated by the CFIA. The data includes key elements from each shipment such as the name and address of the importer, transaction number, the product name, the corresponding Harmonized System (HS) Code number, port of entry, country of origin, and volume of the shipment as well as several other pieces of import data.

The IRS enables CFIA staff to have access to key import information on Canadian importers and the products that they import. The most current data in the system is about one week old (goods have cleared CBSA about one week prior to CFIA receiving the information). An inspector in the IMFP would often use this system to search for products imported into their area or importers which may fall within the scope of an import-related work specification.

Import Retrieval System (IRS) – User Manual - RDIMS 355959 (Internal access only)

9.6 Automated Import Reference System

CFIA-AIRS is a user-friendly, searchable database of CFIA import requirements. Through a series of questions and answers, the system will lead you to information on all CFIA import requirements for specific commodities.

Importers with questions regarding requirements for potential imports can be referred to AIRS, as the system is available from the CFIA's external website.

The link to AIRS is below:

Automated Import Reference System

9.7 Client Management System

The Client Management (CMS) is a software application that has been designed to process LSTS store information received from CFIA clients. The CMS provides a means of tracking client registration, licensing, accreditation or recognition data by program area. This application is linked to IMS, LSTS, and MCAP systems.

When Inspectors utilize the search/add client function within IMS, LSTS and MCAP, they are accessing CMS. Inspectors need to be cautions when adding a new client to the CMS. For many companies, there could be a number of entries for the same company in the CMS. To avoid introducing more versions of the same company unnecessarily, if the company has been inspected before, inspectors must make sure to use the same client entry in the CMS. If there is a Record Number generated, use it to select the correct version of the client.

9.8 Records/Documents Information Management System

All information created, sent and received in the course of an employee's duties at CFIA, is the property of the Government of Canada and is to be treated as an asset of the Agency. RDIMS is a tool to assist employees in managing their information. RDIMS manages information throughout its life cycle, from its creation to disposal.

It is important for inspectors in the IMFP to understand the importance of this information management system and be able to effectively use it to name, store, access and share information pertaining to their program.

For more information on RDIMS, the RDIMS User Reference Manual is available on the IMFP page of Merlin, under Technical Training Materials and Manuals / Information Systems, or CFIA staff can access this document using RDIMS 2323210.

9.8.1 RDIMS Naming Conventions

A document entitled Using RDIMS to Effectively Manage Records Generated in Relation to Work Specifications was created in order to provide guidance to IMFP staff on naming conventions in RDIMS when work specification documents and reports are created.

Following the conventions set out in this document will allow IMFP staff to search and retrieve documents more efficiently. To allow for different levels of search capability, an effort has been made to simplify the naming conventions while still providing required information in the document title.

This document is available on the IMFP page of Merlin, or CFIA staff can access this document using RDIMS 3191242.

Chapter 10: Calculations

10.0 Scope

This chapter provides examples of calculations that inspectors may need to perform while conducting inspections and complaint investigations. In addition to a handy conversion chart, examples of calculations used in the following situations are included:

  • addition of chemicals to achieve concentrations in parts per million (ppm)
  • addition of vitamins A and D to fluid milk
  • degree-hours for fermentation of ready-to-eat meats
  • calculations for common food additives (nitrate, nitrite, sulphur dioxide)
  • calculations for allergens in finished goods

10.1 Metric/Imperial Conversion Tables

Table 1: Length
Starting UnitFormulaDestination Unit
inches (in) Multiply by 2.54 centimetres (cm)
centimetres (cm) Divide by 2.54 inches (in)
feet (ft) Multiply by 0.305 metres (m)
metres (m) Divide by 0.305 feet (ft)
yards (yds) Multiply by 0.914 metres (m)
metres (m) Divide by 0.914 yards (yds)
mile (mi) Multiply by 1.609 kilometres (km)
kilometres (km) Divide by 1.609 mile (mi)
Table 2: Area
Starting UnitFormulaDestination Unit
square inches (sq in) Multiply by 6.452 square centimetres (cm2)
square centimetres (cm2) Divide by 6.452 square inches (sq in)
square feet (sq ft) Multiply by 0.092 square metres (m2)
square metres (m2) Divide by 0.092 square feet (sq ft)
Table 3: Volume
Starting UnitFormulaDestination Unit
cubic inches (cu in) Multiply by 16.388 cubic centimetres (cm3)
cubic centimetres (cm3) Divide by 16.388 cubic inches (cu in)
Imperial fluid ounce (imp fl oz) Multiply by 28.413 millilitres (mL)
millilitres (mL) Divide by 28.413 Imperial fluid ounce (imp fl oz)
US fluid ounce (US fl oz) Multiply by 29.66 millilitres (mL)
millilitres (mL) Divide by 29.66 US fluid ounce (US fl oz)
Imperial (imp gal) Multiply by 4.546 litres (L)
litres (L) Divide by 4.546 Imperial (imp gal)
US gallon (US gal) Multiply by 3.785 litres (L)
litres (L) Divide by 3.785 US gallon (US gal)
Table 4: Weight
Starting UnitFormulaDestination Unit
ounces (oz) Multiply by 28.38 grams (g)
grams (g) Divide by 28.38 ounces (oz)
pounds (lbs) Multiply by 0.453 kilograms (kg)
kilograms (kg) Divide by 0.453 pounds (lbs)
tonne (t) Multiply by 1000 kilograms (kg)
kilograms (kg) Divide by 1000 tonne (t)
(metric ton)
short ton Multiply by 907.185 kilograms (kg)
kilograms (kg) Divide by 907.185 short ton
foot-pounds Multiply by 1.356 Newton-metres (N-m)
Newton-metres (N-m) Divide by 1.356 foot-pounds
Table 5: Temperature
Starting UnitFormulaDestination Unit
°Fahrenheit F - 32) × 5/9 °Celsius
°Celsius C × 9/5) + 32 °Fahrenheit

10.2 Concentration in parts per million (ppm) of Substances in Water

It may be easier to understand the concept of parts per million (ppm) if we consider that one ppm is one part out of one million parts. For example, one gram in one million grams or one millilitre out of one million millilitres:

1 g / 1,000,000 g
or
1 mL / 1,000,000 mL
or
1 part / 1,000,000 parts

It is also commonly understood that one ppm is equal to 1 mg of solute in 1 L of solution:

1 mg solute/1,000 mL solution
or
1 mg solute/1 L solution
or
0.001 g solute/1 L solution
or
0.000001 kg solute/1 L solution

For the sake of comparison:

  • 1 mg solute/L solution = 1 ppm
  • 4.546 mg solute/imp gal solution = 1 ppm
  • 3.785 mg solute/US gal solution = 1 ppm

Note: assume that 1 millilitre of water is equal to 1 gram of water (1 mL H2O = 1 g H2O).

To determine how much of a chemical must be added to water to reach a desired concentration in parts per million, the following information is required:

  • Desired concentration of final solution
  • Final volume of solution
  • Concentration or amount of active ingredient/chemical in substance/chemical being added to the water

Once you have determined the required information, use the following formula:

  • Amount of solute required = [Desired final concentrations of active ingredient in ppm (mg active ingredient/L) × Total volume of tank (L final volume)] / Concentration of solute in ppm

10.2.1 Diluting sodium hypochlorite (bleach) solutions

Example:

Gravelle's Veggies-to-Go wants to sanitize their inspection tables in water containing 200 ppm of chlorine (Cl). How much standard bleach should be added to his 1000 litre sanitizer tank?

What we know:

  • Final volume of solution = 1000 L
  • Desired ppm of final solution = 200 ppm

We will need to determine the amount of chlorine in standard bleach. Commercial bleach is a solution of sodium hypochlorite (NaClO) typically sold at a concentration of 5.25% 'available chlorine'. It is also available at higher concentrations (e.g. 12%) so it is important to verify the concentration on the label. For this example, we will assume that the bleach is 5.25% available chlorine (typical household bleach).

5.25% available chlorine = 5.25g NaClO/100mL = 52,500mg NaClO/L or ppm

We now know there is 52,500 ppm of available chlorine in the solute (bleach). We can now solve for the amount of solute required to have 200 ppm of available chlorine in a 1000 L tank.

Given that the ratio between the desired concentration (200 ppm) and the concentration of chlorine in the bleach (52,500 ppm) must be the same as the ratio between the final volume (1000L) and the amount of bleach required:

  • C1 × V1 = C2 × V2
  • V2 = (C1 × V1) / C2
  • V2 = (200 ppm × 1000 L) / 52, 500 ppm
  • V2 = 3.81 L (or 4 L)

Therefore, Gravelle's Veggies-to-Go should add 4 L of standard bleach to the 1000 L tank in order to obtain 200 ppm of chlorine in the tank.

The availability of chlorine in solution to kill microorganisms is highly dependent on the pH of the water, and the amount of dissolved minerals and organic matter. It is highly recommended that manufacturers verify the concentration of their chlorine solutions using test strips, or other methods, and adjust the concentration accordingly. The above calculation should be used to determine a starting point only.

10.3 Vitamins A and D in Fluid Milk

Division 8 of the Food and Drug Regulations requires that fluid milk contain enough added vitamin D that a reasonable daily intake of the milk contains between 300 and 400 International Units (IU) of vitamin D. Skimmed and partially skimmed milk must also contain enough added vitamin A that a reasonable daily intake of the milk contains between 1200 IU and 2500 IU of vitamin A. As well, evaporated and evaporated skimmed milk must contain enough vitamin C that a reasonable daily intake of the milk contains between 60 and 75 milligrams of vitamin C.

Health Canada has determined that a reasonable daily intake of milk is 852mL (Schedule K: Reasonable Daily Intake for Various Foods, Food and Drug Regulations), thus allowing the calculation of the desired vitamin concentration ranges and target levels (Table 6):

Table 6 - Target Fortification Levels for Fluid and Evaporated Milk
VitaminRangeTarget Level
A 140.8 – 293 IU / 100 mL 216.9 IU / 100 mL
D 35.2 – 46.9 IU / 100 mL 41.0 IU /100 mL
C 14.08 – 17.6 mg / 100 mL 15.84 mg / 100 mL

The appropriate vitamin fortification target level is the midpoint of the concentration range.

10.3.1 Calculating Vitamin Concentration in Fluid Milk

There are two basic vitamin concentration calculations typically used in the fluid milk industry:

  1. Theoretical Value, used by dairy personnel to determine how much vitamin premix should be added to achieve the desired vitamin concentration in the product. The pasteurization method used (batch or continuous flow) will affect how this value is calculated, as will the use of diluted vitamin premix
  2. Calculated Value, used to estimate the actual vitamin concentration in the milk. The use of diluted vitamin premix will also affect the calculation of this value

The following calculation information is taken from the Dairy Products Inspection Manual.

10.3.1.1 Determining the Concentration of Diluted Vitamin Solution

If the vitamin solution has been diluted, the concentration of the diluted vitamin solution must be determined prior to calculating either the Theoretical Value or the Calculated Value.

The following information is required:

  • Concentration of the vitamin premix
  • Volume of the vitamin premix used
  • Volume of the diluted vitamin solution to be prepared

Once this information has been obtained, use the following formula:

Cd × Vd = Cp × Vp

where Cd = concentration of diluted vitamin solution

Example:

The concentration of a vitamin D premix is 205,000 IU/mL. 24 mL of this premix is used in the preparation of 500 mL of diluted vitamin solution. What is the concentration of the diluted vitamin solution?

Using

  • Cd = (Cp × Vp) / Vd
  • Cd (IU/mL) = (205,000 IU/mL × 24 mL) / 500 mL
  • Cd = 9840 IU/mL

This value will be used for "C" when calculating the Theoretical Value or the Calculated Value in the next two sections.

10.3.1.2 Calculating Theoretical Values for Batch Method Pasteurization

Information required:

  • T = Theoretical Concentration of Vitamin in the Final Product (IU/100 mL)
  • V = Volume of Vitamin Premix used (mL)
  • C = Concentration of Vitamin Premix (IU/mL)
  • Q = Quantity of Milk to be Fortified (mL)Footnote 7

Equation used:

T = VC/Q

Example:

  • T = Theoretical Concentration of Vitamin in the Final Product (IU/100mL)
  • V = 3.35mL
  • C = 205,000 IU/mL (of Vitamin D)
  • Q = 1800L (1800L × 1000mL/L = 1800000mL)

T = (205,000 IU/mL × 3.35mL) / 1,800,000mL

T = 0.382 IU/mL of vitamin D

Multiply by 100 to convert T to IU/100mL

Therefore:

(0.3815 IU/mL) (100) = 38.15 IU/100mL

T = 38.15 IU/100mL of Vitamin D

10.3.1.3 Calculating Theoretical Values for Continuous Flow Method Pasteurization

Information required:

  • T = Theoretical Concentration of Vitamin in the Final Product (IU/100mL)
  • C = Concentration of Vitamin Premix (or concentration of diluted Vitamin solution) (IU/mL)
  • P = Vitamin Pump Speed (mL/minute)
  • F = Flow rate of Milk (mL/minute)Footnote 8

Equation used:

T = CP/F

Example 1:

  • T = Theoretical Concentration of Vitamin in the Final Product (IU/100mL)
  • C = 95,000 IU/mL (of Vitamin A)
  • P = 3.5mL/minute
  • F = 292L/minute (292L/min × 1000mL/L = 292,000mL/min)
  • T = CP/F
    T = (95,000 IU/mL × 3.5mL/minute) / 292mL/minute
  • T = (332,500 IU/minute) / (292,000mL/minute)
  • T = 1.14 IU/mL of Vitamin A

This needs to be converted to IU/100mL. Do this by multiplying your calculated T value by 100.

Therefore:

  • (1.14 IU/mL)(100) = 114 IU/100mL
  • T = 114 IU/100mL of Vitamin A

Example 2:

In this example, 24mL of a 205,000 IU/mL vitamin D solution is used to produce 500mL of diluted vitamin solution. The vitamin pump speed is 9840 IU/mL and the flow rate of milk is 64L/minute. Determine the theoretical concentration of vitamin D.

First, determine the Concentration of the diluted Vitamin solution (10.3.1.1):

Cd = (Cp × Vp) / Vd

Cd = (205,000 IU/mL × 24mL) / 500mL = 9840 IU/mL

Then use this value for "C" in the formula T= CP/ F

  • T = CP/F
  • T = (9840 IU/mL × 2.6mL/minute) / 64,000mL/minute
  • T = (25584 IU/minute) / 64,000mL/minute
  • T = 0.400 IU/mL of Vitamin D

This needs to be converted to IU/100mL. Do this by multiplying your calculated T value by 100.

Therefore:

  • (0.400 IU/mL)(100) = 40.0 IU/100mL
  • T = 40 IU/100mL of Vitamin D

10.3.2 Calculated Values

Information required:

  • CV = Calculated level of vitamins in final product (IU/100mL)
  • C = Vitamin Premix Concentration (or concentration of diluted Vitamin solution) (IU/mL)
  • U = Total volume of Vitamin Premix used (or volume of diluted Vitamin solution) (mL)
  • Q = Total Quantity of fortified finished product (mL)Footnote 9

Equation used:

CV = CxU/Q

Example 1:

  • CV = Calculated level of vitamins in final product (IU/100mL)
  • C = 50,000 IU/mL (of Vitamin A)
  • U = 64.8mL
  • Q = 1810L (1810L × 1000mL/L = 1,810,000mL)
  • CV = CxU/Q
  • CV = (50,000 IU/mL × 64.8mL) / 1,810,000mL
  • CV = 3240000 IU / 1,810,000mL
  • CV = 1.79 IU/mL of Vitamin A

This needs to be converted to IU/100mL. Do this by multiplying your calculated T value by 100.

Therefore:

  • (1.79 IU/mL)(100) = 179 IU/100mL
  • T = 179 IU/100mL of Vitamin A

Example 2:

In this example, 126.2mL of a 205,000 IU/mL vitamin D solution is used to produce 7.6L of diluted vitamin D solution.

First, determine the Concentration of the diluted Vitamin solution (10.3.1.1):

  • Cd = (Cp × Vp) / Vd
    • = (205,000 IU/mL × 126.2mL) / 7600mL
    • = (258710000 IU) / 7600mL
    • = 3404.1 IU/mL

Then use this value for "C" in the formula CV = CU/Q.

  • CV = Calculated level of vitamins in final product (IU/100mL)
  • C = 3404.1 IU/mL
  • U = 7560mL
  • Q = 60,586L (60,586L × 1000mL/L = 60,586,000mL)
  • CV = CU/Q
  • CV = (3404.1 IU/mL × 7560mL) / 60,586,000mL
  • CV = 25734996 IU / 60,586,000mL
  • CV = 0.425 IU/mL of Vitamin D

This needs to be converted to IU/100mL. Do this by multiplying your calculated T value by 100.

Therefore:

  • (0.427 IU/mL)(100) = 42.7 IU/100mL
  • T = 42.7 IU/100mL of Vitamin D
10.3.2.1 Determining the Volume of Vitamin Premix Prepared by Weighing

Sometimes, solutions may be prepared by weighing the premix instead of using a volumetric measure. In order to convert the weight of premix to a volume, you need to know the Specific Gravity (density) of the premix.

Information required:

  • V = Amount of vitamin premix used (mL)
  • M = Weight of premix used (g)
  • SG = Specific Gravity (density) of premix (g/mL)

Formula Used:

  • V = M/SG

Example:

  • V = x (mL)
  • M = Weight of premix used = 3.5g
  • SG = Specific Gravity (density) of premix = 1.045g/mL

Use the formula V = M/SG = 3.5g/(1.045g/mL) = 3.35mL of vitamin premix used

10.4 Degree-hours Calculation

Degree-Hours are the product of time (h) at a particular temperature multiplied by the temperature (°C) in excess of the critical temperature at which the growth of a particular microbiological pathogen effectively begins. Degree-Hours are calculated for each temperature used in the process.

Certain strains of the bacteria Staphylococcus aureus are capable of producing a highly heat stable toxin that causes illness in humans. Above a critical temperature of 15.6°C, Staphylococcus aureus multiplication and toxin production can take place. This multiplication and resultant toxin production ceases once a pH of 5.3 is reached. Processors are consequently required to control this hazard by verifying that their product attains a pH of 5.3 within pre-defined degree-hours limits. The examples presented in this section will reflect the control of Staphylococcus aureus; however, the methodology is the same for other microbiological pathogens. The appropriate Guideline table for the microbiological pathogen in question must be used.

10.4.1 Fermentation at a constant temperature (Constant Temperature Process)

When fermentation is done at a constant temperature, operators can either use the Guidelines table or the calculation method to determine the degree-hours limits and maximum time for fermentation at a given room temperature.

10.4.1.1 Determining the Maximum Degree/Hours Using the Guideline Table

Use the following table (Table 7) to determine the maximum degree-hours for fermentation room temperatures to control Staphylococcus aureus:

  1. less than 33°C
  2. between 33°C and 37°C
  3. in excess of 37°C
Table 7 – Degree-hours guidelines for the control of Staphylococcus aureus.
Degrees-hours limit for the corresponding temperatureFermentation Room Temperature (°C)Maximum Allowed Hours to Achieve a pH of 5.3 (Based on Guideline)
665 20 150.0
665 22 103.4
665 24 78.9
665 26 63.8
665 28 53.6
665 30 46.2
665 32 40.5
555 33 31.8
555 34 30.1
555 35 28.6
555 36 27.2
555 37 25.9
500 38 22.3
500 40 20.5
500 42 18.9
500 44 17.6
500 46 16.4
500 48 15.4
500 50 14.5

Answers:

  1. 665 degree-hours when the highest fermentation temperature is less than 33°C.
  2. 555 degree-hours when the highest fermentation temperature is between 33°C and 37°C.
  3. 500 degree-hours when the highest fermentation temperature is greater than 37°C.

Note: The degree-hours above depend upon the highest temperature in the
fermentation process prior to the time that a pH of 5.3 or less is attained.

10.4.1.2 Determining the Maximum Degree-Hours Using the Calculation Method
Information required:
  • Degrees in excess of the critical temperature for microbial pathogen growth (e.g. 15.6°C for Staphylococcus aureus)
  • Hours required to reach pH necessary to stop microbial pathogen growth (e.g. 5.3 for Staphylococcus aureus)
Steps:
  1. Subtract the critical temperature required for microbial pathogen growth from the temperature of the fermentation room
  2. Determine the number of hours required at the above temperature necessary to reach the critical pH value
  3. Multiply steps 1 and 2
Examples:

All examples will be for the control of Staphylococcus aureus. You will determine whether each process meets the guideline presented in the preceding table.

Process A

The fermentation room temperature is a constant 26°C. It takes 55 hours for the pH to reach 5.3.

  • Degrees above 15.6°C: 26°C - 15.6°C = 10.4°C
  • Hours to reach pH of 5.3: 55 h
  • Degree-Hours calculation: (10.4°C) × (55 h) = 572 degree-hours

The corresponding degree-hours limit (less than 33°C) is 665 degree-hours.

Conclusion: Process A meets the guideline because its degree-hours is less than the limit.

Process B

The fermentation room temperature is a constant 35°C. It takes 40 hours for the pH to reach 5.3.

  • Degrees above 15.6°C: 35°C - 15.6°C = 19.4°C
  • Hours to reach pH of 5.3: 40 h
  • Degree-Hours calculation: (19.4°C) × (40 h) = 776 degree-hours

The corresponding degree-hours limit (between 33°C and 37°C) is 555 degree-hours.

Conclusion: Process B does not meet the guideline because its degree-hours exceed the limit.

10.4.2 Fermentation Done at Different Temperatures (Variable Temperature Processes)

When the fermentation takes place at various temperatures, each step in the progression is analysed for the number of degree-hours it contributes using the calculations outlined in the preceding section. The degree-hours are then totalled for all the steps, and compared to the guideline recommendation (Table 8) for the highest temperature reached during fermentation.

Examples:

All examples will be for the control of Staphylococcus aureus.

Process C

It takes 35 hours for product to reach a pH of 5.3 or less. Fermentation room temperature is 24°C for the first 10 hours, 30°C for second 10 hours and 35°C for the final 15 hours.

Table 8: Times and Temperatures –Process C
Hours Fermentation Room temperature (°C) Critical Temperature Adjustment (°C) Degrees above 15.6°C Degree-hours
10 24° (24° - 15.6°) = 8.4° 84
10 30° (30° - 15.6°) = 14.4° 144
15 35° (35° - 15.6°) = 19.4° 291
Total: 519

The highest temperature reached = 35°C

The corresponding degree/hour limit = 555 degree-hours (between 33°C and 37°C)

Conclusion: Process C meets the guideline because its degree-hours is less than the limit.

Process D

It takes 38 hours for product to reach a pH of 5.3 or less. Fermentation room temperature is 24°C for the first 10 hours, 30°C for second 10 hours and 37°C for the final 18 hours.

Table 9: Times and Temperatures – Process D
Hours Fermentation room temperature (°C) Critical Temperature Adjustment (°C) Degrees above 15.6°C Degree-hours
10 24° (24° - 5.6°) = 8.4° 84
10 30° (30° - 15.6°) = 14.4° 144
18 37° (37° - 15.6°) = 21.4° 385.2
Total: 613.2

The highest temperature reached = 37°C

The corresponding degree-hour limit = 555 (between 33°C and 37°C)

Conclusion: Process D does not meet the guidelines because its degree-hours exceed the limit.

10.5 Common Food Additives

10.5.1 Nitrite and Nitrate Additives

According to the Food and Drug Regulations, the combination of sodium/potassium nitrite and the combination of sodium/potassium nitrate should not exceed 200 ppm each (200 ppm + 200 ppm)

Note: should not exceed 120 ppm for side bacon

10.5.1.1 Determining How Much Nitrite/Nitrate to Add to Achieve a Specific Concentration

Information required:

  • Quantity of product to which the nitrite or nitrate will be added
  • Maximum quantity of nitrite or nitrate for the above quantity of product

Useful conversions:

  • 1 kg = 1000 g
  • 200 ppm = 0.02%
  • 1 g of product may contain a maximum 200 μg sodium nitrate/nitrite
  • 1 kg of product may contain a maximum 200 mg (0.2 g) of sodium nitrate/nitrite

Formula:

Desired ppm combined nitrates/nitrates (g/kg) = [Amount of combined nitrates/nitrates (g)] / Batch size (kg)

Example:

A company wants to add 200 ppm sodium nitrite to 250 kg of sausage mix. How much sodium nitrite should they add?

What we know:

Desired ppm = 200 ppm = 200 mg/kg = 0.200 g/kg

Final batch size = 250 kg sausage mix

  • Desired ppm sodium nitrate (g/kg) = Amount of sodium nitrate (g) / Batch size (kg)
  • [0.200 g sodium nitrate / 1 kg Final mixture] = [x g sodium nitrate / 250 kg Final mixture]
  • (0.200)(250) = × g sodium nitrate
  • 50 = x g sodium nitrate

Therefore, the company should add 50 g of sodium nitrate to 250 kg of sausage mix to achieve 200 ppm sodium nitrate in the sausage mix.

10.5.1.2 Determining How Much Product to Add to Achieve a Specific Concentration

For this style of question, you may use the equation:

  • C1M1 = C2M2
  • C1 = initial concentration
  • C2 = final concentration
  • M1 = initial mass (or volume)
  • M2 = final mass (or volume)

Example:

According to the company laboratory report, the latest batch of sausage mix weighs 200 kg and contains 340 ppm of nitrate. The manager has decided to add some more untreated sausage mix to the batch to satisfy the Food and Drug Regulations. How much sausage mix must be added to reduce the nitrate concentration to 200 ppm?

  • C1 = initial concentration = 340 ppm nitrate
  • C2 = final concentration = 200 ppm nitrate
  • M1 = initial mass (or volume) = 200 kg sausage mix
  • M2 = final mass (or volume) = 200 kg sausage mix + X (which is additional amount of sausage mix in kg)

Therefore,

  • C1M1 = C2M2
  • (340 ppm nitrate)(200 kg sausage mix) = (200 ppm nitrate)(200 kg sausage mix + x)
  • Divide both sides of the equation by 200 ppm nitrate to reduce the equation to: 340 kilograms sausage mix = 200 kilograms sausage mix + x
  • 340 kg sausage mix = 200 kg sausage mix + x
  • Subtract 200 kilograms sausage mix from both sides of the equation to solve for x
  • 140 kg sausage mix = x

10.5.2 Sulphur Dioxide (SO2)

According to the Food and Drug Regulations, the permitted concentration of sulphur dioxide (SO2) in certain products is 200 ppm. Since SO2 is a gas, and consequently difficult to handle, industry uses various salts of sulphurous acid:

Table 10: Sulphur Dioxide (SO2)
Molar Weight SO2 Content Multiplier
Sulphur dioxide (SO2) 64.07 100% 1.0
Sodium sulfite (Na2SO3) 126.05 50.8% 1.97
Sodium bisulfite (NaHSO3) 104.07 61.5% 1.63
Sodium metabisulfite (Na2S2O5) 190.12 67.4% 1.48

In order to determine how much of any given salt is required for a final SO2 concentration, you must:

  1. determine the amount of SO2 needed for that concentration and then
  2. multiply your result by the appropriate multiplier (see preceding Table) for the salt you wish to use.
Example:

A company wishes to achieve a final SO2 concentration of 150 ppm in 250 kg of product. How much NaHSO3 must they add?

150 ppm SO2 = 150 mg SO2/kg product

Therefore,

  1. 150 mg SO2 / 1 kg product = x mg SO2 / 250 kg product

    (150 mg SO2)(250 kg product) = (x mg SO2)(1 kg product)

    [(150 mg SO2)(250 kg product)] / (1 kg product) = [(x mg SO2)(1 kg product)] / (1 kg product)

    x = 37500 mg

    x = 37.5 g SO2

  2. By applying the multiplication factor from the table above:

    37.5 g SO2 × 1.63 = 61.1 g NaHSO3

Therefore, 61.1 g NaHSO3 must be added in order to achieve 150 ppm SO2.

10.6 Allergens

When an undeclared allergen is found in a food, the severity of consequences is determined by calculating the concentration of allergenic protein in the food (usually in parts per million (ppm) (mg/kg)) and amount of allergenic protein in a serving size of that product (mg protein/serving size). The results of this calculation will be used during the course of a Health Risk Assessment (HRA) to help determine the extent to which human health may be affected. This information will further guide the course of action taken by the CFIA. For more information on this topic, consult Chapter 7 of the CFIA's Food Allergy Reference Manual.

10.6.1 Example calculations for protein concentration in finished goods

Example:

During the course of an inspection, the inspector discovers that there are undeclared allergens in 15g packages of dry soup mix. The manufacturer has failed to indicate in the ingredient listing that there is skim milk powder in the product.

The inspector learns that skim milk powder is present as 5% of the dry soup mix. The specification sheet from the manufacturer of the skim milk powder shows that the skim milk powder is 11% protein.

What is the allergen concentration per serving of this product?

What we know:

  • package size (one serving) = 15 g
  • amount of skim milk powder in soup mix = 5% or 5 g skim milk powder/100 g soup mix
  • amount of milk protein in skim milk powder = 11% or 11 g milk protein/100 g skim milk powder
  • 1 ppm = 1 mg allergenic protein/1 kg product
  • 1% = 10,000 ppm
Method 1:

To determine the amount of skim milk powder in one serving, multiply the serving size by the percentage skim milk powder in the soup mix

  • 15 g soup mix × (5 g skim milk powder / 100 g soup mix) = 0.75 g skim milk powder

To determine the amount of milk protein (from the skim milk powder) in one serving, multiply the amount of skim milk powder in one serving by percentage milk protein in the skim milk powder. This is the amount of milk protein that a consumer will be exposed to from serving of the soup

  • 0.75 g skim milk powder × (11 g milk protein / 100 g skim milk powder) = 0.0825 g milk protein

To determine the concentration (ppm) of the milk protein in the dry soup mix, convert the amount of milk protein to milligrams (mg) and the amount of the serving size to kilograms (kg). Divide the amount of milk protein (in mg) in one serving by the serving size (in kg). This equals the protein concentration in mg allergenic protein per kg product, or ppm.

  • 82.5 mg milk protein / 0.015 kg soup mix = 5500 mg milk protein / 1 kg soup mix

Therefore, the concentration of the milk protein in the dry soup mix is 5500 ppm.

Method 2:

To determine the percent of the dry soup mix that is undeclared milk protein, multiply the percent amount of skim milk powder in the product by the percent milk protein in the skim milk powder: 5% x 11% = 0.05 x 0.11 = 0.0055 = 0.55%

Since we know that 1% = 10,000 ppm:

  • 1% / 10,000 ppm = 0.55% / X ppm
  • X = 5500 ppm

To determine the amount of milk protein in one serving, multiply the concentration in ppm (which is mg allergenic protein/kg product) by the serving size in kg:

  • 5500 ppm x 0.015 kg = 82.5 mg milk protein in one serving of soup mix
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