Archived - Imported and Manufactured Food Program Inspection Manual
Chapter 2: Legal Authorities
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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
- 2.1.2 Food and Drugs Act
- 2.1.3 Food and Drug Regulations
- 2.1.4 Consumer Packaging and Labelling Act and Regulations
- 2.1.5 Relationship between Acts and Regulations
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
- 2.2.1 A Brief History
- 2.2.2 Definitions
- 2.2.3 Authorities in the FDA
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.
The FDA contains definitions that the inspector should be familiar with. Some of these are listed below:
- "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"
- "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"
- "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
188.8.131.52 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.
184.108.40.206 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.
220.127.116.11.1 Direct Powers
Table 1 (below) outlines the direct powers afforded to a designated inspector under Section 23 of the FDA.
|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.|
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 18.104.22.168 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:
- any food, drug, cosmetic or device;
- anything used for the manufacture, preparation, preservation, packaging or storing thereof; and
- 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.
22.214.171.124.2 Indirect powers
Table 2 below outlines the indirect powers afforded to designated inspectors
|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.|
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.
126.96.36.199 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).
|(a) has in or on it any poisonous or harmful substance||
|(b) is unfit for human consumption||
|(c) consists in whole or in part of any filthy, putrid, disgusting, rotten, decomposed or diseased animal or vegetable substance||
|(d) is adulterated||
|(e) was manufactured, prepared, preserved, packaged or stored under unsanitary conditions Table Note 2||
- 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
188.8.131.52 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.
184.108.40.206 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
- import into Canada,
- send, convey or receive for conveyance from one province to another, or
- 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.
220.127.116.11 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
- 2.3.2 Standardized vs. Unstandardized Foods
- 2.3.3 Microbiological Standards
- 2.3.4 Nutrient Enrichment or Fortification
- 2.3.5 Food Additives
- 2.3.6 Adulterated Foods
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:
|4||Cocoa and Chocolate Products|
|7||Spices, Dressings and Seasonings|
|9||Fats and Oils|
|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|
|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|
|27||Low-Acid Foods Packaged in Hermetically Sealed Containers|
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.
- 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:
- the food shall contain only the ingredients included in the standard for the food;
- each ingredient shall be incorporated in the food in a quantity within any limits prescribed for that ingredient; and
- 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:
- 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
- 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
|Product||Section of the FDR|
|Cocoa and Chocolate Products||B.04.012|
|Powdered Milk Products||B.08.014A|
|Product||Section of the FDR|
|Cheese (Pasteurized Source)||B.08.048 (1a)|
|Cheese (Unpasteurized Source)||B.08.048 (2a)|
|Product||Section of the FDR|
|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
- any nutritive material that is used, recognized or commonly sold as an article or ingredient of food;
- vitamins, mineral nutrients and amino acids, other than those listed in the tables to Division 16,
- spices, seasonings, flavouring preparations, essential oils, oleoresins and natural extractives;
- agricultural chemicals, other than those listed in the tables to Division 16,
- food packaging materials and components thereof; and
- 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.
Table 5 below describes particular situations and the section(s) of the FDA and/or FDR to be cited for the violation.
|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.
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