The Canadian Food Inspection Agency (CFIA) pursues a policy of managing the National Chemical Residue Monitoring Program (NCRMP) in accordance with the principles established in the manuals entitled:

"Comprehensive five year plan for Chemical and Biological Risk Management", AAFC, 1992
"Residues of Veterinary Drugs in Foods", CODEX Alimentarius, FAO/ WHO, Second ed, Rome 1993
"Pesticide Residues in Food", Codex Alimentarius, FAO/ WHO second ed Rome 1993.

These manuals provides a comprehensive description of the approaches utilized. There is a recognition that no government agency can routinely monitor for all residue / commodity combinations nor is it necessary to do so in order to protect consumers. With a clear understanding of toxicological, pharmacokinetic and physiological parameters it is possible to quantitatively assess concerns that have the greatest impact on public health. This approach is usually referred to as Ranked Risk Assessment.

Statistical Considerations:

Although the monitoring program is not designed to provide highly accurate statistical estimates of the violative percentages of a population, such estimates are conveniently made available as auxiliary information. For example if no violative samples are detected in a sample of 300 units it is convenient to infer with 95% confidence that the violative rate in the population falls at something less than 1.00%. Although precision becomes rapidly attenuated with smaller sample sizes, useful information can still be obtained from smaller sample sizes. Smaller size samples must be carried out for longer periods before significant inferences can be drawn from the data provided. In addition smaller sample sizes are severely restricted in their ability to show trends over the short time period. With a sample size of 300, seasonal trends may be evident especially if the seasonal variation is larger. By comparison seasonal variations would not be as evident in sample sizes of less than 150 samples / year.

If initial monitoring indicates that a contaminant in a given food commodity presents a significant problem sampling plans may be adjusted, but only to the point that such effort will aid in the understanding of the problem or facilitate regulatory control. Such increased sampling may permit a study of trends, geographical variation and seasonal prevalence and thereby aid in the design of effective control strategies. Merely increasing the monitoring sample size without a strategy which first addresses potential benefits from such an increase is of little avail. Once a problem has been identified by the monitoring program, an effective control strategy would depend not on increased rate of monitoring but rather on the implementation of effective follow-up or directed sampling.

PROGRAM DEFINITIONS

CFIA-HC FOOD SAMPLING AND TESTING TERMINOLOGY

Food sampling and testing are part of CFIA and HC daily activities and are conducted for a multitude of reasons in both organizations, covering a wide range of activities including monitoring, directed sampling, compliance testing, pre-market surveys, post-market surveys and all other data gathering activities. Based on the design and the purpose of the sampling and testing, different terminology is used by both organizations.

Together these activities may be referred to as surveillance activities in a broader perspective.

The following terminology is intended to harmonize the definitions used by both CFIA and HC.

Monitoring is an unbiased sampling, the processing and analysis of samples to provide information on the occurrence and/or levels of chemical residues / contaminants, food additives, microbiological organisms and nutritional components in pre-defined sample populations. Monitoring information is normally obtained through random sampling. The sampled lots are not held and are usually available to consumers before the results are known.

Monitoring sampling is conducted to assess human dietary exposure, perform risk assessments, monitor trends, identify potential problems and at-risk population groups, set standards and guidelines, and evaluate the effectiveness of programs.

Directed sampling is biased, directed at targeted sample populations (e.g., commodity types or geographical areas) to investigate and verify any suspected problems of potential health risk suggested in the monitoring program.

Directed sampling is investigative in nature, and can trigger detention of product pending risk assessment and compliance action.

Compliance testing is directed at specific samples suspected of not complying with specific regulations and guidelines governing the sale and distribution of food. The product is detained until the test results indicate the appropriate disposition. The approach for compliance testing is referred to as in-depth sampling and follows Codex Alimentarius specifications. The establishment of a chain of custody of the sample is essential if legal proceedings are expected to ensue.

Compliance testing is a regulatory control measure to prevent the marketing or remove from market a product known to be contaminated or adulterated.

Blitzes are used to obtain a snapshot in time at some point during the fiscal year. The scheduling of blitzes is unannounced. A blitz may allow for the sampling for example of every herd presented for slaughter for a specified, usually short, period of time not exceeding 2 to 6 weeks.

Legal sampling is undertaken for specific conditions where legal action is the anticipated follow up action. Certain additional criteria are demanded during the sampling submission and laboratory testing of these samples. Adherence to all quality assurance is essential. Legal advice should be sought prior to the initiation of such activities.

Comparison of component name in other jurisdictions
CFIA component	USDA - FSIS component	Codex component
Monitoring	Monitoring	Non-biased sampling
Directed sampling	Surveillance sampling	Directed or biased sampling
Compliance	Enforcement or pre-sampling	Compliance or suspect sampling
Special or pilot surveys	Special projects	(none described)
Blitzes	Special projects	(none described)
Legal sampling	Compliance	Compliance

Legal Authority

The Canadian Food and Drugs Act prescribes certain restrictions on the production, sale, composition and content of foods and food products. Paragraph 4 (below) of the Act describes prohibitions on the sale of food. From the standpoint of the chemical residue and contamination programs the most important restrictions are those detailed in sections 4(a) and 4(d). While a Health Hazard Assessment could find food in violation of any of the 5 sections, the restriction most often used by CFIA

Prohibited sales of food (Food and Drugs Act)

4. No person shall sell an article of food that:

(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; or

(e) was manufactured, prepared, preserved, packaged or stored under unsanitary conditions.

inspectors is the prohibition against the sale of "adulterated" food (4(d). Standards for "adulteration" can be found throughout the Food and Drug Regulations but most are to be found in Division 15 of the Regulations. Key sections of Division 15 are outlined in the box below.

DIVISION 15

Adulteration of food (Regulations)

B.15.001. A food named in column III of an item of Table I to this Division is adulterated if the substance named in Column I of that item is present therein or has been added thereto in an amount exceeding the amount, expressed in parts per million, shown in column II of that item for that food.

B.15.002.

(1) Subject to subsections (2) and (3), a food is adulterated if an agricultural chemical or any of its derivatives is present therein or has been added thereto, singly or in any combination, in an amount exceeding 0.1 part per million, unless it is listed and used in accordance with the tables to Division 16.

(2) Subject to subsection (3), a food is exempt from paragraph 4(d) of the Act if the only agricultural chemicals that are present therein or have been added thereto are any of the following:

(a) a fertilizer;

(b) an adjuvant or a carrier of an agricultural chemical;

(d) silicon dioxide;

(e) sulphur; or

(f) viable spores of Bacillus thuringiensis Berliner.

(3) A food or a food made from a product of any such food is exempt from paragraph 4(d) of the Act if the agricultural chemicals named in columns I and II of that item are present therein or have been added thereto in an amount not exceeding the limit, expressed in parts per million, set out in column III of that item for that food.

(4) A food set out in a Notice of Interim Marketing Authorization published under subsection B.01.056(6) is exempt from paragraph 4(d) of the Act in respect of any agricultural chemical or derivative of such a chemical, and any veterinary drug, set out in that notice that is present in the food in an amount not exceeding the maximum residue limit, expressed in parts per million, set out for the food in that notice.

B.15.003. A food named in column IV of an item of Table III to this Division is exempt from paragraph 4(d) of the Act if the drug named in column I, and analyzed as being the substance named in column II, of that item is present in the food in an amount not exceeding the limit, expressed in parts per million, set out in column III of that item for that food.

For agricultural chemicals, a distinction which includes all the pesticides, a maximum residue limit (MRL) of 0.1 ppm is established in foods by B.15.002. (1). However if the agricultural chemical is listed in DIVISION 15, Table II, then it becomes exempted from the 0.1 ppm restriction and instead the limit published in the tables of DIVISION 15 becomes the MRL. This is the effect of B.15.002. (3), above.

There has been an ongoing question about the product to which the MRL applies. With the recent amendment of B.15.002 (3), (Canada Gazette Part II Vol., 132 No. 3 page 358 - Jan. 26/98) it has become clear that the published MRLs apply not only to the raw agricultural product but to manufactured food items prepared from those raw commodities. Thus a tolerance previously applicable to fresh produce now applies equally to fresh, frozen, canned, pickled forms of the product.

In a similar manner B.15.003 exempts compounds listed in Table III of DIVISION 15 from the limitations of a zero tolerance which would otherwise result. This table establishes MRLs for veterinary drugs. Foods containing drugs at a measurable level, (> 0.0 ppm) are prohibited from sale by paragraph 4(d) unless the drug and food appear and conform with Table III DIVISION 15.

Participating Laboratories and Locations
Laboratory name	Laboratory address
Calgary Food Laboratory	Canadian Food Inspection Agency, Calgary Food Laboratory 3650 - 36 Street N.W. Calgary, Alberta T2L 2L1
Cantest Ltd., Burnaby, B.C. http://www.cantest.com	Cantest Limited 4606 Canada Way Burnaby, British Columbia, V5G 1K5 Tel:(604) 734-7276 Fax:(604) 731-2386
Dartmouth Food Laboratory	Canadian Food Inspection Agency, Dartmouth Food Laboratory, 1992 Baffin Street, Dartmouth, NS B3B 1Y9
J-R Laboratory, Burnaby, BC http://www.jrlabs.ca/index.cfm	J-R Laboratories Limited, Unit # 12, 3871 North Fraser Way, Burnaby, British Columbia, V5J 5G6 Tel:(604) 432-9311 Fax:(604) 432-7768
Maxxam Analytics Inc., Mississauga, Ont. http://www.maxxam.ca/	Maxxam Analytics Inc., 5550 McAdam Road, Mississauga, Ontario, L4Z 1P1 Tel:(905) 890-2555 Fax:(905) 890-0370
Ottawa Food Laboratory	Canadian Food Inspection Agency, Building # 22 , Central Exp'l Farm Ottawa, Ontario K1A 0C5
Saskatoon Food Laboratory	Canadian Food Inspection Agency, Health of Animals Laboratory, 116 Veterinary Road, Saskatoon, Saskatchewan S7N 2R3

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