Guidelines for the General Cleanliness of Food - An Overview

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Eva Pietrzak National Manager,
Food Microbiology and Extraneous Matter Evaluation Section,
Food Safety Division,
CFIA Tower 2,
4^th floor,
Rm 153
1440 Merivale
Ottawa, ON.
K1A 0Y9

e-mail: Eva.Pietrzak@inspection.gc.ca

1. Introduction

The purpose of this overview is to provide to all interested parties a ready reference of the current guidelines and associated methods used by the Canadian Food Inspection Agency (CFIA) for determining the general cleanliness of foods. It should be of assistance to the food industry, other concerned regulatory agencies (Federal, Provincial, and Territorial) and the individual consumer.

This revised overview replaces the version dated March 2006, and supplements the document entitled "Health Protection Branch Standards and Guidelines for the Microbiological Safety of Food - Interpretive Summary" dated May 31, 1999.

2. Guidelines

In addition to standards, the Health Products and Food Branch (HPFB) also develops microbiological and extraneous matter guidelines. While the development and maintenance of extraneous material guidelines and methods comes under the jurisdiction of the CFIA. Although these guidelines are not defined in the Regulations, as are the standards, they may also be used in judging compliance with Sections 4, 5 and 7 of the Act.

A given guideline may embody the same limiting criteria that would be employed in a standard. Frequently, however, they are based on fewer data than are used in developing a standard but they serve as useful indicators of levels achievable using Good Manufacturing Practices (GMPs). Since guidelines are not part of the Regulations, they can be readily modified, if necessary, as additional data become available.

There are two distinct groups of guidelines; microbiological guidelines and extraneous material guidelines. The latter includes foreign matter associated with objectionable conditions or practices in manufacturing, processing, storing, transporting and handling of food. Examples of extraneous materials are animal and insect filth such as excreta, hairs, feather barbules, whole or parts of insects etc., and tramp material such as paint flakes, wood splinters, pieces of metal, glass and so forth.

3. Two- and Three-Class Attributes Lot Acceptance Sampling Plans

Standards and guidelines are expressed in terms of 2-Class Plans or 3-Class Plans depending on the degree of hazard involved. Two-Class Plans are used where no living cells of a specific organism or where no piece of a specific type of extraneous material is tolerated in foods. Three-Class Plans are used where some cells of the organism in question, or, where the presence of certain amounts of extraneous material are tolerated. For a detailed discussion of the concepts that these plans involve and their application, refer to the second edition of "Microorganisms in Foods, Volume 2, Sampling for microbiological analysis: Principles and specific applications," compiled by The International Commission on Microbiological Specifications for Foods (ICMSF) of the International Association of Microbiological Societies and published in 1986 by the University of Toronto Press.

The symbols used in the plans and their definitions are as follows:

Lot: A batch or production unit which may be identified by the same code. When there is no code identification, a lot may be considered as (a) that quantity of product produced under essentially the same conditions, at the same establishment and representing no more than one day's production; or (b) the quantity of the same variety of product from one and the same manufacturer available for sampling at a fixed location.

n: The number of sample units usually but not always selected at random from a lot and examined in order to satisfy the requirements of a particular acceptance plan used. This is the sample.

m: The numerical value of “m” represents acceptable concentrations of microorganisms or amounts of extraneous material, usually per g or mL. In a 2-class plan, “m” separates sample units of acceptable and defective quality; in a 3-class plan, “m” separates sample units of acceptable quality from those of marginally acceptable quality. The “m” values listed in the following tables are based on levels achievable under GMP.

M: (Only in a 3-class plan), the numerical value of “M” represents unacceptable concentrations of microorganisms or amounts of extraneous material, usually per g or mL, that indicate a (potential) health or injury hazard, imminent spoilage or gross insanitation; “M” separates sample units of marginally acceptable quality from those of defective quality. A value determined for any one sample unit of a sample that is greater than that of “M” renders the pertaining lot unacceptable.

c: The maximum allowable number of marginally acceptable sample units. “c” is the acceptance number of a plan. When this number is exceeded, the lot becomes unacceptable.

Standards and guidelines can be applied only when the appropriate method of analysis (or equivalent) is used.

4. Nature Of Concern

Health 1 The health hazard identified represents a direct risk to human health. Appropriate action should be taken against the product to limit exposure in the population. Follow-up action should ensure that the cause has been determined and appropriate corrective action has been taken to correct the problem.

Health 2 The health hazard identified represents a risk to human health if present in sufficient numbers. Appropriate action should be taken to limit exposure in the population to the product if the M value is exceeded. Repeated violations should be investigated. If c/m values are exceeded, progressive steps should be taken to bring about compliance, initially review GMP/HACCP.

Sanitation The hazard identified is an indication of a breakdown in hygienic practice. A review of the manufacturer’s GMP/HACCP is appropriate where M or c/m values are exceeded.

5. Equivalent Methods

While a complete description of method development, status and definitions is provided in the document entitled “Procedure for the Development and Management of Food Microbiological and Extraneous Material Methods” the following is offered to clarify this term:

Generally, for a specific bacterium all Official Methods (MFO) are equivalent to each other; all HPB Methods (MFHPB) are equivalent to each other; and all Laboratory Procedures (MFLP) are equivalent to each other. When “Accredited Laboratories” and Government Laboratories are involved in compliance activity, MFOs must be used for analysing certain foods that are specified in the Regulations of the Food and Drugs Act. When an MFO is non-existent, then the next higher classification of method should be used (i.e. MFHPB then MFLP). In some circumstances, only an MFLP will be available and will be the method for analysis. “Rapid kits” and other MFLPs may be used to screen large numbers of food samples for specific bacteria and/or pathogens, and when presumptive isolates are found, confirmation (and possibly reanalysis) should proceed using the higher classification of methods (i.e. MFHPB or MFO).

Note: It is imperative that the “Application Section” of each method be reviewed before use, so as to determine the method’s applicability to the food or environmental sample in question.

6. Summaries Of Guidelines and Analytical Methods

The following table presents a summary of the current guidelines and methods of analysis.

For more information contact:

Eva Pietrzak National Manager,
Food Microbiology and Extraneous Matter Evaluation Section,
Food Safety Division,
CFIA
1440 Merivale
Ottawa, ON.
K1A 0Y9

e-mail: Eva.Pietrzak@inspection.gc.ca

Phone#; 613-773-5812
Fax#; 613-773-5957

Table 1. Extraneous material guidelines that relate to the safety and cleanliness of food

Note:
A) Live infestation of a food commodity is not tolerated.

B) Contamination of a food commodity by three or more species of stored products insect pests may be considered evidence of unsanitary conditions.

C) Final evaluation should be based on the overall extraneous material content of the product.

D) These guidelines are subject to change when new data and/or new information indicate the need for change.

The following table represents the more commonly occurring defects but should not be taken as representing the only defect of concern.

Acceptance Sampling Plan Parameters
Product; Method; Defects		n	c	m	M
Alimentary Paste (semolina derived) Method ExFHPB-1	Insect Fragments Premilling contamination: 1. Field insect fragments and unidentified insect fragments ≥ 0.595 mm	3	1	35/225g	70/225g
	2. Stored food insect pest fragments ≥ 0.595 mm	3	1	15/225g	30/225g
	Postmilling contamination: 1. Stored food insect pest fragments > 0.595 mm	3	1	5/225g	10/225g
	2. Unidentified insect fragments > 0.595 mm	3	1	5/225g	10/225g
Bakery Products (no fruit/nuts) Method ExFLP-22	rodent hairs	3	1	1/225g	3/225g
Bottled Beverages Candling/Filtering	Visible glass - Unsatisfactory; for action, a health hazard evaluation should be requested

Acceptance Sampling Plan Parameters
Product; Method; Defects			n	c	m	M
Bean Curd (dry, wet) Method ExFLP-20	whole and equivalent whole insects		3	1	1/100g	3/100g
	insect fragments		3	1	65/100g	120/100g
	mites (dead)		3	1	15/100g	50/100g
	rodent hairs		3	1	0/100g	3/100g
Cheese (whole or grated) Method ExFLP-5 (total filth)	insect fragments (not mites)		3	1	4/225g	8/225g
	*mites (dead)		3	1	25/225g	34/225g
	rodent hairs		3	1	1/225g	3/225g
	other mammalian hair (not dyed) *same for process cheese		3	1	1/225g	3/225g
	metal pieces	0.1 - <1.0 mm	3	1	8/225g	16/225g
		1.0 - <2.0 mm	3	1	1/225g	3/225g
		≥ 2.0 mm	3	1	0/225g	0/225g
Cheese (solid, whole) Method: Visual inspection For Surface Contamination Only			mites - shall contain no more than 5 dead mites per square 2.5 cm and to a depth of 0.6 cm. Live mites not tolerated.
Cherries (brined, glacé, maraschino) Method ExFLP-4	a) insect damaged b) mites (dead) c) mouldy, d) any combination of a, b, and c		3 (250g each)	1	3%	9%
	Pits and pit fragments		Not More Than One Pit Or 2 Pieces Of Pit ≥ 2mm (in longest dimension) per 50 cherries
Chocolate Method ExFLP-16	magnetic metal particles	≥ 0.5 - <1.0 mm	3	2	100/100g	300/100g
		1.0 - <2.0 mm	3	2	5/100g	10/100g
		≥ 2 mm	3	0	0/100g	0/100g
		Method - AOAC 16th ed. method 16.2.01 B(b)
	rodent hairs		3	1	1/100g	3/100g
Cocoa Beans Method ExFHPB-2	a) insect damaged b) mouldy c) combination of a and b		8 (100 beans each)	2	5%	10%

Acceptance Sampling Plan Parameters
Product; Method; Defects		n	c	m	M
Cocao Powder Method ExFLP-16 magnetic metal particles	≥ 0.5 - < 1.0mm	3	2	100/100g	300/100g
	1.0 - < 2.0mm	3	2	5/100g	10/100g
	≥ 2.0mm	3	0	0/100g	0/100g
Coffee Beans (green, whole) Method ExFHPB-3	a) insect damaged b) mouldy c) combination of a and b	8 (100 beans each)	4	6%	12%
Coffee Beans (roasted, whole) Method ExFHPB-3	a) Total filth	8 (100 beans each)	4	0.2% (by weight)	0.5% (by weight)
	b) Defectives a) insect b) mouldy c) combination of a and b	8 (100 beans each)	4	6%	12%
Coffee (ground roasted beans) Method AOAC 16th ed. method 16.2.02(b)	insect fragments	3	1	35/25g	60/25g
Dates (whole) Method ExFHPB-4	a) insect damaged b) mites (dead) c) mouldy/sour d) worthless e) dirty f) any combination of a, b, c, d, e	8 (50 dates each)	2	6%	12%
Pitted Dates: Pits or pit fragments		Not More Than 2 Pits Or 4 Pieces Of Pit ≥ 2 mm (longest dimension) per 100 dates
Date Material (chopped, macerated, sliced, pressed) Method ExFLP-14 Pits or pit fragments		Not More Than One Pit Or Three Pieces Of Pit ≥ 2mm (longest dimension) PER 300g DATE MATERIAL

Acceptance Sampling Plan Parameters
Product; Method; Defects		n	c	m	M
Figs (whole) Method ExFHPB-5	a) insect damaged b) mites (dead) c) mouldy/sour d) dirty e) worthless f) any combination of a, b, c, d, e	8 (50 figs each)	2	12%	22%
Fig Paste Method ExFHPB-6	A) Coleoptera, Lepidoptera: whole and equivalent whole forms of insects (more than half a head including entire frons) of adults, pupae and larvae	8	2	10/100g	20/100g
	B) Coleop., Lepidop.,: exuvial heads (as above)	8	2	10/100g	15/100g
	C) Diptera: adult heads (as above) and pupae, larvae - whole or equivalent whole (head including entire mouth hook)	8	2	8/100g	12/100g
	D) mites (dead)	8	2	75/100g	150/100g
Kelp, Kelp Products And Other Sea Vegetation Products Method ExFLP-23	insect fragments	3	2	25/25g	75/25g
	rodent hairs	3	1	1/25g	2/25g
	feather barbules	3	1	1/25g	2/25g
	heavy filth	3	1	70mg/25g (0.28%)	188mg/25g (0.75%)
Mushrooms (canned, dried, fresh, frozen) Method ExFLP-17	maggots < 2mm	6	2	10/100g	20/100g
	maggots ≥ 2mm	6	2	0/100g	5/100g
	mites (dead)	6	2	20/100g	75/100g
	mould	6	average of 10% or less of decomposed mushrooms by weight.
	nematodes	6	0	0/100g	0/100g

Acceptance Sampling Plan Parameters
Product; Method; Defects		n	c	m	M
Pepper (ground black) Method AOAC 16th ed. 16.14.23 A for light filth: 16.14.23 B for heavy filth	insect fragments	3	1	200/50g	320/50g
	heavy filth	3	2	200mg/50g	320mg/50g
	rodent hairs	3	2	1/50g	2/50g
Raisins, Currants (processed) Method ExFLP-13	mouldy fruit	3	2	6/100	12/100
	insects - whole or equivalent whole forms of insects (more than half a head including entire frons)	3	1	10/225g	20/225g
	rodent hairs	the total number in 675g (3x225g) shall not exceed 3 rodent hairs
	heavy filth	3	2	40mg/100g	60mg/100g
Rice (white, brown) Method ExFLP-21 (white) ExFLP-12 (brown)	whole or equivalent whole forms of insects	3	1	1/100g	3/100g
	insect fragments	3	1	25/100g	50/100g
	rodent hairs	3	2	0/100g	3/100g
Rice Flour Method AOAC 16th ed. 982.32 for light filth	pre-milling insect fragments ≥ 0.2mm	3	1	80/100g	150/100g
	post-milling insect fragments >0.2mm	3	1	25/100g	50/100g
	rodent hairs	3	2	0/100g	3/100g
Spirulina Method ExFLP-23	insect fragments	3 (25g each)	2	25/25g	75/25g
	rodent hairs	3 (25g each)	shall not exceed a total of 1/75g
	feather barbules	3 (25g each)	shall not exceed a total of 1/75g
Sunflower Seeds Method: Visual, confirm at 30x magnification	a) insect damaged, b) mouldy, c) combination of a and b	3 (100 seeds each)	1	5%	10%

Acceptance Sampling Plan Parameters
Product; Method; Defects		n	c	m	M
Tea (bagged black tea) Method ExFLP-18	heavy filth	3	1	70mg/25g	120mg/25g
Thyme (ground) Method AOAC 16th ed. 16.14.05 A & B for light and heavy filth	insect fragments	3	1	280/10g	370/10g
	heavy filth	3	1	280mg/10g	400mg/10g
	rodent hairs	3	2	0/10g	1/10g
Turmeric (ground) Method AOAC 16th ed. 16.14.05 for light and heavy filth	insect fragments	3	1	280/10g	370/10g
	heavy filth	3	1	140mg/10g	200mg/10g
	rodent hairs	3	2	0/10g	1/10g
Wheat Flour (white) Method ExFLP-19	pre-milling insect fragments ≥ 0.2mm	3	1	20/50g	50/50g
	post-milling insect fragments >0.2mm	3	1	10/50g	20/50g
	rodent hairs	3	2	0/50g	2/50g