This FDA Circular shall take effect immediately and supersede other regulations or guidelines...

February 27, 2013

FDA CIRCULAR NO. 010-13

 

As part of the mandate of the Food and Drug Administration to protect the public health and pursuant to the provisions of Republic Act No. 9711 otherwise known as the "Food and Drug Administration Act of 2009", the Bureau Circular No. 01-A s. 2004 Guidelines for the Assessment of Microbiological Quality of Processed Food is hereby revised with the following considerations: 1. Addition of new food category/products, 2. The need to update old references, 3. Adoption of approved CODEX Alimentarius Commission Guidelines.

This FDA Circular is hereby issued to serve as guidelines for the assessment of microbiological quality of certain processed foods; and help ensure that food manufacturers comply with Good Manufacturing Practices (GMP).

The reference criteria are prescribed in Tables 1-14. The tables contain a description of the food to which a criterion applies, the required test(s) or the microorganisms considered to be acceptable, marginally acceptable or critical, and the number of samples which should conform to the limits.

The methods used for the enumeration or detection of specified microorganisms shall be those that have been internationally established. Such methods, as well as the cited specifications were obtained from the following internationally recognized references:

1. FDA Bacteriological Analytical Manual published by the AOAC

2. Compendium of Analytical Methods of the Canadian Health Protection Branch

3. Compendium of Methods for the Microbiological Examination of Foods compiled by the American Public Health Association (APHA)

4. Specifications and Standards for Foods, Food Additives, etc., Japan External Trade Organization

5. Microorganisms in Foods by the International Commission on Microbiological Specifications for Foods (ICMSF)

6. Codex Alimentarius Commission Guidelines

7. International Standards Organization (ISO) Microbiological Methods

8. Australia New Zealand Food Authority (ANZFA)

This FDA Circular shall take effect immediately and supersede other regulations or guidelines inconsistent herewith.

 

(SGD.) KENNETH Y. HARTIGAN-GO, MDActing Director IV

ATTACHMENT

Table 1.	Milk and Dairy Products
Food Description	Test/Microorganism	n	c	m	M
	Reference Criteria
Milk Powders	Salmonella/25g, normal routine	10	0	0
(e.g., whole, nonfat or	for high risk population	30	0	0
filled milk, buttermilk,	SPC/APC, cfu/g	5	2	5x 103	5x 104
whey and whey protein	Enterobacteriaceae cfu/g	5	1	10	102
concentrate)
(intended for children
more than 36 months
of age and adults)
Sweetened Condensed	1 Coliforms, cfu/g	5	1	10	102
Milk	Yeast and Molds Count, cfu/g	5	1	10	102
	SPC/APC, cfu/g	5	1	103	104
Liquid Milk	Commercial Sterility	6	0	Commercially
(evaporated or ready				sterile
to drink) and
Cream (UHT/sterilized)
Pasteurized Milk	2 Coliforms, cfu/mL	5	1	102	103
	Salmonella/25mL	5	0	0
	Listeria monocytogenes/25 mL	5	0	0
	Psychrotrophic bacteria, cfu/mL	5	1	10	102
	SPC/APC, cfu/mL	5	1	5x104	105
	• for flavored milk	5	2	5x104	106
Pasteurized Cream	1 Coliforms, cfu/g	5	1	102	103
	Salmonella/25g	5	0	0
	Listeria monocytogenes/25g	5	0	0
	Psychrotrophic bacteria, cfu/g	5	1	10	102
	SPC/APC, cfu/g	5	1	5x104	105
Yogurt and other	S. aureus (coagulase +), cfu/mL	5	2	10	102
fermented milk	1 Coliforms, cfu/mL	5	2	10	102
	Salmonella/25mL	5	0	0
	Lactic Acid, cfu/mL
	(required minimum level: > 106)	-	-	-	-
Cheese and Cheese	S. aureus (coagulase +), cfu/g	5	2	102	103
Products;	E. coli, MPN/g	5	1	11	110
e.g., Cottage Cheese;	Coliforms, MPN/g	5	1	11	103
Soft and Semi-soft	Psychrotrophic bacteria, cfu/g	5	2	102	103
cheese	Salmonella/25g	5	0	0
(moisture > 39%,	Listeria monocytogenes/25g	5	0	0
pH > 5)
Processed Cheese	1 Coliforms, cfu/g	5	1	10	102
Spread	S. aureus (coagulase +), cfu/g	5	1	10	102
	SPC/APC, cfu/g	5	2	104	5x104
All Raw Milk Cheese;	Campylobacter/25g	5	0	0
Raw Milk Un-ripened	Salmonella/25g	5	0	0
cheese w/ moisture >	Listeria monocytogenes/25g	5	0	0
50%, pH > 5.0	S. aureus (coagulase +), cfu/g	5	2	102	103
Table 2.	Fats, Oils and Fat Emulsions
Food Description	Test/Microorganism	n	c	m	M
	Reference Criteria
Butter	Enterococci, cfu/g	5	1	10	102
(whipped, pasteurized)	YMC, cfu/g	5	1	20	102
	Proteolytic bacteria, cfu/g	5	1	102	103
	Coliforms, cfu/g	5	1	10	102
	S. aureus (coagulase +), cfu/g	5	0	102
	Psychrotrophic bacteria, cfu/g	5	1	10	102
	SPC/APC, cfu/mL	5	1	5x104	105
Butter made from	Coliforms, cfu/g	5	1	10	102
unpasteurized milk or	E. coli, MPN/g	5	1	3	11
milk products	S. aureus (coagulase +), cfu/g	5	1	10	102
	Salmonella/25g	5	0	0
	Listeria monocytogenes/25g	5	0	0
	SPC/APC, cfu/g	5	1	5x104	105
Margarine	S. aureus (coagulase +), cfu/g	5	0	10
	Faecal Coliform, MPN/g	5	2	50	5x102
	Listeria monocytogenes/25g	5	0	0
	Salmonella/25g	5	0	0
	SPC/APC, cfu/g	5	2	2.5x104	2.5x105
	YMC, cfu/g	5	2	50	5x102
Table 3.	Edible Ices, Including Sherbet and Sorbet
Food Description	Test/Microorganism	n	c	m	M
	Reference Criteria
Ice Cream and Sherbet	1 Coliforms, cfu/g	5	1	10	103
(plain and flavored)	Listeria monocytogenes/25g	5	0	0
	Salmonella/25g	5	0	0
	SPC/APC, cfu/g	5	2	104	5x104
	S. aureus (coagulase +), cfu/g	5	1	10	102
Ice Cream with added	1 Coliforms, cfu/g	5	2	10	103
ingredients (nuts, fruits,	S. aureus (coagulase +), cfu/g	5	1	10	102
cocoa, etc.)	Salmonella/25g	5	0	0
	SPC/APC, cfu/g	5	2	5x104	2x105
	Listeria monocytogenes/25g	5	0	0
Flavored Ice	SPC/APC, cfu/g	5	2	102	104
(e.g., Ice candy)	Coliforms, MPN/g	5	0	3.0
	YMC, cfu/g	5	0	102
	Salmonella/25g	5	0	0
Table 4.	Confectioneries
Food Description	Test/Microorganism	n	c	m	M
	Reference Criteria
Cocoa Powder	Molds, cfu/g	5	2	102	104
	Salmonella/25g	5	0	0
	Coliforms, MPN/g	5	2	1.8	10
	SPC/APC, cfu/g	5	2	104	106
Chocolate Products	Molds, cfu/g	5	2	102	104
	Salmonella/25g	10	0	0
	Coliforms, MPN/g	5	2	1.8	102
	SPC/APC, cfu/g	5	2	104	106
Chocolate	Molds, cfu/g	5	2	102	103
Confectionaries	Salmonella/25g	5	0	0
(chocolate bars, blocks,	Coliforms, MPN/g	5	2	1.8	102
bonbons)	SPC/APC, cfu/g	5	2	103	106
Sugar Confectionaries	Molds, cfu/g	5	2	10	102
(Hard and soft candies,	Salmonella/25g	5	0	0
toffees, caramel,	Coliforms, MPN/g	5	2	1.8	102
fondants, creams,	SPC/APC, cfu/g	5	2	104	106
nougats and pastes)
Table 5.	Fruits and Vegetables, Nuts and Seeds
Food Description	Test/Microorganism	n	c	m	M
	Reference Criteria
Frozen Vegetables	E. coli, MPN/g	5	2	110	103
and Fruits
(pH > 4.5)
Fermented Vegetables,	YMC, cfu/g	5	2	102	104
Ready to Eat (e.g.,	Coliforms, MPN/g	5	0	3
Kimchi)	E. coli, MPN/g	5	0	3
	Salmonella/25g	5	0	0
	Staphylococcus aureus, cfu/g	5	0	10
Fruits and Vegetable	Commercial sterility	6	0	Commercially
products in Hermetically				sterile
sealed containers
(thermally processed)
Dried Vegetables	E. coli, MPN/g	5	2	110	103
Coconut (desiccated)	Refer to PNS/BAFPS 25:2007
Peanut Butter and other
Nut Butters
• consumed without	Salmonella/25g	10	0	0
heating or other
treatment to
destroy microbes
• used as ingredient	Salmonella/25g	20	0	0
in high moisture
food
Sun Dried Fruits	Molds, cfu/g	5	2	102	104
	Osmophilic Yeasts, cfu/g	5	2	10	103
	E. coli, MPN/g	5	2	3	11
1.	Coliforms must be negative for E. coli
Table 6.	Egg and Egg Products
Food Description	Test/Microorganism	n	c	m	M
	Reference Criteria
Pasteurized Egg	Coliforms, cfu/g	5	2	10	103
Products	Salmonella/25g	10	0	0
(liquid, frozen or dried)	YMC, cfu/g (for dried products)	5	0	10
	SPC/APC, cfu/g	5	0	2.5x104	105
Table 7.	Cereals and Cereal Products
Food Description	Test/Microorganism	n	c	m	M
	Reference Criteria
Breakfast Cereals	Molds, cfu/g	5	2	10	103
	Yeast and Yeastllike fungi, cfu/g	5	2	10	102
	Coliform, cfu/g	5	2	10	102
	SPC/APC, cfu/g	5	2	103	104
Cereals/Cereal Grains	YMC, cfu/g	5	2	102	104
	SPC/APC, cfu/g	5	2	102	106
	Coliform, cfu/g	5	2	102	104
	E. coli, MPN/g	5	2	102	104
Cultured seeds and	E. coli, MPN/g	5	2	10	102
grains	Coliforms, cfu/g	5	2	102	104
(e.g., bean sprouts,	Salmonella/25g	5	0	0
alfalfa, etc.)
Soya Flours,	Molds, cfu/g	5	2	103	105
Concentrates and	Salmonella/25g	5	0	0
Isolates
Flour, Corn meal, Corn	Molds, cfu/g	5	2	102	104
grits, Semolina	Yeast and Yeastllike fungi, cfu/g	5	2	102	102
	Coliform, cfu/g	5	2	10	102
	Bacillus subtilis, cfu/g	5	2	10	102
	"rope spores"
Frozen entrees	B. cereus, cfu/g	5	1	102	104
containing Rice or
Corn Flour as main
ingredient
Soy Protein	Coliforms, cfu/g	5	2	102	103
	E. coli, MPN/g	5	1	10	102
	Psychrotrophic bacteria, cfu/g	5	2	102	104
	Clostridium perfringens, cfu/g	5	2	10	102
	YMC, cfu/g	5	2	10	102
	Salmonella/25g	5	0	0
	SPC/APC, cfu/g	5	2	102	105
Tofu	B. cereus, cfu/g	5	2	102	103
	E. coli, MPN/g	5	0	1.8
	S. aureus (coagulase +), cfu/g	5	2	102	103
Pasta Products and	Coliforms, cfu/g	5	2	10	103
Noodles Uncooked	YMC, cfu/g	5	2	102	105
(wet and dry)	S. aureus (coagulase +), cfu/g	5	1	102	104
	Salmonella/25g	5	0	0
	SPC/APC, cfu/g	5	2	103	105
Starch	Coliforms, cfu/g	5	2	10	102
	YMC, cfu/g	5	2	102	103
	Salmonella/25g	5	0	0
	SPC/APC, cfu/g	5	2	103	5x104
Table 8.	Bakery Products
Food Description	Test/Microorganism	n	c	m	M
	Reference Criteria
Frozen Bakery products	S. aureus (coagulase +), cfu/g	5	1	102	104
(ready to eat) with low-	Salmonella/25g	5	0	0
acid or high aw fillings
or toppings
Frozen Bakery Products	S. aureus (coagulase +), cfu/g	5	1	102	104
(to be cooked) with low-	Salmonella/25g	5	0	0
acid or high aw fillings
or toppings
(e.g., meat pies, pizzas)
Frozen and Refrigerated	Molds, cfu/g	5	2	102	104
Doughs	Yeasts and Yeastlike Fungi, cfu/g	5	2	105	106
(Chemically leavened)	Coliforms, cfu/g	5	2	10	102
	Psychrotrophic bacteria, cfu/g	5	2	10	103
	SPC/APC, cfu/g	5	2	102	107
	Salmonella/25g	5	0	0
	S. aureus (coagulase +), cfu/g	5	2	102	104
	E. coli, MPN/g	5	0	3.0
Frozen and	Molds, cfu/g	5	2	102	104
Refrigerated Doughs	Yeasts and Yeastlike Fungi, cfu/g	5	2	105	106
	Coliforms, cfu/g	5	2	10	102
	Psychrotrophic bacteria, cfu/g	5	2	10	103
	SPC/APC, cfu/g	5	2	103	106
Baked Goods	S. aureus (coagulase +), cfu/g	5	2	102	104
(microbiologically	MYC, cfu/g	5	2	102	104
sensitive types, e.g.,	SPC/APC, cfu/g	5	2	104	106
containing eggs and	Coliforms, cfu/g	5	2	50	103
dairy products)
Coated or Filled,	1 Coliforms, MPN/g	5	2	3	20
Dried  Shelf-Stable	Salmonella/25g	10	0	0
Biscuits
Table 9.	Ready to Eat Savouries
Food Description	Test/Microorganism	n	c	m	M
	Reference Criteria
Snack Foods	Molds, cfu/g	5	2	10	103
	Yeast and Yeastllike fungi, cfu/g	5	2	10	102
	Coliform, cfu/g	5	2	10	102
	SPC/APC, cfu/g	5	2	103	104
Table 10.	Meat and Meat Products **
Food Description	Test/Microorganism	n	c	m	M
	Reference Criteria
Dried Animal Products	S. aureus (coagulase +), cfu/g	5	1	102	104
	Clostridium perfringens, cfu/g	5	1	102	104
	Salmonella/25g	10	0	0
Meat Paste & Paté	Salmonella/25g	5	0	0
(heat treated)	Clostridium perfringens, cfu/g	5	2	102	103
	S. aureus (coagulase +), cfu/g	5	2	102	103
	1 Coliforms, cfu/g	5	2	10	102
	SPC/APC, cfu/g	5	2	104	105
Cold Cuts, Frozen and	E. coli, MPN/g	5	0	1.8
Chilled Hot Dogs,	Salmonella/25g	10	0	0
Corned Beef, Luncheon	S. aureus (coagulase +), cfu/g	5	2	102	103
Meat	SPC/APC, cfu/g	5	2	105	106
Packaged cooked	S. aureus (coagulase +), cfu/g	5	2	102	103
cured/salted meat (ham,	Salmonella/25g	5	0	0
bacon)	Listeria monocytogenes/25g	5	0	0
Fermented, comminuted	E. coli, MPN/g	5	0	1.8
meat, not cooked (dry	S. aureus (coagulase +), cfu/g	5	1	103	104
and semi-dry fermented	Salmonella/25g	5	0	0
sausages)
Cooked Poultry Meat,	S. aureus (coagulase +), cfu/g	5	1	103	104
Frozen to be reheated	Salmonella/25g	5	0	0
before eating (e.g.,
prepared frozen meals)
Cured/Smoked Poultry	S. aureus (coagulase +), cfu/g	10	1	103	104
Meat	Salmonella/25g	10	0	0
Dehydrated Poultry	Salmonella/25g	10	0	0
Products
Fresh/Frozen Raw	SPC/APC, cfu/g (at 20°C)	5	3	5x105	107
Chicken
(during processing)
Meat Products in	Commercial sterility	6	0	Commercially
hermetically sealed				sterile
containers
Table 11.	Fish and Fish Products
Food Description	Test/Microorganism	n	c	m	M
	Reference Criteria
Fresh Frozen Fish a	E. coli, MPN/g	5	3	11	500
and Cold-Smoked b	S. aureus (coagulase +), cfu/g	5	2	103	104
	V. parahaemolyticus, cfu/g	5	2	102	103
	Salmonella/25g	5	0	0
	SPC/APC, cfu/g	5	3	5x105	107
Pre-Cooked Breaded	E. coli, MPN/g	5	2	11	500
Fish	S. aureus (coagulase +), cfu/g	5	1	103	104
	SPC/APC, cfu/g	5	2	5x105	107
Frozen Raw	E. coli, MPN/g	5	3	11	500
Crustaceans c	S. aureus (coagulase +), cfu/g	5	2	103	104
	Salmonella/25g	5	0	0
	V. parahaemolyticus, cfu/g	5	1	102	103
	SPC/APC, cfu/g	5	3	106	107
Frozen Cooked	E. coli, MPN/g	5	2	11	500
Crustaceans	S. aureus (coagulase +), cfu/g	5	0	102
	Salmonella/25g	20	0	0
	V. parahaemolyticus, cfu/g	10	1	102	103
	SPC/APC, cfu/g	5	2	5x105	5x106
Cooked, Chilled and	E. coli, MPN/g	5	1	11	500
Frozen Crabmeat d	S. aureus (coagulase +), cfu/g	5	0	103
	V. parahaemolyticus, cfu/g	10	1	102	103
	SPC/APC, cfu/g	5	2	105	106
Fresh and Frozen	E. coli, MPN/g	5	0	16
Bivalve Molluscs e	Salmonella/25g	20	0	0
	V. parahaemolyticus, cfu/g	10	1	102	103
	SPC/APC, cfu/g	5	0	5x105
Fish and Shellfish	Commercial Sterility	6	0	Commercially
products in hermetically				sterile
sealed containers
(thermally processed)
Table 12.	Spices, Soups, Sauces, Salads and Protein Products
Food Description	Test/Microorganism	n	c	m	M
	Reference Criteria
Dry Mixes for Soup	Clostridium perfringens, cfu/g	5	2	102	103
and Sauces	YMC, cfu/g	5	3	102	104
	Coliforms, cfu/g	5	3	10	103
	SPC/APC, cfu/g	5	2	104	106
	Salmonella/25g	5	0	0
Yeast	Salmonella/25g	20	0	0
Spices	Molds, cfu/g	5	2	102	104
	SPC/APC, cfu/g	5	2	104	106
Spices (ready to eat)	1 Coliforms, cfu/g	5	2	102	103
	S. aureus (coagulase +,), cfu/g	5	2	102	104
	Salmonella/25g	5	0	0
	Molds, cfu/g	5	2	102	104
	SPC/APC, cfu/g	5	2	104	106
Salad Dressing,	SPC/APC, cfu/g	5	2	10	102
pH < 4.6	YMC, cfu/g	5	2	10	102
(e.g., Mayonnaise,	Salmonella/25g	5	0	0
Thousand Island, Ranch,	Listeria monocytogenes/25g	5	0	0
French)
Table 13.	Beverages
Food Description	Test/Microorganism	n	c	m	M
	Reference Criteria
Non Alcoholic Beverages	YMC, cfu/mL	5	0	1
(e.g., Ready to drink,	Coliforms, cfu/mL	5	0	1
softdrinks, iced tea,	SPC/APC, cfu/mL	5	1	10	102
energy drinks)
Frozen Juice	SPC/APC, cfu/mL	5	2	102	105
Concentrate	YMC, cfu/mL	5	1	10	50
Powdered Beverages	SPC/APC, cfu/g	5	0	3x103
(e.g., iced tea, powdered	Coliforms, cfu/g	5	0	10
juices/mixes)
Table 14.	Food for Infants and Young Children
Food Description	Test/Microorganism	n	c	m	M
	Reference Criteria
Powdered Infant	Routine analysis:
Formula with or without	Cronobacter spp./10g	30	0	0
added Lactic acid	* Salmonella/25 g	60	0	0
producing cultures	For complaint investigation
(intended for 0 to 6	(additional to routine analysis):
months old)	1 Coliforms, MPN/g	5	2	3	11
	E. coli, MPN/g	10	1	1.8	10
	2 Process Hygiene Indicators:
	SPC/APC, cfu/g	5	2	5x102	5x103
	Enterobacteriaceae/10g	10	2	0	3 NA
Follow-up Formula/Milk	Routine analysis:
Supplement	* Salmonella/25 g	60	0	0
(intended for infants 6	For complaint investigation
months on and for young	(additional to routine analysis):
children 12-36 months	1 Coliforms, MPN/g	5	2	3	11
of age)	E. coli, MPN/g	10	1	1.8	10
	2 Process Hygiene Indicators:
	SPC/APC, cfu/g	5	2	5x102	5x103
	Enterobacteriaceae/10g	10	2	0	3 NA
Infant Formula-liquid	Commercial Sterility	6	0	Commercially
(UHT/sterilized)				Sterile
Baby foods in	Commercial Sterility	6	0	Commercially
hermetically sealed				Sterile
containers
Dried and Instant	1 Coliforms, MPN/g	5	1	3	20
products requiring	SPC/APC, cfu/g	5	2	103	104
reconstitution	* Salmonella/25g	60	0	0
	Listeria monocytogenes/25g	5	0	0
Dried products requiring	1 Coliforms, cfu/g	5	2	10	102
reconstitution and	Salmonella/25g	5	0	0
boiling before	SPC/APC, cfu/g	5	3	104	105
consumption
Cereal based foods	Bacillus cereus, cfu/g	10	1	102	104
for infants	Clostridium perfringens, cfu/g	5	1	10	102
	SPC/APC, cfu/g	5	2	103	104
	Salmonella/25 g	10	0	0
	Coliforms, MPN/g	5	2	3	20

 

Footnotes

1. Coliforms must be negative for E. coli.

** Effective 16 February 2010, all meat and meat products are being handled and regulated by the National Meat Inspection Service (NMIS) of the Department of Agriculture as mandated by RA 9296 "Meat Inspection Code of the Philippines and DA-DOH joint Administrative Order No. 1, s. 2009". Any guidelines set by the NMIS shall supersede the specifications herein stated once it is made available.

a. For fish derived from inshore/inland waters of doubtful bacteriological quality, particularly warm areas or harvested during summer. Tests for Salmonella and V. parahaemolyticus recommended if fish is to be eaten raw.

b. Test for S. aureus recommended for smoked fish.

c. Test for S. aureus recommended for breaded products. Salmonella and V. parahaemolyticus applied to products from waters or harvested during summer.

d. SPC/APC for frozen products only.

e. Criteria to be used only for molluscs from approved harvesting areas where waters are free from enteric bacteria or virus contamination and no significant contamination by toxic metals or chemicals may be accumulated by animals.

  Tests for Salmonella and V. parahaemolyticus recommended for molluscs from endemic areas or harvested from warm waters during summer.

* 25g sample units may be composited to a quantity not to exceed 400g.

 n = 60 ® 4 x 15 (25g) composite units

2. Process hygiene criteria to be applied to the finished product (powder form) or at any other previous point that provides the information necessary for the purpose of verification. The criteria is intended to be used by the manufacturer as a means of ongoing assessment of their hygiene programs. (CAC/RCP 66-2008).

3. NA = not applicable

Legend:

n — number of sample units selected from a lot of food to be examined

m — acceptable level of microorganism determined by a specified method; the values are generally based on levels that are achievable under GMP

M — level which when exceeded in one or more samples would cause the lot to be rejected as this indicates potential health hazard or imminent spoilage

c — maximum allowable number of defective or marginally acceptable units