3701-21-01(V) Definitions

"Time/temperature controlled for safety food" or "TCS food" means a food that needs time/temperature control for safety to limit pathogenic microorganism growth or toxin formation.

(1)

TCS food includes:

(a)

An animal food that is raw or heat-treated; a plant food that is heat-treated or consists of raw seed sprouts, cut melons, cut leafy greens, cut tomatoes or mixtures of cut tomatoes that are not modified in a way so that they are unable to support pathogenic microorganism growth or toxin formation, or garlic-in-oil mixtures that are not modified in a way so that they are unable to support pathogenic microorganism growth or toxin formation; and

(b)

Except as specified in paragraph (V)(2)(d) of this rule, a food that because of the interaction of its aw and pH values is designated as product assessment (PA) needed in table A or B of this rule. Table A. Interaction of pH and aw for control of spores in food heat-treated to destroy vegetative cells and subsequently packaged pH of 4.6 or less · pH greater than 4.6 to 5.6 · pH greater than 5.6 aw less than or equal to 0.92 · non-TCS food · non-TCS food · non-TCS food aw greater than 0.92 to 0.95 · non-TCS food · non-TCS food · PA aw greater than 0.95 · non-TCS food · PA · PA Table B. Interaction of pH and aw for control of vegetative cells and spores in food not heat-treated or heat-treated but not packaged pH less than 4.2 · pH 4.2 to 4.6 · pH greater than 4.6 to 5.0 · pH greater than 5.0 aw less than 0.88 · non-TCS food · non-TCS food · non-TCS food · non-TCS food aw 0.88 to 0.90 · non-TCS food · non-TCS food · non-TCS food · PA aw greater than 0.90 to 0.92 · non-TCS food · non-TCS food · PA · PA aw greater than 0.92 · non-TCS food · PA · PA · PA

(2)

TCS food does not include:

(a)

An air-cooled hard-boiled egg with shell intact, or an egg with shell intact that is not hard-boiled, but has been pasteurized to destroy all viable salmonellae;

(b)

A food in an unopened hermetically sealed container that is commercially processed to achieve and maintain commercial sterility under conditions of non-refrigerated storage and distribution;

(c)

A food that because of its pH or aw value, or interaction of aw and pH values, is designated as a non-TCS food in table A or B of paragraph (V)(1) of this rule;

(d)

A food that is designated as product assessment (PA) needed in table A or B of paragraph (V)(1) of this rule and has undergone a product assessment showing that the growth or toxin formation of pathogenic microorganisms that are reasonably likely to occur in that food is precluded due to:

(i)

Intrinsic factors including added or natural characteristics of the food such as preservatives, antimicrobials, humectants, acidulants, or nutrients,

(ii)

Extrinsic factors including environmental or operational factors that affect the food such as packaging, modified atmosphere such as reduced oxygen packaging, shelf life and use, or temperature range of storage and use, or

(iii)

A combination of intrinsic and extrinsic factors; or

(e)

A food that does not support the growth or toxin formation of pathogenic microorganisms in accordance with paragraph (V)(2)(a), (V)(2)(b), (V)(2)(c) or (V)(2)(d) of this rule even though the food may contain a pathogenic microorganism or chemical or physical contaminant at a level sufficient to cause illness or injury.