SECTION 310:260-3-6. Processes and controls

(a)   General.

(1)   All operations in the manufacturing, processing, packing, and holding of food (including operations directed to receiving, inspecting, transporting, and segregating) must be conducted in accordance with adequate sanitation principles.

(2)   Appropriate quality control operations must be employed to ensure that food is suitable for human consumption and that food-packaging materials are safe and suitable.

(3)   Overall sanitation of the plant must be under the supervision of one or more competent individuals assigned responsibility for this function.

(4)   Adequate precautions must be taken to ensure that production procedures do not contribute to allergen cross-contact and to contamination from any source.

(5)   Chemical, microbial, or extraneous-material testing procedures must be used where necessary to identify sanitation failures or possible allergen cross-contact and food contamination.

(6)   All food that has become contaminated to the extent that it is adulterated must be rejected, or if appropriate, treated or processed to eliminate the contamination.

(b)   Raw materials and other ingredients.

(1)   Raw materials and other ingredients shall be inspected and segregated or otherwise handled as necessary to ascertain that they are clean and suitable for processing into food and shall be stored under conditions that will protect against allergen cross-contact and against contamination and minimize deterioration. Raw materials shall be washed or cleaned as necessary to remove soil or other contamination. Water used for washing, rinsing, or conveying food shall be safe and of adequate sanitaryquality. Water may be reused for washing, rinsing, or conveying food if it does not cause allergen cross-contact orincreases the level of contamination of the food. Containers and carriers of raw materials should be inspected on receipt to ensure that their condition has not contributed to the contamination or deterioration of food.

(2)   Raw materials and other ingredients shall either not contain levels of microorganisms that may render the food injurious to the health of in humans, or they shall be pasteurized or otherwise be treated during manufacturing operations so that they no longer contain levels that would cause the product to be adulterated.

(3)   Raw materials and other ingredients susceptible to contamination with aflatoxin or other natural toxins shall comply with current FDA regulations for poisonous or deleterious substances before these materials or ingredients are incorporated into finished food.

(4)   Raw materials, other ingredients, and rework susceptible to contamination with pests, undesirable microorganisms, or extraneous material shall comply with applicable FDA regulations for natural or unavoidable defects if a manufacturer wishes to use the materials in manufacturing food.

(5)   Raw materials, other ingredients, and rework shall be held in bulk, or in containers designed and constructed so as to protect against allergen cross-contact and against contamination and shall be held at such temperature and relative humidity and in such a manner as to prevent the food from becoming adulterated. Material scheduled for rework shall be identified as such and separated from other foods.

(6)   Frozen raw materials and other ingredients shall be kept frozen. If thawing is required prior to use, it shall be done in a manner that prevents the raw materials and other ingredients from becoming adulterated.

(7)   Liquid or dry raw materials and other ingredients received and stored in bulk form shall be held in a manner that protects against allergen cross-contact and against contamination.

(8)   Raw materials and other ingredients that are food allergens, and rework that contains food allergens, must be identified and held in a manner that prevents allergen cross-contact.

(c)   Manufacturing operations.

(1)   Equipment and utensils and finished food containers shall be maintained in an adequate condition through appropriate cleaning and sanitizing, as necessary. Insofar as necessary, equipment shall be taken apart for thorough cleaning.

(2)   All food manufacturing, including packaging and storage, shall be conducted under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms and allergen cross-contact.

(3)   Food that can support the rapid growth of undesirable microorganisms shall be held at temperatures that will prevent the food from becoming adulterated during manufacturing, processing, packing, and holding.

(4)   Measures such as sterilizing, irradiating, pasteurizing, freezing, refrigerating, controlling pH or controlling aw that are taken to destroy or prevent the growth of undesirable microorganismsshall be adequate under the conditions of manufacture, handling, and distribution to prevent food from being adulterated.

(5)   Work-in-process and rework shall be handled in a manner that protects against allergen cross-contact, contamination, and growth of undesirable microorganisms.

(6)   Effective measures shall be taken to protect finished food from allergen cross-contact and from contamination by raw materials, other ingredients, or refuse. When raw materials, other ingredients, or refuse are unprotected, they shall not be handled simultaneously in a receiving, loading, or shipping area if that handling could result in allergen cross-contact or contaminated food. Food transported by conveyor shall be protected against allergen cross-contact and against contamination as necessary.

(7)   Equipment, containers, and utensils used to convey, hold, or store raw materials and other ingredients, work-in-process, rework or other food shall be constructed, handled, and maintained during manufacturing processing, packing, and holding in a manner that protects against allergen cross-contact and against contamination.

(8)   Adequate measures shall be taken to protect against the inclusion of metal or other extraneous material in food.

(9)   Food, raw materials, and other ingredients that are adulterated:

(A)   Shall be disposed in a manner that protects against the contamination of other food; or

(B)   If the adulterated food is capable of being reconditioned, it shall be:

(i)   Reconditioned (if appropriate) using a method that has been proven to be effective; or

(ii)   Reconditioned (if appropriate) and reexamined and subsequently found not to be adulterated before being incorporated into other food.

(10)   Steps such as washing, peeling, trimming, cutting, sorting and inspecting, mashing, dewatering, cooling, shredding, extruding, drying, whipping, defatting, and forming shall be performed so as to protect food against allergen cross-contact and against contamination.

(11)   Heat blanching, when required in the preparation of food capable of supporting microbial growth, should be effected by heating the food to the required temperature, holding it at this temperature for the required time, and then either rapidly cooling the food or passing it to subsequent manufacturing without delay. Growth and contamination by thermophilic microorganisms in blanchers should be minimized by the use of adequate operating temperatures and by periodic cleaning and sanitizing as necessary.

(12)   Batters, breading, sauces, gravies, dressings, dipping solutions, and other similar preparations that are held and used repeatedly over time shall be treated or maintained in such a manner that they are protected against allergen cross-contact and against contamination, and minimizing the potential for the growth of undesirable microorganisms.

(13)   Filling, assembling, packaging, and other operations shall be performed in such a way that the food is protected against allergen cross-contact, contamination, and growth of undesirable microorganisms.

(14)   Food such as, but not limited to, dry mixes, nuts, immediate moisture food, and dehydrated food, that relies on the control of aw for preventing the growth of undesirable microorganisms shall be processed to and maintained at a safe moisture level.

(15)   Food such as, but not limited to, acid and acidified food, that relies principally on the control of pH for preventing the growth of undesirable microorganisms shall be monitored and maintained at a pH of 4.6 or below.

(16)   When ice is used in contact with food, it shall be made from water that is safe and of adequate sanitary quality in accordance with 310:260-3-4(a), and shall be used only if it has been manufactured in accordance with current good manufacturing practice as outlined in these regulations.

(17)   Food-manufacturing areas and equipment used for manufacturing human food shall not be used to manufacture nonhuman food grade animal feed or inedible products, unless there is no reasonable possibility for the contamination of the human food.

(18)   Food manufacturing shall not be performed in places of human residence nor shall manufacturing areas open directly into rooms occupied as residence or sleeping quarters.

(19)   Meaningful coding of products sold or otherwise distributed from a manufacturing, processing, packing, or repacking activity should be utilized to enable positive lot identification to facilitate, where necessary, the segregation of specific food lots that may have become contaminated or otherwise unfit for their intended use. Records should be retained for a period of time that exceeds the shelf life of the product, except that they need not be retained more than two (2) years.

[Source: Amended at 37 Ok Reg 1385, eff 9-11-20]