Ala. Admin. Code r. 420-3-16-.02

Current through Register Vol. 43, No. 02, November 27, 2024

Section 420-3-16-.02 - Definitions

Products which have a standard of identity defined in the Code of Federal Regulations (CFR) are referenced in Appendix L.

(1)Abnormalities of Milk - The following types of lacteal secretions are not suitable for sale for Grade "A" purposes.

(a) Abnormal Milk - Milk that is visibly changed in color, odor, or texture.

(b) Undesirable Milk - Milk that, prior to the milking of the animal, is expected to be unsuitable for sale, such as milk containing colostrum.

(c) Contaminated Milk - Milk that is unsaleable or unfit for human consumption following treatment of the animal with veterinary products, (i.e. antibiotics), which have withhold requirements, or treatment with medicines or insecticides not approved for use on dairy animals by the U.S. Food and Drug Administration (FDA) or the U.S. Environmental Protection Agency (EPA).

(2)Acidified Milk - Acidified milk (buttermilk, etc.) is the product defined in the CFR, Title 21, §131.111.

(a) Acidified Low-fat Milk - Acidified low-fat milk (buttermilk, etc.) is the product defined in the CFR, Title 21, §131.111.

(b) Acidified Skim Milk - Acidified skim milk (buttermilk, etc.) is the product defined in the CFR, Title 21, §131.111.

(3)Adulterated Milk and Milk Products - Any milk or milk product shall be deemed to be adulterated if one or more of the conditions described in §402 of the Federal Food, Drug, and Cosmetic Act (FFD&CA), as amended (21 U.S.C. 342) exist (refer to Appendix L.).

(4)And/Or - Where the term "and/or" is used, "and" shall apply where appropriate; otherwise "or" shall apply.

(5)Aseptic Processing and Packaging - Aseptic processing, when used to describe a milk and/or milk product, means that the milk and/or milk product has been subjected to sufficient heat processing and packaged in a hermetically sealed container to conform to the applicable requirements of 21 CFR Parts 108, 110, and 113 and to maintain the commercial sterility of the milk and/or milk product under normal non-refrigerated conditions.

(6)Aseptic Processing and Packaging System (APPS) -

For the purposes of this rule, the APPS in a milk plant is comprised of the processes and equipment used to process and package aseptic Grade "A" low-acid milk and/or milk products. The APPS shall be regulated in accordance with the applicable requirements of 21 CFR Parts 108, 110, and 113. The APPS shall begin at the constant level tank and end at the discharge of the packaging machine, provided that the process authority may provide written documentation which will clearly define additional processes, or equipment that are considered critical to the commercial sterility of the product.

(7)Automatic Milking Installation (AMI) - The AMI covers the entire installation of one (1) or more automatic milking units, including the hardware and software utilized in the operation of individual automatic milking units, the animal selection system, the automatic milking machine, the milk cooling system, the system for cleaning and sanitizing the automatic milking unit, the teat cleaning system, and the alarm systems associated with the process of milking, cooling, cleaning, and sanitation.

(8)Board - The Board of Health of the State of Alabama as defined by Code of Ala. 1975, § 22-2-1, § 22-2-2, and § 22-20-7 or the State Health Officer or his/her designee, when acting for the Board for the purpose of these rules, the Division of Environmental Program Management, Bureau of Environmental and Health Service Standards Administration or County Board of Health, as defined by Code of Ala. 1975, § 22-3-1.

(9)Bulk Milk Hauler or Sampler - A bulk milk hauler or sampler is any person who collects official samples and may transport raw milk from a farm, or raw milk products to, or from a milk plant, frozen dessert plant, receiving station, or transfer station and has in their possession a permit from any Health Officer to sample such products.

(10)Bulk Milk Pickup Tanker - A bulk milk pickup tanker is a vehicle, including the truck, tank, and those appurtenances necessary for its use, used by a milk hauler or sampler to transport bulk raw milk for pasteurization, ultra-pasteurization, aseptic processing and packaging, or retort processed after packaging from a dairy farm to a milk plant, frozen dessert plant, receiving station, or transfer station.

(11)Buttermilk - Buttermilk is a fluid product resulting from the manufacture of butter from milk or cream. It contains not less than 81/4 percent of milk solids not fat.

(a) Grade "A" Dry Buttermilk - Grade "A" dry buttermilk means dry buttermilk, which complies with the applicable provisions of this rule.

(b) Grade "A" Dry Buttermilk Products - Grade "A" dry buttermilk products means dry buttermilk products, which complies with the applicable provisions of this rule.

(c) Concentrated (Condensed) Buttermilk -Concentrated (condensed) buttermilk is the product resulting from the removal of a considerable portion of water from buttermilk.

(d) Grade "A" Concentrated (Condensed) and Dry Buttermilk and Buttermilk Products - Grade "A" concentrated (condensed) and dry buttermilk and buttermilk products means concentrated (condensed), or dry buttermilk and buttermilk products, which comply with the applicable provisions of this rule. The words "concentrated (condensed) and dry milk products" shall be interpreted to include concentrated (condensed) and dry buttermilk and buttermilk products.

(12)Camel Milk - Camel milk is the normal lacteal secretion practically free of colostrum, obtained by the complete milking of one (1) or more healthy camels. Camel milk shall be produced according to the sanitary standards of this rule. The word "milk" shall be interpreted to include camel milk (refer to the Note: on page 35).

(13)Clean - Direct product contact surfaces that have had the effective and thorough removal of product and/or contaminants.

(14)Clean-In-Place (CIP) Cleaning - The removal of soil from product contact surfaces in their process position by circulating, spraying, or flowing chemical solutions and water rinses onto and over the surfaces to be cleaned. Components of the equipment, which are not designed to be CIP, are removed from the equipment to be Cleaned-Out-Of-Place (COP) or manually cleaned. Product contact surfaces shall be inspectable, except when the cleanability by CIP has been documented and accepted by the Health Officer. In such accepted equipment, all product and solution contact surfaces do not have to be readily accessible for inspection, (i.e., permanently installed pipelines and silo tanks).

(15)Common Name - The generic term commonly used for domestic animals, (i.e., cattle, goats, sheep, horses, water buffalo, camels, etc.) (refer to the Note: on page 35).

(16)Concentrated (Condensed) Milk - Concentrated (condensed) milk is a fluid product, unsterilized, and unsweetened, resulting from the removal of a considerable portion of the water from the milk, which when combined with potable water in accordance with instructions printed on the container label, results in a product conforming with the milkfat and milk solids not fat levels of milk as defined in this section.

(a) Concentrated (Condensed) Milk Products -Concentrated (condensed) milk products shall be taken to mean and to include homogenized concentrated (condensed) milk, concentrated (condensed) skim milk, concentrated (condensed) reduced fat or low-fat milk, and similar concentrated (condensed) products made from concentrated (condensed) milk or concentrated (condensed) skim milk, which when combined with potable water in accordance with instructions printed on the container label, conform with the definitions of the corresponding milk products in this section.

(b) Grade "A" Concentrated (Condensed) Skim Milk -Grade "A" concentrated (condensed) skim milk means concentrated (condensed) skim milk, which complies with the applicable provisions of this rule.

(17)Confections - Confections are candy, cakes, cookies, cereal products, and glazed fruits.

(18)Cooling Pond - A cooling pond is a man-made structure designed for the specific purpose of cooling animals.

(19)Cottage Cheese - Cottage cheese is the product defined in the CFR, Title 21, §133.128.

(20)Cream - Cream is the product defined in the CFR, Title 21, §131.3(a).

(a) Light Cream - Light Cream is the product defined in the CFR, Title 21, §131.155.

(b) Light Whipping Cream - Light whipping cream is the product defined in the CFR, Title 21, §131.157.

(c) Heavy Cream or Heavy Whipping Cream - Heavy cream or heavy whipping cream is the product defined in the CFR, Title 21, §131.150.

(d) Whipped Cream - Whipped cream is the product defined in the CFR, Title 21, §131.150 or 131.157, into which air or gas has been incorporated.

(e) Whipped Light Cream - Whipped light cream is the product defined in the CFR, Title 21, §131.155, into which air or gas has been incorporated.

(f) Sour Cream or Cultured Sour Cream - Sour cream or cultured sour cream is the product defined in the CFR, Title 21, §131.160.

(g) Acidified Sour Cream - Acidified sour cream is the product defined in the CFR, Title 21, §131.162.

(21)Cultured Milk - Cultured milk (buttermilk, etc.) is the product defined in the CFR, Title 21, §131.112.

(22)Dairy Farm - A dairy farm is any place or premises where one (1) or more lactating animals (cows, goats, sheep, water buffalo, or other hooved mammals) are kept for milking purposes and from which a part or all of the milk, milk products, or frozen desserts are provided, sold, or offered for sale to a milk plant, frozen dessert plant, receiving station, or transfer station.

(23)Dairy Plant Sampler - A person responsible for the collection of official samples for regulatory purposes outlined in Rule 420-3-16-.07. This person is an employee of the Health Officer and is evaluated at least once every two (2) year period by a Sampling Surveillance Officer (SSO) or a properly delegated Sampling Surveillance Regulatory Agency Official (dSSO). SSOs or properly dSSOs are not required to be evaluated for sampling collection procedures.

(24)Drug - Drug means the following:

(a) Articles recognized in the official United States Pharmacopeia, Official Homeopathic Pharmacopeia of the United States, or Official National Formulary or any Supplement to any of them.

(b) Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.

(c) Articles (other than food) intended to affect the structure or any function of the body of man or other animals.

(d) Articles intended for use as a component of any articles specified in clause (a), (b) or (c), but does not include devices or their components, parts, or accessories.

(25)Dry Curd Cottage Cheese - Dry curd cottage cheese is the product defined in the CFR, Title 21, §133.129.

(26)Eggnog - Eggnog or boiled custard is the product defined in 21 CFR § 131.170.

(27)Filled Milk or Filled Milk Products - Filled milk or filled milk products shall be taken to mean any substance, mixture, or compound, in part or whole, regardless of the name under which it may be processed, packaged, sold, or offered for sale in imitation or having the appearance or semblance of milk or milk products and which contains a mixture of any milk or milk product and any fat or oil other than milkfat. Filled milk and filled milk products shall contain the minimum percentages of wholesome fat or oil other than milkfat and solids, not fat, as defined in these rules for milk and milk products. Nothing herein is intended to make legal any food substance which is otherwise prohibited or illegal.

(28)Food Allergens - Food allergens are proteins in foods that are capable of inducing an allergic reaction or response in some individuals. Foods that are considered allergens are defined in the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004 (Public Law 108-282) and Section 201(qq) of the FFD&CA. Information about food allergens may also be found at: http://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAllergens/default.htm.

(a) Allergen Cross-Contact - Allergen cross-contact means the unintentional incorporation of a food allergen into a food.

(29)Frozen Desserts - A frozen dessert is any clean, frozen, or partially frozen combination of two or more of the following: milk, milk products, egg or egg products, sweetening agents, water, fruit or fruit juices, vegetables, confections, nut meat, or other harmless and wholesome food products, certified natural or artificial flavors or colors, or harmless stabilizers and/or emulsifiers, and shall mean and include ice cream, frozen custards, ice milk, sherbets, ices, imitation frozen desserts, and any product used for similar purposes and designated as a frozen dessert by the Health Officer. Milk and milk products in frozen desserts may be Grade "A" or ungraded.

(30)Frozen Dessert Mix - Frozen dessert mix is the unfrozen combination of all ingredients of a frozen dessert with or without fruits, fruit juices, confections, nut meats, flavoring, harmless coloring, or emulsifiers and/or stabilizers, either in the liquid or dry form.

(31)Frozen Dessert Plant - Frozen dessert plant shall mean and include any place or premises where mix or frozen dessert is manufactured, processed, or frozen for distribution or sale.

(32)Frozen Milk Concentrate - Frozen milk concentrate is a frozen milk product with a composition of milk fat and milk solids not fat in such proportions that when a given volume of concentrate is mixed with a given volume of water the reconstituted product conforms to the milk fat and milk solids not fat requirements of whole milk. In the manufacturing process, water may be used to adjust the primary concentrate to the final desired concentration. The adjusted primary concentrate is pasteurized, packaged, and immediately frozen. This product is stored, transported, and sold in the frozen state.

(33)Goat Milk - Goat milk is the normal lacteal secretion, practically free of colostrums, obtained by the complete milking of one or more healthy goats. Goat milk sold in retail packages shall contain not less than 2.5 percent milkfat and not less than 7.5 percent milk solids not fat. Goat milk shall be produced according to the sanitary standards of these rules. The word "milk" shall be interpreted to include goat's milk and should comply with all the requirements of these rules. The word "lactating animals" shall be interpreted to include goats, sheep, water buffalo, and other hooved mammals, and shall comply with all the requirements of these rules.

(34)Goat's Milk Ice Cream - Goat's milk ice cream is the product defined in the CFR, Title 21, §135.115.

(35)Grade "A" Dry Milk and Whey Products - Grade "A" dry milk and whey products are products which have been produced for use in Grade "A" pasteurized, ultra-pasteurized, or aseptically processed milk products and which have been manufactured under the provisions of the Grade "A" Condensed and Dry Milk Products and Condensed and Dry Whey, 1978, Recommended Sanitation Rule for Condensed and Dry Milk Products and Condensed and Dry Whey Used in Grade "A" Pasteurized Milk Products.

(36)Half-And-Half - Half-and-half is the product defined in the CFR, Title 21, §131.180.

(37)Health Department - The State of Alabama, Department of Public Health or County Health Department, as defined by Code of Ala. 1975, § 22-1-1 and § 22-3-10 and any officer, agent, or employee of the Department authorized to act for the Department with respect to the enforcement and administration of these rules.

(38)Health Officer - The State Health Officer of the Alabama Department of Public Health or a County Health Officer, as provided in Code of Ala. 1975, § 22-2-8 and § 22-3-4, or their authorized representatives and any officer or agent or employee of the said Department authorized to act for the Department with respect to the enforcement and administration of these rules.

(39)Hermetically Sealed Container - A hermetically sealed container is a container that is designed and intended to be secure against the entry of microorganisms and, thereby, maintain the commercial sterility of its contents after processing.

(40)Homogenized - "Homogenized" means milk or a milk product that has been treated to ensure breakup of the fat globules to such an extent that after forty-eight (48) hours of quiescent storage at 45°F (7°C), no visible cream separation occurs on the milk and the fat percentage of the top one-hundred (100) milliliters of milk in a quart or of proportionate volumes in containers of other sizes does not differ by more than 10 percent from the fat percentage of the remaining milk, as determined, after thorough mixing.

(41)Hooved Mammals' Milk - Hooved mammals' milk is the normal lacteal secretion, practically free of colostrum, obtained by the complete milking of one (1) or more healthy hooved mammals. Hooved mammals for the purpose of this rule, include, but are not limited to, the members of the Order Cetartiodactyla, such as: Family Bovidae (cattle, water buffalo, sheep, goats, yaks, etc.), Family Camelidae (llamas, alpacas, camels, etc.), Family Cervidae (deer, reindeer, moose, etc.), and Family Equidae (horses, donkeys, etc.). This product shall be produced according to the sanitary standards of this rule (refer to the Note: of page 35).

(42)Ice Cream and Frozen Custard - Ice cream and frozen custard is the product defined in the CFR, Title 21, §135.110.

(43)Imitation Milk, Imitation Milk Products, or Imitation Frozen Desserts - Imitation milk, imitation milk products, or imitation frozen desserts shall be taken to mean any substance, mixture, or compound, in part or whole, regardless of the name under which it may be processed, packaged, sold, or offered for sale in imitation, or having the appearance or semblance of milk, milk products, or frozen desserts and which does not contain any milk, milk product, or frozen dessert product. Imitation milk, milk products, and frozen desserts shall contain the minimum percentages of wholesome fat, or oil other than milkfat and solids-not-fat as the words "milk" and/or "milk products" or "frozen desserts" appear in these rules, they shall be interpreted to include "imitation milk" and/or "imitation milk products" and/or "imitation frozen desserts." Nothing herein is intended to make legal any food substance, which is otherwise, prohibited, or illegal.

(44) Industry Plant Sampler - A person responsible for the collection of official samples for regulatory purposes at a milk plant, receiving station, or transfer station as outlined in Appendix B. This person is an employee of the milk plant, receiving station, or transfer station and is evaluated at least once every two (2) year period by a SSO or a properly dSSO.

(45)Inspection/Audit Report - A handwritten or electronically generated official regulatory report used for the documentation of findings observed during an inspection/audit.

(46)International Certification Program (ICP) - The ICP means the National Conference on Interstate Milk Shipments (NCIMS) voluntary program designed to utilize Third Party Certifiers (TPCs) authorized by the NCIMS Executive Board in applying the requirements of the NCIMS Grade "A" Milk Safety Program for Milk Companies located outside the geographic boundaries of NCIMS member states that desire to produce and process Grade "A" milk and/or milk products for importation into the United States.

(47)Letter of Intent (LOI) - A formal written signed agreement between a TPC authorized under the NCIMS voluntary ICP, and a milk company that intends to be certified and IMS listed under the NCIMS voluntary ICP. A copy of each written signed agreement shall be immediately submitted to the ICP Committee following the signing by the TPC and milk company.

(48)Letter of Understanding (LOU) - A formal written signed agreement between a TPC and the NCIMS Executive Board that acknowledges the NCIMS' authorization of the TPC to operate under the NCIMS voluntary ICP. It also states the TPCs responsibilities under the NCIMS voluntary ICP; their agreement to execute them accordingly; and their understanding of the consequences for failing to do so. The LOU shall include, but is not limited to, the issues and concerns addressed in all documents involved in the NCIMS voluntary ICP.

(49) Low-Acid Aseptic and Retort Milk And/Or Milk Products - Milk and/or milk products having a water activity (a_w) greater than 0.85 and a finished equilibrium pH greater than 4.6 and are regulated under 21 CFR Parts 108, 110, and 113. Aseptically processed and packaged low-acid milk and/or milk products and retort processed after packaging low-acid milk and/or milk products are stored under normal non-refrigerated conditions. Excluded from this definition are low-acid milk and/or milk products that are labeled for storage under refrigerated conditions.

(50)Low-Sodium Milk or Low-Sodium Low-fat Milk or Low-Sodium Skim Milk - Low-sodium milk or low-sodium low-fat milk or low-sodium skim milk is the product resulting from the treatment of milk, low-fat milk, or skim milk, as defined in these rules by a process of passing the milk, low-fat milk, or skim milk through an ion exchange resin process or any other process which has been recognized by the FDA that effectively reduces sodium content of the product to less than ten (10) milligrams in one-hundred (100) milliliters.

(a) Lactose Reduced Milk or Lactose Reduced Low-fat Milk or Lactose-Reduced Skim Milk - Lactose-reduced milk or lactose reduced low-fat milk or lactose-reduced skim milk is the product resulting from the treatment of milk, low-fat milk, or skim milk, as defined in these rules by the addition of safe and suitable enzymes to convert sufficient amounts of the lactose to glucose and/or galactose, so that the remaining lactose is less than 30 percent of the lactose in milk, low-fat milk, or skim milk.

(b) Lactose Reduced Milk Products - Lactose reduced milk products are the milk products defined in this section that result from appropriate treatment with safe and suitable enzymes, so that the lactose content of the respective milk product has been reduced by at least 70 percent.

(51)Mellorine - is the product defined in the CFR, Title 21, §135.130.

(52)Memorandum of Agreement (MOA) - A formal written signed memorandum that states the requirements and responsibilities of each party TPC and milk company to participate and execute the NCIMS voluntary ICP. The MOA shall include, but is not limited to, the issues and concerns addressed in all documents involved in the NCIMS voluntary ICP. This agreement shall be considered the milk company's permit to operate in the context of the NCIMS Grade "A" Milk Safety Program and shall be renewed, signed, and dated on an annual basis.

(53)Milk - Milk is the product defined in the CFR, Title 21, §131.110.

(54)Milk Company - A milk company is a private entity that is listed on the IMS list by a TPC including all associated dairy farms, bulk milk haulers or samplers, milk tank trucks, milk transportation companies, milk plants, receiving stations, transfer stations, dairy plant samplers, industry plant samplers, milk distributors, etc., and their servicing milk and/or water laboratories, as defined in the Grade "A" Pasteurized Milk Ordinance (PMO), 2017 Revision, located outside the geographic boundaries of NCIMS member states.

(55)Milk Distributor - A milk distributor is any person who offers for sale or sells to another, any milk or milk products.

(56)Milk Hauler - A milk hauler is any person who transports raw milk and/or raw milk products to or from a milk plant, frozen dessert plant, receiving station, or transfer station.

(57)Milk Plant - A milk plant is any place, premises, or establishment where milk or milk products are collected, handled, processed, stored, pasteurized, ultra-pasteurized, aseptically processed, bottled, or prepared for distribution.

(58)Milk Producer - A milk producer is any person who operates a dairy farm and provides sells or offers milk for sale to a milk plant, frozen dessert plant, receiving station, or transfer station.

(59)Milk Products - Milk products include the following: cream, light cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, sour cream, acidified sour cream, cultured sour cream, half-and-half, sour half-and-half, acidified sour half-and-half, cultured half-and-half, reconstituted or recombined milk and milk products, concentrated milk, concentrated milk products, skim milk, low-fat milk, frozen milk concentrate, eggnog, buttermilk, cultured milk, cultured low-fat milk, cultured skim milk, acidified milk, acidified low-fat milk, acidified skim milk, frozen dessert mix, yogurt, low-fat yogurt, nonfat yogurt, low-sodium milk, low-sodium low-fat milk, low-sodium skim milk, lactose-reduced milk, lactose-reduced low-fat milk, lactose-reduced skim milk, aseptically processed and packaged milk, and milk products as defined in this rule, milk, low-fat milk, or skim milk with added safe and suitable microbial organisms and any other milk product made by the addition or subtraction of milk fat or addition of safe and suitable optional ingredients for protein, vitamin, or mineral fortification of milk products defined herein; cottage cheese, dry curd cottage cheese, and low-fat cottage cheese. This definition is not intended to include milk products such as evaporated milk, evaporated skim milk, condensed milk (sweetened or unsweetened), dietary products (except as defined herein), infant formula, dry milk products (except as defined herein), canned eggnog in a rigid metal container, butter or cheese, except when they are combined with other substances to produce any pasteurized (or aseptically processed) milk or milk products defined herein.

(a) Aseptically Processed Milk and Milk Products -Aseptically processed milk and milk products are products hermetically sealed in a container and so thermally processed in conformance with 21 CFR 113 and the provisions so as to render the product free of micro-organisms capable of reproducing in the product under normal non-refrigeration conditions of storage and distribution. The product shall be free of viable microorganisms (including spores) of public health significance.

(60)Milk Tank Truck - A milk tank truck is the term used to describe both a bulk milk pickup tanker and a milk transport tank.

(61)Milk Tank Truck Cleaning Facility - Any place, premises, or establishment, separate from a milk plant, receiving station, or transfer station where a milk tank truck is cleaned and sanitized.

(62)Milk Tank Truck Driver - A milk tank truck driver is any person who transports raw or pasteurized milk or milk products to or from a milk plant, receiving station, or transfer station. Any transportation of a direct farm pickup requires the milk tank truck driver to have responsibility for accompanying official samples.

(63)Milk Transportation Company - A milk transportation company is the person responsible for a milk tank truck(s).

(64)Milk Transport Tank - A milk transport tank is a vehicle, including the truck and tank, used by a milk hauler to transport bulk shipments of milk from a transfer station, receiving station, milk plant, or frozen dessert plant to another transfer station, receiving station, milk plant, or frozen dessert plant.

(65)Misbranded Milk, Milk Products, and Frozen Desserts - Milk, milk products, and frozen dessert products are misbranded:

(a) When their container(s) bear or accompany any false or misleading written, printed, or graphic matter;

(b) When such milk, milk products, and frozen desserts do not conform to their definitions as contained in these rules; or

(c) When such products are not labeled in accordance with Rule 420-3-16-.05. When one or more of the conditions described in §403 of the FFD&CA, as amended (21 U.S.C. 343) exist, refer to Appendix L.

(66)Officially Designated Laboratory - An officially designated laboratory is a commercial laboratory authorized to do official work by the Health Officer or a milk industry laboratory official, designated by the Health Officer for the examination of producer samples of Grade "A" raw milk for pasteurization, ultra-pasteurization, aseptic processing and packaging, or retort processed after packaging and commingled milk tank truck samples of raw milk for drug residues and bacterial limits.

(67)Official Laboratory - An official laboratory is a biological, chemical, or physical laboratory, which is under the direct supervision of the State Health Department.

(68)Pasteurization - The terms "pasteurization," "pasteurized," and similar terms shall mean the process of heating every particle of milk or milk product in properly designed and operated equipment to one of the temperatures given in the following table and held continuously at or above that temperature for at least the corresponding specified time.

BATCH (VAT) PASTEURIZATION
Temperature	Time
*145°F(63°C)	30 Minutes
Continuous Flow (HTST and HHST) Pasteurization
*161°F(72°C)	15 Seconds
191°F(89°C)	1 Second
194°F(90°C)	0.5 Second
201°F(94°C)	0.1 Second
204°F (96°C)	0.05 Second
212°F(100°C)	0.01 Second

*If the fat content of the milk product is 10 percent or more or if it contains added sweeteners, the specified temperature shall be increased by 5°F (3°C); provided, that eggnog and frozen dessert mix shall be heated to at least the following temperature and time specifications:

BATCH (VAT) PASTEURIZATION
Temperature	Time
155°F(69°C)	30 Minutes
Continuous Flow HTST Pasteurization
175°F(80°C)	25 Seconds
180°F(83°C)	15 Seconds

Provided further, that nothing in this definition shall be construed as barring any other pasteurization process, which has been recognized by the FDA to be equally efficient and which is approved by the State Health Officer.

(69)Person - The word "person" shall include any individual, plant operator, partnership, corporation, company, firm, trustee, association, or institution.

(70)Rating Agency - A rating agency shall mean a state agency, which certifies interstate milk shippers (bulk tank units, receiving stations, transfer stations, and milk plants) as having attained the Sanitation Compliance and Enforcement Ratings necessary for inclusion on the IMS list. The ratings are based on compliance with the requirements of the PMO and were conducted in accordance with the procedures set forth in the Methods of Making Sanitation Ratings of Milk Shippers and the Certifications/Listings of Single-Service Containers and Closures for Milk and/or Milk ProductsManufacturers (MMSR). Ratings are conducted by FDA certified Sanitation Rating Officers (SROs). They also certify single-service containers and closures for milk and/or milk products manufacturers for inclusion on the IMS list. The certifications are based on compliance with the requirements of the PMO and were conducted in accordance with the procedures set forth in the MMSR. The definition of a rating agency also includes a TPC that conducts ratings and certifications of milk companies located outside the geographic boundaries of NCIMS Member States that desire to produce and process Grade "A" milk and/or milk products for importation into the United States.

(71)Receiving Station - A receiving station is any place, premises, or establishment where raw milk is received, collected, handled, stored, or cooled and prepared for further transporting.

(72)Reconstituted or Recombined Milk and Milk Products - Reconstituted or recombined milk and/or milk products shall mean milk or milk products defined in this rule which result from reconstituting or recombining of milk constituents with potable water when appropriate.

(73)Regulatory Agency - The Regulatory Agency shall mean the State of Alabama or their authorized representative. The term "Regulatory Agency," whenever it appears in the rule shall mean the appropriate agency, including a TPC authorized under the NCIMS voluntary ICP, having jurisdiction and control over the matters embraced within this rule.

(74)Retort Processed After Packaging - The term "Retort Processed after Packaging," when used to describe a milk, milk product, or frozen dessert product means that the milk, milk product, or frozen dessert product has been subjected to sufficient retort heat processing after packaged in a hermetically sealed container, to conform to the applicable requirements of 21 CFR Parts 108, 110, and 113 and to maintain the commercial sterility of the milk, milk product, or frozen dessert product under normal non-refrigerated conditions.

(75)Retort Processed After Packaging System (RPPS) - For the purposes of this rule, the RPPS in a milk plant is comprised of the processes and equipment used to retort process after packaging low-acid Grade "A" milk and/or milk products. The RPPS shall be regulated in accordance with the applicable requirements of 21 CFR Parts 108, 110, and 113. The RPPS shall begin at the container filler and end at the palletizer, provided that the process authority may provide written documentation which will clearly define additional processes and/or equipment that are considered critical to the commercial sterility of the milk and/or milk product.

(76)Sanitization - Sanitization is the application of any effective method or substance to a clean surface for the destruction of pathogens and of other organisms as far as is practicable. Such treatment shall not adversely affect the equipment, the milk or milk product, frozen dessert, or the health of the consumers and shall be acceptable to the Health Officer.

(77)Sheep Milk - Sheep milk is the normal lacteal secretion, practically free of colostrums, obtained by the complete milking of one (1) or more healthy sheep. Sheep milk shall be produced according to the sanitary standards of this rule. The word "milk" shall be interpreted to include sheep milk.

(78)Sherbert - Sherbert is the product defined in the CFR, Title 21, §135.140.

(79)Sold - means a transfer of milk or milk products that involves any direct or indirect form of compensation in exchange for the right to acquire such milk or milk products.

(80)Sterilized - Sterilized, when applied to piping, equipment, and containers used for milk, milk products, and frozen desserts products, shall mean the condition achieved by application of heat, chemical sterilant(s), or other appropriate treatment that renders the piping equipment and containers free of viable microorganisms.

(81)Third Party Certifier (TPC) - A TPC is a non-governmental individual(s) or organization authorized under the NCIMS voluntary ICP that is qualified to conduct the routine regulatory functions and enforcement requirements of the PMO in relationship to milk plants, receiving stations, transfer stations, associated dairy farms, bulk milk hauler/samplers, milk tank trucks, milk transportation companies, dairy plant samplers, industry plant samplers, milk distributors, etc. participating in the NCIMS voluntary ICP. TPC provides the means for the rating and listing of milk plants, receiving stations, transfer stations, and their related raw milk sources. They also conduct the certification and IMS listing of related milk and/or water laboratories and related single-service container and closure manufacturers on the IMS list. To be authorized under the NCIMS voluntary ICP, a valid LOU shall be signed between the NCIMS Executive Board and the TPC.

(82) Time/Temperature Control for Safety of Milk and/or Milk Products (TCS) - Milk and/or milk products that require TCS to limit pathogenic microorganism growth or toxin formation includes:

(a) Milk or milk products that are raw, heat-treated, pasteurized, or ultra-pasteurized; or

(b) Except as specified in (e) below of this definition, a milk or milk product that because of the interaction of its a_w and pH values is designated as product assessment (PA) as required in either Table A or B as follows:

Table A. Interaction of pH and a_w for Control of Spores in Milk and Milk Products Pasteurized to Destroy Pathogenic Vegetative Cells and Subsequently Packaged*
a_w values	pH values
4.6 or less	>4.6 - 5.6	>5.6
0.92 or less	Non-TCS**	Non-TCS	Non-TCS
>0.92 - .95	Non-TCS	Non-TCS	PA***
>0.95	Non-TCS	PA	PA

*Refer to Appendix R. for instruction on how to use Table A.

**TCS means Time/Temperature Control for Safety Milk and Milk Products.

***PA means either that the product needs time and temperature control, or further product assessment is required to determine if the milk or milk product is Non-TCS.

Table B. Interaction of pH and a_w for Control of Pathogenic Vegetative Cells and Spores in Milk and Milk Products not Pasteurized, but not Packaged*
a_w values	pH values
<4.2	4.2 - 4.6	>4.6 - 5.0	>5.0
<0.88	Non-TCS	Non-TCS	Non-TCS	Non-TCS
>0.88 - 0.90	Non-TCS	Non-TCS	Non-TCS	PA
>0.90 - 0.92	Non-TCS	Non-TCS	PA	PA
>0.92	Non-TCS	PA	PA	PA

*Refer to Appendix R for instruction on how to use Table B. This definition does not include:

(c) A milk or milk product that because of its pH or a_w value, or interaction of a_w and pH values, is designated as Non-TCS in Table A or B as specified in (b) above of this definition;

(d) A milk or milk product, in an unopened hermetically sealed container, that is commercially processed to achieve and maintain commercial sterility under conditions of non-refrigerated storage and distribution;

(e) A milk or milk product for which evidence (acceptable to FDA) demonstrates that time/ temperature control for safety is not required as specified under this definition (such as, a product containing a preservative known to inhibit pathogenic microorganisms, or other barriers to the growth of pathogenic microorganisms, or a combination of barriers that inhibit the growth of pathogenic microorganisms); or

(f) A milk or milk product that does not support the growth of pathogenic microorganisms as specified under this definition even though the milk or milk product may contain a pathogenic microorganism or chemical or physical contaminant at a level sufficient to cause illness or injury.

(83)Transfer Station - A transfer station is any place, premises, or establishment where milk or milk products are transferred directly from one milk tank truck to another.

(84)Ultra-Pasteurized - UP when used to describe a dairy product, means that such product shall have been thermally processed at or above 280°F (138°C) for at least two (2) seconds, either before or after packaging, so as to produce a product which has an extended shelf-life under refrigerated conditions.

(85)Water Buffalo Milk - Water buffalo milk is the normal lacteal secretion, practically free of colostrum, obtained by the complete milking of one (1) or more healthy water buffalo. Water buffalo milk shall be produced according to the sanitary standards of this rule. The word "milk" shall be interpreted to include water buffalo milk (refer to the Note: on page 35).

(86)Water Ices - Water ices is the product defined in the CFR, Title 21, §135.160.

(87)Whey Products - Whey products mean any fluid product removed from whey; or made by the removal of any constituent from whey; or by the addition of any wholesome substance to whey or parts thereof.

(a) Grade "A" Whey Products - Grade "A" whey products means any fluid product removed from whey; or made by the removal of any constituent from whey; or by the addition of any wholesome substance to whey or parts thereof which have been manufactured under the provisions of this rule.

(b) Dry Whey Products - Dry whey products mean products resulting from the drying of whey or whey products and any product resulting from the combination of dry whey products with other wholesome dry ingredients.

(c) Grade "A" concentrated (condensed) and Dry Whey and Whey Products - Grade "A" concentrated (condensed) and dry whey and whey products means concentrated (condensed) or dry whey and whey products, which complies with the applicable provisions of this rule. The words "concentrated (condensed) and dry milk products" shall be interpreted to include concentrated (condensed) and dry whey and whey products.

(88)Yogurt - Yogurt is the product defined in the CFR, Title 21, §131.200.

(a) Lowfat Yogurt - Lowfat yogurt is the product defined in the CFR, Title 21, §131.203.

(b) Nonfat Yogurt - Nonfat yogurt is the product defined in the CFR, Title 21, §131.206.

Ala. Admin. Code r. 420-3-16-.02

Adopted by Alabama Administrative Monthly Volume XXXVII, Issue No. 01, October 31, 2018, eff. 12/2/2018.

Author: G. M. Gallaspy, Jr.

Statutory Authority:Code of Ala. 1975, §§ 22-2-2, 22-20-7.