Alabama Administrative Code Chapter 420-3-16 — Production, Processing, Handling, Or Distribution Of Milk, Milk Products And Frozen Desserts

420 Alabama Department of Public Health

Ala. Admin. Code r. 420-3-16-.01 Purpose

These rules define “milk and certain milk products,” “frozen desserts,” “milk producer,” pasteurization,” etc.; prohibits the sale of raw milk, adulterated and misbranded milk products, and frozen desserts; requires permits for the sale of milk, milk products, and frozen desserts and the manufacturing of single-service container and closures; regulates the inspection of bulk milk haulers, bulk milk tankers, milk samplers, dairy farms, milk plants, frozen dessert plants, and the manufacturing of single-service containers and closures; provides for the examination, labeling, pasteurization, aseptic processing, packaging, distribution, and sale of milk, milk products, and frozen desserts; provides for the construction of future dairy farms, frozen dessert plants, milk plants, and the manufacturers of single-service containers and closure plants; and provides for the enforcement of these rules and the fixing of penalties.

History

• Author: G. M. Gallaspy, Jr.
• Authority: Code of Ala. 1975, §§22-2-2, 22-20-7.
• Repealed and New Rule: Filed October 18, 2018; effective December 2, 2018.

Ala. Admin. Code r. 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 8¼ 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 Chapter 420-3-16 Health Supp. 12/31/18 3-16-10 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 TPC’s 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 (aw) 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.

*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:

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 Products Manufacturers (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 aw and pH values is designated as product assessment (PA) as required in either Table A or B as follows:

*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.

*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 aw value, or interaction of aw 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.

History

• Author: G. M. Gallaspy, Jr.
• Authority: Code of Ala. 1975, §§22-2-2, 22-20-7.
• Repealed and New Rule: Filed October 18, 2018; effective December 2, 2018.

Ala. Admin. Code r. 420-3-16-.03 Adulterated Or Misbranded Milk, Milk Products Or Frozen Desserts

(1) No person shall, within the State of Alabama or its jurisdiction, produce, provide, sell, offer, or expose for sale or have in possession with intent to sell, any milk, milk product, or frozen dessert which is adulterated or misbranded; provided, that in an emergency, the sale of pasteurized milk and milk products, which have not been graded, or the grade of which is unknown, may be authorized by the Health Officer, in which case, such products shall be labeled "ungraded."

Note: The option for the emergency sale of pasteurized milk and/or milk products as cited above shall not be applicable to a milk company that is IMS listed under the NCIMS voluntary ICP.

(2) Any adulterated or misbranded milk, milk products, or frozen desserts may be impounded by the Health Officer and disposed of in accordance with applicable laws or regulations.

Note: Adulterated and/or misbranded milk and/or milk products from milk companies IMS listed under the ICP shall not gain entry into the U.S.

(3) Milk plants shall establish and maintain a written recall plan for initiating and affecting the recall of adulterated milk and/or milk products from the market when appropriate for the protection of public health.

(4) Administrative Procedures - This rule shall be used in impounding the products of or preferring charges against, persons who adulterate or misbrand their milk, milk products, or frozen desserts or label them with any grade designation not authorized by the Health Officer under the terms of these rules or who sell or deliver ungraded milk or milk products, except as may be permitted under this rule in an emergency. An emergency is defined as a general and acute shortage in the milkshed, not simply one (1) distributor's shortage.

Note: The option for the emergency sale of pasteurized milk and/or milk products as cited above shall not be applicable to a milk company IMS listed under the ICP.

Recall Plan - A milk plant shall establish a written recall plan that shall include procedures as described in 21 CFR Part 7 (Subpart A and C).

Note: For additional information and guidance from FDA regarding product recalls, milk plants should also refer to the current Guidance for Industry: Product recalls, including removals and corrections at http://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129259.htm.

History

• Author: G. M. Gallaspy, Jr.
• Authority: Code of Ala. 1975, §§22-2-2, 22-20-7.
• Repealed and New Rule: Filed October 18, 2018; effective December 2, 2018.

Ala. Admin. Code r. 420-3-16-.04 Permits Prescribed

(1) It shall be unlawful for any person who does not possess a permit from the Health Officer to bring into, send into, or receive into the State of Alabama or its jurisdiction, for sale or to sell or offer for sale therein, or to have in storage any milk, milk products, or frozen desserts defined in these rules; provided, grocery stores, restaurants, soda fountains, and similar establishments where milk, milk products, or frozen desserts are served or sold at retail, but not processed, may be exempt from the requirements of these rules.

(2) Only a person who complies with the requirements of these rules shall be entitled to receive and retain such a permit. Permits shall not be transferrable with respect to person and/or locations and shall remain the property of the Alabama Department of Public Health. The permit may be suspended or revoked for violation of these rules.

(3) The term “permit,” whenever it appears in this rule shall also mean a milk company operating under the ICP possessing a valid MOA with a TPC.

(4) Any person desiring to operate a milk processing plant, frozen dessert plant, or single-service manufacturing facility shall make written application for a permit on forms prescribed by the State Health Officer, as shown in Appendix M. Milk, milk product, and single-service manufacturer processor permits shall automatically expire on September 30 of each year and are renewable each year upon written application submitted within fifteen (15) days prior to expiration. Dairy farm permits are good until revoked.

(5) Prior to approval of an application for a permit, the State Health Officer shall inspect the proposed dairy, frozen dessert plant, milk processing plant, or single-service manufacturing facility to determine compliance with the requirements of these rules.

(6) The State Health Officer shall issue a permit to the applicant, if his/her inspection reveals the dairy plant, frozen dessert plant, milk processing plant, or single-service manufacturing facility complies with the requirements of these rules.

(7) Permits are issued only to applicants who meet the following inspection requirements:

(a) Completion of an application for permit.

(b) Approval of submitted plans for all physical facilities, equipment, and processes utilized by the applicant.

(c) Submittal of a milk processor fee for those facilities that require a fee.

(d) Satisfactory approval inspection by the Health Officer.

(8) Provided, that the manufacture of condensed and dry milk products, which do not meet the requirements of this rule for Grade “A” condensed or dry milk products and which are intended for other uses, shall not be construed to violate the terms of this rule, if such products are processed, packaged, and stored separately and are plainly identified.

(9) It shall be unlawful for any person to manufacture in a milk plant under a permit for Grade “A” condensed or dry milk products in the State of Alabama or its jurisdiction any condensed and dry milk products which do not meet the requirements of this rule for Grade “A” condensed or dry milk products without a permit from the Health Officer who shall require that such condensed and dry milk products be processed, packaged, and stored separately from Grade “A” condensed or dry milk products and that each container of such products be plainly marked in such a manner as to prevent confusion of the product with Grade “A” condensed or dry milk products.

(10) Permit Suspension - The Health Officer shall suspend such permit whenever he/she has reason to believe that a public health hazard exists; or whenever the permit holder has violated any of the requirements of these rules; or whenever the permit holder has interfered with the Health Officer in the performance of his/her duties; provided, the Heath Officer shall, in all cases, except where the milk, milk product, frozen dessert, or single-service container product involved creates, or appears to create, an imminent hazard to the public health or, in any case, of a willful refusal to permit authorized inspection, serve upon the holder a written notice of intent to suspend permit, which notice shall specify with particularity the violation(s) in question and afford the holder such reasonable opportunity to correct such violation(s) as may be agreed to by the parties or in the absence of agreement fixed by the Health Officer, before making any order of suspension effective. A suspension of permit shall remain in effect until the violation has been corrected to the satisfaction of the Health Officer.

(a) Upon notification, acceptable to the Health Officer, by any person whose permit has been suspended, or upon application within forty-eight (48) hours of any person who has been served with a notice of intention to suspend, and in the latter case before suspension, the Health Officer shall within seventy-two (72) hours proceed to a hearing to ascertain the facts of such violation(s) or interference and upon evidence presented at such hearing shall affirm, modify, or rescind the suspension or intention to suspend.

(b) Upon repeated violation(s), the Health Officer may revoke such permit following reasonable notice to the permit holder and an opportunity for a hearing. This section is not intended to preclude the institution of court action as provided in Rule 420-3-16-.05-.06.

(11) Administrative Procedures - Issuance of Permits - Every milk producer, milk distributor, bulk milk hauler or sampler, milk tank truck, a milk transportation company, frozen dessert plant, milk plant, receiving station, transfer station, and milk tank truck cleaning facility operator shall hold a valid permit. The permit for a milk tank truck may be issued to the milk transportation company. Milk producers who transport milk or milk products only from their own dairy farms; employees of a milk distributor or milk plant operator who possesses a valid permit; and employees of a milk transportation company that possesses a valid permit and transports milk or milk products from a milk plant, receiving station, or transfer station shall not be required to possess a bulk milk hauler’s or sampler’s permit.

(a) Grocery stores, restaurants, soda fountains, and similar establishments where milk and milk products are served or sold at retail, but not processed, may be exempt from the requirements of this section.

(b) While compliance with the requirements for Grade “A” condensed and dry milk products is necessary to receive and retain a permit for these products, it is not the intent of this rule to limit the production of a milk plant that condenses and/or dries milk or milk products to Grade “A” products.

(c) The manufacture of ungraded products for other uses in milk plants operating under a permit for the manufacture of Grade “A” condensed and dry milk products is allowed under conditions specified in Rule 420-3-16-.08 and whereby such products are processed, packaged, and stored separately. In such cases, a second permit is required, which is issued with the understanding that ungraded products shall be handled in such a manner so as to avoid confusion with the Grade “A” production.

(d) Either or both permits may be temporarily suspended for the violation of any applicable provision of this rule, or revoked for a serious or repeated violation. Suspension of permits for violation of sanitation items of Rule 420-3-16-.08 is provided for in Rule 420-3-16-.06. In addition, the Health Officer may, at any time, institute court action under the provisions of Rule 420-3-16-.07.

(e) There is no specific frequency for the issuance of permits. This should be in accordance with the policies of the Health Officer and in agreement with those employed for the issuance of permits under this rule.

(f) Suspension of Permit - When any requirement(s) of this rule is violated, the permit holder is subject to the suspension of their permit.

(g) The Health Officer may forego suspension of the permit, provided the milk and/or milk product in violation is not sold or offered for sale as a Grade “A” milk and/or milk product. A Health Officer may allow the imposition of a monetary penalty in lieu of a permit suspension, provided the milk and/or milk product in violation is not sold or offered for sale as a Grade “A” milk and/or milk product. Except, that a milk producer may be assessed a monetary penalty in lieu of permit suspension for violative counts provided:

1. If the monetary penalty is due to a violation of the bacterial or cooling temperature standards, the Health Officer shall conduct an inspection of the facility and operating methods and make the determination that the conditions responsible for the violation have been corrected. Samples shall then be taken at the rate of not more than two (2) per week on separate days within a three (3) week period in order to determine compliance with the appropriate standard as determined in accordance with Rule 420-3-16-.07.

2. If the monetary penalty is due to a violation of the somatic cell count standard, the Health Officer shall verify that the milk supply is within acceptable limits as prescribed in Rule 420-3-16-.08. Samples shall then be taken at the rate of not more than two (2) per week on separate days within a three (3) week period in order to determine compliance with the appropriate standard as determined in accordance with Rule 420-3-16-.07.

Note: The option to issue a monetary penalty in lieu of a permit suspension as cited above shall not be applicable to a TPC authorized under the ICP.

(12) This rule adopted pursuant to Code of Ala. 1975, Section §22-20-5, as amended, is intended to accord an individual administrative hearing in any and all matters concerning those rules heretofore adopted and promulgated by the State Board of Health, and all such rules adopted and promulgated in the future by the State Committee of Public Health, where procedural due process is indicated and not otherwise provided.

Note: TPCs authorized under the ICP shall follow the hearing procedures and process addressed in this rule.

(13) Reinstatement of Permits - Any permit holder whose permit has been suspended may make written application for the reinstatement of their permit.

(a) When the permit suspension has been due to a violation of any of the bacterial, coliform, or cooling temperature standards, the Health Officer, within one (1) week after the receipt of notification for reinstatement of permit, shall issue a temporary permit after determining by an inspection of the facilities and operating methods that the conditions responsible for the violation have been corrected. When a permit suspension has been due to a violation of the somatic cell count standard, the Health Officer may issue a temporary permit whenever a resampling of the herd’s milk supply indicates the milk supply to be within acceptable limits as prescribed in Rule 420-3-16-.08. Samples shall then be taken at the rate of not more than two (2) per week on separate days within a three (3) week period. This accelerated sampling applies to bacteria, coliform, somatic cell count, and temperature. The Health Officer shall reinstate the permit upon compliance with the appropriate standard as determined in accordance with Rule 420-3-16-.07.

(b) Whenever the permit suspension has been due to a violation of a requirement other than bacteriological, coliform, somatic cell count, drug residue test, or cooling-temperature standards, the notification shall indicate that the violation(s) has been corrected. Within one (1) week of the receipt of such notification, the Health Officer shall make an inspection/audit of the applicant’s facility, and as many additional inspections or audits thereafter as are deemed necessary, to determine that the applicant’s facility is complying with the requirements. When the findings justify, the permit shall be reinstated.

(c) When a permit suspension has been due to a positive drug residue, the permit shall be reinstated in accordance with the provisions of Appendix N.

History

• Author: G. M. Gallaspy, Jr.
• Authority: Code of Ala. 1975, §§22-2-2, 22-20-7.
• Repealed and New Rule: Filed October 18, 2018; effective December 2, 2018.

Ala. Admin. Code r. 420-3-16-.05 Labeling

(1) All bottles, containers, and packages containing milk, milk products, or frozen desserts defined in Rule 420-3-16-.02 shall be labeled in accordance with the applicable requirements of the FFD&CA, the Nutrition Labeling and Education Act (NLEA) of 1990, and regulations developed there under, the CFR, and in addition, shall comply with applicable requirements of this section as follows:

(a) The name of the contents as given in the definitions in these rules.

(b) The words "Grade “A”” on the exterior surface. Acceptable locations shall include the principal display panel, the secondary or informational panel, or the cap/cover.

(c) The identity of the milk or frozen dessert plant where pasteurized, ultra-pasteurized, aseptically processed and packaged, retort processed after packaging, condensed, and/or dried.

(d) The word "reconstituted" or "recombined,” if the product is made by reconstitution or recombination.

(e) The volume or proportion of water to be added for recombining in the case of concentrated milk or milk products.

(f) The word "ultra-pasteurized,” if the milk or milk product has been ultra-pasteurized.

(g) The word "pasteurized,” if the milk or milk product has been pasteurized.

(h) The word "homogenized,” if the milk or milk product has been homogenized.

(i) The phrase "protein fortified" or "fortified with protein,” if the food contains not less than 10 percent milk-derived nonfat solids.

(j) The ingredients in order of predominance by weight.

(k) The words "keep refrigerated after opening" in the case of aseptically processed and packaged low-acid milk, milk products, frozen desserts, and retort processed after packaging low-acid milk, milk products, and frozen desserts.

(l) The dating of milk, milk products, and frozen dessert mix, which is not frozen at the plant, in which it was pasteurized, shall be as follows: The expiration date (the date the product is to be removed from the market) shall be embossed or otherwise indicated on the outside of the carton or container, so as to be easily readable and discernible. This date shall be expressed as the month and day (i.e., Jan. 30). The management of each milk plant or frozen dessert plant shall provide the State Health Officer a list of the milk, milk products, and frozen dessert mixes to be marketed and the number of days each product shall remain on the market. Before changing any expiration date, the State Health Officer shall be notified in writing fourteen (14) days prior to the effective date of such change. In no case, during any twenty-four (24) hour period, shall more than one (1) expiration code date be assigned to milk or a milk product or frozen dessert mix, which is to be processed and/or marketed by that plant. The State Health Officer shall conduct shelf-life studies of milk, milk products, and frozen desserts as often as he/she deems necessary to determine the compliance with bacteriological standards at the end of the plant's specified product shelf-life. In case the products fail to meet the bacteriological standards at the specified shelf-life provided by plants, the State Health Officer shall require a reduction of shelf-life as he/she may deem appropriate. Shelf-life samples shall be collected from the plant where possible or from the distribution system while still in possession of the plant.

(m) The common name of the hooved mammal producing the milk shall precede the name of the milk, milk product, or frozen dessert when the product is made from other than cattle’s milk (i.e. goat, sheep, water buffalo, or other hooved mammals’ milk, or milk products respectively).

(n) In the case of condensed or dry milk products the following shall also apply:

1. The identity of the milk plant where condensed and/or dried; and if distributed by another party, the name and address of the distributor shall also be shown by a statement, such as “Distributed by.”

2. A code or lot number identifying the contents with a specific date, run, or batch of the product, and the quantity of the contents of the container.

3. Seal number on inlet, outlet, wash connections, and vents; and

(2) All packages and other containers, including frozen desserts or other similar products defined in this rule, shall be labeled in accordance with the applicable requirements of the FFD&CA, as amended; the Fair Packaging and Labeling Act (FP&LA) and regulations developed thereunder; and, in addition, shall bear the name and address or permit number of the plant where processed and packaged.

(3) All vehicles and milk tank trucks containing milk, milk products, or frozen desserts shall be legibly marked with the name and address of the plant or hauler in possession of the contents.

(4) Milk tank trucks transporting raw heat-treated or pasteurized milk and milk products to a milk or frozen dessert plant from another milk or frozen dessert plant, receiving station, or transfer station are required to be marked with the name and address of the milk plant, frozen dessert plant, or hauler and shall be sealed. In addition, for each such shipment, a shipping statement shall be prepared containing at least the following information:

(a) Shipper's name, address, and permit number - Each milk tank truck load of milk shall include the IMS bulk tank unit identification number(s) or the IMS listed milk or frozen dessert plant number for farm groups listed with a milk plant or frozen dessert plant on the farm weight ticket or manifest.

(b) Permit identification of hauler.

(c) Point of origin of shipment.

(d) Tanker identity number.

(e) Name of product.

(f) Weight of product.

(g) Grade of product.

(h) Temperature of product when loaded.

(i) Date of shipment.

(j) Name of supervising Health Officer at the point of origin.

(k) Whether the contents are raw, pasteurized or in the case of cream, lowfat milk or skim milk, whether it has been heat treated.

(l) One (1) copy of the shipping statement shall be retained by the consignor, one (1) by the common carrier, and at least two (2) copies shall be delivered to the consignee with the shipment. The consignee shall forward at least one (1) copy to the State Health Officer in the receiving area. Upon request, the State Health Officer shall be notified by telegram, telephone message or electronic message, prior to delivery; such message being promptly confirmed by letter of such shipments of raw milk. The telegram or telephone message, confirmed by letter, shall contain the information required on the shipping statement, the destination, and the expected time of arrival at the destination.

(m) Entries made on shipping statements by consignors or consignees shall be legible. When the interstate shipment is derived from more than one point of origin, separate shipping statements for each of the sources involved, shall accompany the shipment. Shipping statements shall be retained on file for a period of at least six (6) months.

(n) All cans of raw milk from individual dairy farms shall be identified by the name or number of the individual milk producer.

(5) Administrative Procedures

(a) Emergency Supplies/Labeling - When the sale of “ungraded” milk, milk products, or frozen desserts is authorized during emergencies, under the terms of Rule 420-3-16-.03, the label must bear the designation “ungraded.” When such labeling is not available, the State Health Officer shall take immediate steps to inform the public that the particular supply is “ungraded” and that the supply will be properly labeled as soon as the distributor can obtain the required labels.

Note: The option for the sale of “ungraded” milk, milk products, or frozen desserts, as cited above, shall not be applicable to a milk company IMS listed under the ICP.

(b) Identity Labeling

1. “Identity,” as used in this rule, is defined as the name and address or permit number of the milk or frozen dessert plant at which the pasteurization, ultra-pasteurization, aseptic processing and packaging, retort processed after packaging, condensing, and/or drying takes place. It is recommended that the voluntary national uniform coding system for the identification of milk and frozen dessert plants, at which milk, milk products, and frozen dessert products are packaged, be adopted in order to provide a uniform system of codes throughout the country.

2. In cases where several milk plants are operated by one (1) firm, the common firm name may be utilized on milk bottles, containers, and packages; provided, the location of the milk plant at which the contents are pasteurized, ultra-pasteurized, aseptically processed and packaged, retort processed after packaging, condensed and/or dried is also shown, either directly or by a code. This requirement is necessary in order to enable the Health Officer to identify the source of the pasteurized, ultra-pasteurized, aseptically processed and packaged, retort processed after packaging, condensed and/or dried milk and/or milk products, and frozen dessert products. The street address of the milk or frozen dessert plant does not need to be shown when only one (1) milk or one (1) frozen dessert plant, of a given name, is located within the municipality.

3. The identity labeling requirement may be interpreted as permitting milk or frozen dessert plants and persons to purchase and distribute, under their own label, milk, milk products, and frozen desserts processed and packaged at another plant, provided, the label contains the name, address, and permit number of the manufacturer or that the label contains the name and address of the distributor and the statement “Processed or Manufactured at (name and address)” or that the processing and packaging milk plant is identified by the permit number of the manufacturer.

(c) Misleading Labels - The Health Officer shall not permit the use of any misleading marks, words, or endorsements upon the label. They may permit the use of registered trade designs or similar terms on the bottle cap or label, when in their opinion, they are not misleading and are not so used as to obscure the labeling required by this rule. For dry milk products, the outer bag shall be preprinted Grade “A” before filling. The use of super grade designations shall not be permitted; however, this should not be construed as prohibiting the use of official grade designations awarded to dry milk products by the United States Department of Agriculture (USDA). Grade designations such as “Grade “AA” Pasteurized,” “Selected Grade “A” Pasteurized,” “Special Grade “A” Pasteurized,” etc., gives the consumer the impression that such a grade is significantly safer than Grade “A.” Such an implication is false, because the rule requirements for Grade “A” pasteurized, ultra-pasteurized, aseptically processed and packaged low-acid milk, milk products, and frozen desserts or retort processed after packaged low-acid milk, milk products, and frozen desserts, when properly enforced, will ensure that this grade of milk, milk products, and frozen desserts will be as safe as they can practically be made. Descriptive labeling terms shall not be used in conjunction with the Grade “A” designation or name of the milk, milk product, or frozen dessert and shall not be false or misleading.

History

• Author: G. M. Gallaspy, Jr.
• Authority: Code of Ala. 1975, §§22-2-2, 22-20-7.
• Repealed and New Rule: Filed October 18, 2018; effective December 2, 2018.

Ala. Admin. Code r. 420-3-16-.06 Inspection Of Dairy Farms, Milk, And Frozen Dessert Plants

(1) Each dairy farm, milk plant, frozen dessert plant, receiving station, and transfer station whose milk, milk products, or frozen desserts are intended for consumption within Alabama or its jurisdiction and each milk hauler/sampler who collects samples of raw milk for pasteurization, bacteriological, chemical, or temperature standards and hauls milk from a dairy farm to a milk plant, frozen dessert plant, transfer station, or receiving station and his bulk milk pickup tank and its appurtenances shall be inspected by the Health Officer prior to the issuance of a permit. Following the issuance of a permit, each bulk milk pickup tanker and its appurtenances used by a milk hauler who collects samples of raw milk for pasteurization, for bacterial, chemical, or temperature standards and hauls milk from a dairy farm to a milk plant, frozen dessert plant, transfer station, or receiving station shall be inspected/audited at least once every twenty-four (24) months. Each hauler's or sampler’s pickup and sampling procedures shall be inspected at least once every twenty-four (24) months. Prior to the issuance of a permit as specified in Rule 420-3-16-.04, the Health Officer shall inspect all dairy farms, milk plants, and frozen dessert plants, the milk and/or milk products from which are intended for consumption and which are subject to provisions of these rules. Inspections of dairy farms shall be quarterly for dairies with a sanitation score of ninety (90) or more. Dairies with a sanitation score of less than ninety (90) shall be inspected monthly until such time as a score of ninety (90) or more is received. At no time shall a period of one-hundred (100) days lapse without an official inspection. Four (4) inspections per year of all milk and frozen dessert plants shall be required, but in no instance shall two (2) inspections in any one (1) month be included in the required number of yearly inspections. At no time shall a period of ninety (90) days lapse without an official inspection.

(2) The Health Officer having jurisdiction may require more frequent inspections of plants than the minimum number set forth in this rule. In case the Health Officer discovers the violation of any item of sanitation prescribed in Rule 420-3-16-.09 or 420-3-16-.10 for the grade of milk being currently produced at any dairy farm or plant, he/she shall make a second inspection of the said dairy farm or plant after a lapse of such time as he/she deems necessary for the correction of the defect or violation discovered, but not before the lapse of three (3) days. The Health Officer shall, upon finding the violation of the same item of Rule 420-3-16-.09 or 420-3-16-.10 on two (2) consecutive inspections, serve upon the permit holder a written notice of intent to suspend permit, which notice shall specify with particularity the violation(s) in question and afford the permit holder a reasonable time to correct such violation.

(3) The violation of the same item in Rule 420-3-16-.09 or 420-3-16-.10 on three (3) consecutive inspections shall call for permit suspension or revocation after proper notification outlines above in accordance with Rule 420-3-16-.04 and/or court action; provided, that when the Health Officer finds that a critical processing element violation involving the following:

(a) Proper pasteurization, whereby, every particle of milk or milk product may not have been heated to the proper temperature and held for the required time in properly designed and operating equipment;

(b) A cross connection exists whereby direct contamination of pasteurized milk or milk product is occurring; or

(c) Conditions exist whereby direct contamination of pasteurized milk or milk product is occurring.

(d) The Health Officer shall take immediate action to prevent further processing of such milk or milk product until such violations of critical processing element(s) have been corrected. Should correction of such critical processing elements not be accomplished immediately, the Health Officer shall take prompt action to suspend the permit as provided for in Rule 420-3-16-.04. Provided in the case of dairy plants producing aseptically processed milk and milk products, when an inspection of the dairy plant and its records reveal that the process used has been less than the required scheduled process, it shall be considered an imminent hazard to public health and the Health Officer shall take immediate action to suspend the permit of the plant for the sale of aseptically processed milk and milk products in conformance with Rule 420-3-16-.04.

(4) A copy of the inspection/audit report, electronically generated or handwritten, shall be posted by the Health Officer in a conspicuous place upon the inside wall of the dairy farm, and said inspection report shall not be removed or defaced by any person except the Health Officer. Also, copies of all laboratory analysis of samples from products entering the processing plant shall be maintained on appropriate ledger forms supplying all information specified by the Health Officer. All inspection reports of milk and frozen dessert plants shall be posted by the Health Officer in a conspicuous place upon an inside wall of the plant being inspected. Said inspection reports shall not be removed or defaced by any person except the Health Officer. The inspection report shall be entered on appropriate ledger forms approved by the State Health Officer containing all information needed by the Health Officer, and this ledger shall be kept currently posted. A copy of each inspection shall be available to the Bureau of Environmental Services for records audit.

(5) Every milk producer, hauler or sampler, distributor, or plant operator shall, upon request of the Health Officer, permit access of officially designated persons to all parts of his/her establishment or facilities to determine compliance with the provisions of these rules. A distributor or plant operator shall furnish the Health Officer, upon request, for official use only, a true statement of the actual quantities of milk, milk products, and frozen desserts of each grade purchased and sold and a list of all sources of such milk, milk products, frozen desserts, records of inspections, tests, and pasteurization time and temperature records.

(6) It shall be unlawful for any person who is in an official capacity, to obtain any information under the provisions of this chapter which is entitled to protection as a trade secret (including information as to quantity, quality, source, or disposition of milk or milk products or results of inspections, audits, or tests thereof) to use such information to his/her own advantage or to reveal it to any unauthorized person.

(7) Administrative Procedures

(a) Inspection Frequency

1. For the purposes of determining the inspection frequency for dairy farms, transfer stations, milk plants, frozen dessert plants, or the portion of a milk plant that is IMS listed to produce aseptically processed and packaged low-acid milk and/or milk products and/or retort processed after packaged low-acid milk and/or milk products, the interval shall include the designated ninety (90) day period.

2. For the purposes of determining the inspection frequency for bulk milk haulers or samplers, industry plant samplers, and dairy plant samplers, the interval shall include the designated twenty-four (24) month period.

3. One (1) bulk milk pickup tanker inspection every twenty-four (24) months, one (1) hauler or sampler or industry plant sampler pickup, and sampling procedures each twenty-four (24) months, one (1) producer inspection each quarter for dairies with a sanitation score of ninety (90) or more, one (1) producer inspection each month for dairies with a sanitation score of less than ninety (90), one (1) plant inspection, and one (1) receiving station every ninety (90) days is a legal minimum.

4. Milk haulers, dairy farms, milk plants, and frozen dessert plants experiencing difficulty meeting requirements should be visited more frequently. Inspections of dairy farms shall be made at milking time as often as possible and of processing plants at different times of the day in order to ascertain if the processes of equipment assembly, sanitizing, pasteurization, cleaning, and other procedures comply with the requirements of these rules.

(b) Enforcement Procedure

1. This rule provides that a dairy farm, bulk milk hauler or sampler, milk tank truck, milk tank truck cleaning facility, milk plant, frozen dessert plant, receiving station, transfer station, or distributor shall be subject to suspension of permit and/or court action if two (2) successive inspections disclose a violation of the same requirement.

2. Experience has demonstrated that strict enforcement of these rules leads to a better and friendlier relationship between the Health Department and the dairy industry than does a policy of enforcement which seeks to excuse violations and to defer penalty therefore. The Health Officer's criterion of satisfactory compliance should be neither too lenient nor unreasonably stringent. When a violation is discovered, the Health Officer should point out to the milk producer, bulk milk hauler or sampler, industry plant sampler, truck cleaning facility, plant operator, or responsible person for the milk tank truck, milk tank truck cleaning facility, milk plant, receiving station, transfer station, or distributor the requirement that has been violated, discuss a method for correction and set a time for correcting the violated requirement.

3. The penalties of suspension or revocation of permit and/or court action are provided to prevent continued violation of the provisions of these rules but are worded to protect the dairy industry against unreasonable or arbitrary action. When a condition is found which constitutes an imminent health hazard, prompt action is necessary to protect the public health; therefore, the Health Officer is authorized in Rule 420-3-16-.04 to suspend the permit immediately. However, except for such emergencies, no penalty is imposed on the producer, milk hauler or sampler, milk plant, or frozen dessert plant upon the first violation of any of the sanitation requirements listed in Rule 420-3-16-.09 or 420-3-16-.10.

4. A producer, milk hauler or sampler, milk tank truck, cleaning facility, receiving station, or distributor, milk plant, or frozen dessert plant found violating any requirement on two (2) consecutive inspections must be notified in writing and given a reasonable time to correct the violation(s) before a third inspection is made. The requirement of giving written notice shall be deemed to have been satisfied by the handing to the operator or by the posting of an inspection report as required by this rule. After receipt of a notice of violation, but before the allotted time has elapsed, the producer, milk hauler, milk plant, or frozen dessert plant shall have an opportunity to appeal the interpretation to the Health Officer or for an extension of the time allowed for correction.

5. Aseptic Processing Milk Plants - Because aseptically processed milk and milk products are stored at room temperature and not refrigerated after processing, they must be considered an imminent hazard to public health wherever it is revealed by an inspection or a review of the processing records that the process is less than the required scheduled process and the products produced have not maintained their commercial sterility. Prompt action by the Health Officer to suspend the permit must be initiated in order to protect the public health. The Health Officer shall stop the sale of all under processed product and follow at least the minimum requirements of 21 CFR 113.89 (refer to Appendix L) before releasing any product.

(c) Inspection Report/Audit

1. A copy of the inspection report/audit shall be filed by the Health Officer and retained for at least twenty-four (24) months. The results shall be entered on appropriate ledger forms. The use of a computer or other information retrieval system may be used. Examples of field inspection forms are included in Appendix M.

History

• Author: G. M. Gallaspy, Jr.
• Authority: Code of Ala. 1975, §§22-2-2, 22-20-7.
• Repealed and New Rule: Filed October 18, 2018; effective December 2, 2018.

Ala. Admin. Code r. 420-3-16-.07 Examination Of Milk And Milk Products

(1) It shall be the responsibility of the bulk milk hauler or sampler to collect a representative sample of milk from each farm bulk milk tank and/or silo or from a properly installed and operated in-line-sampler or aseptic sampler, that is approved for use by the Health Officer and FDA to collect representative samples, prior to transferring or as transferring milk utilizing an aseptic sampler from a farm bulk milk tank and/or silo, truck, or other container. All samples shall be collected and delivered to a milk plant, frozen dessert plant, receiving station, transfer station, or other location and approved by the Health Officer.

(2) It shall be the responsibility of the industry plant sampler to collect a representative sample of milk for Appendix N testing from the following:

(a) Each milk tank truck or from a properly installed and operated aseptic sampler, which is approved for use by the Health Officer and FDA to collect representative samples, prior to transferring milk from a milk tank truck; and/or

(b) Each raw milk supply that has not been transported in bulk milk pickup tankers or from a properly installed and operated in-line sampler or aseptic sampler, which is approved for use by the Health Officer and FDA to collect representative samples, prior to transferring the milk from a farm bulk milk tank(s)/silo(s), milk plant raw milk tank(s) and/or silo(s), other raw milk storage container(s), etc. for processing at that location.

(3) During any consecutive six (6) months, at least four (4) samples of raw milk for pasteurization, ultra pasteurization, aseptic processing and packaging, or retort processed after packaging shall be collected from each producer in at least four (4) separate months, except when three (3) months show a month containing two (2) sampling dates separated by at least twenty (20) days. These samples shall be obtained under the direction of the Health Officer or shall be taken from each producer under the direction of the Health Officer and delivered in accordance with this section. During any consecutive six (6) months, at least four (4) samples of raw milk for pasteurization, ultra pasteurization, or aseptic processing and packaging, or retort processed after packaging shall be collected in at least four (4) separate months, except when three (3) months show a month containing two (2) sampling dates separated by at least twenty (20) days. These samples shall be taken by the Health Officer from each milk plant after receipt of the milk by the plant and prior to pasteurization, ultra pasteurization, aseptic processing and packaging, or retort processed after packaging. During any consecutive six (6) months, at least four (4) samples of pasteurized milk, ultra pasteurized milk, flavored milk, flavored reduced fat or lowfat milk, flavored non-fat (skim) milk, each fat level of reduced fat or lowfat milk, and each milk product defined in these rules, shall be collected by the Health Officer in at least four (4) separate months, except when three (3) months show a month obtaining two (2) sample dates separated by at least twenty (20) days from every milk and frozen dessert plant. All pasteurized and ultra-pasteurized milk and/or milk products required sampling and testing is to be conducted only when there are test methods available that are validated by FDA and accepted by the NCIMS. Milk and/or milk products that do not have validated and accepted methods are not required to be tested (refer to M-a-98, latest revision), for the specific milk and/or milk products that have FDA validated and NCIMS accepted test methods. Aseptically processed and packaged low-acid milk and/or milk products and retort processed after packaged low-acid milk and/or milk products shall be exempt from the sampling and testing requirements of this Item. During any consecutive six (6) months, at least four (4) samples of each frozen dessert product and frozen dessert mix for resale defined in these rules shall be taken from every frozen dessert plant except when three (3) months show a month obtaining two (2) sample dates separated by at least twenty (20) days from every milk and frozen dessert plant. In addition, the Health Officer shall collect and examine monthly at least one (1) sample of each frozen dessert mix being manufactured for resale. Sample of milk, milk products, and frozen desserts shall be taken while in possession of the producer or distributor at any time. Samples of milk, milk products, and frozen desserts from dairy retail stores, food service establishments, grocery stores, and other places where milk, milk products, and frozen desserts are sold shall be examined periodically as determined by the Health Officer. Proprietors of such establishments shall furnish the Health Officer, upon request, with the name of all distributors from whom milk, milk products, or frozen desserts are obtained.

Note: The sampling of milk and/or milk products from locations where milk and/or milk products are sold as cited above, shall not be applicable to a TPC authorized under the ICP.

(4) Required bacterial counts, somatic cell counts, and cooling temperature checks shall be performed on raw milk for pasteurization, ultra-pasteurization, aseptic processing and Chapter 420-3-16 Health Supp. 12/31/18 3-16-40 packaging, or retort processed after packaging. In addition, drug tests for Beta Lactams on each producer’s milk shall be conducted at least four (4) times during any consecutive six (6) months.

(5) All pasteurized and ultra-pasteurized milk and/or milk products required sampling and testing to be done only when there are test methods available that are validated by FDA and accepted by the NCIMS, otherwise there would not be a requirement for sampling. Required bacterial counts, coliform counts, drug tests for Beta Lactams, phosphatase, and cooling temperature determinations shall be performed on Grade “A” pasteurized and ultra-pasteurized milk and/or milk products defined in this rule only when there are validated and accepted test methodology (refer to M-a-98, latest revision), for the specific milk and/or milk products that have FDA validated and NCIMS accepted test methods.

Note: When multiple samples of the same milk and/or milk products, except for aseptically processed and packaged low-acid milk and retort processed after packaged low-acid milk and/or milk products, are collected from the same producer or processor from multiple tanks or silos on the same day, the laboratory results are averaged arithmetically by the Health Officer or by personnel approved by the Milk Laboratory Control Agency at an official or officially designated laboratory, with industry consent where applicable, and recorded as the official results for that day. This is applicable for bacterial (standard plate count and coliform), somatic cell count, and temperature determinations only.

(6) Whenever two (2) of the last four (4) consecutive bacterial counts (except those for aseptically processed milk and milk products), somatic cell count, coliform determinations, or cooling temperatures, taken on separate days, exceed the limit of the standard for the milk, milk products, and/or frozen desserts, the Health Officer shall send a written notice thereof to the person concerned. This notice shall be in effect, so long as two (2) of the last four (4) consecutive samples exceed the limit of the standard. An additional sample shall be taken within twenty-one (21) days of the sending of such notice, but not before the lapse of three (3) days. Immediate suspension of permit in accordance with Rule 420-3-16-.04 and/or court action shall be instituted whenever the standard is violated by three (3) of the last five (5) bacterial counts (except those for aseptically processed milk and milk products), coliform determinations, cooling temperatures, or somatic cell counts.

(7) Laboratory facilities shall be provided at every plant to determine the presence of antibiotics in milk and/or frozen desserts. Every tank truck of raw milk shall be examined for the presence of antibiotics upon arrival at the plant. Such examinations shall be made before the milk is processed and milk containing antibiotics shall not be processed. The Health Officer shall be notified immediately of all positive antibiotic tests. Appropriate records shall be maintained at the plant showing the results of all examinations.

(8) Whenever a phosphatase test is positive, the cause shall be determined. Where the cause is improper pasteurization, it shall be corrected and any milk, milk product, or frozen dessert involved shall not be offered for sale. Whenever a product does not meet the butterfat standards as prescribed in these rules, the product shall not be offered for sale.

(9) Whenever a pesticide residue test is positive, an investigation shall be made to determine the cause, and the cause shall be corrected. An additional sample shall be taken and tested for pesticide residues and no milk, milk product, or frozen dessert as defined in this rule shall be offered for sale until it is shown by a subsequent sample to be free of pesticide residues or below the actionable levels established for such residues.

(10) Whenever a drug residue test is confirmed positive, an investigation shall be made to determine the cause, and the cause shall be corrected in accordance with the provisions of Appendix N.

(11) Samples shall be analyzed at an appropriate official or officially designated laboratory. All sampling procedures, including the use of approved in-line samplers and approved aseptic samplers for milk tank trucks or for farm bulk milk tanks and/or silos, and required laboratory examinations shall be in substantial compliance with the most current editions of Standard Methods for the Examination of Dairy Products (SMEDP) of the American Public Health Association, Official Methods of Analysis (OMA) and the Association of Official Analytical Chemists (AOAC), and International Official Methods of Analysis (IOMA). Such procedures, including the certification of sample collectors and examinations shall be evaluated in accordance with the procedures.

(12) Assays of milk and/or milk products as defined in this rule, including aseptically processed and packaged low-acid milk and/or milk products and retort processed after packaged low-acid milk and/or milk products, to which vitamin(s) A and/or D have been added for fortification purposes, shall be conducted at least annually in a laboratory, which has been accredited by FDA and which is acceptable to the Health Officer, using test methods acceptable to FDA or other official methodologies, which gives statistically equivalent results to the FDA methods (refer to M-a-98, latest revision), for the specific milk and/or milk products that have FDA validated and NCIMS accepted test methods for vitamins). Vitamin testing laboratories are accredited, if they have one (1) or more certified analysts and meet the quality control requirements of the program established by FDA. Laboratory accreditation and analyst certification parameters are specified in the Evaluation of Milk Laboratories (EML) manual. In addition, all milk plants fortifying milk and/or milk products with vitamins shall keep volume control records. These volume control records shall cross reference the form and amount of vitamin D, vitamin A and/or vitamins A and D used with the amount of milk and/or milk products produced and indicate a percent of expected use, plus or minus.

(13) Administrative Procedures

(a) All violations of bacteria, coliform, confirmed somatic cell counts, and cooling temperature standards should be followed promptly by inspection to determine and correct the cause (refer to Appendix E). Aseptically processed milk and milk products packaged in hermetically sealed containers are exempt from the refrigerated storage requirements of this rule.

(b) Therefore, whenever a breakdown in the processing or packaging of these products occurs, an imminent hazard to public health exists. Prompt action is needed by the Health Officer.

(c) Laboratory Techniques - Procedures for the collection, including the use of approved in-line samplers and approved aseptic samplers for milk tank trucks or for farm bulk milk tanks and/or silos, and the holding of samples; the selection and preparation of apparatus, media, and reagents; and the analytical procedures, incubation, reading, and reporting of results, shall be in substantial compliance with the FDA/NCIMS 2400 Forms, SMEDP and OMA. The procedures shall be those specified therein for:

1. Bacterial count at 32°C Standard Plate Count (SPC) or Petrifilm Aerobic Count (PAC) methods (refer to M-a-98, latest revision, for the specific milk and/or milk products for which these tests are approved).

2. Alternate methods, for bacterial counts at 32°C Plate Loop Count (PLC), Spiral Plate Count (SPLC), BactoScan FC (BSC), TEMPO AC-Aerobic Count (TAC), and Peel Plate AC- Aerobic Count (PPAC) methods (refer to M-a-98, latest revision, for the specific milk and/or milk products for which these tests are approved).

3. Coliform count at 32°C Coliform Plate Count (CPC), Petrifilm Coliform Count (PCC) and/or High Sensitivity Coliform Count (HSCC), TEMPO CC-Coliform Count (TCC) and Peel Plate E. Coli and Coliform (PPEC) and/or Peel Plate E. Coli and Coliform High Volume Sensitivity (PPECHVS) methods (refer to M-a-98, latest revision, for the specific milk and/or milk products for which these tests are approved).

4. A viable bacterial count of nonfat dry milk shall be made in accordance with the procedures in SMEDP for the SPC or PAC of Dry Milk, except agar plates shall be incubated for seventy-two (72) hours.

5. Drug Testing - Beta lactam test methods which have been independently evaluated or evaluated by FDA and have been found acceptable by FDA and the NCIMS for detecting Beta lactam drug residues in raw milk, or pasteurized milk, or a particular type of pasteurized milk product at current target testing or tolerance levels, shall be used for each Beta lactam drug of concern. This does not apply to those milk products for which there are not any approved Beta lactam test methods available (refer to M-a-85, latest revision, for the approved Beta lactam test methods and M-a-98, latest revision, for the specific milk and/or milk product for which there are approved Beta lactam test methods available). Enforcement action shall be taken on all confirmed positive Beta lactam results (refer to Appendix N). A result shall be considered confirmed positive for Beta lactams if it has been obtained by using a test method, which has been evaluated and deemed acceptable by FDA and accepted by the NCIMS at levels established in memoranda transmitted periodically by FDA (refer to Appendix N, IV).

6. Screening and Confirmatory Methods for the Detection of Abnormal Milk - The results of the screening test or confirmatory test shall be recorded on the official records of the dairy farm and a copy of the results sent to the milk producer.

7. When a warning letter has been sent, because of excessively high somatic cell counts, an official inspection of the dairy farm should be made by regulatory personnel or certified industry personnel. This inspection should be made during milking time.

(i) Milk (Non-Goat) - Any of the following confirmatory or screening test procedures shall be used: Single Strip Direct Microscopic Somatic Cell Count (DMSCC) or Electronic Somatic Cell Count (ESCC).

(ii) Goat Milk - DMSCC or ESCC may be used for screening raw goat milk samples, to indicate a range of somatic cell levels, as long as the somatic cell standard for goat milk remains 1,500,000/mL. Screening for official purposes shall be conducted by an analyst (s) certified for that procedure.

(iii) Only the Pyronine Y-Methyl Green stain or “New York modification” Single Strip DMSCC test procedures shall be used to confirm the level of somatic cells in goat milk by certified analysts.

(iv) Sheep Milk - Any of the following confirmatory or screening test procedures shall be used: Single Strip DMSCC or ESCC. When results from the Single Strip DMSCC procedure exceed the 750,000/mL standard set forth in this rule, the count shall have been derived from, or be confirmed by, the Pyronine Y Methyl-Green Stain or the “New York modification.”

(v) Camel Milk - Any of the following confirmatory or screening test procedures shall be used: Single Strip DMSCC or ESCC. When results exceed the 750,000/mL standard set forth in this rule, the count shall have been derived from, or be confirmed by, the Single Strip DMSCC using the Pyronine Y Methyl-Green Stain or the "New York modification,” and conducted by analysts certified for that procedure (refer to the Note: on page 35).

8. Electronic Phosphatase Tests - The phosphatase test is an index of the efficiency of the pasteurization process. In the event an accredited laboratory finds that a sample confirms positive for phosphatase, the pasteurization process shall be investigated and corrected. When a laboratory phosphatase test is confirmed positive, or if any doubt should arise as to the compliance of the equipment, standards, or methods outlined in Rule 420-3-16-.10(1)(a) the Health Officer should immediately conduct field phosphatase testing at the milk plant (refer to Appendix G).

9. Vitamin testing shall be performed using test methods acceptable to FDA or other official methodologies, which give statistically equivalent results to the FDA methods.

10. Any other tests, which have been approved by FDA to be equally accurate, precise, and practical.

11. All standards used in the development and use of drug residue detection methods designed for the PMO monitoring programs shall be referenced to a United States Pharmacopeia (USP) standard when available. When a USP standard is not available, then the original method shall define the standard to be used.

12. Procedural or reagent changes for official tests shall be submitted to FDA for acceptance prior to being used by certified NCIMS milk laboratories.

13. Sampling Procedures - SMEDP contains guidance for the sampling of milk, milk products, and frozen dessert products. Optionally, sample collection time may be identified in military time (24 hour clock) (refer to Appendix G for a reference to drug residues in milk, milk products, and frozen dessert products and the conditions under which a positive phosphatase reaction may be encountered in properly pasteurized milk or cream), (refer to Appendix B for reference to farm bulk milk hauling programs regarding training, licensing/permitting, routine inspection, and the evaluation of sampling procedures).

(i) When samples of raw milk for pasteurization, ultra-pasteurization, aseptic processing and packaging, or retort processed after packaging are taken at a milk or frozen dessert plant prior to pasteurization, ultra-pasteurization, aseptic processing and/or retort processing, respectively, they shall be drawn following adequate agitation from randomly selected storage tanks/silos. All counts and temperatures shall be recorded on a milk-ledger form as soon as reported by the laboratory. A computer or other information retrieval system may be used.

(ii) When bacterial counts except for aseptically processed milk and milk products, and temperature determinations are made of several samples of the same milk or milk products collected from the same supply or processor on the same day, these values are averaged arithmetically, and the results recorded as the count or temperature determinations of the milk or milk product for that day. All counts and temperatures should be recorded on a milk ledger form for dairy farms or milk plants as soon as reported by the laboratory.

(iii) A computer of other information retrieval system may be used.

(iv) See Appendix G for a reference to antibiotics in milk and the conditions under which a positive phosphatase reaction may be encountered in properly pasteurized milk or cream.

Note: Milk from animals not currently in the PMO may be labeled as Grade “A” and IMS listed upon FDA’s acceptance of validated the PMO, Section 6, and Appendix N test methods for the animal to be added (refer to M-a-98, latest revision, for the specific milk and/or milk products that have FDA validated and NCIMS accepted test methods).

14. Farm Bulk Milk Hauling - The farm bulk milk hauler occupies a unique position in the producer/processor/ Health Officer relationship. The milk hauler is a critical factor in the current structure of milk marketing. As a weigher and sampler, he/she stands as the official and, frequently, the only judge of milk volumes bought and sold. As the milk receiver, the hauler's operating habits directly affect the quality of milk committed to his/her care. When the bulk milk hauler's obligations include the collection and delivery of samples to the laboratory for analysis, he/she becomes a vital part of the quality control and regulatory programs. Any deviation from acceptable practices by the milk hauler may result in the suspension and/or revocation of his/her permit (see Appendix B for reference to farm milk hauling program regarding training, licensing, permitting, routine inspection, and the evaluation procedure).

Note: The industry should be encouraged by the Health Officer to achieve day-to-day compliance with the foregoing standards by performing tests on each producer's milk, including platform tests for odors, temperature, and sediment. Bacterial counts should be conducted following laboratory pasteurization as a check for thermoduric organisms. Examinations for the presence of phychro-philic bacteria are also recommended. Periodic screening tests for presence of added water, antibiotics, and pesticide residues should be performed on producer’s milk. Plants should reject milk of abnormal odor and high temperature, as well as milk that is found to be unsatisfactory by the sediment test. Follow-up inspection on the dairy farm should be made by the field man to determine the cause and to institute corrective measures whenever milk is rejected by the plant.

History

• Author: G. M. Gallaspy, Jr.
• Authority: Code of Ala. 1975, §§22-2-2, 22-20-7.
• Repealed and New Rule: Filed October 18, 2018; effective December 2, 2018.

Ala. Admin. Code r. 420-3-16-.08 Standards For Milk And Milk Products

(1) All Grade “A” raw milk and/or milk products for pasteurization, ultra-pasteurization, aseptic processing and packaging, or retort processed after packaging, and all Grade “A” pasteurized, ultra-pasteurized, aseptically processed and packaged low-acid milk, and/or milk products, or retort processed after packaged low-acid milk and/or milk products, shall be produced, processed, manufactured, and pasteurized, ultra-pasteurized, aseptically processed and packaged, or retort processed after packaged to conform to the following chemical, physical, bacteriological, and temperature standards and the sanitation requirements of this rule.

(2) No process or manipulation other than pasteurization, ultra-pasteurization, aseptic processing and packaging, or retort processed after packaging; processing methods integral therewith; and appropriate refrigeration shall be applied to milk, milk products, and frozen desserts for the purpose of removing or deactivating microorganisms; provided, that filtration and/or bactofugation processes are performed in the milk plant in which the milk, milk products, and frozen desserts are pasteurized, ultra- pasteurized, aseptically processed and packaged, or retort processed after packaged. Provided, that in the bulk shipment of cream, nonfat (skim) milk, reduced fat or lowfat milk, the heating of the raw milk, one (1) time, to temperatures greater than 52°C (125°F) but less than 72°C (161°F), for separation purposes, is permitted when the resulting bulk shipment(s) of cream, nonfat (skim) milk, reduced fat or lowfat milk are labeled heat-treated. In the case of heat-treated cream, the cream may be further heated to less than 75°C (166°F) in a continuing heating process and immediately cooled to 7°C (45°F) or less when necessary for enzyme deactivation (such as lipase reduction) for a functional reason.

(3) Milk plants, receiving stations, and transfer stations participating in the NCIMS voluntary HACCP Program, shall also comply with the requirements of Appendix K. Whey shall be from cheese made from Grade “A” raw milk for pasteurization, ultra-pasteurization, aseptic processing and packaging, or retort processed after packaging as provided in this rule.

(4) Buttermilk shall be from butter made from Grade “A” cream, which has been pasteurized prior to use in accordance with Rule 420-3-16-.10(16). Provided, that this requirement shall not be construed as barring any other heat treatment process which has been recognized by the FDA to be equally efficient in the destruction of staphylococcal organisms and which is approved by the Health Officer.

(5) Buttermilk and whey used in the manufacture of Grade “A” milk, milk products, and frozen desserts shall be produced in a milk/cheese plant that complies with Rule 420-3-16-.10(1-15), 420-3-16-.10(17), and 420-3-16-.10(20-22).

(6) Whey shall be from the following:

(a) Cheese made from Grade “A” raw milk for pasteurization, which has been pasteurized prior to use, in accordance with Rule 420-3-16-.10(16), or

(b) Cheese made from Grade “A” raw milk for pasteurization, which has been heat-treated to a temperature of at least 64°C (147°F) and held continuously at that temperature for at least twenty-one (21) seconds or to at least 68°C (153°F) and held continuously at that temperature for at least fifteen (15) seconds, in equipment meeting the pasteurization requirements provided for in this rule. Provided, that this requirement shall not be construed as barring any other heat treatment process which has been recognized by the FDA to be equally efficient in the destruction of staphylococcal organisms and which is approved by the Health Officer.

*Goat Milk 1,500,000/ml.

**Not applicable to acidified or cultured milk and/or milk products, eggnog, cottage cheese, and other milk and/or milk products as identified in the latest revision of M-a-98.

***Results of the analysis of milk and/or milk products which are weighed in order to be analyzed shall be reported in # per gm (refer to the current edition of the SMEDP).

****Not applicable to acidified or cultured milk and/or milk products, eggnog, cottage cheese, pasteurized and ultra-pasteurized flavored (non-chocolate) milk and/or milk products, and other milk and/or milk products as identified in the latest revision of M-a-98.

*****Raw sheep milk samples that have previously been frozen may be tested for Appendix N drug residue if the samples meet the sampling requirements cited in Appendix B.

Note: It is not allowed to test frozen raw milk samples for bacteria or somatic cells.

History

• Author: G. M. Gallaspy, Jr.
• Authority: Code of Ala. 1975, §§22-2-2, 22-20-7.
• Repealed and New Rule: Filed October 18, 2018; effective December 2, 2018.

Ala. Admin. Code r. 420-3-16-.09 Sanitation Requirements For Grade "A" Raw Milk For Pasteurization, Ultra-Pasteurization, Aseptically Processing and Packaging, Or Retort Processed After Packaging

(1) Abnormal Milk

(a) Lactating animals which show evidence of the secretion of milk with abnormalities in one (1) or more quarters, based upon bacteriological, chemical, or physical examination, shall be milked last or with separate equipment and the milk shall be discarded. Lactating animals producing contaminated milk, that is, lactating animals which have been treated with, have consumed chemical, medicinal, or radioactive agents, which are capable of being secreted in the milk and which in the judgment of the Health Officer may be deleterious to human health, shall be milked last or with separate equipment and the milk disposed of as the Health Officer may direct. For applicability to AMIs refer to Appendix Q.

(b) Public Health Reason

1. The health of lactating animals is a very important consideration because a number of diseases of lactating animals, including salmonellosis, staphylococcal infection, may be transmitted to man through the medium of milk. The organisms of most of these diseases may get into the milk either directly from the udder or indirectly through infected body discharges which may drop, splash, or be blown into the milk.

2. Bovine mastitis is an inflammatory and, generally, highly communicable disease of the bovine udder. Usually, the inciting organism is a streptococcus of bovine origin (Type B), but the disease is often caused by a staphylococcus or other infectious agent. Occasionally, lactating animals’ udders become infected with hemolytic streptococci of human origin, which may result in milk borne epidemics of scarlet fever or septic sore throat. The toxins of staphylococci, and possibly other organisms in milk may cause severe gastroenteritis. Some of these toxins are not destroyed by pasteurization.

(c) Administrative Procedures - This item is deemed to be satisfied when:

1. Milk from lactating animals being treated with medicinal agents which are capable of being secreted in the milk, is not offered for sale for such period as is recommended by the attending veterinarian or as indicated on the package label of the medicinal agent.

2. Milk from lactating animals treated with or exposed to insecticides not approved for use on dairy cattle by the U.S. EPA is not offered for sale.

3. The Health Officer requires such additional tests for the detection of abnormal milk as he/she deems necessary.

4. Bloody, stringy, off-colored milk or milk that is abnormal to sight or odor, is so handled and disposed of as to preclude the infection of other cows and the contamination of milk utensils.

5. Lactating animals secreting milk with abnormalities are milked last or in separate equipment, which effectively prevents the contamination of the wholesome supply. Milking equipment used on animals with abnormalities in their milk is maintained clean to reduce the possibility of reinfecting or cross infection of the dairy animals.

6. Equipment, utensils, and containers used for the handling of abnormal milk are not used for the handling of milk to be offered for sale unless they are first cleaned and effectively sanitized.

7. Processed animal waste derivatives, used as a feed ingredient for any portion of the total ration of the lactating dairy animal have been:

(a) Properly processed in accordance with at least those requirements contained in the Model Regulations for Processed Animal Wastes (MRPAW) developed by the Association of American Feed Control (AAFC) officials; and

(b) Do not contain levels of deleterious substances, harmful pathogenic organisms, or other toxic substances which are secreted in the milk at any level which may be deleterious to human health.

8. Unprocessed poultry litter and unprocessed recycled animal body discharges are not fed to lactating dairy animals.

(2) Milking Barn or Parlor - Construction

(a) A milking barn or parlor shall be provided on all dairy farms in which the milking herd shall be housed during milking time operations. For applicability to AMIs, refer to Appendix Q. The areas used for milking purposes shall:

1. Have floors constructed of concrete or equally impervious materials: Provided convalescent (maternity) pens located in milking areas of stanchion-type barns may be used when they comply with the guidelines specified in Appendix C.

2. Have walls and ceilings which are smooth, painted or finished in an approved manner, in good repair, and ceiling dust tight.

3. Have separate stalls or pens for horses, calves, and bulls.

4. Be provided with natural and/or artificial light, well distributed for day and/or night milking.

5. Provide sufficient air space and air circulation to prevent condensation and excessive odors.

6. Not be overcrowded, and

7. Have dust-tight, covered boxes or bins, or separate storage facilities for ground, chopped, or concentrated feed.

(b) Public Health Reason - When milking is done elsewhere than in a suitable place provided for this purpose, the milk may be contaminated. Floors constructed of concrete or other impervious materials can be kept clean more easily than floors constructed of wood, earth, or similar materials; and are, therefore, more apt to be kept clean. Painted or properly finished walls and ceilings encourage cleanliness. Tight ceilings and feed rooms reduce the likelihood of dust and extraneous material getting into the milk. Adequate light makes it more probable that the barn will be clean and that the lactating animals will be milked in a sanitary manner.

(c) Administrative Procedures - This item is deemed to be satisfied when:

1. A milking barn or parlor is provided on all dairy farms.

2. Gutters, floors, and feed troughs are constructed of good quality concrete or equally impervious material. Floors shall be easily cleaned (brushed surfaces permitted) and shall be graded to drain and maintained in good repair and free of excessive breaks or worn areas that may create pools.

3. Gravity flow manure channels in milking barns, if used, shall be constructed in accordance with the specifications of Appendix C.

4. Stall barns, when used with gutter grates over manure storage pits, are designed and constructed in accordance with the specifications of Appendix C.

5. Walls are finished with tile, smooth-surfaced concrete, cement plaster, brick, or other equivalent materials with light-colored surfaces; provided, existing barns with wood walls will not be considered a violation provided they are properly maintained. Walls, partitions, doors, shelves, windows, and ceilings shall be kept in good repair, and surfaces shall be refinished whenever wear or discoloration is evident. Ceilings are constructed of smooth dressed lumber, plywood, or similar material. Whenever feed is stored overhead, ceilings shall be constructed to prevent the sifting of chaff and dust into the milking barn or parlor. If an opening is provided from a loft into the milking portion of the barn, such opening shall be provided with a dust-tight door which shall be kept closed during milking operations.

6. Bullpens, maternity calf stalls, and horse stalls are partitioned from the milking portion of the barn. Such portions of the barn that are not separated by tight partitions shall comply with all requirements of this item.

7. The milking barn is provided with natural and/or artificial light to ensure that all surfaces and particularly the working areas will be plainly visible. The equivalent of at least 20 foot-candles (110 lux) of light in all working areas shall be provided.

8. Air circulation is sufficient to minimize odors and to prevent condensation upon walls and ceilings.

9. Overcrowding is not evidenced by the presence of calves, lactating animals, or other barnyard animals in walks or feed alleys. Inadequate ventilation and excessive odors may also be evidence of an overcrowded barn.

10. A dust-tight partition provided with doors that are kept closed, except when in actual use, shall separate the milking portion of the barn from any feed room or silo in which feed is ground or mixed or in which sweet feed is stored. Feed may be stored in the milking portion of the barn, only in such manner as will not increase the dust content of the air, attract flies, or interfere with cleaning of the floor (as in covered, dust-tight boxes or bins). Open feed dollies or carts may be used for distributing the feed, but not storing feed in the milking barn. When conditions warrant, the Health Officer may approve a barn without four walls extending from floor to roof or a shed-type barn provided the requirement of paragraph 3, prohibiting animals and fowl entering the barn is satisfied. Animal housing areas (stables without stanchions, such as loose-housing stables, pen stables, resting barns, free-stall barns, holding barns, loafing sheds, wandering sheds) may be of shed-type construction provided no milking is conducted therein. They are classified as part of the animal yard under Rule 430-3-16-.09(4).

(3) Milking Barn/Stable or Parlor Cleanliness

(a) The interior shall be kept clean. Floors, walls, ceilings, windows, pipelines, and equipment shall be free of filth and/or litter and shall be clean. Swine, fowl, and other animals other than the milking herd shall be kept out of the milking barn area. Feed shall be stored in a manner that will not increase the dust content of the air or interfere with the cleaning of the floor (for applicability to AMIs, refer to Appendix Q). Surcingles, or belly straps, milk stools, and anitkickers shall be kept clean and stored above the floor.

(b) Public Health Reason - A clean interior reduces the chances of contamination of the milk or milk equipment during milking. The presence of other animals increases uncleanliness and the potential for spread of disease. Clean milk stools and surcingles reduce the likelihood of contamination of the milker’s hands between the milking of one (1) lactating animal and the milking of another.

(c) Administrative Procedures - This item is deemed to be satisfied when:

1. The interior of the milking barn or parlor is kept clean.

2. Leftover feed in feed mangers appears fresh and is not wet or soggy.

3. The bedding material, if used, does not contain more manure than has accumulated since the previous milking.

4. Outside surfaces of pipeline systems located in milking barn or parlor are reasonably clean.

5. Gutter cleaners are reasonably clean.

6. All pens, calf stalls, and bullpens, if not separated from the milking barn, stable, or parlor, are clean.

7. Swine, fowl, and animals other than the milking herd are kept out of the milking barn.

8. Gravity flow manure channels in milking barns, if used, shall be maintained in accordance with Appendix C.

9. Stall barns, when used with gutter grates over manure storage pits, are operated and maintained in accordance with the specifications of Appendix C.

10. Milk stools are not padded and are constructed to be easily cleaned. Milk stools, surcingles, and antikickers are kept clean and are stored above the floor in a clean place in the milking barn, stable, parlor, or milkhouse when not in use.

11. In barns in which water under pressure is not available, the floors may be brushed dry and limed. In the latter event, care should be exercised to prevent caking of the lime. When lime or phosphate is used, it shall be spread evenly on the floor as a thin coating. If clean floors are not maintained by this method, the sanitarian should require cleaning with water.

(4) Lactating Animal Yard

(a) The lactating animal yard shall be graded and drained and shall have no standing pools of water or accumulations of organic waste. Provided, that in loafing or lactating animal housing areas, lactating animal droppings and soiled bedding shall be removed, or clean bedding added, at sufficiently frequent intervals to prevent the soiling of the lactating animal’s udder and flanks. Cooling ponds shall be allowed provided they are constructed and maintained in a manner that does not result in the visible soiling of flanks, udders, bellies, and tails of lactating animals exiting the pond. Waste feed shall not be allowed to accumulate. Manure packs shall be properly drained and shall provide a reasonable firm footing. Swine shall be kept out of the lactating animal yard.

(b) Public Health Reason - The lactating animal yard is interpreted to be that enclosed or unenclosed area in which the lactating animals are apt to congregate, approximately adjacent to the barn including lactating animal’s housing areas. This area is, therefore, particularly apt to become filthy with manure droppings, which may result in the soiling of the lactating animal’s udders and flanks. The grading and drainage of the lactating animal yard as far as practicable is required because wet conditions are conducive to fly breeding and make it difficult to keep manure removed and the lactating animals clean. If manure and barn sweepings are allowed to accumulate in the lactating animal yard, fly breeding will be promoted; and the lactating animals, because of their habit of lying down, will be more apt to have manure-soiled udders. Lactating animals should not have access to piles of manure, in order to avoid the soiling of udders and the spread of diseases among dairy animals.

(c) Administrative Procedures - This item is deemed to be satisfied when:

1. The animal yard, which is the enclosed or unenclosed area adjacent to the milking barn in which the lactating animals may congregate, including animal housing areas and feed lots, is graded and drained; depressions and soggy areas are filled; lactating animal lanes are reasonably dry.

2. Approaches to the barn door and the surroundings of stock watering and feeding stations are solid to the footing of the animal.

3. Wastes from the barn or milkhouse are not allowed to pool in the cowyard. Cowyards which are muddy due to recent rains should not be considered as violating this item.

4. Manure, soiled bedding, and waste feed are not stored or permitted to accumulate therein in such a manner as to permit the soiling of lactating animal’s udders and flanks. Animal-housing areas (stables without stanchions, such as loose-housing stables, pen stables, resting barns, and holding barns, shall be considered a part of the cowyard. Manure packs shall be solid to the footing of the animal (see Appendix C).

5. Cowyards are kept reasonably free of animal droppings. Animal droppings shall not be allowed to accumulate in piles that are accessible to the animals.

(5) Milkhouse or Room - Construction and Facilities

(a) A milkhouse or room of sufficient size shall be provided in which the cooling, handling, and storing of milk and the washing, sanitizing, and storing of milk containers and utensils shall be conducted except as provided for in Rule 420-3-16.09(12).

(b) The milkhouse shall be provided with a smooth floor constructed of concrete or equally impervious material graded to drain and maintained in good repair. Liquid waste shall be disposed of in a sanitary manner. All floor drains shall be accessible and shall be trapped, if connected to a sanitary sewer system.

(c) The walls and ceilings shall be constructed of smooth material, in good repair, well painted, or finished in an equally suitable manner.

(d) The milkhouse shall have adequate natural and/or artificial light and be well-ventilated.

(e) The milkhouse shall be used for no other purpose than milkhouse operations. There shall be no direct opening into any barn, stable, or parlor, or into a room used for domestic purposes; provided, a direct opening between the milkhouse and milking barn or parlor is permitted with a tight-fitting, self-closing, solid door(s) hinged to be single or double acting is provided. Screened vents in the wall between the milkhouse and a breezeway, which separates the milkhouse from the milking parlor, are permitted, provided; animals are not housed within the milking facility.

(f) Water under pressure shall be piped into the milkhouse.

(g) The milkhouse shall be equipped with a two (2) compartment wash vat and adequate hot water heating facilities.

(h) When a transportation tank is used for the cooling and/or storage of milk on the dairy farm, such tank shall be provided with a suitable shelter for the receipt of milk. Such shelter shall be adjacent to, but not a part of, the milkroom and shall comply with the requirements of the milkroom with respect to construction, light, drainage, insect and rodent control, and general maintenance. In addition, the following minimum criteria shall be met:

1. An accurate, accessible temperature-recording device shall be installed in the milk line downstream from an effective cooling device, which cools the milk to 7°C (45°F) or less. Electronic records that comply with Appendix H, IV. Temperature-recording devices used in storage tanks and V., Criteria 4, 7, 8, 9, 11, and 12 with or without hard copy, may be used in place of temperature-recording records (refer to the Note: on page 51). An indicating thermometer shall be installed as close as possible to the recording device for verification of recording temperatures. This indicating thermometer shall comply with all applicable requirements in Appendix H. This thermometer shall be used to check the temperature-recording device during the regulatory inspection and the results recorded on the recording record or into the electronic data collection, storage, and reporting system.

2. Temperature-recording charts shall be maintained on the premises for a period of a minimum of six (6) months and are available for review by the Health Officer. Except that, the electronic storage of required temperature records, with or without hard copy, shall be acceptable, provided the computer and computer generated temperature records are readily available for review by the Health Officer.

3. The milk shall be sampled at the direction of the Health Officer in a manner so as to preclude contaminating the milk tank truck or sample, by a permitted milk sample collector.

4. The milk tank truck shall be effectively agitated in order to collect a representative sample.

(i) When the Health Officer determines conditions exist whereby the direct loading of a milk tank truck (through by-passing the use of a farm bulk milk tank[s] and/or silo[s]) can be adequately protected and sampled without contamination, a shelter need not be provided if the following minimum criteria are met:

(I) The milk hose connection is accessible to, and made from within, the milkhouse. The milk hose connection to the milk tank truck is completely protected from the outside environment at all times. Provided, based on the Health Officer’s acceptance, the direct loading of milk from the milkhouse to the milk tank truck may be conducted through a properly designed hose port that adequately protects the milkhouse opening or by studding the milk transfer and associated CIP cleaned lines outside the milkhouse wall in accordance with Rule 420-3-16-.09 Administrative Procedures 13.

(II) To assure continued protection of the milk, the milk tank truck manhole shall be sealed after the truck has been cleaned and sanitized.

(III) The milk tank truck shall be washed and sanitized at the permitted milk plant, receiving station, or transfer station receiving the milk, or a permitted milk tank truck cleaning facility.

(IV) An accurate, accessible temperature-recording device shall be installed in the milk line downstream from an effective cooling device, which cools the milk to 7°C (45°F) or less. Electronic records that comply with the applicable provisions of Appendix H, IV. Temperature-recording devices used in storage tanks and V., Criteria 4, 7, 8, 9, 11, and 12 with or without hard copy, may be used in place of temperature-recording records (refer to the Note: on page 51). An indicating thermometer shall be installed as close as possible to the recording device for verification of recording temperatures. This indicating thermometer shall comply with all applicable requirements in Appendix H. This thermometer shall be used to check the temperature-recording device during the regulatory inspection and the results recorded on the recording record or into the electronic data collection, storage, and reporting system.

(V) Temperature-recording records shall be maintained on the premises for a period of a minimum of six (6) months and are available for review by the Health Officer. Except that, the electronic storage of required temperature records, with or without hard copy, shall be acceptable, provided the computer and computer generated temperature records are readily available for review by the Health Officer.

(VI) The milk shall be sampled at the direction of the Health Officer, in a manner so as to preclude contaminating the milk tank truck or sample, by a permitted milk sample collector. The milk in the milk tank truck shall be effectively agitated in order to collect a representative sample.

(VII) The milk tank truck shall be parked on a self-draining concrete or equally impervious surface during filling and storage.

(VIII) When direct loading of a milk tank truck using either a hose port, as addressed above, or stubbing the milk transfer and associated CIP cleaned lines outside the milkhouse wall in accordance with Rule 420-3-16-.10(5), Administrative Procedures 13, overhead protection of the milk hose connection to the milk tank truck shall be provided.

(j) Public Health Reason - Unless a suitable, separate place is provided for the cooling, handling, and storing of milk and for the washing, sanitizing, and storage of milk utensils, the milk or the utensils may become contaminated. Construction which permits easy cleaning promotes cleanliness. A well-drained floor of concrete or other impervious material promotes cleanliness. Ample light promotes cleanliness, and proper ventilation reduces the likelihood of odors and condensation. A well-equipped milkhouse, which is separated from the barn, stable or parlor, and the living quarters, provides a safeguard against the exposure of milk, milk equipment, and utensils to contamination.

(k) Administrative Procedures - This item is deemed to be satisfied when:

1. A separate milkhouse of sufficient size is provided for the cooling, handling, and storing of milk and the washing, sanitizing, and storing of milk containers and utensils; except as provided for in Rule 420-3-16-.10(12).

2. The floors of all milkhouses are constructed of good quality concrete (float finish permissible) or equally impervious tile or brick laid closely with impervious material, or metal surfacing with impervious joints or other material the equivalent of concrete and maintained free of breaks, depressions, and surface peelings.

3. The floor slopes to drain so that there are no pools of standing water. The joints between the floor and the walls shall be water tight.

4. The liquid wastes are disposed of in a sanitary manner. All floor drains are accessible and are trapped and grated, if connected to a sanitary sewer.

5. Walls are finished with tile, smooth, surfaced concrete, cement plaster, cement block, or other equivalent materials with light-colored surfaces. The surfaces and joints shall be smooth. Ceilings are constructed of smooth dressed lumber, plywood, or similar materials. Walls, partitions, doors, shelves, windows, and ceilings shall be kept in good repair; and surfaces shall be refinished whenever wear or discoloration is evident. Walls (other than tile) and ceilings are well-painted with a light-colored, washable paint. Sheet metal, tile, cement block, brick, concrete, cement plaster, or similar materials of light color may be used and the surfaces and joints shall be smooth.

6. A minimum of 20 foot-candles (220 lux) of light is provided at all working areas from natural and/or artificial light for milkhouse operations.

7. The milkhouse is adequately ventilated to minimize condensation on floors, walls, ceilings, and clean utensils. Windows and solid doors are closed during dusty weather.

8. The milkhouse is adequately ventilated to minimize odors and condensation on floors, walls, ceilings, and clean utensils.

9. Vents, if installed, and lighting fixtures are installed in a manner to preclude the contamination of bulk milk tanks or clean utensil storage areas.

10. The milkhouse is used for no other purpose than milkhouse operations.

11. There is no direct opening into any barn or room used for domestic purposes; except that an opening between the milkhouse and milking barn or parlor is permitted with a tight-fitting, self-closing solid door(s) hinged to be single or double acting is provided. Except that screened vents are permitted in the wall between the milkhouse and a breezeway, which separates the milkhouse from the milking parlor, provided animals are not housed within the milking facility.

12. A vestibule, if used, complies with the applicable milkhouse construction requirements.

13. The transfer of milk from a bulk milk tank to a bulk milk pickup tanker is through a hose port located in the milkhouse wall. The hose port shall be fitted with a tight door, which shall be in good repair. It shall be kept closed except when the hose port is in use. An easily cleanable surface shall be constructed under the hose port, adjacent to the outside wall and sufficiently large to protect the milk hose from contamination.

(l) Provided, milk can be transferred from a bulk milk tank to a bulk milk pickup tanker by stubbing the milk transfer and associated CIP cleaned lines outside the milkhouse wall, provided:

1. A concrete slab of adequate size, to protect the transfer hose, shall be provided under the stubbed sanitary milk and CIP cleaned lines.

2. The outside wall of the milkhouse, where the sanitary piping and concrete slab are located shall be properly maintained and kept in good repair.

3. The sanitary piping, stubbed outside the milkhouse, shall be properly sloped to assure complete drainage and the ends of the piping, which are located outside, shall be capped when the transfer hose is disconnected.

4. After the completion of milk transfer, the milk lines, and transfer hose shall be properly CIP cleaned.

5. After the CIP cleaning process has been completed; the transfer hose shall be disconnected, drained, and stored in the milkhouse. Proper storage of the transfer hose includes capping the ends and storing the entire hose up off the floor. The sanitary piping outside the milkhouse shall be capped at all times, except when transferring milk or being CIP cleaned. When the caps are not being used, they shall be properly cleaned and sanitized after each use and stored in the milkhouse to protect them from contamination. A transfer hose manufactured with permanent hose end fittings, attached in such a manner that will assure a crevice-free joint between the hose and the fitting, may be stored outside of the milkhouse, provided, it is CIP cleaned; the stubbed piping and hose length are of sufficient design to allow complete drainage after cleaning and sanitizing; and the hose remains connected to the stubbed piping when not in use.

6. Means shall be provided to sanitize the milk-contact surfaces of the transfer hose and bulk milk pickup tanker fittings prior to the connection of the transfer hose to the bulk milk pickup tanker.

7. At all times, the bulk milk pickup tanker manhole opening(s) shall remain closed, except for brief periods for sampling and examination, when environmental conditions permit.

8. Water under pressure is piped into the milkhouse.

9. Each milkhouse is provided with facilities for heating water in sufficient quantity and to such temperatures for the effective cleaning of all equipment and utensils (see Appendix C).

10. The milkhouse is equipped with a wash-and-rinse vat having at least two (2) compartments. Each compartment must be of sufficient size to accommodate the largest utensil or container used. The cleaning-in-place vat for milk pipelines and milk machines may be accepted as one part of the two-compartment vat; provided, the cleaning-in-place station rack in or on the vat and the milking machine inflations and appurtenances are completely removed from the vat during the washing, rinsing, and/or sanitizing of other utensils and equipment. Where CIP cleaning/re-circulated systems eliminate the need for hand washing of equipment, the presence of the second wash vat compartment may be optional, if so determined by the Health Officer on an individual basis. Hot and cold water is piped to each compartment.

11. A transportation tank may be used for cooling and/or storing milk on the dairy farm. Such tank shall be provided with a suitable shelter for the receipt of milk. Such shelter shall be adjacent to, but not a part of, the milkhouse and shall comply with the requirements of the milkhouse with respect to construction items; lighting; drainage; insect and rodent control; and general maintenance. In addition, the following minimum criteria shall be met:

(i) An accurate, accessible temperature-recording device shall be installed in the milk line downstream from an effective cooling device, which cools the milk to 7°C (45°F) or less. Electronic records that comply with the applicable provisions of Appendix H, IV, and V, with or without hard copy, may be used in place of temperature-recording records. An indicating thermometer shall be installed as close as possible to the recording device for verification of recording temperatures. This indicating thermometer shall comply with all applicable requirements in Appendix H. This thermometer shall be used to check the temperature recording device during the regulatory inspection and the results recorded on the recording records or into the electronic data collection, storage, and reporting system.

(ii) Temperature-recording records shall be maintained on the premises for a period of a minimum of six (6) months and are available for review by the Health Officer. Except that, the electronic storage of required temperature records, with or without hard copy, shall be acceptable, provided the computer and computer generated temperature records are readily available for review by the Health Officer.

(iii) The milk shall be sampled at the direction of the Health Officer in a manner so as to preclude contaminating the milk tank truck or sample by an acceptable milk sample collector.

(iv) The milk tank truck shall be effectively agitated in order to collect a representative sample.

(m) When the Health Officer determines conditions exist whereby the direct loading of a milk tank truck (through by-passing the use of a farm bulk milk tank[s] and/or silo[s]) can be adequately protected and sampled without contamination, a shelter need not be provided if the following minimum criteria are met:

1. The milk hose connection is accessible to, and made from within, the milkhouse. The milk hose connection to the milk tank truck is completely protected from the outside environment at all times. Provided, based on Health Officer acceptance, the direct loading of milk from the milkhouse to the milk tank truck may be conducted through a properly designed hose port that adequately protects the milkhouse opening or by stubbing the milk transfer and associated CIP cleaned lines outside the milkhouse wall in accordance with Rule 420-3-16-.10(05), Administrative Procedures 13.

2. To assure continued protection of the milk, the milk tank truck manhole shall be sealed after the truck has been cleaned and sanitized.

3. The milk tank truck shall be washed and sanitized at the permitted milk plant, receiving station, or transfer station receiving the milk or at a permitted milk tank truck cleaning facility.

4. An accurate, accessible temperature-recording device shall be installed in the milk line downstream from an effective cooling device, which cools the milk to 7°C (45°F) or less. Electronic records that comply with Appendix H, IV, and V, Criteria 4, 7, 8, 9, 11, and 12 with or without hard copy, may be used in place of temperature-recording records (refer to the Note: on page 51). An indicating thermometer shall be installed as close as possible to the recording device for verification of recording temperatures. This indicating thermometer shall comply with all applicable requirements in Appendix H. This thermometer shall be used to check the temperature-recording device during the regulatory inspection and the results recorded on the recording records or into the electronic data collection, storage, and reporting system.

5. Temperature-recording records shall be maintained on the premises for a period of a minimum of six (6) months and are available for review by the Health Officer. Except that, the electronic storage of required temperature records, with or without hard copy, shall be acceptable, provided the computer and computer generated temperature records are readily available for review by the Health Officer.

6. The milk shall be sampled at the direction of the Health Officer, in a manner so as to preclude contaminating the milk tank truck or sample, by a permitted milk sample collector. The milk in the milk tank truck shall be effectively agitated in order to collect a representative sample.

7. The milk tank truck shall be parked on a self-draining concrete or equally impervious surface during filling and storage.

8. When direct loading of a milk tank truck using either a hose port, as addressed above, or stubbing the milk transfer and associated CIP cleaned lines outside the milkhouse wall in accordance with Rule 420-3-16-.10(05), Administrative Procedures 13, overhead protection of the milk hose connection to the milk tank truck shall be provided.

Note: With the identified Criteria 4, 7, 8, 9, 11, and 12 cited within Appendix H, V, the words “dairy farm” shall be substituted for “milk plant” wherever the words “milk plant” appears.

(6) Milkhouse or Room Cleanliness

(a) The floors, walls, ceilings, port holes, windows, tables, shelves, cabinets, wash vats, nonproduct-contact surfaces of milk containers, utensils, and other milkroom equipment shall be clean. Only articles directly related to milkroom activities shall be permitted in the milkroom. The milkroom shall be free of trash, animals, and fowl.

(b) Public Health Reason - Cleanliness in the milkroom reduces the likelihood of contamination of the milk.

(c) Administrative Procedures - This item is deemed to be satisfied when:

1. The milkroom structure, equipment, and other milkroom facilities used in its operation or maintenance are clean at all times.

2. Incidental articles such as desks, refrigerators, and storage cabinets may be in the milkroom provided they are kept clean and ample space is available to conduct the normal operations in the milkroom and will not cause contamination of the milk.

3. Vestibules, if provided, are kept clean.

4. Animals and fowl are kept out of the milkroom.

(7) Toilet

(a) Every dairy farm shall be provided with one or more toilets, conveniently located and properly constructed, operated, and maintained in accordance with the Rules of the State Board of Health. The waste shall be inaccessible to flies and shall not pollute the soil surface or contaminate any water supply.

(b) Public Health Reason - The organisms of typhoid fever, dysentery, and gastrointestinal disorders may be present in the body wastes of persons who have these diseases. In the case of typhoid fever, well persons (carriers) also may discharge the organisms in their body wastes. If a toilet is not fly-tight and so constructed as to prevent overflow, infection may be carried from the excreta to the milk, either by flies or through the pollution of ground water supplies or streams to which the lactating animals have access.

(c) Administrative Procedures - This item is deemed to be satisfied when:

1. There is at least one (1) flush toilet connected to a public sewer system or to an individual sewage-disposal system. Such sewage systems shall be constructed and operated in accordance with plans and instructions of the State Board of Health.

2. A toilet is convenient to the milking barn and the milkroom. There shall be no evidence of human defecation or urination about the premises.

3. No toilet opens directly into the milkroom.

4. The toilet room, including all fixtures and facilities, is kept clean and free of flies and odors.

5. Where flush toilets are used, doors to toilet rooms are tight and self-closing. All outer openings in toilet rooms shall be screened or otherwise protected against the entrance of insects.

6. All new or extensively remodeled barns must be provided with a flush type toilet connected to a public sewer or an individual sewage disposal system. Chapter 420-3-16 Health Supp. 12/31/18 3-16-68

(8) Water Supply

(a) Water for milkhouse and milking operations shall be from a supply properly located, protected, and operated and shall be easily accessible, adequate, and of a safe, sanitary quality.

(b) Public Health Reason

1. A dairy farm water supply should be accessible in order to encourage its use in ample quantity in cleaning operations. It should be adequate so that cleaning and rinsing will be thorough and it should be of safe, sanitary quality in order to avoid the contamination of milk utensils.

2. A polluted water supply used in the rinsing of the dairy utensils and containers may be more dangerous than a similar water supply which is used for drinking purposes only. Bacteria grows much faster in milk than in water and the severity of an attack of a given disease depends largely upon the size of the dose of disease organisms taken into the system. Therefore, a small number of disease organisms consumed in a glass of water from a polluted well may possibly result in no harm, whereas, if left in a milk utensil which has been rinsed with the water, they may, after several hours, grow in the milk, increase in such numbers as to cause disease when consumed.

(c) Administrative Procedures - This item is deemed to be satisfied when:

1. The water supply for milkhouse and milking operations is approved as safe by the appropriate regulatory agency and, in the case of individual water systems, complies with the specifications outlined in Appendix D, and the bacteriological standards outlined in Appendix G.

2. No cross-connection exists between a safe water supply and any unsafe or questionable water supply or any other source of pollution.

3. There are no submerged inlets through which a safe water supply may be contaminated.

4. The well or other source of water is located and constructed in such a manner that neither underground or surface contamination from any sewerage system, privy, or other source of pollution can reach such water supply.

5. New individual water supplies and water supply systems which have been repaired or otherwise become contaminated are thoroughly disinfected before being placed in use. The supply shall be made free of the disinfection by pumping the waste before any sample for bacteriological testing shall be collected.

6. All containers and tanks used in the transportation of water are sealed and protected from possible contamination. These containers and tanks shall be subjected to a thorough cleaning and a bacteriological treatment prior to filling with potable water to be used at the dairy farm. To minimize the possibility of contamination of the water during its transfer from the potable tanks to the elevated or ground-water storage at the dairy farm, a suitable pump, hose, and fittings shall be provided. When the pump, hose, and fittings are not being used, the outlets shall be capped and stored in a suitable dust-proof enclosure so as to prevent their contamination. The storage tank at the dairy farm shall be constructed of impervious material provided with a dust and rainproof cover, and also provided with an approved-type vent and roof hatch. All new reservoirs or reservoirs which have been cleaned shall be disinfected prior to placing them into service (see Appendix D).

7. Samples for bacteriological examination are taken upon the initial approval of the physical structure based upon the requirements of these rules; and when any repair or alteration of the water supply system has been made, and at least every three (3) years; provided, that water supplies with buried well casing seals, installed prior to the adoption of this section, shall be tested at intervals no greater than six (6) months apart. Whenever such samples indicate either the presence of E. coli bacteria or the coliform group or whenever the well casing, pump, or seal needs replacing or repair, the well casing and seal shall be brought above the ground surface and shall comply with all other applicable construction criteria of this paragraph; provided, that when water is hauled to the dairy farm, such water shall be sampled for bacteriological examination at the point of use and submitted to a laboratory at least four (4) times in separate months during any consecutive six (6) months. Bacteriological examinations shall be conducted in a laboratory acceptable to the Health Officer.

8. Current records of water test results shall be retained on file with the Health Department; provided, that when water is hauled to the dairy farm, such water shall be sampled for bacteriological examination at the point of use and submitted to a laboratory at least four (4) times in separate months during any consecutive six (6) months. Bacteriological examinations shall be conducted in a laboratory acceptable to the Health Officer. To determine if water samples have been taken at the frequency established in this section, the interval shall include the designated period plus the remaining days of the month in which the sample is due.

(9) Utensils and Equipment - Construction

(a) All multi-use containers, equipment, and utensils used in the handling, storage, or transportation of milk shall be made of smooth, nonabsorbent, corrosion-resistant, nontoxic materials, and shall be so constructed as to be easily cleaned. All containers, utensils, and equipment shall be in good repair. All milk pails used for hand milking and stripping shall be seamless and of the hooded type. Multiple-use woven material shall not be used for straining milk. All single-service articles shall have been manufactured, packaged, transported, and handled in a sanitary manner and shall comply with the applicable requirements of Rule 420-3-16.10(11). Articles intended for single-service use shall not be reused.

(b) Farm holding/cooling tanks, welded sanitary piping, and transportation tanks shall comply with the applicable requirements of Rule 420-3-16-.10(10) and 420-3-16.10(11).

(c) Public Health Reason

1. Milk containers and other utensils without flush joints and seams, without smooth, easily cleaned, and accessible surfaces, and not made of durable, non-corrodible material, are apt to harbor accumulations in which undesirable bacterial growth is supported. Single-service articles which have not been manufactured and handled in a sanitary manner may contaminate the milk.

2. Milk pails of small-mouth design, known as hooded milk pails, decrease the possibility of hairs, dust, chaff, and other undesirable foreign substances getting into the milk at the time of milking.

(d) Administrative Procedures - This item is deemed to be satisfied when:

1. All multi-use containers, equipment, and utensils which are exposed to milk or milk products, or from which liquids may drip, drain, or be drawn into milk or milk products, are made of smooth, impervious, nonabsorbent, safe materials of the following types:

(i) Stainless steel of the American Iron and Steel Institute (AISI) 300 series; or

(ii) Equally corrosion-resistant, nontoxic metal; or

(iii) Heat-resistant glass; or

(iv) Plastic or rubber and rubber-like materials which are relatively inert, resistant to scratching, scoring, decomposition, crazing, chipping, and distortion under normal use conditions; are nontoxic, fat resistant, relatively nonabsorbent, relatively insoluble, do not release component chemicals, or impart flavor or odor to the product, and which maintain their original properties under repeated use conditions.

2. Single-service articles have been manufactured, packaged, transported, and handled in a sanitary manner and comply with the applicable requirements of Rule 420-3-16-.10(11).

3. Articles intended for single-service use are not reused.

4. All containers, equipment, and utensils are free of breaks and corrosion.

5. All joints in such containers, equipment, and utensils are smooth and free from pits, cracks, or inclusions.

6. Cleaned-in-place milk pipelines and return-solution lines are self-draining. If gaskets are used, they shall be self-positioning and of material meeting specifications described in 1.(iv) above and shall be of such design, finish, and application as to form a smooth, flush interior surface. If gaskets are not used, all fittings shall have self-positioning faces designed to form a smooth, flush interior surface. All interior surfaces of welded joints in pipelines shall be smooth and free of pits, cracks, and inclusions.

7. Detailed plans for cleaned-in-place pipeline systems are submitted to the Health Officer for written approval prior to installation. No alteration or addition shall be made to any milk pipeline system without prior written approval of the Health Officer.

8. Strainers, if used, are of perforated metal design or so constructed as to utilize single-service strainer media.

9. Seamless hooded pails having an opening not exceeding one-third the area of that of an open pail of the same size are used for hand milking and hand stripping.

10. All milking machines, including heads, milk claws, milk tubing, and other milk-contact surfaces can be easily cleaned and inspected. Pipelines, milking equipment, and appurtenances, which require a screwdriver or special tool, shall be considered easily accessible for inspection providing the necessary tools are available at the milkhouse. Milking systems shall not have components incorporated in the return solution lines, which by design do not comply with the criteria for product-contact surfaces. Some examples of these are:

(i) Ball type plastic valves;

(ii) Plastic tees with barbed ridges to better grip the plastic or rubber hoses; and

(iii) The use of polyvinyl chloride (PVC) water type piping for return solution lines.

11. Milk cans have umbrella-type lids.

12. Farm holding-cooling tanks, welded sanitary piping, and transportation tanks comply with the applicable requirements of Rule 420-3-16-.10(10) and 420-3-16-.10(11).

13. During filling, flexible plastic/rubber hoses may be used between the fill valves of bottom fill and top fill bulk milk storage tanks, when needed for functional purposes. Such hoses shall be drainable, be as short as practical, have sanitary fitting, and be supported to maintain uniform slope and alignment. The end fittings of such hoses shall be permanently attached in such a manner that will assure a crevice-free joint between the hose and the fitting, which can be cleaned by mechanical means. The hoses shall be included as part of a CIP cleaning system.

14. Transparent flexible plastic tubing (up to 150 feet in length) used in connection with milk transfer stations shall be considered acceptable if it meets the “3-A Sanitary Standards for Multiple-Use Plastic Materials Used as Product Contact Surfaces for Dairy Equipment, Number 20#” and if it remains sufficiently clear that the interior surfaces can be properly inspected. Short lengths of flexible plastic tubing (8 feet or less) may be inspected for cleanliness by sight or by use of a “rod.” The transparency or opacity of such tubing under this condition is not a factor in determining cleanliness.

15. AMIs shall comply with all applicable PMO requirements and/or 3-A Standards.

(10) Utensils and Equipment-Cleaning

(a) The product-contact surfaces of all multi-use containers, equipment, and utensils used in the handling, storage, or transportation of milk shall be cleaned after each usage.

(b) Public Health Reason - Milk cannot be kept clean or free of contamination if permitted to come into contact with unclean containers, utensils, or equipment.

(c) Administrative Procedures - This item is deemed to be satisfied when:

1. There shall be a separate wash manifold for all CIP cleaned milk pipelines in all new or extensively remodeled facilities.

2. The product-contact surface of all multi-use containers, equipment, and utensils used in the handling, storage or transportation of milk are cleaned after each milking or once every twenty-four (24) hours for continuous operations.

3. There shall not be any partial removal of milk from milk storage/holding tanks by the bulk milk hauler/sampler, except partial pickups may be permitted when the milk storage/holding tank is equipped with a seven (7) day recording device complying with the specifications of Appendix H or other recording device acceptable to the Health Officer, provided the milk storage/holding tank shall be clean and sanitized when empty and shall be emptied at least every seventy-two (72) hours. In the absence of a temperature-recording device, partial pickups may be permitted as long as the milk storage/holding tank is completely empty, clean, and sanitized prior to the next milking. In the event of an emergency situation, such as inclement weather, natural disaster, etc., a variance may be permitted at the discretion of the Health Officer.

(11) Utensils and Equipment-Sanitization

(a) The product-contact surfaces of all multi-use containers, equipment, and utensils used in the handling, storage or transportation of milk shall be sanitized before each usage.

(b) Public Health Reason - Mere cleaning of containers, equipment, and utensils does not ensure the removal or destruction of all disease organisms which may have been present. Even very small numbers remaining may grow to dangerous proportions, since many kinds of disease bacteria grow rapidly in milk. For this reason, all milk containers, equipment, and utensils must be treated with an effective sanitizer before each usage.

(c) Administrative Procedures - This item is deemed to be satisfied when: All product-contact surfaces of multi-use containers, utensils, and equipment used in the handling, storage, or transportation of milk are sanitized before each usage by one of the following methods or by any method which has been demonstrated to be equally effective:

1. Complete immersion in hot water at a temperature of at least 170°F (77°C) for at least five (5) minutes or exposure to a flow of hot water at a temperature of at least 170°F (77°C) as determined by use of a suitable accurate thermometer (at the outlet) for at least five (5) minutes.

2. Certain chemical compounds are effective for the sanitization of milk utensils, containers, and equipment. These are contained in 40 CFR 180.940 and shall be used in accordance with label directions or the electro-chemical activation (ECA) device manufacturer’s instructions, if produced onsite in accordance with Appendix F for further discussion of approved sanitizing procedures.

(12) Utensils and Equipment-Storage

(a) All containers, utensils, and equipment used in the handling, storage, or transportation of milk, unless stored in sanitizing solutions, shall be stored to assure complete drainage and shall be protected from contamination prior to use; provided, that pipeline milking equipment, such as, milker claws, inflations, weigh jars, meters, milk hoses, milk receivers, tubular coolers, plate coolers, and milk pumps which are designed for mechanical cleaning and other equipment, as accepted by FDA, which meets these criteria may be stored in the milking barn or parlor provided this equipment is designed, installed, and operated to protect the product and solution-contact surfaces from contamination at all times. Some of the parameters to be considered in determining protection are:

1. Proper location of equipment.

2. Proper drainage of equipment.

3. Adequate and properly located lighting and ventilation.

(b) Public Health Reason - Careless storage of milk utensils which previously have been properly treated is apt to result in recontamination of such utensils, thus rendering them unsafe.

(c) Administrative Procedures - This item is deemed to be satisfied when:

1. All milk containers, utensils, and equipment, including milking machine vacuum hoses, are stored in the milkhouse in a sanitizing solution or on racks until used. Milk pipelines and pipeline milking equipment, such as, milker claws, inflations, weigh jars, meters, milk hoses, milk receivers, tubular coolers, plate coolers, and milk pumps which are designed for mechanical cleaning and other equipment as accepted by FDA, which meet these criteria may be mechanically cleaned, sanitized, and stored in the milking barn or parlor, provided this equipment is designed, installed, and operated to protect the product and solution contact surface from contamination at all times. Some of the parameters to be considered in determining protection are proper location of equipment, proper drainage of equipment, and adequate and properly located lighting and ventilation. The milking barn or parlor must be used only for milking. Concentrates may be fed in the barn during milking, but the barn shall not be used for the housing of animals. When manual cleaning of product-contact surfaces is necessary, the cleaning shall be done in the milkhouse.

2. Means are provided to effect complete drainage of equipment when such equipment cannot be stored to drain freely.

3. Clean cans or other containers are stored in the milkhouse within a reasonable time after delivery to the dairy farm.

4. Strainer pads, parchment papers, gaskets, and similar single-service articles are stored in a suitable container or cabinet and protected against contamination.

(13) Utensils and Equipment-Handling

(a) After sanitization, all containers, utensils, and equipment shall be handled in such manner as to prevent contamination of any product-contact surface.

(b) Public Health Reason - Handling milk pails by inserting the fingers under the hood, carrying an armful of milk can covers against a soiled shirt, or jacket or similar handling of utensils will nullify the effect of sanitization.

(c) Administrative Procedures - This item is deemed to be satisfied when:

1. Sanitized product-contact surfaces, including farm cooling holding tank openings and outlets, are protected against contact with unsanitized equipment and utensils, hands, clothing, splash, condensation, and other sources of contamination.

2. Any sanitized product-contact surface which has been otherwise exposed to contamination is again cleaned and sanitized before being used.

(14) Milking Flanks, Udders, and Teats

(a) Milking shall be done in the milking barn, stable, or parlor. The flanks, udders, bellies, and tails of all milking lactating animals shall be free from visible dirt. All brushing shall be completed prior to milking. The udders and teats of all milking lactating animals shall be clean and dry before milking. Teats shall be treated with a sanitizing solution just prior to the time of milking and shall be dry before milking. Wet hand milking is prohibited.

(b) Public Health Reason - If milking is done elsewhere than in a suitable place provided for this purpose, the milk may become contaminated. Cleanliness of the lactating animals is one of the most important factors affecting the bacterial count of the milk. Under usual farm conditions, lactating animals contaminate their udders by standing in polluted water or by lying down in the pasture or animal yard. Unless the udders and teats are carefully cleaned just before milking, particles of filth or contaminated water are apt to drop or be drawn into the milk. Such contamination of the milk is particularly dangerous because manure may contain the organisms of brucellosis, tuberculosis, and polluted water may contain the organisms of typhoid fever and other intestinal diseases. Application of sanitizing solutions to the teats, followed by thorough drying just prior to the time of milking, has the advantage of giving an additional margin of safety with reference to such disease organisms as they are not removed by ordinary cleaning and it is helpful in the control of mastitis.

(c) Administrative Procedures - This item is deemed to be satisfied when:

1. Milking is done in a milking barn or parlor.

2. Brushing is completed prior to milking.

3. Flanks, bellies, tails, and udders are clipped as often as necessary to facilitate cleaning of these areas and are free from dirt. The hair on the udders shall be of such length that it is not incorporated with the teat in the inflation during milking.

4. Udders and teats of all milking animals are clean and dry before milking. Teats shall be cleaned, treated with a sanitizing solution, and dry just prior to milking. Provided that the sanitizing of teats shall be required if the udder is dry and the teats have been thoroughly cleaned (not dry wiped) and dried (manually wiped dry) prior to milking. The determination of what constitutes a dry udder and cleaned and dried teats shall be made by the Health Officer.

Note: Additional alternative udder preparation methods may also be used once they have been evaluated by FDA and found acceptable.

5. Wet hand milking is prohibited.

(15) Milking - Surcingles, Milk Stools, and Anti-kickers

(a) Surcingles, milk stools, and anti-kickers shall be kept clean and stored above the floor.

(b) Public Health Reason - Clean milk stools and clean surcingles (or belly straps) reduce the likelihood of contamination of milkers' hands between the milking of one lactating animal and the milking of another.

(c) Administrative Procedures - This item is deemed to be satisfied when:

1. Milk stools are not padded and are constructed to be easily cleaned.

2. Milk stools, surcingles, and anti-kickers are kept clean and are stored above the floor in a clean place in the milking barn, parlor, or milkhouse when not in use.

(16) Protection from Contamination

(a) Milking, milkhouse operations, equipment, and facilities shall be located and conducted to prevent any contamination of milk, container, utensils, and equipment.

1. Milk shall not be strained, poured, transferred, or stored unless it is properly protected from contamination.

2. After sanitization, all containers, utensils, and equipment shall be handled in such a manner as to prevent the contamination of any milk product-contact surface.

3. Vehicles used to transport milk from the dairy farm to the milk plant, receiving station, or transfer station shall be constructed and operated to protect their contents from sun, freezing, and contamination. Such vehicles shall be kept clean, inside and out, and any substance capable of contaminating the milk shall not be transported with the milk.

(b) Public Health Reason - Because of the nature of milk and its susceptibility to contamination by disease producing bacteria and other contaminants, every effort should be made to provide adequate protection for the milk at all times. This should include the proper placement of equipment so that work areas in the milking barn and milkhouse are not overcrowded. The quality of any air which is used for the agitation or movement of milk or is directed at a milk product-contact surface should be such that it will not contaminate the milk. The effect of sanitization of equipment can be mollified if the equipment is not protected after sanitization. To protect milk during transportation, delivery vehicles shall be properly constructed and operated.

(c) Administrative Procedures - This item is deemed to be satisfied when:

1. Equipment and operations are so located within the milking barn and milkhouse as to prevent overcrowding and contamination of cleaned and sanitized containers, equipment, and utensils by splash, condensation, or manual contact.

2. During processing, pipelines and equipment used to contain or conduct milk and milk products shall be effectively separated from tanks or circuits containing cleaning and/or sanitizing solutions.

3. All milk which has overflowed, leaked, been spilled, or improperly handled is discarded.

4. All product-contact surfaces of containers, equipment, and utensils are covered or otherwise protected to prevent the access of insects, dust, condensation, and other contamination. All openings, including valves and piping attached to milk storage and transport tanks, pumps, or vats shall be capped or otherwise properly protected. Gravity type strainers used in the milkhouse do not have to be covered. Milk pipelines used to convey milk from pre-coolers to the farm bulk tank must be fitted with effective drip deflectors.

5. The receiving receptacle is raised above the floor (as on a dolly or cart) or placed at a distance from the lactating animals to protect it against manure and splash when milk is poured and/or strained in the milking barn. Such receptacle shall have a tight-fitting cover, which shall be closed except when milk is being poured.

6. Each pail or container of milk is transferred immediately from the milking barn, stable, or parlor to the milkhouse.

7. Pails, cans, and other equipment containing milk are properly covered during transfer and storage.

8. Whenever air under pressure is used for the agitation or movement of milk or is directed at a milk-contact surface, it is free of oil, dust, rust, excessive moisture, extraneous materials, and odor, and shall otherwise comply with the applicable standards of Appendix H.

9. Sanitized product-contact surfaces, including bulk milk tank openings and outlets, are protected against contact with unsanitized utensils and equipment, hands, clothing, splash, condensation, and other sources of contamination.

10. Any sanitized product-contact surface, which has been otherwise exposed to contamination, is again cleaned and sanitized before being used.

11. Vehicles used to transport milk from the dairy farm to the milk plant, receiving station, or transfer station are constructed and operated to protect their contents from sun, freezing, and contamination.

12. Vehicles have bodies with solid enclosures and tight, solid doors.

13. Vehicles are kept clean, inside and out.

14. No substance capable of contaminating milk is transported with the milk (refer to Items 10 and 11 and Appendix B for information on the construction of milk tank trucks).

(17) Drug and Chemical Control

(a) Cleaners and sanitizers used on dairy farms shall be purchased in containers from the manufacturer or distributor which properly identify the contents or if bulk cleaners and sanitizers are transferred from the manufacturer's or distributor's container, that the transfer only occur into a dedicated end-use container which is specifically designed and maintained according to the manufacturer's specifications for that specific product. The label on the dedicated end-use container shall include the product name, chemical description, use directions, precautionary and warning statement, first aid instructions, and the name and address of the manufacturer or distributor.

(b) Equipment used to administer medicinals/drugs is not cleaned in the wash vats and is stored so as not to contaminate the milk or milk contact surfaces of equipment.

(c) Drugs intended for the treatment of non-lactating dairy animals are segregated from those drugs used for lactating dairy animals. Separate shelves in cabinets, refrigerators, or other storage facilities satisfy this Item. This required storage system shall also be followed for drugs intended for use in goats, sheep, and other dairy animals.

(d) The only drugs that shall be stored with the lactating drugs are drugs that are specifically indicated on the drug label or on a veterinarian’s label for extra-label drug use to be used in a specific class/species of lactating dairy animals. For the purpose of complying with this item “lactating dairy animals” shall mean those dairy animals that are currently producing milk.

1. The name and address of the manufacturer or distributor (for O.T.C. medicinals/drugs) or veterinary practitioner dispensing the product (for Rx and extra-label use medicinals/drugs) and, if the drug is dispensed by a pharmacy on the order of a veterinarian, the labeling shall include the name of the prescribing veterinarian and the name and address of the dispensing pharmacy, and may include the address of the prescribing veterinarian.

2. Directions for use and prescribed holding times.

3. Cautionary statements, if needed.

4. Active ingredient(s) in the drug product.

5. Unapproved and/or improperly labeled medicinals/drugs are not used to treat dairy animals and are not stored in the milkhouse, milking barn, stable, or parlor. Medicinals/drugs intended for treatment of non-lactating dairy animals are segregated from those medicinals/drugs used for lactating animals (separate shelves in cabinets, refrigerators, or other storage facilities satisfied this item).

Note: Topical antiseptics, wound dressings, (unless intended for direct injection into the teat) vaccines, and other biologics and dosage form vitamins and/or mineral products are exempt from labeling and storage requirements, except when it is determined that they are stored in such a manner that they may contaminate the milk or milk product surfaces of containers or utensils.

(18) Personnel-Handwashing Facilities

(a) Adequate handwashing facilities shall be provided, including a lavatory fixture with hot and cold or warm running water, soap or detergent, and individual sanitary towels in the milkhouse and in/or convenient to the milking barn, parlor, or flush toilet.

(b) Public Health Reason - The hands of the milker in his preparation for milking come into contact with almost identically the same kind of material as may have contaminated the udders. During the course of his duties and natural habits outside of the milking barn, the dairyman's hands must be assumed to have been exposed to body discharges. Washing facilities are required in order to increase the assurance that milker's and bulk milk hauler’s or sampler’s hands will be washed.

(c) Administrative Procedures - This item is deemed to be satisfied when:

1. Handwashing facilities are located in the milkhouse and in/or convenient to the milking barn, parlor, or flush toilet.

2. Handwashing facilities include soap or detergent, hot and cold running water, individual sanitary towels, and a lavatory fixture. Utensil wash and rinse vats shall not be considered as handwashing facilities.

(19) Personnel-Cleanliness

(a) Hands shall be washed clean and dried with an individual sanitary towel immediately before milking, before performing any milkhouse function, and immediately after the interruption of any of these activities. Milkers and milk haulers or samplers shall wear clean outer garments while milking or handling milk, milk containers, utensils, or equipment.

(b) Public Health Reason - The reasons for clean hands of the persons doing the milking are similar to those for cleanliness of the animal’s udders. The milker's hands must be assumed to have been exposed to contamination during the course of his/her normal duties on the farm and at milking time. Because the hands of all workers frequently come into contact with their clothing, it is important that the clothes worn during milking and the handling of milk be clean.

(c) Administrative Procedures - This item is deemed to be satisfied when:

1. Hands are washed clean and dried with an individual sanitary towel immediately before milking, before performing any milkhouse function, and immediately after the interruption of any of these activities.

2. Milkers, milk haulers, or samplers wear clean outer garments while milking or handling milk, milk containers, utensils, or equipment.

(20) Cooling

(a) Raw Milk for pasteurization, ultra-pasteurization, aseptic processing, and packaging or retort processed after packaging shall be cooled to 10°C (50°F) or less within four (4) hours or less of the commencement of the first milking and to 7°C (45°F) or less, within two (2) hours after the completion of milking; provided, that the blend temperature after the first milking and subsequent milkings does not exceed 10°C (50°F).

(b) Public Health Reason

1. Milk produced by disease-free animals and under clean conditions usually contains relatively few bacteria immediately after milking. These multiply to enormous numbers in a few hours unless the milk is cooled. When the milk is cooled quickly to 45°F (7°C) or less, there is only a slow increase in numbers of bacteria. In order to understand this, it is necessary to recall merely that bacteria are actually infinitesimal plants and that most plants do not grow in cold weather.

2. Usually, the bacteria in milk are harmless, and if this were always true, there would be no reason to cool milk except to delay souring. There is however, no way for the dairyman or Health Officer to be absolutely sure that no disease bacteria have entered the milk even though observance of the other items of these rules will greatly reduce this likelihood. The likelihood of transmitting disease is much increased then the milk contains large numbers of disease bacteria. Therefore, it is extremely important for milk to be cooled quickly so that small numbers of bacteria which may have entered will not multiply.

(c) Administrative Procedures - This item is deemed to be satisfied when:

1. Raw milk for pasteurization is cooled to 10°C (50°F) or less within two (2) hours of the commencement of the first milking; provided that the blend temperature after the first milking and subsequent milkings does not exceed 10°F (50°F).

2. Recirculated cold water which is used in plate or tubular coolers or heat exchanges is from a safe source and protected from contamination. Such water shall be tested semi-annually and shall comply with the current bacteriological standards established by the EPA for drinking water.

3. All farm bulk tanks manufactured after January 1, 2000, shall be equipped with an approved temperature-recording device.

(i) The temperature-recording device shall be operated continuously and be maintained in a properly functioning manner. Circular charts shall not overlap. Electronic records that comply with the applicable provisions of Appendix H, IV, and V, with or without hard copy, may be used in place of temperature-recording records.

(ii) The temperature-recording device shall be verified every six (6) months and documented in a manner acceptable to the Health Officer using an accurate (+/- 1°C [2°F] thermometer that has been calibrated by a traceable standard thermometer, within the past six (6) months, with the results and date recorded, and the thermometer being properly identified or by using a traceable standard thermometer that has been calibrated within the last year.

(iii) Temperature-recording records shall be maintained on the premises for a period of a minimum of six (6) months and are available for review by the Health Officer. Except that the electronic storage of required temperature records, with or without hard copy, shall be acceptable, provided the computer and computer generated temperature records are readily available for review by the Health Officer.

(iv) The temperature-recording device should be installed in an area convenient to the milk storage tank and acceptable to the Health Officer.

(v) The temperature-recording device sensor shall be located to permit the registering of the temperature of the contents when the tank contains no more than 20 percent of its calibrated capacity.

(vi) The temperature-recording device shall comply with the current technical specifications for tank recording thermometers.

(vii) A temperature-recording device and/or any other device that meets the intent of these Administrative Procedures and technical specifications and is acceptable to the Health Officer can be used to monitor/record the bulk tank temperature.

(viii) The temperature-recording records shall properly identify the producer, date installed, tank or silo identification, if more than one (1), and signature or initials of the person installing the record.

(21) Vehicles

(a) Vehicles used to transport milk from the dairy farm to the milkplant or receiving station shall be constructed and operated to protect their contents from sun, freezing, and contamination. Such vehicles shall be kept clean inside and out, and no substance capable of contaminating milk shall be transported with milk.

(b) Public Health Reason - To protect milk during transportation, delivery vehicles must be properly constructed and operated.

(c) Administrative Procedures - This item is deemed to be satisfied when:

1. Vehicles used to transport milk from the dairy farm to the milk plant or receiving station are constructed and Health Chapter 420-3-16 Supp. 12/31/18 3-16-85 operated to protect their contents from the sun, freezing, and contamination.

2. Vehicles have bodies with solid enclosures and tight, solid doors.

3. Vehicles are kept clean inside and out.

4. No substance capable of contaminating the milk is transported with the milk.

Note: See Rule 420-3-16-.09(9) and 420-3-16-.09(10) for information on the construction of bulk milk pickup tankers.

(22) Insect and Rodent Control

(a) Effective measures shall be taken to prevent the contamination of milk, containers, equipment, and utensils by insects and rodents, and by chemicals used to control such vermin. Milkrooms shall be free of insects and rodents. Surroundings shall be kept neat, clean, and free of conditions which might harbor or be conducive to the breeding of insects and rodents. Feed shall be stored in such a manner that it will not attract birds, rodents, or insects.

(b) Public Health Reason - Proper manure disposal reduces the breeding of flies, which are considered capable of transmitting infection by physical contact or through excreta to milk or milk containers, utensils, or equipment. Insects that visit unsanitary places may carry pathogenic organisms on their bodies and may carry living bacteria for as long as four (4) weeks within their bodies, and may pass them on to succeeding generations by infecting their eggs. Effective screening tends to prevent the presence of flies, which are a public health menace. Flies may contaminate the milk with disease germs, which may multiply and become sufficiently numerous to present a public health hazard. The surroundings of a dairy should be kept neat and clean to encourage cleanliness and reduce insect and rodent harborages.

(c) Administrative Procedures - This item is deemed to be satisfied when:

1. Surroundings are kept neat, clean, and free of conditions which might harbor or be conducive to the breeding of insects and rodents. Manure shall be spread directly on the fields or stored for not more than four (4) days in a pile on the ground surface and then spread on the fields or stored for not more than seven (7) days in a impervious-floored bin or on an impervious-curbed platform and then spread or stored in a tight-screened and trapped manure shed or effectively treated with larvicides or disposed of in any other manner which controls insect breeding.

2. Manure packs in loafing areas, stables without stanchions, pen stables, resting barns, wandering sheds, and free-stall housing are properly bedded and managed to prevent fly breeding.

3. Milkrooms are free of insects and rodents.

4. Milkrooms are effectively screened or otherwise protected against the entrance of vermin.

5. Outer milkhouse doors are tight and self-closing. Screen doors shall open outward.

6. Effective measures are taken to prevent the contamination of milk, containers, utensils, and equipment by insects and rodents, and by chemicals used to control such vermin. Insecticides and rodenticides not approved for use in the milkhouse shall not be stored in the milkhouse.

7. Only insecticides and rodenticides approved for use by the Health Officer and/or registered with the EPA are used for insect and rodent control (see Appendix C).

8. Insecticides and rodenticides are used only in accordance with the manufacturer's label directions and are used so as to prevent the contamination of milk, milk containers, equipment, utensils, feed, and water.

9. Covered boxes, bins, or separate storage facilities for ground, chopped, or concentrated feeds are provided.

10. Feed may be stored in the milking portion of the barn only in such a manner as will not attract birds, insects, or rodents. Open feed dollies or carts may be used for distributing the feed, but not storing feed, in the milking barn. Feed dollies, carts, fully automated feeding systems, or other feed containers, may be exempt from the use of covers, provided they do not attract birds, insects, or rodents.

Note: A convenient inspection form for producer dairy farms which summarizes the applicable sanitation requirements is found in Appendix M.

History

• Author: G. M. Gallaspy, Jr.
• Authority: Code of Ala. 1975, §§22-2-2, 22-20-7.
• Repealed and New Rule: Filed October 18, 2018; effective December 2, 2018.

Ala. Admin. Code r. 420-3-16-.10 Sanitization Requirements For Grade "A" Pasteurized Milk, Frozen Dessert, Ultra-Pasteurized, And Aseptically Processed Milk And Milk Products, And Retort Processed After Packaged Low-Acid Milk And/Or Milk Products

Milk plants shall comply with all items of this section. The PMO, with appendices, and the supporting milk plant-specific procedures required herein, shall constitute a milk plant’s food safety plan as required by 21 CFR 117.126 to the extent that the procedures address all the hazards identified by the milk plant as applicable for that milk plant. A milk plant shall have a written Hazard Analysis for each kind or group of milk, milk product, and frozen dessert processed. Provided, in the case of milk plants or portions of milk plants that are IMS listed to produce aseptically processed and packaged low-acid milk, milk products, and frozen desserts, and/or retort processed after packaging low-acid milk, milk products, and frozen desserts the APPS or RPPS, respectively, as defined by this rule, shall be exempt from Rule 420-3-16-.10(7); 420-3-16-.10(11-13); 420-3-16-.10(15-16); 420-3-16-.10(19); 420-3-16-.10(22); 420-3-16-.10(24) and shall comply with the applicable portions of 21 CFR Parts 108, 110, and 113. Those Items, contained within the APPS and RPPS, shall be inspected by FDA or a Health Officer, when designated by FDA.

A receiving station shall comply with Rule 420-3-16-.10(1) to 420-3-16-.10(15A-B), inclusive, and Rule 420-3-16-.10(23), 420-3-16-.10(26) and 420-3-16-.10(28), except that the partitioning requirement of Rule 420-3-16-.10(5) shall not apply.

A transfer station shall comply with Rule 420-3-16-.10(1), 420-3-16-.10(4), 420-3-16-.10(6-12), 420-3-16-.10(14), 420-3-16-.10(15A), 420-3-16-.10(23), 420-3-16-.10(26) and 420-3-16-.10(28) and as climatic and operating conditions require the applicable provisions of Rule 420-3-16-.10(2-3). Provided, that in every case, overhead protection shall be provided.

Facilities for the cleaning and sanitizing of milk tank trucks shall comply with Rule 420-3-16-.10(1), 420-3-16-.10(4), 420-3-16-.10(6-12), 420-3-16-.10(14), 420-3-16-.10(15A-B), 420-3-16-.10(26), and 420-3-16-.10(28) and as climatic and operating conditions require, the applicable provisions of Rule 420-3-16-.10(2-3). Provided, that in every case, overhead protection shall be provided.

In the case of milk plants, receiving stations, and transfer stations which have HACCP Systems regulated under Appendix K., the HACCP System shall address the public health concerns described in this section in a manner that provides protection equivalent to the requirements in this section.

Milk plants that have HACCP Systems, which are regulated under the NCIMS voluntary HACCP Program, shall comply with all of the requirements of Rule 420-3-16-.10(16). Pasteurization, Aseptic Processing and Packaging, and Retort Processed after Packaging of this rule and pasteurization shall be managed as a critical control point (CCP) as described in Appendix H, VIII. Milk and Milk Product Continuous-Flow (HTST and HHST) Pasteurization-CCP Model HACCP Plan Summary; and Milk and Milk Product Vat (Batch) Pasteurization-CCP Model HACCP Plan Summary.

(1) Floors Construction

(a) The floors of all rooms in which milk, milk products, or frozen desserts are processed, handled or stored or in which milk containers, equipment, and utensils are washed, shall be constructed of concrete or other equally impervious and easily cleaned material, and shall be smooth, properly sloped, provided with trapped drains, and kept in good repair; provided cold-storage rooms used for storing milk and milk products need not be provided with floor drains when the floors are sloped to drain to one (1) or more exits; provided further, that storage rooms for storing dry ingredients, packaged dry ingredients, packaged dry milk or milk products, and packaging materials need not be provided with drains and the floors may be constructed of tightly joined wood.

(b) Public Health Reason - Floors constructed of concrete or other similarly impervious material can be kept clean more easily than floors constructed of wood or other pervious or easily disintegrating material. They will not absorb organic matter and are, therefore, more apt to be kept clean and free of odors. Properly sloped floors facilitate flushing and help to avoid undesirable conditions. Trapping of drains prevents sewer gas from entering the plant.

(c) Administrative Procedures - This item is deemed to be satisfied when:

1. The floors of all rooms in which milk is handled, processed, or stored or in which milk containers, utensils, and/or equipment are washed, are constructed of good quality concrete or equally impervious tile or brick laid closely with impervious joint material or metal surfacing with impervious joints, or other material which is the equivalent of good quality concrete. The floors of storage rooms for dry ingredients and/or packaging material may be constructed of tightly joined wood.

2. The floor surface is smooth and sloped so that there are no pools of standing water after flushing and the joints between the floor and the walls are impervious.

3. The floors are provided with trapped drains. Cold-storage rooms used for storing milk and milk products need not be provided with floor drains when the floors are sloped to drain to one or more exits. Storage rooms for dry ingredients, dry packaged milk and/or milk products, aseptically processed and packaged low-acid milk and/or milk products and/or packaging materials, and retort processed after packaged low-acid milk and/or milk products and/or packaging materials are not required to be provided with drains.

Note: Refer to Rule 420-3-16-.10(11) for requirements for floors of drying chambers.

(2) Walls and Ceilings Construction

(a) Walls and ceilings of rooms in which milk, milk products, or frozen desserts are handled, processed, packaged, or stored or in which milk containers, utensils, and equipment are washed shall have a smooth, washable, light-colored surface in good repair.

(b) Public Health Reason - Painted or otherwise properly finished walls and ceilings are more easily kept clean and are, therefore, more apt to be kept clean. A light-colored paint or finish aids in the even distribution of light and the detection of unclean conditions.

(c) Administrative Procedures - This item is deemed to be satisfied when:

1. Walls and ceilings are finished with smooth, washable, light-colored tile, smooth surface concrete, cement plaster, or other equivalent materials with washable, light-colored surfaces.

2. Walls, partitions, windows, and ceilings are kept in good repair and refinished as often as the finish wears off or becomes discolored

Note: Rule 420-3-16-.10(11) for requirements for walls for drying chambers. Storage rooms used for the storage of packaged dry milk and/or milk products, aseptically processed and packaged low-acid milk and/or milk products, and retort processed after packaged low-acid milk and/or milk products are exempt from the ceiling requirements of this Item.

(3) Doors and Windows

(a) Effective means shall be provided to prevent the access of insects and rodents. All openings to the outside shall have solid doors or glazed windows which shall be closed during dusty weather.

(b) Public Health Reason - Freedom from insects in the milk or frozen dessert plant reduces the likelihood of contamination of milk or milk products. For information on disease transmission by flies see Rule 420-3-16.09(7).

(c) Administrative Procedures - This item is deemed to be satisfied when:

1. All openings to the outer air are effectively protected by:

(i) Screening; or

(ii) Effective electric screen panels; or

(iii) Fans or air curtains which provide sufficient air velocity so as to prevent the entrance of insects; or

(iv) Properly constructed flaps where it is impractical to use self-closing doors or air curtains; or

(v) Any effective combination of (i), (ii), (iii) or (iv) or by any other method which prevents the entrance of insects.

2. All outer doors are tight and self-closing. Screen doors shall open outward.

3. All outer openings are rodent proofed to the extent necessary to prevent the entry of rodents.

Note: The evidence of insects and/or rodents in the plant shall be considered under Rule 420-3-16-.10(9).

(4) Lighting and Ventilation

(a) All rooms in which milk, milk products, or frozen desserts are handled, processed, or stored and/or in which milk containers, equipment, and utensils are washed shall be well-lighted and well-ventilated.

(b) Public Health Reason - Ample light promotes cleanliness. Proper ventilation reduces odors and prevents condensation upon interior surfaces.

(c) Administrative Procedures - This item is deemed to be satisfied when:

1. Adequate light sources are provided (natural, artificial, or a combination of both) which furnish at least twenty (20) foot-candles (220 lux) of light in all working areas. This shall apply to all rooms where milk or milk products are handled, processed, packaged, or stored or where utensils, containers, and equipment are washed. Dry storage and cold storage rooms shall be provided with at least five (5) foot-candles (55 lux) of light.

2. Ventilation in all rooms is sufficient to keep them reasonably free of odors and excessive condensation on equipment, walls, and ceilings.

3. Pressurized ventilating systems, if used, have a filtered air intake.

4. For milk plants that condense and/or dry milk or milk products, ventilating systems in packaging rooms, where used, are separate systems and where possible have the ducts installed in a vertical position.

(5) Separate Rooms

(a) There shall be separate rooms for:

1. The pasteurizing, processing, cooling, reconstitution, condensing, drying, and packaging of milk, milk products, and frozen desserts.

2. Packaging of dry milk or milk products.

3. The cleaning of milk cans, containers, bottles, cases, dry milk, or milk product containers.

4. Cleaning and sanitizing facilities for milk tank trucks in plants receiving milk or whey in such tanks.

5. Receiving cans of milk, milk products, and frozen dessert products in plants receiving such cans.

6. The fabrication of containers and closures for milk and/or milk products, except for aseptically processed and packaged low-acid milk and/or milk products and/or retort processed after packaging low-acid milk and/or milk products in which the containers and closures are fabricated within the APPS or RPPS, respectively.

(i) Rooms in which milk, milk products, and frozen dessert products are handled, processed, stored, condensed, dried, and packaged or in which milk or frozen dessert containers, utensils, and equipment are washed or stored, shall not open directly into any stable or any room for domestic purposes. All rooms shall be of sufficient size for their intended purposes.

(ii) Designated areas or rooms shall be provided for the receiving, handling, and storage of returned packaged milk, milk products, and frozen desserts.

(b) Public Health Reason - If the washing and sanitization of containers are conducted in the same room in which the pasteurizing, processing, cooling, condensing, drying, or packaging or bottling is done, there is opportunity for the pasteurized product to become contaminated. For this reason, separate rooms are required as indicated. The unloading of cans of raw milk directly into the pasteurizing room is apt to increase the prevalence of insects therein, as well as, to render it to public.

(c) Administrative Procedures - This item is deemed to be satisfied when:

1. Pasteurizing, processing, reconstitution, cooling, condensing, drying, and packaging of milk and milk products are conducted in a single room(s), but not in the same room(s) used for the cleaning of milk cans, portable storage bins, bottles, and cases or the unloading and/or cleaning and sanitizing of milk tank trucks, provided that these rooms may be separated by solid partitioning doors that are kept closed. Provided further, that cooling, plate or tubular, may be done in the room where milk tank trucks are unloaded and/or cleaned and sanitized. Separation/clarification of raw milk may be done in an enclosed room where milk tank trucks are unloaded and/or cleaned and sanitized.

Note: Packaging of dry milk or milk products shall be conducted in a separate room.

2. All returned packaged milk, milk products, and frozen desserts which have physically left the premises of the processing plant shall be received, handled, and stored in separate areas or rooms isolated from the Grade “A” and frozen dessert dairy operations. Such separate areas or rooms shall be clearly defined and marked for such use.

3. All bulk milk and milk product storage tanks are vented into a room used for pasteurization, processing, cooling, or packaging operations or into a storage tank gallery room, provided that vents located elsewhere which are adequately equipped with air filters so as to preclude the contamination of the milk, milk product, or frozen dessert products shall be considered satisfactory.

4. Solid doors installed in required partitions are self-closing.

5. Facilities for the cleaning and sanitizing of milk tank trucks are properly equipped for manual and/or mechanical operations. When such facilities are not provided on the plant premises, these operations shall be performed at a receiving station, transfer station, or separate tank cleaning facility (refer to Appendix B).

6. Rooms in which milk, milk products, or frozen dessert products are handled, processed, or stored or in which milk containers, utensils, and equipment are washed or stored, do not open directly into any stable or any room used for domestic purposes.

7. All rooms shall be of sufficient size for their intended purposes.

8. Cottage cheese vats shall be located in a separate room, maintained free from flies and other vermin, and kept in a clean condition.

(6) Toilet-Sewage Disposal Facilities

(a) Every milk and frozen dessert plant shall be provided with toilet facilities conforming to the Rules of the Alabama State Board of Health. Toilet rooms shall not open directly into any room in which milk, frozen desserts, and milk products are processed. Toilet rooms shall be completely enclosed and shall have tight-fitting, self-closing doors. Dressing rooms, toilet rooms, and fixtures shall be kept in a clean condition, in good repair and shall be well ventilated and well lighted. Sewage and other liquid wastes shall be disposed of in a sanitary manner.

(b) Public Health Reason

1. Human excreta are potentially dangerous and must be disposed of in a sanitary manner. The organisms causing typhoid fever, para-typhoid fever, and dysentery may be present in the body discharges of active cases or carriers. Sanitary toilet facilities are necessary to protect the milk, milk products, or frozen dessert products, equipment, containers, and utensils from fecal contamination which may be carried by flies, other insects, hands, or clothing. When the toilet facilities of a satisfactory type are kept clean and in good repair, the opportunities for the spread of contamination by the above means are minimized. The provision of an intervening room or vestibule between the toilet room and any room in which milk, milk products, or frozen desserts are processed makes it less likely that contaminated flies will enter these rooms. It will also minimize the spread of odors.

2. The wastes resulting from the cleaning and rinsing of containers, equipment, utensils, and floors from flush toilets and from washing facilities should be properly disposed of so as not to contaminate the milk and frozen dessert containers, utensils, or equipment, or to create a nuisance or a public health hazard.

(c) Administrative Procedures - This item is deemed to be satisfied when:

1. The milk or frozen dessert plant is provided with toilet facilities conforming to the Rules of the State Board of Health.

2. Toilet rooms do not open directly into any room in which milk and/or milk products are processed, condensed, or dried.

3. Toilet rooms are completely enclosed and have tight-fitting, self-closing doors.

4. Dressing rooms, toilet rooms, and fixtures are kept in a clean condition, in good repair, and are well-ventilated and well-lighted.

5. Toilet tissue and easily cleanable covered waste receptacles are provided in toilet rooms.

6. All plumbing is installed to meet the applicable provisions of the state or local plumbing code.

7. Sewage and other liquid wastes are disposed of in a sanitary manner.

8. Non-water-carried sewage disposal facilities are not used.

(7) Water Supply

(a) Water for milk and frozen dessert plant purposes shall be from a supply properly located, protected, and operated and be easily accessible, adequate, and of a safe, sanitary quality.

(b) Public Health Reason - The water supply should be accessible in order to encourage its use in cleaning operations; and it should be adequate so that cleaning and rinsing may be thorough; and it should be of safe, sanitary quality in order to avoid the contamination of milk, frozen dessert, containers, utensils, and equipment.

(c) Administrative Procedures - This item is deemed to be satisfied when:

1. Water for milk and frozen dessert plant purposes is from an adequate supply, properly located, protected, and operated. It shall be easily accessible and of a safe, sanitary quality.

2. The water supply is approved as safe by the Health Officer and, in the case of individual water systems, complies with at least the specification outlined in Appendix D and the bacteriological standards outlined in Appendix G.

3. There is no cross-connection between the safe water supply and any unsafe or questionable water supply or any source of pollution through which the safe water supply might become contaminated. A connection between the water supply piping and a make-up tank (such as for cooling or condensing), unless protected by an air gap or effective backflow preventor, constitutes a violation of this requirement. An approved air gap is defined as the unobstructed vertical distance through the free atmosphere of at least twice the diameter of the largest incoming water supply pipe or faucet to the flood level of the vessel or receptacle. The distance of the air gap is to be measured from the bottom of the potable inlet supply pipe or faucet to the top of the effective overflow, (i.e., flood level rim or internal overflow of the vessel). In no case, may the effective air gap be less than 2.54 centimeter (one [1] inch).

4. Condensing water for milk or milk product evaporators and water used to produce vacuum and/or to condense vapors in vacuum heat processing equipment is from a source complying with 2 above, provided when approved by the Health Officer, water from sources not complying with 2 above may be used when the evaporator or vacuum heat equipment is constructed and operated to preclude contamination of such equipment or its contents by condensing water or by water used to produce vacuum. Means of preventing such contamination are:

(i) Use of a surface-type condenser in which the condensing water is physically separated from the vapors and compensated, or

(ii) Use of reliable safeguards to prevent the overflow of condensing water from the condenser into the evaporator. Such safeguards include a barometric leg extending at least thirty-five (35) feet vertically from the invert of the outgoing condensing water line to the free level at which the leg discharges or a safety shut-off valve, located on the water feed line to the condenser, automatically actuated by a control which will shut off the in-flowing water when the water level rises above a predetermined point in the condenser. This valve may be actuated by water, air, or electricity and shall be designed so that failure of the primary motivating power will automatically stop the flow of water into the condenser.

5. Condensing water for milk or milk product evaporators complying with 2 above and water reclaimed from milk or milk products, may be reused when all necessary means of protection are afforded and it complies with the procedures outlined in Appendix D, V.

6. New individual water supplies and water supply systems, which have been repaired or otherwise become contaminated, are disinfected before being placed in use (refer to Appendix D). The supply shall be made free of the disinfectant by pumping to waste before any sample for bacteriological testing shall be collected.

7. Samples for bacteriological testing of individual water supplies are taken upon the initial approval of the physical structure, each six (6) months thereafter, and when any repair or alteration of the water supply system has been made. Samples shall be taken by the Health Officer and examination shall be conducted in an official laboratory. To determine if water samples have been taken at the frequency established in this item, the interval shall include the designated six (6) month period plus the remaining days of the month in which the sample is due.

8. Current records of water test results are retained on file with the Health Officer or as the Health Officer directs.

9. Water supply outlets are provided immediately available to the cottage cheese vats. The hose for transport of water for washing cottage cheese curd shall be arranged in such a way as to preclude the possibility of the hose touching the floor or the product.

10. A potable water supply, which meets the criteria of this rule, may be connected to the product feed line of a steam vacuum evaporator, provided that the water supply is protected at the point of connection by an approved backflow prevention device.

11. Water supply piping connected to raw or pasteurized milk, milk product, or frozen dessert product lines or vessels shall be protected with an effective backflow preventer.

Note: Refer to Rule 420-3-16-.15(c), Administrative Procedures, for additional requirements involving the protection of milk and milk products.

(8) Handwashing Facilities

(a) Convenient handwashing facilities shall be provided in toilet rooms, receiving rooms, or tank truck unloading areas and including hot and cold and/or warm running water, soap, and individual sanitation towels or other approved hand drying devices. Handwashing facilities shall be kept clean and in good repair. The use of a common towel is prohibited. No employees shall resume work after using the toilet room without first washing his hands. Handwashing facilities shall be kept clean.

(b) Public Health Reason - Proper use of handwashing facilities is essential to personal cleanliness, and reduces the likelihood of contamination of milk, milk products, or frozen desserts. Chapter 420-3-16 Health Supp. 12/31/18 3-16-98

(c) Administrative Procedures - This item is deemed to be satisfied when:

1. Convenient handwashing facilities are provided, including hot and cold and/or warm running water, soap, and individual sanitary towels, or other approved hand-drying devices.

2. Handwashing facilities are provided in all toilets and in all rooms in which milk plant and frozen dessert plant operations are conducted.

3. Handwashing facilities are kept in a clean condition and in good repair.

4. Steam-water mixing valves and vats for washing bottles, cans, and similar equipment are not used as handwashing facilities.

(9) Milk and Frozen Dessert Plant Cleanliness

(a) All rooms in which milk, milk products, and frozen desserts are handled, processed, or stored and/or in which containers, utensils, and/or equipment are washed or stored, shall be kept clean, neat, and free of evidence of insects and rodents. Only equipment directly related to processing operations or to handling of containers, utensils, and equipment shall be permitted in the pasteurizing, processing, cooling, condensing, drying, packaging, and bulk milk, milk product, or frozen dessert product storage rooms.

(b) Public Health Reason - Clean floors, free of litter, clean walls, ceilings, and all other areas of the milk and frozen dessert plant are conducive to clean milk and frozen dessert handling operations. Cleanliness and freedom from insects and rodents reduces the likelihood of contamination of the milk, milk product, or frozen dessert products. Excess or unused equipment, or equipment not directly related to the plant operations, can be detrimental to the cleanliness of the plant.

(c) Administrative Procedures - This item is deemed to be satisfied when:

1. Only equipment directly related to processing operations or the handling of containers, utensils, and equipment is permitted in the pasteurizing, processing, cooling, condensing, drying, packaging, and bulk milk, or bulk milk, or bulk frozen dessert product storage rooms.

2. All piping, floors, walls, ceilings, fans, shelves, tables, and the non-product contact surfaces of other facilities and equipment are clean.

3. No trash, solid waste, or waste dry product is stored within the plant except in covered containers. Waste containers at the packaging machine or bottle washer may be uncovered during operation of such equipment.

4. All rooms in which milk, milk products, or frozen desserts are handled, processed or stored, and/or in which containers, utensils, and equipment are washed or stored, are kept clean, neat, and free of evidence of insects and rodents.

(10) Sanitary Piping

(a) All sanitary piping, fittings, and connections which are exposed to milk, milk products, frozen desserts, or from which liquids may drip, drain, or be drawn into milk, milk products, and frozen dessert products shall consist of smooth, impervious, corrosion resistant, nontoxic, easily cleanable material which is approved for milk product-contact surfaces. All piping shall be in good repair. Pasteurized milk, milk products, and frozen dessert products shall be conducted from one piece of equipment to another only through sanitary piping.

(b) Public Health Reason

Milk and frozen dessert piping and fittings are sometimes so designed as to be difficult to clean; or they may be constructed of metal which corrodes easily. In either case, it is unlikely that they will be kept clean. Sanitary milk piping is a term which applies to properly designed and properly constructed piping. The purpose of the third sentence is to prevent exposure of the pasteurized product to contamination.

(c) Administrative Procedures - This item is deemed to be satisfied when:

1. All sanitary piping, fittings, and connections which are exposed to milk, milk products, or frozen dessert products from which liquids may drip, drain, or be drawn into milk or frozen dessert products, consist of smooth, impervious, corrosion-resistant, nontoxic, and easily cleanable material.

2. All sanitary piping, connections and fittings consist of:

(i) Stainless steel of the AISI 300 series; or

(ii) Equally corrosion-resistant metal which is nontoxic and nonabsorbent; or

(iii) Heat-resistant glass; or

(iv) Plastic, rubber, and rubberlike materials which are relatively inert, resistant to scratching, scoring, decomposition, crazing, chipping, and distortion under normal use conditions; which are nontoxic, fat resistant, relatively nonabsorbent; which do not impart flavor or odor to the products; and which maintain their original properties under repeated use conditions, may be used for gaskets, sealing applications and for short, flexible takedown jumpers or connections where flexibility is required for essential or functional reasons.

3. Sanitary piping, fittings, and connections are designed to permit easy cleaning, kept in good repair, and free of breaks or corrosion and contain no dead ends of piping in which milk may collect.

4. All interior surfaces of demountable piping, including valves, fittings, and connections are designed, constructed, and installed to permit inspection and drainage.

5. All cleaned-in-place (CIP) milk and frozen dessert pipelines and return-solution lines are rigid, self-draining, and so supported to maintain uniform slope and alignment. Return solution lines shall be constructed of material meeting the specifications of 2 above. If gaskets are used, they shall be self-positioning, of material meeting the specifications outlined in 2(iv) above; and designed, finished, and applied to form a smooth, flush interior surface. If gaskets are not used, all fittings shall have self-positioning faces designed to form a smooth, flush interior surface. All interior surfaces of welded joints in pipelines shall be smooth and free from pits, cracks, or inclusions. In the case of welded lines, all welds shall be inspected by the use of a boroscope or other appropriate available inspection device as they are made; and such welds shall be approved by the Health Officer. Each cleaning circuit shall have access points for inspection in addition to the entrances and exits. These may be valves, removable sections, fittings, or other means of combinations that are adequate for inspection of the interior of the line. These access points shall be located at sufficient intervals to determine the general condition of the interior surfaces of the pipeline. Detailed plans for welded pipeline systems shall be submitted to the Health Officer for written approval prior to installation. No alteration or addition shall be made to any welded milk pipeline system without prior written approval from the Health Officer.

6. Pasteurized milk, milk products, and frozen dessert products are conducted from one piece of equipment to another only through sanitary milk piping provided cottage cheese, cheese dressings, or cheese ingredients may be transported by other methods which protect the product from contamination.

7. For milk plants and frozen dessert plants that dry milk, milk products, or frozen dessert products, because of the high pressure required to obtain proper dispersal of the product in the drying chamber, the pipeline between the high-pressure pump and the dryer nozzle may be connected with pressure-tight threaded fittings or may be welded.

(11) Construction and Repair of Containers and Equipment

(a) All multi-use containers and equipment with which milk, milk products, and frozen dessert products come into contact shall be of smooth, impervious, corrosion-resistant, nontoxic material; shall be constructed for ease of cleaning; and shall be kept in good repair. All single-service containers, closures, gaskets, and other articles with which milk, milk products, and frozen desserts come in contact shall be nontoxic and shall have been manufactured, packaged, transported, and handled in a sanitary manner. Articles intended for single-service use shall not be reused.

(b) Public Health Reason

1. When equipment is not constructed and located so that it can be cleaned easily and which is not kept in good repair, it is unlikely that it will be properly cleaned.

2. Single-service articles which have not been manufactured and handled in a sanitary manner may contaminate the milk.

(c) Administrative Procedures - This item is deemed to be satisfied when:

1. All multi-use containers and equipment with which milk, milk products, and frozen dessert products come into contact are of smooth, impervious, corrosion-resistant, and nontoxic material.

2. All milk and frozen dessert contact surfaces of multi-use containers and equipment consist of:

(i) Stainless steel of the AISI 300 series; or

(ii) Equally corrosion-resistant metal which is non-toxic and nonabsorbent; or

(iii) Heat-resistant glass; or

(iv) Plastic or rubber and rubberlike materials which are relatively inert, resistant to scratching, scoring, decomposition, crazing, chipping, and distortion under normal use conditions; which are non-toxic, fat resistant, relatively non-absorbent, and do not impart flavor or odor to the product; and which maintain their original properties under repeated use conditions.

3. All joints in containers, equipment, and utensils are flush and finished as smooth as adjoining surfaces or if the surface is vitreous, it must be continuous. Tile floors are not acceptable in dryers. Joints on equipment coming in contact with dry milk or milk products only or used for hot air piping may be sealed by other acceptable means. Where a rotating shaft is inserted through a surface with which milk, milk products, or frozen desserts come into contact, the joint between the moving and stationary surfaces shall be close-fitting. Grease and oil from gears, bearings, and cables shall be kept out of the milk, milk products, and frozen dessert products. Where a thermometer or temperature sensing element is inserted through a surface with which milk, milk products, or frozen desserts come into contact, a pressure-tight seal shall be provided ahead of all threads and crevices.

4. All openings in covers of tanks, vats, separators, etc., are protected by raised edges, or otherwise, to prevent the entrance of surface drainage. Condensation-diverting aprons shall be provided as close to the tank or vat as possible on all pipes, thermometers, or temperature sensing elements, and other equipment extending into a tank, bowl, vat, or similar equipment unless a water-tight joint is provided.

5. All surfaces with which milk, milk products, and frozen dessert products come into contact, except pneumatic ducts and cyclonic or air separator collectors, are easily accessible or demountable for manual cleaning or are designed for CIP cleaning; provided, flexible plastic or rubber tanker loading and unloading hoses with screw-type hose clamps shall be considered in compliance, if an appropriate screwdriver or tool is readily available for disassembly. All product-contact surfaces shall be readily accessible for inspection and shall be self-draining.

6. There are no threads used in contact with milk, milk products, and frozen dessert products, except where needed for functional and safety reasons, such as in clarifiers, pumps, and separators. Such thread shall be of a sanitary type, except those used on high-pressure lines between the high pressure pump and dryer nozzle.

7 All multi-use containers and other equipment have rounded corners, are in good repair, and free from breaks, crevices, and corrosion. Milk cans shall have umbrella-type covers.

8. Strainers, if used, are of perforated metal design and so constructed as to utilize single-service strainer media. Multiple-use woven material shall not be used for straining milk; provided, when required for functional reasons inherent to the production of certain milk products, such as buttermilk, whey, dry whey, and dry milk products, woven material may be used where it is impractical to use perforated metal. However, woven material parts shall be mechanically cleaned by such methods that thoroughly clean the woven material and do not contaminate the product.

9. Sifters for dry milk products are so constructed as to utilize single-service or multi-service use strainer media conforming with:

(i) Plastic materials listed in 2(iv) above; or

(ii) Woven stainless steel wire conforming to 2(i) above; or

(iii) Cotton, linen, silk, or synthetic fibers which are non-toxic, relatively insoluble, easily cleanable, and do not impart a flavor to the product.

(iv) Tailings shall be continuously discharged from sifters through dust-tight connections to an enclosed container and shall not be used for human consumption.

10. All single-service containers, closures, gaskets, and other articles which milk, milk products, or frozen dessert products come in contact are nontoxic.

11. The manufacture, packing, transportation, and handling of single-service containers, closures, caps, gaskets, and similar articles comply with the requirements of Appendix J; provided, all paper, plastics, foil, adhesives, and other components of containers used in the packaging of milk and/or milk products that have been condensed and/or dried shall be free from deleterious substances and comply with the requirements of the FFD&CA.

12. Inspections and tests shall be made by the Health Officer or any agency authorized by them.

Note: The option for “Inspections and tests” as cited in 12 above, shall only be made by a TPC authorized under the ICP.

13. Provided that all paper, plastics, foil, adhesives, and other components of containers and closures used in the packaging of milk, milk products, and frozen dessert products that have been aseptically processed and packaged or retort processed after packaging are governed under the applicable provisions of 21 CFR Parts 110 and 113 and shall not be subject to this Item.

Note: 3-A Sanitary Standards and Accepted Practices for dairy equipment are developed by 3-A SSI. 3-A SSI is comprised of equipment fabricators, processors, and regulatory sanitarians, which include state milk regulatory officials, USDA Agricultural Marketing Service Dairy Programs, the USPHS/FDA CFSAN/MST, academic representatives, and others.

14. Equipment manufactured in conformity with 3-A Sanitary Standards and Accepted Practices complies with the sanitary design and construction standards of this rule. For equipment not displaying the 3-A Symbol, the 3-A Sanitary Standards and Accepted Practices may be used by Health Officers as guidance in determining compliance with this rule.

(12) Cleaning and Sanitizing of Containers and Equipment

(a) The product-contact surfaces of all multi-use containers, utensils, and equipment used in the transportation, processing, condensing, drying, packaging, handling, and storage of milk, milk products, or frozen desserts shall be effectively cleaned after each usage and shall be sanitized before each use; provided, piping, equipment, and containers used to process, conduct, or package aseptically processed milk and milk products beyond the final heat treatment process shall be sterilized before any aseptically processed milk or milk product is packaged and shall be re-sterilized whenever any unsterile product has contaminated it.

(b) Public Health Reason - Milk, milk products, and frozen dessert products cannot be kept clean and safe if permitted to come into contact with containers, utensils and equipment which have not been properly cleaned and sanitized.

(c) Administrative Procedures - This item is deemed to be satisfied when:

1.All multi-use containers and utensils are thoroughly cleaned after each use and all equipment is thoroughly cleaned at least once each day used, unless the Health Officer has reviewed and accepted information, in consultation with FDA, supporting the cleaning of multi-use containers and utensils at frequencies extending beyond one (1) day or seventy-two (72) hours in the case of storage tanks or forty-four (44) hours in the case of evaporators, which are continuously operated. Supporting information shall be submitted to and approved by the Health Officer prior to initiating the qualification period if required. Finished product produced during an extended run shall meet all applicable requirements of Rule 420-3-16-.08. Any significant equipment or processing changes shall be communicated to the Health Officer, and may result in a re-verification of the extended run proposal, if it is determined that the change could potentially affect the safety of the finished milk and/or milk product(s).

2. The supporting information may include but is not limited to:

(i) Statement of proposal, including desired cleaning frequency.

(ii) Product and equipment description.

(iii) Intended use and consumers.

(iv) Distribution and storage temperatures of product.

(v) Diagram of process of interest.

(vi) Process parameters, including temperature and times.

(vii) Hazard evaluation and safety assessment.

(viii) Review of equipment for sanitary design.

(xi) When indicated by a hazard evaluation and safety assessment, a plan for initial qualification shall be developed to address identified critical process parameters.

3. Otherwise, storage tanks shall be cleaned when emptied and shall be emptied at least every seventy-two (72) hours. Records shall be available to verify that milk storage in these tanks does not exceed seventy-two (72) hours. These records shall be available for at least the previous three (3) months or from the time of the last regulatory inspection, whichever is longer. In the case of pasteurized storage tanks, which are CIP cleaned at intervals of less than seventy-two (72) hours, the CIP cleaning records required under Item 2b shall be considered adequate. Storage tanks, which are used to store raw milk and/or milk products or heat-treated milk products longer than twenty-four (24) hours and silo tanks used for the storage of raw milk and/or milk products or heat-treated milk products, shall be equipped with a seven (7) day temperature-recording device complying with the specifications of Appendix H, IV. Electronic records that comply with the applicable provisions of Appendix H, IV, and V, with or without hard copy, may be used in place of the seven (7) day temperature-recording records. Otherwise provided, evaporators shall be cleaned at the end of a continuous operation, not to exceed forty-four (44) hours, and records shall be available to verify that the operation time does not exceed forty-four (44) hours.

4. Drying equipment, cloth-collector systems, packaging equipment, and multi-use dry milk products and dry whey storage containers are cleaned at intervals and by methods recommended by the manufacturer and approved by the Health Officer. Such methods may include cleaning without water by use of vacuum cleaners, brushes, or scrapers. After cleaning, such equipment is sanitized by a method approved by the Health Officer. Cloth collector systems and all dry product-contact surfaces downstream from the dryer shall be sanitized or purged at intervals and by methods recommended by the manufacturer and approved by the Health Officer. Storage bins used to transport dry milk or milk products shall be dry cleaned after each usage and washed and sanitized at regular intervals.

Note: Appendix F contains additional information on dry cleaning of drying equipment, packaging equipment, and dry milk product and dry whey storage containers.

5. All milk tank trucks that transport Grade “A” milk and/or milk products shall be washed and sanitized at a permitted milk plant, receiving station, transfer station, or milk tank truck cleaning facility. The milk tank truck shall be cleaned and sanitized prior to its first use. When the time elapsed after cleaning and sanitizing and before its first use, exceeds ninety-six (96) hours, the tank shall be re-sanitized.

Note: Appendix B contains additional information on the cleaning and sanitizing requirements for milk tank trucks.

6. Whenever a milk tank truck has been cleaned and sanitized, as required by the Health Officer, it shall bear a tag or a record shall be made showing the date, time, place, and signature or initials of the employee or contract operator doing the work, unless the milk tank truck delivers to only one (1) receiving facility where responsibility for cleaning and sanitizing can be definitely established without tagging. The tag shall be removed at the location where the milk tank truck is next washed and sanitized and kept on file for fifteen (15) days as directed by the Health Officer.

7. Pipelines and equipment designed for mechanical cleaning meet the following requirements.

(i) An effective cleaning and sanitizing regimen for each separate cleaning circuit shall be followed.

(ii) A temperature recording device, complying with the specifications in Appendix H, IV, or a recording device which provides sufficient information to adequately evaluate the cleaning and sanitizing regimen and which is approved by the Health Officer, shall be installed in the return solution or other appropriate areas to record the temperature and time which the line or equipment is exposed to cleaning and sanitizing solutions. Optionally, time may be identified in military time (24 hour clock). Electronic records that comply with the applicable provisions of Appendix H, IV, and V, with or without hard copy, may be used in place of the cleaning records described above. For purposes of this rule, recording devices which produce records not meeting the specifications of Appendix H, IV may be acceptable if:

I. The temperature-recording device provides a continuous record of the monitoring of the cleaning cycle time and temperature, cleaning solution velocity or cleaning pump operation, and the presence or strength of cleaning chemicals for each cleaning cycle.

II. The record shows a typical pattern of each circuit cleaned, so that changes in the cleaning regimen may be readily detected.

III. Electronic storage of required cleaning records, with or without hard copy printouts may be acceptable; provided, the electronically generated records are readily available for review by the Health Officer. Electronic records shall meet the criteria of this rule and Appendix H, V. Except that, electronic storage of required cleaning records, with or without hard copy, shall be acceptable; provided, the computer and computer generated records are readily available for review by the Health Officer and meet the criteria of this rule and 21 CFR Part 11.

(iii) Temperature recording charts shall be identified, dated, and retained for three (3) months or until the next regulatory inspection, whichever is longer.

(iv) During each official inspection, the Health Officer shall examine and initial temperature recording charts to verify the time of exposure to solutions and their temperatures.

8. Plants in which containers are washed manually are equipped with a two (2) compartment wash-and-rinse vat for this purpose. Such plants shall also provide a steam cabinet or individual steam-jet plate with hood for sanitizing of cleaned containers or if sanitizing is done with chemicals, a third treatment vat.

9. In plants utilizing automatic bottle washers, such washers must provide for bactericidal treatment by means of steam, hot water, or chemical treatment. Soaker-type bottle washers, in which bactericidal treatment depends upon the causticity of the washing solution, the caustic strength for a given soaking time and temperature shall be as specified in the following table listing combinations of causticity, time, and temperature of equal bactericidal value, for the soaker tank of soaker-type bottle washers:

TABLE 2

COMBINATIONS OF CAUSTICITY, TIME, AND TEMPERATURE OF EQUAL BACTERICIDAL VALUE, FOR SOAKER TANK OF SOAKER-TYPE BOTTLE WASHERS

(Based on NSDA Specifications for Beverage Bottles)

Temperature, Degrees

Concentration of NaO H, Percent

Note: The National Soft Drink Association (NSDA), Washington, D.C. 20036 alkali test, the NSDA caustic test, or other suitable test may be used to determine the strength of the soaker solution. The caustic strength shall be tested monthly by the Health Officer.

10. When caustic is so used, subsequent final rinsing of the bottles shall be with water which has been treated with heat or chemicals to assure freedom from viable pathogenic or otherwise harmful organisms, to prevent recontamination of the treated bottles during the rinsing operation.

11. All multi-use containers, equipment, and utensils are sanitized before use, employing one or a combination of the methods prescribed under Rule 420-3-16-.09(11). Additionally, for milk and frozen dessert plants that condense or dry milk products the following methods are acceptable or any other method, which has been demonstrated to be equally efficient:

(i) Exposure to an enclosed jet of stream for not less than one (1) minute.

(ii) Exposure to hot air at a temperature of at least 83°C (180°F) for at least twenty (20) minutes as measured by an acceptable indicating thermometer located in the coldest zone. 12. Assembled equipment shall be sanitized prior to each day’s run, unless the FDA and the Health Officer have reviewed and accepted information supporting the sanitizing of multi-use containers, utensils, and equipment at frequencies extending beyond one (1) day. Tests to determine the efficiency of sanitization should be made by the Health Officer at intervals sufficient to satisfy the Health Officer that the sanitization process is effective.

13. For milk plants that dry milk, milk products, or frozen dessert products, higher temperatures and longer periods may be necessary for the sanitization of high-pressure lines. It has been demonstrated that alkaline cleaners at 72°C (160°F) for thirty (30) minutes, followed by an acid cleaner for thirty (30) minutes at the same temperature, produce satisfactory results. Studies have indicated that effective sanitization of the dryer may be accomplished by the following procedure:

(i) Operate the spray nozzles with water at a temperature and rates at least as high as those employed during the drying operation.

(ii) Adjust airflow to give at least 0.5 inch (water) pressure in the drying chamber.

(iii) Continue the operation for twenty (20) minutes while a temperature of not less than 85°C (185°F) is being registered at the discharge from the dryer.

14. Portions of the drying system not reached by this treatment or dryers in which this procedure is not practical shall be treated by one of the methods prescribed above, or by other methods of demonstrated effectiveness.

15. The residual bacteria count of multi-use containers and closures shall be conducted as outlined in Appendix J. The residual bacterial count of multi-use containers used for packaging pasteurized milk and/or milk products shall not exceed one (1) colony per milliliter (1/mL) of capacity, when the rinse test is used, or fifty (50) colonies per fifty (50) square centimeters (cm2) one (1) colony per square centimeter) of product-contact surface, when the swab test is used, in three (3) out of four (4) samples taken at random on a given day. Coliform organisms shall be undetectable in all multi-use containers.

16. The residual bacteria count of single-service containers and closures, used for packaging pasteurized milk and/or milk products shall not exceed fifty (50) colonies per container, or in the case of dry product packaging, shall not exceed one (1) colony per milliliter (1/mL) of capacity when the rinse test is used, except that in containers less than 100 mL the count shall not exceed ten (10) colonies or fifty (50) colonies per fifty (50) cm2 (one [1] colony per square centimeter) of product-contact surface, when the swab test is used, in three (3) out of four (4) samples taken at random on a given day. Coliform organisms shall be undetectable in all single-service containers and/or closures.

17. When single-service containers and/or closures are fabricated in another plant that conforms to the Standards of Appendix J and the Health Officer has information that they do comply, the Health Officer may accept the containers and/or closures as being in conformance without additional testing. If there is reason to believe that containers and/or closures do not conform to the bacteriological standards, additional testing may be required. If containers and/or closures are fabricated in the milk plant, the Health Officer shall collect, during any consecutive six (6) months, at least four (4) sample sets of containers with applied closures, as defined in Appendix J from each manufacturing line, as defined in Appendix J, in at least four (4) separate months, except when three (3) months show a month containing two (2) sampling dates separated by at least twenty (20) days, and analyze the sample sets at an Official Commercial or Industry Laboratory, approved by the Milk Laboratory Control Agency specifically for the examinations required under Appendix J.

18. Plants which utilize multi-use plastic containers for pasteurized milk, milk products, and frozen desserts shall comply with the following criteria:

(i) The plastic material from which the containers are molded shall be of safe material.

(ii) The plastic material shall comply with the material specifications of Rule 420-3-16-.10(11).

(iii) All containers shall be identified as to plant of manufacture, date of manufacture, and type and class of plastic material used. This information may be by code, provided the code is revealed to the Health Officer.

(iv) A device shall be installed in the filling line capable of detecting in each container before it is filled, volatile organic contaminants in amounts that are of public health significance. Such device must be constructed so that it may be sealed by the Health Officer to prevent the changing of its sensitivity functioning level. Models using an air-injection system and with a testing device built into the detection equipment do not have to be sealed. To assure proper functioning of the system, the operator needs to be able to adjust the sensitivity. However, those models utilizing an external testing device must be sealed. Any container detected by the device as being unsatisfactory must be automatically made unusable to prevent refilling. In addition, the device must be interconnected so that the system will not operate unless the detecting device is in proper operating condition, provided any other system so designed and operated will provide equal assurance of freedom from contamination and recognized by the FDA to be equally efficient may be accepted by the Health Officer. When other systems are used in place of a device for the detection of volatile organic contaminants, the following criteria has been developed to determine what constitutes equal assurance:

(v) A soaker-type washer shall be used for cleaning and sanitizing the containers and shall conform with the following criteria:

I. If caustic is used, the caustic strength for a given washing time and temperature shall be as specified in Table 2 of this item; or

II. If a cleaning compound, other than caustic is used, the compound shall be a mild or moderately alkaline, granular composition formulated from a blend of sodium phosphate, and anionic synthetic detergents and conform to the following:

III. The used solution shall have at least a 3 percent concentration with a pH of at least 11.9 and an alkalinity expressed as sodium oxide of at least 2.5 percent.

IV. There shall be at least a two (2) minute soak time in the soaker tank.

V. The temperature of the soaker tank shall be at least 69°C (155°F); and the final rinse subsequent to the soaking tank shall be with a sanitizing solution.

VI. The soaker-type washer system shall be so designed and operated that unless the time, temperature, and concentration, as specified for the soaker solutions, are met, the containers cannot be discharged from the washer. The mechanism for control of the time, temperature, and concentration of the use solution shall be sealed.

VII. A standard must be available for the use of the Health Officer for testing the proper sensitivity functioning levels of the detection device.

VIII. A thorough inspection procedure shall be in effect to remove any containers which show stress cracks, splitting, pitting, discoloration, or cloudiness, as well as any unremoved soil. This shall be carried out with adequate light and be much more thorough than the customary cursory inspection given to glass bottles.

IX. The containers shall comply with the applicable construction requirements of Rule 420-3-16-.10(11). The closure for the container shall be single-service. Screw-type closures shall not be used.

X. The container shall not impart into the product pesticide residual levels or other chemical contaminants in excess of those considered acceptable under the FFDCA, as amended and regulations issued there under.

XI. The phrase "Use only for food" shall appear on all containers.

19. The following requirements are for NCIMS listed milk plants choosing to use single-service glass bottles for the packaging of Grade “A” milk and/or milk products:

(i) Single-service glass containers shall be manufactured from non-toxic materials, packaged, and shipped in a manner that protects them from contamination, (i.e., shrink-wrapped in plastic or other methods acceptable to the Health Officer). All containers shall be identified (coding is acceptable) as to the plant of manufacture. Closures for the containers shall be single-service, designed to protect the pouring lip of the container and from an IMS listed fabricator.

(ii) These containers shall be inspected prior to filling to determine general condition, damage, and/or the presence of foreign materials, broken glass, and other contaminates, etc.

(iii) Single-service glass containers shall be sanitized immediately prior to filling. Sanitizing solutions shall be removed from the container prior to filling. Inverted draining, sterile air evacuation, or other effective methods acceptable to the Health Officer may accomplish this.

(iv) As determined by the Health Officer, single-service glass containers that are received at the processing plant in an unclean and/or unprotected state shall be properly cleaned and sanitized immediately prior to packaging. This cleaning and sanitizing operation shall be conducted in a room separate from case washing operations and rooms used for the pasteurization, processing, cooling, and packaging of milk and milk products. Equipment and procedures used for the cleaning of single-service glass bottles shall meet all the requirements of this Item 5 including recommended sanitization efficiency tests by the Health Officer.

(v) Single-service glass containers shall be labeled with wording to designate “single-service use only.”

(13) Storage of Cleaned Containers and Equipment

(a) After cleaning, all multi-use milk product containers, utensils, and equipment shall be transported and stored to assure complete drainage and shall be protected from contamination before use.

(b) Public Health Reason - If containers and equipment are not protected from contamination, the value of sanitization may be partly or entirely nullified.

(c) Administrative Procedures - This item is deemed to be satisfied when:

1. All multi-use containers, equipment, and utensils, after cleaning, are transported and/or stored on metal racks or racks made of impervious food grade material, in clean cases, elevated above the floor. Containers shall be stored inverted on racks or in cases constructed of relatively nonabsorbent, corrosion-resistant, nontoxic materials, or otherwise protected from contamination.

2. Floors are not flushed or washed when crates of clean bottles are stacked on them.

(14) Storage of Single-Service Containers, Utensils, and Materials

(a) Single-service closure, closure stock, parchment paper containers, gaskets, liners, bags, and other single-service articles for use in contact with milk, milk products, and frozen desserts shall be purchased and stored in sanitary tubes, wrappings, or cartons; shall be kept therein in a clean, dry place until used; and shall be handled in a sanitary manner.

(b) Public Health Reason - Soiled or contaminated closures, parchment paper, gaskets, and single-service containers nullify the benefits of the safeguards prescribed throughout these rules. Packing the closures in tubes which remain unbroken until they are placed in the bottling machine is the best method of assuring closure cleanliness.

(c) Administrative Procedures - This item is deemed to be satisfied when:

1. Single-service closures, closure stock, parchment paper, containers, gaskets, liners, bags, and other single-service articles for use in contact with milk, milk products, and frozen desserts are purchased and stored in sanitary tubes, wrappings, or cartons; are kept in a clean, dry place until used; and are handled in a sanitary manner.

2. Paperboard shipping containers used to enclose plastic bags or unfilled containers are used only once unless other methods are employed to protect the containers from contamination.

3. Tubes or cartons are not refilled with spilled caps, gaskets, or parchment papers.

4. Cartons or boxes from which contents have been partially removed are kept closed.

5. Suitable cabinets are provided for storage of tubes after removal from the large outer box and for storage of opened cartons, unless other satisfactory means are employed to protect the caps, closures, or containers.

(15) Protection from Contamination

(a) Milk and frozen dessert plant operations, equipment, and facilities shall be located and conducted to prevent any contamination of milk, milk products, or frozen desserts, ingredients, equipment, containers, and utensils. All milk, milk products, or frozen dessert products or ingredients which have been spilled, overflowed, or leaked shall be discarded. The processing or handling of products other than milk and milk products in the pasteurization plant shall be performed to preclude the contamination of such milk, milk products, and frozen desserts. The storage, handling, and use of poisonous or toxic materials shall be performed to preclude the contamination of milk, milk products, and frozen desserts or ingredients of such milk, milk products, and frozen desserts or the product-contact surfaces of all equipment, containers, or utensils. Milk plant operations that handle nondairy food allergens shall have a written food allergen control plan to protect milk, milk products, and frozen dessert products from allergen cross-contract, including during storage and use, and to ensure proper declaration of allergens on product labeling.

(b) Public Health Reason - Because of the nature of milk, milk products, and frozen desserts and their susceptibility to contamination by bacteria, chemicals, and other adulterants, as well as the potential for allergen cross-contact of such products in certain facilities, every effort should be made to provide adequate protection for the milk, milk products, and frozen desserts at all times. Public health officials have long recognized that raw milk contains microorganisms of public health concern and it is important to understand that these microorganisms may be found in the milk plant environment if measures are not taken to minimize the risk of contamination by these microorganisms. Contamination of milk from the environment can result in milkborne illness. Misuse of pesticides and other harmful chemicals can provide opportunities for contamination of the milk, milk product, or frozen dessert or equipment with which the milk, milk product, or frozen dessert comes in contact.

(c) Administrative Procedures - This item is deemed to be satisfied when:

1. Equipment and operations are so located within the plant as to prevent overcrowding and contamination of cleaned and sanitized containers, equipment, and utensils by splash, condensation, or manual contact.

2. Packaged milk, milk products, and frozen desserts which have physically left the premise or the processing plant are not repasteurized for Grade “A” or grade manufacturing use. The Health Officer may, on a specific individual request, authorize reprocessing of packaged milk, milk products, and frozen desserts; provided, all other aspects of this item, including proper storage temperature and container integrity are complied with; provided, that the re-pasteurization of milk, milk products, and frozen desserts shipped in milk transport tankers which have been pasteurized at another Grade “A” or manufacturing grade plant and have been handled in a sanitary manner and maintained at 7°C (45°F) or less is permitted. Equipment, designated areas, or rooms utilized for storage, processing, and handling of returned packaged milk, milk products, and frozen desserts are maintained, operated, cleaned, and sanitized so as to preclude contamination of Grade “A” milk, milk products, frozen dessert products, equipment, and the operations.

Note: The option for the authorizing of the reprocessing of packaged milk and/or milk products on an individual request, as cited in 2 above, shall not be applicable to a TPC authorized under the ICP.

3. All product-contact surfaces of containers, equipment, and utensils are covered or otherwise protected to prevent the access of insects, dust, condensation, and other contamination. All openings, including valves and piping attached to milk and milk product storage tanks and milk tank trucks, pumps, or vats, etc., shall be capped or otherwise properly protected. While unloading at a receiving station, transfer station, or pasteurization plant, one of the following conditions shall be met:

(i) If the area is completely enclosed (walls and ceiling, with doors closed) during the unloading process and the dust-cover or dome and the manhole cover is opened slightly and held in this position by the metal clamps used to close the cover, then a filter is not required. However, if the dust-cover and/or manhole cover(s) are opened in excess of that provided by the metal clamps or the covers have been removed, then a suitable filter is required for the manhole.

(ii) If the area is not completely enclosed or doors of the unloading area are open during unloading, a suitable filter is required for the manhole or air inlet vent and suitable protection must be provided over the filter material either by design of the filter holding apparatus or a roof or ceiling over the area. When weather and environmental conditions permit, manhole openings and covers of milk tank trucks may be opened outdoors for the short period of time necessary for the collection of samples for animal drug residue screening. Direct connections from milk tank truck to milk tank truck must be made from valve to valve or through the manhole lid; provided, all connections are made ferrule-to-ferrule and adequate protection is provided for the air vent.

(iii) Receiving and dump vats shall be completely covered, except during washing and sanitizing, and when milk is being dumped. Where strainers are used, the cover for the vat opening shall be designed to cover the opening with the strainer in place.

4. Ingredients added to milk, milk products, and frozen desserts are handled in such a manner as to avoid contamination.

5. Whenever air under pressure is used for the agitation or movement of milk, or is directed at a milk-contact surface, it is free of oil, dust, rust, excessive moisture, extraneous materials, and odor, and shall otherwise comply with the applicable standards of Appendix H. Air intakes for drying equipment shall be located so as to minimize the amount of atmospheric contamination and shall be equipped with suitable single-service filters, multi-use filters, or continuous air filter systems (refer to Appendix H). The use of steam containing toxic substances is expressly prohibited. Whenever steam is used in contact with milk, milk products, or frozen desserts it shall be of culinary quality and shall comply with the applicable standards of Appendix H.

6. Air exhausts from the dryer systems are covered when dryers are not in operation.

7. Standardization is done before the pasteurization process is started, unless pasteurized milk or milk products are used for standardization. Such pasteurized milk products shall be protected against contamination. In no case shall pasteurized milk or milk products be standardized with unpasteurized milk unless the standardized product is subsequently pasteurized. Reconstituted or recombined milk and milk products shall be pasteurized after reconstitution or recombining of all ingredients. Standardization of Grade “A” milk and milk products with other than Grade “A” milk and milk products is prohibited. These rules permit standardization as a process of adjusting the milkfat of milk in a milk plant by the addition or removal of cream or non-fat milk.

8. All multi-use cases used to encase packaged milk, milk product, or frozen dessert containers are cleaned prior to their use.

9. All ingredients and non-product-contact materials used in the preparation or packaging of milk, milk products, and frozen desserts are stored in a clean place and are so handled as to prevent their contamination.

10. Pasteurized milk and milk products are not strained or filtered, except through a perforated metal strainer; provided, pasteurized milk and milk products that are concentrated (condensed) in membrane processing systems may be filtered; provided, a single service in-line filter that is sanitized after assembly may be allowed if it is a part of the membrane processing system.

11. Only those poisonous or toxic materials, including, but not limited to, insecticides, rodenticides, detergents, sanitizers, caustics, acids, related cleaning compounds, and medicinal agents necessary for the maintenance of the dairy or frozen dessert plant are present in the dairy and frozen dessert plant.

12. Those poisonous or toxic materials that are necessary are not stored in any room where milk, milk products, or frozen desserts are received, processed, pasteurized, condensed, dried, or stored or where equipment, containers, or utensils are washed or where single-service containers, closures, bags, or caps are stored.

13. Those poisonous or toxic materials that are necessary are stored in a separate area of the plant in prominently and distinctly labeled containers; provided, this does not preclude the convenient availability of detergents or sanitizers to areas where equipment, containers, and utensils are washed and sanitized.

14. Only insecticides and rodenticides approved by the Health Officer and/or registered with the EPA shall be used for insect and rodent control. Such insecticides and rodenticides shall be used only in accordance with the manufacturer's label directions and shall be prevented from contaminating milk, milk products, frozen dessert products, containers, equipment, and utensils.

15. During processing, pipelines and equipment used to contain or conduct milk, milk products, and frozen desserts shall be effectively separated from tanks or circuits containing cleaning and/or sanitizing solutions. In the case of separating non-Grade “A” and Grade “A” milk or milk products, a water rinse after processing non-Grade “A” and prior to Grade “A” is adequate separation; provided, both processed as Grade “A” and raw and pasteurized milk or milk products are kept physically separated.

16. Grade “A” raw milk or milk products and non-Grade “A” raw products, dairy or non-dairy, shall be separated by one (1) valve.

17. Grade “A” pasteurized milk or milk products and non-Grade “A” pasteurized products, dairy or non-dairy, shall be separated by one (1) valve.

18. Provided, during the actual flushing of raw milk or milk product lines and vessels with water, there shall be a sufficient separation between water piping and unpasteurized milk or milk products or lines used to conduct unpasteurized milk or milk products, to prevent the accidental addition of water.

19. Water piping and raw milk and milk product lines and vessels may be separated by one (1) fail-safe valve that upon loss of air or power shall move to a position that will close or block the water lines from milk or milk product lines or vessels. Water piping conducting water which has undergone an equivalent process to pasteurization as described in Rule 420-3-16 (15) and pasteurized milk and milk product lines or vessels may also be separated by one (1) fail-safe valve. In addition, a sanitary check-valve or a sanitary valve arrangement(s) that is equally effective shall be located between the fail-safe valve and the milk product line(s) and/or vessel(s). Sanitary piping shall be used downstream from the sanitary check-valve. Provisions shall be made for cleaning this sanitary piping.

Note: Refer to Rule 420-3-16-.10(7), Administrative Procedures page 74, for additional requirements involving the protection of the water system.

20. When two (2) grades of milk or milk products are received in the same milk plant in dual receiving equipment, a swing type dump grill is not permitted. When two (2) grades of milk or milk products are received in the milk plant by milk tank trucks, the following options may be used:

(i) Separate receiving equipment and unloading pumps shall be provided; or

(ii) The receiving equipment and pump shall be subjected to a water rinse, as provided in Administrative Procedures 15 above, prior to use with Grade “A” milk or milk product; or

(iii) The non-Grade “A” milk or milk product shall be received last and the equipment washed and sanitized prior to receiving Grade “A” milk or milk products.

21. All milk, milk products, and frozen desserts which have overflowed, leaked, have been spilled, or improperly handled are discarded. Milk, milk products, and frozen desserts drained from processing equipment at the end of a run, collected from a defoamer system, and milk solids rinsed from equipment, containers, or pipelines shall be re-pasteurized only if such milk, milk products, and frozen desserts are handled in a sanitary manner and maintained at 7°C (45°F) or less. When the handling and/or refrigeration of such milk, milk products, and frozen desserts are not in compliance with this requirement, they shall be discarded. Milk, milk products, and frozen desserts from damaged, punctured, or otherwise contaminated containers or product from out of code containers shall not be re-pasteurized for use.

22. Means are provided to prevent contamination of milk containers, utensils, and equipment by drippings, spillage, and splash from overhead piping, platforms, or mezzanines.

23. The processing of foods and/or drinks other than Grade “A” milk and milk products are performed to preclude the contamination of such milk, milk products, and frozen desserts.

24. During processing, pipelines and equipment used to contain or conduct milk, milk products, and frozen dessert products shall be effectively separated from tanks/silos and/or circuits containing cleaning and/or sanitizing solutions. This can be accomplished by:

(i) Physically disconnecting all connection points between tanks/silos and/or circuits containing cleaning and/or sanitizing solutions from pipelines and equipment used to contain or conduct milk and/or milk products; or

(ii) Separation of all connection points between such circuits by at least two (2) automatically controlled valves with a drainable opening to the atmosphere between the valves; or by a single-bodied double seat mixproof valve, with a drainable opening to the atmosphere between the seats, if:

(I) the drainable opening to the atmosphere (vent) is equal to the largest pipeline connected to the mixproof valve or one (1) of the following exceptions:

a. If the cross sectional area of the vent opening is less than that of the largest pipe diameter for the double seat valve, the maximum pressure in the space between the two (2) valve seats for the double seat valve shall be equivalent to or less than the maximum pressure in the space between the two (2) blocking seats of two (2) automatically controlled compression type valves (three [3]-way valve to the drain and a two [2]-way valve separating product lines from cleaning and/or sanitizing solution lines); or

b. In low pressure gravity drain applications, (i.e., cheese curd transfer lines from cheese process vats where the product line is the same size or larger than the cleaning and/or sanitizing solution line), the vent may be the size of the solution line and the valves or valve seats are not required to be position detectable. In order to accept this variation, the valve(s) shall fail to the blocked position upon loss of air or power, and there shall not be any pumps capable of pushing milk and/or milk product, cleaning solutions, and/or sanitizing solutions into this valve arrangement.

(II) Both valves and valve seats, in the case of single-bodied double seat valves, are position detectable and capable of providing an electronic signal when not properly seated in the blocked position (refer to Appendix H, I-pg. H-1).

(III) These valves or valve seats, in the case of single-bodied double seat valves, are part of an automatic fail-safe system that shall prevent the contamination of milk, milk products, and frozen dessert products with cleaning and/or sanitizing solutions. Automatic fail-safe systems shall be unique to each particular installation, but are normally based on the premise that both blocking valve seats are properly seated in the blocked position before the CIP cleaning system can be activated for the cleaning circuit containing this valve arrangement, except as provided in (VI) below.

(IV) The system shall not have any manual overrides.

(V) Controls for the fail-safe system are secured as directed by the Health Officer in order to prevent unauthorized changes.

(VI) The vent is not cleaned until milk and/or milk products have been removed or isolated, except in the case of a properly designed and operated single-bodied double seat valve, in which case, the vent may be cleaned while milk and/or milk products are present in one (1) of the valve housings. A properly designed and operated single-bodied double-seat valve shall incorporate the following:

I. There shall not be any impingement of cleaning liquid on the opposite valve seat gasket during seat lifting, even in the case of damaged or missing gaskets.

II. The pressure in the critical seat area of the valve vent cavity, even in the case of damaged or missing gaskets, shall be demonstrated to be atmospheric or less at all times.

III. During a seat-lift operation, the position of the seat opposite to the seat being lifted shall be monitored by a position detection device that is interlocked with the cleaning pump or source of the CIP cleaning solution pressure such that if this opposite seat is determined to be other than fully closed, the cleaning pump or source of the CIP cleaning solution pressure shall be immediately de-energized.

IV. The single-bodied double seat valve vent cavity cleaning option shall have an Automated Fail-Safe Control System and the Control System shall comply with applicable provisions of Appendix H, VI.

(VII) Variations from the above specifications may be individually evaluated and found to also be acceptable if the level of protection is not compromised.

(iii) In the case of higher-heat-shorter-time (HHST) pasteurized milk and milk products that are processed and the equipment cleaned and/or chemically sanitized above the atmospheric boiling point of the milk or milk product or cleaning and/or sanitizing solutions, the required separation between pipe lines and equipment used to contain or conduct milk and milk products and tanks or circuits containing cleaning and/or chemical sanitizing solutions may be accomplished using an alarmed steam block(s), located between the milk and milk product or cleaning and/or chemical sanitizing solutions if:

(I) The steam block is equipped with a visible steam trace that exits at the bottom of the steam block;

(II) The steam trace is equipped with a temperature sensor that is capable of differentiating between those temperatures that indicate steam exiting the steam trace has not been exposed to liquid in the steam block and temperatures that will occur when liquid is present in the steam block;

(III) This steam trace shall be physically isolated from other steam lines or traces such that the temperature sensor measures the steam temperature only from that single trace;

(IV) The temperature sensor is integrated with automatic controls, such that when there is milk or milk products on one (1) side of the steam block and cleaning and/or chemical sanitizing solutions on the other side of the steam block, and the temperature sensor in the steam trace detects a temperature that indicates that liquid, rather than steam, is present in the steam trace, the cleaning pump shall be de-energized, and when needed to prevent solution pressure on the steam block, the cleaning and/or chemical sanitizing solution are automatically drained away from the steam block. Except that in systems where the cleaning and/or sanitizing solution is circulated by the timing pump, that pump may continue to operate during an alarmed condition; provided, a legal flow-diversion device (FDD) is used to divert the cleaning and/or chemical sanitizing solution flow away from the steam block.

(V) During times when a steam block(s) is used as described in this section to provide separation between pipe lines and equipment used to contain or conduct milk and milk products and tanks or circuits containing cleaning and/or chemical sanitizing solutions, there shall be no time delays or other means that delay an immediate automatic response to liquid exiting the steam trace;

(VI) Although the automatic control system is not required to comply with Appendix H, VI, there shall be means provided to test and verify the accuracy of the sensor and the operation of the control system.

(VII) In order to facilitate testing, the temperature set point that will activate the automatic controls described in this section shall be identified for each steam block used for this purpose. Means shall be provided to verify that lowering the temperature below this set point will activate the control system when a steam block(s) is used, as described in this section, to provide separation between pipe lines and equipment used to contain or conduct milk and milk products and tanks or circuits containing cleaning and/or chemical sanitizing solutions.

Note: The valve arrangement(s) described in this section shall not be used to separate raw products, dairy, non-dairy, or water, from pasteurized milk or milk products; provided, nothing in this section shall be construed as barring any other means to separate milk and milk product from cleaning/sanitizing solution in systems which have been recognized by the FDA to be equally effective and which are approved by the Health Officer.

25. Except as permitted in Rule 420-3-16-.10(16), there shall be no physical connection between unpasteurized products, dairy, non-dairy, or water, and pasteurized milk or milk products. Pasteurized non-dairy products not completely separated from pasteurized milk and milk products shall be pasteurized in properly designed and operated equipment at times and temperatures which meet at least the minimum times and temperatures provided for in the definition of pasteurization.

In the case of water, it shall:

(i) Meet at least the minimum times and temperatures provided for in the definition of pasteurization in equipment that may not meet Rule 420-3-16-.10(16); or

(ii) Meet the requirements found in Appendix H, Rule 420-3-16-.10(16); or

(iii) Have undergone an equivalent process found acceptable by FDA and the Health Officer; or

(iv) Have undergone a hazard evaluation and safety assessment of the specific water supply and application involved and has undergone an additional treatment to destroy or remove bacteria acceptable to the Health Officer, in consultation with the FDA, to ensure the water will not compromise the safety of the milk or milk product. Supporting information shall be submitted to and approved by the Health Officer. The supporting information may include, but is not limited to the following:

(I) Statement of proposal.

(II) Intended use.

(III) Review of equipment to be used in the process.

(IV) Diagram of the process of interest.

(V) Documentation that the source water shall meet or exceed the EPA Safe Drinking Water Bacteriological Standards. Safety Assessment comparison of samples from the facility’s water source, pasteurized water, and proposed equivalent water. Water samples shall be collected daily for two (2) weeks following approval of the initial installation and every six (6) months thereafter.

(VI) Protocol for the continued monitoring of criteria and procedures; provided, that daily tests shall be conducted for one (1) week following any repairs or alteration to the system.

a. In the event of a water control authority issued boil water order or other emergency that renders the water supply to be a public health concern, the established approved equivalency protocol shall be evaluated to determine that it will continue to produce water equivalent to pasteurized water. In addition, a safety assessment shall be made of the milk, milk products, and frozen dessert products that may have been affected during the time that the water utilized may not have been equivalent to pasteurized water.

b. This section does not require separate raw and pasteurized CIP cleaning systems.

26. Pasteurized re-circulation lines, divert lines, and leak-detect lines connecting to the constant-level tank shall be designed so that there is an air gap between the termination of these pipelines and the raw milk or milk product overflow level. This air gap shall be equivalent to at least two (2) times the diameter of the largest of these pipelines. For purposes of this section, an overflow is defined as the flood rim of the constant-level tank or any unrestricted opening below the flood rim of the constant-level tank which is large enough that it is at least equivalent to two (2) times the diameter of the largest of these pipelines.

27. All milk and/or milk products that have overflowed, leaked, been spilled, or improperly handled are discarded. Milk and/or milk products drained from processing equipment at the end of a run, collected from a defoamer system, and milk or milk product solids rinsed from equipment, containers, or pipelines shall be repasteurized only if such milk or milk products are handled in a sanitary manner and maintained at 7ºC (45ºF) or less. When the handling and/or cooling of such milk and/or milk products are not in compliance with this requirement, they shall be discarded. Milk, milk products, and frozen dessert products from damaged, punctured, or otherwise contaminated containers or product from out-of-code containers shall not be repasteurized for Grade “A” use.

28. Means are provided to prevent contamination of milk and/or milk products, containers, utensils and equipment by drippings, spillage, and splash from overhead piping, platforms, or mezzanines.

29. The processing of foods and/or drinks other than Grade “A” milk, milk products, and/or frozen dessert products are performed to preclude the contamination of such milk, milk products, and frozen dessert products.

30. No product is handled in the milk or frozen dessert plants that may create a public health hazard. Permission to handle products other than those defined in Rule 420-3-16-.02 or to conduct operations in equipment or rooms, other than those for which they are designated, should be provisional and subject to revocation if found objectionable.

31. In no case shall pasteurized milk, milk products, and frozen dessert products be standardized with unpasteurized milk or milk products, unless the standardized milk or milk product is subsequently pasteurized.

32. Reconstituted or recombined milk and milk products shall be pasteurized after reconstitution or recombining of all ingredients.

33. Raw milk or milk product-to-water-to-pasteurized milk or milk product plate or double/triple tube type heat exchangers may be used for heat-exchange purposes other than legal pasteurization, when constructed, installed, and operated in accordance with the following:

(i) Plate or double/triple tube type heat exchangers, as described above, shall be constructed, installed, and operated so that pasteurized milk or milk product in the plate or double/triple tube type heat exchanger will automatically be under greater pressure than the heat-transfer water in the plate or double/triple tube type heat exchanger at all times.

(ii) The pasteurized milk or milk product between the outlet of the last flow promoting device and the entrance to the plate or double/triple tube type heat exchanger shall rise to a vertical elevation of 30.5 centimeters (twelve [12] inches) above the highest heat-transfer water level, downstream from the water supply tank, and shall be open to the atmosphere at this or a higher elevation.

(iii) The pasteurized milk or milk product between its outlet from the plate or double/triple tube type heat exchanger and the nearest point downstream open to the atmosphere shall rise to a vertical elevation of 30.5 centimeters (twelve [12] inches) above the highest heat-transfer water level, downstream from the water supply tank, and shall be open to the atmosphere at this or a higher elevation.

(iv) The overflow of the top rim of the water supply tank shall always be lower than the lowest heat-transfer water level in the plate or double/triple tube type heat exchanger.

(v) A pump(s) or flow-promoting device(s), which can affect the proper pressure relationships within the plate or double/triple tube type heat exchanger, shall not be located between the pasteurized milk or milk product outlet from the plate or double/triple tube type heat exchanger and the nearest downstream point open to the atmosphere.

(vi) A pump(s) shall not be located between the heat-transfer water inlet to the plate or double/triple tube type heat exchanger and the water supply tank, unless it is designed and installed to operate only when pasteurized milk or milk product is flowing through the pasteurized milk or milk product side of the plate or double/triple tube type heat exchanger and when the pressure of the pasteurized milk or milk product is higher than the maximum pressure produced by the pump(s). This may be accomplished by wiring the heat-transfer water pump(s) so that it cannot operate unless:

(I) Pasteurized milk or milk product is flowing through the pasteurized milk or milk product side of the plate or double/triple tube type heat exchanger.

(II) The pasteurized milk or milk product pressure exceeds, by at least 6.9 kPa (1 psi), the maximum pressure developed by the heat-transfer water pump. A pressure differential controller shall be installed with a sensor located at the heat-transfer water inlet to the plate or double/triple tube type heat exchanger and the pasteurized milk or milk product outlet of the plate or double/triple tube type heat exchanger. The differential set point of this pressure differential controller shall be tested by the Health Officer upon installation; at least once every three (3) months thereafter; whenever the regulatory seal has been broken; and following any repair or replacement. Accuracy shall be determined by utilizing testing procedures as outlined in Appendix I, Test 9.2.1 to assure that the pressure differential controller probes are accurately calibrated. Also, the applicable procedures cited in Appendix I, Test 9.2.2 shall be utilized to assure that the pressure differential controller is accurately calibrated and will de-energize the heat-transfer water pump at the required differential pressure set point.

(vii) All heat-transfer water in the plate or double/triple tube type heat exchanger shall automatically drain freely back to the water supply tank or to the floor when the heat transfer water pump(s) are shut down and the heat-transfer water connection(s) at the plate or double/triple tube type heat exchanger is disconnected.

34. Food Allergen Control - A milk plant operation that handles nondairy food allergens shall implement a written food allergen control plan that includes procedures, practices, and processes to control food allergens. Food allergen controls shall include those procedures, practices, and processes employed for:

(i) Ensuring protection of food from allergen cross-contact, including during storage and use.

(ii) Labeling the finished food, including ensuring that the finished food is not misbranded under Section 403(w) of the FFD&CA with an undeclared food allergen.

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

35. Environmental Monitoring - A milk plant shall have a written environmental monitoring program that is implemented and supported by records for milk, milk products, and frozen desserts exposed to the environment when the milk, milk products, and frozen desserts do not subsequently receive a treatment that would significantly minimize the pathogen. The environmental monitoring program shall, at a minimum:

(i) Be supported by scientific information.

(ii) Include written procedures and records.

(iii) Identify environmental monitoring locations and the number of sample sites to be tested during routine environmental monitoring.

(iv) Identify the timing and frequency for collecting and testing samples.

(v) Identify the environmental pathogen or appropriate indicator microorganism for which to test.

(vi) Identify the test(s) conducted, including the analytical method used, and the test result.

(vii) Identify the laboratory conducting the testing.

(viii) Include corrective action procedures for environmental monitoring test results.

36. Supplier Control Program - A milk plant or frozen dessert plant shall have a supplier control program for raw materials and ingredients that is implemented and supported by records to control food safety hazards. The supplier control program shall, at a minimum;

(i) Document that all milk and/or milk product ingredients are obtained from an IMS listed source or, when an IMS source does not exist that the supplier has, at a minimum, a functional risk-based program with appropriate controls to significantly minimize hazards for all milk, milk product, and frozen dessert ingredients obtained from non-IMS listed sources utilized in the milk plant’s Grade “A” milk and/or milk products.

(ii) Document that a supplier of non-milk and/or milk, milk product, and frozen desserts product ingredients has a functional and written food safety program that includes allergen management, if utilized in the milk plant’s Grade “A” milk and/or milk products.

(16) Pasteurization, Aseptic Processing and Packaging and Retort Processed After Packaging

(a) Pasteurization shall be performed as defined in Rule 420-3-16-.02 and 420-3-16-.10(16). Aseptic processing and packaging and retort processed after packaging shall be performed Chapter 420-3-16 Health Supp. 12/31/18 3-16-130 in accordance with the applicable requirements of 21 CFR Parts 108, 110, and 113 (refer to Appendix L).

1. In all cases, except for the specific exemptions provided for in Administrative Procedures 3, pasteurization of raw milk or milk product shall be performed before the raw milk, milk product, or frozen dessert product enters the reverse osmosis (RO), ultra-filtration (UF), evaporator, or condensing equipment and shall be performed in the milk plant where the processing is done. All condensed milk, milk products, and frozen dessert products transported to a milk plant or frozen dessert plant for drying shall be re-pasteurized at the milk plant or frozen dessert plant at which it is dried. If condensed whey containing at least 40 percent total solids has been partially crystallized by cooling, it may be transported to a separate milk plant for drying without re-pasteurization, provided the following conditions are complied with:

2. The condensed, partially crystallized whey is cooled and maintained at 7°C (45°F) or less.

3. Milk tank trucks dedicated to hauling pasteurized product shall be used to transport the condensed, partially crystallized whey and shall be washed and sanitized immediately prior to filling and then sealed after filling until unloading.

4. Separate unloading pumps and pipelines shall be provided and used only for the unloading of the condensed, partially crystallized whey. Such pumps and pipelines shall be cleaned and sanitized as a separate cleaning circuit.

(b) Public Health Reason

1. The public health value of pasteurization is unanimously agreed upon by health officials. Long experience conclusively shows its value in the prevention of diseases which may be transmitted through milk. Pasteurization is the only practical commercial measure which, if properly applied to all milk, will destroy all milk-borne disease organisms. Examination of lactating animals and milk handlers, while desirable and of great value can be done only at intervals and, therefore, it is possible for pathogenic bacteria to enter the milk for varying periods before the disease condition is discovered. Disease bacteria may also enter milk accidentally from other sources such as flies, contaminated water, utensils, etc. It has been demonstrated that the time-temperature combinations specified by these rules, if applied to every particle of milk, will devitalize all milk-borne pathogens. Compilations of outbreak of milk-borne disease by the U.S. Public Health Service (USPHS) and FDA over many years indicate that the risk of contracting disease from raw milk is approximately fifty (50) times as great as from milk labeled "pasteurized."

2. A note of caution is in order. Although pasteurization devitalizes the organisms, it does not destroy the toxins that may be formed in milk and/or milk products when certain staphylococci are present (as from udder infections), and when the milk, milk products, and/or frozen dessert product are not properly refrigerated before pasteurization. Such toxins may cause severe illness. Aseptic processing and packaging and retort processed after packaging have also been conclusively demonstrated to be effective in preventing outbreaks from milk borne pathogens.

3. Numerous studies and observations clearly prove that the food value of milk is not significantly impaired by pasteurization.

(c) Administrative Procedures - The pasteurization portion of this item is deemed to be satisfied when:

1. Every particle of milk, milk product, or frozen dessert is heated in properly designed and operated equipment to one of the temperatures specified in the following table and held continuously at or above that temperature for at least the time specified:

*If the fat content of the milk product is 10 percent or greater, or a total solids of 18 percent or greater 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:

2. Provided, nothing shall be construed as barring any other pasteurization process for milk, milk products, and/or frozen dessert products which has been recognized by the FDA as provided in FFD&CA to be equally efficient and which is approved by the State Health Officer.

3. All milk and milk products, (i.e., milk solids, whey, nonfat dry milk, condensed milk, cream, skim milk, etc.), eggs, egg products, cocoa, cocoa products, emulsifiers, stabilizers, vitamins, and liquid sweeteners shall be added prior to pasteurization; provided, ingredients which may be added after pasteurization are those flavoring ingredients and other ingredients which have been found to be safe and suitable and which include:

(i) Ingredients permitted by the CFR standards of identity when considering a standardized milk or milk product.

(ii) Fresh fruits and vegetables added to cultured milk and milk products; provided, the resultant equilibrium pH level (4.6 or below when measured at 24°C (75°F) of the finished product is reached without undue delay and is maintained during the shelf life of the product.

(iii) Ingredients subjected to prior heating or other technology, which has been demonstrated to the FDA to be sufficient to destroy or remove pathogenic microorganisms.

(iv) Ingredients having an Aw of 0.85 or less.

(v) Ingredients having a high acid content (pH level of 4.6 or below when measured at 24°C (75°F) or high alkalinity (pH level greater than 11 when measured at 24°C [75°F]).

(vi) Roasted nuts.

(vii) Dry sugars and salts.

(viii) Flavor extracts having a high alcohol content.

(ix) Safe and suitable bacterial cultures and enzymes.

(x) Ingredients which have been found to be safe and suitable by the FDA.

All such additions shall be made in a sanitary manner which prevents the contamination of the added ingredient or the milk or milk product.

4. All milk and milk products shall be pasteurized, prior to the entrance into RO, UF, evaporator, or condensing equipment, and shall be performed in the milk plant where the processing is done, except that:

(i) If the product is whey, pasteurization is not required, provided:

(I) The product is acid whey (pH less than 4.7); or

(II) It is processed in RO or UF equipment at temperatures at or below 7°(C) (45°F).

(ii) If the product is raw milk for pasteurization, the product may be concentrated by the use of RO or UF membrane filtration without pasteurization prior to the entrance into the equipment; provided, the following sampling, testing, design, installation, and operational criteria are met:

(I) Prior to processing, all raw milk supplies are sampled and tested for antibiotic residues in accordance with the provisions of Appendix N.

(II) The RO or UF filtration system is designed and operated to assure that milk or milk product temperature is maintained at or below 18.3°C (65°F) throughout the process; provided, the product temperature may rise above 18.3°C (65°F) for a period of not more than fifteen (15) minutes, further provided, should the product temperature rise above 21.1°C (70°F), the product shall be either immediately diverted to the system's balance tank until the product is again below 18.3°C (65°F) or diverted to exit the system entirely. Diverted product that has exited the system shall be either discarded, immediately cooled to below 7°C (45°F), or immediately pasteurized.

(III) The RO or UF system shall be equipped with temperature monitoring and recording devices that comply with the applicable specifications outlined in Appendix H. At a minimum, milk or milk product temperature shall be monitored and recorded prior to entering the system, prior to entering each stage of the modules in series that contains cooling, and the retentate stream prior to any final cooler and upon exiting the system.

(IV) If the RO or UF system is not designed, installed, and operated in accordance with the above noted criteria, the raw milk or milk product shall be pasteurized prior to entering the RO or UF system.

5. Milk and/or milk products for pasteurization may be processed by micro-filtration (MF) systems prior to pasteurization for the sole purpose of the removal of micro-organisms; provided,

(i) Prior to processing, all raw milk supplies are sampled and tested for antibiotic residues in accordance with the provisions of Appendix N.

(ii) If there is a continuous, circulating retentate loop with a feed and bleed system, the following design, installation and operational criteria shall be complied with:

(I) The MF system is designed and operated to assure that milk or milk product temperature in the circulating retentate loop is maintained at or below 18.3°C (65°F), or at or above 51.7°C (125°F) throughout the process; provided, the product temperature may rise above 18.3°C (65°F) or fall below 51.7°C (125°F) for a period of not more than fifteen (15) minutes; further provided, should the product temperature rise above 21.1°C (70°F) or fall below 48.9°C (120°F), the product shall be either immediately diverted to the system's balance tank until the product is again below 18.3°C (65°F) or above 51.7°C (125°F), or be diverted to exit the system entirely. Diverted product that has exited the system shall be either discarded, immediately cooled to below 7°C (45°F), or immediately pasteurized.

(II) The MF system shall be equipped with temperature monitoring and recording devices that comply with the applicable specifications outlined in Appendix H. At a minimum, milk or milk product temperature shall be monitored and recorded prior to entering the MF system and within the circulating retentate loop of each module just prior to the circulation pump.

(III) The permeate from the MF system is either immediately cooled to below 7°C (45°F), or immediately pasteurized.

6. All condensed milk and milk products transported to a milk plant for drying shall be repasteurized at the milk plant where it is dried.

7. If condensed whey containing at least 40 percent total solids has been partially crystallized by cooling, it may be transported to a separate milk plant for drying without re-pasteurization; provided, the following conditions are complied with:

(i) The condensed, partially crystallized whey is cooled and maintained at 7°C (45°F) or less.

(ii) Milk tank trucks used to transport the condensed, partially crystallized whey shall be washed and sanitized immediately prior to filling and are sealed after filling until unloading.

(iii) Separate unloading pumps and pipelines shall be provided and used only for the unloading of the condensed, partially crystallized whey. Such pumps and pipelines shall be cleaned and sanitized as a separate cleaning circuit.

8. The design and the operation of pasteurization equipment and all appurtenances thereto shall comply with the applicable specifications and operational procedures of sub-items (I), (II), (III), (IV), and (V) as follows:

(17) Batch Pasteurization

(1) All indicating and recording thermometers used in connection with the batch pasteurization of milk, milk products, or frozen desserts shall comply with the applicable specifications set forth in Appendix H. (Specifications for test thermometers and other test equipment appear in Appendix I).

(2) Public Health Reason

(a) Unless the temperature-control instruments and devices used on pasteurization equipment are accurate within known limits, there can be no assurance that the proper pasteurization temperature is being applied. Pasteurization must be performed in equipment which is properly designed and operated, and which ensures that every particle of milk, milk products, or frozen desserts will be held continuously at the proper temperature for the specified period of time.

(b) Recording thermometers are the only known means for furnishing the Health Officer with a record of the time and temperature of pasteurization. Experience has shown that recording thermometers due to their mechanical complexity are not entirely reliable. Therefore, mercury indicating thermometers or equivalent, which are much more reliable are needed to provide a check on the recording thermometers and assurance that proper temperatures are being applied.

(c) The recording thermometer shows the temperature of the product immediately surrounding its bulb, but cannot indicate the temperature of the product in other portions of the holder. Similarly, it shows the holding time in manual-discharge vats but not in automatic-discharge systems. The pasteurizer must, therefore, be so designed and so operated and, where necessary; provided, with such automatic controls as to assure that every portion of the milk, milk product, or frozen dessert product will be subjected to the proper temperature for the required length of time.

(d) Unless the inlet and outlet valves and connections to vats properly designed and operated, cold pockets of product may be held in the outlet valve or pipe-line; raw product may leak into the vat or pocket during the filling, holding, or emptying time; and raw or incompletely pasteurized product may leak into the outlet line during the filling, heating, or holding period.

(e) Tests have shown that when foam is present on product in vats or pockets during pasteurization, the temperature of the foam may be well below the pasteurization temperature. In such cases, pathogenic organisms that may be in the foam will not be killed. Experience indicates that some foam is present at some time in all vats, particularly at certain seasons. Furthermore, in filling vats, product frequently is splashed on the surfaces and fixtures above the product level as well as on the underside of the vat cover. Droplets of this splash may drop back into the body of the product, and since they may not have been at pasteurization temperature for the required time, they may contain living pathogenic organisms. Heating the air above the product, above pasteurization temperature, remedies these conditions. When air heating is not provided, its need may frequently be demonstrated by swabbing product from the upper vat walls, and from the underside of the cover, at the end of the holding period, and running phosphatase tests on the swab samples.

(f) Many plant operators have reported that the use of airspace heaters, especially with partly filled vats with uninsulated lids, makes it easier to maintain the product at a uniform and sufficiently high temperature. It also helps to prevent the growth of thermophilic organisms and promotes easier cleaning.

(g) Obviously, if the design and construction of pasteurization vat and pocket covers do not prevent leakage, condensation, and the entrance of water and dust, the product may become contaminated with material containing disease bacteria. Keeping the covers closed during operation will decrease the chance of dust, flies, sputum droplets, drip, and splash entering the product.

(3) Administrative Procedures - This item is deemed be satisfied when:

(a) Time and Temperature Controls for Batch Pasteurizers

1. Temperature Difference - The pasteurizer shall be so designed that the simultaneous temperature difference between the milk, milk product, or frozen dessert mix at the center and the coldest milk, milk product, or frozen dessert mix in the vat will not exceed 1°F (0.5°C) at any time during the holding period. The vat shall be provided with adequate agitation, operating throughout the holding period. No batch of milk, milk product, or frozen dessert mix shall be pasteurized unless it covers a sufficient area of the agitator to ensure adequate agitation.

2. Location and Required Readings of Indicating and Recording Thermometers - Each batch pasteurizer shall be equipped with both an indicating and a recording thermometer. The thermometers shall read not less than the required pasteurization temperature throughout the required holding period. The plant operator shall check the temperature shown by the recording thermometer against the temperature shown by the indicating thermometer at the start of the holding period; this comparison shall be noted on the recording thermometer chart. The recording thermometer shall not read higher than the indicating thermometer. No batch of milk, milk products, or frozen dessert mix shall be pasteurized unless it is sufficient to cover the bulbs of both the indicating and the recording thermometers.

3. Assurance of Minimum Holding Periods - Batch pasteurizers shall be so operated that every particle of milk, milk product, or frozen dessert mix will be held at not less than the minimum pasteurization temperature continuously for at least thirty (30) minutes. When milk, milk products, or frozen dessert mix are raised to pasteurization temperature in the vat, and cooling is begun in the vat, simultaneously with or before the opening of the outlet valve, the recorder chart shall show at least thirty (30) minutes at not less than minimum pasteurization temperature. When milk, milk products, or frozen dessert mix are preheated to pasteurization temperature before entering the vat, the recorder chart shall show a holding period of at least thirty (30) minutes at not less than the minimum pasteurization temperature plus the time of filling from the level of the recorder bulb. When cooling is begun in the holder after the opening of the outlet valve, or is done entirely outside the holder, the recording chart shall show at least thirty (30) minutes at not less than the minimum pasteurization temperature plus the time of emptying to the level of the recording thermometer bulb. When the recorder time interval on the recorder chart at the pasteurization temperatures includes filling and/or emptying time, such intervals shall be indicated on the recorder chart by the operator, by removing the recording thermometer bulb from the product for a sufficient time to depress the pen or by turning cold water into the vat jacket at the end of the holding period or by inscribing the holding time on the chart. The filling time and the emptying time for each holder so operated shall be determined by the Health Officer, initially, and after any change which may affect these times. No product shall be added to the holder after the start of the holding period.

(b) Airspace Heating

1. Means shall be provided and used in batch pasteurizers to keep the atmosphere above the milk, milk products, and frozen dessert mix at a temperature not less than 5°F (3°C) higher than the minimum required temperature of pasteurization during the holding period (see Appendix H).

2. Each batch pasteurizer shall be equipped with an airspace thermometer. The surface of the milk, milk product, or frozen dessert mix shall be at least one (1) inch (25 millimeters) below the bottom of the thermometer bulb when the vat is in operation.

3. The temperature shown by the airspace thermometer shall be recorded on the recording thermometer chart each time the pasteurizer is in operation. The chart shall show and shall indicate the start of the holding period and the end of the holding period at a given time or reference point as indicated or the recording chart.

(c) Inlet and Outlet Valves and Connections - The following definitions shall apply to inlet and outlet valves and connections:

1. "Valve stop" shall mean a guide which permits turning the valve plug to, but not beyond, the fully closed position.

2. "90 stop" shall mean a stop so designed as to prevent turning the plug more than 90°.

3. "120 stop" shall mean a stop which prevents turning the plug more than 120°.

4. "180 stop" shall mean a stop which prevents turning the plug more than 180°, but which permits two fully closed positions, each diametrically opposite the other.

5. "Valve with an irreversible plug" shall mean one in which the plug cannot be reversed in the shell.

6. "Single-quadrant stop" shall mean a 90° stop in a valve with an irreversible plug.

7. "The fully open position" shall mean that position of the valve seat which permits the maximum flow into or out of the pasteurizer.

8. "The closed position" shall mean any position of the valve seat which stops the flow of milk, milk product, or frozen dessert mix into or out of the pasteurizer.

9. "The fully closed position" shall mean that closed position of the valve seat which requires the maximum movement of the valve to reach the fully open position.

10. "The just closed position" shall mean that closed position of a plug-type valve in which the flow into or out of the holder is barely stopped or any closed position within 0.078 inch thereof as measured along the maximum circumference of the valve seat.

11. "Leakage" shall mean the entrance of unpasteurized milk, milk product, or frozen dessert mix into a batch pasteurizer during the holding or emptying period or the entrance of unpasteurized product into any pasteurized product line at any time.

12. "Leak-protector valve" shall mean a valve provided with a leak-diverting device, which, when the valve is in any closed position, will prevent leakage of product past the valve or in the case of batch pasteurizers filled or emptied by suction or compressed air, will prevent leakage of product past the valve or the leakage of product due to the leakage of air past the suction valve or the compressed air valve, as the case may be.

13. "Closed-coupled valve" shall mean a valve, the seat of which is either flush with the inner wall of the pasteurizer or so closely coupled that no product in the valve inlet is more than 1°F (0.5°C) colder than the product at the center of the pasteurizer at any time during the holding period. A closed-coupled valve which is not truly flushed shall be considered as satisfying this requirement when:

(i) The vat outlet is so flared that the smallest diameter of the large end of the flare is not less than the diameter of the outlet line, plus the depth of the flare.

(ii) The greatest distance from the valve seat to the small end of the flare is not greater than the diameter of the outlet line.

(iii) In the case of batch pasteurizers, the outlet and the agitator are so placed as to ensure that product currents will be swept into the outlet.

(d) Design and Installation of Valves and Connections - All valves and connections shall comply with the following requirements:

1. Valves and pipeline connections shall meet the requirements of Rule 420-3-16-.10(10).

2. All pipelines and fittings shall be so constructed and so located that leakage will not occur. Dependence shall not be placed on soldered joints to prevent leakage.

3. To prevent clogging and to promote drainage, all leak-protection grooves shall be at least 0.187 inch (5 millimeters) wide and at least 0.094 inch (2.3 millimeters) deep at the center. Mating grooves shall provide these dimensions throughout their combined length whenever the valve is in, or approximately in, the fully closed position. All single-leak grooves and all mating leak grooves when mated, shall extend throughout the entire depth of the seat so as to divert leakage occurring at all points throughout the depth of the seat and so as to prevent air bindings. Washers or other parts shall not obstruct leak-protector grooves.

4. A stop shall be provided on all plug-type outlet valves and on all plug-type inlet valves in order to guide the operator in closing the valve so that unpasteurized product may not inadvertently be permitted to enter the outlet line or the holder, respectively. The stop shall be so designed that the plug will be irreversible when the plug is provided with any grooves or their equivalent unless duplicate, diametrically opposite grooves are also provided. In the case of two-way, plug-type valves (i.e., those having only one inlet and one outlet), a 180° stop or any combination of stops permitting two fully closed positions, may be substituted for a 90° stop; provided, there are no air-relief grooves in the plug and that all leak grooves are located symmetrically with respect to the valve inlet. Stops shall be so designed that the operator cannot turn the valve beyond the stop position either by raising the plug or by any other means.

5. Outlet valves, in addition to the requirements listed above, shall be so designed as to prevent the accumulation of unpasteurized product in the product passages of the valve when the valve is in any closed position.

6. All outlets from vat pasteurizers shall be equipped with close-coupled leak-protector valves or be otherwise similarly protected during filling, holding, and emptying periods.

7. All leak-protector grooved outlet valves shall be installed in the proper position to ensure the function of the leak-protector groves and the drainage of the leak-detector valve.

8. All outlet valves shall be kept fully closed during filling, heating, and holding periods.

9. Close-coupled vat pasteurizer outlet valve bodies and plugs shall be made of stainless steel or of other materials that have heat transfer properties at least equal to stainless steel.

10. All inlet pipelines are disconnected during the holding and emptying periods, and all outlet pipelines are disconnected during the filling and holding periods.

11. Recording Charts - All recording thermometer charts shall comply with all the applicable requirements of Rule 420-3-16-.10(21)(a).

(18) High Temperature, Short-Time (HTST) Continuous-Flow Pasteurization

(a) Public Health Reason - See Public Health Reason under Rule 420-3-16-.10(16) and 420-3-16-.10(17).

(b) Administrative Procedures - This item deemed to be satisfied when:

1. Indicating Thermometers and Recorder/Controller Instruments - All indicating thermometers and recorder/controller instruments and devices used in connection with the high-temperature, short-time continuous-flow pasteurization of milk, milk products, or frozen dessert mix shall comply with the applicable specifications, set forth in Appendix H.

(c) Automatic Milk Controller - Each high-temperature, short-time continuous-flow (HTST) pasteurization system shall be equipped with an automatic milk-flow control of the diversion type which complies with the following definition, specifications, and performance requirements:

(d) Automatic Milk or Milk Product-Flow Controls - The term "automatic milk or milk product flow control" shall mean those safety devices which control the flow of product in relation to the temperature of the product or heating medium and/or pressure, vacuum, or other auxiliary equipment. Milk-flow controls shall not be considered as part of the temperature control equipment. Milk-flow controls shall be of the flow-diversion type, which automatically cause the diversion of the product in response to a sublegal pasteurization temperature. At sublegal temperatures, flow-diversion devices return the product to the raw product side of the heating systems continuously until legal pasteurization temperatures are obtained; at which time, the device restores forward flow through the pasteurizer.

(e) Flow-Diversion Devices (FDDs) - All FDDs used in continuous pasteurizers shall comply with the following or equally satisfactory specifications:

1. Forward flow of subtemperature product due to the omission or looseness of the connecting clip, shall be prevented by making the valve and its actuating mechanism integral; or where there is a connecting device, by making it impossible to assemble the valve and its actuating mechanism, except in such manner that it will function properly; or where there is a connecting device which may be omitted or shaken loose by providing for pushing instead of pulling, the valve to the diverted position; or by providing that the pump will shut down when the product is below the pasteurization temperature and the valve is not in the fully-diverted position; or by any other equally satisfactory means. For the detection of the FDD and valve seat positions, refer to Appendix H, I, position detection devices of this rule.

2. When a packing gland is used to prevent leakage around the actuating stem, it shall be impossible to tighten the stem packing nut to such an extent as to prevent the valve from assuming the fully-diverted position.

3. A leak escape shall be installed on the forward-flow side of the valve seat. However, when back pressure is exerted on the forward-flow side of the valve seat, while the product flow is being diverted, the leak-escape should lie between two valve seats or between two portions of the same seat, one upstream and one downstream from the leak-escape. The leak-escape shall be designed and installed to discharge all leakage to the outside or to the constant-level tank through a line separate from the diversion line; provided, when leakage is discharged to the constant-level tank, a sight glass shall be installed in the leak-escape line to provide a visual means of leak detection.

4. The closure of the forward-flow seat shall be sufficiently tight so that leakage past it will not exceed the capacity of the leak escape-device, as evidenced when the forward-flow line is disconnected; and, in order that proper seating may not be disturbed, the length of the connecting rod shall not be adjustable by the user.

5. The FDD shall be so designed and installed that failure of the primary motivating power shall automatically divert the flow of product.

6. The FDD shall be located downstream from the holder. The flow-control sensor shall be located in the product line not more than eighteen (18) inches = forty-six (46) centimeters upstream from the flow-control device.

7. In the case of higher-heat, shorter-time (HHST) pasteurizing systems utilizing the temperatures of 191°F (89°C) and above and holding times of one second and less, the FDD may be located downstream from the regenerator and/or cooler section; provided, when the FDD is located downstream from the regenerator and/or cooler section, the FDD shall be automatically prevented from assuming the forward-flow position until all product-contact surfaces between the holding tube and FDD have been held at or above the required pasteurization temperature continuously and simultaneously for at least the required pasteurization time as defined in Rule 420-3-16-.02(68).

8. The pipeline from the diversion port of the FDD shall be self-draining, and shall be free of restrictions or valves, unless such restrictions are noticeable and valves are so designed that stoppage of the diversion line cannot occur. In the case of continuous flow pasteurization systems, which have the FDD located downstream from the regenerator and/or cooler and are inter-wired or are computer controlled to thoroughly clean the system, including the divert pipeline before the re-starting of production, a cooling section, which is not self-draining, may be present in the divert pipeline.

9. When it is used, the pipeline from the leak detector port of the FDD shall be self-draining and shall be free of restrictions or valves.

10. For the timing pump, a one (1) second maximum “off” time delay is allowed to maintain the flow-promoting device in the “on” position through the travel time of the FDD.

11. If the area between the divert and leak-detect valve seats is not self-draining when the FDD is in the diverted position, a delay of at least one (1) second and not more than five (5) seconds is required between the movement of the divert and leak-detect valves when the FDD assumes the forward-flow position. Except that, the delay may be longer than five (5) seconds if: the timing system is a magnetic flow meter based timing system; or if the holding time in diverted-flow through an unrestricted divert valve line is longer than the required pasteurization time as specified in the definition of Pasteurization of this rule; and except that, no time delay is required in pasteurization systems in which the FDD is located downstream from the pasteurized regenerator and in which all forward-flow product-contact surfaces of the FDD are sanitized, or sterilized during the normal start-up process.

12. In the case of HHST pasteurizing systems utilizing temperatures and holding times to meet the definition of ultra-pasteurization (UP) of this rule, the FDD may be located downstream of the regenerator and/or cooler section. Said FDD may alternatively be a system of the “Steam-Block Type” as described in Appendix H. This FDD system shall allow for the flow of water and/or milk, milk product, or frozen dessert to the constant-level tank through appropriate valves and coolers during sterilization and when diverted.

(f) Milk-Flow Controller Instrumentation - The following requirements shall be met with respect to the instrumentation of the milk-flow controller:

1. The thermal-limit controller shall be set and sealed so that forward-flow of product cannot start unless the temperature at the controller sensor is above the required pasteurization temperature as defined in Rule 420-3-16-.02(68) for the milk, milk product, and frozen dessert, and the process used nor continue during descending temperatures when the temperature is below the required pasteurization temperature. The seal shall be applied by the Health Officer after testing, and shall not be removed without immediately notifying the Health Officer. The system shall be so designed that no product can be by-passed around the controller sensor which shall not be removed from its proper position during the pasteurization process. The cut-in and cut-out milk temperatures, as shown by the indicating thermometer, shall be determined at the beginning of each day’s operation and entered upon the recorder chart daily by the plant operator.

2. In the case of HHST pasteurization systems utilizing the temperatures of 191°F (89°C) and above, and holding times of one (1) second or less, with the FFD located downstream from the regenerator and/or cooler section, additional temperature controllers and timers shall be interwired with the thermal-limit-controller; and the control system shall be set and sealed so that forward-flow of product cannot start until all product-contact surfaces between the holding tube and FFD have been held at or above the required pasteurization temperature, continuously and simultaneously for at least the required pasteurization time as defined in Rule 420-3-16-.02(68). The control system shall also be set and sealed so that forward-flow cannot continue when the temperature of the product in the holding tube is below the required pasteurization temperature.

3. Provided, for systems used for the processing of milk, milk products and frozen desserts labeled as ultra-pasteurized (UP), it is not necessary to set and seal the thermal-limit-controller at or above 138°C (280°F). Also, provided, these systems shall meet all the public health control requirements for HHST systems, and that the recorder-controller chart shows that the UP milk, milk product, and frozen dessert has been processed at a minimum temperature of 138°C (280°F), and has been verified by the Health Officer to have a calculated holding time of at least two (2) seconds. The seal, if required, shall be applied by the Health Officer after the equipment has been tested, and shall not be removed without immediately notifying the Health Officer. The seal shall be applied by the Health Officer after test and shall not be removed without immediately notifying the Health Officer. The system shall be so designed that no product can be bypassed around the control sensors, which shall not be removed from their proper position during the pasteurization process. For these HHST systems, daily measurement by the operator of the cut-in and cut-out temperatures is not required.

4. Manual switches for the control of pumps, homogenizers, or other devices which produce flow through the holder shall be wired so that the circuit is completed only when the product is above the required pasteurization temperature as defined in Rule 420-3-16-.02(68) for the milk product and the process used, or when the diversion device is in the fully-diverted position.

(g) Holding Tube

1. Holding tubes shall be designed to provide for the holding of every particle of milk or milk product for at least the time required in Rule 420-3-16-.02(68) for the milk or milk product and the process used.

2. The holding tube shall be so designed that the simultaneous temperature difference between the hottest and coldest product in any cross section of flow at any time during the holding period will not be greater than 1°F (0.5°C). This requirement may be assumed to have been satisfied without testing in tubular holders of seven (7) inches (17.8 centimeters) or smaller diameter which are free of any fitting through which the product may not be thoroughly swept.

3. No device shall be permitted for short circuiting a portion of the holder to compensate for changes in rate of product flow. Holding tubes shall be installed so that sections of pipe cannot be left out, resulting in a shortened holding time.

4. The holding tube shall be arranged to have a continuously upward slope in the direction of flow of not less than 0.25 inch (2.1 centimeters) per foot.

5. Supports for holding tubes shall be provided to maintain all parts of holding tubes in a fixed position, free from any lateral or vertical movement.

6. The holding tube shall be so designed that no portion between the inlet and the flow-control temperature sensor is heated.

(h) The following items apply to HHST systems:

1. The holding time for the HHST processes must be determined from the pumping rate rather than by the salt conductivity test because of the short holding tube. The holding tube length must be such that the fastest flowing particle of any product will not traverse the holding tube in less than the required holding time. Since laminar flow (the fastest flowing particle travels twice as fast as the average flowing particle) can occur in the holding tube during pasteurization of high-viscosity products, holding tube lengths are calculated as twice the length required to hold the average flow for the time standard.

2. With the direct steam heating processes, the holding time is reduced because the product volume increases as the steam condenses to water during heating in the injector. This surplus water is evaporated as the pasteurized product is cooled in the vacuum chamber. For example, with a 120°F (66°C) increase by steam injection which is probably the maximum temperature rise that will be used, a volume increase of 12 percent will occur in the holding tube. The measurement of the average flow rate at the discharge of the pasteurizer does not reflect this volume increase in the holding tube. However, this volume increase (i.e., holding time decrease) must be considered in the calculations.

3. For those HHST systems capable of operating with less than 518 kPa (75 psig) pressure in the holding tube, a pressure limit indicator/pressure switch shall be interwired so that the FDD will move to the divert position if the milk, milk product, and frozen dessert pressure falls below a prescribed value. For operating temperatures between 89°C (191°F) and 100°C (212°F) the instrument shall be set at 69 kPa (10 psi). To prevent vaporization in the holding tube, which may substantially reduce residence times, HHST systems operating above 100°C (212°F), the instrument shall be set at 69 kPa (10 psi) above the boiling pressure of the product, at its maximum temperature in the holding tube.

4. With the steam injection process, a differential pressure limit indicator across the injector is needed to keep the heated milk or milk product in the liquid phase and to ensure adequate isolation of the injection chamber. The instrument shall have a differential pressure switch so that the FDD will move to the divert position, if the pressure drop across the injector falls below 69 kPa (10 psi).

(i) Indicating and Recording Thermometers

1. An indicating thermometer shall be located as near as practicable to the temperature sensor of the recorder/controller, but may be located a short distance upstream from the latter where product between the two thermometers does not differ significantly in temperature.

2. The temperature shown by the recorder/controller shall be checked daily by the plant operator against the temperature shown by the indicating thermometer. Readings shall be recorded on the chart. The recorder/controller shall be adjusted to read no higher than the indicating thermometer.

3. The recorder/controller charts shall comply with the applicable provisions of Rule 420-3-16-.10(21)(a).

(j) Flow-Promoting Devices

1. The pump or pumps and other equipment which may produce flow through the holder shall be located upstream from the holder; provided, that pumps and other flow-promoting devices shall be located downstream from the holder if means are provided to eliminate negative pressure between the holder and the inlet to such equipment. When vacuum equipment is located downstream from the holder, an effective vacuum breaker, plus an automatic means of preventing a negative pressure in the line between the FDD and the vacuum chamber shall be acceptable.

2. The speed of pumps or other flow-promoting devices governing the rate of flow through the holder shall be so controlled as to ensure the holding of every particle of product for at least the time required as defined in Rule 420-3-16-.02(68) for the milk or milk product and the process used. In all cases, the motor shall be connected to the metering pump by means of gears, pulleys, or a variable-speed drive, with the gear box, the pully box, or the setting of the variable speed protected in such a manner that the holding time cannot be shortened without detection by the Health Officer. This shall be accomplished by the application of suitable seal(s) after tests by the Health Officer and such seal shall not be broken without immediately notifying the Health Officer. The provision shall apply to all homogenizers used as timing pumps. Variable speed drives used in connection with the metering pump shall be so constructed that wearing or stretching of the belt results in a slow-down, rather than a speed-up, of the pump. The metering or timing pump shall be of the positive displacement type or shall comply with the specifications for magnetic flow meter systems as outlined in Appendix H. Timing pumps and homogenizers, when used as a timing pump, shall not have by-pass lines connected from their outlet pipelines to their inlet pipelines during processing if an additional flow-promoting or vacuum producing device is located within the system. When a homogenizer is used in conjunction with a timing pump, it shall be either:

(i) Of larger capacity than the timing pump. In which case an unrestricted, open, recirculation line shall be used to connect the outlet pipeline from the homogenizer to its inlet line. The recirculation line must be of at least the same or larger diameter than the inlet pipeline feeding product to the homogenizer. A check valve, allowing flow from the outlet line to the inlet line, may be used in the re-circulating line provided it is of the type which provides a cross-sectional area at least as large as the recirculating line.

(ii) Of smaller capacity than the timing pump. In which case a relief line and valve shall be used. Such relief line shall be located after the timing pump and before the inlet to the homogenizer and shall return product to the balance tank or to the outlet of the balance tank upstream of any booster pump or other flow-promoting device.

5. For those systems which do not homogenize all products and wish to utilize a by-pass line to by-pass the homogenizer while processing such product, the by-pass line must be connected with valves which are so designed that both lines cannot be open at the same time. This may be accomplished with three (3)- way plug valves with properly designed and operating pins or other automatic, fail-safe valves which accomplish the same objective.

6. The holding time shall be taken to mean the flow time of the fastest particle of milk, at or above the required pasteurization temperature as defined in Rule 420-3-16-.02(68), for the milk or milk product and the process used, throughout the holder section (i.e., that portion of the system that is outside of the influence of the heating medium, slopes continuously upward in the downstream direction, and is located upstream from the FDD). Tests for holding time shall be made when all equipment and devices are operated and adjusted to provide for maximum flow. When a homogenizer is located upstream from the holder, the holding time shall be determined with the homogenizer in operation with no pressure on the homogenizer valves. For those systems which do not homogenize all products and utilize by-pass lines as outlined in (i) above, the holding time shall be tested in both flow patterns and the fastest time used. The holding time shall be tested during both forward and diverted flow. If it is necessary to lengthen the holding time during diverted flow, an identifiable restriction may be placed in the vertical portion of the diversion pipeline. When vacuum equipment is located downstream from the holder, the holding time shall be tested with the metering pump operating at maximum flow, and the vacuum equipment adjusted to provide for the maximum vacuum. The holding time shall be tested in both forward and diverted flow by the Health Officer initially; semi-annually thereafter; after any alteration or replacement that may affect the holding time; and whenever the seal of the speed setting has been broken.

(k) Heating by Direct Addition of Steam - Steam injection is an inherently unstable process; accordingly, when steam in injected into a fluid, condensation of the steam may not be completed inside the injector unless the proper design criteria are used. Lack of complete condensation inside the injector would cause temperature variations in the holding tube that could lead to some product particles being processed below pasteurization temperature. When culinary steam is introduced directly into milk or milk products, as the means of terminal heating to achieve pasteurization temperature, the steam injector shall be designed, installed, and operated to comply with the following or equally satisfactory specifications:

1. The product and steam flows must be isolated from pressure fluctuations inside the injection chamber. One method of isolation is to insert supplementary orifices on the product inlet and the heated product outlet of each injector. The two (2) supplementary orifices must be sized for at least a 10 psi (69kPa) product pressure drop across the injector during a simulation of normal operations. Excessive vibrations, pressure fluctuations, or erratic noise levels indicate an unstable steam injection system and a need to check the isolation of the injection chamber.

2. The product pressure in the holding tube must be of sufficient magnitude to condense the steam and keep the heated product in the liquid phase. If this pressure is too low, the resultant vaporization in the holding tube will substantially reduce residence times. A minimum product pressure in the holding tube of 10 psi (.69 kPa) for operating temperatures from 191°F (89°C) through 212°F (100°C) is satisfactory. For units which have operating temperatures above 212°F (100°C) the pressure of the product in the holding tube must be at least 10 psi (.703 KPI) above the boiling pressure of the product at its maximum temperature in the holding tube.

3. The process should be as free as possible of non-condensable gases that may evolve from the product or be carried in the steam supply. Any two-phase flow caused by the non-condensable gases would displace the product in the holding tube, resulting in reduced residence times. In addition, these gases in the steam supply may also markedly alter the condensation mechanism at the point of injection. Accordingly, the steam boiler shall be supplied with a deaerator. The deaerator will aid in keeping the product in the holding tube as free as possible of non-condensable gases.

(l) Prevention of Product Adulteration with Added Water

1. When culinary steam is introduced directly into the milk or milk product, downstream from the FDD, means shall be provided to preclude the addition of steam to the milk or milk product, unless the FDD is in the forward-flow position. This provision may be satisfied by the use of an automatic steam control valve with a temperature sensor located downstream from the steam inlet, or by the use of an automatic solenoid valve installed in the steam line and so wired through the FDD controls, so that steam cannot flow unless the FDD is in the forward-flow position.

2. When culinary steam is introduced directly into the milk or milk product, automatic means (i.e., stand-alone and/or programmable logic controller [PLC]-based ratio control system) shall be provided to maintain a proper temperature differential between incoming and outgoing milk or milk product to preclude dilution with water.

3. Where a water feed line is connected to a vacuum condenser and the vacuum condenser is not separated from the vacuum chamber by a physical barrier, means shall be provided to preclude the backup and overflow of water from the vacuum condenser to the vacuum chamber. This provision may be satisfied by the use of a safety shut-off valve, located on the water feed line to the vacuum condenser, automatically actuated by a control which will shut off the in-flowing water if, for example, the condensate pump stops and the water level rises above a predetermined point in the vacuum condenser. This valve may be actuated by water, air, or electricity, and shall be so designed that failure of the primary motivating power will automatically stop the flow of water into the vacuum condenser.

(m) Aseptic Processing Systems

1. Public Health Reason - Aseptically processed milk and milk products are being packaged in hermetically sealed containers and stored for long periods of time under non-refrigerated conditions. These conditions are favorable to the growth of many types of bacteria (pathogenic, toxin producing, and spoilage types). Because of this, every precaution must be taken to ensure that all viable organisms and their spores are destroyed by the chosen heat process for the particular milk or milk product and that the subsequent handling, packaging, and storage processes do not provide an opportunity for recontamination of the product. The selected process must conform to the acceptable requirements for low acid canned foods.

2. Administrative Procedures - The aseptic processing portion of this item is deemed to be satisfied when the design and operation of aseptic processing systems comply with the applicable specifications and operational procedures of sub-items C, D, and E as follows; provided, nothing shall be construed as barring any other aseptic processing system which have been recognized by the FDA to be equally effective and which is approved by the Health Officer.

(n) Indicating Thermometers and Recorder/Controller Instruments: All indicating thermometers, recorder/controller instrument devices used in connection with aseptic processing systems used for the aseptic processing of milk or milk products shall comply with the applicable specifications set forth in Appendix H.

(o) Aseptic Processing Equipment

1. Temperature Indicating Device - Each aseptic processing system shall be equipped with at least one mercury-in-glass thermometer or an equivalent temperature-indicating device.

2. Temperature Recorded/Controller - An accurate temperature recorded/controller shall be installed in the product at the holding-tube outlet and before the inlet to the cooler or regenerator. The following requirements shall be met with respect to the instrumentation of the temperature recorded/controller:

(i) The temperature recorded/controller shall be set and sealed so that during product processing the forward flow of product cannot start unless the temperature at the controller sensor is above the required temperature for the product and the process used, nor continue during descending temperatures when the temperature is below the required temperature. The seal shall be applied by the Health Officer after testing, and shall not be removed without immediately notifying the Health Officer. The system shall be so designed that no product can be bypassed around the controller sensor which shall not be removed from its proper position during the processing of aseptic milk and milk products.

(ii) Additional temperature controllers and timers shall be interwired with the thermal limit controller, and the control system shall be set and sealed so that forward flow of product cannot start until all product-contact surfaces between the holding tube and flow-diversion device have been held at or above the required sterilization temperature, continuously and simultaneously for at least the required sterilization time. The control system shall also be set and sealed so that forward flow cannot continue when the temperature of the product in the holding tube is below the required temperature. The seal shall be applied by the Health Officer after test, and shall not be removed without immediately notifying the Health Officer. The system shall be so designed that no product can be bypassed around the control sensors, which shall not be removed from their proper position during the processing of aseptic milk and milk products.

(iii) Manual switches for the control of pumps, homogenizers, or other devices which produce flow through the holder, shall be wired so that the circuit is completed only when the milk is above the required temperature for the product and the process used, or when the diversion device is in the fully-diverted position.

(p) Metering Pump

1. A metering pump shall be located upstream from holding tube and shall be operated to maintain the required metering pump by means of a common drive shaft or by means of gears, pulleys, or a variable-speed drive with the gear box, the pulley box, or the setting of the variable speed protected in such a manner that the hold time cannot be shortened without detection by the Health Officer. This shall be accomplished by the application of a suitable seal(s) after tests by the Health Officer and such seal shall not be broken without immediately notifying the Health Officer. The provision shall apply to all homogenizers used as timing pumps. Variable speed drives used in connection with the metering pump shall be so constructed that wearing or stretching of the belt results in a slowdown, rather than a speedup of the pump. The metering or timing pump shall be of the positive displacement type or shall comply with the specifications for magnetic flow meter systems.

2. The holding time shall be taken to mean the flow time of the fastest particle of product throughout the holder section (i.e., that portion of the system that is outside of the influence of the heating medium, slopes continuously upward in the down-stream direction, and is located upstream from the FDD). Tests for holding time shall be made when all equipment and devices are operated and adjusted to provide for maximum flow. When a homogenizer is located upstream from the holder, the holding time shall be determined with the homogenizer in operation with no pressure on the homogenizer valves. For those systems which do not homogenize all milk or milk products and utilize by-pass lines as outlined in (j)2(i) above, the holding time shall be tested in both flow patterns and the fastest time used. The holding time shall be tested during both forward and diverted-flow. If it is necessary to lengthen the holding time during diverted-flow, an identifiable restriction may be placed in the vertical portion of the diversion pipeline. When vacuum equipment is located downstream from the holding tube, the holding time shall be tested with the timing pump operating at maximum flow and the vacuum equipment adjusted to provide for the maximum vacuum. The holding time shall be tested by the Health Officer initially, semi-annually thereafter, after any alteration or replacement that may affect the holding time, and whenever the seal of the speed setting has been broken.

(q) Product Holding Tube

1. The product holding tube shall be designed to give continuous holding of every particle of product for at least the minimum holding time specified in the scheduled process. The holding tube shall be designed so that no portion of the tube between the product inlet and the product outlet can be heated, and it must be sloped upward at least 0.25 (2.1 cm/m) inch per foot. Supports for tubes shall be provided to maintain all parts of holding tubes in a fixed position, free from any lateral or vertical movement.

2. No device shall be permitted for short circuiting a portion of the holder to compensate for changes in rate of production flow. Holding tubes shall be installed so that sections of pipe cannot be left out, resulting in a shortened holding time. The holding time for the processes must be determined from the pumping rate rather than by the salt conductivity test.

3. The holding tube length must be such that the fastest flowing particle of any product will not traverse the holding tube in less than the required holding time.

Note: Since laminar flow (the fastest flowing particle travels twice as fast as the average flowing particle) can occur in the holding tube during aseptic processing of high-viscosity products, holding tube lengths are calculated as twice the length required to hold the average flow for the time standard. With the steam injection process, the holding time is reduced because the product volume increases as the steam condenses to water during heating in the injector. This surplus water is evaporated as the aseptically processed product is cooled in the vacuum chamber. For example, with a 120°F (66°C) increase by steam injection, which is probably the maximum temperature rise that will be used, a volume increase of 12 percent will occur in the holding tube. The measurement of the average flow rate at the discharge of the aseptic processor does not reflect this volume increase in the holding tube. However, this volume increase (i.e., holding time decrease) must be considered in the calculations.

4. With the steam injection process, a pressure limit indicator is needed in the holding tube to keep the heated product in the liquid phase. The instrument must have a pressure switch so that the FDD will move to the divert position if the product pressure falls below a prescribed value. The pressure switch must be set at a pressure 10 psi (.703 kPa) above the boiling pressure of the product at its maximum temperature in the holding tube.

5. With the steam injection process, a differential pressure limit indicator across the injector is needed to ensure adequate isolation of the injection chamber. The instrument must have a differential pressure switch so that the FDD will move to the divert position if the pressure drop across the injector falls below 10 psi (.703 kPa).

6. Heating by Direct Addition of Steam - Injection is an inherently unstable process; accordingly, when steam is injected into a fluid, condensation of the steam may not be completed inside the injector unless the proper design criteria are used. Lack of complete condensation inside the injector would cause temperature variations in the holding tube that could lead to some product particles being processed below filed process temperature. When culinary steam is introduced directly into milk or milk products as the means of terminal heating to achieve aseptic processing temperature, the steam injector shall be designed, installed, and operated to comply with the following or equally satisfactory specifications.

7. The product and steam flows must be isolated from pressure fluctuations inside the injection chamber. One method of isolation is to insert supplementary orifices on the product inlet and the heated product outlet of each injector. The two supplementary orifices must be sized for at least a 10 psi (.703 kPa) product pressure drop across the injector during a simulation of normal operations. Excessive vibrations, pressure fluctuations, or erratic noise levels indicate an unstable steam injection system and a need to check the isolation of the injection chamber.

8. The product pressure in the holding tube must be of sufficient magnitude to condense the steam and keep the heated product in the liquid phase. If this pressure is too low, the resultant vaporization in the holding tube will substantially reduce residence times. For units which have operating temperatures above 212°F (100°C), the pressure of the product in the holding tube must be at least 10 psi (.703 kPa) above the boiling pressure of the product at its maximum temperature in the holding tube.

9. The process should be as free as possible of non-condensable gases that may evolve from the product or be carried in the steam supply. Any two-phase flow caused by the non-condensable gases would displace the product in the holding tube, resulting in reduced residence times. In addition, these gases in the steam supply may also markedly alter the condensation mechanism at the point of injection. Accordingly, the steam boiler shall be supplied with a deaerator. The deaerator will aid in keeping the product in the holding tube as free as possible on non-condensable gases.

(r) Prevention of Product Adulteration with Added Water

1. When culinary steam is introduced directly into the milk or milk product downstream from the FDD, means shall be provided to preclude the addition of steam to the milk or milk product unless the FDD is in the forward-flow position. This provision may be satisfied by the use of an automatic steam control valve with a temperature sensor located downstream from the steam inlet, or by the use of an automatic solenoid valve installed in the steam line and so wired through.

2. Where a water feed line is connected to a vacuum condenser and the vacuum condenser is not separated from the vacuum chamber by a physical barrier, means shall be provided to preclude the back-up and overflow of water from the vacuum condenser to the vacuum chamber. This provision may be satisfied by the use of a safety shutoff valve located on the water feed line to the vacuum condenser, automatically actuated by a control which will shut off the inflowing water, if, for example, the condensate pump stops and the water level rises above a predetermined point in the vacuum condenser. This valve may be actuated by water, air, or electricity, and shall be so designed that failure of the primary motivating power will automatically stop the flow of water into the vacuum condenser.

(s) FDD - All FDDs used in continuous aseptic process systems shall comply with the following or equally satisfactory specifications:

1. Forward flow of sub-temperature product due to the omission of looseness of the connecting clip shall be prevented by making the valve and its actuating mechanism integral; or, where there is a connecting device, by making it impossible to assemble the valve and its actuating mechanism, except in such manner that it will function properly; or, where there is a connecting device which may be omitted or shaken loose by providing for pushing, instead of pulling, the valve to the diverted position; or by providing that the pump will shut down when the product is below the aseptic processing temperature and the valve is not in the fully-diverted position; or by any other equally satisfactory means.

2. When a packing gland is used to prevent leakage around the actuating stem, it shall be impossible to tighten the stem packing nut to such an extent as to prevent the valve from assuming the fully-diverted position.

3. A leak escape shall be installed on the forward-flow side of the valve seat. However, when back pressure is exerted on the forward-flow side of the valve seat, while the product flow is being diverted, the leak escape should lie between two portions of the same seat, one upstream and the other downstream from the leak escape. The leak escape shall be designed and installed to discharge all leakage to the outside, or to the constant-level tank through a line separate from the diversion line; provided, when leakage is discharged to the constant-level tank, a sight glass shall be installed in the leak escape line to provide a visual means of leak detection.

4. The closure of the forward-flow seat shall be sufficiently tight so that leakage past it will not exceed the capacity of the leak escape device, as evidenced when the forward-flow line is disconnected; and, in order that proper seating may not be disturbed, the length of the connecting rod shall not be adjustable by the user.

5. The FDD shall be so designed and installed that failure of the primary motivating power shall automatically divert the flow of milk.

6. The FDD shall be located down-stream from the regenerator and/or cooler section. The FDD shall be automatically prevented from assuming the forward-flow position until all product-contact surfaces between the holding tube and FDD have been held at or above the required sterilization temperature continuously and simultaneously for at least the required sterilization time.

7. The pipeline from the diversion port of the FDD shall be self-draining, and shall be free of restrictions or valves, unless such restrictions or valves are so designed that stoppage of the diversion line cannot occur.

8. When it is used, the pipeline from the leak detector port of the FDD shall be self-draining, and shall be free of restrictions or valves.

(t) Pasteurizers and Aseptically Processing Systems Employing Regenerative Heating

1. Public Health Reason - To prevent contamination of the pasteurized product in regenerators, the raw product must always be under less pressure than the pasteurized product or the heat-transfer medium. In the case of milk-to-milk regenerators or milk regenerators, this requirement is necessary to prevent contamination of the pasteurized product by the raw product if flaws should develop in the metal or in the joints separating the two kinds of product.

2. Administrative Procedure - This item is deemed to be satisfied when:

(19) Milk-To-Milk Product-To-Milk or Milk Product Regenerative Heating

(1) Pasteurizers employing milk-to-milk regenerative heating with both sides closed to the atmosphere shall comply with the following or equally satisfactory specifications:

(a) Regenerators shall be constructed, installed, and operated so that pasteurized or aseptic product in the regenerator will automatically be under greater pressure than raw product in the regenerator at all times.

(b) The pasteurized product, between its outlet from the regenerator and the nearest point downstream open to the atmosphere, shall rise to a vertical elevation of 12 (30.5cm) inches above the highest raw product level downstream from the constant-level tank and shall be open to the atmosphere at this or a higher elevation.

(c) The overflow of the top rim of the constant-level raw product tank shall always be lower than the lowest product level in the regenerator.

(d) No pump or flow-promoting device which can affect the proper pressure relationships within the regenerator shall be located between the pasteurized or aseptic product outlet from the regenerator and the nearest downstream point open to the atmosphere.

(e) No pump shall be located between the raw product inlet to the regenerator and the constant-level tank, unless it is designed and installed to operate only when product is flowing through the pasteurized product side of the regenerator, and when the pressure of the pasteurized milk product is higher than the maximum pressure produced by the pump. This may be accomplished by wiring the booster pump so that it cannot operate unless:

1. The metering pump is in operation.

2. The FDD is in forward-flow position.

3. The pasteurized product pressure exceeds, by at least 6.9 kPa (1 psi) the maximum pressure developed by the booster pump. Pressure gauges shall be installed at the raw product inlet to the regenerator and the pasteurized product outlet of the regenerator or the outlet of the cooler. The accuracy of required pressure gauges shall be checked by the Health Officer on installation, quarterly thereafter, and following repair or adjustment.

(i) The motor, casing, and impeller of the booster pump shall be identified, and such records thereof maintained as directed by the Health Officer. All electric wiring interconnections should be in permanent conduit (except that rubber covered cable may be used for final connections) with no electrical connections to defeat the purpose of any provisions of these rules.

(ii) All raw products in the regenerators will automatically drain freely back into the constant-level raw product tank or to the floor when the raw product pump(s) are shut down and the raw product outlet from the regenerator is disconnected.

(iii) When vacuum equipment is located downstream from the FDD, means shall be provided to prevent the lowering of the pasteurized or milk product level in the regenerator during periods of diverted-flow or shutdown. An effective vacuum breaker, plus an automatic means of preventing a negative pressure, shall be installed in the line between the vacuum chamber and the pasteurized product inlet to the regenerator.

4. In the case of HHST pasteurization systems utilizing the temperatures of 191°F (89°C) and above, and holding times of one (1) second or less, with the FDD located downstream from the regenerator and/or cooler section, the requirement that the pasteurized product from the outlet of the regenerator or cooler shall rise to a vertical elevation of twelve (12) inches above the highest raw product level downstream from the constant-level tank and shall be open to the atmosphere at this or a higher elevation, may be eliminated--provided a differential pressure controller is used to monitor the highest pressure in the raw product side of the regenerator and the lowest pressure in the pasteurized side of the regenerator, and the controller is interlocked with the FFD and is set and sealed so that whenever improper pressures occur in the regenerator, forward flow of product is automatically prevented and will not start again until all product-contact surfaces between the holding tube and FFD have been held at or above the required pasteurization temperature, continuously and simultaneously for at least the required pasteurization time as defined in Rule 420-3-16-.02(68).

5. When culinary steam is introduced directly into milk or milk products as the means of terminal heating to achieve pasteurization temperature, and vacuum equipment is located downstream from the holding tube, the requirement that a vacuum breaker be installed at the inlet to the pasteurized or aseptic side of the regenerator may be eliminated; provided, that the differential pressure controller is installed and wired to control the FDD as described in (iii) above.

6. When the differential pressure controller is installed and wired to control the FDD as described in (i) above, the raw product booster pump may be permitted to run at all times; provided, the metering pump is in operation.

(20) Milk or Milk Product-To-Water-To-Milk or Milk Product Regenerative Heating

OPTION I: Milk-to-water-to-milk regenerators with both the product and the heat-transfer water in the raw product section closed to the atmosphere shall comply with the following or equally satisfactory specifications:

(a) Regenerators of this type shall be so designed, installed, and operated that the heat-transfer-medium side of the regenerator in the raw product section will automatically be under greater pressure than the raw side at all times.

(b) The heat-transfer water shall be safe water and the heat-transfer water shall be in a covered tank which is open to the atmosphere at an elevation higher by at least twelve (12) inches (30.5 cm) than any raw product level downstream from the constant-level tank. The heat-transfer water between its outlet from the regenerator and the nearest point downstream open to the atmosphere shall rise to a vertical elevation of at least twelve (12) inches (30.5 cm) above any raw product in the system and shall be open to the atmosphere at this or a higher elevation.

(c) The heat-transfer water circuit shall be full of water at the beginning of the run, and all loss of water from the circuit shall be automatically and immediately replenished whenever raw product is present in the regenerator.

(d) The overflow of the top rim of the constant-level raw product tank shall always be lower than the lowest product level in the raw product section of the regenerator. The regenerator shall be designed and installed so that all raw product shall drain freely back to the upstream supply tank when the raw product pumps are shut down and the raw product line is disconnected from the regenerator outlet.

(e) No pump shall be located between the raw product inlet to the regenerator and the raw product supply tank, unless it is designed and installed to operate only when water is flowing through the heat-transfer section of the regenerator, and when the pressure of the heat-transfer water is higher than the pressure of the raw product. This may be accomplished by wiring the booster pump so that it cannot operate unless:

1. The heat-transfer water pump is in operation.

2. Pressure gauges shall be installed at the raw product inlet and the heat-transfer water outlet of the regenerator. The heat-transfer water pressure exceeds, by at least 6.9 kPa (1 psi), the raw milk or milk product pressure in the regenerator. A differential pressure controller shall be installed at the raw milk or milk product inlet and the heat-transfer water outlet of the regenerator. The raw milk or milk product booster pump shall be wired so that it cannot operate unless the differential pressure is met. The accuracy of the required differential pressure controller shall be checked by the Health Officer on installation; quarterly thereafter; and following repair or replacement.

OPTION II: Milk or milk product-to-water-to-milk or milk product regenerators may also be constructed, installed, and operated such that the pasteurized milk or milk product in the regenerator will be under greater pressure than the heat-transfer-medium in the pasteurized milk or milk product side of the regenerator:

(a) A differential pressure recorder-controller shall be used to monitor pressures of the pasteurized product and the heat-transfer medium. One pressure sensor shall be installed at the pasteurized milk or milk product outlet of the regenerator and the other pressure sensor shall be installed at the heat-transfer-medium inlet of the aseptic product side of the regenerator. This recorder-controller shall divert the FDD whenever the lowest pressure of pasteurized milk or milk product in the regenerator fails to exceed the highest pressure of heat-transfer-medium in the aseptic product side of the regenerator by at least one (1) psi (6.9 kPa). Forward flow of product shall be automatically prevented until all product-contact surfaces between the holding tube and the FDD have been held at or above the required pasteurization sterilization temperature continuously and simultaneously for at least the pasteurization time.

(b) The heat-transfer-medium pump shall be wired so that it cannot operate unless the metering pump is in operation.

Note: See Appendix H for further discussion concerning methods of achieving the required pressure relationships within the regenerator.

(21) Pasteurization Records

(a) Pasteurization Records - All temperature and flow rate pasteurization recording charts or alternative records, acceptable to the FDA, in place of charts shall be preserved for a period of three (3) months. The use of such charts shall not exceed the time limit for which they are designed. Overlapping of recorded data shall be a violation of this Item. The following information shall be entered on the charts or other records acceptable to FDA in place of charts as applicable:

1. Batch Pasteurizers.

(i) Date.

(ii) Number or location of recorder when more than one is used.

(iii) A continuous record of the product temperature.

(iv) Extent of holding period, including filling and emptying times when required.

(v) Reading of the airspace thermometer, at the start of the holding period and at the end of the holding period, at a given time or reference point as indicated on the chart; provided, if the airspace thermometer is a digital combination airspace/recording thermometer which provides a continuous recording of the airspace temperature and has been calibrated by the Health Officer in accordance with Appendix I, Test 4, the recording of the airspace temperature on the chart shall only be required at the start of the holding period.

(vi) Reading of indicating thermometer at the start of the holding period, at a given time or reference point as indicated on the chart.

(vii) Quarterly, the initials of the Health Officer opposite the required readings of the indicating thermometer and airspace thermometer. Refer to Rule 420-3-16-.10(16)(C)2.(i).

(viii) Quarterly, the time accuracy of the recording thermometer as determined by the Health Officer (refer to Appendix I, Test 3).

(ix) Amount and name of pasteurized milk or milk product represented by each batch or run on the chart.

(x) Record of unusual occurrences.

(xi) Signature or initials of operator.

(xii) Name of milk plant.

(b) High-Temperature Short-Time (HTST) and HHST Pasteurizers, Short-Time Pasteurizers-Recording thermometer charts shall contain all the information specified in 1 above, except for (iv) and (v) above, in addition, shall include the following:

1. A record of the time during which the FDD is in the forward-flow position.

2. The cut-in and cut-out product temperatures recorded daily by the operator at the beginning of the run (HTST only) and initialed quarterly by the Regulatory Agency; and (III) and (vi) from above shall also be recorded immediately after a chart has been changed.

Note: The recorded temperature shown on the controller chart shall be used to determine that the required temperature for milk products containing higher fat and/or sweeteners has been achieved.

3. Continuous-Flow Pasteurization Systems with Magnetic Flow Meter Based Timing Systems: Flow rate recording charts shall be capable of continuously recording flow at the flow alarm set point and at least 19 liters (5 gallons) per minute higher than the high flow alarm setting. Flow rate recording charts shall contain all the information specified in subitem (a). above except (iii), (iv), (v), (vi), and (vii), and, in addition, shall include the following:

(i) A continuous record of the status of the high and low-flow/loss of signal alarms.

(ii) A continuous record of the flow rate.

4. Electronic Data Collection, Storage, and Reporting: Electronic collection, storage, and reporting of required pasteurization records, with or without hard copy printouts, may be acceptable, provided the electronically generated records are readily available at the milk plant for review by the Health Officer and meet the criteria of this section and Appendix H, V.

5. HTST and HHST Pasteurizers - Recording charts shall contain all the information specified in (a) from above except for (iv) and (v), and reference to airspace thermometers, and in addition shall include the following:

(i) A record of the time during which the FDD is in the forward-flow position.

(ii) The cut-in and cut-out milk or milk product temperatures, recorded daily by the operator, at the beginning of the run (HTST only), and initialed quarterly by the Health Officer, or in the case of milk plants regulated under the NCIMS voluntary HACCP Program, a qualified industry person acceptable to the Health Officer; and (ii), (iii), and (vi) from above and shall also be recorded immediately after a chart has been changed.

(iii) Not later than one working day after the actual process, and before shipment or release for distribution, a representative of plant management who is qualified by suitable training or experience shall review all processing and production records for completeness to ensure that the product received the scheduled process. The records, including the recording thermometer chart(s), shall be signed or initialed and dated by the reviewer.

(22) Equipment Tests and Examination

(a) The Health Officer shall perform the indicated tests on the following instruments and devices identified in Table 4 initially upon installation; at least once each three (3) months thereafter, including the remaining days of the month in which the equipment tests are due; whenever any alteration or replacement is made which may affect the proper operation of the instrument or device; or whenever a regulatory seal has been broken. Provided, that the pasteurization holding time tests shall be conducted at least once each six (6) months thereafter, including the remaining days of the month in which the equipment test is due.

Note: A TPC authorized under the ICP may utilize appropriately trained and TPC authorized in-country regulatory personnel to comply with (22) above.

(b) On an emergency basis, pasteurization equipment may be tested and temporarily sealed by a milk plant employee provided the following conditions are met:

1. The individual applying the seal(s) shall be employed by the milk plant in which the seal(s) was removed.

2. The individual has satisfactorily completed training acceptable to the Health Officer on test controls for pasteurization equipment.

3. The individual has demonstrated the ability to satisfactorily conduct all pasteurization control tests in the presence of a regulatory official within the past year.

4. The individual shall be in possession of authorization from the Health Officer to perform these pasteurization equipment tests.

5. The individual shall immediately notify the Health Officer of the time of the shutdown that would necessitate the breaking and removal of the regulatory seal(s). Permission to test and reseal the equipment shall be obtained for each specific incident. The individual shall also notify the Health Officer of the identity of the pasteurization equipment controls affected, the cause, if known, of the pasteurization equipment failure, the repairs made, and the results of the pasteurization equipment testing. Test results for the pasteurization equipment testing shall be recorded on a similar document for all milk plants (refer to the reference in Appendix M for an example). The individual shall provide to the Health Officer the identity and volume of milk and/or milk products processed during the period that the temporary seal(s) was applied.

6. If regulatory pasteurization equipment testing reveals that the pasteurization equipment or controls are not in compliance with the provisions of this rule, all milk and/or milk products that were processed during this period may be recalled by the Health Officer.

7. The Health Officer or a properly trained regulatory official commissioned by the responsible Health Officer of each participating non-U.S. country or political subdivision thereof shall remove the temporary seal(s), retest the pasteurization equipment, and apply the regulatory seal(s) within ten (10) working days of the notification by the milk plant.

8. Grade “A” milk and/or milk products shall not be processed after ten (10) working days of the notification by the milk plant without the affected pasteurization equipment being tested and sealed by the Health Officer or a properly trained regulatory official, commissioned by the responsible Health Officer of each participating non-U.S. country or political subdivision thereof.

(c) In the case of milk plants with HACCP Plans regulated under the NCIMS voluntary HACCP Program, pasteurization equipment may be tested and sealed by industry personnel acceptable to the Health Officer, if the following conditions are met:

1. Test results for the pasteurization equipment testing shall be recorded on a similar document for all milk plants (refer to the reference in Appendix M for an example).

2. Industry personnel conducting the pasteurization equipment testing shall be adequately trained and shall be able to demonstrate an acceptable understanding and ability to conduct these pasteurization equipment tests to the Health Officer.

(i) Industry personnel shall physically demonstrate to the Health Officer that they understand and can perform the required pasteurization equipment tests according to the requirements of this rule.

(ii) The Health Officer shall accept a field practical exercise, a written exam, formal classroom training, on-the-job training, or any combination of these except that, if industry personnel do not physically demonstrate the appropriate capability to perform the pasteurization equipment tests to the satisfaction of the Health Officer, they are not acceptable for conducting such pasteurization equipment tests.

(iii) Continued training such as, but not limited to, on-the-job training with supervision or an acceptable pasteurizer training course shall be completed before they reapply for pasteurizer equipment testing approval.

(I) Pasteurization equipment tests shall be conducted at a frequency not less than the requirements of this rule. Industry personnel shall have responsibility for the performance of all required pasteurization equipment tests. At least each six (6) months, the Health Officer shall physically supervise these pasteurization equipment tests. Regulatory supervised pasteurization equipment tests shall include the semi-annual HTST and HHST pasteurization equipment tests, if applicable. These six (6) month pasteurization equipment tests shall be performed at a time that is mutually convenient to all parties. Because these pasteurization equipment tests are required to support a CCP, the industry is responsible for conducting these pasteurization equipment tests even in the absence of the regulatory official.

(II) Upon initial installation or extensive modification of any pasteurization equipment, pasteurization equipment tests shall be physically supervised or conducted by the Health Officer.

(III) Sealing guidance for pasteurization equipment by industry is as follows:

a. All pasteurization equipment that is required to be sealed within this rule shall also be sealed under the HACCP System. The sealing shall be done by a trained, qualified individual who is acceptable to the milk plant and the Health Officer.

b. The Health Officer may verify any pasteurization equipment sealing and evaluate (accept or reject) the skills and knowledge of the individual performing the sealing.

c. During an audit, the auditor may conduct any or all of the pasteurization equipment tests. The auditor shall, through a combination of the physical examination of the pasteurization equipment and a records review, satisfy themselves that the pasteurization equipment is properly installed and operated.

For HTST systems with the FDD located downstream of the regenerator and/or cooler section.

(23) Cooling of Milk, Milk Products, and Frozen Desserts

(a) All raw milk, milk products, and frozen dessert mix shall be maintained at 7°C (45°F) or less until processed. All whey and whey products for condensing and/or drying shall be maintained at a temperature of 7°C (45°F) or less; or 57°C (135°F) or greater until processed, except that acid-type whey with a titratable acidity of 0.40% or above, or a pH of 4.6 or below, is exempted from these temperature requirements.

(b) For a milk or milk product flavoring slurry that contains milk and/or milk products and is not to be injected within a HTST pasteurization system as a part of a liquid ingredient injection system as outlined in Appendix H, the tanks and/or vessels used to blend and hold the slurry shall be completely emptied and cleaned after each four (4) hours of operation or less, unless the slurry is stored at a temperature of 7°C (45°F) or less, or at a temperature of 66°C (150°F) or greater and maintained thereat.

(c) All pasteurized milk and milk products, except the following, are cooled immediately in approved equipment prior to filling or packaging to a temperature of 7°C (45°F) or less, unless drying is commenced immediately after condensing:

1. Those to be cultured.

2. Cultured sour cream at all milkfat levels with a pH of 4.70 or below*.

3. Acidified sour cream at all milkfat levels with a pH of 4.60 or below*.

4. All yogurt products at all milkfat levels with an initial pH of 4.80 or below* at filling.

5. Cultured buttermilk at all milkfat levels with a pH of 4.60 or below*.

6. Cultured cottage cheese at all milkfat levels with a pH of 5.2 or below*.

(i) Filled at 63°C (145°F) or above* for containers of four (4) ounces (118 ml) or larger, or

(ii) Filled at 69°C (155°F) or above* for containers of 2.9 ounces (85.6 ml), and

(iii) The additional applicable critical factors*, as cited below, shall also be utilized for either hot fill temperature to determine the acceptability of filling at these temperatures, or

(iv) The addition of potassium sorbate at a minimum concentration of 0.06% and filled at 13°C (55°F) or less*, or

(v) The addition of one (1) of the specified microbial inhibitors and/or preservatives, at the specified concentration as addressed in M-a-97, and filled at 13°C (55°F) or less*; and

7. All condensed whey and whey products shall be cooled during the crystallization proess to 10°C (50°F) or less within seventy-two (72) hours of condensing, including the filling and emptying time, unless filling occurs above 57°C (135°F), in which case, the seventy-two (72) hour time period begins when cooling is started.

*Critical factors including, but not limited to, pH, filling temperature, cooling times and temperatures, and potassium sorbate concentration or specified microbial inhibitors and/or preservatives, at the specified concentration as addressed in M-a-97, if applicable, shall be monitored and documented by the processing facility for verification by the Health Officer. pH limit with a pH variance of + 0.05 units to account for reproducibility and inaccuracies in pH measurements. Formulation or processing changes that affect critical factors shall be communicated to the Health Officer.

Note: Microbial inhibitors and/or preservatives and/or all of their individual components shall have GRAS status; and pathogen inhibition shall be supported by documented challenge study results that are acceptable to the Health Officer and FDA.

8. All pasteurized milk and milk products, except the following, shall be stored at a temperature of 7°C (45°F) or less and maintained thereat following filling or until further processed.

(i) Cultured sour cream at all milkfat levels with a pH of 4.70 or below* and cooled to 7°C (45°F) or less within one hundred sixty eight (168) hours of filling**.

(ii) Acidified sour cream at all milkfat levels with a pH of 4.60 or below* and cooled to 7°C (45°F) or less within one hundred sixty eight (168) hours of filling**.

(iii) All yogurt products at all milkfat levels with an initial pH of 4.80 or below* at filling, with a pH of 4.60 or below within twenty-four (24) hours of filling* and cooled to 7°C (45°F) or less within ninety-six (96) hours of filling**.

(iv) Cultured buttermilk at all milkfat levels with a pH of 4.60 or below* and cooled to 7°C (45°F) or less within twenty-four (24) hours of filling**.

(v) Cultured cottage cheese at all milkfat levels with a pH of 5.2 or below* and:

I. Filled at 63°C (145°F) or above* for containers of four (4) ounces (118 ml) or larger, cooled to 15°C (59°F) or less within ten (10) hours of filling**, and cooled to 7°C (45°F) or less within twenty-four (24) hours of filling**.

II. Filled at 69°C (155°F) or above* for containers of 2.9 ounces (85.6 ml), cooled to 15°C (59°F) or less within ten (10) hours of filling**, and cooled to 7°C (45°F) or less within twenty-four (24) hours of filling**.

III. The addition of potassium sorbate at a minimum concentration of 0.06% and filled at 13°C (55°F) or less*, cooled to 10°C (50°F) or less within twenty-four (24) hours of filling**, and cooled to 7°C (45°F) or less within seventy-two (72) hours of filling**, or

IV. The addition of one (1) of the specified microbial inhibitors and/or preservatives, at the specified concentration as addressed in M-a-97, filled at 13° (55°F) or less*, cooled to 10°C (50°F) or less with twenty-four (24) hours of filling**, and cooled to 7°C (45°F) or less within seventy-two (72) hours of filling**.

*Critical factors including, but not limited to, pH, filling temperature, cooling times and temperatures, and potassium sorbate concentration or specified microbial inhibitors and/or preservatives, at the specified concentration as addressed in M-a-97, if applicable, shall be monitored and documented by the processing facility for verification by the Health Officer. pH limit with a pH variance of + 0.05 units to account for reproducibility and inaccuracies in pH measurements. Formulation or processing changes that affect critical factors shall be communicated to the Health Officer.

Note: Microbial inhibitors and/or preservatives and/or all of their individual components shall have GRAS status; and pathogen inhibition shall be supported by documented challenge study results that are acceptable to the Health Officer and FDA.

**Cooling temperatures monitored at the slowest cooling portion, (i.e., in the middle of the container), of the slowest cooling container, (i.e., in the middle of the pallet).

9. All pasteurized milk and milk products to be condensed and/or dried shall be stored at a temperature of 10°C (50ºF) or less and be maintained thereat until further processed. Every refrigerated room or tank in which milk or milk products, whey and whey products, and condensed milk and milk products are stored shall be equipped with an accurate indicating thermometer.

10. On delivery vehicles, the temperature of milk and milk products shall not exceed 7°C (45°F). Aseptically processed and packaged low-acid milk and/or milk products and retort processed after packaged low-acid milk and/or milk products to be packaged in hermetically sealed containers shall be exempt from the cooling requirements of this item.

11. Electronic Data Collection, Storage and Reporting - The electronic storage of required cleaning records and product storage temperature records, with or without hard copy printouts, shall be acceptable, provided, the electronically generated records are readily available at the milk plant for review by the Health Officer. Electronic records that comply with the applicable provisions of Appendix H, IV, and V, with or without hard copy, may be used in place of the cleaning records.

(d) Public Health Reason - When milk, milk products, and frozen dessert mix are not cooled within a reasonable time after it is received at the pasteurization plant, its bacterial content will be materially increased. The same reasoning applies to cooling the milk, milk products, and frozen desserts after pasteurization, unless drying is commenced immediately after condensing.

(e) Administrative Procedures - This item is deemed to be satisfied when:

1. All raw milk, milk products, and frozen dessert mix shall be maintained at 7°C (45°F) or less until processed, except that acid-type whey with a titratable acidity of 0.40 percent or above, or a pH of 4.6 or below, is exempted from these temperature requirements; provided, all balance or surge tanks (continuous flow with a retention time not to exceed one [1] hour) for raw milk and milk products, pasteurized milk and milk products, and whey and whey products may be maintained at any temperature for up to twenty-four (24) hours.

2. All whey and whey products for condensing and/or drying are maintained at a temperature of 7°C (45°F) or less; or 57°C (135°F) or greater until processed. Storage tanks containing whey and whey product above 7°C (45°F) and below 57°C (135°F) shall be emptied, cleaned, and sanitized after each four (4) hours of use or less.***

3. For a milk or milk product flavoring slurry that contains milk and/or milk products and is not intended to be injected within a HTST pasteurization system as a part of a liquid ingredient injection system as outlined in Appendix H., the tanks and/or vessels used to blend and hold the slurry shall be completely emptied and cleaned after each four (4) hours of operation or less, unless the slurry is stored at a temperature of 7°C (45°F) or less, or at a temperature of 66°C (150°F) or greater and maintained thereat.

4. All pasteurized milk, milk products, and frozen dessert mix, except the following, shall be cooled immediately prior to filling or packaging, in approved equipment, to a temperature of 7°C (45°F) or less, unless drying is commenced immediately after condensing:

(i) Those to be cultured.

(ii) Cultured sour cream at all milkfat levels with a pH of 4.70 or below*.

(iii) Acidified sour cream at all milkfat levels with a pH of 4.60 or below*.

(iv) All yogurt products at all milkfat levels with an initial pH of 4.80 or below* at filling.

(v) Cultured buttermilk at all milkfat levels with a pH of 4.60 or below*.

(vi) Cultured cottage cheese at all milkfat levels with a pH of 5.2 or below*.

I. Filled at 63°C (145°F) or above* for containers of four (4) ounces (118 ml) or larger, or

II. Filled at 69°C (155°F) or above* for containers of 2.9 ounces (85.6 ml), and Chapter 420-3-16 Health Supp. 12/31/18 3-16-174

III. The additional applicable critical factors*, as cited below, shall also be utilized for either hot fill temperature to determine the acceptability of filling at these temperatures, or

IV. The addition of potassium sorbate at a minimum concentration of 0.06 percent and filled at 13°C (55°F) or less*, or

V. The addition of one (1) of the specified microbial inhibitors and/or preservatives, at the specified concentration as addressed in M-a-97, and filled at 13°C (55°F) or less*; and

(vii) All condensed whey and whey products shall be cooled during the crystallization process to 10°C (50°F) or less within seventy-two (72) hours of condensing, including the filling and emptying time, unless filling occurs above 57° (135°F), in which case, the seventy-two (72) hour time period begins when cooling is started.***

*Critical factors including, but not limited to, pH, filling temperature, cooling times and temperatures, and potassium sorbate concentration or specified microbial inhibitors and/or preservatives, at the specified concentration as addressed in M-a-97, if applicable, shall be monitored and documented by the processing facility for verification by the Health Officer. The pH limit with a pH variance of + 0.05 units to account for reproducibility and inaccuracies in pH measurements. Formulation or processing changes that affect critical factors shall be communicated to the Health Officer.

Note: Microbial inhibitors and/or preservatives and/or all of their individual components shall have GRAS status; and their pathogen inhibition shall be supported by documented challenge study results that are acceptable to the Health Officer and the FDA.

5. All pasteurized milk and milk products, except the following, shall be stored at a temperature of 7°C (45°F) or less and be maintained thereat following filling or until further processed:

(a) Cultured sour cream at all milkfat levels with a pH of 4.70 or below* and cooled to 7°C (45°F) or less within one hundred sixty eight (168) hours of filling**.

(b) Acidified sour cream at all milkfat levels with a pH of 4.60 or below* and cooled to 7°C (45°F) or less within one hundred sixty eight (168) hours of filling**.

(c) All yogurt products at all milkfat levels with an initial pH of 4.80 or below* at filling, with a pH of 4.60 or below within twenty-four (24) hours of filling* and cooled to 7°C (45°F) or less within ninety-six (96) hours of filling**.

(d) Cultured buttermilk at all milkfat levels with a pH of 4.60 or below* and cooled to 7°C (45°F) or less within twenty-four (24) hours of filling**.

(e) Cultured cottage cheese at all milkfat levels with a pH of 5.2 or below*.

(i) Filled at 63°C (145°F) or above* for containers of four (4) ounces (118 ml) or larger, cooled to 15°C (59°F) or less within ten (10) hours of filling**, and cooled to 7°C (45°F) or less within twenty-four (24) hours of filling**, or

(ii) Filled at 69°C (155°F) or above* for containers of 2.9 ounces (85.6 ml), cooled to 15°C (59°F) or less within ten (10) hours of filling**, and cooled to 7°C (45°F) or less within twenty-four (24) hours of filling**, or

(iii) The addition of potassium sorbate at a minimum concentration of 0.06 percent and filled at 13°C (55°F) or less*, cooled to 10°C (50°F) or less within twenty-four (24) hours of filling**, and cooled to 7°C (45°F) or less within seventy-two (72) hours of filling**, or

(iv) The addition of one (1) of the specified microbial inhibitors and/or preservatives, at the specified concentration as addressed in M-a-97, filled at 13°C (55°F) or less*, cooled to 10°C (50°F) or less with twenty-four (24) hours of filling**, and cooled to 7°C (45°F) or less within seventy-two (72) hours of filling**.

(f) All condensed whey and whey products shall be cooled during the crystallization process to 10°C (50°F) or less within seventy-two (72) hours of condensing, including the filling and emptying time, unless filing occurs above 57°C (135°F), in which case, the seventy-two (72) hour time period begins when cooling is started.

*Critical factors including, but not limited to, pH, filling temperature, cooling times, and temperatures, and potassium sorbate concentration or specified microbial inhibitors and/or preservatives, at the specified concentration as addressed in M-a-97, if applicable, shall be monitored and documented by the processing facility for verification by the Health Officer. The pH limit with a pH variance of + 0.05 units to account for reproducibility and inaccuracies in pH measurements. Formulation or processing changes that affect critical factors shall be communicated to the Health Officer

Note: Microbial inhibitors and/or preservatives and/or all of their individual components shall have GRAS status; and pathogen inhibition shall be supported by documented challenge study results that are acceptable to the Health Officer and the FDA.

**Cooling temperatures monitored at the slowest cooling portion (i.e., in the middle of the container) of the slowest cooling container (i.e., in the middle of the pallet).

6. All pasteurized milk and milk products to be condensed and/or dried, shall be stored at a temperature of 10°C (50°F) or less and be maintained thereat until further processed. If storage tanks are used between the condenser and dryer, any such storage tank(s) containing pasteurized milk or milk products stored above 10°C (50°F) and below 57°C (135°F) shall be completely emptied and cleaned after each six (6) hours of operation or less.***

7. Each refrigerated room in which pasteurized milk, milk products, and frozen dessert mix are stored is equipped with an indicating thermometer that complies with the applicable specifications of Appendix H. Such thermometer shall be located in the warmest zone of the refrigerated room.

8. Each storage tank shall be equipped with an indicating thermometer, the sensor of which shall be located to permit the registering of the temperature of the contents when the tank contains no more than 20 percent of its calibrated capacity. Such thermometer shall comply with the applicable specification of Appendix H.

9. On delivery vehicles, the temperature of milk and milk products shall not exceed 7°C (45°F).

10. All surface coolers comply with the following specifications:

(i) The sections of open-surface coolers shall be so installed as to leave a gap of at least 6.4 millimeters (0.25 of an inch) between the header sections to permit easy cleaning.

(ii) Where header ends are not completely enclosed within the cooler covers, condensation or leakage from the headers shall be prevented from entering the milk or milk product by so shaping the exposed header faces above and below all gaps that condensation is directed away from the tubes, and by using deflectors at the bottom of the headers; or by shortening the bottom of the headers; or by shortening the bottom trough; or by some other approved method.

(iii) The location of supports of cooler sections shall prevent condensation and leakage from entering the milk, milk product, or frozen dessert.

(iv) All open-surface coolers shall be provided with tight-fitting shields that protect the milk, milk product, or frozen dessert product from contamination by insects, dust, drip, splash, or manual contact.

11. Recirculated cooling water which is used in plate or tubular coolers and/or heat exchangers, including those systems in which a freezing point depressant is used, is from a safe source and protected from contamination. Such water shall be tested semiannually and shall comply with the bacteriological standards of Appendix G. Samples shall be taken by the Health Officer and examination shall be conducted in an official laboratory. Recirculated cooling water systems which become contaminated through repair work or otherwise shall be properly treated and tested before being returned to use. Freezing point depressants and other chemical additives, when used in recirculating systems, shall be non-toxic under conditions of use. Propylene glycol and all additives shall be either USP Grade, Food Grade, or GRAS. To determine if recirculated cooling water samples have been taken at the frequency established in this item, the interval shall include the designated six (6) month period plus the remaining days of the month in which the sample is due.

12. Recirculated cooling water contained in corrosion resistant, continuous piping, with no joints or welds, which fail to meet applicable American Society of Mechanical Engineers (ASME) or equivalent standards in the non-potable water contact areas, may be considered to be protected from contamination, as required above, when cooled by non-potable water flowing over the exterior of the piping, within open evaporative type cooling tower. In these systems, the recirculated cooling water piping shall be properly maintained and shall be installed so that it is at least two (2) pipe diameters above the flood rim of the cooling tower.

13. Water from an open, evaporative cooling tower may be used to cool water in an intermediate cooling media loop that will subsequently be used to cool product, provided that the water in the intermediate cooling media loop is effectively protected against infiltration and contamination by tower water at all times.

14. If a plate type or double/triple tube type heat exchanger is used to exchange heat between the water from the open tower and the water in the intermediate cooling media loop, it shall be protected by an isolation system to assure that there is no possibility of contamination of the intermediate cooling media loop water by the tower water. The isolation system shall include:

(i) Tower water heat exchangers shall be constructed, installed, and operated so that the intermediate cooling media water in the heat exchanger will automatically be under greater pressure than the open tower water in the heat exchanger at all times.

(ii) The tower water heat exchanger shall be effectively isolated from the tower water system and the tower water side of the heat exchanger shall drain during shut down.

(iii) The isolation system shall be controlled with a pressure differential controller set to a minimum of 6.9 kPa (1 psi). Pressure sensors shall be installed at the tower water inlet to the heat exchanger and intermediate cooling water outlet of the heat exchanger. The differential pressure controller shall be interwired with the related supply valves and/or pumps to automatically shut down all supply pumps and return valves in the isolation system to a fail-safe position to isolate the heat exchanger from the open tower water system, as would occur in a shut down or power failure.

(iv) The intermediate cooling water shall rise to a vertical elevation of at least 30.5 centimeters (12 inches) above the highest tower water in the tower water heat exchanger isolation system, and shall be open to the atmosphere at this elevation. During a shut down, the intermediate cooling water shall not drain from the tower water heat exchanger.

(v) The isolation system shall meet one (1) of the following:

(I) In a system with tower water supplied directly from the tower water distribution line without a balance tank, or with a balance tank higher than the lowest water level in the tower water heat exchanger (refer to Figures 8, 9, and 10 in Appendix D.).

(II) In this application, the isolation system shall begin at the normally closed tower water supply stop "block" valve and ends at the check-valve in the line returning to the open cooling tower.

(III) Isolation is accomplished by meeting all of the following:

I. Closing the tower water supply valve. This tower water supply valve shall be a normally closed (spring-to-close) valve.

II. Opening a full port vent valve on the supply side of the tower water heat exchanger and a full port drain valve prior to a check-valve in the tower water return line. This drain valve shall be normally open (spring-to-open).

III. The drain valve and any pipes or pumps located between the drain valve and the heat exchanger shall be lower than the lowest liquid level in the heat exchanger.

IV. De-energize any dedicated tower water supply pump, if present, located between the tower water reservoir and the tower water heat exchanger.

V. If a tower water return pump is used, a bypass line may be used to flood the dry pump at start up.

(IV) In a system with the overflow of an atmospheric balance tank lower than the lowest water level in the heat exchanger (refer to Figures 11 and 12 in Appendix D, VII).

(V) In this application, the isolation system shall begin at the tower water balance tank and end at the check-valve in the line returning to the open cooling tower.

(VI) Isolation is accomplished by meeting all of the following:

I. De-energizing the “local tower water supply pump”, if present (refer to Figure 11 in Appendix D, VII).

II. Opening a full port vent valve on the supply side of the tower water heat exchanger.

III. Open a full port drain valve prior to a check-valve in the tower water return line.

IV. This drain valve shall be normally open (spring-to-open). Chapter 420-3-16 Health Supp. 12/31/18 3-16-180

V. The drain valve and any pipes or pumps located between it and the heat exchanger shall be lower than the lowest liquid level in the heat exchanger.

(VII) Variations from the above isolation systems may be individually evaluated and found to also be acceptable by the Health Officer, if the level of protection required by this Administrative Procedure is not compromised.

(VIII) Testing - A means to test the response of this isolation system shall be developed and available at the milk plant. The accuracy of the required differential pressure controller shall be checked by the Health Officer on installation; every six (6) months thereafter; and following repair or replacement.

***Note: Nothing shall be construed as barring other time and temperature relationships, which have been recognized by FDA to be equally efficient and which are approved by the Health Officer.

(24) Bottling, Packaging, and Container Filling

(a) Bottling, packaging, and container filling of milk, milk products, and frozen dessert products shall be done at the place of pasteurization in a sanitary manner by approved mechanical equipment.

(b) For milk plants that dry milk products, these dry milk products shall be packaged in new containers which protect the contents from contamination, and after packaging, shall be stored in a sanitary manner.

(c) For milk plants that condense and/or dry milk or milk products, these condensed and dry milk products may be transported in sealed containers in a sanitary manner from one (1) milk plant to another for further processing and/or packaging.

(d) Condensed and dry milk product packaging containers shall be stored in a sanitary manner.

(e) Public Health Reason - Manual bottling, packaging, and container filling is very apt to result in the exposure of the milk, milk product, and frozen dessert products to contamination, which would nullify the effect of pasteurization. The transfer of milk, milk product, and frozen dessert products from the place of pasteurization to another milk plant for bottling, packaging, or container filling may subject the pasteurized milk or milk product to unnecessary risks of contamination. Reuse of packages for dry milk products is likely to result in contamination of the dry milk products.

(f) Administrative Procedures - This item is deemed to be satisfied when:

1. All milk and milk products, including concentrated (condensed) milk and milk products, are bottled and packaged at the milk plant where final pasteurization is performed. Such bottling and packaging shall be done without undue delay following final pasteurization.

2. All bottling or packaging is done on approved mechanical equipment. The term "approved mechanical equipment" shall not be interpreted to exclude manually operated machinery, but is interpreted to exclude methods in which the bottling and capping devices are not integral within the same system.

3. All pipes, connections, defoaming devices, and similar appurtenances shall comply with Rule 420-3-16-.10-11. Milk and milk products from continuous defoamers are not returned directly to the filler bowl.

4. Bottling or packaging machine supply tanks and bowls are equipped with covers that are constructed to prevent any contamination from reaching the inside of the filler tank or bowl. All covers shall be in place during operation.

5. A drip deflector is installed on each filler valve. Drip deflectors shall be designed and adjusted to divert condensation away from the open container.

6.) Container in-feed conveyors to automatic bottling or packaging machines have overhead shields to protect the bottles or packages from contamination. These shields shall extend from the bottle washer discharge to the bottle feed-star, or in the case of single-service packaging machines, from the forming unit discharge to the filling unit and from the filling unit to the closure unit. Overhead shields shall be required on can in-feed conveyors when the cans are fed to the filler with the covers off.

7. Container coding/dating devices are designed, installed, and operated such that the coding/dating operations are performed in a manner that open containers are not subjected to contamination. Shielding shall be properly designed and installed to preclude the contamination of open containers.

8. Container fabricating materials, such as paper stock, foil, wax, plastic, etc., are handled in a sanitary manner and protected against undue exposure during the package assembly operation.

9. Bottling and packaging machine floats are designed to be adjustable without removing the cover.

10. The filler pipe of all bottling and packaging machines have a diversion apron or other acceptable device, as close to the filler bowl as possible, to prevent condensation from entering the inside of the filler bowl.

11. Filling cylinders on packaging machines are protected from contamination by overhead shields. When lubricants are used on filler pistons, cylinders or other milk or milk product-contact surfaces, the lubricant shall be food-grade and applied in a sanitary manner.

For milk plants that condense and/or dry milk or milk products, the following shall apply:

(i) The filling of condensed and dry milk product containers is done by mechanical equipment. The term "mechanical equipment" shall not be interpreted to exclude manually operated equipment.

(ii) All pipes, connections, and similar appurtenances comply with Rule 420-3-16-.10-11.

(iii) Filling devices are constructed so as to prevent any contamination from reaching the product. Covers of filling devices, if used, shall be in place during operation.

(iv) Packaged dry milk and milk products are stored and arranged so as to be easily accessible for inspection and to permit cleaning of the storage room.

(v) All condensed and dry milk product containers are filled in a sanitary manner by methods which:

(I) Protect the product from airborne contamination.

(II) Prevent manual contact with condensed and dry milk product-contact surfaces.

(III) Minimize manual contact with the product.

(iv) All final containers for dry milk products shall be new and of the single-service type and sufficiently substantial to protect the contents from impairment of quality with respect to sanitation, contamination, and moisture, under customary conditions of handling, transportation, and storage.

(vii) If portable storage bins are used, they comply with the applicable provisions of Rule 420-3-16-.10-11.

(viii) Containers are closed immediately after being filled.

(25) Capping, Container Closure and Sealing, and Dry Milk Product Storage

(a) Capping, closing, or sealing of Grade “A” milk and milk product containers shall be done in a sanitary manner by approved mechanical capping, closing, or sealing equipment. The cap or closure shall be designed and applied in such a manner that the pouring lip is protected to at least its largest diameter and, with respect to fluid product containers, removal cannot be made without detection. Frozen dessert containers shall be closed in a sanitary manner approved by the Health Officer.

(b) Public Health Reason - Hand-capping exposes the milk or milk product to contamination. A cover extending over the pouring lip of the container protects it from contamination during subsequent handling and prevents the sucking back into the bottle, by temperature contraction, of any contaminated liquid on the cap, including milk or milk products which have been forced out by temperature expansion and which may have become contaminated. Caps or closures that are applied in such a manner that they cannot be removed without detection help to assure the consumer that the milk and milk products have not been contaminated after packaging.

(c) Administrative Procedures - This item is deemed to be satisfied when:

1. The capping, closing, or sealing of Grade “A” milk and milk product containers is done in a sanitary manner on approved mechanical capping, closing, or sealing equipment. The term "approved mechanical capping, closing, or sealing equipment" shall not exclude manually operated machinery. Hand-capping shall be prohibited. Provided, if suitable mechanical equipment for the capping or closing of specific container(s) of three (3) gallons 12.8 liters or more is not available, other methods which eliminate all possibility of contamination may be approved by the Health Officer.

2. All mechanical capping or closure mechanisms are designed to minimize the need for adjustment during operation.

3. Bottles and packages which have been imperfectly capped or closed are emptied immediately into approved sanitary containers. Such milk, milk products, or frozen desserts shall be protected from contamination, maintained at 45°F (7°C) or less, except dry milk products, and subsequently re-pasteurized or discarded.

4. All caps and closures are designed and applied in such a manner that the pouring lip is protected to at least its largest diameter and, with respect to fluid product containers, removal cannot be made without detection. Single-service containers are so constructed that the product and the pouring and opening areas are protected from contamination during handling, storage, and when the containers are initially opened.

5. All caps and closures are handled in a sanitary manner. The first cap from each tube, the first lap(s) from each roll of cap or cover stock, and the first sheet of parchment or cover paper shall be discarded. The subsequent use of loose caps which are left in the cappers at the end of an operation period after removal from the cap tubes shall be a violation of this paragraph, provided that loose plastic caps and closures supplied by the manufacturer in plastic bags may be returned to storage in a protective wrap if removed from a hopper/descrambler immediately after a production run. Plastic caps and closures remaining in the chute between the hopper and the cupping device shall be discarded. Provided further that if suitable equipment is not available for capping cottage cheese, dry curd cottage cheese, and lowfat cottage cheese, other methods of capping which eliminate possible chance of contamination may be approved by the Health Officer.

6. Closures for cottage cheese, dry curd cottage cheese, and lowfat cottage cheese containers shall extend over the top edges of the container so as to protect the product from contamination during subsequent handling.

7. Provided, that this requirement shall not apply to cottage cheese, dry curd cottage cheese, and lowfat cottage cheese container closures, when such closures are supplied in a totally enclosed package, or wrapped so as to protect the closures.

(26) Personnel - Cleanliness

(a) Hands shall be thoroughly washed before commencing plant functions and as often as may be required to remove soil and contamination. No employee shall resume work after visiting the toilet room without thoroughly washing his hands. All persons while engaged in the processing, pasteurization, handling, storage, transportation, or packaging of milk, milk products, frozen desserts, containers, equipment, and utensils shall wear clean outer garments. All persons, while engaged in the processing of milk, milk products, or frozen desserts, shall wear adequate hair coverings and shall not use tobacco.

(b) Public Health Reason - Clean clothing and clean hands (including clean fingernails) reduce the possibility of milk, milk products, frozen desserts, containers, utensils, and equipment from becoming contaminated.

(c) Administrative Procedures - This item is deemed to be satisfied when:

1. Hands are thoroughly washed before commencing plant functions and as often as may be required to remove soil and contamination.

2. Each employee washes his hands following a visit to the toilet room and prior to resuming work.

3. All persons, while engaged in the processing, pasteurization, handling, storage, transportation, or packaging of milk, milk products, frozen desserts, containers, equipment, and utensils wear clean outer garments.

4. The use of tobacco products is prohibited in all rooms in which milk, milk products, and frozen dessert products are handled, processed, or stored, or in which milk, milk products, and frozen dessert products, containers, utensils, and/or equipment are washed. These rooms shall include, but are not limited to, the receiving, processing, packaging, milk, milk product, and frozen dessert product storage, cooling and dry storage ingredients, single-service article storage, and container/utensil wash-up areas. Any person engaged in the processing of milk, milk products, and frozen dessert products wears adequate hair coverings.

5. Specially provided clean rubbers or boot covers, clean coveralls, and white cap, clean cloth or paper, are worn whenever it is necessary to enter the drying chambers. Such articles of clothing are stored in such a manner as to be protected from contamination. Boot covers which have come into contact with areas other than those within the dryer are not considered clean.

(27) Vehicles

(a) All vehicles used for transportation of pasteurized milk, milk products, and frozen desserts shall be constructed and operated so that the milk, milk products, and frozen dessert are maintained at 45°F (7°C) or less, and are protected from sun, from freezing, and from contamination. Milk tank cars, milk tank trucks, and frozen dessert transport vehicles, and portable shipping bins shall not be used to transport or contain any substances that may be toxic or harmful to humans.

(b) Public Health Reason - The exposure of milk to the sun will alter the flavor of milk and will tend to increase the temperature, thus increasing the possibility of bacterial growth. Freezing alters the physical and chemical properties of milk. Milk, milk products, and frozen dessert products, as well as empty containers, should be protected against contamination at all times.

(c) Administrative Procedures - This item is deemed to be satisfied when:

1. All vehicles are kept clean.

2. Material which is capable of contaminating milk, milk products, and frozen desserts is not transported with milk, milk products, or frozen desserts.

3. Milk and milk products, except dry milk products, are maintained at 7°C (45°F) or less.

4. The operation of milk tank cars and shipping bins comply with the following provisions:

(i) Milk, milk products, and frozen dessert products shall be conducted to and from tank cars or shipping bins only through sanitary conveying equipment. Such equipment shall be capped or otherwise protected when not in use.

(ii) Inlets and outlets of shipping bins shall be provided with tight-fitting dust caps or covers.

(iii) Facilities shall be provided for the adequate washing and sanitizing of shipping bins, piping, and accessories at all milk plants receiving or shipping milk, milk products, and frozen dessert products in shipping bins.

(iv) Shipping bins shall be cleaned at the receiving milk plant immediately after being emptied. The clean shipping bins shall be sanitized at the shipping milk plant before loading. Milk tank trucks which must make more than one trip while unloading a tank car need not be cleaned and sanitized after each time they are emptied.

(v) Piping connections and pumps used with shipping bins shall be cleaned and sanitized after each use.

5. The doors of tank cars and covers of shipping bins are sealed with a metal seal immediately after loading. The seal shall remain unbroken until the contents are delivered to the consignee. Contents of the tank car or shipping bin shall be labeled as prescribed in Section 4 by means of a tag attached to the tank car or shipping bin.

6. Vehicles have fully enclosed bodies with well-fitted, solid doors.

(28) Surroundings

(a) Milk and frozen dessert plant surroundings shall be kept neat, clean, and free from conditions which might attract or harbor flies, other insects, and rodents or which otherwise constitute a nuisance.

(b) Public Health Reason - The surroundings of a plant should be kept neat and clean to prevent attracting rodents, flies, and other insects which may contaminate the milk, milk products, or frozen desserts. Insecticides and rodenticides not approved for use in plants or approved insecticides and rodenticides not used in accordance with label recommendations may contaminate the milk, milk products, or frozen desserts processed by the plant.

(c) Administrative Procedures - This item is deemed to be satisfied when:

1. There is no accumulation of trash, garbage, or similar waste in areas adjacent to the milk or frozen dessert plant. Waste material stored in suitable covered containers shall be considered in compliance.

2. Driveways, lanes, and areas serving milk and frozen dessert plant vehicular traffic are graded, drained, and free from pools of standing water.

3. Outdoor areas for milk tank truck unloading are constructed of smooth concrete or equally impervious material, properly sloped to drain, and equipped with trapped drains of sufficient size.

4. Only insecticides and rodenticides approved for use by the Health Officer and/or registered with the FDA shall be used for insect and rodent control.

5. Rooftops are kept clean of dry milk or milk products, which may accumulate and contribute to unsanitary conditions.

Note: A convenient inspection form for milk and frozen dessert plants, receiving stations, and transfer stations, which summarizes the applicable sanitation requirements are found in Appendix M.

History

• Author: G. M. Gallaspy, Jr.
• Authority: Code of Ala. 1975, §§22-2-2, 22-20-7.
• Repealed and New Rule: Filed October 18, 2018; effective December 2, 2018.

Ala. Admin. Code r. 420-3-16-.11 Animal Health

(1) All milk for pasteurization, ultra-pasteurization, aseptic processing and packaging, or retort processed after packaging shall be from herds under a TB eradication program, which meets one (1) of the following conditions:

(a) Areas which have modified accredited advanced TB status or higher as determined by the USDA; or

(b) An area which fails to maintain such status:

1. Any herd shall have been accredited by USDA; or

2. Shall have passed an annual TB test; or

3. The area shall have established a TB testing protocol for livestock that assures TB protection and surveillance of the dairy industry within the area and that is approved by the FDA, the USDA and the Health Officer.

Note: Under the Federal USDA Bovine TB Eradication Program, only cattle, bison, and captive cervids are covered under the USDA State TB status determination. Therefore, other hooved mammals (goats, sheep, water buffalo, camels, etc.) are not covered within the program and shall comply with one (1) of the options cited under 3 below.

(2) All milk for pasteurization, ultra-pasteurization, aseptic processing and packaging or retort processed after packaging shall be from herds under a brucellosis eradication program, which meets one (1) of the following conditions:

(a) Located in a Certified Brucellosis-Free Area as defined by the USDA and enrolled in the testing program for such areas; or

(b) Meet USDA requirements for a Certified Brucellosis-Free Herd; or

(c) Participating in a milk ring testing program at least two (2) times per year at approximately one hundred eighty (180) day intervals and all herds with positive milk ring results shall have the entire herd blood tested within thirty (30) days from the date of the laboratory ring tests; or (d) Have an individual blood agglutination test on all cattle or bison six (6) months of age or older, except steers and spayed heifers, annually with an allowable maximum grace period not exceeding two (2) months.

Note: Under the Federal USDA Bovine Brucellosis Eradication Program, only cattle and bison are covered under the USDA State brucellosis status determination. Therefore, cattle are the only dairy animal currently covered by both the Federal USDA brucellosis and TB programs. All other hooved mammals (goats, sheep, water buffalo, camels, etc.) are not covered within these programs and shall comply with one (1) of the options cited under (3) below.

(3) Goat, sheep, water buffalo, camel, or any other hooved mammal milk for pasteurization, ultra-pasteurization, aseptic processing and packaging, or retort processed after packaging, defined under this rule, shall be from a herd or flock that:

(a) Has passed an annual whole herd or flock brucellosis and/or TB testing as recommended by the State Veterinarian or USDA Area Veterinarian in Charge (AVIC) using tests approved by USDA APHIS for the specific disease and species (blood testing for brucellosis and the caudal fold tuberculin test for TB); or

(b) Has passed an initial whole herd brucellosis and/or TB testing, followed only by testing replacement animals or any animals entering the milking group or sold as dairy animals using tests approved by USDA APHIS for the specific disease and species (blood testing for brucellosis and the caudal fold tuberculin test for TB); or

(c) Has passed an annual random individual animal brucellosis and/or TB testing program, using tests approved by USDA APHIS for the specific disease and species (blood testing for brucellosis and the caudal fold tuberculin test for TB), sufficient to provide a confidence level of 99 percent with a P value of 0.05. Any herd or flock with one (1) or more confirmed positive animals shall go to 100 percent testing until the whole herd tests show no positive animals are found; or

(d) Has passed a USDA APHIS approved bulk milk test for the specific disease and species, at USDA APHIS recommended frequency, with an implementation date based on the availability of the bulk milk test once USDA APHIS has approved such a test for the specific disease and species (The brucellosis ring test is USDA APHIS approved for the bovine species and is not suitable for most non-bovine species.); or

(e) Is determined to be free of brucellosis and/or TB as provided by the development and implementation of a state administered brucellosis-free and/or TB-free herd certification program involving a documented surveillance program, which includes records supporting the tests required in this section, and an official annual written certification from the State Veterinarian documenting their brucellosis-free and/or TB-free status. The surveillance program shall be documented and the official annual written state brucellosis-free and/or TB-free certification shall be retained on file with the State Health Officer. This official annual written state brucellosis-free and/or TB-free certification shall include a current list of Grade “A” non-cattle dairy herds and/or flocks (goats, sheep, water buffalo, camels, etc.) that are covered within the documented surveillance program and contained within the official annual written state brucellosis-free and/or TB-free certification (refer to the Note: on page 35).

(f) The following table will provide the random sampling size needed to achieve 99 percent confidence with a P value of 0.05:

(g) For diseases other than brucellosis and TB, the Health Officer shall require such physical, chemical, or bacteriological tests as he/she deems necessary. The diagnosis of other diseases in dairy animals shall be based upon the findings of a licensed and accredited veterinarian or an accredited veterinarian in the employ of an official agency. Any diseased animal disclosed by such test(s) shall be disposed of as the Health Officer directs.

(h) Records supporting the tests required in this section shall be available to the Health Officer and be validated with the signature of a licensed and accredited veterinarian or an accredited veterinarian in the employ of an official agency.

Note: For the ICP, references to USDA and/or state in Items (a) through (e) above shall mean the government agency responsible for animal disease control in the country or region of that country. The term “accredited veterinarian” shall mean an individual veterinarian authorized for those activities in said country or region of that country.

(4) Public Health Reason

(a) The health of the animal is a very important consideration because a number of diseases of cattle, including TB, brucellosis, Q-fever, salmonellosis, staphylococcic infection, and streptococcic infection may be transmitted to man through the medium of milk. The organisms of most of these diseases may get into the milk either directly from the udder or indirectly through infected body discharges which may drop, splash, or be blown into the milk.

(b) The great reduction in the incidence of bovine TB in man indicates that the practice of good sanitation in animal husbandry, the testing of cattle and removal of the reactors from the herds, and the pasteurization of milk have been effective in the control of this disease. The reservoir of bovine TB still exists, however, constant vigilance against this disease must be continued by industry and health agencies.

(5) Administrative Procedures - This item is deemed to be satisfied when:

(a) Bovine Tuberculosis - All tuberculin tests and retests shall be made and any reactors disposed of, in accordance with the current edition of Uniform Methods and Rules; Bovine TB Eradication, Uniform Methods and Rules for Establishment and Maintenance of TB-Free Accredited Herds of Cattle, Modified Accredited Areas and Areas Accredited Free of Bovine TB in the Domestic Bovine, as published by the USDA at the time of the adoption of these rules. For TB test purposes, the herd is defined as all adult cattle twenty-four (24) months of age and over, including any commingled beef animals. Dairy cattle less than two (2) years of age and already milking shall be included in the herd test. A letter or other official correspondence attesting to the accreditation status of the locality in which the herd is located, including the date of accreditation, or a certificate identifying the animals tested, the date of injection, the date of reading of the test, and the results of the test signed by a USDA accredited veterinarian shall be evidence of compliance with the above requirements and shall be filed with the Health Officer (see Appendix A).

Note: For the ICP, an official letter or other official correspondence attesting to the accreditation status of the locality in which the herd is located, including the date of accreditation or recertification or certificate identifying the animals tested, the date of injection, the date of the reading of the test, and the results of the test signed by the county’s veterinary services shall be provided as directed by the TPC.

(b) Bovine Brucellosis - All brucellosis tests, retests, disposal of reactors, vaccination of calves, and certification of herds and areas shall be in accordance with the current edition of Brucellosis Eradication Recommended Uniform Methods and Rules, as published by the USDA. All reactors disclosed on blood agglutination tests shall be separated immediately from the milking herd; the milk of these reactors shall not be used for human consumption.

(c) A certificate identifying each animal, signed by the veterinarian and the director of the laboratory making the test, shall be filed as directed by the Health Officer.

Provided, that in the event the herd is subject to the milk ring test, the record shall be required to show only the date and results of such test. Within thirty (30) days following the expiration of an official milk ring testing program or in the case of a herd subject to annual blood tests, thirteen

(13) months following the last annual blood tests, the Health Officer shall notify the herd owner or operator of the necessity to comply with the brucellosis requirements. The failure of the herd owner or operator to comply with the brucellosis requirements within thirty (30) days of written notice shall result in immediate suspension of the permit (See Appendix A).

Note: For the ICP, a certificate identifying each animal signed by the country’s veterinary services and director of the laboratory conducting the testing shall be provided as directed by the TPC.

(d) Other Diseases - Cows which show a complete induration of one quarter or extensive induration in one or more quarters of the udder upon physical examination, whether secreting abnormal or not shall be permanently excluded from the milking herd; provided this shall not apply in the case of a quarter that is completely dry. Lactating animals giving bloody, stringy, or otherwise abnormal milk based on bacteriological, chemical, or physical examination, but without entire or extensive induration of the udder, shall be excluded from the herd until re-examination shows that the milk has become normal. For other diseases such tests and examinations as the Health Officer may require shall be made at intervals and by methods prescribed by him or the Alabama State Veterinarian, and any diseased or dead animals or reactors shall be disposed of as either may require.

History

• Author: G. M. Gallaspy, Jr.
• Authority: Code of Ala. 1975, §§22-2-2, 22-20-7.
• Repealed and New Rule: Filed October 18, 2018; effective December 2, 2018.

Ala. Admin. Code r. 420-3-16-.12 Milk And Milk Products Which May Be Sold

From and after thirty-five (35) days from the date on which this rule is adopted, only Grade “A” pasteurized, ultra-pasteurized, aseptically processed, and packaged low-acid milk, milk products, frozen desserts, or retort processed after packaged low-acid milk, milk products, and frozen desserts shall be sold to the final consumer, restaurants, soda fountains, grocery stores, or similar establishments. Provided, only Grade "A" milk and milk products shall be sold to milk plants for use in the commercial preparation of Grade "A” milk and/or milk products; provided further, that in an emergency, the sale of pasteurized, ultra-pasteurized, aseptically processed, and packaged low-acid milk, milk products, frozen products, or retort processed after packaged low-acid milk, milk products, or frozen desserts which have not been graded or the grade of which is unknown, may be authorized by the Health Officer, in which case, such milk and/or milk products shall be labeled "ungraded.”

Note: The option for the sale of “ungraded” milk and/or milk products as cited above shall not be applicable to a milk company IMS listed under the ICP.

History

• Author: G. M. Gallaspy, Jr.
• Authority: Code of Ala. 1975, §§22-2-2, 22-20-7.
• Repealed and New Rule: Filed October 18, 2018; effective December 2, 2018.

Ala. Admin. Code r. 420-3-16-.13 Transferring: Delivery Containers Cooling

(1) Except as permitted in this section, no milk product, milk hauler, or distributor shall transfer milk or milk products from one container or milk tank truck to another on the street in any vehicle, store, or in any place except a milk plant, frozen dessert plant, receiving station, transfer station, or milk house especially used for that purpose. The dipping or ladling of milk or fluid milk products is prohibited.

(2) It shall be unlawful to sell or serve any milk or fluid milk product except in individual, original container received from the distributor or from an approved bulk dispenser; provided, this requirement shall not apply to milk for mixed drinks requiring less than 1/2 (236 ml) pint of milk or to cream, whipped cream, or half-and-half which is consumed on the premises and which may be served from the original container of not more than 1/2 (1.9 l) gallon capacity or from a bulk dispenser approved for such service by the Health Officer.

(3) It shall be unlawful to sell any pasteurized milk, milk product, or frozen dessert which has not been maintained at the temperature set forth in Rule 420-3-16-.(09-10). If containers of pasteurized milk or milk products are stored in ice, the storage container shall be properly drained.

(4) Administrative Procedures - This item is deemed to be satisfied when:

(a) Transferring - The dipping or ladling of milk and fluid milk products is expressly prohibited except for immediate cooking purposes. Milk, milk product, and frozen dessert containers which have been filled and sealed at a milk or frozen dessert plant shall be used for the delivery of milk, milk products, or frozen desserts. Caps, closures, or labels shall not be removed or replaced during transportation.

(b) Bulk Dispensers - Bulk dispensers approved by the Health Officer shall satisfy the following sanitary design, construction, and operation requirements:

1. All dispensers shall comply with the applicable requirements of Rule 420-3-16-.10.

2. Product-contact surfaces shall be inaccessible to manual contact, droplet infection, dust, or flies; but the delivery orifice may be exempted from this rule.

3. All parts of the dispensing device with which milk or milk products come into contact, including any measuring device, shall be thoroughly cleaned and sanitized at the milk plant; provided dispensing valves which are applied to the dispenser subsequent to its delivery to the retail vendor may be cleaned and sanitized at such establishments.

4. The dispensing container shall be filled at the milk or frozen dessert plant and shall be so sealed that it is impossible to withdraw any part of its contents or to introduce any substance without breaking the seal(s).

5. The milk or milk products shall be thoroughly and automatically mixed with each dispensing operation, except for milk or milk products which remain homogeneous.

6. All cans shall be thoroughly cleaned and sanitized. Milk, milk products, and frozen desserts shall be kept at or below 45°F (7°C) at all times. The dispenser tube shall be integral with the dispensing container, shall be protected, and shall be under adequate refrigeration during transportation and storage.

History

• Author: G. M. Gallaspy, Jr.
• Authority: Code of Ala. 1975, §§22-2-2, 22-20-7.
• Repealed and New Rule: Filed October 18, 2018; effective December 2, 2018.

Ala. Admin. Code r. 420-3-16-.14 Distribution Of Milk And Milk Products From Points Beyond Local Jurisdiction

(1) Milk and/or milk products, from points beyond the limits of routine inspection of the ADPH or its jurisdiction, shall be sold in Alabama or its jurisdiction provided they are produced and pasteurized, ultra-pasteurized, aseptically processed and packaged, retort processed after packaging, concentrated (condensed), or dried under regulations which are substantially equivalent to this rule and have been awarded acceptable Milk Sanitation Compliance and Enforcement Ratings; or have been awarded an acceptable HACCP listing, under the NCIMS voluntary HACCP Program as specified in Appendix K; or are from a country that USPHS/FDA has determined, after conferring with the NCIMS, to have in place a public health regulatory program and government oversight of that program that have an equivalent effect on the safety of regulated milk and/or milk products.

(2) Administrative Procedures - This item is deemed to be satisfied when the Health Officer should accept, without their actual physical inspection, supplies of milk, milk products, and frozen desserts from an area or an individual shipper not under their routine inspection, provided:

(a) Upon arrival, raw milk and/or raw milk products for pasteurization shall comply with bacteriological, chemical, and temperature standards of Rule 420-3-16-.08 as determined in accordance with Rule 420-3-16-.07. Provided, that direct shipped producer milk that is under the supervision of more than one (1) regulatory agency may be exempt from the bacteriological requirement for commingled samples. However, the receiving regulatory agency shall have the right to use the individual producer samples to determine compliance with the bacteriological standards using the individual producer raw milk standards.

(b) After receipt, pasteurized, ultra-pasteurized, aseptically processed, and packaged, retort processed after packaging, concentrated (condensed), or dried milk, milk products, and frozen desserts shall comply with the bacteriological, chemical, and temperature requirements of Rule 420-3-16-.08 as determined in accordance with Rule 420-3-16-.03, 420-3-16-.05, and 420-3-16-.13.

Note: Raw, pasteurized, and ultra-pasteurized milk, milk products, and frozen dessert products beyond the limits of routine inspection shall be sampled as the Health Officer requires.

(c) The milk, milk products, or frozen desserts are produced and processed under regulations substantially equivalent to these rules.

(d) The supplies are under routine official supervision.

(e) The milk supplies have been awarded by a SRO certified by the FDA, a Milk Sanitation Compliance rating equal to that of the local supply or equal to 90 percent or higher.

(f) The supplies have been awarded by a SRO, certified by the FDA, an Enforcement Rating equal to the local supply, or equal to 90 percent or higher, or if the enforcement rating is below 90 percent on a rating, a re-rating shall occur within six (6) months of this rating. Both the Milk Sanitation Compliance and Enforcement Ratings shall be equal to 90 percent or greater on the re-rating or the supply is considered in violation of this section.

(g) All ratings are made on the basis of procedures outlined in Methods of Making Sanitation Ratings of Milk Shipper’s (MMSR).

Note: Names of interstate milk shippers and their ratings, as reported by rating agencies, are contained on the IMS list issued electronically by the FDA. This list may be obtained from the FDA website at http://www.fda.gov/Food/Guidance Regulation/FederalStateFoodPrograms/ucm2007965.htm.

(h) The supplies have been awarded by a SRO, certified by the FDA, a satisfactory listing under the NCIMS voluntary HACCP Program as specified in Appendix K.

(i) The foreign supplies have been awarded a satisfactory listing by a TPC SRO certified by the FDA, under the ICP.

(j) FDA has determined that the foreign country’s public health regulatory program and the government oversight of that program have an equivalent effect on the safety of the regulated milk and/or milk product. It is USPHS/FDA’s responsibility to determine equivalence and USPHS/FDA shall confer with NCIMS prior to finalizing a determination of equivalence. The foreign government shall provide adequate assurance that the level of public health protection provided by its dairy safety system is equivalent to that provided by the NCIMS program.

(k) Aseptically processed and packaged low-acid milk and/or milk products in the definition of milk products of this rule shall be considered to be Grade "A" milk and/or milk products. The sources(s) of the milk and/or milk products used to produce aseptically processed and packaged low-acid milk and/or milk products shall be IMS listed. Aseptically processed and packaged low-acid milk and/or milk products shall be labeled "Grade "A" and meet Rule 420-3-16-.05 labeling requirements of this rule. The milk plant or portion of the milk plant that is producing aseptically processed and packaged low-acid milk and/or milk products shall be awarded a Milk Sanitation Compliance Rating of at least 90 percent and an enforcement rating equal to the local supply, or equal to 90 percent or higher, or if the Enforcement Rating is below 90 percent on a rating, a re-rating shall occur within (6) months of this rating. Both the Milk Sanitation Compliance and Enforcement Ratings shall be equal to 90 percent or higher on the re-rating or the supply is considered in violation of this section. In the case of HACCP/Aseptic listings, an acceptable HACCP listing by a SRO is required. For milk plants that produce aseptically processed and packaged Grade “A” low-acid milk and/or milk products, prior to the milk plant participating in the NCIMS Aseptic Processing and Packaging Program or the Aseptic Pilot Program, the Health Officer's and Rating Agency's personnel shall have completed a training course that is acceptable to the NCIMS and FDA addressing the procedures for conducting regulatory inspections and ratings under the NCIMS Aseptic Processing and Packaging Program or Aseptic Pilot Program. The NCIMS Aseptic Pilot Program addressing aseptically processed and packaged acidified and fermented high-acid milk and/or milk products regulated under 21 CFR Parts 108, 110, and/or 114 shall expire on December 31, 2017, unless extended by future conference action.

(l) Retort processed after packaging low-acid milk and/or milk products as addressed in the definition of milk products of this rule shall be considered to be Grade "A" milk and/or milk products if they are used as an ingredient to produce any milk and/or milk product defined in the definition of milk products of this rule; or if they are labeled as Grade “A” as described in Rule 420-3-16-.05. Retort processed after packaging low-acid milk and/or milk products shall be labeled "Grade "A" and meet Rule 420-3-16-.05 whenever they meet the provisions cited within the definition of milk products of this rule. The source(s) of the milk and/or milk products used to produce retort processed after packaging Grade “A” low-acid milk and/or milk products shall be IMS listed. The milk plant or portion of the milk plant that is producing retort processed after packaging Grade “A” low-acid milk and/or milk products shall be awarded a Milk Sanitation Compliance Rating of at least 90 percent and an enforcement rating equal to the local supply, or equal to 90 percent or higher; or if the enforcement rating is below 90 percent on a rating, a re-rating shall occur within (6) months of this rating. Both, the Milk Sanitation Compliance and Enforcement Ratings shall be equal to 90 percent or higher on the re-rating; or the supply is considered in violation of this section. In the case of HACCP/Retort listings, an acceptable HACCP listing by a SRO is required. For milk plants that produce retort processed after packaging Grade “A” low-acid milk and/or milk products and prior to the milk plant participating in the NCIMS Retort Processed after Packaging Program, the Health Officer's and Rating Agency's personnel shall have completed a training course that is acceptable to the NCIMS and FDA addressing the procedures for conducting regulatory inspections and ratings under the NCIMS Retort Processed after Packaging Program.

History

• Author: G. M. Gallaspy, Jr.
• Authority: Code of Ala. 1975, §§22-2-2, 22-20-7.
• Repealed and New Rule: Filed October 18, 2018; effective December 2, 2018.

Ala. Admin. Code r. 420-3-16-.15 Future Dairies, Milk Plants, And Frozen Dessert Plants

Properly prepared plans for all milkhouses, milking barns, stables, parlors, milk tank truck cleaning facilities, transfer stations, receiving stations, milk plants, and frozen dessert plants regulated under these rules which are hereafter constructed, reconstructed, or extensively altered, shall be submitted to the Health Officer for written approval before work is begun.

History

• Author: G. M. Gallaspy, Jr.
• Authority: Code of Ala. 1975, §§22-2-2, 22-20-7.
• Repealed and New Rule: Filed October 18, 2018; effective December 2, 2018.

Ala. Admin. Code r. 420-3-16-.16 Personnel Health

(1) No person affected with any disease capable of being transmitted to others through the contamination of food in a communicable form, or while a carrier of such disease, shall work at any dairy farm, milk plant, or frozen dessert plant in any capacity which brings him into contact with the production, handling, storage, or transportation of milk, milk products, frozen desserts, containers, equipment, and utensils; and no dairy farm or milk or frozen dessert plant operator shall employ in any such capacity any such person, or any person suspected of having any disease in a communicable form, or of being a carrier of such disease. Any producer or distributor of milk, milk products, or frozen dessert plant where any communicable disease occurs, or who suspects that any employee has contracted any disease in a communicable form, or has become a carrier of such disease shall notify the Health Officer immediately.

(2) Administrative Procedures

(a) Milk and frozen dessert plant operators who have received reports under this section from employees who have handled pasteurized, ultra-pasteurized, aseptically processed and packaged low-acid milk, and/or milk, milk products, and frozen dessert products, or retort processed after packaged low-acid milk and/or milk products, or associated milk and/or milk product-contact surfaces shall immediately report these facts to the appropriate Health Officer.

(b) Milk and frozen dessert plant employees, or applicants to whom a conditional offer of employment has been made, shall be instructed by the milk plant that the employee or applicant or applicants to whom a conditional offer of employment has been made is responsible to report to the milk plant management, in a manner that allows the milk and frozen dessert plants to prevent the likelihood of the transmission of diseases that are transmissible through foods, if the employee or applicant to whom a conditional offer of employment has been made:

1. Is diagnosed with an illness due to Hepatitis A virus, Salmonella typhi, Shigella species, Norwalk and Norwalk-like Viruses, Staphylococcus aureus, Streptococcus pyogenes, Escherichia coli 0157:H7, enterohemorrhagic Escherichia coli, enterotoxigenic Escherichia coli, Campylobacter jejuni, Entamoeba histolytica, Giardia lamblia, Non-typhoidal Salmonella, Rotovirus, Taenia solium, Yersinia enterocolitica, Vibrio cholerae O1 or other infectious or communicable disease that has been declared by the Secretary of Health and Human Services (HHS) to be transmissible to others through the handling of food, or has been clearly shown to be so based upon verifiable epidemiological data; or

2. Is exposed to or suspected of causing a confirmed foodborne disease outbreak of one (1) of the diseases specified in Item 1 above, including an outbreak at an event such as a family meal, church supper, or ethnic festival because the employee or applicant to whom a conditional offer of employment has been made:

(i) Prepared food implicated in the outbreak; or

(ii) Consumed food implicated in the outbreak; or

(iii) Consumed food at the event prepared by a person who is infected or ill.

3. Lives in the same household as a person who attends or works in a day care center, school, or similar institution experiencing a confirmed outbreak of one (1) of the diseases specified in Item 1 above.

4. Similarly, milk and frozen dessert plant employees shall be instructed by the milk and frozen dessert plant management to report to the milk plant management if the employee, or applicant to whom a conditional offer of employment has been made:

5. Has a symptom associated with acute gastrointestinal illness such as abdominal cramps or discomfort, diarrhea, fever, or loss of appetite for three (3) or more days, vomiting, jaundice; or

6. Has a pustular lesion such as a boil or infected wound that is:

(i) On the hands, wrists, or exposed portions of the arms, unless the lesion is covered by a durable, moisture proof, tight-fitting barrier; or

(ii) On other parts of the body if the lesion is open or draining, unless the lesion is covered by a durable, moisture proof, tight-fitting barrier.

History

• Author: G. M. Gallaspy, Jr.
• Authority: Code of Ala. 1975, §§22-2-2, 22-20-7.
• Repealed and New Rule: Filed October 18, 2018; effective December 2, 2018.

Ala. Admin. Code r. 420-3-16-.17 Procedure When Infection Is Suspected

(1) When a person who may have handled pasteurized, ultra-pasteurized, aseptically processed and packaged low-acid milk, and/or milk products or retort processed after packaged low-acid milk, milk products, frozen dessert products, or associated milk, milk products, and frozen dessert products contact surfaces meets one (1) or more of the conditions specified in the Rule 420-3-16-.16, the Health Officer is authorized to require any or all of the following measures:

(a) The immediate restricting of that person from duties that require handling pasteurized milk or milk products, or the handling of related milk or milk product-contact surfaces. This restriction may be lifted after an appropriate medical clearance or cessation of symptoms or both, according to the following table:

(b) The immediate exclusion of the affected milk or milk products from distribution and use when medically appropriate (i.e., a medical evaluation of the sequence of events indicates that contamination of milk or milk product may have occurred).

(c) The immediate requesting of medical and bacteriological examination of the person at risk.

Note: Persons at risk who decline to be examined may be reassigned to duties where they will not be required to handle pasteurized, ultra-pasteurized, aseptically processed and packaged low-acid milk and/or milk products, or retort processed after packaged low-acid milk and/or milk products and associated milk and/or milk product-contact surfaces.

(2) In the case of milk plants, receiving stations, or transfer stations that have HACCP Systems which are regulated under the NCIMS voluntary HACCP Program, the HACCP System shall address the public health concerns described in this section in a manner that provides protection equivalent to the requirements in this section.

History

• Author: G. M. Gallaspy, Jr.
• Authority: Code of Ala. 1975, §§22-2-2, 22-20-7.
• Repealed and New Rule: Filed October 18, 2018; effective December 2, 2018.

Ala. Admin. Code r. 420-3-16-.18 Adoption By Reference

Requirements for Production, Processing, Handling, or Distribution of Milk, Milk Products, Frozen Desserts, and Single Service Manufacturing Products

(1) Adoption by reference-The document entitled Grade “A” Pasteurized Milk Rule, 2017 Revision, Promulgated by the U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, is hereby incorporated by reference and made a part of this rule as if set out in full and all provisions thereof are adopted as a rule of the State Board of Health.

(2) Availability – Said document is available at the office of Director, Division of Food, Milk, and Lodging, RSA Tower, Suite 1250, 201 Monroe Street, Montgomery, Alabama 36104.

(3) Control – Where there is consistency between Chapter 420-3-16 and the Grade “A” Pasteurized Milk Rule, 2017 Revision, these rules control. Where these rules are silent, the Grade “A” Pasteurized Milk Rule, 2017 Revision controls.

History

• Author: G. M. Gallaspy, Jr.
• Authority: Code of Ala. 1975, §§22-2-2, 22-20-7.
• New Rule: Filed October 18, 2018; effective December 2, 2018.

Ala. Admin. Code r. 420-3-16-.19 Enforcement Interpretation

The Health Officer shall enforce this rule and a certified copy of which shall be on file in the office of the State Health Officer. Where the mandatory compliance with provisions of the appendices is specified, such provisions shall be deemed a requirement of these rules.

History

• Author: G. M. Gallaspy, Jr.
• Authority: Code of Ala. 1975, §§22-2-2, 22-20-7.
• Repealed and New Rule: Filed October 18, 2018; effective December 2, 2018.
• Editor's note: New Rule .18 was inserted and the original rule .18 was renumbered .19 as per certification filed October 18, 2018; effective December 2, 2018.

Ala. Admin. Code r. 420-3-16-.20 Penalty Fixed

Any violation of these rules shall constitute a misdemeanor as set forth and declared punishable in Code of Ala. 1975, §22-1-8.

History

• Author: G. M. Gallaspy, Jr.
• Authority: Code of Ala. 1975, §§22-2-2, 22-20-7.
• Repealed and New Rule: Filed October 18, 2018; effective December 2, 2018.
• Editor's note: Rule .19 was renumbered .20 as per certification filed October 18, 2018; effective December 2, 2018.

Ala. Admin. Code r. 420-3-16-.21 Application Of Rules

(1) These rules shall apply only to milk, milk products, and frozen desserts intended for sale for human consumption and single-service containers and closures used for milk, milk products, and frozen desserts.

(2) These rules supersede all prior rules and all rules and parts of rules in conflict with this rule are hereby repealed upon the date these rules become effective.

History

• Author: G. M. Gallaspy, Jr.
• Authority: Code of Ala. 1975, §§22-2-2, 22-20-7.
• Repealed and New Rule: Filed October 18, 2018; effective December 2, 2018.
• Editor's note: Rule .20 was renumbered .21 as per certification filed October 18, 2018; effective December 2, 2018.

Ala. Admin. Code r. 420-3-16-.22 Unconstitutionality Provided Against

Should any section, paragraph, sentence, clause, or phrase of these rules be declared unconstitutional or invalid by any court of competent jurisdiction, the remainder of these regulations shall not be affected thereby.

History

• Author: G. M. Gallaspy, Jr.
• Authority: Code of Ala. 1975, §§22-2-2, 22-20-7.
• Repealed and New Rule: Filed October 18, 2018; effective December 2, 2018.
• Editor's note: Rule .21 was renumbered .22 as per certification filed October 18, 2018; effective December 2, 2018.