Title of Regulation: 2VAC5-490. Regulations Governing Grade "A" Milk (amending 2VAC5-490-10, 2VAC5-490-15, 2VAC5-490-32, 2VAC5-490-35, 2VAC5-490-36, 2VAC5-490-37, 2VAC5-490-40, 2VAC5-490-50, 2VAC5-490-73, 2VAC5-490-105, 2VAC5-490-131, 2VAC5-490-138, 2VAC5-490-140; adding 2VAC5-490-30.1).

Statutory Authority: § 3.2-5206 of the Code of Virginia.

Effective Date: December 10, 2010.

Agency Contact: John A. Beers, Program Supervisor, Department of Agriculture and Consumer Services, P. O. Box 1163, Richmond, VA 23218, telephone (804) 786-1452, FAX (804) 371-7792, TTY (800) 828-1120, or email john.beers@vdacs.virginia.gov.

Summary:

The final amendments adopt the provisions of the 2009 revision of the Pasteurized Milk Ordinance (PMO). The PMO is a federal model regulation for states to adopt to govern the production, processing, distribution, and sale of grade A milk and milk products.

The changes to the final regulations (i) adopt by reference the 2009 version of "Evaluation of Milk Laboratories" published by the Food and Drug Administration Laboratory Quality Assurance Team in place of the 2007 version referenced in the proposed regulation and (ii) correct a typographical error to make the last sentence in 2VAC5-490-35 D read correctly.

Part I
Definitions and Standards of Identity

2VAC5-490-10. Definitions and standards of identity.

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"A hazard that is reasonably likely to occur" means a hazard for which a prudent milk plant, receiving station or transfer station operator would establish controls because experience, illness data, scientific reports, or other information provide a basis to conclude that there is a reasonable possibility that, in the absence of these controls, the hazard will occur in the particular type of milk, milk product, condensed milk, condensed milk product, dry milk, or dry milk product being processed.

"Abnormal milk" means milk that is visibly changed in color, odor or texture.

"Acidified milk" means "acidified milk" as defined in 21 CFR 131.111.

"Acidified milk product" means a product with an acidity of not less than 0.50% expressed as lactic acid, which product is obtained by the addition of food grade acids to pasteurized cream, half-and-half, heavy cream, light cream, lowfat milk, milk, skim milk, or sour cream.

"Acidified sour cream" means "acidified sour cream" as defined in 21 CFR 131.162.

"Adulterated milk" or "adulterated milk product" means any milk, milk product, condensed milk product, or dry milk product which meets one or more of the conditions specified in Section 402 of the Federal Food, Drug and Cosmetic Act, as amended (21 USC § 342).

"Aseptically processed milk" means milk that is hermetically sealed in a container and so thermally processed before or after packaging in conformance with 21 CFR Part 113 and the provisions of this chapter so as to render the product free of microorganisms capable of reproducing in the product under nonrefrigeration conditions of storage and distribution and that is free of viable microorganisms (including spores) capable of causing disease in humans.

"Aseptically processed milk product" means any milk or milk product that is hermetically sealed in a container and so thermally processed before or after packaging in conformance with 21 CFR Part 113 and the provisions of this chapter so as to render the product free of microorganisms capable of reproducing in the product under normal nonrefrigeration conditions of storage and distribution and that is free of viable microorganisms (including spores) capable of causing disease in humans.

"Aseptic processing" means that the product has been subjected to sufficient heat processing and packaged in a hermetically sealed container, to conform to the applicable requirements of 21 CFR Part 113 and the provisions of this chapter and to maintain the commercial sterility of the product under normal nonrefrigerated conditions.

"Audit" means an evaluation of the entire milk plant, receiving station or transfer station facility and HACCP System to ensure compliance with the voluntary HACCP program requirements of this chapter.

"Automatic milking installation" means the entire installation of one 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.

"Boiled custard" means "eggnog" as defined in 21 CFR 131.170.

"Bulk milk hauler" means any person who holds a permit issued by the Virginia Department of Agriculture and Consumer Services to collect official milk samples and transport: (i) raw milk from a dairy farm to a milk plant, receiving station or transfer station; or (ii) raw milk products from one milk plant, receiving station or transfer station to another milk plant, receiving station or transfer station.

"Buttermilk" means the fluid milk product that remains after the manufacture of butter from milk or cream and contains not less than 8.25% of milk solids not fat.

"Cancel" means to permanently nullify, void, or delete a grade A permit issued by the State Regulatory Authority.

"Centralized deviation log" means a centralized log or file identifying data detailing any deviation of critical limits and the corrective actions taken.

"CFR" means the Code of Federal Regulations.

"Clean" means the surfaces of equipment and facilities have had an effective and thorough removal of product, soils, and contaminants.

"Coffee cream" means "light cream."

"Commercially sterile" means (i) the food has been thermally processed by the application of heat to render the food free of viable microorganisms (including spores) of public health significance and microorganisms capable of reproducing in the food under normal nonrefrigerated conditions of storage and distribution; or (ii) the food has been processed with the application of heat and the water activity of the food has been controlled to render the food free of microorganisms capable of reproducing in the food under normal nonrefrigerated conditions of storage and distribution.

"Concentrated milk" means "concentrated milk" as defined in 21 CFR 131.115.

"Concentrated milk product" means any of the following foods: homogenized concentrated milk, homogenized concentrated skim milk, concentrated lowfat milk, concentrated milk, and concentrated skim milk, which when combined with potable water according to the instructions printed on the food's container, conforms to the definition of the corresponding milk product in this chapter.

"Condensed buttermilk" means the product resulting from the removal of a considerable portion of water from buttermilk.

"Condensed and dry milk product" means grade A condensed milk, grade A condensed and dry whey, grade A dry milk product, or grade A dry milk and whey product.

"Condensed milk" means concentrated milk as defined in 21 CFR 131.115. This definition does not include:

1. Any sterilized milk or milk product, when the sterilized milk or milk product is hermetically sealed in a container and processed, either before or after sealing, so as to prevent microbial spoilage; or

2. Any evaporated milk or sweetened condensed milk, except when the evaporated milk or sweetened condensed milk is combined with other substances in the commercial preparation of any pasteurized, ultra-pasteurized, or aseptically processed milk or milk product.

"Condensed whey" means "condensed whey" as defined in 21 CFR 184.1979(a)(2).

"Consumer" means any person who uses any grade A milk, grade A milk product, or milk product.

"Corrective action" means procedures followed when a deviation occurs.

"Cottage cheese" means "cottage cheese" as defined in 21 CFR 133.128.

"Cottage cheese dry curd" means "dry curd cottage cheese."

"Cream" means "cream" as defined in 21 CFR 131.3(a).

"Critical control point" means a step at which control can be applied and is essential to prevent or eliminate a milk, milk product, condensed milk, condensed milk product, dry milk, or dry milk product safety hazard or reduce it to an acceptable level.

"Critical limit" means a maximum value or a minimum value to which a biological, chemical, or physical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of a milk, milk product, condensed milk, condensed milk product, dry milk, or dry milk product safety hazard.

"Cultured half-and-half" means "sour half-and-half."

"Cultured milk" means "cultured milk" as defined in 21 CFR 131.112.

"Cultured sour cream" means "sour cream."

"Dairy farm" means any place or premises where any cow, goat, sheep, water buffalo, or other mammal (except humans) is kept, from which cow, goat, sheep, water buffalo, or other mammal (except humans) milk or any milk product is provided, sold or offered for sale for human consumption or provided to a milk plant, cheese plant, frozen desserts plant, transfer station, or receiving station.

"Deficiency" means an element that is inadequate or missing from the requirements of a HACCP System or with the voluntary HACCP program requirements of this chapter.

"Deny" means the State Regulatory Authority will not issue a grade A permit to the applicant.

"Deviation" means a failure to meet a critical limit.

"Drug" means: (i) 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; (ii) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; (iii) articles other than food intended to affect the structure or any function of the body of man or other animals; and (iv) articles intended for use as a component of any articles specified in clause (i), (ii), or (iii) of this definition, but does not include devices or their components, parts, or accessories.

"Dry buttermilk" means "dry buttermilk" as defined in 7 CFR 58.251.

"Dry buttermilk product" means "dry buttermilk product" as defined in 7 CFR 58.251.

"Dry cream" means "dry cream" as defined in 21 CFR 131.149.

"Dry curd cottage cheese" means "dry curd cottage cheese" as defined in 21 CFR 133.129.

"Dry milk product" means a product resulting from the drying of any milk or milk product and any product resulting from the combination of a dry milk product with other safe and suitable dry ingredients.

"Dry whey" means "dry whey" as defined in 21 CFR 184.1979.

"Dry whey product" means a product 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.

"Dry whole milk" means "dry whole milk" as defined in 21 CFR 131.147.

"Eggnog" means "eggnog" as defined in 21 CFR 131.170.

"Eggnog-flavored milk" means a milk product, to which an emulsifier and a maximum of 0.5% stabilizer may have been added consisting of a mixture of (i) at least 3.25% butterfat, (ii) at least 0.5% egg yolk solids, (iii) sweetener, and (iv) flavoring.

"Evaporated milk" means "evaporated milk" as defined in 21 CFR 131.130.

"Flavored milk" means milk to which a flavor or sweetener has been added.

"Flavored milk product" means any milk product to which a flavor or sweetener has been added.

"Fortified milk" means milk, other than vitamin D milk, the vitamin or mineral content of which milk has been increased.

"Fortified milk product" means any milk product, other than a vitamin D milk product, the vitamin or mineral content of which milk product has been increased.

"Frozen milk concentrate" means the frozen milk product which, when water is added in accordance with instructions on the package containing the frozen milk product, the reconstituted milk product contains the percentage of milkfat and the percentage of milk solids not fat of milk.

"Goat milk" means the normal lacteal secretion, practically free of colostrum, obtained by the complete milking of one or more healthy goats which, when sold in retail packages, contains not less than 2.5% milkfat and not less than 7.5% nonfat milk solids not fat.

"Grade A condensed and dry whey" means condensed or dry whey which complies with the provisions of the "Grade "A" Pasteurized Milk Ordinance, 2005 2009 Revision" and this chapter.

"Grade A condensed milk" means condensed milk which complies with the provisions of the "Grade "A" Pasteurized Milk Ordinance, 2005 2009 Revision" and this chapter.

"Grade A dry milk product" means any dry milk product which complies with the provisions of the "Grade "A" Pasteurized Milk Ordinance, 2005 2009 Revision" and this chapter.

"Grade A dry milk and whey product" means any dry milk or whey product which has been produced for use in any grade A pasteurized, ultra-pasteurized, or aseptically processed milk product; and which has been manufactured under the provisions of the "Grade "A" Pasteurized Milk Ordinance, 2005 2009 Revision" and this chapter.

"Grade A permit" means the written document issued by the state regulatory authority to the person who operates a: (i) dairy farm to produce raw milk for pasteurization, ultra-pasteurization, or aseptic processing; (ii) milk plant; (iii) receiving station; (iv) transfer station; (v) milk condensing plant; (vi) milk drying plant; (vii) whey condensing plant; or (viii) whey drying plant; after the State Regulatory Authority has inspected and approved the person's operation and determined the person's compliance with the provisions of this chapter for the operations specified in this definition.

"HACCP" means hazard analysis critical control point.

"HACCP plan" means the written document, which is based upon the principles of HACCP and delineates the procedures to be followed.

"HACCP system" means the implemented HACCP plan and prerequisite programs, including other applicable requirements of the voluntary HACCP program of this chapter.

"Half-and-half" means "half-and-half" as defined in 21 CFR 131.180.

"Hazard" means a biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.

"Hazard analysis" means the process of collecting and evaluating information on hazards associated with the milk, milk product, condensed milk, condensed milk product, dry milk, or dry milk product under consideration, to decide which are reasonably likely to occur and must be addressed in the HACCP plan.

"Heavy cream" means "heavy cream" as defined in 21 CFR 131.150.

"Lactose-reduced lowfat milk" means the product resulting from the addition of safe and suitable enzymes to convert enough lactose to glucose or galactose so that less than 30% of the lactose remains in the lowfat milk from which the product is made.

"Lactose-reduced milk" means the product resulting from the addition of safe and suitable enzymes to convert enough lactose to glucose or galactose so that less than 30% of the lactose remains in the milk from which the product is made.

"Lactose-reduced skim milk" means the product resulting from the addition of safe and suitable enzymes to convert enough lactose to glucose or galactose so that less than 30% of the lactose remains in the skim milk from which the product is made.

"Light cream" means "light cream" as defined in 21 CFR 131.155.

"Light whipping cream" means "light whipping cream" as defined in 21 CFR 131.157.

"Lowfat dry milk" means "lowfat dry milk" as defined in 21 CFR 131.123.

"Lowfat yogurt" means "lowfat yogurt" as defined in 21 CFR 131.203.

"Low-sodium lowfat milk" means the milk product resulting from the treatment of lowfat milk by a process of passing the lowfat milk through an ion exchange resin process, or by any other process which has been recognized by the Food and Drug Administration that effectively reduces the sodium content of the product to less than 10 milligrams in 100 milliliters.

"Low-sodium milk" means the milk product resulting from the treatment of milk by a process of passing the milk through an ion exchange resin process, or by any other process which has been recognized by the Food and Drug Administration that effectively reduces the sodium content of the product to less than 10 milligrams in 100 milliliters.

"Low-sodium skim milk" means the milk product resulting from the treatment of skim milk by a process of passing the skim milk through an ion exchange resin process, or by any other process which has been recognized by the Food and Drug Administration that effectively reduces the sodium content of the product to less than 10 milligrams in 100 milliliters.

"Market milk" means milk.

"Market milk product" means milk product.

"Milk" means the whole, fresh, clean lacteal secretion obtained by the complete milking of one or more healthy cows, goats, sheep, water buffalo, or other mammal (except humans) intended for human consumption excluding that obtained before and after birthing, for such a period as may be necessary to render the milk practically colostrum free.

"Milk condensing plant" means any plant in which milk or any milk product is condensed or dried, or in which milk or any milk product is received, separated, or otherwise processed for drying and packaging.

"Milk drying plant" means any plant in which milk or any milk product is condensed or dried, or in which milk or any milk product is received, separated, or otherwise processed for drying and packaging.

"Milkfat" means the fat of milk.

"Milkhouse" means the building or room in which there is conducted on a grade A dairy farm (i) the cooling, handling, and storing of milk and (ii) the washing, sanitizing, and storing of milk containers and utensils.

"Milk plant" means any place, premises, or establishment where any milk or milk product is collected, handled, processed, stored, pasteurized, ultra-pasteurized, aseptically processed, condensed, dried, bottled, or prepared for distribution.

"Milk producer" means any person who operates a dairy farm and who provides, sells, or offers milk for sale for human consumption or to a milk plant, receiving station, or transfer station.

"Milk product" means: (i) acidified lowfat milk, acidified nonfat milk, acidified milk, acidified milk product, acidified reduced fat milk, acidified skim milk, acidified sour cream, acidified sour half-and-half, aseptically processed milk, aseptically processed milk product, buttermilk, coffee cream, concentrated milk, concentrated milk product, cottage cheese, cottage cheese dry curd, cream, cultured half-and-half, cultured milk, cultured lowfat milk, cultured nonfat milk, cultured reduced fat milk, cultured skim milk, cultured sour cream, cultured sour half-and-half, dry curd cottage cheese, eggnog, eggnog-flavored milk, flavored milk, flavored milk product, fortified milk, fortified milk product, frozen milk concentrate, goat milk, half-and-half, heavy cream, heavy whipping cream, lactose-reduced lowfat milk, lactose-reduced nonfat milk, lactose-reduced milk, lactose-reduced reduced fat milk, lactose-reduced skim milk, light cream, light whipping cream, lowfat cottage cheese, lowfat milk, lowfat yogurt, low-sodium lowfat milk, low-sodium nonfat milk, low-sodium milk, low-sodium reduced fat milk, low-sodium skim milk, milk, nonfat milk, nonfat yogurt, recombined milk, recombined milk product, reconstituted milk, reconstituted milk product, reduced fat milk, sheep milk, skim milk, sour cream, sour half-and-half, table cream, vitamin D milk, vitamin D milk product, whipped cream, whipped light cream, whipping cream, or yogurt; (ii) any of the following foods: milk, lowfat milk, or skim milk with added safe and suitable microbial organisms; or (iii) any food made with a food specified in (i) of this definition by the addition or subtraction of milkfat or addition of safe and suitable optional ingredients for protein, vitamin, or mineral fortification. Nothing in this definition shall be deemed to include any evaporated milk, evaporated skim milk, condensed milk (sweetened or unsweetened), infant formula, ice cream or other dessert, dietary product, dry milk product (except as defined herein), canned eggnog in a rigid metal container, or butter or cheese, except when butter or cheese is combined with other substances to produce any pasteurized or aseptically processed food as specified in this definition grade A milk and grade A milk products meeting the requirements of 2VAC5-490-15.

"Misbranded milk" or "misbranded milk product" means any milk, milk product, or condensed and dry milk product that: (i) satisfies any of the conditions specified in § 403 of the Federal Food Drug, and Cosmetic Act, as amended (21 USC 343), (ii) does not conform to its definition; or (iii) is not labeled in accordance with 2VAC5-490-40.

"Nonconformity" means a failure to meet specified requirements of the HACCP system.

"Nonfat dry milk" means "nonfat dry milk" as defined in 21 CFR 131.125.

"Nonfat dry milk fortified with vitamins A and D" means "nonfat dry milk fortified with vitamins A and D" as defined in 21 CFR 131.127.

"Nonfat yogurt" means "nonfat yogurt" as defined in 21 CFR 131.206.

"Normal storage" means storage at a temperature of 45°F or cooler, but does not include freezing.

"Official laboratory" means a biological, chemical, or physical laboratory operated by the Commonwealth of Virginia.

"Officially designated laboratory" means: (i) a commercial laboratory authorized by the State Regulatory Authority to examine milk, milk product, condensed and dry milk product, producer samples of Grade "A" raw milk for pasteurization, or commingled milk tank truck samples of raw milk or milk products or (ii) a milk-industry laboratory authorized by the State Regulatory Authority to examine milk producer samples of raw milk for pasteurization, and for drug residues and bacterial limits, samples of raw milk commingled in a tank truck.

"Pasteurization" or "pasteurized" means the process of heating every particle of milk, or milk product, or whey in equipment designed and operated in conformance with this chapter, 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 for the equipment indicated:

Temperature	Time	Equipment
145°F*	30 minutes	Vat Pasteurization
161°F*	15 seconds	High Temperature Short Time
191°F	1.0 second	High Temperature Short Time
194°F	0.5 second	High Temperature Short Time
201°F	0.1 second	High Temperature Short Time
204°F	0.05 second	High Temperature Short Time
212°F	0.01 second	High Temperature Short Time

*If: (i) the fat content of the milk or milk product is 10% or more greater; (ii) the total solids content of the milk or milk product is 18% or greater; or (ii) (iii) the milk or milk product contains added sweeteners; (iii) the product is condensed milk; or (iv) the milk product is a condensed milk product, then pasteurization means increasing the specified temperature by 5°F.

*If the dairy product is cream for butter-making, then "pasteurization" means heating to at least 165°F and holding continuously in a vat pasteurizer for not less than 30 minutes or pasteurizing by the High Temperature Short Time method at a minimum temperature of not less than 185°F for not less than 15 seconds.

*If the milk product is eggnog, then "pasteurization" means heating to at least the following temperatures for the corresponding time specifications and equipment:

Temperature	Time	Equipment
155°F	30 minutes	Vat Pasteurization
175°F	25 seconds	High Temperature Short Time
180°F	15 seconds	High Temperature Short Time

Nothing in this definition shall be construed as barring any other process which has been recognized by the Food and Drug Administration as being equally efficacious as pasteurization, so long as that other process has been approved by the State Regulatory Authority.

"Person" means any individual, plant operator, partnership, corporation, company, firm, trustee, or institution.

"Prerequisite programs" means procedures, including Good Manufacturing Practices, that address operational conditions that provide the foundation for the HACCP system.

"Public" means any person in the Commonwealth.

"Pull date" means the date affixed to a consumer package or container of grade A pasteurized milk or grade A pasteurized milk product which is the date after the day of manufacturing and processing of the package or container and the last day on which the grade A pasteurized milk or grade A pasteurized milk product as determined by the milk plant may be offered for sale to consumers under normal storage.

"Raw milk" means: (i) any milk or any milk product which has not been pasteurized, ultra-pasteurized, or aseptically processed; or (ii) or any milk or any milk product which has been pasteurized, ultra-pasteurized, or aseptically processed and which has been exposed to microbiological contamination before, during, or after packaging.

"Receiving station" means any place, premises, or establishment where raw milk is: (i) received, collected, handled, stored, or cooled; and (ii) prepared for further transporting.

"Recombined milk" means the food which, when combined with potable water according to the instructions printed on the food's container, conforms to the milk fat and nonfat milk solids requirements for milk, as specified in the definition of "milk."

"Recombined milk product" means the food which, when combined with potable water according to the instructions printed on the food's container, conforms to the milk fat and milk nonfat solids requirements for the milk product designated on the food's container.

"Reconstituted milk" means "recombined milk."

"Reconstituted milk product" means "recombined milk product."

"Reduced lactose whey" means "reduced lactose whey" as defined in 21 CFR 184.1979a.

"Reduced minerals whey" means "reduced minerals whey" as defined in 21 CFR 184.1979b.

"Revoke" means to permanently annul, repeal, rescind, countermand, or abrogate a Grade A permit issued by the State Regulatory Authority.

"Safe and suitable" means "safe and suitable" as defined in 21 CFR 130.3(d).

"Sanitization" means 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, and when used does not adversely affect: (i) the equipment which comes in contact with milk, milk product, or condensed and dry milk product; (ii) the milk, milk product, or condensed and dry milk product; or (iii) the health of consumers.

"Septage" means material accumulated in a pretreatment system or privy.

"Sewage" means water-carried and nonwater-carried human excrement; kitchen, laundry, shower, bath, or lavatory wastes separately or together with such underground, surface, storm and other water and liquid industrial wastes as may be present from residences, buildings, vehicles, industrial establishments or other places.

"Sheep milk" means the normal lacteal secretion, practically free of colostrum, obtained by the complete milking of one or more healthy sheep.

"Sour cream" means "sour cream" as defined in 21 CFR 131.160.

"State Regulatory Authority" means the Commissioner of Agriculture and Consumer Services or his agent when carrying out any duty specified in § 3.2-5207 of the Code of Virginia or the State Health Commissioner or his agent when carrying out any duty specified in § 3.2-5208 of the Code of Virginia.

"Suspend" means to temporarily nullify, void, debar, or cease for a period of time a grade A permit issued by the State Regulatory Authority.

"Sweetened condensed milk" means "sweetened condensed milk" as defined in 21 CFR 131.120.

"Table cream" means "light cream" as defined in 21 CFR 131.155.

"Transfer station" means any place, premises, or establishment where milk or milk products are transferred directly from one milk tank truck to another.

"Trim" means to shorten the hair on the udder and tail of milking cows and goats by clipping, singeing, cutting, or other means.

"Ultra-pasteurized" means, when used to describe any milk or milk product, that the milk or milk product has been thermally processed at a temperature of 280°F (138°C) or hotter for at least two seconds, either before or after packaging, so as to produce a product that has an extended shelf life under normal storage.

"Validation" means the element of verification focused on collecting and evaluating scientific and technical information to determine whether the HACCP plan, when properly implemented, will effectively control the hazards.

"Verification" means those activities, other than monitoring, that determine the validity of the HACCP plan and that the HACCP system is operating according to the plan.

"Vitamin A milk" means milk, the vitamin A content of which has been increased to at least 2000 International Units per quart.

"Vitamin A milk product" means a milk product, the vitamin A content of which has been increased to at least 2000 International Units per quart.

"Vitamin D milk" means milk, the vitamin D content of which has been increased to at least 400 International Units per quart.

"Vitamin D milk product" means a milk product, the vitamin D content of which has been increased to at least 400 International Units per quart.

"Water buffalo milk" means the normal lacteal secretion, practically free of colostrum, obtained by the complete milking of one or more healthy water buffalo.

"Whey" means "whey" as defined in 21 CFR 184.1979.

"Whey condensing plant" means a plant in which whey is condensed or in which whey is received and processed for drying and packaging.

"Whey drying plant" means a plant in which whey is dried or in which whey is received and processed for drying and packaging.

"Whey product" 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.

"Whipped cream" means "heavy cream" as defined in 21 CFR 131.150 or "light whipping cream" as defined in 21 CFR 131.157, into which air or gas has been incorporated.

"Whipped light cream" means "light whipped cream" as defined in 21 CFR 131.155, into which air or gas has been incorporated.

"Whipping cream" means "light whipping cream" as defined in 21 CFR 131.157.

"Yogurt" means "yogurt" as defined in 21 CFR 131.200.

Part II
Grade A Milk and Milk Products

2VAC5-490-15. Grade A milk and milk products.

Grade A milk, milk products, and condensed and dry milk products shall comply with the specific standard of identity established for each milk product, condensed milk product or dry milk product and the requirements of this chapter.

A. Grade A milk and milk products regulated under this chapter include:

1. All milk and milk products with a standard of identity provided for in 21 CFR Part 131, with the exception of 21 CFR 131.120 sweetened condensed milk;

2. Cottage cheese as defined by 21 CFR 133.128 and dry curd cottage cheese as defined by 21 CFR 131.129;

3. Whey and whey products as defined in 21 CFR 184.1979, 21 CFR 184.1979a, 21 CFR 184.1979b, and 21 CFR 184.1979c; whey product; dry whey product; and grade A condensed and dry whey and whey products;

4. Modified versions of these foods listed in subdivisions 1 and 2 of this subsection, pursuant to 21 CFR 130.10 – Requirements for foods named by use of a nutrient content claim and a standardized term;

5. Milk and milk products as defined in subdivisions 1, 2, 3, and 4 of this subsection, packaged in combination with other food or foods not included in this section that are appropriately labeled with a statement of identity to describe the food in final package form (e.g. "cottage cheese with pineapple" or "fat free milk with plant sterols"); and

6. Products not included in subdivisions 1 through 5 of this subsection shall be grade A milk products if they contain a minimum of (i) 2.0% milk protein as determined by total kjeldahl nitrogen (TKN) X 6.38; and (ii) 65% by weight milk, milk product, or a combination of milk products.

B. Safe and suitable nongrade A dairy ingredients may be utilized in the production of grade A milk and milk products included under 2VAC5-490-15 A when added to a level needed for a functional or technical effect; limited by good manufacturing practices (GMPs); and are either (i) prior sanctioned or otherwise approved by the federal Food and Drug Administration, (ii) generally recognized as safe (GRAS), or (iii) an approved food additive listed in the Code of Federal Regulations with the exception that for those grade A milk and milk products for which a federal standard of identity has been established only ingredients provided for under the standard of identity for each grade A milk or milk product may be utilized. Nongrade A dairy ingredients shall not be used to increase the weight or volume of grade A milk or milk products or to displace any grade A dairy ingredients nor shall using nongrade A dairy ingredients to increase the weight or volume of grade A milk or milk products be considered a suitable functional or technical effect.

C. Grade A milk and milk products shall also include those milk and milk products included under 2VAC5-490-15 A and 2VAC5-490-15 B that have been aseptically processed and then packaged.

D. Grade A milk and milk products shall not include:

1. A milk or milk product in which the milkfat of the milk or milk product has been substituted in part or in whole by any other animal or vegetable fat; provided that other fat sources may be included when they are used for purposes currently accepted in any other grade A milk or milk product, such as carriers for vitamins and as an ingredient in emulsifiers and stabilizers:

2. Coffee based products where coffee or water is the primary ingredient as indicated in the ingredient statement;

3. Tea based products where tea or water is the primary ingredient as indicated in the ingredient statement;

4. Dietary products (except as defined in 21 CFR 130.10);

5. Infant formula;

6. Ice cream or other frozen desserts;

7. Butter;

8. Standardized cheese with the exception of cottage cheese as defined under 21 CFR 133.128 and dry curd cottage cheese as defined under 21 CFR 131.129 and nonstandardized cheese; or

9. Puddings.

E. Milk and milk products which have been retort processed after packaging, or which have been concentrated (condensed) or dried shall conform to the requirements of 2VAC5-490-15 A and 2VAC5-490-15 B if they are utilized as an ingredient in any grade A milk or milk product or if they are labeled as grade A under 2VAC5-490-15 A 4.

F. Powdered dairy blends may be labeled grade A and used as ingredients in grade A milk and milk products, such as cottage cheese dressing mixes or starter media for cultures used to produce various grade A cultured milk and milk products, if they meet the requirements of this chapter. If powdered dairy blends are used as an ingredient in grade A milk and milk products, blends of dairy powders must be blended under conditions which meet all applicable grade A powdered dairy blends requirements. Grade A powder blends must be made from grade A powdered milk and milk products, except that small amounts of functional ingredients not to exceed 10% by weight of the finished blend which are not grade A are allowed in grade A blends when the finished ingredient is not available in grade A form (e.g., sodium caseinate).

G. Grade A milk and milk products, and condensed and dry milk products include: (i) (a) acidified lowfat milk, acidified nonfat milk, acidified milk, acidified milk product, acidified reduced fat milk, acidified skim milk, acidified sour cream, acidified sour half-and-half, aseptically processed milk, aseptically processed milk product, boiled custard, buttermilk, coffee cream, concentrated milk, concentrated milk product, condensed buttermilk, cottage cheese, cottage cheese dry curd, cream, cultured half-and-half, cultured milk, cultured lowfat milk, cultured nonfat milk, cultured reduced fat milk, cultured skim milk, cultured sour cream, cultured sour half-and-half, dry buttermilk, dry buttermilk product, dry cream, dry curd cottage cheese, dry whole milk, eggnog, eggnog-flavored milk, flavored milk, flavored milk product, fortified milk, fortified milk product, frozen milk concentrate, goat milk, half-and-half, heavy cream, heavy whipping cream, lactose-reduced lowfat milk, lactose-reduced nonfat milk, lactose-reduced milk, lactose-reduced reduced fat milk, lactose-reduced skim milk, light cream, light whipping cream, lowfat cottage cheese, lowfat dry milk, lowfat milk, lowfat yogurt, low-sodium lowfat milk, low-sodium nonfat milk, low-sodium milk, low-sodium reduced fat milk, low-sodium skim milk, milk, nonfat milk, nonfat dry milk, nonfat dry milk fortified with vitamins A and D, nonfat yogurt, recombined milk, recombined milk product, reconstituted milk, reconstituted milk product, reduced lactose whey, reduced fat milk, reduced minerals whey, sheep milk, skim milk, sour cream, sour half-and-half, table cream, vitamin A milk, vitamin A milk product, vitamin D milk, vitamin D milk product, whipped cream, whipped light cream, whipping cream, or and yogurt; (b) any of the following foods: milk, lowfat milk, or skim milk with added safe and suitable microbial organisms; or (c) any food made with a food specified in clause (i) (a) of this definition by the addition or subtraction of milkfat or addition of safe and suitable optional ingredients for protein, vitamin, or mineral fortification; and (ii) grade A condensed milk, grade A condensed whey, grade A dry whey, grade A dry milk product, grade A dry milk and grade A dry whey product. Nothing in this section shall be deemed to include any evaporated milk, evaporated skim milk, condensed milk (sweetened or unsweetened), infant formula, ice cream or other dessert, dietary product, dry milk product (except as defined herein), canned eggnog in a rigid metal container, or butter or cheese, except when butter or cheese is combined with other substances to produce any pasteurized or aseptically processed food as specified in this definition.

H. Persons holding a valid permit on January 1, 2011, to receive and process milk for manufacturing purposes pursuant to 2VAC5-531-50 of the Regulations Governing Milk for Manufacturing Purposes and who have manufactured dairy products not previously considered to be grade A dairy products prior to January 1, 2011, may continue to manufacture and sell those specific dairy products they produced prior to January 1, 2011, after [ [the effective date of these regulations] December 10, 2010 ]; however, this limited exemption shall not apply to any new or revised dairy products the permit holder wishes to manufacture if the new or revised dairy product is considered to be grade A.

2VAC5-490-30.1. Permit exemption for restaurants making yogurt.

Restaurants as defined in § 35.1-1 of the Code of Virginia shall be exempt from the requirements of this chapter for the manufacturer of yogurt provided (i) the restaurant manufactures the yogurt from pasteurized milk and milk products and cultures obtained from an approved source; and (ii) all of the yogurt is utilized by the restaurant or sold on site to the final consumer either as an ingredient in other foods or as yogurt.

2VAC5-490-32. Authority to impound milk and milk products.

The State Regulatory Authority may impound any condensed milk, condensed milk product, dry milk, dry milk product, milk, or milk product if the condensed milk, condensed milk product, dry milk, dry milk product, milk or milk product if it is in violation of any requirement of this chapter.

2VAC5-490-35. The examination of milk and milk products.

A. The State Regulatory Authority shall collect during any consecutive six months at least four samples of raw milk, collected in at least four separate months, except when three months show a month containing two sampling dates separated by at least 20 days for pasteurization, ultra-pasteurization, or aseptic processing from each dairy farm that holds a grade A permit.

B. After receipt of the milk by the milk plant and prior to pasteurization, ultra-pasteurization or aseptic processing the State Regulatory Authority shall collect during any consecutive six months at least four samples of raw milk, collected in at least four separate months, except when three months show a month containing two sampling dates separated by at least 20 days for pasteurization, ultra-pasteurization, or aseptic processing from each milk plant located within the Commonwealth that holds a grade A permit.

C. The State Regulatory Authority shall collect during any consecutive six-month period at least four samples of each heat-treated, pasteurized, ultra-pasteurized, and aseptically processed milk product, collected in at least four separate months, except when three months show a month containing two sampling dates separated by at least 20 days, from each milk plant located in the Commonwealth and holding a grade A permit.

D. The State Regulatory Authority shall, except when the production is not on a yearly basis, during each month collect from each milk condensing plant, milk drying plant, whey condensing plant or whey drying plant holding a grade A permit at least one sample of raw milk for pasteurization, after receipt of the milk by the plant and before pasteurization, and at least one sample of each grade A condensed milk product, grade A dry milk product, grade A condensed whey, and grade A dry whey manufactured. If the production of grade A dry milk products or grade A dry whey is not on a yearly basis, the State Regulatory Authority [ the ] shall collect at least five samples within a continuous production period.

E. The State Regulatory Authority may collect samples of milk and milk products as it deems necessary from retail establishments selling milk or milk products to determine compliance with 2VAC5-490-20, 2VAC5-490-40, 2VAC5-490-50 and 2VAC5-490-80. Each person who operates the retail establishment shall furnish the State Regulatory Authority, upon the request of the State Regulatory Authority, with the names of all distributors from whom the person has obtained milk or milk products.

F. The State Regulatory Authority shall provide the remaining portion of the original raw milk sample from each grade A dairy farm which has been screened positive for animal drug residues by a milk plant, receiving station, or transfer station to the grade A dairy farms' milk marketing organization upon request.

G. Each grade A permit holder operating a milk plant within the Commonwealth shall provide to the State Regulatory Authority laboratory determinations of the quantity of vitamin A and vitamin D present in each of the milk plant's milk and milk products to which vitamin A or vitamin D has been added. Each grade A permit holder who operates a milk plant shall provide these laboratory determinations at least annually from a laboratory certified to determine the amount of vitamin A and vitamin D in milk and milk products under the requirements established in "Evaluation of Milk Laboratories," 2005 [ 2007 2009 ] revision, available from the Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Field Programs, Division of HACCP, Laboratory Quality Assurance Branch, HFH-450, 6502 South Archer Road, Summit-Argo, Illinois 60501, USA. Each grade A permit holder who operates a milk plant shall pay for the cost of the laboratory determinations.

2VAC5-490-36. Drug residue monitoring, farm surveillance and follow up.

A. Each grade A permit holder operating a milk plant, receiving station, or transfer station shall:

1. Prior to processing any raw milk from bulk tanks on farms, test for residues of beta lactam drugs all raw milk that the milk plant, receiving station, or transfer station receives for pasteurization, ultra-pasteurization, or aseptic processing;

2. Test each shipment of bulk tank raw milk received for pasteurization, ultra-pasteurization, or aseptic processing by screening tests methods which have been Association of Official Analytical [ Chemists- (AOAC)-reviewed Chemists (AOAC) reviewed ] and Food and Drug [ Administration- (FDA)-accepted Administration (FDA) accepted ]. In lieu of any test specified in this subdivision a grade A permit holder may use AOAC first-action and AOAC final-action tests methods. Nothing in this subdivision shall be deemed to require the testing of individual raw milk samples prior to processing collected from each grade A dairy farm included in any shipment of bulk tank raw milk for pasteurization, ultra-pasteurization, or aseptic processing;

3. Implement a random-sampling program when the Commissioner of the Food and Drug Administration determines that a potential problem exists with animal drug residues or other contaminants in the milk supply. Each grade A permit holder operating a milk plant, receiving station, or transfer station shall analyze the samples for the contaminant by a method determined by FDA to be effective in determining compliance with actionable levels or established tolerances. Each grade A permit holder operating a milk plant, receiving station, or transfer station shall continue the random-sampling program until such time that the Commissioner of the Food and Drug Administration is reasonably assured that the problem has been corrected. The sampling program shall represent and include during any consecutive six months, at least four samples collected in at least four separate months, except when three months show a month containing two sampling dates separated by at least 20 days.

4. Retain each sample found to be positive for drug residues for a period of 120 hours after the sample test result is positive for drug residues for the use of the State Regulatory Authority unless directed otherwise by a representative of the State Regulatory Authority;

5. Abstain from selling or offering for sale any pasteurized, ultra-pasteurized, or aseptically processed milk, milk product, or condensed and dry milk product processed from raw milk for pasteurization, ultra-pasteurization, or aseptic processing before results of drug screening tests are available and which raw milk later tests positive for drug residues. All of the grade A permit holder's milk commingled with any raw milk which tests positive for drug residues shall be deemed adulterated. Any grade A permit holder operating a milk plant, receiving station, or transfer station shall report to the State Regulatory Authority instances of adulteration immediately;

6. Record the results of tests on samples of raw milk and retain such records for a period of six months; report records of all results of tests on samples of raw milk to the State Regulatory Authority by the fifteenth day of each month for the preceding month; and maintain and make available to the State Regulatory Authority for inspection and review at the permitted facility records of results of tests on samples of raw milk. Each record of results of tests on samples of raw milk required by this subdivision shall include:

a. The analyst's signature, date, time, and place where the test was performed;

b. The registration identification of each pickup tanker of bulk raw milk or raw milk sampled;

c. The test method used;

d. The Interstate Milk Shipper Bulk Tank Unit identification number of each grade A milk supply included on each pickup tanker of bulk raw milk tested; and

e. A statement as to whether the test results were positive or negative. If the results were positive, the grade A permit holder shall also record:

(1) The identity of each producer contributing to the load from which the positive sample of raw milk was taken;

(2) The name of the person notified at the State Regulatory Authority of the positive test results;

(3) The date and time of day the person at the State Regulatory Authority was notified of the positive test results; and

(4) The method of notification of the State Regulatory Authority;

7. Immediately notify the State Regulatory Authority and the milk marketing cooperative or broker of any shipment of bulk tank raw milk for pasteurization, ultra-pasteurization, or aseptic processing when the shipment of bulk tank raw milk is found to be positive for drug residues. Nothing in this subdivision shall be deemed to include individual raw milk samples collected from each grade A dairy farm included in any shipment of bulk tank raw milk for pasteurization, ultra-pasteurization, or aseptic processing;

8. Test each producer sample of raw milk to determine the farm of origin represented by any sample of raw milk which tests positive for drug residues and immediately report to the State Regulatory Authority the result of each producer sample representing the raw milk for pasteurization, ultra-pasteurization, or aseptic processing found to be positive for drug residues;

9. Provide by facsimile machine or other electronic means to the Virginia Department of Agriculture and Consumer Services copies of load manifests, producer weight tickets, laboratory worksheets where the results of laboratory tests are originally recorded, and records from electronic readers documenting the results for samples tested for all positive loads; and

10. Immediately discontinue receiving shipments of raw milk from the grade A permit holder whose milk tests positive for drug residues, until subsequent tests are no longer positive for drug residues.

B. Each grade A dairy farm permit holder's milk marketing cooperative or milk marketing agent shall be responsible for the collection and testing of follow-up milk samples for animal drug residues required for permit reinstatement and resumption of milk shipment from the dairy farm each time the grade A dairy farm permit holder's milk test positive for animal drug residues.

C. Each grade A dairy farm permit holder's milk marketing cooperative or milk marketing agent shall comply with the following when following up on a producer's dairy farm after a positive animal drug residue:

1. Only person's who hold valid permits to weigh, sample and collect milk issued by the Virginia Department of Agriculture and Consumer Services shall collect and deliver follow-up milk samples to laboratories for official testing for the purpose of permit reinstatement and the resumption of milk shipments from the dairy farm;

2. Reports of laboratory testing shall be provided from officially designated laboratories for each milk sample tested for animal drug residues and shall include the following information:

a. The name of the grade A dairy farm permit holder;

b. The patron number of the grade A dairy farm permit holder;

c. The date, time and temperature of the milk sample when collected;

d. The name of the person who collected the milk sample;

e. The name of the test method used to test the milk sample; and

f. The test result for the milk sample; and

3. Only confirmation test methods approved under M-I-96-10 (Revision #5) #7) dated March 10, 2004 January 4, 2010, and titled "Drug Residue Test Methods for Confirmation of Presumptive Positive Results and Initial Producer [ Traceback" Trace Back" ] may be used for follow-up milk sample testing.

2VAC5-490-37. Laboratory certification.

A. Each grade A permit holder operating a dairy plant that receives any milk that could require load confirmation or producer trace-back as a result of a positive animal drug residue on a load of milk delivered at the plant shall provide to the Virginia Department of Agriculture and Consumer Services results of animal drug residue tests from an officially designated laboratory. Each officially designated laboratory shall maintain a listing in the IMS List – Sanitation Compliance and Enforcement Ratings of Interstate Milk Shippers as an approved milk laboratory certified to test load and producer samples. All laboratory results from officially designated laboratories shall be reported to the Virginia Department of Agriculture and Consumer Services within six hours of the initial presumptive positive result at the plant. Existing dairy plants holding permits on May 23, 2007, shall have until December 31, 2007, to comply with this section.

B. Each officially designated laboratory shall comply with the requirements contained in the "Evaluation of Milk Laboratories, 2005 [ 2007 2009 ] revision" for certification and listing in the "IMS List – Sanitation Compliance and Enforcement Ratings of Interstate Milk Shippers."

Part V
Labeling

2VAC5-490-40. Labeling.

No person may produce, provide, manufacture, sell, offer for sale, or store in the Commonwealth or, bring, send into, or receive into the Commonwealth any milk, milk product, or condensed and dry milk product for use in the commercial preparation of grade A pasteurized, ultra-pasteurized, or aseptically processed milk or milk products which are not labeled in compliance with the following:

1. Each grade A permit holder's bottles, containers, and packages enclosing any milk or milk products shall be labeled in accordance with the requirements of the Federal Food, Drug and Cosmetic Act, as amended, the Nutrition Labeling and Education Act (NLEA) of 1990, and regulations developed thereunder;

2. The grade A permit holder shall label or mark all bottles, containers, and packages enclosing any milk or milk products with:

a. The name of a defined milk product, if there is a definition, and if there is no definition, a name that is not false or misleading;

b. The word "reconstituted" or "recombined" if the milk product is made by reconstitution or recombination;

c. The term "grade A" located on the exterior of the package on the principal display panel, the secondary or informational panel, or the cap or cover;

d. The identity of the plant where the grade A permit holder's milk or milk product is pasteurized, ultra-pasteurized, or aseptically processed by specifying:

(1) The street address, city, state, and zip code of the plant; or

(2) The code assigned the plant under the National Uniform Coding System for Packaging Identification of Milk and Milk Product Processing Plants.

e. In the case of concentrated milk or concentrated milk products the volume or proportion of water to be added for recombining;

f. The name of the milk product that the concentrated milk product will produce, which name shall be preceded by the term "concentrated." In the case of flavored milk or flavored reconstituted milk, the grade A permit holder shall substitute the name of the principal flavor for the word "flavored";

g. In the case of aseptically processed milk and milk products the words "keep refrigerated after opening;"

h. In the case of aseptically processed and packaged milk or milk products, the term "UHT" ultra-high-temperature;

i. The term "ultra-pasteurized" if the milk or milk product has been ultra-pasteurized;

j. The term "goat" preceding the name of the milk or milk product when the milk or milk product is goat milk or is made from goat milk;

k. The term "sheep" preceding the name of the milk or milk product when the milk or milk product is sheep milk or is made from sheep milk;

l. The term "water buffalo" preceding the name of the milk or milk product when the milk or milk product is water buffalo milk or is made from water buffalo milk;

m. As in the case of cow's milk, goat's milk, sheep's milk, and water buffalo's milk, the common or usual name of the mammal from which the milk was obtained shall precede the name of the milk, milk product, condensed milk, condensed milk product, dry milk or dry milk product;

n. The information appearing on the label of any bottle, container, or package of milk or milk product shall contain no marks, pictures, graphics, or words which are misleading;

o. The "pull date" which shall not interfere with the legibility of other labeling required for the milk or milk product and shall be expressed by: the first three letters in the name of the month, followed by or preceded by the numeral or numerals constituting the calendar date after which the product shall not be sold or expressed numerically by the number of the month followed by the number of the day. For example, June 1 shall be expressed "JUN 1," "1 JUN," "06 01," or "06-01";

p. The grade A permit holder who operates a milk plant and offers for sale milk or milk product within the Commonwealth shall file and certify with the State Regulatory Authority the maximum number of days after manufacturing or processing the grade A permit holder's milk or milk products which will be used to determine the "pull date." The grade A permit holder shall establish a "pull date" that under normal storage the milk or milk product meets for a minimum of 96 hours after the "pull date," standards set by this chapter;

q. No person may sell or offer for sale any packaged grade A pasteurized milk, grade A pasteurized milk product, or milk product after the date of the "pull date" on the package;

r. No person may sell or offer for sale any grade A pasteurized milk, grade A pasteurized milk product, or milk product in a package that does not bear the "pull date"; and

s. Nothing in this chapter shall apply to containers of grade A pasteurized milk, grade A milk products, or milk products which are not to be sold in the Commonwealth.; and

t. In the case of condensed or dry milk products the label shall also contain (i) the identity of the State Regulatory Authority issuing the processing plant's permit; (ii) the identity of the distributor if the condensed or dry milk products are distributed by a party other than the processing plant; (iii) the code or lot number identifying the contents with a specific date, run, or batch of the product; and (iv) a statement of the quantity of the contents of the container.

Part VI
Standards for Milk and Milk Products

2VAC5-490-50. Quality standards for milk and milk products.

A. No person may produce, provide, manufacture, sell, offer for sale, or store in the Commonwealth, or, bring, send, or receive into the Commonwealth, any milk, milk product, condensed milk product or dry milk product for use in the commercial preparation of grade A pasteurized, ultra-pasteurized, or aseptically processed milk or milk products which do not comply with the following:

1. Grade A raw milk for pasteurization or ultra-pasteurization or aseptic processing and all grade A pasteurized, ultra-pasteurized, or aseptically processed milk or milk products shall be produced, processed, and pasteurized or ultra-pasteurized, or aseptically processed to conform with the following chemical, bacteriological, somatic cell, cryoscope, and temperature standards, and with the requirements of this chapter;

2. No process or manipulation other than (i) pasteurization; (ii) ultra-pasteurization; (iii) aseptic processing; or (iv) processing methods integral with pasteurization, ultra-pasteurization, or aseptic processing; and refrigeration may be applied to milk or milk products for the purpose of removing or deactivating microorganisms provided that filtration, bactofugation, or filtration and bactofugation may be performed in the plant in which the milk or milk product is pasteurized, ultra-pasteurized, or aseptically processed. Nothing in this chapter is deemed to prohibit any grade A permit holder who operates a milk plant from preparing bulk shipments of cream, skim milk, or lowfat milk labeled as "heat treated"; if the raw milk, raw cream, skim milk, or lowfat milk is heated, one time, to a temperature warmer than 125°F but cooler than 161°F for separation purposes;

3. Grade A raw milk for pasteurization, ultra-pasteurization, or aseptic processing shall comply with the following standards:

a. The temperature of the raw milk shall be cooled to 40°F or cooler, but not frozen, within two hours after milking and the temperature after the first or any subsequent milking shall not be warmer than 50°F;

b. The bacteria count of the raw milk shall not exceed 100,000 bacteria per milliliter prior to commingling with any other milk; and the bacteria count of the raw milk that is commingled shall not exceed 300,000 bacteria per milliliter prior to pasteurization;

c. Raw milk shall freeze at or below -0.530° Hortvet;

d. Raw milk shall have no positive results of tests for drug residues by detection methods reported to the State Regulatory Authority by official laboratories, officially designated laboratories, milk plants, receiving stations, or transfer stations;

e. The somatic cell count of raw cow's milk, water buffalo's milk or raw sheep's milk shall not exceed 750,000 somatic cells per milliliter. The somatic cell count of raw goat's milk shall not exceed 1,000,000 1,500,000 somatic cells per milliliter;

f. Raw milk shall not exceed the actionable level, tolerance level, or safe level for any chemical residue or pesticide residue specified in: 40 CFR Part 180 and 21 CFR Parts 70, 71, 73, 74, 80, 82, 130, 131, 133, 170, 172, 173, 174, 175, 176, 177, 178, 189, 556, 570, 573, 589. In the event that no actionable level, tolerance level, or safe level for a chemical residue or pesticides residue has been established in 40 CFR Part 180 and 21 CFR Parts 70, 71, 73, 74, 80, 82, 130, 131, 133, 170, 172, 173, 174, 175, 176, 177, 178, 189, 556, 570, 573, 589, the tolerance level shall be deemed to be zero; and

g. Raw milk shall not contain aflatoxin residues equal to or greater than 0.50 parts per billion as determined by the Charm II aflatoxin test or other equivalent method.

4. Grade A pasteurized or ultra-pasteurized, milk and milk products shall comply with the following standards:

a. The temperature of milk products shall be cooled to 45°F or cooler (but not frozen) and maintained at that temperature;

b. The bacteria count for any milk or milk products (except cultured products) shall not exceed 20,000 bacteria per milliliter;

c. Except for commingled milk shipped in a transport tank the coliform count for any milk or milk products shall not exceed 10 coliform organisms per milliliter. Commingled milk shipped in a transport tank shall not exceed 100 coliform organisms per milliliter;

d. The phenol value of test samples of pasteurized finished product shall be no greater than the maximum specified for the particular product as determined and specified by: (i) any phosphatase test method prescribed in the Official Methods of Analysis, 18th Edition, 2005, published by the Association of Official Analytical Chemists; (ii) the Fluorometer test method; (iii) the Charm ALP test method; or (iv) other equivalent method as determined by the Virginia Department of Agriculture and Consumer Services. A phenol value greater than the maximum specified for the particular product shall mean that the product was not properly pasteurized. A phenol value less than the maximum specified for the particular product shall not be deemed to mean that the product was properly pasteurized, unless there is evidence of proper pasteurization equipment in conformance with this chapter and records to determine an adequate pasteurization process has been completed for each separate batch or lot of milk, milk product, condensed milk, condensed milk product, dry milk, or dry milk product;

e. Milk or milk products shall have no positive results of tests for drug residues by detection methods reported to the State Regulatory Authority by official laboratories, officially designated laboratories, milk plants, receiving stations, or transfer stations;

f. Milk or milk products shall not exceed the actionable level, tolerance level, or safe level for any chemical residue or pesticide residue specified in: 40 CFR Part 180 and 21 CFR Parts 70, 71, 73, 74, 80, 82, 130, 131, 133, 170, 172, 173, 174, 175, 176, 177, 178, 189, 556, 570, 573, 589. In the event that no actionable level, tolerance level, or safe level for a chemical residue or pesticides residue has been established in 40 CFR Part 180 and 21 CFR Parts 70, 71, 73, 74, 80, 82, 130, 131, 133, 170, 172, 173, 174, 175, 176, 177, 178, 189, 556, 570, 573, 589, the tolerance level shall be deemed to be zero; and

g. Milk or milk products shall not contain aflatoxin residues equal to or greater than 0.50 parts per billion as determined by the Charm II aflatoxin test or other equivalent method.

5. Grade A aseptically processed milk and milk products shall comply with the following standards:

a. Aseptically processed milk and milk products shall be commercially sterile;

b. Aseptically processed milk and milk products shall have no positive results of tests for drug residues by detection methods reported to the State Regulatory Authority by official laboratories, officially designated laboratories, milk plants, receiving stations, or transfer stations;

c. Aseptically processed milk and milk products shall not exceed the actionable level, tolerance level, or safe level for any chemical residue or pesticide residue specified in 40 CFR Part 180 and 21 CFR Parts 70, 71, 73, 74, 80, 82, 130, 131, 133, 170, 172, 173, 174, 175, 176, 177, 178, 189, 556, 570, 573, 589. In the event that no actionable level, tolerance level, or safe level for a chemical residue or pesticides residue has been established in 40 CFR Part 180 and 21 CFR Parts 70, 71, 73, 74, 80, 82, 130, 131, 133, 170, 172, 173, 174, 175, 176, 177, 178, 189, 556, 570, 573, 589, the tolerance level shall be deemed to be zero; and

d. Aseptically processed milk and milk products milk shall not contain aflatoxin residues equal to or greater than 0.05 parts per billion.

6. Grade A nonfat dry milk shall comply with the following standards:

a. The butterfat content shall not be greater than 1-1/4%;

b. The moisture content shall not be greater than 4.0%;

c. The titratable acidity shall not exceed 0.15%;

d. The solubility index shall not exceed 1-1/4 milliliters;

e. The bacteria count shall not exceed 30,000 bacteria per gram;

f. The coliform count shall not exceed 10 coliform organisms per gram; and

g. The amount of scorched particles shall not exceed 15 particles per gram.

7. Grade A whey for condensing or drying shall be maintained at a temperature of 45°F (7°C) or less, or 135°F (57°C) or greater; provided that, acid-type whey with a titratable acidity of 0.40% or above or a pH of 4.6 or below shall be exempt for the requirements of this subdivision;

8. Grade A pasteurized condensed whey and whey products shall be cooled to 50°F (10°C) or less during crystallization and within 72 hours of condensing. The coliform count of grade A pasteurized condensed whey and whey products shall not exceed 10 coliform organisms per gram; and

9. The coliform count of grade A dry whey, grade A dry whey products, grade A dry buttermilk, and grade A dry buttermilk products shall not exceed 10 coliform organisms per gram.

B. Sanitation requirements for grade A raw milk.

1. Each person who holds a grade A permit to produce raw milk for pasteurization, ultra-pasteurization, or aseptic processing shall comply with:

a. The following administrative procedures contained in the "Grade [ A "A" ] Pasteurized Milk Ordinance 2005 [ , ] 2009 Revision": Section 4. – Labeling,; Section 7. - Standards for Grade "A" Raw Milk for Pasteurization, Ultra-Pasteurization or Aseptic Processing, Items 1r, 2r, 3r, 4r, 5r, 6r, 7r, 8r, 9r, 10r, 11r, 12r, 13r(1), 13r(2), 13r(4), 13r(5), 14r, 15r, 16r, 17r, 18r(2), 19r,; Section 8. – Animal Health; Section 10. – Transferring; Delivery Containers; Cooling; and Section 13. – Personnel Health;

b. The following appendices contained in the "Grade [ A "A" ] Pasteurized Milk Ordinance 2005 [ , ] 2009 Revision": Appendices A, B, C, D, F, G, N, Q and R; and

c. Item 1r. Abnormal milk. Each person who holds a grade A permit to produce raw milk for pasteurization, ultra-pasteurization, or aseptic processing shall:

(1) Milk last or with separate equipment cows, sheep, goats, water buffalo, or other mammals which show evidence of the secretion of abnormal milk in one or more quarters (based upon bacteriological, chemical, or physical examination) and discard the milk obtained from cows, sheep, goats, water buffalo, or other mammals which show evidence of the secretion of abnormal milk in one or more quarters based upon bacteriological, chemical, or physical examination; and

(2) Milk last or with separate equipment cows, sheep, goats, water buffalo, or other mammals treated with, or which have consumed, chemical, medicinal, or radioactive agents which are capable of being secreted in the milk and which may be deleterious to human health; and dispose of in a manner which will not pollute the environment or any human food the milk obtained from cows, sheep, goats, water buffalo, or other mammals treated with, or which have consumed, chemical, medicinal, or radioactive agents which are capable of being secreted in the milk and which may be deleterious to human health;

d. Item 2r. Milking barn, stable, or parlor-construction. Each person who holds a grade A permit to produce raw milk for pasteurization, ultra-pasteurization, or aseptic processing shall:

(1) Provide on the person's dairy farm a milking barn, stable, or parlor in which the milking herd shall be housed during milking time;

(2) Provide on the grade A permit holder's dairy farm a milking barn, stable, or parlor which, milking barn, stable, or parlor shall:

(a) Have floors constructed of concrete or equally impervious material;

(b) Have walls and ceiling which are smooth, painted, or finished in an approved manner, and in good repair and have a ceiling which is dust tight;

(c) Have separate stalls or pens for horses, calves, and bulls;

(d) Have natural or artificial light, well distributed for day or night milking;

(e) Have sufficient air space and air circulation to prevent condensation and excessive odors;

(f) Have dust-tight covered boxes or bins, or separate storage facilities for ground, chopped, or concentrated feed; and

(g) Not be overcrowded; and

(3) Provide and use only an "automatic milking installation" that complies with the requirements of Appendix Q of the "Grade [ A "A" ] Pasteurized Milk Ordinance [ , 2009 Revision ]" if the person milks any cows, goats, sheep, water buffalo, or other mammals (except humans) using robots or other automated means in the absence of any human;

e. Item 3r. Milking barn, stable, or parlor-cleanliness. Each person who holds a grade A permit to produce raw milk for pasteurization, ultra-pasteurization, or aseptic processing shall:

(1) Keep the interior of the milking barn, stable, or parlor clean;

(2) Keep the floors, walls, windows, pipelines, and equipment in the milking barn, stable, or parlor free of filth or litter and clean;

(3) Keep swine and fowl out of the milking barn, stable, and parlor; and

(4) Keep surcingles, belly straps, milk stools and antikickers clean and stored above the floor;

f. Item 4r. Cow yard, sheep yard, goat yard, water buffalo yard or other milking mammal yard. Each person who holds a grade A permit to produce raw milk for pasteurization, ultra-pasteurization, or aseptic processing shall:

(1) Provide and maintain the cow yard, sheep yard, goat yard, water buffalo yard or other milking mammal yard, to be graded and drained, and to have no standing pools of water or accumulations of organic wastes;

(2) In the cow loafing, goat loafing, sheep loafing, water buffalo loafing or other milking mammal loafing, cattle-housing, sheep-housing, goat-housing, water buffalo-housing, or other milking mammal-housing areas remove cow droppings, sheep droppings, goat droppings, water buffalo droppings, and other milking mammal droppings and remove soiled bedding or add clean bedding at sufficiently frequent intervals to prevent the soiling of the cow's, sheep's, goat's, water buffalo's, or other milking mammal's udder and flanks;

(3) Assure that waste feed does not accumulate in the goat yard, cow yard, sheep yard, water buffalo yard, other milking mammal yard, cow loafing, sheep loafing, goat loafing, water buffalo loafing, other milking mammal loafing, cattle-housing, sheep-housing, goat-housing, water buffalo-housing, or other milking mammal-housing area;

(4) Maintain any manure packs so as to be properly drained and so as to provide a reasonably firm footing; and

(5) Keep swine and fowl out of the cow yard, sheep yard, goat yard, water buffalo yard, other milking mammal yard, cow loafing, sheep loafing, goat loafing, water buffalo loafing, other milking mammal loafing, cattle-housing, sheep-housing, goat-housing, water buffalo-housing, or other milking mammal-housing area.

g. Item 5r. Milkhouse or room-construction and facilities. Each who holds a grade A permit to produce raw milk for pasteurization, ultra-pasteurization, or aseptic processing shall:

(1) Provide a milkhouse or milkroom of sufficient size 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 under subdivision 1 n of this subsection;

(2) Provide a milkhouse with a smooth floor, constructed of concrete or equally impervious material graded to drain, and maintained in good repair;

(3) Dispose of in a sanitary manner all liquid waste generated in the milkhouse;

(4) Provide one or more floor drains in the milkhouse, which floor drains shall be accessible, and if connected to a sanitary sewer system trapped;

(5) Provide in the milkhouse walls and ceilings constructed of a smooth material, in good repair, well painted, or finished in an equally suitable manner;

(6) Provide adequate natural or artificial light and ventilation in the milkhouse;

(7) Use the milkhouse for no other purpose than milkhouse operations;

(8) Provide no direct opening from the milkhouse into any barn, stable, or into any room used for domestic purposes, other than a direct opening between the milkhouse and milking barn, stable, or parlor provided with a tight-fitting, self-closing, solid door, which door has been hinged to be single or double acting;

(9) Provide in the milkhouse water under pressure which has been piped into the milkhouse;

(10) Provide in the milkhouse a two-compartment wash vat and adequate hot water heating facilities;

(11) Except as provided for under subdivision 1 g (12) of this subsection provide a suitable shelter for the receipt of milk when the grade A permit holder uses a transportation tank for the cooling or storage of milk on the grade A permit holder's dairy farm, which shelter adjacent to, but not a part of, the milkroom; and with the requirements of the milkroom shall comply with respect to construction, light, drainage, insect and rodent control, and general maintenance. In addition to providing a suitable shelter as required by this subsection, the grade A permit holder shall:

(a) Install an accurate, accessible temperature-recording device in the milk line used to fill the transportation tank downstream from an effective cooling device capable of cooling the milk to 40°F or less before the milk enters the transportation tank;

(b) Install an indicating thermometer as close as possible to the temperature-recording device in the milk line used to fill the transportation tank to be used for verification of recording temperatures, which indicating thermometer shall:

(i) Have a temperature span of not less than 50°F including normal storage temperatures plus or minus 5°F, with an extension of the scale on either side permitted and graduated in not more that 2°F divisions;

(ii) Have temperature scale divisions spaced not less that 0.0625 inches apart between 35°F and 55°F;

(iii) Have an accuracy within plus or minus 2°F throughout the scale range; and

(iv) Have the stem fitting installed in a pressure-tight seat or other sanitary fitting with no threads exposed;

(c) Provide an effective means to agitate the transport tank or an approved in-line sampling device in order to collect a representative milk sample;

(12) If the State Regulatory Authority determines conditions exist whereby the milk transport tank may be adequately protected and sampled without contamination, a shelter need not be provided if the grade A permit holder:

(a) Provides a means to make all milk hose connections to the transport tank accessible from within the milkhouse;

(b) Provides a means to completely protect the milk hose connection to the transport tank from the outside environment;

(c) Ensures he utilizes only milk transport tanks the manholes of which have been sealed after cleaning and sanitizing;

(d) Ensures he utilizes only milk transport tanks that have been washed and sanitized at permitted dairy plants or a permitted milk tank truck cleaning facilities acceptable to the State Regulatory Agency;

(e) Installs an accurate, accessible temperature-recording device in the milk line used to fill the transportation tank downstream from an effective cooling device capable of cooling the milk to 40°F or less before the milk enters the transportation tank;

(f) Installs an indicating thermometer as close as possible to the temperature-recording device in the milk line used to fill the transportation tank to be used for verification of recording temperatures, which indicating thermometer shall:

(i) Have a temperature span of not less than 50°F including normal storage temperatures plus or minus 5°F, with an extension of the scale on either side permitted and graduated in not more that 2°F divisions;

(ii) Have temperature scale divisions spaced not less that 0.0625 inches apart between 35°F and 55°F;

(iii) Have an accuracy within plus or minus 2°F throughout the scale range; and

(iv) Have the stem fitting installed in a pressure-tight seat or other sanitary fitting with no threads exposed;

(g) Provides an effective means to agitate the transport tank or an approved in-line sampling device in order to collect a representative milk sample; and

(h) Provides a self-draining concrete or equally impervious surface on which the transport tank can be parked during filling and storage;

h. Item 6r. Milkhouse or milkroom-cleanliness. Each person who holds a grade A permit to produce raw milk for pasteurization, ultra-pasteurization, or aseptic processing shall:

(1) Keep clean the floors, walls, ceilings, windows, tables, shelves, cabinets, wash vats, nonproduct contact surfaces of milk containers, utensils, equipment, and other milkroom equipment in the milkroom;

(2) Place in the milkroom only those articles directly related to milkroom activities; and

(3) Keep the milkroom free of trash, animals, and fowl;

i. Item 7r. Toilets. Each person who holds a grade A permit to produce raw milk for pasteurization, ultra-pasteurization, or aseptic processing shall:

(1) Provide on the person's grade A dairy farm one or more toilets, which shall be conveniently located and properly constructed, and operated, and maintained in a sanitary manner;

(2) Prevent the access of flies to the waste contained in or from the toilet;

(3) Prevent the waste contained in or from the toilet from polluting the soil surface or contaminating any water supply; and

(4) Assure that there is no direct opening from the toilet into any milkroom;

j. Item 8r. Water supply. Each person who holds a grade A permit to produce raw milk for pasteurization, ultra-pasteurization, or aseptic processing shall:

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

(2) Assure that any well casing which is part of a water supply that provides water for any milkhouse or milking operation is not located closer to any source of contamination which may contaminate the water supply than is specified as follows:

(a) No grade A permit holder may locate a well casing closer than 10 feet to a pit;

(b) No grade A permit holder may locate a well casing closer than 10 feet to any sewer pipe, floor drain, or other pipe which may back up;

(c) No grade A permit holder may locate a well casing closer than 50 feet to any above-ground gas, oil, petroleum, or chemical storage tank;

(d) No grade A permit holder may locate a well casing closer than 50 feet to any accumulated animal manure;

(e) No grade A permit holder may locate a well casing closer than 50 feet to any area to which livestock has access; or animal-holding area, feedlot, or loafing area on dirt;

(f) No grade A permit holder may locate a well casing closer than 50 feet to any pit not drained to the surface of the ground. Nothing in this requirement shall apply to a residential basement;

(g) No grade A permit holder may locate a well casing closer than 100 feet to any pit privy. Existing well casings located on grade A dairy farms holding valid permits issued by the State Regulatory Authority on September 1, 1993, shall be exempt from the 100 foot distance requirement of this subdivision until the existing permit is canceled or revoked;

(h) No grade A permit holder may locate a well casing closer than 100 feet to any animal-manure disposal area;

(i) No grade A permit holder may locate a well casing closer than 100 feet to any cess pool;

(j) No grade A permit holder may locate a well casing closer than 100 feet to any dry well;

(k) No grade A permit holder may locate a well casing closer than 100 feet to any structure which stores animal manure;

(l) No grade A permit holder may locate a well casing closer than 100 feet to any septic tank or drain field; and

(m) No grade A permit holder may locate a well casing closer than 100 feet to any underground or partially-buried gas, oil, petroleum, or chemical storage tank;

(3) Construct the water supply so that the well casing terminates at least two feet above the highest-known flood plane for the location in which the water supply is located; and

(4) Construct the water supply so that no potable water supply pipe attached to the water supply is located closer than 10 feet measured horizontally to any sewer pipe, soil pipe, or drain;

k. Item 9r. Utensils and equipment-construction. Each person who holds a grade A permit to produce raw milk for pasteurization, ultra-pasteurization, or aseptic processing shall:

(1) Provide multiuse containers, equipment, and utensils for use in the handling, storage, or transportation of any milk, which multiuse containers, equipment, and utensils, shall be made of smooth, nonabsorbent, corrosion-resistant, and nontoxic materials; constructed as to be easily cleaned; and in good repair;

(2) Provide milk pails which are constructed to be seamless and of the hooded type if the grade A permit holder does hand milking and stripping;

(3) Abstain from using multiple-use woven material for straining any milk;

(4) Use only single-service articles which have been manufactured, packaged, transported, stored, and handled in a sanitary manner and that comply with the requirements of subdivision C 1 of this section;

(5) Abstain from reusing any article intended for single-service use; and

(6) Provide farm holding or cooling tanks, welded sanitary piping, and transportation tanks which comply with the requirements of subdivisions C 1 l and C 1 m of this section on any grade A dairy farm;

l. Item 10r. Utensils and equipment; cleaning. Each person who holds a grade A permit to produce raw milk for pasteurization, ultra-pasteurization, or aseptic processing shall:

(1) Clean after each use the product-contact surfaces of all multiuse containers, multiuse equipment, and multiuse utensils used in the handling, storage, or transportation of any milk; and

(2) Offer for sale or sell no milk which has passed through any equipment, if the milk-contact surfaces of the equipment are no longer visible, or are covered or partially covered by an accumulation of milk solids, milk fat, cleaning compounds or other soils. Any milk which passes through equipment, the milk-contact surfaces of which are no longer visible, or are covered or partially covered by an accumulation of milk solids, milk fat, cleaning compounds, or other soils shall be deemed adulterated;

m. Item 11r. Utensils and equipment; sanitization. Each person who holds a grade A permit to produce raw milk for pasteurization, ultra-pasteurization, or aseptic processing shall sanitize before each use the product-contact surfaces of all multiuse containers, equipment, and utensils used in the handling, storage, or transportation of any milk;

n. Item 12r. Utensils and equipment; storage. Each person who holds a grade A permit to produce raw milk for pasteurization, ultra-pasteurization, or aseptic processing shall store containers, utensils, and equipment used in the handling, storage, or transportation of any milk in a sanitizing solution or store the containers, utensils, and equipment used in the handling, storage, or transportation of any milk to assure complete drainage, and protected from contamination prior to use. Nothing in this requirement shall be deemed to prohibit a grade A permit holder from storing in a milking barn or milking parlor a milk pipeline, or the following pipeline milking equipment: milker claw, inflation, weigh jar, meter, milk hose, milk receiver, tubular cooler, plate cooler, or milk pump; if the milk pipeline or pipeline milking equipment specified in this subdivision is designed for mechanical cleaning; and designed, installed, and operated to protect the milk product and solution-contact surfaces from contamination at all times;

o. Item 13r. Milking; flanks, udders, and teats. Each person who holds a grade A permit to produce raw milk for pasteurization, ultra-pasteurization, or aseptic processing shall:

(1) Milk all cows, sheep, goats, water buffalo, and other mammals in a milking barn, stable, or parlor;

(2) Trim the hair from the udder and tail of all milking cows, sheep, goats, water buffalo, and other mammals to facilitate cleaning of the udder and tail;

(3) Keep the flanks, udders, bellies, and tails of all milking cows, sheep, goats, water buffalo, and other mammals free of visible dirt;

(4) Keep the hair on the udders of all milking cows, sheep, goats, water buffalo and other mammals to a length that the hair on the udder of any cow, sheep, goat, water buffalo, or other mammal cannot be incorporated with the teat in the inflation during milking;

(5) Abstain from milking any cow, sheep, goat, water buffalo, or other mammal whose udder or teats is not clean and dry;

(6) Treat with a sanitizing solution, just prior to milking, the teats of each milking cow, sheep, goat, water buffalo, and other mammal and dry the teats of each milking cow, sheep, goat, water buffalo, and other mammal before milking; and

(7) Milk all cows, sheep, goats, water buffalo, and other mammal with dry hands;

p. Item 14r. Protection from contamination. Each person who holds a grade A permit to produce raw milk for pasteurization, ultra-pasteurization, or aseptic processing shall:

(1) Locate and operate the milking and milk house operations, equipment, and facilities to prevent any contamination of the milk, equipment, containers, or utensils;

(2) Transfer immediately from the milking barn, stable, or parlor to the milkhouse each pail or container of milk;

(3) Strain, pour, transfer, or store any milk unless it is protected from contamination;

(4) Handle all containers, utensils and equipment that have been sanitized in such a manner as to prevent contamination of any product-contact surfaces;

(5) Transport from the grade A permit holder's dairy farm to a milk plant or receiving station all milk in cans, using vehicles which are constructed and operated to protect the milk from sun, freezing, and contamination;

(6) Keep clean the inside and outside of each vehicle used to transport from the grade A permit holder's dairy farm to a milk plant or receiving station any milk in cans; and

(7) Transport no substance capable of contaminating the milk when transporting milk;

q. Item 15r. Drug and chemical control. Each person who holds a grade A permit to produce raw milk for pasteurization, ultra-pasteurization, or aseptic processing shall:

(1) Store all drugs and medicinals in such a manner that neither the drugs nor the medicinals can contaminate any milk or the milk product-contact surface of any equipment, containers or utensils;

(2) Abstain from using unapproved or improperly labeled medicinals or drugs to treat any dairy animals or store unapproved or improperly labeled medicinals or drugs in the milkhouse, milking barn, stable or parlor. Except for topical antiseptics, wound dressings (unless intended for direct injection into the teat), vaccines and other biologics, and dosage form vitamins and mineral products a drug or medicinal is properly labeled only if the drug or medicinal is labeled with the following:

(a) For over-the-counter medicinals or drugs, the name and address of the manufacturer or distributor, or for prescription and extra-label use medicinals or drugs, the name of the veterinary practitioner dispensing the product;

(b) Directions for use of the drug or medicinal and the prescribed holding time;

(c) Any cautionary statement for the drug or medicinal, if needed; and

(d) The active ingredient or ingredients in the drug or medicinal;

(3) Except for topical antiseptics, wound dressings (unless intended for direct injection into the teat), vaccines and other biologics, and dosage form vitamins and mineral products, segregate all medicinals and drugs used for lactating dairy animals from any medicinals and drugs used for nonlactating dairy animals;

(4) Except for topical antiseptics, wound dressings (unless intended for direct injection into the teat), vaccines and other biologics, and dosage form vitamins and mineral products, provide separate shelves in a cabinet, refrigerator, or other storage facility for the storage of all medicinals and drugs for treatment of nonlactating dairy animals separate from those medicinals or drugs used for lactating dairy animals; and

(5) Store topical antiseptics, wound dressings (unless intended for direct injection into the teat), vaccines and other biologics, and dosage-form vitamins and mineral products in a manner that does not contaminate any milk or the milk-product surfaces of any containers or utensils;

r. Item 16r. Personnel; hand-washing facilities. Each person who holds a grade A permit to produce raw milk for pasteurization, ultra-pasteurization, or aseptic processing shall provide hand-washing facilities that are convenient to the milkhouse, milking barn, stable, or parlor, and flush toilet and that include separate hot and cold running water; soap or detergent; and individual sanitary towels;

s. Item 17r. Personnel; cleanliness. Each person who holds a grade A permit to produce raw milk for pasteurization, ultra-pasteurization, or aseptic processing shall:

(1) Wash clean and dry with an individual sanitary towel the person's hands immediately before milking, before performing any milkhouse function, and immediately after the interruption of milking or performing any milkhouse function; and

(2) Wear clean outer garments while milking or handling any milk, milk containers, utensils, or equipment. Bulk milk haulers shall wear clean outer garments while handling any milk, milk containers, utensils, or equipment;

t. Item 18r. Cooling. Each person who holds a grade A permit to produce raw milk for pasteurization, ultra-pasteurization, or aseptic processing shall:

(1) Cool to 40°F or cooler (but not freeze), all raw milk for pasteurization, ultra-pasteurization, or aseptic processing, within two hours after the grade A permit holder completes milking; and assure that the temperature of the grade A permit holder's raw milk is not warmer than 50°F after the first milking or any subsequent milking. Raw milk for pasteurization which is warmer than a temperature of 50°F after the first milking or any subsequent milking shall be deemed a public health hazard and shall not be offered for sale or sold; and

(2) Agitate all raw milk for pasteurization for not less than five minutes at least once every hour; assure that the milk in the farm's bulk milk cooling or holding tank covers the agitator paddle sufficiently to facilitate proper cooling and sampling after the completion of the first milking; and abstain from selling or offering for sale milk which does not cover the agitator paddle sufficiently to facilitate proper cooling and sampling after the completion of the first milking;

u. Item 19r. Insect and rodent control. Each person who holds a grade A permit to produce raw milk for pasteurization, ultra-pasteurization, or aseptic processing shall:

(1) Take effective measures to prevent the contamination of any milk, containers, equipment, and utensils by insects, rodents, and other animals, and by chemicals used to control insects, rodents, and other animals;

(2) Maintain the milkroom free of insects, rodents and other animals;

(3) Keep the areas surrounding the: milkhouse; milking barn; milking stable; milking parlor; cattle, sheep, water buffalo, other mammal, or goat housing; cattle, sheep, water buffalo, other mammal, or goat loafing; water supply; or other facilities on the grade A permit holder's dairy farm neat, clean, and free of conditions which might harbor or be conducive to the breeding of insects and rodents; and

(4) Store all feed in such a manner that the feed will not attract birds, rodents or insects.

C. Sanitation requirements for grade A pasteurized, ultra-pasteurized, or aseptically processed milk or milk products.

1. Each person who holds a grade A permit to produce grade A pasteurized, ultra-pasteurized, or aseptically processed milk or milk products shall comply with:

a. The following administrative procedures contained in the "Grade [ A "A" ] Pasteurized Milk Ordinance 2005 [ , ] 2009 Revision": Section 7. Standards for Grade "A" Pasteurized, Ultra-pasteurized and Aseptically Processed Milk and Milk Products, Items 1p, 2p, 3p, 4p, 5p, 6p, 7p, 8p, 9p, 10p, 11p, 12p, 13p, 14p, 15p, 16p, 17p, 18p, 19p, 20p, 21p, and 22p;

b. The following appendices contained in the "Grade [ A "A" ] Pasteurized Milk [ Ordinance-- ] 2005 [ Ordinance, ] 2009 Revision:" Appendices D, F, G, H, I, J, K, L, N, O and R;

c. Item 1p. Floors; construction. Each person who holds a grade A permit to produce grade A pasteurized, ultra-pasteurized, or aseptically processed milk, or milk products shall:

(1) Except as specified in subdivision C 1 c (2) of this section, provide floors, for all rooms in which milk or milk products are processed, handled, or stored, or in which milk containers, equipment, or utensils are washed constructed of concrete or other equally impervious and easily cleaned material and which are smooth, properly sloped, provided with trapped drains, and kept in good repair;

(2) The floor in any cold-storage room used for storing milk and milk products need not be provided with floor drains if the floors are sloped to drain to one or more exits from the cold-storage room. The floor in any storage room used for storing dry ingredients or packaging materials need not be provided with drains and the floor in any storage room used for storing dry ingredients or packaging materials may be constructed of tightly joined wood;

d. Item 2p. Walls and ceilings; construction. Each person who holds a grade A permit to produce grade A pasteurized, ultra-pasteurized, or aseptically processed milk, or milk products shall provide walls and ceilings of rooms in which milk or milk products are handled, processed, or stored, or in which milk containers, utensils, or equipment are washed, that have a smooth, washable, light-colored surface, and that are in good repair;

e. Item 3p. Doors and windows. Each person who holds a grade A permit to produce grade A pasteurized, ultra-pasteurized, or aseptically processed milk, or milk products shall provide:

(1) Effective means to prevent the access of flies and rodents to any part of a milk plant, receiving station, or transfer station; and

(2) Solid doors or glazed windows for all openings to the outside of any milk plant, receiving station, or transfer station and keep the doors and windows closed during dusty weather;

f. Item 4p. Lighting and ventilation. Each person who holds a grade A permit to produce grade A pasteurized, ultra-pasteurized, or aseptically processed milk, or milk products shall provide rooms in which any milk or milk products are handled, processed, or stored or in which any milk containers, equipment, or utensils are washed, that are well lighted and well ventilated;

g. Item 5p. Separate rooms. Each person who holds a grade A permit to produce grade A pasteurized, ultra-pasteurized, or aseptically processed milk, or milk products shall:

(1) Provide separate rooms for: (i) pasteurizing, processing, cooling, and packaging milk and milk products; (ii) cleaning milk cans, bottles, and cases; (iii) the fabrication of containers and closures for milk and milk products; (iv) cleaning and sanitizing facilities for bulk milk transport tanks if the grade A permit holder receives any milk or milk product in bulk milk transport tanks; and (v) receiving cans of milk and milk products separate from clauses (i), (ii) and (iii) of this subdivision, unless all of the grade A permit holder's milk or milk products are received in bulk milk transport tanks;

(2) Not use any room with a direct opening into any stable or room used for domestic purposes to handle, process, or store any milk or milk products or; wash or store any milk containers, utensils, or equipment;

(3) Use rooms of sufficient size so as not to be crowded to handle, process, or store any milk or milk products or wash or store any milk containers, utensils, or equipment; and

(4) Provide designated areas or rooms for the receiving, handling and storage of returned packaged milk and milk products if the permit holder receives any returned packaged milk or milk products;

h. Item 6p. Toilet-sewage disposal facilities. Each person who holds a grade A permit to produce grade A pasteurized, ultra-pasteurized, or aseptically processed milk, or milk products shall provide each milk plant with toilet facilities conforming with the regulations of the Commonwealth and the following requirements: no toilet room may open directly into any room in which milk or milk products are processed; the toilet room shall be completely enclosed and shall have tight-fitting, self closing doors; the dressing room, toilet room, and fixtures shall be kept in a clean condition, in good repair, and shall be well ventilated and well lighted; and sewage and other liquid wastes from the toilet room shall be disposed of in a sanitary manner;

i. Item 7p. Water supply. Each person who holds a grade A permit to produce grade A pasteurized, ultra-pasteurized, or aseptically processed milk, or milk products shall:

(1) Provide water for each milk plant from a supply which is properly located, protected, and operated; and

(2) Provide water from a supply which is easily accessible for inspection by the State Regulatory Authority, adequate, and of a safe, sanitary quality;

j. Item 8p. Hand-washing facilities. Each person who holds a grade A permit to produce grade A pasteurized, ultra-pasteurized, or aseptically processed milk, or milk products shall:

(1) Provide hand-washing facilities, including separate hot and cold running water, mix valve, soap, and individual sanitary towels or other approved hand-drying devices, convenient in any area where milk or milk products are handled, processed, or stored, and any area where containers, utensils, or equipment, are washed or stored; and

(2) Keep the hand-washing facilities clean and in good repair;

k. Item 9p. Milk plant cleanliness. Each person who holds a grade A permit to produce grade A pasteurized, ultra-pasteurized, or aseptically processed milk, or milk products shall:

(1) Keep clean, neat, and free of any evidence of animals, insects or rodents, all rooms in which milk or milk products are handled, processed, or stored or in which containers, utensils, or equipment are washed or stored; and

(2) Permit only equipment directly related to processing operations or to the handling of containers, utensils, and equipment, in pasteurizing, processing, cooling, packaging, or bulk milk storage rooms;

l. Item 10p. Sanitary piping. Each person who holds a grade A permit to produce grade A pasteurized, ultra-pasteurized, or aseptically processed milk, or milk products shall:

(1) Use only sanitary piping, fittings, and connections consisting of smooth, impervious corrosion-resistant, nontoxic, easily cleanable materials that are exposed to any milk or milk products, or from which liquids may drip, drain, or be drawn into any milk or milk products;

(2) Keep all piping in good repair;

(3) Except as specified in subdivision 1 l of this subsection, use only sanitary piping to transfer any pasteurized or ultra-pasteurized milk or milk products from one piece of equipment to another piece of equipment; and

(4) Transport cottage cheese, cheese dressings, or cheese ingredients by methods which protect the product from contamination;

m. Item 11p. Construction and repair of containers and equipment. Each person who holds a grade A permit to produce grade A pasteurized, ultra-pasteurized, or aseptically processed milk, or milk products shall:

(1) Use only multiuse containers and equipment, that may come in contact with any milk or milk products constructed of smooth, impervious, corrosion-resistant, and nontoxic materials; constructed for ease of cleaning; and kept in good repair;

(2) Use only single-service containers, closures, gaskets, and other articles, that may come in contact with any milk or milk products, that are nontoxic and have been manufactured, packaged, transported, and handled in a sanitary manner;

(3) Abstain from using more than once any articles intended for single-service use; and

(4) Use only single-service containers, closures, caps, gaskets, and similar articles manufactured, packed, transported, and handled in a manner which complies with the requirements of Appendix J, "Standards for the Fabrication of Single-Service Containers and Closures for Milk and Milk Products"; contained in the "Grade [ A "A" ] Pasteurized Milk Ordinance, 2005 2009 [ revision" Revision" ];

n. Item 12p. Cleaning and sanitizing of containers and equipment. Each person who holds a grade A permit to produce grade A pasteurized, ultra-pasteurized, or aseptically processed milk, or milk products shall:

(1) Effectively clean and sanitize before each use the product-contact surfaces of all multiuse containers and equipment, utensils, and equipment used in the transportation, processing, handling, and storage of any milk or milk products;

(2) Use only multi-use containers for packaging pasteurized milk and milk products that comply with the following: (i) the residual bacteria count on multi-use containers may not exceed one per milliliter of capacity when the rinse test is used, or the residual bacteria count on multi-use containers shall not exceed 50 colonies per eight square inches (one per square centimeter) of product-contact surface, when the swab test is used; in three-out-of-four samples taken at random on a given day; and (ii) all multi-use containers shall be free of coliform organisms; and

(3) Use only single-service containers for packaging pasteurized milk and milk products that comply with the following: (i) the residual bacteria count of single-service containers shall not exceed 50 per container, when the rinse test is used, except that in containers less than 100 milliliters, the count shall not exceed 10, or the residual bacteria count of single-service containers shall not exceed 50 colonies per eight square inches (one per square centimeter) of product contact surface, when the swab test is used; in three-out-of-four samples taken at random on a given day; and (ii) all single-service containers shall be free of coliform organisms;

o. Item 13p. Storage of cleaned containers and equipment. Each person who holds a grade A permit to produce grade A pasteurized, ultra-pasteurized, or aseptically processed milk, or milk products, shall after cleaning any multiuse milk or milk product containers, utensils, or equipment, transport or store the multiuse milk or milk product containers, utensils, or equipment in a manner that assures complete drainage and in a manner that protects the multiuse milk or milk product containers, utensils, or equipment from contamination before use;

p. Item 14p. Storage of single-service containers, utensils, and materials. Each person who holds a grade A permit to produce grade A pasteurized, ultra-pasteurized, or aseptically processed milk, or milk products shall:

(1) Purchase all single-service caps, cap stock, parchment paper, containers, gaskets, and other single-service articles for use in contact with milk or milk products, in sanitary tubes, wrappings, or cartons;

(2) Store in a clean dry place until used, single-service caps, cap stock, parchment paper, containers, gaskets, and other single-service articles for use in contact with milk or milk products;

(3) Store single-service caps, cap stock, parchment paper, containers, gaskets, and other single-service articles for use in contact with milk or milk products in sanitary tubes, wrappings, or cartons; and

(4) Handle single-service caps, cap stock, parchment paper, containers, gaskets, and other single-service articles for use in contact with milk or milk products in a sanitary manner;

q. Item 15p. Protection from contamination. Each person who holds a grade A permit to produce grade A pasteurized, ultra-pasteurized, or aseptically processed milk, or milk products shall:

(1) Locate the person's equipment and facilities and conduct milk plant operations to prevent any contamination of any milk or milk products, ingredients, equipment, containers, or utensils;

(2) Discard all milk, milk products, or ingredients which have been spilled, overflowed, or leaked;

(3) Perform the processing and handling of products other than milk and milk products in the person's milk plant to preclude the contamination of any milk or milk products;

(4) Store, handle, or use any toxic material to preclude the contamination of any milk, milk product, or ingredient, and the milk product contact surfaces of all equipment, containers, or utensils; and

(5) Clean, prior to use, all multi-use cases used to encase packaged milk or milk product containers;

r. Item 16p. Pasteurization and ultra-pasteurization. Each person who holds a grade A permit to produce grade A pasteurized, ultra- pasteurized, or aseptically processed milk, or milk products shall:

(1) Perform pasteurization or ultra-pasteurization as defined in 2VAC5-490-10; and

(2) Perform aseptic processing in compliance with the provisions of 21 CFR Part 113, 21 CFR Part 108, and the Administrative Procedures of Item 16p, 16p(C), 16p(D), and 16p(E) of the "Grade [ A "A" ] Pasteurized Milk Ordinance, 2005 2009 [ revision" Revision" ];

s. Item 17p. Cooling of milk. Each person who holds a grade A permit to produce grade A pasteurized, ultra-pasteurized, or aseptically processed milk, or milk products shall:

(1) Maintain all raw milk and milk products at a temperature of 45°F or cooler, but not frozen, until processed;

(2) Maintain all whey and whey products for condensing, drying, or condensing and drying at a temperature of 45°F (7°C) or cooler; or 135°F (57°C) 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;

(2) (3) Immediately cool, except for the following milk or milk products to be cultured, all pasteurized or ultra-pasteurized milk or milk products prior to filling or packaging in approved cooling equipment to a temperature of 45°F or cooler, but not frozen unless drying is commenced immediately after condensing:

(a) Those milk or milk products to be cultured;

(b) Cultured sour cream at all milkfat levels with a pH of 4.70 or below:

(c) Acidified sour cream at all milkfat levels with a pH of 4.60 or below;

(d) All yogurt products at all milkfat levels with an initial pH of 4.80 or below at filling;

(e) Cultured buttermilk at all milkfat levels with a pH of 4.60 or below; and

(f) All condensed whey and whey products shall be cooled during the crystallization process to 50°F (10°C) or less within 72 hours of condensing, including the filling and emptying time, unless filling occurs above 135°F (57°C), in which case, the 72 hour time period begins when cooling started;

(3) (4) Store, transport, and deliver at a temperature of 45°F or cooler, but not frozen, all pasteurized or ultra-pasteurized milk or milk products with the following exceptions:

(a) Cultured sour cream at all milkfat levels with a pH of 4.70 or below shall be cooled to 45°F (7°C) or cooler within 168 hours of filling;

(b) Acidified sour cream at all milkfat levels with a pH of 4.60 or below shall be cooled to 45°F (7°C) or cooler within 168 hours of filling;

(c) All yogurt products at all milkfat levels with an initial pH of 4.80 or below at filling and with a subsequent pH of 4.60 or below within 24 hours after filling shall be cooled to 45°F (7°C) or cooler within 96 hours after filling; and

(d) Cultured buttermilk at all milkfat levels with a pH of 4.60 or below shall be cooled to 45°F (7°C) or cooler within 24 hours after filling; and

(5) Store all pasteurized milk and milk products to be condensed, dried, or condensed and dried at a temperature of 50°F (10°C) or cooler until further processed;

(4) (6) Equip with an accurate indicating thermometer each of the rooms or tanks in which any milk, or milk products, whey, or whey products are stored; and

(7) Provide ready access at the plant to cleaning records and product storage temperature records stored electronically for review by the State Regulatory Authority. Electronic records of cleaning shall comply with the applicable provisions of Appendix H, Sections IV and V of the "Grade [ A "A" ] Pasteurized Milk Ordinance, 2009 [ revision" Revision" ];

t. Item 18p. Bottling and packaging. Each person who holds a grade A permit to produce grade A pasteurized, ultra-pasteurized, or aseptically processed milk, or milk products shall:

(1) Bottle or package all milk or milk products (except for cottage cheese, dry curd cottage cheese and lowfat cottage cheese) at the place of pasteurization in the grade A permit holder's milk plant and in approved mechanical equipment; and

(2) Transport all cottage cheese, dry curd cottage cheese, or lowfat cottage cheese not creamed or packaged in the grade A permit holder's milk plant in sealed containers and in a protected, sanitary manner from the grade A permit holder's milk plant to another grade A permit holder's milk plant for creaming or packaging; Package and store in a sanitary manner all dry milk products in new containers, which protect the contents from contamination; and

(3) Transport and store in a sanitary manner all condensed and dry milk products in sealed containers from one milk plant to another milk plant for further processing or packaging;

u. Item 19p. Capping. Each person who holds a grade A permit to produce grade A pasteurized, ultra-pasteurized, or aseptically processed milk, or milk products shall:

(1) Cap or close all milk or milk product containers in a sanitary manner by use of approved mechanical capping or closing equipment; and

(2) Use only caps or closures for all milk or milk products, which protect the pouring lip of a milk or milk product container to at least its largest diameter and, use with respect to fluid product containers, only caps or closures that the removal of the cap or closure cannot be made without detection;

v. Item 20p. Personnel; cleanliness. No person who holds a grade A permit to produce grade A pasteurized, ultra-pasteurized, or aseptically processed milk, or milk products shall:

(1) Permit any person in a milk plant to commence any plant function before the person has thoroughly washed the person's hands to remove soil and contamination or to permit any person in a milk plant to continue any plant function if the person's hands are not clean;

(2) Permit any person in a milk plant to resume work after the person has visited the toilet room before the person has thoroughly washed the person's hands;

(3) Permit any person in a milk plant to engage in the processing, pasteurization, handling, storage, or transportation of any milk, milk products, containers, equipment or utensils, unless the person is wearing clean outer garments;

(4) Permit any person in a milk plant, to engage in the processing of any milk or milk products unless the person wears adequate hair covering; or

(5) Permit any person in a milk plant, to engage in the processing of any milk or milk products if the person is using tobacco;

w. Item 21p. Vehicles. Each person who holds a grade A permit to produce grade A pasteurized, ultra-pasteurized, or aseptically processed milk, or milk products shall use vehicles to transport pasteurized and ultra-pasteurized milk and milk products that are constructed and operated so that the milk or milk products are maintained at a temperature of 45°F or cooler, but not frozen and protected from sunlight, from freezing, and from contamination;

x. Item 22p. Surroundings. Each person who holds a grade A permit to produce grade A pasteurized, ultra-pasteurized, or aseptically processed milk, or milk products shall keep neat, clean, and free from conditions which might attract or harbor flies, other insects, rodents, or which otherwise constitute a nuisance, the area surrounding any milk plant;

y. Each grade A permit holder's receiving station shall comply with subdivisions C 1 a through q of this section, inclusive, and subdivisions C 1, s, v, and x of this section, except that the partitioning requirement of subdivision C 1 g of this section shall not be deemed to apply;

z. Each grade A permit holder's transfer station shall comply with subdivisions C 1 c, f, h through n, p, q, s, v, and x of this section; and as climatic and operating conditions require, the provisions of subdivisions C 1 d and e of this section; except that each person shall provide overhead protection for a transfer station; and

a1. Each grade A permit holder's facilities for the cleaning and sanitizing of bulk tanks which transport milk and milk products shall comply with subdivisions C 1 a, f, h through n, p, q, v, and x of this section; and as climatic and operating conditions require, the provisions of subdivisions C 1 d and e of this section except that each grade A permit holder shall provide overhead protection for facilities for the cleaning and sanitizing of bulk tanks which transport milk and milk products in the grade A permit holder's milk plant, receiving station, or transfer station.

D. Minimum facilities requirements for milk processing plant. Each person who holds a grade A permit to produce grade A pasteurized, ultra-pasteurized, or aseptically processed milk or milk products shall:

1. Provide a separate receiving room meeting the requirements of subdivision C 1 y of this section from any other area of the plant for the receipt of milk or milk products in bulk if the plant receives any milk or milk products in bulk;

2. Provide cleaning and sanitizing facilities for milk tank trucks as part of the plant's receiving room facilities if the plant receives any milk or milk products in bulk;

3. Provide a separate receiving room from any other area of the plant for the receipt of milk or milk product in cans or other containers if the plant receives any milk or milk product in cans or other containers;

4. Provide a separate room from any other area of the plant for the cleaning of milk cans or containers, bottles, milk cases, and dry milk or milk product containers if the plant receives any milk in cans or containers or washes any bottles, milk cases, or dry milk or milk product containers;

5. Provide a separate room for the fabrication of containers and closures for milk and milk products if the plant fabricates any containers or closures;

6. Provide a separate room for the packaging of dry milk or milk products if the plant packages any dry milk or milk product; and

7. Provide separate rooms from any other area of the plant for each of the following operations performed on any milk, milk product, or condensed and dry milk product: (i) pasteurization; (ii) processing; (iii) cooling; (iv) reconstitution; (v) condensing; (vi) drying; and (vii) packaging, if the operation is performed in the plant.

2VAC5-490-73. Mandatory pasteurization for all milk, milk products, condensed milk, condensed milk products, dry milk, and dry milk products in final package form intended for direct human consumption.

No person shall cause to be delivered into intrastate commerce or shall sell, otherwise distribute, or hold for sale with intent to sell or other distribution after shipment offer to sell in intrastate commerce any milk, milk product, condensed milk, condensed milk product, dry milk, or dry milk product in final package form for direct human consumption unless the product has been pasteurized or is made from milk, milk product, condensed milk, condensed milk product, dry milk, or dry milk product that has all been pasteurized, except where alternative procedures to pasteurization are provided for under 21 CFR Part 133 for curing of certain cheese varieties.

2VAC5-490-105. New or test facilities and equipment; equipment design, construction and approval process.

A. At the request of any grade A permit holder, the State Regulatory Authority may allow the temporary installation of equipment or the temporary construction of dairy facilities that the State Regulatory Authority has no or limited regulatory experience with, on a trial basis, to determine if the equipment or dairy facilities can comply with the requirements of this chapter under normal conditions of use. The State Regulatory Authority will at a minimum evaluate the equipment or facilities for compliance with the requirements of this chapter when newly installed, as well as, complete a separate evaluation of the inspection record during the trial of the equipment or facilities to comply with the requirements of this chapter over time under normal conditions of use.

B. At the conclusion of each trial, the State Regulatory Authority shall inform the grade A permit holder in writing if the equipment or facilities or both the equipment and facilities comply with the requirements of this chapter. If the equipment or facilities do not comply or both the equipment and facilities do not comply with the requirements of this chapter, the State Regulatory Authority shall inform the grade A permit holder in writing to alter or remove his equipment or facilities or to alter or remove both his equipment and facilities within a maximum of six months from the date of receipt of the written decision by the permit holder.

C. The State Regulatory Authority shall not may renew or extend any temporary installation of equipment or the temporary construction of dairy facilities beyond the time specified in the written agreement between the grade A permit holder and the State Regulatory Authority for more than one year after the time specified in the written agreement for any reason. The State Regulatory Authority shall not accept any agreement between the grade A permit holder and the State Regulatory Authority for the temporary installation of equipment or the temporary construction of dairy facilities that proposes to be evaluated for a period longer than one year.

D. If the State Regulatory Authority agrees to allow the temporary installation of equipment or the temporary construction of dairy facilities, the State Regulatory Authority and the grade A permit holder installing the equipment or constructing the facilities shall each sign a written agreement that at a minimum includes:

1. A description of the equipment or facilities and detailed plans for their installation acceptable to the State Regulatory Authority;

2. The name of the grade A permit holder and the physical address where the equipment or facilities will be installed;

3. The name and contact information for the person or persons who will be installing the equipment or constructing the facilities;

4. A detailed plan including:

a. A description of the items to be evaluated by the State Regulatory Authority;

b. Criteria to judge the acceptability of performance by which each item being evaluated will be measured by the State Regulatory Authority;

c. A time table specifying the length of the trial, the minimum number of inspections and time periods between inspections;

d. How inspection findings will be documented and reviewed with the permit holder and at what frequency;

e. A provision for the State Regulatory Authority to end the temporary installation agreement before the completion of the timeline and reject the equipment or facilities as not complying with the requirements of this chapter if continuation of the trial will not substantially affect the decision of the State Regulatory Authority;

f. A provision that at the end of the timeline specified in the agreement, the permit holder will remove or alter the equipment or facilities within a maximum of six months from the date he receives written instruction to do so from the State Regulatory Authority to comply with the requirements of this chapter if the State Regulatory Authority does not approve the equipment or facilities; and

g. A provision that the permit holder's failure to remove or alter the equipment or facilities to comply with the requirements of this chapter within six months after receipt of written instructions from the State Regulatory Authority shall be considered sufficient cause for permit suspension.

Part XI
Voluntary HACCP Program

Article 1
Program Participation

2VAC5-490-131. HACCP program participation voluntary.

A. Participation in the HACCP program is voluntary for each person who operates a dairy plant, receiving station or transfer station and the State Regulatory Authority responsible for the permitting and auditing of each person's dairy plant, receiving station or transfer station. No person operating a milk plant, receiving station or transfer station may participate in the voluntary HACCP program unless the State Regulatory Agency responsible for the permitting and auditing of each person's dairy plant agrees to participate in the voluntary HACCP program, also.

B. Each person volunteering to operate his milk plant, receiving station or transfer station under the voluntary HACCP program shall provide a written commitment to the State Regulatory Authority responsible for his milk plant, receiving station or transfer station that he will supply the necessary resources to support participation in the voluntary HACCP program.

C. Each State Regulatory Authority volunteering to participate in the voluntary HACCP program shall provide a written commitment to the person requesting to operate a milk plant, receiving station or transfer station under the voluntary HACCP program that the State Regulatory Authority will supply the necessary resources to support participation in the voluntary HACCP program.

D. Each person operating a milk plant, receiving station or transfer station and participating in the voluntary HACCP program shall have a minimum of 60 days of HACCP System records prior to a HACCP listing audit. Each milk plant, receiving station or transfer station shall be inspected and permitted initially by the State Regulatory Authority and shall be regulated initially under the requirements of this chapter without taking into consideration the provisions of this part until the State Regulatory Authority conducts an acceptable HACCP listing audit documenting the successful implementation of a fully functioning HACCP System in the person's milk plant, receiving station or transfer station.

E. Each person operating a milk plant, receiving station or transfer station and participating in the voluntary HACCP program shall:

1. Comply with all of the provisions applicable to the voluntary HACCP program contained in:

a. Section 7, Standards for grade "A" milk and milk products;

b. Item 16p, Pasteurization and aseptic processing;

c. Item 16p(E), Pasteurization and aseptic processing records, equipment tests and examinations;

d. Section 13, Personnel health;

e. Section 14, Procedure when infection or high risk of personnel health;

f. Appendix H, Pasteurization Equipment and procedures;

g. Appendix I, Pasteurization equipment and controls tests;

h. Appendix K, HACCP Program; and

i. Appendix R, Determination of Time/Temperature Control for Safety of Milk and Milk Products contained in the "Grade [ A "A" ] Pasteurized Milk Ordinance, 2005 2009 [ revision" Revision" ];

2. Prepare their HACCP Plan based on the following HACCP principles:

a. Conduct a hazard analysis;

b. Determine the critical control points;

c. Establish critical limits;

d. Establish monitoring procedures;

e. Establish corrective actions;

f. Establish verification procedures; and

g. Establish recordkeeping and documentation procedures;

3. Prior to the implementation of a HACCP Plan develop, document and successfully implement written prerequisite programs which provide the basic environment and operating conditions that are necessary for the production of safe, wholesome food.

2VAC5-490-138. Training.

Each person operating a milk plant, receiving station or transfer station and participating in the voluntary HACCP program shall ensure that each person who is responsible for: (i) developing a hazard analysis; (ii) delineating control measures; (iii) developing a HACCP plan that is appropriate for the specific milk plant, receiving station or transfer station; (iv) validating and modifying the HACCP plan; or (v) performing required HACCP plan record reviews has received basic HACCP training and an orientation to the HACCP requirements contained in Appendix K of the "Grade [ A "A" ] Pasteurized Milk Ordinance, 2005 2009 [ revision" Revision" ].

Part XII
Interpretation and Enforcement

2VAC5-490-140. Interpretation and enforcement.

A. This chapter is based on the "Grade [ A "A" ] Pasteurized Milk [ Ordinance- ] 2005 [ Ordinance, ] 2009 [ recommendations Revision ]." Except as otherwise provided in this chapter, the provisions of this chapter shall be interpreted in a manner consistent with interpretations accorded the "Grade [ A "A" ] Pasteurized Milk [ Ordinance- ] 2005 [ Ordinance, ] 2009 [ recommendations Revision ]."

B. The administrative procedures used to conduct case decisions under this chapter shall conform to the provisions of the Virginia Administrative Process Act.

C. The State Regulatory Authority shall comply with the following administrative procedures when summarily suspending a grade A permit as specified in 2VAC5-490-31 B:

1. The State Regulatory Authority shall serve upon the grade A permit holder a written notice of suspension. The written notice of suspension shall specify the violations in question and inform the grade A permit holder of the right to appear before the State Regulatory Authority in person, by counsel, or by other qualified representative at a fact-finding conference for the informal presentation of factual data, arguments, and proof to appeal this determination of violation;

2. Upon receipt of written application from any person whose grade A permit has been summarily suspended (within 30 days after the effective date of the summary suspension) the State Regulatory Authority shall within seven days after the date of receipt by the State Regulatory Authority of a written application from any person whose grade A permit has been summarily suspended proceed to hold an informal fact-finding conference to ascertain the facts of the violations in question and upon evidence presented at the informal fact-finding conference shall affirm, modify, or rescind the summary suspension;

3. The State Regulatory Authority shall, unless the parties consent, ascertain the fact basis for their decisions of cases through informal conference proceedings. Such conference proceedings include the rights of parties to the case to have reasonable notice thereof, to appear in person or by counsel or other qualified representative before the State Regulatory Authority for the informal presentation of factual data, argument, or proof in connection with any case, to have notice of any contrary fact basis or information in the possession of the agency which can be relied upon in making an adverse decision, to receive a prompt decision of any application for license, benefit, or renewal thereof, and to be informed, briefly and generally in writing, of the factual or procedural basis for an adverse decision in any case;

4. No person whose grade A permit has been summarily suspended may be granted an informal fact-finding conference by the State Regulatory Authority unless the State Regulatory Authority receives the person's written application within 30 days after the effective date of the summary suspension;

5. From any adverse decision of an informal fact-finding conference, the grade A permit holder may request a formal hearing under § 2.2-4020 of the Code of Virginia by writing the Program Manager of the Office of Dairy and Foods within 30 days stating the request and by providing the State Regulatory Authority with a statement of the issues in dispute. If the request for a formal conference is denied, the State Regulatory Authority shall notify the grade A permit holder in writing and further may affirm or modify the decision of the informal fact-finding conference; and

6. If a formal fact-finding conference is denied, the State Regulatory Authority shall notify the grade A permit holder of the right to file an appeal in the circuit court.

DOCUMENTS INCORPORATED BY REFERENCE (2VAC5-490)

[ Drug Residue Test Methods for Confirmation of Presumptive Positive Results and Initial Producer Traceback, M-I-96-10 (Revision #5) #7), March 10, 2004 January 4, 2010, published by the Food and Drug Administration, Milk Safety Branch (HFS-626), 5100 Paint Branch Parkway, College Park, MD 20740-3835.

Evaluation of Milk Laboratories, 2005 2007 Revision, published by the Food and Drug Administration Laboratory Quality Assurance Team, HFH-450, 6502 South Archer Road, Summit-Argo, Illinois 60501.

Grade "A" Pasteurized Milk Ordinance, 2005 2009 Revision, published by the Food and Drug Administration, Milk Safety Branch (HFS-626), 5100 Paint Branch Parkway, College Park, MD 20740-3835.

Drug Residue Test Methods for Confirmation of Presumptive Positive Results and Initial Producer Trace Back, M-I-96-10 (Revision #7), January 4, 2010, published by the Food and Drug Administration, Dairy and Egg Branch (HFS 316), 5100 Paint Branch Parkway, College Park, MD 20740-3835.

Evaluation of Milk Laboratories, 2009 Revision, published by the Food and Drug Administration Laboratory Proficiency and Evaluation Team, HFH-450, 6502 South Archer Road, Summit-Argo, Illinois 60501.

Grade "A" Pasteurized Milk Ordinance, 2009 Revision, published by the Food and Drug Administration, Milk Safety Branch (HFS-626), 5100 Paint Branch Parkway, College Park, MD 20740-3835. ]

Official Methods of Analysis of the Association of AOAC International, 18th Edition, 2005, published by the Association of Official Analytical Chemists International, 481 North Frederick Avenue, Suite 500, Gaithersburg, Maryland 20877-2417.

Uniform Methods and Rules: Brucellosis Eradication - effective October 1, 2003, available from U.S. Department of Agriculture, Animal and Plant Health Inspection Service, Veterinary Services, Federal center Building, Hyattsville, Maryland 20782 or Federal Veterinarian in Charge, USDA/APHIS-VS, Virginia Area Office, 7th Floor, Federal Building, 400 N. 8th Street, Richmond, Virginia 23240.

Uniform Methods and Rules: Bovine Tuberculosis Eradication - effective January 1, 2005, available from U.S. Department of Agriculture, Animal and Plant Health Inspection Service, Veterinary Services, federal Center Building, Hyattsville, Maryland 20782 or Federal Veterinarian in Charge, USDA/APHIS-VS, Virginia Area Office, 7th Floor, Federal Building, 400 N. 8th Street, Richmond, Virginia 23240.