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Milk production and processing regulations

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Chapter 901:3-12 Dairy and Dairy Products Sanitary Requirements

901:3-12-01 Definitions
901:3-12-02 Quality Requirements
901:3-12-03 Bacterial Count.
901:3-12-04 Somatic Cell Count.
901:3-12-05 Drug Residue Level.
901:3-12-06 Radionuclides.
901:3-12-07 Pesticides And Herbicides.
901:3-12-08 Added Water.
901:3-12-09 Health Of Herd.
901:3-12-10 Milking Facility And Housing.
901:3-12-11 Milking Procedure.
901:3-12-12 Cooling.
901:3-12-13 Milkhouse Or Milkroom.
901:3-12-14 Farm Chemicals And Animal Drugs.
901:3-12-15 Utensils And Equipment.
901:3-12-16 Water Supply.
901:3-12-17 Sewage Disposal.
901:3-12-18 Qualifications For Farm License Or Registration.
901:3-12-19 Premises Of Milk Plant
901:3-12-20 Buildings.
901:3-12-21 Facilities.
901:3-12-22 Equipment And Utensils.
901:3-12-23 Protection And Transport Of Raw Milk And Cream.
901:3-12-24 Raw Product Storage.
901:3-12-25 Quality, Composition And Wholesomeness.
901:3-12-26 Pasteurization, Sterilization And Cooking.
901:3-12-27 Cleaning And Sanitizing Treatment.
901:3-12-28 Packaging And General Information.
901:3-12-29 Storage Of Finished Product.
901:3-12-30 Drying.
901:3-12-31 Cooling Dry Products.
901:3-12-32 Requirements For Instant Nonfat Dry Milk.
901:3-12-33 Coolers And Freezers.
901:3-12-34 Starter Room.
901:3-12-35 Make Room.
901:3-12-36 General Construction and repair
901:3-12-37 Whey Disposal.
901:3-12-38 Operations And Operating Procedures.
901:3-12-39 Plant Records.
901:3-12-40 Insect And Rodent Control Program.
901:3-12-41 Clothing And Shoe Covers.
901:3-12-42 Labeling.
901:3-12-43 Personnel Cleanliness.
901:3-12-44 Personnel Health.

Chapter 901:3-12

Dairy and Dairy Products Sanitary Requirements

901:3-12-01 Definitions.

As used in rules 901:3-12-01 to 901:3-12-46 of the Administrative Code:

(A) "Cleaned-in-place" and its acronym "C.I.P." mean the procedure by which sanitary pipelines or pieces of dairy equipment are mechanically cleaned in place by circulation.

(B) "Dairy farm" and "farm" mean a place or premise where one or more milking cows, goats, sheep or other animals as may be determined by the director and are kept, and from which all or a portion of the milk produced thereon is delivered, sold, or offered for sale to a manufacturing plant.

(C) "Dairy plant" and "plant" mean any place, premise, or establishment where milk or dairy products are received or handled for processing or manufacturing and/or prepared for distribution. When "plant" is used in connection with the production, transportation, grading, or use of milk, it means any plant that handles or purchases milk for manufacturing purposes; when used in connection with requirements for plants or licensing or registration of plants, it means only those plants that manufacture dairy products.

(D) "Dairy product" means butter, natural cheese, processed cheese, dry whole milk, nonfat dry milk dry buttermilk, dry whey, evaporated whole milk evaporated skim milk, condensed whole milk and plain condensed skim milk, sweetened condensed skim milk, and such other products, for human consumption, as may be otherwise designated.

(E) "Director" means the director of the Ohio department of agriculture or official, employee, or contractor of the department designated by the director of agriculture.

(F) "Drug" means drug as defined in division (A)(6) of section 3715.01 of the Revised Code.

(G) "Excluded Milk" means all of a producer's milk excluded from the market by the provisions of rule 901:3-12-02 of the Administrative Code.

(H) "License" or "Registration" means a license or registration issued by the director as provided in section 917.09 of the Revised Code.

(I) "Milk" means:

(1) The lacteal secretion practically free from colostrum obtained by the complete milking of one or more healthy cows; or

(2) The lacteal secretion practically free from colostrum obtained by the complete milking of one or more healthy goats. Goat milk shall only be used to manufacture dairy products that are legally provided for in 21 C.F.R. or recognized as non-standardized traditional products normally manufactured from goat milk; or

(3) The lacteal secretion practically free from colostrum obtained by the complete milking of one or more healthy sheep. Sheep milk shall only be used to manufacture dairy products that are legally provided for in 21 C.F.R. or recognized as non-standardized traditional products normally manufactured from sheep milk.

(J) "Milk for manufacturing purposes" means milk produced for processing and intended for manufacturing into products for human consumption and is not subject to grade A requirements.

(K) "Official Methods" means the "Official Methods of Analysis of the Association of Official Agricultural Chemists, as published by the Association of Official Analytical Chemists."

(L) "Producer" means the person who holds a license from the department of agriculture to produce milk for manufacturing purposes.

901:3-12-02 Quality Requirements.

(A) Acceptability of raw milk from each producer shall be based on a visual examination for appearance and odor or by an acceptable test procedure for bacterial count, somatic cell count and drug residue test as specified in rules 901:3-12-03, 901:3-12-04 and 901:3-12-05 of the Administrative Code.

(B) The appearance of acceptable raw milk shall be normal and free of excessive coarse sediment. The milk shall not show any abnormal condition including but not limited to: curdled, ropy, bloody or mastitic. When milk is tested for sediment and it exceeds the following United States department of agriculture standards, it shall be considered as adulterated:

No. 1 (acceptable) – not to exceed 0.50 mg. or equivalent.

No. 2 (acceptable) – not to exceed 1.50 mg. or equivalent.

No. 3 (probational, not over ten days) – not to exceed 2.50 mg. or equivalent.

No. 4 (reject)(considered to be adulterated) – over 2.50 mg. or equivalent.

Adulterated milk may be embargoed by the director and disposed of in accordance with division (E) of section 917.02 of the Revised Code.

Methods for determining the sediment content of the milk of individual producers shall be those described in the latest edition of the standard methods for the examination of dairy products. Sediment content shall be based on comparison with applicable charts of the United States sediment standards for milk and milk products, 7 C.F.R. Part 58, Subpart T, section 58.2728 through section 58.2732.

(C) The odor shall be fresh and sweet. The milk shall be free from objectionable feed and other off-odors that would adversely affect the finished product.

(D) Cows which show evidence of the secretion of abnormal milk in one or more quarters based upon bacteriological, chemical, or physical examination shall be milked last or with separate equipment, and the milk shall be discarded. Cows treated with, or cows which have consumed chemical, medicinal, or radioactive agents which are capable of being secreted in the milk and which in the judgement of the director, may be deleterious to human health, shall be milked last or with separate equipment, and the milk disposed of as the director may direct. In making determinations regarding the impact of radioactive agents on human health, the director shall consult with the director of health.

(E) A plant or hauler shall reject specific producer raw milk if the milk fails to meet the requirements for appearance and odor or if it tests positive for drug residue.

(F) All reject milk shall be identified either with a reject tag or colored with harmless food coloring.

(G) A plant shall not accept milk from a producer if:

(1) Three of the last five milk samples have exceeded the maximum bacterial count as specified in rule 901:3-12-03 of the Administrative Code;

(2) Three of the last five milk samples have exceeded the maximum somatic cell count as specified in rule 901:3-12-04 of the Administrative Code; or

(3) The producer's last milk sample was positive on a drug residue test as specified in rule 901:3-12-05 of the Administrative Code.

(H) Quality testing of milk from new producers, producers whose license or registration has been suspended and transfer producers shall meet the requirements in this rule for:

(1) Acceptable raw milk;

(2) Bacterial count;

(3) Somatic cell count; and

(4) Drug residue level.

Thereafter, each milk shipment shall meet the requirements of acceptable milk, and shall be tested in accordance with the provisions of rules 901:3-12-03, 901:3-12-04 and 901:3-12-05 of the Administrative Code.

(1) Prior to receipt of the first shipment of milk from a producer, whose milk shipment is shifted from one plant to another plant, the processor shall make a request to the director for the following information; and may receive the producer's milk if:

(1) The producer holds a valid, active license or registration as set forth in rule 901:3-10-04 of the Administrative Code; and

(2) The last shipment of milk received from the producer by the former plant meet the requirements for:

(a) Acceptable milk;

(b) Bacterial count;

(c) Somatic cell count; and

(d) Drug residue level.

901:3-12-03 Bacterial Count.

(A) During at least four separate months within any consecutive six month period, the director shall collect, at irregular intervals, and submit producer raw milk samples to a laboratory for examination to determine the bacterial count.

(B) Samples shall be analyzed at a laboratory approved by the director. Each producer raw milk sample shall be tested for bacterial count using one of the following methods or any other method listed in the standard methods for the examination of dairy products, most recent edition published by the American public health association; or by any other equivalent method approved by the director:

(1) Direct microscopic clump count;

(2) Standard plate count;

(3) Plate loop count;

(4) Pectin gel plate count;

(5) PetrifilmTM aerobic count;

(6) Spiral plate count;

(7) Hydrophobic grid membrane filter count; or

(8) Impedance/conductance count.

(C) Whenever the producer raw milk bacterial count indicates the presence of more than 500,000 bacteria per ml. for milk shipped from the farm bulk milk tank, or more than 1,000,000 bacteria per ml. for producer raw milk shipped from the farm via cans, the following procedures shall be applied:

(1) The producer shall be notified of an excessive bacterial count; and

(2) Whenever two of the last four bacterial counts exceed the bacterial standard as stated in paragraph (C) of this rule, the director shall send a written warning notice to the producer. The notice shall be in effect so long as two of the last four consecutive samples exceed the bacterial standard.

(D) An additional sample shall be taken no sooner than three days and no later than twenty-one days after sending of the warning notice required in paragraph (C)(2) of this rule. If this sample also exceeds the bacterial standard, the producer license or registration shall be suspended until satisfactory compliance is obtained. Shipment may be resumed and the producer license or registration reinstated by the director when an additional sample of the producer raw milk is tested and found satisfactory. The producer license or registration shall remain in a warning status as long as two of the last four bacterial counts exceed the standard. The director shall suspend the producer license or registration immediately, in accordance with section 917.22 of the Revised Code, whenever three of the last five bacterial counts exceed the standard.

901:3-12-04 Somatic Cell Count.

(A) During at least four separate months within any consecutive six month period, the director shall, at irregular intervals, collect and submit producer raw milk samples to a laboratory for examination to determine the somatic cell count.

(B) The somatic cell standard for acceptable raw milk shall be 250,000 per ml. more than the standard established in rule 901:3-10-08 of the Administrative Code. Goat milk shall remain at the same level as established in rule 901:3-10-08 of the Administrative Code.

(C) A screening test may be conducted on goat herd milk. When a goat herd screening sample exceeds either of the following screening test results, a confirmatory test shall be conducted using either:

(1) The California mastitis test – weak positive (CMT 1); or

(2) The Wisconsin mastitis test – WMT value of 18 mm.

(D) Samples shall be analyzed at a laboratory approved by the director. Each producer raw milk sample shall be tested for somatic cell count using one of the following methods or any other method listed in the "standard methods for the examination of dairy products", most recent edition, or by any other equivalent method approved by the director:

(1) Direct microscopic somatic cell count (single strip procedure). Pyronin Y-Methyl Green Stain or "New York" modification shall be used for goat milk;

(2) Electronic somatic cell count;

(3) Flow cytometry/opto-electronic somatic cell count; or

(4) Membrane filter DNA somatic cell count.

(E) The results of the confirmatory test on goat milk for somatic cells shall be the official results.

(F) Whenever the producer raw milk somatic cell count indicates the presence of more than the standard established in paragraph (B) of this rule, the following procedures shall be applied:

(1) The producer shall be notified of an excessive somatic cell count; and

(2) Whenever two of the last four somatic cell counts exceed the somatic cell standard as stated in paragraph (B) of this rule, the director shall send a written warning notice to the producer. The notice shall be in effect so long as two of the last four consecutive samples exceed the somatic cell standard.

(G) An additional sample shall be taken no sooner than three days and no later than twenty-one days after sending of the warning notice. If this sample also exceeds the somatic cell standard, the producer license or registration shall be suspended until satisfactory compliance is obtained. Shipment may be resumed and the producer license or registration reinstated by the director when an additional sample of the producer raw milk is tested and found satisfactory. The producer license or registration shall remain in a warning status as long as two of the last four somatic cell counts exceed the standard. The director shall suspend the producer license or registration immediately, in accordance with section 917.22 or the Revised Code, whenever three of the last five somatic cell counts exceed the standard.

901:3-12-05 Drug Residue Level.

(A) Industry responsibilities.

(1) Sampling and testing program:

(a) All milk shipped for processing or intended to be processed on the farm where it was produced shall be sampled and tested, prior to processing, for beta lactam drug residue. Collection, handling and testing of samples shall be done according to procedures approved by the director;

(b) When so specified by the director, all milk shipped for processing, or intended to be processed on the farm where it was produced, shall be sampled and tested, prior to processing, for other drug residues;

(c) When the director determines that a potential problem exists with an animal drug residue or other contaminant in the milk supply, a sampling and testing shall be conducted, as determined by the director. The testing shall continue until such time that the director determines with reasonable assurance that the potential problem has been remedied; and

(d) The dairy industry shall analyze samples for beta lactams and other drug residues by methods evaluated by the association of official analytical chemists and accepted by the director as effective in determining compliance with established "safe levels" or tolerances as established and amended by the United States food and drug administration. The industry may employ on a temporary basis other test methods evaluated by the Virginia polytechnic institute and state university, or by other institutions using equivalent evaluation procedures, and determined to demonstrate accurate compliance results. These test methods may be used until they are evaluated by the AOAC and accepted or rejected by the director.

(2) Individual producer sampling:

(a) For bulk milk a milk sample for beta lactam drug residue testing shall be taken at each farm and shall include milk from each farm bulk tank;

(b) For can milk a milk sample for beta lactam drug residue testing shall be formed separately at the receiving plant for each can milk producer included in a delivery, and shall be representative of all milk received from the producer; or

(c) For producer/processor a milk sample for beta lactam drug residue testing shall be formed separately according to paragraphs (A)(2)(a) and (A)(2)(b) of this rule for milk produced or received by a producer/processor.

(3) Load sampling and testing:

(a) For bulk milk a load sample shall be taken from the bulk milk pickup tanker after its arrival at the plant and prior to further commingling;

(b) For can milk a load sample representing all of the milk received on a shipment shall be formed at the plant, using a sampling procedure that includes milk from every can on the vehicle; or

(c) For producer/processor a load sample shall be formed at the plant using a sampling procedure that includes all milk produced and received.

(4) Sample and record retention. A load sample that tests positive for drug residue shall be retained according to guidelines established by the appropriate state regulatory agency. The records of all sample test results shall be retained for a period of not less than twelve months.

(5) Industry follow-up:

(a) When a load sample tests positive for drug residue, industry personnel shall notify the director immediately, according to state policy, of the positive test result and of the intended disposition of the shipment of milk containing the drug residue. All milk testing positive for drug residue shall be disposed of in a manner that removes it from the human or animal food chain, except when acceptably reconditioned under United States food and drug administration compliance policy guidelines;

(b) Each individual producer sample represented in the positive-testing load sample shall be individually tested in a laboratory approved by the director to determine the producer of the milk sample testing positive for drug residue. Identification of the producer responsible for producing the milk testing positive for drug residue, and details of the final disposition of the shipment of milk containing the drug residue, shall be reported immediately to the director, according to state policy; and

(c) Milk shipment from the producer identified as the source of milk testing positive for drug residue shall cease immediately and may resume only after a sample from a subsequent milking does not test positive for drug residue.

(B) Regulatory agency responsibilities.

(1) Monitoring and surveillance. The director shall monitor the milk industry's drug residue program by conducting unannounced on-site inspections to observe testing and sampling procedures and to collect samples for comparison drug residue testing. In addition, the director shall review industry records for compliance with state policy. The review shall seek to determine that:

(a) Each producer is included in a routine, effective drug residue milk monitoring program utilizing association of official analytical chemists evaluated and federal drug administration approved methods to test samples for the presence of drug residue;

(b) The director receives prompt notification from industry personnel of each occurrence of a sample testing positive for drug residue, and of the identity of each producer identified as a source of milk testing positive for drug residue;

(c) The director receives prompt notification from industry personnel of the intended and final disposition of milk testing positive for drug residue, and that disposal of the load is conducted in a manner that removes it from the human or animal food chain, except when acceptably reconditioned under federal drug administration compliance policy guidelines; and

(d) Milk shipment from a producer identified as a source of milk testing positive for drug residue completely and immediately ceases until a milk sample taken from the dairy herd does not test positive for drug residue.

(2) Enforcement:

(a) The director may deny, suspend or revoke the producer's license or registration for violation of this rule.

(b) The producer shall review the "Milk and Dairy Beef Quality Assurance Program" with a licensed veterinarian within thirty days after each occurrence of shipping milk testing positive for drug residue. A certificate confirming that the "Quality Assurance Program" has been reviewed shall be signed by the responsible producer and a licensed veterinarian. The director shall be notified after the program has been reviewed; and

(c) If a producer ships milk testing positive for drug residue three times within a twelve month period, the director may revoke the producer's license or registration.

901:3-12-06 Radionuclides.

Composite milk samples from selected areas in the state shall be tested for biologically significant radionuclides at a frequency which the director determines to be adequate to protect the consumer.

901:3-12-07 Pesticides and Herbicides.

Composite milk samples shall be tested for pesticides and herbicides at a frequency which the director determines is adequate to protect the consumer. The test results from the samples shall not exceed established food and drug administration limits.

901:3-12-08 Added Water.

(A) Added water is considered to be an adulteration of the product. Milk samples from each producer shall be tested for added water at a frequency of at least four times a year to establish a cryoscope herd history for the producer. The director shall send the producer a written warning when the cryoscope reading exceeds five percent added water above the established herd history. The warning shall be in effect for one year from the date of the warning letter. The director shall immediately suspend the producer license or registration for adulteration with added water when the cryoscope reading exceeds five per cent above the established herd history on the second occasion.

(B) If the director determines that a producer, processor or hauler has purposefully caused the milk or milk product to be adulterated, the director may immediately suspend the license or registration of the producer, processor or hauler pursuant to section 917.22 of the Revised Code.

901:3-12-09 Health of Herd.

(A) All animals in the herd shall be maintained in a healthy condition.

(B) All milk for manufacturing shall be from herds which are located in an accredited free state or modified accredited tuberculosis area, as determined by the United States department of agriculture. Herds located in an area that fails to maintain accredited status shall have passed an annual tuberculosis test.

(C) All milk for manufacturing shall be from herds under a brucellosis eradication program which meets one of the following conditions:

(1) The herd is located in a certified brucellosis-free area as defined by the United States department of agriculture and is enrolled in the testing program for the area; or

(2) The herd meets United States department of agriculture requirements for an individually certified herd; or

(3) The herd participates in a milk ring testing program that meets the requirements of the United States department of agriculture as described in "Brucellosis Eradication Uniform Methods and Rules" at least four times per year at approximately ninety-day intervals; or

(4) The herd has an individual blood agglutination test annually with an allowable maximum grace period not exceeding two months.

(D) Regardless of location or other herd status, a milk producer whose herd has a suspicious milk ring test result shall have the entire herd blood tested within thirty days after the date of the laboratory test.

(E) Regardless of location or other herd status, a milk producer whose herd is identified as the origin of a brucellosis reactor animal shall have the entire herd blood tested within thirty days after the laboratory tests, unless the test requirement has been waived by epidemiologic investigation conducted by the director.

(F) Regardless of location or other herd status, a milk producer whose herd is identified as the origin of a tuberculosis reactor or suspect, shall follow all statutes, rules, and recommendations of the Ohio department of agriculture concerning the testing and disposition of animals in the herd.

(G) For diseases other than brucellosis and tuberculosis, the director may require appropriate physical, chemical, or bacteriological tests. The diagnosis of other diseases in dairy cattle shall be based upon test results and the diagnosis of a licensed veterinarian or a veterinarian in the employ of a governmental agency. The milk producer shall dispose of any animal diagnosed as being diseased in accordance with applicable laws and rules.

901:3-12-10 Milking Facility and Housing.

(A) The milking barn, stable, or parlor shall be of a size and arrangement that will promote a sanitary milking operation. It shall be provided with natural or artificial light, well distributed for day or night milking and have sufficient air space and air circulation to prevent condensate and excessive odors. The floors and gutters shall be in good repair and constructed of concrete or other impervious material. Concentrates and feed, when stored in the milking facility, shall be kept in a tightly covered box or bin. The facility shall be kept clean, the manure removed daily and no swine or fowl shall be permitted in any part of the milking facility.

(B) If milk is exposed in the milking facility, it shall be protected in a manner that prevents any contamination of the milk, equipment, containers, or utensils. No milk shall be strained, poured, transferred, or stored unless it is properly protected from contamination.

(C) Milk stools, surcingles and antikickers shall be kept clean and stored off the floor.

(D) The cowyard, housing area or loafing area shall be of ample size to prevent overcrowding, shall be drained to prevent forming of standing water pools, insofar as practicable, and shall be kept clean. The dairy animals shall be prevented from having any access to stored or accumulated manure.

901:3-12-11 Milking Procedure.

(A) The milk producer shall ensure that milking is done only in the milking barn, stable, or parlor. The flanks, udders, bellies, and tails of all milking animals shall be free from visible dirt. All brushing shall be completed prior to milking. The udders and teats of all milking animals shall be clean and dry before milking. The milk producer shall ensure that the animals' teats are treated with a sanitizing solution just prior to the time of milking and shall be dry before milking. Wet-hand milking is prohibited.

(B) The milker's outer clothing shall be clean. His hands shall be clean and dry immediately before milking, before performing any milkhouse function, and prior to resumming any of these activities if interrupted. No person with an infected cut or open sore on their hands or arms shall milk dairy animals, or handle milk or milk containers, utensils or equipment.

(C) Dairy animals, which secrete abnormal milk, shall be milked last or with separate equipment.

(D) Dusty operations should not be conducted immediately before or during milking. Strong flavored feeds should only be fed after milking.

901:3-12-12 Cooling.

(A) A manufacture milk producer shall do one of the following:

(1) In the case of manufacture milk that is stored in cans on the manufacture milk producer's farm, cool the milk to and store it at a temperature of sixty degrees Fahrenheit (60°F), sixteen degrees Celsius (16°C), or lower within two hours after completion of the milking; or

(2) In the case of all other manufacture milk that is stored on the manufacture milk producer's farm in cans or bulk, cool the milk and store it at fifty degrees Fahrenheit (50°F), sixteen degrees Celsius (16°C), or lower within two hours after completion of the milking.

(B) Manufacture milk stored in accordance with paragraph (A)(1) of this rule shall be used exclusively in the manufacture of cheese.

(C) This rule does not apply to raw milk that is delivered to a manufacture milk plant not later than two hours after completion of milking.

901:3-12-13 Milkhouse or Milkroom.

(A) A milkhouse or milkroom shall be provided for handling and cooling milk and for washing, handling, and storing the utensils and equipment. Other products shall not be handled or other activities performed in the milkroom, which would be likely to contaminate milk, or otherwise create a public health hazard.

(B) The milkhouse or milkroom that is a part of the barn or other building, shall be partitioned and sealed to prevent the entrance of dust, flies, or other contamination. The floor of the milkhouse or milkroom shall be of concrete or other impervious material and graded to drain so that there are no pools of standing water. The walls and ceilings shall be constructed of smooth easily cleaned material. All newly constructed milkhouses shall have walls and ceilings constructed of smooth material, kept in good repair, and well painted with a light-colored washable paint or finished in an equally suitable manner. All outside doors shall open outward and be self-closing, unless they are provided with tight-fitting, self-closing, screen doors that open outward or unless other effective means are provided to prevent the entrance of flies or insects. A direct opening between the milkhouse or milkroom and the milking barn, stable, or parlor is permitted when the opening has a tight fitting, self-closing, solid door. The milkhouse or milkroom shall have sufficient air space and air circulation to prevent condensate and excessive odors. It shall be provided with natural or artificial light, well deistributed for day or night milkhouse activities.

(C) The milkhouse or milkroom shall be equipped with a two-compartment wash vat, utensil rack, milk cooling facilities and have an adequate supply of hot water available for cleaning milking equipment. If a farm bulk tank is used, it shall be situated in the milkhouse or milkroom to allow access to all areas of the milkhouse or milkroom and to the exterior of the bulk milk tank for cleaning and servicing. The farm bulk tank shall not be located over a floor drain or under a ventilator.

(D) The truck approach to the milkhouse or milkroom shall be properly graded and surfaced to prevent mud or pooling of water at point of loading. The transferring of milk from a bulk holding / cooling tank to a transport tank is through a hose port located in the milkhouse wall. The port shall be fitted with a tight door, which shall be in good repair. It shall be kept closed when the port is not in use. An easily cleanable surface shall be constructed under the hose port, adjacent to the outside wall and sufficiently large to protect the milk hose from contamination.

(E) The milkhouse or milkroom shall be kept clean and free of trash. Animals and fowl shall not be allowed access to the milkhouse or milkroom at any time.

901:3-12-14 Farm Chemicals and Animal Drugs.

(A) Animal biologics and other drugs intended for treatment of animals, and insecticides approved for use in dairy operations, shall be clearly labeled and used in accordance with label instructions, and shall be stored in a manner which will prevent accidental contact with milk and milk contact surfaces.

(B) Only drugs that are approved by the food and drug administration or biologics approved by the United States department of agriculture for use in dairy animals that are properly labeled according to the food and drug administration or the United States department of agriculture regulations shall be administered to such animals.

(C) When drug storage is located in the milkroom, milkhouse, or milking area, the drugs shall be stored on a shelf or in a storage unit and shall be stored in a manner which will prevent accidental contact with milk and milk contact surfaces. Such drugs shall further be segregated in such a way so that drugs labeled for use in lactating dairy animals are separated from drugs labeled for use in non-lactating dairy animals.

(D) Drugs labeled for use in non-dairy animals shall not be stored with drugs labeled for use in dairy animals. When drugs labeled for use in non-dairy animals are stored in the barn, the drugs shall be located in an area of the barn separate from the milking area.

(E) Herbicides, fertilizers, pesticides, and insecticides that are not approved for use in dairy operations shall not be stored in the milkhouse, milkroom, or milking area.

901:3-12-15 Utensils and Equipment.

(A) Utensils, milk cans, milking machines, pipeline systems, and other equipment used in the handling of milk shall be maintained in good condition, shall be free from rust, open seams, milkstone, or any unsanitary condition, and shall be washed, rinsed, and drained after each milking, stored in suitable facilities, and sanitized immediately before use with at least 50 PPM chlorine solution or its equivalent. New or replacement can lids shall be umbrella type. All new utensils and equipment shall comply with applicable 3-A sanitary standards.

(B) Farm bulk tanks shall meet 3-A sanitary standards for construction at the time of installation and shall be installed in accordance with rule 901:3-12-13 of the Administrative Code.

(C) Single service articles shall be properly stored and shall not be reused.

901:3-12-16 Water Supply.

The dairy farm water supply shall be properly located, protected, and operated, and shall be easily accessible, ample, and of safe, sanitary quality for the cleaning of dairy utensils and equipment. The water supply shall come from a source which is approved by the state regulatory authority; or from a spring, dug well, driven well, bored well, or drilled well, the water from which complies with Chapter 3701-28 of the Administrative Code. A source that does not conform with the construction requirements of the state regulatory authority, but is tested annually by a laboratory approved by the director and found to be safe and of sanitary quality shall be satisfactory. Provided, that after adoption of this regulation any new sources of water supply or any farm water supply requiring repairs or reconstruction or any source from which tested samples have been found unsatisfactory shall meet the construction requirements of Chapter 3701-28 of the Administrative Code.

901:3-12-17 Sewage Disposal.

House, milkhouse or milkroom and toilet wastes shall be disposed of in a manner that will not pollute the soil surface, contaminate any water supply, or be exposed to insects.

901:3-12-18 Qualifications for Farm License or Registration.

No person shall be issued a farm license or registration unless they are in compliance with rules 901:3-12-01 to 901:3-12-17 of the Administrative Code.

901:3-12-19 Premises of Milk Plants.

(A) The premises shall be kept in a clean and orderly condition, and shall be free from strong or foul odors, smoke, or excessive air pollution. Driveways and adjacent plant traffic areas shall be constructed of concrete, asphalt, or similar material and maintained to keep dust and mud to a minimum.

(B) The adjacent plant surroundings shall be free from refuse, rubbish, and waste materials to prevent the harborage of rodents, insects and other vermin.

(C) A suitable drainage system shall be provided which will allow rapid drainage of all water from plant buildings and driveways, including surface water around the plant and on the premises. All water shall be disposed of in a manner as to prevent a nuisance or health hazard.

901:3-12-20 Buildings.

The building or buildings shall be of sound construction and shall be kept in good repair to prevent the entrance or harborage of rodents, birds, insects, vermin, and other animals. Any openings around service pipes through outside walls shall be effectively sealed around the openings or sealed with tight metal collars.

(A) All openings to the outer air including doors, windows, skylights, and transoms shall be effectively protected or screened to prevent the entrance of flies and other insects, rodents, birds, dust, and dirt. All outside doors opening into processing rooms shall be in good condition and fit properly. All hinged, outside screen doors shall open outward. All doors shall be tight-fitting and self-closing. All doors and windows shall be kept clean and in good repair. Outside conveyor openings and other special-type outside openings shall be effectively protected to prevent the entrance of flies and rodents by means of doors, screens, flaps, fans, or tunnels. Outside openings for sanitary pipelines shall be covered when not in use. On new construction, window sills should be slanted downward at an angle of forty-five degrees.

(B) The walls, ceilings, partitions, posts of rooms in which milk or dairy products are processed, manufactured, handled, packaged, or stored (except dry storage of packaged finished products and supplies) or in which utensils are washed and stored, shall have a smooth finish with a suitable material of light color, which is substantially impervious to moisture and shall be kept clean. These surfaces shall be refinished as often as necessary to maintain a neat, clean surface.

(C) Floors:

(1) The floors of all rooms in which milk or dairy products are processed, manufactured, packaged, or stored or in which utensils are washed shall be constructed of tile properly laid with impervious joint material, concrete, or other equally impervious material. The floors shall be smooth, kept in good repair, graded so that there will be no pools of standing water or milk products after flushing. Drains shall be equipped with traps properly constructed and shall be kept in good repair. On new construction, bell-type traps shall not be used. The plumbing shall be installed to prevent the backup of sewage into the drain lines and onto the floor of the plant.

(2) Sound, smooth wood floors which can be kept clean may be used in rooms where new containers, supplies and designated packaged finished products are stored.

(D) Lighting and ventilation:

(1) Light shall be ample and well distributed. All rooms in which dairy products are manufactured or packaged or where utensils are washed shall have at least thirty foot-candles of light intensity on all working surfaces and at least fifty foot-candles of light intensity in areas where dairy products are graded or examined for condition and quality. In all other rooms, there shall be at least five foot-candles of light intensity when measured at a distance of thirty inches from the floor. Where contamination of product by broken glass is possible, light bulbs, fluorescent tubes, skylights, or other fixtures over the product shall be protected against breakage.

(2) There shall be adequate heating, ventilation, or air conditioning in all to facilitate maintenance of sanitary conditions. Exhaust or inlet fans, vents, hoods, or temperature and humidity control facilities shall be provided as needed to minimize or eliminate undesirable room temperatures, objectionable odors, moisture condensation, or mold. Inlet fans shall be screened and should be provided with an adequate air filtering device to eliminate dirt and dust from incoming air. Ventilation systems shall be cleaned periodically and shall be maintained in good repair. Exhaust outlets shall be screened or be provided with self-closing louvers to prevent the entrance of insects when not in use.

(E) Rooms in which any raw materials, packaging materials, ingredient supplies, or dairy products are handled, manufactured, packaged, or stored shall be designed, constructed, and maintained to assure desirable room temperatures and enhance clean, orderly operating conditions free from objectionable odors and vapors. Enclosed bulk milk receiving rooms when present shall be separated from the processing rooms by a partition. Rooms for receiving can milk shall be separated from processing rooms by a partition (partial or complete), by suitable arrangement of equipment, or by allowing enough distance between receiving and processing operations to avoid possible contamination of milk or dairy products during manufacturing and handling. Processing rooms shall be kept free from equipment and materials which not routinely used.

(1) Coolers and freezers used for storage of dairy products shall be clean, reasonably dry and maintained at proper uniform temperature and humidity levels by providing adequate circulation of air at all times to protect the product and minimize mold growth. Coolers and freezers shall be free from rodents, insects and pests. Shelves shall be kept clean and dry. Refrigeration units shall have provisions for the collection and disposal of condensate.

(2) Supply rooms used for the storage of packaging materials, containers, and miscellaneous ingredients shall be kept clean, dry, orderly, free from insects, rodents, and mold and maintained in good repair. Such items stored therein shall be adequately protected from dust, dirt, or other extraneous matter and so arranged on racks, shelves, or pallets to permit access to the supplies and to permit cleaning and inspection of the room. Insecticides, rodenticides, cleaning compounds, and other nonfood products shall be properly labeled and segregated, and stored in a separate room or cabinet away from milk, dairy products, ingredients, or packaging supplies.

(3) Boiler and tool rooms shall be separated from other rooms where milk and dairy products are processed, manufactured, packaged, handled, or stored. Such rooms shall be kept orderly and reasonably free from dust and dirt.

(4) Toilet and dressing room facilities shall be conveniently located to all processing operations.

(a) Toilet rooms shall not open directly into any room in which milk or dairy products are processed, manufactured, packaged or stored. Doors shall be self-closing. Ventilation shall be provided by mechanical means or by screened openings to the outer air. Fixtures including but not limited to toilet stools, sinks, lights and lockers, shall be kept clean and in good repair.

(b) If employees are furnished with a locker or other storage facility, the lockers or other storage facilities shall be kept clean and orderly. Adequate hand-washing facilities shall be provided as specified in rule 901:3-12-21(b) of the Administrative Code. Durable, legible signs shall be posted conspicuously in each toilet or locker room directing employees to wash their hands before returning to work.

(5) Adequate sanitary facilities shall be provided for the handling of starter cultures.

901:3-12-21 Facilities.

(A) Water supply:

(1) There shall be an ample supply of safe and hot and cold water. Adequate facilities shall be provided for proper distribution of water throughout the plant and the water shall be protected against contamination. Water from other facilities, when officially approved, may be used for boiler feed water and condenser water provided that such waterlines are completely separated from the waterlines carrying the sanitary water supply, and the equipment is constructed and controlled as to preclude contamination of product contact surfaces. There shall be no cross connection between the safe water supply and any unsafe or questionable water supply, or any other source of pollution through which contamination of the safe water supply is possible. The Director shall make bacteriological examinations of the sanitary water supply and the recirculated water supply at least twice a year, or as often as necessary to determine purity and suitability for use in manufacturing dairy products. The processor shall keep on file a copy of all water test results for a period of one year.

(2) The location, construction and operation of any well shall comply with the requirements of private water systems rules chapter 3701-28 of the Administrative Code.

(B) Convenient hand-washing facilities shall be Provided, including hot and cold running water, soap or other detergents, and sanitary single-service towels or air dryers. Such facilities shall be located in or adjacent to toilet and dressing rooms and also at other places in the plant convenient to all personnel handling dairy products. Vats for washing equipment or utensils shall not be used as hand-washing facilities. Metal or plastic containers shall be provided for used towels and other wastes. Waste containers located in the plant should be covered.

(C) Steam shall be supplied in sufficient volume and pressure for the satisfactory operation of each applicable piece of equipment. Culinary steam used in direct contact with milk or dairy products shall be free from harmful substances or extraneous material, only nontoxic boiler compounds shall be used, or a secondary steam generator shall be used in which soft water is converted to steam and no boiler compounds are used. Steam traps, strainers, and condensate traps shall be used wherever applicable to insure a satisfactory and safe steam supply. Culinary steam shall comply with appendix H. Of the U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Grade A Pasteurized Milk Ordinance, most recent edition.

(D) The method for supplying air under pressure which comes in contact with milk or dairy products or any product contact surface shall comply with the 3-A accepted practices for supplying air under pressure. The air used at the point of application shall be free from volatile substances, volatiles which may impart any flavor or odor to the products, and extraneous or harmful substances.

(E) Dairy wastes shall be properly disposed of from the plant and premises. Waste containers located outside the plant shall be covered. The sewer system shall have sufficient slope and capacity to readily remove all liquid waste from the processing operations. Where a public sewer is not available, all liquid wastes shall be properly disposed of in a manner not to contaminate milk equipment or to create a nuisance or public health hazard. Containers used for the collection and holding of solid wastes shall be constructed of metal, plastic, or other equally impervious material and shall be kept covered with tight fitting lids. These containers shall be placed outside the plant on a concrete slab or on a rack raised at least twelve inches above the ground. Alternatively waste containers may be kept inside a suitably enclosed, clean and fly proof room. Solid wastes shall be disposed of regularly and the containers shall be cleaned before reuse. Accumulation of dry wastepaper and cardboard shall be kept to a minimum. Paper burned at the plant shall be done in a properly constructed incinerator. The waste paper and cardboard may also be compressed or bagged and hauled away.

(F) Water reclaimed from the condensing of milk and dairy products shall comply with the specifications outlined in Appendix D of the Grade A Pasteurized Milk Ordinance. Reclaimed water shall not be used for the purposes of sanitizing product contact surfaces and equipment.

901:3-12-22 Equipment and Utensils.

(A) All equipment and utensils used for the processing of milk and manufacture of dairy products shall be constructed in a manner to be readily demountable when necessary for cleaning, sanitizing and inspection. The product contact surfaces of all utensils and equipment shall be constructed of stainless steel or of other equally corrosion-resistant material. Nonmetallic parts, other than glass, having product contact surfaces shall meet the 3-A Sanitary Standards for plastic or rubber and rubberlike materials.

(B) all equipment and piping shall be designed and installed to be easily accessible for cleaning and shall be kept in good repair, free from cracks and corroded surfaces. New or rearranged equipment shall be set away from walls or spaced in such a manner to facilitate proper cleaning. All parts or interior surfaces of equipment, pipes (except certain piping cleaned in place) or fittings, including valves and connections, shall be accessible for inspection. Milk and dairy product pumps shall be of sanitary design and easily dismantled for cleaning or shall be of specially approved construction to allow effective cleaning-in-place.

(C) All C.I.P. systems shall comply with the 3-A sanitary practices for permanently installed sanitary product, pipelines, and cleaning systems for those C.I.P. circuits that can not be readily inspected.

(D) Weigh cans and receiving tanks shall meet the 3-A Sanitary Standards and be protected sufficiently with the necessary covers or baffles to prevent contamination from splash, condensate, and drippage. The cans and tanks shall be easily accessible for cleaning

and shall be elevated above the floor to provide easy access for the cleaning of floors and adjacent wall areas.

(E) Can rinsers shall have sufficient capacity and ability to provide throughly rinsed, dry cans and covers. Rinsers shall be maintained in a clean and satisfactory operating condition and shall be kept free from accumulation of scale or debris which adversely affects the efficiency of the rinser.

(F) Product storage tanks shall be fully enclosed or tightly covered and be well insulated. The entire interior surface, agitator and all appurtenances shall be accessible for thorough cleaning and inspection. Any opening or vent at the top of the tank including the entrance of the agitator shaft shall be suitably protected against the entrance of dust, moisture, insects, oil, or grease. The sight glasses, if used, shall be clean, and in good repair. Tanks which have hinged covers shall be so designed that moisture or dust on the surface cannot enter the tank when the covers are raised.

If the storage tanks are equipped with air agitation, the system shall be of an approved type and properly installed in accordance with the 3-A accepted practices for supplying air under pressure.

Storage tanks intended to hold product for longer than eight hours shall be equipped with refrigeration and/or be insulated in order to hold the product at the required product temperature. All new storage tanks shall meet the appropriate 3-A Sanitary Standards and shall be equipped with thermometers in good repair.
(G) Surface coolers shall be equipped with hinged or removable covers for the protection of the product. The edges of the fins shall be so designed as to divert condensate on non-product contact surfaces away from product contact surfaces. All gaskets or swivel connections shall be leak proof.

(H) Vacuum chambers shall be constructed in a manner to facilitate cleaning and all product contact surfaces shall be accessible for inspection. A vacuum chamber shall be equipped with a vacuum breaker and a check valve at the product discharge line. Only steam which meets the requirements of culinary steam shall be used. The incoming steam supply shall be regulated by an automatic solenoid valve which will cut off the steam supply in the event the flow diversion device of the H.T.S.T. pasteurizer is not in the forward flow position. Condensers, when used, shall be equipped with a water level control and an automatic safety shutoff valve.

(I) Hot wells shall be enclosed or covered and shall be equipped with an indicating thermometer either in the hot well or in the hot milk inlet line to the hotwell. If used for holding high heat products, a hot well shall also have a temperature recorder.

(J) Open-type evaporators and/or vacuum pans shall be equipped with an automatic condenser water level control, barometric leg, or so constructed

So as to prevent water from entering the product, and shall meet the applicable 3-A

Sanitary Standards. When enclosed-type condensers are used, no special controls are necessary to prevent water from entering the product.

(K) If product, including foam, held in the surge tank is not maintained at a minimum of 1500 F., then two or more surge tanks shall be installed to permit flushing and cleaning during processing. Such tanks shall be completely emptied and washed after each four hours of operation or less. Covers easily removable for cleaning shall be provided and used at all times.

(L) High pressure lines may be cleaned in place and shall be of such construction that dead ends, valves, and high pressure pumps can be disassembled for manual cleaning. New high pressure pumps shall meet the 3-A Sanitary Standards regarding homogenizers and high pressure pumps of the plunger type.

(M) Spray dryers shall be of continuous discharge type construction. All joints and seams in the product contact surfaces shall be welded and ground to a smooth finish. All dryers shall be constructed to facilitate ease in cleaning and inspection. Sight glasses of sufficient size shall be located at strategic positions. Dryers shall be equipped with air intake and exhaust recording thermometers. In gas-fired dryers, precautions shall be taken to assure complete combustion.

(N) The air filter system shall consist of fiberglass, cotton flannel, wool flannel, spun metal,

electrostatic material or other equally acceptable filtering media, which are non-shedding and which do not release to the atmosphere, toxic volatiles, or volatiles which may impart any flavor or odor to the product. Filtering media or devices shall prevent the entrance of foreign substances into the drying chamber. The filtering system shall be cleaned or the component parts shall be replaced as often as necessary to maintain a clean air supply. Air shall be drawn into the dryer from sources free from objectionable odors, smoke, dust, or dirt.

(O) Roller dryers. The drums of a roller dryer shall be smooth, readily cleanable, and free of pits and corrosion. The knives shall be maintained in a condition not to cause scoring of the drums. The end boards shall have an impervious surface and be readily cleanable. They shall be provided with a means of adjustment to prevent leakage and accumulation of milk solids. The stack, the hood, the drip pan inside of the hood, and related shields shall be constructed of stainless steel and shall be readily cleanable. The lower edge of the hood shall be constructed to prevent condensate from entering the product zone. The hood shall be properly located and the stack shall be of adequate capacity to remove the vapors. The stack shall be closed when the dryer is not in operation. The augers shall be of stainless steel construction or be properly plated, and shall be readily cleanable. The auger troughs and related shields shall be constructed of stainless steel and be readily cleanable. All air entering the dryer room shall be filtered to eliminate dust and dirt. The filter system shall consist of filtering media or a device that will effectively, and in accordance with good manufacturing practices, prevent the entrance of foreign substances into the drying room. The filtering system shall be cleaned and component parts replaced as often as necessary to maintain a clean and adequate air supply. All dryer adjustments shall be made and the dryer shall be operating normally before food grade powder can be collected from the dryer.

(P) Collectors and conveyors shall be constructed of stainless steel or equally noncorrosive material and be constructed to facilitate cleaning and inspection. Filter sack collectors, if used, shall be in good condition and the system shall be of such construction that all parts are accessible for cleaning and inspection.

(Q) Dry dairy product cooling equipment shall be provided with sufficient capacity to cool the product to 1200 F. or lower immediately after removal from dryer and prior to packaging. If bulk bins are used, the product should be cooled to approximately 900 F. But shall be not more than 1200 F. A dry air supply, that meets the requirements of paragraph (N) of this rule, shall be provided where air cooling and conveying is used.

(R) Each plant handling dry milk products shall be equipped with a heavy duty industrial vacuum cleaner. A regular schedule shall be established for its use in vacuuming applicable areas.

(S) Brine tanks used for the treating of parchment liners shall be constructed of noncorrosive material, have a safe means of heating the salt solution for the treatment of the liners, and shall be provided with a satisfactory drainage outlet.

(T) Churn salt brine vats shall be constructed of stainless steel or equally corrosion-resistant metal and shall be constructed according to applicable 3-A Sanitary Standards. The vats shall be in good repair and equipped with tight-fitting lids.

901:3-12-23 Protection and Transport of Raw Milk and

Cream.

(A) Equipment and facilities:

(1) Milk cans used in transporting milk from the dairy farm to the plant shall meet the requirements of utensils and equipment as specified in rule 901:3-12-15 of the Administrative Code.

(2) New farm bulk tanks shall meet the 3-A Sanitary Standards for construction and shall be installed in accordance with the requirements of the Director.

(B) Transporting milk or cream:

(1) Vehicles used for the transportation of can milk or cream shall be of the enclosed type, constructed and operated to protect the product from extreme temperature, dust, or other adverse conditions, and they shall be kept clean. Cans, or bulk tanks on vehicles, used for the transportation of milk from the farm to the plant shall not be used for any other purpose.

The exterior shell of transfer tanks shall be clean and free from open seams or cracks which would permit liquid to enter the jacket. The interior shell shall consist of stainless steel and constructed that it will not buckle, sag, or prevent complete drainage. All product contact surfaces shall be smooth, easily cleaned, and maintained in good repair. The pump and hose cabinet shall be fully enclosed with tight-fitting doors and the inlet and outlet shall be provided with dust covers to provide adequate protection from road dust. New and replacement transport tanks shall meet the 3-A Sanitary Standards for milk transport tanks.
(C) Enclosed or covered facilities shall be available for cleaning and sanitizing of transport tanks, piping and accessories, at central locations or at all plants that receive or ship milk or dairy products in transport tanks.

(D) Transfer of milk to transport tanks shall be transferred under sanitary conditions from farm bulk tanks through stainless steel piping or approved tubing. The ends of the sanitary piping and tubing shall be capped when not in use.

901:3-12-24 Raw Product Storage.

(A) All milk shall be held and processed under conditions and at temperatures that will prevent contamination and rapid deterioration. Drip milk from can washers or any other sources shall not be used for the manufacture of dairy products. Bulk milk in storage tanks within the dairy plant shall be handled in such a manner as to minimize bacterial levels and shall be maintained at 50o F. or lower until processing begins. This does not preclude holding milk or whey at higher temperatures for a period of time, where applicable, for specific manufacturing or processing practices.

(B) The bacteriological level of raw commingled milk in storage tanks shall meet the following standards:

3.0 million per ml. or lower until January 1, 2002;
2.5 million per ml. or lower from January 1, 2002 until December 31, 2002;
2.0 million per ml. or lower from January 1, 2003 until December 31, 2003;
1.5 million per ml. or lower from January 1, 2004 until December 31, 2004;
1.0 million per ml. or lower after January 1, 2005;
(C) Whenever the commingled raw milk bacterial count indicates the presence of more than the standard established in paragraph (B) of this rule, the following procedures shall be applied:

(1) The processor shall be notified in writing of an excessive bacterial count and the Director may initiate an investigation to determine the cause; and

(2) processor license action shall be taken only if the investigation reveals the cause of the commingled raw milk bacterial count violation is a result of a problem that can be controlled by the processor; and

the processor license or registration may be reinstated by the Director when the cause of the violation has been corrected.
901:3-12-25 Quality, Composition and Wholesomeness.

(A) All necessary precautions shall be taken to prevent contamination or adulteration of the milk or products during manufacturing. All substances and ingredients used in the processing or manufacturing of any dairy product shall be subject to inspection and shall be wholesome and free from impurities. All finished products shall comply with the requirements of the Federal Food, Drug, and Cosmetic Act as to composition and wholesomeness.

(B) Chlorinating facilities shall be provided for butter wash water if needed and all other necessary precautions shall be taken to prevent contamination of products.

(C) The Director may sample product as often as necessary to ensure microbiological control. All samples shall be collected and held in substantial compliance with the "Standard Methods for the Examination of Dairy Products," as amended, of the "American Public Health Association" and with the "Official Methods of Analysis of the Association of Official Analytical Chemists," as amended."

(D) All necessary precautions shall be taken throughout the entire manufacturing operation to prevent the adulteration of one product with another. The commingling of one type of liquid or dry product with another shall be considered as an adulteration of that product. This does not prohibit the normal standardization of similar products in accordance with good manufacturing practices or the production of specific products for special uses, provided applicable labeling requirements are met.

(E) All products sampled and tested by the Director shall meet the specifications for that product as specified in the Code of Federal Regulations. The Director may remove or embargo product offered for sale that has been determined to be a public health risk. Product determined to be improperly labeled shall not be offered for sale until the product has been properly labelled as specified in rule 901:3-12-44 of the Administrative Code.

901:3-12-26 Pasteurization, Sterilization and

Cooking.

(A) When pasteurization is intended or required, or when a product is designated "pasteurized" every particle of the product shall be subjected to temperatures and holding periods that will assure proper pasteurization of the product. When product is desired to be heat-treated, the product shall be heated to temperatures greater than 125o F. but less than 161o F., provided, cream may be heated further to less than 166o F. in a continuous heating process and immediately cooled to 45o F. or less when necessary for enzyme deactivation for a functional reason.

(B) Pasteurization shall comply with the applicable specifications of item 16p in the latest edition of the Grade A Pasteurized Milk Ordinance, as amended, of the Food and Drug Administration, Public Health Services, United States Department of Health and Human Services. The recording and indicating thermometers of heat-treating devices shall be checked by the Director as often as required. Nothing in this rule shall be construed as barring any other pasteurization process that has been recognized by the Food and Drug Administration to be equally effective and which is approved by the Director.

(C) The phenol value of test samples of a pasteurized finished product shall be no greater than the maximum specified for that product as determined and specified by the phosphatase test method prescribed in the latest edition of "Official Methods of Analysis of the Association of Official Agricultural Chemists."

(D) All milk, buttermilk and whey used in the manufacture of dry dairy products shall be pasteurized at the plant where dried. Milk or skim milk to be used in the manufacture of nonfat dry milk shall be pasteurized prior to condensing. Condensed skim manufactured from pasteurized skim milk may be transported to a drying plant, provided, the condensed skim milk is effectively repasteurized at the drying plant, prior to drying, at not less than 1750 F. or at least twenty-five seconds.

(E) All buttermilk or cream from which it is derived shall be pasteurized prior to condensing at a temperature of at not less than 1850 F. for at least fifteen seconds.

(F) All cheese whey or milk from which it is derived shall be pasteurized prior to condensing at a temperature of not less than 1610 F. for at least fifteen seconds.

(G) The milk or cream shall be pasteurized at the plant where the milk or cream is processed into butter. Cream or re-melt butter for butter manufacturing shall be pasteurized at a temperature of not less than 1650 F. and held continuously in a vat at such temperature for at least thirty minutes; or pasteurized by the H.T.S.T. method at a temperature of not less than 1850 F. for at least fifteen seconds; or by any other equivalent time and temperature combination.

(H) The pasteurization of cream for plastic or frozen cream shall be pasteurized at the plant where the milk or cream is processed. The temperature for the vat pasteurization method shall be not less than 1700 F. for at least thirty minutes. Pasteurization by the H.T.S.T. method shall be at a temperature of not less than 1900 F. for at least fifteen seconds or by any other temperature and holding time which will assure adequate pasteurization and comparable keeping quality characteristics.

(I) After the H.T.S.T. unit has been tested according to appendix i in the latest edition of the grade A Pasteurized Milk Ordinance, as amended, of the Food and Drug Administration, Public Health Services, United States Department of Health and Human Services, the public health controls shall be sealed at the correct setting by the director to assure pasteurization. The H.T.S.T. pasteurizer shall be tested initially upon installation, at least each six months, and whenever any alteration or replacement is made which affects the proper operation of the pasteurizer. When direct steam pasteurizers are used, the steam, prior to entering the product, shall be conducted through a steam strainer and a steam purifier equipped with a steam trap and only steam meeting the requirements for culinary steam shall be used.

(J) Sterilization or the complete destruction of all living organisms is performed in one of the following methods:

(1) the complete in-container method, by heating the container and contents to a range of 2120 F. to 2800 F. for a time sufficient to destroy all living organisims; or

(2) by a continuous flow U.T.S.T. method at 2800 F. or above for a time sufficient to destroy all living organisims, then packaged aseptically; or,

(3) the product is initially sterilized according to continuous flow U.T.S.T. method as stated in paragraph (B)(2) of this rule, then packaged and given further heat treatment to complete the sterilization process.

(K) Cooking.

(1) Each batch of cheese within the cooker, including the optional ingredients, shall be thoroughly commingled and the contents shall be pasteurized at a temperature of not less than 1580FFF. and held at that temperature for at least thirty seconds.

(2) Cheese particles or ingredients shall not be added after the cooker batch of cheese has reached the final heating temperature. After holding for the required period of time, the hot cheese shall be emptied from the cooker as quickly as possible.

(3)Cookers shall be of the steam jacketed or direct steam type. They shall be constructed of stainless steel or other equally corrosion-resistant material. All product contact surfaces shall be readily accessible for cleaning.

Each cooker shall be equipped with an indicating thermometer and a temperature recording device.
Steam check valves on direct steam type cookers shall be mounted flush with the cooker wall, be constructed of stainless steel and designed to prevent the backup of product into the steam line, or the steam line shall be constructed of stainless steel pipes and fittings which can be readily cleaned. If direct steam is applied to the product, only culinary steam shall be used.
901:3-12-27 Cleaning and Sanitizing Treatment.

(A) Equipment and utensils:

(1) Equipment, sanitary piping and utensils used in receiving, storing and processing of the milk, and manufacturing and handling of the product shall be maintained in a sanitary condition. Sanitary seal assemblies shall be removable on all agitators, pumps and vats, and shall be inspected at regular intervals and shall be kept clean. Unless other provisions are recommended in the following supplemental sections, all equipment not designed for C.I.P. cleaning shall be disassembled after each day's use for thorough cleaning. Dairy cleaners, detergents, wetting agents, sanitizing agents or other similar materials, which will not contaminate or adversely affect the products, shall be used. Steel wool or metal sponges shall not be used in the cleaning of any dairy equipment or utensils. All product contact surfaces shall be subjected to an effective sanitizing treatment immediately prior to use, except where dry cleaning is permitted. Utensils and portable equipment used in processing and manufacturing operations shall be stored above the floor in clean, dry locations and in a self-draining position on racks constructed of impervious, corrosion-resistant material.

C.I.P. cleaning, including spray ball systems, shall be used only on equipment and pipeline systems which have been designed and engineered for that purpose. When such cleaning is used, careful attention shall be given to the proper procedures to assure satisfactory cleaning. All C.I.P. installations and cleaning procedures shall be in accordance with 3-A suggested methods for the installation and cleaning of cleaned-in-place sanitary milk pipelines for milk and dairy products. The established cleaning procedure shall be posted or made available to employees and followed. Following the circulation of the cleaning solution, the equipment and lines shall be thoroughly rinsed with lukewarm water and inspected for effectiveness of cleaning. All caps, plugs, special fittings, valve seats, cross ends, pumps, plates, and tee ends shall be opened or removed and brushed clean. Immediately prior to beginning the flow of product, the product contact surfaces shall be sanitized.
(B) A covered or enclosed wash dock and cleaning and sanitizing facilities shall be available at all plants that receive or ship milk in transport tanks. Milk transport tanks, sanitary piping, fittings, and pumps shall be cleaned and sanitized at least once each day after use. If they are not to be used immediately after emptying, then they shall be washed promptly after use and sanitized immediately before use. Each transport tank shall be identified by a tag attached to the outlet valve after cleaning and sanitizing. The tag shall bear the plant name and specific location where cleaned, date and time of cleaning and sanitizing, the name of the person who cleaned the tank and the name of the person who sanitized the tank. The tag shall remain in place until removed at the location where the tank truck is next received and kept on file for fifteen days. Tagging is not required in situations where the tank truck is received at only one milk plant where responsibility for cleaning and sanitizing can be definitely established without tagging.

(C) All product contact surfaces of all multi-use containers, utensils and equipment used in the transportation, processing, handling and storage shall be cleaned and sanitized after each production run. Storage tanks shall be emptied at least once every ninety-six hours after filling.

(D) Dryers, conveyors, sifters, and storage bins shall be cleaned as often as necessary to maintain such equipment in a clean and sanitary condition. The kind of cleaning procedure, whether wet or dry, and the frequency of cleaning shall be based upon observation of actual operating results and conditions.

901:3-12-28 Packaging and General Information. (A) The size, style and type of packaging containers used for dairy products shall be commercially acceptable and acceptable to the director. The packaging containers and materials shall satisfactorily cover and protect the quality of the contents during storage, shipment and under normal conditions of handling. The weight and shape of each size or style shall be as uniform as is possible.

(B) Packaging materials for dairy products shall provide sufficiently low permeability to air and vapor to prevent the formation of mold growth and surface oxidation. Packaging materials shall be practically free of bacterial contamination. In addition, the outer package wrapper should be resistant to punctures, tearing, cracking, or breaking under normal conditions of handling, shipping, and storage. When special-type packaging is used, the instructions of the manufacturer shall be followed closely as to application and methods of closure.

(C) Caps or covers which extend over the lip of the container shall be used on all cups or tubs containing two pounds or less to protect the product from contamination during subsequent handling.

(D) Liners and wrappers. Supplies of parchment liners, wrappers, and other packaging material shall be protected against dust, mold, and other possible contamination.

Prior to use, parchment liners for bulk butter packages shall be completely immersed in a boiling salt solution in a suitable container constructed of stainless steel or other equally noncorrosive material. The liners shall be maintained in the solution for not less than thirty minutes. The solution should consist of at least fifteen pounds of salt for every eighty-five pounds of water and shall be strengthened or changed as frequently as necessary to keep the solution at full strength and in good condition.
(2) Other liners, such as polyethylene plastic, shall be treated or handled in a manner to prevent contamination of the liner prior to filling.

(E) Packaging, cutting and repackaging of all dairy products shall be conducted under rigid sanitary conditions. The atmosphere of the packaging rooms shall have no more than ten mold colonies per cubic foot of air and be practically free from bacterial contamination. Methods for determining the level of contamination shall be as prescribed by the latest edition of standard methods for the examination of Dairy Products, most recent edition published by the American Public Health Association. (F) An area shall be provided for filling bulk bins, drums, bags, or other bulk containers and shall be constructed in accordance with rule 901:3-12-20 and 901:3-12-22 of the Administrative Code. The number of control panels and switch boxes in this area shall be kept to a minimum. Control panels shall be mounted a sufficient distance from the walls to facilitate cleaning or shall be mounted in the wall and provided with tight-fitting removable doors to facilitate cleaning. An adequate dust collection system shall be provided at the point of packaging to minimize the accumulation of product dust within the packaging area and, where needed, a dust collector shall be provided and properly maintained to keep roofs and outside areas free of dry product. Only packaging materials that are used within one day may be kept in the packaging area. These materials shall be kept off the floor. Unnecessary fixtures, equipment, or inaccessible areas which may collect dust and harbor insects, shall not be allowed in the packaging area.

(G) An area shall be provided for the transfer of bulk dry dairy products from bags or drums to the hoppers and conveyors which are connected to the fillers. This area shall meet the same requirements for construction and facilities as the bulk packaging operation. Areas and facilities provided for the transfer of dry dairy products from portable bulk bins will be acceptable if gasketed surfaces or direct connections are used that significantly eliminate the escape of product into the area.

(H) Packages or containers used for the packaging of nonfat dry milk or other dry milk products shall be any clean, sound commercially accepted container or packaging material that is acceptable to the Director. Those packages or containers that satisfactorily protect the contents through shipment, without significant impairment of quality with respect to flavor, wholesomeness or moisture content under the normal conditions of handling shall be used. In no instance will containers which have previously been used for nonfood items or food which would be deleterious to the dairy product be allowed to be used for the bulk handling of dairy products.

(I) Containers to be filled shall be protected at all times from possible contamination. Containers, which are to be lined, shall not be prepared more than one hour in advance of filling. Every precaution shall be taken during the filling operation to minimize product dust and spillage. When necessary, a mechanical shaker shall be provided. The tapping of containers shall be prohibited. The containers shall be closed immediately after filling and the exteriors shall be vacuumed or brushed when necessary to render them practically free of product particles before transfer from the filling room to the palleting or dry storage areas.

(J) The entire repackaging operation shall be conducted in a sanitary manner with all precautions taken to prevent contamination and to minimize dust. All exterior surfaces of individual containers shall be practically free of product before over wrapping or packing in shipping containers. The flow shall be kept free of dust accumulation, waste, cartons, liners, or other refuse. Conveyors, packaging and carton making equipment shall be vacuumed frequently during the operating day to prevent the accumulation of dust. No bottles or glass materials of any kind shall be permitted in the repackaging or hopper room. The inlet openings of all hoppers and bins shall be of minimum size, screened and placed considerably above the floor level. The room and all packaging equipment shall be cleaned as often as necessary to maintain a sanitary operation. Close attention shall be given to specific points of equipment where residues of the dry product may accumulate. A thorough cleanup including windows, doors,

Walls, light fixtures, and ledges, shall be performed as frequently as necessary to maintain a high level of cleanliness and sanitation. All waste dry dairy products including the remaining product at the fillers shall be properly identified and disposed of as animal feed.

(K) All supplies shall be placed on dunnage or pallets and arranged in an orderly manner for accessibility and cleaning of the room. Supplies shall be kept enclosed in their original packaging material until used. After removal of supplies from the original containers, the supplies shall be kept in enclosed metal cabinets, bins, or on shelving and if not enclosed shall be protected from powder and dust or other contamination. The room shall be vacuumed as often as necessary and shall be kept clean and orderly.

(L) Churn areas, in addition to proper construction and sanitation, shall be equipped that the air is kept free from objectionable odors and vapors and extreme temperatures by means of adequate ventilation and exhaust systems or air conditioning and heating facilities.

(M) Areas used for packaging print or bulk butter and related products shall, in addition to proper construction and sanitation, have an atmosphere relatively free from mold (not exceeding ten mold colonies per cubic foot of air), dust, or other airborne contamination.

(N) When filling bulk butter containers, the lined butter containers shall be protected from possible contamination prior to filling.

(O) If cheese is to be paraffined, a drying room of adequate size shall be provided to accommodate the maximum production of cheese during the flush period. Adequate shelving and air circulation shall be provided for proper drying.

suitable temperature and humidity control facilities shall be provided.

(P) For rind cheese, a separate room or compartment shall be provided for paraffining and boxing the cheese. The room or compartment shall be of adequate size and the temperature shall be maintained near the temperature of the drying room to avoid sweating of the cheese prior to paraffining.

(Q) For rindless blocks, a suitable space shall be provided for proper wrapping and boxing of the cheese. The area shall be free from dust, condensation, mold or other conditions which may contaminate the surface of the cheese or contribute to an unsatisfactory packaging of the cheese.

(R) Coolers or curing rooms where cheese is held for curing or storage shall be clean and maintained at the proper uniform temperature and humidity to adequately protect the cheese. Proper circulation of air shall be maintained at all times. The rooms shall be free from rodents, insects, and pests. The shelves shall be kept clean and dry.

(S) When small packages of cheese are cut and wrapped, an area shall be provided for the cleaning, preparation, cutting and wrapping operation.

(T) Packaging rindless cheese or cutting and repackaging all styles of bulk cheese shall be conducted under rigid sanitary conditions. The atmosphere of the packaging rooms and the equipment and packaging material shall have no more than ten mold colonies per cubic foot of air and be practically free from bacterial contamination.

901:3-12-29 Storage of Finished Product.

(A) All fluid processed product for bulk shipment shall be stored and maintained at a temperature of 50o F. This does not preclude holding milk or whey at higher temperatures for a period of time, where applicable to particular manufacturing or processing practices.

(B) Storage rooms for the dry storage of product shall be adequate in size, clean, orderly, free from rodents, insects, and mold, and maintained in good repair. Storage rooms shall be provided with natural or artificial light, well distributed with at least five foot-candles of light and have sufficient air space and air circulation to prevent condensation and excessive odors. The ceilings, walls, beams, and floors shall be free from structural defects and inaccessible areas which may harbor insects. The dry storage of product shall be stored an adequate distance from the wall in aisles, rows, or sections and lots, in such a manner as to be orderly and easily accessible for inspection. Care shall be taken in the storage of any non-dairy products in the same room, in order to prevent contamination or damage to the dairy product from mold, odors, vermin or insects. Control of humidity and temperature shall be maintained at all times, consistent with good manufacturing practices, to prevent conditions detrimental to the product and container.

(C) Refrigerated storage of finished product shall be placed on shelves, dunnage, or pallets and properly identified. All products shall be kept under refrigeration at temperatures of 400 F. or lower after packaging and until ready for distribution or shipment except products that are cured. After curing, the products shall be kept refrigerated as stated above. The product shall not be exposed to any substance from which it might absorb any odors or be contaminated by drippage or condensation.

(D) Plastic cream or frozen cream intended for storage shall be placed in quick freezer rooms immediately after packaging, for rapid and complete freezing within twenty-four hours. The packages shall be stacked or spaced in such a manner that air can freely circulate between and around the packages. The rooms shall be maintained at -100 F. or lower and shall be equipped with high-velocity air circulation for rapid freezing. After the products have been completely frozen, they may be transferred to a freezer storage room for further storage.

(E) The freezer storage room shall be maintained at a temperature of 00 F. or lower. Adequate air circulation is desirable.

(F) Surge tanks or balance tanks if used between the evaporators and the dryer shall be used to hold only the minimum amount of condensed product necessary for a uniform flow to the dryers. Such tanks holding product at temperatures below 1500 F. shall be completely emptied and washed after each four hours of operation or less. Alternate tanks shall be provided to permit continuous operation during washing of tanks.

901:3-12-30 Drying. Each dryer should be operated at not more than the manufacturer's rated capacity for the highest quality dry product and, therefore, consistent with the most efficient operation. This does not preclude the remodeling or redesigning of dryers after installation or after properly engineering. The dry products shall be removed from the drying chamber continuously during the drying process.

901:3-12-31 Cooling Dry Products.

Prior to packaging and immediately following removal from the drying chamber, the dry product shall be cooled to a temperature not exceeding

1200 F.

901:3-12-32 Requirements for Instant Nonfat

Dry Milk.

(A) All instant nonfat dry milk offered for sale shall be sampled and tested by the director at least once each month for the purpose of assuring that the product meets the requirements of rule 901:3-12-32(B) of the Administrative Code. In addition the dry milk plant shall have each sublot of approximately four-thousand pounds tested and analyzed prior to being packaged or offered for sale. Product not meeting the requirements of rule 901:3-12-32(B) of the Administrative Code shall not be offered as extra grade.

(B) Requirements for extra grade instant nonfat dry milk:

(1) the flavor and odor shall be sweet, pleasing and desirable but may possess the following flavors to a slight degree: chalky, cooked, feed, flat;

(2) the physical appearance shall possess a uniform white to light cream natural color; shall be reasonably free-flowing, and shall be free from lumps except those that readily break up with very slight pressure;

(3) the standard plate count shall not exceed thirty thousand per gram;

(4) the coliform count shall not exceed ten per gram;

(5) the milkfat shall not exceed 1.25 percent;

(6) the moisture shall not exceed 4.5 percent;

(7) scorched particles shall not exceed fifteen mg.;

(8) the solubility index shall not exceed one ml.;

(9) the titratable acidity shall not exceed 0.15 percent;

(10) the dispersibility shall not be less than eighty-five percent by the Modified Moats-Dabbah method; and

(11) the direct microscopic clump count shall not exceed seventy-five million per gram.

901:3-12-33 Coolers and Freezers.

The coolers and freezers shall be equipped with facilities for maintaining proper temperature and humidity conditions, consistent with good manufacturing practices for the applicable product, to protect the quality and condition of the products during storage or during tempering prior to further processing. Coolers and freezers shall be kept clean, orderly, free from insects, rodents, and mold, and shall be maintained in good repair. They shall be adequately lighted and proper circulation of air shall be maintained at all times. The floors, walls, and ceilings shall be of construction that permits thorough cleaning.

901:3-12-34 Starter Room. Starter rooms or areas shall be properly equipped and maintained for the propagation and handling of starter cultures. All necessary precautions shall be taken to prevent contamination of the starter cultures, room, equipment, and air therein.

901:3-12-35 Make Room. The room in which the cheese is manufactured shall be of adequate size. The vats shall be adequately spaced to permit movement around the vats and presses for proper cleaning and satisfactory working conditions. Adequate ventilation shall be provided.

901:3-12-36 General Construction, Repair, and

Installation. All equipment and utensils necessary for the manufacture of cheese and related products shall meet the same general requirements as outlined in rule 901:3-12-22 of the Administrative Code. In addition, for certain other equipment the following requirements shall be met:

(A) Bulk starter vats shall be constructed of stainless steel or equally corrosion-resistant metal and shall be in good repair, equipped with tight-fitting lids and have adequate temperature controls such as valves, indicating and/or recording thermometers. New vats shall be constructed in accordance with the applicable 3-A Sanitary Standards.

(B) Cheese vats:

(1) The vats used for making cheese shall be of metal construction with adequate jacket capacity for uniform heating. The inner liner shall be constructed of at least sixteen gage stainless steel or other equally corrosion-resistant metal, to include copper, properly pitched from side to center and from rear to front for adequate drainage. The liner shall be smooth, free from excessive dents or creases and shall extend over the edge of the outer jacket. The outer jacket, when metal, shall be constructed of stainless steel or other metal which can be kept clean and sanitary. The junction of the liner and outer jackets shall be constructed to prevent milk or cheese from entering the inner jacket.

(2) The vat shall be equipped with a suitable sanitary outlet valve. Effective valves shall be provided and properly maintained to control the application of heat to the vat.

(C) mechanical agitators shall be of sanitary construction. The carriage and track shall be constructed to prevent the dropping of dirt or grease into the vat. Metal blades, forks, or stirrers shall be constructed of stainless steel and of material approved in the 3-A Sanitary Standards for plastic and rubber or rubberlike materials and shall be free from rough or sharp edges which might scratch the equipment or create metal particles or shavings.

(D) Curd mill, knives, hand rakes, shovels, paddles, strainers, and miscellaneous equipment shall be constructed of stainless steel or of material approved in the 3-A Sanitary Standards for plastic and rubberlike material. The product contact surfaces of the curd mill shall be stainless steel. All equipment shall be constructed in a manner that they can be kept clean. The wires in the curd knives shall be stainless steel, kept tight and replaced when necessary.

(E) Hoops, forms, and followers shall be constructed of stainless steel or heavy tinned steel or of material approved in the 3-A Sanitary Standards for plastic and rubberlike material. If tinned, they shall be kept tinned and free from corrossion. All hoops, forms, and followers shall be kept in good repair. Drums or other special forms used to press and store cheese shall be clean and sanitary.

(F) The cheese press shall be constructed of stainless steel, approved materials as listed in 3-A Sanitary Standards or of other materials acceptable to the Director. All welded joints and all surfaces, seams, and openings shall be readily cleanable. Press cloths shall be maintained in good repair and in a sanitary condition. Single-service press cloths shall be used only once.

(G) The rindless cheese press used to heat seal the wrapper applied to rindless cheese shall have square interior corners, reasonably smooth interior surfaces and controls that provide uniform pressure and heat equally to all surfaces.

(H) The metal paraffin tanks shall be adequate in size, be equipped with wood to support the cheese, have heat controls and an indicating thermometer. The cheese wax shall be kept clean.

901:3-12-37 Whey Disposal.

(A) Adequate sanitary facilities shall be provided for the disposal of whey. Necessary precautions shall be taken to minimize flies, insects, and development of objectionable odors.

(B) Whey or whey products intended for human consumption shall at all times be handled in a sanitary manner in accordance with the procedures of rules 901:3-12-01 to 901:3-12-44 of the Administrative Code as specified for handling milk and dairy products.

901:3-12-38 Operations and Operating Procedures.

(A) The natural cheese shall be cleaned free of all nonedible portions. Paraffin, bandages, rind surface mold, unclean areas or any other part which is unwholesome or unappetizing.

(B) Forming containers either lined or unlined shall be assembled and stored in a sanitary manner to prevent contamination. The handling of containers shall be done with extreme care and in a sanitary manner. Preforming and assembling of pouch liners and containers shall be kept to a minimum. The supply shall be rotated to limit exposure to possible contamination prior to filling.

(C) Container filling.

(1) Hot fluid cheese from the cookers may be held in hot wells or hoppers to assure a constant and even supply of processed cheese to the filler or slice former.

(2) Filler valves shall effectively measure the desired amount of product into the pouch or container in a sanitary manner and shall cut off sharply without drip or drag of cheese across the opening.

(3) An effective system shall be used to maintain accurate and precise weight control.

(4) Damaged or unsatisfactory packages shall be removed from production, and the cheese may be salvaged into sanitary containers, and added back to cookers.

(5) After filling, the container shall be hermetically sealed. Bulk containers for unsterilized product shall be suitable and adequate to protect the product in storage or transit.

(6) The bulk container (including bulk tankers) shall be cleaned and sanitized before filling, and filled and closed in a sanitary manner.

(D) Aseptic product filling. A previously sterilized product shall be filled under conditions which prevent contamination of the product by living organisms or spores. The containers prior to being filled shall be sterilized and maintained in a sterile condition. The containers shall be sealed in a manner that prevents contamination of the product.

901:3-12-39 Plant Records. Adequate plant records shall be maintained of all required tests on all raw milk receipts. Such records shall be available for examination at all reasonable times by the Director. The following are the records which shall be maintained for examination at the plant or receiving station where performed:

(A) Rejections of raw milk, identifying source and reason for rejection: retain for two months;

(B) Pasteurization recorder charts: retain for six months;

(C) C.I.P. recorder charts: retain for six months; and

(D) Production records showing date, quantity, and type of product produced: retain for twelve months;

(E) Milk receipt log or record showing weigher, sampler identity, route identity, patron number, name of producer, milk temperature on receipt and milk weight: retain for two months.

901:3-12-40 Insect and Rodent Control Program. In addition to any commercial pest control service, a designated employee shall be made responsible for the performance of a regularly scheduled insect and rodent control program. Poisonous substances, insecticides, and rodenticides shall be properly labeled, and shall be handled, stored, and used in such a manner that will not create a public health hazard.

901:3-12-41 Clothing and Shoe Covers. Clean clothing and shoe covers shall be provided exclusively for the purpose of cleaning the interior of the drier when it is necessary to enter the drier to perform the cleaning operation.

901:3-12-42 Labeling.

(A) Consumer packaged product shall be legibly marked with the name of the product, net weight, name and address of packer, manufacturer, or distributor and other identification that may be required by the Director.

(B) All commercial bulk packages containing dairy products manufactured under the provisions of rule 901:3-12-01 to 901:3-12-44 of the Administrative Code shall be adequately and legibly marked with the name of the product, net weight, code or date of manufacture, vat or lot number, name and address of processor, manufacturer, or distributor or other assigned plant identification, and any other identification that may be required by the Director.

(C) Packages of plastic or frozen cream shall be labeled in accordance with paragraph (B) of this rule and shall be marked with the percent of milkfat.

901:3-12-43 Personnel Cleanliness.

All employees shall wash their hands before beginning work and upon returning to work after using toilet facilities, eating, smoking, or otherwise soiling their hands. Employees shall keep their hands clean and follow good hygienic practices while on duty. Expectorating or use of tobacco in any form shall be prohibited in each room and compartment where any milk, dairy product, or supplies are prepared, stored, or otherwise handled. Clean white or light-colored washable outer garments and caps (paper caps or hair nets acceptable) shall be worn by all persons in receiving, testing, processing, manufacturing, packaging rooms or by persons handling dairy products.

901:3-12-44 Personnel Health.

No person afflicted with a communicable disease shall be permitted in any room or compartment where milk and dairy products are prepared, manufactured, or otherwise handled. No person who has a discharging or infected wound, sore or lesion on hands, arms, or other exposed portion of the body shall work in any dairy processing rooms or in any capacity resulting in contact with milk or dairy products. Milk processors who have received reports, under this rule, from employees who have handled pasteurized milk, pasteurized milk products or associated product contact surfaces shall immediately report these conditions to the director. When a person who may have handled milk or dairy products or milk product contact surfaces has one or more of the conditions specified in this rule, the director is authorized to require any or all of the measures listed in rule 901:3-10-59 of the Administrative Code.

Grade A Milk Rules

901:3-10 MILK AND MILK PRODUCTS

901:3-10-01 Definitions
901:3-10-02 Interpretation of adjectives and adverbs.
901:3-10-03 Adulterated or Misbranded milk or milk products.
901:3-10-04 License; registration; license or registration fees; milk inspection fees.
901:3-10-05 Labeling.
901:3-10-06 Inspection of dairy farms, milk plants, receiving stations, transfer stations, and milk haulers.
901:3-10-07 The examination of milk and milk products.
901:3-10-08 Standards for milk and milk products.
901:3-10-09 Abnormal raw milk.
901:3-10-10 Milking barn, stable, or parlor; construction.
901:3-10-11 Milk barn, stable, or parlor; cleanliness.
901:3-10-12 Cowyard.
901:3-10-13 Milkhouse or room; construction and facilities.
901:3-10-14 Milkhouse or room; cleanliness.
901:3-10-15 Farm toilet.
901:3-10-16 Farm water supply.
901:3-10-17 Farm utensils and equipment; construction.
901:3-10-18 Farm utensils and equipment: cleaning.
901:3-10-19 Farm utensils and equipment: sanitization.
901:3-10-20 Farm utensils and equipment: storage.
901:3-10-21 Farm utensils and equipment: handling.
901:3-10-22 Milking: flanks, udders, and teats.
901:3-10-23 Milking: surcingles, milk stools, and antikickers.
901:3-10-24 Protection from contamination; cleaners and sanitizers; medicinals or drugs.
901:3-10-25 Farm personnel; hand-washing facilities.
901:3-10-26 Farm personnel: cleanliness.
901:3-10-27 Cooling raw milk.
901:3-10-28 Vehicles.
901:3-10-29 Insect and rodent control.
901:3-10-30 Sanitation requirements for receiving stations, transfer stations, and milk tank truck cleaning and sanitizing facilities.
901:3-10-31 Floors; construction.
901:3-10-32 Walls and ceilings: construction.
901:3-10-33 Doors and windows.
901:3-10-34 Lighting and ventilation.
901:3-10-35 Separate rooms.
901:3-10-36 Toilet-sewage disposal facilities.
901:3-10-37 Water supply.
901:3-10-38 Hand-washing facilities.
901:3-10-39 Milk plant cleanliness.
901:3-10-40 Sanitary piping.
901:3-10-41 Construction and repair of containers and equipment.
901:3-10-42 Cleaning and sanitizing of containers and equipment.
901:3-10-43 Storage of cleaned containers and equipment.
901:3-10-44 Storage of single-service containers, utensils, and materials.
901:3-10-45 Protection from contamination.
901:3-10-46 Pasteurization; Aseptic Processing.
901:3-10-47 Cooling of milk.
901:3-10-48 Bottling and packaging.
901:3-10-49 Capping.
901:3-10-50 Personnel; Cleanliness.
901:3-10-51 Vehicles.
901:3-10-52 Surroundings.
901:3-10-53 Animal health.
901:3-10-54 Milk and milk products which may be sold.
901:3-10-55 Transferring; emptying farm bulk milk tanks; picking up raw milk without unnecessary delay; delivery containers; cooling.
901:3-10-56 Reciprocity.
901:3-10-57 Submission of plans for alterations or new dairy facilities.
901:3-10-58 Personnel Health.
901:3-10-59 Procedure when infection or high risk of infection is discovered.
901:3-10-60 Definitions.
901:3-10-61 Interpretation of adjectives and adverbs.
901:3-10-62 Adulterated or misbranded whey, condensed, and dry milk products.
901:3-10-64 Labeling.
901:3-10-65 Inspection of condensing and drying plants.
901:3-10-66 Examination of whey, condensed, and dry milk products.
901:3-10-67 Standards for milk, milk products, whey, condensed, and dry milk products.
901:3-10-68 Sanitation requirements for milk tank truck cleaning and sanitizing facilities.
901:3-10-69 Milk plant construction.
901:3-10-70 Toilet; sewage disposal: water supply.
901:3-10-71 Hand-washing facilities.
901:3-10-72 Milk plant cleanliness.
901:3-10-73 Sanitary piping.
901:3-10-74 Construction and repair of containers and equipment.
901:3-10-75 Cleaning and sanitizing of containers and equipment.
901:3-10-76 Storage of cleaned containers and equipment: and storage of single-service containers, utensils, and materials.
901:3-10-77 Protection from contamination.
901:3-10-78 Pasteurization.
901:3-10-79 Cooling, packaging, and container filling.
901:3-10-80 Container closure, sealing, and storage.
901:3-10-81 Personnel; cleanliness.
901:3-10-82 Vehicles.
901:3-10-83 Surroundings.
901:3-10-84 Reciprocity.
901:3-10-85 Submission of plans for alterations or new condensing plants and drying plants.
901:3-10-86 Personnel health: procedure when infection or high risk of infection is discovered.

901:3-10 MILK AND MILK PRODUCTS

901:3-10-01 Definitions.

(A) "Aseptic processing," when used to describe a milk product, means heat processing and packaging in a hermetically sealed container, in accordance with the applicable requirements of 21 C.F.R. Part 113 and rule 901:3-10-46 of the Administrative Code, sufficient to maintain the commercial sterility of the product under normal nonrefrigerated conditions.

(B) "Aseptically processed milk and milk products" means products hermetically sealed in a container and thermally processed, in conformance with 21 C.F.R. Part 113 and rules 901:3-10-01 to 901:3-10-59 of the Administrative Code, so as to render the product free of microorganisms capable of reproducing in the product under normal nonrefrigerated conditions of storage and distribution. The product shall be free of viable microorganisms (including spores) of public health significance.

(C) "Dairy farm" means any place or premises where one or more cows or goats are kept and from which milk or milk products are provided, sold, or offered for sale to a milk plant, receiving station, or transfer station.

(D) "Director" means the director of agriculture or an official, employee, or contractor of the department of agriculture designated by the director of agriculture.

(E) "Drug" means:

(1) Articles recognized in the official United States Pharmacopoeia, Official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and

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

(3) Articles (other than food) intended to affect the structure or any function of the body of man or other animals; and

(4) Articles intended for use as a component of any articles specified in paragraph (e)(1), (e)(2), or (e)(3) of this rule, but does not include devices or their components, parts, or accessories.

(F) "Grade A goat milk" means the normal lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy goats, which is intended to be sold for human consumption in fluid form, or for human consumption in fluid form upon the premises of a governmental agency or institution. Grade A goat milk shall contain not less than seven and one-half per cent goat milk solids-not-fat and not less than two and one-half per cent goat milkfat. Grade A goat milk that is in final package form for beverage use shall contain not less than seven and one-half per cent goat milk solids-not-fat and not less than two and one-half per cent goat milkfat.

(G) "Grade A milk" means the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows, which is intended to be sold for human consumption in fluid form, or used in grade A milk products, or for human consumption in fluid form upon the premises of a governmental agency or institution. Grade A milk shall contain not less than eight and one-half per cent milk solids-not-fat and not less than three per cent milkfat. Grade A milk that is in final package form for beverage use shall contain not less than eight and one-quarter per cent solids-not-fat and not less than three and one-quarter per cent milkfat.

(H) "Grade A milk products" means cream, light cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, sour cream, acidified sour cream, cultured sour cream, half-and-half, sour half-and-half, acidified sour half-and-half, cultured half-and-half, reconstituted or recombined milk and milk products, concentrated milk, concentrated milk products, skim milk, lowfat milk, frozen milk concentrate, eggnog, buttermilk, cultured buttermilk, cultured milk, cultured lowfat milk, cultured skim milk, yogurt, lowfat yogurt, nonfat yogurt, acidified milk, acidified lowfat milk, acidified skim milk, low-sodium milk, low-sodium lowfat milk, low-sodium skim milk, lactose-reduced milk, lactose-reduced lowfat milk, lactose-reduced skim milk, aseptically processed and packaged milk and milk products as defined in paragraph (B) of this rule, cottage cheese, dry curd cottage cheese, lowfat cottage cheese, and milk, lowfat milk, or skim milk with added safe and suitable microbial organisms whether or not milkfat has been added or subtracted, each such product is a grade A milk product if it meets the applicable standards of identity, quality, strength, and purity adopted for the product under authority of 3715. of the Revised Code and contains optional ingredients only under the conditions permitted by the applicable standards adopted under 3715. of the Revised Code. Optional ingredients may include but are not limited to ingredients for the protein, vitamin, or mineral fortification of milk products. Grade A milk products does not mean evaporated milk, evaporated skim milk, sweetened or unsweetened condensed milk, dietary products except as specifically included, infant formula, ice cream and other frozen desserts, dry milk products except grade A dry milk products, canned eggnog in a rigid metal container, or butter or cheese except when combined with grade A milk or a grade A milk product.

(I) "Heat-treated" means the process or manipulation of heating raw milk or raw milk products to a temperature greater than one hundred twenty-five degrees Fahrenheit (fifty-two degrees Celsius) but less than one hundred sixty-one degrees Fahrenheit (seventy-two degrees Celsius).

(J) "Hermetically sealed container" means a container that is designed and intended to be secure against the entry of microorganisms, thereby maintaining the commercial sterility of its contents after processing.

(K) "Milk" or "milk products" means grade A milk, grade A goat milk, and grade A milk products, as the context requires.

(L) "Milk hauler" means any person who transports by means of any truck, tank, or other container, raw milk or a raw milk product in fluid form from one location to another.

(M) "Milk plant" means any place, premises, or establishment, including governmental operations, where any grade A milk, grade A goat milk, or grade A milk product is collected, handled, controlled, processed, stored, pasteurized, ultra-pasteurized, aseptically processed, bottled, or prepared for distribution. Milk plant does not include any place where any grade A milk, grade A goat milk, or grade A milk product is purchased in package form and is stored and handled for the sole purpose of sales to the ultimate consumer.

(N) "Milk processor" means any person who operates or controls a milk plant located in this state or from which grade A milk, grade A goat milk, or grade A milk products are sold or offered for sale for consumption in this state.

(O) "Milk producer" or "producer" means any person located in this state who sells or offers for sale grade A milk from a cow or goat owned or controlled by the producer, and any person who sells or offers for sale for consumption in this state grade A milk from a cow or goat owned or controlled by the producer.

(P) "Official laboratory" means a biological, chemical, or physical laboratory approved by the director to conduct all tests or analyses required by this chapter.

(Q) "Officially designated laboratory" means a commercial laboratory authorized to do official work by the director or a milk industry laboratory officially designated by the director for the examination of producer samples of grade A raw milk for pasteurization and commingled milk tank truck samples of raw milk for drug residues or bacterial limits.

(R) "Pasteurization," "pasteurized," and similar terms mean the process of heating every particle of milk or milk product in properly designed and operated equipment to one of the temperatures given in the

following table and holding the milk or milk product continuously at or above that temperature for at least the corresponding specified time:

Temperature Time

145 degrees F (63 degrees C)* 30 minutes

161 degrees F (72 degrees C)* 15 seconds

191 degrees F (89 degrees C) 1 second

194 degrees F (90 degrees C) 0.5 second

201 degrees F (94 degrees C) 0.1 second

204 degrees F (96 degrees C) 0.05 second

212 degrees F (100 degrees C) 0.01 second

* If the fat content of the milk product is ten per cent or more, or if it contains added sweeteners, the specified temperature shall be increased by five degrees "F" (three degrees "C").

Eggnog shall be heated to at least the following temperature and time specifications:

Temperature Time

155 degrees F (69 degrees C) 30 minutes

175 degrees F (80 degrees C) 25 seconds

180 degrees F (83 degrees C) 15 seconds

Nothing in this definition shall be construed as barring any other pasteurization process which has been recognized to be equally effective and which is approved by the director.

(S) "Person" means any individual, partnership, corporation, company, firm, trustee, association, governmental agency, or other entity.

(T) "Receiving station" means a milk plant where raw milk is received, collected, handled, stored, or cooled and is prepared for further transporting.

(U) "Safe levels" means guides for prosecutorial discretion. They do not legalize residues found in milk that are below the safe level. "Safe levels" are not and cannot be transformed into tolerances that are established for animal drugs under section 512 (b) of the Federal Food, Drug and Cosmetic Act. "Safe levels":

(1) Do not bind the courts, the public, including a milk producer, or the director; and

(2) Do not have the "force of law" of tolerances, or of binding rules.

(V) "Sanitization" means the application of any effective method or substance to a clean surface for the destruction of pathogens. Sanitization also shall destroy other organisms, as far as is practicable. Sanitization shall not adversely affect the equipment, the milk or milk product, or the health of the consumers. The method or substance used for sanitization shall be acceptable to the director.

(W) "Sterilized," when used in reference to piping, equipment, and containers used for milk and milk products, means rendering the piping, equipment, and containers free of viable microorganisms by application of heat, a chemical sterilant or sterilants, or other appropriate treatment.

(X) "Transfer station" means a milk plant where milk or milk products are transferred directly from one milk tank truck to another.

(Y) "Ultra-pasteurized," when used to describe grade a milk or a grade A milk product, means that the product has been thermally processed at or above two hundred eighty degrees Fahrenheit (one hundred thirty-eight degrees Celsius) for at least two seconds, either before or after packaging, so as to produce a product with an extended shelf life under refrigerated conditions.

901:3-10-02 Interpretation of adjectives and adverbs.

In the administration and enforcement of sections 3717.61 to 3717.69 of the Revised Code and rules 901:3-10-01 to 901:3-10-59 of the Administrative Code, the director shall interpret all adjectives and adverbs such as adequate, approved, clean, convenient, effectively, good, sanitary, satisfactory, sufficient, safe, or suitable in accordance with the provisions of the administrative procedures of the Grade A Pasteurized Milk Ordinance, as amended, of the food and drug administration, public health service, United States department of health and human services, to the extent that those provisions are not in conflict with the laws of this state.

901:3-10-03 Adulterated or Misbranded milk or milk products.

No milk producer, milk processor or milk hauler shall produce, provide, sell, offer, or expose for sale or use for human consumption, or have in his or her possession with intent to sell or distribute for human consumption, any milk or milk product which is adulterated or misbranded, as provided in the applicable provisions of Chapters 3715. and 3717. of the Revised Code and rules of the director adopted thereunder, or exceeds the specific tolerances set forth in regulations adopted under the food, drug, and cosmetic act, 21 U.S.C. 301 et seq., as those statutes, rules, and regulations from time to time may be amended. In an emergency, the sale or use of pasteurized milk and milk products which have not been graded, or the grade of which is unknown, may be authorized by the director, in which case such milk and milk products shall be labeled "ungraded" any adulterated or misbranded milk or milk product may be impounded by the director and disposed of in accordance with applicable laws and rules.

901:3-10-04 License; registration; license or registration fees; milk inspection fees.

(A) No person located in Ohio shall act as or hold the person's self out as a producer; processor; milk dealer; raw milk retailer; weigher, sampler, or tester; or milk hauler unless the person holds a valid license or registration issued by the director under section 917.09 of the Revised Code and this rule.

(B) A person whose religion prohibits the person from obtaining a license under this rule, in place of a license, shall register with the director as a producer; processor; milk dealer; raw milk retailer; milk hauler; or weigher, sampler, or tester. The registrant shall submit a religious exemption certificate with the application for each desired registration type. A registrant is subject to all provisions governing licensees such as provisions concerning testing, sampling and inspection of dairy products. A registrant is subject to provisions governing issuance of a temporary weigher, sampler, or tester license. A registration shall be suspended, revoked and canceled under the same terms as a license.

(C) The director shall issue a license or registration for each license or registration type by the following dates:

(1) September 1, 1998 for processors, milk dealers and raw milk retailers;

(2) November 1, 1998 for weigher, sampler, or testers and milk haulers; and

(3) January 1, 1999 for producers.

Persons holding a valid license after the effective date of this rule and on or before the dates specified in paragraphs (C)(1), (C)(2), and (C)(3) of this rule, shall be issued a license or registration as specified in division (a) of section 917.09 of the Revised Code and based upon receipt of a completed application and the fifteen dollar license fee.

Persons not holding a valid license or registration and are actively engaged in the business as a producer, processor, raw milk retailer, or milk hauler after the effective date of this rule and on or before the dates specified in paragraphs (C)(1), (C)(2), and (C)(3) of this rule, may apply for and receive a provisional license or registration.

Provisional licenses or registrations may be issued by the director based upon receipt of an application, a license or registration fee and upon determination by the director that the applicant is in compliance with requirements as determined by the director. Provisional licenses shall be valid until January 1, 2000.

The director shall issue a license or registration for each application thereafter upon a determination that the applicant is in compliance with sections 917.01 to 917.23 of the Revised Code and rules adopted thereunder of the Administrative Code.

(D) The director has determined the following categories for each license or registration type to be as follows:

(1) Producer

(a) Grade A bulk milk producer (milking cows)

(b) Grade A can milk producer (milking cows)

(c) Grade A bulk milk producer (milking goats)

(d) Grade A can milk producer (milking goats)

(e) Grade A bulk milk producer (milking sheep)

(f) Grade A can milk producer (milking sheep)

(g) Manufacture bulk milk producer (milking cows)

(h) Manufacture can milk producer (milking cows)

(I) Manufacture bulk milk producer (milking goats)

(j) Manufacture can milk producer (milking goats)

(k) Manufacture bulk milk producer (milking sheep)

(l) Manufacture can milk producer (milking sheep)

(2) Processor

(a) Grade A fluid milk processor

(b) Grade A cultured milk processor

(c) Grade A milk receiving station

(d) Grade A milk transfer station

(e) Grade A condensed milk products processor

(f) Grade A dry milk products processor

(g) Manufacture milk receiving station

(h) Manufacture milk transfer station

(I) Butter manufacturer

(j) Frozen desserts manufacturer

(k) Natural cheese manufacturer

(l) Processed cheese manufacturer

(m) Cottage cheese manufacturer

(n) Condensed milk products manufacturer

(o) Dry milk products manufacturer

(p) Dairy product blender

(q) Nonstandardized dairy product manufacturer

(3) Milk dealer

(4) Raw milk retailer

(5) Weigher, sampler, or tester

(a) In plant weigher

(b) In plant sampler

(c) In plant babcock tester

(d) In plant infrared tester

(e) In plant turbidemetric tester

(f) Bulk tank weigher, sampler

(6) Milk hauler

(a) Grade A bulk milk hauler

(b) Manufacture bulk milk hauler

(c) Grade A can milk hauler

(d) Manufacture can milk hauler

(E) An application shall be submitted for each license type as follows: milk producer; milk processor; milk dealer; milk hauler; weigher, sampler, or tester; and raw milk retailer. A license fee of fifteen dollars shall accompany each license or registration application. After the initial issuance of a license or registration, an application and license fee as set forth in this paragraph shall be submitted when an additional category within the license type is desired. A license or registration shall remain valid unless suspended, revoked or canceled.

(F) The director may issue a temporary weigher, sampler or tester license or registration to an applicant upon determination that the applicant has met all qualifications for licensure under sections 917.09 and 917.091 of the Revised Code and rules adopted thereunder of the Administrative Code except successful completion of an exam. A temporary weigher, sampler or tester license shall remain in effect for ninety days or the date of the examination, whichever comes first.

(G) A person when licensed or registered as a milk hauler shall provide the director with a list adequately identifying all owned or leased tanks or conveyances used to haul raw milk. Thereafter, the milk hauler shall provide the director with any additions, or deletions to such list. The director shall assign an identification number for each tank or conveyance. The milk hauler shall mount at the rear of each tank or conveyance an easily readable identification number in a manner acceptable to the director.

(H) An application for a milk dealer license or registration shall be accompanied by evidence of financial responsibility. Upon filing thereof and payment of the prescribed license fee, the director shall issue to the applicant a license or registration.

(I) Licenses or registrations are not transferable with respect to persons or locations.

(J) Licenses or registrations may be canceled by the director if the licensee or registrant:

(1) Makes such a request of the director;

(2) Transfers the licensed or registered activity to another location;

(3) Transfers the licensed or registered activity to another person;

(4) Does not perform the licensed category activity or registered category activity for six months; or

(5) Expired.

Cancellation of license, registration or category thereunder shall be at no cost to the licensee or registrant.

(K) Milk producers, milk processors and milk haulers located in Ohio shall pay the milk inspection fees prescribed by the milk sanitation board in accordance with section 917.031 of the Revised Code, in addition to the license or registration fee prescribed by section 917.09 of the Revised Code and this rule. Inspection fees shall be paid to the treasurer, state of Ohio, within fifteen days after the receipt of the invoice. Failure to pay inspection fees shall be cause for license or registration revocation. As provided in the applicable provisions of section 917.031 of the Revised Code no inspection fees shall be prescribed for manufacture milk producers, processors, or haulers until on or after July 1, 1998.

(L) Any license or registration issued under this rule may be denied, suspended, or revoked by the director for violation of sections 917.01 to 917.23 of the Revised Code or rules adopted thereunder of the Administrative Code. Except as provided by section 917.22 of the Revised Code and by this rule, the denial, suspension, or revocation of a license or registration is not effective until notice in writing of the violation has been delivered to the licensee or registrant and a reasonable opportunity for the correction of the violation has been given and a hearing afforded before the director. Upon determination by the director that a dairy product exceeds bacterial or chemical standards established by 917. of the Revised Code or rules of the Administrative Code adopted thereunder, that a dairy product is adulterated as described in section 3715.59 of the Revised Code, or that an emergency exists that presents a clear and present danger to the public health, the director, in addition to taking any other appropriate legal actions, may order a denial, suspension, or revocation of any license or registration, effective immediately without a hearing, provided that thereafter an opportunity for a hearing shall be afforded without delay.

(M) All proceedings under sections 917.01 to 917.23 of the Revised Code and this chapter are subject to 119. and section 917.22 of the Revised Code.

(N) When the director determines that a grade A milk producer sold or offered for sale raw milk containing drug residues in excess of levels specified in rule 901:3-10-08 of the Administrative Code, the grade A milk producer license shall be:

(1) Immediately suspended for a minimum of two days on the first occurrence in a twelve month period;

(2) Immediately suspended for a minimum of four days on the second occurrence in a twelve month period; and

(3) Immediately suspended for a minimum of four days on the third and subsequent occurrences in a twelve month period, and the director shall initiate administrative procedures to revoke the grade A milk producer license.

(4) Whenever a grade A milk producer license is suspended or revoked for drug residues found in raw milk, in no event shall that grade A milk producer license be reinstated by the director until:

(a) A sample taken from the grade A milk producer's milk is no longer positive for drug residues; and

(b) The grade A milk producer has on display in the milkhouse a quality assurance certificate signed by the grade a milk producer and a licensed veterinarian stating that the "Milk and Dairy Beef Residue Prevention Protocol," is in place and has been implemented for the dairy herd.

(c) A copy of the certificate of completion, signed by both the producer and a licensed veterinarian, shall be provided to the director.

901:3-10-05 Labeling.

(A) All bottles, containers, and packages enclosing milk or milk products defined in rule 901:3-10-01 of the Administrative Code shall comply with the applicable provisions of Chapters 3715. and 3717. of the Revised Code, the rules adopted thereunder by the director, and paragraph (B) of this rule.

(B) All bottles, containers, and packages enclosing milk or milk products, except milk tank trucks, storage tanks, and cans of raw milk from individual dairy farms shall be marked conspicuously with:

(1) The words "Grade A";

(2) The identity of the plant where pasteurized, ultra-pasteurized, or aseptically processed;

(3) The word "reconstituted" or "recombined" if the product is made by reconstitution or recombination;

(4) The volume or proportion of water to be added for reconstituting or recombining, in the case of concentrated milk or milk products;

(5) The words "Keep Refrigerated After Opening," in the case of aseptically processed milk and milk products;

(6) in the case of aseptically processed and packaged milk and milk products, the term "UHT";

(7) The words "Ultra-Pasteurized," if the milk or milk product has been ultra-pasteurized; and

(8) The word "goat" shall precede the name of the milk or milk product when the product is or is made from goat milk.

(C) All vehicles and milk tank trucks containing milk or milk products shall be legibly marked with the name and address of the person in possession or control of the contents.

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

(1) Shipper's name, address, and license number;

(2) License number of hauler, if not an employee of the shipper;

(3) Point of origin of shipment;

(4) Tanker identity number;

(5) Name of product;

(6) Weight of product;

(7) Grade of product;

(8) Temperature of product;

(9) Date of shipment;

(10) Name of shipper's official regulating agency at the point of origin of the shipment; and

(11) Whether the contents are raw, pasteurized, or, in the case of cream, skim milk, and lowfat milk, whether they have been heat-treated.

(E) One copy of the shipping statement shall be retained by the consignor, one by the milk hauler, and at least two copies shall be delivered to the consignee with the shipment. The consignee shall forward at least one copy to the director. Upon request, the director shall return to the shipper's official regulating agency the following information:

(1) Date and time of arrival of product;

(2) temperature of product;

(3) Bacterial count and butterfat test of product on individual shipment;

(4) Adequacy of seals; and

(5) Other pertinent information.

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

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

(H) Each bulk milk pickup tanker load of milk shall be accompanied by documentation (weight ticket or manifest) which shall include the IMS BTU identification number(s) or the IMS listed plant number (for farm groups listed with a plant.)

901:3-10-06 Inspection of dairy farms, milk plants, receiving stations, transfer stations, and milk haulers.

(A) The director shall inspect each dairy farm, milk plant, receiving station, transfer station, and each milk hauler and his or her milk tank truck and its appurtenances that are located in Ohio prior to the issuance of a license. Following the issuance of a license, the director shall do all of the following:

(1) Inspect each milk tank truck and its appurtenances at least once every six months;

(2) Inspect each hauler's pickup and sampling procedures at least once every twenty-four months;

(3) Inspect each dairy farm and transfer station at least once every six months; and

(4) Inspect each milk plant and receiving station at least once every three months.

(B) If the director finds a violation of any sanitation requirement set forth in rules 901:3-10-09 to 901:3-10-59 of the Administrative Code, the director shall make a second inspection after the time deemed necessary to remedy the violation, which shall not be less than three days. The director need not make a second inspection when the violation constitutes a clear and present danger to the public health requiring immediate license action under paragraph (C) of rule 901:3-10-04 of the Administrative Code if the director determines that there has been a violation of the same requirements of rules 901:3-10-09 to 901:3-10-59 of the Administrative Code on the second inspection, the director may initiate proceedings for license suspension or revocation in accordance with divisions (C) and (D) of section 3717.67 of the Revised Code and may institute other appropriate legal proceedings.

(C) One copy of the inspection report shall be handed to the operator or other responsible person or shall be posted in a conspicuous place on an inside wall of the establishment. The inspection report shall not be defaced and shall be made available to the director upon request. An identical copy of the inspection report shall be filed with the records of the director.

(D) Every milk producer, hauler, and milk processor shall permit access of duly authorized inspectors to all parts of his or her establishment or facilities to determine compliance with the provisions of rules 901:3-10-01 to 901:3-10-59 of the Administrative Code. Inspectors shall use disposable plastic boots or sanitize their outer footwear prior to inspection of a milk producer's premises.

(E) A milk processor shall furnish the director, upon request, for official use only, a true statement of the actual quantities of milk and milk products of each grade purchased and sold, a list of all sources of the milk and milk products, and records of inspections, tests, and pasteurization time and temperature.

(F) No person shall knowingly use to his or her advantage or reveal to any unauthorized person any information which is entitled to protection as a trade secret and which was obtained under the provisions of rules 901:3-10-01 to 901:3-10-59 of the Administrative Code.

901:3-10-07 The examination of milk and milk products.

(A) Each milk hauler shall collect a representative sample of milk from each farm bulk tank, truck, or other container prior to transferring milk from the tank, truck, or container. All samples shall be collected and held in substantial compliance with the "Standard Methods for the Examination of Dairy Products," as amended, of the "American Public Health Association" and with the "Official Methods of Analysis of the Association of Official Analytical Chemists," as amended, and delivered to a milk plant, receiving station, transfer station, or other location approved by the director.

(B) During at least four separate months within any consecutive six month period, the director shall collect samples of:

(1) Each producer's raw milk for pasteurization. The director may obtain these samples either after they have been delivered in accordance with paragraph (A) of this rule or from the producer's farm bulk tank or other container;

(2) Each milk processor's raw milk for pasteurization, ultra-pasteurization, or aseptic processing. The director shall obtain these samples from the milk plant after receipt of the milk by the milk plant and prior to pasteurization, ultra-pasteurization, or aseptic processing;

(3) Pasteurized milk, flavored milk, flavored lowfat milk, flavored skim milk, each fat level of lowfat milk, and each milk product defined in rule 901:3-10-01 of the Administrative Code, except those aseptically processed. The director shall obtain these samples from the milk processor's milk plant or from a vehicle used for transportation of pasteurized milk and milk products; and

(4) Grade A heat-treated milk products from milk plants offering grade A heat-treated products for sale.

(C) Samples of milk and milk products shall be obtained by the director while the milk or milk product is in the possession of the producer or milk processor or at any time prior to delivery to a store or consumer.

(D) The director shall perform bacterial counts, somatic cell counts, and cooling temperature checks on each sample of a milk producer's or milk processor's raw milk for pasteurization collected under paragraph (B) of this rule. In addition, drug tests on each producer's milk or on commingled raw milk shall be conducted at least four times during any consecutive six months. Except as otherwise provided in this paragraph, the director shall perform required bacterial counts, drug tests, coliform determinations, phosphatase tests, and cooling temperature checks on each sample of a milk processor's heat-treated milk products and pasteurized milk and milk products collected under paragraph (B) of this rule. A phosphatase test is not required to be performed on heat-treated milk products.

(E) Whenever a phosphatase test is positive, the cause shall be determined by the director. The cause shall be corrected, and any milk or milk product involved shall not be offered for sale.

(F) Whenever an appropriate analysis shows milk or a milk product to contain an adulterant prohibited by rule 901:3-10-03 of the Administrative Code, or the director determines that an emergency exists which presents a clear and present danger as described in paragraph (C) of rule 901:3-10-04 of the Administrative Code, the milk producer, milk processor, or milk hauler, upon notification by the director, shall stop the sale or use of the milk or milk product for human consumption. The milk or milk product shall not be sold or used for human consumption until the director has found that a subsequent sample or samples, collected by the director and analyzed in an official laboratory, show the milk or milk product to be free of the adulterant or below established tolerances or safe levels for the previously found adulterant. An investigation shall be made by the director to determine the cause, and the cause shall be corrected by the milk producer, milk processor, or milk hauler.

(G) Drug residue monitoring, surveillance, reporting, traceback, disposition of milk containing drug residues, and sale of milk containing drug residues shall be conducted in the following manner:

(1) The milk processor shall:

(a) Screen all bulk milk pickup tanker loads of raw milk for beta lactam drug residues;

(b) Screen for other drug residues, as specified by the director, by employing a random sampling program on bulk milk pickup tanker raw milk. The random bulk milk pickup tanker raw milk sampling program shall represent and include during any consecutive six months, at least four samples collected in at least four separate months. Samples collected under this random sampling program shall be analyzed as specified by the director;

(c) Complete the bulk milk pickup tanker raw milk testing prior to processing the milk;

(d) Retain or deliver, as directed by the director, bulk milk pickup tanker raw milk samples found by the milk processor to be positive for drug residues;

(e) Record all sample results required by paragraph (G) of this rule on forms satisfactory to the director and retain such records for a period of six months;

(f) Immediately notify the milk hauler, and the director of the results of a screening analyses as required by paragraph (G) (1) (a) of this rule when a bulk milk pickup tanker load of raw milk is found to be positive for drug residues;

(g) Immediately notify the director of the ultimate disposition of the bulk milk pickup tanker load of raw milk, when the ultimate disposition is performed by the milk processor;

(h) When a bulk milk pickup tanker load of raw milk is found to be positive for drug residues, have the milk producer samples, collected under paragraph (A) of this rule individually tested to determine the violative milk producer, or milk producers of origin, using a laboratory, and methodology acceptable to the director; and

(I) Immediately notify the director and milk hauler of all positive test results of the milk producer samples tested in paragraph (G) (1) (h) of this rule.

(2) The milk hauler shall:

(a) Not transport raw milk from a milk producer's dairy farm found violative under paragraph (G) (1) (h) of this rule, until such time that subsequent analyses of the milk producer's raw milk is no longer positive for drug residue; and

(b) Immediately notify the director and the milk processor making notification in paragraph (G) (1) (f) of this rule of the ultimate disposition of the raw milk, if the ultimate disposition is not performed by the milk processor.

(3) The milk producer, upon being notified of a positive drug residue shall not sell or offer for sale raw milk, until such time that subsequent analysis of the milk producer's raw milk is no longer positive for drug residues. This analysis shall be acceptable to the director.

(H) Examinations and tests to detect adulterants or misbranding prohibited by rule 901:3-10-03 of the Administrative Code and to determine compliance with the standards of identity prescribed by this chapter shall be conducted as the director shall require.

(I) Assays of milk and milk products to which vitamin "A" or "D" have been added shall be made at least annually in a laboratory approved by the director for this purpose. All milk processors fortifying products with vitamins must keep volume control records. These volume control records must cross reference the form and amount of vitamin A, vitamin D and/or vitamin A & D used with the amount of products produced and indicate a percent of expected use.

(J) Pasteurized milk and milk product samples shall be analyzed at an official laboratory. Tests of producer samples of grade A raw milk for pasteurization and commingled milk tank truck samples of raw milk for drug residues and for bacteria shall be performed either in an official laboratory or in an officially designated laboratory. These laboratories shall conduct sampling procedures and required laboratory examinations in substantial compliance with the "Standard Methods for the Examination of Dairy Products," as amended, of the "American Public Health Association" and with the "Official Methods of Analysis of the Association of Official Analytical Chemists," as amended. The tests and procedures shall be those specified therein or any other tests and procedures which have been approved by the director as being equally accurate, precise, and practical.

(K) Whenever two of the last four consecutive bacterial counts (except those for aseptically processed milk and milk products), somatic cell counts, coliform determinations, or cooling temperatures, taken on separate days, exceed the relevant standard established in rule 901:3-10-08 of the Administrative Code for a licensee's milk or milk products, the director shall send a written notice thereof to the licensee. This notice shall be in effect so long as two of the last four consecutive samples exceed the standard cited in the notice. The director shall analyze an additional sample that was collected within twenty-one days of the sending of the notice but not before the lapse of three days. The director shall suspend the license immediately, in accordance with divisions (C) and (D) of section 3717.67 of the Revised Code, whenever the standard is violated by three of the last five bacterial counts (except for aseptically processed milk and milk products), coliform determinations, cooling temperatures, or somatic cell counts.

(L) Whenever a container or containers of aseptically processed milk or milk products are found to be in violation of the standards established by rule 901:3-10-08 of the Administrative Code, the milk processor immediately shall stop distribution of the aseptically processed milk or milk product and shall notify the director immediately. The director shall perform an inspection and the milk processor shall not distribute the aseptically processed milk or milk product until the director determines that the processes, equipment, and procedures used are suitable for consistent production of a sterile product.

(M) If the director determines that tests of aseptically processed milk and milk products are necessary, the director shall perform the tests in a laboratory established in accordance with chapter XXI of the "Bacteriological Analytical Manual," as amended, of the food and drug administration, public health service, United States department of health and human services.

(N) Pyronine y-methyl green stain shall be used in the confirmatory test of direct microscopic somatic cell counts in goat milk.

(O) The director shall send written notification of tests which are approved for the examination of milk and milk products within thirty days of the effective date of this rule to:

(1) Milk sanitation board members;

(2) Official laboratories;

(3) Officially designated laboratories;

(4) All Ohio milk processors including receiving stations and transfer stations;

(5) Milk marketing organizations; and,

(6) Statewide trade organizations.

Thereafter, notification shall be sent whenever the list of approved tests is changed or modified.

901:3-10-08 Standards for milk and milk products.

(A) All grade A raw milk and milk products for pasteurization, ultra-pasteurization, or aseptic processing; all grade A heat-treated milk products for bulk shipment; all grade A pasteurized, ultra- pasteurized, or aseptically processed milk; and all other grade A milk products shall be produced, processed, and pasteurized, ultra-pasteurized, or aseptically processed to conform to the following chemical, bacteriological, and temperature standards and shall be in compliance with the sanitation requirements of rules 901:3-10-01 to 901:3-10-59 of the Administrative Code:

Chemical, bacteriological, and temperature standards

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Grade A raw milk and milk products for pasteurization, ultra- pasteurization, or aseptic processing:

Temperature: Cooled to 45øF(7øC) or less within two hours after milking, provided that the blend

temperature after the first and subsequent milkings does not exceed 50øF(10øC).

Bacterial limits: Individual producer milk not to exceed 100,000 per ml. prior to commingling with other

producer milk. Not to exceed 300,000 per ml. as commingled milk prior to pasteurization.

Drugs: No zone greater than equal to 16 mm. with the Bacillus stearothermophilus disc assay method when approved in paragraph (J) of rule 901:3-10-07 of the Administrative Code. No positive results on drug residue detection methods specified or approved under paragraph (J) of rule 901:3-10-07 of the Administrative Code.

Drugs

Somatic cell count: Individual producer milk: Not to exceed 750,000 per ml. Producer goat milk: Not to exceed 1,000,000 per ml.

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Grade A pasteurized milk and milk products and bulk shipped heat-treated products:

Temperature: Cooled to 45øF(7øC) or less and maintained thereat.

Bacterial limits*: 20,000 per ml.

Coliform **: Not to exceed 10 per ml. In the case of bulk milk transport tank shipments, shall not

exceed 100 per ml.

Phosphatase ** Less than 1 microgram per ml. by the "Scharer Rapid Method" (less than 500 milliunits

Per L. by the fluorometric procedure) or equivalent.

Drugs * :No zone greater than or equal to 16 mm. with Bacillus stearothermophilus disc assay method

when approved under paragraph (J) of rule 901:3-10-07 of the Administrative Code.

(*) Not applicable to cultured products

(**) Not applicable to bulk shipped heat-treated milk products

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Grade A aseptically processed milk and milk products:

Temperature: None

Bacterial limits: No growth by test specified in paragraph (J) of rule 901:3-10-07 of the Administrative

Code.

Drugs: No zone greater than or equal to 16 mm. with the Bacillus stearothermophilus disc assay method when approved under paragraph (J) of rule 901:3-10-07 of the Administrative Code.

(B) Except as provided in this paragraph, no process or manipulation other than pasteurization, ultra-pasteurization, or aseptic processing; processing methods integral therewith; and appropriate refrigeration shall be applied to milk and milk products for the purpose of removing or deactivating microorganisms. Bulk shipments of cream, skim milk, or lowfat milk may be heated one time to temperatures greater than one hundred twenty-five degrees Fahrenheit (fifty-two degrees Celsius) but less than one hundred sixty-one degrees Fahrenheit (seventy-two degrees Celsius) for separation purposes when the resulting bulk shipments of cream, skim milk, or lowfat milk are labeled heat-treated. In the case of heat-treated cream, the cream may be further heated to less than one hundred sixty-six degrees Fahrenheit (seventy-five degrees Celsius) in a continuing heating process and immediately cooled to forty-five degrees Fahrenheit (seven degrees Celsius) or less when necessary for enzyme deactivation (such as lipase reduction) for a functional reason.

901:3-10-09 Abnormal raw milk.

Cows which show evidence of the secretion of abnormal milk in one or more quarters based upon bacteriological, chemical, or physical examination shall be milked last or with separate equipment, and the milk shall be discarded. Cows treated with, or cows which have consumed chemical, medicinal, or radioactive agents which are capable of being secreted in the milk and which, in the judgment of the director, may be deleterious to human health, shall be milked last or with separate equipment, and the milk disposed of as the director may direct. In making determinations regarding the impact of radioactive agents on human health, the director shall consult with the Director of Health.

901:3-10-10 Milking barn, stable, or parlor; construction.

The milk producer shall provide a milking barn, stable, or parlor. The milking herd shall be housed in the barn, stable, or parlor during milking operations. The areas used for milking purposes shall meet all of the following standards:

(A) Areas used for milking purposes shall have floors which are in good repair and are constructed of concrete or equally impervious materials, except that convalescent (maternity) pens located in milking areas of stanchion-type barns may have floors constructed of other materials when the convalescent pens meet the following criteria:

(1) Milk from animals milked in convalescent pens with non-impervious floors is not entered into the distribution system or sold;

(2) Routine milking in pens is not allowed;

(3) Convalescent pens are located so that no contamination of milk holding transfer facilities or water supplies occurs. Convalescent pens shall not be within fifty feet of a well;

(4) A curb of no less than six inches is provided on all exposed sides of the convalescent pens;

(5) Convalescent pens are well-bedded, clean, and dry at all times;

(6) No water faucet or drinking fountain is located within the curbed area;

(7) The convalescent pen base is reconstructed sufficiently often to maintain reasonably clean conditions; and

(8) The number of convalescent pens is limited to one pen per fifty milking cows on the dairy farm.

(B) Areas used for milking purposes shall have walls and ceilings which are smooth, painted or finished in an approved manner, and are in good repair. Ceilings shall be dust-tight;

(C) The milk producer shall provide separate stalls or pens for horses, calves, and bulls;

(D) Areas used for milking purposes shall be provided with natural or artificial light, well distributed for day or night milking;

(E) The milk producer shall ensure that areas used for milking purposes have sufficient airspace and air circulation to prevent condensation and excessive odors;

(F) Areas used for milking purposes shall not be overcrowded; and

(G) The milk producer shall use dust-tight covered boxes and bins or separate storage facilities for ground, chopped, or concentrated feed.

901:3-10-11 Milk barn, stable, or parlor; cleanliness.

The interior shall be kept clean. Floors, walls, ceilings, windows, pipelines, and equipment shall be free of filth and/or litter and shall be clean. Swine and fowl shall be kept out of the milking area.

901:3-10-12 Cowyard.

The cowyard shall be graded and drained and shall have no standing pools of water or accumulations of organic wastes; provided, that in loafing or cattlehousing areas, cow droppings and soiled bedding shall be removed, or clean bedding added, at sufficiently frequent intervals to prevent the soiling of the cow's udder and flanks. Waste feed shall not be allowed to accumulate. Manure packs shall be properly drained and shall provide a reasonably firm footing. Swine shall be kept out of the cowyard.

901:3-10-13 Milkhouse or room; construction and facilities.

(A) The milk producer shall ensure that cooling, handling, and storing of milk and washing sanitizing, and storing of milk containers and utensils is conducted only in a milkhouse or room of sufficient size that meets the requirements of this rule, except as provided in rule 901:3-10-20 of the Administrative Code.

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

(C) The walls and ceilings shall be constructed of smooth material, kept in good repair, and well painted with a light-colored washable paint or finished in an equally suitable manner.

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

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

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

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

(H) When a transportation tank is used for the cooling or storage of milk on the dairy farm, the tank shall be provided with a suitable shelter for the receipt of milk. The shelter shall be adjacent to, but not a part of, the milkroom and shall comply with the requirements of this rule.

(I) The milk producer and milk hauler shall ensure that milk is transferred from a bulk-holding or cooling tank to a transport tank only through a hose port located in the milkhouse wall. The port shall be fitted with a tight door which shall be kept in good repair. The door shall be kept closed except when the port is in use. An easily cleanable surface shall be constructed under the hose port adjacent to the outside wall and shall be sufficiently large to protect the milk hose from contamination.

901:3-10-14 Milkhouse or room; cleanliness.

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

901:3-10-15 Farm toilet.

Every dairy farm shall be provided with one or more toilets, conveniently located, properly constructed, operated, and maintained in a sanitary manner. The waste shall be inaccessible to flies and shall not pollute the soil surface or contaminate any water supply.

901:3-10-16 Farm water supply.

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

901:3-10-17 Farm utensils and equipment; construction.

(A) All multi-use containers, equipment, and utensils used in the handling, storage, or transportation of milk shall be made of smooth, nonabsorbent, corrosion-resistant, nontoxic materials, and shall be so constructed as to be easily cleaned. All containers, utensils, and equipment shall be in good repair. All milk pails used for hand milking and stripping shall be seamless and of the hooded type. Multiple-use woven material shall not be used for straining milk. All single-service articles shall have been manufactured, packaged, transported, and handled in a sanitary manner and shall comply with the applicable requirements of rule 901:3-10-41 of the Administrative Code. Articles intended for single-service use shall not be reused.

(B) Farm holding/cooling tanks, welded sanitary piping, and transportation tanks shall comply with the applicable requirements of rules 901:3-10-40 and 901:3-10-41 of the Administrative Code.

901:3-10-18 Farm utensils and equipment: cleaning.

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

901:3-10-19 Farm utensils and equipment: sanitization.

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

901:3-10-20 Farm utensils and equipment: storage.

The milk producer shall store all containers, utensils, and equipment used in the handling, storage, or transportation of milk to assure complete drainage, unless they are stored in sanitizing solutions. The items shall be protected from contamination prior to use. The milk producer may store pipeline milking equipment such as milker claws, inflations, weigh jars, meters, milk hoses, milk receivers, tubular coolers, plate coolers and milk pumps which are designed for mechanical cleaning in the milking barn or parlor if the equipment is designed, installed, and operated to protect the product- and solution-contact surfaces from contamination at all times. The milk producer shall store strainer pads, parchment papers, gaskets, and similar single-service articles in suitable containers or cabinets to protect them against contamination and in a location convenient to their use.

901:3-10-21 Farm utensils and equipment: handling.

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

901:3-10-22 Milking: flanks, udders, and teats.

The milk producer shall ensure that milking is done only in the milking barn, stable, or parlor. The flanks, udders, bellies, and tails of all milking cows shall be free from visible dirt. All brushing shall be completed prior to milking. The udders and teats of all milking cows shall be clean and dry before milking. The milk producer shall ensure that the animals' teats are treated with a sanitizing solution just prior to the time of milking and shall be dry before milking. Wet-hand milking is prohibited.

901:3-10-23 Milking: surcingles, milk stools, and antikickers.

Surcingles, milk stools, and antikickers shall be kept clean and stored above the floor.

901:3-10-24 Protection from contamination; cleaners and sanitizers; medicinals or drugs.

(A) The milk producer shall ensure that all milking and milkhouse operations, equipment, and facilities are located and conducted in a manner that prevents any contamination of milk, equipment, containers, or utensils. No milk shall be strained, poured, transferred, or stored unless it is properly protected from contamination.

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

(C) The milk producer shall not clean equipment used to administer medicinals or drugs in the utensil wash and rinse vats and shall store those items in such a manner as not to contaminate the milk or milk-contact surfaces of equipment.

(D) The milk producer shall store drugs and medicinals in such a manner that they cannot contaminate the milk or milk product-contact surfaces of equipment, containers, or utensils. These products shall be labeled properly with labels which include all of the following:

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

(2) Directions for use, and prescribed withholding times;

(3) Cautionary statements, if needed; and

(4) Active ingredient(s) in the drug product. This requirement is met by displaying the drug's common or generic name. Listing of a trade or brand name is not in compliance with this rule.

All words, statements, and other information required by this rule to appear on the label or labeling shall be prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

No milk producer shall use medicinals or drugs which have not been approved by the United States food and drug administration or which are labeled improperly to treat dairy animals and shall not store any such items in the milkhouse, or the milking barn, stable, or parlor. The milk producer shall separate medicinals or drugs intended for treatment of non-lactating dairy animals from medicinals or drugs used for lactating dairy Animals. Separate shelves in cabinets, refrigerators, or other storage facilities is satisfactory separation.

901:3-10-25 Farm personnel; hand-washing facilities.

The milk producer shall provide adequate hand-washing facilities, including a lavatory fixture with running water, soap or detergent, and individual sanitary towels, convenient to the milkhouse, milking barn, stable, parlor, and flush toilet. Utensil wash and rinse vats shall not be used as hand-washing facilities.

901:3-10-26 Farm personnel: cleanliness.

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

901:3-10-27 Cooling raw milk.

(A) The milk producer shall cool raw milk for pasteurization to forty-five degrees fahrenheit (seven degrees Celsius) or less within two hours after milking. While the milk is in the possession of the producer or hauler, the blend temperature after the first milking and subsequent milkings shall not exceed fifty degrees Fahrenheit (ten degrees Celsius).

(B) Recirculated cold water which is used in plate or tubular coolers or heat exchangers is from a safe source and protected from contamination.

901:3-10-28 Vehicles.

Vehicles used to transport milk in cans or in bulk from the dairy farm to the milk plant, receiving station or transfer station shall be constructed and operated to protect their contents from sun, freezing, and contamination. Such vehicles shall be kept clean, inside and out. No substance capable of contaminating milk shall be transported with milk.

901:3-10-29 Insect and rodent control.

Effective measures shall be taken to prevent the contamination of milk, containers, equipment, and utensils by insects and rodents, and by chemicals used to control such insects and rodents. Milkrooms shall be free of insects and rodents. Surroundings shall be kept neat, clean, and free of conditions which might harbor or be conducive to the breeding of insects and rodents.

901:3-10-30 Sanitation requirements for receiving stations, transfer stations, and milk tank truck cleaning and sanitizing facilities.

(A) A receiving station shall comply with rules 901:3-10-31 to 901:3-10-45, 901:3-10-47, 901:3-10-50, and 901:3-10-52 of the Administrative Code, except that the partitioning requirement of rule 901:3-10-35 of the Administrative Code shall not apply.

(B) A transfer station shall comply with rules 901:3-10-31, 901:3-10-34, 901:3-10-36 to 901:3-10-42, 901:3-10-44, 901:3-10-45, 901:3-10-50, and 901:3-10-52 of the Administrative Code, and as climatic and operating conditions require, the applicable provisions of rules 901:3-10-32 and 901:3-10-33 of the Administrative Code; provided, that in every case, overhead protection shall be provided

(C) Facilities for the cleaning and sanitizing of milk tank trucks shall comply with rules 901:3-10-31, 901:3-10-34, 901:3-10-36 to 901:3-10-42, 901:3-10-44, 901:3-10-45, 901:3-10-50, and 901:3-10-52 of the Administrative Code, and as climatic and operating conditions require, the applicable provisions of rules 901:3-10-32 and 901:3-10-33 of the Administrative Code; provided, that in every case, overhead protection shall be provided.

901:3-10-31 Floors; construction.

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

901:3-10-32 Walls and ceilings: construction.

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

901:3-10-33 Doors and windows.

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

901:3-10-34 Lighting and ventilation.

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

901:3-10-35 Separate rooms.

(A) The milk processor shall provide separate rooms for the following operations if conducted at the milk plant:

(1) The pasteurizing, processing, cooling, and packaging of milk and milk products;

(2) The cleaning of milk cans, bottles, and cases;

(3) The cleaning and sanitizing of tanks and appurtenances of milk tank trucks, the facilities of which comply with rule 901:3-10-30, paragraph (C), of the Administrative Code; and

(4) The receiving of cans of milk and milk products.

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

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

901:3-10-36 Toilet-sewage disposal facilities.

Every milk plant shall be provided with toilet facilities conforming with the applicable requirements of the Ohio basic building code as adopted by the board of building standards under authority of section 3781.10 of the Revised Code. Toilet rooms shall not open directly into any room in which milk and/or milk products are processed. Toilet rooms shall be completely enclosed and shall have tight-fitting, self-closing doors. Dressing rooms, toilet rooms, and fixtures shall be kept in a clean condition, in good repair, and shall be well ventilated and well lighted. Sewage and other liquid wastes shall be disposed of in a sanitary manner.

901:3-10-37 Water supply.

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

901:3-10-38 Hand-washing facilities.

Convenient hand-washing facilities shall be provided, including hot and cold and/or warm running water, soap, and individual sanitary towels or other approved hand-drying devices. Hand-washing facilities shall be kept in a clean condition and in good repair.

901:3-10-39 Milk plant cleanliness.

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

901:3-10-40 Sanitary piping.

All sanitary piping, fittings, and connections which are exposed to milk or milk products, or from which liquids may drip, drain, or be drawn into milk or milk products, shall consist of smooth, impervious, corrosion resistant, nontoxic, easily cleanable material. All piping shall be in good repair. Pasteurized milk and milk products shall be conducted from one piece of equipment to another only through sanitary piping; provided, that cottage cheese, cheese dressings, or cheese ingredients may be transported by other methods which protect the product from contamination.

901:3-10-41 Construction and repair of containers and equipment.

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

901:3-10-42 Cleaning and sanitizing of containers and equipment.

(A) The milk processor shall clean and shall sanitize the product-contact surfaces of all multi-use containers, utensils, and equipment used in the transportation, processing, handling, and storage of milk and milk products effectively after each use. Storage tanks shall be emptied at least once every seventy-two hours after filling. Storage tanks, used to store raw milk or heat-treated milk products longer than twenty-four hours, and silo tanks, used to store raw milk or heat-treated milk products, that were installed after July 1, 1980 shall be equipped with a seven-day temperature recording device.

(B) The milk processor shall sterilize piping, equipment, and containers used to process, conduct, or package aseptically processed milk and milk products beyond the final heat treatment process before using the items to package any aseptically processed milk or milk product. The milk processor shall resterilize any item that is contaminated by any unsterile product.

(C) The milk processor shall not remove milk or milk products from a milk tank truck which does not bear a tag showing the date, time, place, and signature of the person who cleaned and sanitized the milk tank truck. The milk hauler shall not place milk or milk products into a milk tank truck which does not bear a tag showing the date, time, place, and signature of the person who cleaned and sanitized the milk tank truck.

901:3-10-43 Storage of cleaned containers and equipment.

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

901:3-10-44 Storage of single-service containers, utensils, and materials.

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

901:3-10-45 Protection from contamination.

Milk plant operations, equipment, and facilities shall be located and conducted to prevent any contamination of milk or milk products, ingredients, equipment, containers, and utensils. All milk or milk products or ingredients which have been spilled, overflowed, or leaked shall be discarded. The processing or handling of products other than milk and milk products in the pasteurization plant shall be performed to preclude the contamination of such milk and milk products. The storage, handling, and use of poisonous or toxic materials shall be performed to preclude the contamination of milk and milk products, or ingredients of such milk and milk products, or the product-contact surfaces of all equipment, containers, or utensils.

901:3-10-46 Pasteurization; Aseptic Processing.

(A) The milk processor shall perform pasteurization as defined in paragraph (R) of rule 901:3-10-01 of the Administrative Code. The design and the operation of pasteurization equipment and all appurtenances thereto shall comply with the applicable specifications and operational procedures in the administrative procedures of item 16p of the Grade A pasteurized Milk Ordinance, as amended, of the Food and Drug Administration, public health service, United States Department of Health and Human Services.

(B) The milk processor shall perform aseptic processing as defined in paragraph (A) of rule 901:3-10-01 of the Administrative Code and in accordance with the requirements of item 16p of the Grade A Pasteurized Milk Ordinance, as amended, of the Food and Drug Administration, Public Health Service, United States Department of Health and Human Services and its relevant administrative procedures.

901:3-10-47 Cooling of milk.

(A) The milk processor shall maintain all raw milk and milk products at forty-five degrees Fahrenheit (seven degrees Celsius) or less until processed. The milk processor shall cool all pasteurized milk and milk products, except those to be cultured, in approved equipment to a temperature of forty-five degrees Fahrenheit (seven degrees Celsius) or less immediately prior to filling or packaging. Recirculated cold water which is used in coolers and exchangers, including those systems in which a freezing point depressant is used, is from a safe source and is protected from contamination. Freezing point depressants, when used in recirculated systems, shall be nontoxic.

(B) The milk processor shall store all pasteurized milk and milk products at an ambient air temperature of forty-five degrees Fahrenheit (seven degrees Celsius) or less. On delivery vehicles, the milk processor shall maintain all milk and milk products at a temperature of forty-five degrees Fahrenheit (seven degrees Celsius) or less. The milk processor shall equip every room or tank in which milk or milk products are stored with an accurate thermometer. Aseptically processed milk and milk products to be packaged in hermetically sealed containers are exempt from the cooling requirements of this rule.

901:3-10-48 Bottling and packaging.

(A) Except as provided in paragraph (B) of this rule, no person shall bottle or package milk or milk products except at the place of pasteurization and using approved mechanical equipment. The bottling and capping devices of the equipment shall be integrated into one system but may be operated manually.

(B) A milk processor may transport cottage cheese, dry curd cottage cheese, and lowfat cottage cheese in sealed containers in a protected, sanitary manner from one plant to another for creaming or packaging. If suitable equipment is not available for packaging dry curd cottage cheese, the milk processor may use other methods of packaging which minimize possible contamination and are approved by the director.

901:3-10-49 Capping.

No person shall cap or close milk and milk product containers except in a sanitary manner and using approved mechanical capping or closing equipment, which may include manually operated equipment. The cap or closure shall be designed and applied in such a manner that a pouring lip is protected to at least its largest diameter and, with regard to fluid product containers, the cap or closure cannot be removed without detection. If suitable mechanical equipment for capping or closing containers of three gallons or more is not available, or if suitable equipment for capping cottage cheese, dry curd cottage cheese, lowfat cottage cheese, or sour cream is not available, the milk processor may use other methods, including hand-capping, which eliminate all possibility of contamination and are approved by the director. Except as otherwise provided in this paragraph, handcapping is prohibited.

901:3-10-50 Personnel; Cleanliness.

(A) Hands shall be thoroughly washed before commencing plant functions and as often as may be required to remove soil and contamination. No employee shall resume work after visiting the toilet room without thoroughly washing his hands. All persons, while engaged in the processing, pasteurization, handling, storage, or transportation of milk, milk products, containers, equipment, and utensils, shall wear clean outer garments.

(B) The use of tobacco products is prohibited in all rooms in which milk or milk products are processed, handled, or stored; or in which milk containers, equipment, and utensils are washed.

(C) Adequate head coverings shall be worn by all persons in rooms in which milk or milk products are processed, handled, or stored; or in which milk containers, equipment, and utensils are washed.

901:3-10-51 Vehicles.

No person shall transport pasteurized milk and milk products except in vehicles constructed and operated so that the milk and milk products are maintained at forty-five degrees Fahrenheit (seven degrees Celsius) or less, and are protected from sun, from freezing, and from contamination.

901:3-10-52 Surroundings.

Milk plant surroundings shall be kept neat, clean, and free from conditions which might attract or harbor flies, other insects, rodents, or which otherwise constitute a nuisance.

901:3-10-53 Animal health.

(A) All milk for pasteurization shall be from herds which are located in an accredited free state or modified accredited tuberculosis area, as determined by the United States Department of Agriculture. Herds located in an area that fails to maintain accredited status shall have passed an annual tuberculosis test.

(B) All milk for pasteurization shall be from Herds under a brucellosis eradication program which meets one of the following conditions:

(1) The herd is located in a certified brucellosis- free area as defined by the United States Department of Agriculture and is enrolled in the testing program for the area; or

(2) The herd meets United States Department of Agriculture requirements for an individually certified herd; or

(3) The herd participates in a milk ring testing program that meets the requirements of the United States Department of Agriculture as described in "Brucellosis Eradication Uniform Methods and Rules" at least four times per year at approximately ninety-day intervals; or

(4) The herd has an individual blood agglutination test annually with an allowable maximum grace period not exceeding two months.

(C) Regardless of location or other herd status, a milk producer whose herd has a suspicious (positive) milk ring test result shall have the entire herd blood tested within thirty days after the date of the laboratory test.

(D) Regardless of location or other herd status, a milk producer whose herd is identified as the origin of a brucellosis reactor animal shall have the entire herd blood tested within thirty days after the laboratory test(s), unless the test requirement has been waived by the director.

(E) Regardless of location or other herd status, a milk producer whose herd is identified as the origin of a tuberculosis reactor or suspect, shall follow all statutes, rules, and recommendations of the Ohio Department of Agriculture concerning the testing and disposition of animals in the herd.

(F) For diseases other than brucellosis and tuberculosis, the director may require appropriate physical, chemical, or bacteriological tests. The diagnosis of other diseases in dairy cattle shall be based upon test results and the diagnosis of a licensed veterinarian or a veterinarian in the employ of a governmental agency. The milk producer shall dispose of any animal diagnosed as being diseased in accordance with applicable laws and rules.

901:3-10-54 Milk and milk products which may be sold.

Except as otherwise permitted by section 3717.61 of the Revised Code, only grade A pasteurized, ultra-pasteurized, or aseptically processed milk and milk products shall be sold or donated to the final consumer or to a retailer or other vendor. In an emergency, the sale or use of pasteurized milk and milk products that have not been graded, or the grade of which is unknown, may be authorized by the director, in which case such milk and milk products shall be labeled "ungraded."

901:3-10-55 Transferring; emptying farm bulk milk tanks; picking up raw milk without unnecessary delay; delivery containers; cooling.

(A) No milk producer, milk processor, or milk hauler shall transfer milk or milk products from one container or milk tank truck to another except in a milk plant, receiving station, transfer station, or milkhouse. Dipping or ladling milk of fluid milk products is prohibited.

(B) When a milk hauler starts to empty a farm bulk milk tank, the tank should be emptied completely. When necessary, a milk hauler may empty a farm bulk milk tank partially and the partial pickup shall be recorded on the "Receipt of Producer Milk" form. A farm bulk milk tank shall not be emptied partially two consecutive times. Farm bulk milk tanks shall be completely emptied, cleaned, and sanitized at least every seventy-two hours.

(C) After a milk hauler pumps the raw milk from the first farm bulk tank on the milk route into the tank truck or tanker, the milk hauler shall complete the milk route without unnecessary delay. If there is a delay of more than two hours between any two consecutive pickups, the milk hauler shall clean and sanitize the pickup hose and pump prior to the next pickup and shall record the delay on the "Receipt of Producer Milk" form.

(D) No person shall sell any pasteurized milk or milk product which has not been maintained at the temperatures set forth in rules 901:3-10-08 and 901:3-10-47 of the Administrative Code. If containers of pasteurized milk or milk products are stored in ice, the storage container shall be properly drained.

.901:3-10-56 Reciprocity.

(A) Grade A milk and grade A milk products produced and processed by the milk producers and milk processors licensed by the director may be sold in all political subdivisions of the state.

(B) Grade A milk and grade A milk products entering Ohio may be sold in all political subdivisions in Ohio, if:

(1) They are produced, transported, processed, and otherwise handled under rules substantially equivalent to rules 901:3-10-01 to 901:3-10-59 of the Administrative Code;

(2) The shipper has been awarded a milk sanitation compliance and enforcement rating in the "Sanitation Compliance and Enforcement Ratings of Interstate Milk Shippers," as amended, that is acceptable to the director;

(3) The responsible governmental agency in the state of origin extends the same rights and privileges to milk producers and milk processors licensed in Ohio;

(4) The milk plant in which the grade A milk or milk products are processed is licensed by the director; and

(5) The milk hauler is licensed by the director or by an out-of-state governmental agency.

(C) No milk producer located in another state shall be licensed under section 3717.67 of the Revised Code.

901:3-10-57 Submission of plans for alterations or new dairy facilities.

Applicants and licensees shall submit two complete sets of properly prepared plans to the director for written approval before work is begun for all new or extensively altered milkhouses, milking barns, stables, parlors, transfer stations, receiving stations, hauling facilities, and milk plants that will be used in operations licensed under sections 3717.61 to 3717.69 of the Revised Code. The director will review plans promptly and return one complete set of approved plans or recommend changes in writing.

901:3-10-58 Personnel Health.

No persons affected with any disease capable of being transmitted to others through the contamination of food shall work at a milk plant in any capacity which brings them into direct contact with finished products, such as pasteurized or aseptically processed milk or milk products, or which brings them into direct contact with associated pasteurized or aseptically processed milk product contact surfaces. Milk processors who have received reports, under this rule, from employees who have handled pasteurized milk, pasteurized milk products or associated product contact surfaces shall immediately report these facts to the director.

901:3-10-59 Procedure when infection or high risk of infection is discovered.

When a person who may have handled pasteurized or aseptically processed milk or milk products or pasteurized or aseptically processed milk product contact surfaces meets one or more of the conditions specified in rule 901:3-10-58 of the Administrative Code, the director is authorized to require any or all of the following measures:

(A) The immediate restricting of that person from duties which require handling finished product, such as pasteurized milk or milk products, or the handling of related product contact surfaces. This restriction may be lifted after an appropriate medical clearance or cessation of symptoms or both, according to the following criteria:

Health Status--Removing Restrictions

Is diagnosed with an illness due to Hepatitis A virus, Salmonella Typhi, Shigella species, Norwalk and Norwalk- like Viruses, Staphylococcus Aureus, Streptococcus Pyogenes, Escherichia coli 0157:H7, Enterohemorrhagic Escherichia coli, Enterotoxigenic Escherichia coli, Campylobacter Jejuni, Entamoeba Histolytica, Giardia Lamblia, Non- Typhoidal Salmonella, Rotovirus, Taenia, Solium, Yersinia Enterocolitica, Vibrio Cholerae 01 or other infectious or communicable disease that has been declared by the Secretary of Health and Human Services to be transmissible to others through the handling of food or has been clearly shown to be so based upon verifiable epidemiclogical data.

Restrictions lifted by medical clearance.

Meeting a high risk scenario as specified in Rule 901:3-10-58. Restrictions lifted when symptoms cease or medical documentation is provided that infection does not exist.

Asymptomatic, but stools positive for Salmonella Typhi, Shigella, or Shigella, or Escherichia coli 0157:H7. Restrictions lifted by medical clearance.

Past illness from Salmonella typhi, Shigella, Escherichia coli 0157:h7 or other human pathogens for which humans have been determined to be carriers. Restrictions lifted by medical clearance.

In the case of diagnosed or suspected Hepatitis A, onset of jaundice within the last seven days. Restrictions lifted by medical clearance

In the case of diagnosed or suspected Hepatitis A, onset of jaundice occurred more than seven days Restrictions lifted by medical clearance or jaundice ceases.

(B) The immediate exclusion of the affected dairy products from distribution and use when medically appropriate.

(C) The immediate requesting of medical and bacteriological examination of the person at risk.

901:3-10-60 Definitions.

As used in rules 901:3-10-60 to 901:3-10-86 of the Administrative Code:

(A) "Director" means the director of agriculture. Unless the context requires otherwise, "director" also means an appropriately authorized designee of the director of agriculture.

(B) "Drug" means:

(1) Articles recognized in the official United States Pharmacopoeia, Official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and

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

(3) Articles (other than food) intended to affect the structure or any function of the body of man or other animals; and

(4) Articles intended for use as a component of any articles specified in paragraph (b)(1), (b)(2), or (b)(3) of this rule, but does not include devices or their components, parts, or accessories.

(c) "Grade A condensed milk" means milk, unsterilized and unsweetened, resulting from the vacuum removal of a considerable portion of water, that has been produced for use in grade A milk or grade A milk products and that complies with the applicable provisions of sections 3717.61 to 3717.69 of the Revised Code and rules 901:3-10-60 to 901:3-10-86 of the Administrative Code. This definition does not include such products as aseptically processed milk and milk products, as defined in paragraph (B) of rule 901:3-10-01 of the Administrative Code, Evaporated Milk, Evaporated Skim Milk or Sweetened Condensed Milk, except when they are combined with other substances in the commercial preparation of any grade A milk or milk product, as defined in section 3717.61 of the Revised Code and rule 901:3-10-01 of the Administrative Code.

(D) "Grade A condensed whey" means the product that results from the vacuum, ultra filtration, or reverse osmosis removal of a considerable portion of water from whey and that complies with the applicable provisions of sections 3717.61 to 3717.69 of the Revised Code and rules 901:3-10-60 to 901:3-10-86 of the Administrative Code.

(E) "Grade A dry milk products" means products resulting from the drying of milk or milk products and any product resulting from the combination of dry milk products with other wholesome dry ingredients if the products are produced for use in grade A milk or other grade A milk products and comply with the applicable provisions of sections 3717.61 to 3717.69 of the Revised Code and rules 901:3-10-60 to 901:3-10-86 of the Administrative Code.

(F) "Grade A dry whey" means any product resulting from the drying of grade A whey and any product resulting from the combination of dry whey with other wholesome dry ingredients if the product complies with the applicable provisions of sections 3717.61 to 3717.69 of the Revised Code and rules 901:3-10-60 to 901:3-10-86 of the Administrative Code.

(G) "Grade A nonfat dry milk" means the product obtained by removal of water only from grade A pasteurized skim milk containing not more than five per cent by weight of moisture and not more than one and one-half per cent by weight of milkfat, unless otherwise indicated.

(H) "Grade A Whey" means the liquid substance obtained by separating the coagulum from grade A milk, grade A cream, or grade A skim milk. The acidity of the whey may be adjusted by the addition of safe and suitable pH-adjusting ingredients prior to pasteurization.

(I) "Milk condensing and/or drying plant" means a plant in which milk or milk products are condensed or dried or in which milk or milk products are received, separated, or otherwise processed for drying and packaging or that processes grade A condensed and dry milk products, except for grade A whey or condensed and dry whey.

(J) "Milk," "milk products," "grade A milk," and "grade A milk products" have the same meaning as the terms are given in rule 901:3-10-01 of the Administrative Code.

(K) "Milk hauler" means any person who transports by means of any truck, tank, or other container, raw milk or a raw milk product in fluid form from one location to another.

(L) "Milk plant" means a milk or a whey condensing and/or drying plant.

(M) "Milk processor" means any person who operates or controls a milk plant located in this state or from which grade A milk, grade A goat milk, or grade A milk products are sold or offered for sale for consumption in this state.

(N) "Milk producer" or "producer" means any person located in this state who sells or offers for sale grade A milk from a cow or goat owned or controlled by the producer, and any person who sells or offers for sale for consumption in this state grade A milk from a cow or goat owned or controlled by the producer.

(O) "Official laboratory" means a biological, chemical, or physical laboratory approved by the director to conduct all tests or analyses required by this chapter of the Administrative Code.

(P) "Officially designated laboratory" means a commercial laboratory authorized to do official work by the director or a milk industry laboratory officially designated by the director for the examination of producer samples of grade A raw milk for pasteurization and commingled milk tank truck samples of raw milk for drug residues or bacterial limits.

(Q) "Pasteurization," "Pasteurized" and similar terms mean the process of heating every particle of milk, milk products, or grade A whey in properly designed and operated equipment to one of the temperatures given in the following table and holding the milk, milk product, or grade A whey continuously at or above that temperature for at least the corresponding specified time:

TEMPERATURE TIME

145 degrees F (63 degrees C)* 30 minutes

161 degrees F (72 degrees C)* 15 seconds

191 degrees F (89 degrees C) 1 second

194 degrees F (90 degrees C) 0.5 second

201 degrees F (94 degrees C) 0.1 second

204 degrees F (96 degrees C) 0.05 second

212 degrees F (100 degrees C) 0.01 second

(*)If the fat content of the milk product is ten per cent or more or if it contains added sweeteners, and for condensed milk and condensed milk products, the specified temperature shall be increased by five degrees F (three degrees C).

Nothing in this definition shall be construed as barring any other pasteurization process that has been recognized to be equally effective and that is approved by the director.

(R) "Pasteurized milk products" means commercially prepared grade A pasteurized milk products prepared in accordance with sections 3717.61 to 3717.69 of the Revised Code and rules 901:3-10-01 to 901:3-10-59 of the Administrative Code.

(S) "Person" means any individual, partnership, corporation, company, firm, trustee, association, governmental agency, or other entity.

(T) "Sanitization" means the application of any effective method or substance to a clean surface for the destruction of pathogens. Sanitization also shall destroy other organisms, as far as is practicable. Sanitization shall not adversely affect the equipment, milk, milk products, whey, condensed, and dry milk products, or the health of consumers. The method or substance used for sanitization shall be acceptable to the director.

(U) "Whey condensing and/or drying plant" means a milk plant in which grade A whey is condensed or dried or in which grade A whey is received and processed for drying and packaging or that processes grade A condensed whey and/or grade A dry whey.

(V) "Whey, condensed, or dry milk products" means grade A condensed milk and milk products, grade A condensed whey, grade A dry milk and milk products, grade A dry whey, grade A non-fat dry milk, grade A whey, grade A modified whey products, grade A modified condensed whey products, and grade A modified dry whey products, as the context requires.

901:3-10-61 Interpretation of adjectives and adverbs.

In the administration and enforcement of sections 3717.61 to 3717.69 of the Revised Code and rules 901:3-10-60 to 901:3-10-86 of the Administrative Code, the director shall interpret all adjectives and adverbs such as adequate, approved, clean, convenient, effectively, good, sanitary, satisfactory, sufficient, safe, or suitable in accordance with the provisions of the administrative procedures of the "grade A Condensed and Dry Milk Products and Condensed and Dry Whey," supplement I to the grade A Pasteurized Milk Ordinance, as amended, of the Food and Drug Administration, Public Health Service, United States Department of Health and Human Services, to the extent that those provisions are not in conflict with the laws of this state.

901:3-10-62 Adulterated or misbranded whey, condensed, and dry milk products.

No milk processor shall produce, provide, sell, offer, or expose for sale or use for human consumption, or have in his or her possession with intent to sell or distribute for human consumption, any whey, condensed, or dry milk products intended for use in the commercial preparation of pasteurized milk products that are adulterated or misbranded, as provided in the applicable provisions of Chapters 3715. and 3717. of the Revised Code and rules of the director adopted thereunder, or that exceed the specific tolerances set forth in regulations adopted under the Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et seq., as those statutes, rules, and regulations from time to time may be amended.

901:3-10-64 Labeling.

(A) All containers and packages enclosing whey, condensed, or dry milk products as defined in rule 901:3-10-60 of the Administrative Code shall comply with the applicable provisions of Chapters 3715. and 3717. of the Revised Code, the rules adopted thereunder by the director, and paragraph (B) of this rule.

(B) All containers and packages enclosing whey, condensed, or dry milk products except milk tank trucks and storage tanks shall be conspicuously and permanently marked with:

(1) The name of the contents, as given in the definitions in rule 901:3-10-60 of the Administrative Code, and the common name of the ingredients;

(2) The words "Grade A";

(3) The identity of the plant in which the product was manufactured or processed; and

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

(C) All vehicles and milk tank trucks containing whey or condensed milk or milk products shall be legibly marked with the name and address of the person in possession or control of the contents.

(D) Milk tank trucks transporting whey or condensed milk or milk products to a milk plant from sources of supply not licensed by the director shall be marked with the name and address of the shipper or hauler and shall be sealed. In addition, for each such shipment, a shipping statement shall be prepared containing at least the following information:

(1) Shipper's name, address, and license number;

(2) License number of hauler, if not an employee of shipper, and if required to be licensed;

(3) Point of origin of shipment;

(4) Tanker identity number;

(5) Name of product;

(6) Weight of product;

(7) Grade of product;

(8) Temperature of product, when applicable;

(9) Date of loading; and

(10) Name of shipper's official regulating agency at the point of origin of the shipment.

(E) One copy of the shipping statement shall be retained by the consignor, one by the common carrier, and at least two copies shall be delivered to the consignee with the shipment. The consignee shall forward at least one copy to the director. Upon request, the director shall return to the shipper's official regulating agency the following information:

(1) Date and time of arrival of product;

(2) Temperature of product;

(3) Bacterial count of product on individual shipment;

(4) Adequacy of seals; and

(5) Other pertinent information.

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

901:3-10-65 Inspection of condensing and drying plants.

(A) The director shall inspect each milk plant as defined in paragraph (L) of rule 901:3-10-60 of the Administrative Code that is located in Ohio prior to the issuance of a license. Following the issuance of a license, the director shall inspect each milk plant as defined in paragraph (L) of rule 901:3-10-60 of the Administrative Code at least once every three months. If the director finds a violation of any sanitation requirement set forth in rules 901:3-10-68 to 901:3-10-86 of the Administrative Code, the director shall make a second inspection after the time deemed necessary to remedy the violation, which shall not be less than three days. The director need not make a second inspection when the violation constitutes a clear and present danger to the public health requiring immediate license action under paragraph (C) of rule 901:3-10-63 of the Administrative Code. If the director determines that there has been a violation of the same requirement of rules 901:3-10-68 to 901:3-10-86 of the Administrative Code on the second inspection, the director shall initiate proceedings for license suspension or revocation in accordance with divisions (c) and (d) of section 3717.67 of the Revised Code or may institute other appropriate legal proceedings.

(B) One copy of the inspection report shall be handed to the operator or other responsible person or shall be posted in a conspicuous place on an inside wall of the establishment. The inspection report shall not be defaced and shall be made available to the director upon request. An identical copy of the inspection report shall be filed with the records of the director.

(C) Every milk processor shall permit access of duly authorized inspectors to all parts of his or her establishment or facilities to determine compliance with the provisions of rules 901:3-10-60 to 901:3-10-86 of the Administrative Code. A milk processor shall furnish the director, upon request, for official use only, a true statement of the actual quantities of milk, milk products, whey, condensed, and dry milk products of each grade purchased and sold, a list of all sources of the milk, milk products, whey, condensed, and dry milk products, and records of inspections, tests, and pasteurization time and temperature.

(D) No person shall knowingly use to his or her advantage or reveal to any unauthorized person any information which is entitled to protection as a trade secret and which was obtained under the provisions of rules 901:3-10-60 to 901:3-10-86 of the Administrative Code.

901:3-10-66 Examination of whey, condensed, and dry milk products.

(A) The director shall collect and examine at least one sample of raw milk for pasteurization after receipt of the milk by the milk condensing or drying plant and before pasteurization, and at least one sample of each whey, condensed, and dry milk product being manufactured during each month. The director may take and examine samples of milk products and whey resulting from processing for drying as often as the director may deem necessary. If a whey, condensed, or dry milk product is not produced on a year-round basis, at least five samples of the product shall be taken within a continuous production period.

(B) Examinations and tests to detect adulterants or misbranding prohibited by rule 901:3-10-62 of the Administrative Code and to determine compliance with the standards of identity prescribed by this chapter of the Administrative Code shall be conducted as the director shall require.

(C) Whenever a phosphatase test is positive, the cause shall be determined by the director. The processor shall correct the violation and shall not offer for sale any whey, condensed, or dry milk product involved.

(D) Whenever a drug or pesticide residue test shows grade A raw milk for pasteurization or a whey, condensed, or dry milk product to contain drug residues in excess of the level specified in rule 901:3-10-67 of the Administrative Code or an adulterant prohibited by rule 901:3-10-62 of the Administrative Code, the milk processor shall stop its sale or use for human consumption. The raw milk, whey, condensed, or dry milk product shall not be sold or used for human consumption until a subsequent sample or samples, collected by the director and analyzed in an official laboratory, show it to be in compliance with the standard or standards previously violated.

(E) Drug residue monitoring, surveillance, reporting, traceback, disposition of milk containing drug residues, and sale of milk containing drug residues shall be conducted in the following manner:

(1) The milk processor shall:

(a) Screen all bulk milk pickup tanker loads of raw milk for beta lactam drug residues;

(b) Screen for other drug residues, as specified by the director, by employing a random sampling program on bulk milk pickup tanker raw milk. The random bulk milk pickup tanker raw milk sampling program shall represent and include during any consecutive six months, at least four samples collected in at least four separate months. Samples collected under this random sampling program shall be analyzed as specified by the director.

(c) Complete the bulk milk pickup tanker raw milk testing prior to processing the milk;

(d) Retain or deliver, as directed by the director, bulk milk pickup tanker raw milk samples found by the milk processor to be positive for drug residues;

(e) Record all sample results required by paragraph (E) of this rule on forms satisfactory to the director and retain such records for a period of six months;

(f) Immediately notify the milk hauler, and the director of the results of a screening analyses as required by paragraph (E) (1) (a) of this rule when a bulk milk pickup tanker load of raw milk is found to be positive for drug residues;

(g) Immediately notify the director of the ultimate disposition of the bulk milk pickup tanker load of raw milk, when the ultimate disposition is performed by the milk processor;

(h) When a bulk milk pickup tanker load of raw milk is found to be positive for drug residues, have the milk producer samples, collected under paragraph (A) of rule 901:3-10-07 of the Administrative Code individually tested to determine the violative milk producer, or milk producers of origin, using a laboratory, and methodology acceptable to the director; and

(I) Immediately notify the director and milk hauler of all positive test results of the milk producer samples tested in paragraph (E) (1) (h) of this rule.

(2) The milk hauler shall:

(a) Not transport raw milk from a milk producer's dairy farm found violative under paragraph (E) (1) (h) of this rule, until such time that subsequent analyses of the milk producer's raw milk is no longer positive for drug residue; and

(b) Immediately notify the director and the milk processor making notification in paragraph (E) (1) (f) of this rule of the ultimate disposition of the raw milk, if the ultimate disposition is not performed by the milk processor.

(3) The milk producer, upon being notified of a positive drug residue shall not sell or offer for sale raw milk, until such time that subsequent analysis of the milk producer's raw milk is no longer positive for drug residues. This analysis shall be acceptable to the director.

(F) Whenever two of the last four consecutive bacterial counts, coliform determinations, or cooling temperatures, taken on separate days, exceed the relevant standard established in rule 901:3-10-67 of the Administrative Code for a milk processor's milk, milk products, whey, condensed, or dry milk products, the director shall send a written notice thereof to the milk processor. This notice shall be in effect as long as two of the last four consecutive samples exceed the standard cited in the notice. The director shall analyze an additional sample that was collected within twenty-one days of the sending of the notice but not before the lapse of three days. The director shall suspend the license immediately, in accordance with divisions (C) and (D) of section 3717.67 of the Revised Code, whenever the standard is violated by three of the last five bacterial counts, coliform determinations, or cooling temperatures.

(G) Pasteurized milk, milk product, whey, condensed, and dry milk product samples shall be analyzed at an official laboratory. This laboratory shall conduct all sampling procedures and required laboratory examinations in substantial compliance with the "Standard Methods for the Examination of Dairy Products," as amended, of the "American Public Health Association" and with the "Official Methods of Analysis of the Association of Official Analytical Chemists," as amended. The tests and procedures shall be those specified therein or any other tests and procedures which have been approved by the director as bring equally accurate, precise, and practical.

(H) The director shall send written notification of tests which are approved for the examination of milk and milk products within thirty days of the effective date of this rule to:

(1) Milk sanitation board members;

(2) Official laboratories;

(3) Officially designated laboratories;

(4) All Ohio milk processors including receiving stations and transfer stations;

(5) Milk marketing organizations; and,

(6) Statewide trade organizations.

Thereafter, notification shall be sent whenever the list of approved tests is changed or modified.

901:3-10-67 Standards for milk, milk products, whey, condensed, and dry milk products.

(A) All raw milk for pasteurization, raw milk products, whey, condensed, and dry milk products shall be processed, pasteurized, and manufactured in accordance with the sanitation requirements of rules 901:3-10-68 to 901:3-10-86 of the Administrative Code and the following chemical, physical, bacteriological, and temperature standards:

Chemical physical, bacteriological, and temperature standards

Grade A raw milk for pasteurization: Temperature: Cooled to 45øF (7øC) or less within two hours after milking, provided that the blend temperature after the first and subsequent milkings does not exceed 50øF (10øC).

Bacterial Limit: Not to exceed 300,000 per ml. as commingle milk prior to pasteurization.

Drugs: No zone greater than or equal to 16mm. with the Bacillus stearothermophilus disc assay method when approved in paragraph (J) of rule 901:3-10-07 of the Administrative Code. No positive results on drug residue detection methods specified in or approved under paragraph (J) of rule 901:3-10-07 of the

Administrative Code.

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Grade A pasteurized: Temperature: Cooled to 45øF (7øC) or less and maintained thereat unless drying is commenced immediately after condensing.

Bacterial Limit: Not to exceed 30,000 per gram.

Coliform Limit: Not to exceed 10 per gram.

Drugs: No zone greater than or equal to 16mm. with the Bacillus stearothermophilus disc assay method when approved under paragraph (G) of rule 901:3-10-66 of the Administrative Code.

Phosphatase: Less than 1 microgram per ml. by the Scharer rapid method of OR equivalent.

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Grade A nonfat dry milk:

Not more than:

Butterfat- 1.50 per cent; Moisture- 4.00 per cent; Titratable acidity- 0.15 per cent; Solubility index except for U.S. high heat, 2.00 per ml.- 1.25 per ml.,

Bacterial Limit: 30,000 per gram

Coliform Limit: 10 per gram

Scorched particles disc B: 15.0 per gram

Drugs: No zone greater than or equal to 16mm. with the Bacillus stearothermophilus disc assay method when approved under paragraph (G) of rule 901:3-10-66 of the Administrative Code.

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Grade A whey for condensing:

Temperature: Maintained at a temperature of 45øF (7øC) or less or 145øF (63øC) or greater except that acid whey with a titratable acidity of 0.40 per cent or above or a pH of 4.6 or below may be maintained at a temperature of 46øF (8øC) to 144øF (62øC) if the conditions of rule 901:3-10-79 of the Administrative Code have been met.

Drugs: No zone greater than or equal to 16mm. with the Bacillus stearothermophilus disc assay method when approved under paragraph (G) of rule 901:3-10-66 of the Administrative Code.

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Grade A pasteurized condensed whey:

Temperature: Cooled to 45øF (7øC) or less during crystallization within 18 hours of condensing.

Bacterial Limit: Not to exceed 30,000 per gram.

Coliform Limit: Not to exceed 10 per gram.

Drugs: No zone greater than or equal to 16mm. with the Bacillus stearothermophilus disc assay method when approved under paragraph (G) of rule 901:3-10-66 of the Administrative Code.

Phosphatase: Less than 1 microgram per ml. by the Scharer rapid method or equivalent.

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Grade A dry whey:

Bacterial Limit: Not to exceed 30,000 per gram.

Coliform: Not to exceed 10 per gram.

Drugs: No zone greater than or equal to 16mm. with the Bacillus stearothermophilus disc assay method when approved under paragraph (G) of rule 901:3-10-66 of the Administrative Code.

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(B) No process or manipulation other than pasteurization, processing methods integral therewith, and appropriate refrigeration shall be applied to milk, milk products, or whey for the purpose of removing or deactivating microorganisms.

(C) Whey, condensed and dry milk products shall be made only from grade A milk, grade A milk products, or grade A whey.

(D) Grade A whey used in the manufacture of grade A condensed whey and grade A dry whey shall be made from cottage cheese or cheese that is made from grade A raw milk for pasteurization produced in accordance with sections 3717.61 to 3717.69 of the Revised Code and rules 901:3-10-01 to 901:3-10-59 of the Administrative Code. The grade A whey shall meet one of the following conditions:

(1) The whey was produced in a milk plant licensed under sections 3717.61 to 3717.69 of the Revised Code and rules 901:3-10-01 to 901:3-10-59 of the Administrative Code; or

(2) The whey was produced in a cheese plant that complies with rules 901:3-10-31 to 901:3-10-45, 901:3-10-47, 901:3-10-50 to 901:310-52 of the Administrative Code and was made from cheese made from grade A raw milk for pasteurization that meets one of the following conditions:

(A) The raw milk was pasteurized before use in accordance with rule of the Administrative Code; or

(B) The raw milk was heat-treated to a temperature of at least one hundred forty-seven degrees Fahrenheit (sixty-four degrees Celsius) and held continuously at that temperature for at least twenty-one seconds or to at least one hundred fifty-three degrees Fahrenheit (sixty-eight degrees Celsius) and held continuously at that temperature for at least fifteen seconds in equipment meeting the pasteurization requirements of rule 901:3-10-46 of the Administrative Code.

The requirements of paragraphs (D) (2) (a) and (D) (2) (b) of this rule do not prohibit using any other heat-treatment process that has been recognized to be equally effective in destroying staphylococcal organisms and that is approved by the director.

901:3-10-68 Sanitation requirements for milk tank truck cleaning and sanitizing facilities.

Facilities operated by a licensee for cleaning and sanitizing tank trucks hauling milk, milk products, whey, or condensed milk or milk products shall comply with paragraphs (A) and (D) of rule 901:3-10-69, rules 901:3-10-70 to 901:3-10-75, paragraph (B) of rule 901:3-10-76, and rules 901:3-10-77, 901:3-10-81, and 901:3-10-83 of the Administrative Code, and, as climatic and operating conditions require, the applicable provisions of paragraphs (B) and (C) of rule 901:3-10-69 of the Administrative Code. In every case, overhead protection shall be provided.

901:3-10-69 Milk plant construction.

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

(B) Walls and ceilings of rooms in milk plants in which milk, milk products, whey, condensed, or dry milk products are handled, processed, packaged, or stored; or in which containers, utensils, and equipment are washed; shall have a smooth, washable, light-colored surface that is in good repair.

(C) The milk processor shall maintain effective means to prevent the access of flies and rodents into the milk plant. All openings to the outside shall have solid doors or glazed windows which shall be closed during dusty weather.

(D) All rooms in which milk, milk products, whey, condensed, or dry milk products are processed, handled, stored, or packaged or in which containers, equipment, and utensils are washed shall be well lighted and well ventilated.

(E) The milk processor shall provide separate rooms for the following operations if conducted at the milk plant:

(1) The pasteurizing, processing, cooling, condensing, and drying of milk, milk products, whey, or condensed milk or milk products;

(2) The packaging of dry milk products and dry whey;

(3) The cleaning of milk cans, containers, and dry milk product and dry whey containers;

(4) The cleaning and sanitizing of tanks and appurtenances of milk tank trucks, the facilities of which comply with rule 901:3-10-68 of the Administrative Code; and

(5) The receiving of cans of milk and milk products.

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

901:3-10-70 Toilet; sewage disposal: water supply.

(A) The milk processor shall provide, in each milk Plant, toilet facilities conforming with the Applicable requirements of the Ohio basic building code as adopted by the Board of Building Standards under Authority of Sections 3781.10 of the Revised Code. Toilet rooms shall not open Directly into any room in which milk, milk products, whey, condensed, and dry milk products are processed. Toilet rooms shall be completely Enclosed and shall have tight-fitting, self-closing doors. Dressing rooms, toilet rooms, and fixtures shall be kept clean, in good repair, and shall be well ventilated and well lighted. Sewage and other liquid wastes shall be disposed of in a sanitary manner.

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

901:3-10-71 Hand-washing facilities.

The milk processor shall provide hand-washing facilities, including hot and cold and/or warm running water, soap, and individual sanitary towels or other approved hand-drying devices. The milk processor shall keep hand-washing facilities clean and in good repair.

901:3-10-72 Milk plant cleanliness.

The milk processor shall keep all rooms in which milk, milk products, whey, condensed, and dry milk products are handled, processed, or stored; or in which containers, utensils, or equipment are washed or stored; clean, neat, and free of evidence of insects and rodents. The milk processor shall permit only equipment directly related to processing operations or to handling of containers, utensils, and equipment in the pasteurizing, processing, cooling, packaging, and bulk milk or whey storage rooms.

901:3-10-73 Sanitary piping.

All sanitary piping, fittings, and connections which are exposed to milk, milk products, whey, condensed, and dry milk products; or from which liquids may drip, drain, or be drawn into milk, milk products, whey, condensed, and dry milk products shall consist of smooth, impervious, corrosion-resistant, nontoxic, easily cleanable material. The milk processor shall maintain all piping in good repair. Milk, milk products, whey, condensed, and condensed milk products shall be conducted from one piece of equipment to another only through sanitary piping.

901:3-10-74 Construction and repair of containers and equipment.

The milk processor shall not use multi-use containers and equipment with which milk, milk products, whey, condensed, and dry milk products come into contact unless they are made of smooth, impervious, corrosion-resistant, nontoxic materials. these containers and equipment shall be constructed for ease of cleaning and shall be kept in good repair. The milk processor shall not use single-service containers, closures, gaskets, and other articles with which milk, milk products, whey, condensed, and dry milk products come in contact unless they are nontoxic and have been manufactured, packaged, transported, and handled in a sanitary manner. The milk processor shall not reuse articles intended for single-service use.

901:3-10-75 Cleaning and sanitizing of containers and equipment.

(A) The milk processor shall clean and shall sanitize, effectively after each use, the product-contact surfaces of all multi-use containers, utensils, and equipment used in the processing, drying, packaging, storing, handling, and transporting of milk, milk products, whey, condensed, and dry milk products. the milk processor shall clean and shall sanitize or purge cloth-collector systems used on dryers at intervals and by methods approved by the director. storage tanks shall be emptied at least once every seventy-two hours after filling. Storage tanks, used to store raw milk or whey longer than twenty-four hours, and silo tanks, used to store raw milk or whey, that were installed after July 1, 1980 shall be equipped with a seven-day temperature recording device.

(B) The milk processor shall not remove milk, Milk products, whey, condensed milk or milk products from a milk tank truck which does not bear a tag showing the date, time, place, and signature of the person who cleaned and sanitized the milk tank truck. the milk hauler shall not place milk, milk products, whey, condensed milk or milk products into a milk tank truck which does not bear a tag showing the date, time, place, and signature of the person who cleaned and sanitized the milk tank truck.

901:3-10-76 Storage of cleaned containers and equipment: and storage of single-service containers, utensils, and materials.

(A) After cleaning, the milk processor shall transport and store all multi-use milk, milk product, whey, condensed, and dry milk product containers, utensils, and equipment in such a manner to assure complete drainage and protection from contamination before use.

(B) Single-service parchment paper, containers, gaskets, liners, bags, and other single-service articles used in contact with milk, milk products, whey, condensed, and dry milk products by the milk processor shall be clean, purchased in, and stored in sanitary wrappings or cartons; shall be kept therein; and shall be stored in a clean, dry place until used. the milk processor shall handle the articles in a sanitary manner.

901:3-10-77 Protection from contamination.

Milk processors shall locate and operate milk plants, equipment, and facilities in such a manner as to prevent any contamination of milk, milk products, whey, condensed, dry milk products, ingredients, equipment, containers, and utensils. The milk processor shall discard all milk, milk products, whey, condensed, dry milk products, or ingredients that have been spilled, have overflowed, or have leaked out of their container. The milk processor may process or handle products other than grade a milk, grade A milk products, whey, condensed, and dry milk products in a milk plant if the non-grade A products are processed and handled in such a manner as to preclude contamination of, or commingling with, the grade A products. The milk processor shall store, handle, and use poisonous or toxic materials in such a manner as to preclude the contamination of milk, milk products, whey, condensed, dry milk products, ingredients, or the product-contact surfaces of any equipment, containers, or utensils.

901:3-10-78 Pasteurization.

(A) The milk processor shall perform pasteurization in accordance with paragraph (Q) of rule 901:3-10-60 of the Administrative Code. In all cases, raw milk, raw milk products, or whey shall be pasteurized before the raw milk, raw milk products, or whey enter the evaporator or condensing equipment. the raw milk, raw milk products, or whey shall be pasteurized in the plant in which the evaporation or condensing is done.

(B) All condensed milk or milk products transported to a drying plant shall be repasteurized at the plant at which it is dried.

(C) Grade A condensed whey may be transported to a separate drying plant for drying without repasteurization if the following conditions are met:

(1) The condensed whey contains at least forty percent total solids and has been crystallized partially by cooling;

(2) The condensed, partially crystallized whey is cooled and maintained at forty-five degrees Fahrenheit (seven degrees Celsius) or less;

(3) Milk transport tanks used to transport the condensed, partially crystallized whey are washed and sanitized immediately prior to filling and are sealed after filling until unloading; and

(4) The milk processor provides separate pumps and pipelines which are used only for unloading the condensed, partially crystallized whey. the milk processor shall clean and sanitize these pumps and pipelines as a separate cleaning circuit.

901:3-10-79 Cooling, packaging, and container filling.

(A) The milk processor shall equip every room or tank In which milk, milk products, whey, condensed milk And milk products are stored with an accurate thermometer. The milk processor shall comply with the following temperature requirements:

(1) All raw milk and milk products shall be maintained at forty-five degrees Fahrenheit (seven degrees Celsius) or less until processed;

(2) All whey for condensing shall be maintained at a temperature of forty-five degrees Fahrenheit (seven degrees Celsius) or less or one hundred forty-five degrees Fahrenheit (sixty-three degrees Celsius) or greater until processed, except that acid whey for condensing with a titratable acidity of 0.40 per cent or above, or a pH of 4.6 or below, may be maintained at a temperature of forty-six degrees Fahrenheit (eight degrees Celsius) to one hundred forty-four degrees Fahrenheit (sixty-two degrees Celsius), if all of the following conditions are met:

(a) Each shipping statement contains the titratable acidity or pH and the temperature of the whey prior to shipment to the milk processor;

(b) A titratable acidity or pH and temperature of the whey are checked and recorded upon arrival of the shipment at the receiving plant prior to unloading; and

(c) The processor retains on file the shipping statements and records of titratable acidity, pH, and temperature for a period of at least six months.

The milk processor shall not accept shipments of acid whey for condensing which fall to meet the requirements of this paragraph;

(3) All pasteurized milk, pasteurized milk products, pasteurized whey, and pasteurized condensed milk and milk products shall be cooled immediately in approved equipment to a temperature of forty-five degrees Fahrenheit (seven degrees Celsius) or less, unless drying is commenced immediately after condensing;

(4) If surge tanks or balance tanks are used between the evaporator and the drier, the tanks shall hold the product at a temperature of one hundred fifty degrees Fahrenheit (sixty-six degrees Celsius) or more or shall be emptied completely and cleaned after no more than four hours of operation;

(5) All condensed whey shall be cooled during the crystallization process to forty-five degrees Fahrenheit (seven degrees Celsius) or less within eighteen hours of condensing; and

(6) All pasteurized milk, pasteurized milk products, pasteurized whey, and pasteurized condensed milk and milk products shall be stored at a temperature of forty-five degrees Fahrenheit (seven degrees Celsius) or less until further processed.

(B) The milk processor shall fill whey, condensed, and dry milk product containers only by using mechanical equipment and methods that preclude contamination. The milk processor shall package dry milk products only in new containers that protect the contents from contamination and, after packaging, shall store the containers in a sanitary manner. Whey, condensed, and dry milk products may be transported in sealed containers in a sanitary manner from one plant to another for further processing or packaging. The milk processor shall store condensed and dry milk product packaging containers in a sanitary manner.

901:3-10-80 Container closure, sealing, and storage.

The milk processor shall close or seal all condensed and dry milk product containers in a sanitary manner by methods that preclude product contamination.

901:3-10-81 Personnel; cleanliness.

(A) Hands shall be thoroughly washed before commencing plant functions and as often as may be required to remove soil and contamination. No employee shall resume work after visiting the toilet room without thoroughly washing his hands. All persons, while engaged in the processing, pasteurization, handling, storage, or transportation of milk, milk products, whey, condensed and dry milk products, containers, equipment, and utensils, shall wear clean outer garments.

(B) The use of tobacco products is prohibited in all rooms in which milk, milk products, whey, condensed, and dry milk products are processed, handled, or stored; or in which milk containers, equipment, and utensils are washed.

(C) Adequate head coverings shall be worn by all persons in rooms in which milk, milk products, whey, condensed, and dry milk products are processed, handled, or stored; or in which milk containers, equipment, and utensils are washed.

901:3-10-82 Vehicles.

The milk processor shall not use a vehicle for transporting milk, milk products, whey, condensed milk or milk products unless it is constructed and operated in such a manner that the milk, milk products, whey, condensed milk or milk products are maintained at forty-five degrees Fahrenheit (seven degrees Celsius) or less and are protected from sun, freezing, and contamination. The milk processor shall not use milk tank cars, milk tank trucks, or portable shipping bins to transport or contain any substances that may be toxic or harmful to humans. The milk processor shall transport dry whey and dry milk products in a sanitary manner.

901:3-10-83 Surroundings.

The milk processor shall keep milk plant surroundings neat, clean, and free from conditions which might attract or harbor flies, other insects, or rodents, or that otherwise constitute a nuisance.

901:3-10-84 Reciprocity.

(A) Whey, condensed, and dry milk products processed by processors licensed by the director may be sold in all political subdivisions of the state.

(B) Whey, condensed, and dry milk products entering Ohio may be sold in all political subdivisions in Ohio, if:

(1) They are produced, transported, processed, and otherwise handled under rules substantially equivalent to rules 901:3-10-60 to 901:3-10-86 of the Administrative Code;

(2) The shipper has been awarded a milk sanitation compliance and enforcement rating in the "Sanitation Compliance and Enforcement Ratings of Interstate Milk Shippers," as amended, that is acceptable to the director;

(3) The responsible governmental agency in the state of origin extends the same rights and privileges to milk plants licensed in Ohio; and

(4) The milk plant in which the whey, condensed, or dry milk products were processed is licensed by the director.

901:3-10-85 Submission of plans for alterations or new condensing plants and drying plants.

Applicants and licensees shall submit two complete sets of properly prepared plans to the director for written approval before work is begun for all new or extensively altered milk plants that will be used in operations licensed under sections 3717.61 to 3717.69 of the Revised Code. The director will review plans promptly and return one complete set of approved plans or recommend changes in writing.

901:3-10-86 Personnel health: procedure when infection or high risk of infection is discovered.

(A) No persons affected with any disease capable of being transmitted to others through the contamination of food shall work at a milk plant in any capacity which brings them into direct contact with finished products, such as pasteurized milk, pasteurized milk products, pasteurized whey, pasteurized condensed milk, pasteurized condensed milk products, and dry milk products, or which brings them into direct contact with associated pasteurized milk product contact surfaces. Milk processors who have received reports, under this rule, from employees who have handled pasteurized milk, pasteurized milk products, pasteurized whey, pasteurized condensed milk, pasteurized condensed milk products, and dry milk products or associated product contact surfaces shall immediately report these facts to the director.

(B) When a person who may have handled pasteurized milk, pasteurized milk products, pasteurized whey, pasteurized condensed milk, pasteurized condensed milk products, and dry milk products or pasteurized milk product contact surfaces meets one or more of the conditions specified in paragraph (a) of this rule, the director is authorized to require any or all of the following measures:

(1) The immediate restricting of that person from duties which require handling finished product, such as pasteurized milk, pasteurized milk products, pasteurized whey, pasteurized condensed milk, pasteurized condensed milk products, and dry milk products; or the handling or related product contact surfaces. This restriction may be lifted after an appropriate medical clearance or cessation of symptoms or both, according to the following criteria:

HEALTH STATUS

Is diagnosed with an illness due to Hepatitis A Virus, Salmonella typhi, Shigella species, Norwalk and Norwalk-like Viruses, Staphylococcus aureus, Streptococcus pyogenes, Escherichia coli 0157:h7, enterohemorrhagic Escherichia coli, enterotoxlgenic Escherichia coli, Campylobacter jejuni, Entamoeba histolytica, Giardia lamblia, Non-typhoidal Salmonella, Rotovirus, Taenia, solium, Yersinia enterocolitica, Vibrio cholerae 01 or other infectious or communicable disease that has been declared by the Secretary of Health and Human Services to be transmissible to others through the handling of food or has been clearly shown to be so based upon verifiable epidemiological data.

Restrictions lifted by medical clearance.

Meeting a high risk scenario as specified in rule 901:3-10-86, paragraph (A). Restrictions lifted when symptoms cease or medical documentation is provided that infection does not exist.

Asymptomatic, but stools positive for Salmonella typhi, Shigella, or Escherichia coli 0157:h7. Restrictions lifted by medical clearance.

Past illness from Salmonella typhi, Shigella, Escherichia coli 0157:h7 or other human pathogens for which humans have been determined to be carriers. Restrictions lifted by medical clearance.

In the case of diagnosed or suspected Hepatitis A, onset of jaundice within the last seven days. Restrictions lifted by medical clearance

In the case of diagnosed or suspected Hepatitis A, onset of jaundice occurred more than seven days Restrictions lifted by medical clearance or jaundice ceases.

(2) The immediate exclusion of the affected dairy products from distribution and use when medically appropriate.

(3) The immediate requesting of medical and bacteriological examination of the person at risk

FROZEN DESSERT RULES

Effective September 20, 1999

TABLE OF CONTENTS

901:3-14-01 Definitions
901:3-14-02 Standard of Identity
901:3-14-03 Frozen Dessert Labeling
901:3-14-04 Chemical, Bacteriological and Temperature Standards
901:3-14-05 Pasteurization
901:3-14-06 Hazard Analysis and Hazard Analysis Critical Control Point Plan
901:3-14-07 Corrective Actions
901:3-14-08 Verification
901:3-14-09 Records
901:3-14-10 Sanitation Control Procedures
901:3-14-11 Training

901:3-14-01 DEFINITIONS.

(A) "Critical Limit" means the maximum or minimum value to which a physical, biological or chemical parameter must be held to prevent, eliminate or reduce to an acceptable level the occurrence of a food safety hazard.

(B) "Critical Control Point" means a point; step or procedure in food processing at which appropriate measures may be taken to prevent, eliminate or reduce to acceptable levels a food safety hazard.

(C) "Drug" means drug as defined in division (A)(6) of section 3715.01 of the Revised Code.

(D) "Food Safety Hazard" means any biological, chemical, or physical property that may cause food to be unsafe for human consumption.

(E) "Hazard Analysis Critical Control Point" and its acronym "HACCP" mean a systematic approach to the identification of food safety hazards that are reasonably likely to occur in conjunction with the manufacture of frozen dessert and the measures necessary to prevent or correct the occurrence.

(F) "Hazard Analysis Critical Control Point Plan" and "HACCP plan" means a detailed written program implementing the HACCP findings.

(G) "Reasonably Likely To Occur" when used in conjunction with "food safety hazard" means a food safety hazard which a prudent frozen dessert manufacturer would foresee as having an appreciable risk of happening unless appropriate measures are taken.

901:3-14-02 Standard of Identity.

Frozen dessert means those articles of food denominated in 21 C.F.R. 135 Subpart B and shall conform to the descriptions contained therein.

901:3-14-03 Frozen Dessert Labeling.

In addition to the labeling requirements of Revised Code sections 917.11 and 3715.02; when a frozen dessert is made from goat milk the word "goat" shall proceed the name of the product on the label.

901:3-14-04 Chemical, Bacteriological and Temperature Standards

(A) No raw milk or milk products intended for use in the manufacture of frozen dessert shall be accepted by the frozen dessert manufacturer unless the milk and milk products meet the following standards at the time of delivery:

Temperature 45 degrees F (7 degrees C) or less.

Bacterial limits not to exceed 300,000 per ml.

Drugs no positive results on drug residue detection methods specified or approved under paragraph (J) of rule 901:3-10-07 of the Administrative Code which have been found to be acceptable for use with raw milk.

These standards shall be maintained by the frozen dessert manufacturer through pasteurization.

(B) Pasteurized frozen dessert shall meet the following standards:

Bacterial limits not to exceed 30,000 per ml. These bacterial limits shall not apply to yogurt containing viable organisms.

Coliform not to exceed 10 per ml. In the case of transport tank shipments, not to exceed 100 per ml.

Phosphatase less than one microgram per ml. by the "Scharer Rapid Method." Less than 500 millinuits per L. By the fluorometric or Charm APL methods.

Drugs no positive results on drug residue detection methods specified or approved under paragraph (J) of rule 901:3-10-07 of the Administrative Code which have been found to be acceptable for use with pasteurized milk products.

After pasteurization the frozen dessert shall be cooled to forty-five degrees Fahrenheit (seven degrees C) or less and maintained at that temperature and within the foregoing standards while the frozen dessert is in the control of the frozen dessert manufacturer.

901:3-14-05 Pasteurization.

(A) Frozen desserts shall be pasteurized by holding the mixture continuously at or above the following temperatures for not less than the corresponding time:

TEMPERATURE TIME

155 degrees F (69 degrees C) 30 minutes

175 degrees F (80 degrees C) 25 seconds

180 degrees F (83 degrees C) 15 seconds

191 degrees F (89 degrees C) 1.0 second

194 degrees F (90 degrees C) 0.5 second

201 degrees F (94 degrees C) 0.1 second

204 degrees F (96 degrees C) 0.05 second

212 degrees F (100 degrees C) 0.01 second

The equipment used and the operation of the equipment shall comply with part II, section 7, and items 16p(A), 16p(B), 16p(D) and 16p(E) of "the Grade"A" Pasteurized Milk Ordinance."

(B) Dairy products, egg products, cocoa products, emulsifiers, stabilizers, vitamins, liquid sweeteners and dry sugars shall be added to the frozen dessert before it is pasteurized. These ingredients, except for dairy products may be added after pasteurization only if:

(1) The processor demonstrates to the director's satisfaction that the addition of these ingredients prior to pasteurization will negatively impact the ability to produce the product or the quality of the product; and

(2) Records are maintained to the director’s satisfaction showing the science proving the ingredients which are added after pasteurization are safe and suitable; and

(3) The ingredients are safely and sanitarily added to the frozen dessert product.

(C) Flavoring and coloring ingredients may be added after pasteurization when:

(1) The ingredient has been subjected to a prior heat treatment sufficient to destroy pathogenic microorganisms; or

(2) The ingredient has 0.85 per cent water activity or less when the water activity is calculated by dividing the water vapor pressure of the ingredient by the vapor pressure of pure water when at the same temperature as the ingredient; or

(3) The ingredient has a pH less than 4.7; or

(4) The ingredients are roasted nuts, fruits and vegetables added at the freezer; or

(5) There is an alcohol content in the ingredient sufficient to assure that pathogenic microorganisms will not be transferred to the final product; or

(6) The ingredients consist of safe and suitable bacterial cultures; or

(7) The ingredients are subjected to any process acceptable to the director, which will assure that the ingredient is free of pathogenic microorganisms.

(D) Frozen desserts may be pasteurized at a milk plant other than the milk plant where it is packaged for retail sale provided it is transported to the packaging milk plant in a tote using a single service liner which complies with the following specifications:

(1) Totes used to transport frozen dessert mix shall be:

(a) constructed and managed to protect their contents from sun, freezing, and contamination;

(b) constructed for ease of cleaning;

(c) constructed of smooth, impervious, corrosion-resistant, nontoxic material;

(d) kept in good repair;

(e) kept clean; and

(f) constructed to be fully enclosed when in transport. Provided, totes of five gallon capacity or less are not required to be fully enclosed.

(2) The single service liner used to transport frozen dessert mix shall:

(a) be fabricated from material complying with 21 C.F.R. parts 175 through 178;

(b) be nontoxic;

(c) be free from deleterious substances;

(d) be free of coliform organisms; and

(e) have a residual bacteria count not to exceed fifty per container, when the rinse test is used, or not over fifty colonies per eight square inches (one per square centimeter) of product contact surface, when the swab test is used.

(3) No substance capable of contaminating the frozen dessert mix shall be transported with the product.

901:3-14-06 Hazard Analysis and Critical Control Point Plan.

(A) Every frozen dessert manufacturer shall conduct, or have conducted for it, an analysis to determine whether there are food safety hazards that are reasonably likely to occur in conjunction with the manufacturing of frozen dessert and to identify the critical control points and preventive measures that apply to control those hazards. The analysis shall include food safety hazards, which can occur both within and outside the processing plant environment, including food safety hazards that can occur before, during, and after processing.

(B) If the analysis done under paragraph (A) of this rule discloses one or more food safety hazards that are reasonably likely to occur the frozen dessert manufacturer shall create and implement a HACCP plan. (1) The HACCP plan shall be specific to:

(a) each location where frozen desserts are manufactured; and

(b) each kind of frozen dessert manufactured by the processor.

(2) The HACCP plan shall:

(a) list the food safety hazards that are reasonably likely to occur, as identified in accordance with paragraph (A) of this rule, and that thus must be controlled for each frozen dessert. Consideration should be given to whether any food safety hazards are reasonably likely to occur as a result of the following:

(I) natural toxins;

(II) microbiological contamination;

(III) chemical contamination;

(IV) pesticides;

(V) drug residues;

(VI) unapproved use of direct or indirect food or color additives; and

(VII) physical hazards.

(b) list the critical control points for each of the identified food safety hazards, including as appropriate:

(I) critical control points designed to control food safety hazards that could be introduced in the processing plant environment; and

(II) critical control points designed to control food safety hazards introduced outside the processing plant environment, including food safety hazards that occur before, during, and after processing.

(c) list the critical limits that must be met at each of the critical control points;

(d) list the procedures, and frequency thereof, that will be used to monitor each of the critical control points to ensure compliance with the critical limits;

(e) include any corrective action plans that have been developed in accordance with paragraph (B) of rule 901:3-14-07 of the administrative code;

(f) list the verification procedures, and frequency thereof, that the processor will use in accordance with paragraph (A) of rule 901:3-14-08 of the administrative code;

(g) provide for a record keeping system that documents the monitoring of the critical control points. The records shall contain the actual values and observations obtained during monitoring.

(C) Signing and dating the HACCP plan.

(1) The HACCP plan shall be signed and dated, either by the most responsible individual onsite at the manufactured milk processing facility or by a higher level official of the processor. This signature shall signify that the HACCP plan has been accepted for implementation by the firm.

(2) The HACCP plan shall be dated and signed:

(a) upon initial acceptance;

(b) upon any modification; and

(c) upon verification of the plan in accordance with paragraph (A)(1) of rule 901:3-14-08 of the Administrative Code.

(D) Every frozen dessert manufacturer required to create and implement a HACCP plan shall:

(1) For a currently licensed manufacturer; submit a copy of their HACCP plan to the director no later than one year and ninety days from the effective date of this rule; and

(2) For any manufacturer licensed after the effective date of this rule; submit a copy of their HACCP plan to the director with the application for the milk processor license.

(3) The director shall, within thirty days of receipt of the HACCP plan, either approve or disapprove the HACCP plan. The director shall disapprove the HACCP plan if it does not comply with the requirements of paragraphs (B) and (C) of this rule.

(4) If the director disapproves a HACCP plan he shall return the plan to the licensee with a statement of the changes necessary to bring the plan into compliance. The licensee shall have thirty days from its receipt of the plan to resubmit it to the director for reconsideration.

(5) The HACCP plan shall be implemented by the frozen dessert manufacturer immediately upon notice of approval of the plan by the director.

(E) A licensed frozen dessert manufacturer shall be exempt from the requirements of this rule if he requests an exemption in writing and all of the following apply:

(1) The frozen dessert manufacturer only manufactures frozen dessert mix for sale and no other frozen dessert;

(2) The frozen dessert manufacturer holds a processor license with a category designation of grade A fluid milk processor, grade A cultured milk processor or grade A condensed milk products processor;

(3) The equipment and facility used to manufacture frozen dessert mix is routinely inspected by the director and used in the processing of grade A dairy products;

(4) The temperature requirements for pasteurization in rule 901:3-14-05 of the Administrative Code are met;

(5) The frozen dessert manufacturer maintains the frozen dessert mix in compliance with the requirements of rule 901:3-14-04 of the Administrative Code; and

(6) The frozen dessert is manufactured in compliance with rules 901:3-14-01 to 901:3-14-11 of the Administrative Code.

901:3-14-07 Corrective Actions.

(A) Whenever a deviation from a critical limit occurs, a frozen dessert manufacturer shall take corrective action either by:

(1) Following a corrective action plan that is appropriate for the particular deviation, or

(2) Following the procedures in paragraph (C) of this rule.

(B) A frozen dessert manufacturer may develop written corrective action plans, which become part of their HACCP plans in accordance with paragraph (B)(2)(e) of rule 901:3-14-06 of the Administrative Rule, by which they predetermine the corrective actions that they will take whenever there is a deviation from a critical limit. A corrective action plan that is appropriate for a particular deviation is one that describes the steps to be taken and assigns responsibility for taking those steps, to ensure that:

(1) No product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation; and

(2) The cause of the deviation is corrected.

(C) When a deviation from a critical limit occurs and the frozen dessert manufacturer does not have a corrective action plan that is appropriate for that deviation, the manufacturer shall:

(1) Segregate and hold the affected product, at least until the requirements of paragraphs (C)(2) and (C)(3) of this rule are met;

(2) Perform or obtain a review to determine the acceptability of the affected product for distribution. The review shall be performed by an individual who is qualified in accordance with rule 901:3-14-11 of the Administrative Code;

(3) Take corrective action, when necessary, with respect to the affected product to ensure that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation;

(4) Take corrective action, when necessary, to correct the cause of the deviation;

Perform or obtain a timely reassessment to determine whether the HACCP plan needs to be modified to reduce the risk of recurrence of the deviation, and modify the HACCP plan as necessary.

(D) All corrective actions taken in accordance with this section shall be fully documented in records that are subject to verification in accordance with paragraph (A)(3)(b) of rule 901:3-14-08 of the Administrative Code and the record keeping requirements of rule 901:3-14-09 of the Administrative Code.

901:3-14-08 Verification.

(A) Every frozen dessert manufacturer shall verify that the HACCP plan is adequate to control food safety hazards that are reasonably likely to occur, and that the plan is being effectively implemented. Verification shall include, at a minimum:

(1) A reassessment of the adequacy of the HACCP plan whenever any changes occur that could affect the hazard analysis or alter the HACCP plan in any way or at least annually. Such changes may include changes in the following: raw materials or source of raw materials, product formulation, processing methods or systems, finished product distribution systems, or the intended use or consumers of the finished product. The HACCP plan shall be modified immediately whenever a reassessment reveals that the plan is no longer adequate to fully meet the requirements of paragraph (B) of rule 901:3-14-06 of the Administrative Code.

(2) Ongoing verification activities including:

(a) a review of any consumer complaints that have been received by the processor to determine whether they relate to the performance of critical control points or reveal the existence of unidentified critical control points;

(b) the calibration of process-monitoring instruments; and,

(c) the performing of periodic end product or in-process microbial testing.

(3) A review, including signing and dating, by a responsible individual of the records that document:

(a) the monitoring of critical control points. The purpose of this review shall be, at a minimum, to ensure that the records are complete and to verify that they document values that are within the critical limits. This review shall occur within one week of the day that the records are made;

(b) the taking of corrective actions. The purpose of this review shall be, at a minimum, to ensure that the records are complete and to verify that appropriate corrective actions were taken in accordance with rule 901:3-14-07 of the Administrative Code. This review shall occur within one week of the day that the records are made; and

(c) the calibrating of any process control instruments used at critical control points and the performing of any periodic end product or in-process testing that is part of the frozen dessert manufacturer's verification activities. The purpose of these reviews shall be, at a minimum, to ensure that the records are complete, and that these activities occurred in accordance with the frozen dessert manufacturer's written procedures. These reviews shall occur within a reasonable time after the records are made.

(B) Frozen dessert manufacturers shall immediately follow the procedures in rule 901:3-14-07 of the Administrative Code whenever any verification procedure, including the review of a consumer complaint, reveals the need to take a corrective action.

Whenever a frozen dessert manufacturer does not have a HACCP plan because a hazard analysis has revealed no food safety hazards that are reasonably likely to occur, the frozen dessert manufacturer shall reassess the adequacy of that hazard analysis whenever there are any changes that could reasonably affect whether a food safety hazard now exists. Such changes may include, but are not limited to changes in: raw materials or source of raw materials, product formulation, processing methods or systems, finished product distribution systems, or the intended use or consumers of the finished product.

The calibration of process-monitoring instruments, and the performing of any periodic end-product and in-process testing, in accordance with paragraphs (A)(2)(b) and (A)(2)(c) of this rule shall be documented in records that are subject to the record keeping requirements of rule 901:3-14-09 of the Administrative Code.

901:3-14-09 Records.

(A) Each frozen dessert manufacturer shall maintain sanitation control records that document the verification and corrections prescribed by rules 901:3-14-07 and 901:3-14-08 of the Administrative Code. These records shall also include:

(1) The name and location of the processor;

(2) The date and time of the activity that the record reflects;

(3) The signature or initials of the person performing the operation; and

(4) Where appropriate, the identity of the product and the production code, if any. Processing and other information shall be entered on records at the time that it is observed.

(B) Record retention.

(1) All records required by this part shall be retained at the manufacture milk processing facility for at least one years after the date they were prepared.

(2) Records that relate to the general adequacy of equipment or processes being used by a frozen dessert manufacturer, including the results of scientific studies and evaluations, shall be retained at the processing facility for at least one years after their applicability to the product being produced at the facility.

(C) The records may be maintained on computers if appropriate controls are implemented to ensure the integrity of the electronic data and signatures.

901:3-14-10 Sanitation Control Procedures.

(A) Each frozen dessert manufacturer shall have and implement a written sanitation standard operating procedure (SSOP) that is specific to each location where frozen desserts are processed. The processor shall correct in a timely manner, those conditions and practices that are not met. The SSOP shall detail the practices and procedures implemented to ensure sanitary conditions and practices are maintained in each of the following areas:

(1) Safety of the water that comes into contact with food or food contact surfaces, or is used in the manufacture of ice;

(2) Condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments;

(3) Prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to pasteurized product;

(4) Maintenance of hand washing, hand sanitizing, and toilet facilities;

(5) Protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants;

(6) Proper labeling, storage, and use of toxic compounds;

(7) Control of employee health conditions that could result in the microbiological contamination of food, food packaging materials, and food contact surfaces; and

(8) Exclusion of pests from the milk processing facility.

(B) The SSOP shall be implemented at the same time as the HACCP plan.

901:3-14-11 Training.

(A) No person shall be qualified either through completion of a training course or through work experience to apply HACCP principles unless the person can establish to the satisfaction of the director of agriculture or his representative the ability to:

(1) Develop a HACCP plan or adapt a generic HACCP plan that meets the requirements of paragraph (B) of rule 901:3-14-06 of the Administrative Code;

(2) Determine, in accordance with rule 901:3-14-07 of the Administrative Code, when a deviation from a critical limit occurs, whether or not the HACCP plan needs to be modified to reduce the risk of reoccurrence of the deviation, and modifying the plan as necessary;

(3) Implement the requirements of rule 901:3-14-08 of the Administrative Code by:

(a) verifying the adequacy of a HACCP plan;

(b) reassessing the adequacy of a HACCP plan; and,

Conducting a review of the records documenting a HACCP plan.

(B) A person may establish that they meet the requirements of paragraph (A)(1) through (A)(3) of this rule by:

(1) Submitting evidence of the successful completion of a formal training course in HACCP principles; or

(2) Submitting a resume of work experience and work product demonstrating their ability to perform the tasks listed in paragraphs (A)(1) through (A)(3) of this rule