Chapter 901:11-2 Ohio Manufacture Milk Rules
(A) "Cl.eaned-in-place" and its acronym "CIP" means the procedure by which sanitary pipelines or pieces of dairy equipment are mechanically cleaned in place by circulation.
(B) "Dairy farm" and "farm" means a place or premise where one or more lactating animals (cows, goats, sheep, water buffalo, or other hooved mammals) are kept for milking purposes and from which a part of all of the milk or milk products are provided, sold, or offered for sale to a manufacturing plant, receiving station, or transfer station.
(C) "Dairy plant" and "plant" means 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:
(1) Articles recognized in the official United States pharmacopoeia, official homeopathic pharmacopoeia of the United States, or official national formulary;
(2) Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals;
(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 (F)(1), (F)(2) or (F)(3) of this rule, but does not include devices or their components, parts or accessories.
(I) "Milk" means the lacteal secretion practically free of colostrum obtained by the complete milking of one or more lactating animals (cows, goats, sheep, water buffalo, or other hooved mammals). The milk shall only be used to manufacture dairy products, as defined in this rule, or recognized as non-standardized traditional products normally manufactured from a specific breed's 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 AOAC International (OMA)" 18th edition, Dr. William Horsitz, editor, published by AOAC International, Suite 500, 481 North Frederick Ave., Gaithersburg, Maryland 20877-2417 USA which can be found at http://www.aoac org/.
(M) "Producer" means the person who holds a license from the Ohio department of agriculture to produce milk for manufacturing purposes.
(N) "Standard Methods" means the "Standard Methods for the Examination of Dairy Products (SMEDP)," 17th edition, 2004, edited by H. Michael Wehr, PhD and Joseph F. Frank, PhD, American public health association, 800 I Street, N.W. Washington, DC 02001 which can be found at http://www.apha.org/.
(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 901:11-2-03 to 901:11-2-05 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:
(1) No. 1 acceptable - not to exceed 0.50 mg. or equivalent.
(3) No. 3 probational, not over a ten day period - not to exceed 2.50 mg. or equivalent.
(4) No. 4 reject, considered to be adulterated - over 2.50 mg. or equivalent.
(D) Methods for determining the sediment content of the milk of individual producers shall be those described in the standard methods. Sediment content shall be based on comparison with applicable charts of the United States sediment standards for milk and milk products which are found in Title 7 C.F.R. parts 58-134 (2011).
(E) 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.
(F) Lactating animals 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. Lactating animals treated with, or lactating animals 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 may consult with the director of health.
(G) A plant, hauler, weigher or sampler 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.
(H) All reject milk shall be identified either with a reject tag or colored with harmless food coloring.
(I) A plant shall not accept milk from a producer if:
(J) 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 the items listed in this paragraph. Thereafter, each milk shipment shall meet the requirements of acceptable milk, and shall be tested in accordance with the provisions of rules 901:11-2-03 to 901:11-2-05 of the Administrative Code.
(1) Acceptable raw milk;
(2) Bacterial count;
(3) Somatic cell count; and,
(4) Drug residue level.
(K) 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:
(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.
(A) During at least four separate months within any consecutive six month period, each dairy plant or co-operative association shall collect and submit individual producer raw milk samples to a laboratory for examination to determine the bacterial count of the samples. Samples shall be representative of all raw milk shipped from bulk tanks and all raw milk received in cans.
(B) Samples shall be analyzed at a laboratory approved by the director, and the laboratory results shall be transmitted to the department as requested by the director. Each producer's raw milk sample shall be tested for bacterial count using one of the following methods :
(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;
(8) Impedance/conductance count ;
(10) Any equivalent method approved by the director.
(C) Milk shall not exceed the following bacterial standards:
(1) Milk shipped from the farm in a bulk milk tank shall not have a raw milk bacteria count of more than five hundred thousand bacteria per mL.
(2) Milk shipped from the farm in cans shall not have a raw milk bacteria count of more than one million bacteria per mL.
(D) Whenever the producer's raw milk bacteria count exceeds the standards in paragraph (C) of this rule, the producer shall be notified of the excessive bacteria count.
(E) Whenever two of the last four bacteria counts exceed the bacteria 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.
(F) 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 (E) of this rule. If this sample also exceeds the bacteria standard as established in paragraph (C) of this rule, 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 bacteria counts exceed the standard. The director shall suspend the producer license or registration immediately for at least seven days, in accordance with section 917.22 of the Revised Code, whenever three of the last five bacteria counts within any twelve month period exceed the standard.
(1) The director shall suspend the producer license or producer registration for at least fourteen consecutive days, in accordance with section 917.22 of the Revised Code, whenever a second suspension occurs within any twelve month period.
(2) The director shall suspend the producer license or producer registration for at least thirty consecutive days, in accordance with section 917.22 of the Revised Code, whenever three or more suspensions occur within any twelve month period.
Five Year Review (FYR) Dates: 09/17/2017
Promulgated Under: 119.03
Statutory Authority: 917.02
Rule Amplifies: 917.05, 917.22
Prior Effective Dates: 06/18/01, 06/06/05, 09/19/07, 08/09/09, 4/22/10
(A) During at least four separate months within any consecutive six month period, each dairy plant or co-operative association shall collect and submit producer raw milk samples to a laboratory for examination to determine the somatic cell count of the samples. Samples shall be representative of all raw milk shipped from bulk tanks and received in cans.
(B) The somatic cell standard for acceptable raw milk shall be the lesser of one million or two hundred fifty thousand per mL. more than the standard adopted in the PMO. Goat milk shall remain at the same level as adopted in the PMO.
(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 and the laboratory results shall be transmitted to the department as requested by the director. Each producer's raw milk sample shall be tested for somatic cell count using one of the following methods , any other method listed in the standard methods, 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 exceeds 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 for at least one day, in accordance with section 917.22 of the Revised Code, whenever three of the last five somatic cell counts within any twelve month period exceed the standard.
(1) The director shall suspend the producer license or producer registration for at least seven consecutive days, in accordance with section 917.22 of the Revised Code, whenever a second suspension occurs within any twelve month period.
(2) The director shall suspend the producer license or producer registration for at least fourteen consecutive days, in accordance with section 917.22 of the Revised Code, whenever a third suspension occurs within any twelve month period.
(3) The director shall suspend the producer license or producer registration for at least thirty consecutive days, in accordance with section 917.22 of the Revised Code, whenever four or more suspensions occur within any twelve month period.
Five Year Review (FYR) Dates: 09/17/2017
Promulgated Under: 119.03
Statutory Authority: 917.02
Rule Amplifies: 917.05, 917.22
Prior Effective Dates: 06/18/01, 06/06/05, 09/19/07, 08/09/09, 4/22/10
(A) Dairy plant responsibilities.
(1) Sampling and testing program:
(a) All raw milk shipped for processing or intended to be processed on the farm where it was produced shall be sampled and tested, prior to processing, and all individual producer raw milk samples submitted to an approved laboratory for examination to determine bacteria and somatic cell counts shall also be tested for beta lactam drug residue. Collecting, handling and testing of samples shall be done according to procedures approved by the director, and the laboratory results shall be transmitted to the department as requested by the director;
(b) When so specified by the director, all raw milk shipped for processing, or intended to be processed on the farm where it was produced, shall be sampled and tested, prior to processing, and all individual producer raw milk samples submitted to an approved laboratory for examination to determine bacteria and somatic cell counts shall also be tested for other drug residues. Collecting, handling and testing of samples shall be done according to procedures approved by the director, and the laboratory results shall be transmitted to the department as requested by the director;
(c) When the director determines that a potential problem exists with an animal drug residue or other contaminant in the milk supply, additional sampling and additional testing shall be conducted, as ordered 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 plant shall analyze samples for beta lactams and other drug residues by methods evaluated by the association of official analytical chemists, which can be found at http://www.aoac.org/, 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 dairy plant may employ on a temporary basis other test methods 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) Dairy plant follow-up:
(a) When a load sample tests positive for drug residue, dairy plant personnel shall notify the director immediately, in accordance with 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 an effective routine drug residue milk monitoring program utilizing the official methods 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.
(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 Drug Residue Prevention" manual with a licensed veterinarian within thirty days after each occurrence of shipped milk testing positive for drug residue. A validation form confirming that the "Milk and Dairy Beef Drug Residue Prevention" manual has been reviewed and that a valid veterinary client-patient relationship exists shall be signed by the responsible producer and a licensed veterinarian. The validation form shall be submitted to the director after the manual 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.
Five Year Review (FYR) Dates: 09/17/2017
Promulgated Under: 119.03
Statutory Authority: 917.02
Rule Amplifies: 917.05, 917.22
Prior Effective Dates: 06/18/01, 06/06/05, 09/19/07, 08/09/09, 04/22/10, 10/2/11
Composite milk samples from selected areas in the state should be tested for biologically significant radionuclides at a frequency which the director determines to be adequate to protect the consumer.
Composite milk samples should 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.
(A) Added water is considered to be an adulteration of the product. Producer milk samples may be tested for added water to establish a cryoscope herd history for the producer. The director shall send the producer a written warning when the cryoscope reading exceeds five per cent 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.
(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;
(2) The herd meets United States department of agriculture requirements for an individually certified herd;
(3) The herd participates in a milk ring testing program at least two times per year at approximately one hundred eighty day intervals and all herds with positive milk ring results shall have the entire herd blood tested within thirty days from the date of the laboratory ring test; or
(4) The herd has an individual blood agglutination test annually with an allowable maximum grace period not exceeding two months.
(D) Goat, sheep, water buffalo, or any other hooved mammal milk for pasteurization, ultrapasteurization, or aseptic processing shall be from a herd or flock that:
(1) Has passed an annual whole herd or flock brucellosis test as recommended by the state veterinarian or United States department of agriculture area veterinarian in charge ;
(2) Has passed an initial whole herd brucellosis test, followed only by testing replacement animals or any animals entering the milking group or sold as dairy animals;
(3) Has passed an annual random blood testing program sufficient to provide a confidence level of ninety-nine per cent with a P value of 0.05. Any herd or flock with one or more confirmed positive animals shall go to one hundred percent testing until the whole herd tests shows no positive animals are found; or
(4) Has passed a United States department of agriculture approved bulk milk test at the recommended frequency with implementation date based on availability of the test.
(E) Regardless of location or other herd status, a milk producer whose herd:
(1) Has a suspicious milk ring test result shall have the entire herd blood tested within thirty days after the date of the laboratory test.
(2) 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 an epidemiological investigation conducted by the director.
(3) 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.
(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 kept clean and drained to prevent forming of standing water pools, insofar as practicable. The dairy animals shall be prevented from having any access to stored or accumulated manure.
(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. Hands shall be clean and dry immediately before milking and performing any milkhouse function, and prior to resuming 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, 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.
(A) A manufacture milk producer shall do one of the following:
(1) In the case of manufacture milk that is stored in cans on a manufacture milk producer's farm, cool the milk to and store it at a temperature of sixty degrees Fahrenheit (sixteen degrees Celsius) or lower within two hours after completion of the milking; or
(2) In the case of manufacture milk that is stored in a bulk tank on the manufacture milk producer's farm, cool the milk to and store it at a temperature of fifty degrees Fahrenheit (ten degrees Celsius) 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.
(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 distributed 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 milk 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 milk 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 farm bulk milk 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.
(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.
(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.
(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 fifty parts per million chlorine solution or a sanitizing solution listed in 21 C.F.R. 178.1010(2014) that is used in accordance with label directions. New or replacement can lids shall be umbrella type. All new utensils and equipment shall comply with applicable 3-A sanitary standards.
(C) Single service articles shall be properly stored and shall not be reused.
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, as outlined in Chapter 3701-28 of the Administrative Code, 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.
House, milkhouse, 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.
(B) The licensed dairy farm or dairy plant shall be inspected annually after the initial licensing inspection.
(C) Any license or registration issued under this rule may be denied, suspended, or revoked as specified in paragraph (J) of rule 901:11-1-04 of the Administrative Code. All proceedings under Chapter 917. of the Revised Code are subject to Chapter 119. of the Revised Code.
Five Year Review (FYR) Dates: 01/10/2018
Promulgated Under: 119.03
Statutory Authority: 917.02
Rule Amplifies: 917.02, 917.09
Prior Effective Dates: 06/18/01, 06/06/05, 09/19/07, 1/10/13
(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.
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.
(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, and 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 have an atmosphere relatively free from mold (not exceeding ten mold colonies per cubic foot of air). 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 are 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 paragraph (B) of rule 901:11-2-21 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.
(A) The water supply for the plant shall be properly located, protected, and operated and shall be easily accessible, ample, and of safe, sanitary quality for the cleaning of utensils and equipment:
(1) There shall be an ample supply of safe 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; and
(2) The location, construction and operation of 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 must comply with the requirements found in appendices D and G of the PMO.
(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 shall 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 PMO.
(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, 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 PMO. Reclaimed water which meets category I requirements may be used for the purposes of sanitizing product contact surfaces and equipment.
(A) All equipment and utensils used for the processing of milk and manufacturing 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 steal 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 CIP systems shall comply with the 3-A sanitary practices for permanently installed sanitary product, pipelines, and cleaning systems for those CIP 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 thoroughly 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. 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.
(1) 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.
(2) 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.
(3) 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 on 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 high-temperature, short-time (HTST) pasteurizer is not in the forward flow position. When condensers are used they 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 one hundred fifty degrees Fahrenheit, 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) Air filter system intake media shall consist of fiberglass with a downstream backing dense enough to prevent fiberglass break off from passing through, or cotton flannel, wool flannel, spun metal, activated carbon, activated alumina, non-woven fabric, absorbent cotton fiber, electrostatic or other materials which under conditions of intended use are non-toxic, 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) 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 one hundred twenty degrees Fahrenheit or lower immediately after removal from dryer and prior to packaging. If bulk bins are used, the product should be cooled to approximately ninety degrees Fahrenheit but shall not be more than one hundred twenty degrees Fahrenheit. 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.
(A) Equipment and facilities:
(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 shall be kept clean. Cans or bulk tanks on vehicles which are used for the transportation of milk from the farm to the plant shall not be used for any other purpose.
(2) The exterior shell of the farm bulk milk transport 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 so 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 farm bulk milk 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 farm bulk milk 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.
(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 fifty degrees Fahrenheit 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 be one million per mL or lower.
(C) Whenever the commingled raw milk bacterial count indicates the presence of more than one million per mL, 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;
(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
(3) The processor license or registration may be reinstated by the director when the cause of the violation has been corrected.
(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 (2004) 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 as defined in rule 901:11-2-01 of the Administrative Code.
(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 labeled as specified in rule 901:11-2-42 of the Administrative Code.
(F) All finished products sampled and tested by the director shall not exceed total coliform, Escherichia coli and Escherichia coli O157:H7 standards established by the department.
(1) The director shall order a stop sale on a product lot when the lot sample exceeds five hundred p/mL total coliform and one hundred p/mL Escherichia coli. The lot shall remain on hold until the department has completed an official laboratory analysis of a second sample from the same lot.
(2) When a second sample from the same lot exceeds five hundred p/mL total coliform, one hundred p/mL Escherichia coli and the presence of Escherichia coli O157:H7 is detected, the lot shall be destroyed.
Five Year Review (FYR) Dates: 09/17/2017
Promulgated Under: 119.03
Statutory Authority: 917.02
Rule Amplifies: 917.02, 917.05
Prior Effective Dates: 06/18/01, 06/06/05, 09/19/07, 4/22/10
(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 one hundred twenty-five degrees Fahrenheit but less than one hundred sixty-one degrees Fahrenheit, provided, cream may be heated further to less than one hundred sixty-six degrees Fahrenheit in a continuous heating process and immediately cooled to forty-five degrees Fahrenheit or less when necessary for enzyme deactivation for a functional reason.
(B) Pasteurization shall comply with the applicable specifications of item 16p of the PMO . 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 official methods .
(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 manufacturing 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 one hundred seventy-five degrees Fahrenheit for 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 one hundred eighty-five degrees Fahrenheit 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 one hundred sixty-one degrees Fahrenheit 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 one hundred sixty-five degrees Fahrenheit and held continuously in a vat at such temperature for at least thirty minutes; or pasteurized by the HTST method at a temperature of not less than one hundred eighty-five degrees Fahrenheit 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 one hundred seventy degrees Fahrenheit for at least thirty minutes. Pasteurization by the HTST method shall be at a temperature of not less than one hundred ninety degrees Fahrenheit 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 HTST unit has been tested according to appendix I PMO . The public health controls shall be sealed at the correct setting by the director to assure pasteurization. The HTST 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 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 two hundred twelve degrees Fahrenheit to two hundred eighty degrees Fahrenheit for a time sufficient to destroy all living organisms;
(2) By a continuous flow ultra high-temperature, short-time (UHTST) method at two hundred eighty degrees Fahrenheit or above for a time sufficient to destroy all living organisms, then packaged aseptically; or
(3) The product is initially sterilized according to continuous flow UHTST method as stated in paragraph (B) of this rule, then packaged and given further heat treatment to complete the sterilization process.
(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 one hundred fifty-eight degrees Fahrenheit 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.
(4) Each cooker shall be equipped with an indicating thermometer and a temperature recording device.
(5) 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.
(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 CIP 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.
(2) CIP 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 CIP installations and cleaning procedures shall be in accordance with 3-A suggested methods for the installation and cleaning of clean-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. Product contact surfaces shall be sanitized immediately prior to beginning the flow of product.
(B) A covered or enclosed wash dock and cleaning and sanitizing facilities shall be available at all plants that receive or ship milk in bulk milk transport tanks. Bulk 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 bulk milk 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 bulk milk tank transport truck is next received and kept on file for fifteen days. Tagging is not required in situations where the bulk milk transport 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, conveyor, sifters, and storage bins shall be cleaned as often as necessary to maintain such equipment in a clean and sanitary condition. The cleaning procedure, whether wet or dry, and the frequency of cleaning shall be based upon observation of actual operating results and conditions.
(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 under normal conditions of handling during storage and shipment . The weight and shape within 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.
(1) 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 an atmosphere relatively free from mold (not exceeding 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.
(F) An area shall be provided for filling bulk bins, drums, bags, or other bulk containers and shall be constructed in accordance with rules 901:11-2-20 and 901:11-2-22 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 floor 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 so 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, have an atmosphere relatively free from mold (not exceeding ten mold colonies per cubic foot of air) 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 an atmosphere relatively free from mold (not exceeding ten mold colonies per cubic foot of air) and be practically free from bacterial contamination.
(A) All fluid processed product for bulk shipment shall be stored and maintained at a temperature of fifty degrees Fahrenheit. 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, have an atmosphere relatively free from mold (not exceeding ten mold colonies per cubic foot of air) 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 forty degrees Fahrenheit 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 minus ten degrees Fahrenheit 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 zero degree Fahrenheit 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 one hundred fifty degrees Fahrenheit 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.
Each dryer should be operated at not more than the manufacturer's rated capacity for the highest quality dry product and 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.
Prior to packaging and immediately following removal from the drying chamber, the dry product shall be cooled to a temperature not to exceed one hundred twenty degrees Fahrenheit.
(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 paragraph (B) of rule 901:11-2-32 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 paragraph (B) of rule 901:11-2-32 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, and 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 per cent;
(6) The moisture shall not exceed 4.5 per cent;
(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 per cent;
(10) The dispersibility shall not be less than eighty-five per cent by the modified Moats-Dabbah method; and
(11) The direct microscopic clump count shall not exceed seventy-five million per gram.
The coolers and freezers shall be equipped to maintain proper temperature and humidity conditions, which are consistent with good manufacturing practices for the applicable product, in order 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 have an atmosphere relatively free from mold, (not exceeding ten mold colonies per cubic foot of air) 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.
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 within the starter room.
The room in which the cheese is manufactured shall be of adequate size and be provided with adequate ventilation. The vats shall be adequately spaced to permit movement around the vats and presses for proper cleaning and satisfactory working conditions.
All equipment and utensils necessary for the manufacture of cheese and related products shall meet the same general requirements as outlined in rule 901:11-2-22 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, including copper, properly pitched from side to center and from rear to front for adequate drainage. The liner shall be smooth and free from excessive dents or creases. The liner 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.
(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 listed in Chapter 901:11-2 of the Administrative Code as specified for handling milk and dairy products.
(A) The natural cheese shall be cleaned free of all nonedible portions including 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 . Cheese may be salvaged into sanitary containers and added back to cookers.
(5) The filling of small containers with product shall be done in a sanitary manner. The containers shall not contaminate or detract from the quality of the product in any way.
(6) 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.
(7) The bulk container (including bulk tankers) shall be cleaned and sanitized before filling, and filled and closed in a sanitary manner.
(D) When filling aseptic product, the previously sterilized product shall be filled under conditions which prevent contamination of the product by living organisms or spores. Prior to being filled, the containers shall be sterilized and maintained in a sterile condition. The containers shall be sealed in a manner that prevents contamination of the product.
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 records shall be maintained for examination at the plant or receiving station where performed:
(A) Rejections of raw milk identifying the source and reason for rejection shall be retained for two months;
(B) Pasteurization recorder charts shall be retained for six months;
(C) CIP recorder charts shall be retained for six months;
(D) Production records showing date, quantity, and type of product produced shall be retained for twelve months; and
(E) Milk receipt log or record showing weigher, sampler identity, route identity, patron number, name of producer, milk temperature on receipt and milk weight shall be retained for two months.
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 labeledand handled, stored, and used in such a manner that will not create a health hazard.
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.
(A) All retail packaged product shall be legibly labeled in accordance with the applicable requirements of the Federal Food Drug and Cosmetic Act (2004), the Nutrition Labeling and Education Act (1990), regulations developed there under, and with:
(1) The name of the product;
(2) The net weight;
(3) The name and address of the packer, manufacturer, or distributor; and,
(4) Any other identification that may be required by the director.
(B) All commercial bulk packages containing dairy products manufactured under the provisions of rules 901:11-2-01 to 901:11-2-44 of the Administrative Code shall be adequately and legibly labeled with:
(1) The name of the product;
(2) The net weight;
(3) The production code or date of manufacture, vat or lot number;
(4) The federal information processing standards number or the name and address of the manufacturer; and
(5) 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 per cent of milkfat.
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 are acceptable) shall be worn by all persons in receiving, testing, processing, manufacturing, packaging rooms, or by persons handling dairy products.
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 milk, dairy products or associated product contact surfaces shall immediately report these conditions to the director.
The director may require any or all of the measurers listed in section thirteen and section fourteen of the PMO.