902 KAR 50:120. Unpasteurized goat milk.
RELATES TO: KRS Chapter 217C
STATUTORY AUTHORITY: KRS 194.050, 217C.090
NECESSITY, FUNCTION, AND CONFORMITY: The Cabinet for Human Resources is directed by KRS 217C.090 to issue administrative regulations allowing, upon written recommendation of a physician, the sale of goat milk which has not been pasteurized. This administrative regulation sets uniform standards for the production, handling, sampling, examination, and sale, at the farm, of goat's milk which has not been pasteurized and for the inspection of the goat farm facilities; and provides for the issuance, revocation, and reinstatement of farm permits.
Section 1. Permits. (1) No person shall sell or offer for sale unpasteurized goat milk, without first obtaining a permit from the cabinet.
(2) Prior to the issuance of a permit to a goat milk producer, the cabinet shall conduct an inspection of the producer's facilities. A producer not in compliance with this administrative regulation, shall not be issued a permit, and violations shall be given to the producer in writing and posted in a conspicuous place at the farm. A permit may be issued if the inspection reveals compliance with this administrative regulation.
(3) Permits shall not be transferable with respect to persons or locations and shall remain valid unless suspended or revoked by the cabinet.
(4) The cabinet shall suspend the permit, if the cabinet has reason to believe that a public health hazard exists; the permit holder has violated any of the requirements of this administrative regulation; or the permit holder has interfered with the cabinet in the performance of its duties. The cabinet shall in all cases, except if the milk involved creates, or appears to create, an imminent hazard to the public health; or in a case of willful refusal to permit authorized inspection, serve upon the permit holder a written notice of intent to suspend permit. The notice shall specify the violation in question and afford the permit holder reasonable opportunity to correct the violation as may be agreed to by the parties; or in the absence of agreement, fixed by the cabinet before making an order of suspension effective. A suspension of permit shall remain in effect until the violation has been corrected to the satisfaction of the cabinet. Upon notification acceptable to the cabinet by a person whose permit has been suspended, or upon application within forty-eight (48) hours by a person who has been served with a notice of intention to suspend, and in the latter case before suspension, the cabinet shall within seventy-two (72) hours proceed to a hearing to ascertain the facts of the violation or interference. Upon evidence presented at the hearing the hearing officer shall affirm, modify, or rescind the suspension or intention to suspend. Upon repeated violation, the cabinet may revoke the permit following reasonable notice to the permit holder and an opportunity for a hearing.
(5) A producer whose permit has been suspended may make written application for reinstatement of the permit on Form DFS-7A, "Application for Reinstatement of Permit", incorporated by reference. A copy of Form DFS-7A, "Application for Reinstatement of Permit", revised October 1986, is available for inspection and copying, 8 a.m. until 4:30 p.m., Monday through Friday, at the Office of the Commissioner for Health Services, 275 East Main Street, Frankfort, Kentucky 40621.
(6) If the permit suspension has been due to violation of quality or temperature standards, the cabinet, within one (1) week after receipt of Form DFS-7A, "Application for Reinstatement of Permit", shall conduct an inspection and collect a sample to determine if compliance with this administrative regulation has been met. If the inspection and sample analysis indicate compliance with this administrative regulation, permit reinstatement may be made.
(7) If the permit suspension has been due to the presence of a pathogenic organism in the milk sample, collection and analysis shall continue at the rate of at least two (2) per week for two (2) weeks after conditions of subsection (6) of this section have been met.
Section 2. Sale Restrictions and Volume Control. (1) Unpasteurized goat milk shall be sold from a permitted goat producer only to persons with a written recommendation from a physician.
(2) A written recommendation statement from a physician shall be for a specific individual and shall be kept on file at the producer location and subject to inspection by the cabinet.
(3) Written recommendation statements shall be kept on file by the producer for at least one (1) year.
(4) The producer shall keep on file records stating volume of unpasteurized goat milk sold and date of sales to each person having submitted a written recommendation statement.
(5) All sale of unpasteurized goat milk regulated under this administrative regulation shall be from on-the-farm sales only.
Section 3. Inspection of Goat Farm. (1) Inspection of each goat farm shall be made prior to the issuance of a permit.
(2) Inspection of each goat farm shall be made at least one (1) time each two (2) months after the issuance of a permit.
(3) If the violation of any requirement in Section 6 of this administrative regulation is found to exist on an inspection, a second inspection shall be required after the time deemed necessary to remedy the violation, but not before three (3) days. This second inspection shall be used to determine compliance with the requirements of Section 6 of this administrative regulation. A violation of the same requirement of Section 6 of this administrative regulation on the second inspection shall call for permit suspension in accordance with Section 1(4) of this administrative regulation.
(4) One (1) copy of the inspection report shall be provided the operator, or other responsible person, or be posted in a conspicuous place on an inside wall of the milk house. The inspection report shall not be defaced and shall be made available to the cabinet upon request. An identical copy of the inspection report shall be filed with the records of the cabinet.
(5) Every goat producer shall, upon request of the cabinet, permit access of officially designated persons to all parts of the milk house or facilities to determine compliance with the provisions of this administrative regulation.
(6) No person shall, in an official capacity, obtain information under the provisions of this administrative regulation (including information as to the quantity, quality, source, or disposition of milk or milk products, or results of inspections or tests to use the information to his own advantage or to reveal it to an unauthorized person.
Section 4. Sampling Frequency and Required Test. (1) A representative sample of each producer's milk shall be collected at the farm by the cabinet each month and analyzed in an official laboratory for bacteria count, somatic cell count, antibiotics, adulteration with water, and temperature.
(2) Additional samples shall be collected at the farm by the cabinet at least every two (2) months and analyzed for pathogenic organisms in an official laboratory as directed by the cabinet.
(3) Samples of raw milk may be collected for pesticide analysis as directed by the cabinet.
(4) If two (2) of the last four (4) consecutive bacterial counts, somatic cell counts, or cooling temperatures, taken on separate days, exceed the limit of the standard, the cabinet shall send a written notice to the person concerned. The notice shall be in effect so long as two (2) of the last four (4) consecutive samples exceed the limit of the standard. An additional sample shall be taken within twenty-one (21) days of the sending of the notice, but not before the lapse of three (3) days. Immediate suspension of permit in accordance with Section 1(4) of this administrative regulation or court action shall be instituted if the standard is violated by three (3) of the last five (5) bacterial counts, cooling temperatures, or somatic cell counts.
(5) If an antibiotic or pesticide residue test is positive, an investigation shall be made to determine the cause, and the cause shall be corrected. An additional sample shall be taken and tested for antibiotic or pesticide residues. No milk shall be offered for sale until it is shown, by a subsequent sample, to be free of antibiotic or pesticide residues or below the actionable levels established for residues.
(6) If pathogenic organisms are found in the milk, immediate permit suspension shall occur and no milk shall be sold from the farm until at least four (4) consecutive tests taken on separate days contain no pathogenic organisms upon laboratory analysis.
(7) All samples shall be analyzed in an official laboratory or an officially designated laboratory. Analytical procedures shall be in compliance with "Standard Methods for the Examination of Dairy Products" or "Official Methods of Analysis" of the Association of Official Analytical Chemists. Methods for determining quality testing shall be those described in the "Standard Methods for the Examination of Dairy Products", 16th Edition, 1992, published by the American Public Health Association, and the "Official Methods of Analysis", 15th Edition, 1990, Volumes I and II, published by the Association of Official Analytical Chemists, Inc., unless otherwise approved by the cabinet. Copies of the "Standard Methods for the Examination of Dairy Products", revised 1992, incorporated by reference, and the "Official Methods of Analysis", revised 1990, incorporated by reference, are available for inspection and copying, 8 a.m. until 4:30 p.m., Monday through Friday, at the Office of the Commissioner, Department for Health Services, 275 East Main Street, Frankfort, Kentucky 40621.
Section 5. Bacterial, Chemical, and Temperature Standards. (1) Unpasteurized goat milk shall be produced, handled, stored, and packaged to conform with the following standards:
(a) Temperature - cooled to forty-five (45) degrees Fahrenheit or less within two (2) hours after milking. Subsequent milkings shall not exceed fifty (50) degrees Fahrenheit if blended with previous milkings.
(b) Bacterial limits - not to exceed 20,000 per ml.
(c) Somatic cells - not to exceed 1,000,000 per ml.
(d) Antibiotics - negative.
(e) Coliform - not to exceed ten (10) per ml.
(f) Pathogens - negative.
(g) Pesticides and chemical adulterants - negative.
(2) No process, manipulation, or additives shall be applied to the milk, other than appropriate refrigeration, for the purpose of removing or deactivating microorganisms.
Section 6. Sanitation Requirements. (1) Abnormal milk. Goats, which show evidence of the secretion of abnormal milk based upon bacteriological, chemical, or physical examination, shall be milked last or with separate equipment and the milk shall be discarded. Goats treated with, or goats which have consumed chemical, medicinal, or radioactive agents which are capable of being secreted in the milk and which, in the judgment of the cabinet may be damaging to human health, shall be milked last or with separate equipment and the milk disposed of as the cabinet may direct.
(2) Milking barn or parlor construction. A milking barn or parlor shall be provided on all farms in which the milking herd shall be housed during milking operations. The areas used for milking purposes shall:
(a) Have floors constructed of concrete or equally impervious material;
(b) Have walls and ceiling which are smooth, painted or finished in an approved manner, in good repair, and ceiling dust tight;
(c) Be provided with natural or artificial light, well distributed for day or night milking;
(d) Provide sufficient air space and air circulation to prevent condensation and excessive odors;
(e) Not be overcrowded; and
(f) Have dust tight covered boxes or bins, or separate storage facilities for ground, chopped, or concentrated feed.
(3) Milking barn or parlor cleanliness. The interior shall be kept clean. Floors, walls, ceilings, windows, pipelines, and equipment shall be clean and free of filth or litter. Swine and fowl shall be kept out of the milking area.
(4) Goat yard. The goat yard shall be graded and drained, and shall have no standing pools of water or accumulations of organic wastes. In loafing or goat housing areas, goat droppings and soiled bedding shall be removed, or clean bedding added, at sufficiently frequent intervals to prevent the soiling of the goat's udder and flanks. Waste feed shall not be allowed to accumulate. Manure packs shall be properly drained and shall provide a firm footing. Swine shall be kept out of the goat yard.
(5) Milk house or room construction and facilities. A milk house or room shall be a sufficient size for the cooling, handling, storing, and packaging of milk; and the washing, sanitizing, and storing of milk containers and utensils, except as provided for in subsection (12) of this section.
(a) The milk house shall have a smooth floor constructed of concrete or equally impervious material graded to drain and maintained in good repair. Liquid waste shall be disposed of in a sanitary manner; all floor drains shall be accessible and shall be trapped if connected to a sanitary sewer system.
(b) Walls and ceilings shall be constructed of smooth material, in good repair, and well painted or finished in an equally suitable manner.
(c) The milk house shall have adequate natural or artificial light and be well ventilated.
(d) The milk house shall be used for only milk house operations; there shall be no direct opening into a barn, stable, or room used for domestic purposes. A direct opening between the milk house and milking barn, or parlor is permitted if a tight-fitting, self-closing solid door hinged to be single or double acting is provided.
(e) Potable water under pressure shall be piped into the milk house.
(f) The milk house shall be equipped with a two (2) compartment wash vat and adequate hot water heating facilities.
(g) Bottling or packaging may be carried out in the milk room if it is done in a sanitary manner and by a method which prevents contamination.
(6) Milk house or room cleanliness. The floors, walls, ceilings, windows, tables, shelves, cabinets, wash vats, nonproduct contact surfaces of milk containers, utensils, and equipment shall be clean. Only articles directly related to milk room activities shall be permitted in the milk room. The milk room shall be free of trash, animals, and fowl.
(7) Toilet. Every farm shall be provided with one (1) or more toilets, conveniently located and properly constructed, operated, and maintained in a sanitary manner. The waste shall be inaccessible to flies and shall not pollute the soil surface or contaminate the water supply.
(8) Water supply. Water for milk house and milking operations shall be from a supply properly located, protected, and operated; and shall be easily accessible, adequate, and of a safe, sanitary quality.
(a) No cross-connection shall exist between a safe water supply and an unsafe or questionable water supply, or any other source of pollution.
(b) The well or other source of water shall be located and constructed to prevent underground or surface contamination from a sewerage systems, privy, or other source of pollution from reaching the water supply.
(c) Individual water supplies and water supply systems which have been repaired or become contaminated shall be thoroughly disinfected before being placed in use. The supply shall be made free of the disinfectant by pumping to waste before a sample for bacteriological testing shall be collected.
(d) All containers and tanks used in the transportation of water shall be sealed and protected from possible contamination. These containers and tanks shall be subjected to a thorough cleaning and a bacteriological treatment prior to filling with potable water to be used at the farm.
(e) Samples for bacteriological examination shall be taken upon the initial approval of the physical structure, if a repair or alteration of the water supply system has been made, and at least every year.
(9) Utensils and equipment construction. All multiuse containers, equipment, and utensils used in the handling, storage, or transportation of milk shall be made of smooth, nonabsorbent, corrosion-resistant, nontoxic materials, and shall be constructed for easy cleaning. All containers, utensils, and equipment shall be in good repair. All milk pails used for hand milking and stripping shall be seamless and of the hooded type. Multiple-use woven material shall not be used for straining milk. All single-service articles shall be manufactured, packaged, transported, and handled in a sanitary manner and shall comply with requirements of subsection (11) of this section. Articles intended for single-service use shall not be reused. Containers for purchasing milk may be provided by the person purchasing the milk; in which case, the containers shall not be washed, sanitized, or stored at the farm.
(10) Utensils and equipment cleaning. The product-contact surfaces of all multiuse containers, equipment, and utensils used in the handling, storage, or transportation of milk shall be cleaned after each usage.
(11) Utensils and equipment sanitation. The product contact surfaces of all multiuse containers, equipment, and utensils used in the handling, storage, or transportation of milk shall be sanitized before each use.
(12) Utensils and equipment storage. All containers, utensils, and equipment used in the handling, storage, or transportation of milk, unless stored in sanitizing solutions, shall be stored to assure complete drainage, and protected from contamination prior to use. Pipeline milking equipment such as milker claws, inflations, weigh jars, meters, milk hoses, milk receivers, tubular coolers, and milk pumps which are designed for mechanical cleaning may be stored in the milking barn or parlor if this equipment is designed, installed, and operated to protect the product and solution-contact surfaces from contamination at all times.
(13) Utensils and equipment handling. After sanitization, all containers, utensils, and equipment shall be handled in a manner to prevent contamination of a product-contact surface.
(14) Milking flanks, udders, and teats. Milking shall be done in the milking barn or parlor. The flanks, udders, and bellies of all milking goats shall be free from visible dirt. All brushing shall be completed prior to milking. The udders and teats of all milking goats shall be cleaned and treated with a sanitizing solution prior to milking, and shall be dry before milking. Wet hand milking is prohibited.
(15) Milking surcingles, milk stools, and antikickers. Surcingles, milk stools, and antikickers shall be kept clean and stored above the floor.
(16) Protection from contamination. The milking area, milk house operations, and equipment shall be located and conducted to prevent contamination of milk, equipment, containers, and utensils. No milk shall be strained, poured, transferred, or stored unless it is properly protected from contamination. Hand capping of bottles, containers, or packages may be done if volume does not cause this to be impractical and protection from contamination is maintained.
(17) Personnel handwashing facilities. Adequate handwashing facilities shall be provided in the milk house with running potable water, soap or detergent, and individual sanitary towels.
(18) Personnel cleanliness. Hands shall be washed clean and dried with an individual sanitary towel immediately before milking or performing any milk house function, and immediately after the interruption of any of these activities. Milkers shall wear clean outer garments while milking or handling milk, milk containers, utensils, or equipment.
(19) Cooling. Raw milk shall be cooled to forty-five (45) degrees Fahrenheit or less within two (2) hours after milking. The blend temperature after the first milking and subsequent milkings shall not exceed fifty (50) degrees Fahrenheit.
(20) Insect and rodent control. Effective measures shall be taken to prevent the contamination of milk, containers, equipment, and utensils by insects, rodents, and chemicals used to control vermin. Milk rooms shall be free of insects and rodents. Surroundings shall be kept neat, clean, and free of conditions which might harbor or be conducive to the breeding of insects and rodents.
Section 7. Animal Health. (1) All milk shall be from herds which are free from tuberculosis and brucellosis.
(a) Tuberculin test. The herd shall be located in an area within the state which meets the requirements of a modified accredited area in which not more than one-half (1/2) of one (1) percent of the goat herd have been found to be infected with tuberculosis. This requirement is in accordance with the "Bovine Tuberculosis Eradication, Uniform Methods and Rules", February 3, 1989, for establishing and maintaining tuberculosis-free herds of goat and modified accredited areas approved by the Animal and Plant Health Inspection Service, Veterinary Services, U. S. Department of Agriculture. If the herd is not located in a modified accredited area, it shall be tested annually under the jurisdiction of the program. Additions to the herd shall be from a modified accredited area or from herds meeting the requirements of this administrative regulation. Copies of the "Bovine Tuberculosis Eradication, Uniform Methods and Rules", incorporated by reference, are available for inspection and copying, 8 a.m. until 4:30 p.m., Monday through Friday, at the Office of the Commissioner for Health Services, 275 East Main Street, Frankfort, Kentucky 40621. This publication may also be obtained from the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C., 20402.
(b) Brucellosis test. The herd shall be located in an area within the state in which the percentage of the goat herd affected with brucellosis does not exceed one (1) percent and the percentage of herds in which brucellosis is present does not exceed five (5) percent. This requirement is in accordance with the "Brucellosis Eradication, Uniform Methods and Rules", May 6, 1992, for establishing and maintaining certified brucellosis-free areas approved by the Animal and Plant Health Inspection Service, Veterinary Services, U. S. Department of Agriculture. If the herd is located in an area that does not meet these requirements, the herd shall be blood-tested annually or milk-ring-tested semiannually. Additions to the herd shall be from herds meeting the requirements of this administrative regulation. Copies of the "Brucellosis Eradication, Uniform Methods and Rules", incorporated by reference, are available for inspection and copying, 8 a.m. until 4:30 p.m., Monday through Friday, at the Office of the Commissioner for Health Services, 275 East Main Street, Frankfort, Kentucky 40621. This publication may also be obtained from the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C., 20402.
(2) The cabinet shall require physical, chemical, or bacteriological tests necessary to prevent the spread of diseases or the contamination of the milk with pathogenic organisms.
(3) A certificate identifying test results of each animal, signed by a veterinarian, shall be submitted to the cabinet for each test required by this section.
(4) Failure to comply with the requirements of this section shall result in immediate permit suspension.
Section 8. Milk which May be Sold. Goat milk sold at a farm permitted under this administrative regulation shall be limited to milk produced at the particular farm and no milk shall be transferred from one farm to another or delivered from the farm to another place or location for sale.
Section 9. Construction Plan. Properly prepared plans for all milking barns, parlors, and milk houses shall be submitted to the cabinet for written approval prior to a permit being issued.
Section 10. Personnel Health. No person affected with a disease in a communicable form, or while a carrier of disease, shall work at the farm in any capacity which brings him in contact with the handling, storage, or sale of milk, containers, equipment, and utensils. No farm operator shall employ in any capacity a person suspected of having a disease in a communicable form, or of being a carrier of a communicable disease. An owner of a dairy farm on which a communicable disease occurs, or who suspects that an employee has contracted a disease in a communicable form, or has become a carrier of a disease, shall notify the cabinet immediately.
Section 11. Procedure if Infection is Suspected. If reasonable cause exists to suspect the possibility of transmission of infection from a person concerned with the handling of milk, the cabinet shall require any or all of the following measures:
(1) The immediate exclusion of that person from milk handling;
(2) The immediate exclusion of the milk supply concerned from distribution and sale;
(3) Adequate medical and bacteriological examination of the person, involved in milk production or handling activities.
Section 12. Disclaimer. Milk produced in compliance with the requirements of this administrative regulation does not assure the absence of pathogenic organisms.
Section 13. Hearing Procedure. (1) Upon notification of intent to suspend or upon suspension, the producer may request a hearing. The request for a hearing shall be made in writing on Form DFS-8, "Request for Hearing", revised January 1989, to the cabinet within ten (10) days after notification by the cabinet of an enforcement proceeding. Form DFS-8, "Request for Hearing", is incorporated by reference and may be viewed or obtained, 8 a.m. until 4:30 p.m., Monday through Friday, at the Office of the Commissioner of Health Services, 275 East Main Street, Frankfort, Kentucky 40621.
(2) The cabinet shall notify the requesting party in writing of the:
(a) Name of the hearing officer; and
(b) Time and place of the hearing.
(3) All parties shall be allowed a reasonable time to prepare for the hearing, including the right to:
(a) Be represented by counsel;
(b) Present evidence on his behalf; and
(c) Cross-examine witnesses.
(4) A transcript of the hearing shall not be made unless requested. The expense of transcribing the hearing shall be the responsibility of the requesting party.
(5) The hearing officer shall make written findings of fact and conclusions of law, and render a decision based upon the evidence presented. The decision of the hearing officer shall be the final decision of the cabinet. (15 Ky.R. 763; Am. 987; eff. 9-21-88; 20 Ky.R. 2222; eff. 3-14-94.)