Current through Register Vol. 51, No. 3, September 1, 2024
RELATES TO: KRS Chapter 217C
NECESSITY, FUNCTION, AND CONFORMITY:
KRS
217C.090 authorizes the secretary of the
Cabinet for Health and Family Services to issue administrative regulations
allowing, upon written recommendation of a physician, the sale of goat milk
which has not been pasteurized. This administrative regulation establishes
uniform standards for the production, handling, sampling, examination, and
sale, at the farm, of goat's milk which has not been pasteurized; the
inspection of the goat farm facilities; and the issuance, revocation, and
reinstatement of farm permits.
Section
1. Applicability.
(1) This
administrative regulation is applicable only to dairy goat farms offering
unpasteurized goat milk direct to the consumer.
(2) All other dairy goat farms shall follow
the applicable administrative regulation under 902 KAR Chapter 50.
(3) Milk produced in compliance with the
requirements of this administrative regulation shall not guarantee the absence
of pathogenic organisms.
Section
2. Sale Restrictions.
(1) The
sale of unpasteurized goat milk pursuant to this administrative regulation
shall be from on the farm sales only.
(2) Unpasteurized goat milk for direct
consumer consumption shall only be sold from a permitted goat producer to
persons with a written recommendation from a physician.
(3) A written recommendation statement from a
physician shall be:
(a) For a specific
individual;
(b) Kept on file at the
producer location for one (1) year; and
(c) Subject to inspection by the
cabinet.
(4) The
producer shall keep on file records stating the volume of unpasteurized goat
milk sold and the date of sales to each person having submitted a written
recommendation statement.
Section
3. Permits.
(1) A person shall
not 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 dairy goat producer offering unpasteurized goat
milk for sale, the cabinet shall conduct an inspection of the producer's
facilities.
(3) If the producer is
not in compliance with this administrative regulation:
(a) The permit shall not be issued;
(b) The violations shall be given to the
producer in writing; and
(c) The
findings posted in a conspicuous place at the farm.
(4) A permit shall be issued if the
inspection reveals compliance with this administrative regulation.
(5) Permits shall not be transferable with
respect to persons or locations and shall remain valid unless suspended or
revoked by the cabinet.
Section
4. Inspection of Goat Farm.
(1)
Each dairy goat farm offering unpasteurized milk for sale shall be inspected at
least one (1) time each two (2) months after the issuance of a
permit.
(2) If the violation of any
requirement of this administrative regulation is found to exist on an
inspection, a second inspection shall be required after the time necessary to
remedy the violation, but not before three (3) days.
(3) This second inspection shall be used to
determine compliance with the requirements of this administrative
regulation.
(4) If a violation of
the same requirement of this administrative regulation is found on the second
inspection, the permit shall be suspended in accordance with Section 12 of this
administrative regulation.
(5) A
copy of the inspection report shall be:
(a)
Provided to the producer or other responsible person;
(b) Posted in a conspicuous place on an
inside wall of the milk house; and
(c) Filed with the department.
(6) Every producer offering
unpasteurized goat milk for sell 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.
Section 5.
Animal Health.
(1) All milk shall be from
herds that 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", incorporated by reference in
902
KAR 50:032.
(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, in
accordance with the "Brucellosis Eradication, Uniform Methods and Rules",
incorporated by reference in
902
KAR 50:032.
(2) 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.
(3) Failure to comply with the requirements
of this section shall result in immediate permit suspension.
Section 6. Sampling Frequency and
Required Test.
(1) A representative sample of
the un-pasteurized goat milk shall be collected at the farm by the cabinet each
month.
(2) All samples shall be
analyzed for bacteria count, somatic cell count, antibiotics, adulteration with
water, and temperature in an official laboratory or an officially designated
laboratory.
(3) 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.
(4) Samples of unpasteurized goat milk may be
collected for pesticide analysis as directed by the cabinet.
(5)
(a) If
two (2) of the last four (4) consecutive bacterial counts, somatic cell counts,
or cooling temperatures, taken on separate days, exceed the limit established
in Section 7 of this administrative regulation, the cabinet shall send a
written notice to the producer;
(b)
The notice shall be in effect so long as two (2) of the last four (4)
consecutive samples exceed the limit of the standard; and
(c) 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.
(6) Immediate suspension of permit in
accordance with Section 12 of this administrative regulation shall be
instituted if the limit established in Section 7 of this administrative
regulation is violated by three (3) of the last five (5) bacterial counts,
cooling temperatures, or somatic cell counts.
(7)
(a) If
an antibiotic or pesticide residue test is positive, an investigation shall be
made to determine the cause, and the cause shall be corrected.
(b) An additional sample shall be taken and
tested for antibiotic or pesticide residues.
(c) Milk shall not 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.
(8) If pathogenic organisms are
found in the milk, immediate permit suspension shall occur and milk shall not
be sold from the farm until at least four (4) consecutive tests taken on
separate days contain no pathogenic organisms upon laboratory
analysis.
Section 7.
Bacterial, Chemical, and Temperature Standards.
(1) Unpasteurized goat milk shall be
produced, handled, stored, and packaged to conform to the following standards:
(a) Temperature - cooled to between
thirty-six (36) and forty (40) degrees Fahrenheit or less within two (2) hours
after milking. Subsequent milkings shall not exceed forty-five (45) degrees
Fahrenheit if blended with previous milkings.
(b) Bacterial limits - not to exceed 20,000
per milliliter.
(c) Somatic cells -
not to exceed 1,000,000 per milliliter.
(d) Antibiotics - negative.
(e) Coliform - not to exceed ten (10) per
milliliter.
(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 8. Sanitation Requirements.
(1) The milking area, milk house operations,
and equipment shall be located and conducted to prevent contamination of milk,
equipment, containers, and utensils.
(2) Abnormal milk.
(a) Goats that show evidence of secreting
abnormal milk based upon bacteriological, chemical, or physical examination,
shall be milked last or with separate equipment and the milk shall be
discarded.
(b) Goats treated with,
or who have consumed chemical, medicinal, or radioactive agents capable of
being secreted in the milk and damaging to human health, shall be milked last
or with separate equipment and the milk discarded.
(3) Milking barn or parlor construction.
(a) A milking barn or parlor shall be
provided on all farms and located to be readily accessible to both the milk
room and animal housing area.
(b)
The milking barn or parlor shall:
1. Have
floors constructed of concrete or equally impervious material;
2. Have walls and ceilings that are water
resistant, cleanable, smooth, in good repair, and the ceiling dust
tight;
3. Be provided with natural
or artificial light, well distributed for day or night milking;
4. Have ventilation and fresh air inlets for
air circulation to prevent condensation and excessive odors;
5. Not be overcrowded; and
6. Have dust tight covered boxes or bins, or
separate storage facilities for feed.
(c) The interior of the milking barn or
parlor shall be kept clean.
(d)
Swine and fowl shall be kept out of the milking area.
(4) Goat yard.
(a) The goat yard shall be graded and
drained, and shall have no standing pools of water or accumulations of organic
wastes.
(b) 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.
(c) Waste
feed shall not be allowed to accumulate.
(d) Manure packs shall be properly drained
and shall provide a firm footing.
(e) Swine shall be kept out of the goat
yard.
(5) Milk house or
room construction and facilities.
(a) A milk
house or room shall:
1. Be a sufficient size
for the:
a. Cooling, handling, storing, and
packaging of milk; and
b. Washing,
sanitizing, and storing of milk containers and utensils, except as provided in
subsections (8)(c) and (d) of this section;
2. Have a smooth floor constructed of
concrete or equally impervious material graded to drain, and maintained in good
repair;
3. Have walls and ceilings
constructed of smooth material, in good repair, and well painted or finished in
an equally suitable manner;
4. Have
adequate natural or artificial light and be well ventilated;
5. Be used for only milk house operations;
and
6. Be free of trash, animals,
and fowl.
(b) There
shall not be a direct opening from the milk house or room into a barn, stable,
or room used for domestic purposes.
(c) 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.
(d) Potable water under pressure shall be
piped into the milk house.
(e) The
milk house shall be equipped with a two (2) compartment wash vat and adequate
hot water heating facilities.
(f)
Separate handwashing facilities shall be provided in the milk house with
running potable water, soap or detergent, and individual sanitary
towels.
(g) Bottling or packaging
may be carried out in the milk house or room if it is done in a sanitary manner
and by a method that prevents contamination.
(6) 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.
(7) Water supply. Water for
milk house or room, and milking operations shall be:
(a) From a supply properly located,
protected, and operated; and
(b)
Easily accessible, adequate, and of a safe, sanitary quality.
(c) No cross-connection shall exist between a
safe water supply and an unsafe or questionable water supply, or any other
source of pollution.
(d) A well or
other source of water shall be located and constructed to prevent underground
or surface contamination from a sewerage system, privy, or other source of
pollution from reaching the water supply.
(e) Individual water supplies and water
supply systems that 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.
(f) 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.
(g) 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.
(8) Utensils and equipment.
(a) All multiuse containers, equipment, and
utensils used in the handling, storage, or transportation of milk shall be:
1. Made of smooth, nonabsorbent,
corrosion-resistant, nontoxic materials;
2. Constructed for easy cleaning;
and
3. In good repair.
(b) Multiple-use woven material
shall not be used for straining milk.
(c) All single-service articles shall be
manufactured, packaged, transported, and handled in a sanitary manner. Articles
intended for single-service use shall not be reused.
(d) Containers for purchasing milk may be
provided by the person purchasing the milk, and these containers shall not be
washed, sanitized, or stored at the farm.
(e) The product-contact surfaces of all
multiuse containers, equipment, and utensils used in the handling, storage, or
transportation of milk shall be:
1. Cleaned
after each usage; and
2. Sanitized
before each use.
(f)
After sanitization, all containers, utensils, and equipment shall be handled in
a manner to prevent contamination of a product-contact surface.
(g) 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.
(h) Pipeline milking equipment such as milker
claws, inflations, weigh jars, meters, milk hoses, milk receivers, tubular
coolers, and milk pumps that 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.
(9) Insect and rodent control.
(a) Effective measures shall be taken to
prevent the contamination of milk, containers, equipment, and utensils by
insects, rodents, and chemicals used to control vermin;
(b) Milk houses or rooms shall be free of
insects and rodents; and
(c)
Surroundings shall be kept neat, clean, and free of conditions that harbor or
are conducive to the breeding of insects and rodents.
Section 9. Milking Procedures.
(1) All milking shall be done in the milking
barn or parlor.
(2) Milking by hand
shall be prohibited.
(3) The
flanks, udders, and bellies of all milking goats shall be free from visible
dirt.
(4) All brushing shall be
completed prior to milking.
(5) 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.
(6) 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.
(7) All
personnel shall wear clean outer garments while milking or handling milk, milk
containers, utensils, or equipment.
Section 10. Personnel Health.
(1) A person shall not work at the farm in
any capacity while having a disease in a communicable form, or being a carrier
of a communicable disease.
(2) The
owner of a dairy goat 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.
(3) If reasonable
cause exists to suspect the possibility of transmission of infection from a
person involved with the handling of milk, the cabinet shall require the
following measures:
(a) The immediate
exclusion of that person from milk handling;
(b) The immediate exclusion of the milk
supply concerned from distribution and sale; and
(c) Adequate medical and bacteriological
examination of the person involved in milk production or handling
activities.
Section
11. Trade Secrets. 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 or her own advantage or to reveal it to an unauthorized
person.
Section 12. Permit
Suspension, Revocation and Hearing Procedure. In addition to the penalties
established in
KRS 217C.990, the
cabinet may suspend or revoke an individual producer's permit, in accordance
with
KRS
217C.040.
(1) The cabinet shall, upon notice to the
producer, immediately suspend the permit if:
(a) There is reason to believe that an
imminent public health hazard exists;
(b) The producer or an employee has
interfered with the cabinet in the performance of the cabinet's duties;
or
(c) The producer or an employee
has falsified records.
(2)
(a) A
producer whose permit has been suspended three (3) times within a twelve (12)
month period for a violation of any type in accordance with this administrative
regulation, shall be issued a notice that upon the fourth suspension within a
twelve (12) month period the producer shall appear at the cabinet for a
conference to show cause why the permit should be reinstated.
(b) Upon the fourth suspension within a
twelve (12) month period, the producer shall appear before the cabinet to show
cause why the permit should be reinstated.
(c) At this conference the cabinet may set
conditions under which the permit may be reinstated.
(d) This permit suspension shall remain in
effect until the conditions of the conference have been met.
(3) In all other instances of
violation of this administrative regulation, the cabinet shall:
(a) Serve on the producer a written notice
stating the violation; and
(b)
Afford the producer a reasonable opportunity to correct the
violation.
(4) A
producer whose permit has been suspended may, at any time, submit an
"Application for Reinstatement of Permit" incorporated by reference in
902
KAR 50:033.
(5) Suspension of a permit shall remain in
effect until the violation has been corrected.
(6) For serious or repeated violations of any
of the requirements of this administrative regulation the producer's permit may
be permanently revoked.
(7) Prior
to revocation, the cabinet shall notify the producer in writing, stating the
reasons for which the permit is subject to revocation and advising the permit
shall be permanently revoked at the end of ten (10) days following the service
of the notice, unless the "Request for a Hearing", incorporated by reference in
902
KAR 50:033, is filed in accordance with
KRS
217C.100.
STATUTORY AUTHORITY:
KRS
217C.090