Current through Register Vol. 51, No. 3, September 1, 2024
RELATES TO: KRS Chapter 13B, 211.090, 217.025, 217C.060,
217C.100
NECESSITY, FUNCTION, AND CONFORMITY:
KRS
194A.050(1) requires the
Cabinet for Health and Family Service to promulgate administrative regulations
necessary to operate the programs and fulfill the responsibilities vested in
the cabinet.
KRS
211.180(1)(c) authorizes the
cabinet to promulgate administrative regulations for the safe handling of food
and food products.
KRS
217C.040 authorizes the cabinet to promulgate
regulations for the the production, transportation, processing, handling,
sampling, examination, grading, sale, and other matters relating to Grade A and
manufactured milk and milk products as may be necessary to protect the public
health. This administrative regulation establishes enforcement procedures to
prevent the sale of Grade A and manufactured milk and milk products adulterated
with antibiotics and other inhibitory substances, chemicals, and excessive
water.
Section 1. Antibiotics and other
Inhibitory Substances Enforcement Procedure.
(1) Sampling procedure.
(a) Antibiotic tests shall be performed a
minimum of four (4) times during any consecutive six (6) months on each
producer's milk or on raw commingled loads and all Grade A processed milk
(except cultured products). When commingled milk is tested, milk from each
individual producer shall be represented in the sample.
(b) Commingled loads that show any level of
antibiotics shall require each individual producer's milk on the load to be
tested.
(c)
1. An individual producer's milk sample found
to be positive shall be reported to the Milk Safety Branch and confirmed by
laboratory report; and
2. No
additional milk shall be collected from the individual producer until the
producer is compliant with enforcement procedures listed in subsection (4) of
this section.
(2) All loads of raw milk shall be screened
for antibiotics and other inhibitory substances prior to receipt by the
plant.
(3) Utilization of milk on a
load showing levels of antibiotics shall be as follows:
(a) A load of raw milk with an antibiotic
level below the M-a-85 (Revision #16) standards, may be accepted by the
plant.
(b) A load of raw milk with
a positive antibiotic level above the M-a-85 (Revision #16) standards shall not
be utilized by the plant and shall be reported to the Milk Safety
Branch.
(c) If a load of raw milk
is commingled into a plant storage tank with other loads and later found to be
positive, the storage tank shall be tested and found to be negative prior to
processing.
(d) Intentional
blending of loads found to be positive for antibiotics shall be
prohibited.
(e) Raw milk
inadvertently processed and later found to be positive for antibiotics or other
inhibitory substances shall be reported to the Milk Safety Branch prior to
shipment for sale. Each case will be handled individually and may require
testing to determine if antibiotics are present which would prohibit
sale.
(4) Enforcement
procedures.
(a) Producers with first
antibiotic or other inhibitory substances violation during the past twelve (12)
months shall require a negative sample to be obtained from the producer's milk
supply by a certified sample collector prior to the milk being collected by the
hauler. Test results shall be reported to the Milk Safety Branch as soon as
possible.
(b) Producers with the
second antibiotic or other inhibitory substances violation during the past
twelve (12) months shall:
1. Be notified by
the Milk Safety Branch of the suspension by telephone and confirmed by letter.
The letter confirming the suspension shall include an Application for
Reinstatement of Permit, DFS-7A, incorporated by reference in
902
KAR 50:033.
2. Prior to an official sample being
collected for reinstatement purposes, the producer shall request permit
reinstatement in writing and indicate the problem has been corrected.
3. A representative of the Milk Safety Branch
shall visit the dairy producer after the request for reinstatement is received
and prior to the first official sample being taken.
4. During this farm visit the producer shall
demonstrate a method of marking cows treated with antibiotics to assure milk
from treated cows is not offered for sale.
5. Upon acceptance of the exclusion procedure
for treated cows, an official sample shall be collected and found to be
negative for antibiotics prior to shipment.
6. The first shipment of milk following the
negative sample shall not exceed four (4) milkings for Grade A purposes or six
(6) milkings for manufacturing purposes.
(c) Producers with more than two (2)
antibiotic or other inhibitory substances violations during the past twelve
(12) months shall:
1. Have their permits
suspended; and
2. May request an
administrative hearing by submitting a Request for a Hearing, incorporated by
reference in
902
KAR 50:033, to the Milk Safety Branch within ten (10)
days, to show cause why their permit should not be revoked.
3. The hearing shall be conducted in
accordance with
KRS
217C.100.
(5) Company or producer association policy.
Companies or producer associations having policies requiring producer penalties
for offering milk for sale containing antibiotics or other inhibitory
substances may have precedence over the enforcement policy outlined in this
administrative regulation provided that:
(a)
The policy is filed in writing with the Milk Safety Branch;
(b) The policy is approved by the Milk Safety
Branch as being as or more stringent than the enforcement procedures listed in
this administrative regulation; and
(c) Evidence is forwarded in writing that
company policy was carried out on each positive producer's milk sample
found.
Section
2. Adulterated Milk (Excessive Water).
(1)
(a)
Producers whose milk supplies are found to contain over ten (10) percent
excessive water shall be issued a notice requiring the supply to be withheld
from sale immediately.
(b) Milk
from this supply shall not be sold until a sample is collected by a certified
sample collector, analyzed in a certified laboratory, and is negative for
excessive water.
(2)
(a) Producers whose milk supplies are found
to contain more than two (2) percent but less than ten (10) percent excessive
water shall be issued a notice of adulteration and the milk supply resampled
after the lapse of three (3) days.
(b) Should the resample continue to show more
than two (2) percent excessive water, the producer shall be issued a notice
requiring the supply to be withheld from sale immediately.
(c) Milk shall not be sold from this supply
until a sample is collected by a certified sample collector, analyzed in a
certified laboratory, and is negative for excessive water.
(3)
(a)
Producers whose milk supplies are found to contain between five-tenths (.5)
percent to two (2) percent excessive water shall be notified and the milk
supply resampled after a lapse of three (3) days.
(b) Should the resample continue to have
between five-tenths (.5) percent to two (2) percent excessive water, a
supervised sample shall be collected by an inspector or other authorized
person. The supervised sample shall be used as a future reference point for the
accurate freezing point for the supply.
(4) Producers who repeatedly have milk
samples test positive for excessive water shall be issued a notice of permit
suspension.
(5) A producer whose
permit has been suspended may, at any time, submit an "Application for
Reinstatement of Permit", DFS-7A, incorporated by reference in
902
KAR 50:033, to the Milk Safety Branch.
(6) Suspension of a permit shall remain in
effect until a negative excessive water sample is obtained.
Section 3. Procedures for Testing
Milk Samples for Chemical Contaminants.
(1)
Raw milk samples shall be collected and analyzed for chemical contaminants a
minimum of annually from all bulk tank truck loads representing Kentucky dairy
producers and imported supplies from other states.
(2) Semiannual samples shall be collected
from loads having a previous history of chemical contaminants.
(3) Finished milk and milk products
manufactured and sold within Kentucky shall also be collected and
analyzed.
(4)
(a) Whenever a Kentucky inspected bulk tank
load of raw milk tests positive for any level of a chemical contaminant, the
individual milk producers represented on the load will be immediately notified
by telephone and confirmed by letter.
(b) Milk from each individual producer shall
be sampled on a screening basis after notification.
(c) If out-of-state bulk tank loads are found
to be contaminated, the shipping state regulatory agency will be immediately
notified by telephone and confirmed in writing.
(5)
(a)
Whenever laboratory results of an individual producer's milk sample shows a
violation of an established tolerance level for a particular chemical
contaminant, the supply shall be withheld from the market channels.
(b) The producer shall be notified by
telephone and confirmed in writing.
(c) An additional follow-up confirming sample
shall be collected within ten (10) working days after notification of
exclusion.
(d) Continued sampling
of an excluded milk producer's supply shall be maintained until an acceptable
level of the contaminant is attained.
(e) The frequency of additional sampling may
be at seven (7), fifteen (15), thirty (30), or sixty (60) day intervals. Higher
levels will be sampled on a more frequent basis.
(f) Whenever levels based on an official
sample fall below acceptable tolerance levels, the producer will be notified by
telephone and confirmed in writing that the supply is again acceptable for
sale.
(6)
(a) A producer may assist with testing
individual cows, feeds, and water supplies at their own expense.
(b) Results from producer obtained testing
shall be submitted to the Milk Safety Branch.
(7) The following procedure will be followed
whenever any level of polychlorinated biphenyls (PCBs) are found in a
producer's milk supply:
(a) The milk producer
shall be notified of the level of PCBs in the milk supply by telephone,
confirmed by letter, and the milk supply excluded.
(b) A farm inspection shall be made to
determine the type of silo being used.
(c) Concrete silos coated with cumar or other
sealers containing PCBs shall be condemned for use with the dairy
herd.
(d) A producer with a
condemned silo may:
1. Abandon the silo (do
not store feed); or
2. Recoat the
silo. If a silo is recoated, the producer shall notify the Milk Safety Branch
for approval prior to the silo being filled.
(e) The producer's milk supply shall be
placed on a continuous surveillance program until a negative sample is
obtained.
Section
4. Incorporation by Reference.
(1) "M-a-85 (Revision #16)", December 2018,
is incorporated by reference.
(2)
This material may be inspected, copied, or obtained, subject to applicable
copyright law, at Milk Safety Branch, Division of Public Health Protection and
Safety, Department for Public Health, 275 East Main Street, Frankfort, Kentucky
40621, Monday through Friday, 8 a.m. to 4:30 p.m.
STATUTORY AUTHORITY:
KRS
194A.050(1),
211.180(1)(c),
217C.040