Ohio Administrative Code
Title 901:11 - Dairy
Chapter 901:11-2 - Ohio Manufacture Milk Rules
Section 901:11-2-05 - Drug residue level
Universal Citation: OH Admin Code 901:11-2-05
Current through all regulations passed and filed through September 16, 2024
(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.
(2) Enforcement:
(a) The director may deny, suspend or revoke
the producer's license or registration for violation of this rule;
(b) The producer shall review the "Milk and
Dairy Beef 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:
10/24/2017 and
10/24/2022
Promulgated
Under: 119.03
Statutory
Authority: 917.02
Rule
Amplifies: 917.05,
917.22
Prior
Effective Dates: 06/18/2001, 06/06/2005, 09/19/2007, 08/09/2009, 04/22/2010,
10/02/2011, 02/21/2016
Disclaimer: These regulations may not be the most recent version. Ohio may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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