Illinois Administrative Code
Title 77 - PUBLIC HEALTH
Part 785 - MANUFACTURED DAIRY PRODUCTS
Subpart K - ADMINISTRATIVE PROCEDURES
Section 785.1220 - Drug Residue Monitoring and Farm Surveillance
Universal Citation: 77 IL Admin Code ยง 785.1220
Current through Register Vol. 48, No. 12, March 22, 2024
This Section describes the Department's Drug Residue Monitoring and Farm Surveillance Program. It is established to reference safe levels and/or tolerances and to assure milk supplies are in compliance with these safe levels or established tolerances for drug residues in milk.
a) Industry Responsibilities
1) Monitoring and Surveillance
A) Industry shall screen all bulk milk
pick-up tankers for beta lactam drug residues. Additionally, other drug
residues shall be screened for by employing a random sampling program on bulk
milk pick-up tankers. The random bulk milk pick-up tanker sampling program
shall represent and include, during any six months, at least four samples
collected in at least four separate months. Samples shall be analyzed as
specified by the Department.
B)
Bulk milk pick-up tanker testing shall be completed prior to processing the
milk. Bulk milk pick-up tanker samples found to have a violative drug residue
shall be retained as determined necessary by the Department. Industry shall
also record all sample results and retain those records for a period of six
months.
2) Reporting and
Farm Traceback
A) When a bulk milk pick-up
tanker is found to have a violative drug residue, the Department shall be
immediately notified of the results and the ultimate disposition of the raw
milk.
B) The individual sample
collected from each producer's milk that was in the bulk milk pick-up tanker
that was found to have a violative drug residue shall be immediately tested to
determine which producer or producers have created or contributed to the drug
residue.
C) Further pickups of the
violative individual producer or producers shall be immediately discontinued
until such time that subsequent tests no longer indicate violative drug
residues and enforcement requirements of subsection (b)(2) of this Section have
been met.
b) Department Responsibilities
1) Monitoring and
Surveillance
A) The Department shall monitor
industry surveillance activities by making unannounced on-site inspections to
collect samples from bulk milk pick-up tankers and to review industry records
of the random sampling program.
B)
The Department shall also perform routine sampling and testing for drug
residues determined to be necessary.
2) Enforcement
A) If testing reveals violative drug
residues, the milk shall be disposed of in a manner that removes it from the
human or animal food chain except where reconditioned under Department
approval.
B) When the individual
testing as required in subsection (a)(2)(B) of this Section is complete and the
tests indicate any drug residue at or above the tolerance and/or safe levels,
the producer's permit will be summarily suspended. Another sample will be taken
from milk produced after corrections have been made to determine whether this
adulteration is continual. For the third occurrence of a drug residue in any 12
month period, the Department shall initiate administrative procedures pursuant
to revocation of the producer's permit.
C) If the resample shows no violative drug
residue, the permit will then be conditionally reinstated until such time as
the producer and a licensed veterinarian have completed a quality assurance
program, but in no case for longer than 30 days.
D) When the field representative has
transmitted to the Department a copy of the quality assurance program
completion certificate signed by the producer and a licensed veterinarian, the
producer's manufactured raw milk permit shall be fully reinstated.
3) The following describes the
penalty procedures for the Department's drug residue control program for
manufactured raw milk.
A) These procedures
shall be followed when individual sample testing for drug residues has been
completed, test results indicate a violative drug residue, and the producer's
or producers' manufactured raw milk permit is summarily suspended in accordance
with subsection (b)(2)(B) of this Section. The producer or producers shall
submit to the Department an equivalent penalty to the 96 hour period following
the violative shipment for the second and third occurrences in any 12 month
period. The equivalent penalty for the second and third occurrences shall be
$4.00 per hundred weight of the milk produced during 96 hours following the
violative shipment. The penalty shall be paid to the Department by the first
buyer of the milk, by the last day of the month immediately following the
violation. Following the third occurrence of drug residue violation in any 12
month period, the Department shall initiate administrative procedures, pursuant
to Section
785.1200,
to permanently revoke the producer's permit.
B) The producer's manufactured raw milk
permit will be conditionally reinstated for up to 30 days when a subsequent
sample of the producer's milk does not contain a violative drug residue. The
producer and a licensed veterinarian must complete a quality assurance (QA)
program within the 30 day conditional reinstatement of the manufactured raw
milk permit.
C) When the field
representative has transmitted to the Department a copy of the quality
assurance program completion certificate signed by the producer and a licensed
veterinarian, the producer's manufactured raw milk permit shall be fully
reinstated.
4) All
monies collected through the drug residue control program shall be deposited in
the Food and Drug Safety Fund and will be dedicated to drug residue prevention
efforts, producer education and providing information for the prevention of
drug residue.
c) Established Tolerances and/or Safe Levels of Drug Residues
1) Tolerances for drug residues that may
result in milk are set forth in 21 CFR 556(1999).
2) "Safe levels" are used by the Department
for prosecutorial discretion. They do not legalize residues found in milk that
are below the safe level. Safe levels as established by the Federal Food and
Drug Administration will be transmitted by the Department via Technical
Releases.
Disclaimer: These regulations may not be the most recent version. Illinois 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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