Current through March 20, 2024
Authority: IC 15-17-3-21; IC 15-18-1-14
Affected: IC 15-17-2-2; IC 15-18-1-31
Sec.1.
(a) Milk shall
be screened for the presence of drug residues as follows:
(1) Any milk plant that accepts raw milk
shall test each bulk milk pickup tanker for beta lactam drug residues. Each
bulk milk pickup tanker shall be sampled after the last producer has been
picked up and before any additional commingling of milk using a representative
sample from the truck. Samples shall be tested as follows:
(A) Using a test that has been approved by
the United States Food and Drug Administration for screening milk for drug
residues.
(B) In a laboratory that
is certified by the state veterinarian by an analyst that is certified by the
state veterinarian. When a drug residue test is positive, confirmatory testing
and testing to determine the farm of origin shall be conducted in accordance
with Appendix N of the Grade A Pasteurized Milk Ordinance.
(2) The state veterinarian may implement a
testing program to test milk from bulk milk pickup tankers for other drug
residues.
(3) The state
veterinarian may implement a testing program to test milk from any source for
drug residues. The testing programs may include samples from farm bulk tanks,
milk plants, or finished products as part of a monthly quality program or other
surveillance program. Samples that test positive for drug residues are subject
to the provisions of this section.
(4) Milk plants shall keep records of all
drug residue tests that are conducted on bulk milk pickup tankers and farm bulk
milk tanks and must include the information indicated in Appendix N of the PMO
incorporated by reference in
345 IAC
8-3-1. The records shall be kept for not less than two
(2) years.
(b) All tests
completed under this section must meet the following requirements:
(1) The test must be a test approved by the
United States Food and Drug Administration for screening milk samples for drug
residues.
(2) The test must be
conducted as follows:
(A) By an analyst
approved by the state veterinarian under the standards in Appendix N of the PMO
incorporated by reference in
345 IAC
8-3-1.
(B)
In a laboratory approved by the state veterinarian under the standards in
Appendix N of the PMO incorporated by reference in
345 IAC
8-3-1.
(3) A test that is being run to confirm a
positive drug residue test result must be the same test that was used to obtain
the initial positive drug residue result. A person may use a different
confirmatory test, however, if the state veterinarian approves the use of that
confirmatory test. The state veterinarian may approve the use of a confirmatory
test that is different from a prior test after:
(A) evaluating the circumstances surrounding
the request; and
(B) determining
that the use of the proposed confirmatory test is consistent with the purposes
of this section.
(c) Milk tests positive for drug residues if
a test meeting the requirements in subsection (b) indicates the presence of
drug residues in the milk at any level.
(d) Whenever milk tests positive for drug
residues and is confirmed, the following apply:
(1) The milk that tests positive for drug
residues is adulterated under IC
15-17-2-2
and must be disposed of in a manner that:
(A)
removes it from the human and animal food chain; or
(B) acceptably reconditions the milk under
United States Health and Human Services-Food and Drug Administration compliance
policy guidelines.
(2)
The state veterinarian shall determine the origin of the contaminated milk.
Milk from the farm of origin creates an imminent hazard to the public health.
The state veterinarian shall:
(A) suspend the
Grade A farm permit or manufacturing grade farm permit; or
(B) take other equally effective measures to
prevent the sale of milk containing drug residues.
(3) When a drug test shows the producer's
milk is negative for drug residues, the state veterinarian may:
(A) reinstate the farm permit; or
(B) take other action to allow the sale of
milk for human food.
(e) All positive drug residue test results
must be called into the office of the state veterinarian immediately, and a
written report of the test results must be faxed or delivered to the office of
the state veterinarian within twenty-four (24) hours of the test. The producer
whose milk tested positive must be notified of the positive drug residue test
immediately. The company that conducted the test is responsible for the
reporting requirements in this subsection.
(f) A producer whose milk tests positive for
drug residues shall pay a fine and participate in drug residue education
activities as follows:
(1) The following is
imposed on a producer for the first positive test for drug residues within a
twelve (12) month period:
(A) The positive
producer must pay a fine to the board equal to the result of the following
equation:
(DP) (2 days) ($3) - (PR)
However, if the result is less than five dollars ($5), then
the fine is five dollars ($5).
(B) The positive producer must, in
conjunction with his or her veterinarian and an official of the board:
(i) complete an approved protocol to prevent
future drug residue violations; and
(ii) provide proof of completion to the
board, office of the state veterinarian within thirty (30) days of the drug
residue violation.
Failure to complete the protocol and submit proof of
completion within thirty (30) days will result in action to suspend the
producer's permit.
(2) The following is imposed for a second
positive test for drug residues within a twelve (12) month period:
(A) The fine set forth in subdivision (1) is
imposed.
(B) The positive producer
must, in conjunction with his or her veterinarian and an official of the board:
(i) complete an approved protocol to prevent
future drug residue violations; and
(ii) provide proof of completion to the
board, office of the state veterinarian within thirty (30) days of the drug
residue violation. Failure to complete the protocol and provide proof of
completion will result in action to suspend the producer's permit.
(C) The producer must attend a
meeting called by the state veterinarian to discuss the violations and
demonstrate that appropriate practices have been implemented to mitigate the
risk of further residue violations.
(3) The third or subsequent positive test
result for drug residues within a twelve (12) month period shall result in the
following:
(A) The board shall initiate
action under IC 15-18 to suspend or revoke a producer's Grade A permit if the
producer has a permit.
(B) The fine
set forth in subdivision (1) is imposed.
(C) If a producer requests reinstatement of
the producer's permit, the producer must submit to the state veterinarian a set
of written procedures that he or she will follow to prevent future drug residue
violations. The procedures must be specific, practical, and reasonably likely
to lessen the possibility of a drug residue violation when followed by the
producer.
(g)
The following definitions apply throughout this section:
(1) "DP" or "daily production" means the
amount of milk, measured by hundredweight, produced by the positive producer in
one (1) day, measured on the day in which the drug residue violation
occurred.
(2) "PR" or "producer
reimbursement" means an amount assessed against the positive producer to
reimburse others for milk contaminated by the positive producer's contaminated
milk, not including the value of the positive producer's contaminated milk for
which he or she was not paid.
(3)
"Revocation period" means the period after a Grade A producer's permit is
revoked under this rule that he or she may not apply for a Grade A
permit.
(h) The
following shall apply to penalties imposed by this section:
(1) In cases where the positive producer
holds a Grade A permit from the board, the provisions in this section shall
operate in place of and as an equivalent to the penalties in Appendix N of the
Pasteurized Milk Ordinance.
(2) All
monetary penalties must be:
(A) paid by the
producer; and
(B) received by the
office of the state veterinarian within sixty (60) days of notice of the drug
residue violation.
(3)
The state veterinarian may, by special permit, allow a producer that objects to
the imposition of a fine to dump two (2) days of milk production on a first
offense and four (4) days of milk production on the second or third offense
instead of paying a monetary fine where payment of a fine would impose undue
hardship on a producer. The state veterinarian may:
(A) set the conditions under which the milk
is to be dumped; and
(B) require
documentation from the producer showing the circumstances under which the milk
was dumped.
(4) Proof
that a producer reimbursement was in fact assessed must be submitted to the
office of the state veterinarian within sixty (60) days of notice of the drug
residue violation along with any monetary penalty due.
(5) No penalty may exceed one thousand
dollars ($1,000) for a first offense or two thousand dollars ($2,000) for a
subsequent offense. Civil penalties collected under this section must be
deposited in the dairy drug residue abatement fund established under IC
15-18-1-31.
(i) The state veterinarian may
suspend the permit of a producer that does not comply with the requirements of
this rule within the designated time periods allowed under this rule until such
time as the violation is remedied.
(j) The following are examples that
illustrate the calculation of the fine imposed by this rule:
(1) A fine is calculated as follows for a
first or subsequent offense:
(A) Total
positive truck load CWT: 500
(B)
Positive producer's CWT on positive tanker (two (2) days' production):
100
(C) Producer's daily production
CWT: 50
(D) Co-op requires producer
to pay for other producers' milk that is contaminated at fifteen dollars ($15)
per CWT.
Penalty = (DP) (2 days) ($3) - (PR).
= [50 (2) ($3)] - [(500 - 100) ($15)].
= [$300 fine] - [$6,000 reimbursement paid to other
producers]. Because the reimbursement to other producers exceeded the fine, no
money is payable to the state as long as proof of the reimbursement assessment
is provided to the board.
(2) A fine is calculated as follows for a
first or subsequent offense:
(A) Total
positive truck load CWT: 500
(B)
Positive producer's CWT on positive tanker (two (2) days' production):
400
(C) Producer's daily production
CWT: 200
(D) Co-op requires
producer to pay for other producers' milk that is contaminated at fifteen
dollars ($15) per CWT.
Penalty = (DP) (2 days) ($3) - (PR).
= [200 (2) ($3)] - [(500 - 400) ($15)].
= [$1,200 fine] - [$1,500 reimbursement paid to other
producers].
Because the reimbursement to other producers exceeded the
fine, no money is payable to the state as long as proof of the reimbursement
assessment is provided to the board.
(3) A fine is calculated as follows for a
first or subsequent offense:
(A) Positive bulk
tank on monthly quality check or otherwise.
(B) Producer's daily production (CWT): 50
Penalty = (DP) (2 days) ($3) - (PR).
= [50 (2) ($3)] - 0.
Because there was no reimbursement to other producers, all of
the three hundred dollar ($300) fine is payable to the state.
This version of section effective September 17, 2018. See
also preceding version of section, effective until September 17,
2018.
