Alabama Administrative Code › Title 420 - ALABAMA STATE BOARD OF HEALTH › Chapter 420-3-16 - PRODUCTION, PROCESSING, HANDLING OR DISTRIBUTION OF MILK, MILK PRODUCTS AND FROZEN DESSERTS › APPENDICES › Appendix N - DRUG RESIDUE TETING AND FARM SURVEILLANCE

Current through Register Vol. 42, No. 9, June 28, 2024
I.
INDUSTRY RESPONSIBILITIES MONITORING AND
				  SURVEILLANCE
Industry shall screen all bulk milk pickup tankers and/or all
				  raw milk supplies that have not been transported in bulk milk pickup tankers,
				  regardless of final use, for Beta lactam drug residues. Additionally, other
				  drug residues shall be screened for by employing a random sampling program on
				  bulk milk pickup tankers and/or all raw milk supplies that have not been
				  transported in bulk milk pickup tankers when the Commissioner of the FDA
				  determines that a potential problem exists as cited in Rule
				  420-3-16-.07. The random bulk
				  milk pickup tanker and/or all raw milk supplies that have not been transported
				  in bulk milk pickup tankers sampling program shall represent and include,
				  during any consecutive six (6) months, at least four (4) samples collected in
				  at least four (4) separate months, except when three (3) months show a month
				  containing two (2) sampling dates separated by at least twenty (20) days.
				  Samples collected under this random sampling program shall be analyzed as
				  specified by the FDA (refer to Rule
				  420-3-16-.07).
The bulk milk pickup tanker shall be sampled after the last
				  producer has been picked up and before any additional commingling. These bulk
				  milk pickup tanker samples may be collected using an approved aseptic sampler.
				  The sample shall be representative. Bulk milk pickup tanker testing shall be
				  completed prior to processing the milk. Bulk milk pickup tanker samples
				  confirmed positive for drug residues using approved test methods and/or
				  verified screening positive using test methods not evaluated by the FDA and
				  accepted by the NCIMS without additional confirmation required shall be
				  retained as determined necessary by the Health Officer.
All raw milk supplies that have not been transported in bulk
				  milk pickup tankers shall be sampled prior to processing the milk. The
				  sample(s) shall be representative of each farm bulk milk tank(s)/silo(s), milk
				  plant raw milk tank(s) and/or silo(s), other raw milk storage container(s),
				  etc. Testing of all raw milk supplies that have not been transported in bulk
				  milk pickup tankers shall be completed prior to processing the milk.
Note:
On-farm producer/processors that plan to
				  store or ship their raw sheep milk frozen shall sample their raw sheep milk
				  prior to freezing. The sample shall be obtained by a bulk milk hauler or
				  sampler permitted by the Health Officer where the dairy farm is located. The
				  raw sheep milk sample shall then be tested in a certified laboratory or
				  screening facility. If this is the on-farm producer/processor's only raw sheep
				  milk supply, this testing would suffice for the required Appendix N testing for
				  all raw milk supplies that have not been transported in bulk milk pickup
				  tankers, which are required to be completed prior to processing the milk. In
				  the case of sheep milk dairy farms, the raw milk sample may be frozen in
				  accordance with a sample protocol approved by the Health Officer in which the
				  dairy farm is located as specified in Appendix B and transported to a certified
				  laboratory for testing. The test results, or raw milk samples, shall clearly
				  distinguish the lot number of the frozen raw sheep milk and accompany the
				  frozen raw sheep milk to the plant.
All presumptive positive test results for drug residues using
				  approved test methods or verified screening positive test results using test
				  methods not evaluated by the FDA and accepted by the NCIMS from analysis
				  conducted on commingled raw milk tanks, bulk milk pickup tankers, and/or all
				  raw milk supplies that have not been transported in bulk milk pickup tankers or
				  farm raw milk tanks/silos (only milk offered for sale) samples shall be
				  reported to the regulatory agency in which the testing was conducted. Bulk milk
				  pickup tanker and/or all raw milk supplies that have not been transported in
				  bulk milk pickup tankers samples confirmed positive for drug residues using
				  approved test methods or verified screening positive using test methods not
				  evaluated by FDA and accepted by the NCIMS without additional confirmation
				  required shall be retained or disposed of as determined by the regulatory
				  agency.
Industry plant samplers shall be evaluated according to the
				  requirements specified in Section 6 and at the frequency addressed in Section
				  5.
REPORTING AND FARM TRACE BACK
When a bulk milk pickup tanker and/or a raw milk supply that
				  has not been transported in bulk milk pickup tankers is found to be presumptive
				  positive for drug residues using approved test methods or verified screening
				  positive for drug residues using test methods not evaluated by the FDA and
				  accepted by the NCIMS, the regulatory agency in which the testing was conducted
				  shall be immediately notified of the results and the ultimate disposition of
				  the raw milk.
The producer samples from the bulk milk pickup tanker found
				  to be confirmed positive for drug residues using approved test methods or
				  verified screening positive for drug residues using test methods not evaluated
				  by the FDA and accepted by the NCIMS without additional confirmation required
				  shall be individually tested to determine the farm of origin. The samples shall
				  be tested as directed by the regulatory agency.
Upon official notification to the regulatory agency and milk
				  producer of a violative individual producer's milk, further farm pickups by
				  bulk milk pickup tankers and/or all raw milk supplies that have not been
				  transported in bulk milk pickup tankers and/or farm use of the violative
				  individual producer's milk shall be immediately discontinued until such time
				  that subsequent tests are no longer positive for drug residues.
RECORD REQUIREMENTS
Results of all testing may be recorded in any format
				  acceptable to the Health Officer that includes at least the following
				  information:
1. Identity of the person doing the test.
2. Identity of the bulk milk pickup tanker or farm bulk milk
				  tank(s)/ silo(s), milk plant raw milk tank(s) and/or silo(s), other raw milk
				  storage container(s), etc. used for the storage of all raw milk supplies that
				  have not been transported in bulk milk pickup tankers being tested*.
3. Date/time the test was performed (time, day, month and
				  year).
4. Identity of the test performed/lot #/any and all controls
				  (+/-).
5. Results of the test.
6 Follow-up testing if the initial test was positive/any and
				  all controls (+/-).
7. Site where test was performed.
8. Prior test documentation shall be provided for a
				  presumptive positive load.
*Include the BTU number(s) of the dairy farms present on the
				  bulk milk pickup tanker and/or all raw milk supplies that have not been
				  transported in bulk milk pickup tankers with the above information.
Records of all sample test results shall be maintained for a
				  minimum of six (6) months by the industry at the location where the test
				  methods were run and/or another location as directed by the regulatory agency
				  and as agreed to by industry. For the laboratory survey, two (2) years of
				  records shall be available at the facility at the time of the survey.
II.
REGULATORY AGENCY RESPONSIBILITIES
Upon receipt of notification from industry of a bulk milk
				  pickup tanker and/or a raw milk supply that has not been transported in bulk
				  milk pickup tankers, which contains milk from another regulatory agency's
				  jurisdiction, is found to be presumptive positive for drug residues using
				  approved test methods or verified screening positive for drug residues using
				  test methods not evaluated by the FDA and accepted by the NCIMS, it is the
				  responsibility of the receiving regulatory agency to notify the regulatory
				  agency(ies) from which the milk originated.
MONITORING AND SURVEILLANCE
Regulatory agencies shall monitor industry surveillance
				  activities during either routine or unannounced on-site quarterly inspections
				  to collect samples from bulk milk pickup tankers and/or all raw milk supplies
				  that have not been transported in bulk milk pickup tankers and to review
				  industry records of their sampling program. Samples should be collected and
				  analyzed from at least 10 percent of the bulk milk pickup tankers and/or all
				  raw milk supplies that have not been transported in bulk milk pickup tankers
				  scheduled to arrive on the day of the inspection. The test method used shall be
				  appropriate for the drug being analyzed and shall be capable of detecting the
				  same drugs at the same concentrations as the test method being used by
				  industry. Alternately, the regulatory agency or Laboratory Evaluation Officer
				  (LEO) may take known samples with them on the audit visit and observe the
				  Industry Analyst (IA) test the samples. Receiving locations that choose to
				  certify all receiving IAs certified under the provisions of the NCIMS
				  Laboratory Certification Program are exempt from the sample collection
				  requirements of this section. Receiving locations where all approved receiving
				  IAs and Industry Supervisors (ISs) successfully participate in a biennial
				  on-site evaluation and annual spilt sample comparisons by LEOs are also exempt
				  from the sample collection requirements of this section.
A review shall include, but not be limited to, the
				  following:
1. Is the program an appropriate routine monitoring program
				  for the detection of drug residues?
2. Is the program utilizing appropriate test methods?
3. Is each producer's milk represented in a testing program
				  for drug residues and tested at the frequency prescribed in Section I for drug
				  residues?
4. Is the program assuring timely notification to the
				  appropriate regulatory agency of positive results, the ultimate disposition of
				  the bulk milk pickup tanker, and/or a raw milk supply that has not been
				  transported in bulk milk pickup tankers and of the trace back to the farm of
				  origin?
5. Is the dairy farm pickup and/or use of the violative
				  individual producer's milk suspended until subsequent testing establishes the
				  milk is no longer positive for drug residues?
To satisfy these requirements
a. There shall be an agreement between the Health Officer and
				  industry that specifies how this notification is to take place. This
				  notification shall be "timely" for example by telephone or fax, and supported
				  in writing.
b. The ultimate disposition should either be prearranged in a
				  documented agreement between the Health Officer and the industry, or physically
				  supervised by the Health Officer. The milk should be disposed of in accordance
				  with provisions of M-I-06-5 or an FDA and Health Officer reviewed and accepted
				  specific drug residue milk diversion protocol for use as animal feed.
c. All screening test positive (confirmed) loads using an
				  approved test method shall be broken down (producer trace back) using the same
				  or an equivalent test method (M-I-96-10, latest revision). Confirmation tests
				  (load and producer trace back/permit enforcement action) shall be performed by
				  an Official Laboratory, Officially Designated Laboratory or Certified Industry
				  Supervisor (CIS). Positive producers shall be handled in accordance with this
				  appendix.
d. All verified screening test positive loads using test
				  methods not evaluated by the FDA and accepted by the NCIMS without additional
				  confirmation required shall be broken down (producer trace back) using the same
				  test method. Producer trace back shall be performed as cited in a prior
				  documented agreement with the regulatory agency (refer to Section VI). Verified
				  screening positive producers shall be handled in accordance with this
				  appendix.
e. All screening test positive (confirmed) loads shall be
				  broken down (producer trace back) using the same or an equivalent test method
				  (M-I-96-10, latest revision). Confirmation tests (load and producer trace
				  back/permit action) shall be performed by an Official Laboratory, Officially
				  Designated Laboratory, or Certified Industry Supervisor (CIS). Positive
				  producers shall be handled in accordance with this appendix.
f. When a farm bulk milk tank(s)/silo(s), milk plant raw milk
				  tank(s) and/or silo(s), other raw milk storage container(s), etc. is (are) used
				  for a milk plant's raw milk supply(ies) that has (have) not been transported in
				  bulk milk pickup tankers, is (are) found to be positive (confirmed) for drug
				  residues, the farm of origin of the drug residue has consequently already been
				  determined and further testing is not required to determine the farm of origin.
				  Confirmation tests shall be performed by an Official Laboratory, Officially
				  Designated Laboratory, or Certified Industry Supervisor. Positive producers
				  shall be handled in accordance with this appendix.
g. The suspension and discontinuance of farm bulk milk tank
				  pick up and/or the use of raw milk supplies that have not been transported in
				  bulk milk pickup tankers is the responsibility of the industry; under the
				  direction and supervision of the Health Officer. At the discretion of the
				  Health Officer, records should be maintained by industry and/or the Health
				  Officer that:
(1) Establish the identity of the producer for raw milk
				  supplies that have not been transported in bulk milk pickup tankers that tested
				  positive or the producer and the identity of the load that tested
				  positive.
(2) Establish that milk is not picked up or used from the
				  drug residue positive producer until the regulatory agency has fulfilled their
				  obligations under Section II., as applicable, based on the test method
				  utilized, and has cleared the milk for pick up and/or use.
Sufficient records should be reviewed to assure that all bulk
				  milk pickup tankers and/or all raw milk supplies that have not been transported
				  in bulk milk pickup tankers are sampled before additional commingling at the
				  milk receiving facility and the results were made available to the appropriate
				  BTU(s).
The Health Officer shall also perform routine sampling and
				  testing for drug residues determined to be necessary as outlined in Section
				  6.
ENFORCEMENT
If testing reveals milk positive for drug residues, the milk
				  shall be disposed of in a manner that removes it from the human or animal food
				  chain, except where acceptably reconditioned under FDA Compliance Policy Guide
				  (CPG 7126.20). The Health Officer shall determine the producer(s) responsible
				  for the violation.
Permit Suspension and the Prevention of the Sale of
				  Milk
-Any time milk is found to test as a confirmed positive using an
				  approved test method, the regulatory agency shall immediately suspend the
				  producer's Grade "A" permit or equally effective measures shall be taken to
				  prevent the sale of milk containing drug residues. Upon official notification
				  to the regulatory agency and milk producer of a confirmed positive, future farm
				  pickups by bulk milk pickup tankers and/or all raw milk supplies that have not
				  been transported in bulk milk pickup tankers and/or farm use of the violative
				  individual producer's milk are prohibited until subsequent testing reveals the
				  milk is free of drug residue.
Prevention of the Sale of Milk
- Any time milk
				  is found to test as a verified screening positive for a drug residue using test
				  methods not evaluated by the FDA and accepted by the NCIMS without additional
				  confirmation required, the regulatory agency shall immediately take effective
				  measures to prevent the sale of the milk containing drug residues.
Penalties for Confirmed Positive Milk
- The
				  penalty shall be for the value of all milk on the contaminated load and/or raw
				  milk supply that has not been transported in bulk milk pickup tankers plus any
				  costs associated with the disposition of the contaminated load or raw milk
				  supply that has not been transported in bulk milk pickup tankers. The
				  regulatory agency may accept certification from the violative producer's milk
				  marketing cooperative or purchaser of milk as satisfying the penalty
				  requirements.
Reinstatement
- The Grade "A" producer's permit
				  may be reinstated, or other action taken, to allow the sale of milk for human
				  food when a representative sample taken from the producer's milk, prior to
				  commingling with any other milk, is no longer positive for drug residue.
Follow-Up
- Whenever a drug residue test is
				  confirmed positive using an approved test method or verified screening positive
				  using test methods not evaluated by the FDA and accepted by the NCIMS, an
				  investigation shall be made to determine the cause. The farm inspection is
				  completed by the regulatory agency or its agent to determine the cause of the
				  residue and actions taken to prevent future violations including:
1. On-farm changes in procedures necessary to prevent future
				  occurrences as recommended by the Health Officer.
2. Discussion and education on the Drug Residue Avoidance
				  Control measures outlined in Appendix C.
Permit Revocation
- After a third violation for
				  a drug residue in a twelve (12) month period, the Health Officer shall initiate
				  administrative procedures pursuant to the revocation of the producer's Grade
				  "A" permit under the authority of Section 3, due to repeated violations.
HEALTH OFFICER RECORDS
In regards to the industry reporting a confirmed positive
				  using an approved test method or verified screening positive using test methods
				  not evaluated by the FDA and accepted by the NCIMS tanker and/or a raw milk
				  supply that has not been transported in bulk milk pickup tankers result, the
				  regulatory agency's records shall indicate the following:
1. What were the Health Officer's directions?
2. When was the Health Officer notified? By whom?
3. What was the identity of the load or farm bulk milk
				  tank(s)/silo (s), milk plant raw milk tank(s) and/or silo(s), other raw milk
				  storage container(s), etc. when used for a milk plant's raw milk supply(ies)
				  that has (have) not been transported in bulk milk pickup tankers?
4. What screening and/or confirmatory test(s) were used and
				  who were the analyst (s)?
5. What was the disposition of the adulterated milk?
6. Which producer(s) was responsible?
7. Record of negative test results prior to subsequent milk
				  pickup from the violative producer(s).
III.
TESTING PROGRAM FOR DRUG RESIDUES ESTABLISHED
				  DEFINITIONS
For purposes of this appendix the following definitions are
				  to be used:
(1)
Presumptive Positive
- A presumptive
				  positive test is a positive result from an initial testing of a bulk milk
				  pickup tanker and/or raw milk supply that has not been transported in bulk milk
				  pickup tankers using an M-a-85, latest revision, or M-I-92-11 approved test
				  method, which has been promptly repeated in duplicate with positive (+) and
				  negative (-) controls that give the proper results using the same test method,
				  on the same sample, with one (1) or both of these duplicate retests giving a
				  positive result.
(2) Screening Test Positive (Load or Raw Milk Supply that has
				  not been Transported in Bulk Milk Pickup Tankers Confirmation) - A screening
				  test positive (confirmation) result is obtained when the presumptive positive
				  sample is tested in duplicate, using the same or equivalent (M-I-96-10, latest
				  revision) test method as that used for the presumptive positive, with a
				  positive (+) and negative (-) control that gives the proper results, and either
				  or both of the duplicates are positive. A screening test positive (load or farm
				  bulk milk tank(s)/silo(s), milk plant raw milk tank(s) and/or silo(s), other
				  raw milk storage container(s), etc. when used for a milk plant's raw milk
				  supply(ies) that has (have) not been transported in bulk milk pickup tankers
				  confirmation) is to be performed by an Official Laboratory, Officially
				  Designated Laboratory or CIS using the same or an equivalent test (M-I-96-10,
				  latest revision).
Note:
When a farm bulk milk tank(s)/silo(s),
				  milk plant raw milk tank(s) and/or silo(s), other raw milk storage
				  container(s), etc. is used for a milk plant's raw milk supply(ies) that has not
				  been transported in bulk milk pickup tankers is found to be positive
				  (confirmed) for drug residues using approved test methods, the farm of origin
				  for the drug residue has consequently already been determined and further
				  testing is not required to determine the farm of origin.
(3)
Individual Producer Load
- An individual
				  producer bulk milk pickup tanker is a bulk milk pickup tanker or a
				  compartment(s) of a bulk milk pickup tanker that contains milk from only one
				  (1) dairy farm.
(4)
Individual On-Farm Producer/Processor's Raw Milk
				  Supply
- An individual on-farm producer/processor's raw milk supply may
				  be transported in bulk milk pickup tankers; and/or their raw milk supply may be
				  stored in a farm bulk milk tank(s)/silo(s) on the dairy farm that directly
				  feeds the batch (vat) pasteurizer(s) or constant-level tank of a HTST
				  pasteurization system or piped from a farm bulk milk tank(s)/silo(s) to a raw
				  milk tank(s) and/or silo(s) in the milk plant that feeds the batch (vat)
				  pasteurizer(s) or constant-level tank of a HTST pasteurization system; and/or
				  other raw milk storage containers.
(5)
Industry Analyst
- A person under the
				  supervision of a Certified Industry Supervisor (CIS) or Industry Supervisor
				  (IS) who is assigned to conduct screening of bulk milk pickup tankers and/or
				  all raw milk supplies that have not been transported in bulk milk pickup
				  tankers for Appendix N.
(6)
Industry Supervisor/Certified Industry Supervisor
- An individual trained by a LEO who is responsible for the supervision
				  and training of Industry Analysts (IA) who test milk tank trucks and/or all raw
				  milk supplies that have not been transported in bulk milk pickup tankers for
				  Appendix N.
(7)
Certified Industry Supervisor (CIS)
- An
				  Industry Supervisor (IS) who is evaluated and listed by a LEO as certified to
				  conduct drug residue screening tests using approved test methods at industry
				  drug residue screening sites for
Grade "A" PMO
, Appendix N.
				  enforcement actions (confirmation of bulk milk pickup tankers, farm bulk milk
				  tank(s)/silo(s), milk plant raw milk tank(s) and/or silo(s), or other raw milk
				  storage container(s), etc. when used for a milk plant's raw milk supply(ies)
				  that has (have) not been transported in bulk milk pickup tankers, producer
				  trace back and/or permit actions).
(8)
Verified Screening Positive
- A verified
				  screening positive test is a positive result from an initial testing using test
				  methods not evaluated by the FDA and accepted by the NCIMS of a bulk milk
				  pickup tanker and/or raw milk supply that has not been transported in bulk milk
				  pickup tankers, which has been promptly repeated in duplicate with positive (+)
				  and negative (-) controls that give the proper results, using the same test
				  method, on the same sample, with one (1) or both of these duplicate retests
				  giving a positive result.
(9)
Producer Trace Back With Permit Suspension Action
				  Not Required
- A producer trace back test is performed after a verified
				  screening positive load using test methods not evaluated by FDA and accepted by
				  the NCIMS without additional confirmation required is identified by a
				  laboratory using the same test method as was used to obtain the verified
				  screening positive load. A verified screening positive producer test result is
				  obtained in the same manner as a verified screening positive for a bulk milk
				  pickup tanker. After an initial positive result is obtained on a producer
				  sample, that sample is then tested in duplicate using the same test method as
				  was used to obtain the initial producer positive result. This testing is
				  performed with positive (+) and negative (-) controls and if either or both of
				  the duplicates are positive and the controls give the proper results, the
				  producer sample is a verified screening positive (refer to Section VI).
Note:
When a farm bulk milk tank(s)/silo(s),
				  milk plant raw milk tank(s) and/or silo(s), other raw milk storage
				  container(s), etc. is used for a milk plant's raw milk supply(ies) that has not
				  been transported in bulk milk pickup tankers is found to be verified screening
				  positive for drug residues using only test methods not evaluated by the FDA and
				  accepted by the NCIMS without additional confirmation required, the farm of
				  origin for the drug residue has consequently already been determined and
				  further testing is not required to determine the farm of origin.
CERTIFIED INDUSTRY SUPERVISORS; EVALUATION AND
				  RECORDS
Reference:
EML
1.
Certified Industry Supervisors (CISs)/Industry
				  Supervisors (ISs)/Industry Analysts (IAs)
- Regulatory agencies may
				  choose to allow ISs to be certified. Under this program, these CISs may
				  officially confirm presumptive positive bulk milk pickup tanker loads and/or
				  all raw milk supplies that have not been transported in bulk milk pickup
				  tankers, and confirm producer milk for regulatory purposes (producer trace
				  back/permit action) using approved test methods. In the implementation of
				  Appendix N, the LEO shall use the appropriate Appendix N FDA/NCIMS 2400 Form
				  when evaluating Official Laboratories, Officially Designated Laboratories, or
				  CISs, ISs, and IAs.
The Certified Industry Supervisor/Industry Supervisor shall
				  report to the LEO the results of all competency evaluations performed on
				  Industry Analysts. The names of all Certified Industry Supervisors, Industry
				  Supervisors, and Industry Analysts, as well as their training and evaluation
				  status, shall be maintained by the LEO and updated as replacement, additions,
				  and/or removals occur. The LEO shall verify (document) that each Certified
				  Industry Supervisor and/or Industry Supervisor has established a program that
				  ensures the proficiency of the Industry Analysts they supervise. The LEO shall
				  also verify that each Industry Supervisor and Industry Analyst has demonstrated
				  proficiency in performing drug residue analysis at least biennially.
				  Verification may include an analysis of split samples and/or an on-site
				  performance evaluation or another proficiency determination that the LEO and
				  the FDA Laboratory Proficiency Evaluation Team (LPET) agree is
				  appropriate.
Failure by the Industry Supervisor or Industry Analyst to
				  demonstrate adequate proficiency to the LEO shall lead to their removal from
				  the LEO list of Industry Supervisors and/or Industry Analysts. Reinstatement of
				  their testing status shall only be possible by completing retraining and/or
				  successfully analyzing split samples and/or passing an on-site evaluation or
				  otherwise demonstrating proficiency to the LEO (refer to the
EML
, which describes the certification requirements for
				  Certified Industry Supervisors and the training requirements for Industry
				  Supervisors and Industry Analysts).
2.
Sampling and Testing of Bulk Milk Pickup Tankers
-The bulk milk pickup tanker shall be sampled after the last producer
				  has been picked up and before any additional commingling. The sample shall be
				  representative. The sample analysis shall be completed before the milk is
				  processed.
3.
Sampling and Testing of Raw Milk Supplies that have
				  Not been Transported in Bulk Milk Pickup Tankers
- All raw milk supplies
				  that have not been transported in bulk milk pickup tankers shall be sampled
				  prior to processing the milk. The sample(s) shall be representative of each
				  farm bulk milk tank(s)/silo(s), milk plant raw milk tank(s) and/or silo(s), or
				  other raw milk storage container(s) supply. Testing of all raw milk supplies
				  that have not been transported in bulk milk pickup tankers shall be completed
				  prior to processing the milk.
4.
Bulk Milk Pickup Tanker Unloaded Prior to Negative
				  Test Result
- If the bulk milk pickup tanker is unloaded and commingled
				  prior to obtaining a negative test result and the screening test is presumptive
				  positive using an approved test method or verified screening positive using
				  test methods not evaluated by the FDA and accepted by the NCIMS, the regulatory
				  agency shall be immediately notified. If the bulk milk tanker sample is
				  confirmed positive using an approved test method or verified screening positive
				  using test methods not evaluated by the FDA and accepted by the NCIMS without
				  additional confirmation required then the commingled milk is adulterated and
				  unacceptable for human consumption regardless of any subsequent test results
				  from the commingled milk. The milk shall be disposed of under the supervision
				  of the regulatory agency.
5.
Raw Milk Supplies that have Not been Transported in
				  Bulk Milk Pickup Tankers Processed Prior to Negative Results
- If the
				  raw milk supply that has not been transported in bulk milk pickup tankers is
				  processed prior to obtaining a negative test result and the screening test is
				  presumptive positive using an approved test method or verified screening
				  positive using test methods not evaluated by FDA and accepted by the NCIMS, the
				  regulatory agency shall be immediately notified. If the sample of the raw milk
				  supply that has not been transported in bulk milk pickup tankers is confirmed
				  positive using an approved test method or verified screening positive using
				  test methods not evaluated by the FDA and accepted by the NCIMS without
				  additional confirmation required then the processed milk is adulterated and
				  unacceptable for human consumption regardless of any subsequent test results
				  from the raw milk supply and/or pasteurized milk or milk products. The
				  processed milk shall be disposed of under the supervision of the regulatory
				  agency.
BULK MILK PICKUP TANKER AND/OR ALL RAW MILK SUPPLIES
				  THAT HAVE NOT BEEN TRANSPORTED IN BULK MILK PICKUP TANKERS SCREENING
				  TEST
1. Performance Tests/Controls - Each lot of test kits
				  purchased shall be tested by positive (+) and negative (-) controls in each
				  screening facility prior to its initial use and each testing day thereafter.
				  Records of all positive (+) and negative (-) control performance tests shall be
				  maintained.
2. Initial Drug Testing Procedures - The following procedures
				  apply to testing bulk milk pickup tankers and/or all raw milk supplies that
				  have not been transported in bulk milk pickup tankers for drug residues
				  following the provisions of Appendix N. Industry analysts may screen tankers
				  and/or all raw milk supplies that have not been transported in bulk milk pickup
				  tankers and receive or reject milk. Milk plants, receiving stations, transfer
				  stations, and other screening locations may choose to participate in the
				  Industry Supervisor Certification Program.
a. Industry Presumptive Positive Options - There are two (2)
				  industry options for the milk represented by a presumptive positive
				  sample:
(1) The regulatory agency involved (origin and receipt) shall
				  be notified. The appropriate regulatory agency shall take control of the
				  presumptive positive load and/or raw milk supply that has not been transported
				  in bulk milk pickup tankers. A written copy of the presumptive positive test
				  results shall follow the initial regulatory agency notification. Testing for
				  confirmation of that presumptive positive load and/or raw milk supply that has
				  not been transported in bulk milk pickup tankers shall be in an Official
				  Laboratory, Officially Designated Laboratory, or by a Certified Industry
				  Supervisor at a location acceptable to the Health Officer. Documentation of
				  prior testing shall be provided to the analyst performing the load and/or raw
				  milk supply that has not been transported in bulk milk pickup tankers
				  confirmation. The presumptive positive load and/or raw milk supply that has not
				  been transported in bulk milk pickup tankers may be re-sampled, at the
				  direction of the regulatory agency, prior to analysis with the same or
				  equivalent test (M-I-96-10, latest revision), as was used to obtain the
				  presumptive positive result. This analysis shall be done in duplicate with
				  positive (+) and negative (-) controls. If either or both of the duplicate
				  samples are positive and the positive (+) and negative (-) controls give the
				  correct reactions, the sample is deemed a Screening Test Positive (Confirmed
				  Load and/or Raw Milk Supply that has Not been Transported in Bulk Milk Pickup
				  Tankers Confirmation). A written copy of the test results shall be provided to
				  the regulatory agency. The milk which that sample represents is no longer
				  available for sale or processing into human food.
(2) The owner of the presumptive positive milk may reject the
				  load and/or raw milk supply that has not been transported in bulk milk pickup
				  tankers without further testing. At that time, the milk represented by the
				  presumptive positive test is not available for sale or processing into human
				  food. The milk cannot be re-screened. The Health Officer involved (origin and
				  receipt) shall be notified. Under this option, producer trace backs shall be
				  conducted for the reject load.
Note:
When a farm bulk milk tank(s)/silo(s),
				  milk plant raw milk tank(s) and/or silo(s), other raw milk storage
				  container(s), etc. is used for a milk plant's raw milk supply(ies) that has not
				  been transported in bulk milk pickup tankers is found to be positive
				  (confirmed) for drug residues, the farm of origin for the drug residue has
				  consequently already been determined and further testing is not required to
				  determine the farm of origin.
3.
Re-Sampling
a. Presumptive Results Using Approved Test Methods
				  -Occasionally, an error in sampling or a suspicious test result is discovered
				  after a presumptive result is initially obtained using approved test methods.
				  When this happens, the regulatory agency may allow the industry to re-sample
				  the bulk milk pickup tanker and/or raw milk supply that has not been
				  transported in bulk milk pickup tankers. The reasons that made the re-sampling
				  necessary shall be clearly documented in testing records and reported to the
				  regulatory agency. This written record shall be provided to the regulatory
				  agency and shall be maintained with the record of the testing for that load
				  and/or raw milk supply that has not been transported in bulk milk pickup
				  tankers.
b. Screening Test Results Using Approved Test Methods -
				  Re-sampling or additional analysis of screening test results should be
				  discouraged. However, the regulatory agency may direct re-sampling and/ or
				  analysis, when it has determined that procedures for sampling and/or analysis
				  did not adhere to accepted NCIMS practices (
SMEDP,
FDA/NCIMS
				  2400 Forms, Appendix N. and the applicable FDA interpretative or informational
				  memoranda). This decision by the regulatory agency shall be based on objective
				  evidence. A regulatory agency allowing re-sampling shall plan a timely
				  follow-up to identify the problem and initiate corrective action to ensure the
				  problem that led to the need for re-sampling is not repeated. If re-sampling
				  and/or analysis are necessary, it shall include a review of the samplers,
				  analysts, and/or laboratories to identify the problem(s) and initiate
				  corrective action to ensure the problem(s) is not repeated. The reasons that
				  made the re-sampling or analysis necessary shall be clearly documented in
				  testing records maintained by the regulatory agency, and shall be maintained
				  with the record of the testing for that load and/or raw milk supply that has
				  not been transported in bulk milk pickup tankers.
Producer Trace Back
a. All screening test confirmed positive loads using an
				  approved test method shall be broken down (producer trace back) using the same
				  or an equivalent test method (M-I-96-10, latest revision). Confirmation tests
				  (load and producer trace back/permit action) shall be performed in an Official
				  Laboratory, Officially Designated Laboratory, or by a CIS. Positive producers
				  shall be handled in accordance with this appendix.
Note:
When a farm bulk milk tank(s)/silos, milk
				  plant raw milk tank(s) and/or silo(s), other raw milk storage container(s),
				  etc. is used for a milk plant's raw milk supply(ies) that has not been
				  transported in bulk milk pickup tankers is found to be confirmed positive for
				  drug residues using an approved test method, the farm of origin for the drug
				  residue has consequently already been determined and further testing is not
				  required to determine the farm of origin.
b. All verified screening positive loads using test methods
				  not evaluated by the FDA and accepted by the NCIMS without additional
				  confirmation required shall be broken down (producer trace back) using the same
				  test method. Verification producer trace back tests shall be performed as cited
				  in a prior documented agreement with the regulatory agency (refer to Section
				  VI). Verified screening positive producers shall be handled in accordance with
				  this appendix.
Note:
When a farm bulk milk tank(s)/silos, milk
				  plant raw milk tank(s) and/or silo(s), other raw milk storage container(s),
				  etc. is used for a milk plant's raw milk supply(ies) that has not been
				  transported in bulk milk pickup tankers, is found to be verified screening
				  positive for drug residues using test methods not evaluated by FDA and accepted
				  by the NCIMS without additional confirmation required the farm of origin for
				  the drug residue has consequently already been determined and further testing
				  is not required to determine the farm of origin.
Assuring Representative Samples From Individual - Producer
				  Loads And Multiple-Farm Tank Loads From An Individual Producer Representative
				  samples shall be secured from each farm storage tank(s)/silo(s) of milk prior
				  to loading onto a bulk milk pickup tanker and/or other raw milk supply
				  transportation method at the dairy farm. The representative sample(s) shall
				  travel with the bulk milk pickup tanker and/or other raw milk supply
				  transportation method to a designated location acceptable to the regulatory
				  agency.
Record Requirements
- Results of all testing may
				  be recorded in any format acceptable to the Health Officer that includes at
				  least the following information:
1. Identity of the person doing the test.
2. Identity of the bulk milk pickup tanker or farm bulk milk
				  tank(s)/silo(s), milk plant raw milk tank(s) and/or silo, or other raw milk
				  storage container(s), etc. used for the storage of raw milk supplies that have
				  not been transported in bulk milk pickup tankers being tested*.
3. Date/time the test was performed (time, day, month and
				  year).
4. Identity of the test performed/lot #/any and all controls
				  (+/-).
5. Results of the test, if the analysis results are positive
				  the record shall show:
a. The identity of each producer contributing to the positive
				  load.
b. Who at the Health Officer was notified.
c. When did this notification take place.
d. How was this notification accomplished.
6. Follow-up testing if initial test was positive/any and all
				  controls (+/-).
7. Site where test was performed.
8. Prior test documentation shall be provided for a
				  presumptive positive load.
Include the BTU number(s) of the dairy farms present on the
				  bulk milk pickup tanker and/or all raw milk supplies that have not been
				  transported in bulk milk pickup tankers with the above information.
SCREENING TESTS NECESSARY TO IMPLEMENT THE PROVISIONS
				  OF APPENDIX N FOR BULK MILK PICKUP TANKERS AND/OR ALL RAW MILK SUPPLIES THAT
				  HAVE NOT BEEN TRANSPORTED IN BULK MILK PICKUP TANKERS
1. Performance Tests/Controls (+/-):
a. Each lot of kits purchased is tested by positive (+) and
				  negative (-) controls.
b. Each screening facility runs a positive (+) and negative
				  (-) control performance test each testing day.
c. All NCIMS approved bulk milk pickup tanker and/or all raw
				  milk supplies that have not been transported in bulk milk pickup tankers
				  screening tests include the following format: All presumptive positive test
				  results shall be repeated in duplicate as soon as possible at the direction of
				  the regulatory agency on the same sample with single positive (+) and negative
				  (-) controls by a certified analyst (Official Laboratory, Officially Designated
				  Laboratory, or Certified Industry Supervisor) using the same or equivalent test
				  (M-I-96-10, latest revision). If the duplicate tests are negative, with
				  appropriate (+/-) control results, the bulk milk pickup tanker and/or all raw
				  milk supplies that have not been transported in raw milk bulk milk pickup
				  tankers is reported as negative. If one (1) or both duplicate test(s) is
				  positive (+), the test result is reported to the regulatory agency in which the
				  testing was conducted, as a screening test positive (confirmed).
d. All test methods used by industry, which have not been
				  evaluated by the FDA and accepted by the NCIMS for bulk milk pickup tanker
				  and/or all raw milk supplies that have not been transported in bulk milk pickup
				  tankers include the following format: One (1) of the options provided for in
				  Section VI of this Appendix shall be followed.
e. All positive (+) controls used for drug residue testing
				  kits are labeled to indicate a specific drug and concentration level for that
				  drug.
(1) For tests that have been validated and only detect
				  Penicillin, Ampicillin, Amoxicillin, and Cephapirin, the positive (+) control
				  is Pen G @ 5 ± 0.5 ppb.
(2) For test kits validated for the detection of Cloxacillin,
				  the positive (+) control may be Cloxacillin @ 10 ± 1 ppb.
(3) For test kits validated for one (1) drug residue only,
				  the positive (+) control is ± 10% of the safe level/tolerance of the
				  drug residue detected.
2. Work Area
a. Temperature within specifications of the test kit
				  manufacturer's labeling.
b. Adequate lighting for conducting the test kit
				  procedure.
3. Test Kit Thermometers
a. Thermometer traceable to a NIST Certified
				  Thermometer.
b. Graduation interval not greater than 1°C.
c. Dial thermometers are not used to determine the
				  temperatures of samples, reagents, refrigerators, or incubators in milk
				  laboratories.
4. Refrigeration
a. Test kit reagent storage temperature specified by
				  manufacturer.
5. Balance (Electronic)
a. 0.01 g for preparation of positive (+) controls.
b. Balance with appropriate sensitivity for calibration of
				  pipetting devices within a tolerance of ± 5%. These devices may be
				  calibrated at another location acceptable to the LEO.
6. Screening Test Sampling Requirements
a. Temperature of milk in the bulk milk pickup tanker and/or
				  all raw milk supplies that have not been transported in bulk milk pickup
				  tankers determined and recorded.
b. Representative bulk milk pickup tanker and/or all raw milk
				  supplies that have not been transported in bulk milk pickup tankers sample for
				  drug residue testing collected.
c. Samples tested within seventy-two (72) hours of
				  collection.
7. Screening Test Volumetric Measuring Devices
a. Single use devices provided by kit manufacturers are
				  acceptable for Appendix N screening analysts.
b. NCIMS certified laboratories require calibrated
				  pipetting/dispensing devices. These devices may be calibrated at another
				  location acceptable to the LEO.
c. Measuring devices with tips bearing calibration lines
				  provided by test kit manufacturers are acceptable for Appendix N
				  screening.
IV.
ESTABLISHED TOLERANCES AND/OR SAFE LEVELS OF DRUG
				  RESIDUES
"Target testing levels" are used by the FDA as guides for
				  prosecutorial discretion. They do not legalize residues found in milk that are
				  below the target testing levels. In short, the FDA uses the "target testing
				  levels" as prosecutorial guidelines and in full consistency with CNI v. Young.
				  They do not dictate any result; they do not limit the FDA's discretion in any
				  way; and they do not protect milk producers or milk from court enforcement
				  action.
"Target testing levels" are not and cannot be transformed
				  into tolerances that are established for animal drugs under Section 512 (b) of
				  the
FFD&CA
as amended. "Target testing levels" do
				  not:
1. Bind the courts, the public, including milk producers, or
				  the FDA, including individual FDA employees.
2. Do not have the "force of law" of tolerances, or of
				  binding rules.
Notification, changes, or additions of "target testing
				  levels" shall be transmitted via Memoranda of Information (M-I's).
V.
APPROVED TEST METHODS
Regulatory agencies and industry shall use test methods from
				  M-a-85, latest revision, for analysis of bulk milk pickup tankers and/or all
				  raw milk supplies that have not been transported in raw milk bulk milk pickup
				  tankers for Beta lactams residues, following the testing procedures specified
				  in Section III of this Appendix. AOAC First Action and AOAC Final Action
				  methods are accepted in accordance with Section 6. Enforcement action based on
				  each test method may be delayed until the evaluation is completed and the
				  method is found to be acceptable to the FDA and complies with the provisions of
				  Rule 420-3-16-.07.
One (1) year after two (2) or more drug test methods have
				  been evaluated by the FDA and accepted by the NCIMS for a particular non-Beta
				  lactam drug or drug family, other unevaluated drug test methods for that
				  particular non-Beta lactam drug or drug family are not acceptable for
				  determining a Screening Test Positive (Confirmation) on a milk tank truck load
				  of milk and/or all raw milk supplies that has not been transported in bulk milk
				  pickup tankers. The acceptance of evaluated drug test methods by the FDA and
				  the NCIMS for drugs other than Beta lactams does not mandate any additional
				  screening by industry or regulatory agencies with the evaluated drug test
				  method, unless it is determined by the Commissioner of the FDA that a potential
				  problem exists with other animal drug residues in the milk supply.
New drug test methods which are submitted to NCIMS from the
				  FDA for acceptance shall not detect drug residues at less than 50 percent of
				  the tolerance level or 25 percent of the target testing level* for individual
				  drugs, with the exception of the following that may be accepted for Appendix N
				  and other drug testing:
1. Penicillin G at 2 ppb.
2. Tetracycline drug kits that detect tetracyclines at levels
				  greater than 150 ppb for Chlortetracycline, 119 ppb for Oxytetracycline, and 67
				  ppb for Tetracycline.
*Target testing levels are set by the FDA based on available
				  science. They are not determined by the detection limits of commercially
				  available test methods.
VI.
TEST METHODS FOR NON-BETA LACTAMS RESIDUE TESTING
				  THAT HAVE NOT BEEN EVALUATED BY FDA AND ACCEPTED BY THE NCIMS
Provided, that until at least two (2) test methods are found
				  acceptable by the FDA and the NCIMS for detecting a particular drug or drug
				  family, other than Beta lactams, as cited in M-a-85, latest revision, and
				  M-I-92-11 in raw milk, non-Beta lactam screening test methods, which have not
				  been evaluated and accepted by the FDA and the NCIMS, may be used for the
				  initial screening, provided that the test method manufacturer's data indicates
				  that testing sensitivity is at or below U.S. target testing/ or tolerance
				  levels.
UTILIZING A DRUG TEST METHOD THAT HAS NOT BEEN
				  EVALUATED BY FDA AND ACCEPTED BY THE NCIMS FOR INITIAL SCREENING FOLLOWED BY A
				  DRUG TEST METHOD THAT HAS BEEN EVALUATED BY FDA AND ACCEPTED BY THE NCIMS
				  (M-a-85, latest revision, and M-I-92-11) FOR DETERMINING A SCREENING TEST
				  POSITIVE (LOAD AND/OR RAW MILK SUPPLY THAT HAS NOT BEEN TRANSPORTED IN BULK
				  MILK PICKUP TANKERS CONFIRMATION)
Test methods not evaluated by the FDA and accepted by the
				  NCIMS may be used for screening bulk milk pickup tankers and/or all raw milk
				  supplies that have not been transported in raw milk bulk milk pickup tankers
				  for non-Beta lactam drug residues with the documented permission of the
				  regulatory agency(ies). In advance of using such a test method, a prior
				  documented agreement shall be obtained among the user of the test method, the
				  milk supplier, and the regulatory agency(ies) to determine the facility and
				  protocols to be used to confirm the presence of a non- Beta lactam drug residue
				  with a test method evaluated by FDA and accepted by the NCIMS as cited in
				  M-a-85, latest revision, and M-I-92-11. An M-I-96-10, latest revision, test
				  method(s) shall be used for confirmation.
One (1) of the following two (2) options (1 or 2) shall be
				  used for confirmation:
1. If the initial test result from a drug test method that
				  has not been evaluated by the FDA and accepted by the NCIMS is found to be
				  positive, testing shall promptly be repeated in duplicate with positive (+) and
				  negative (-) controls that give the proper results using the same test method
				  on the same sample. The initial test result is verified as a screening positive
				  when one (1) or both of these duplicate retests give a positive result. The
				  regulatory agency involved (origin and receipt) shall be notified. The
				  appropriate regulatory agency shall take control of the verified screening
				  positive load and/or raw milk supply that has not been transported in bulk milk
				  pickup tankers. A written copy of the verified screening positive test results
				  shall follow the initial regulatory agency notification. Testing for
				  confirmation of that verified screening positive load and/or raw milk supply
				  that has not been transported in bulk milk pickup tankers shall utilize a test
				  method from M-a-85, latest revision, and M-I-92-11, and shall be conducted in
				  an Official Laboratory, Officially Designated Laboratory, or by a CIS at a
				  location acceptable to the regulatory agency. Documentation of all prior
				  testing shall be provided to the analyst performing the load and/or raw milk
				  supply that has not been transported in bulk milk pickup tanker's confirmation.
				  The verified screening positive load and/or raw milk supply that has not been
				  transported in bulk milk pickup tankers may be re-sampled, at the direction of
				  the regulatory agency, prior to analysis with an M-I-96-10, latest revision,
				  test method. This analysis shall be done in duplicate with positive (+) and
				  negative (-) controls. If either or both of the duplicate samples are positive
				  and the positive (+) and negative (-) controls give the proper results, the
				  sample is deemed a Screening Test Positive (load and/or raw milk supply that
				  has not been transported in bulk milk pickup tanker's confirmation). A written
				  copy of the test results shall be provided to the regulatory agency. The milk
				  which that sample represents is no longer available for sale or processing into
				  human food. Producer trace back, reporting, and enforcement as defined in this
				  appendix shall occur.
2. If the initial test result from a drug test method that
				  has not been evaluated by the FDA and accepted by the NCIMS is found to be
				  positive, the sample shall promptly be retested using a test method from
				  M-a-85, latest revision, and M-I-92-11. The initial positive M-a-85 and
				  M-I-92-11 test is found to be a presumptive positive by promptly repeating in
				  duplicate with positive (+) and negative (-) controls that give the proper
				  results, using the same test method, on the same sample, with one (1) or both
				  of these duplicate retests giving a positive result. The regulatory agency
				  involved (origin and receipt) shall be notified. The appropriate regulatory
				  agency shall take control of the presumptive positive load and/or raw milk
				  supply that has not been transported in bulk milk pickup tankers. A written
				  copy of the presumptive positive test results shall follow the initial
				  regulatory agency notification. Testing for confirmation of that presumptive
				  positive load and/or raw milk supply that has not been transported in bulk milk
				  pickup tankers shall be conducted in an Official Laboratory, Officially
				  Designated Laboratory or by a CIS at a location acceptable to the regulatory
				  agency. Documentation of all prior testing shall be provided to the analyst
				  performing the load and/or raw milk supply that has not been transported in
				  bulk milk pickup tanker's confirmation. The presumptive positive load and/or
				  raw milk supply that has not been transported in bulk milk pickup tankers may
				  be re-sampled, at the direction of the regulatory agency, prior to analysis
				  with an M-I-96-10, latest revision, test method. This analysis shall be done in
				  duplicate with positive (+) and negative (-) controls. If either or both of the
				  duplicate samples are positive and the positive (+) and negative (-) controls
				  give the proper results, the sample is deemed a Screening Test Positive (load
				  and/or raw milk supply that has not been transported in bulk milk pickup
				  tanker's confirmation). A written copy of the test results shall be provided to
				  the regulatory agency. The milk which that sample represents is no longer
				  available for sale or processing into human food. Producer trace back,
				  reporting, and enforcement as defined in this appendix shall occur.
UTILIZING A DRUG TEST METHOD THAT HAS NOT BEEN
				  EVALUATED BY FDA AND ACCEPTED BY THE NCIMS FOR THE INITIAL SCREENING AND
				  DETERMINING A VERIFIED SCREENING POSITIVE LOAD AND/OR RAW MILK SUPPLY THAT HAS
				  NOT BEEN TRANSPORTED IN BULK MILK PICKUP TANKERS WHEN A DRUG TEST METHOD THAT
				  HAS BEEN EVALUATED BY FDA AND ACCEPTED BY THE NCIMS (M-a-85, latest revision,
				  and M-I-92-11) IS NOT AVAILABLE
Test methods not evaluated by the FDA and accepted by the
				  NCIMS may be used for screening and verifying bulk milk pickup tankers and/or
				  all raw milk supplies that have not been transported in raw milk bulk milk
				  pickup tankers for non-Beta lactam drug residues with the documented permission
				  of the regulatory agency(ies). In advance of using such a test method, a prior
				  documented agreement shall be obtained among the user of the test method, the
				  milk supplier, and the regulatory agency(ies) to determine the facility and
				  protocols to be used to verify the presence of a non-Beta lactam drug
				  residue.
If the initial test result from a drug test method that has
				  not been evaluated by the FDA and accepted by the NCIMS is found to be
				  positive, the sample shall promptly be retested in a facility identified in the
				  prior documented agreement using the same drug test method. The initial
				  positive test is found to be a verified screening positive by promptly
				  repeating in duplicate with positive (+) and negative (-) controls that give
				  the proper results, using the same test, on the same sample, with one (1) or
				  both of these duplicate retests giving a positive result. The regulatory agency
				  involved (origin and receipt) shall be notified. The appropriate regulatory
				  agency may take control of the verified screening positive load and/or raw milk
				  supply that has not been transported in bulk milk pickup tankers. A written
				  copy of the verified screening positive test results shall follow the initial
				  regulatory agency notification. The verified screening positive load and/or raw
				  milk supply that has not been transported in bulk milk pickup tankers shall be
				  disposed of to remove it from the human or animal food chain. Producer trace
				  back shall be conducted by industry using the same drug test method at the
				  direction of the regulatory agency as cited in the prior documented agreement.
				  If the initial producer test result from the drug test method is found to be
				  positive, the sample shall promptly be retested in a facility identified in the
				  prior documented agreement using the same drug test method. The initial
				  positive test is found to be a verified producer screening positive by promptly
				  repeating in duplicate with positive (+) and negative (-) controls that give
				  the proper results, using the same test method, on the same sample, with one
				  (1) or both of these duplicate retests giving a positive result. The regulatory
				  agency shall be notified of the producer trace-back results. The verified
				  screening positive milk is removed from the human and/or animal food chain,
				  which is managed between the user of the test method, the milk supplier, and
				  the dairy producer. Future pickups and/or use of the violative individual
				  producer's milk are prohibited until subsequent testing, utilizing the same
				  drug test method or equivalent that has not been evaluated by the FDA and
				  accepted by the NCIMS, of a representative sample taken from the producer's
				  milk, prior to commingling with any other milk, is no longer positive for drug
				  residue. Whenever a drug residue test is verified screening positive, an
				  investigation may be completed by the regulatory agency or its agent to
				  determine the cause of the drug residue and actions taken to prevent future
				  violations.
Note:
When a farm bulk milk tank(s)/silo(s),
				  milk plant raw milk tank(s) and/or silo(s), other raw milk storage
				  container(s), etc. is used for a milk plant's raw milk supply(ies) that has not
				  been transported in bulk milk pickup tankers is found to be confirmed positive
				  for drug residues using an approved test method or verified screening positive
				  for drug residues using test methods not evaluated by FDA and accepted by the
				  NCIMS without additional confirmation required, the farm of origin for the drug
				  residue has consequently already been determined and further testing is not
				  required to determine the farm of origin.
Author:
G. M. Gallaspy, Jr.
Statutory Authority:
Code of Ala. 1975,
					 §§
											22-2-2,
					 22-20-7.