Grade "A" Pasteurized Milk Ordinance (2003 Revision)
Appendices L through N
Appendix L. Applicable Regulations, Standards of Identity for Milk and
Milk Products and the Federal Food, Drug, and Cosmetic Act
- 21 CFR PART 11 - ELECTRONIC
RECORDS; ELECTRONIC SIGNATURES
- 21 CFR 58.334 Pasteurization
- 21 CFR 58.2601 Whey
- 21 CFR 58.2651 Dry
Buttermilk and Dry Buttermilk Product
- 21 CFR PART 101 - FOOD
LABELING
- 21 CFR PART 108 - EMERGENCY
PERMIT CONTROL
- 21 CFR PART 110 - CURRENT
GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD
- 21 CFR PART 113 - THERMALLY
PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS
- 21 CFR PART 130.10 -
Requirements for foods named by use of a nutrient content claim and a
standardized term
- 21 CFR 131.3 Definitions -
Cream, Pasteurized and Ultra-pasteurized
- 21 CFR 131.110 Milk
- 21 CFR 131.111 Acidified
Milk
- 21 CFR 131.112
Cultured Milk
- 21 CFR 131.115 Concentrated
Milk
- 21 CFR 131.120 Sweetened
Condensed Milk
- 21 CFR 131.123 Lowfat Dry
Milk
- 21 CFR 131.125 Nonfat Dry
Milk
- 21 CFR 131.127 Nonfat Dry
Milk fortified with vitamins A and D
- 21 CFR 131.147 Dry Whole
Milk
- 21 CFR 131.149 Dry Cream
- 21 CFR 131.150 Heavy Cream
- 21 CFR 131.155 Light Cream
- 21 CFR 131.157 Light
Whipping Cream
- 21 CFR 131.160 Sour Cream
- 21 CFR 131.162 Acidified
Sour Cream
- 21
CFR 131.170 Eggnog
- 21
CFR 131.180 Half-and-Half
- 21
CFR 131.200 Yogurt
- 21
CFR 131.203 Lowfat Yogurt
- 21
CFR 131.206 Nonfat Yogurt
- 21
CFR 133.128 Cottage Cheese
- 21
CFR 133.129 Dry Curd Cottage Cheese
- 21 CFR 173.310 Boiler Water
Additives
- 21 CFR 184.1979 Whey
- 21 CFR 184.1979(2)
Concentrated Whey
- 21 CFR 184.1979(3) Dried or
Dry Whey
- 21 CFR 184.1979a Reduced
Lactose Whey
- 21 CFR 184.1979b Reduced
Minerals Whey
- 21 CFR 184.1979c Whey
Protein Concentrate
- Federal Food, Drug and
Cosmetic Act, as amended Sec. 402.
[342] Adulterated Food
- Federal Food, Drug and
Cosmetic Act, as amended Sec. 403.
[343] Misbranded Food
Appendix M. Reports and Records
The following forms are available at: http://www.fda.gov/opacom/morechoices/fdaforms/cfsan.html
- FORM FDA 2359 MILK
PLANT INSPECTION REPORT
- FORM FDA 2359a DAIRY FARM
INSPECTION REPORT
- FORM FDA 2359b MILK PLANT EQUIPMENT TEST
REPORT
- FORM FDA 2359c SINGLE-SERVICE
MANUFACTURING PLANT INSPECTION REPORT
- FORM FDA 2359g CONDENSED AND DRY MILK & WHEY
PLANT INSPECTION
- FORM FDA 2399 MILK SAMPLE
COLLECTOR EVALUATION FORM
- FORM FDA 2399a MILK
TANK TRUCK, HAULER REPORT AND SAMPLER EVALUATION FORM
- FORM FDA 2399b MILK TANK TRUCK INSPECTION
FORM
- MILK PLANT, RECEIVING STATION OR TRANSFER STATION NCIMS
HACCP SYSTEM AUDIT REPORT FORM
Appendix N. Drug Residue Testing and Farm Surveillance
I. INDUSTRY RESPONSIBILITIES
MONITORING AND SURVEILLANCE:
Industry shall screen all 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. The random bulk milk pickup tanker
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 FDA. (Refer to
Section 6 of this Ordinance)
The bulk milk pickup tanker shall be sampled after the last
producer has been picked up and before any additional commingling. The
sample must be representative. Bulk milk pickup tanker testing shall be
completed prior to processing the milk. Industry plant samplers shall
be evaluated according to the requirements specified in Section 6. THE
EXAMINATION OF MILK AND MILK PRODUCTS and at the frequency addressed in Section
5. INSPECTION OF DAIRY FARMS AND MILK PLANTS of this Ordinance.
Bulk milk pickup tanker samples found to be positive for drug residues shall
be retained as determined necessary by the Regulatory Agency. All
presumptive positive test results for drug residues from analysis done on
commingled raw milk tanks, bulk milk pickup tankers, farm raw milk tanks (only
milk offered for sale) or finished milk or milk product samples must be
reported to the Regulatory Agency.
REPORTING AND FARM TRACEBACK:
When a bulk milk pickup tanker is found to be positive for
drug residues, the Regulatory Agency 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 positive for drug residues, shall be individually tested to determine
the farm of origin. The samples shall be tested as directed by the
Regulatory Agency.
Further pickups 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 Regulatory Agency that includes at least the following
information:
- Identity of the person doing the test;
- Identity of the bulk milk pickup tanker being
tested*;
- Date/time the test was performed (Time, Day,
Month and Year);
- Identity of the test performed/lot #/any and
all controls (+/-);
- Results of the test;
- Follow-up testing if initial test was
positive/any and all controls (+/-);
- Site where test was performed, and
- Prior test documentation shall be provided
for a presumptive positive load.
*Include the BTU number(s) of the farms present
on the bulk milk pickup tanker with the above information.
Records of all sample results shall be maintained for a
minimum of six (6) months by the industry at the location where the tests were
run, and/or another location as directed by the Regulatory Agency.
II. REGULATORY AGENCY RESPONSIBILITES
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 to review industry records
of the sampling program. Samples should be collected and analyzed from at
least 10% of the bulk milk pickup tankers scheduled to arrive on the day of the
inspection. The 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 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 test the samples.
Receiving locations that choose to certify all receiving analysts, certified
under the provisions of the NCIMS Laboratory Certification Program, are exempt
from the sample collection requirements of this Section.
A review shall include, but not be limited to, the
following:
- Is the program an appropriate routine monitoring program
for the detection of drug residues?
- Is the program utilizing appropriate test methods?
- Is each producer's milk represented in a testing program
for drug residues and tested at the frequency prescribed in I. A. for drug
residues?
- Is the program assuring timely notification to the
appropriate Regulatory Agency of positive results, the ultimate disposition of
the bulk milk pickup tanker milk, and of the traceback to the farm of origin?
- Is the farm pickup suspended until subsequent testing
establishes the milk is no longer positive for drug residues?
To satisfy these requirements:
- There
should be an agreement between the Regulatory Agency and industry that would
specify how this notification is to take place. This notification must be
"timely" for example by telephone or fax, and supported in writing.
- This
ultimate disposition should either be prearranged in an agreement between the
Regulatory Agency and the industry, or physically supervised by the Regulatory
Agency. The milk should be disposed of in accordance with the provisions
of M-I-90-9 or an FDA and Regulatory Agency reviewed and accepted Beta lactam
milk diversion protocol for use as animal feed.
- All
screening test positive (confirmed) loads must be broken down (producer
traceback) using the same or an equivalent test method (M-I-96-10, latest
revision). Confirmation tests (load and producer traceback/permit action)
shall be performed by an Official or Officially Designated Laboratory or
Certified Industry Supervisor. Positive producers shall be handled in
accordance with this Appendix.
- The
suspension and discontinuance of farm bulk milk tank pick up is the
responsibility of the industry, under the direction and supervision of the
Regulatory Agency. At the discretion of the Regulatory Agency, records
should be maintained by industry and/or the Regulatory agency that:
- (1) Establish the identity of the producer and the
identity of the load that tested positive; and
- (2) Establish that no milk is picked up from the
positive testing producer until the Regulatory Agency has fulfilled their
obligations under II.-ENFORCEMENT of this Appendix and cleared the milk.
Sufficient records should be reviewed to assure that all
farm bulk milk pickup tankers are sampled before commingling and the results
were made available to the appropriate BTU(s).
The Regulatory Agency shall also perform routine sampling
and testing for drug residues determined to be necessary as outlined in Section
6 of this Ordinance.
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 Regulatory Agency shall determine the
producer(s) responsible for the violation.
Suspension: Any time milk is found to test as a confirmed
positive for a drug residue, 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.
Penalties: Future pick-ups are prohibited until
subsequent testing reveals the milk is free of drug residue. The penalty
shall be for the value of all milk on the contaminated load plus any costs
associated with the disposition of the contaminated load. 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
positive, 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:
- On-farm changes in procedures necessary to prevent
future occurrences as recommended by the Regulatory Agency.
- Discussion and education on the Drug Residue
Avoidance Control measures outlined in Appendix C. of this Ordinance.
Permit Revocation: After a third violation in a
twelve (12) month period, the Regulatory Agency shall initiate administrative
procedures pursuant to the revocation of the producer's Grade "A" permit under
the authority of Section 3. Permits of this Ordinance, due to repeated
violations.
REGULATORY AGENCY RECORDS:
In regards to the industry reporting a positive tanker
result, the Regulatory Agency's records should indicate the following:
- What were the Regulatory Agency's directions?
- When was the Regulatory Agency
notified? By whom?
- What was the identity of the load?
- What screening and/or confirmatory test(s)
were used and who were the analyst(s)?
- What was the disposition of the adulterated
milk?
- Which producer(s) was responsible?
- 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:
- Presumptive Positive: A presumptive
positive test is a positive result from an initial testing of a tanker using an
M-a-85 (latest revision) approved test, which has been promptly repeated in
duplicate with positive and negative controls using the same test, on the same
sample, with one or both of these duplicate retests giving a positive result.
- Screening Test Positive (Load
Confirmation): A screening test positive result is obtained when the
presumptive positive sample is tested in duplicate, using the same or
equivalent (M-I-96-10, latest revision) test as that used for the presumptive
positive, with a positive and negative control, and either or both of the
duplicates are positive and the controls give the proper results. A
screening test positive (load confirmation) is to be preformed by an Official
State Laboratory, Officially Designated Laboratory or Certified Industry
Supervisor using the same or an equivalent test (M-I-96-10, latest revision).
- Producer Traceback/Permit Action: A
producer traceback/permit action test is performed after a screening test
positive load is identified by an Official State Laboratory, Officially
Designated Laboratory or Certified Industry Supervisor using the same or an
equivalent (M-I-96-10, latest revision) test as was used to obtain the
screening test positive (load confirmation). A confirmed producer test
positive result is obtained in the same manner as a confirmation (screening
test positive) for a load. After an initial positive result (producer
presumptive positive) is obtained on a producer sample, that sample is then
tested in duplicate using the same test as was used to obtain the producer
presumptive positive result. This testing is performed with a positive
and negative control and if either or both of the duplicates are positive and
the controls give the proper results, the producer sample is confirmed as
positive.
- Individual Producer Load: An
individual producer bulk milk pickup tanker is a tanker, or a compartment of a
tanker, that contains milk from only one (1) dairy farm.
- Industry Analyst: A person under the
supervision of the Certified Industry Supervisor or Industry Supervisor who is
assigned to conduct screening of bulk milk pickup tankers for Appendix N. drug
residue requirements.
- Industry Supervisor/Certified Industry
Supervisor: An individual trained by the State LEO who is responsible for
the supervision and training of Industry Analysts who test bulk milk pickup
tankers for Appendix N. drug residue requirements.
- Certified Industry Supervisor: An
Industry Supervisor who is evaluated and listed by a State LEO as certified to
conduct drug residue screening tests at industry drug residue screening sites
for Grade "A" PMO, Appendix N. regulatory actions
(confirmation of tankers, producer traceback and/or permit actions).
CERTIFIED INDUSTRY SUPERVISORS; EVALUATION AND RECORDS:
References: EML and IMS-a-30, Supplement 2
-
Certified Industry Supervisors/Industry
Supervisors/Industry Analysts: Regulatory Agencies may choose to allow
Industry Supervisors to be certified. Under this program, these Certified
Industry Supervisors may officially confirm presumptive positive tanker loads
and confirm producer milk for regulatory purposes (producer traceback/permit
action). In the implementation of Appendix N. of this Ordinance,
the LEO will use the appropriate Appendix N. 2400 Series Form when evaluating
Official State Laboratories, Officially Designated Laboratories or Certified
Industry Supervisors, Industry Supervisors and Industry Analysts.
The Certified Industry Supervisor/Industry Supervisor shall
report to the LEO the result 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 State LEO and updated as
replacement, additions and/or removals occur. The State 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 State 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 State LEO and the Laboratory Quality
Assurance Team (LQAT) 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 IMS-a-30, Supplement 2, which describes the certification
requirements for Certified Industry Supervisors and the training requirements
for Industry Supervisors and Industry Analysts.)
- 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
must be representative. The sample analysis shall be completed before the
milk is processed.
- 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 positive, the
Regulatory Agency shall be immediately notified. 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.
BULK MILK PICKUP TANKER
SCREENING TEST:
- Performance Tests/Controls: Each lot
of test kits purchased shall be tested by positive (+) and negative (-)
controls, as defined in the SCREENING TESTS NECESSARY TO IMPLEMENT THE
PROVISIONS OF APPENDIX N. FOR BULK MILK PICKUP TANKERS of this Section, 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.
- Initial Drug Testing Procedures: The
following procedures apply to testing bulk milk pickup tankers for drug
residues following the provisions of Appendix N. Industry analysts may
screen 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.
- 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. A written copy of the presumptive
positive test results shall follow the initial Regulatory Agency
notification. Testing for confirmation of that presumptive positive load
shall be in an Official State Laboratory, Officially Designated Laboratory or
by a Certified Industry Supervisor at a location acceptable to the Regulatory
Agency. Documentation of prior testing shall be provided to the analyst
performing the load confirmation. The presumptive positive load 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). 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 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 Regulatory Agency involved
(origin and receipt) shall be notified. Under this option, producer
tracebacks shall be conducted.
- Re-Sampling:
- Presumptive Results: Occasionally, an error in sampling or a suspicious
test result is discovered after a presumptive result is initially
obtained. When this happens, the Regulatory Agency may allow the industry
to re-sample the bulk milk pickup tanker. 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.
- Screening Test Results: 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,
2400 Series Forms, Appendix N. and the applicable FDA interpretative or
informational memoranda). This decision by the Regulatory Agency must be
based on objective evidence. A Regulatory Agency allowing re-sampling
must 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 is 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.
- Producer Traceback: All screening test positive
(confirmed) loads must be broken down (producer traceback) using the same or an
equivalent test method (M-I-96-10, latest revision). Confirmation tests
(load and producer traceback/permit action) shall be performed in an Official
State Laboratory, or Officially Designated Laboratory or by a Certified
Industry Supervisor. Positive producers shall be handled in accordance
with this Appendix.
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) of
milk prior to loading onto a bulk milk pickup tanker at the dairy farm.
The representative sample(s) shall travel with the bulk milk pickup tanker to a
designated location acceptable to the Regulatory Agency.
Record Requirements: Results of all testing may be
recorded in any format acceptable to the Regulatory Agency that includes at
least the following information:
- Identity of the person doing the test;
- Identity of the bulk milk pickup tanker being
tested*;
- Date/time the test was performed (Time, Day,
Month and Year);
- Identity of the test performed/lot #/any and
all controls (+/-);
- Results of the test, if the analysis results
are positive the record should show:
- The identity of each
producer contributing to the positive load;
- Who at the Regulatory
Agency was notified;
- When did this notification
take place; and
- How was this notification
accomplished.
- Follow-up testing if initial test was
positive/any and all controls (+/-);
- Site where test was performed; and
- Prior test documentation shall be provided
for a presumptive positive load.
*Include the BTU number(s) of the farms present
on the bulk milk pickup tanker with the above information.
SCREENING
TESTS NECESSARY TO IMPLEMENT THE PROVISIONS OF APPENDIX N. FOR BULK MILK PICKUP
TANKERS:
- Performance Tests/Controls (+/-):
- Each lot
of kits purchased is tested by positive (+) and negative (-) controls.
- Each
screening facility runs a positive (+) and negative (-) control performance
test each testing day.
- All
NCIMS Approved Bulk Milk Pickup Tanker Screening Tests Include The Following
Format: All presumptive positive test results are to 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 State Laboratory, Officially Designated Laboratory or
Certified Industry Supervisor) using the same or equivalent test (M-I-96-10,
latest revision). If the duplicate tests, with appropriate control (+/-)
results are negative (-), the tanker is reported as negative. If one or both
duplicate test(s) is positive (+), the test result is reported to the
Regulatory Agency as a screening positive.
- 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 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.
- Work Area:
- Temperature within specifications of the test
kit manufacturer's labeling.
- Adequate lighting for test kit procedure.
- Test Kit Thermometers:
- Thermometer
traceable to a NIST Certified Thermometer.
- Graduation
interval not greater than 1°C.
- Dial
thermometers are not used to determine temperatures of samples, reagents,
refrigerators, or incubators in milk laboratories.
- Refrigeration:
- Test kit reagent storage temperature specified
by manufacturer.
- Balance (Electronic):
- 0.01 g
for preparation of positive (+) controls.
- 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 State LEO.
- Screening Test Sampling Requirements:
- Temperature of milk in the bulk milk pickup
tanker determined and recorded.
- Representative bulk milk pickup tanker sample
for drug residue testing collected.
- Samples tested within seventy-two (72) hours of
collection.
- Screening Test Volumetric Measuring Devices:
- Single
use devices provided by kit manufacturers are acceptable for Appendix N.
screening analysts.
- NCIMS
Certified Laboratories require calibrated pipetting/dispensing devices. These
devices may be calibrated at another location acceptable to the State LEO.
- 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
"Safe levels" are used by FDA as guides for
prosecutorial discretion. They do not legalize residues found in milk that are
below the safe level. In short, FDA uses the "safe levels" as
prosecutional guidelines and in full consistency with CNI v. Young stating, in direct and unequivocal language, that the "safe levels"
are not binding. They do not dictate any result; they do not limit the Agency's
discretion in any way; and they do not protect milk producers, or milk from
court enforcement action.
"Safe 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. "Safe levels" do not:
- Bind the courts, the public, including milk producers, or
the Agency, including individual FDA employees; and
- Do not have the "force of law" of tolerances,
or of binding rules.
Notification, changes or additions of "safe levels"
will be transmitted via Memoranda of Information (M-I's).
V. APPROVED METHODS
Regulatory Agencies and industry shall use tests from the
most recent revision of M-a-85 for analysis of bulk milk pickup tankers for
Beta lactam 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 of this Ordinance. Drug
residue detection methods shall be evaluated at the safe level or
tolerance. Regulatory action based on each test kit method may be delayed
until the evaluation is completed and the method is found to be acceptable
to FDA and complies with the provisions of Section 6 of this Ordinance.
One (1) year after test(s) have been evaluated by FDA and
accepted by the NCIMS for a particular drug or drug family, other unevaluated
tests are not acceptable for screening milk. The acceptance of evaluated
tests does not mandate any additional screening by industry with the evaluated
method.