U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
FDA Prime Connection
IMS-a-30 - Actions of the 1991 National Conf. on IMS
HHS,PHS,FDA,CFSAN,OC,DCP,MSB
200 `C' Street, SW
Washington, D.C.
August 22, 1991
IMS-a-30
TO: All Regional Food and Drug Directors
Attn: Regional Milk Specialists
FROM: Milk Safety Branch, HFF-346
SUBJECT: Actions of the 1991 National Conference on
Interstate Milk Shipments
The National Conference on Interstate Milk Shipments
(NCIMS) was held in Louisville Kentucky April 21-26,
1991. At the Conference, the state delegates approved
a number of recommended changes to the Pasteurized
Milk Ordinance (PMO) and related documents. FDA
responded to the Executive Board of NCIMS concerning
each of the recommended actions at the July 25, 1991
Executive Board meeting. The following actions were
mutually concurred. These changes are effective
September 9, 1991, except as noted.
Some of the actual language as adopted by Conference
delegates was modified in order to maintain continuity
with the present language and to insure compatibility
with other existing sections of the PMO. The
modifications have not changed the intent of the voted
actions.
**********
PMO Pages 6 & 30 Section 1. DEFINITIONS
(problem 202)
Add the following definition:
FF. DRUG.--The term "drug" means (A)
articles recognized in the official United
States Pharmacopeia, official Homeopathic
Pharmacopeia of the United States, or
official National Formulary, or any
supplement to any of them; and (B) articles
intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of
disease in man or other animals; and (C)
articles (other than food) intended to
affect the structure or any function of the
body of man or other animals; and (D)
articles intended for use as a component of
any articles specified in clause (A), (B),
or (C), but does not include devices or
their components, parts, or accessories.
Change the word "antibiotic" to "drug" in
all places where appropriate.
**********
PMO Pages 10 & 38 Section 6. THE
EXAMINATION
OF MILK AND
MILK
PRODUCTS
(problem 213)
Change 3rd. sentence of 2nd paragraph to
read as follows:
During any consecutive six months, at least
four samples of raw milk for
pasteurization, ultra pasteurization or
aseptic processing, collected in at least
four separate months, shall be taken, by
the regulatory agency from each milk plant
after receipt of the milk by plant and
prior to pasteurization, ultra
pasteurization or aseptic processing.
(problem 216)
Add, after first sentence of sixth
paragraph, the following:
See Appendix N page ____.
Effective date July 1, 1992
**********
Page 40 Section 6. ADMINISTRATIVE PROCEDURES
LABORATORY TECHNIQUES,
Change sub paragraph 4 to read as follows:
4. Disc assay methods for drugs specified
in Appendix G. In addition, methods which
have been evaluated by AOAC and recommended
by FDA at currently referenced levels shall
be used for regulatory action for each drug
of concern. FDA shall review the AOAC
evaluation for each test kit and make a
determination as to the acceptability of
the use of the method in accordance with
all applicable sections of this document.
Regulatory action shall be taken on all
positive results (see Appendix N). A result
shall be considered positive if it has been
obtained by using a method which has been
evaluated and deemed acceptable by FDA at
levels established in memoranda transmitted
periodically by FDA as required by Section
III of Appendix N.
Effective date July 1,1992
**********
PMO Pages 11 & 38 Section 6. THE EXAMINATION
OF MILK AND MILK PRODUCTS
(PROBLEM 232)
Rewrite the 6th paragraph and add a new 7th
paragraph as follows:
Whenever a pesticide residue test is
positive, an investigation shall be made to
determine the cause, and the cause shall be
corrected. An additional sample shall be
taken and tested for pesticide residues and
no milk or milk products shall be offered
for sale until it is shown by a subsequent
sample to be free of pesticide residues or
below the actionable levels established for
such residues.
Whenever a drug residue test is positive,
an investigation shall be made to determine
the cause, and the cause shall be corrected
in accordance with the provisions of
Appendix N.
Effective July 1, 1992
**********
PMO Page 13 & 42 Section 7. STANDARDS
FOR MILK AND
MILK
PRODUCTS
(problem 101, 105 & 216)
Change Table 1 CHEMICAL,
BACTERIOLOGICAL, AND
TEMPERATURE STANDARDS
Drugs-------------- No zone greater than
or equal to 16 mm with
Bacillus
sterothermophilus disc
assay method specified
in Appendix G, Page
184
No positive results on
drug residue detection
methods as referenced
in Section 6.
Laboratory Techniques
**********
Somatic Cell Count ---------------- 750,000
***
*** Goat
Milk
1,000,000
Effective date July 1,1993
**********
Phosphatase**----- Less than 1 microgram
per ml by the Sharer
Rapid Method (less
than 500 milliunits/L
by the Fluorometric
Procedure) or
equivalent.
**********
PMO Page 16 & 54 Item 12r.
(problem 123)
Change Item 12r. to read as follows:
"--tubular coolers, plate coolers and
milk pumps which are designed for
mechanical cleaning and other
equipment, as accepted by FDA, which
meets these criteria may be---".
Change Administrative Procedures to read
the same.
**********
PMO Page 32 Section 3 PERMITS
ADMINISTRATIVE PROCEDURES
REINSTATEMENT OF PERMITS
Change first sentence of 3rd. paragraph to
read as follows:
Whenever the permit suspension has been due
to a violation of a requirement other than
bacteriological, coliform, somatic cell
count, or drug residue test, or cooling-
temperature standards, the notification
shall indicate that the violation(s) has
been corrected.
Add new 4th. paragraph as follows:
When a permit suspension has been due to
positive drug residues, the permit shall be
reinstated in accordance with the
provisions of Appendix N.
Effective date July 1, 1992
**********
PMO Page 57 Item 16r PROTECTION FROM
CONTAMINATION
(PROBLEM 132)
Add the following sub paragraph under
paragraph 11:
d. Active ingredient(s) in the drug
product.
**********
PMO Page 70 Item 11p CONSTRUCTION AND
REPAIR OF CONTAINERS
AND EQUIPMENT
ADMINISTRATIVE
PROCEDURES
(Problem 144)
Change wording in paragraph 10 as follows:
10. The manufacture, packing,
transportation, and handling of
single-service containers, closures,
caps, gaskets, and similar articles
comply with requirements of Appendix
J, Standards for the Fabrication of
Single-Service Containers for Milk and
Milk Products
Effective date July 1,1992
***********
PMO Page 72 Item 12p CLEANING AND SANITIZING OF
CONTAINERS AND EQUIPMENT
ADMINISTRATIVE PROCEDURES
(Problem 144)
Change paragraph 6. to read as follows:
6. a. The residual bacteria count of
multi-use containers used for packaging
pasteurized milk and milk products shall
not exceed one per milliliter of capacity
when the rinse test is used, or not over 50
colonies per 8 square inches (one per
square centimeter) of product-contact
surface, when the swab test is used, in 3-
out-of-4 samples taken at random on a given
day. All multi-use containers shall be free
of coliform organisms.
6. b. The residual bacteria count of
single-service containers used for
packaging pasteurized milk and milk
products shall not exceed 50 per container,
when the rinse test is used, except that in
containers less than 100ml, the count shall
not exceed 10, or not over 50 colonies per
8 square inches (1 per square centimeter)
of product contact surface, when the swab
test is used, in 3-out-of-4 samples taken
at random on a given day. All single-
service containers shall be free of
coliform organisms.
When single-service containers are
fabricated in another plant which conforms
to the Standards of Appendix J, the
regulatory agency may accept the containers
as being in conformance without additional
tests. If there is reason to believe that
containers do not conform to the
bacteriological standards, additional tests
may be required. If containers are
fabricated in the dairy plant, the
regulatory agency shall collect at least 4
sets of containers each 6 months and
determine conformance.
Effective date July 1, 1992
************
PMO Page 74 Item 15p PROTECTION FROM
CONTAMINATION
ADMINISTRATIVE PROCEDURES
15p(a)
Add the following paragraph:
6. All multi-use cases used to encase
packaged milk and milk product
containers are cleaned prior to their
use.
(subsequent paragraphs will be renumbered)
**********
PMO Page 215 Appendix I PASTEURIZATION
EQUIPMENT AND CONTROLS-TESTS
(problem 142)
Add test procedures 8 as follows:
8. CIP TIME DELAY RELAY
Application.--To all high-
temperature short-time pasteurizer
systems in which it is desired to run
the timing pump and/or other flow
promoting devices during the CIP
cycle.
Frequency.--Upon installation and
semiannually thereafter, or whenever
the seal on the time delay relay is
broken.
Criteria.--When the mode switch
on the flow diversion device is moved
from process product to CIP, the flow
diversion device shall move
immediately to the diverted position
and remain in the diverted position
for at least 10 minutes before
starting its normal cycling in the CIP
mode. Simultaneously, the booster pump
shall be turned off and shall not run
during the 10 minute time delay.
Apparatus.--Stopwatch.
Method.--Adjust set point on the
time delay relay equal to or greater
than 10 minutes.
Procedure.--
a. Operate pasteurizer in forward
flow with the mode switch on the flow
diversion device in the process
product position, at a flow rate below
the Flow Alarm set point and above the
Los-of-Signal Alarm set point, using
water above pasteurization
temperature.
b. Move the mode switch on the
flow diversion device to the CIP
position. The flow diversion device
should move immediately to the
diverted position, and the booster
pump should stop running. Start the
stopwatch when the flow diversion
device moves to the diverted position.
c. Stop the stopwatch when the
flow diversion device moves to the
forward position for its initial cycle
in the CIP mode. The booster pump may
start at this time.
d. Record results for the office
record.
e. Install and seal enclosure
over the time delay relay.
Corrective Action.--If the flow
diversion device does not remain in
the diverted position for at least 10
minutes after the mode switch is moved
from process product to CIP, increase
the set point on the time delay relay
and repeat this test procedure. If the
booster pump runs at any time during
the 10 minute delay, the booster pump
wiring is in need of repair.
**********
PMO Page 239 Appendix J.
(Problem 144)
Change title to read as follows:
APPENDIX J,
STANDARDS FOR THE MANUFACTURE OF SINGLE-seRVICE
CONTAINERS FOR MILK AND MILK PRODUCTS
Change second sentence of first
paragraph to read as follows:
Standards for the Fabrication of
Single-Service Containers and Closures
for Milk and Milk Products - 1991,
were developed to assure the
production of safe, nontoxic and
sanitary packaging materials for milk
and milk products. All Grade A milk
and milk product plants, as defined in
the Grade A Pasteurized Milk
Ordinance, shall use single-service
containers and closures from plants
certified or listed as foreign
manufacturers in the latest quarterly
publication of the Sanitation
Compliance and Enforcement Ratings of
Interstate Milk Shippers (IMS List).
Effective date July 1, 1992
**********
PMO Page____ Appendix N DRUG RESIDUE
MONITORING AND FARM
SURVEILLANCE
(problem 232)
Add new Appendix N as follows:
Appendix N
Drug Residue Monitoring and Farm Surveillance
This appendix is established to reference
safe levels and/or established tolerances
and to assure that milk supplies are in
compliance with these safe levels or
established tolerances for drug residues in
milk.
I. INDUSTRY RESPONSIBILITIES
A. Monitoring and Surveillance.
Industry shall screen all bulk milk pickup
tankers 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 months, at least four
(4) samples collected in at least four (4)
separate months. Samples collected under
this random sampling program shall be
analyzed as specified by FDA. (See M-a-75).
Bulk milk pickup tanker testing shall be
completed prior to processing the milk.
Bulk milk pickup tanker samples found to be
positive for drug residues shall be
retained as determined necessary by the
regulatory agency. Industry shall also
record all sample results and retain such
records for a period of six months.
B. 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 shall be immediately discontinued
until such time that subsequent tests are
no longer positive for drug residues.
Implementation date January 1,1992
II REGULATORY AGENCY RESPONSIBILITIES
A. Monitoring and Surveillance
State regulatory agencies shall monitor
industry surveillance activities by making
unannounced on-site inspections to collect
samples from bulk milk pickup tankers and
to review industry records of the random
sampling program. A review shall include,
but not be limited to the following:
1. Is the program an appropriate routine
monitoring program for detection of
drug residues? Is the program
utilizing appropriate test methods?
2. Is each producers milk represented in
a testing program for drug residues
and tested at the frequency prescribed
in I A. above for drug residues?
3. 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
trace back to the farm of origin? Is
farm pickup suspended until subsequent
testing establishes the milk is no
longer positive for drug residues?
The regulatory agency shall also perform
routine sampling and testing for drug
residues determined to be necessary as
outlined in Section 6 and M-a-75.
B. 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
guidelines. The regulatory agency shall
determine the producer responsible for the
violation.
Penalties. The regulatory agency shall
immediately suspend the Grade A permit of
the responsible producer for a minimum of
two days or equivalent penalty as
determined by the regulatory agency. On
the second occurrence of violative drug
residues in a 12 month period, the
producer's permit shall be suspended for a
minimum of four (4) days or equivalent
penalty as determined by the regulatory
agency. For a third occurrence of
violative drug residues in a 12 month
period, the suspension of permit shall be
the same as the 2nd occurrence and the
regulatory agency shall initiate
administrative procedures pursuant to
revocation of the producer's permit.
Reinstatement. The Grade A producer permit
may be restored to a temporary permit
status after the penalty when a sample
taken from the producers milk in the farm
bulk tank is no longer positive for drug
residues. In no event shall the Grade A
permit of the violative producer be
reinstated by the regulatory agency until
the responsible producer and a licensed
veterinarian have signed a quality
assurance certificate, for display in the
milkhouse, which states that the "Milk and
Dairy Beef Residue Prevention Protocol", is
in place and being implemented for the
dairy herd(s) from which the adulterated
milk containing violative drug residues was
shipped.
Implementation date July 1, 1992
III 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 -- that they do not dictate any
result, that they do not limit the agency's
discretion in any way, and that 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 Federal Food, Drug and
Cosmetic Act. "Safe levels" do not (1)
bind the courts, the public (including milk
producers), or the agency (including
individual FDA employees), and (2) 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).
AOAC First Action and AOAC Final Action
methods are accepted in accordance with
Section 6. Other drug residue detection
methods may be submitted to AOAC for
evaluation at the safe level or tolerance.
Regulatory action based on each method test
kit may be delayed until the AOAC
evaluation is completed and the method is
found to be acceptable by AOAC and complies
with the provisions of Section 6.
Industry may employ other methods which
have been evaluated by Virginia Polytechnic
Institute and State University (Bishop et
al, 1991) which have been demonstrated to
provide positive results, as described in
Section 6 A, 4. These methods or
equivalently evaluated methods may be
employed until they have been evaluated
through AOAC and accepted by FDA.
Implementation date January 1, 1992
***********
PROCEDURES Page 4 Section III Rating and
Certification
(Problem 305)
Change Section III, C.,1 to read as
follows:
Have been standardized by PHS/FDA as State
Milk Sanitation Rating Officers, and hold a
currently valid certificate of
qualification in one or any combination of
the following areas: milk pasteurization
plants, dairy farms and transfer/receiving
stations.
**********
PROCEDURES Page 9 Section V. Responsibilities
of Participating State
Agencies
(Problem 311)
Add the following to Section V.
D. Reports to Database
State regulatory or rating agencies
shall submit drug residue summary data
to a third party data base.
**********
SSCC (Problem 144) Single Service Committee
Recommendations
The committees recommendations which were
accepted by the NCIMS and concurred with by
FDA will entail a complete rewrite of the
Single Service document. This revised
document is being prepared for printing and
should be available for distribution in the
near future.
**********
(Problem 233)
The Conference delegates recommended as a solution to
Problem 233 that point values be changed for minor
violations of Item 8r. FDA did not concur with this
recommended action. The NCIMS Executive board voted to
accept FDA's non concurrence with the understanding
that FDA will send out a memorandum addressing the
anomalies found as water supply violations.
**********
The following actions were also taken as a result of
problems adopted by the Conference and concurred with
by PHS/FDA. They do not require changes to the PMO or
related documents.
Problem 108
When testing goat milk using the B.
Sterothermophilus disc assay and a zone of
14-16mm occurs the SPC from that sample
should be reported out and may be used by
regulatory agencies to satisfy the
requirements of 4 samples in 6 months.
FDA will issue a supplemental memo to M-I-83-2
to clarify this change regarding reporting of
results for goat milk samples.
**********
Problem 112
The NCIMS chairman appointed a study
committee to: "look at the issue of
disposal and/or reconditioning of drug
adulterated milk as outlined in the
problem. An acceptable workable solution
should be presented to the 1993 NCIMS".
***********
Problem 116
NCIMS chairman to request that FDA prepare
an interpretive memorandum on water
supplies.
FDA will prepare the memorandum.
************
Problems 127,133 & 134
NCIMS chairman appointED a committee to
work with FDA, on suggested changes to
point values for violation of drug labeling
and storage requirements. Committee to
report back to Executive Board and further
may request that FDA issue a M-a memorandum
if appropriate.
**********
Problem 143
Delete requirement for water-to-milk flow
rate comparisons when testing flow holding
times of magnetic flow meter HTST systems.
FDA agreed to conduct a study of this
matter and change the test procedure for
meter based timing systems if the study
supports the claim. In the interim water-
to-milk flow rates are still needed on all
HTST pasteurizer systems
**********
Problem 203
Refer the question of adding sheep milk to
the PMO, to the Goat Milk committee.
**********
Problem 206
Change definition of Ultra Pasteurized.
Request that research be conducted by a
qualified entity with proper equipment to
report back to 1993 Conference on this
issue.
**********
Problem 230
Add provisions to industry farm inspection
portion of Appendix B to require program be
in writing and reviewed periodically by
PHS/FDA and require agency to conduct
seminars at least biennially.
NCIMS to appoint committee to work with FDA
to work out details of how and where this
would be added to Appendix B.
**********
Problem 234
Bulk Milk Pickup Tanker Inspection- Send
problem to MMSR committee for a proposed
solution for submission to 1993 Conference.
**********
Problem 235
Require a shipper desiring a rating to
comply with new Appendix N of PMO.
This issue was referred to MMSR committee
for recommendations as to how it would be
implemented.
**********
Problem 237
Review point values for receiving
stations.
The recommendation on this problem was to
send it to the MMSR committee for a report
back to the 1993 NCIMS.
**********
Problem 240
Change the laboratory survey sheets to
reflect that Electronic Somatic Cell counts
below 100,000 be reported as <100,000 per
ml.
Laboratory survey sheets will be changed.
**********
Problem 241
Change policy used to determine
coequivalency between similar test
procedures on split sample analysis.
Policy will be changed.
**********
Problem 243
Require that NCIMS chairman be required to
send letter to all states not practicing
reciprocity.
**********
Problem 244
Recommend that NCIMS appoint committee to
develop a mechanism whereby NCIMS serve as
the acquirer of "state of the art"
demonstration equipment for HTST
pasteurization systems. FDA will use the
equipment to conduct training for
regulatory and industry personnel.
Chairman has appointed the committee.
**********
Problem 304
Requested that the chairman appoint a
committee to study the development of a
method of funding for appropriate
Conference activities.
Chairman has appointed the committee.
**********
Problem 310
Recommend that the problem be sent to a
committee to study.(inclusion of
manufactured grade milk in conference
scope)
Chairman has appointed committee.
**********
Problem 313
NCIMS chairman to appoint committee to work
with FDA in establishing the mechanism for
reporting information to a third party
National Data Center.
**********
Page changes in the PMO and related documents
reflecting the above changes are being initiated and
will be printed and distributed at a later date.
Copies of this memorandum are enclosed for
distribution to state regulatory agencies and to state
milk sanitation rating officers in your region.
Johnnie G. Nichols
Chief, Milk Safety Branch, HFF-346
Center for Food Safety and Applied
Nutrition
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