U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
FDA Prime Connection
IMS-a-31 - Actions of the 1993 National Conference on Interstate Milk Shipments
HHS,PHS,FDA,CFSAN,OFP,DCP,MSB
200 'C' Street, SW
Washington, D.C.
September 19, 1993
IMS-a-31
To: All Regional Food and Drug Directors
Attn: Regional Milk Specialists
From: Milk Safety Branch, HFS-626
Subject: Actions of the 1993 National Conference on Interstate Milk Shipments
The National Conference on Interstate Milk Shipments (NCIMS) was held in
Arlington, Texas May 23-28, 1993. During the Conference, the state delegates
approved several changes to the Pasteurized Milk Ordinance (PMO) and related
documents. FDA responded to the NCIMS Executive Board on August 5, 1993
concerning each of the problems passed during the 1993 Conference. FDA and the
members of the Executive Board concurred on the following changes unless
otherwise noted. These changes are effective September 19, 1993 except as
noted.
Some of the language as adopted by the 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. All page references to the PMO are based on the
1989 edition.
*****************
EML Page 1
Problem 103
After the first paragraph add the following:
For NCIMS regulatory purposes the following definitions shall apply:
Official Laboratory.--An official laboratory is a biological, chemical or
physical laboratory which is under the direct supervision of the State or local
regulatory agency.
Officially Designated Laboratory.--An officially designated laboratory is
a commercial laboratory authorized to do official work by the regulatory agency
or a milk industry laboratory officially designated by the regulatory agency for
the examination of producer samples of Grade A raw milk for pasteurization and
commingled milk tank truck samples of raw milk for drug residues or bacterial
limits.
*****
EML Page 15, Table 2
LQAB has been instructed to rewrite the EML, and when that occurs, Table 2 will
be modified to incorporate the language of Problems 221 and 222.
Problem 221 (single underline)
Problem 222 (double underline)
Table 2 of the Evaluations of Milk Laboratories (EML) for PLC and SPC under
Rejection Limit #1 (L1), change 0.330 to 0.268 and under Rejection Limit #2
(L2), change 0.220 to 0.179.
On page 2 of the EML, Table 2, add the following to the bottom of the table:
Advanced Fluorometer L1 = 0.281 L2 = 0.187
*****
MMSR Page 2 and 6, Section II. Rating Methods for Raw Milk for Pasteurization
and Section III. Rating method for transfer stations, receiving stations and
processing plants
Problem 276
In Part II replace the existing #1 with the following and change the old #1 to
#2 and the old #2 to #3.
After the Definitions and after to Rating Methods for Raw Milk for
Pasteurization, insert the following:
RATING METHODS FOR RAW MILK FOR PASTEURIZATION
1. DRUG RESIDUE COMPLIANCE, PROCEDURE FOR DETERMINING BTU COMPLIANCE WITH
APPENDIX N. Upon initiating an IMS rating or check rating it is necessary to
determine compliance of the BTU with the requirements of Appendix N. The
following criterion is to be used in making that determination. If the BTU is
not in substantial compliance, a rating or check rating is not to be completed
and the State Rating Agency shall immediately withdraw IMS certification.
a. Record Review. Determine from records that are stored in a manner
acceptable to the rating agency that all milk pick-up tankers are screened daily
prior to processing for beta lactams with an approved test method; as necessary,
determine that all producers are randomly tested 4 times in any consecutive 6
months for other drug residues as directed by M-a-75.
Compliance with the above item would be satisfied in the following manner:
(1) Records indicating that milk was always shipped to an IMS listed
shipper will suffice for actual test results.
(2) If milk is shipped to a non-listed plant, records indicating actual
testing must be provided or available for review.
b. Notification and Disposition. If a load sample or individual producer
sample is positive for a drug residue, determine if the regulatory agency was
immediately notified and told the method of proper disposition to keep
contaminated milk out of the food chain.
c. Reinstatement. Determine if the violative producer was not allowed to ship
milk until the milk no longer tested positive for drug residues.
In Part III. page 6, replace the existing #1 with the following and change the
old #1 to #2 and the old #2 to #3.
RATING METHODS FOR TRANSFER STATIONS,
RECEIVING STATIONS, AND PROCESSING PLANTS
1. DRUG RESIDUE COMPLIANCE, PROCEDURE FOR DETERMINING TRANSFER STATION,
RECEIVING STATION, AND PROCESSING PLANT COMPLIANCE WITH APPENDIX N.
Upon initiating an IMS rating or check rating it is necessary to determine
compliance of the transfer station, receiving station, and processing plant with
the requirements of Appendix N. The following criteria are to be used in making
that determination. If the transfer station, receiving station and processing
plant are not in substantial compliance, a rating or check rating is not to be
completed and the State Rating Agency shall immediately withdraw IMS
certification.
a. Record Review. Determine from records that are stored in a manner
acceptable to the rating agency that all milk pick-up tankers are screened daily
prior to processing for beta lactams with an approved test method; as necessary,
determine that all producers are randomly tested 4 times in any consecutive 6
months for other drug residues as directed by M-a-75.
Transfer stations, receiving stations and processing plants having raw supplies
attached with loads that occasionally are diverted by direct farm shipment,
shall be deemed in compliance if the following criteria are met:
(1) Records indicating that milk was always shipped to an IMS listed
shipper will suffice for actual test results.
(2) If milk is shipped to a non-listed transfer station, receiving
station and processing plant, records indicating actual testing must be
provided or available for review.
b. Regulatory Notification. If a load of milk was found to have a positive
drug residue determine if the regulatory agency was properly notified.
c. Industry Notification. If a load of milk was found to have a positive drug
residue, determine if the holder of the BTU permit that the farms are attached
to was properly notified.
*****
MMSR Page 23 Form 2359K
Problem 322
This problem will modify the example using this form to show that:
Two points are debited for violations of item 16r (11a), and for the
improper storage of drugs except that seven points are debited when drugs
are stored in a manner that they may contaminate milk or milk handling
equipment. Seven points are debited when drugs are stored in a manner
that is a violation of 16r (11, b, c & d). (Not to exceed 7 points total)
*****
PMO Page 1 and 25, Section 1. Definitions and PMO Page 8 and 33, Section 4.
Labeling
Problem 247
Add the following definition after definition A-1. on pages 1 and 25:
A-2. Sheep Milk.--Sheep milk is the normal lacteal secretion practically free
of colostrum, obtained by the complete milking of one or more healthy sheep.
Sheep milk shall be produced according to the sanitary standards of this
ordinance. The word "milk" shall be interpreted to include sheep milk.
Change #8 on page 8 and 33 as follows:
8. The word "Goat" or "Sheep" shall precede the name of the milk or milk
product when the product is or is made from goat or sheep milk, respectively.
*****
PMO Page 8 and 33, Section 4. Labeling
Problem 251
Change the following paragraph as indicated:
Milk tank trucks transporting raw, heat-treated or pasteurized milk and
milk products to a milk plant from another milk plant, receiving or transfer
station sources of supply not under the routine supervision of the regulatory
agency are required to be marked with the name and address of the milk plant or
hauler and shall be sealed;. F in addition, for each such shipment, a shipping
statement shall be prepared containing at least the following information:
*****
PMO Page 9 and 34 Section 4. Labeling, and MMSR Page 15 Section VI. Part 2
a.Preparation of Interstate Milk Shipper Report
Problem 338
At the end of Section 4 on Page 9, and on Page 34 before the Administrative
Procedures, add the following paragraph:
Each bulk milk pickup tanker load of milk shall be accompanied by documentation
(weight ticket or manifest) which shall include the IMS BTU Identification
Number(s) or the IMS Listed Plant Number (for farm groups listed with a plant).
Change the MMSR Page 15 as follows:
A. INDIVIDUAL SHIPPER OF RAW MILK FOR PASTEURIZATION
This shipper is commonly referred to a bulk tank unit or BTU. Following
computation of the sanitation compliance rating, Form FDA 2359K and Part I
"Report of Enforcement Methods," FDA 2359j, the resultant data will be
transferred to the "Interstate Milk Shipper Report," 2359i. The earliest rating
date shall be the date of the first day of the rating. Each BTU shall be
assigned an identification number beginning with the 2 digit State code, which
shall be included on the 2359i.
****NOTE**** The next edition of form 2359i will be changed to include "Plant
Code #/BTU #" in block 5.
*****
PMO Page 11 and 38, Section 6. The Examination of Milk and Milk Products
Problem 261
Change Paragraph 3 as follows:
Required bacterial counts, somatic cell counts, and cooling temperature
checks shall be performed on raw milk for pasteurization. In addition, drug
tests on each producer's milk or on commingled raw milk shall be conducted at
least four times during any consecutive 6 months. When commingled milk is
tested, all producers shall be represented in the sample. All individual
sources of milk shall be tested when test results on the commingled milk are
positive. Required bacterial counts, drug tests, coliform determinations,
phosphatase, and cooling temperature checks shall be performed on pasteurized
milk and milk products.
*****
PMO Page 12 and 39, Section 6. The Examination of Milk and Milk Products
Problem 263
Change the last paragraph of this section as follows:
Samples shall be analyzed at an official or appropriate officially
designated laboratory. All sampling procedures and required laboratory
examinations shall be in substantial compliance with the ... Edition of Standard
Methods for the Examination of Dairy Products of the American Public Health
Association, and the ... Edition of Official Methods of Analysis of the
Association of Official Analytical Chemists. (Insert edition number current at
time of adoption.) Such procedures, including the certification of sample
collectors, and examinations shall be evaluated in accordance with the
Evaluation of Milk Laboratories, 1985 Revision, United States Public Health
Service/Food and Drug Administration. Aseptically processed milk and milk
products packaged in hermetically sealed containers shall be tested in
accordance with Chapter 23 of the FDA's Bacteriological Analytical Manual,
6th edition of 1984. Examinations and tests to detect adulterants, including
pesticides, shall be conducted as the regulatory agency requires. Assays of
milk and milk products to which vitamin(s) A and/or D have been added, shall be
made at least annually in a laboratory acceptable which has been certified by
the U. S. Food and Drug Administration and which is acceptable to the regulatory
agency.
Implementation date July 1, 1995
*****
PMO Page 12 and 39, Section 6. The Examination of Milk and Milk Products
Problem 266
Following the last paragraph of Section 6. add:
In addition, all facilities fortifying products with vitamins must keep
volume control records. These volume control records must cross reference the
form and amount of vitamin D, Vitamin A and/or vitamin A & D used with the
amount of products produced and indicate a percent of expected use, plus or
minus.
*****
PMO Page 13 and 42, Section 7, Standards for Milk and Milk Products
Problem 119
Add the following underlined text as indicated:
No process or manipulation other than pasteurization, ultra pasteurization
or aseptic processing, processing methods integral therewith, and appropriate
refrigeration shall be applied to milk and milk products for the purpose of
removing or deactivating microorganisms: Provided, that in the bulk shipment of
cream, skim milk or lowfat milk, the heating of the raw milk, one time, to
temperatures greater than 52oC (125oF) but less than 72oC (161oF) for separation
purposes is permitted when the resulting bulk shipment(s) of cream, skim milk
and/or lowfat milk are labeled heat-treated. In the case of heat-treated cream,
the cream may be further heated to less than 75oC (166oF) in a continuing
heating process and immediately cooled to 7oC (45oF) or less when necessary for
enzyme deactivation (such as lipase reduction) for a functional reason.
*****
PMO Pages 15, 47, & 48 Section 7, Item 5r. Milkhouse or Room-- Construction and
Facilities
Problem 159
Add the following at the end of the 5th paragraph of this item on pages 15 & 47
as indicated:
The milkhouse shall be used for no other purpose than milkhouse operations.
There shall be no direct opening into any barn, stable, or into a room used for
domestic purposes: Provided, that a direct opening between the milkhouse and
milking barn, stable, or parlor is permitted when a tight-fitting, self-closing
solid door(s) hinged to be single or double acting is provided. Screened vents
in the wall between the milkhouse and a breezeway which separates the milkhouse
from the milking parlor are permitted, provided animals are not housed within
the milking facility.
Change #11 in Administrative Procedures, page 48 to read:
11. There is no direct opening into any barn, stable or room used for
domestic purposes; except that an opening between the milkhouse and milking
barn, stable or parlor is permitted when a tight-fitting, self closing, solid
door(s) hinged to be single or double acting is provided., except that screened
vents are permitted in the wall between the milkhouse and a breezeway which
separates the milkhouse from the milking parlor, provided animals are not housed
within the milking facility.
*****
PMO Page 23 24 107 108 Sections 13 and 14
Problem 320
Replace PMO Part 1 and Part 2 Section 13 with the following:
SECTION 13.
PERSONNEL HEALTH
No persons affected with any disease capable of being transmitted to
others through the contamination of food shall work at a milk plant in any
capacity which brings them into direct contact with finished products such as
pasteurized or aseptically processed milk or milk products or which brings them
into direct contact with associated pasteurized or aseptically processed milk
product contact surfaces.
ADMINISTRATIVE PROCEDURES
Milk plant operators who have received reports under this section from
employees who have handled pasteurized milk, pasteurized milk products, or
associated product contact surfaces shall immediately report these facts to the
appropriate milk regulatory agency.
Dairy plant employees (or applicants to become employees) shall be
instructed by the dairy plant that the employee or applicant is responsible to
report to the dairy plant management in a manner that allows the dairy plant to
prevent the likelihood of disease transmission of diseases that are
transmissible through foods if the employee or applicant:
1. Is diagnosed with an illness due to Hepatitis A virus, Salmonella
typhi, Shigella species, Norwalk and Norwalk-like Viruses, Staphylococcus
aureus, Streptococcus pyogenes, Escherichia coli 0157:H7, enterohemorrhagic
Escherichia coli, enterotoxigenic Escherichia coli, Campylobacter jejuni,
Entamoeba histolytica, Giardia lamblia, Non-typhoidal Salmonella, Rotovirus,
Taenia solium, Yersinia enterocolitica, Vibrio cholerae O1 or other infectious
or communicable disease that has been declared by the Secretary of Health and
Human Services to be transmissible to others through the handling of food or has
been clearly shown to be so based upon verifiable epidemiological data, or
2. Is exposed to, or suspected of causing, a confirmed foodborne disease
outbreak of one of the diseases specified in number (1) above, including an
outbreak at an event such as a family meal, church supper, or ethnic festival
because the applicant or employee:
a. Prepared food implicated in the outbreak, or
b. Consumed food implicated in the outbreak, or
c. Consumed food at the event prepared by a person who is
infected or ill.
3. Lives in the same household as a person who attends or works in a day
care center or school or similar institution experiencing a confirmed outbreak
of one of the diseases specified in number (1) above.
Similarly, dairy plant employees shall be instructed by the dairy plant
management to report to the dairy plant management if the employee (or
applicant):
4. Has a symptom associated with acute gastrointestinal illness such as:
abdominal cramps or discomfort, diarrhea, fever, loss of appetite for three or
more days, vomiting, jaundice, or
5. Has a pustular lesion such as a boil or infected wound that is:
a. on the hands, wrists, or exposed portions of the arms unless the
lesion is covered by a durable, moisture proof, tight-fitting
barrier, or
b. on other parts of the body if the lesion is open or draining
unless the lesion is covered by a durable, moisture proof, tight-
fitting barrier.
Section 14.
Procedure When Infection
or High Risk of Infection
is Discovered
When a person who may have handled pasteurized or aseptically processed milk or
milk products or pasteurized or aseptically processed milk product contact
surfaces meets one or more of the conditions specified in the administrative
procedures of Section 13, the regulatory agency is authorized to require any or
all of the following measures:
1. The immediate restricting of that person from duties which require
handling finished product such as pasteurized milk or milk products, or the
handling of related product contact surfaces. This restriction may be lifted
after an appropriate medical clearance or cessation of symptoms or both,
according to the following criteria:
ZDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDD?
3 3
3 Table 4 - Removal of Restrictions When 3
3 Infection or High Risk of Infection is 3
3 Discovered is available in hardcopy 3
3 from the Milk Safety Branch. 3
3 3
@DDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDY
2. The immediate exclusion of the affected dairy products from distribution
and use when medically appropriate (i.e., a medical evaluation of the sequence
of events indicates that contamination of product may have occurred).
3. The immediate requesting of medi cal and bacteriological examination
of the person at risk (Note: Persons at risk who decline to be examined may be
reassigned to duties where they will not be required to handle finished
products, such as pasteurized or aseptically processed milk or pasteurized or
aseptically processed milk products and associated product contact surfaces).
*****
PMO Page 40, Section 6 The Examination of Milk and Milk Products,
Administrative Procedures
Problem 236 (single underline)
Problem 268 (double underline)
Problem 243 (bold italics)
Change the following paragraphs as indicated:
Any one of t The Wisconsin Mastitis Test or California Mastitis Test
following three tests may be used for screening raw sheep and goat milk samples
to indicate a range of somatic cell levels as long as the somatic cell standard
for sheep and goat milk remains 1,000,000/ml.: California Mastitis Test, White-
side Test, Wisconsin Mastitis Test.
One Any of the following confirmatory or screening tests shall be used:
Direct Microscopic Somatic Cell Counting Single Strip Procedure, Electronic
Somatic Cell Counting, Optical Somatic Cell Counting, Flow Cytometry/Opto
Electronic Somatic Cell Counting, or Membrane Filter DNA Somatic Cell Counting.
Pyronine Y-Methyl green stain or `New York' modification' shall be used in the
confirmatory test for Direct Microscopic Somatic Cell Counts in sheep and goat
milk.
Laboratories using acceptable screening tests: the Wisconsin Mastitis
Test, Modified Whiteside or California Mastitis Test for sheep and goat milk
shall confirm that sample of herd milk which exceeds any of the following
screening test results:18 mm, or a value of one (1), respectively.
1. California Mastitis Test - 1
2. Modified Whiteside Test - 1+
3. Wisconsin Mastitis Test - 18mm.
*****
PMO Page 40 Section 6 Administrative Procedures, Laboratory Techniques
Problem 209 (underlined) and 269 (double underlined)
Following #7 add a new #8 as indicated:
8. All standards used in the development and use of drug residue
detection methods designed for PMO monitoring programs will be referenced to a
United States Pharmacopeia (USP) standard when available. When a USP standard
is not available, then the original method must define the standard to be used.
Add a new #9 following the new #8 as follows:
9. Procedural or reagent changes for official tests must be submitted to
the Food and Drug Administration for acceptance prior before being used by
certified NCIMS milk laboratories.
*****
PMO Page 40 Section 6 and Pages 298 and 299, Appendix N, Drug Residue Monitoring
and Farm Surveillance
Problem 215
Change page 40, sub-paragraph 4 to read as follows:
4. Disc assay methods for drugs specified in Appendix G. In addition,
methods which have been independently evaluated or evaluated by FDA.
by AOAC and have been found acceptable by FDA for detecting drug
residues at currently referenced safe or tolerance levels shall be
used 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.
Change pages 298 - 299, Appendix N, last 2 paragraphs as follows:
AOAC First Action and AOAC Final Action methods are accepted in
accordance with Section 6. Other d Drug residue detection methods
may shall be submitted to AOAC for evaluatedion at the safe level or
tolerance. Regulatory action based on each test kit method may be
delayed until the AOAC evaluation is completed and the method is found
to be acceptable by AOAC to FDA and complies with the provisions of
Section 6.
*****
PMO Page 54, Section 7, Item 12r. Utensils and Equipment - Storage
Problem 132
Change #4 in Administrative Procedures as follows:
4. Strainer pads, parchment papers, gaskets and similar single-service
articles are stored in a suitable container or cabinet and protected against
contamination., in a location convenient to their use.
*****
PMO Page 55, Section 7, Item 14r. Milking--Flanks, Udders and Teats
Problem 133
Change #4 in Administrative Procedures as follows:
4. Udders and teats of all milking cows are clean and dry before
milking. Teats shall be cleaned, treated with a sanitizing solution and
dry just prior to milking.
*****
PMO Page 76, Section 7, Item 15p(B) Protection from Contamination
Problem 149
Change #1. as follows:
1. During processing, pipelines and equipment used to contain or
conduct milk and milk products shall be effectively separated from tanks or
circuits containing cleaning and/or sanitizing solutions. Tanks, pipelines and
equipment used to contain or conduct pasteurized milk and milk products shall be
separated from tanks, pipelines and equipment used to contain or conduct raw
milk and milk products. This section does not require separate raw and
pasteurized CIP systems.
*****
PMO Page 84, Section 7. Item 16p(B)
Problem 121
Following 2. b. (9), add the following:
(10) The flow-diversion device shall be interwired, via micro-switches to
the timing pump or timing system, to insure that flow occurs only when the
valve(s) are in the fully forward-flow or fully divert position. A one
second maximum "off" time delay is allowable to maintain the flow-
promoting device in the "on" position through the travel time of the
valve(s).
*****
PMO Page 97 item 16p.(E)2 Temperature Recording Charts, Equipment Tests and
Examinations
Problem 89-117
Add the following at the end of this section:
2. EQUIPMENT TESTS AND EXAMINATIONS.--The regulatory agency shall
perform the indicated tests on the following instruments and devices initially
on installation, and at least once each 3 months thereafter, and whenever any
alteration or replacement is made which may affect the proper operation of the
instrument or device; Provided, that the holding time test shall be conducted
at least every 6 months.
On an emergency basis, pasteurization equipment may be tested and
temporarily sealed by a dairy plant employee provided the following conditions
are met:
a. The individual applying the seal(s) is employed in a supervisory
capacity by the plant in which the seal was removed; and
b. The individual has satisfactorily completed a course of instruction,
acceptable to the regulatory agency, on test controls for pasteurization
equipment that includes a minimum of 8 hours classroom instruction; and
c. The individual has demonstrated the ability to satisfactorily conduct
all pasteurization control tests, in the presence of a regulatory official
within the past year; and
d. The individual is in possession of authorization from the regulatory
agency to perform these tests; and
e. The individual will immediately notify the regulatory agency of the
time of the shutdown that would necessitate the removal of the regulatory
seals. Permission to test (and seal) the equipment must be obtained for
each specific incident. The individual will also notify the regulatory
agency of the identity of the controls affected, the cause (if known) of
the equipment failure, the repairs made and the result of testing (when
completed). The individual will provide the identity and volume of
products processed during the period that temporary seals were applied to
the regulatory agency; and
f. If regulatory tests reveal that equipment or controls are not in
compliance with the provisions of this document, all products that were
processed during that period will be recalled; and
g. The regulatory agency will remove the temporary seals, retest the
equipment and apply regulatory seals within 3 working days of notification
by industry; and
h. No Grade A dairy products will be processed after three working days
without the affected equipment being tested and sealed by the regulatory
agency.
*****
PMO Page 103, Section 7, Item 20p. Personnel--Cleanliness
Problem 152
Change #4 in Administrative Procedures as follows:
4. Tobacco is not used by any person while engaged in the processing of
milk or milk products and adequate head coverings are worn. The use of tobacco
products is prohibited in all rooms in which milk or milk products are
processed, handled or stored, or in which milk containers, equipment and
utensils are washed. These rooms shall include but are not limited to the
receiving, processing, packaging, product storage (cooling and dry storage
ingredients), single-service article storage, and container/utensil wash up
areas. Adequate head coverings are worn by any person engaged in the
processing of milk or milk products.
*****
PMO Page 151 Appendix D, V. Water Reclaimed From the Condensing of Milk and
Milk Products.
Problem 116
Add the following underlined text at the end of this section (before the note):
Condensing water from milk evaporators and water reclaimed from milk or milk
products may be used for the following limited applications:
1. pre-rinsing of the product surfaces where pre-rinses will not be used
in food products; and
2. Cleaning solution make-up water; provided that for either use, items
# 3-11 of this section are satisfied, and:
a. There is no carry-over of water from one day to the next, and any
water collected is used promptly, or
The temperature of all water in the storage and distribution
system is maintained at 63oC (145oF) or higher by automatic means,
or
The water is treated with a suitable, approved chemical to
suppress bacterial propagation by means of an automatic
proportioning device, prior to the water entering the storage tank,
and
b. Distribution lines and hose stations are clearly identified as
"limited use reclaimed water", and
c. Water handling practices and guidelines are clearly described and
prominently displayed at appropriate locations within the plant, and
d. These water lines are not permanently connected to product
vessels, without a break to the atmosphere and sufficient automatic
controls, to prevent the inadvertent addition of this water to
product streams.
Recovered water may be used as boiler feedwater for boilers, not used for
generating culinary steam or in a thick, double walled, enclosed heat exchanger.
*****
PMO Page 181, Appendix G. Chemical and Bacteriological Tests
Problem 211, Problem 227, and Problem 278
Change paragraph 4 as follows:
Criteria.--An MPN (Most Probable Number of coliform organisms) of
less than 2.2/100 ml by 1.1 per 100 ml, when ten replicate tubes
containing 10 ml, or when five replicate tubes containing 20 ml are tested
using the multiple tube fermentation technique, or less than 1 per 100 ml
by the membrane filter technique, or less than 1.1 per 100 ml when using
an mmo-mug technique (The MMO-MUG technique is not acceptable for
recirculated cooling water). 100 q 2.5 ml water will be used for this
analysis. Any sample producing a bacteriological result of TNTC--Too
Numerous To Count--(greater than 200 total bacterial colonies per 100 ml)
or confluent growth by the membrane filter technique), or a
bacteriological result of Turbid by the multiple Tube Fermentation (Most
Probable Number -MPN) technique, without coliform present confluent
without coliform present shall have a subsequent heterotrophic plate
count of less than 500 colonies/ml in order to be deemed satisfactory.
*****
PMO Page 210, Appendix I, Pasteurization Equipment and Controls - Tests
Problem 123
Change the section titled STOPWATCH as indicated:
STOPWATCH
Type.--Pocket type, o Open face, hand indicating fractional seconds.
Accuracy.--Accurate to 0.2 of a second.
Hands.--Sweep hand (if applicable), one complete turn every 60 seconds or
less.
Scale.--Divisions of not over 0.2 of a second.
Crown.--Depression of crown or push button starts, stops, and resets to
zero.
*****
PMO Page 214, Appendix I, Pasteurization Equipment and Controls - Tests
Problem 125
Change test #4. Device Assembly, Dual Stem Device as follows:
Apparatus.--None
Method.--Observe function of metering pump when flow-diversion device is
improperly assembled.
*****
PMO Page 217, Appendix I, Pasteurization Equipment and Controls - Tests
Problem 126
Change the example following test 7 as follows:
Example:--For a thermometer used at pasteurization temperature set points
of 71.7oC (161oF) and 74.4oC (166oF), a water bath at a temperature of 78.3oC
(173oF) could be used. 10.6oC (19oF) lower than 78.3oC (173oF) water bath would
be 67.8oC (154oF); 3.9oC (7oF) lower than 78.3oC (173oF) water bath would be
74.4oC (166oF). On a thermometer with a range of 66oC to 80oC (150oF to 175oF)
used at pasteurization temperatures of 72oC and 75oC (161oF and 167oF), a water
bath of 77oC (170oF) could be used. 11oC (19oF) below 77oC (170oF) would be
66oC (151oF); 4oC (7oF) below 77oC (170oF) would be 73oC (163oF). Hence, after
immersing the thermometer which has been previously cooled, in the 787.3oC
(1703oF) bath, the stopwatch is started when the thermometer reads 67.86oC
(1541oF) and stopped when it reads 74.33oC (1663oF).
NOTE.--The test included the pasteurization temperature set points of 71.72oC
(161oF) and 74.45oC (166oF). If the pasteurization temperature set points had
been 71.7oC (161oF) and 79.4oC (175oF), it would not have been possible to
include both set points within a 6.7oC (12oF) span. With these set points the
test would have to be done separately for each set point.
*****
PMO Page 226, 227, and 228 Appendix I - Pasteurization Equipment and Controls-
Tests
Problem 164
Change l. as indicated on page 226:
l. Repeat procedure k. using milk. For all gear-driven timing pumps,
and for those homogenizers used as timing pumps when the measured holding time
for water is less than 120% of the legal holding time, repeat procedure `k'
using milk.
On page 227, delete sections m. and n. and on page 228 delete section o. and
replace them with the following:
m. Record this result for the office record.
*****
PMO Page 298 Appendix N, II, Regulatory Responsibilities, Part B Enforcement
Problem 292
Add the following sentence as indicated:
Reinstatement. The Grade A producer permit may be restored to a temporary
permit status after the penalty when a sample taken from the producer's 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. A copy of the Certificate of Completion
signed by both the producer and a licensed veterinarian shall be provided to the
regulatory agency.
*****
PMO Page 300 New Appendix O.
Problem 264
Add the following appendix to the PMO:
APPENDIX O.
VITAMIN FORTIFICATION OF FLUID
MILK PRODUCTS
PROCESS/METHODS OF VITAMIN ADDITION
Vitamin fortification can be accomplished by the addition of vitamins at
many different points in the processing system. These range from addition to
the raw tanker before unloading, to the silo tank, to the pasteurizing vat (for
vat pasteurization), to the HTST balance tank, and on a continuous basis into
the pipeline after standardization and prior to pasteurization. Both batch
addition and addition with metering pumps can be used. The batch procedure
requires accurate measurement of the volume of milk to be fortified, accurate
measurement of the vitamin concentrate, and proper mixing. When a metering
pump(s) is used with an HTST unit or an HHST unit the pump(s) must be installed
so as to be activated only when the unit is in forward flow. The addition of
vitamins must be accomplished prior to pasteurization.
The problem of under-fortification is often related to the point in the
system where fortification takes place. Vitamins A and D are fat soluble and
will gradually become more concentrated in the milk fat portion of the milk.
Both oil and water base vitamins are susceptible to this migration problem.
If vitamins are added in the proper amount before separation and
standardization, and the product is separated and standardized, then the low fat
product will tend to be under fortified and the high fat product over fortified.
To reduce this effect, it has been found that if the vitamin concentrate used is
in an evaporated milk carrier, the separation of the vitamins to the fat or
cream phase is minimized. Processors who use this procedure should perform
confirmatory assays to ensure proper fortification levels of each product.
Many HTST systems are now being used with in-line fat standardization
which also makes possible switching without stopping from products being
fortified with Vitamin D to those being fortified with both A and D. These
systems require metered injection of the proper vitamins at a point after
standardization and before pasteurization. Sanitary positive displacement
pumps are available for this purpose.
There are two types available, one is a piston-type positive displacement
metering pump without valves. It is equipped with a micrometer, which allows
accurate and reproducible amounts of vitamins to be added based on the rate of
product flow through the system.
The other type of metering pump also is a positive displacement or
peristaltic pump which offers precise control. This is because volume can be
controlled by the size of tubing used and pump speed. The pump is easy to
clean because only the tube is in contact with the vitamin concentrates. These
pumps also have a history of reproducibility and reliability. All metering
pumps should be designed specifically to conform with this Ordinance as
recommended by equipment employed in sanitary applications.
The best point for injection of the vitamin is ahead of the homogenizer,
which in most cases is a point of low pressure. This allows the homogenization
process to distribute the vitamin throughout the milk. A positive displacement-
type pump must be used. Otherwise negative pressures at the point of injection
can create problems. A small vacuum can result in relatively large volumes of
vitamin concentrate being drawn into the milk system in a very short time
period.
Simple, single speed HTST systems running one product, for example,
homogenized vitamin D milk, would work very well with one metering pump. More
complex systems having two or more operating speeds and running products to
which both vitamin D and vitamins A & D are added, require more than one pump
and a valving arrangement. See Figure 41 for an example of such an arrangement.
To avoid the need for two pumps or the constant adjusting of pumps where
both vitamin D and vitamin A & D concentrates are used in the same HTST systems,
the vitamin D concentrate can be diluted with water or skim milk so that it can
be fed into the system at the same rate as the vitamin A & D concentrate.
Regulatory personnel should be notified for their approval if this procedure is
used. Provision should be made to keep these solutions at 40~F. (4.4~C) or less
during the fortification process. Extreme care should be taken to make precise
measurements. Small errors in measurements and calculation can have a major
effect on the final concentration in the finished product. Containers and
equipment used for dilution should be cleaned and sanitized daily or more
frequently if necessary.
Essential to proper results are the following:
(1) Management must be committed to proper fortification and concerned with
both over and under levels.
(2) Design the system correctly for proper addition in which concentrate is
added after standardization and before pasteurization.
(3) Keep accurate records of vitamins used and products produced, checked
daily against theoretical use. Care should be taken that adequate fortification
of small run products like skim milk is not masked by much larger volumes of 2%
or other partly skimmed milk products.
(4) Use an accurate, sanitary, positive displacement metering pump with a
scheduled cleaning procedure after use.
(5) Use a check valve on the injection line to prevent milk from being pushed
back into the line. This depends on pump displacement.
(6) Check meter calibration regularly by determining delivery rate accuracy.
(7) Use insulated vessels, such as thermos jugs, for holding diluted
concentrates to maintain temperatures of 40~F. (4.4~C.) and below. A regular
systematic cleaning and sanitizing schedule must be maintained for these
vessels.
(8) Check finished products regularly. Results should be reported in
International Units (I.U.)/946 milliliters (1 quart). Because of the
sensitivity and difficulty in performing these tests, it is necessary to
procure the services of a competent laboratory, one that is familiar with the
handling and testing of vitamin fortified dairy products.
GOOD MANUFACTURING PRACTICES
Good manufacturing practices require that the vitamin A & D levels not be
less than 2000 International Units per 946 milliliters (1 quart) of vitamin A
and 400 International Units of vitamin D. Fluid dairy products are allowed not
less than 100% and not more than 150% of required values or label claims to be
in compliance with good manufacturing practices.
TESTING METHODS
The Association of Official Analytical Chemists (AOAC), Fifteenth Edition
1990, recommends a liquid chromatography method for vitamin D. The Carr-Price
Method is recommended by AOAC for vitamin A. Other methods for vitamin A
include fluorescent spectrophotometry (see Journal of Dairy Science, Volume 58,
page 558) and liquid chromatography methods. Most plant quality control
laboratories are not equipped to perform these analyses.
TYPE OF CONCENTRATES AVAILABLE
A number of different types of concentrates are available. All contain
vitamin D and/or vitamin A palmitate with a carrier consisting of any of the
following: butter oil, corn oil, evaporated milk, non-fat dry milk,
polysorbate 80, propylene glycol and glycerol monooleate. It is best to store
all concentrates under refrigeration unless manufacturer directions indicate
otherwise. To achieve adequate dispersion, viscous concentrates should be
brought to room temperature before addition.
NEED FOR ADDITION
Vitamin A is fat soluble, that is it will dissolve when mixed with fat and
will not dissolve in water. For this reason Vitamin A is found in whole milk
and to a lesser degree in lowfat and absent in non-fat milk, unless these
products are fortified.
Vitamin D is the major regulator of calcium absorption in the intestine.
Fortification of fresh milk with Vitamin D is acknowledged to have virtually
eliminated rickets in milk drinking children. Since normal levels of Vitamin D
are necessary for optimal calcium absorption in children, it is also known that
these levels are required as one increases in age. It has been associated with
reducing the incidence of osteoporosis in premenopausal women.
Vitamin A performs many functions. One is to enable the retina of the eye
to respond to dim light. Deficiency of Vitamin A produces night blindness.
Vitamin A is also involved in the ability of the eye to discern color.
Vitamins A and D can be a potential threat to public health if consumed at
excessive levels. Over fortification with levels of Vitamin A over 6,000 I.U.
and Vitamin D over 800 I.U. should be considered harmful; therefore it is
necessary to accurately control the proper level of fortification.
PROBLEMS INVOLVED WITH FORTIFICATION
Natural Levels
Milk and milk products which contain a large proportion of fat are
relatively good dietary sources of Vitamin A, but as is the case with other
natural foods, the Vitamin D content of unfortified milk is quite low. As with
other milk components, Vitamin A & D levels are affected by breed, season, diet,
lactation and, in the case of Vitamin D, animal exposure to sunlight.
In general, when cows are transferred from pasture to winter rations in
the fall, a decline in the Vitamin A & D levels can be expected in the raw milk.
This occurs slowly through the winter season until the cows are once more on
pasture in the spring. With proper selection of feed and diet concentrates this
effect can be kept to a minimum. Natural levels of Vitamin A range from 400
I.U. in winter to 1200 I.U. in summer, and Vitamin D, 5 I.U. in winter to 40
I.U. in summer. These are approximate ranges to indicate possible seasonal
variations. Because of seasonal and other variations in natural vitamin levels,
it is necessary to monitor the level of fortification to assure that levels are
within good manufacturing practices.
Vitamin D is very stable in homogenized whole milk and is not affected by
pasteurization or other processing procedures. Vitamin D in fortified
homogenized whole milk will remain constant, with little or no loss of vitamin
potency, during long periods of proper storage. No loss of vitamin D will be
experienced under normal shelf life periods.
Vitamin A and D fortified skim milk products are subject to decreases in
vitamin A, because the vitamin is no longer protected by fat as it is in whole
milk. In fluid skim or low fat milk, added vitamin A deteriorates gradually
during normal storage of the milk at 4.4~C (40~F.) in the dark but is destroyed
rapidly when the milk is exposed to sunlight in transparent glassbottles or
translucent plastic containers. The photo destruction of added vitamin A is
dependent on the intensity and wave length of light and milk source. The use of
amber or brown glass bottles, pigmented plastic containers formulated with
specific light barriers and colored paper cartons retard this destruction.
Vitamin A losses in 2% milk, from five dairy plants, ranged from 8% to 31% when
they were exposed to 200 foot candles of fluorescent light for 24 hours in
opaque plastic containers. Use of pigmented containers or gold shields over
fluorescent tubes practically eliminated these losses. Problems associated with
natural levels, loss of vitamin A during storage and the problems with the
mechanical additiondiscussed in the following section of this guideline indicate
the difficulty in providing a product that will have proper potency levels.
NOTE: Figure 41 details a two-speed vitamin fortification installation
using two pumps and two vitamin concentrate sources. This enables
changing from different vitamin concentrates and different speed pumps
via the adjustment of three-way valves.
Recommendations:
1. Use sanitary check valve(s) to separate milklines from vitamin
concentrates.
2. Keep all milk contact surfaces of sanitary design that are easily
cleanable and available for inspection.
*****
Procedures Page 2 Section I. Standards A. Milk Sanitation Standards
Problem 101 (single underline)
Problem 102 (double underline)
Change #4 and add #5 as follows:
4. For the purpose of these Procedures and NCIMS in total, the District
of Columbia and each participating U.S. Trust Territory shall be
considered as a State with all the rights, duties, responsibilities,
and privileges of a State.
5. For the purpose of these Procedures and NCIMS in total, each
participating non - U. S. country or political subdivision thereof
shall be considered as a State with all the rights, duties,
responsibilities, and privileges of a State, provided the governing
regulatory body of such non - U. S. country or political subdivision
thereof shall meet the requirements of Part 2 of this section by
establishing a Memorandum of Understanding with the Public Health
Service/Food and Drug Administration (PHS/FDA) which provides an
acceptable basis for NCIMS to verify equivalence in the State or
local area concerned.
*****
Procedures Page 12 Section VI.D.
Problem 204
Add the following for #7 and renumber the existing #7 and #8 to become #8 and #9
respectively.
7. Regulatory compliance with Appendix N will be determined by the FDA
regional milk specialist through check ratings and will be reported
on an annual written state evaluation. This annual Appendix N
evaluation will be reported to the Milk Safety Branch Headquarters.
Any state regulatory agency not in substantial compliance with
Appendix N will be individually identified on a separate page in the
Quarterly IMS list with the approval of the NCIMS Executive Board.
A state regulatory agency in non-compliance with Appendix N for a
second consecutive year and again, with the approval of the NCIMS
Executive Board, would not be an active participant in future IMS
Conferences until substantial compliance is achieved.
IMPLEMENTATION DATE July 1, 1995
The following procedure for determining state regulatory compliance with
Appendix N will be included in the appropriate guidance document for FDA
inspectors:
DRUG RESIDUE COMPLIANCE
PROCEDURE FOR DETERMINING REGULATORY
COMPLIANCE WITH APPENDIX N
Regulatory compliance will be determined by the FDA regional milk specialist
through check ratings and will be reported on an annual written state evaluation
of Appendix N. This annual Appendix N evaluation will be reported to the Milk
Safety Branch Headquarters. Any state regulatory agency not in substantial
compliance with Appendix N will be individually identified on a separate page in
the Quarterly IMS List with the approval of the NCIMS Executive Board.
Substantial compliance will be determined using the following criteria:
A. Determine if the regulatory agency has made unannounced, on-site
inspections to collect samples for drug residue testing. Samples should
be collected and analyzed from at least 10% of the bulk milk pickup
tankers scheduled to arrive on the day of inspection.
B. Determine if the regulatory agency has properly evaluated the industry
program to determine if the industry has:
1. An appropriate monitoring program (the proper tests).
2. An adequate monitoring program (sufficient tests).
3. Every producer represented as demonstrated by record review in
accordance with the following criteria:
a. Records indicating that milk was always shipped to an IMS listed
shipper will suffice for actual test results.
b. If milk is shipped to a non-listed plant, records indicating
actual testing must be provided or available for review.
4. Timely reporting of positive drug test results to the regulatory
agency.
C. Is traceback to violative producers timely on all positive loads?
D. Determine if the violative producer's permit was suspended when his sample
tested positive for drug residues.
E. Determine if the violative producer was given the appropriate penalty.
F. After the producer has a drug-free test, determine if a temporary permit
was issued for a period not to exceed 30 days.
G. After the temporary permit was issued, determine if the producer and
veterinarian signed the Quality Assurance Certificate (QAC). The QAC
shall be available in the manner prescribed by Appendix N.
H. Determine if the producer was issued a full permit after the QAC was
signed.
I. Is the regulatory agency monitoring the disposition of all contaminated
loads?
The following timetable for implementation of this problem was also passed:
May, 1993 24th NCIMS
Aug, 1993 NCIMS Executive Board Meeting
Oct 1, 1993 Start of Federal fiscal year, and the start of state
Appendix N evaluations by FDA Milk Specialists.
Apr 1, 1994 Completion by FDA Milk Specialists of state Appendix N
evaluations.
Jul 1, 1994 IMS List published with list of non-complying state
regulatory agencies.
Spring,1995 25th NCIMS
July 1,1995 Non-complying states would not be an active participant
in future NCIMS conferences until substantial compliance is
achieved.
*****
Procedures Page 21 22 23 & 24, Constitution
Problem 306
Change Article IV, Section 1 as follows:
SECTION 1. The voting delegates, of the Conference, are representatives of
the State rating, State enforcement agencies, and like
representatives from the District of Columbia, participating
U. S. Trust Territories and each participating non-U. S.
country or political subdivisions thereof, as identified in
Article X, Section 4, Subdivision 3, of this Constitution.
Change Article IV, Section 4 to read:
Section 4. The Board shall be composed of twenty-two (22) members as
follows: Four (4) members from Group I (Eastern States);
six (6) members from Group II (Central States) (2 at large);
and four (4) members from Group III (Western States), all to
be elected by the General Assembly by majority vote (General
Assembly is defined as qualified voting delegates
from the various States and the District of Columbia,
assembled at a biennial or special meeting, of the
Conference); plus....
Add a new Subdivision to Article IV, Section 5 to read:
Subd. 4. Other Membership
In the case of participating U. S. Trust Territories, non-U.S.
Countries or political subdivision thereof, each U.S Trust
Territory, non-U. S. country or subdivision thereof shall be
assigned to Group I, Group II, or Group III by the NCIMS Executive
Board.
Change Article X, Section 4, Subdivision 3 to read:
Subd. 3. Only a registrant at the biennial or special meeting, of the
Conference, who is a representative of a state rating agency
or a State enforcement agency responsible for the enforcement
of sanitation laws for Grade "A" milk and milk products,
Grade "A" nonfat dry milk and Grade "A" whey, or a like
representative from the District of Columbia, or
participating U. S. Trust Territory, a participating
non-U. S. country or political subdivision thereof is
entitled to be a voting delegate. When any State is
represented by both rating ......
*****
Procedures Page 23 29, Constitution
Problem 307
Amend Article IV, Section 6, to read:
Section 6. The board shall elect a Chairman and a Vice Chairman from its
membership after each biennial meeting, of the Conference,
and each may retain his/her position at the pleasure of the
Board as long as he/she is officially a member of the Board.
If the Chairman can not perform his/her duties the Board
shall again elect a Chairman. The Board shall retain the
services of an Executive Secretary-Treasurer. The Executive
Secretary-Treasurer shall be bonded; shall have no vote on
the Board; shall have no vote in biennial or special
meetings, of the Conference; but shall perform all duties
required in Article VIII of this Constitution. The
compensation of the Executive Secretary-Treasurer shall be
set by the Board.
Note - The words "Executive Secretary-Treasurer" should be replaced with
"Executive Secretary" throughout the Constitution and Bylaws.
Add a new Section 8 to Article VIII --- DUTIES OF THE EXECUTIVE SECRETARY
TREASURER
SECTION 8. The Executive Secretary shall act as Treasurer of the
Conference and handle all financial matters of the Conference
as directed by the Executive Board.
*****
Procedures Page 24 Constitution
Problem 310
To Article IV add a new Section 8 as follows:
Section 8. Elected members of the Executive Board who retire or change
disciplines from which elected (such as becoming consultants)
may no longer continue to serve on the Executive Board in
their current position. Should the Conference Chairman
retire or change positions he/she may continue to serve as
Past Chairman.
*****
Procedures Page 24 Constitution
Problem 311
Change Article V, Section 2 as follows:
SECTION 2. The Board shall meet prior to each biennial or special
meeting of the Conference and after the biennial or special
meeting closes. The Chairman shall call special meetings
of the Board at any time at the request of two-thirds (2/3)
of its members. In addition to the required meetings of
the Board prior to and after biennial or special meetings,
of the Conference, and special meetings of the Board
called at the request of two-thirds (2/3) of the Board
members, the Chairman is empowered to call special
meetings of the Board at any time, as the need arises
with the concurrence of two-thirds (2/3) of the Board
members. With the concurrence of two-thirds (2/3) of the
Board members, special Board meetings may be conducted by
using telephone conference calls and electronic mail (FAX)
ballots.
*****
Procedures Constitution Page 31 & 32 Article X Section 4 subd. 3
Problem 301
Add the following footnote in the Procedures to the end of Section 4, subd. 3.:
Each voting delegate at the biennial or special meeting of the Conference
may cast a vote only for his/her own State.2
2 The Twenty-Fourth NCIMS directed the NCIMS Chairman to provide for the
following constitutional amendment at the 1995 NCIMS Conference, to be
effective October 1, 1995:
Delegates and/or alternates will not be allowed to vote at a NCIMS
from a state which fails to honor the reciprocity provisions set
forth in Section 1-A paragraphs 2 and 3 of the Procedures Governing
the Cooperative State-Public Health Service/Food and Drug
Administration Program for Certification of Interstate Milk
Shippers.
The NCIMS Chairman is directed to submit an amendment reflecting the above
wording to the 1995 NCIMS Conference
*****
SSCC Page 1
Problem 111
Change definition #3 as follows:
3. "Paper stock" means any paper made from: the following materials:
a. Paper and paperboard made manufactured from clean, sanitary
virgin chemical or mechanical pulp or from "broke and trim"
of such paper and paperboard, provided they have been
handled, treated and stored in a clean sanitary manner., or
reclaimed fiber using acceptable or approved protocol in
compliance with 21 CFR 176.260.
b. Components meeting the requirements of the Federal Food,
Drug and Cosmetic Act2 as amended.
Change definition #4 as follows:
4. "Broke and trim" means paper and paperboard that have been discarded
anywhere in the process of manufacture, such as on paper-making
machines in the form of trim. This may also include unprinted trim
from the converting process provided the trim has been handled,
treated and transported in a clean, sanitary manner. This does not
include post consumer wastes.
*****
SSCC Page 3
Problem 110
Add the following definition after #14:
15. "Manufacturer" means any person or company in the business of
manufacturing a single-service container or closure product which is
capable for use by a milk plant for the packaging of a finished
Grade "A" milk product.
*****
SSCC Page 9
Problem 109
SSCC Committee with MSB and MIF will develop language to allow use of recycled
plastic and plastic resins, using an acceptable or approved protocol to assure
the safety of the final product. The language changes will be completed and
incorporated into the SSCC on or before January 1, 1994.
*****
The following problems were passed without reference to a document:
Problem 124
This Conference action referred a proposed change in test procedures for
electronic recording thermometer temperature accuracy to FDA for further study.
The results of this study are to be reported to the 1995 Conference.
*****
Problem 130
The Food and Drug Administration should evaluate the adequacy of several
commonly applied cleaning and sanitizing regimens for defoamer screens with
research and/or NCIMS involvement as appropriate. The findings of these studies
should be issued in the form of an M-I from FDA or brought to the 1995
conference.
*****
Problem 163
Directs FDA to review results of Pennsylvania test results which indicated a
variation in holding time measurements when different methods of adding salt
were used. If the results of this review indicate a problem, an M-I will be
issued.
*****
Problem 166
Requests the NCIMS Executive Board to appoint a study committee to study mixing
human and animal wastes in liquid manure holding systems and report their
results to the 1995 Conference
*****
Problem 205
This Conference action provides that raw milk laboratory samples not be
considered hazardous material for disposal.
*****
Problem 206
This Conference action allows containers with a volume greater than one gallon
to be sub-sampled in order to be submitted for analysis.
*****
Problem 217
This Conference action provides that a microwave oven may be used to remelt
agar.
*****
Problem 219
This Conference action directs that the laboratory evaluation forms be modified
to include the Fossomatic models 250, 300, and 360.
*****
Problem 223
This Conference action directs FDA to revise the EML, present the first draft
to the Laboratory Committee before 7/1/94 and provide the final document to the
1995 NCIMS.
*****
Problem 229
This Conference action directs FDA to change laboratory form 2400a to delete
part 1.e and change 1.f to read:
If raw and retail milk sample temperatures exceed 4.4oC on receipt, do not
test microbiologically unless sample collected less than 3 hours before
and temperature is not higher than that at collection, 7oC (45oF) maximum.
*****
Problem 230
This Conference action directs FDA to change the laboratory form 2400 to provide
for 0.5oC increments for laboratory thermometers that are either new or
replacements.
*****
Problem 231
This Conference action retains a variance of 1.0oC in laboratory incubator
temperatures. (This applies to milk laboratories only.)
*****
Problem 238
Allows universal raw milk samples to be used for electronic somatic cell count
to be any universal raw milk sample taken in accordance with existing PMO
requirements and which is aged less than 72 hours.
*****
Problem 245
This Conference action establishes a review by the MMSR Committee of the current
point values used to compute sanitation compliance ratings of raw milk for
pasteurization. Proposed changes from this review are to be submitted to the
1995 NCIMS Conference.
*****
Problem 274
This Conference action directs FDA to establish procedures (if possible) for
collection of raw milk samples from manholes or outlet valves. This problem was
carried over from the 1989 and 1991 Conferences.
*****
Problem 279
This Conference action directs the NCIMS Chairman to appoint a committee to
establish the protocol and parameters, and implement a pilot project to evaluate
a performance based farm inspection system.
*****
Problem 284
This Conference action directs FDA to include the state associations of the
American Veterinary Medical Association and American Association of Bovine
Practitioners in the distribution of informational memoranda related to drug
issues.
*****
Problem 285
This Conference action provides that after drug screening test kits have been
evaluated and accepted by FDA, there will be up to a 180 day period for the
state agencies to complete training of "Industry Supervisors", and an additional
90 day period for Industry Supervisors to complete delegation procedures. (Note:
NCIMS Executive Board extended this time period from 90 days to 180 days at the
August 5, 1993 meeting)
*****
Problem 302
Sent a proposed change to the Procedures, Pages 14 and 15, paragraph VII.
C(1.)(C)(1) to the MMSR Committee for further study and recommendation. This
change would provide that dairies scoring 90 or more on ratings or check ratings
would not be withdrawn when the score required withdrawal.
*****
Problem 317
Directs the NCIMS Chairman to appoint a standing committee to review, evaluate
and advise the NCIMS Executive Board and FDA, on matters related to determining
the equivalent effect of sanitary and phytosanitary standards which may be used
to determine the acceptability of imported products under any existing or future
U. S. trade agreements.
*****
Problem 321
This problem was referred to the Resolution Committee. Resolution #5 was passed
which directs the Conference Chairman to appoint a committee to review, evaluate
and study the current program, and to further develop appropriate recommendations
for the 1995 Conference.
*****
Problem 326
This problem allows rating or check rating officer to use professional judgement
on whether or not to access a debit or allow time for correction of long
standing equipment or equipment installation violations when the preexisting
condition does not present a public health hazard.
*****
Problem 327
This problem was referred to the MMSR Committee for further study. It would
change the MMSR Part II. Rating method for raw milk for pasteurization, 1.
Collection of data, b. Recording of Laboratory and other test data, part (2) on
page 4 to require that drug residue requirements are met, and would change form
2359K to reflect a seven point debit under item 16 for an insufficient number of
drug samples examined during the six month period prior to a rating.
*****
Problem 328
This conference action requested the MMSR Committee to clearly define the method
of calculating enforcement ratings, especially Part I, Number 10 and Part II,
Number 9.
*****************
All changes related to the PMO have been incorporated into the 1993 edition
which will be distributed in October of 1993. Changes to related documents will
be added as these documents are updated.
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, HFS-626
Division of Cooperative Programs
Center for Food Safety and Applied Nutrition
U.S. Food and Drug Administration
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