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IMS-a-31: Actions of the 1993 National Conference on Interstate Milk Shipments

<< Back to Index of Memoranda of Conference Actions (IMS-a) Main Page
 

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 forPasteurization, 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.
    1. 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.
    2. 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.
    3. 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.

    1. 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.

    2. Regulatory Notification. If a load of milk was found to have a positive drug residue determine if the regulatory agency was properly notified.
    3. 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:

  1. 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:  

  1. 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:

  1. 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:
    1. Prepared food implicated in the outbreak, or
    2. Consumed food implicated in the outbreak, or
    3. 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:
    1. on the hands, wrists, or exposed portions of the arms unless the lesion is covered by a durable, moisture proof, tight-fitting barrier, or
    2. 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:

    Table 4 - Removal of Restrictions When Infection or High Risk of Infection is Discovered is available in hardcopy from the Milk Safety Branch.

  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:

  1. 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:

  2. 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:

  1. 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:

  1. 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:

  1. 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:

  1. 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:

    1. The individual applying the seal(s) is employed in a supervisorycapacity by the plant in which the seal was removed; and
    2. 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
    3. 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
    4. The individual is in possession of authorization from the regulatory agency to perform these tests; and
    5. 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
    6. 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
    7. The regulatory agency will remove the temporary seals, retest the equipment and apply regulatory seals within 3 working days of notification by industry; and
    8. No Grade A dairy products will be processed after three working days without the affected equipment being tested and sealed by the regulatory gency.

PMO Page 103, Section 7, Item 20p. Personnel--Cleanliness

Problem 152

Change #4 in Administrative Procedures as follows:

  1. 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:
    1. 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
    2. Distribution lines and hose stations are clearly identified as "limited use reclaimed water", and
    3. Water handling practices and guidelines are clearly described and prominently displayed at appropriate locations within the plant, and
    4. 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 he "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 nd 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:

  1. 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.
  2. 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.

  1. 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:

  1. 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.
  2. 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:
      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.
    4. Timely reporting of positive drug test results to the regulatory agency.
  3. Is traceback to violative producers timely on all positive loads?
  4. Determine if the violative producer's permit was suspended when his sample tested positive for drug residues.
  5. Determine if the violative producer was given the appropriate penalty.
  6. After the producer has a drug-free test, determine if a temporary permit was issued for a period not to exceed 30 days.
  7. 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.
  8. Determine if the producer was issued a full permit after the QAC was signed.
  9. 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:

  1. "Paper stock" means any paper made from: the following materials:
    1. 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.
    2. Components meeting the requirements of the Federal Food, Drug and Cosmetic Act2 as amended.

Change definition #4 as follows:

  1. "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:

  1. "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