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Summary of the 29th NCIMS April 26 – May 1, 2003. 30 th Annual Southern Dairy Conference February 9-10, 2004. Summary of the 29th NCIMS April 26 – May 1, 2003. A total of 150 Proposals were deliberated: 79 passed (37 as submitted, 42 as amended), 66 were voted “no action”,

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Summary of the 29th NCIMSApril 26 – May 1, 2003

30th Annual

Southern Dairy Conference

February 9-10, 2004


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Summary of the 29th NCIMSApril 26 – May 1, 2003

  • A total of 150 Proposals were deliberated:

    • 79 passed (37 as submitted, 42 as amended),

    • 66 were voted “no action”,

    • 4 were “withdrawn”, and

    • 1 was left on the “table”


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Summary of the 29th NCIMSApril 26 – May 1, 2003



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Summary of the 29th NCIMSCouncil I

Proposal 101

Section 7, STANDARDS FOR GRADE “A” MILK AND MILK PRODUCTS, Table 1


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Summary of the 29th NCIMSCouncil I

Proposal 101 (continued)

Section 7, STANDARDS FOR GRADE “A” MILK AND MILK PRODUCTS, Table 1

***** Not applicable to bulk shipped heat-treated milk products, ultra-pasteurized products that have been thermally processed at or above 138oC (280oF) for at least two (2) seconds to produce a product which has an extended shelf life (ESL) under refrigerated conditions, and condensed products.

Note add a * to the current ****


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Summary of the 29th NCIMSCouncil I

Proposal 102

Section 7, STANDARDS FOR GRADE “A” MILK AND MILK PRODUCTS

Table 1-Bacteriological Limits **

** Not applicable to acidified or cultured products.


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Summary of the 29th NCIMSCouncil I

Proposal 103

Makes Changes to the PMO to Provide for Automatic (Robotic) Milking

Section 1 - Definitions

Section 6 - Laboratory Techniques to Detect Undesirable Milk (formerly abnormal milk) (NOTE: FDA did not concur with this.)

Section 7 – 1r, 2r, 3r, 9r

Appendix A - Laboratory Techniques to Detect Undesirable Milk (formerly abnormal milk) (NOTE: FDA did not concur with this.)

New Appendix Q - 1r, 2r, 3r, 9r, 10r, 11r, 12r, 13r, 14r, 18r


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Summary of the 29th NCIMSCouncil I

Proposal 103

Makes Changes to the PMO to Provide for Automatic (Robotic) Milking

Item 13r: AMI MANUFACTURERS SHALL SUBMIT DATA TO FDA TO SHOW THAT THE TEAT PREPPING SYSTEM EMPLOYED IN THEIR SYSTEM IS EQUIVALENT TO ITEM 13r, ADMINISTRATIVE PROCEDURES #4.

EACH INSTALLER SHALL PROVIDE THE PRODUCER AND THE REGULATORY AGENCY WITH A COPY OF THIS APPROVAL.


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Summary of the 29th NCIMSCouncil I

Proposal 107

Section I, Pg. 1 – Add the following definition:

Cooling Pond: A cooling pond is a man-made structure designed for the specific purpose of cooling cows.

Page 24 – Item 4r.

Cowyard – Insert after the second sentence:

Cooling ponds shall be allowed provided they are constructed and maintained in a manner that does not result in the visible soiling of flanks, udders, bellies andtails of lactating animals exiting the pond.


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Summary of the 29th NCIMSCouncil I

Proposal 108

PMO, Section 7, Item 5r, 12p, Appendix B, and Form 2359 Item 12

Clarifies wording which passed the 1999 NCIMS requiring that milk tank trucks be washed at a permitted milk tank truck cleaning facility, milk plant, receiving station or transfer station.


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Summary of the 29th NCIMSCouncil I

Proposal 109

  • PMO, Section 7, Item 5r (M-I-95-3)

  • Requirements if:

    • Hauler uses the farmer’s pump, located in the milkhouse and transfer hose

    • Farmer mechanically cleans the hose, which is located outside of the milkhouse

    • Cleaning connections “stubbed” through the milkhouse wall


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Summary of the 29th NCIMSCouncil I

Proposal 113

PMO, Section 7, Item 9r (M-a-69)

Milking system solution return lines shall not contain:

Ball type plastic valves

Plastic tees with barbed ridges

P.V.C. water piping


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Summary of the 29th NCIMSCouncil I

Proposal 114

PMO, Section 7, Item 9r, Administrative Procedure 12

Allows for the use of a flexible plastic/rubber hose for the top filling of farm bulk milk tanks.

Hose must be drainable; as short as practical; have sanitary fitting; supported; part of mechanical cleaning system, etc.


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Summary of the 29th NCIMSCouncil I

Proposal 116

PMO, Section 7, Item 9r, Administrative Procedure 13

(M-a-12 and M-a-15)

Allows for long transparent plastic tubing (150 feet or less) with transfer systems, if remain sufficiently clear; and

Shorter (8 feet or less) opaque plastic tubing-(opacity is not a factor in determining cleanliness) can determine by sight or a “rod”.


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Summary of the 29th NCIMSCouncil I

Proposal 117

PMO, Section 7, Item 13r (M-I-96-7)

Example of acceptable udder prep:

Provided that the sanitizing of teats shall not be required if the udder is dry and the teats have been thoroughly cleaned (not dry wiped) and dried (manually wiped dry) prior to milking. The determination of what constitutes a dry udder and cleaned and dried teats shall be made by the Regulatory Agency.


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Summary of the 29th NCIMSCouncil I

Proposal 118

  • PMO, Section 7, Item 18r, Administrative Procedures - 3b

  • Farm recording thermometers on tanks manufactured after 1/1/2000:

  • Verified at least every 6 months using a thermometer that is:

  • Accurate (+/– 1°C (2 °F));

  • Calibrated by a traceable standard thermometer, within the past six (6) months; with the results and date recorded and the thermometer being properly identified; or by

  • A traceable standard thermometer that has been calibrated within the last year.

  • Documented in a manner acceptable to the Regulatory Agency.


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Summary of the 29th NCIMSCouncil I

Proposal 119

PMO, Section 7, Item 5p- Separate Rooms

(M-a-2)

…provided that these rooms may be separated by solid partitioning doors that are kept closed.


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Summary of the 29th NCIMSCouncil I

Proposal 120

PMO, Section 7, Item7p- Water Supply (M-a-1)

An approved air gap is defined as the unobstructed vertical distance through the free atmosphere of at least twice the diameter of the largest incoming water supply pipe or faucet to the flood level of the vessel or receptacle. The distance of the air gap is to be measured from the bottom of the potable inlet supply pipe or faucet to the top of the effective overflow (i.e., flood level rim or internal overflow) of the vessel. In no case, may the effective air gap be less than one (1) inch (2.54 cm.).


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Summary of the 29th NCIMSCouncil I

Proposal 121

PMO, Section 7, Item12p, Administrative Procedure 1-Changes to Extended Run Acceptance:

1. All multi-use containers and utensils are thoroughly cleaned after each use and all equipment is thoroughly cleaned at least once each day used unless the Regulatory Agency has reviewed and accepted information, in consultation with FDA, supporting the cleaning of multi-use containers and utensils at frequencies extending beyond one (1) day or seventy-two (72) hours in the case of storage tanks. Supporting information shall be submitted to and approved by the Regulatory Agency prior to initiating the qualification period if required. Finished product produced during an extended run must meet all applicable requirements of Section 7………..


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Summary of the 29th NCIMSCouncil I

Proposal 122

PMO and DMO, Section 7, Item 12p-Administrative Procedure, Item 1

Evaporators shall be cleaned at the end of a continuous operation not to exceed forty-four (44) hours, and records must be available to verify that the operation time does not exceed forty-four (44) hours.


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Summary of the 29th NCIMSCouncil I

Proposal 124

PMO, Section 7, Item12p

Electronic Records and Signatures (add at the end of 12p 2(b)3 the following):

Except that, electronic storage of required cleaning records, with or without hard copy, shall be acceptable, provided the computer and computer generated records are readily available and meet the criteria of this Section and the Code of Federal Regulations 21 CFR Part 11.


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Summary of the 29th NCIMSCouncil I

Proposal 126

PMO and DMO, Section 7, Item 11p- (M-a-70)

CONSTRUCTION AND REPAIR OF CONTAINERS AND EQUIPMENT, Administrative Procedures 5:

5. All surfaces… are easily accessible or demountable for manual cleaning or are designed for mechanical cleaning. Provided, that flexible plastic or rubber tanker loading and unloading hoses with screw-type hose clamps shall be considered in compliance, if an appropriate screwdriver or tool is readily available for disassembly.


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Summary of the 29th NCIMSCouncil I

Proposal 127

PMO, Section 7, Item 12p- (Last sentence of Administrative Procedures 6)

If containers are fabricated in the dairy plant, the Regulatory Agency shall collect, during any consecutive six (6) months, at least four (4) sample sets, as defined in Appendix J, from each manufacturing line, as defined in Appendix J, in at least four (4) separate months, except when three (3) months show a month containing two (2) sampling dates separated by at least twenty (20) days, and analyze the sample sets at an Official, Commercial or Industry Laboratory, approved by the State Milk Laboratory Certifying Agency specifically for the examinations required under Appendix J.


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Summary of the 29th NCIMSCouncil I

Proposal 128

PMO, Section 7, Item 12p- Administrative Procedure 7b (M-a-67)

Add to the PMO the long standing acceptance for the safe use of multiuse Polycarbonate plastic milk containers and the criteria for soaker type washers when used in place of a device for the detection of volatile organics.

Note: Meeting the criteria will constitute equal safety assurances as a device for the detection of volatile organics.


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Summary of the 29th NCIMSCouncil I

Proposal 129

PMO, Section 7, Item 15p(B) - Administrative Procedure 1. b. (7)

Completes the low pressure gravity drain example for “block-and-bleed” type separations between cleaning/sanitizing solutions and product.

If a common drain line is used to connect vent lines from more than one (1) block-and-bleed vent, such as in the case of drain lines from a series of cheese vats with a common drain for the block-and-bleed vent lines, the cross sectional area of the common drain line must be at least equal to the total cross sectional area of the lines connected to the header.


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Summary of the 29th NCIMSCouncil I

Proposal 129

PMO, Section 7, Item 15p(B) - Administrative Procedure 1. b. (7) Continued)

Or, a common drain line of the same size as the vent may be used, if provisions are included in a fail-safe control system to sequence the use and cleaning of the vats to assure that no more than one (1) vat attached to that drain can be washed at the same time.


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Summary of the 29th NCIMSCouncil I

Proposal 130

PMO, Section 7, Item 15p(B)-Administrative Procedures 2.

Add the following at the end:

Pasteurized Water Flush:

or has undergone a hazard evaluation and safety assessment of the specific water supply and application involved and has been treated, as necessary, following a protocol acceptable to the Regulatory Agency, in consultation with FDA, to ensure the water will not compromise the safety of the product.


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Summary of the 29th NCIMSCouncil I

Proposal 131

PMO, Section 7, Item 15p (B) - ADMINISTRATIVE PROCEDURE 1c.

Allows and sets requirements for instrumented steam block separations between cleaning/sanitizing solutions and product in aseptic and HHST processing systems.

NOTE: The effective date shall be one year beyond the effective date of other Proposals from the 2003 NCIMS.


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Summary of the 29th NCIMSCouncil I

Proposal 132

PMO, Section 7, Item 16p(B)2. b. and AppendixH.

Allows and sets criteria for Steam-Block Type Flow Diversion Devices in HHST processing systems, utilizing UP times/temperatures.


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Summary of the 29th NCIMSCouncil I

Proposal 133

PMO, Section 7, Item 16p(B)

In the case of HHST systems, which have the FDD located downstream from the regenerator and/or cooler and are inter-wired or are computer controlled to thoroughly clean the system, including the divert pipeline before the re-starting of production, a cooling section, which is not self-draining, may be present in the divert pipeline.


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Summary of the 29th NCIMSCouncil I

Proposal 135

PMO, Section 7, Item 16p(B)

Allows and establishes requirements for:

HTST systems that are designed like HHST systems, with the FDD at the end of the cooler section.


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Summary of the 29th NCIMSCouncil I

Proposal 136

PMO, Section 7, Item 16p(B)-Automatic Milk Controller

(M-a-56)

Provided, that for systems used for the processing of products labeled as Ultra-Pasteurized (UP) milk and milk products, it is not necessary to set and seal the thermal limit controller at or above 138ºC (280ºF). Also, provided that these systems shall meet all the public health control requirements for HHST systems, and that the recorder-controller chart shows that the UP product has been processed at a minimum temperature of 138ºC (280ºF), and has been verified by the Regulatory Agency to have a calculated holding time of at least two (2) seconds.


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Summary of the 29th NCIMSCouncil I

Proposal 141

PMO, Section 7, Item 16p(B)

Eliminates the requirement to identify the motor, casing or impeller of the booster pump in all systems, except those that use a single pressure switch on the pasteurized side.


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Summary of the 29th NCIMSCouncil I

Proposal 142

PMO, Section 7, Item 16p(E)

Allows authorized plant employees to test and temporarily seal pasteurization equipment on an emergency basis and the State has up to 10 working days from the notification from industry to retest and reseal. (NOTE: Was 3 days)

The plant employee has satisfactorily completed training acceptable to the Regulatory Agency on test controls for pasteurization equipment.

If regulatory tests reveal that equipment or controls are not in compliance with the provisions of this Ordinance, all products that were processed during that period may be recalled;


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Summary of the 29th NCIMSCouncil I

Proposal 145

PMO, Section 7, Item 16p(E)

Corrects an error in the requirements for magnetic flow meter based timing system charts

1) A continuous record of the status of the high and low-flow/loss of signal alarms.


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Summary of the 29th NCIMSCouncil I

Proposal 147

PMO, Section 7, Item 17p-Cooling

Recirculated cooling water contained in corrosion resistant, continuous piping, with no joints or welds, which fail to meet applicable ASME or equivalent standards in the non-potable water contact areas, may be considered to be protected from contamination, as required above, when cooled by non-potable water flowing over the exterior of the piping, within open evaporative type cooling tower. In these systems, the recirculated cooling water piping shall be properly maintained and shall be installed so that it is at least two (2) pipe diameters above the flood rim of the cooling tower.


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Summary of the 29th NCIMSCouncil I

Proposal 148

PMO, Appendix C (M-a-65)

Adds to the PMO the long standing requirements for REVERSE FLUSH SYSTEMS for flushing milk hoses, teat cup clusters, milker claws and inflations between cows.


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Summary of the 29th NCIMSCouncil I

Proposal 150

PMO, Appendix C (M-a-73)

Adds to the PMO the long standing criteria for the use of INTERMITTENT, TIMED-RELEASE, HIGH-PRESSURE, INSECT FOGGING OR SPRAYING SYSTEMS on Grade “A” dairy farms.


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Summary of the 29th NCIMSCouncil I

Proposal 151

PMO, Appendix C. V., Drug Residue Avoidance Control Measures

Identifies lactating animal identification and treatment records and maintenance criteria for drug residue avoidance control measures on the dairy farm.


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Summary of the 29th NCIMSCouncil I

Proposal 152

PMO, Appendix D. and MMSR (M-a-80 [revised])

Adds to the PMO the long standing requirement that State Water Control Authority requirements, which are less stringent than the PMO, shall be superseded by the PMO. State Water Control Authority requirements, which are more strict than the PMO, shall not be considered in determining the acceptability of water supplies during ratings, check-ratings, single-service listing evaluations and audits.


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Summary of the 29th NCIMSCouncil I

Proposal 153

  • PMO, Appendix D. (M-a-63 [revised])

  • Adds to the PMO the long standing requirements regarding well pits:

    • Prohibits new well pits on new water supplies;

    • “Existing water supplies”, are those, which were in use by a producer at the time they applied for a Grade “A” permit. (Note: If they meet the criteria they are acceptable.)

    • Requires elimination of pits upon major construction


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Summary of the 29th NCIMSCouncil I

Proposal 154

PMO, Appendix D., VI Water Reclaimed from Heat Exchange Processes

Allows and sets requirements for the use of water from the current milking, obtained directly from the discharge of a raw milk heat exchanger for the one-time, pre-rinsing of dairy equipment or for non-potable uses.

(Note:May be collected in the equipment wash vat during milking prior to being used as a pre-rinse.)


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Summary of the 29th NCIMSCouncil I

Proposal 155

  • PMO, Appendix H. I., HTST PASTEURIZATION

  • Allows and sets requirements for the installation of pressure relief valves within HTST and HHST pasteurization systems.

  • Between the Timing Pump and the Beginning of the Holding Tube

  • Downstream from the Holding Tube in HTST Systems


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Summary of the 29th NCIMSCouncil I

Proposal 156

PMO, Appendix H. I., HTST PASTEURIZATION

Allows liquid injection systems to be used for standardization of butterfat in systems without separators and located after the last regenerator section and before the timing pump and for operation of these systems for other additions (similar ingredients) when there is not a separator or when the separator is by-passed.

Economic adulteration concerns to be addressed under PMO, Section 2 Adulterated or Misbranded Milk or Milk Products


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Summary of the 29th NCIMSCouncil I

Proposal 158

  • PMO, Appendix I, TEST 4 (M-a-17)

  • Requires that indicating and recording thermometers be compared:

    • At or above minimum legal pasteurization temperature;

    • At operating temperatures within the accurate range for the thermometer/chart used; and

    • Immediately record and identify. (Can inscribe a line intersecting the recorded temperature arc.)


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Summary of the 29th NCIMSCouncil I

Proposal 161

PMO, Appendix I, TESTS 5 (FDD) and 11 (Flow Alarm)

The appropriate temperature elements may be placed in a water or oil bath to simulate the normal pasteurization (or aseptic) temperature of the holding tube as an alternative to heating the water in the system above the pasteurization (or aseptic) temperature.


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Summary of the 29th NCIMSCouncil I

Proposal 162

PMO, Appendix I, TEST 15

Once a hand-held communication device has been shown to cause a given electronic control device to react adversely, the test does not have to be repeated every three months using that specific hand-held communication device on the adversely affected electronic control device. If the electronic control device is altered or there is a change in the hand-held communication device used, the electronic control device would be required to be tested.  


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Summary of the 29th NCIMSCouncil I

Proposal 163

PMO, Appendix J, (M-a-91) “Component Part”

Grade “A” milk and milk product plants as defined in this Ordinance shall use single-service containers and closures from plants certified in the latest semi-annual publication of the IMS List. Plants assembling two (2) or more components into a final assembled product andfabricators of film and/or closures, which may become a product contact surface for Grade “A” containers, are required to be inspected/certified and listed in the IMS List.


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Summary of the 29th NCIMSCouncil I

Proposal 163

PMO, Appendix J (M-a-91) “Component Part” (Cont.)

 On page 250 add a new Sub-item (c) to read as follows:

c. It is the responsibility of the inspected/certified and listed plant to maintain records verifying the bacterial and chemical safety of all components parts utilized in the final assembled product.


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Summary of the 29th NCIMSCouncil I

Proposal 164

PMO, Appendix J

Rewrite of the entire APPENDIX J. STANDARDS FOR THE FABRICATION OF SINGLE-SERVICE CONTAINERS AND CLOSURES FOR MILK AND MILK PRODUCTS


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Summary of the 29th NCIMSCouncil I

Proposal 166

Modify the “Milk Tank Truck, Hauler Report and Sampler Evaluation” FDA, Form 2399a, Section III., Item 14 by adding:

“b. Or sterile needle for aseptically dispensing milk sample from the bulk tank sample septum into a sample container (vial)”

Note: Proposed solution will become effective upon the receipt of data and acceptance by FDA


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Summary of the 29th NCIMSCouncil I

Proposal 167

  • Refer to the Hauler Committee to redesign “Milk Tank Truck, Hauler Report and Sampler Evaluation” FDA, Form 2399a to:

    • Eliminate Section 1, (which relates to the milk tank truck and its appurtenances rather than to the hauler)

  • AND

    • Correct the title to “Hauler Report and Sampler Evaluation.” and make recommendations to FDA for form correction


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Summary of the 29th NCIMSCouncil I

Proposal 168

PMO, Appendix O (M-I-92-13)

Adds information from this M-I into Appendix O as well as information from (or reference to) various applicable Sections of 21 CFR. (100%-150% = “A” 400-600 I.U. and “D” 2000-3000 I.U.)

Specific “harmful” levels (previously over 6000 I.U. for “A” and 800 I.U. for “D”) should be referred to FDA for a health hazard review.

The Scientific Advisory Committee was asked help to review current scientific literature to develop science based regulatory programs and regulatory action levels.


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Summary of the 29th NCIMSCouncil I

Proposal 169

DMO, 16p (clarification):

Milk products and whey shall be pasteurized prior to the entrance into RO, UF, evaporator or condensing equipment.

Provides guidance for RO/UF processing of unpasteurized milk based on previous accepted processes.

Recommends that the NCIMS Chair appoint a Study Committee to evaluate membrane filtration technology (RO/UF) and make recommendations to FDA to allow for the immediate implementation of alternative processes found acceptable to the Committee, State and FDA


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Summary of the 29th NCIMSCouncil I

Proposal 170

No Document Referenced

Request the NCIMS Executive Board to direct the NCIMS Technical Committee to study and make recommendations regarding pressure controls on the cooling sections of HHST and similar systems used to heat, hold and cool previously pasteurized milk and milk product used to produce UP products


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Summary of the 29th NCIMSCouncil I

Proposal 172

No Document Referenced

Request the Scientific Committee to review the scientific criteria for holding heated dairy products at temperatures at or above 145oF before processing.



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Summary of the 29th NCIMSCouncil II

FDA 2400 Forms

  • Proposal 207: Amend M-a-85 and the current Charm SL Beta-lactam 2400 Form:

    • Add the Charm SL-6TM Beta-lactam Test to M-a-85 and amend the current SL Beta-lactam 2400 form by adding both the original SL Beta-lactam Test and the new SL-6TM Beta-lactam Test.

  • Proposal 208: Amend M-a-85 and the current IDEXX Snap Beta-lactam 2400 Form:

  • Add the IDEXX new SNAP® Beta-lactam Test Kit to

  • M-a-85 and amend the current IDEXX Snap Beta- lactam 2400Form by adding the IDEXX new SNAP® Beta-lactam Test Kit.


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    Summary of the 29th NCIMSCouncil II

    Proposal 215

    • PMO, Section 1- Definitions

    • Add back to the PMO, definitions for:

      • Aseptic Processing,

      • Sanitization, and

      • Ultra-Pasteurization.


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    Summary of the 29th NCIMSCouncil II

    Proposal 217

    • Provides for Water Buffalo Milk to be regulated under the PMO by amending Sections 1, 4, and 8.

    • NOTE:This Proposal shall become effective upon FDA’s acceptance of validated PMO, Section 6 and Appendix N test methods for water buffalo milk.


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    Summary of the 29th NCIMSCouncil II

    Proposal 218

    • Provides for “Hooved Mammals Milk” to be regulated under the PMO by amending Sections 1, 4, 6 and 8.

    • NOTE: Milk from animals, not currently in the PMO, may be labeled as Grade “A” and IMS listed upon FDA’s acceptance of validated PMO, Section 6 and Appendix N test methods for the animal to be added.


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    Summary of the 29th NCIMSCouncil II

    Proposal 218

    COMMON NAME: The generic term commonly used for domestic animals (i.e.,cattle, goats, sheep, horses, water buffalo, etc.). 

    HOOVED MAMMALS MILK: Hooved mammals milk is the normal lacteal secretion practically free of colostrum, obtained by the complete milking of one (1) or more healthy hooved mammals. This product shall be produced according to the sanitary standards of this Ordinance.


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    Summary of the 29th NCIMSCouncil II

    Proposal 218

    • Charge is given to the Other Species Committee to review the PMO to clarify the terminology used in respect to animals referred to in the PMO and make the appropriate Proposals to the 2005 NCIMS to make the PMO more technically correct and clear in it’s terms, i.e., cattle, not bovine, when cattle is what is really meant.


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    Summary of the 29th NCIMSCouncil II

    Proposal 220

    • PMO Section 3-Permits

    • Except, that a milk producer may be assessed a monetary penalty in lieu of permit suspension for violative counts provided:

    • If the monetary penalty is due to a violation of bacterial or cooling temperature standard, the Regulatory Agency shall conduct an inspection of the facility and operating methods and make the determination that the conditions responsible for the violation have been corrected.  Samples shall then be taken at the rate of not more than two (2) per week on separate days within a three (3) week period in order to determine compliance with the appropriate standard as determined in accordance with Section 6 of this Ordinance.


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    Summary of the 29th NCIMSCouncil II

    Proposal 220

    • PMO Section 3-Permits

    • If the monetary penalty is due to a violation of the somatic cell count standard, the Regulatory Agency shall verify that the milk supply is within acceptable limits as prescribed in Section 7.  Samples shall then be taken at the rate of not more than two (2) per week on separate days within a three (3) week period in order to determine compliance with the appropriate standard as determined in accordance with Section 6 of this Ordinance.


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    Summary of the 29th NCIMSCouncil II

    Proposal 227

    • Amend PMO and DMO, Sections 3 and 5

      • Section 3-REINSTATEMENT OF PERMITS: Any permit holder whose permit has been suspended may make written application for the reinstatement of their permit.

      • Section 5-Every permit holder shall, upon the request of the Regulatory Agency, permit access of officially designated persons to all parts of their establishment or facilities to determine compliance with the provisions of this Ordinance.

      • Inspection every..transfer station, or milk tank truck cleaning facility inspection every six (6) months or one (1) plant or receiving station inspection every three (3) months is not a desirable frequency, it is instead a legal minimum.


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    Summary of the 29th NCIMSCouncil II

    Proposal 228

    • Amend PMO, DMO and MMSR to include requirements for an industry plant sampler:

      • INDUSTRY PLANT SAMPLER: A person responsible for the collection of official samples for regulatory purposes at a milk plant, receiving station or transfer station as outlined in Appendix N. This person is an employee of the milk plant, receiving station or transfer station and is evaluated at least once every two (2) year period by a State Sampling Surveillance Officer or a properly delegated Sampling Surveillance Regulatory Official.

      • Section 5-Restates that dairy plant samplers and industry plant samplers are to be inspected every 24 months.


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    Summary of the 29th NCIMSCouncil II

    Proposal 228

    • Section 5-Suspension of permit ….

    • or in the case of an industry plant sampler, shall cease the collection of official regulatory samples until successfully re-trained and re-evaluated by Regulatory Agency.

    • Section 7, Item 5r

    • A transportation tank may be used for the cooling and/ or storage of milk on a dairy farm (with or without a shelter):

      • The milk shall be sampled at the direction of the Regulatory Agency in a manner so as to preclude contaminating the milk tank truck or sample, by a permitted milk sample collector.


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    Summary of the 29th NCIMSCouncil II

    Proposal 228

    • Appendix B. MILK SAMPLING, HAULING AND TRANSPORTATION: Training

      Appropriate training should also be provided to industry plant samplers with regularly scheduled refresher short courses.

    • MMSR-“GUIDANCE FOR COMPUTING ENFORCEMENT CREDIT FOR PART I, ITEM 9 AND/OR PART II, ITEM 8 OF THE “REPORT OF ENFORCEMENT METHODS”:

      Item 5. Samplers (Including Dairy Plant and Industry Plant Samplers at the Receiving Site) Evaluated Every Two (2) Years and Reports Properly Filed


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    Summary of the 29th NCIMSCouncil II

    Proposal 233

    • Section 6 and Appendix N of PMO and DMO amended (M-a-75)

      • Requiring testing of the milk supply when the Commissioner of the FDA determines that a potential problem exists with animal drug residues or other contaminants in the milk supply.


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    Summary of the 29th NCIMSCouncil II

    Proposal 234

    • PMO, DMO and MMSR amended to provide for arithmetic averaging of SPC, SSCC, coliform counts and temperature determinations

    • Section 6:Note: When multiple samples of the same milk or milk products, except for aseptically processed milk and milk products, are collected from the same producer or processor from multiple tanks or silos on the same day, the laboratory results are averaged arithmetically by the Regulatory Agency and recorded as the official results for that day. This is applicable for bacterial (standard plate count and coliform), somatic cell count and temperature determinations only.


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    Summary of the 29th NCIMSCouncil II

    Proposal 234

    • MMSR: Records Systematically Maintained and Current:

    • c. All test results for bacterial, coliform, cooling temperature, phosphatase, drug residues, pesticides, if available, and vitamin assay recorded on appropriate ledger or computer for each individual milk and milk product. (Use the arithmetic average for bacterial counts, coliform counts, and cooling temperature determinations when samples are collected of the same milk or milk product from the same plant on the same day from multiple storage tanks or silos.)


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    Summary of the 29th NCIMSCouncil II

    Proposals 237, 239 & 240

    • PMO, Section 6 and Appendix B, and Appendix M-Forms 2399 and 2399a

    • LABORATORY TECHNIQUES

      • Amended to provide for the use of approved in-line samplers, based on results of FDA’s requested third party validation study.

      • NOTE:New York to conduct the study.


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    Summary of the 29th NCIMSCouncil II

    Proposals 237, 239 and 240

    • In-line samplers approved by FDA based on the following:

    • The sampling device operation shall be overseen on the farm by a bulk milk hauler/sampler permitted by the state.

    • FDA requests a third party validation study to be performed on the sampling devices currently in use in New York state.

    • The in-line samplers will be considered validated for use for collecting regulatory samples on the passage of this Proposal in the state of New York and until the validation study is evaluated by FDA.


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    Summary of the 29th NCIMSCouncil II

    Proposal 248

    • PMO and DMO, APPENDIX N.

      • Amended by adding language from:

        • M-a-78 (Revised)-Effective Date-3/6/92;

        • M-a-79 (Revision #1)-3/10/94; and

        • M-a-86 (Revision #3)-Implementation Date-7/23/2001


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    Summary of the 29th NCIMSCouncil II

    Proposal 254

    • MMSR was amended by adding a new Appendix B incorporating the provisions of

    • M-I-97-2, the Table of Farm Water Supply Violations (2 (minor) and 5 (major) point water debits)


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    Summary of the 29th NCIMSCouncil II

    Proposal 255

    • Correct MMSR, Section D. Computation of Enforcement Ratings, Item 4. Milk Plants

      • Milk Plants with an Unattached Supply of Raw Milk (Note: Also includes Plants with an Attached Supply)

      • 3.) The utilization of milk from a separately rated source, which has a milk sanitation compliance rating, which is not equal to ninety percent (90%) or greater, or from an unlisted source, would initiate an immediate withdrawal of the shipper from the IMS List.


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    Summary of the 29th NCIMSCouncil II

    Proposal 255

    • 4.) The utilization of milk from a separately rated source, which has an enforcement rating, which is not equal to ninety percent (90%) or greater, is a violation of Section 11 of theGrade "A" PMO and would be debited under Item 4, Part III, Form FDA 2359j, "Report of Enforcement Methods" (Page 2).


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    Summary of the 29th NCIMSCouncil II

    Proposal 256

    • Amend the MMSR, Section F. Publication Of The “Interstate Milk Shippers Report,” Option 1.

      • When using Option 1 (90% and farms not listed with plant), it is no longer required to list the “volume (cwt.) received” when listing the name of each shipper of raw milk for the preceding thirty (30) days on the back of the 2359i.


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    Summary of the 29th NCIMSCouncil II

    Proposal 257

    • Amend the MMSR, 2001 Revision, by changing the method of calculating the “Evaluation of Sampling Procedures”-Part I, Item 9, “Report of Enforcement Methods”:

      • Change the interpretation of Item 6

        • Sampling Procedures in Substantial Compliance-Will only look at the samplers that have been evaluated.

      • Change the Weight of Items 5, 6 and 7.

        • #5 20 to 30 Weight

        • #6 20 to 15 Weight

        • #7 10 to 15 Weight


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    Summary of the 29th NCIMSCouncil II

    Proposal 257

    • This Proposal only addressed the example on page 38 (Farms Only-Part I, Item 9) and did not address (Plants-Part II, Item 8)

    • This was addressed at the NCIMS Executive Board meeting on 9/18/2003 and it was recommended that MSB issue a M-a to address this conflict and two different methods of calculating these two Items when conducting an Enforcement Rating.


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    Summary of the 29th NCIMSCouncil II

    Proposal 258

    • Request that FDA will update the EML after the issuance of the IMS-a following each conference..

    Proposal 259

    • Request FDA to take necessary steps to post the EML on the website.



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    Summary of the 29th NCIMSCouncil III

    Proposal 301

    • NCIMS Constitution

      ARTICLE V ‑‑‑‑‑‑ AMENDMENTS TO THE CONSTITUTION

      Section 1. This Constitution may be amended at a biennial meeting of the Conference with the delegates having had forty‑five (45) days notice from the Executive Board or its designee of such proposal to amend. Adoption of an amendment to the Constitution shall require at least two‑thirds (2/3) majority of the vote of the delegate quorum.


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    Summary of the 29th NCIMSCouncil III

    • NCIMS By-laws:

    • ARTICLE I ‑‑‑‑‑‑ DUTIES OF THE BOARD

    • SECTION 15.The Executive Board or its designee shall notify the voting delegates at least forty‑five (45) days prior to the Conference of any proposed Constitution or Bylaw changes.


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    Summary of the 29th NCIMSCouncil III

    Proposal 301

    NCIMS Constitution and By-laws

    NCIMS Liaison Committee to study the issue of Conference frequency as it relates to the cost and frequency for publishing conference documents and costs to the States, and report back the the 2005 NCIMS.


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    Summary of the 29th NCIMSCouncil III

    Proposal 302

    NCIMS By-laws:

    Revise the Bylaws of the Conference to add the Scientific Advisory and Hauling Procedures Committees to the list of standing committees.


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    Summary of the 29th NCIMSCouncil III

    Proposal 303

    No Document Referenced

    The Conference directs the Chairman to appoint a committee representing all Conference participants to study the additional requirements currently in the PMO, Item 16p(C), (D), and (E), beyond what is required in 21 CFR 113 and 21 CFR 108.


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    Summary of the 29th NCIMSCouncil III

    Proposal 305

    The NCIMS Executive Board, in consultation with FDA to establish a Committee to develop, implement and maintain oversight of a voluntary State Contracted Third PartyRegulatory InspectionPilot Program for foreign firms that wish to be listed in the IMS List.

    The Committee will evaluate the Pilot Program and report back to the 2005 NCIMS.


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    Summary of the 29th NCIMSCouncil III

    Proposal 306

    Procedures Document

    Changed the State Program Evaluations, conducted by FDA, from biennial to triennial.


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    Summary of the 29th NCIMSCouncil III

    Proposal 315

    PMO, Definition P-Milk Products and Procedures, Section II., Scope, A. Products Covered (M-a-83)

    Add to the PMO the long standing guidance in M-a-83 regarding when powdered dairy blends may and must meet Grade “A” requirements and be labeled as Grade “A” and provides for exceptions for certain ingredients.


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    Summary of the 29th NCIMSCouncil III

    Proposal 316

    PMO and DMO, MMSR, and Procedures

    Provisions for including the voluntary NCIMS HACCP Program for milk plants, receiving stations, and transfer stations.



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