Summary of the 29th NCIMSApril 26 – May 1, 2003 30th Annual Southern Dairy Conference February 9-10, 2004
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of 150 Proposals were deliberated: • 79 passed (37 as submitted, 42 as amended), • 66 were voted “no action”, • 4 were “withdrawn”, and • 1 was left on the “table”
Summary of the 29th NCIMSCouncil I Proposal 101 Section 7, STANDARDS FOR GRADE “A” MILK AND MILK PRODUCTS, Table 1
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 ****
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.
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
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.
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.
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.
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
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
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.
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”.
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.
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.
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.
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.).
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………..
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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;
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.
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.
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.
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.
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.
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.
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
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.)
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
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
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.)
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.
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.
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.
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.