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M-I-04-10: Questions and Answers from a FY'04 Regional Milk Seminar, an Advanced Milk Processing Course and a Special Problems in Milk Protection Course

<< Back to Index of Memoranda of Information (M-I) Main Page

December 27, 2004 

TO: All Regional Food and Drug Directors
Attn: Regional Milk Specialists

FROM: Milk Safety Branch (HFS-626)

SUBJECT: Questions and Answers from a FY'04 Regional Milk Seminar, an Advanced Milk Processing Course and a Special Problems in Milk Protection Course

Following are questions and answers from a Regional Milk Seminar, an Advanced Milk Processing Course and a Special Problems in Milk Protection Course held during the second half of FY' 04.

In accordance with procedures established through the National Conference on Interstate Milk Shipments (NCIMS), if an answer to these questions results in a new understanding of a long-standing situation or installation, and the condition as it exists does not present an immediate public health hazard, reasonable judgment should be exercised and adequate time provided for modification and correction.

An electronic version of this memorandum is available for distribution to Regional Milk Specialists, State Milk Regulatory Agencies, State Laboratory Evaluation Officers and State Milk Sanitation Rating Officers in your region. The electronic version should be widely distributed to representatives of the dairy industry and other interested parties and also will be available on the FDA Web Site at http://www.cfsan.fda.gov (Updated Web Address) at a later date.

If you would like an electronic version of this document prior to it being available on the CFSAN Web Site, please e-mail your request to Robert.Hennes@fda.hhs.gov

/s/

Norris A. Robertson, Jr.
Milk Sanitation Officer
Milk Safety Team

/s/

CAPT Robert F. Hennes, RS, MPH, Chief
Milk Safety Team


QUESTIONS AND ANSWERS
from the
ADVANCED MILK PROCESSING COURSE (FD-5108), APRIL 26-30, 2004- ARLINGTON, TEXAS,
NE REGION MILK SEMINAR, MAY 3-6, 2004-NORTH CONWAY, NEW HAMPSHIRE
and the
SPECIAL PROBLEMS IN MILK PROTECTION COURSE (FD-5107),
AUGUST 2-6, 2004-BOISE , IDAHO

In this document, all references to the Grade "A" Pasteurized Milk Ordinance (PMO) are to the 2003 Grade "A" PMO.

  1. PMO-Section 1 and Appendix L
    1. May frozen Grade "A" cream be used to make sour cream?

      Yes. Frozen Grade "A" cream may be used to make sour cream provided the thawed cream complies with the definition in 21 CFR 131.3 (a) (cream) and is thawed and handled in a sanitary manner.

  2. PMO-Section 1 and Appendix L
    1. May whey protein concentrate (WPC) and/or milk protein concentrate (MPC) be used as ingredients in yogurt to increase the nonfat solids content?

      Yes. 21 CFR 131.200 (d), which would have precluded WPC or MPC use, was one of several provisions of the standard of identity for yogurt that were stayed in 1982, 47 FR 41519, September 21, 1982.

      NOTE: If WPC and MPC are used in a Grade "A" yogurt product, they must be Grade "A" and come from an IMS Listed source.

  3. PMO-Section 1; and the Procedures GOVERNING THE COOPERATIVE STATE-PUBLIC HEALTH SERVICE/FOOD AND DRUG ADMINISTRATION PROGRAM OF THE NATIONAL CONFERENCE ON INTERSTATE MILK SHIPMENTS (PROCEDURES)-Section II
    1. In the production of Grade "A" fermented milk products, such as yogurt and cottage cheese, is it mandatory for the dairy ingredients, including powdered dairy blends of starter media for cultures, to be Grade "A" in order for the finished milk product to be Grade "A"?

       Yes. In the case of powdered dairy blends used for starter culture media, small amounts of functional ingredients, (the total of all such ingredients shall not exceed 5% by weight of the finished blend) which are not Grade "A" are allowed in Grade "A" blends when the finished ingredient is not available in Grade "A" form, i.e., sodium caseinate. This is similar to the existing PMO wording that allows such dairy ingredient(s) in small cans of freeze-dried starter culture need not be Grade "A".

    2. In a cheese plant that desires to produce Grade "A" whey, must the dairy ingredients, i.e., starter media, etc., used to make the cheese and produce the whey be from a Grade "A" listed source?

      Yes; however, the exception provided in a. above would also apply.

  4. PMO-Section 4
    1. On a bag of packaged Grade "A" NFDM or other Grade "A" dry milk or whey product, can you put a sticker with Grade "A" on the pre-printed label?

      No. Section 4 of the PMO states: "For dry milk products, the outer bag must be preprinted "Grade "A" before filling."

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  5. PMO-Section 4
    1. May an aseptically processed and packaged Grade "A" milk product be labeled as "Ultra-Pasteurized (UP)" and "Keep Refrigerated"?

      No.

  6. PMO-Section 4 and Appendix L
    1. Is "low carb" an authorized nutrient content claim for milk and milk products?

      No. The nutrient content claim "low carb" is not defined in FDA regulation or the PMO, and therefore, it is not an authorized nutrient content claim. Grade "A" milk and milk products so labeled are considered to be in violation of Section 4 of the PMO.

  7. PMO-Section 4; and the Interstate Milk Shippers (IMS) List
    1. A plant is reconstituting Grade "A" non-fat dry milk with water and shipping it to another listed plant. What is the correct product code to be listed on FDA Form 2359i-Interstate Milk Shipper's Report for this product?

      This reconstituted raw non-fat milk product would be coded as #1-(Raw Milk for Pasteurization). The shipping statement for this product must also identify this product as "reconstituted".

  8. PMO-Section 5; and the Methods of Making Sanitation Ratings of Milk Supplies (MMSR)
    1. Under the traditional system (inspections/ratings/check ratings), must the Regulatory Agency conduct follow-up inspections on significant farm violations? If so, how soon?

      Yes. The PMO does not specifically define significant farm violations. Should the violation of any requirement set forth in Section 7 of the PMO, be found to exist during a farm inspection, the permit holder must be notified in writing. The sanitarian should discuss a method for correction and afford the holder such reasonable opportunity to correct such violation(s) as may be agreed to by the parties, or in the absence of agreement, fixed by the Regulatory Agency. A follow-up inspection should occur after a predetermined period of time deemed reasonable to correct the violation, however, this follow-up inspection cannot occur before the lapse of three (3) days. The requirement of giving written notice shall be deemed to have been satisfied by the handing to the operator or by the posting of an inspection report, as required by this Section. After receipt of a notice of violation, but before the allotted time has elapsed, the permit holder shall have the opportunity to appeal the sanitarian's interpretation to the Regulatory Agency or request an extension of the time allowed for correction.

      The follow-up inspection shall be used to determine whether the violation(s) has been corrected. Any violation of the same requirement of Section 7 on such inspection, shall call for permit suspension in accordance with Section 3 and/or court action.

      The Regulatory Agency shall also make such other inspections and investigations as are necessary for the enforcement of this Ordinance.

      The Regulatory Agency shall suspend such permit, whenever it has reason to believe that a public health hazard exists.

      IMS-a-2 (Revised) addresses the evaluation of Regulatory Agency enforcement procedures when the Rating Officer or Regional Milk Specialist discovers that a violation of any requirement of Section 7 of the PMO is identified on a routine inspection and a follow-up inspection is not conducted until the time of the next routine inspection. Part I-Dairy Farms, Item 10-Permit issuance, suspension, revocation, reinstatement, hearings, and/or court actions taken as required, or Part II-Milk Plants, Item 9-Permit issuance, suspension, revocation, reinstatement, hearings, and/or court actions taken as required, should be pro-rated when follow-up inspections are not being conducted as called for in Section 5 of the PMO. With respect to the method of evaluating this situation, it appears that the Rating Officer or Regional Milk Specialist must judge whether or not the time interval between the debiting of a violation and conducting the follow-up inspection was unreasonably too long. For example, if a great deal of construction was involved, a longer period of time for the defect to be remedied might be warranted, as compared to the time to clean soiled milk utensils.

      In view of the importance of milk sanitarians to "follow-up" on violations of sanitary requirements on producer dairies and in plants as soon as possible, we would certainly suggest that nonconformity with this practice, should also be highlighted in the supplementary narrative portion of the "Report of Milk Sanitation Rating Surveys" or the cover letter provided to the State by the Regional Milk Specialist.

  9. PMO-Section 5 and Appendix B
    1. Is an FDA certified State Sampling Surveillance Officer (SSO) required to have their sampling practices evaluated every two years?

      Yes, if they are also responsible for the collection of official regulatory samples.

    2. Is a State delegated SSO required to have their sampling practices evaluated every two years?

      Yes, if they are also responsible for the collection of official regulatory samples.

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  10. PMO-Section 5; PROCEDURES; the EVALUATION OF MILK LABORATORIES (EML); and FDA's COMPLIANCE PROGRAM 18003-NCIMS MILK SAFETY PROGRAM
    1. What constitutes proper delegation from a State SSO to other regulatory/certified industry personnel that will conduct regulatory inspections of bulk milk hauler/samplers?

      The FDA Certified State SSO may delegate the inspection of bulk milk hauler/samplers, who collect samples of raw milk for pasteurization from individual producers, to other qualified State, Regional or Local Regulatory Agency personnel or certified industry personnel as outlined in Section 5 of the PMO. In all cases, documentation of delegation is required and records of individual evaluations must be reported as required by Section 8 of the EML, and a copy kept on file by the appropriate State Agency.

      Section 8 of the EML states: "When delegation of sampling surveillance responsibilities is necessary, the SSO certified by the Food and Drug Administration, shall certify responsible individuals every three (3) years, following the same procedures that governed his certification and transmit reports of each joint and/or check evaluation to the Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Compliance, Division of Cooperative Programs, Laboratory Quality Assurance Team."

      SSO's shall standardize regulatory/certified industry personnel initially and every three (3) years through a system of joint review of a minimum of five (5) bulk milk hauler/samplers. The minimum criteria for regulatory/certified industry personnel certification or re-certification entail the individual showing at least eighty percent (80%) agreement on each item of sampling surveillance. This certification is valid for three (3) years, unless withdrawn for cause, and shall not be allowed to expire. In all cases, documentation of delegation is required and records of individual evaluations must be reported as required by Section 8 of the EML, and a copy kept on file by the appropriate State Agency.

      The SSO will recommend withdrawal to the Regional Milk Specialist if standardized regulatory/certified industry personnel do not maintain the required proficiency or if the individual has failed to meet the criteria listed above for re-certification. A copy of the official notice of certification withdrawal shall be sent to the Director of the appropriate State Agency, the SSO, Laboratory Quality Assurance Team (LQAT) and Milk Safety Team (MST).

  11.  PMO-Section 6
    1. Prior to permit suspension, is a regulatory inspection/investigation required after a violative (bacteriological, coliform, somatic cell count, drug residue test or cooling-temperature standard) Section 6 sample? If so, how soon must it be done?

      No.

      Section 6 of the PMO states: "All violations of bacteria, coliform, confirmed somatic cell counts and cooling temperature standards should be followed promptly by inspection to determine and correct the cause."

      Section 6 also states: "Whenever a drug residue test is confirmed positive, an investigation shall be made to determine the cause, and the cause shall be corrected in accordance with the provisions of Appendix N."

      The PMO does not establish a specific time frame for these follow-up inspections/investigations.

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  12. PMO-Section 6
    1. If the Regulatory Agency delegates farm sampling and testing to the industry, should the Regulatory Agency determine which days the industry must report test results for official regulatory purposes or allow the industry to select which day's results are to be reported to the Regulatory Agency?

      The Regulatory Agency is required to randomly identify which day's laboratory results are to be submitted for official regulatory purposes. The bulk milk hauler/sampler must collect a "universal sample" from each farm bulk tank when each bulk tank is picked up. Required tests must be completed on each "universal sample". Industry laboratories cannot select which day's producer sample results they will report to the Regulatory Agency for a producer's official results for Section 6 required samples.

  13. PMO-Section 6
    1. Is there any latitude given to milk plants to collect their own regulatory milk samples (Section 6-4 in 6 months) for products that are made seasonally or infrequently? 

      No. All required Section 6 (four (4) samples in six (6) months) plant samples of Grade "A" milk and milk products are required to be collected by the Regulatory Agency.

  14. PMO-Section 6
    1. If a farm has two bulk tanks that are sampled on separate days, which laboratory results are to be used for official regulatory purposes?

      The Regulatory Agency is responsible to randomly identify which day's sample results are to be used for official regulatory purposes. The sample results for this sample are submitted to the Regulatory Agency and are recorded in the official producer's laboratory records. Industry laboratories cannot select which day's sample results they will report to the Regulatory Agency for official regulatory purposes.

    2. If both tanks are not sampled on the same day, should the Regulatory Agency ask the laboratory for the results on both tanks to assure that both tanks are being sampled?

      No. It is recommended that the Regulatory Agency randomly specify which tank's official sample results are to be submitted for official regulatory purposes.

  15. PMO-Sections 6 and 7, Items 5r and 14r and Appendix H; and Standard Methods for the Examination of Dairy Products (SMEDP)
    1. May a single farm, direct load, milk tank truck, without a shelter being provided, be air agitated at the dairy farm and then sampled at that farm outside?

      Yes, if acceptable to the Regulatory Agency. Item 5r of the PMO states: "When the Regulatory Agency determines conditions exist whereby the milk tank truck can be adequately protected and sampled without contamination, a shelter need not be provided if the following minimum criteria are met:...e. 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. The milk in the milk tank truck shall be effectively agitated in order to collect a representative sample." Also, with this scenario, the bulk milk hauler/sampler must be granted the authority by the Regulatory Agency to break the seal on the milk tank truck and to apply a new seal after the sample(s) has been collected.

      If during routine inspections, ratings, or check ratings, either the milk contact surface or milk in the milk tank truck were not adequately protected from contamination, it would be considered a violation of Item 14r.

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  16. PMO-Section 7, Item 3r
    1. Are cow deck mats that are bolted down on only one side but can be lifted from the other side for cleaning and inspection, considered a violation?

      This determination is based on the cleanliness of the deck mats and the floor underneath. This must be evaluated on a case-by-case basis.

  17. PMO-Section 7, Item 5r
    1. Some milkhouse drains are plumbed to discharge into the parlor pit to alert the milker when the outlet valve on the bulk tank is not closed. Does a milkhouse drain that is plumbed in this manner need a trap?

      With or without a trap in the drain, this situation would be considered a direct opening between the milkhouse and the parlor and would be considered a violation of Item 5r(b)-Miscellaneous Requirements of the PMO.

  18. PMO-Section 7, Item 5r
    1. May wastewater from the milkhouse be disposed of in an open trench or ditch? If this is not acceptable, where would this be debited on the "Dairy Farm Inspection Report"?

      Yes; however, the wastewater must be disposed of in a sanitary manner. If, during an inspection, rating or check rating, it is determined that the wastewater disposal method is creating an unsanitary condition, this would be considered a violation of Item 5r(c)-Miscellaneous Requirements of the PMO.

      NOTE: The State Regulatory Agency should consult their State Wastewater Control Authority concerning proper disposal of wastewater for their State.

  19. PMO-Section 7, Item 5r; and MMSR
    1. On farms, may two compartment utensil wash vats be connected directly to a sanitary sewer?

      Yes. Provided the floor drain is properly trapped.

  20. PMO-Section 7, Item 6r
    1. Are a washer and/or dryer, located in the milkhouse, considered a violation of the PMO?

      Yes. They would be considered unnecessary articles and are not directly related to milkhouse activities. The milkhouse shall be used for no other purpose than milkhouse operations.

  21. PMO-Section 7, Item 8r and Appendix D
    1. On a dairy farm, may heat exchange water and potable water be stored together in a tank that has an appropriate atmospheric break, and then be used for all purposes on the dairy farm, including the cleaning and sanitizing of milking equipment and the bulk milk tank, hand-washing, etc.?

      Yes. The water storage vessel and reclaimed water supply must meet all the requirements of Appendix D, Part VI of the PMO. The potable and reclaimed water piping must enter the vessel through an acceptable air gap or backflow prevention device.  In no case, may the reclaimed water be directly connected to the potable water lines without appropriate protection or be returned back into the farm's individual well or public water supply.

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  22.  PMO-Section 7, Item 8r and Appendix D; and M-b-241 and Supplement 1
    1. Does the discharge line from a Kube Kooler need to be protected similar to a plate cooler discharge?

      Yes. In no case, may the reclaimed water be directly connected to the potable water lines without appropriate protection or be returned back into the farm's individual well or public water supply.

  23. PMO-Section 7, Item 8r and Appendix D; and MMSR-Appendix B
    1. Must a test kit be available on a farm that has a water source that the Regulatory Authority has only approved on the condition that continuous chemical disinfection is applied?

      Appendix D, IV.-Continuous Water Disinfection of the PMO, states: "Water supplies which are otherwise deemed satisfactory, but which prove unable to meet the bacteriological standards prescribed herein, shall be subjected to continuous disinfection." Since it must be presumed that the safety of the supply is dependent on the chemical disinfectant residual, the Regulatory Agency must determine there is an appropriate residual each time an official inspection is made. This would also include the record of chemical disinfectant monitoring. Since the Regulatory Agency is responsible for ascertaining the supply is safe, it should be expected on State Ratings and FDA Check Ratings to see records of chemical disinfectant monitoring and bacteriological tests. The Regulatory Agency should recommend the producer monitor the supply as often as they deem necessary to be reasonably assured the system is being adequately maintained. Test kits are required for the Regulatory Agency. Since the Regulatory Agency should recommend the producer maintain some kind of monitoring records, it would probably be simpler for an appropriate test kit to be located on the farm and accessible for everyone to use. The optimum chlorine residual should range from .1 to .8 ppm with this being raised to 1.0 ppm during emergencies, i.e., floods, etc. (Refer to MMSR-Appendix B--5 point debit-Continuous chemical disinfection system, required by the Regulatory Agency, is not operational.)

  24. PMO-Section 7, Item 9r
    1. Are CIP dump valves for farm pipeline systems required to be constructed to meet Item 9r of the PMO?

      Yes.

  25. PMO-Section 7, Item 14r
    1. If plants are allowed to push raw milk with potable water, are farms allowed to do this as well?

      No.

  26. PMO-Section 7, Item 14r
    1. Must lines for cleaning solutions and lines for milk pumps, located in the milkhouse, be capped when not in use?

      If the line is used only for conducting cleaning solutions, it would not be required to be capped when not in use.

      Sanitized product lines and hoses (connected or disconnected) used with milk pumps are required to be capped when not in use.

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  27. PMO-Section 7, Item 15r
    1. What are the labeling requirements for the human drug Ticarcilin disodium, which will be diluted with sterile water, when prescribed for use on dairy cattle?

      It must be properly extra labeled by a veterinarian, as required under Item 15r of the PMO.

  28. PMO-Section 7, Item 15r
    1. What are the labeling requirements for homeopathic drugs?

      They are considered to be unapproved animal drugs. When stored on dairy farms they must comply with the PMO labeling and storage requirements of Section 7, Item 15r. (Refer to M-I-92-10 addendum)

  29. PMO-Section 7, Item 5p
    1. If a vent is located in a wall between the raw milk storage tank gallery room and the case washing room, may a filter be placed over the vent to provide adequate separation between the case washing room and the raw milk storage tank gallery room?

      Yes.

  30.  PMO-Section 7, Items 5p and 15p(A)
    1. May packaged milk, which has left the plant and returned, i.e. from a store, be stored in the finished product cooler, case room, or loading dock?

      Yes to all of the above locations. In all situations the designated marked area or room provided for the receiving, handling, and storage of returned packaged milk and milk products must be properly maintained and operated, so as to preclude the contamination of Grade "A" milk and milk products and equipment and the Grade "A" operations. Packaged milk and milk products, which have physically left the premises or the processing milk plant are not re-pasteurized for Grade "A" use. The Regulatory Agency may, on a specific individual request, authorize reprocessing of packaged milk and milk products, provided all other aspects of this Item, including proper storage temperature and container integrity are complied with.

  31. PMO-Section 7, Item 7p; and MMSR
    1. May a plant be the official record holder for official water sample results, including glycol and chill water? (State pulls the samples.)

      Yes, if the Regulatory Agency so directs.

  32. PMO-Section 7, Item 7p
    1. Is a water line connected directly to a sealed canister piston head within a homogenizer or a water line running through an oil bath that cools the homogenizer gearing system, a water violation? In the above-cited situations, water is not being sprayed over the outside of the pistons and it is not protected by an air break.

      Yes. If it is determined that a water cross-connection exists, the States should be advised of the potential for the contamination of the water supply from the piston heads or hydraulic oil and allowed time to work with their industry to correct the violation.

  33. PMO-Section 7, Item 11p and Appendix J; and MMSR
    1. Is there a violation if, on a rating or check rating unlisted single-service containers/closures are being used for the packaging of Grade "A" milk and milk products? If so, where would it be debited?

      Yes. This would be debited under Item 11(c) on Form FDA 2359-Milk Plant Inspection Report. 

      Also, if it is determined that this violation was occurring at the time of the previous routine regulatory inspection, points would be taken off under Part II-Milk Plant, Item #4-Interpretation on Form FDA 2359j-Report of Enforcement Methods.

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  34. PMO-Section 7, Item 12p
    1. With extended runs, what is meant by "in consultation with FDA"? Does that mean FDA must be in the loop or does it mean that FDA sees all documentation and has approval or what?

      For extended runs, FDA (Regional Milk Specialist(s) and MST, if necessary) must be included in the review and be privy to all appropriate information to provide input to the Regulatory Agency.  With the initial approval of an extended run, the Regulatory Agency makes the determination with input (consultation) from FDA.  FDA may have additional say in this matter, when conducting a check rating of the facility and it evaluates the extended run protocol.  Remember, extended run protocols and approvals are product, process, equipment and plant specific. 

  35. PMO-Section 7, Item 12p; and M-a-74
    1. Is there a limit to the number of days pasteurized cream, which will be bulk shipped for further processing, may be stored in a tank or silo in the shipping plant?

      Yes. M-a-74 states: "Item 12p specifies that storage tanks be cleaned when emptied and shall be emptied at least every 72 hours. We believe the intent of the PMO is to limit the storage of raw and pasteurized milk and milk products in storage tanks to 72 hours maximum.

      Therefore; when pasteurized Grade 'A' milk and milk products are stored in the shipping plant longer than 72 hours before shipment to another plant for further processing, it shall be considered a violation of Item 12p."

      The appropriate debit would be Item 12p(a) and (c).

  36. PMO-Section 7, Item 12p; and Appendix H
    1. Is in-plant reclaimed milk stored in a tank considered raw? If so, is a 7-day recording chart required on the tank if the milk is held longer than 24 hours?

      Yes to both questions.

  37. PMO-Section 7, Item 15p(A)
    1. Is culinary steam required when steam is used to heat cleaning and/or sanitizing solutions in a COP tank and/or CIP system?

      No. However, the steam shall not contain toxic substances.

  38. PMO-Section 7, Item 15p(A) and Appendix H
    1. May ammonia be used in steam contacting milk and milk products? 21 CFR 173.310 seems to preclude its use as it states that when boiler feed water is treated with chemicals, only those nontoxic compounds listed may be used (ammonia is not listed.)

      Yes, ammonia may be used in steam contacting milk and milk products. Aqueous ammonia solutions are listed as GRAS for use in food with no restrictions other than GMP's (21 CFR 184.1139). While there are no restrictions, use as a boiler water additive is mentioned explicitly as an example.  Any ingredients, i.e., sodium hydroxide, sulfuric acid, and phosphoric acid, can be hazardous to workers or make food inedible if used improperly, but there is no safety issue if used under GMP's. 21 CFR 173.310 is intended to authorize a particular use pattern for a specific group of chemicals, and that group of chemicals is not comprehensive of all chemicals that might be so used, ammonia, in fact, is acceptable for this use as specified in 21 CFR 184.1139, (c)(1). 

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  39. PMO-Section 7, Items 16p

    Raw milk for pasteurization may be concentrated by the use of Reverse Osmosis (RO) or Ultra-Filtration (UF) without pasteurization, prior to the entrance into the equipment, provided it meets the criteria cited in Item 16p of the PMO. One of the criteria states: "At a minimum, milk or milk product temperature shall be monitored and recorded prior to entering the system, prior to entering each stage of the modules in series that contains cooling and prior to any final cooler..."

    1. Does this statement require an indicating thermometer and recorder-controller at each of the required locations cited above?

      Yes.

    2. Are each of the required recorder-controllers required to have a frequency (event) pen?

      Yes.

  40. PMO-Section 7, Item 16p
    1. May dry salt be added to Grade "A" milk and milk products post-pasteurization?

      Yes. The addition of salt post-pasteurization must be done in a sanitary manner.

  41.  PMO-Section 7, Items 16p

    An Anderson AV9900 recorder-controller is being used on a raw milk UF system prior to each cooler, to meet the requirements for a raw milk UF systems addressed under Item 16p of the PMO as cited in Question #39:

    1. Is the digital readout on this recorder-controller adequate as an indicating thermometer?

      Yes.

    2. How often do these indicating and recorder-controller thermometers need to be evaluated by the Regulatory Agency for accuracy?

      Section 7 of the PMO does not state a testing frequency for these thermometers; however, they must be accurate whenever they are tested. Therefore, the Regulatory Agency should routinely test the accuracy of these thermometers at an established frequency to assure itself that the thermometers remain accurate. This should be reviewed during State Ratings and FDA Check Ratings in a similar manner as with other thermometers used on storage tanks.

  42. PMO-Section 7, Item 16p(B)
    1. Is it possible to use only two pressure sensors to monitor pressures in a HHST steam injection system, i.e., one located prior to the steam injector and one located at the end of the holding tube, if they are instrumented to divert when either the minimum holding tube pressure or pressure drop across the injector is not met?

      No. The sensor "after the injector" must be located immediately after the injector at the beginning of the holding tube. The sensor used to assure "minimum holding tube pressure" must be located at the downstream end of the holding tube where the pressure is the lowest.

  43. PMO-Section 7, Item 16p(B)
    1. May the final sensor for the thermal sequence logic control for HHST systems be located in the FDD divert line?

      Yes.

  44.  PMO-Section 7, Item 16p(B)
    1. Is it required that both the high-flow and low-flow or loss-of-signal alarm trigger a flow diversion.

      Yes.

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  45. PMO-Section 7, Item 16p(C)
    1. On an aseptic processing system, must the cut-in/cut-out mechanism be set and sealed in a legal control box above the temperature required in the filed process for the product being processed?

      No. The cut-in/cut-out mechanism must be set and sealed to assure compliance at the lowest temperature required by the filed process for any of the milk products being aseptically processed through the system. All milk products aseptically processed through the system must be processed at the minimum temperature required by their individual filed processes. A firm must have records to indicate that a particular product was processed through the system at the temperature required by the process authority in the filed process. Processing recording charts would be at least part of that required record.

  46. PMO-Section 7, Items 16p(C) and 16p(E)
    1. Under aseptic processing conditions, what tests must be conducted when the regulatory seal to the timing pump has been broken?

      You must verify that the pumping rate has not changed and that the holding tube remains the same length and volume. Following this verification, the Regulatory Agency shall reseal the timing pump.

  47. PMO-Section 7, Items 16p(D)
    1. May open type tower water systems be used in a water-to-water plate heat exchanger to cool water that is used in a water-to-product-to-water regenerator system in an HHST system?

      No.

  48. PMO-Section 7, Item 16p(E)
    1. Is there a specified range of flow (Gallons per Minute (GPM) or % of Maximum Flow) required to be documented on the flow chart recorder for meter based timing systems?

      No. The only written requirement is cited in Section 7, Item 16p(E) 1. c. of the PMO, and it states, "Flow rate recording charts shall be capable of continuously recording flow at the flow alarm set point and at least 19 liters (5 gallons) per minute higher than the high flow alarm setting."

  49. PMO-Section 7, Item 16p(E) and Appendix I 

    The red cow book and the PMO do not describe the equipment test for the manual divert test (5.5) in the same way.

    1. Does the equipment test require an increase of the HTST pressure to at least 10 pounds higher than normal operating pressures?

      No.

    2. Which methodology should be followed?

      The procedures described in Appendix I, Test 5.5, of the PMO must be followed.

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  50. PMO-Section 7, Item 16p(E) and Appendix I
    1. With regards to Equipment Test #15-ELECTRO-MAGNETIC INTERFERENCE FROM HAND-HELD COMMUNICATION DEVICES, what is considered an adverse effect?

      In the example cited under Test #15, it states: "For Example: For temperature set point, operate the pasteurizer or aseptic processor on water in diverted-flow in the "Product" mode, at a steady temperature within 3°C (5°F) of the lowest cut-in temperature. In this example, an adverse effect is defined as forward-flow movement of the FDD or any artificial increase in temperature."

    2. What if the unit raises 1°F but the FDD remains in the diverted flow position, would this be a problem?

      Yes. Any artificial increase in temperature would require the unit to be repaired.

  51. PMO-Section 7, Item 16p(E) and Appendix I
    1. If a milk plant does not use hand-held communication devices, including cell telephones, must Test #15 be conducted?

      No. Test #15 applies to all electronic controls used to assure compliance with public health safeguards on pasteurization and aseptic processing equipment that are installed in milk plants where hand-held communication devices are being used.

  52. PMO-Section 7, Item 16p(E) and Appendix I
    1. Does the top of the new Tri-Clover FDD have to be under regulatory seal?

      No.

  53. PMO-Section 7, Item 17p
    1. Where is it stated that captive recirculated cooling water systems used to cool the forming mandrels on paper milk fillers are not required to be sampled and analyzed?

      M-I-88-7, Question 38.

    2. If multiple fillers are looped together, utilizing the same captive recirculated cooling water system, is the captive recirculated cooling water system required to be sampled and analyzed?

      No. However, the cooling media must be safe and properly protected from contamination.

  54. PMO-Section 7, Item 17p
    1. May tower water be used on a secondary water-cooling loop on a VTIS system?

      Yes. Provided that, the secondary water-cooling loop is an enclosed system, as provided for in Section 7, Item 17p, Administrative Procedure #10 of the PMO.

  55. PMO-Section 7, Items 18p and 19p; and MMSR
    1. May cleaning issues observed in packaging and/or capping equipment be pro- rated under Items 18p and/or 19p?

      No.

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  56. PMO-Appendix J, Section A
    1. Is a plant that manufactures the plastic film for three or five gallon Grade "A" milk bags, i.e., for bag-in-box machines, etc., or a plant, which manufactures the caps and nozzles for these bags, required to be listed in the IMS List?

      Yes. Furthermore, the plant that manufactures or assembles the final milk container from component parts must also be listed.

  57. PMO-Appendix J, Section D, Item 19
    1. May a non-IMS listed plant manufacture plastic over-wrap for milk containers, which are manufactured at a listed single-service manufacturing plant?

      Yes. Appendix J, Section D., Item 19(e) of the PMO states: "All packaging materials that contact the product-contact surface of the container or closure shall comply with the requirements of 21 CFR Parts 175-178 and the bacteriological standards of Section C of these standards, but the materials do not have to be manufactured at a listed single-service plant."

  58. EML; and SMEDP

    A plant has a refrigerator in a receiving bay used by bulk milk hauler/samplers to store their "universal" producer samples. A person from the plant laboratory will pick-up the samples once each day for testing.

    1. What are the requirements for this refrigerator, used for this purpose, located in the receiving bay?

      The refrigerator's temperature is required to be monitored. If the receiving bay refrigerator is out of temperature or is not being monitored, the samples would not be acceptable for official analysis.

    2. Temperature control (TC) samples are being left with the route samples. Should someone be checking the TC of the producer samples when they are put into the refrigerator?

      Yes. If the samples are for official IMS testing, then the following information should be recorded at each interim transfer point: Date, Time, and Temperature of each temperature control when samples are received or shipped. The bulk milk hauler/sampler, as a part of maintaining proper "chain of custody" should record this required information. These "universal" samples should be maintained from collection to laboratory receipt in a manor to assure sample integrity. The bulk milk haulers/samplers when they deposit the samples in the refrigerator must assume the samples are for official regulatory purposes. The Regulatory Agency ultimately makes that decision.

    3. How many TC samples are required to be placed in the refrigerator?

      Each set of "universal" producer samples per route that are delivered will have a TC sample. The TC sample remains with the set of samples, until official testing is completed, and is used to report the temperature of the samples at the time of analysis. If no further testing is performed, there is no need to maintain the TC sample. If the samples are not official IMS samples, then we recommend that each TC sample be checked and discarded.

    4. In this situation, at what point are the samples received by the laboratory?

      The fact that the refrigerator is located outside the laboratory is relevant to this question. The samples are received by the laboratory when they are delivered to the laboratory.

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