• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Food

  • Print
  • Share
  • E-mail

M-I-03-17: Questions and Answers from FY'03 Regional Milk Seminars and Special Problems in Milk Protection Courses

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

HHS:PHS:FDA:CFSAN:OC:DCP:MSB

5100 Paint Branch Parkway
College Park, MD 20740-3835

M-I-03-17

December 11, 2003

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

FROM: Milk Safety Branch (HFS-626)

SUBJECT: Questions and Answers from FY'03 Regional Milk Seminars and Special Problems in Milk Protection Courses

Following are questions and answers from Regional Milk Seminars and Special Problems in Milk Protection Courses held in FY 2003.

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 a public health hazard, reasonable judgment should be exercised, and adequate time provided for modification and correction.

Copies of this memorandum are enclosed for distribution to Regional Milk Specialists, State Milk Regulatory Agencies, State Laboratory Evaluation Officers and State Milk Sanitation Rating Officers in your region. This memorandum should be widely distributed to representatives of the dairy industry and other interested parties and will also be available on the FDA Web site at http://www.fda.gov/food at a later date.
 

/s/

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

/s/

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

QUESTIONS and ANSWERS
from the
SOUTHEAST REGION MILK SEMINAR-10/7-10/2002,
PACIFIC REGION MILK SEMINAR-11/19-21/2002
and the
FD 5107 SPECIAL PROBLEMS IN MILK PROTECTION COURSES- 7/14-18 (Rockford, IL) and
8/18-22/2003 (Statesville, NC)

  1. PMO-Section 1 and Appendix L

    Besides M-I-03-9, are there any additional references for Tolerances for Residues of New Animal Drugs in Milk?

    Another useful source is 21 CFR 556-"Tolerances for Residues of New Animal Drugs in Food".

  2. PMO-Sections I and 4; and Appendix L

    May a mixture of non-fat milk solids and water be included as an ingredient in reduced fat milk, lowfat milk, etc.?

    No.

  3. PMO-Sections 1 and 4; and Appendix L

    May you "standardize" cream from 30% to 18% milkfat with water and still label the final product as "cream"?

    No. The standard of identity for cream does not provide for water as an added ingredient.

  4. PMO-Sections I, 4 and 7; and Appendix L

    What is the difference between reconstituting and standardizing a dairy product?

    Reconstituted or recombined milk and/or milk products mean those milk or milk products, as defined in Section I of the PMO, which result from reconstituting or recombining of milk constituents with potable water followed by legal pasteurization. Standardizing a dairy product means adjusting the milkfat content of milk by adding or removing cream or non-fat (skim) milk.

    NOTE: Standardization of Grade "A" milk and milk products with other than Grade "A" milk and milk products is prohibited under the PMO.

  5. PMO-Sections 1, 4 and 7; and Appendix L
    1. May carbon dioxide (CO2) be used in cottage cheese as a headspace filler, during packaging, or be incorporated into the product? If so, what are the labeling requirements?

      Yes to both uses. Exemption for declaration of the CO2 in the food label ingredient statement is dependent upon determination if the amount and usage of the ingredient (CO2) meets the requirements set forth in CFR 21 part 100.100(a)(3) Food, exemptions from labeling, for incidental additives and processing aids. When CO2 is used as a headspace filler, it is considered a "processing aide" and would not require any additional labeling. If incorporated directly into the product, it needs to be identified in the ingredient statement by its common name followed by a parenthetical statement as to its function, i.e., "preservative" or "extends shelf life". IDFA has indicated that they are gathering information for FDA's consideration in determining if the methods of purging the cottage cheese dressing and levels of use of CO2 in finished packages of cottage cheese will meet the requirements for an exemption from ingredient declaration. If that information is provided, FDA will take it under consideration.

    2. May CO2 be incorporated into bulk shipments of milk products? What are the labeling requirements?

      No. This is not allowed by the standard of identity for milk. The resulting product could not be labeled as "milk."

  6. PMO-Sections 1 and 6; and Appendixes L and O

    Natural Vitamin A in whole milk is approximately 1,200 IU/qt. If Vitamin A addition is claimed on the label, it needs to be at 2,000 IU/qt. Is this because of a nutritional consideration?

    Yes.

  7. PMO-Section 3 and Appendix B
    1. If a bulk milk hauler/sampler has not been evaluated in the past two years, does that hauler/sampler hold a valid license or permit?

      Yes. Provided, the license has not expired, been suspended or been revoked.

    2. If the initial license was issued recently, do they still hold a valid permit?

      Yes. An initial evaluation is required prior to issuing the initial permit or license.

  8. PMO-Sections 3 and 5; and Appendix B

    Do milk tank trucks have to be clean before inspection and permit issuances?

    It is recommended; however, it is at the Regulatory Agency's discretion.

  9. PMO-Sections 3 and 6; Appendix N; and IMS-a-44 (Proposal 248)

    M-a-86 (Rev. 3) doesn't specifically address which test kit can be used to test a producer's reinstatement sample following a suspension for a positive drug residue. Specifically, can an industry analyst run the screening test to clear the producer before milk pick-up resumes? What test kit must be used to clear the producer?

    No. An industry analyst cannot run the screening test to clear the producer before milk pick-up resumes. The producer's reinstatement sample is to be analyzed at the Regulatory Agency's discretion by a certified industry supervisor (CIS) or in a certified industry or Regulatory Agency laboratory by a certified analyst, using the same test kit that was used to suspend the producer's permit.

  10. PMO-Sections 3 and 6; Appendix N; and M-I-96-10

    May a producer's milk supply that is screened and confirmed positive, using the Idexx Parallux be reinstated using the Charm SL?

    No. The same test kit that suspended the producer's permit must be used to reinstate the producer's permit.

  11. PMO-Sections 3 and 6; and MMSR

    Consider a farm that dries off (discontinues production) for an extended period of time (60 days or more).

    1. How would State Rating Officers and Regional Milk Specialists deal with the lack of samples during ratings and check ratings?

      Sampling should be conducted during the time the farm is in production.

    2. Should the Regulatory Agency degrade such a farm during the dry period?

      The PMO is silent on this issue. It is at the discretion of the Regulatory Agency.

    3. Does the Regulatory Agency carry the sample history forward through the months where no product was available to sample?

      Yes.

    4. Should the Regulatory Agency conduct accelerated sampling at the beginning of a new production cycle?

      No. However, this is also at the discretion of the Regulatory Agency.

  12. PMO-Sections 3 and 7; Appendix B; and IMS-a-44 (Proposal 108)

    May a Grade "A" Interstate Milk Shippers (IMS) Listed plant unload milk from a milk tank truck that was washed at a non-PMO permitted milk tank truck cleaning facility?

    No. Appendix B, Milk Tank Truck Standards, Item 5., Wash and Sanitize Record, Sub-item a. of the PMO states: "The bulk milk hauler/sampler shall be responsible for assuring that the milk tank truck has been properly cleaned and sanitized at a permitted milk plant, receiving station, transfer station, or milk tank truck cleaning facility. A milk tank truck without proper cleaning and sanitizing documentation shall not be loaded or unloaded until the proper cleaning and sanitization can be verified."

  13. PMO-Section 4

    What labeling is required on a Bill of Laden for bulk shipped heat-treated blends of Grade "A" ingredients being shipped to an IMS plant for the manufacture of Grade "A" dairy products?

    The name of the Grade "A" heat-treated blend must include the proper identity of the individual ingredients that make up the blend of Grade "A" ingredients.

  14. PMO-Section 6; and Appendixes L and O

    Is there some way to adjust/exempt small serving size, high fat products from the requirement to add additional vitamin A, if the product already meets the minimum of 2000 IU per quart? For example, does 21 CFR 130.10 (b) require the addition of more vitamin A to non-fat half-and-half, even though one serving (i.e., one or two tablespoons) is already near the maximum IU per quart of vitamin A (4500 IU) as manufactured? Is there a danger of adding to vitamin levels near toxic levels via the requirements of 21 CFR 130.10 (b)?

    No adjustment or exemption is needed, as 21 CFR 130.10 (b) does not require the addition of vitamins in amounts greater than those needed to restore vitamins lost during the removal of the fat. Standardized foods that are modified to make a nutrient content claim (i.e., non-fat half-and- half) must not be nutritionally inferior to the traditional standardized food. For example, a standardized food that is modified to make a non-fat or reduced fat claim must have added amounts of fat-soluble nutrients in amounts needed to restore what is lost due to complete or partial removal of fat. Amounts added greater than those needed to simply restore lost amounts are not required for the non-fat or reduced-fat food to be nutritionally equivalent to its traditional counterpart.

    21 CFR 130.10 does not require the addition of more vitamin A to non-fat half-and-half. When fat is removed from half-and-half to make a non-fat half-and-half, fat-soluble vitamins that are incidentally lost along with the removal of fat must be replaced only in amounts that are lost. Amounts over and above those that are lost may be added, if a nutrient content claim, such as "added" or "fortified" is made in accordance with 21 CFR 101.54.

    The reference amount for "half-and-half" is 2 tbsp or 30 mL (21 CFR 101.12). The vitamin A content of 2 tbsp of half-and-half is 106 IU (USDA Handbook 8). Vitamin A must be added to bring the vitamin A levels of non-fat, reduced fat, or low-fat versions of half-and-half to that found in regular half-and-half, i.e., 53 IU/tbsp.

  15. PMO-Section 6; Appendix N; and MMSR-Appendix, Part I, Dairy Farms, Product Compliance

    Why are there no PMO monetary (or equivalent) penalties for producers found to have positive drug residues in Section 6 samples when no bulk milk pick-up tankers are contaminated?

    Though there is no direct monetary penalty addressed in the PMO, we do not agree that there is not a penalty suffered by a producer found to have a positive drug residue from a Section 6 sample. A confirmed positive drug residue result found in a Section 6 producer sample requires enforcement action as set forth in Appendix N of the PMO. The producer's permit is suspended and milk cannot be shipped until a properly collected, representative sample indicates the producer's milk is free of drug residues. In addition, the positive Section 6 sample is included in the count that may result in the initiation of action to revoke the producer's permit after a third (3rd) violation in a twelve (12) month period.

  16. PMO and DMO-Section 6; and MMSR

    If an antibiotic analysis is not performed on a sample of milk or not posted with the results of an official monthly sample of milk, are standard plate count (SPC), cooling temperature, coliform, or Direct Microscopic Somatic Cell Counts (DMSCC) still valid tests?

    SPC results are not valid when an antibiotic analysis is not performed on a raw milk sample. SPC and coliform results are not valid when an antibiotic analysis is not performed on a finished milk product sample. All other required milk tests referenced in Section 6 of the PMO and DMO are valid and official and must be treated as such, provided the test(s) itself is valid.

  17. PMO-Section 6; IMS-a-44 (Proposal 234); and MMSR-Appendix

    If a permitted facility has multiple tanks, which are sampled on the same day, must the Regulatory Agency average the sample results?

    Yes. 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 individual sample laboratory results are reported by the laboratory to the Regulatory Agency. The Regulatory Agency arithmetically averages the individual sample laboratory results and records this number as the official result for that day. This is only applicable for bacteria (standard plate count and coliform determination), somatic cell count and temperature determinations. If this arithmetic average is not completed by the Regulatory Agency, it is a records debit on enforcement ratings, as indicated in the Appendix of the MMSR (Part I, Dairy Farms, Item 11, Sub-item c and Part II, Milk Plants, Item 10, Sub-item c).

  18. PMO-Section 6; IMS-a-44 (Proposal 234); and MMSR-Appendix

    How would you average the bacterial counts on a farm with two separate bulk milk storage tanks (i.e., tank #1 has a bacteria count reported at <25,000 and tank #2 has a bacteria count reported at 130,000)?

    The laboratory will report the individual sample results to the Regulatory Agency, as specified by the laboratory 2400 form, and in the case of a reported value of <25,000, the laboratory will make the actual number known to the Regulatory Agency upon request. In this example we will assume that the laboratory reported an actual number of 23,000. The Regulatory Agency is responsible for obtaining these results and calculating the arithmetic average of the two results (23,000 + 130,000 = 153,000/2 = 76,500) for the official sample result. The arithmetic average [76,000] will be reported to the producer and recorded on the producer's ledger sheet, as the official sample result for that sampling event. The estimated number of <25,000 cannot be averaged.

  19. PMO-Section 6; IMS-a-44 (Proposal 166); and SMEDP

    Does the multi-use red rubber sample septum meet the requirements of the single use style septum for the collection of samples in a plant?

    Yes. There is a septum that has several spots/circles where a needle can be inserted. As long as each of these spots/circles is used only once and the septum is sanitized prior to each use, then this is acceptable.

  20. PMO-Section 6; and M-I-02-8

    If there are not any validated laboratory tests available for some pasteurized, condensed or dry milk products, do you still have to take samples?

    Yes. Applicable coliform and temperature determinations are still required.

  21. PMO-Section 6; and 2400 Series Forms

    What is the name of the new Somatic Cell Count (SCC) testing instrument "flow cytrometry" mentioned along with the Bactoscan?

    It is Delta Instruments, Somascope MKII, and comes in two speeds (300 and 500 samples per hour).

  22. PMO-Section 6; and SMEDP

    In regard to coliform testing of cultured products, SMEDP, 16th Edition states: "Samples of cultured or acidified cottage cheese, sour cream, yogurt and milk products must be plated within 24 hours after manufacture to obtain meaningful results." Section 6 of the PMO, under Laboratory Techniques, differs from the SMEDP, yet the Regulatory Agency requires coliform testing on these products regardless of how long it has been since they have been manufactured. How should these samples be marked on laboratory worksheets: "IMS" or not or "official" or not?

    The laboratory worksheets should be marked "IMS" and "official" since the PMO requires that coliform testing be done. The SMEDP is a guidance document used by the NCIMS.

  23. PMO-Section 7

    Is it acceptable for a milk tank truck cleaning facility to be located on a Grade "A" dairy farm?

    Yes. Provided, it meets all the applicable requirements of the PMO.

  24. PMO-Section 7, Item 5r
    1. On a farm, if a single milking is directly loaded into a milk tank truck and delivered to a plant and is subsequently cooled at the plant, how long can that milk be held at the farm without being cooled? Milk that is directly loaded into a milk tank truck may not be held without being cooled. Item 5r, Administrative Procedure 16(d) of the PMO states: "An accurate, accessible temperature recording device shall be installed in the milk line downstream from an effective cooling device, which cools the milk to below 7°C (45°F)." Therefore, the temperature of the milk must be at 7°C (45°F) or below prior to being loaded into the milk tank truck.
    2. What temperature must direct load milk be at when delivered to the plant?

    The required temperature is 7°C (45°F) or less.

  25. PMO-Section 7, Item 5r

    On a Grade "A" dairy farm, can a utensil wash vat constructed of fiberglass or Nalgene be used in a mechanically cleaned system?

    Yes. A utensil wash vat can be constructed of fiberglass or Nalgene, if it is in good repair and the construction materials are non-toxic under the conditions of use. Utensil wash vats should be relatively smooth and be of sufficient size to accommodate the largest utensil or container that is washed manually. When utensil wash vats deteriorate to a condition of poor repair, i.e., excessive corrosion, separated seams, etc., which hampers their intended use and cleanability, then Item 5r would be debited.

  26. PMO-Section 7, Item 8r

    Is plate cooler discharge water that is directly connected to the potable water system without an appropriate back-flow prevention device installed on the potable water line an 8a or 8c debit?

    It is a cross-connection; therefore, a violation of Item 8r, and is debited on Item 8c of Form FDA 2359a "Dairy Farm Inspection Report".

  27. PMO-Section 7, Item 8r

    Does a potable waterline feeding a plate cooler require a backflow preventer?

    Not at the current time.

  28. PMO-Section 7, Items 9r, 10r and 11r

    May a vacuum trap be located directly on top of the receiver jar?

    Yes. Provided that all areas of the vacuum trap and associated piping from which liquids may drip, drain or be drawn into milk or milk products or onto milk product contact surfaces meet product contact surface requirements for construction, materials and finish, and are maintained clean and are sanitized prior to each use.

  29. PMO-Section 7, Item 12r

    On a farm, can a receiver jar be located in a pit in a utility room?

    Yes. The utility room must be maintained in compliance with the requirements for the milking area, including construction and cleanliness, and the pit must have adequate drainage and access.

  30. PMO-Section 7, Item 12r

    Is there a debit if a vacuum trap's lid is not weighted properly and does not properly close when the trap is located in the milking parlor or milking barn? What about when the trap is located in the milkroom?

    Yes. This would be a violation no matter where it is located. Such an opening to the vacuum trap may allow insects, rodents and other contaminants direct access to the receiver jar.

  31. PMO-Section 7, Item 15r

    Is it a violation if a drug has a manufacturer's label on the bottle, which states the drug's active ingredient and trade name, but the veterinarian's label has another manufacturer's trade name for the same exact drug? For example, Flunixin Meglumine, Trade Name Vedegesic, is on the manufacturer's label; however, Banamine is on the veterinarian's label.

    If the drug has all the PMO required labeling information and is stored correctly, it would not be a violation of the PMO.

    In the case of Vedegesic or other generic Flunixin products, i.e., horse approval only, it would have to be properly extra-labeled by a veterinarian for either lactating or non-lactating animals.

    In the case of Banamine, Rx with beef approval labeling, if it is intended for calves and non-lactating cows, it can be stored on the non-lactating shelf with only the prescribing veterinarian's name and address on the container. If the Banamine is intended for lactating cows, a full Extra Label Use (ELU) label is required.

    Technically, the veterinarian should identify the drug Flunixin or Flunixin Meglumine on the over label.

  32. PMO-Section 7, Item 15r

    Is the storage of a syringe or a drug bottle in the hand washing fixture a debit under Item 15b?

    Yes.

  33. PMO-Section 7, Item 15r

    What is the meaning of the term "bulk" drugs?

    United States v. Algon Chemical Inc., 879 F.2d 1154 (3d Cir. 1989) states: "...bulk drug is an active ingredient (in unfinished form) intended for manufacture into finished dosage form drug products." Refer to 21 CFR 207.3 (a) (4). Bulk drugs (or "bulk drug substances") may be supplied in various size containers and may or may not meet USP standards.

  34. PMO-Section 7, Item 15r
    1. Is CVM doing any work on Homeopathic Medicines?

      No. FDA is not reviewing any homeopathic drugs at this time and currently, there are not any FDA approved homeopathic drugs for veterinary use. Homeopathic drugs found on dairy operations must comply with the drug labeling and storage requirements of Item 15r of the PMO.

    2. Does a valid client veterinarian relationship make this legal or allowed?

      No. Technically, a veterinarian's participation in the use of homeopathic drugs has no bearing on this issue. The legal or approved status of homeopathic drugs is an FDA responsibility under the Federal Food, Drug and Cosmetic Act (FFD&C Act).

  35. PMO-Section 7, Item 18r; and Appendix H

    What records are required for farm bulk milk tanks that store temperature information, then print the data at a later date?

    Section 7, Item 18r, Administrative Procedure 3(g) of the PMO states: "A recording thermometer and/or any other device that meets the intent of these Administrative Procedures and technical specifications and is acceptable to the Regulatory Agency can be used to monitor/record the bulk tank temperature." Administrative Procedure 3(c) states: "Recording thermometer charts shall be maintained on the premises for a period of a minimum of six (6) months and available to the Regulatory Agency." Administrative Procedure 3(h) states: "The recording thermometer charts shall properly identify the producer, date, and signature of the person removing the chart." Therefore, bulk tanks that store temperature information must be capable of printing the required information, as cited above, at a frequency and time period acceptable to the Regulatory Agency and at any time the Regulatory Agency requires this information.

  36. PMO-Section 7, Item 18r; and IMS-a-44 (Proposal 118)

    After a bulk milk hauler/sampler calibrates the bulk tank-recording thermometer, where should the results be recorded?

    Section 7, Item 18r, Administrative Procedure 3(b) of the PMO requires that the results shall be documented in a manner acceptable to the Regulatory Agency.

  37. PMO-Section 7, Item 8p

    Is it acceptable for hand washing fixtures to drain to the floor in a milk processing room?

    Yes.

  38. PMO-Section 7, Item 12p

    Once raw milk storage tanks or silos have been cleaned, will re-sanitizing restart the "72 hour" window?

    No. The time restarts when milk enters the milk storage tank or silo following proper cleaning and sanitization.

  39. PMO-Section 7, Item 12p; and Appendix H

    What are the requirements for cleaning charts, if the traditional circular charts are not being used?

    Section 7, Item 12p, Administrative Procedure 2 of the PMO contains these requirements.

  40. PMO-Section 7, Item 15p(A); and Appendix L

    Is it legal to standardize the protein content in Grade "A" non-fat dry milk (NFDM)?

    No. The standard of identity for NFDM does not provide for this.

  41. PMO-Section 7, Item 15p(B); and IMS-a-44 (Proposal 130)

    What are acceptable alternatives to using pasteurized water for pushing or flushing pasteurized product?

    The acceptable alternatives to using pasteurized water include using water that has undergone an equivalent process found acceptable by the Food and Drug Administration (FDA) and the Regulatory Agency or that has undergone a hazard evaluation and safety assessment of the specific water supply and application involved. Should treatment be necessary, a protocol acceptable to the Regulatory Agency, in consultation with FDA, must be followed to ensure the water will not compromise the safety of the product.

    NOTE: In virtually all applications, some additional treatment of potable water will be necessary.

  42. PMO-Section 7, Item 16p(B); and Appendix H

    On a HTST System, is it acceptable to use a computer program or software switch for the "Product", "Inspect" or "CIP" mode switch?

    Yes. Provided it meets the applicable requirements of Appendix H, Part V., "CRITERIA FOR THE EVALUATION OF COMPUTERIZED SYSTEMS FOR GRADE 'A' PUBLIC HEALTH CONTROLS" of the PMO.

  43. PMO-Section 7, Item 16p(B); and Appendixes H and I

    When testing a two-speed HTST system, must a salt test also be performed on the low speed?

    Yes. If a plant processes a product requiring a minimum holding time longer than 15 seconds, i.e., eggnog at 25 seconds, and the HTST system has "dual set points" to allow processing at the low speed, the timing of the HTST System must also be tested at the low speed.

  44. PMO-Section 7, Item 16p(D)

    What is the correct procedure for measuring the height of a vacuum breaker on a HTST system twelve (12) inches (30.5 cm) above the highest raw milk in the system?

    Measure twelve (12) inches (30.5 cm) from the top of the highest raw line or vessel to the bottom of the horizontal pasteurized pipeline downstream from the regenerator and/or cooler section, which the vacuum breaker may be located or on which the vacuum breaker and its connecting vertical pipeline are connected.

  45. PMO-Appendix B

    When a tanker exceeds 72 hours between uses, the PMO requires it to be re-sanitized. Does it need to be re-sanitized at a permitted milk tank truck cleaning facility?

    Yes.

  46. PMO-Appendix J; and IMS-a-44 (Proposal 164)

    Plant "A" manufactures a metal collar, spring and check ball, which will become components of a spray nozzle for aerosol "Whipped Cream" cans. Plant "B" fabricates the plastic portion of the spray nozzle and assembles the plastic and metallic portions into the finished spray nozzle. Do Plants "A" and "B" need to be listed?

    No. We have previously accepted the use of spray nozzles that are made from safe materials to be manufactured in an unlisted source, if they are submerged in a sanitizing solution and drained just prior to being fitted onto the can. If the spray nozzle is to be applied without this sanitizing solution rinse, it and all component parts must come from listed sources.

  47. PMO-Appendix N; M-a-86 (Revision 3); and IMS-a-44 (Proposal 248)

    Is the following scenario possible under M-a-86: A bulk milk pick-up t anker load of milk is found to be presumptive positive with Test A, and the same bulk milk pick-up tanker load of milk is confirmed as a screening positive load with Test B. The producer trace back of the producers on that same bulk milk pick-up tanker is performed with Test C?

    Yes. Provided, the tests are approved and listed in the latest revision of M-a-85 and are equivalent as listed in the latest revision of M-I-96-10.

  48. DMO-Section 7, Preamble; MMSR; and M-I-86-16

    In a cheese plant that is IMS Listed for Grade "A" whey and whey products, where does the IMS listing start? At receiving or at the point where the curd and whey are separated?

    An IMS Listing would start at receiving and would also involve everything up to the point where the whey and curd are separated, including the pasteurization or heat-treatment of the raw milk for cheese making and any pasteurization of starter culture. The listing would continue on through the processing, handling and packaging of the whey and whey products.

    Section 7 of the DMO states: "Whey shall be from cheese made from Grade "A" raw milk for pasteurization provided in the PMO. Whey used in the manufacture of Grade "A" condensed and dry whey shall be produced in a cheese plant that complies with Items 1p, 2p, 3p, 4p, 5p including the requirements in Footnote g, 6p, 7p including the requirements in Footnote h, 8p, 9p, 10p, 11p, 12p, 13p, 14p, 15p, 17p, 20p, 21p and 22p as provided in the PMO.

    Whey shall be from: 1. Cheese made from Grade "A" raw milk for pasteurization, which has been pasteurized prior to use in accordance with Item 16p of the PMO; or 2. Cheese made from Grade "A" raw milk for pasteurization, which has been heat-treated to a temperature of a least 64°C (147°F) and held continuously at that temperature for at least 21 seconds or to at least 68°C (153°F) and held continuously at that temperature for at least 15 seconds, in equipment meeting the pasteurization requirements provided in the PMO. Provided, that this requirement shall not be construed as barring any other heat treatment process which has been recognized by the United States Public Health Service/Food and Drug Administration to be equally efficient in the destruction of staphylococcal organisms and which is approved by the State Regulatory Agency."

  49. MMSR-Item C

    During a rating, are pasteurization chart violations pro-rated?

    Yes.

  50. MMSR-Form FDA 2359i

    Is Block Three (3) of the 2359i for the home State of the firm or that State in which the rating takes place? For Example: Wisconsin Bulk Tank Unit (BTU) of Illinois Plant-does WI or IL go in Block Three (3)?

    Block Three (3) is for the State conducting the rating, and under which the BTU's Listing will be shown in the IMS List. In the example, Wisconsin would be the State listed in Block Three (3).

  51. MMSR-Form FDA 2359j

    Should Regional Milk Specialists (RMS's) and State Rating Officers (SRO's) be using the Report of Milk Sanitation Rating [Form FDA 2359j, Page One (1)]?

    RMS's often provide, in the form of a cover letter or written report, this same information to the State. In this case, the use of this form is optional. SRO's should use this form or provide similar information in a written report.

  52. MMSR-Form FDA 2359j, Dairy Farms-Part I and Appendix, Part I., Dairy Farms, Product Compliance

    If a farm milk sample is not taken within 21 days after a warning letter is issued, what is debited under the enforcement rating?

    That farm will be pro-rated, unless a single farm BTU, under Item 10, "Permit Issuance, Suspension, Revocation, Reinstatement, Hearings, and/or Court Actions, Taken as Required," on Dairy Farms, Part I, on Form FDA 2359j (Page 2), "Report of Enforcement Methods".
     

M-I-03-17
1

December 11, 2003