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M-I-00-08: Questions and Answers from FY 2000 510-Special Problems in Milk Protection Courses

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

200 C Street, SW
Washington DC

M-I-00-08

December 18, 2000

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

FROM: Milk Safety Branch (HFS-626)

SUBJECT: Questions and Answers from FY 2000 510-Special Problems in Milk Protection Courses

Following are the questions and answers from the 510-Special Problems in Milk Protection Courses held in Madison, WI on August 21-25, 2000 and Baton Rouge, LA on September 11-15, 2000.

In accordance with procedures established through the National Conference on Interstate Milk Shipments, 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 judgement 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 is also available on the FDA Web site at http://www.fda.gov and should be widely distributed to representatives of the dairy industry and other interested parties.
 

Joseph M. Smucker, Chief
Milk Safety Branch
 

QUESTIONS AND ANSWERS

510 COURSES
MADISON, WI
AUGUST 21-25, 2000
and
BATON ROUGE, LA

SEPTEMBER 11-15, 2000

  1. PMO, Section 1-Definitions and Appendix L-Standards of Identity for Milk and Milk Products

    A Grade "A" plant (on a farm) is using a Reverse Osmosis (RO) process on unpasteurized whole milk. What Grade "A" products can contain this RO milk as an ingredient?

    In general, Grade "A" milk concentrated in RO equipment can be used as an ingredient in a Grade "A" milk product if the Standard of Identity for that product provides for the use of concentrated milk, or if the applicable section of the Standard of Identity for the product has been stayed. We have reviewed the Standards of Identity for yogurt, cottage cheese and sour cream and believe that milk concentrated, using an RO process, can be used in those product formulations.

  2. PMO, Sections 3-Permits and 5-Inspection of Dairy Farms and Milk Plants and Methods of Making Sanitation Ratings of Milk Shippers (MMSR)

    Do Grade "B" (Manufacturing) plants that wash Grade A tankers need to be IMS Listed or just quarterly inspected?

    Within the 1999 Revisions of MMSR and Procedures, there are no provisions for the IMS Listing of Milk Tank Truck Cleaning Facilities.

    With regard to inspection, yes, each Milk Tank Truck Cleaning Facility shall be inspected by the regulatory agency prior to the issuance of a Grade "A" permit and shall be inspected following the issuance of a permit at least once every 6 months. A Milk Tank Truck Cleaning Facility is "any place, premise, or establishment, separate from a milk plant, receiving or transfer station, where a milk tank truck is cleaned and sanitized". Each Milk Tank Truck Cleaning Facility shall hold a valid Grade "A" permit.

  3. PMO, Section 6-Examination of Milk and Milk Products

    Can the Delvo P 5 Pack test for detecting beta lactams be used with any fat level (fat free, 1%, reduced fat and whole) of chocolate milk or just fat free and whole chocolate milk as cited in M-I-99-3?

    The Delvo P 5 Pack test can be used for the detection of beta lactams with any fat level (fat free, 1%, reduced fat and whole) of chocolate milk.

  4. PMO, Section 6-Examination of Milk and Milk Products

    Can the Delvo P 5 Pack test for detecting beta lactams be used with any fat level (fat free, 1%, reduced fat and whole) of any flavored milk, other than chocolate milk?

    No. The Delvo P 5 Pack test has not been tested for the detection of beta lactams with any fat level (fat free, 1%, reduced fat and whole) of any flavored milk other than chocolate milk.

  5. PMO, Section 6-Examination of Milk and Milk Products, Appendix B-Milk Sampling (Universal Sampling) and Appendix N-Drug Residue Testing and Farm Surveillance

    Do the universal representative samples, taken at the individual farms, have to accompany the bulk milk pickup tanker to the receiving plant?

    Section 6 of the PMO states: "All samples shall be collected and delivered to a milk plant, receiving station, transfer station or other location approved by the regulatory agency." M-a-86 (Revised), Implementation Date-08/01/2000 states: "The representative sample(s) shall travel with the bulk milk pick-up tanker to a designated location acceptable to the State Regulatory Agency."

  6. PMO, Section 7, Items 1r-Abnormal Milk and 12r-Utensils and Equipment-Storage

    The 1999 NCIMS Conference moved the evaluation of Abnormal Milk Handling Equipment (i.e. "The Fresh Cow Bucket") to Item 1r which is a 5 point item. Many State and Industry people think that improper storage (of a reasonably clean fresh cow bucket) shouldn't be debited 5 points (use Professional Judgment) but instead choose to evaluate it under Item 12r(a)-Storage of Cleaned Equipment (2 points). I understand their intent, but I believe the Conference put everything for fresh cow buckets under Item 1r. What is correct?

    Evaluation of abnormal milk handling equipment was moved to Item 1r to deal with the issue of cow-to-cow transfer of infections. Therefore, cleaning, repair and drainage concerns regarding this equipment are evaluated under Item 1r. If storage of this equipment is contributing to a cleaning (housekeeping) concern in the milking area or milkhouse, this is evaluated under Item 3r or 6r, respectively.

  7. PMO, Section 7, Item 3r-Milking Barn, Stable or Parlor-Cleanliness or 6r-Milkhouse-Cleanliness

    Are milker claws stored in the parlor (exterior dirty) still marked under Item 6r(a)?

    Milker claws and all milking equipment is evaluated under Items 3r or 6r depending on whether it is located in the milking area or milkhouse, respectively.

    NOTE: This is a change from previous guidance and is intended to simplify evaluating the cleanliness of the outside of milking and related equipment.

  8. PMO, Section 7, Item 5r-Milkhouse-Construction and Facilities-Lighting and Ventilation (d)

    Is a light fixture over the milk tank opening still in violation of lighting fixtures properly installed, Item 5r-Lighting and Ventilation (d)?

    Yes

  9. PMO, Section 7, Items 5r-Milkhouse-Construction and Facilities-Miscellaneous Requirement (f) and 12p-Cleaning and Sanitizing of Containers and Equipment

    Under the provisions for the direct-shipped (loading) milk on milk tank trucks on the farm, without a shelter provided, where and how is the cleanliness of the tankers to be determined (the manhole must be sealed after the truck has been cleaned and sanitized)?

    The preferable method would be to inspect the trucks at the plant following cleaning and sanitizing and prior to the sealing of the manhole by the plant employee.

    NOTE: If the seal is missing from the manhole during storage or filling, at the farm, it would be debitable under Item 5r-Miscellaneous Requirements (f). It is the producer's responsibility to make sure the tanker is properly sealed prior to use.

  10. PMO, Section 7, Item 5r-Milkhouse-Construction and Facilities-Miscellaneous Requirement (f)

    Can a properly installed flow meter be used in place of the required liquid level sensor device for the milk tank trucks cited in Question 9?

    The requirement of the PMO to prevent the overflow of milk is to have the liquid level sensor device deactivate the milk pump or sound an alarmed when activated. If a piece of equipment can be installed to meet these requirements and be of sanitary design it would be acceptable.

  11. PMO, Section 7, Item 6r-Milkhouse-Cleanliness

    Is abnormal milk stored in the milkhouse, during non-milking times, still evaluated under Item 6r(b)?

    Yes

  12. PMO, Section 7, Item 8r-Water Supply

    Two (2) separate dairy farms are both on the same well. Should a water sample be taken from each milkhouse? The milkhouses are the points of use.

    If this distribution system does not have separate storage reservoirs or other unique features in the system, a single sample may be representative of the individual water system. The results from this single sample must be included in the records for each permitted dairy farm.

  13. PMO, Section 7, Item 9r-Utensils and Equipment-Construction

    Are rolled-on fittings on farm pipelines allowed or do they have to be welded as per 3A? (Are they to be debited?)

    Yes. Roll-on fittings are allowed and if in proper repair they are not debited.

    NOTE: Effective January 2001, 3A Practice #606- 3A Accepted Practices For The Design, Fabrication, and Installation of Milking and Milk Handling Equipment will not allow roll-on fittings in installations claiming to meet the requirements of this practice.

  14. PMO, Section 7, Item 12r-Utensils and Equipment -Storage

    Do single-service filters, stored in a properly protected and clean container, have to remain in their original box or can they be removed and placed in a separate container?

    This would be acceptable if the filters can be removed and stored in a sanitary manner and the container is kept clean and in good repair.

  15. PMO, Section 7, Item 14r-Protection from Contamination

    Is a full sized tee (same diameter as the uptake line), which is uncapped during milking, acceptable physical separation between the CIP and milk system? The uptake line extends below the flood level of the wash vat.

    FDA has not objected to this if the tee is appropriately located above the flood level of the wash vat.

  16. PMO, Section 7, Item 14r-Protection from Contamination

    A bulk milk tank is bulk headed into the milkhouse with the agitator located either outside or in an area that does not meet milkhouse standards. This agitator has a rubber boot or slinger cover to protect the opening through which the agitator shaft enters the tank. An appropriate sanitary seal or cover is needed to completely protect the opening and which extends from the bottom of the agitator motor support base to the outside surface of the bulk tank. Is it acceptable to use a cover or seal that is not manufactured by a tank manufacturer, i.e., a clear plastic cover, that is tight-fitting and adequately protects the opening and meets the requirements listed above? Does this cover have to be clear so that the boot or slinger can be visually observed?

    Yes, if it meets the conditions described below, either a manufacturer's cover or an appropriate cover, designed by the producer or installer, can be acceptable.

    We would recommend, but not require, that the cover be clear so that the boot or slinger can be observed and also to observe if the agitator motor is leaking oil.

    A cover used in place of a properly designed sanitary seal must adequately protect the agitator shaft opening into the tank. It must be tight fitting. It must be constructed to be easily accessible for inspection or must be clear so that visible inspection is possible. If special tools are needed to disassemble an opaque cover for inspection, they must be provided in or convenient to the milkhouse. Side seams, top and bottom fittings must be sealed or properly gasketed to make a tight seal. The surfaces inside the cover must meet product contact requirements, be constructed to free drain back into the tank and be kept clean.

  17. PMO, Section 7, Item 18r-Raw Milk Cooling

    If a farm installs a new bulk milk tank (manufactured after 1/1/2000) and does not have a temperature-recording device, where is this Item debited?

    Raw milk cooling would be debited under Item 18r(a)-Raw Milk Cooling. This Item should be evaluated during routine regulatory inspections; however, during state ratings and FDA check ratings this Item should not be debited until 12/01/2001.

  18. PMO, Section 7, Item 18r-Raw Milk Cooling

    When a recording chart is required under Item 18r and a dairyman does not maintain bulk milk tank temperature recording charts, where is this debited?

    This item would be debited under Item 18r(a)-Raw Milk Cooling. This Item should be evaluated during routine regulatory inspections. However, during state ratings and FDA check ratings this Item should not be debited until 12/01/2001. The 1999 Revision of the PMO 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."

  19. PMO, Section 7, Item 5p-Separate Rooms

    If a "Bossy" cart washer is located in the cooler and is creating a potential contamination problem to packaged milk and milk products that pass by it or are stored next to it, what Item would it be evaluated under?

    Item 5p-Separate Rooms

  20. PMO, Section 7, Item 12p-Cleaning and Sanitizing of Containers and Equipment

    If the milk tank truck(s), cited in Question 9, is determined to be dirty at the plant, where is the tanker debited, plant where washed or the farm where stored?

    As with other milk tank trucks delivering milk to the plant, they would be evaluated under the plant.

  21. PMO, Section 7, Item 12p-Cleaning and Sanitizing of Containers and Equipment

    If a milk storage tank (pasteurized, raw or heat-treated) exceeds the 72 hour requirement to be emptied and cleaned, where is it debited on Form FDA 2359-Milk Plant Inspection Report?

    Item 12(b)

  22. PMO, Section 7, Item 12p-Cleaning and Sanitizing of Containers and Equipment

    If the processing and packaging equipment does not meet the 24-hour cleaning and sanitizing requirement, where is it debited?

    Item 12p(a) and (c)

  23. PMO, Section 7, Item 12p-Cleaning and Sanitizing of Containers and Equipment

    Is a two (2) compartment wash vat required in the milk tank truck receiving area? Can plastic or stainless steel buckets be utilized for the cleaning of milk tank truck appurtenances in place of a two (2) compartment wash vat?

    Adequate facilities must be available if milk tank truck appurtenances are being manually washed in the receiving area. If the use of plastic or stainless steel buckets can adequately clean and sanitize these appurtenances then this would be acceptable. If not, then an appropriate two-(2) compartment wash vat would be required in the receiving area.

  24. PMO, Section 7, Item 12p-Cleaning and Sanitizing of Containers and Equipment

    A pasteurized product tank is used as a surge tank (putting product in and pulling product out throughout the day) and at the end of the day product is put in the tank and stored for the next day's packaging. When does this tank need to be cleaned?

    This tank would need to be properly cleaned and sanitized after its use as a surge tank and prior to product being put into the tank for storage purposes.

  25. PMO, Section 7, Item 16p-Pasteurization and Aseptic Processing

    Has FDA looked at the possibility of "cold pasteurization" of milk?

    Yes. To date, FDA has not found an acceptable method.

  26. PMO-Section 7, Item 17p-Cooling of Milk

    M-I-00-7 (Question 12)-Can Grade "A" cottage cheese be filled "hot" (over 45° F)? The PMO clearly states that pasteurized milk and milk products except those to be cultured, are cooled immediately to 45° F or less in approved equipment...

    FDA has evaluated one "hot fill" process for cottage cheese and accepted the practice as safe.

    Please define the "hot fill" (temperature requirements) process that has been acceptable?

    The details of the one process that has been evaluated and accepted are proprietary and are not releasable. Any new processes or variations of the process should be evaluated on a case-by-case basis.

  27. PMO, Appendix I, Test 11

    What is the proper method for determining the holding time on a steam injected HHST pasteurizer?

    Minimum holding tube length, normally based on pumping rate and holding tube diameter, is determined in place of holding time using the appropriate Subsection of PMO, Appendix I, Test 11.

  28. PMO, Appendix N-Regulatory Responsibilities

    Concern: M-a-79 states in the question and answer section at the top of page 2: "Once AOAC reviewed and FDA accepted methods are available, methods shall be appropriate for the drug being analyzed, and shall be capable of detecting the same drugs at the same concentrations as the methods being used by the industry."

    What methods should be used to analyze these bulk milk pickup tanker audit samples (10% quarterly regulatory sampling) by the regulatory agency? Since the wording states "same drugs" and "same concentrations" then isn't it required to be the "same" test?

    NOTE: As was stated recently by FDA: "What must be considered is what is actually stated and not the intent of the item." The word "equivalent" does not exist in this section of the document.

    Ideally the regulatory agency would use the same test kit as being used by industry. However, FDA has allowed any test kit from M-I-96-10 to be used that detects the same drugs.

    Proposed wording for M-a-79 (Revision #2), August 11, 2000: "Methods used shall be appropriate for the drug being analyzed, and shall be capable of detecting the same drugs at or below the safe level or tolerance as the method being used by industry." (See the latest revision of M-I-96-10.)

    This regulatory agency analysis to audit industry farm bulk milk tanker programs shall be performed in an Official or Officially Designated Laboratory using a method from the latest revision of M-a-85.

  29. MMSR, Section C-Rating Methods for Milk Plants

    This section allows for the prorating of deficiencies in a milk plant that affects only one type of packaging (paper, glass, single-service plastics, multi-use plastics, dispenser, cottage cheese, sour cream or yogurt containers); or the capping of these containers. Only the quantity of all products affected by the deficiency, rather than the entire plant daily production is recorded and used in the computation of the plant sanitation compliance rating. Can you prorate by a specific type of paper machine, i.e., that machine only does a specific type of paper container (Slim Line cartons) or only does school milk size cartons?

    Yes. You can prorate deficiencies that apply to only one type of paper package. When a deficiency in a milk plant effects only one type of packaging or capping, only the quantity (number of pounds) of all products affected by the deficiency are debited and recorded for use in the computation of the plant sanitation compliance rating.

  30. Procedures, Section IV., B-State Responsibilities

    Following a check rating that indicates that a re-rating (Producer Dairies-Raw Milk) or a reinspection (Milk Plants, Receiving Stations and/or Transfer Stations) is required, what date is used when determining a re-rating within sixty (60) days or a reinspection within thirty (30) days is due? Is it the first day of the check rating, last day of the check rating or the day that the State Rating Agency is formally notified?

    The date that the State Rating Agency is formally notified should be the date that you use to determine when a re-rating (within sixty (60)) or a reinspection (within thirty (30)) is due.

  31. Procedures, Section IV., B-State Responsibilities

    What does it mean when a re-rating of an IMS Listed BTU is due from a change in status because of a "significant change in number of producers"?

    FDA considers that a significant change has occurred when a 25% or higher (increase or decrease) in the total number of producers within a BTU has occurred.

  32. SSCC, IMS Listing Requirement and Section C-Bacteriological Examination

    What are the listing and sampling requirements for PET bottle manufacturers (pre-formed at one plant and then finally molded at a second plant)?

    In the second molding step, the temperature of the bottle in the neck and thread areas may not reach high enough temperatures to destroy microorganisms. Thus the following requirements apply:

    1. The first pre-forming plant must be listed, but sampling of the containers is not required at this plant.
    2. If the first pre-forming plant is also molding the containers into their final form, this plant must be listed and the containers must be sampled at this plant.
    3. If the second plant, where containers are molded into their final form, is a single service container manufacturer, this plant must be listed and the containers must be sampled at this plant.
    4. If the second plant is a milk plant where containers are molded into their final form, for use only in that milk plant, this milk plant listing is sufficient, but the containers must be sampled at this plant.

    The appropriate test, such as the rinse test, must be conducted in order to detect any contamination in the neck of the bottle.