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Clarification of a Milk Plant’s and a Regulatory Agency’s PMO Requirements Related to the Temperature Exceptions Cited in Item 17p-Cooling of Milk and Milk Products and the Sampling Requirements of These Specifically Identified Milk and Milk Products in Item 17p as Addressed in Section 6-The Examination of Milk and Milk Products of the Grade “A” pasteurized Milk Ordinance (PMO)

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HHS:PHS:FDA:CFSAN:OFS:DPDFS:DEB:MST

5100 Paint Branch Parkway
College Park, MD 20740-3835

M-I-13-4

May 20, 2013

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

FROM: Dairy and Egg Branch (HFS-316)

SUBJECT: Clarification of a Milk Plant’s and a Regulatory Agency’s PMO Requirements Related to the Temperature Exceptions Cited in Item 17p-Cooling of Milk and Milk Products and the Sampling Requirements of These Specifically Identified Milk and Milk Products in Item 17p as Addressed in Section 6-The Examination of Milk and Milk Products of the Grade "A" Pasteurized Milk Ordinance (PMO)

Item 17p-Cooling of Milk and Milk Products of the PMO provides for cooling temperature exceptions for pasteurized milk and milk products from the PMO requirement of having to be cooled immediately prior to filling or packaging, in approved equipment, to a temperature of 7°C (45°F) or less, unless drying is commenced immediately after condensing, for specifically identified milk and/or milk products.  It also provides for cooling temperature exceptions for pasteurized milk and/or milk products from the PMO requirement of having to be stored at a temperature of 7°C (45°F) or less and maintained thereat following filling or until further processed for specifically identified milk and/or milk products. 

Following is a series of questions and answers related to the cooling temperature exceptions for specifically identified milk and milk products as cited in Item 17p of the PMO:

PMO-Section 7, Item 17p

  1. When a milk plant is utilizing one (1) of the packaging and cooling temperature exceptions cited within Item 17p of the PMO, is the Regulatory Agency required to verify that the milk plant is complying with the specified packaging and cooling temperature exceptions for the specific milk and/or milk product?

    Yes.  This verification may take place prior to the milk plant beginning their Item 17p packaging and cooling temperature exception operation(s), if the milk plant chooses to seek such Regulatory Agency verification, and the operation(s) shall then be reverified during every routine regulatory quarterly inspections.  However, if a milk plant chooses not to seek such prior verification, then the Regulatory Agency shall initially verify and subsequently reverify a milk plant’s Item 17p packaging and cooling temperature exception operation(s) during every routine regulatory quarterly inspection.

  2. What information/scientific documentation shall the milk plant have available for the Regulatory Agency to review for this required verification?

    Item 17p of the PMO cites specific critical milk and milk product formulation, pH, packaging, cooling temperature and cooling time criteria, etc. that shall be met to comply with the PMO.  The milk plant would be required to demonstrate and document to the satisfaction of the Regulatory Agency that the specific critical milk and/or milk product formulation, pH, packaging, cooling temperature and cooling time criteria, etc. are being met.  The scientific documentation shall address the following:

    • Product;
    • Formulation;
    • Processing steps;
    • Size of container(s);

      NOTE:  Item 17p of the PMO is very specific in relationship to container size for hot filled cottage cheese: (145°F (63°C) or above for containers of four (4) ounces (118 ml) or larger and 155°F (69°C) for containers of 2.9 ounces (85.6 ml)*.)

    • Initial pH at filling*;
    • Temperature at filling*, if applicable (hot or cold filled cottage cheese);
    • Concentration of potassium sorbate added*, if applicable (cold filled cottage cheese);
    • Concentration of a M-a-97 specified microbial inhibitor and/or preservative added*, if applicable (cold filled cottage cheese);
    • Intermediate pH after filling*, if applicable (yogurt products);
    • Intermediate cooling temperature after filling**, if applicable (hot and cold filled cottage cheese); and
    • Length of time after filling to cool to 45°F (7°C) or less**.

    *Critical factors including, but not limited to, pH, filling temperature, cooling times and temperatures, and potassium sorbate concentration or specified microbial inhibitors and/or preservatives, at the specified concentration as addressed in M-a-97, if applicable, shall be monitored and documented by the processing facility for verification by the Regulatory Agency. pH limit with a pH variance of + 0.05 units to account for reproducibility and inaccuracies in pH measurements. Formulation or processing changes that affect critical factors shall be communicated to the Regulatory Agency.

    ** Cooling temperatures monitored at the slowest cooling portion, i.e., in the middle of the container, of the slowest cooling container, i.e., in the middle of the pallet.

  3. Must this required Regulatory Agency verification be documented?

    Yes. This required Regulatory Agency verification process documentation shall be milk and/or milk product specific and shall outline the specific criteria that are being met to be in compliance with Item 17p of the PMO.

  4. If a milk plant changes formulation or processing that affects the critical factors is the milk plant required to receive Regulatory Agency verification prior to utilizing the changes in formulation and/or processing in relationship to the packaging and cooling temperature exceptions cited in Item 17p of the PMO?

    No.  However, the PMO requires that formulation and processing changes that affect critical factors shall be communicated to the Regulatory Agency.  The time frame for this communication shall be determined by the Regulatory Agency.

  5. Must required Regulatory Agency verification documentation be available to the Sanitation Rating Officer (SRO) and FDA Regional Milk Specialist (RMS) during ratings and check ratings, respectively?

    Yes.

  6. If required Regulatory Agency verification documentation is not available to the SRO or RMS during ratings or check ratings, respectively, what action is warranted to be taken by the SRO or RMS?

    Without this required Regulatory Agency verification documentation, the Regulatory Agency shall be debited under Part II-Milk Plant, Item 4-Requirements interpreted in accordance with PHS/FDA PMO as indicated by past inspections (Item 17p-5 points) on FORM FDA 2359j-Section B-Report of Enforcement Methods, Page.  This misinterpretation shall also be cited in their State Program Evaluation.

  7. During a rating or check rating, what elements of the required Regulatory Agency verification documentation shall be validated by the SRO or RMS?

    The milk plant shall maintain all of the formulation, process and scientific documentation that were provided to the Regulatory Agency for their required verification.  All of the scientific documentation shall be available to the SRO or RMS for their review so that they can validate that the process is in compliance with Item 17p of the PMO. 

    The SRO or RMS may have the milk plant determine the temperature, if applicable, and pH of the specific milk and/or milk product(s) at filling or make those determinations themselves.  For cottage cheese, the specific container size shall also be determined by the SRO or RMS.

  8. If during the SRO’s or RMS’s review of all of the milk plant’s and Regulatory Agency’s documentation and the physical determinations conducted in the milk plant, it is observed that the milk plant is not complying with All of the specific criteria cited in Item 17p of the PMO for the specific milk and/or milk products, what action is warranted to be taken by the SRO or RMS?

    The specific milk and/or milk product would not be in compliance with the temperature cooling exceptions cited within Item 17p of the PMO and would be in violation of Item 17p of the PMO.  The SRO or RMS shall immediately notify the Regulatory Agency of this violation of the temperature cooling exceptions of Item 17p of the PMO so that they can take the appropriate regulatory action.

  9. Critical factors addressing cooling temperatures state that they are to be monitored at the slowest cooling portion, i.e., in the middle of the container, of the slowest cooling container, i.e., in the middle of the pallet.  If a milk plant is filling different sized containers per specified milk and/or milk product(s) are they required to have cooling temperature data available for every size of container?

    No.  If their largest sized container meets the critical cooling temperature requirements for the specific milk and/or milk product(s), then the smaller sized containers will also meet the cooling temperature requirements of Item 17p of the PMO. 

    One (1) exception to the above statement is if the milk plant hot fills cottage cheese and packages it in containers of four (4) ounces or larger and also in containers of 2.9 ounces.  Then the milk plant would also be required to have the cooling temperature data for the 2.9 ounce container as required by the PMO. 

    Following is a series of questions and answers related to the sampling requirements of these specifically identified milk and/or milk products cited in Item 17p as addressed in Section 6-The Examination of Milk and Milk Products of the PMO:

PMO-Section 6

  1. For the specifically identified milk and/or milk products as cited in Item 17p of the PMO, i.e., cultured/acidified sour cream, yogurt, cultured buttermilk, and cottage cheese that are handled, filled and stored under the cooling temperature exceptions cited in Item 17p of the PMO, what shall the milk and/or milk product temperature be at for the collection of official regulatory samples by the Regulatory Agency as required in Section 6 of the PMO?

    The temperature of each specifically identified milk and/or milk product as cited in Item 17p of the PMO, i.e., cultured/acidified sour cream, yogurt, cultured buttermilk, and cottage cheese shall be at 45°F (7°C) or less at the time of collection by the Regulatory Agency.

  2. Would each specifically identified milk and/or milk product as cited in Item 17p of the PMO, i.e., cultured/acidified sour cream, yogurt, cultured buttermilk, and cottage cheese be required to have the actual temperature of the milk and/or milk products determined before an official regulatory sample can be collected by the Regulatory Agency and submitted for official regulatory analysis in an accredited NCIMS laboratory?

    Yes.

  3. What should the Regulatory Agency do if the milk and/or milk product temperature of the specifically identified milk and/or milk product as cited in Item 17p of the PMO, i.e., cultured/acidified sour cream, yogurt, cultured buttermilk, and cottage cheese is (are) not at 45°F (7°C) or less at the time that the Regulatory Agency is collecting official regulatory samples?

    They shall determine if the specifically identified milk and/or milk product as cited in Item 17p of the PMO, i.e., cultured/acidified sour cream, yogurt, cultured buttermilk, and cottage cheese, is within or has exceeded the specifically identified milk and/or milk product’s PMO required cooling after filling time frame(s). 

    • If the specifically identified milk and/or milk product is not at 45°F (7°C) or less, but is still within the PMO required cooling after filling time frame, then they shall not collect an official regulatory sample from this production run, lot or pallet.
    • Also, if the specifically identified milk and/or milk product has exceeded the PMO required cooling after filling time frame, including any intermediate PMO required cooling after filling time frame, but is at a temperature greater than 45°F (7°C), they shall not collect an official regulatory sample from this production run, lot or pallet; they shall immediately report the results to the milk plant; and take appropriate regulatory action to have the milk plant hold the milk and/or milk product until the Regulatory Agency has determined what the milk plant shall do with the temperature violative milk and/or milk product. 

    If this is observed during a regulatory inspection of the milk plant, Item 17p shall be debited on FORM FDA 2359-Milk Plant Inspection Report and this specifically identified milk and/or milk product temperature violation shall also be recorded on the official Regulatory Agency’s milk plant sampling/testing ledger for the specifically identified milk and/or milk product.

    If a regulatory inspection is not being conducted in conjunction with the Section 6 sample collection, this specifically identified milk and/or milk product temperature violation shall be immediately reported to the Regulatory Agency and recorded on the official Regulatory Agency’s milk plant sampling/testing ledger for the specifically identified milk and/or milk product.  The Regulatory Agency shall take appropriate regulatory action to have the milk plant hold the milk and/or milk product until the Regulatory Agency has determined what the milk plant shall do with the temperature violative milk and/or milk product. 

  4. If the milk and/or milk product temperature is at 45°F (7°C) or less at the time of collection, would each specifically identified milk and/or milk product as cited in Item 17p of the PMO, i.e., cultured/acidified sour cream, yogurt, cultured buttermilk, and cottage cheese be required to have a separate temperature control (TC) for each specifically identified milk and/or milk product that is collected by the Regulatory Agency for official Section 6 regulatory purposes?

    No.  Only a single TC is required in each shipping container for these finished milk and/or milk products. The TC shall be at least one half (1/2) the size of the largest sample container contained in each shipping container being sent for laboratory analysis. 

  5. Does the PMO provide for the sale of these specifically identified milk and/or milk products as cited in Item 17p of the PMO, i.e., cultured/acidified sour cream, yogurt, cultured buttermilk, and cottage cheese, if they are still within the specific PMO required cooling after filling time frame(s), but have not yet attained a temperature of 45°F (7°C) or less?

    No.  These specifically identified milk and/or milk products as cited in Item 17p of the PMO, i.e., cultured/acidified sour cream, yogurt, cultured buttermilk, and cottage cheese, are required to be at 45°F (7°C) or less before they are released from under the immediate control of the milk plant for distribution and sale to the consumer. 

  6. May a milk plant transport the specifically identified milk and/or milk product as cited in Item 17p of the PMO, i.e., cultured/acidified sour cream, yogurt, cultured buttermilk, and cottage cheese to a location under the immediate control of the milk plant that is off-site of the milk plant for the purposes of meeting the PMOrequired cooling after filling time frame(s)?

    Yes.  The Regulatory Agency shall be made aware of this off-site location so that official Section 6 regulatory samples can be collected at this location.

An electronic version of this memorandum is available for distribution to Regional Milk Specialists, Milk Regulatory Agencies and Sanitation Rating Officers in your region. The electronic version 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 at a later date.

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

/s/

Robert F. Hennes, RS, MPH
CAPT U.S. Public Health Service
Dairy and Egg Branch