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M-I-13-3: NCIMS Grade “A” Milk Safety Program Regulatory Agency Options for the Testing and Resealing of Public Health Controls and Adjustment Access Points on Pasteurization Equipment Following Notification from Milk Plant Personnel of a Broken or Removed Regulatory Seal(s)

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

5100 Paint Branch Parkway
College Park, MD 20740-383

M-I-13-3

May 29, 2013

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

FROM: Dairy and Egg Branch (HFS-316)

SUBJECT: NCIMS Grade “A” Milk Safety Program Regulatory Agency Options for the Testing and Resealing of Public Health Controls and Adjustment Access Points on Pasteurization Equipment Following Notification from Milk Plant Personnel of a Broken or Removed Regulatory Seal(s)
 

Regulatory seals shall be applied to pasteurization equipment’s public health controls and adjustment access points as described within the PMO, FDA equipment acceptance memos (M-b’s) and other FDA issued technical questions and answers. Regulatory seals are also required to be applied to points of access to computer programs used to control pasteurization equipment as described in Appendix H-Pasteurization Equipment and Procedures and Other Equipment, Section VI-Criteria for the Evaluation of Computerized Systems for Grade “A” Public Health Controls of the PMO.

NOTE:

  1. Required regulatory seals shall only be applied after testing and verification that the pasteurization equipment’s public health controls and adjustment access points secured by the regulatory seal are in compliance with the PMO.

  2. For the initial installation of pasteurization equipment, all required regulatory testing shall be completed and regulatory seals shall be in place before a pasteurization system is permitted to be used to process Grade “A” milk and/or milk products.

If a required regulatory seal(s) has been broken or re­moved by milk plant personnel, the appropriate Regulatory Agency shall be immediately notified by milk plant personnel; and such notification shall be appropriately documented and retained by the milk plant and the Regulatory Agency. The pasteurization system shall not be allowed to operate until the pasteurization equipment with the broken or removed regulatory seal(s) has been tested and resealed by the Regulatory Agency OR the milk plant is authorized by the Regulatory Agency to operate in compliance with one (1) of the NCIMS Grade “A” Milk Safety Program options cited below:

  • The Regulatory Agency shall test the pasteurization equipment before it is authorized to run, and if verified to be in compliance with the PMO, reseal the pasteurization equipment; or

  • If the Regulatory Agency is not able to retest and reseal the pasteurization equipment as required within the PMO and as described above, the Regulatory Agency has the option of individually evaluating and authorizing the milk plant to operate the pasteurization equipment with the stipulation that until the pasteurization equipment is tested and resealed by the Regulatory Agency such Grade “A” milk and/or milk products that are processed on the affected pasteurization system should not leave the immediate control of the milk plant.  This official authorization shall be appropriately documented by the Regulatory Agency and retained by the milk plant and the Regulatory Agency; or

NOTE:

When the pasteurization equipment is retested by the Regulatory Agency and the test results indicate a deviation from the PMO, the pasteurization system’s records shall be reviewed and evaluated by the Regulatory Agency.  If all applicable PMO pasteurization time, temperature and pressure requirements cannot be verified,  all Grade “A” milk and/or milk products, which were produced while the required regulatory seal(s) was (were) not in place and have not left the immediate control of the milk plant, may be required to be either repasteurized or destroyed.  Any such action, including any voluntary action taken by the milk plant, shall be officially documented and retained by the Regulatory Agency.  If such Grade “A” milk and/or milk products for which all applicable PMO pasteurization time, temperature and pressure requirements cannot be verified, which were produced while the required regulatory seal(s) was (were) not in place and the Grade “A” milk and/or milk products have left the immediate control of the milk plant, the Grade ”A” milk and/or milk products may be required by the Regulatory Agency to be recalled.

  • On an emergency basis, the Regulatory Agency has the option to authorize the pasteurization equipment to be tested and temporarily sealed by milk plant personnel provided the conditions cited in Item 16p(D)-Pasteurization Records, Equipment Tests and Examinations, 2-Equipment Tests and Examinations of the PMO are met.

NOTE:

This is commonly referred to as the “Industry Temporary Retesting and Resealing Program”; or

  • In the case of milk plants with HACCP Plans regulated under the NCIMS voluntary HACCP Program, the Regulatory Agency has the option to authorize the pasteurization equipment to be tested and sealed by milk plant personnel acceptable to the Regulatory Agency, provided the conditions cited in Item 16p(D)-Pasteurization Records, Equipment Tests and Examinations, 2-Equipment Tests and Examinations of the PMO are met.

With the utilization of any of the four (4) options cited above, Form FDA 2359b-Milk Plant Equipment Test Report or an equivalent Regulatory Agency Form shall be completed by the individual conducting the equipment testing, documenting all applicable tests related to the regulatory seal(s) being broken or removed that were conducted and their results.  This Form, along with the original notification of the broken or removed regulatory seal(s) shall be retained by the milk plant and the Regulatory Agency.  The applicable testing results shall also be documented on the required Regulatory Agency’s milk plant equipment testing ledger forms.  A computer or other information retrieval system may be used for these ledgers

NOTE:

If the pasteurization equipment has not been retested and resealed at the time of a regulatory inspection, a State rating, or an FDA check rating, and is found to have been operated without complying with one (1) of the four (4) NCIMS Grade “A: Milk Safety Program options cited above, the applicable portion(s) of Section 7-Standards for Grade “A” Milk and Milk Products, Item 16p-Pasteurization and Aseptic Processing and Packaging of the PMO shall be debited on FORM FDA 2359-Milk Plant Inspection Report.

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