HHS:PHS:FDA:CFSAN:OFS:DDEMP:MMPB 5001 Campus Drive College Park, MD 20740-3835 January 29, 2020 IMS-a-52 (Revised) To: Director, Office of State Cooperative Programs Attn: All Staff, Division of Milk Safety From: Milk and Milk Products Branch (HFS-316) Subject: Actions of the 2019 National Conference on Interstate Milk Shipments The 37th National Conference on Interstate Milk Shipments (NCIMS) was held in Saint Louis, Missouri, April 26-May 1, 2019. A total of seven-five (75) Proposals were submitted and deliberated at the Conference. During the Conference, the State delegates approved several changes to the Grade “A” Pasteurized Milk Ordinance (PMO) and related NCIMS documents. Following is a table showing the Actions taken by the voting delegates: # OF NO PASSED AS PASSED AS TABLED COUNCIL PROPOSALS ACTION SUBMITTED AMENDED I 23 12 6 5 0 II 42 23 6 13 0 3-Sent to 2400 2-Sent to 2400 Forms Protocol Forms Protocol III 8 1 2 5 0 JOINT 2 0 0 2 0 COUNCIL TOTAL 75 36 14 25 0 3-Sent to 2400 2-Sent to 2400 Forms Protocol Forms Protocol The following Proposals were passed and addressed changes to the PMO: 106, 108, 109, 111, 113, 117, 118, 120, 122, 203, 205, 206 (FDA originally non-concurred), 207, 208, 210 (FDA originally non-concurred), 211 (FDA originally non-concurred), 215, 216, 301, 308, JC-1(FDA originally non-concurred) and JC-2. The following Proposals were passed and addressed changes to the Procedures Governing the Cooperative State-Public Health Service/Food and Drug Administration Program of the National Conference on Interstate Milk Shipments (Procedures): 303, 304, 305, 306, 307, 308 (Identified as Procedures changes). JC-1 and JC-2 (Identified as a new Procedure). _____________________________________________________________________________ IMS-a-52 (Revised) 1 January 24, 2020 The following Proposals were passed and addressed changes to the Methods of Making Sanitation Ratings of Milk Shippers and the Certifications/Listings of Single-Service Containers and/or Closures for Milk and/or Milk Products Manufacturers (MMSR): 215, JC-1, and JC-2. The following Proposals were passed and addressed changes to the Constitution and/or the Bylaws of the National Conference on Interstate Milk Shipments (Constitution and Bylaws): 304. The following Proposals were passed and addressed changes to the Evaluation of Milk Laboratories (EML): 223, 306, and JC-2. The following Proposals were identified as FDA/NCIMS 2400 Forms and were voted on as a block to be handled by FDA and the NCIMS Laboratory Committee following the procedures for issuing and updating FDA/NCIMS 2400 Forms: 230, 234, 238, 239, and 241. The following Proposals identified the development of new FDA/NCIMS 2400 Forms or changes to FDA/NCIMS 2400 Forms and were not voted on as a block to be handled by FDA and the NCIMS Laboratory Committee following the procedures for issuing and updating FDA 2400 Forms: 228, 229 and 240. The following Proposals were passed and addressed changes to the inspection forms utilized in the Program and a new form introducing critical listing element for fermented high-acid milk and or milk products: 301 and JC-2 • FORM FDA 2359m-MILK PLANT, RECEIVING STATION OR TRANSFER STATION NCIMS HACCP SYSTEM AUDIT REPORT (10/13) Proposal 301 • FORM FDA 2359q-NCIMS ASEPTIC PROGRAM COMMITTEE-CRITICAL LISTING ELEMENTS Proposal JC-2 The following Proposals were passed and will be assigned to a Standing Committee, ad hoc Committee, Special Assignment Committee or the development of a Pilot Program: Joint Council (JC) Proposal-1: The Liaison Committee requests the Chair to assign this proposal to an NCIMS standing committee, special committee, or ad hoc committee as approved by the NCIMS Executive Board. The assigned committee is charged to work cooperatively with FDA to develop a pilot program which will establish a regulatory framework to find efficiencies in inspection activities for facilities that manufacture both Grade “A” and non-Grade “A” products and be implemented by FDA and the participating States. In developing the details of the inspectional model(s) to pilot, the assigned committee will, at least, consider: the regulatory authorities of state regulatory agencies, the eligibility criteria for pilot consideration, the types of non-Grade “A” products manufactured in dual-grade facilities, the resource needs and potential hurdles likely to be encountered, and the metrics for evaluating success. _____________________________________________________________________________ IMS-a-52 (Revised) 2 January 24, 2020 When implemented, the pilot program will meet the Agency’s commitment to the NCIMS of identifying additional ways to maximize state and federal resources and to create greater efficiencies through its obligations under the FDA Food Safety Modernization Act while maintaining the high safety of the U.S. milk supply. FDA shall inform and confer with the assigned committee to answer questions and address concerns to provide clarity and transparency at a frequency determined by the NCIMS Executive Board. A complete report of the pilot program will be shared at the 2021 Conference. In recognition that FDA is strongly committed to developing and implementing the dairy inspection pilot program and stands ready to work in a collaborative spirit on the framework for this pilot program immediately with the assigned committee, the Liaison Committee requests an effective date of the receipt and acceptance of FDA concurrence at the next NCIMS Executive Board meeting after the Conference. Proposal 112: The NCIMS Chairman shall assign to either a standing committee or an ad hoc committee, with input from affected stakeholders, the responsibility of reviewing the NCIMS role in regulating the repackaging of yogurt, sour cream, acidified sour cream and cultured milk and/or milk products and report to the 2021 NCIMS Conference. Note: This proposal was passed as amended as a substitute solution. Proposal 114: This proposal requests the NCIMS Chair assign an NCIMS standing committee, special committee, or ad hoc committee as approved by the NCIMS Executive Board to study the safety of water used in the dairy industry, including technologies to produce disinfected and/or Pasteurized Equivalent Water as prescribed in Section VII, Appendix D. and Appendix H. and report back to the 2021 NCIMS conference. Note: This proposal was passed as amended substitute solution. Proposal 212: This proposal directs the NCIMS Hauling Procedures Committee to conduct a comprehensive review of FDA Form 2399a and report back to the 2021 Conference. The following Proposals were passed and are of significance to the Grade “A” Milk Safety Program: Joint Council (JC) Proposal 2: Contains modifications to the PMO, Methods, Procedures, Bylaws and EML documents that address the regulation and rating of milk plants producing Grade “A” fermented high-acid, shelf-stable milk and/or milk products. These products are produced by fermentation using live and active cultures and then processed and packaged on equipment that is utilized to produce aseptic low-acid food products which have a Low Acid Canned Foods (LACF) filing as required by 21 CFR 113 or which are processed and packaged in accordance with all applicable provisions of the PMO to achieve shelf stability and then stored and distributed under normal non-refrigerated conditions. _____________________________________________________________________________ IMS-a-52 (Revised) 3 January 24, 2020 Proposal 118: This proposal incorporated Appendix Q. requirements for the operation of automatic milking installations (AMIs) into Section 7, STANDARDS FOR GRADE “A” RAW MILK FOR PASTEURIZATION, ULTRA-PASTEURIZATION, ASEPTIC PROCESSING AND PACKAGING OR RETORT PROCESSING AFTER PACKAGING. Revised Appendix Q. GENERAL REQUIREMENTS FOR AMI COMPUTER SYSTEMS and incorporated the AMI computer control requirements into Appendix H. As a result, Appendix Q. requirements were deleted in its entirety. FDA responded in writing to the NCIMS Conference Chair on August 20, 2019 and met with the NCIMS Executive Board on October 23-24, 2019 concerning the Proposals passed during the 2019 Conference. Within FDA’s letter dated August 20, 2019, FDA concurred with all the passed Proposals except for Proposals 206, JC-1, 210, and 211. 206: FDA originally non-concurred with this Proposal because the Proposal is fundamentally flawed and cannot be fixed with minor editorial corrections. FDA understands this proposal was well-intentioned to resolve confusion created by inconsistencies between the FDA/NCIMS 2400 form and other conference documents. However, as written the text on page 29 and 30 can be interpreted to mean that all sampling procedures, including the use of approved in-line samplers and approved aseptic samplers for milk tank trucks or for farm bulk milk tanks and/or silos shall be in substantial compliance with FDA/NCIMS 2400 Forms. It would be further interpreted that if there was a discrepancy between SMEDP and the FDA/NCIMS 2400 Forms, the FDA/NCIMS Forms would have primacy in resolving issues related to sampling procedures, including the use of approved in-line samplers and approved aseptic samplers for milk tank trucks or for farm bulk milk tanks and/or silos. FDA/NCIMS 2400 Forms are specific to sample analysis and laboratory techniques, not sampling procedures. The PMO, Appendix B. and the SMEDP establish sampling procedure requirements. In addition, FDA Forms 2399 and 2399a are used when evaluating sampling procedures, not the FDA/NCIMS 2400 Forms. During the October 23-24, 2019 NCIMS Executive Board meeting, FDA and the Executive Board did not reach mutual concurrence with Proposal 206; therefore Proposal 206 in accordance with Section X-Application of Conference Agreements, A-Implementation of Changes 4, of the Procedures will be referred to the next Conference for discussion JC-1: FDA originally non-concurred with this Proposal because as written Appendix T. compliance would have to be determined once every thirty-six (36) months by a federal check rating or by a state rating.