Regulatory Register - 2023 NCIMS Special Edition

Regulatory Register

2023 NCIMS Special Edition

Dairy stakeholders met to address 72 proposals submitted to revise the Pasteurized Milk Ordinance (PMO) and its related documents at the National Conference on Interstate Milk Shipments (NCIMS) April 3-7 in Indianapolis.

National Milk Producers Federation (NMPF) staff attended the conference to advocate for dairy cooperatives and their producer members. Many NMPF members also attended and played key roles in conference deliberations, which featured more than 400 attendees -- a record -- after taking a four-year hiatus due to the COVID-19 pandemic. NMPF was pleased with many of the outcomes of the proposals and made significant progress in achieving reasonable solutions on many key issues.

A chart with the final outcomes for all proposals is included at the end. Please note that the listed outcomes represent NMPF staff record and are subject to change based on official 2023 NCIMS Meeting Transcript.

The conference once again highlighted the successful collaboration between the U.S. Public Health Service/Food and Drug Administration, state regulators and dairy industry representatives to promote and protect a safe supply of Grade A milk and milk products. All proposals relate to the 2019 Pasteurized Milk Ordinance (PMO), the 2019 Methods of Making Sanitation Ratings of Milk Shippers, the 2019 Evaluation of Milk Laboratories, and the 2017 Procedures Governing the Cooperative State-Public Health Service/Food and Drug Administration Program for Certification of Interstate Milk Shippers (Procedures) document. This issue details significant proposals affecting dairy cooperatives and producers.

Delegates approved 40 proposals either as submitted or as amended. Below is a summary of some of the significant actions that occurred at the 2023 NCIMS Conference. It’s important to note that proposals do not need to pass the conference to attain practical solutions. Success can be achieved by raising the issue to the attention of conference participants, by generating discussion, or by obtaining formal answers and gaining consensus of all stakeholders. By this measure, each NMPF-submitted proposal achieved a positive outcome.

One highlight from the conference that didn’t include a proposal was an overview from FDA on how it plans to handle M-Is. The agency has begun the long process of going through all of the M-Is, which provide administrative and miscellaneous information, by splitting them in to three categories- 1) They meet the M-I definition; 2) They are related to a conference proposal; and 3) They don’t meet the definition of an M-I. M-Is do not create program requirements and do not convey agency interpretation.

M-Is related to conference proposals will sunset this October; M-Is which do not meet the definition of an M-I will sunset in Oct. 2025. For future questions, FDA will provide direct responses, not publish compilations and FDA responses will not include interpretations. This issue was initiated by an inquiry from NMPF on behalf of our members regarding an M-I impacting the transfer of ownership of a Grade A dairy processing facility.

NMPF submitted three proposals at this conference – all of which had positive outcomes.

Proposal 207

Proposal 207 would require a 48-hour notice prior to on-farm inspection. Reasons for this include the risks to human health following the COVID-19 pandemic, the farm’s biosecurity and overall personnel safety. The proposal was amended at the conference and passed through the delegates to be assigned to a standing or ad-hoc committee to review sections 8, 13, and 14 of the PMO. This is an important first step in recognizing the importance of biosecurity measures on dairy farms and will hopefully lead to further discussion of inspection notices.

Proposal 301

Proposal 301 provided a definition of equivalence for the USPHS/FDA responsibility to determine whether a foreign country’s regulatory program and government oversight of that program has an equivalent effect on the safety of the regulated milk or milk product. The term “equivalence” is important for international trade; unfortunately, the PMO has long lacked a definition. This proposal passed through the delegates as amended to include a plain language definition in line with that of the World Trade Organization. Defining equivalence provides clarity for industry, state and Federal stakeholders about foreign countries’ obligations to participate in the PMO. This proposal reinforces the importance of transparency when analyzing equivalence for foreign countries.

Proposal 302

Proposal 302 was voted no action as 301 was decided to be the proper pathway for equivalence.

Proposal 105

Proposal 105, submitted by the Michigan Milk Producers Association, would require installation of a non-invasive means of determining the temperature of the milk in milk tank trucks used for direct loading of milk. The proposal was amended to be assigned to the Milk Hauling Procedures Committee, as approved by the NCIMS Executive Board, to review section 5r of the 2019 PMO for those provisions related to the sampling and transporting of raw milk products. The proposal was passed as amended by the delegates.

Proposal 112

Proposal 112, submitted by Darigold, Inc., proposed to exempt the requirement of pasteurizing prior to the entrance into an RO Membrane Filtration system for liquid buttermilk coming off a butter churn that will be bulk shipped and further processed at another facility. FDA informed the delegates that this process is already allowed under existing regulations; therefore, the delegates voted no action on this proposal.

Proposal 218

Proposal 218, submitted by the Methods for Making Sanitation Ratings committee, backed eliminating the evaluation of a milking time inspection program from the calculation of enforcement ratings for dairy farms. The justification for removing the milking time inspection program was that it wasn’t being done, giving dairy farms an automatic credit of five points. The proposal passed as amended through the delegates to evenly redistribute the weight of those five points among the remaining items evaluated when calculating the enforcement rating score for dairy farms.

Proposal 311

Proposal 311, submitted by the NCIMS Aseptic Committee, proposes formalizing the NCIMS Aseptic Program Committee (APC) as a standing committee in accordance with the NCIMS Constitution and Bylaws and was passed as submitted by the Delegates.

Proposal JC-4

Proposal JC-4, submitted by the NCIMS Liaison Committee and FDA, proposed changing the enforcement outcome of a milk plant not being in substantial compliance with Appendix T. According to the current procedures, if a milk plant is not in compliance with Appendix T and is subsequently not in compliance with Appendix T during the re-inspection, the milk plant is removed from the IMS List. After discussions between the NCIMS Liaison Committee and FDA, it is proposed to remove the potential for delisting the facility and that a written plan of correction which is determined to be acceptable by the state and FDA. This proposal was passed as amended by the delegates.

Elections and Leadership Changes

Antone Mickelson, Northwest Dairy Association and the chair of NMPF’s NCIMS Committee, was re-elected to his industry spot for the Western States on the NCIMS Executive Board and as Vice Chair of the Conference. After 12 years, Dr. Stephen Beam with the California Department of Food and Agriculture completed his terms as Chair of NCIMS. Subsequently, Casey McCue with New York State Department of Ag. And Markets was elected the new Chair of NCIMS.

For the open central states seats on the Executive Board, the state delegates approved Brian Wise, Ohio Dept. of Agriculture- Dairy Division, Nathan Campbell, Indiana State Board of Animal Health, and Barb Koeltzow, Michigan Department of Agriculture and Rural Development to fill those seats. For the open western state seats, in addition to Antone Mickelson filling the industry seat, Sofia Stifflemire, Texas Department of Health Services, Dustin Cox, New Mexico Department of Agriculture and Gena Reich, Washington State Department of Agriculture were approved by the state delegates.

Hall of Fame Induction

John Sanford, DFA Dairy Brands, was recognized for his outstanding service to the conference by being inducted into the NCIMS Hall of Fame. John has participated in twenty-one NCIMS meetings including 28 years as the Voting Delegate for Tennessee, and more than a decade as an industry participant for Dean Foods and now DFA Dairy Brands. For more than 30 years, his valuable knowledge, expertise, and leadership has been observed on the Single Service Containers and Closures Committee, Methods of Making Sanitation Ratings Committee, and the Appendix N Modification Study Committee. John also served six-year terms on the NCIMS Executive Board. His expertise and knowledge have been integral to the success of the conference’s mission- to continue to protect the milk supply and prevent the incidence of milkborne illness in the United States.

Next Conference

The next NCIMS conference will be held in 2025 in Minneapolis. For further information, please feel free to contact Clay Detlefsen, Jamie Jonker or Miquela Hanselman.

NCIMS 2023 Preliminary Results

The following is a list of the proposals and the final action by the NCIMS voting delegates.

**Outcomes represent NMPF staff record and are subject to change based on official NCIMS Meeting Transcript and October 2023 NCIMS Executive Board Meeting.**

JC-1

PMO: pg. 48, 168, 221

JC-2 2019 PMO Section 7 page 62, 82, 89, 391, 395, MMSR 50, 80 and 81 and FORMS

2359 and 2359L

JC-3 PMO xvii, 62, 389- 391, MMSR 20-21

P=Passed

PA= Passed as Amended

NA= No Ac�on

To align the requirements for water sampling across Section 7, Appendix D, and Appendix G of the 2019 PMO.

This proposal will create a stand-alone element specific for “Animal Food” as item 15p.(C) Animal Food – Holding and Distribution as a 1-point debit by taking 1 point from item 22p. Surroundings. This proposal will move the requirements for allergen controls into item 15p.(A).

To modify coordinating wording in PMO Section 7, Appendix S, and the MMSR to clarify references to the ASEPTIC PROCESSING AND PACKAGING PROGRAM, RETORT PROCESSED AFTER PACKAGING PROGRAM AND FERMENTED HIGH-ACID, SHELFSTABLE PROCESSING AND PACKAGING PROGRAM GRADE “A” PMO/CFR COMPARISON SUMMARY REFERENCE table to correct editorial omissions from Proposal JC-2 at the 2019 NCIMS Conference. A numerical reference will be added to the table for clarity.

PA

This proposal changes the enforcement outcome of a milk plant not being in substantial compliance with Appendix T. According to the current Procedures, if a milk plant is not in compliance with Appendix T and is subsequently not in compliance with Appendix T during the re-inspection, the milk plant is removed from the IMS List. After discussions between the NCIMS Liaison Committee and Key

FDA, it is proposed to remove the potential for delisting the facility; a plan of correction to be implemented by the facility will be jointly developed with FDA and the State. JC-5

This proposal is to modify the language in the 2019 Procedures and 2019 MMSR regarding the expiration dates for individual and area ratings to include 24 months plus the remaining days of the month.

101

102

103 PMO: pg 33

This proposal establishes an NCIMS Study Committee to identify and develop appropriate strategies to prevent contamination of Grade “A” milk and/or milk products with chemical sanitizers.

Request the Chair of NCIMS allow the formation of a study committee within the Technical Engineering Review Committee to examine applicable sections of the PMO for correctness and appropriateness of requirements and testing with respect to steam infusion and steam injection continuous flow pasteurization systems

To remove the words “integral therewith” from Section 7, paragraph 2, page 33 of the 2019 PMO and replace them with the words “and equipment incorporated within these processes”, which clarifies and confirms that other equipment and processes may be included within a complete pasteurization or ultrapasteurization system, provided that such other equipment and processes do not influence the required time, temperature, flow and pressure relationships in the pasteurization or ultrapasteurization system.

104

PMO: pg 33

This proposal request is for a change to Section 7 paragraph 2 on page 33 of the 2019 PMO, to change the wording as follows: No process or manipulation other than pasteurization, ultrapasteurization, aseptic processing and packaging, or retort processed after packaging or fermented high-acid, shelf-stable processing and packaging; processing methods integral therewith (remove this) processing equipment, and processes incorporated within

PMO: pg. 4045

This proposal requires the installation of a non-invasive means of determining the temperature of the milk in milk tank trucks used for direct loading of milk. It is the goal of the proposal that all new milk tank trucks manufactured after January 1, 2023 that are used for direct loading of milk shall be equipped with a non-invasive means of determining the temperature of the milk in the milk tank truck.

106 PMO: pg. 52

Proposes to modify Item 12r in the 2019 PMO to provide definition around positive ventilation in an AMI installation and provide exception for this requirement in instances where it may not be necessary like the installation being separated from the housing unit or modification to the requirement in freezing temperatures.

107 PMO: pg. 55& 85, sec. 7

Make the clauses regarding overrides in Section 7 Item 15p.(B) and Item 14r (separation of product from cleaning and sanitizing solutions) read the same and clarify the exception.

108 PMO: pg. 5657, sec. 7

This proposal incorporates previously issued information (M-I-065) on Item 15r of the Grade “A” Pasteurized Milk Ordinance (PMO) addressing drug labeling, use and storage requirements and inspectional areas into Item 15r of the PMO.

109 PMO: pgs. 78, 336, sec. 7, app. J: 2400

Forms

110 PMO: TOC, pg 84, 86, Index, Sec. 7, 15p

To align the reporting requirements for pasteurized milk containers across 12P. and Appendix J of the 2019 PMO and the 2400i pasteurized milk containers, closures and packaging IMS #22 (PMC) form.

The purpose of this proposal is to update the language in Item 15(p) that addresses the safety of water in contact with pasteurized products to contain an option that allows the use of a hazard analysis, risk evaluation, and validation approach to assessing the safety of a proposed treatment or process for rendering the water safe for use in contact with pasteurized products. Implementation of such treatments or processes would require the plant to demonstrate that critical operating parameters are met, and that the approach adequately addresses pathogens of concern.

111 PMO: pg. 85, 7 item 15p.

This proposal also adjusts the terminology used to described water that contacts pasteurized products to reduce confusion with the term “Pasteurized” and the standards used for pasteurizing milk and milk products using heat treatment. The proposed terminology would consistently use the phrase “water in contact with pasteurized products” as an alternative to the current language in the PMO.

Proposes to allow use in additional system designs of an alarmed steam block to effectively separate pipelines and equipment, used to contain or conduct milk and/or milk products. from tanks/silos and/or circuits containing cleaning and/or sanitizing solutions.

112 PMO: Pg. 92 Proposes to allow the exemption of the requirement of pasteurizing prior to the entrance into an RO Membrane Filtration system for liquid Buttermilk coming off a butter churn that will be bulk shipped and further processed at another facility.

NA- FDA informed the delegates that this process is already allowed under existing regulations therefore the delegates voted no action on this proposal.

113 PMO: Pg. 98

Proposes to allow use of an FDD located after the regenerator and/or cooler section in additional continuous pasteurization system designs.

114 PMO: TOC, 7 Item 16p.(B) & (D), Appendix H, I

Proposal 117, which was accepted at the 2019 Conference, removed the use of the terms HTST and HHST to indicate the location of the FDD in a continuous pasteurization system from most of Item 16(p)(B) and (C) and Appendix H. This proposal makes the same changes to Appendix I, Item 16(p)(D) Table 4, one place in Item 16p.(B), and additional sections of Appendix H.

115 PMO: 111, 112, 114, sec. 7

To provide clarification by the addition of kefir as a cultured milk product and provide a defined product exemption under Item 17p for cooling.

117

PMO: 111, 113228-230, Sec. 7, Item 16p (B), app. H

PMO: Pg. 118, sec. 7

To allow use of separators and liquid ingredient injection within all continuous pasteurization systems

118

PMO: 181182, 281-282, App. D, H

To allow for the transportation of yogurt in sealed container from the original Grade “A” plant where pasteurization occurred to another regulated under Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (21 CFR 117), solely for purposes of addition of fruit and packaging as is allowed for cottage cheese

The purpose of this proposal is to adjust the dose standards and other criteria used to determine the acceptability of a UV water treatment system for use in the Grade A Dairy industry so that they more closely align with the scientifically valid parameters and treatment levels needed to address pathogens that may be of concern for water in contact with milk and milk products

119

PMO: 233, 324, App. H, I

Addition of Test 11.6 and Modification of “Placement of Components” (Appendix H page 233), to address technology improvements in production equipment.

Test 11.5 in the 2019 PMO is specific to one type of Steam Infusion System, containing specific components (steam pop-off relief valve, fixed orifice piece). Recommending to add an alternative Test 11.6 to allow testing of Steam Infusion Systems that do not contain the specific components detailed in test 11.5.

120

PMO: Pg 282283, Sec. 4, App. H

The purpose of this proposal is to include membrane microfiltration technology in Appendix H. Section IX as an acceptable method to produce Pasteurized Equivalent Water (PEW). Membrane microfiltration physically removes microorganisms at a high efficiency (7 log reduction at 0.2 micron) from the process stream and can be used to produce PEW in conjunction with or as a substitute for UV technology.

121 PMO: pg. 286, App. I

To align the requirements of Appendix I test 1 with current field testing practices. NA

PMO: Pgs. 313-314, App.

To provide a Note for step for Test 11.2A in Appendix I. Pasteurization Equipment and Controls – Tests, that provides direction when six consecutive tests within 0.5 seconds of each other cannot be achieved for magnetic flow meter based timing systems similar to those used for Test 11.1 (positive displacement pumps) that would allow the regulatory agency to take the shortest computed hold time as the legal hold time of the pasteurization system when six consecutive tests within 0.5 seconds of each other cannot be achieved.

123 PMO: Pg. 322, App. I

201 PMO: xvii, 33, 60, 77, 90, 92, 93, 111, 113, 114, 115, 122, 213, 214, 215, 216, 219, 226, 255, App. F, H

202 PMO: xvii to xxii, Sec. abbreviations and acronyms

203 PMO: Pg. 8, sec. 1

Clarification of Text in the title for test 11.4 needs to state it specifically applies to Direct Steam Injection systems. (Align with wording in FDA document FDA-2359b).

NA

Make corrections to the PMO where the “degree” sign is incorrectly notated. NA

To update the acronym list to remove tests no longer listed in the PMO and correct symbol inaccuracies.

This proposal is incorporating wording from M-I-12-15 into Definition JJ of the 2019 Pasteurized Milk Ordinance to help clarify how a milk product should be evaluated to determine if it is a Grade “A” product.

PMO: Pg. 9, Sec. 1

Definition JJ of the 2019 PMO allows the use of non-Grade “A” dairy ingredients in PMOdefined Grade “A” products provided the Regulatory Agency, in consultation with FDA, has reviewed and accepted information supporting that the use is to achieve a functional or technical effect in the finished milk or milk product(s). Definition JJ states that when a non-Grade “A” ingredient is used to increase weight or volume of the milk and/or milk product, or displace Grade “A” dairy ingredients, this use is not a suitable functional or technical effect; however, in many, if not all, circumstances when a non-Grade “A” dairy ingredient is needed for such purposes, it will always displace a Grade “A” dairy ingredient to some extent.

This proposal is intended to clarify how these provisions shall be interpreted and applied by amending the PMO to clarify and affirm that a non-grade “A” dairy ingredient may not be used solely and primarily to: 1) increase the weight or volume of the milk and/or milk product, or 2) to displace Grade “A” dairy ingredients. If the ingredient’s primary use is for other functional or technical effects, those uses would be suitable and allowable.

205 PMO: Pg. 16, Sec. 3

This proposal adds language to the PMO to clarify that food manufacturing facilities that are only receiving Grade “A” milk products for use as an ingredient in another food that is not a Grade “A” milk product defined in the Ordinance may be exempt from the permit requirements of Section 3.

206 PMO: Pg. 20

To modify the current language in the 2019 PMO, Section 4, Labeling to include all means of transport for raw, heat treated, and pasteurized milk and milk products transported to a plant from a milk plant, receiving station, or transfer station for further processing.

PA- Amended to be assigned to Hauling Committee to review labels and shipping documents

207 PMO: Pg. 22, Section 5

Proposes requiring a 48-hour notice to a dairy farm prior to inspection. PA- Amended to be assigned to a standing or ad-

28,

proposal would seek to add Industry Plant Samplers to the list of approved Certified Industry Inspections that could be conducted cooperatively.

align the requirements for sampling across Section 6 The Examination of Milk and/or Milk Products of the 2019 PMO to allow all official, “Universal”, samples to be collected by an approved sampler under the authority of the Regulatory Agency.

30, 31, 35, 336-337,

clarify that the FDA/NCIMS 2400 forms should be the primary reference for lab testing procedures before referring to SMEDP and OMA in the PMO.

PMO: Pg. 359, App. N

This proposal is to include language in the Appendix N of the PMO to address facilities collecting Appendix N samples and having them analyzed at off site locations to set a maximum number of hours between the collection of the sample and the analyzing of the sample.

217

PMO, MMSR, Sec. 1, pg 212

This proposal provides clarity, consistency, and uniformity to the text contained within 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). The MMSR Committee conducted a comprehensive review of the document in order to provide editorial clarity, consistency, and uniformity to the text contained throughout the MMSR.

218 MMSR: v, vi, vii, 27, 44-46, 63-68, 70-72, 74-77, 102, 103, 105107, 111, 116.

PMO: 24

This proposal eliminates the evaluation of a milking time inspection program from the calculation of enforcement ratings for dairy farms. This proposal does not make any changes to the expectations of milking time inspections in Sections 5 or 6 of the PMO. The five points currently allocated to “Milking time inspection program established” in the Report of Enforcement Methods is eliminated leaving a total of 95 available credits. Calculation of the enforcement rating for dairy farms is made by taking the sum total of credits earned, dividing by 95, and then multiplying the result by 100.

PA- Points will be evenly redistributed by weight among the remaining items evaluated when calculating the enforcement score for dairy farms.

219

PMO: Pg. 23

The current MMSR document provides for a method to include an unattached supply of raw milk from a BTU, transfer station and/or receiving station to be calculated as part of a milk plant’s SCR. This provision also allows for the inclusions when the unattached BTU, transfer station and/or receiving station has achieved a SCR of less than 90%. Because every BTU, transfer station and/or receiving station must attain a minimum 90% SCR to be eligible for the IMS list, this option is now obsolete and needs to be removed.

PMO:29, 67, 108 and 109

This Proposal clarifies the PMO requirement that broken regulatory seals are to be included in the enforcement calculation of Part II, Item 5-Pasteurization Equipment Tested at the Required Frequency on FORM FDA 2359j, Section B-Report of Enforcement Methods (Page 2) when calculating an Enforcement Rating (ER) for milk plants made during ratings and check ratings.

221 MMSR: 59. 60,93, 94

Modify text in NCIMS forms FORM FDA 2359p and FORM FDA 2359q to reflect updated form numbers used in the FDA low-acid canned food program and to address the potential for suspension of a milk plant’s food facility registration.

222

2019 MMSR, Page 101

As part of the MMSR Committee’s charge in 2017 to update the MMSR document with the passage of Proposal #230, we are proposing the inclusion of additional pertinent animal health information to be updated within the MMSR. This information will include the specific testing requirements and current language within Section 8 of the PMO with regards to Tuberculosis and Brucellosis testing for animals intended for Grade “A” milk production.

223 Lab

M-a-98 Table 3 Pg. 44

Update M-a-98 with phosphatase methods validated for testing eggnog. This submission contains data provided to FDA-LPET demonstrating that phosphatase methods Paslite and FAP are valid for testing eggnog using the flavored milk protocol.

NA

224

225 PMO: pgs. 29, 30, 35, 339

To allow an LEO or certified analyst to conduct training of a new analyst on PMO testing, which would allow the analyst to perform official testing. The LEO or certified analyst will submit required documentation to LPET or LEO and upon approval, the analyst will be granted conditional certification. Once the analyst successfully completes Proficiency Testing for Raw Milk Quality and/or Microbiology & Pasteurization Efficiency samples and is visited and reviewed by LPET or LEO, they may become fully certified for which they were trained.

To clarify primacy of the FDA/NCIMS 2400 forms over SMEDP and OMA in the PMO. NA

227

2400 Forms To update the Petrifilm™ 2400 forms to include the use of the new Petrifilm™ Plate Reader Advanced (Next Generation) instrument.

2400 Forms Occasionally a facility will not have access to raw milk that meets the criteria on existing 2400 series forms to be used as a negative control. Commercially available controls are also not available. This proposal adds language to the 2400 series forms providing a procedure to determine if the available raw milk is suitable for use as a negative control.

228

2400 Forms The Hygiena ZymoSnap is a rapid luminogenic Alkaline Phosphatase system, used on the handheld luminometer the EnSURE Touch. The test vehicle is a self-contained device to which the sample is added through pipetting 75uL. The test comprises a 5-minute incubation with a 10 second read in the luminometer. The output is in mU/L with extensive CLOUD based software and traceability. The test kit can be calibrated using Alkaline Phosphatase standards sold by Hygiena. These standards are lyophilized live ALP standards. The tests portability, the selfcontained device and easy to use luminometer means the ZymoSnap is very adaptable to most testing situations internally and externally.

229

2400 Forms Addition of bioMerieux TEMPO as an approved method for dilution buffer toxic substances testing in 2400 form Cultural Procedures-General Requirements item 26.e.

230

2400 Forms Removing the requirement to complete ten monthly BactoScan comparisons found in 2400 form 2400a-2 BactoscanTM FC/FC+ item 4 “Monitoring of Regulatory Cut-Off Level.”

231

2400 Formspg. 2 Should the proposal for the removal of Addition of 2400 form 2400a-2, BactoscanTM FC/FC+ item 4.b. be denied, Precision Biolabs would like to propose the addition of bioMerieux TEMPO Aerobic count as an approved method for the required monthly monitoring of the regulatory cut-off level in 2400 form 2400a-2, BactoscanTM FC/FC+ item 4.b.

2400 Forms Removing the requirement to perform agar weight loss (Form 2400 Cultural ProceduresGeneral Requirements item 15.e.1.) for laboratories that utilize the bioMerieux TEMPO Aerobic count method for sample analyses.

233 2400 Forms Addition of bioMerieux TEMPO as an approved method for monthly Microbiologically Suitable (MS) Water standard plate count analysis in 2400 form Cultural Procedures-General Requirements item 24.c.1.

301 PMO: Sec. 1, Pg. 4

To provide a definition for “equivalence” for the USPHS/FDA responsibility to determine whether a foreign country’s public health regulatory program and the government oversight of that program has an equivalent effect on the safety of the regulated milk and/or milk product.

302 PMO: Sec. 11 pg. 129, after bullet 10

To provide a definition for “equivalence” for the USPHS/FDA responsibility to determine whether a foreign country’s public health regulatory program and the government oversight of that program has an equivalent effect on the s afety of the regulated milk and/or milk product.

303 PMO This proposal provides editorial corrections in Appendix K and updates language in Appendix K to align it with FDA Form 2359m (10/18) currently in use.

304 PMO, Procedures Incorporates the requirements of M-a-100 into the EML and the Procedures to allow LPETcertified LEOs to provisionally certify new LEO candidates on behalf of LPET. This proposal formalizes a process that was established in M-a-100 to aid states/TPCs during times when LPET is not able to timely conduct new LEO candidate check evaluations. The proposal adds text to Section 4 of the EML and changes the current use of the word “provisional LEO” in the EML to “probational LEO.” It also makes several editorial updates.

305 PMO, Procedures, sec. 1, pg. 4

This proposal provides clarity, consistency, and uniformity to the text contained within the Procedures Governing the Cooperative State-Public Health Service/Food and Drug Administration Program of the National Conference on Interstate Milk Shippers (Procedures). The MMSR Committee conducted a comprehensive review of the document in order to provide editorial clarity,

PA

306

Procedures:

Pg. 10-11, 68

consistency, and uniformity to the text contained throughout the Procedures.

In 2003, the NCIMS Liaison Committee collaborated with FDA to clarify, streamline, and standardize the State Program Evaluation process, resulting in the issuance of M-I-03-12. In 2007, the Liaison Committee and FDA again collaborated to further refine and clarify the State Program Evaluation Process and jointly issued Supplement 1 to the M-I.

This proposal updates the guidelines, report format, and minimum requirements and review criteria, as well as the State Program Evaluation Review process, incorporating these key aspects of the Grade “A” program into the NCIMS Conference documents.

307

Procedures:

pg. 12

This proposal provides new language in the Procedures Governing the Cooperative State Public Health Service/Food and the Drug Administration Program of the National Conference on Interstate Milk Shipments (Procedures) document specifying that a BTU, milk plant, receiving station, and transfer station must achieve Sanitation Compliance Rating (SCR) and Enforcement Rating (ER) of at least 90 to be listed initially on the IMS list.

308

Procedures: 17, 28

MMSR: 16

When a re-inspection/re-audit is required following a PHS/FDA check rating because a milk plant is not in substantial compliance with Appendix T. of the Grade “A” PMO, to then be eligible for listing on the IMS List, upon re inspection/re-audit, the milk plant must be in substantial compliance with Appendix T and shall achieve a Sanitation Compliance Rating of ninety percent (90%) or higher on the re-inspection/re-audit. If the milk is not in substantial compliance with Appendix T at the time of the reinspection/re-audit, the milk plant will be removed from the IMS List.

Currently, if this occurs, the milk plant would be eligible for relisting on the IMS list provided the milk plant only achieves a

Sanitation Compliance and Enforcement Rating of ninety percent (90%) or higher during a re-inspection/re-audit – without having to be in substantial compliance with Appendix T.

This proposal would require milk plants that are removed from the IMS List for not being in substantial compliance with Appendix T. to achieve substantial compliance with Appendix T to be eligible for re-listing on the IMS List. 309 MMSR, Procedures

The Interstate Milk Shippers List platform is not designed to accept the electronic submission of FDA Forms M, N, P and Q. This proposal eliminates the submission requirements for FDA Forms M, N, P and Q when listing HACCP and Aseptic firms.

310 Constitution & Bylaws

Creating a Food Safety Preventive Controls Committee to address issues related to requirements of the Preventive Controls for Human Foods rule and Appendix T in the most current PMO.

It is the intent of this proposal to formalize the NCIMS Aseptic Program Committee (APC) as a standing committee in accordance with the NCIMS Constitution and Bylaws.