No. 37027 (Amendment): Rule R70-310. Grade A Pasteurized Milk

(Amendment)

DAR File No.: 37027
Filed: 11/02/2012 09:13:18 AM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The purpose of this amendment is to adopt the 2011 Pasteurized Milk Ordinance.

Summary of the rule or change:

Every two years the Utah Department of Agriculture and Food (UDAF) amends this rule to adopt the new FDA Pasteurized Milk Ordinance. This rule amendment adopts the 2011 Pasteurized Milk Ordinance. See the following Executive Summary. Note: The numbers at the beginning of each change correspond to the number assigned to each proposal. 101: Allow for the illumination of milk, milk products or whey with ultraviolet light (UV) as an adjunct to thermal pasteurization in order to increase the shelf life of the product. 103: Section 7. Standards for Grade "A" Milk and Milk Products of the 2009 PMO. It specifically addresses changes to the standards for Grade "A" Nonfat Dry Milk (NFDM) by proposing to eliminate the quality testing standards, lowering the bacterial limit from 30,000 per gram to 10,000 per gram to be consistent with USDA's bacterial limit for Extra Grade NFDM, and adds "Dry Milk and Milk Products" to this header. 106: Hauling Allows for additional alternatives for the direct loading of milk on a dairy farm by utilizing stubbed piping outside of the milkhouse wall, as well as a transfer hose through the milkhouse hose port. 113: This Proposal updates the requirements within Item 15p(B)-Protection from Contamination of the PMO for single-bodied double seat valves, used to separate cleaning solutions from product circuits, to be consistent with the 3-A Standard for Double Seat Mixproof Valves (85-01). It also provides a useful clarification and a simplification of the low pressure gravity drain application requirements cited within Item 15p(B). 114: Provides more detailed pasteurized product protection and operational criteria for a milk or milk product-to water-to-milk or milk product regenerator when used for heat exchange purposes. 115: This proposal would allow the circulating loop of a cross-flow membrane microfiltration system to be maintained at an elevated temperature during production as an alternative to the current cooling requirements of ADMINISTRATIVE PROCEDURES #3 of Item 16p. 116: To require that the reading of the airspace thermometer be recorded on batch pasteurizer charts only at the start of the holding period if the airspace thermometer is a digital combination type with a continuous recording of the airspace temperature. 117: demonstrated that the use of potassium sorbate or specific microbial inhibitors combined with filling cottage cheese at 55 degrees F or less and cooling to 45 degrees F or less within 72 hours after filling provide equal or better food safety protection that the current PMO requirement to fill cottage cheese at 45 degrees F. 118: To amend the current requirement found in 16p (E) (1) (c) to quarterly mark the time accuracy of the recording thermometer on flow rate recording charts for use in continuous flow or aseptic processing equipment with magnetic flow meter based timing systems. 119 : This proposal adds the slurry temperature requirements currently found in Appendix H into the Item 17p. Cooling of Milk and Milk Products section of the PMO. 120: This Proposal makes corrections to the errors cited in Section 8-Animal Health of the PMO in relationship to what animal species are covered and not covered under the USDA Tuberculosis (TB) Eradication Program. It also reflects changes to the USDA Brucellosis Eradication Program under the Interim Rule to 9 CFR Part 78 and updates the references to obtain copies of the USDA TB and Brucellosis Eradication Programs cited in Appendix A. Animal Health Control of the PMO. 121: Editorial clarification that Ultraviolet(UV) light disinfection of water as specified in Appendix D Section IV is equivalent to chemical disinfection for water reuse purposes. 123: In Appendix H, the Pasteurized Milk Ordinance (PMO) describes how minor ingredients can be added to a High Temperature Short Time (HTST) pasteurization system. The currently listed method states that the slurry pump must be de-energized. De-energizing the pump has the effect of stopping all product flow within a loop, and does not allow a single pressurized loop to be used for multiple operations. This proposal is to allow an alternate mechanical method-use of Double-Block and Bleed valves that release to a drain-to prevent continued flow to the injection point. 124: This Proposal provides a technical update, clarification and consolidation of the criteria for the use of magnetic flow meter based timing systems within HTST and HHST continuous flow pasteurization systems 126: This Proposal addresses a change to Appendix H-Pasteurization Equipment and Procedures and Other Equipment, V-Criteria for the Evaluation of Electronic Data Collection, Storage and Reporting of the PMO to clarify a potential misinterpretations that additional operator's signatures are required for raw and heat-treated milk and milk product storage tank's temperature records when using electronic records compared to the operator's signatures required for manual records as addressed in the PMO. 127: This Proposal addresses a change to Appendix H-Pasteurization Equipment and Procedures and Other Equipment, VI, Criteria for the Evaluation of Computerized Systems for Grade "A" Public Health Controls to include new frequency drive technology in the sealing process of a pasteurization system; thereby, timing pump speed cannot be controlled through a network or web interface. 128: This Proposal addresses a change to Appendix H-Pasteurization Equipment and Procedures and Other Equipment, VI, Criteria for the Evaluation of Computerized Systems for Grade "A" Public Health Controls to eliminate a second memory chip that was preferable in older pasteurization system's computer/programmable logic controller technology; however, now has detrimental potential with newer technology. 129: To correct a typographical error on the Milk and Milk Product Continuous-Flow (HTST and HHST) Pasteurization - CCP Model HACCP Plan Summary. 205: To eliminate the sampling and testing requirement for bulk shipped heat treated milk products. 208: Add allowances in the PMO for use of an approved alternative farm bulk tank sampling system for the purpose of obtaining the farm bulk tank universal sample as required in Section 6-The Examination of Milk and Milk Products and as referenced in Appendix B-Milk Sampling, Hauling and Transportation of the Grade "A" PMO. FDA/LPET has been provided 200 of the 300 data points required and found the data to be acceptable at the time of submission of this proposal. The other data points well be submitted to FDA/LPET around the end of February for review. 209: This Proposal updates criterion for the Commissioner of FDA to utilize for determination that a potential problem exists with animal drug residues or other contaminants in the milk supply that would result in additional analysis for the contaminant by a method(s) determined by FDA to be effective in determining compliance with actionable levels or established tolerances. 210: To allow for the location of tanker stickers on the front bulkhead of milk tank truck. 212: To establish an acceptable criteria for the onsite production and sanitization use of hypochlorous acid. 214: This Proposal provides an update to Appendix F. Sanitization of the PMO in relationship to the Code of Federal Regulations (CFR) citation referenced under I. Methods of Sanitization, Chemical from 21 CFR 178.1010 to 40 CFR 180.940; corresponding correction to the citation in Item 11r-Utensil and Equipment - Sanitization; and also adds the updated CFR reference to Appendix L. Applicable Regulations, Standards of Identity for Milk and Milk Products and the Federal Food, Drug, and Cosmetic Act of the PMO. This Proposal is only an editorial correction. 215: This proposal is written to update language in Appendix G. Chemical and Bacteriological Tests Section I. Private Water supplies and Recirculated Water - Bacteriological of the 2009 PMO. 216: This Proposal provides a clarification and reorganization of requirements/criteria cited in Appendix A. Guidelines for Computing Enforcement Ratings, Part I. Dairy Farms, Item 10. Permit Issuance, Suspension, Revocation, Reinstatement, Hearings, and/or Court Action Taken as Required and Part II. Milk Plants, Item 9. Permit Issuance, Suspension, Revocation, Reinstatement, Hearings, and/or Court Action Taken as Required within the 2009 MMSR. 217: This Proposal proposes corrections and additions to Section 11-HACCP SYSTEM TRAINING within FORM FDA 2359m, MILK PLANT, RECEIVING STATION OR TRANSFER STATION NCIMS HACCP SYSTEM AUDIT REPORT (10/10). These corrections and additions are warranted to bring Section 11 within FORM FDA 22359m in conformance with the language cited in Appendix K-HACCP PROGRAM of the PMO. 218: This proposal offers a modification to item #2 of the NCIMS HACCP SYSTEM REGULATORY AGENCY REVIEW REPORT (Form FDA 2359n) to provide a location on this form to acknowledge the PMO Appendix K. HACCP Program requirement that State regulators auditing NCIMS HACCP listed milk plants have received training (at least once) in the auditing of milk plants under the NCIMS HACCP program. 219: Accept a flunixin and beta-lactam test for screening under Appendix N. Approve a 2400 form and add the method to the list of allowable tank/tanker screening tests in M-a-85. 222: Request the NCIMS to direct the NCIMS Laboratory Committee to form a review/study group to review SMEDP (Standard Methods for the Examination of Dairy Products) as it is referenced and referred to in the PMO and related documents. This review/study group will; report its work back to the 2013 NCIMS Conference. 224: Revise the 2400 form for Appendix N Bulk Milk Tanker Screening for Neogen BetaStar US to reflect the replacement of this method with the BetaStar Plus BetaLactam Test. Upon approval the BetaStar US kit will be removed from commerce. 225: Add Easygel Aerobic Plate Count Media, Pectin Gel Method, to the Milk Laboratory Evaluation Form. Amend 2400 form accordingly. 226: To update the Idexx SNAP 2400 series form to eliminate the visual read language and include the instructions for how to determine if a test is invalid. 227: Direct the NCIMS Laboratory Committee to review and clarify on all appropriate 2400 forms the intent and meaning of the phrase "Previously negative tested raw milk" currently used in the App N 2400 forms. The clarification should be stated on all appropriate 2400 forms. 228: The current requirement for Appendix N reference and test thermometers is that the graduation interval be not greater than 1.0C (NCIMS Certified Laboratories and Certified Industry Supervisor, 0.5C). It was felt at the time that non certified labs need not meet the tighter requirements of those for certified labs. 229: Allow manufacturers to ship antibiotic test kits unrefrigerated when it is demonstrated that the kits perform as labeled after heat stress and real-time storage to end of labeled shelf life. Modify Charm 3 SL3 Beta-lactam Test shipping requirements in the 2400 form to allow non-refrigerated shipment. 230: To provide clarification to requirements at Items #3 Thermometers and #9 Sample Requirements on FDA Appendix N General Requirements form 2400n. 231: To provide clarification and consistency for FDA Form: 2400j Phosphatase Test - Fluorophos ALP Test System. 232: Addition of wording the to the DMSCC 2400 Series form for how long samples may be run after initial collection. 233: To allow for beta lactam drug residue testing of sheep milk by the Charm SLBL method after a quantity of such milk has been frozen for up to 60 days and properly thawed. Subsequently the samples shall be held at 0-4.4 degrees C and analyzed within 24 hours as per the instructions for frozen controls of the Charm SLBL test method as described in the Charm SL / SL6 / SL3 2400 form. 234: With the number of laboratories no longer running their autoclaves on a continual basis, there is no need to require the performance check be done weekly if the unit is not in use. This wording will allow laboratories to perform the check during weeks when testing under the NCIMS Laboratory Program requires the use of and documentation of autoclave cycles. At a minimum, quarterly performance checks will be required. 235: To add to the 2009 EML the option for Laboratory Evaluation Officer to send the narrative report to the laboratories electronically without the 2400 series forms. 236: This Proposal seeks to add the requirement for a summary template to be submitted along with the laboratory narrative report submitted to the Laboratory Proficiency and Evaluation Team to the 2009 EML. 237: To update the example narratives in the EML and to provide a definition of the usage of 'NOTE". 238: To allow State LEO the same time frame as the Federal LEO for the supplemental surveys. 241: To remove references to SMEDP in the EML where they are not applicable. 242: Update the 2009 EML with the addition of the Federal LEOs to reflect the cooperative program. 243: Addition to the EML to specify that the NCIMS Laboratory Committee shall issue a draft version of the 2400 series forms 90 days after NCIMS Executive Board approval if the FDA has been unable to issue the form by the 90 day time frame. 246: Include the prerequisite for FD373 State Milk Laboratory Evaluation Officers Workshop (LEO) that was listed in the FDA Course catalogue 247: To remove the website listed in the references as a source of the 2400 series forms. Instead directing the reader to contact the federal or state LEO. 248: Change the ranges for the standards for calibrating/ validating the instruments used to measure somatic cells in milk to the following: 100-200, 250-350, 400-550 and 650-800. These changes would apply to standards used on all approved electronic cell counters. 301: This Proposal contains modifications to the PMO, Methods, and Procedures documents that address the regulation and rating of aseptic milk plants producing Grade "A" low acid aseptic milk and milk products. It will incorporate the Aseptic Pilot Program Implementation Committee's findings and determination for aseptic milk plants that produce Grade "A" low acid aseptic milk and milk products into the NCIMS documents and make this Pilot a permanent part of the Grade "A" Milk Safety Program 303: Update items in the Procedures document to the same as the EML. 308: Aseptic FDA requests the Chair to assign this Proposal to the NCIMS Aseptic Pilot Program Implementation Committee (APPIC) as approved by the NCIMS Executive Board. 309: This Proposal contains the provisions for extending the voluntary International Certification Pilot Program (ICPP) for the regulatory oversight, rating and IMS listing of milk shippers and milk laboratories located outside the geographic boundaries of the National Conference on Interstate Milk Shipments (NCIMS) member states. 311: ICPP Expand the ICPP to allow each TPC to Certify up to 6 plants. 313: To request the NCIMS Executive Board establish an Ad HOC committee to align the Pasteurized Milk Ordinance with the FDA Food Safety Modernization Act.

State statutory or constitutional authorization for this rule:

• Section 4-3-2

This rule or change incorporates by reference the following material:

• Removes Grade "A" Pasteurized Milk Ordinance 2007 Revision, published by United States Department of Health and Human Services, 2007
• Updates Grade "A" Pasteurized Milk Ordinance 2007 Revision, published by United States Department of Health and Human Services, 2011

Anticipated cost or savings to:

the state budget:

Changes to Section 205 could save UDAF up to $100/year. Sections 209, 219, and 224, could cost UDAF up to $100/year each. Section 246 could cost UDAF $1,000 for a lab technican to take the required course.

local governments:

Local governments have no responsibilities in Rule R70-310. There will be no budgetary impact to local governments.

small businesses:

Changes to Section 106 reduce the need to purchase a bulk holding tank in some dairy operations. Bulk holding tanks range from $50,000 to $100,000. Specific dairies have not been identified.

persons other than small businesses, businesses, or local governmental entities:

All stakeholder groups were involved in the development of the 2012 Pasteurized Milk Ordinance. Manufacturers of antibiotic test kits could save up to $50/year by changes in Section 229.

Compliance costs for affected persons:

The department has not identified increased costs for affected persons.

Comments by the department head on the fiscal impact the rule may have on businesses:

The proposed amendments, which adopt the 2011 FDA Pasteurized Milk Ordinance, are essential. They are required in order for Utah diary producers to be able to export to their states and internationally.

Leonard M. Blackham, Commissioner

The full text of this rule may be inspected, during regular business hours, at the Division of Administrative Rules, or at:

Agriculture and Food
Regulatory Services
350 N REDWOOD RD
SALT LAKE CITY, UT 84116-3034

Direct questions regarding this rule to:

• Kyle Stephens at the above address, by phone at 801-538-7102, by FAX at 801-538-7126, or by Internet E-mail at [e-mail]
• Don McClellan at the above address, by phone at 801-538-7145, by FAX at 801-538-7126, or by Internet E-mail at [e-mail]
• Kathleen Mathews at the above address, by phone at 801-538-7103, by FAX at 801-538-7126, or by Internet E-mail at [e-mail]
• Richard Clark at the above address, by phone at 801-538-7150, by FAX at 801-538-7126, or by Internet E-mail at [e-mail]

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

12/31/2012

This rule may become effective on:

01/07/2013

Authorized by:

Leonard Blackham, Commissioner

RULE TEXT

R70. Agriculture and Food, Regulatory Services.

R70-310. Grade A Pasteurized Milk.

R70-310-1. Authority.

A. Promulgated Under the Authority of Subsection 4-2-2(1)(j).

B. Scope - this rule shall apply to all Grade A pasteurized milk products sold, bought, processed, manufactured or distributed within the State of Utah.

 

R70-310-2. Adoption of USPHS Ordinance.

The Grade A Pasteurized Milk Ordinance, [2007]2011 Recommendations of the United States Public Health Service/Food and Drug Administration, is hereby adopted and incorporated by reference within this rule. This document is available for public inspection, during normal working hours, and may be reviewed at the main office of the Utah Department of Agriculture and Food, 350 No. Redwood Road, SLC, UT 84116.

 

R70-310-3. Regulatory Agency Defined.

The definition of "regulatory agency" as given in section 1[(x)](LL) of the Grade A Pasteurized Milk Ordinance shall mean the Commissioner of Agriculture and Food of the State of Utah or his authorized representative(s).

 

R70-310-4. Penalty.

Violation of any portion of the Grade A Pasteurized Milk Ordinance [2007]2011 recommendation may result in civil or criminal action, pursuant to Section 4-2-15.

 

KEY: dairy inspections

Date of Enactment or Last Substantive Amendment: [December 8, 2008]2013

Notice of Continuation: June 24, 2009

Authorizing, and Implemented or Interpreted Law: 4-2-2

 

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