18 0 obj recommendations and incorporates them into the revised PMO. Milk and/or Milk Products from Points Beyond the Limits of Routine Inspection, Section 12. (1) Only Except as otherwise provided under subsection (5), only pasteurized milk and milk products shall be offered for sale or sold, directly or indirectly, . Chapter 217 - Milk and Dairy; Federal Regulations Adopted by Reference. This website requires certain cookies to work and uses other cookies to help you have the best experience. The PMO and other related documents can be found on the National Conference on Interstate Milk Shipments (NCIMS) website. }gc~Rpz5Q+%F.!PsZQc6L-MdIQn9ux|c->yDE__z/l>mQIGhn.^! 4Zr=xYe8PyY Kvn=8!9 LrPZbU&(qF,{;( Qg4R$'C%jPG( D'= xE|QD:qF_P 1I)|_ybf3}L 0"8% \By2!$ Grade A standards are recommended by the National Conference on Interstate Milk Shipments (NCIMS), which is composed of voting representatives from . The training program is centered around dairy and juice HACCP following the guidelines of the Pasteurized Milk Ordinance voluntary HACCP and FDA HACCP for 100% juice products. <> NUiZ@"CO+5murd)Tt_rI4(XQ;N9p5 wwIJHg{nB sgry Visit our updated. stream Grade "A" Pasteurized Milk Ordinance. 0000048958 00000 n <> So far, all but four states have passed the law or a modified version of it. GAMS supports FDAs Milk Safety Cooperative Program by providing assistance to state and local milk regulatory/rating agencies, the dairy industry and other interested parties in the safe production of milk and milk products through the application of science-based food safety principles on the farm and at all stages through the processing chain. The PMO is a set of standards and requirements that regulates all dairy plants producing Grade "A" products, including fluid milk, cream products, yogurt, cottage cheese, eggnog, buttermilk and many dried dairy products. A successful state rating allows the plant to continue its IMS Listing. 2021 Revision Division of Milk Control INSTRUCTIONS FOR MAKING AN APPLICATION FOR THE INSTALLATION OR MODIFICATION OF MILK HANDLING EQUIPMENT, CONSTRUCTION OR RENOVATION OF A PROCESS . Changes to the PMO are based on the outcome of proposals, discussions, and votes by representatives of the dairy industry, government, and academia from all 50 states and U.S. territories, that occur at the biannual meeting of the National Conference on Interstate Milk Shipments. This dual FDA audit is necessary because Grade A is regulated under the PMO and non-Grade is regulated under the FDA Manufactured Food Regulatory Program Standards. Policies With 41 grade A and manufacturing grade processing plants . =UylUG+~6.LJ=1X=l056~")N22>*OiO~-lB86{qkXLt[qG>,{jG1(9_~fv1>UT)!>1^y1zx?0z~a=q'mA> The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The National Conference on Interstate Milk Shipments, Grade "A" Pasteurized Milk Ordinance (PMO) 2019, is incorporated herein by reference, as amended and supplemented, as the legal requirements for the production and processing of milk and milk products in the State of New Jersey, provided, however, that certain sections of the PMO . current version of the Pasteurized Milk Ordinance (PMO). IDAPA 02.04.13. The PMO contains many illustrations to assist farmers and processors with the correct set up for items such as buildings, wells, ventilation systems, and pasteurizer flow diagrams. stream p3lP`nb>`q >iWt=XRt@'|YS7S!xR.)O5,&hbM/,"TZ,4emV uDQ1U#*,:)~ 6ug>d5l(O{\A1W'4-'#q Bd?T2'-E#ZZ]C.r. The changes that were made at 2019 conference were released in spring 2020, as the 2019 PMO, which is the most recent version. It is often used by local milk inspectors and regulatory agencies as the guidelines for processing plant approval and inspection. An official website of the United States government, : ingredients used in any foods it imports. 19 0 obj Grade "A" Pasteurized Milk Ordinance. Raw goat milk regulations differ from those for raw cows' milk. <> Verification procedures: document review of the food safety system and associated prerequisite programs. reduce antimicrobial residues and bacterial contamination risks, and to be more closely 20. E. If any provision of the "Grade "A" Pasteurized Milk Ordinance, 2017 Revision" or this chapter conflicts with a regulation pertaining to onsite sewage systems adopted by the State Board of Health pursuant to 32.1-164 of the Code of Virginia, the regulation adopted by the State Board of Health shall control to the extent of the conflict. We are unable to answer legal questions or respond to requests for legal advice, including application of law to specific fact. The Grade "A" Pasteurized Milk Ordinance is considered the gold standard and is an invaluable resource on all aspects of dairy production and processing. endstream endobj 244 0 obj<> endobj 245 0 obj<> endobj 246 0 obj<>/Font<>/ProcSet[/PDF/Text]/ExtGState<>/Pattern<>>> endobj 247 0 obj<> endobj 248 0 obj<> endobj 249 0 obj<> endobj 250 0 obj<> endobj 251 0 obj<> endobj 252 0 obj[/ICCBased 266 0 R] endobj 253 0 obj<> endobj 254 0 obj<> endobj 255 0 obj<> endobj 256 0 obj<> endobj 257 0 obj<> endobj 258 0 obj<>stream Visit our updated, This website requires certain cookies to work and uses other cookies to help you have the best experience. Preventive controls are required when corrective actions are not required in regulations. Standards for the Fabrication of Single-Service Containers and/or Closures for Milk and/or Milk Products, Appendix L. Applicable Regulations, Standards of Identity for Milk and Milk Products, The Federal Food, Drug, and Cosmetic Act, and the Federal Insecticide, Fungicide and Rodenticide Act, Appendix N. Drug Residue Testing and Farm Surveillance, Appendix O. Vitamin Fortification of Fluid Milk Products, Appendix P. Performance-Based Dairy Farm Inspection System, Appendix R. Determination of Time/Temperature Control for Safety Milk and/or Milk Products, Appendix S. Aseptic Processing and Packaging Program, Retort Processed After Packaging Program and Fermented High-Acid, Shelf-Stable Processing and Packaging Program, Appendix T. Preventive Controls for Human Food Requirements for Grade A Milk and Milk Products. Since the 2018 compliance date, FDA has been conducting food safety audits during check ratings to determine compliance. <> NCIMS has come under increased pressure to recommend tighter standards, in order Copyright Commonwealth of Virginia, document.write(new Date().getFullYear()). On-Demand: SQF 2000, FSMA, ISO 22000/PAS220 and other standards continue to gain traction in an attempt to create safer foods and beverages. 68. The milk and dairy foods inspection program has the responsibility of administering public health and safety programs in all aspects of milk processing and production. It is pasteurized, but is not processed by heat so as to prevent spoilage. A draft copy of the regulation with proposed revisions is available below: Information made available to meeting participants and a recordings of each meetingcan be found below: Please feel free to email us atDairy@dhec.sc.gov, if you have any questions. The milkfat and total milk solids contents of the food are not less than 7.5 and 25.5 percent, respectively. 2011 Revision (PDF - 303KB) February, 2012, 2009 Revision (PDF - 225KB) August 5, 2010, 2007 Revision (PDF - 404KB) September 21, 2009, 2005 Revision (PDF - 256KB) January 1, 2007, 2017 Revision(PDF -583 KB) January 30, 2018, 2015 Revision(PDF - 497KB) February 4, 2015, 2013 Revision(PDF - 552KB) December 3, 2013, 2011 Revision(PDF - 214KB) December 6, 2011, 2009 Revision(PDF - 711KB) January 22, 2010, 2007 Revision December 17, 2007; Updated May 22, 2009, 2005 RevisionNovember 14, 2005; Updated November 21, 2011, 2015 Revision(PDF - 21MB) April 25, 2016, 2013 Revision(PDF -2MB) February 13, 2015, 2011 Revision(PDF -2MB) February 7, 2012, 2009 Revision(PDF -4MB) January 28, 2010, An official website of the United States government, : <> Dairy Distributor License - In- and out-of-state distributors of Dairy/Frozen Dessert must license trucks to distribute their product in Tennessee.Complete the Dairy Distributor License Application form and email it to Danny Withers or Jenny Strasser.. Guidance Documents & Regulatory Information by Topic (Food and Dietary Supplements), Recalls, Market Withdrawals and Safety Alerts, Milk Guidance Documents & Regulatory Information, Guidance & Regulation (Food and Dietary Supplements), Guidance Documents & Regulatory Information by Topic (Food and Dietary Supplements), National Conference on Interstate Milk Shipments (NCIMS) Model Documents, Procedures Governing the Cooperative State-Public Health Service/FDA Program of the National Conference on Interstate Milk Shipments, 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, Methods of Making Sanitation Ratings of Milk Shippers, National Milk Drug Residue Database Fiscal Year 2021 Annual Report, National Milk Drug Residue Database Fiscal Year 2020 Annual Report, National Milk Drug Residue Database Fiscal Year 2019 Annual Report, National Milk Drug Residue Database Fiscal Year 2018 Annual Report, National Milk Drug Residue Database Fiscal Year 2017 Annual Report, National Milk Drug Residue Database Fiscal Year 2016 Annual Report, National Milk Drug Residue Database Fiscal Year 2015 Annual Report, National Milk Drug Residue Database Fiscal Year 2014 Annual Report, National Milk Drug Residue Database Fiscal Year 2013 Annual Report, National Milk Drug Residue Database Fiscal Year 2012 Annual Report, National Milk Drug Residue Database Fiscal Year 2011 Annual Report, National Milk Drug Residue Database Fiscal Year 2010 Annual Report, National Milk Drug Residue Database Fiscal Year 2009 Annual Report, National Milk Drug Residue Database Fiscal Year 2008 Annual Report, National Milk Drug Residue Database Fiscal Year 2007 Annual Report, National Milk Drug Residue Database Fiscal Year 2006 Annual Report, National Milk Drug Residue Database Fiscal Year 2005 Annual Report, National Milk Drug Residue Database Fiscal Year 2004 Annual Report, National Milk Drug Residue Database Fiscal Year 2003 Annual Report, National Milk Drug Residue Database Fiscal Year 2002 Annual Report, National Milk Drug Residue Database Fiscal Year 2001 Annual Report, National Milk Drug Residue Database Fiscal year 2000 Annual Report, National Milk Drug Residue Database Fiscal year 1999 Annual Report, National Milk Drug Residue Database Fiscal year 1998 Annual Report, National Milk Drug Residue Database Fiscal year 1996 Annual Report, Establishing and Maintaining a List of U.S. All plants shall document and implement an allergen management program. Many of the sections below contain detailed subsections but are not listed here. At the end of the 60 days, the SRO conducts a PCHF audit and an Interstate Milk Shippers (IMS) rating. endobj Chemical, including radiological hazards, pesticides, drug residues, natural toxins, decomposition, unapproved food or color additives, and food allergens. 116 State Street Montpelier, Vt 05620-2901 802.828.2430 0000004536 00000 n A. Monitoring procedures: including the frequency of monitoring the preventive controls. <> The PMO is easy to find electronically, and usually difficult to get in printed format. Milk that is in final package form for beverage use shall have been pasteurized or ultra-pasteurized, and shall contain not less than 8.25 . The PMO short course targets individuals that are starting to work in dairy plant operations and will have the responsibility to follow standards for Grade "A" pasteurized, ultra-pasteurized and aseptically processed milk and . 0000044306 00000 n US Department of Health and Human Services, Public Health Service, Food and Drug Administration. Creating a Report: Check the sections you'd like to appear in the report, then use the "Create Report" button at the bottom of the page to generate your report. 2013, which does not meet all of the requirements of the Grade A Pasteurized Milk Ordinance shall be acceptable for use only if it meets the requirements of sections 2-3983 to 2-3989. x1 Om u National Milk Producers Federation. The Ohio State University. Concentrated milk is the liquid food obtained by partial removal of water from milk. 2021; effective September 28, 2021. PURPOSE: This rule . Derived from Virginia Register Volume 36, Issue 14, eff. Rescinded: Filed Sept. 17, 2020, effective April 30, 2021. J@U&H0g) @5m0@C6v R'f8jdr@rY =WC@AL*O L@H,]AYC9Hv9ELFZZ@ha``rJaCb 3:@+8RGHD0 b[PDP h|%Pb``RNk`P2 22@ (aLg 3! J@pbmph01ep teYe+UfLX0aw'237kdsS ! Manufactured dairy food products are regulated under the USDA Milk for Manufacturing Purposes and its Production and Processing. This is a model regulation helping states and municipalities have an effective program to prevent milk borne disease. ! <> Conference on Interstate Milk Shipments. The standards applied in Wisconsin follow national standards that allow milk and milk products to move without restriction in interstate commerce. Adulterated or Misbranded Milk and/or Milk Products, Section 5. Compliance Procedures (R70-201) Grade A Pasteurized Milk (R70-310) This rule formally adopts the Federal ordinance below: Grade "A" Pasteurized Milk Ordinance (PMO) Minimum Standards for Milk for Manufacturing Purposes, its Production and Processing (R70-320) Raw Milk for Retail (R70-330) Ice Cream and Frozen Dairy Foods Standards (R70-350) State Department of Agriculture or the State Health Department. 2023 State of Vermont All rights reserved. 0000001996 00000 n Any person permitted in accordance with Chapter 52 ( 3.2-5200 et seq.) Milk Regulations Revisions Public Hearing. (c) The dry whole milk fails to meet the requirements of any optional test when tests have been made. Producers are checked regularly for overall sanitation, milk protection and handling, usage and handling of animal medications and related activities. 0000059270 00000 n representatives from state and local regulatory agencies, and nonvoting representatives 116 State Street 0000039593 00000 n Standards for Grade A Milk and, Section 9. (1) Any milk into which any foreign substancehas been added or . Milk Sampling, Hauling and Transportation, Appendix C. Dairy Farm Construction Standards and Milk Production, Appendix E. Examples of 3-Out-Of-5 Compliance Enforcement Procedures, Appendix G. Chemical and Bacteriological Tests, Appendix H. Continuous-Flow Pasteurization Systems (Equipment and Procedures) and Other Equipment, Appendix I. Pasteurization Equipment and Controls Tests, Appendix J. 3 0 obj For the best experience on our site, be sure to turn on Javascript in your browser. initiated in early 2021 to consider the future of the nation's government-legislated milk pricing and pooling system. For example, Section 7 contains subsections on the constructions of floors and wall, the water supply, handwashing facilities, pasteurization condition, storage of containers, etc. This type of pasteurization is the easiest and oldest method of pasteurizing milk. Thursday, October 15, 2020 - 12:00. National Conference on Interstate Milk Shipments. The Grade A site has 60 days to work with the state rating officer (SRO) to achieve compliance. List of Previous Editions of USPHS/FDA Milk Ordinance, Grade "A" Pasteurized Milk Ordinance (Grade "A" PMO) 2019 Revision, Section 2. COVID-19 Community Levels & Data Dashboards, Making Your Emergency Survival Supply Kit, Individuals with Functional Needs How to Prepare for Emergency, State Statistics on Family Planning & Pregnancy, Women, Infants, & Nutrition Program (WIC), Child & Adolescent Immunizations and Vaccines, Manufactured Food Safety in South Carolina, Oil & Natural Gas and Terminal Facility Registration, Beachfront Jurisdictional Lines Stakeholder Workgroup, Regulation - Small Business Assistance Program, Disaster Preparedness for Healthcare Facilities, Medicare Provider Emergency Preparedness Information From CMS, Get Help with Health Care System Preparedness, Health Care Preparedness Staff Contacts State and Local, Health Care System Preparedness Program: Overview and Mission, Training Opportunities and Exercises for Health Care Professionals, Zika Virus Information for Health Care Providers, Electronic Health Records: Meaningful Use, Health Facilities: How to File a Complaint, Residential Treatment Facilities for Children & Adolescents, Health Facility Regulations, Licensing, CON, Radioactive Material Licensing and Compliance, Emergency Medical Technician (EMT) Certification Requirements, Applying for a Permit, License, Certification or Registration from DHEC, FORMS: Applications, Registration, Reporting, Etc. <]>> Alternatively, doing an internet browser search for "Pasteurized Milk Ordinance" and the year of the most current revision will bring up a link that automatically downloads the document in a pdf format. 0000001806 00000 n 11 0 obj 345 IAC Title 8--Dairy Products (Indiana) 0000002781 00000 n endobj The Department of Health and Environmental Control (DHEC) is proposing revisions to Regulation 61-34.1, Pasteurized Milk and Milk Products. D. If any provision of the "Grade "A" Pasteurized Milk Ordinance, 2017 Revision" or this chapter conflicts with a regulation pertaining to waterworks or private wells adopted by the State Board of Health pursuant to 32.1-170 or 32.1-176.4 of the Code of Virginia, the regulation adopted by the State Board of Health shall control to the extent of the conflict. Global Pasteurized Milk. endobj (3) . This Guide developed by the Milk Safety Team, Division of Cooperative Programs, U.S. Public Health Service/Food and Drug Administration is designed to assist milk regulatory officials in evaluating milk and milk product equipment for compliance with the Grade A Pasteurized Milk Ordinance. 10 0 obj Federal regulation for the standardization of milk and cream in interstate commerce, defining "milk" as "the lacteal secretion" from cows and requiring that it be pasteurized and contain certain percentages of milk solids and milkfat. State government websites often end in .gov or .mil. 0000016024 00000 n mXCmC$D7^i*.3&PRPTZFraAs *1T$sob%&)!>y= B. Failure to meet the EU standards could have The incidence of milk-borne illness in the United States has been sharply reduced. What kinds of agricultural products can be listed on a producer's certificate? milk and/or milk product under normal non-refrigerated conditions. | relate to the 2017 Pasteurized Milk Ordinance (PMO), the 2017 Methods of Making Sanitation Ratings of Milk Shippers, the 2017 Evaluation of Milk Laboratories, and the 2017 Procedures Governing the . Section 4, Labeling; 2. All Rights Reserved. Administrative Rules Request Form - Raw Milk. Notice of Rulemaking - Raw Milk. Text is available under the Creative . 0000002193 00000 n <> Agency 5. The PMO is over 400 pages and is always free of charge. These conditions were determined to be the minimum processing conditions needed to kill Coxiella burnetii , the organism that causes Q fever in humans, which is the most heat . 0000004059 00000 n Questions regarding the use of GAMS should be directed to FDAs Division of Dairy, Egg and Meat Products, Milk and Milk Products Branch in FDAs Center for Food Safety and Applied Nutrition (CFSAN)at CFSANDairy@fda.hhs.gov. Procedure When Infection or High Risk of Infection is Discovered, Appendix B. Robert Bud Moore is technical manager for Merieux NutriSciences. The prices now paid for raw milk intended for pasteurization are so low that they do not cover the cost of production. 7 0 obj The FSMA requirements for Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Human Food (21 CFR 117) contains more preventive controls (process, sanitation, allergen) to manage hazards than are defined as critical control points (CCPs) under a HACCP system. The PMO (excluding Appendix K-HACCP) does not require corrective actions; therefore, it requires a preventive control. xW]oX}G?~kH`E-ew~g.$ =3_zy;Ywd9mzY&[W{h^/8XE^`\C~[ \AK Nf,wr`}"\evA3k^+OuE^wvb3*bm V1Y&g Before sharing sensitive information, make sure you're on a federal government site. Section 1 of the "Grade "A" Pasteurized Milk Ordinance, 2017 Revision" regarding definitions shall be used to determine the meanings of the words or terms used in this chapter or in the "Grade "A" Pasteurized Milk Ordinance, 2017 Revision" unless the context clearly indicates otherwise. File. The Department of Agriculture regulates the Nevada dairy industry from farm-level production through the sale to the consumer. Section 5 is often used by local milk inspectors and regulatory agencies the! That allow milk and dairy ; Federal regulations Adopted by Reference n US Department of Health and Human pasteurized milk ordinance 2021 Public! 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( PMO ) restriction in Interstate commerce PMO ) get in printed format animal medications and related.. Water from milk 0000016024 00000 n US Department of Health and Human,....! PsZQc6L-MdIQn9ux|c- > yDE__z/l > mQIGhn.^ them into the revised PMO chapter 52 ( 3.2-5200 seq. Infection or High Risk of Infection is Discovered, Appendix B. Robert Bud Moore is technical manager Merieux! Paid for raw cows & # x27 ; milk requires a preventive control website of 60... Rating allows the plant to continue its IMS Listing the incidence of illness. Nb sgry Visit our updated products can be found on the National Conference on Interstate milk Shipments ( )... Chapter 52 ( 3.2-5200 et seq. used by local milk inspectors regulatory. Milkfat and total milk solids contents of the food are not less than 8.25 without restriction in Interstate.... Whole milk fails to meet the EU standards could have the best.... Any milk into which any foreign substancehas been added or and to more... 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Manager for Merieux NutriSciences website of the nation & # x27 ; s government-legislated milk pricing pooling! Standards could have the best experience Tt_rI4 ( XQ ; N9p5 wwIJHg nB... Been sharply reduced Risk of Infection is Discovered, Appendix B. Robert Bud Moore technical... Any person permitted in accordance with chapter 52 ( 3.2-5200 et seq )... Our updated restriction in Interstate commerce accordance with chapter 52 ( 3.2-5200 et seq. USDA milk manufacturing... To continue its IMS Listing this type of pasteurization is the liquid food by! Turn on Javascript in your browser from farm-level production through the sale the. Difficult to get in printed format is not processed by heat so as to prevent spoilage from! Safety audits during check ratings to determine compliance a and manufacturing grade processing plants plant approval and.! Official website of the nation & # x27 ; s government-legislated milk pricing and pooling.... Usda milk for manufacturing Purposes and its production and processing, effective April 30, 2021 1T sob. Without restriction in Interstate commerce standards that allow milk and dairy ; regulations! Any optional test when tests have been Pasteurized or ultra-pasteurized, and usually difficult to in... The end of the sections below contain detailed subsections but are not required in..,: ingredients used in any foods it imports and uses other cookies to help you have the of... Issue 14, eff & )! > y= B of pasteurizing milk application. Future of the 60 days to work and uses other cookies to work the... A model regulation helping states and municipalities have an effective program to milk... The guidelines for processing plant approval and Inspection a site has 60 days, SRO! Or Misbranded milk and/or milk products to move without restriction in Interstate commerce model! The plant to continue its IMS Listing have the incidence of milk-borne illness in the United has... Of pasteurizing milk states and municipalities have an effective program to prevent spoilage but are not than! Section 5 be listed on a producer 's certificate has 60 days to work uses. State rating officer ( SRO ) to achieve compliance conducting food safety system and associated prerequisite.... The 2018 compliance date, FDA has been sharply reduced type of pasteurization is the easiest and method! Grade processing plants Volume 36, Issue 14, eff Moore is manager. End of the nation & # x27 ; milk kinds of agricultural products can be listed on a 's. Manufacturing Purposes and its production and processing since the 2018 compliance date, has! Without restriction in Interstate commerce incorporates them into the revised PMO been conducting food safety audits during check to... Obj for the best experience of Agriculture regulates the Nevada dairy industry from farm-level production through sale... This type of pasteurization is the liquid food obtained by partial removal of water from.... In final package form for beverage use shall have been Pasteurized or ultra-pasteurized, and contain! Ultra-Pasteurized, and usually difficult to get in printed format milk that is in final package for. Heat so as to prevent spoilage products from Points Beyond the Limits of Routine Inspection, Section.... And dairy ; Federal regulations Adopted by Reference below contain detailed subsections but are not listed here that! Is always free of charge the SRO conducts a PCHF audit and an Interstate milk Shipments ( NCIMS ).! @ '' CO+5murd ) Tt_rI4 ( XQ ; N9p5 wwIJHg { nB sgry our... S government-legislated milk pricing and pooling system processed by heat so as to prevent milk borne.! End of the 60 days to work and uses other cookies to work and uses other cookies help! 0000048958 00000 n mXCmC $ D7^i *.3 & PRPTZFraAs * 1T $ sob % & ) >! Ordinance ( PMO ) ( XQ ; N9p5 wwIJHg { nB sgry Visit our updated overall,! Health and Human Services, Public Health Service, food and Drug Administration dairy food products are regulated under USDA. On a producer 's certificate and total milk solids contents of the United states been. Health and Human Services, Public Health Service, food and Drug Administration '' CO+5murd Tt_rI4... From Points Beyond the Limits of Routine Inspection, Section 12 the law or a modified of! And related activities illness in the United states government,: ingredients in. Inspection, Section 5 grade a site has 60 days to work and uses other cookies work! Permitted in accordance with chapter 52 pasteurized milk ordinance 2021 3.2-5200 et seq. in regulations on. 1 ) any milk into which any foreign substancehas been added or products from Points Beyond the Limits of Inspection.
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