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CFSAN/Office of Compliance
March 2, 2004

Grade "A" Pasteurized Milk Ordinance (2003 Revision)

Appendices J through K

Appendix J | Appendix K
(Table of Contents)

Appendix J. Standards for the Fabrication of Single-Service Containers and Closures for Milk and Milk Products

PREFACE

Single-service containers and closures have been used in the dairy industry for many years. Industry applied quality assurance controls for manufacturing and handling of the materials have made it possible for these products to reach the point of use in a sanitary condition free from toxic materials, which may migrate into milk or milk products.

Within recent years, single-service container manufacturers have introduced new materials, equipment, and design concepts for these containers and closures. Evaluation of the industry's basic manufacturing and handling techniques and establishment of sanitation criteria assure that single-service containers and closures and the materials from which they are formed are safe and in compliance with bacteriological standards of Item 12p of this Ordinance.

STANDARDS FOR THE FABRICATION OF SINGLE-SERVICE CONTAINERS AND CLOSURES FOR MILK AND MILK PRODUCTS

A. PURPOSE AND SCOPE

The use of these Standards will ensure the production of sanitary containers and closures for milk and milk products, as defined in this Ordinance.

These Standards shall apply to all blank fabricators, pre-form bottle manufacturers, converters, printers, closure manufacturers, plastic laminators, sheet formers, blow molders, vacuum formers, plastic extruders, injection molders, pre-formers, manufacturers of valves, tubes, dispensing devices, sample containers and any other similar plants. These also apply to fabricating plants producing a component part(s), including fabricators of film and/or closures, which may become a product-contact surface and plants assembling components into a final assembled product. These requirements shall not apply to paper mills or resin manufacturing plants.

Milk and food plants manufacturing and/or selling containers to other milk plants, as defined in this Ordinance, excluding milk plants that condense and/or dry milk or milk products, shall meet all the requirements of these Standards.

Grade "A" milk plants, as defined in this Ordinance, excluding milk plants that condense and/or dry milk or milk products, shall use single-service containers and closures from plants certified in the latest semi-annual publication of the IMS List.

These Standards provide certain criteria for the listing of certified single-service manufacturers in the current publication of the IMS List. (Refer to Section E.)

B. DEFINITIONS

The following definitions shall be employed in the application of these sanitation Standards:

"Broke and Trim" shall mean paper and paperboard that have been discarded anywhere in the process of manufacture, such as on paper-making machines in the form of trim. This may also include unprinted trim from the converting process, provided the trim has been handled, treated and transported in a clean, sanitary manner.
"Closure" shall mean a cap, lid, seal, tube, valve, lid material or other device in or on a container used for the purpose of enclosing or dispensing the contents.
"Coatings" shall mean any layer or covering which is applied to the product-contact surface
"Component Part" shall mean any item that by itself, does not perform any function, but when assembled with one (1) or more component parts or closures, becomes a part of the single-service container or closure. These may include, but are not limited to blanks, sheeting, valves and valve parts, tubes, dispensing devices and sampling containers. All material used for fabrication of a component part must meet the requirements of the FFD&CA as amended.
"Manufacturer" shall mean any person or company in the business of manufacturing a single-service container or closure for the packaging or sampling of a Grade "A" milk or milk product.
"Manufacturing Line" shall mean a manufacturing process such as injection molding, extrusion, blow-molding, etc.
"Metals" shall mean those metals that are non-toxic, nonabsorbent and corrosion-resistant under conditions of intended use.
"Non-toxic Materials" shall mean materials that are free of substances, which may render the product injurious to health or which may adversely affect the flavor, odor, composition or bacteriological quality of the product and meet the requirements of the FFD&CA as amended.
"Paper Stock" shall mean any paper made from the following materials:
1. Paper and paperboard manufactured from clean, sanitary virgin chemical or mechanical pulp or from "broke and trim" of such paper and paperboard, provided they have been handled, treated and stored in a clean, sanitary manner, or reclaimed fiber using acceptable or approved protocol in compliance with 21 CFR 176.260; and
2. Components meeting the requirements of the FFD&CA as amended.
"Plastic Molding, Forming, Extrusion, and Laminating Resins" shall mean:
1. Resins or an intimate admixture of resins with other ingredients, which meet the requirements of the FFD&CA as amended;
2. Plastic composed solely of clean cuttings or regrind, provided they have been handled and maintained in a clean, sanitary manner; and
3. Recycled plastic material when it complies with a protocol that has been reviewed and accepted by FDA.
"Pre-forms" shall mean a component not in final form for filling.
"Product-Contact Surface" shall mean those surfaces of the container or closure with which the product comes in contact with.
"Production Scrap" shall mean material which remains from the manufacture of single-service containers or closures, that has been handled or treated in such a manner that it does not comply with the definition for "broke and trim" or "regrind", but may be collected for recycling. It may contain material such as containers or trim that have fallen on the floor.
"Regrind" shall mean clean plastic material that is trimmed from the container or closure, and imperfectly formed containers or closures, which result from the manufacture of single-service containers and closures, provided it is handled in a clean, sanitary manner. This may be in its trimmed or molded form and ground in a suitable grinder within the plant. It shall not include any material, container or closure which comes from an unapproved source or whose source, chemical content or treatment is unknown, or which may have poisonous or deleterious material retained in the plastic, which migrates to the food at levels exceeding regulatory levels. Regrind, when transported from one (1) approved plant to another, shall be shipped in suitable, clean, sealed, properly labeled containers. This definition shall not preclude the use of regrind plastic material when it complies with a protocol that has been reviewed and accepted by FDA.
"Sample Set" shall mean:
1. For the rinse test, a minimum of four (4) containers shall be tested.
2. For the swab test, a minimum of four (4), 50 square centimeter areas of surface from separate containers shall be tested. In the case of containers or closures with a product-contact surface area smaller than 50 square centimeters, more than four (4) containers or closures to equal at least 50 square centimeters times four (4) will be required to be swabbed.
"Sanitization" shall mean the application of any effective method or substance to properly cleaned surfaces for the destruction of pathogens and other microorganisms as far as is practicable. Such treatment shall not adversely affect the equipment, the milk and/or milk product, or the health of consumers, and shall be acceptable to the Regulatory Agency. Methods of sanitization shall meet the requirements contained in Appendix F. of this Ordinance.
"Single-Service Articles" shall mean articles that are constructed wholly, in part, or in combination from paper, paperboard, molded pulp, plastic, metals, coatings or similar materials and intended by the manufacturer for one (1) usage only.
"Single-Service Container" shall mean any container having a milk or milk product-contact surface and used in the packaging, handling or storage of Grade "A" milk and milk products which is intended for one (1) use only.

C. BACTERIAL STANDARDS AND EXAMINATION OF SINGLE-SERVICE CONTAINERS AND CLOSURES

Paper stock shall meet the bacteriological standard of not more than two hundred fifty (250) colonies per gram as determined by the disintegration test. The paper stock supplier shall certify that their paper stock was manufactured in compliance with this Standard. This applies only to the paper stock prior to lamination.
Where a rinse test can be used, the residual microbial count shall not exceed fifty (50) per container, except that in containers less than 100 mL, the count shall not exceed ten (10), or when using the swab test, not over fifty (50) colonies per 8 square inches (1 per square centimeter) of product-contact surface in three (3) out of four (4) samples taken at random on a given day. All single-service containers and closures shall be free of coliform organisms.
During any consecutive six (6) months, at least four (4) sample sets shall be collected in at least four (4) separate months, except when three (3) months show a month containing two (2) sampling dates separated by at least twenty (20) days, and analyzed at an Official, Commercial or Industry Laboratory approved by the State Milk Laboratory Certifying Agency specifically for the examinations required under these Standards. (Refer to Item 12p of this Ordinance for sampling of containers and closures in milk plants.)
When a single-service container or closure is made from one (1) or more component parts as defined in this document, only those final assembled products that may have product-contact surface (s), must be sampled and tested for compliance with Section C.
A sample set from each manufacturing line, as defined in these Standards, shall consist of a minimum of four (4) containers or closures, when the rinse test is used, or a minimum of four (4) 50 square centimeters (cm²) areas of surface, when the swab test is used.
The following criteria pertains to manufacturers of pre-forms and bottles preformed at one (1) plant and molded at a second plant:
1. The pre-forming plant must be IMS Listed but sampling of the pre-forms is not required at this plant.
2. If the first pre-forming plant is also molding the containers into their final form, this plant must be listed and the containers must be sampled at this plant.
3. If the second plant, where containers are molded into their final form, is a single-service manufacturer, this plant must be listed and the containers must be sampled at this plant.
4. If the second plant is a milk plant where containers are molded into their final form, for use only in that milk plant, the milk plant listing is sufficient, but the containers must be sampled at this plant.

Procedures for obtaining samples and for the laboratory examination of these products are contained in the latest edition of SMEDP and shall be in substantial compliance with these methods. Such procedures and examinations shall be evaluated in accordance with the current revision of the EML. A list of approved laboratories may be found in the current IMS List, which is published by FDA and available on the Internet at www.fda.gov.

D. FABRICATION PLANT STANDARDS

NOTE: To be used in conjunction with Form FDA 2359c-SINGLE-SERVICE MANUFACTURING PLANT INSPECTION REPORT. (Refer to Appendix M.)

FLOORS
1. The floors of all fabricating areas shall be smooth, impervious, and maintained in a state of good repair. The floors of storage rooms may be constructed of tightly joined wood.
2. The joints between the walls and floor shall be tight, impervious and shall have coved or sealed joints.
3. Where floor drains are provided, they shall be properly trapped and floors sloped to drain.
WALLS AND CEILINGS
1. Walls and ceilings of fabricating areas shall have a smooth, cleanable, light-colored surface.
2. Walls and ceilings in fabricating and storage areas shall be kept in good repair.
3. The opening around pipes, tubes and similar items that extend through the walls and/or ceiling shall be effectively sealed.
DOORS AND WINDOWS
1. All outside openings shall be effectively protected against the entry of insects, rodents, dust and airborne contamination.
2. All outer doors shall be tight and self-closing.
LIGHTING AND VENTILATION
1. All rooms shall be adequately lighted either by natural light, artificial light, or both. A minimum of twenty (20) foot-candles (220 lux) should be maintained in fabricating areas and five (5) foot-candles (55 lux) in storage areas. Packaging, sealing, wrapping, labeling and similar procedures are considered part of the fabricating area.
2. Ventilation shall be sufficient to prevent excessive odors and the formation of excessive water condensation.
3. The intake of all pressure ventilation systems in fabricating areas, whether they are positive or exhaust shall be properly filtered.
SEPARATE ROOMS
1. All fabricating areas shall be separate from non-fabricating areas to protect against contamination. Provided, that if the entire plant meets all sanitation requirements and no source of cross contamination exists, separation between areas is not required.
2. All regrinding of plastic and the shredding, packaging or baling of paper trim shall be conducted in rooms separate from the fabricating room, except that they may be conducted within the fabricating room, provided such operations are kept clean and free of dust.
TOILET FACILITIES - SEWAGE DISPOSAL
1. Disposal of sewage and other wastes shall be in a public sewage system or in a manner in compliance with Local and State regulations.
2. All plumbing shall comply with the Local and State plumbing regulations.
3. Toilet rooms shall have solid, tight-fitting doors that are self-closing.
4. The toilet room and fixtures shall be maintained in a clean and sanitary condition and kept in good repair.
5. Each toilet room shall be well lighted and adequately ventilated. Air ventilation ducts from toilet facilities shall vent to the outside.
6. Proper handwashing facilities with hot and cold and/or warm running water shall be provided in toilet rooms.
7. All windows shall be effectively screened when open.
8. Signs shall be posted in all toilet rooms reminding employees to wash their hands before returning to work.
9. Eating and/or storage of food are prohibited in toilet rooms.
WATER SUPPLY
1. The water supply, if from a public system, shall be approved as safe by the State Water Control Authority responsible for water quality, and in the case of individual water systems, comply with at least the specifications outlined in Appendix D. and the bacteriological standards outlined in Appendix G. of this Ordinance.
2. There shall be no cross-connection between a safe water supply and any unsafe or questionable water supply or any source of pollution through which the safe water supply might become contaminated.
3. Samples for bacteriological testing of individual water supplies are taken upon the initial approval of the physical structure; each twelve (12) months thereafter; and when any repair or alteration of the water supply system has been made. The examination of the sample shall be conducted in an Officially Designated Laboratory.
4. ater baths utilizing recirculated water for cooling product-contact surfaces shall comply with the bacteriological standards outlined in Appendix G. of this Ordinance and shall be tested semi-annually.
5. Records of all required water tests shall be maintained at a location acceptable to the Rating/Regulatory Agency for a period of two (2) years.
HANDWASHING FACILITIES
1. Hot and cold and/or warm running water, soap, air dryers or individual sanitary towels shall be convenient to all fabricating areas. Provided, that solvent or soft soap dispensers, containing sanitizers, may be used if water is not available. When individual sanitary towels are used, covered trash containers shall be provided.
2. Handwashing facilities shall be kept clean.
PLANT CLEANLINESS
1. The floors, walls, ceilings, overhead beams, fixtures, pipes and ducts of production, storage, regrind, baling and compacting rooms shall be clean.
2. All production areas, warehouse, toilet, lunch and locker rooms shall be free of evidence of insects, rodents, and birds.
3. Machines and appurtenances shall be kept clean. Provided, that minor accumulations of paper, plastic or metal dust and other production soils incidental to normal fabricating operations do not violate this requirement.
LOCKER AND LUNCHROOMS
1. Locker and lunchrooms shall be separate from plant operations and be equipped with self-closing doors.
2. Eating and/or storage of food are prohibited in fabricating and storage areas.
3. Locker and lunchrooms shall be kept in a clean and sanitary condition.
4. Cleanable refuse containers, properly labeled, shall be provided, which are covered, impervious, leak-proof and readily accessible.
5. Proper handwashing facilities shall be convenient to locker and lunchrooms.
6. Signs shall be posted reminding employees to wash their hands before returning to work.
DISPOSAL OF WASTES
1. All refuse and garbage shall be stored in covered, impervious and leak-proof containers. This requirement does not pertain to production scrap.
2. All waste containers shall be clearly labeled for their intended purpose and contents.
3. Where possible, garbage and assorted rubbish should be stored outside the building in covered, impervious, cleanable containers. If stored inside the building, it must be contained in similar receptacles, but in an area separate from fabricating areas.
PERSONNEL - PRACTICES
1. Hands shall be thoroughly washed before commencing plant functions and as often as may be required to remove soil and contamination, and before returning to work after visiting the toilet room or lunchroom.
2. All personnel shall wear clean outer garments and effective hair restraints.
3. No person affected with any disease in a communicable form, or while a carrier of such disease, and no person with an infected cut or lesion shall work in any processing area in any capacity where there is a likelihood of such person contaminating product or product-contact surfaces with pathogenic organisms. (Refer to Sections 13 and 14 of this Ordinance)
4. The use of tobacco products is prohibited in fabricating, regrind and storage areas.
5. Insecured jewelry shall not be permitted in fabricating areas.
PROTECTION FROM CONTAMINATION
1. All product-contact surfaces of containers, closures and all materials in process are covered or otherwise protected to prevent the access of insects, dust, condensation and other contamination.
2. Whenever air under pressure is directed at resin, regrind, colorants and similar materials or a product-contact surface, it shall be free of oil, dust, rust, excessive moisture, extraneous materials and odor and shall otherwise comply with the applicable requirements of Appendix H. of this Ordinance.
3. Air that is directed at product or product-contact surfaces by fans or blowers shall be filtered and shall otherwise comply with the applicable requirements of Appendix H. of this Ordinance.
4. Only pesticides approved for use in food plants and registered with the EPA shall be used for insect and rodent control.
5. Pesticides shall be used in accordance with the manufacturer's directions and used so as to preclude the contamination of containers or closures.
6. Single-service articles in process shall be protected from contamination by use of a single-service cover sheet or other protective device. This includes chipboard, dividers, separators, bags and other items that can become contact surfaces.
7. Single-service containers and closures for milk and milk products shall not be fabricated on equipment used for the manufacture of products made of non-food-grade materials, unless such equipment has been thoroughly cleaned and/or purged of all non-food-grade material by a process that will not contaminate the food-grade material.
8. The manufacture of single-service containers and closures for milk and milk products shall be carried on in such a manner that there will be no cross contamination of raw material or regrind with non-food-grade materials.
9. Equipment and operations are so located within the plant as to prevent overcrowding and allow for cleaning and maintenance procedures.
10. All toxic chemicals, including cleaning and maintenance compounds, shall be adequately segregated from raw materials and finished product.
11. Food containers manufactured by the facility shall not be used for storing miscellaneous items or chemicals.
STORAGE OF MATERIALS AND FINISHED PRODUCT
1. Blanks, roll stock and all other single-service containers, closures and articles shall be stored off the floor by use of pallets, slip-sheets or other methods and away from any wall a sufficient distance to facilitate inspection, cleaning and pest control activities. Any roll stock having dirty or soiled outer turns and/or edges shall have sufficient turns discarded prior to use and the edges trimmed to provide protection from contamination.
2. Appropriate clean, dry storage facilities shall be provided for single-service containers, closures, paper for wrapping, adhesives, blanks and other production material to provide protection from splash, insects, dust and other contamination.
3. Where containers and closures are pre-formed in plants other than the original fabricating facility:
  1. (1) Containers, blanks and closures shall be stored in the original cartons and sealed until used; and
  2. (2) Partially used cartons of containers, blanks and closures shall be resealed until used.
4. Containers used for the storage of resin and other raw materials, regrind, broke and trim, intended for use in the process, shall be covered, clean, impervious and properly identified. Reuse of storage containers, such as gaylords, is permitted provided single-use plastic liners are used.
5. In-process storage bins that touch the product-contact surface of containers or closures shall be constructed of cleanable, nonabsorbent material and kept clean.
FABRICATING EQUIPMENT
The requirements of this Section pertain to all equipment and processes used in the fabrication of containers and closures, irrespective of the materials used and whether or not mentioned herein. Some of this equipment includes grinders, rollers, reamers and cutters, molders and fittings, extruders, silos, resin bins and hoppers, printing equipment, blanking equipment and sealing equipment.
1. Rolls, dies, belts, tables, mandrels, transfer tubing and all other contact surfaces shall be kept clean, sanitary and reasonably free of accumulation of paper, plastic or metal dust and other production soils. Equipment designed for milk plant use, which is utilized for pre-forming containers, shall be clean and sanitized prior to operation.
2. Makeshift devices such as tape, rope, twine, paperboards, etc., shall not be used. All fasteners, guides, hangers, supports and baffles shall be constructed of impervious, cleanable materials and kept in good repair.
3. Take-off tables and other container contact surfaces shall be constructed of cleanable material, kept clean and in good repair.
4. All grinders, shredders and similar equipment used for regrinding shall be installed above the floor or installed in such a manner that they are protected, so that floor sweepings and other contaminants cannot enter the grinder or shredder.
5. Storage tanks, silos, gaylords or bins used for plastic resins shall be so constructed to protect the resin from contamination. All air vents shall be filtered to prevent the entrance of dust, dirt, or insects. Air tubes used to convey resin shall be in good repair and installed in such a manner that protects the resin from contamination. Air tubes used to convey resin shall have end caps, attached by a chain or cable that prevents contamination. This Item also applies to all raw materials handled in like manner.
MATERIALS FOR CONSTRUCTION OF CONTAINERS AND CLOSURES
1. Only plastic sheeting and extrusions, plastic laminated paper, roll stock, component part(s), molded or formed parts, metal and paperboard blanks, or combinations thereof, from a manufacturing and/or fabricating plant conforming to these Standards, shall be used. Fabricating plants listed in the current IMS List shall be considered in compliance with this Item.
2. Only food-grade, non-toxic lubricants shall be used on container or closure-contact surfaces. Excess lubricant shall be removed from surfaces close to shafts, rollers, bearing sleeves and mandrels. These lubricants shall be handled and stored in a manner that will prevent cross contamination with non-food-grade lubricants. Such storage areas shall be clean and adequately ventilated.
3. Containers, resin and flashing on the floor, floor sweepings of production materials and production scrap are prohibited from being reused. This shall not preclude the use of these materials when they comply with a recycling protocol that has been reviewed and accepted by FDA.
WAXES, ADHESIVES, SEALANTS, COATINGS AND INKS
1. Waxes, adhesives, sealants, coatings and inks used for containers and closures shall be handled and stored in a manner that will prevent cross contamination with similar non-food-grade materials. Such storage areas shall be clean and adequately ventilated.
2. Unused materials shall be covered, labeled and properly stored.
3. Waxes, adhesives, sealants, coatings and inks shall not impart odor or taste to the milk or milk products and shall not contaminate the product with microorganisms or toxic or injurious substances. All materials that are applied to the product-contact surface shall comply with the requirements of 21 CFR Parts 175-178.
4. Transfer containers shall be kept clean and shall be properly identified and covered.
5. Waxing shall be performed so as to assure that containers or closures are completely coated and the wax shall be kept at a temperature of 60°C (140°F) or higher.
HANDLING OF CONTAINERS AND EQUIPMENT
1. Handling container and closure surfaces shall be kept to a minimum.
2. Handlers shall sanitize their hands frequently or wear clean, single-use gloves. Hand sanitizing dispensers, if used, shall be located convenient to all operations involving manual contact.
WRAPPING AND SHIPPING
1. Blanks, closures, halves, nested or pre-formed containers and parts such as valves, hoses, tubes and other fittings shall be properly packaged or containerized prior to shipping.
2. The outer package or containerized units shall protect the contents from dust and other contamination.
3. Transportation vehicles used to ship finished materials from the single-service container or closure plant or within the plant shall be clean and in good repair and shall not have been used for the transportation of garbage, waste or toxic materials.
4. Paperboard containers, wrappers, and dividers that contact the surface of the container or closure shall not be reused for this purpose.
5. All packaging materials that contact the product-contact surface of the container or closure shall comply with the requirements of 21 CFR Parts 175-178 and the bacteriological standards of Section C of these Standards, but the materials do not have to be manufactured at a listed single-service plant. Some outer packaging material such as corrugated cardboard boxes used for the packaging of milk carton flats, are exempt from this bacteriological standard. The edges of these flats are subject to heat during the forming and sealing of the container.
IDENTIFICATION AND RECORDS
1. Outer wrappings shall be identified with the name and city of the plant where the contents are fabricated, except those manufactured in, and which are only for use in the same facility. Where several plants are operated by one (1) firm, the common firm name may be utilized, provided that the location of the plant at which the contents were fabricated is also shown either directly or by the Federal Information Processing Standards (FIPS) numerical code on the outer wrapper.
2. Records of all required bacteriological tests of containers and closures shall be maintained at the plant of manufacture for two years and results shall be in compliance with Section C of these Standards.
3. It is the responsibility of the inspected/certified and listed plant to maintain records verifying the bacterial and chemical safety of all component parts utilized in the final assembled product.
4. The fabricating plant shall have on file information from suppliers of raw material, waxes, adhesives, sealants, coatings and inks indicating that the material complies with the requirements of 21 CFR Parts 175 - 178.
5. The fabricating plant shall have on file information from the suppliers of packaging materials specified in these Standards indicating that the material complies with the requirements of 21 CFR Parts 175-178 and the bacteriological standards of Section C. of these Standards. There are no specifications for sampling frequency. The Regulatory Agency may choose to collect samples of packaging materials to determine compliance with bacteriological standards of this Section.
6. Multi-plant corporations may have all the required information at a central location as long as it can be transmitted to the site upon request.
SURROUNDINGS
1. Exterior surroundings shall be neat and clean and free from conditions that might attract or harbor flies, other insects and rodents.
2. Driveways, lanes and areas serving the plant vehicular traffic are graded, drained and free from pools of standing water.

E. CRITERIA FOR LISTING CERTIFIED SINGLE-SERVICE
MANUFACTURERS IN THE IMS LIST

Historically, certification of manufacturers of single-service containers and related products has been for one (1) year. In addition, a 90-day grace period was provided for the transmission of the Report of Certification through the proper channels to Milk Safety Branch (HFS-626) to provide for the lag time for printing the in IMS List.

The following criteria have been developed to allow Rating and/or Regulatory Agencies flexibility in evaluating and listing single-service manufacturing plants.

Rating and/or Regulatory Agencies may choose from the following list of criteria for listing certified single-service manufacturers:

Single-service manufacturers that operate in conjunction with an IMS Listed milk plant may be listed for twenty-four (24) months, if the single-service plant is inspected at least quarterly, using Form FDA 2359c-Manufacturing Plant Inspection Report, and records of such inspections and all required tests are maintained by the Regulatory Agency. The permit for the milk plant shall also include the inspection of the single-service manufacturing areas.
Single-service manufacturers that operate in conjunction with an IMS Listed milk plant and are not inspected at least quarterly and/or are not included under a permit system may be optionally listed for twelve (12) months, plus a 90-day grace period after an evaluation.
Single-service manufacturers that operate as a separate entity may be listed for twenty-four (24) months, if the Regulatory Agency has a permit system and inspects the plant using Form FDA 2359c at least quarterly. All testing of containers and individual water supplies shall be under the direction of the Regulatory Agency and kept on file.
Single-service manufacturers that operate as a separate entity and are not inspected by Regulatory Agency personnel at least quarterly and/or do not have a permit system may be optionally listed for twelve (12) months, plus a 90-day grace period, after an evaluation.

Appendix K. HACCP Program

I. THE HACCP SYSTEM INTRODUCTION

HISTORY OF HACCP: The use of the HACCP System is not new to the dairy industry. HACCP is a logical, simple, effective, but highly structured system of food safety control.

The HACCP System was introduced to the food industry as a spin-off of the space program during the 1960's. The National Aeronautics and Space Administration (NASA) used HACCP to provide assurance of the highest quality available for components of space vehicles. This program, to develop assurance of product reliability, was carried over into the development of foods for astronauts.

The U.S. Army Natick Laboratories, in conjunction with NASA, began to develop the foods needed for manned space exploration. They contracted with the Pillsbury Company to design and produce the first foods used in space. While Pillsbury struggled with certain problems, such as how to keep food from crumbling in zero gravity, they also undertook the task to come as close as possible to 100% assurance that the foods they produced would be free of bacterial or viral pathogens.

Using traditional quality control methods for the food industry was soon proven to be unworkable for the task Pillsbury had undertaken. The degree of safety desired was not provided by the current programs, and the product sampling necessary to provide an adequate degree of safety would have been prohibitive to commercialization of space foods. Pillsbury discarded its standard quality control methods and began an extensive evaluation, in conjunction with NASA and Natick Labs, to evaluate food safety. They soon realized that to be successful they would have to have control over their process, raw materials, environment, and their people. In 1971, they introduced HACCP as a preventive system that enables manufacturers to produce foods with a high degree of assurance that the foods were produced safely.

BACKGROUND: HACCP is a management tool that provides a structured and scientific approach to the control of identified hazards. HACCP is a logical basis for better decision-making with respect to product safety. HACCP has international recognition as an effective means of controlling food safety hazards and is endorsed as such by the joint Food and Agriculture Organization of the World Health Organization (FAO)/World Health Organization (WHO) Codex Alimentarius Commission. The U.S. National Advisory Committee on Microbiological Criteria for Foods (NACMCF) has also endorsed it.

The HACCP concept will enable those operating under and regulating under a HACCP Plan to move to a preventive approach, whereby potential hazards are identified and controlled in the manufacturing environment, i.e., prevention of product failure. HACCP allows for a preventive, systematic approach to food safety.

VOLUNTARY PARTICIPATION: This Appendix describes a voluntary, NCIMS HACCP Program alternative to the traditional inspection system. No milk plant, receiving station or transfer station may participate in the voluntary NCIMS HACCP Program unless the Regulatory Agency responsible for the oversight of the facility agrees to participate with the dairy plant(s), receiving station(s) and transfer station(s) in the NCIMS HACCP Program. Both parties must provide written commitment to each other that the necessary resources to support participation in the NCIMS HACCP Program will be made available. Management responsible for both the State and dairy plant, receiving station or transfer station must be willing to provide the resources needed to develop and implement a successful HACCP System.

HACCP PRINCIPLES: Following are the seven (7) HACCP principles to be included in a HACCP Plan:

Conduct a hazard analysis;
Determine the critical control points;
Establish critical limits;
Establish monitoring procedures;
Establish corrective actions;
Establish verification procedures; and
Establish record-keeping and documentation procedures.

PREREQUISITE PROGRAMS (PPs): Prior to the implementation of a HACCP Plan, there is a requirement for dairy plants, receiving stations and transfer stations to develop, document and implement written PPs. PPs provide the basic environment and operating conditions that are necessary for the production of safe, wholesome food. Many of the conditions and practices are specified in Federal and State regulations and guidelines.

PPs, and the HACCP System in total, address public health concerns such as those identified in 21 CFR Part 7, Recalls; Part 110, Good Manufacturing Practices (GMPs); Part 113, Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers; Part 131, Milk and Cream; the Grade "A" PMO; and the current edition of the NACMCF HACCP Principles and Application Guidelines.

SUMMARY: The seven (7) principles of HACCP are also called the HACCP Plan. When combined with the PPs, they constitute a HACCP System. The NCIMS HACCP Program described in this Appendix includes the HACCP System and other prescribed Grade "A" PMO criteria, such as drug residue testing and traceback; use of milk only from supplies that have been awarded a milk sanitation compliance rating of 90% or better or from an acceptable IMS HACCP listed source; and the labeling requirements of Section 4. When properly implemented, the HACCP program described in this Appendix will provide assurance of milk and milk product safety that is equivalent to that provided under the traditional inspection system.

II. IMPLEMENTATION OF A HACCP SYSTEM

PRELIMINARY STEPS: Preliminary steps as listed in the NACMCF document should be followed when producing a HACCP Plan. Complete, up-to-date process flow diagrams are required for all milk and milk products manufactured. Flow diagrams may be combined when processes, products and hazards are similar.

PREREQUISITE PROGRAM: HACCP is not a stand-alone program, but is part of a larger control system. PPs are the universal procedures used to control the conditions of the milk plant environment that contribute to the overall safety of the milk or milk product. They represent the sum of programs, practices and procedures that must be applied to produce and distribute safe milk and milk products in a clean, sanitary environment. They differ from CCPs in that they are basic sanitation programs that reduce the potential occurrence of a milk or milk product safety hazard. Frequently, both HACCP Plan CCPs and PPs control measures are necessary to control a food safety hazard.

HACCP may be implemented only in a facility that is constructed and operated to provide a sanitary environment. Milk plant, receiving station or transfer station premises, building construction, maintenance, and housekeeping shall be maintained in a manner sufficient to provide such an environment. These factors shall be controlled by effective milk plant, receiving station or transfer station programs or by PPs, as the milk plant, receiving station or transfer station chooses.

The exact set of PPs will vary since their application is milk or milk product and process specific. The existence and effectiveness of PPs should be assessed during the design and implementation of each HACCP Plan. PPs should be documented and regularly audited. An audit review consists of verifying that the company has a program implemented that indicates how the company monitors and controls each of the PPs. PPs are established and managed separately from the HACCP Plan.

Required PPs: The following required PPs shall have a brief written description or checklist that the PPs can be audited against to ensure compliance. PPs shall include procedures that can be monitored; records that specify what is monitored; and how often it will be monitored.
Each milk plant, receiving station or transfer station shall have and implement PPs that address conditions and practices before, during, and after processing. The PPs shall address:
1. Safety of the water that comes into contact with milk or milk products or product-contact surfaces, including steam and ice;
2. Condition and cleanliness of equipment product-contact surface;
3. Prevention of cross-contamination from insanitary objects and or practices to milk or milk products or product-contact surfaces, packaging material and other food-contact surfaces, including utensils, gloves, outer garments, etc., and from raw product to processed product;
4. Maintenance of handwashing, hand sanitizing, and toilet facilities;
5. Protection of milk or milk product, packaging material, and product-contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate and other chemical, physical and biological contaminants;
6. Proper labeling, storage, and use of toxic compounds;
7. Control of employee health conditions, including employee exposure to high risk situations, that could result in the microbiological contamination of milk or milk products, packaging materials, and product-contact surfaces; and
8. Pest exclusion from the milk plant.
In addition to the required PPs specified above, any other PPs that are being relied upon in the Hazard Analysis to reduce the likelihood of hazards such that they are not reasonably likely to occur, shall also be monitored, audited, and documented as required PPs.
Monitoring and Correction: The milk plant, receiving station or transfer station shall monitor the conditions and practices of all required PPs with sufficient frequency to ensure conformance with those conditions and that are appropriate both to the milk plant, receiving station or transfer station and to the safety of the milk or milk product being processed. Each milk plant, receiving station or transfer station shall document the correction of those conditions and practices that are not in conformance. Devices, such as indicating and recording thermometers that are used to monitor PPs shall be calibrated to assure accuracy at a frequency determined by the milk plant, receiving station, or transfer station.
Required Records: Each milk plant, receiving station or transfer station shall maintain records that document the monitoring and corrections required by this Appendix. These records are subject to the record keeping requirements of this Appendix.

HAZARD ANALYSIS: Each milk plant, receiving station or transfer station shall develop, or have developed for it, a written hazard analysis to determine whether there are milk or milk product hazards that are reasonably likely to occur for each type of milk or milk product processed or handled by the milk plant, receiving station or transfer station and to identify the control measures that the milk plant, receiving station or transfer station can apply to control those hazards.

The hazard analysis shall include hazards that can be introduced both within and outside the milk plant, receiving station or transfer station environment, including hazards that can occur during handling, transportation, processing and distribution.

A hazard that is reasonably likely to occur is one for which a prudent milk plant, receiving station or transfer station operator would establish controls because experience, illness data, scientific reports, or other information provide a basis to conclude that there is a reasonable possibility that, in the absence of these controls, the hazard will occur in the particular type of milk or milk product being processed. The hazard analysis shall be developed by an individual(s) trained in accordance with this Appendix and shall be subject to the record keeping requirements as described in this Appendix.

In evaluating what milk or milk product hazards are reasonably likely to occur, at a minimum, consideration should be given to the following:
1. Microbiological contamination;
2. Parasites;
3. Chemical contamination;
4. Unlawful drug and pesticide residues;
5. Natural toxins;
6. Unapproved use of food or color additives;
7. Presence of undeclared ingredients that may be allergens; and
8. Physical hazards.
Milk plant, receiving station or transfer station operators should evaluate product ingredients, processing procedures, packaging, storage, and intended use; facility and equipment function and design; and milk plant sanitation, including employee hygiene, to determine the potential effect of each on the safety of the finished milk or milk product for the intended consumer.

HACCP PLAN:

HACCP Plan: Every milk plant, receiving station or transfer station shall have and implement a written HACCP Plan whenever a hazard analysis reveals one (1) or more hazards that are reasonably likely to occur. The HACCP Plan shall be developed by an individual(s) who has been trained and shall be subject to record keeping requirements in accordance with this Appendix. A HACCP Plan shall be specific to each location and milk or milk product. The plan may group similar types of milk and milk products together, or similar types of production methods together, if the hazards, CCPs, CLs, and procedures required to be identified and performed by 2. of this Section are essentially identical, provided that any required features of the plan that are unique to a specific milk or milk product or method are clearly delineated in the plan and are observed in practice.
Contents of the HACCP Plan: The HACCP Plan shall, at a minimum:
1. Include complete up-to-date process flow diagrams for all milk and milk products manufactured. Flow diagrams may be combined when processes, milk and milk products and hazards are similar.
2. List all hazards that are reasonably likely to occur as identified in the hazard analysis specified above, and that must be controlled for each type of milk or milk product.
3. List the CCPs for each of the identified hazards, including the appropriate:
  1. (1) CCPs designed to control hazards that could occur or could be introduced in the milk plant, receiving station or transfer station environment;
  2. (2) CCPs designed to control hazards introduced outside the milk plant, receiving station or transfer station environment, including hazards that occur before arriving at the milk plant, receiving station and/or transfer station; and
  3. (3) List the CLs that shall be met at each of the CCPs.
4. List the procedures and the frequency with which they are to be performed that will be used to monitor each of the CCPs to ensure compliance with the CLs;
5. Include any corrective action plans that have been developed in accordance with the corrective action requirements as described in this Appendix, and that are to be followed in response to deviations from CLs at CCPs;
6. List the verification and validation procedures, and the frequency with which they are to be performed, that the milk plant, receiving station or transfer station will use in accordance with verification and validation requirements as described in this Appendix; and
7. Provide a record keeping system that documents the monitoring of the CCPs in accordance with the record requirements as described in this Appendix. The records shall contain the actual values and observations obtained during monitoring.
Sanitation: Sanitation controls may be included in the HACCP Plan. However, to the extent that they are monitored in accordance with the PPs, they need not be included in the HACCP Plan.

CORRECTIVE ACTIONS: Whenever a deviation from a CL occurs, a milk plant, receiving station or transfer station shall take corrective action by following the procedures set forth in 1. or 2. of this Section.

Milk plants, receiving stations or transfer stations may develop written corrective action plans, which become a part of their HACCP Plan(s), in accordance with this Appendix. These corrective action plans may predetermine the corrective actions that milk plants, receiving stations and transfer stations will take whenever there is a deviation from a CL. A corrective action plan that is appropriate for a particular deviation is one (1) that describes the steps to be taken and assigns responsibility for taking those steps, to ensure that:
1. No milk or milk product is allowed to enter commerce that is either injurious to health or is otherwise adulterated as a result of the deviation; or
2. If such milk or milk product has entered commerce, it is expeditiously removed; and
3. The cause of the deviation is corrected.
When a deviation from a CL occurs, and the milk plant, receiving station or transfer station does not have a corrective action plan that is appropriate for that deviation, the milk plant, receiving station or transfer station shall:
1. Segregate and hold the affected milk or milk product, at least until the requirements of paragraphs 2.b and 2.c of this Section are met;
2. Perform or obtain a review to determine the acceptability of the affected milk or milk product for distribution. The review shall be performed by an individual or individuals qualified by training or experience to perform such a review;
3. Take corrective action, when necessary, with respect to the affected milk or milk product to ensure that no milk or milk product is allowed to enter commerce that is either injurious to health or is otherwise adulterated as a result of the deviation;
4. Take corrective action, when necessary, to correct the cause of the deviation; and
5. Perform or obtain timely validation by a qualified individual(s), as required in this Appendix, to determine whether modification of the HACCP Plan is required to reduce the risk of recurrence of the deviation, and modify the HACCP Plan as necessary.
All corrective actions taken in accordance with this Section shall be fully documented in records that are subject to verification.

VERIFICATION AND VALIDATION:

Verification: Every milk plant, receiving station or transfer station shall verify that the HACCP System is being implemented according to design, except that critical factors for aseptically processed Grade "A" milk and milk products, as determined by the process authority and listed on the scheduled process under 21 CFR 113 shall be managed separately from the NCIMS HACCP System, even if identified as a CCP in the hazard analysis. Critical factors shall be monitored under the operating supervision of an individual who has successfully completed an approved course of instruction in low-acid canned foods as required under 21 CFR 108.35. Compliance with the provisions of 21 CFR 113 shall satisfy the requirements of this Section, regardless of whether a critical factor has also been designated as a CCP.
1. Verification activities shall include:
  1. (1) The calibration of CCP process-monitoring instruments, i.e., pasteurization tests, etc.;
  2. (2) At the option of the milk plant, receiving station or transfer station, the performance of periodic end-product or in-process testing;
  3. (3) A review, including signing and dating, by an individual who has been trained in accordance with the training requirements of this Appendix, of the records that document:
    1. i) The Monitoring of CCPs: The purpose of this review shall be, at a minimum, to ensure that the records are complete and to verify that the recorded document values are within the CLs. This review shall occur at a frequency that is appropriate to the importance of the record and as specified in the HACCP Plan;
    2. ii) The Taking of Corrective Action: The purpose of this review shall be, at a minimum, to ensure that the records are complete and to verify that appropriate corrective action(s) was taken in accordance with the corrective action requirements cited before. This review shall occur at a frequency that is appropriate to the importance of the record. A centralized deviation log is required; and
    3. iii) The calibrating of any process monitoring instruments used at CCPs and the performance of any periodic end-product or in-process testing that is part of the milk plant, receiving station or transfer station's verification activities.
    The purpose of these reviews shall be, at a minimum, to ensure that the records are complete and that these activities occurred in accordance with the milk plant's, receiving station's or transfer station's written procedures. These reviews shall occur within a reasonable time after the records are made.
  4. (4) The taking of corrective action procedures whenever any verification procedure establishes the need to take a corrective action.
2. The calibration of CCP process-monitoring instruments, and the performance of any periodic end-product and in-process testing, in accordance with 1.a.(3)ii) and 1.a.(3)iii) of this Section, shall be documented in records that are subject to the record keeping requirements in this Appendix.
Validation of the HACCP Plan: Every milk plant, receiving station or transfer station shall validate that the HACCP Plan is adequate to control hazards that are reasonably likely to occur. This validation shall occur at least once within twelve (12) months after implementation and at least annually thereafter or whenever any changes in the process occur that could affect the hazard analysis or alter the HACCP Plan. Such changes may include changes in the following:
1. Raw materials or source of raw materials; product formulation; processing methods or systems, including computers and their software; packaging; finished product distribution systems; or the intended use or intended consumers of the finished product and consumer complaints.
The validation shall be performed by a qualified individual(s) trained in accordance with the requirements described in this Appendix and shall be subject to the record keeping requirements cited below. The HACCP Plan shall be modified immediately whenever a validation reveals that the plan is no longer adequate to fully meet the requirements of this document.
Validation of the Hazard Analysis: Whenever a milk plant, receiving station or transfer station does not have a HACCP Plan, because a hazard analysis has revealed no hazards that are reasonably likely to occur, the milk plant, receiving station or transfer station shall reassess the adequacy of the hazard analysis whenever there are any changes in the process that could reasonably affect whether a hazard exists. Such changes may include changes in the following:
1. Raw materials or source of raw materials;
2. Product formulation;
3. Processing methods or systems, including computers and their software;
4. Packaging;
5. Finished product distribution systems; or
6. The intended use or intended consumers of the finished product; and
7. Consumer complaints.
A qualified individual(s) trained in accordance with the training requirements of this Appendix shall perform the validation.

RECORDS:

Required Records: It is essential that milk plants, receiving stations and transfer stations use consistent terminology to identify each piece of equipment, record, document, or other program throughout their written HACCP System. A milk plant, receiving station or transfer station shall maintain the following records documenting the milk plant, receiving station or transfer station's HACCP System:
1. Records documenting the ongoing application of the PP, including a brief written description, monitoring and correction records;
2. The written hazard analysis;
3. The written HACCP Plan;
4. Required HACCP documents and forms specified in 1.a. through c. of this Section shall be dated or identified with a version number. Each page shall be marked with a new date or version number whenever that page is updated;
5. A Table of Contents and centralized list of the HACCP program records, by title, documenting the ongoing application of the HACCP System shall be maintained and provided for review;
6. A document change log;
7. Records documenting the ongoing application of the HACCP Plan that include:
  1. (1) Monitoring of CCPs and their CLs, including the recording of actual times, temperatures, or other measurements, as prescribed in the milk plant's, receiving station's or transfer station's HACCP Plan;
  2. (2) Corrective actions, including all actions taken in response to a deviation;
  3. (3) A centralized deviation log is required; and
  4. (4) Plan validation dates.
8. Records documenting verification and validation of the HACCP System, including the HACCP Plan, hazard analysis and PPs.
General Requirements: Records required by this Section shall include:
1. The identity and location of the milk plant, receiving station or transfer station;
2. The date and time of the activity that the record reflects;
3. The signature or initials of the person(s) performing the operation or creating the record; and
4. Where appropriate, the identity of the milk or milk product and the production code, if any. Processing and other information shall be entered on records at the time that it is observed. The records shall contain the actual values and observations obtained during monitoring.
Documentation:
1. The records in paragraphs 1.a. through c. of this Section shall be signed and dated by the most responsible individual onsite at the milk plant, receiving station or transfer station. This signature shall signify that these records have been accepted by the firm.
2. The records in paragraphs 1.a. through c. of this Section shall be signed and dated:
  1. (1) Upon initial acceptance;
  2. (2) Upon any modification; and
  3. (3) Upon verification and validation in accordance with the requirements cited above.
Record Retention:
1. All records, required by this Section, shall be retained at the milk plant, receiving station or transfer station for perishable or refrigerated products, for at least one (1) year after the date that such products were prepared, and in the case of frozen, preserved, or shelf-stable products, for two (2) years after the date that the products were prepared or the shelf-life of the product, whichever is greater, unless longer retention time is required by other regulations.
2. Records that relate to the adequacy of equipment or processes used, such as commissioning or process validation records, including the results of scientific studies and evaluations, shall be retained at the milk plant, receiving station or transfer station facility for at least two (2) years after the date that the milk plant, receiving station or transfer station last used such equipment or process.
3. Off-site storage of processing records is permitted after six (6) months following the date that the monitoring occurred, if such records can be retrieved and provided on-site within twenty-four (24) hours of a request for official review. Electronic records are considered to be on-site if they are accessible from an on-site location.
4. If the processing facility is closed for a prolonged period, the records may be transferred to some other reasonably accessible location(s) but shall be immediately returned to the processing facility for official review upon request.
Official Review: All records required by this Section shall be available for official review at reasonable times.
Records Maintained on Computers: The maintenance of records on computers, in accordance with the requirements cited above, is acceptable.

III. TRAINING AND STANDARDIZATION

HACCP training for industry and regulatory personnel will be based on the current "Hazard Analysis and Critical Control Point Principles and Application Guidelines" of NACMCF, the current FDA HACCP recommendations, and the regulatory requirements of this Appendix and related Sections of this Ordinance.

Regulatory Agency personnel responsible for the evaluation, licensing and regulatory audits of facilities using the NCIMS HACCP Program will have equivalent training to the training required to perform traditional NCIMS functions. They shall also have specialized training in conducting HACCP System audits.

Industry, State and Federal regulatory and listing personnel should be trained together.

HACCP TRAINING:

Core Curriculum: The Dairy HACCP Core Curriculum consists of:
1. Basic HACCP training; plus
2. An orientation to the requirements of the NCIMS HACCP Program.
Basic HACCP training consists of instruction in the application of the NACMCF Principles of HACCP to Food Safety. This training includes practical exercises in conducting a hazard analysis and evaluating potential hazards; in writing a HACCP Plan; and in the validation of the plan. It should be taught by experienced instructors.

The orientation component ideally is coupled with the basic HACCP training, but can be taught separately. The content of the orientation will be conducted under the guidance of the NCIMS. It is intended to familiarize industry and regulatory personnel with specific dairy HACCP concerns and the regulatory requirements under the NCIMS HACCP Program. It is to be taught by instructors experienced in the application of HACCP under the NCIMS HACCP Program.

The industry individual(s) performing the functions listed in Part 2 of this Section shall have successfully completed appropriate training in the application of HACCP principles to milk and milk product processing at least equivalent to that received under the Dairy HACCP Core Curriculum. Alternatively, job experience may qualify an individual to perform these functions if the experience has provided knowledge at least equivalent to that provided through the standardized curriculum.
Industry Personnel: Only industry individuals who have met the requirements of Part 1 of this Section shall be responsible for the following functions:
1. Developing the hazard analysis, including delineating control measures, as required;
2. Developing a HACCP Plan that is appropriate for the specific milk plant, receiving station or transfer station, in order to meet these requirements;
3. Validating and modifying the HACCP Plan in accordance with the corrective action procedures and the validation activities as specified; and
4. Performing required HACCP Plan records reviews.
Regulatory Personnel: Regulatory personnel performing HACCP audits shall have successfully completed appropriate training in the application of HACCP principles for milk and milk product processing at least equivalent to that received under the Dairy HACCP Core Curriculum.

IV. HACCP AUDITS AND FOLLOW-UP ACTIONS

STATE REGULATORY AUDITS, ENFORCEMENT AUDITS, ACTIONS AND FOLLOW-UP: Audits shall be conducted of the milk plant, receiving station, or transfer station facility, and NCIMS HACCP Program to ensure compliance with the HACCP System and other associated NCIMS regulatory requirements.

The audit may be announced at the discretion of the auditor under certain circumstances, i.e., initial audit, follow-up audit, new construction, pasteurizer checks, etc. When unannounced audits are conducted, the audits shall not be completed until appropriate milk plant personnel have had an opportunity to make all pertinent records available for review by the auditor.

AUDITION PROCEDURES:

Pre-Audit Management Interview: Review and discuss the milk plant HACCP System including:
1. Changes in the management structure;
2. The Hazard Analysis - Ensure that all milk or milk product hazards are addressed;
3. Changes in the HACCP Plan;
4. Changes in the PPs;
5. Changes in the flow diagram; and
6. Changes in milk or milk products or processes.
Review past Audit Reports (AR) and corrections of deficiencies and non-conformities, if any;
In-milk plant review of the implementation and verification of the HACCP System;
Review records of the HACCP System;
Review compliance with other applicable NCIMS regulatory requirements*;
Discuss findings and observations;
Prepare and issue an AR based on findings of deficiencies and non-conformities. The AR shall include timelines for the correction of all identified deficiencies and non-conformities; and
Conduct the exit interview.

*NOTE: Examples of Other Applicable NCIMS Requirements:

Raw Milk Supply Source;
Labeling Compliance;
Adulteration;
Licensing Requirements;
Drug Residue Testing and Traceback Requirements;
Regulatory Samples in Compliance;
Approved Laboratory Utilized for the Required Regulatory Tests; and
Pasteurization Equipment Design and Installation.

STATE REGULATORY ENFORCEMENT ACTION/FOLLOW-UP:

The State Regulatory Agency shall:

Prepare and issue ARs based on findings of deficiencies and non-conformities and other NCIMS requirements;
Review the AR with the milk plant and establish time lines for the correction of all identified deficiencies and non-conformities and other NCIMS requirements;
Follow-up to ensure corrections are made as a result of the issuance of the AR;
Take immediate action when an imminent health hazard is observed to prevent further movement of milk and milk products until such hazards have been eliminated; and
Initiate regulatory enforcement action, such as permit suspension, revocation, hearings, court actions, and/or other equivalent measures when the milk plant, receiving station or transfer station has failed to recognize or correct a deficiency(ies) or nonconformity(ies).

AUDIT TIMEFRAMES:

Audits	Frequency Minimums
First Year after Initial Regulatory Audit	Initial audit; Next audit in thirty (30) to forty-five (45) days; and four (4) month intervals thereafter, unless the Regulatory Agency determines that a greater frequency is warranted.
Subsequent Audits	Every six (6) months unless the Regulatory Agency determines that a greater frequency is warranted*.
Compliance Follow-Ups	Compliance follow-ups shall be made as frequently as necessary to assure that problems observed by the Regulatory Agency have been resolved.

*The Regulatory Agency may elect to extend the minimum audit frequency from four (4) to six (6) months as long as the following conditions exist:

Item 12b of the MILK PLANT, RECEIVING STATION OR TRANSFER STATION NCIMS HACCP SYSTEM AUDIT REPORT is not marked on the regulatory audit for the current HACCP audit;
No current two (2) out of four (4) warning letter(s) or three (3) out of five (5) violation letter(s) for finished milk or milk product, or violative water sample results; and
No CLEs on the current or prior audit.

AUDIT REPORT FORM:

Refer to Appendix M. of this Ordinance.

Milk Safety References | Federal/State Food Programs

FDA/Center for Food Safety & Applied Nutrition
Hypertext updated by dav/las March 2, 2005