Source: https://easconsultinggroup.com/glossary-of-terms-dairy/
Timestamp: 2018-08-20 05:11:19
Document Index: 770280559

Matched Legal Cases: ['arts 108', 'arts 108', 'arts 108', 'art 131', 'arts 108', 'arts 108', 'arts 108', 'arts 108', 'arts 108']

The operational documents that establish the requirements for Grade “A” dairy farms, dairy plants, transfer stations, receiving stations, dairy plant laboratories, Grade “A” raw milk and finished bulk Grade “A” product. tankers as well as Grade “A”
2015 Pasteurized Milk Ordinance (PMO):
ABNORMALITIES OF MILK: The following types of lacteal secretions are not suitable for sale for Grade “A” purposes.
Abnormal Milk: Milk that is visibly changed in color, odor and/or texture.
Undesirable Milk: Milk that, prior to the milking of the animal, is expected to be unsuitable for sale, such as milk containing colostrum.
Contaminated Milk: Milk that is un-saleable or unfit for human consumption following treatment of the animal with veterinary products, i.e. antibiotics, which have withhold requirements, or treatment with medicines or insecticides not approved for use on dairy animals by FDA or the Environmental Protection Agency (EPA).
ASEPTIC PROCESSING AND PACKAGING: The term “Aseptic Processing and Packaging”, when used to describe a milk and/or milk product, means that the milk and/or milk product has been subjected to sufficient heat processing and packaged in a hermetically sealed container, to conform to the applicable requirements of 21 CFR Parts 108, 110 and 113 and to maintain the commercial sterility of the milk and/or milk product under normal non-refrigerated conditions.
ASEPTIC PROCESSING AND PACKAGING SYSTEM (APPS): For the purposes of this Ordinance, the Aseptic Processing and Packaging System (APPS) in a milk plant is comprised of the processes and equipment used to process and package aseptic Grade “A” low-acid milk and/or milk products. The Aseptic Processing and Packaging System (APPS) shall be regulated in accordance with the applicable requirements of 21 CFR Parts 108, 110 and 113. The Aseptic Processing and Packaging System (APPS) shall begin at the constant level tank and end at the discharge of the packaging machine, provided that the Process Authority may provide written documentation which will clearly define additional processes and/or equipment that are considered critical to the commercial sterility of the product.
AUTOMATIC MILKING INSTALLATION (AMI): The term Automatic Milking Installation (AMI) covers the entire installation of one (1) or more automatic milking units, including the hardware and software utilized in the operation of individual automatic milking units, the animal selection system, the automatic milking machine, the milk cooling system, the system for cleaning and sanitizing the automatic milking unit, the teat cleaning system, and the alarm systems associated with the process of milking, cooling, cleaning and sanitation.
BULK MILK HAULER/SAMPER: A bulk milk hauler/sampler is any person who collects official samples and may transport raw milk from a farm and/or raw milk products to or from a milk plant, receiving station or transfer station and has in their possession a permit from any Regulatory Agency to sample such products.: A bulk milk hauler/sampler is any person who collects official samples and may transport raw milk from a farm and/or raw milk products to or from a milk plant, receiving station or transfer station and has in their possession a permit from any Regulatory Agency to sample such products.
BULK MILK PICKUP TANKER: A bulk milk pickup tanker is a vehicle, including the truck, tank and those appurtenances necessary for its use, used by a bulk milk hauler/sampler to transport bulk raw milk for pasteurization, ultra-pasteurization, aseptic processing and packaging or retort processed after packaging from a dairy farm to a milk plant, receiving station, or transfer station.
BUTTERMILK: Buttermilk is a fluid product resulting from the manufacture of butter from milk or cream. It contains not less than 8¼ percent of milk solids not fat.
Grade “A” Dry Buttermilk: Grade “A” dry buttermilk means dry buttermilk, which complies with the applicable provisions of this Ordinance.
Grade “A” Dry Buttermilk Products: Grade “A” dry buttermilk products means dry buttermilk products, which complies with the applicable provisions of this Ordinance.
Concentrated (Condensed) Buttermilk: Concentrated (condensed) buttermilk is the product resulting from the removal of a considerable portion of water from buttermilk.
Grade “A” Concentrated (Condensed) and Dry Buttermilk and Buttermilk Products: Grade “A” concentrated (condensed) and dry buttermilk and buttermilk products means concentrated (condensed) or dry buttermilk and buttermilk products, which comply with the applicable provisions of this Ordinance. The words “concentrated (condensed) and dry milk products” shall be interpreted to include concentrated (condensed) and dry buttermilk and buttermilk products.
CAMEL MILK: Camel milk is the normal lacteal secretion practically free of colostrum, obtained by the complete milking of one (1) or more healthy camels. Camel milk shall be produced according to the sanitary standards of this Ordinance. The word “milk” shall be interpreted to include camel milk. (Refer to the NOTE on page 31.)
CLEAN: Direct product contact surfaces that have had the effective and thorough removal of product and/or contaminants.
CLEAN-IN-PLACE (CIP) CLEANING: The removal of soil from product contact surfaces in their process position by circulating, spraying, or flowing chemical solutions and water rinses onto and over the surfaces to be cleaned. Components of the equipment, which are not designed to be Cleaned-In-Place (CIP), are removed from the equipment to be Cleaned-Out-Of-Place (COP) or manually cleaned. Product contact surfaces shall be inspectable, except when the cleanability by Cleaned-In-Place (CIP) has been documented and accepted by the Regulatory Agency. In such accepted equipment, all product and solution contact surfaces do not have to be readily accessible for inspection, i.e., permanently installed pipelines and silo tanks.
COMMON NAME: The generic term commonly used for domestic animals, i.e., cattle, goats, sheep, horses, water buffalo, camels, etc. (Refer to the NOTE on page 31.)
CONCENTRATED (CONDENSED) MILK: Concentrated (condensed) milk is a fluid product, unsterilized and unsweetened, resulting from the removal of a considerable portion of the water from the milk, which when combined with potable water in accordance with instructions printed on the container label, results in a product conforming with the milkfat and milk solids not fat levels of milk as defined in this Section.
Concentrated (Condensed) Milk Products: Concentrated (condensed) milk products shall be taken to mean and to include homogenized concentrated (condensed) milk, concentrated (condensed) skim milk, concentrated (condensed) reduced fat or lowfat milk, and similar concentrated (condensed) products made from concentrated (condensed) milk or concentrated (condensed) skim milk, which when combined with potable water in accordance with instructions printed on the container label, conform with the definitions of the corresponding milk products in this Section.
Grade “A” Concentrated (Condensed) Skim Milk: Grade “A” concentrated (condensed) skim milk means concentrated (condensed) skim milk, which complies with the applicable provisions of this Ordinance.
DAIRY FARM: A dairy farm is any place or premises where one (1) or more lactating animals (cows, goats, sheep, water buffalo, camels or other hooved mammal) are kept for milking purposes, and from which a part or all of the milk or milk product(s) is provided, sold or offered for sale to a milk plant, receiving station or transfer station. (Refer to the NOTE on page 31.)
DAIRY PLANT SAMPLER: A person responsible for the collection of official samples for regulatory purposes outlined in Section 6. of this Ordinance. This person is an employee of the Regulatory Agency and is evaluated at least once every two (2)-year period by a Sampling Surveillance Officer (SSO) or a properly delegated Sampling Surveillance Regulatory Agency Official (dSSO). Sampling Surveillance Officers (SSOs) or properly delegated Sampling Surveillance Regulatory Agency Officials (dSSOs) are not required to be evaluated for sampling collection procedures.
EGGNOG OR BOILED CUSTARD: Eggnog or boiled custard is the product defined in 21 CFR 131.170.
FOOD ALLERGENS: Are proteins in foods that are capable of inducing an allergic reaction or response in some individuals. Foods that are considered allergens are defined in the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004 (Public Law 108-282) and Section 201(qq) of the Federal Food, Drug and Cosmetic Act (FFD&CA). Information about Food Allergens may also be found at:
Q-1. ALLERGEN CROSS-CONTACT: Allergen cross-contact means the unintentional incorporation of a food allergen into a food.
R. FROZEN MILK CONCENTRATE: Frozen milk concentrate is a frozen milk product with a composition of milk fat and milk solids not fat in such proportions that when a given volume of concentrate is mixed with a given volume of water the reconstituted product conforms to the milk fat and milk solids not fat requirements of whole milk. In the manufacturing process, water may be used to adjust the primary concentrate to the final desired concentration. The adjusted primary concentrate is pasteurized, packaged, and immediately frozen. This product is stored, transported and sold in the frozen state.
GOAT MILK: Goat milk is the normal lacteal secretion, practically free of colostrum, obtained by the complete milking of one (1) or more healthy goats. Goat milk sold in retail packages shall contain not less than 2½ percent milk fat and not less than 7½ percent milk solids not fat. Goat milk shall be produced according to the sanitary standards of this Ordinance. The word “milk” shall be interpreted to include goat milk.
HACCP DEFINITIONS: (For use in conjunction with Appendix K. of this Ordinance.)
AUDIT: An evaluation of the entire milk plant, receiving station or transfer station facility and NCIMS HACCP System to ensure compliance with the NCIMS HACCP System and other NCIMS regulatory requirements, with the exception of the Aseptic Processing and Packaging System (APPS) for aseptic processing and packaging milk plants and Retort Processed after Packaging System (RPPS) for retort processed after packaging milk plants, respectively.
CENTRALIZED DEVIATION LOG: A centralized log or file identifying data detailing any deviation of Critical Limits (CLs) and the corrective actions taken as required in Appendix K. of this Ordinance.
CONTROLMEASURE: Any action or activity that can be used to prevent, eliminate, or reduce a significant hazard that is managed at a Critical Control Point (CCP).
CRITICAL CONTROL POINT (CCP): A step at which control can be applied and is essential to prevent or eliminate a milk and/or milk product safety hazard or reduce it to an acceptable level.
CRITICAL LIMIT (CL): A maximum and/or minimum value to which a biological, chemical, or physical parameter shall be controlled as a Critical Control Point (CCP) to prevent, eliminate, or reduce to an acceptable level the occurrence of a milk and/or milk product safety hazard.
CRITICAL LISTING ELEMENT (CLE): An item on FORM FDA 2359M-MILK PLANT, RECEIVING STATION OR TRANSFER STATION NCIMS HACCP SYSTEM AUDIT REPORT identified with a double star (**). The marking of a CLE by a Milk Sanitation Rating Officer (SRO) or FDA auditor, indicates a condition that constitutes a major dysfunction likely to result in a potential compromise to milk and/or milk product safety, or that violates NCIMS requirements regarding drug residue testing and/or trace back or raw milk sources, whereby a listing may be denied or withdrawn.
DAIRY HACCP CORE CURRICULUM: The core curriculum consists of:
An orientation to the requirements of the NCIMS voluntary HACCP Program.
DEFICIENCY: An element inadequate or missing from the requirements of the HACCP System or Appendix K. of this Ordinance.
DEVIATION: A failure to meet a Critical Limit (CL).
HAZARD ANALYSIS CRITICAL CONTROL POINT (HACCP): A systematic approach to the identification, evaluation, and control of significant milk and/or milk product safety hazards.
HACCP PLAN: The written document, which is based upon the principles of HACCP and delineates the procedures to be followed.
HACCP SYSTEM: The implemented HACCP Plan and Prerequisite Programs (PPs), including other applicable NCIMS requirements.
HAZARD: A biological, chemical, and/or physical agent that is reasonably likely to cause illness or injury in the absence of its control.
HAZARD ANALYSIS: The process of collecting and evaluating information on hazards associated with the milk and/or milk product under consideration, to decide which are reasonably likely to occur and shall be addressed in the HACCP Plan.
MONITOR: To conduct a planned sequence of observations or measurements to assess whether a Critical Control Point (CCP) is under control or to assess the conditions and practices of all required Prerequisite Programs (PPs).
NON-CONFORMITY: A failure to meet specified requirements of the HACCP System as described in Appendix K. of this Ordinance.
POTENTIAL HAZARD: Any hazard to be evaluated by the hazard analysis.
PREREQUISITE PROGRAMS (PPS): Procedures, including Good Manufacturing Practices (GMPs), which address operational conditions that provide the foundation for the HACCP System. The required Prerequisite Programs (PPs) specified in Appendix K. of this Ordinance are sometimes called Sanitary Standard Operating Procedures (SSOPs) in other HACCP Systems.
VALIDATION: The element of verification focused on collecting and evaluating scientific and technical information to determine whether the HACCP Plan, when properly implemented, will effectively control the hazards.
VERIFICATION: Those activities, other than monitoring, that determine the validity of the HACCP Plan and that the HACCP System is operating according to the plan.6
HOOVED MAMMALS’ MILK: Hooved mammals’ milk is the normal lacteal secretion, practically free of colostrum, obtained by the complete milking of one (1) or more healthy hooved mammals. Hooved mammals for the purpose of this Ordinance, include but are not limited to, the members of the Order Cetartiodactyla, such as: Family Bovidae (cattle, water buffalo, sheep, goats, yaks, etc.), Family Camelidae (llamas, alpacas, camels, etc.), Family Cervidae (deer, reindeer, moose, etc.), and Family Equidae (horses, donkeys, etc.). This product shall be produced according to the sanitary standards of this Ordinance. (Refer to the NOTE on page 31.)
INDUSTRY PLANT SAMPLER: A person responsible for the collection of official samples for regulatory purposes at a milk plant, receiving station or transfer station as outlined in Appendix N. of this Ordinance. This person is an employee of the milk plant, receiving station or transfer station and is evaluated at least once every two (2) year period by a Sampling Surveillance Officer (SSO) or a properly vdelegated Sampling Surveillance Regulatory Agency Official (dSSO).
INSPECTION/AUDIT REPORT: A hand written or electronically generated official regulatory report used for the documentation of findings observed during an inspection/audit.
INTERNATIONAL CERTIFICATION PROGRAM (ICP): The International Certification Program (ICP) means the NCIMS voluntary program designed to utilize Third Party Certifiers (TPCs) authorized by the NCIMS Executive Board in applying the requirements of the NCIMS Grade “A” Milk Safety Program for Milk Companies (MCs) located outside the geographic boundaries of NCIMS Member States that desire to produce and process Grade “A” milk and/or milk products for importation into the United States.
LETTER OF INTENT (LOI): A formal written signed agreement between a Third Party Certifier (TPC) authorized under the NCIMS voluntary International Certification Program (ICP), and a Milk Company (MC) that intends to be certified and IMS Listed under the NCIMS voluntary International Certification Program (ICP). A copy of each written signed agreement shall be immediately submitted to the International Certification Program (ICP) Committee following the signing by the Third Party Certifier (TPC) and Milk Company (MC).
LETTER OF UNDERSTANDING (LOU): A formal written signed agreement between a Third Party Certifier (TPC) and the NCIMS Executive Board that acknowledges the NCIMS’ authorization of the Third Party Certifier (TPC) to operate under the NCIMS voluntary International Certification Program (ICP). It also states the Third Party Certifier’s (TPC’s) responsibilities under the NCIMS voluntary International Certification Program (ICP); their agreement to execute them accordingly; and their understanding of the consequences for failing to do so. The Letter of Understanding (LOU) shall include, but is not limited to, the issues and concerns addressed in all documents involved in the NCIMS voluntary International Certification Program (ICP).
LOW-ACID ASEPTIC AND RETORT MILK AND/OR MILK PRODUCTS: Milk and/or milk products having a water activity (aw) greater than 0.85 and a finished equilibrium pH greater than 4.6 and are regulated under 21 CFR Parts 108, 110 and 113. Aseptically processed and packaged low-acid milk and/or milk products and retort processed after packaging low-acid milk and/or milk products are stored under normal non-refrigerated conditions. Excluded from this definition are low-acid milk and/or milk products that are labeled for storage under refrigerated conditions.
MEMORANDUM OF AGREEMENT (MOA): A formal written signed memorandum that states the requirements and responsibilities of each party (Third Party Certifier (TPC) and Milk Company (MC)) to participate and execute the NCIMS voluntary International Certification Program (ICP). The Memorandum of Agreement (MOA) shall include, but is not limited to, the issues and concerns addressed in all documents involved in the NCIMS voluntary International Certification Program (ICP). This agreement shall be considered the Milk Company’s (MC’s) permit to operate in the context of the NCIMS Grade “A” Milk Safety Program and shall be renewed (signed and dated) on an annual basis.
MILK COMPANY (MC): A Milk Company (MC) is a private entity that is listed on the IMS List by a Third Party Certifier (TPC) including all associated dairy farms, bulk milk haulers/samplers, milk tank trucks, milk transportation companies, milk plants, receiving stations, transfer stations, dairy plant samplers, industry plant samplers, milk distributors, etc. and their servicing milk and/or water laboratories, as defined in the Grade “A” PMO, located outside the geographic boundaries of NCIMS Member States.
MILK DISTRIBUTOR: A milk distributor is any person who offers for sale or sells to another any milk and/or milk products.
MILK PLANT: A milk plant is any place, premises; or establishment where milk or milk products are collected, handled, processed, stored, pasteurized, ultra-pasteurized, aseptically processed and packaged, retort processed after packaged, condensed, dried, packaged, or prepared for distribution.
MILK PRODUCER: A milk producer is any person who operates a dairy farm and provides, sells or offers milk for sale to a milk plant, receiving station or transfer station.
MILK PRODUCTS: Grade “A” Milk and Milk Products include:
All milk and milk products with a standard of identity provided for in 21 CFR Part 131, excluding 21 CFR 131.120 Sweetened Condensed Milk.
Cottage cheese (21 CFR 133.128) and dry curd cottage cheese (21 CFR 131.129)2.
Whey and whey products as defined in 21 CFR 184.1979, 184.1979a, 184.1979b, 184.1979c, and Section 1., Whey Products of this Ordinance.
Modified versions of these foods listed above in Items 1 and 2, pursuant to 21 CFR 130.10- requirements for foods named by use of a nutrient content claim and a standardized term.
Milk and milk products as defined in Items 1, 2, 3 and 4 above, packaged in combination with food(s) not included in this definition that are appropriately labeled with a statement of identity to describe the food(s) in final packaged form, e.g., “cottage cheese with pineapple” and “fat free milk with plant sterols”.
Products not included in Items 1-5 are Grade “A” milk products which have a minimum of 2.0% milk protein (Total Kjeldahl Nitrogen (TKN) X 6.38) and a minimum of sixty five percent (65%) by weight milk, milk product or a combination of milk products.Safe and suitable (as defined in 21 CFR 130.3(d)) non-grade “A” dairy ingredients, can be utilized in the products defined in Items 1-6 when added to a level needed for a functional or technical effect, and limited by Good Manufacturing Practices (GMPs) and are either:
Prior sanctioned or otherwise approved by FDA, or
GRAS (generally recognized as safe), or
An approved food additive listed in the CFR.
A statement of the proposed usage of a non-grade “A” dairy ingredient, including the expected functional and/or technical effect(s) in the finished milk or milk product(s) and justification of why this cannot be performed by a currently available Grade “A” dairy ingredient;
Non-grade “A” dairy ingredient description, composition and required usage level;
Finished milk or milk product(s) description including the current, if applicable, and proposed formula(s) including the current, if applicable, and proposed labeling information (e.g. statement of identity, ingredient declaration) and:
Applicable and recognized analytical measurements and/or organoleptic observations and evaluations that objectively demonstrate that the non-grade “A” dairy ingredient provides a specific functional and/or technical effect(s) that could not be achieved when using a currently available Grade “A” dairy ingredient(s) when used at similar concentrations and with similar proximates, i.e. protein, fat, ash, lactose, moisture, etc.
This definition shall include those milk and milk products, as defined above, which have been aseptically processed and then packaged.
A milk or milk product in which the milkfat of the milk or milk product has been substituted in part or in whole by any other animal or vegetable fat; provided that other fat sources may be included when they are used for purposes currently accepted in any other Grade “A” milk or milk product, such as carriers for vitamins and as an ingredient in emulsifiers and stabilizers;
Coffee based products where coffee or water is the primary ingredient as indicated in the ingredient statement;
Tea based products where tea or water is the primary ingredient as indicated in the ingredient statement;
Dietary products (except as defined herein);
Ice cream or other frozen desserts;
Cheese (standardized, except cottage cheese (21 CFR 133.128) and dry curd cottage cheese (21 CFR 131.129)2, or non-standardized); or
Milk and milk products which have been retort processed after packaging, or which have been concentrated (condensed) or dried are only included in this definition if they are used as an ingredient to produce any milk or milk product defined above or if they are labeled as Grade “A” as described in Section 4. of this Ordinance.
Powdered dairy blends may be labeled Grade “A” and used as ingredients in Grade “A” milk and milk products, such as cottage cheese dressing mixes or starter media for cultures used to produce various Grade “A” cultured milk and milk products, if they meet the requirements of this Ordinance. If used as an ingredient in Grade “A” milk and milk products, blends of dairy powders shall be blended under conditions, which meet all applicable Grade “A” powdered dairy blends requirements. Grade “A” powder blends shall be made from Grade “A” powdered milk and milk products, except that small amounts of functional ingredients, (total of all such ingredients shall not exceed ten percent (10%) by weight of the finished blend) which are not Grade “A” are allowed in Grade “A” blends when the finished ingredient is not available in Grade “A” form, e.g., sodium caseinate. This is similar to the existing FDA position that such dairy ingredient in small cans of freeze-dried starter culture need not be Grade “A”.
Dry Milk Products: Dry milk products mean products resulting from the drying of milk or milk products and any product resulting from the combination of dry milk products with other wholesome dry ingredients.
Grade “A” Dry Milk Products: Grade “A” dry milk products mean dry milk products, which comply with the applicable provisions of this Ordinance.
MILK TANK TRUCK: A milk tank truck is the term used to describe both a bulk milk pickup tanker and a milk transport tank.
MILK TANK TRUCK CLEANING FACILITY: Any place, premises, or establishment, separate from a milk plant, receiving station or transfer station, where a milk tank truck is cleaned and sanitized.
MILK TANK TRUCK DRIVER: A milk tank truck driver is any person who transports raw or pasteurized milk or milk products to or from a milk plant, receiving station or transfer station. Any transportation of a direct farm pickup requires the milk tank truck driver to have responsibility for accompanying official samples.
MILK TRANSPORT TANK: A milk transport tank is a vehicle, including the truck and tank, used by a bulk milk hauler/sampler to transport bulk shipments of milk and milk products, from a milk plant, receiving station or transfer station to another milk plant, receiving station or transfer station.
MILK TRANSPORTATION COMPANY: A milk transportation company is the person responsible for a milk tank truck(s).
OFFICIAL LABORATORY: An official laboratory is a biological, chemical or physical laboratory, which is under the direct supervision of the Regulatory Agency.
OFFICIALLY DESIGNATED LABORATORY: An officially designated laboratory is a commercial laboratory authorized to do official work by the Regulatory Agency, or a milk industry laboratory officially designated by the Regulatory Agency for the examination of producer samples of Grade “A” raw milk for pasteurization, ultra-pasteurization, aseptic processing and packaging or retort processed after packaging and commingled milk tank truck samples of raw milk for drug residues and bacterial limits.
PASTEURIZATION: The terms “pasteurization”, “pasteurized” and similar terms shall mean the process of heating every particle of milk or milk product, in properly designed and operated equipment, to one (1) of the temperatures given in the following chart and held continuously at or above that temperature for at least the corresponding specified time:
Batch (Vat) Pasteurization
Continuous Flow (HTST and HHST) Pasteurization
Provided further, that nothing shall be construed as barring any other process found equivalent to pasteurization for milk and milk products, which has been recognized by FDA as provided in Section 403 (h)(3) of the FFD&CA.
PERSON: The word “person” shall include any individual, milk plant operator, partnership, corporation, company, firm, trustee, association or institution.
RATING AGENCY: A Rating Agency shall mean a State Agency, which certifies interstate milk shippers (BTUs, receiving stations, transfer stations, and milk plants) as having attained the Sanitation Compliance and Enforcement Ratings necessary for inclusion on the IMS List. The ratings are based on compliance with the requirements of the Grade “A” PMO and were conducted in accordance with the procedures set forth in the Methods of Making Sanitation Ratings of Milk Shippers and the Certifications/Listings of Single-Service Containers and Closures for Milk and/or Milk Products Manufacturers (MMSR). Ratings are conducted by FDA certified Milk Sanitation Rating Officers (SROs). They also certify single-service containers and closures for milk and/or milk products manufacturers for inclusion on the IMS List. The certifications are based on compliance with the requirements of the Grade “A” PMO and were conducted in accordance with the procedures set forth in the Methods of Making Sanitation Ratings of Milk Shippers and the Certifications/Listings of Single-Service Containers and Closures for Milk and/or Milk Products Manufacturers (MMSR). The definition of a Rating Agency also includes a Third Party Certifier (TPC) that conducts ratings and certifications of Milk Companies (MCs) located outside the geographic boundaries of NCIMS Member States that desire to produce and process Grade “A” milk and/or milk products for importation into the United States.
RECONSTITUTED OR RECOMBINED MILK AND/OR MILK PRODUCTS:
Reconstituted or recombined milk and/or milk products shall mean milk or milk products defined in this Section which result from reconstituting or recombining of milk constituents with potable water when appropriate.4
REGULATORY AGENCY: The Regulatory Agency shall mean the … of the …1 or their authorized representative. The term, “Regulatory Agency”, whenever it appears in the Ordinance shall mean the appropriate agency, including a Third Party Certifier (TPC) authorized under the ational Certification Program (ICP), having jurisdiction and control over the matters embraced within this Ordinance.
RETORT PROCESSED AFTER PACKAGING: The term “Retort Processed after Packaging”, when used to describe a milk and/or milk product, means that the milk and/or milk product has been subjected to sufficient retort heat processing after packaged in a hermetically sealed container, to conform to the applicable requirements of 21 CFR Parts 108, 110 and 113 and to maintain the commercial sterility of the milk and/or milk product under normal non- refrigerated conditions.
RETORT PROCESSED AFTER PACKAGING SYSTEM (RPPS): For the purposes of this Ordinance, the Retort Processed after Packaging System (RPPS) in a milk plant is comprised of the processes and equipment used to retort process after packaging low-acid Grade “A” milk and/or milk products. The Retort Processed after Packaging System (RPPS) shall be regulated in accordance with the applicable requirements of 21 CFR Parts 108, 110 and 113. The Retort Processed after Packaging System (RPPS) shall begin at the container filler and end at the palletizer, provided that the Process Authority may provide written documentation which will clearly define additional processes and/or equipment that are considered critical to the commercial sterility of the milk and/or milk product.
SANITIZATION: Is 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.
SHEEP MILK: Sheep milk is the normal lacteal secretion, practically free of colostrum, obtained by the complete milking of one (1) or more healthy sheep. Sheep milk shall be produced according to the sanitary standards of this Ordinance. The word “milk” shall be interpreted to include sheep milk.
THIRD PARTY CERTIFIER (TPC): A Third Party Certifier (TPC) is a non- governmental individual(s) or organization authorized under the NCIMS voluntary International Certification Program (ICP) that is qualified to conduct the routine regulatory functions and enforcement requirements of the Grade “A” PMO in relationship to milk plants, receiving stations, transfer stations, associated dairy farms, bulk milk hauler/samplers, milk tank trucks, milk transportation companies, dairy plant samplers, industry plant samplers, milk distributors, etc. participating in the NCIMS voluntary International Certification Program (ICP). The Third Party Certifier (TPC) provides the means for the rating and listing of milk plants, receiving stations, transfer stations and their related raw milk sources. They also conduct the certification and IMS listing of related milk and/or water laboratories and related single-service container and closure manufacturers on the Sanitation Compliance and Enforcement Ratings of Interstate Milk Shippers (IMS) List. To be authorized under the NCIMS voluntary International Certification Program (ICP), a valid Letter of Understanding (LOU) shall be signed between the NCIMS Executive Board and the Third Party Certifier (TPC).
TIME/TEMPERATURE CONTROL FOR SAFETY OF MILK AND/OR MILK
PRODUCTS: Milk and/or milk products that require time/temperature control for safety (TCS) to limit pathogenic microorganism growth or toxin formation includes: Milk or milk products that are raw, heat-treated, pasteurized, or ultra-pasteurized; or
Table A. Interaction of pH and aw for Control of Spores in Milk and Milk Products Pasteurized to Destroy Pathogenic Vegetative Cells and Subsequently Packaged*
4.6 or less > 4.6 – 5.6 > 5.6
0.92 or less Non-TCS** Non-TCS Non-TCS
> 0.92 – .95 Non-TCS Non-TCS PA***
> 0.95 Non-TCS PA PA
* Refer to Appendix R. of this Ordinance for instruction on how to use Table A.
** TCS means TIME/TEMPERATURE CONTROL FOR SAFETY MILK AND MILK PRODUCTS.
*** PA means either that the product needs time and temperature control or further Product Assessment is required to determine if the milk or milk product is Non-TCS.
Table B. Interaction of pH and aw for Control of Pathogenic Vegetative Cells and Spores in Milk and Milk Products not Pasteurized or Pasteurized but not Packaged*
< 4.2 4.2 – 4.6 >4.6 – 5.0 > 5.0
< 0.88 Non-TCS Non-TCS Non-TCS Non-TCS
0.88 – 0.90 Non-TCS Non-TCS Non-TCS PA
> 0.90 – 0.92 Non-TCS Non-TCS PA PA
> 0.92 Non-TCS PA PA PA
* Refer to Appendix R. of this Ordinance for instruction on how to use Table B. This definition does not include:
A milk or milk product that because of its pH or aw value, or interaction of aw and pH values, is designated as Non-TCS in Table A or B as specified in 2 above of this definition;
A milk or milk products, in an unopened hermetically sealed container, that is commercially processed to achieve and maintain commercial sterility under conditions of non-refrigerated storage and distribution;
A milk or milk product for which evidence (acceptable to FDA) demonstrates that time/ temperature control for safety is not required as specified under this definition (such as, a product containing a preservative known to inhibit pathogenic microorganisms, or other barriers to the growth of pathogenic microorganisms, or a combination of barriers that inhibit the growth of pathogenic microorganisms); or
A milk or milk product that does not support the growth of pathogenic microorganisms as specified under this definition even though the milk or milk product may contain a pathogenic microorganism or chemical or physical contaminant at a level sufficient to cause illness or injury.
TRANSFER STATION: A transfer station is any place, premises, or establishment where milk or milk products are transferred directly from one (1) milk tank truck to another.
ULTRA-PASTEURIZATION (UP): The term “Ultra-Pasteurization”, when used to describe a milk and/or milk product, means that such milk and/or milk product shall have been thermally processed at or above 138°C (280°F) for at least two (2) seconds, either before or after packaging, so as to produce a milk and/or milk product, which has an extended shelf-life under refrigerated conditions. (Refer to 21 CFR 131.3.)
WATER BUFFALO MILK: Water buffalo milk is the normal lacteal secretion, practically free of colostrum, obtained by the complete milking of one (1) or more healthy water buffalo. Water buffalo milk shall be produced according to the sanitary standards of this Ordinance. The word “milk” shall be interpreted to include water buffalo milk. (Refer to the NOTE on page 31.)
WHEY PRODUCTS: Whey products mean any fluid product removed from whey; or made by the removal of any constituent from whey; or by the addition of any wholesome substance to whey or parts thereof.
Grade “A” Whey Products: Grade “A” whey products means any fluid product removed from whey; or made by the removal of any constituent from whey; or by the addition of any wholesome substance to whey or parts thereof which have been manufactured under the provisions of this Ordinance.
Grade “A” Concentrated (Condensed) and Dry Whey and Whey Products: Grade “A” concentrated (condensed) and dry whey and whey products means concentrated (condensed) or dry whey and whey products, which complies with the applicable provisions of this Ordinance. The words “concentrated (condensed) and dry milk products” shall be interpreted to include concentrated (condensed) and dry whey and whey products.
Grade “A” Single Service Definitions:
“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.
“Certified Single-Service Consultant (SSC)” shall mean an individual who has been certified by the Public Health Service/Food and Drug Administration (PHS/FDA), has a valid certificate of qualification to conduct the certification and listing of foreign single-service containers and/or closures for milk and/or milk products manufacturers on the IMS List- Sanitation Compliance and Enforcement Ratings of Interstate Milk Shippers (IMS List) and does not have direct responsibility for the routine regulatory inspection and enforcement or regulatory auditing of the foreign single-service containers and/or closures manufacturer to be certified.
“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 the fabrication of a component part shall 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 and/or closure for the packaging or sampling of a Grade “A” milk and/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:
“Plastic Molding, Forming, Extrusion, and Laminating Resins” shall mean:
“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, closures or trim that have fallen on the floor.
“Regrind” shall mean clean plastic material that is trimmed from the container and/or closure, and imperfectly formed containers and/or closures, which result from the manufacture of single-service containers and/or 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 and/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:
For the swab test, a minimum of four (4), 250 cm2 areas of surface from separate containers or closures shall be tested. In the case of containers or closures with a product- contact surface area smaller than 250 cm2, more than four (4) containers or closures to equal at least 250 cm2 times four (4) shall 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, glass, rubber, ceramic, 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/or milk products which is intended for one (1) use only.
“Single-Service Containers and/or Closures Manufacturer Certification” shall mean the certification conducted by a Milk Sanitation Rating Officer (SRO) for U.S. manufacturers of single-service containers and/or closures for milk and/or milk products; or a Third Party Certifier’s (TPC’s) Milk Sanitation Rating Officer (SRO) or a Certified Single-Service Consultant (SSC) for foreign manufacturers of single-service containers and/or closures for milk and/or milk products, which measures the degree to which the provisions of Appendix J. of this Ordinance are being complied with by the single-service containers and/or closures manufacturer for inclusion on the IMS List-Sanitation Compliance and Enforcement Ratings of Interstate Milk Shippers (IMS List). The certification is based on compliance with the requirements of Appendix J. of this Ordinance and is conducted in accordance with the procedures set forth in the Methods of Making Sanitation Ratings of Milk Shippers and the Certifications/Listings of Single-Service Containers and/or Closures for Milk and/or Milk Products Manufacturers (MMSR).
PMO Drug Residue Definitions – Appendix N:
Presumptive Positive: A presumptive positive test is a positive result from an initial testing of a bulk milk pickup tanker and/or raw milk supply that has not been transported in bulk milk pickup tankers using an M-a-85, latest revision, or M-I-92-11 approved test method, which has been promptly repeated in duplicate with positive (+) and negative (-) controls that give the proper results using the same test method, on the same sample, with one (1) or both of these duplicate retests giving a positive result.
Screening Test Positive (Load or Raw Milk Supply that has Not been Transported in Bulk Milk Pickup Tankers Confirmation): A screening test positive (confirmation) result is obtained when the presumptive positive sample is tested in duplicate, using the same or equivalent (M-I-96-10, latest revision) test method as that used for the presumptive positive, with a positive (+) and negative (-) control that give the proper results, and either or both of the duplicates are positive. A screening test positive (load or farm bulk milk tank(s)/silo(s), milk plant raw milk tank(s) and/or silo(s), other raw milk storage container(s), etc. when used for a milk plant’s raw milk supply(ies) that has (have) not been transported in bulk milk pickup tankers confirmation) is to be performed by an Official Laboratory, Officially Designated Laboratory or CIS using the same or an equivalent test (M-I-96-10, latest revision).
Producer Trace Back/Permit Suspension Action: A producer trace back/permit suspension action test is performed after a screening test positive load (confirmation) is identified by an Official Laboratory, Officially Designated Laboratory or CIS using the same or an equivalent (M-I-96-10, latest revision) test method as was used to obtain the screening test positive load (confirmation). A confirmed producer test positive result is obtained in the same manner as a screening test positive (confirmation) for a load. After an initial positive result (producer presumptive positive) is obtained on a producer sample, that sample is then tested in duplicate using the same test method as was used to obtain the producer presumptive positive result. This testing is performed with a positive (+) and negative (-) control and if either or both of the duplicates are positive and the controls give the proper results, the producer sample is confirmed as positive.NOTE: When a farm bulk milk tank(s)/silo(s), milk plant raw milk tank(s) and/or silo(s), other raw milk storage container(s), etc. is used for a milk plant’s raw milk supply(ies) that has not been transported in bulk milk pickup tankers, is found to be confirmed positive for drug residues using approved test methods, the farm of origin for the drug residue has consequently already been determined and further testing is not required to determine the farm of origin.
Individual Producer Load: An individual producer bulk milk pickup tanker is a bulk milk pickup tanker, or a compartment(s) of a bulk milk pickup tanker, that contains milk from only one (1) dairy farm.
Individual On-Farm Producer/Processor’s Raw Milk Supply: An individual on-farm producer/processor’s raw milk supply may be transported in bulk milk pickup tankers; and/or their raw milk supply may be stored in a farm bulk milk tank(s)/silo(s) on the dairy farm that directly feeds the batch (vat) pasteurizer(s) or constant-level tank of a HTST pasteurization system or piped from the a farm bulk milk tank(s)/silo(s) to a raw milk tank(s) and/or silo(s) in the milk plant that feeds the batch (vat) pasteurizer(s) or constant-level tank of a HTST pasteurization system; and/or other raw milk storage containers.
Industry Analyst (IA): A person under the supervision of a Certified Industry Supervisor (CIS) or Industry Supervisor (IS) who is assigned to conduct screening of bulk milk pickup tankers and/or all raw milk supplies that have not been transported in bulk milk pickup tankers for Appendix N. drug residue requirements.
Industry Supervisor/Certified Industry Supervisor (IS/CIS): An individual trained by a LEO who is responsible for the supervision and training of Industry Analysts (IAs) who test milk tank trucks and/ or all raw milk supplies that have not been transported in bulk milk pickup tankers for Appendix N. drug residue requirements.
Certified Industry Supervisor (CIS): An Industry Supervisor (IS) who is evaluated and listed by a LEO as certified to conduct drug residue screening tests using approved test methods at industry drug residue screening sites for Grade “A” PMO, Appendix N. enforcement actions (confirmation of bulk milk pickup tankers, farm bulk milk tank(s)/silo(s), milk plant raw milk tank(s) and/or silo(s), or other raw milk storage container(s), etc. when used for a milk plant’s raw milk supply(ies) that has (have) not been transported in bulk milk pickup tankers, producer trace back and/or permit actions).
Verified Screening Positive: A verified screening positive test is a positive result from an initial testing using test methods not evaluated by FDA and accepted by the NCIMS of a bulk milk pickup tanker and/or raw milk supply that has not been transported in bulk milk pickup tankers, which has been promptly repeated in duplicate with positive (+) and negative (-) controls that give the proper results, using the same test method, on the same sample, with one (1) or both of these duplicate retests giving a positive result.
Producer Trace Back With Permit Suspension Action Not Required: A producer trace back test is performed after a verified screening positive load using test methods not evaluated by FDA and accepted by the NCIMS without additional confirmation required is identified by a laboratory using the same test method as was used to obtain the verified screening positive load. A verified screening positive producer test result is obtained in the same manner as a verified screening positive for a bulk milk pickup tanker. After an initial positive result is obtained on a producer sample, that sample is then tested in duplicate using the same test method as was used to obtain the initial producer positive result. This testing is performed with positive (+) and negative (-) controls and if either or both of the duplicates are positive and the controls give the proper results, the
Methods of Making Sanitation Ratings – Definitions:
AREA RATING: An area rating, if used, shall apply to raw milk for pasteurization, ultra- pasteurization, aseptic processing and packaging and retort processed after packaging. An area rating consists of more than one (1) producer group operating under the supervision of a single Regulatory Agency and which is rated as a single entity. An individual dairy farm shall only be included in one (1) IMS Listing.2. ASEPTIC CRITICAL LISTING ELEMENT (ACLE): An Item on FORM FDA 2359p- NCIMS ASEPTIC PROCESSING AND PACKAGING PROGRAM AND/OR RETORT PROCESSED AFTER PACKAGING PROGRAM CRITICAL LISTING ELEMENTS (Low- Acid (pH greater than 4.6) Aseptic and Retort Milk and/or Milk Products). The identification of any Aseptic Critical Listing Element (ACLE) element by a Milk Sanitation Rating Officer (SRO) or FDA Regional Milk Specialist as not being in compliance, whereby a listing shall be immediately denied or withdrawn.
ASEPTIC CRITICAL LISTING ELEMENT (ACLE): An Item on FORM FDA 2359p- NCIMS ASEPTIC PROCESSING AND PACKAGING PROGRAM AND/OR RETORT PROCESSED AFTER PACKAGING PROGRAM CRITICAL LISTING ELEMENTS (Low- Acid (pH greater than 4.6) Aseptic and Retort Milk and/or Milk Products). The identification of any Aseptic Critical Listing Element (ACLE) element by a Milk Sanitation Rating Officer (SRO) or FDA Regional Milk Specialist as not being in compliance, whereby a listing shall be immediately denied or withdrawn.3. ASEPTIC OR RETORT MILK PLANT RATING: A rating of a milk plant or portion of a milk plant that produces aseptically processed and packaged Grade “A” low-acid milk and/or milk products and/or retort processed after packaged Grade “A” low-acid milk and/or milk products that is rated separately from the rating of pasteurized and/or ultra-pasteurized Grade “A” milk and/or milk products produced in the milk plant. This rating shall be made for all milk plants producing aseptically processed and packaged Grade “A” low-acid milk and/or milk products and/or retort processed after packaged Grade “A” low-acid milk and/or milk products as defined in the Grade “A” PMO. An NCIMS HACCP milk plant listing that produces aseptically processed and packaged Grade “A” low-acid milk and/or milk products and/or retort processed after packaged Grade “A” low-acid milk and/or milk products shall have only an NCIMS HACCP listing.
ASEPTIC OR RETORT MILK PLANT RATING: A rating of a milk plant or portion of a milk plant that produces aseptically processed and packaged Grade “A” low-acid milk and/or milk products and/or retort processed after packaged Grade “A” low-acid milk and/or milk products that is rated separately from the rating of pasteurized and/or ultra-pasteurized Grade “A” milk and/or milk products produced in the milk plant. This rating shall be made for all milk plants producing aseptically processed and packaged Grade “A” low-acid milk and/or milk products and/or retort processed after packaged Grade “A” low-acid milk and/or milk products as defined in the Grade “A” PMO. An NCIMS HACCP milk plant listing that produces aseptically processed and packaged Grade “A” low-acid milk and/or milk products and/or retort processed after packaged Grade “A” low-acid milk and/or milk products shall have only an NCIMS HACCP listing.NOTE: The raw milk receiving area may be rated with the aseptic or retort milk plant, or with a separately listed pasteurization and/or ultra-pasteurized milk plant, or separately as a receiving station.NOTE: The raw milk receiving area may be rated with the aseptic or retort milk plant, or with a separately listed pasteurization and/or ultra-pasteurized milk plant, or separately as a receiving station.5. ASEPTIC PROCESSING AND PACKAGING SYSTEM (APPS): For the purposes of this document, the Aseptic Processing and Packaging System (APPS) in a milk plant is comprised of the processes and equipment used to process and package aseptic Grade “A” low- acid milk and/or milk products. The Aseptic Processing and Packaging System (APPS) shall be regulated in accordance with the applicable requirements of 21 CFR Parts 108, 110 and 113. The Aseptic Processing and Packaging System (APPS) shall begin at the constant level tank and end at the discharge of the packaging machine, provided that the Process Authority may provide written documentation which will clearly define additional processes and/or equipment that are considered critical to the commercial sterility of the product.
ASEPTIC PROCESSING AND PACKAGING SYSTEM (APPS): For the purposes of this document, the Aseptic Processing and Packaging System (APPS) in a milk plant is comprised of the processes and equipment used to process and package aseptic Grade “A” low- acid milk and/or milk products. The Aseptic Processing and Packaging System (APPS) shall be regulated in accordance with the applicable requirements of 21 CFR Parts 108, 110 and 113. The Aseptic Processing and Packaging System (APPS) shall begin at the constant level tank and end at the discharge of the packaging machine, provided that the Process Authority may provide written documentation which will clearly define additional processes and/or equipment that are considered critical to the commercial sterility of the product.
AUDIT: An evaluation of the entire milk plant, receiving station, or transfer station facility, and NCIMS HACCP System to ensure compliance with the NCIMS HACCP System and other NCIMS regulatory requirements, with the exception of the Aseptic Processing and Packaging System (APPS) for aseptic processing and packaging milk plants and the Retort Processed after Packaging System (RPPS) for retort processed after packaging milk plants, respectively.
BULK TANK UNIT (BTU): A dairy farm or group of dairy farms from which raw milk for pasteurization, ultra-pasteurization, aseptic processing and packaging or retort processed after packaging is collected under the routine supervision of one (1) Regulatory Agency and rated as a single entity and given a Sanitation Compliance and Enforcement Rating. An individual dairy farm shall only be included in one (1) IMS Listing.
CERTIFIED MILK LABORATORY EVALUATION OFFICER (LEO): A Regulatory Agency or Milk Laboratory Control Agency employee who has been certified by the Public Health Service/Food and Drug Administration (PHS/FDA) Laboratory Proficiency Evaluation team (LPET) using the Evaluation of Milk Laboratories (EML) to evaluate milk laboratories for the purpose of accrediting or approving laboratories that conduct official NCIMS milk testing and has a valid certificate of qualification.
CERTIFIED MILK SANITATION RATING OFFICER (SRO): A Regulatory Agency employee who has been certified by the Public Health Service/Food and Drug Administration (PHS/FDA), has a valid certificate of qualification and does not have direct responsibility for the routine regulatory inspection and enforcement or regulatory auditing of the shipper to be rated or listed. Directors, administrators, supervisors, etc. may be certified as Milk Sanitation Rating Officers (SROs). A Milk Sanitation Rating Officer (SRO) may be certified to make HACCP milk plant, receiving station or transfer station listings.
CERTIFIED SAMPLING SURVEILLANCE OFFICER (SSO): A Regulatory Agency employee who has been certified by the Public Health Service/Food and Drug Administration (PHS/FDA) and has a valid certificate of qualification. Directors, administrators, supervisors, etc., Milk Sanitation Rating Officers (SROs), Laboratory Evaluation Officers (LEOs), etc. may be certified as Sampling Surveillance Officers (SSOs).
CERTIFIED SINGLE-SERVICE CONSULTANT (SSC): An individual who has been certified by the Public Health Service/Food and Drug Administration (PHS/FDA), has a valid certificate of qualification to conduct the certification and listing of foreign single-service containers and/or closures for milk and/or milk products manufacturers on the IMS List- Sanitation Compliance and Enforcement Ratings of Interstate Milk Shippers (IMS List) and does not have direct responsibility for the routine regulatory inspection and enforcement or regulatory auditing of the foreign single-service containers and/or closures manufacturer to be certified.
CRITICAL LISTING ELEMENT (CLE): An item on FORM FDA 2359m-MILK PLANT, RECEIVING STATION OR TRANSFER STATION NCIMS HACCP SYSTEM AUDIT REPORT identified with a double star (**). The marking of a Critical Listing Element (CLE) element by a Milk Sanitation Rating Officer (SRO) or FDA auditor, indicates a condition that constitutes a major dysfunction likely to result in a potential compromise to milk and/or milk product safety, or that violates NCIMS requirements regarding drug residue testing and trace back and/or raw milk sources, whereby a listing may be denied or withdrawn.
ENFORCEMENT RATING: This is a measure of the degree to which enforcement provisions of the Grade “A” PMO are being applied by the Regulatory Agency.
FDA AUDIT: An evaluation conducted by FDA of the entire milk plant, receiving station, or transfer station facility to ensure compliance with the NCIMS HACCP System and other NCIMS regulatory requirements, with the exception of the Aseptic Processing and Packaging System (APPS) for aseptic processing and packaging milk plants and Retort Processed after Packaging System (RPPS) for retort processed after packaging milk plants, respectively.
HACCP LISTING: An inclusion on the IMS List–Sanitation Compliance and Enforcement Ratings of Interstate Milk Shippers (IMS List) based on a Milk Sanitation Rating Officer’s (SRO’s) evaluation of a milk plant’s, receiving station’s or transfer station’s NCIMS voluntary HACCP Program and other applicable NCIMS requirements.
INDIVIDUAL RATING: An individual rating is the rating of a single producer group, milk plant, receiving station, and/or transfer station under the supervision of a single Regulatory Agency. Milk plants producing Grade “A” condensed and/or dried milk and milk products and/or Grade “A” condensed or dry whey and whey products may be rated separately from the same milk plant producing other Grade “A” milk and/or milk products, provided each listing holds a separate permit. Milk plants that produce aseptically processed and packaged Grade “A” low-acid milk and/or milk products, and/or retort processed after packaged Grade “A” low-acid milk and/or milk products, and pasteurized and/or ultra-pasteurized Grade “A” milk and/or milk products shall be rated separately. Provided, that an NCIMS HACCP milk plant listing that produces aseptically processed and packaged Grade “A” low-acid milk and/or milk products and/or retort processed after packaged Grade “A” low-acid milk and/or milk products shall have only an NCIMS HACCP listing. An individual dairy farm shall only be included in one (1) IMS Listing.
LETTER OF INTENT (LOI): A formal written signed agreement between a Third Party Certifier (TPC), authorized under the NCIMS voluntary International Certification Program (ICP), and a Milk Company (MC) that intends to be certified and IMS Listed under the NCIMS voluntary International Certification Program (ICP). A copy of each written signed agreement shall be immediately submitted to the International Certification Program (ICP) Committee following the signing by the Third Party Certifier (TPC) and Milk Company (MC).
LISTING AUDIT: An evaluation conducted by a Milk Sanitation Rating Officer (SRO) of the entire milk plant, receiving station or transfer station facility to ensure compliance with the NCIMS voluntary HACCP Program and other NCIMS regulatory requirements, with the exception of the Aseptic Processing and Packaging System (APPS) for aseptic processing and packaging milk plants and the Retort Processed after Packaging System (RPPS) for retort processed after packaging milk plants, respectively.
MILK PLANT: A milk plant is any place, premises, or establishment where milk and/or milk products are collected, handled, processed, stored, pasteurized, ultra-pasteurized, aseptically processed and packaged, retort processed after packaged, condensed, dried, packaged, or prepared for distribution.
RATING AGENCY: A Rating Agency shall mean a State Agency, which certifies interstate milk shippers (BTUs, receiving stations, transfer stations, and milk plants) as having attained the Sanitation Compliance and Enforcement Ratings necessary for inclusion on the IMS List. The ratings are based on compliance with the requirements of the Grade “A” PMO and were conducted in accordance with the procedures set forth in the Methods of Making Sanitation Ratings of Milk Shippers and the Certifications/Listings of Single-Service Containers and/or Closures for Milk and/or Milk Products Manufacturers (MMSR). Ratings are conducted by FDA certified Milk Sanitation Rating Officers (SROs). They also certify single-service containers and closures for milk and/or milk products manufacturers for inclusion on the IMS List. The certifications are based on compliance with the requirements of the Grade “A” PMO and were conducted in accordance with the procedures set forth in the Methods of Making Sanitation Ratings of Milk Shippers and the Certifications/Listings of Single-Service Containers and/or Closures for Milk and/or Milk Products Manufacturers (MMSR). The definition of a Rating Agency also includes a Third Party Certifier (TPC) that conducts ratings and certifications of Milk Companies (MCs) located outside the geographic boundaries of NCIMS Member States that desire to produce and process Grade “A” milk and/or milk products for importation into the United States.
RECIPROCITY: For the purposes of the National Conference on Interstate Milk Shipments (NCIMS) agreements, reciprocity shall mean any action or requirements on the part of any Regulatory Agency will not cause or require any action in excess of the requirements of the current edition of the Grade “A” PMO and Related Documents of the NCIMS agreements.
REGULATORY AGENCY: A Regulatory Agency shall mean an agency which has adopted an ordinance, rule or regulation in substantial compliance with the current edition of the Grade “A” PMO and is responsible for the enforcement of such ordinance, rule or regulation, which is in substantial compliance with the Grade “A” PMO for a listed interstate milk shipper. The term “Regulatory Agency” whenever it appears in the MMSR shall also mean the appropriate Third Party Certifier (TPC) having jurisdiction and control over the matters cited within this MMSR.
RETORT PROCESSED AFTER PACKAGING SYSTEM (RPPS): For the purposes of this document, the Retort Processed after Packaging System (RPPS) in a milk plant is comprised of the processes and equipment used to retort process after packaging low-acid Grade “A” milk and/or milk products. The Retort Processed after Packaging System (RPPS) shall be regulated in accordance with the applicable requirements of 21 CFR Parts 108, 110 and 113. The Retort Processed after Packaging System (RPPS) shall begin at the container filler and end at the palletizer, provided that the Process Authority may provide written documentation which will clearly define additional processes and/or equipment that are considered critical to the commercial sterility of the milk and/or milk product.
SINGLE-SERVICE CONTAINERS AND/OR CLOSURES MANUFACTURER: A single-service containers and/or closures manufacturer shall mean any person or company in the business of manufacturing a single-service container and/or closure for the packaging or sampling of Grade “A” milk and/or milk products in accordance with Appendix J. Standards for the Fabrication of Single-Service Containers and/or Closures for Milk and/or Milk Products of the Grade “A” PMO.
SINGLE-SERVICE CONTAINERS AND/OR CLOSURES MANUFACTURER AUDIT: The designated PHS/FDA and NCIMS Procedures method to ensure that the published certification/listing of a single-service containers and/or closures for milk and/or milk products manufacturer on the IMS List-Sanitation Compliance and Enforcement Ratings of Interstate Milk Shippers (IMS List) is valid and maintained during the interval between certifications.
SINGLE-SERVICE CONTAINERS AND/OR CLOSURES MANUFACTURER CERTIFICATION: This is the certification conducted by a Milk Sanitation Rating Officer (SRO) for U.S. manufacturers of single-service containers and/or closures for milk and/or milk products; or a Third Party Certifier’s (TPC’s) Milk Sanitation Rating Officer (SRO) or a Certified Single-Service Consultant (SSC) for foreign manufacturers of single-service containers and/or closures for milk and/or milk products, which measures the degree to which the provisions of Appendix J. Standards for the Fabrication of Single-Service Containers and/or Closures for Milk and/or Milk Products of the Grade “A” PMO are being complied with by the single-service containers and/or closures manufacturer for inclusion on the IMS List-Sanitation Compliance and Enforcement Ratings of Interstate Milk Shippers (IMS List). The certification is based on compliance with the requirements of Appendix J. of the Grade “A” PMO and is conducted in accordance with the procedures set forth in the Methods of Making Sanitation Ratings of Milk Shippers and the Certifications/Listings of Single-Service Containers and/or Closures for Milk and/or Milk Products Manufacturers (MMSR).
THIRD PARTY CERTIFIER (TPC): A Third Party Certifier (TPC) is a non-governmental individual(s) or organization authorized under the NCIMS voluntary International Certification Program (ICP) that is qualified to conduct the routine regulatory functions and enforcement requirements of the Grade “A” PMO in relationship to milk plants, receiving stations, transfer stations, associated dairy farms, bulk milk hauler/samplers, milk tank trucks, milk transportation companies, dairy plant samplers, industry plant samplers, milk distributors, etc. participating in the NCIMS voluntary International Certification Program (ICP). The Third Party Certifier (TPC) provides the means for the rating and listing of milk plants, receiving stations, transfer stations and their related raw milk sources. They also conduct the certification and IMS listing of related milk and/or water laboratories and related single-service container and closure manufacturers on the Sanitation Compliance and Enforcement Ratings of Interstate Milk Shippers (IMS) List. To be authorized under the NCIMS voluntary International Certification Program (ICP), a valid Letter of Understanding (LOU) shall be signed between the NCIMS Executive Board and the Third Party Certifier (TPC).
NCIMS Procedures Definitions:
ADVERSE ACTION: A re-inspection, re-rating or withdrawal of the IMS Listing of an individual IMS listed milk shipper or the withdrawal of the certification of an individual IMS listed single-service containers and/or closures manufacturer.
AREA RATING: An area rating, if used, shall apply to raw milk for pasteurization, ultra- pasteurization, aseptic processing and packaging and retort processed after packaging. An area rating consists of more than one (1) producer group operating under the supervision of a single Regulatory Agency and which is rated as a single entity. An individual dairy farm shall only be included in one (1) IMS Listing.
BULK TANK UNIT (BTU): A dairy farm or group of dairy farms from which raw milk for pasteurization, ultra-pasteurization, aseptic processing and packaging and/or retort processed after packaging is collected under the routine supervision of one (1) Regulatory Agency and rated as a single entity and given a Sanitation Compliance and Enforcement Rating. An individual dairy farm shall only be included in one (1) IMS Listing.
CERTIFIED MILK SANITATION RATING OFFICER (SRO): A Regulatory Agency employee who has been certified by the Public Health Service/Food and Drug Administration (PHS/FDA); has a valid certificate of qualification; and does not have direct responsibility for the routine regulatory inspection and enforcement or regulatory auditing of the shipper to be rated or listed. Directors, administrators, supervisors, etc. may be certified as Milk Sanitation Rating Officers (SROs). A Milk Sanitation Rating Officer (SRO) may be certified to make HACCP milk plant, receiving station or transfer station listings.
CHECK RATING: The designated PHS/FDA and NCIMS Procedures method to ensure that the published rating of a milk shipper on the IMS LIST-Sanitation Compliance and Enforcement Ratings of Interstate Milk Shippers (IMS List) is valid and maintained during the interval between ratings.
DAIRY FARM: A dairy farm is any place or premises where one (1) or more lactating animals (cows, goats, sheep, water buffalo, or other hooved mammal) are kept for milking purposes, and from which a part or all of the milk is provided, sold or offered for sale to a milk plant, receiving station or transfer station.
ENFORCEMENT RATING: This is a measure of the degree to which enforcement provisions of the Grade “A” Pasteurized Milk Ordinance (Grade “A” PMO) are being applied by the Regulatory Agency.
IMS LISTED SHIPPER: An interstate milk shipper (BTU, receiving station, transfer station, or milk plant), which has been certified by a Rating Agency as having attained the Sanitation Compliance and Enforcement Ratings necessary for inclusion on the IMS List. The ratings are based on compliance with the requirements of the Grade “A” PMO and were made in accordance with the procedures set forth in the Methods of Making Sanitation Ratings of Milk Shippers and the Certifications/Listings of Single-Service Containers and/or Closures for Milk and/or Milk Products Manufacturers (MMSR). For milk plants that produce aseptically processed and packaged Grade “A” low-acid milk and/or milk products and/or retort processed after packaged Grade “A” low-acid milk and/or milk products, prior to the milk plant participating in the NCIMS Aseptic Processing and Packaging Program and/or Retort Processed after Packaging Program, respectively, the Regulatory Agency’s regulatory and Rating Agency’s rating personnel shall have completed a training course that is acceptable to the NCIMS and PHS/FDA addressing the procedures for conducting regulatory inspections and ratings under the NCIMS Aseptic Processing and Packaging Program and/or Retort Processed after Packaging Program.
INDIVIDUAL RATING: An individual rating is the rating of a single producer group, milk plant, receiving station, and/or transfer station under the supervision of a single Regulatory Agency. Milk plants producing Grade “A” condensed and/or dried milk and/or milk products and/or Grade “A” condensed and/or dry whey and/or whey products may be rated separately from the same milk plant producing other Grade “A” milk and/or milk products, provided each listing holds a separate permit. Milk plants that produce aseptically processed and packaged Grade “A” low-acid milk and/or milk products, and/or retort processed after packaged Grade “A” low-acid milk and/or milk products and pasteurized and/or ultra-pasteurized Grade “A” milk and/or milk products shall be rated separately. Provided that an NCIMS HACCP milk plant listing that produces aseptically processed and packaged Grade “A” low-acid milk and/or milk products and/or retort processed after packaged Grade “A” low-acid milk and/or milk products shall have only an NCIMS HACCP listing. An individual dairy farm shall only be included in one (1) IMS Listing.
MEMORANDUM OF CONFERENCE ACTIONS (IMS-a): A memorandum issued by PHS/FDA providing the transmittal of information related to the actions taken at NCIMS Conferences and between PHS/FDA and the NCIMS Executive Board to PHS/FDA Regional staff and Regulatory/Rating Agencies.
MEMORANDUM OF INFORMATION (M-I): A memorandum issued by PHS/FDA providing the transmittal of administrative and miscellaneous information by PHS/FDA to PHS/FDA Regional staff and Regulatory/Rating Agencies.
MEMORANDUM OF INTERPRETATION (M-a): A memorandum issued by PHS/FDA, following the Procedures document, providing clarification of the intent or meaning of wording related to the Grade “A” PMO and the Evaluation of Milk Laboratories (EML) to PHS/FDA Regional staff and Regulatory/Rating Agencies.
MEMORANDUM OF MILK ORDINANCE EQUIPMENT COMPLIANCE (M-b): A memorandum issued by PHS/FDA that provides a notice of PHS/FDA’s review of equipment related to compliance with the Grade “A” PMO to PHS/FDA Regional staff and Regulatory/Rating Agencies.
MILK COMPANY (MC): A Milk Company (MC) is a private entity that is listed on the IMS List by a Third Party Certifier (TPC) including all associated dairy farms, bulk milk haulers/ samplers, milk tank trucks, milk transportation companies, milk plants, receiving stations, transfer stations, dairy plant samplers, industry plant samplers, milk distributor, etc., and their servicing milk and/or water laboratories, as defined in the Grade “A” PMO, located outside the geographic boundaries of NCIMS Member States.
RECIPROCITY: For the purpose of the NCIMS agreements, reciprocity shall mean no action or requirements on the part of any Regulatory Agency will cause or require any action in excess of the requirements of the current edition of the Grade “A” PMO and related documents of the NCIMS agreements.
REGULATORY AGENCY: A Regulatory Agency shall mean an agency which has adopted an ordinance, rule or regulation in substantial compliance with the current edition of the Grade “A” PMO and is responsible for the enforcement of such ordinance, rule or regulation, which is in substantial compliance with the Grade “A” PMO for a listed interstate milk shipper. The term, “Regulatory Agency”, whenever it appears in the Procedures shall also mean the appropriate Third Party Certifier (TPC) having jurisdiction and control over the matters cited within these Procedures.
REGULATORY/RATING AGENCY PROGRAM EVALUATION: An evaluation of a Regulatory/Rating Agency’s program by PHS/FDA. This shall include check ratings of IMS Listed Shippers, an assessment of a Regulatory/Rating Agency’s administrative procedures and records, adoption of the Grade “A” PMO (or equivalent laws and regulations), and compliance with NCIMS Procedures.
SINGLE-SERVICE CONTAINERS AND/OR CLOSURES MANUFACTURER: A
single-service containers and/or closures manufacturer shall mean any person or company in the business of manufacturing a single-service container and/or closure for the packaging or sampling of Grade “A” milk and/or milk products in accordance with Appendix J. Standards for the Fabrication of Single-Service Containers and/OR Closures for Milk and/OR Milk Products of the Grade “A” PMO.
SINGLE-SERVICE CONTAINERS AND/OR CLOSURES MANUFACTURER
AUDIT: The designated PHS/FDA and NCIMS Procedures method to ensure that the published certification/listing of a single-service containers and/or closures for milk and/or milk products manufacturer on the IMS List-Sanitation Compliance and Enforcement Ratings of Interstate Milk Shippers (IMS List) is valid and maintained during the interval between certifications.
CERTIFICATION: This is the certification conducted by a Milk Sanitation Rating Officer (SRO) for U.S. manufacturers of single-service containers and/or closures for milk and/or milk products; or a Third Party Certifier’s (TPC’s) Milk Sanitation Rating Officer (SRO); or a Certified Single-Service Consultant (SSC) for foreign manufacturers of single-service containers and/or closures for milk and/or milk products, which measures the degree to which the provisions of Appendix J. Standards for the Fabrication of Single-Service Containers and Closures for Milk and/OR Milk Products of the Grade “A” PMO are being complied with by the single-service containers and/or closures manufacturer for inclusion on the IMS List-Sanitation Compliance and Enforcement Ratings of Interstate Milk Shippers (IMS List). The certification is based on compliance with the requirements of Appendix J. of the Grade “A” PMO and is conducted in accordance with the procedures set forth in the Methods of Making Sanitation Ratings of Milk Shippers and the Certifications/Listings of Single-Service Containers and/or Closures for Milk and/or Milk Products Manufacturers (MMSR).
Evaluation of Milk Laboratories:
BACTOSCAN INDUSTRY OPERATOR (BIO): A person who operates a BactoScan FC under the supervision of a certified BactoScan analyst and analyzes samples for regulatory compliance.
CERTIFIED INDUSTRY SUPERVISOR (CIS): An industry supervisor who is evaluated and listed by an LEO as certified to conduct drug residue screening tests at industry drug residue screening sites for Grade “A” PMO, and Appendix N regulatory actions (confirmation of milk tank trucks, producer trace back and/or permit actions).
CERTIFIED MILK LABORATORY EVALUATION OFFICER (LEO): A Regulatory Agency or Milk Laboratory Control Agency employee who has been certified by the FDA/LPET, using the Evaluation of Milk Laboratories (EML) to evaluate milk laboratories for the purpose of accrediting or approving laboratories that conduct official NCIMS milk testing and who has a valid certificate of qualification.
FOOD AND DRUG ADMINISTRATION/LABORATORY PROFICIENCY EVALUATION TEAM LABORATORY EVALUATION OFFICER (FDA/LPET): An FDA employee that has been internally standardized to evaluate State Central Milk Laboratories for the purpose of accreditation to conduct official NCIMS milk testing. They are standardized to evaluate and certify milk Laboratory Evaluation Officers (LEOs) working for a Regulatory Agency or Milk Laboratory Control Agency for the purpose of accrediting other official and officially designated laboratories participating in the NCIMS Grade “A” Milk Safety Program.
INDUSTRY ANALYST (IA): A person under the supervision of a CIS or IS who is assigned to conduct screening of milk tank trucks for Grade “A” PMO, Appendix N drug residue requirements.
INDUSTRY SUPERVISOR (IS): An individual trained by an LEO who is responsible for the supervision and training of IAs who screen milk tank trucks for Grade “A” PMO, Appendix N drug residue requirements.
INTERNATIONAL CERTIFICATION PROGRAM (ICP): The NCIMS voluntary program designed to utilize Third Party Certifiers (TPCs) authorized by the NCIMS Executive Board in applying the requirements of the NCIMS Grade “A” Milk Safety Programs for Milk Companies (MCs) located outside the geographic boundaries of NCIMS Member States that desire to produce and process Grade “A” milk and/or milk products for importation into the United States.MILK LABORATORY CONTROL AGENCY: A governmental or other Regulatory Agency body which has adopted an ordinance, rule or regulation in substantial compliance with the current edition of the EML and is responsible for the enforcement of such ordinance, rule or regulation in substantial compliance with the Grade “A” Milk Safety Program for a listed milk laboratory. The Milk Laboratory Control Agency has authority, recognized by the NCIMS, to oversee and control the activities of milk laboratories and/or personnel involved with official NCIMS Grade “A” milk testing. The term, “Milk Laboratory Control Agency”, whenever it appears in the EML shall also mean the appropriate Third Party Certifier (TPC) having jurisdiction and control over the matters cited in this EML.OFFICIAL LABORATORY: A biological, chemical or physical laboratory which is under the direct supervision of the Regulatory Agency or Milk Laboratory Control Agency.
OFFICIALLY DESIGNATED LABORATORY: A commercial laboratory authorized to do official work by the Regulatory Agency, or a milk industry laboratory officially designated by the Regulatory Agency or Milk Laboratory Control Agency for the examination of producer samples of Grade “A” raw milk for pasteurization, ultra- pasteurization, aseptic processing and packaging or retort processed after packaging and commingled milk tank truck samples of raw milk for drug residues.
RATING AGENCY: A State Agency, which certifies interstate milk shippers (BTUs, receiving stations, transfer stations, and milk plants) as having attained the Sanitation Compliance and Enforcement Ratings necessary for inclusion on the IMS List. The ratings are based on compliance with the requirements of the Grade “A” PMO and are conducted in accordance with the procedures set forth in the Methods of Making Sanitation Ratings of Milk Shippers (MMSR). Ratings are conducted by FDA certified Milk Sanitation Rating Officers (SROs). They also certify single-service containers and closures for milk and/or milk products manufacturers for inclusion in the IMS List. The certifications are based on compliance with the requirements of the Grade “A” PMO and are conducted in accordance with the procedures set forth in the MMSR. The definition of a Rating Agency also includes a TPC that conducts ratings and certifications of Milk Companies (MCs) located outside the geographic boundaries of NCIMS member states that desire to produce and process Grade “A” milk and/or milk products for importation into the United States.
REGULATORY AGENCY: An agency which has adopted an ordinance, rule or regulation in substantial compliance with the current edition of the Grade “A” PMO and is responsible for the enforcement of such ordinance, rule or regulation, which is in substantial compliance with the Grade “A” PMO for a listed interstate milk shipper and milk laboratory. The “Regulatory Agency”, whenever it appears in the EML shall also mean the appropriated TPC having jurisdiction and control over the matters cited within this EML.
STATE CENTRAL MILK LABORATORY: A State owned and operated Official Laboratory with analysts employed by the State working in conjunction with the State Regulatory Agency designated as the primary State laboratory for the examination of producer samples of Grade “A” raw and commingled raw milk for pasteurization, ultra- pasteurization, aseptic processing and packaging or retort processed after packaging, pasteurized milk and milk products, and dairy waters, as necessary.
THIRD PARTY CERTIFIER (TPC): Non-governmental individual(s) or organization authorized under the NCIMS voluntary ICP that is qualified to conduct the routine regulatory functions and enforcement requirements of the Grade “A” PMO in relationship to milk plants, receiving stations, transfer stations, associated dairy farms, bulk milk hauler/samplers, milk tank trucks, milk transportation companies, dairy plant samplers, industry plant samplers, milk distributors, etc. participating in the NCIMS voluntary ICP. The TPC provides the means for the rating and listing of milk plants, receiving stations, transfer stations and their related raw milk sources. They also conduct the certification and IMS listing of related milk and/or water laboratories and related single-service container and closure manufacturers on the Sanitation Compliance and Enforcement Ratings of Interstate Milk Shippers (IMS) List. To be authorized under the NCIMS voluntary ICP, a valid Letter of Understanding (LOU) shall be signed between the NCIMS Executive Board and the TPC