Glossary of Terms Dairy
Note: The National Conference on Interstate Milk Shipments (NCIMS) is a cooperative program where certain dairy products are only allowed by state law to be sold as “GRADE ‘A’ in all 50 US States and most territories. This state-based regulatory program is unique as there is no US Food & Drug Administration definition of “GRADE ‘A’. All “GRADE ‘A’ dairy products must originate from raw milk produced on Grade “A” farms and processed only in Grade A dairy plants. Grade “A” dairy products including all drinking milks, cream products (including sour cream and ½ & ½ ), yogurts, cottage cheese, buttermilks as well as some dried or powdered milk and whey products and certain products which are determined to meet the criteria for a Grade “A” dairy beverage.
A
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.
Allergen Cross-Contact – Unintentional incorporation of a food allergen into a food.
Area Rating – Applies 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.
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(SRO) or FDA Regional Milk Specialist as not being in compliance, whereby a listing shall be immediately denied or withdrawn.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 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 Processing And Packaging – Milk and/or milk product 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) – Comprised of the processes and equipment used to process and package aseptic Grade “A” low-acid milk and/or milk products. Regulated in accordance with the applicable requirements of 21 CFR Parts 108, 110 and 113. 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.
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.
B
Broke and Trim – 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.
Bulk Milk Hauler/Samper – 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 – 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.
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.
Buttermilk – Fluid product resulting from the manufacture of butter from milk or cream. It contains not less than 8¼ percent of milk solids not fat.
C
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 traceback 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 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.
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.
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.
Closure – 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 – Any layer or covering which is applied to the product-contact surface.
Common Name – The generic term commonly used for domestic animals, i.e., cattle, goats, sheep, horses, water buffalo, camels, etc.
Component Part – 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.
Concentrated (Condensed) Milk – 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.
Concentrated (Condensed) Milk Products – 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.
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). Not suitable for Grade “A” purposes.
Control Measure – 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).
Cooling Pond – Man-made structure designed for the specific purpose of cooling cows.
Corrective Action – Procedures followed when a deviation occurs.
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.
D
Dairy Farm – 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.
Dairy HACCP Core Curriculum – The core curriculum consists of: Basic HACCP training; plus an orientation to the requirements of the NCIMS voluntary HACCP Program.
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).
Deficiency – An element inadequate or missing from the requirements of the HACCP System or Appendix K.
Deviation – A failure to meet a Critical Limit (CL).
Dry Milk Products – 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 mean dry milk products, which comply with the applicable provisions of this Ordinance.
E
F
FDA 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.
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: http://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAllergens/default.htm.
Frozen Milk Concentrate – 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.
G
H
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.
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.
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.
Hooved Mammals’ Milk – 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.
I
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.
Individual Rating – 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.
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 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).
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.
Inspection/Audit Report – A handwritten or electronically generated official regulatory report used for the documentation of findings observed during an inspection/audit.
International Certification Program (ICP) – 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.
L
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).
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.
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.
M
Manufacturing Line – Manufacturing process such as injection molding, extrusion, blow-molding, etc.
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.
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.
Metals – Those metals that are non-toxic, nonabsorbent and corrosion-resistant under conditions of intended use.
Milk Company (MC) – 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 – 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). Whey and whey products as defined in 21 CFR 184.1979, 184.1979a, 184.1979b, 184.1979c, and Section 1., Whey Products. 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 Products other than these 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”.
Milk Tank Truck – 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 – 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 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 – Person responsible for a milk tank truck(s).
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).
N
Non-toxic Materials – 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.
O
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 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.
P
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
Components meeting the requirements of the FFD&CA as amended.
Plastic Molding, Forming, Extrusion, and Laminating Resins – Resins or an intimate admixture of resins with other ingredients, which meet the requirements of the FFD&CA as amended; Plastic composed solely of clean cuttings or regrind provided they have been handled and maintained in a clean, sanitary manner; and Recycled plastic material when it complies with a protocol that has been reviewed and accepted by FDA.
Pre-forms – A component, not in final form for filling.
Product-Contact Surface – Those surfaces of the container or closure with which the product comes in contact with.
Production Scrap – 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.
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:
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.
Presumptive Positive – 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.
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. 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.
Producer Trace Back With Permit Suspension Action Not Required – 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.
R
Receiving Station – Any place, premises, or establishment where raw milk is received, collected, handled, stored, or cooled and prepared for further transporting.
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.
Reconstituted Or Recombined Milk And/Or Milk Products – Milk or milk products defined in this Section which result from reconstituting or recombining of milk constituents with potable water when appropriate.
Regrind – 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.
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.
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.
Retort Processed After Packaging – “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) – 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.
S
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).
Sheep Milk – 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.
Single-Service Articles – 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 – 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 – 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 – 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).
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.
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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
Except as specified in 3 below of this definition, a milk or milk product that because of the interaction of it’s aw and pH values is designated as Product Assessment (PA) as required in either Table A or B as follows: either Table A or B as follows:
Transfer Station – Any place, premises, or establishment where milk or milk products are transferred directly from one (1) milk tank truck to another.
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Undesirable Milk – Milk that, prior to the milking of the animal, is expected to be unsuitable for sale, such as milk containing colostrum. Not suitable for Grade “A” purposes.
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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 plan.
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Whey Products: Grade “A” – 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.
Dry Whey Products: Dry whey products mean products resulting from the drying of whey or whey products and any product resulting from the combination of dry whey products with other wholesome dry ingredients.
Concentrated (Condensed) and Dry Whey and Whey Products: 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.