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CFSAN/Office of Compliance
March 2, 2004
An Ordinance defining "milk" and certain "milk products", "milk producer", "pasteurization", etc.; prohibiting the sale of adulterated and misbranded milk and milk products; requiring permits for the sale of milk and milk products; regulating the inspection of dairy farms and milk plants; the examination, labeling, pasteurization, aseptic processing and packaging and distribution and sale of milk and milk products; providing for the construction of future dairy farms and milk plants; the enforcement of this Ordinance; and the fixing of penalties.
Be it ordained by the ... of ...1 as follows:
Terms used in this document, not specifically defined herein, are those within Title 21, Code of Federal Regulations (CFR) and/or the Federal Food, Drug, and Cosmetic Act (FFD&CA) as amended.
The following additional definitions shall apply in the interpretation and the enforcement of this Ordinance:
Reference: FDA Compliance Policy Guide 555.250 - Statement of Policy for Labeling and Preventing Cross-Contact of Common Food Allergens available on the Internet at: http://www.fda.gov/ora/compliance_ref/cpg/cpgfod/cpg555-250.htm
Milk products also include those dairy foods made by modifying the federally standardized products listed in this Section in accordance with 21 CFR 130.10-Requirements for foods named by use of a nutrient content claim and a standardized term.
This Definition shall include those milk and milk products, as defined herein, which have been aseptically processed and then packaged.
Milk and milk products which have been retort processed after packaging or which have been concentrated (condensed) or dried are included in this Definition only if they are used as an ingredient to produce any milk or milk product defined herein or if they are labeled as Grade "A" as described in Section 4.
Powdered dairy blends may be labeled Grade "A" and used as ingredients in Grade "A" dairy products, such as cottage cheese dressing mixes or starter media for cultures used to produce various Grade "A" cultured products, if they meet the requirements of this Ordinance. If used as an ingredient in Grade "A" products, such as those listed above, blends of dairy powders must be blended under conditions, which meet all applicable Grade "A" requirements. Grade "A" powder blends must be made from Grade "A" powdered dairy products, except that small amounts of functional ingredients, (total of all such ingredients shall not exceed 5% 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, i.e., 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".
This definition is not intended to include dietary products (except as defined herein), infant formula, ice cream or other frozen desserts, butter or cheese.
| Temperature | Time |
|---|---|
| 63°C (145°F)* | 30 minutes |
| 72°C (161°F)* | 15 seconds |
| 89°C (191°F) | 1.0 second |
| 90°C (194°F) | 0.5 seconds |
| 94°C (201°F) | 0.1 seconds |
| 96°C (204°F) | 0.05 seconds |
| 100°C (212°F) | 0.01 seconds |
*If the fat content of the milk product is ten percent (10%) or more, or if it contains added sweeteners, or if it is concentrated (condensed), the specified temperature shall be increased by 3°C (5°F).
Provided, that eggnog shall be heated to at least the following temperature and time specifications:
| Temperature | Time |
|---|---|
| 69°C (155°F) | 30 minutes |
| 80°C (175°F) | 25 seconds |
| 83°C (180°F) | 15 seconds |
Provided further, that nothing shall be construed as barring any other pasteurization process, which has been recognized by FDA to be equally efficient and which is approved by the Regulatory Agency.
No person shall, within the ... of ...1, or its jurisdiction, produce, provide, sell, offer, or expose for sale or have in possession with intent to sell any milk or milk product, which is adulterated or misbranded. Provided, that in an emergency, the sale of pasteurized milk and milk products, which do not fully meet the requirements of this Ordinance, may be authorized by the Regulatory Agency.
Any adulterated or misbranded milk or milk products, may be impounded by the Regulatory Agency and disposed of in accordance with applicable laws or regulations.
This Section of the Ordinance shall be used in impounding the milk or milk products of, or preferring charges against, persons who adulterate or misbrand their milk or milk products; or label them with any grade designation not authorized by the Regulatory Agency under the terms of this Ordinance; or who sell or deliver ungraded milk or milk products, except as may be permitted under this Section in an emergency. An emergency is defined as a general and acute shortage in the milk shed, not simply one (1) distributor's shortage.
It shall be unlawful for any person who does not possess a permit from the Regulatory Agency of the ... of ...1 to manufacture, bring into, send into or receive into the ... of ...1 or its jurisdiction, for sale, or to sell, or offer for sale therein or to have in storage any milk or milk products, defined in this Ordinance. Provided, that grocery stores, restaurants, soda fountains and similar establishments where milk or milk products are served or sold at retail, but not processed may be exempt from the requirements of this Section. Provided further, that brokers, agents, and distributors representing, buying from, and/or selling condensed and dry milk products from or to a milk plant having a valid permit are not required to have a permit.
Only a person who complies with the requirements of this Ordinance shall be entitled to receive and retain such a permit. Milk plants, receiving stations and transfer stations permitted under the NCIMS HACCP Program shall meet the applicable provisions of this Ordinance, including Appendix K. Permits shall not be transferable with respect to persons and/or locations.
Provided, that the manufacture of condensed and dry milk products, which do not meet the requirements of this Ordinance for Grade "A" condensed or dry milk products and which are intended for other uses, shall not be construed to violate the terms of this Ordinance, if such products are processed, packaged and stored separately and are plainly identified.
It shall be unlawful for any person to manufacture in a milk plant under a permit for Grade "A" condensed or dry milk products in the...of...1 or its jurisdiction any condensed and dry milk products which do not meet the requirements of this Ordinance for Grade "A" condensed or dry milk products without a permit from the Regulatory Authority who shall require that such condensed and dry milk products be processed, packaged and stored separately from Grade "A" condensed or dry milk products and that each container of such products be plainly marked in such a manner as to prevent confusion of the product with Grade "A" condensed or dry milk products.
The Regulatory Agency shall suspend such permit, whenever it has reason to believe that a public health hazard exists; or whenever the permit holder has violated any of the requirements of this Ordinance; or whenever the permit holder has interfered with the Regulatory Agency in the performance of its duties. Provided, that the Regulatory Agency shall, in all cases, except where the milk or milk product involved creates, or appears to create, an imminent hazard to the public health; or in any case of a willful refusal to permit authorized inspection/audit, serve upon the holder a written notice of intent to suspend permit, which notice shall specify with particularity the violation(s) in question and afford the holder such reasonable opportunity to correct such violation as may be agreed to by the parties, or in the absence of agreement, fixed by the Regulatory Agency, before making any order of suspension effective. A suspension of permit shall remain in effect until the violation(s) has been corrected to the satisfaction of the Regulatory Agency.
Upon notification, acceptable to the Regulatory Agency, by any person whose permit has been suspended, or upon application within forty-eight (48) hours of any person who has been served with a notice of intention to suspend, and in the latter case before suspension, the Regulatory Agency shall within seventy-two (72) hours proceed to a hearing to ascertain the facts of such violation(s) or interference and upon evidence presented at such hearing shall affirm, modify or rescind the suspension or intention to suspend.
Upon repeated violation(s), the Regulatory Agency may revoke such permit following reasonable notice to the permit holder and an opportunity for a hearing. This Section is not intended to preclude the institution of court action as provided in Sections 5 and 6.
ISSUANCE OF PERMITS: Every milk producer, milk distributor, bulk milk hauler/sampler, milk tank truck5, milk transportation company and each milk plant, receiving station, transfer station, milk tank truck cleaning facility operator shall hold a valid permit. The permit for a milk tank truck(s) may be issued to the milk transportation company. Milk producers who transport milk or milk products only from their own dairy farms; employees of a milk distributor or milk plant operator who possesses a valid permit; and employees of a milk transportation company that possesses a valid permit and transports milk or milk products from a milk plant, receiving station or transfer station shall not be required to possess a bulk milk hauler/sampler's permit. Grocery stores, restaurants, soda fountains and similar establishments where milk and milk products are served or sold at retail, but not processed, may be exempt from the requirements of this Section.
While compliance with the requirements for Grade "A" condensed and dry milk products is necessary to receive and retain a permit for these products, it is not the intent of this Ordinance to limit the production of a milk plant that condenses and/or dries milk or milk products, to Grade "A" products.
The manufacture of ungraded products for other uses in milk plants operating under a permit for the manufacture of Grade "A" condensed and dry milk products is allowed under conditions specified in Section 7 of this Ordinance and whereby such products are processed, packaged, and stored separately. In such cases, a second permit is required, which is issued with the understanding that ungraded products will be handled in such a manner so as to avoid confusion with the Grade "A" production.
Either or both permits may be temporarily suspended for the violation of any applicable provision of this Ordinance, or revoked for a serious or repeated violation. Suspension of permits for violation of sanitation Items of Section 7 is provided for in Section 5. In addition, the Regulatory Agency may, at any time, institute court action under the provisions of Section 6. There is no specific frequency for the issuance of permits. This should be in accordance with the policies of the Regulatory Agency and in agreement with those employed for the issuance of permits under this Ordinance.
SUSPENSION OF PERMIT: When any requirement(s) of this Ordinance is violated, the permit holder is subject to the suspension of their permit.
The Regulatory Agency may forego suspension of the permit, provided the milk or milk product in violation is not sold or offered for sale as Grade "A" milk or milk product. A Regulatory Agency may allow the imposition of a monetary penalty in lieu of a permit suspension, provided the milk or milk product in violation is not sold or offered for sale as Grade "A" milk or milk product. Except, that a milk producer may be assessed a monetary penalty in lieu of permit suspension for violative counts provided:
HEARINGS: If a State Administrative Procedure Act (APA), which provides procedures for administrative hearings and judicial review of administrative determinations, is available, the APA shall be made applicable by reference to the hearings provided for in the Ordinance. If such APA is not available, appropriate procedures, including provision for notice, hearing officer, their authority, record of hearing, rules of evidence and court review shall be established by the appropriate authority.
REINSTATEMENT OF PERMITS: Any permit holder whose permit has been suspended may make written application for the reinstatement of their permit.
When the permit suspension has been due to a violation of any of the bacterial, coliform or cooling temperature standards, the Regulatory Agency, within one (1) week after the receipt of notification for reinstatement of permit, shall issue a temporary permit after determining by an inspection of the facilities and operating methods that the conditions responsible for the violation have been corrected. When a permit suspension has been due to a violation of the somatic cell count standard, the Regulatory Agency may issue a temporary permit whenever a resampling of the herd's milk supply indicates the milk supply to be within acceptable limits as prescribed in Section 7. Samples shall then be taken at the rate of not more than two (2) per week on separate days within a three (3) week period and the Regulatory Agency shall reinstate the permit upon compliance with the appropriate standard as determined in accordance with Section 6 of this Ordinance.
Whenever the permit suspension has been due to a violation of a requirement other than bacteriological, coliform, somatic cell count, drug residue test or cooling-temperature standards, the notification shall indicate that the violation(s) has been corrected. Within one (1) week of the receipt of such notification, the Regulatory Agency shall make an inspection/audit of the applicant's facility, and as many additional inspections/audits thereafter as are deemed necessary, to determine that the applicant's facility is complying with the requirements. When the findings justify, the permit shall be reinstated.
When a permit suspension has been due to a positive drug residue, the permit shall be reinstated in accordance with the provisions of Appendix N.
All bottles, containers and packages containing milk or milk products defined in Section 1 of this Ordinance shall be labeled in accordance with the applicable requirements of the FFD&CA, the Nutrition Labeling and Education Act (NLEA) of 1990, and regulations developed there under, the CFR, and in addition, shall comply with applicable requirements of this Section as follows:
All bottles, containers and packages containing milk or milk products, except milk tank trucks, storage tanks and cans of raw milk from individual dairy farms, shall be conspicuously marked with:
All vehicles and milk tank trucks containing milk or milk products shall be legibly marked with the name and address of the milk plant or hauler in possession of the contents.
Milk tank trucks transporting raw, heat-treated or pasteurized milk and milk products to a milk plant from another milk plant, receiving station or transfer station are required to be marked with the name and address of the milk plant or hauler and shall be sealed; in addition, for each such shipment, a shipping statement shall be prepared containing at least the following information:
All cans of raw milk from individual dairy farms shall be identified by the name or number of the individual milk producer.
Each milk tank truck containing milk shall be accompanied by documentation, weigh ticket or manifest, which shall include the IMS BTU Identification Number(s) or the IMS Listed Milk Plant Number, for farm groups listed with a milk plant.
The purpose of this Section is to require labeling that will permit easy identification of the milk and milk product and its origin. It is required that the milk or milk product be designated by its common or usual name.
LABELING OF EMERGENCY SUPPLIES: When the sale of ungraded milk or milk products is authorized during emergencies, under the terms of Section 2, the label must bear the designation "ungraded". When such labeling is not available, the Regulatory Agency shall take immediate steps to inform the public that the particular supply is "ungraded" and that the supply will be properly labeled as soon as the distributor can obtain the required labels.
IDENTITY LABELING: "Identity", as used in this Section, is defined as the name and address or permit number of the milk plant at which the pasteurization, ultra-pasteurization, aseptic processing, condensing and/or drying takes place. It is recommended that the voluntary national uniform coding system for the identification of milk plants, at which milk and milk products are packaged, be adopted in order to provide a uniform system of codes throughout the country.
In cases where several milk plants are operated by one firm, the common firm name may be utilized on milk bottles, containers and packages. Provided, that the location of the milk plant at which the contents were pasteurized, ultra-pasteurized, aseptically processed, condensed and/or dried is also shown, either directly or by a code. This requirement is necessary in order to enable the Regulatory Agency to identify the source of the pasteurized, ultra-pasteurized, aseptically processed, condensed and/or dried milk or milk products. The street address of the milk plant need not be shown when only one (1) milk plant of a given name is located within the municipality.
The identity labeling requirement may be interpreted as permitting milk plants and persons to purchase and distribute, under their own label, milk and milk products processed and packaged at another milk plant, provided, that the label reads, "Processed at ... (name and address)", or that the processing and packaging milk plant is identified by a proper code.
MISLEADING LABELS: The Regulatory Agency shall not permit the use of any misleading marks, words or endorsements upon the label. They may permit the use of registered trade designs or similar terms on the bottle cap or label, when in their opinion, they are not misleading and are not so used as to obscure the labeling required by this Ordinance. For dry milk products, the outer bag must be preprinted "Grade "A" before filling. The use of super grade designations shall not be permitted. However, this should not be construed as prohibiting the use of official grade designations awarded to dry milk products by the United States Department of Agriculture (USDA). Grade designations such as "Grade "AA" Pasteurized", "Selected Grade "A" Pasteurized", "Special Grade "A" Pasteurized", etc., give the consumer the impression that such a grade is significantly safer than Grade "A". Such an implication is false, because the Ordinance requirements for Grade "A" pasteurized, ultra-pasteurized, or aseptically processed milk when properly enforced, will ensure that this grade of milk will be as safe as milk can practically be made. Descriptive labeling terms must not be used in conjunction with the Grade "A" designation or name of the milk or milk product and must not be false or misleading.
Each dairy farm, milk plant, receiving station, transfer station, milk tank truck cleaning facility whose milk or milk products are intended for consumption within ...of...1 or it's jurisdiction, and each bulk milk hauler/sampler who collects samples of raw milk for pasteurization, for bacterial, chemical or temperature standards and hauls milk from a dairy farm to a milk plant, receiving station or transfer station and each milk tank truck and its appurtenances shall be inspected/audited by the Regulatory Agency prior to the issuance of a permit. Following the issuance of a permit, the Regulatory Agency shall:
Should the violation of any requirement set forth in Section 7, or in the case of a bulk milk hauler/sampler, industry plant sampler or milk tank truck also Section 6 and Appendix B, be found to exist on an inspection/audit, a second inspection/audit shall be required after the time deemed necessary to remedy the violation, but not before three (3) days. This second inspection/audit shall be used to determine compliance with the requirements of Section 7 or in the case of a bulk milk hauler/sampler, industry plant sampler or milk tank truck also Section 6 and Appendix B. Any violation of the same requirement of Section 7, or in the case of a bulk milk hauler/sampler or milk tank truck also Section 6 and Appendix B, on such second inspection/audit, shall call for permit suspension in accordance with Section 3 and/or court action or in the case of an industry plant sampler, shall cease the collection of official regulatory samples until successfully re-trained and re-evaluated by the Regulatory Agency. Provided, that when the Regulatory Agency finds that a critical processing element violation involving:
The Regulatory Agency shall take immediate action to prevent further movement of such milk or milk product until such violations of critical processing element(s) have been corrected. Should correction of such critical processing element(s) not be accomplished immediately, the Regulatory Agency shall take prompt action to suspend the permit as provided for in Section 3 of this Ordinance. Provided, that in the case of milk plants producing aseptically processed milk and milk products, when an inspection of the milk plant and its records reveal that the process used has been less than the required scheduled process, it shall be considered an imminent hazard to public health and the Regulatory Agency shall take immediate action to suspend the permit of the milk plant for the sale of aseptically processed milk and milk products in conformance with Section 3 of this Ordinance.
One (1) copy of the inspection/audit report shall be handed to the operator, or other responsible person or be posted in a conspicuous place on an inside wall of the establishment. Said inspection/audit report shall not be defaced and shall be made available to the Regulatory Agency upon request. An identical copy of the inspection/audit report shall be filed with the records of the Regulatory Agency.
The Regulatory Agency shall also make such other inspections and investigations as are necessary for the enforcement of this Ordinance.
Every permit holder shall, upon the request of the Regulatory Agency, permit access of officially designated persons to all parts of their establishment or facilities to determine compliance with the provisions of this Ordinance. A distributor or milk plant operator shall furnish the Regulatory Agency, upon request, for official use only, a true statement of the actual quantities of milk and milk products of each grade purchased and sold, a list of all sources of such milk and milk products, records of inspections, tests and pasteurization time and temperature records.
It shall be unlawful for any person who, in an official capacity, obtains any information under the provisions of this Ordinance, which is entitled to protection as a trade secret, including information as to the quantity, quality, source or disposition of milk or milk products or results of inspections/audits or tests thereof, to use such information to their own advantage or to reveal it to any unauthorized person.
INSPECTION FREQUENCY: For the purposes of determining the inspection frequency for dairy farms and transfer stations the interval shall include the designated six (6) month period plus the remaining days of the month in which the inspection is due.
For the purposes of determining the inspection frequency for milk plants and receiving stations the interval shall include the designated three (3) month period plus the remaining days of the month in which the inspection is due.
One (1) milk tank truck inspection every twelve (12) months, or bulk milk hauler/sampler's or industry plant sampler's pickup and sampling procedures inspection each twenty-four (24) months, or one (1) producer, transfer station, or milk tank truck cleaning facility inspection every six (6) months, or one (1) milk plant or receiving station inspection every three (3) months is not a desirable frequency, it is instead a legal minimum. Bulk milk hauler/samplers, industry plant samplers, milk tank trucks, milk tank truck cleaning facilities, dairy farms, milk plants, receiving stations and transfer stations experiencing difficulty meeting requirements should be visited more frequently. Milk plants that condense and/or dry milk or milk products and which operate for a short duration of time or intermittent periods of time should also be inspected more frequently. Inspections of dairy farms shall be made at milking time as often as possible and of milk plants at different times of the day in order to ascertain if the processes of equipment assembly, sanitizing, pasteurization, cleaning and other procedures comply with the requirements of this Ordinance.
For the purpose of determining the minimum audit frequency for milk plants, receiving stations and transfer stations regulated under the NCIMS HACCP Program the interval shall include the remaining days of the month in which the audit is due.
ENFORCEMENT PROCEDURES: This Section provides that a dairy farm, bulk milk hauler/sampler, milk tank truck, milk tank truck cleaning facility, milk plant, receiving station, transfer station or distributor, except those processing aseptically processed milk and milk products, shall be subject to suspension of permit and/or court action if two (2) successive inspections disclose a violation of the same requirement.
Experience has demonstrated that strict enforcement of the Ordinance leads to a better and friendlier relationship between the Regulatory Agency and the milk industry than does a policy of enforcement which seeks to excuse violations and to defer penalty thereof. The sanitarian's criterion of satisfactory compliance should be neither too lenient nor unreasonably stringent. When a violation is discovered, the sanitarian should point out to the milk producer, bulk milk hauler/sampler, industry plant sampler, responsible person for the milk tank truck, milk tank truck cleaning facility, milk plant, receiving station, transfer station or distributor the requirement that has been violated, discuss a method for correction and set a time for correcting the violated requirement.
The penalties of suspension or revocation of permit and/or court action are provided to prevent continued violation of the provisions of this Ordinance but are worded to protect the dairy industry against unreasonable or arbitrary action. When a condition is found which constitutes an imminent health hazard, prompt action is necessary to protect the public health; therefore, the Regulatory Agency is authorized in Section 3, to suspend the permit immediately. However, except for such emergencies, no penalty is imposed on the milk producer, bulk milk hauler/sampler, responsible person for the milk tank truck, milk tank truck cleaning facility, milk plant, receiving station, transfer station or distributor upon the first violation of any of the sanitation requirements listed in Section 7. A milk producer, bulk milk hauler/sampler, responsible person for the milk tank truck, milk tank truck cleaning facility, milk plant, receiving station, transfer station or distributor found violating any requirement must be notified in writing and given a reasonable time to correct the violation(s) before a second inspection is made, but not before three (3) days. The requirement of giving written notice shall be deemed to have been satisfied by the handing to the operator or by the posting of an inspection report, as required by this Section. After receipt of a notice of violation, but before the allotted time has elapsed, the milk producer, bulk milk hauler/sampler, responsible person for the milk tank truck, milk tank truck cleaning facility, milk plant, receiving station, transfer station or distributor shall have an opportunity to appeal the sanitarian's interpretation to the Regulatory Agency or request an extension of the time allowed for correction.
ENFORCEMENT PROCEDURES - ASEPTIC PROCESSING MILK PLANTS: Because aseptically processed milk and milk products are stored at room temperature and are not refrigerated after processing they must be considered an imminent hazard to public health whenever it is revealed by an inspection or a review of the processing records that the process is less than the required scheduled process and the products produced have not maintained their commercial sterility. Prompt action by the Regulatory Agency to suspend the permit must be initiated in order to protect the public health. The Regulatory Agency shall stop the sale of all under-processed milk or milk product and follow at least the minimum requirements of 21 CFR 113.89 before releasing any product. (Refer to Appendix L.)
CERTIFIED INDUSTRY INSPECTION: The Regulatory Agency may certify industry personnel, with their consent, to carry out cooperatively the provisions of this Ordinance with respect to the supervision of dairy farms, bulk milk haul/sampler's pickup and sampling procedures, and/or milk tank trucks. States utilizing certified industry inspections shall have on file and available for review, a written program that describes how the requirements of this Ordinance and related documents shall be implemented. Delegation of the inspection and evaluation of bulk milk hauler/sampler's pickup and sampling procedures shall be done by the Sampling Surveillance Officer in accordance with the Evaluation of Milk Laboratories (EML).
Reports of all inspections conducted by such personnel to determine compliance with the provisions of this Ordinance shall be maintained by the industry at a location acceptable to the Regulatory Agency. The Certified Industry Inspector may perform all punitive actions and all inspections for the issuance or reinstatement of permits. Initial inspections and change of market inspections are required and shall be conducted by the Regulatory Agency in conjunction with the Certified Industry Inspector.
When a producer changes market, the producer records for the preceding twenty-four (24) months shall be transferred with the producer, through the Regulatory Agency, and will continue to be a part of the producer's record.
Industry personnel shall be certified every three (3) years by the Regulatory Agency.
At least annually, the Certified Industry Inspector shall attend an educational seminar provided by the Regulatory Agency, or equivalent training acceptable to the Regulatory Agency.
At least once in each six (6) month period, the Regulatory Agency shall inspect the records maintained by the Industry for the Certified Industry Inspection Program and conduct farm field work to assure the program meets the provisions of the Regulatory Agency's written plan and requirements of this Ordinance and related documents.
Initial certification by the Regulatory Agency shall not be made during the course of an official inspection. Re-certification by the Regulatory Agency may be conducted during the course of an official inspection.
Purpose of Certification: The purpose of certification is to have the applicant formally demonstrate their inspection ability to apply proper interpretations of this Ordinance, related documents, and the Regulatory Agency's procedures.
Designation of Individuals to Be Certified: Candidates shall submit requests for certification to the Regulatory Agency. The applicant for certification shall have had experience in the field of milk sanitation, and shall be an employee of a milk plant, a producer association, officially designated laboratory or shall be employed on a consulting basis.
Recording of Qualification Data: Prior to conducting the certification procedure, background information shall be secured on the applicant. This shall include academic training, experience in milk sanitation and related fields, in-service courses attended, etc. This information is to be retained by the Regulatory Agency as part of the applicant's file, along with appropriate records of the applicant's performance during the certification examination.
Field Procedure: Only one (1) applicant shall be certified at a time. The certification is to be conducted without prompting from the Regulatory Agency or comparison of inspection results in any way until the entire procedure is completed. Initial certification shall not be made during the course of an official inspection by the Regulatory Agency.
At least twenty-five (25) randomly selected dairy farms and/or five (5) milk tank trucks shall be visited. After the necessary inspections have been completed, the Regulatory Agency shall compare their results with those of the candidate. The percentage agreement for each Item of sanitation shall be determined by dividing the number of agreements by the total number of dairy farms and/or milk tank trucks inspected.
Criteria for Certification: In order to be certified, an industry inspector shall agree with the Regulatory Agency eighty percent (80%) of the time on individual Items of sanitation and shall further agree to comply with the administrative procedures established by the Regulatory Agency for the program of dairy farm and/or milk tank truck supervision. The Regulatory Agency should allow sufficient time to discuss the findings with the applicant.
Duration of Certification: Certification of industry inspection personnel shall be for a period not exceeding three (3) years from the date of formal certification or re-certification, unless revoked.
Re-Certification: The Regulatory Agency shall notify the certified industry inspector of the need for certification renewal at least sixty (60) days prior to its expiration. If re-certification is desired, the inspector will make appropriate arrangements for the renewal procedure. Re-certification can be made for the succeeding three (3) year period, by following the procedures outlined above. Provided, that re-certification may be conducted during the course of an official inspection by the Regulatory Agency.
Reports and Records: Upon satisfactory completion of certification or re-certification, the certified industry inspector shall be issued a certificate. The milk plant(s) or officially designated laboratory(ies) employing the inspector shall be formally notified by letter of the certification. The letter shall outline the purpose of the certification and the conditions under which the certification may be retained. A copy of the notification letter, together with a copy of the qualification data above and a resume of the percentage agreement on individual items, shall be retained by the Regulatory Agency.
Revocation of Certification: The certification of an industry inspector may be revoked by the Regulatory Agency upon a finding that the inspector is:
INSPECTION/AUDIT REPORTS: A copy of the inspection/audit report shall be filed as directed by the Regulatory Agency and retained for at least twenty-four (24) months. The results shall be entered on appropriate ledger forms. The use of a computer or other information retrieval system may be used. Examples of field inspection/audit forms are identified in Appendix M.
It shall be the responsibility of the bulk milk hauler/sampler to collect a representative sample of milk from each farm bulk tank prior to transferring milk from a farm bulk tank, truck or other container. All samples shall be collected and delivered to a milk plant, receiving station, transfer station or other location approved by the Regulatory Agency.
NOTE: If the production of any Grade "A" condensed or dry milk product as defined in this Ordinance is not on a yearly basis, at least 5 samples shall be taken within a continuous production period.
Samples of milk and milk products shall be taken while in the possession of the producer, milk plant or distributor at any time prior to delivery to the store or consumer. Samples of milk and milk products from dairy retail stores, food service establishments, grocery stores and other places where milk and milk products are sold shall be examined periodically as determined by the Regulatory Agency and the results of such examination shall be used to determine compliance with Sections 2, 4 and 10. Proprietors of such establishments shall furnish the Regulatory Agency, upon request, with the names of all distributors from whom milk or milk products are obtained.
Required bacterial counts somatic cell counts and cooling temperature checks shall be performed on raw milk for pasteurization. In addition, drug tests on each producer's milk shall be conducted at least four (4) times during any consecutive six (6) months.
Required bacterial counts, drug tests, except those products for which there are not any approved drug test kits available, coliform determinations, phosphatase and cooling temperature determinations shall be performed on Grade "A" pasteurized milk and milk products defined in this Ordinance. Required drug residue tests shall be performed on aseptically processed milk and milk products.
NOTE: When multiple samples of the same milk or milk products, except for aseptically processed milk and milk products, are collected from the same producer or processor from multiple tanks or silos on the same day, the laboratory results are averaged arithmetically by the Regulatory Agency and recorded as the official results for that day. This is applicable for bacterial (standard plate count and coliform), somatic cell count and temperature determinations only.
Whenever two (2) of the last four (4) consecutive bacterial counts (except those for aseptically processed milk and milk products), somatic cell count, coliform determinations, or cooling temperatures, taken on separate days, exceed the standard for the milk and/or milk products as defined in this Ordinance, the Regulatory Agency shall send a written notice thereof to the person concerned. This notice shall be in effect as long as two (2) of the last four (4) consecutive samples exceed the standard. An additional sample shall be taken within twenty-one (21) days of the sending of such notice, but not before the lapse of three (3) days. Immediate suspension of permit, in accordance with Section 3, and/or court action shall be instituted whenever the standard is violated by three (3) of the last five (5) bacterial counts (except those for aseptically processed milk and milk products), somatic cell counts, coliform determinations or cooling temperatures.
Whenever a phosphatase test is positive, the cause shall be determined. Where the cause is improper pasteurization, it shall be corrected and any milk or milk product involved shall not be offered for sale.
Whenever a pesticide residue test is positive, an investigation shall be made to determine the cause and the cause shall be corrected. An additional sample shall be taken and tested for pesticide residues and no milk or milk products as defined in this Ordinance shall be offered for sale until it is shown by a subsequent sample to be free of pesticide residues or below the actionable levels established for such residues.
Whenever a drug residue test is confirmed positive, an investigation shall be made to determine the cause, and the cause shall be corrected in accordance with the provisions of Appendix N.
Whenever a container or containers of aseptically processed milk or milk product is found to be non-sterile, due to under-processing, the Regulatory Agency shall consider this to be an imminent hazard to public health and shall suspend the permit of the milk plant for the sale of aseptically processed milk and milk products. No aseptically processed milk and milk product shall be sold until it can be shown that the processes, equipment and procedures used are suitable for consistent production of a sterile product. All products from the lot that were found to contain one (1) or more non-sterile units shall be recalled and disposed of as directed by the Regulatory Agency.
Samples shall be analyzed at an appropriate official or officially designated laboratory. All sampling procedures, including the use of approved in-line samplers, and required laboratory examinations shall be in substantial compliance with the most current edition of Standard Methods for the Examination of Dairy Products (SMEDP) of the American Public Health Association, and the most current edition of Official Methods of Analysis of AOAC INTERNATIONAL (OMA). Such procedures, including the certification of sample collectors and examinations shall be evaluated in accordance with the EML. Aseptically processed milk and milk products packaged in hermetically sealed containers shall be tested in accordance with FDA's Bacteriological Analytical Manual (BAM).
Each milk plant regulated under the NCIMS HACCP Program shall adequately document its response to each regulatory sample test result that exceeds any maximum level specified in Section 7 of this Ordinance. The Regulatory Agency will monitor and verify that appropriate action(s) was taken by the milk plant.
Examinations and tests to detect adulterants, including pesticides, shall be conducted, as the Regulatory Agency requires. When the Commissioner of the FDA determines that a potential problem exists with animal drug residues or other contaminants in the milk supply, samples shall be analyzed for the contaminant by a method(s) determined by FDA to be effective in determining compliance with actionable levels or established tolerances. This testing will continue until such time that the Commissioner of the FDA is reasonably assured that the problem has been corrected. The determination of a problem is to be based upon:
Assays of milk and milk products as defined in this Ordinance, to which vitamin (s) A and/or D have been added, shall be made at least annually in a laboratory, which has been accredited by FDA and which is acceptable to the Regulatory Agency, using test methods acceptable to FDA or other official methodologies, which gives statistically equivalent results to the FDA methods.
Vitamin testing laboratories are accredited if they have one (1) or more certified analysts and meet the quality control requirements of the program established by FDA. Laboratory accreditation and analyst certification parameters are specified in the EML manual.
In addition, all facilities fortifying milk or milk products with vitamins must keep volume control records. These volume control records must cross reference the form and amount of vitamin D, vitamin A and/or vitamins A and D used with the amount of products produced and indicate a percent of expected use, plus or minus.
ENFORCEMENT PROCEDURES: All violations of bacteria, coliform, confirmed somatic cell counts and cooling temperature standards should be followed promptly by inspection to determine and correct the cause. (Refer to Appendix E. Examples of Three (3)-out-of-Five (5) Compliance Enforcement Procedures)
Aseptically processed milk and milk products packaged in hermetically sealed containers are exempt from the refrigerated storage requirements of this Ordinance. Therefore, whenever a breakdown in the processing or packaging of these products occurs an imminent hazard to public health exists. Prompt action is needed by the Regulatory Agency. Milk plants aseptically processing milk and milk products in hermetically sealed containers should be encouraged to perform bacterial and other quality tests on each lot of aseptically processed milk and milk product produced in order to ascertain that these products have been properly processed and have not been rendered non-sterile after aseptic processing and packaging. The Regulatory Agency may utilize industry records, of each lot of aseptically processed milk and milk products, to determine when lots can be released for sale after a violation of the bacterial standards has existed.
LABORATORY TECHNIQUES: Procedures for the collection, including the use of approved in-line samplers, and holding of samples; the selection and preparation of apparatus, media and reagents; and the analytical procedures, incubation, reading and reporting of results, shall be in substantial compliance with the FDA 2400 series forms, SMEDP and OMA. The procedures shall be those specified therein for:
When a warning letter has been sent, because of excessively high somatic cell counts, an official inspection of the dairy should be made by regulatory personnel or certified industry personnel. This inspection should be made during milking time.
Any of the following confirmatory or screening tests shall be used: Direct Microscopic Somatic Cell Counting Single Strip Procedure, Electronic Somatic Cell Counting or Flow Cytometry/Opto-Electronic Somatic Cell Counting. Pyronine Y-Methyl green stain or "New York modification" shall be used in the confirmatory test for Direct Microscopic Somatic Cell Counts in goat milk.
SAMPLING PROCEDURES: SMEDP contains guidance for sampling of milk and milk products. (Refer to Appendix G. for a reference to drug residues in milk and the conditions under which a positive phosphatase reaction may be encountered in properly pasteurized milk or cream. Refer to Appendix B. for reference to farm bulk milk hauling programs regarding training, licensing/permitting, routine inspection and the evaluation of sampling procedures.)
When samples of raw milk for pasteurization are taken at a milk plant prior to pasteurization, they shall be drawn following adequate agitation from randomly selected storage tanks. All counts and temperatures should be recorded on a milk-ledger form as soon as reported by the laboratory. A computer or other information retrieval system may be used.
NOTE: Milk from animals not currently in the Grade "A" PMO may be labeled as Grade "A" and IMS listed upon FDA's acceptance of validated Grade "A" PMO, Section 6 and Appendix N. test methods for the animal to be added.
All Grade "A" raw milk or milk products for pasteurization, ultra-pasteurization, or aseptic processing and all Grade "A" pasteurized, ultra-pasteurized or aseptically processed milk and milk products, shall be produced, processed, manufactured and pasteurized, ultra-pasteurized, or aseptically processed to conform to the following chemical, physical, bacteriological and temperature standards and the sanitation requirements of this Section.
No process or manipulation other than pasteurization, ultra-pasteurization or aseptic processing; processing methods integral therewith; and appropriate refrigeration shall be applied to milk and milk products for the purpose of removing or deactivating microorganisms. Provided, that in the bulk shipment of cream, nonfat (skim) milk or reduced fat or lowfat milk, the heating of the raw milk, one time, to temperatures greater than 52°C (125°F) but less than 72°C (161°F), for separation purposes, is permitted when the resulting bulk shipment(s) of cream, nonfat (skim) milk or reduced fat or lowfat milk are labeled heat-treated. In the case of heat-treated cream, the cream may be further heated to less than 75°C (166°F) in a continuing heating process and immediately cooled to 7°C (45°F) or less when necessary for enzyme deactivation (such as lipase reduction) for a functional reason.
Milk plants, receiving stations and transfer stations participating in the NCIMS HACCP Program, shall also comply with the requirements of Appendix K. of this Ordinance.
Whey shall be from cheese made from Grade "A" raw milk for pasteurization as provided in this Ordinance.
Buttermilk shall be from butter made from Grade "A" cream, which has been pasteurized prior to use in accordance with Item 16p of this Ordinance. Provided, that this requirement shall not be construed as barring any other heat treatment process which has been recognized by the FDA to be equally efficient in the destruction of staphylococcal organisms and which is approved by the Regulatory Agency.
Buttermilk and whey used in the manufacture of Grade "A" milk and milk products shall be produced in a milk/cheese plant that complies with Items 1p, 2p, 3p, 4p, 5p 6p, 7p 8p, 9p, 10p, 11p, 12p, 13p, 14p, 15p, 17p, 20p, 21p and 22p as provided in this Ordinance.
Whey shall be from:
| GRADE "A" RAW MILK AND MILK PRODUCTS FOR PASTEURIZATION, ULTRA-PASTEURIZATION OR ASEPTIC PROCESSING | Temperature................ | Cooled to 10°C (50°F) or less within four (4) hours or less, of the commencement of the first milking, and to 7°C (45°F) or less within two (2) hours after the completion of milking. Provided, that the blend temperature after the first milking and subsequent milkings does not exceed 10°C (50°F). |
| Bacterial Limits........... | Individual producer milk not to exceed 100,000 per mL prior to commingling with other producer milk. Not to exceed 300,000 per mL as commingled milk prior to pasteurization. | |
| Drugs....................... | No positive results on drug residue detection methods as referenced in Section 6 - Laboratory | |
| Somatic Cell Count*... | Individual producer milk not to exceed 750,000 per mL. | |
| GRADE "A" PASTEURIZED MILK AND MILK PRODUCTS AND BULK SHIPPED HEAT-TREATED MILK PRODUCTS | Temperature................ | Cooled to 7°C (45°F) or less and maintained thereat. |
| Bacterial Limits**...... | 20,000 per mL, or gm.*** | |
| Coliform****.............. | Not to exceed 10 per mL. Provided, that in the case of bulk milk transport tank shipments, shall not exceed 100 per mL. | |
| Phosphatase*****......... | Less than 350 milliunits/L for fluid products and other milk products by the Fluorometer or Charm ALP or equivalent. | |
| Drugs**...................... | No positive results on drug residue detection methods as referenced in Section 6 - Laboratory Techniques which have been found to be acceptable for use with pasteurized and heat-treated milk and milk products | |
| GRADE "A" PASTEURIZED CONCENTRATED (CONDENSED) MILK AND MILK PRODUCTS | Temperature............ | Cooled to 7°C (45°F) or less and maintained thereat unless drying is commenced immediately after condensing. |
| Coliform............... | Not to exceed 10 per gram. Provided, that in the case of bulk milk transport tank shipments shall not exceed 100 per ml. | |
| GRADE "A" ASEPTICALLY PROCESSED MILK AND MILK PRODUCTS | Temperature................ | None. |
| Bacterial Limits........... | Refer to 21 CFR 113. 3(e)(1)****** | |
| Drugs**....................... | No positive results on drug residue detection methods as referenced in Section 6 - Laboratory Techniques that have been found to be acceptable for use with aseptically processed milk and milk products. | |
| GRADE "A" NONFAT DRY MILK | No More Than: | |
| Butterfat.................. | 1.25% | |
| Moisture.................. | 4.00% | |
| Titratable Acidity........ | 0.15% | |
| Solubility Index......... | 1.25mL. | |
| Bacterial Estimate....... | 30,000 per gram | |
| Coliform.................. | 10 per gram | |
| Scorched Particles disc B..................... |
15.0 per gram | |
| GRADE "A" WHEY FOR CONDENSING | Temperature............. | Maintained at a temperature of 45°F (7°C) or less, or 63°C (145°F) or greater, except for acid-type whey with a titratable acidity of 0.40% or above, or a pH of 4.6 or below. |
| GRADE "A" PASTEURIZED CONDENSED WHEY AND WHEY PRODUCTS | Temperature.............. | Cooled to 7°C (45°F) or less during crystallization, within 48 hours of condensing. |
| Coliform Limit........... | Not to exceed 10 per gram | |
| GRADE "A" DRY WHEY, GRADE "A" DRY WHEY PRODUCTS, GRADE "A" DRY BUTTERMILK, AND GRADE "A" DRY BUTTERMILK PRODUCTS | Coliform Limit........... | Not to exceed 10 per gram |
* Goat Milk 1,000,000 per mL
** Not applicable to acidified or cultured
products.
*** Results of the analysis of dairy products which are
weighed in order to be analyzed will be reported in # per gm. (Refer to the
current edition of the SMEDP)
**** Not applicable to bulk shipped heat-treated
milk
products.
***** Not applicable to bulk shipped heat-treated milk
products; UP products that have been thermally processed at or above 138°C
(280°F) for at least two (2) seconds to produce a product which has
an extended shelf life (ESL) under refrigerated conditions; and condensed
products.
****** 21 CFR 113.3(e)(1) contains the definition of "COMMERCIAL
STERILITY".
