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CFSAN/Office of Compliance
October 10, 2000; Revised: 2005

Methods of Making Sanitation Ratings of Milk Shippers

2005 Revision

(Available in PDF, 1.2 Mb)

PREFACE

TABLE OF CONTENTS

METHODS OF MAKING SANITATION RATINGS OF MILK SHIPPERS

DEFINITIONS
RATING METHODS FOR RAW MILK FOR PASTEURIZATION
1. Drug Residue Compliance - Procedure for Determining BTU or Attached Supply Compliance with Appendix N. of the Grade "A" PMO
  1. Record Review
  2. Regulatory Notification and Disposition
  3. Reinstatement
2. COLLECTION OF DATA
  1. Number of Dairy Farms to be Rated
  2. Random Selection of Dairy Farms to be Rated
  3. Number of Bulk Milk Hauler/Samplers to be Evaluated
  4. Recording of Inspection Data
  5. Recording of Laboratory and Other Test Data
3. COMPUTATION OF SANITATION COMPLIANCE RATINGS
RATING METHODS FOR MILK PLANTS, RECEIVING STATIONS AND TRANSFER STATIONS
1. Drug Residue Compliance - Procedure for Determining Milk Plant, Receiving Station and Transfer Station Compliance with Appendix N. of the Grade "A" PM.
  1. Record Review
  2. Regulatory Notification
  3. Industry Notification
2. COLLECTION OF DATA
  1. Recording of Inspection Data
  2. Recording of Laboratory and Other Test Data
  3. Recording of Data for Milk Plants, Receiving Stations and Transfer Stations Being Listed Under the NCIMS HACCP Listing Procedure.
3. COMPUTATION OF SANITATION COMPLIANCE RATINGS
COMPUTATION OF ENFORCEMENT RATINGS
1. PURPOSE
2. RAW MILK FOR PASTEURIZATION ONLY
3. RECEIVING STATION OR TRANSFER STATION
4. MILK PLANTS
  1. Milk Plant with an Unattached Supply of Raw Milk
  2. Milk Plant with an Attached Supply of Raw Milk
PREPARATION OF THE SRO's REPORT
1. PURPOSE
2. SUMMARY OF RATING RESULTS
3. SUPPLEMENTARY NARRATIVE REPORT
4. RECOMMENDATIONS OF THE SRO
PUBLICATION OF THE "INTERSTATE MILK SHIPPER'S REPORT"
1. PURPOSE
2. PREPARATION OF THE "INTERSTATE MILK SHIPPER'S REPORT"
  1. Individual Shipper of Raw Milk for Pasteurization
  2. Receiving Station or Transfer Station
  3. Milk Plant
3. PREPARATION OF THE "INTERSTATE MILK SHIPPER's REPORT" FOR HACCP LISTINGS.
EXAMPLES OF RATING AND NCIMS HACCP LISTING FORMS (PDF, 312 kb)
- FORM FDA 2359j-MILK SANITATION RATING REPORT-SECTION A. REPORT OF THE MILK SANITATION RATING (Page 1)
- FORM FDA 2359j- MILK SANITATION RATING REPORT-SECTION B. REPORT OF ENFORCEMENT METHODS (Page 2)
- FORM FDA 2359k-STATUS OF RAW MILK FOR PASTEURIZATION
- FORM FDA 2359L-STATUS OF MILK PLANTS (including drying and condensing milk products plants, receiving stations and transfer stations)
- FORM FDA 2359i-INTERSTATE MILK SHIPPER's REPORT
- FORM FDA 2359i-INTERSTATE MILK SHIPPER's REPORT (Electronic Submission)
- EVALUATION OF SAMPLING PROCEDURES (BTU) (Part I, Item 9)
- EVALUATION OF SAMPLING PROCEDURES (Plant, Receiving Station or Transfer Station) (Part II, Item 8)
- MILK PLANT, Receiving Station or Transfer Station NCIMS HACCP SYSTEM AUDIT REPORT
- NCIMS HACCP SYSTEM REGULATORY AGENCY REVIEW REPORT
- PERMISSION FOR PUBLICATION - INTERSTATE MILK SHIPPER's LISTING
EXAMPLES OF HOW TO PROPERLY COMPLETE RATING AND NCIMS HACCP LISTING FORMS (PDF, 312 kb)
- FORM FDA 2359j-MILK SANITATION RATING REPORT-SECTION A. REPORT OF THE MILK SANITATION RATING (Page 1)
- FORM FDA 2359j-MILK SANITATION RATING REPORT-SECTION B. REPORT OF ENFORCEMENT METHODS (Page 2) (Example: Plant Only)
- EVALUATION OF SAMPLING PROCEDURES (Plant-Part II, Item 8)
- FORM FDA 2359j-MILK SANITATION RATING REPORT-SECTION B. REPORT OF ENFORCEMENT METHODS (Page 2) (Example: BTU and Receiving Station)
- EVALUATION OF SAMPLING PROCEDURES (BTU-Part I, Item 9)
- EVALUATION OF SAMPLING PROCEDURES (Receiving Station-Part II, Item 8)
- FORM FDA 2359j-MILK SANITATION RATING REPORT-SECTION B. REPORT OF ENFORCEMENT METHODS (Page 2) (Example: BTU Only)
- FORM FDA 2359k-STATUS OF RAW MILK FOR PASTEURIZATION
- FORM FDA 2359L-STATUS OF MILK PLANTS (including drying and condensing milk products plants, receiving stations and transfer stations)
- FORM FDA 2359L-STATUS OF MILK PLANTS (including drying and condensing milk products plants, receiving stations and transfer stations)
- FORM FDA 2359i-INTERSTATE MILK SHIPPER's REPORT
- FORM FDA 2359i-Interstate Milk Shipper's Report (Electronic Submission)
- MILK PLANT, Receiving Station or Transfer Station NCIMS HACCP SYSTEM AUDIT REPORT
- NCIMS HACCP SYSTEM REGULATORY AGENCY REVIEW REPORT
- FORM FDA 2359i-INTERSTATE MILK SHIPPER's REPORT (NCIMS HACCP Listing)
- PERMISSION FOR PUBLICATION - INTERSTATE MILK SHIPPER's LISTING

TABLE FOR COMPUTING PERCENT VIOLATION ( PDF, 16 kb)
APPENDIX A. GUIDELINES FOR COMPUTING ENFORCEMENT RATINGS
- (FORM FDA 2359j - MILK SANITATION RATING REPORT-SECTION B. REPORT OF ENFORCEMENT METHODS (Page 2)
  - PART I. DAIRY FARMS
  - PART II. MILK PLANTS
  - PART III. INDIVIDUAL SHIPPER RATING
  - GUIDANCE FOR COMPUTING ENFORCEMENT CREDIT FOR PART I, ITEM 9 AND/OR PART II, ITEM 8 OF FORM FDA 2359j-MILK SANITATION RATING REPORT-SECTION B. REPORT OF ENFORCEMENT METHODS (Page 2)
APPENDIX B. TABLE OF FARM WATER SUPPLY VIOLATIONS

PREFACE

The objective of a rating is to provide an assessment of State and Local sanitation activities regarding public health protection and milk quality control. This is accomplished by evaluating sanitation compliance and enforcement standards of the current edition of the Grade "A" Pasteurized Milk Ordinance (Grade "A" PMO) and Related Documents as listed in the Procedures Governing the Cooperative State-Public Health Service/Food and Drug Administration Program of the National Conference on Interstate Milk Shipments (Procedures). Rating results are used for the purpose of evaluating the sanitation compliance and enforcement requirements of shippers to determine the degree of compliance with public health standards as expressed in the Grade "A" PMO. Rating results are further utilized as a means of uniform education and interpretation, in addition to providing a basis for the acceptance/rejection of shippers by Regulatory Officials beyond the limits of routine inspection. Rating results are intended to establish uniform reciprocity between States to prevent unnecessary restrictions of the interstate flow of milk and milk products, yet assure public health protection.

The rating method for evaluating the sanitary quality of milk measures the extent to which a shipper complies with the standards contained in the Grade "A" PMO. These nationally recognized standards, rather than local requirements, are used as a yardstick in order that ratings of individual Bulk Tank Units (BTU's) or attached shippers and milk plants may be comparable to each other, both interstate and intrastate. Ratings are expressed in terms of percentage compliance. For example, if the milk plant and dairy farms comply with all of the requirements of the Grade "A" PMO, the Sanitation Compliance Rating of the pasteurized milk supply would be one hundred percent (100%); whereas, if the plant or some of the dairy farms fail to satisfy one (1) or more of these requirements, the Sanitation Compliance Rating would be reduced in proportion to the amount of milk and milk products involved in the violation and to the relative public health significance of the violated Item(s). Procedures for collection of data, computation of Sanitation Compliance Ratings for raw milk for pasteurization and pasteurized milk, and computation of the Enforcement Rating of the Regulatory Agency, responsible for administering milk sanitation regulations, are described in the following Sections.

METHODS OF MAKING SANITATION RATINGS OF MILK SHIPPERS

A. DEFINITIONS

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.

AREA RATING: An area rating, if used, shall apply to raw milk for pasteurization only. 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.
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.
BULK TANK UNIT (BTU): A dairy farm or group of dairy farms from which raw milk for pasteurization 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.
CERTIFIED MILK SANITATION RATING OFFICER (SRO): A State employee who has been standardized 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 inspection and enforcement or regulatory auditing of the shipper to be rated or listed. Directors and administrators, etc. may be certified as SRO's. A SRO may be certified to make HACCP plant, receiving station or transfer station listings.
CRITICAL LISTING ELEMENT (CLE). An item on the Milk Plant, Receiving Station or Transfer Station NCIMS HACCP System Audit Report identified with a double star (**). The marking of a CLE element by a SRO or FDA auditor, indicates a condition that constitutes a major dysfunction likely to result in a potential compromise to milk or milk product safety, or that violates NCIMS requirements regarding drug residue testing and trace back or raw milk sources, whereby a listing may be denied or withdrawn.
DAIRY FARM: A dairy farm is any place or premises where one (1) or more lactating animals (cows, goats, sheep, water buffalo, or other hooved mammal) are kept for milking purposes, and from which a part or all of the milk or milk product(s) is provided, sold or offered for sale to a milk plant, receiving station or transfer station.
ENFORCEMENT RATING: This is a measure of the degree to which enforcement provisions of the Grade "A" PMO are being applied by the Regulatory Agency.
FDA AUDIT. An evaluation conducted by FDA of the entire milk plant, receiving station, or transfer station facility to ensure compliance with the NCIMS HACCP System and other NCIMS regulatory requirements.
HACCP LISTING. An inclusion in the IMS List-Sanitation Compliance and Enforcement Ratings of Interstate Milk Shippers (IMS List) based on a SRO'S evaluation of a milk plant's, receiving station's or transfer station's NCIMS HACCP Program and other applicable NCIMS requirements.
INDIVIDUAL RATING: An individual rating is the rating of a single producer group, milk plant, receiving station, and/or transfer station under the supervision of a single Regulatory Agency.
LISTING AUDIT. An evaluation conducted by a SRO of the entire milk plant, receiving station or transfer station facility to ensure compliance with the NCIMS HACCP Program and other NCIMS regulatory requirements.
MILK PLANT: A milk plant is any place, premises, or establishment where milk or milk products are collected, handled, processed, stored, pasteurized, aseptically processed, packaged, or prepared for distribution.
RECEIVING STATION: A receiving station is 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 no action or requirements on the part of any Regulatory Agency will cause or require any action in excess of the requirements of the current edition of the Grade "A" PMO and Related Documents of the NCIMS agreements.
REGULATORY AGENCY: A Regulatory Agency shall mean an agency which has adopted an ordinance, rule or regulation in substantial compliance with the current edition of the Grade "A" PMO or two (2) agencies which have mutually agreed to share the responsibilities for the enforcement of an ordinance, rule or regulation in substantial compliance with the Grade "A" PMO for a listed interstate milk shipper. The mutual agreement shall specify the details of how the rating will be made, so long as the details do not conflict with the basic intent of this document.
TRANSFER STATION: A transfer station is any place, premises, or establishment where milk or milk products are transferred directly from one (1) milk tank truck to another.

B. RATING METHODS FOR RAW MILK FOR PASTEURIZATION

Drug Residue Compliance - Procedure for Determining BTU or Attached Supply Compliance with Appendix N. of the Grade "A" PMO
During an Interstate Milk Shippers' (IMS) rating or check rating, it is necessary to determine compliance of the BTU or attached supply with the requirements of Appendix N. of the Grade "A" PMO. The following criteria are to be used in making that determination. If the BTU or attached supply is not in substantial compliance, a rating or check rating is not to be completed and the Rating Agency shall immediately withdraw the IMS certification.
1. Record Review
  Determine from records that are stored in a manner acceptable to the Rating Agency that all milk pick-up tankers are screened daily, prior to processing, for Beta lactams with an approved test method. As necessary, determine that all producers are randomly tested four (4) times in any consecutive six (6) months for other drug residues, if directed by M-a-75.
  
  Compliance with the above Item would be satisfied in the following manner:
  1. 1.) Records indicating that milk was always shipped to an IMS listed shipper will suffice for actual test results.
  2. 2.) If milk is shipped to a non-listed milk plant, receiving station and/or transfer station, records indicating actual testing must be provided or available for review. When the Regulatory Agency has determined adequate documentation for compliance with this Section exists, the Rating Agency may accept this documentation. SRO's may at their discretion request records on the testing of loads of milk that are sent to non-listed milk plants, receiving stations and/or transfer stations. If records are requested, the SRO should choose and request to review records for no more than fifteen (15) days, unless these selected records show a problem.
2. Regulatory Notification and Disposition
  If a load sample or individual producer sample is positive for a drug residue, determine if the Regulatory Agency was immediately notified, including the method of proper disposition to keep the contaminated milk out of the food chain.
3. Reinstatement
  Determine if the violative producer was not allowed to ship milk until the milk no longer tested positive for drug residues.

COLLECTION OF DATA

Data from which the ratings are determined are obtained by the SRO from the records on file with the Regulatory Agency and from the evaluation of sanitary practices and facilities at the dairy farms. It is not necessary, except on very small BTU's or attached supplies, to inspect every farm, since a sufficiently accurate determination of the percentage compliance with the sanitation requirements can be determined by rating statistically selected dairy farms.

Number of Dairy Farms to be Rated

1.) The minimum number of dairy farms to be included in the rating depends upon the number in the area to be rated and the accuracy desired. To attain an accuracy such that the probable error in the individual percentages of compliance with the various Items of sanitation will be less than five percent (5%), the minimum number of dairy farms selected at random for inspection during the rating shall be determined from TABLE 1.

**TABLE 1**

**MINIMUM NUMBER OF DAIRY FARMS TO BE SELECTED AT RANDOM FOR INCLUSION IN A RATING.**
Number in BTU or Attached Supply	Number to be Rated
1 to 24	All
25 to 54	25
55 to 59	26
60 to 64	27
65 to 71	28
72 to 78	29
79 to 86	30
87 to 94	31
95 to 105	32
106 to 116	33
117 to 130	34
131 to 147	35
148 to 167	36
168 to 191	37
192 to 222	38
223 to 262	39
263 to 316	40
317 to 394	41
395 to 514	42
515 to 725	43
726 to 1,192	44
1,193 to 5,000	50
5,001 to 10,000	100
10,001 and Over	200

2.) TABLE 1 is used to determine separately the number of dairy farms to be included in the rating. The probable error is not applicable to small samples. If the total number is twenty-five (25) or less, the entire number must be rated.

Random Selection of Dairy Farms to be Rated
The individual dairy farms included in the rating must be representative to reflect conditions throughout the BTU or attached supply. It is important that the selection method excludes elements of pre-selection and provides a truly random sample. The selection of farms for a rating should be made from a current listing of producers making up the BTU or attached supply and may be compared to a list for the previous sixty (60) days to determine if an appreciable shifting of producers has taken place. Random selections, once made, should be deviated from only in cases of emergencies. Replacements, where necessary, should also be selected at random. Whenever possible, random selection or announcements of such selections for only one (1) day's work at a time should be made.

Examples of methods, which are satisfactory for the random selection for dairy farms, include the following:
1. 1.) The name of each dairy farm in the BTU or attached supply is written on a small card, one (1) name per card. These cards are then thoroughly shuffled and the number of dairy farms to be included in the rating, as determined from Table 1, are selected.
2. 2.) The selection of dairy farms is made at intervals from a complete card index, ledger record, or other list. When this method is used, the sequence interval chosen must be such that the entire card index, ledger record, or other list is subject to the sampling method. The sequence interval may be determined by dividing the total number of dairy farms by the number needed for the rating.
  For Example: If there were 280 dairy farms in the BTU or attached supply, Table 1 indicates that forty (40) will be included in the rating and the sequence interval in this case would be every seventh (7^th) dairy. The first dairy farm in sequence is picked at random from the complete index, record or list in order that chance alone determines the selection of individual farms.
3. 3.) Immediately prior to the initial random drawing of dairy farms to be selected for inclusion in a rating, every producer, which produces forty percent (40%) or more of the volume of milk in a BTU, which consists of five (5) producers or more, must become a separate BTU.
Number of Bulk Milk Hauler/Samplers to be Evaluated
At each producer dairy, during the rating or check-rating of a BTU, determine the identification of the bulk milk hauler/sampler(s), from at least the previous thirty (30) days, to be used when computing the "Evaluation of Sampling Procedures" Form. Obtaining records on bulk milk hauler/samplers from other States may be necessary, depending on the Regulatory Agency, which issued the permit(s)
Recording of Inspection Data
1. 1.) During a rating, inspection data are recorded on Form FDA 2359a-Dairy Farm Inspection Report, the Items of which correspond to the Items of sanitation in Section 7 of the Grade "A" PMO.
2. 2.) Sanitary conditions are evaluated in terms of the requirements of Section 7 of the Grade "A" PMO. Professional judgment alone must dictate whether an observed deficiency is representative of significant day-to-day sanitary conditions or is an anomaly. When significant violations of any given requirement are noted, the corresponding Item(s) or sub-item(s) on the individual FORM FDA 2359a-DAIRY FARM INSPECTION REPORT are marked with an "X". Each sub-item found in violation should be carefully marked, as this affects the computation of the Sanitation Compliance Rating.
3. 3.) The number of pounds of milk sold daily is needed for computing the rating and is entered in the appropriate place at the top of Form FDA 2359a-Dairy Farm Inspection Report.
  NOTE: A deficiency should not be based entirely on a discussion held with a farm employee. Confirmation of a deficiency should be made with the responsible owner or manager in charge.
Recording of Laboratory and Other Test Data
1. 1.) Regulatory Agency records are used in determining compliance with bacterial, drug residue, somatic cell, and cooling temperature requirements. The acceptance of data from official or officially designated laboratories is contingent upon the utilization of standard procedures by the laboratories concerned. Accordingly, it is necessary for the SRO to determine from the official State Laboratory-Certifying Agency that both sampling and laboratory procedures have been approved in accordance with the methods of the current edition of the Evaluation of Milk Laboratories (EML). Ratings shall not be conducted when an approved laboratory is not utilized by the Regulatory Agency for the necessary tests.
2. 2.) Compliance with bacterial, drug residue, somatic cell, and cooling temperature requirements is based on whether, at the time of the rating, a dairy farm meets the standards of Section 7 of the Grade "A" PMO. Credit for bacterial, somatic cell and cooling temperature requirements shall be given if no more than two (2) of the last four (4) sample results exceed the limits. Provided, that the last sample result is within the limit. No credit for compliance with bacterial, drug residue, somatic cell and cooling temperature requirements shall be given when less than the required number of samples have been examined during the preceding six (6) months. For rating purposes, the preceding six (6) months is considered to be the elapsed period of the month in which the rating is made and the preceding six (6) months. Dairy farms, which have had a permit for less than six (6) months at the time of the rating and for which the Regulatory Agency has not yet examined the required number of samples, shall be given credit. Provided, that the last sample result is within the limits.
3. 3.) The SRO may utilize the Regulatory Agency's records in determining compliance with those Items of sanitation which require laboratory tests to complete the evaluation.

COMPUTATION OF SANITATION COMPLIANCE RATINGS
1. Rating results are transferred to Form FDA 2359k-Status of Raw Milk for Pasteurization. This Form may be obtained from the Regional Offices of the PHS/FDA. The Form is sufficiently flexible to permit various combinations of pages to be used for reporting ratings of area or individual shippers.
2. The identity of each dairy farm, included in the rating, and the total pounds of milk sold daily, expressed to the nearest 100 pound unit (cwt.), are entered in the first, "Name of Dairy Farm", and second, "Pounds Sold Daily (100# Units)", columns, respectively, of Form FDA 2359k-Status of Raw Milk for Pasteurization.
  For Example: 3,760 pounds of milk sold per day will result in an entry of thirty-eight (38) in the "Pounds Sold Daily (100# Units)" column.
  
  Violations of Items or sub-items are indicated by an "X" or by inserting the point value of the violation in the appropriate column(s). The sum of the weights of all Items and sub-items found violated at each dairy farm is entered in the "Total Debits" column. This figure is then multiplied by the number in the "Pounds Sold Daily (100# Units)" column, and the results are entered in the "Pounds Sold Daily (100# Units) X Total Debits" column. When all entries have been made, the figures entered in the "Pounds Sold Daily (100# Units) X Total Debits" column are totaled as are the figures in the "Pounds Sold Daily (100# Units)" column from all the dairy farms rated. (Refer to Section H, #9, for an example.)
  
  NOTE: Item 8-Water Supply on FORM FDA 2359a-DAIRY FARM INSPECTION REPORT has been divided into two (2) point and five (5) point violations/debits. The maximum point value for the entire Item 8r cannot exceed five (5) points on Form FDA 2359k-Status of Raw Milk for Pasteurization. (Refer to Appendix B. Table of Farm Water Supply Violations, which provides guidance, which may be used to differentiate between two (2) point (minor) and five (5) point (major) violations of Section 7, Item 8r of the Grade "A" PMO during State Ratings and FDA Check Ratings.)
  
  Non-compliance with Item 15r-DRUG AND CHEMICAL CONTROL, Administrative Procedures #'s 5, 6 and 7 of the Grade "A" PMO (debited under 15r(d) and (e) on FORM FDA 2359a-DAIRY FARM INSPECTION REPORT), would constitute a five (5) point debit, not to exceed a total of seven (7) points for the entire Item 15-Drugs on FORM FDA 2359k-Status of Raw Milk for Pasteurization.
  
  Non-compliance with Item 18r-RAW MILK COOLING, Administrative Procedure #3 of the Grade "A" PMO, would constitute a one (1) point debit, not to exceed a total of five (5) points for the entire Item 18-Cooling on Form FDA 2359k-Status of Raw Milk for Pasteurization.
3. The Sanitation Compliance Rating is Derived from the Following Formula:
  Rating = 100 - (The Sum of the "Pounds Sold Daily (100# Units) X Total Debits" column) divided by (The Sum of the "Pounds Sold Daily (100# Units)" column.
  
  This rating figure is entered in the appropriate space in the upper right hand corner of Form FDA 2359k-Status of Raw Milk for Pasteurization. It is also entered on FORM FDA 2359j-MILK SANITATION RATING REPORT-SECTION A. Report of the Milk Sanitation Rating (Page 1), in the appropriate location.
4. Provision is also made on the Form for computing the percentage of dairy farms violating individual Items of sanitation. The number of dairy farms violating each Item shall be totaled and the percentage computed by dividing this number by the total number of dairy farms rated and then multiplying by 100. The percentage of producers violating an Item may also be determined by using the "Table for Computing Percent Violation".

C. RATING METHODS FOR MILK PLANTS, RECEIVING STATIONS AND TRANSFER STATIONS

Drug Residue Compliance - Procedure for Determining Milk Plant, Receiving Station and Transfer Station Compliance with Appendix N. of the Grade "A" PMO
During an IMS rating/listing audit or check rating/FDA audit, it is necessary to determine compliance of the milk plant, receiving station and transfer station with the requirements of Appendix N. of the Grade "A" PMO. The following criteria are to be used in making that determination. If the milk plant, receiving station or transfer station is not in substantial compliance, a rating/listing audit or check rating/FDA audit is not to be completed and the Rating Agency shall immediately withdraw the IMS certification.
1. Record Review
  Determine from records that are stored in a manner acceptable to the Rating/Listing Agency that all milk pick-up tankers are screened daily, prior to processing, for Beta lactams with an approved test method. As necessary, determine that all producers are randomly tested four (4) times in any consecutive six (6) months for other drug residues, if directed by M-a-75.
  
  Milk plants, receiving stations and transfer stations having an attached supply with loads that occasionally are diverted by direct farm shipment shall be deemed in compliance if the following criteria are met:
  1. 1.) Records indicating that milk was always shipped to an IMS listed shipper will suffice for actual test results.
  2. 2.) If milk is shipped to a non-listed milk plant, receiving station and/or transfer station, records indicating actual testing must be provided or available for review. When the Regulatory Agency has determined adequate documentation for compliance with this Section exists, the Rating Agency may accept this documentation. SRO's may at their discretion request records on the testing of loads of milk that are sent to non-listed milk plants, receiving stations and/or transfer stations. If records are requested, the SRO should choose and request to review records for no more than fifteen (15) days, unless these selected records show a problem.
2. Regulatory Notification
  If a load of milk was found to have a positive drug residue, determine if the Regulatory Agency was properly notified.
3. Industry Notification
  If a load of milk was found to have a positive drug residue, determine if the permit holder of the BTU or attached supply that the farms are attached to, was properly notified.
COLLECTION OF DATA
Data from which ratings are determined are obtained by SRO's from the records on file with the Regulatory Agency and from the evaluation of sanitary practices and facilities at the milk plants, receiving stations and transfer stations. Receiving stations and transfer stations may be considered as an integral part of the milk plant to which milk is shipped. Therefore, all such stations not having individual ratings and supplying milk to the plant selected for the rating must be included. Receiving stations and/or transfer stations, which are not an integral part of a milk plant, shall have individual ratings and may be rated separate from their BTU's.
1. Recording of Inspection Data
  1. 1.) During a rating, inspection data are recorded on Form FDA 2359-Milk Plant Inspection Report, the Items of which correspond to the Items of sanitation in Section 7 of the Grade "A" PMO..
  2. 2.) Sanitary conditions are evaluated in terms of the requirements of Section 7 of the Grade "A" PMO. Professional judgment alone must dictate whether an observed deficiency is representative of significant day-to-day sanitary conditions or is an anomaly. When significant violations of any given requirement are noted, the corresponding Item(s) or sub-item(s) on the individual Form FDA 2359-Milk Plant Inspection Report are marked with an "X". Each sub-item found in violation should be carefully marked, as this affects the computation of the Sanitation Compliance Rating.
  3. 3.) The average number of pounds of milk and milk products processed daily is needed for computing the rating and is entered in the appropriate place at the top of Form FDA 2359-Milk Plant Inspection Report. When a deficiency in a milk plant affects only one (1) type of packaging, i.e., paper, glass, single-service plastics, multi-use plastics, dispenser, cottage cheese, sour cream or yogurt containers; or the capping of these containers; or an individual pasteurization unit used, i.e., vat, HTST, HHST, or aseptic processing; or product(s) that have not been pasteurized at minimum pasteurization times and temperatures; only the quantity of all products affected by the deficiency, rather than the entire plant's production, is recorded for use in the computation of the plant's Sanitation Compliance Rating. Only violations of Items 16p, 18p and 19p of the Grade "A" PMO are to receive partial debits. Provided, that bacterial count, coliform count and cooling temperature may be partially debited for the particular product involved. All other violations should be considered as affecting the entire production of the milk plant.
2. Recording of Laboratory and Other Test Data
  1. 1.) Regulatory Agency records are used in determining compliance with bacterial, coliform, phosphatase, drug residue, and cooling temperature requirements. The acceptance of data from official or officially designated laboratories is contingent upon the utilization of standard procedures by the laboratories concerned. Accordingly, it is necessary for the SRO to determine from the official State Laboratory-Certifying Agency that both sampling and laboratory procedures have been approved in accordance with the methods of the current edition of the EML. Ratings and HACCP listing audits shall not be conducted when an approved laboratory has not been utilized by the Regulatory Agency for the necessary tests.
  2. 2.) Compliance with bacterial, coliform and cooling temperature requirements is based on whether, at the time of the rating, a milk plant's Grade "A" milk and milk products meet the standards of Section 7 of the Grade "A" PMO. Each product, including commingled raw milk prior to pasteurization, for each of the above applicable requirements, shall be debited if two (2) of the last four (4) sample results exceed the limit(s), and the last sample result is in violation. A debit shall be given when less than the required number of samples has been examined during the preceding six (6) months. For rating purposes, the preceding six (6) months is considered to be the elapsed period for the month in which the rating is made and the preceding six (6) months. Milk plants which have had a permit for less than six (6) months at the time of the rating or which do not operate on a year round basis and for which the Regulatory Agency has not yet examined the required number of samples shall not be debited. Provided, that the last sample result is within the limit(s).
  3. 3.) The SRO may utilize Regulatory Agency's records in determining compliance with those Items of sanitation, which require laboratory tests to complete the evaluation. Official records of Equipment Tests may also be used in lieu of performing such Equipment Tests during the rating. Provided, that the SRO is satisfied as to the competency of the Regulatory Agency's personnel to perform these Equipment Tests as described in Appendix I. of the Grade "A" PMO.
3. Recording of Data for Milk Plants, Receiving Stations and Transfer Stations Being Listed Under the NCIMS HACCP Listing Procedure
  1. 1.) Prior to conducting the initial HACCP listing audit, there shall be a Regulatory audit conducted of the milk plant, receiving station, or transfer station and the milk plant, receiving station, or transfer station shall have a minimum of sixty (60) days of HACCP System records prior to a HACCP listing audit.
  2. 2.) The listing audit may be announced at the discretion of the auditor under limited circumstances, such as, the initial audit or a re-audit in response to an FDA audit. When unannounced audits are conducted, the audits shall not be completed until appropriate plant personnel have had an opportunity to make all pertinent records available for review by the auditor.
  3. 3.) Listing Audit Procedures
    1. A.) Pre-Audit Management Interview: Review and discuss the milk plant's, receiving station's or transfer station's HACCP System including:
      1. (i) The management structure;
      2. (ii) The Hazard Analysis: Ensure that all milk or milk product hazards are addressed;
      3. (iii) The HACCP Plan;
      4. (iv) The Prerequisite Program (PP);
      5. (v) The flow diagrams; and
      6. (vi) The products/processes.
    2. B.) Review past Audit Reports (AR) and corrections of deficiencies and non-conformities if any.
    3. C.) In-plant review of implementation and verification of the HACCP System.
    4. D.) Review records of the HACCP System.
    5. E.) Review compliance with other applicable NCIMS regulatory requirements*.
    6. F.) Discuss findings and observations.
    7. G.) Prepare and issue an AR based on findings of deficiencies and non-conformities.
    8. H.) Conduct the exit interview.
      *Examples of Other Applicable NCIMS Requirements:
      1. Raw Milk Supply Source;
      2. Labeling Compliance;
      3. Adulteration;
      4. Licensing Requirements;
      5. Drug Residue Testing and Trace Back Requirements;
      6. Regulatory Samples in Compliance;
      7. Approved Laboratory Utilized for the Required Regulatory Tests; and
      8. Pasteurization Equipment Design, Construction, and Installation.
  4. 4.) Criteria and Procedures for Denial or Withdrawal of a Listing
    1. A.) A Listing under the NCIMS HACCP Program may be denied or withdrawn when CLE's have been noted indicating that the plant, receiving station or transfer station has failed to recognize or correct a deficiency(ies) or nonconformity(ies) indicating:
      1. (i) A major HACCP System dysfunction that is reasonably likely to result in a milk or milk product safety hazard or an adverse health consequence(s).*
        *A milk or milk product safety hazard that is reasonably likely to occur is one for which a prudent milk plant, receiving station or transfer station operator would establish controls because experience, illness data, scientific reports, or other information provides a basis to conclude that there is a reasonable likelihood that, in the absence of those controls, the milk or milk product hazard will occur in the particular type of milk or milk product being processed.
      2. (ii) A series of observations that leads to a finding of a potential HACCP System failure that is likely to result in a compromise to milk or milk product safety.
      3. (iii) Drug Residue testing and trace back requirements are not met.
      4. (iv) Milk is received from a supply other than a NCIMS listed source or from a listed source with a sanitation compliance score below 90.
    2. B.) Significant deficiencies involving one (1) or more CLE's constitute grounds for denial or withdrawal of a plant's, receiving station's or transfer station's NCIMS HACCP Listing.
      Observations of CLE related concerns and anomalies that do not meet these criteria should be discussed with the milk plant, receiving station or transfer station being audited and/or the Regulatory Agency but not marked on the AR as a CLE or used to justify the denial or removal of a listing. In this case, professional judgment should be exercised to allow the milk plant, receiving station or transfer station to retain it's listing and benefit from the observation by making the necessary corrections to their HACCP System.
      CLE's are noted on the Milk Plant, receiving Station or Transfer Station NCIMS HACCP System Audit Report with a double star (**) and cover the following areas of the NCIMS HACCP Program:
      1. (i) HAZARD ANALYSIS: Flow Diagram and Hazard Analysis conducted and written for each kind or group of milk or milk products processed.
      2. (ii) HACCP PLAN: HACCP Plan prepared for each kind or group of milk or milk products processed.
      3. (iii) HACCP PLAN CRITICAL LIMITS (CL's): CL's are adequate to control the hazard identified.
      4. (iv) HACCP PLAN CORRECTIVE ACTION: Corrective action taken for milk or milk products produced during a deviation from CL's defined in the HACCP Plan.
      5. (v) HACCP PLAN VERIFICATION AND VALIDATION: Calibration of Critical Control Point (CCP) process monitoring instruments performed as required and at the frequency defined in the HACCP Plan.
      6. (vi) HACCP SYSTEM RECORDS: Information on HACCP records not falsified.
      7. (vii) OTHER NCIMS REQUIREMENTS: Incoming milk supply from a NCIMS listed source(s) with a sanitation compliance score(s) of 90 or above and drug residue control program implemented.
      8. (viii) HACCP SYSTEM AUDIT FOLLOW-UP ACTION: A series of observations that lead to a finding of a potential HACCP System failure that is likely to result in a compromise to milk or milk product safety.
COMPUTATION OF SANITATION COMPLIANCE RATINGS
The criteria and procedures for actions following a HACCP listing audit are found in Section C., 2., c. of this document. Sanitation Compliance Ratings shall be made of dairy farms that are attached supplies of milk plants, receiving stations, or transfer stations listed under the HACCP listing procedure.
1. Rating results are transferred to Form FDA 2359L-Status of Milk Plants. This Form may be obtained from the Regional Offices of the PHS/FDA.
2. The name of the plant and the total pounds of milk and milk products processed daily, expressed to the nearest 100 pound unit (cwt.), are entered in the first, "Name of Plant", and second, "Pounds Processed Daily (100# Units)", columns, respectively, of Form FDA 2359L-Status of Milk Plants.
  For Example. 86,340 pounds processed per day will result in an entry of 863 in the "Pounds Processed Daily (100# Units)" column.
  
  If the plant's daily output varies, the recorded quantity is the daily average, based on actual operating days, for the week preceding the rating. Violations of Items or sub-items are indicated by an "X" or by inserting the point value of the violation in the appropriate column(s). When a deficiency in a milk plant affects one (1) type of packaging, capping, or individual pasteurization unit used, the number of pounds of all products so packaged, capped or pasteurized are debited. In such cases, entries are made on separate lines below the name of the plant. The name or names of the product(s) affected by the violation(s) of Items 16p, 18p, 19p, or bacterial, coliform or cooling temperature standards of the Grade "A" PMO is entered in the "Name of Plant" column, together with a parenthetic entry of the total volume in 100 pound units (cwt.) of the product(s) involved. Care must be taken not to enter this quantity in the "Pounds Processed Daily (100# Units)" column where it would again be included in the total pounds processed daily. (Refer to Section H, #'s 9 and 10 for examples.)
3. For receiving or transfer stations operated by the plant and under the same routine supervision as the plant and shipping to the plant, the name of the station is entered in the "Name of Plant" column, together with a parenthetic entry of the hundredweight (cwt.) shipped daily. No entry is made in the "Pounds Processed Daily (100# Units)" column.
  If the pounds shipped daily by a station to the milk plant varies, the recorded quantity is the daily average, based on actual operating days, of the shipments for the week preceding the rating. Violations of Items or sub-items are indicated by an "X" or by inserting the point value of the violation in the appropriate column(s).
  
  To facilitate the rating computations, receiving station's or transfer station's entries follow the entries for the milk plant. If the rating of the receiving station or transfer station is equal to, or greater than, that of the milk plant, or equal to ninety percent (90%) or greater, the milk plant rating is considered as being inclusive of the receiving station's or transfer station's violation(s); therefore, no entry is made in the "Total Debits" column, for the station(s). However, if the receiving station's and/or transfer station's rating is less than ninety percent (90%) and lower than the milk plant's rating, it is subtracted from the rating of the milk plant, which it supplies, and the difference is entered in the "Total Debits" column. This difference is then multiplied by the number of pounds of milk shipped daily by the receiving and/or transfer station to the milk plant and entered in the "Pounds Processed Daily X Total Debits" column. (Refer to Section H, #11 for an example.)
4. The computation procedure for a milk plant is similar to that for dairy farms, except that a modified procedure is necessary in computing debits for violations involving only one (1) type of packaging, capping or individual pasteurization unit used; or individual product(s) violating the bacterial, coliform or cooling temperature standards; and for violations involving receiving or transfer stations. The latter is explained in the preceding paragraph. For such violations, the entry in the "Total Debits" column is multiplied by the actual number of pounds of product involved, as entered parenthetically in the "Name of Plant" column, rather than by the plant's entire production from the "Pounds Processed Daily (100# Units)" column. This figure is entered in the "Pounds Processed Daily (100# Units) X Total Debits" column.
  The formula for determining the Sanitation Compliance Rating for the milk plant is as follows:
  
  Rating = 100 - (The Sum of the "Pounds Processed Daily (100# Units) X Total Debits" column) divided by (The Sum of the "Pounds Processed Daily (100# Units)" column)
  
  This rating figure is entered in the appropriate space in the upper right hand corner of Form FDA 2359L-Status of Milk Plants. It is also entered on Form FDA 2359j-MILK SANITATION RATING REPORT-SECTION A. Report of Milk Sanitation Rating (Page 1), in the appropriate location.
5. The name(s) of the BTU(s), receiving station(s) and/or transfer station(s) shipping milk to the milk plant, which are separately rated and listed, are also entered in the "Name of Plant" column, below the name of the plant but the quantity of milk supplied daily is entered parenthetically in the same manner as for locally supervised receiving and/or transfer stations. The poundage is not recorded in the "Pounds Processed Daily (100# Units)" column, since this quantity is already accounted for in the milk plant figures. If the rating for the receiving station(s) and/or transfer station(s) is equal to, or greater than, that of the milk plant, the plant rating is considered as being inclusive of the receiving station's and/or transfer station's violations; therefore, no entry is made in the "Total Debits" column. However, if the receiving station's and/or transfer station's rating(s) is less than ninety percent (90%) and lower than that of the milk plant, the difference is entered in the "Total Debits" column. For the station(s), this difference is then multiplied by the number of pounds of milk shipped daily by the receiving station(s) and/or transfer station(s) to the milk plant and entered in the "Pounds Processed Daily (100# Units) X Total Debits" column.
6. If, upon receipt, one (1) or more shipper(s) of unattached raw milk for pasteurization violates the bacterial and/or cooling temperature standards, the violations are debited against the rating of the receiving station(s) and/or transfer station(s) shipping the milk, prior to combining the ratings in accordance with the methods described above.

D. COMPUTATION OF ENFORCEMENT RATINGS

For all NCIMS HACCP listings, complete the NCIMS HACCP SYSTEM REGULATORY AGENCY REVIEW REPORT. Enforcement ratings shall be made for dairy farms that are listed with milk plants, receiving stations, or transfer stations that are listed under the NCIMS HACCP listing procedure. These enforcement ratings shall be made using the procedures for raw milk for pasteurization addressed in 2. of this Section.

PURPOSE
1. FORM FDA 2359j consists of two (2) parts: SECTION A. Report of the Milk Sanitation Rating is on Page 1 and SECTION B. Report of Enforcement Methods is on Page 2. (Refer to Section G, #'s 1 and 2 for an example of this Form.. This Form provides a means of measuring the degree to which the enforcement provisions of the Grade "A" PMO are being applied by the Regulatory Agency. It serves to delineate specific areas where a milk sanitation program needs strengthening. The rating method provides for separate appraisals of these provisions as they are applied to dairy farms, milk plants, receiving stations and transfer stations. In some cases, the enforcement rating is derived by combining these appraisals with an appraisal of other regulatory actions for which the Regulatory Agency is responsible.
2. Appraisal of Items is based on the SRO's observations made during the rating and their review of the Regulatory Agency's records for the lesser of the following periods:
  1. 1.) The period since the last rating, but not less than six (6) months; or
  2. 2.) The two (2) years preceding the date of the current rating.
3. Enforcement rating scores shall be computed utilizing the "Guidelines for Computing Enforcement Ratings", contained in Appendix A. of this document.
4. The enforcement rating applies directly to the individual Regulatory Agency; therefore, there are no provisions for combining the enforcement ratings of two (2) or more enforcement agencies. Enforcement ratings shall be made in accordance with the procedures in the following Sections.
5. For rating purposes, to determine if inspections have been made at the required frequency, the interval shall include the designated period, plus the remaining days of the month in which the inspection is due.
RAW MILK FOR PASTEURIZATION ONLY
1. When an individual shipper offers for sale only raw milk for pasteurization directly from dairy farms, known as a BTU, and there are no milk plant(s), receiving and/or transfer station(s) involved, all Items in Part I-DAIRY FARMS, FORM FDA 2359j - MILK SANITATION RATING REPORT-SECTION B. Report of Enforcement Methods (Page 2) shall be evaluated. The total of the credit column of Part I will be the enforcement rating and should be recorded on Page 1 of this Form, in the appropriate location. (Refer to Section H, #'s 1 and 7 for examples.)
2. When an Item requires separate action on the part of the Regulatory Agency with respect to each dairy farm, compliance is prorated on the proportion of dairy farms included in the rating for which official records show the Item to have been satisfied.
3. When an Item requires an action by the Regulatory Agency that affects the entire program, quantitative estimates of compliance by the above-described procedure are not applicable. These Items have the "Percent Complying" column blocked out and the full weight of the Item is debited or credited, depending upon whether the milk sanitation program is satisfying the pertinent provisions of the Grade "A" PMO. In appraising these Items, the SRO's judgement should be based on the attainment of objectives toward which the provisions of the appropriate Sections are directed and not on occasional circumstances or insignificant deviations in procedure. (Refer to Section H, #7 for an example.)
4. For rating purposes, to determine if tests have been made at the required frequency, the interval shall include the designated period, plus the remaining days of the month in which the test(s) is due.
5. For dairy farms inspected under the provisions of Appendix P. of the Grade "A" PMO, the following rating criteria applies:
  1. 1.) At each three (3) month categorization during the rating period, the previous twelve (12) month producer records were used to determine the proper categorization of individual producers into twelve (12), six (6), four (4) and three (3) month inspection intervals.
  2. 2.) Dairy farms were re-categorized properly every three (3) months.
  3. 3.) The due date for the next inspection is calculated from the date of the last routine inspection, unless, the due date was scheduled to occur before the re-categorization. However, the due date may be extended up to thirty (30) days after the re-categorization date for producers assigned to a six (6), four (4) or three (3) month inspection frequency, if the due date was scheduled to occur before the re-categorization date.
RECEIVING STATION OR TRANSFER STATION
1. When an individual shipper offers for sale raw milk for pasteurization, which is shipped from a receiving station or transfer station, with one (1) or more dairy farms rated with it, all Items in Part II-Milk Plants, except Numbers 5 and 7, and all Items on Part III-Individual Shipper Rating on FORM FDA 2359j-MILK SANITATION RATING REPORT-SECTION B. Report of Enforcement Methods (Page 2), shall be evaluated. When a receiving station and/or transfer station receives and trans-ships raw milk for pasteurization from one (1) or more rated and listed BTU's and wishes a separate listing for its facilities, all Items in Part II, except Numbers 5 and 7, and all Items in Part III, except Number 1 shall be evaluated. The procedures outlined in D., 3., b and D., 4., a.3.) should be followed in computing the enforcement rating of the receiving station and/or transfer station.
2. The total weight, which can be earned in Part II, is seventy-five (75). Therefore, the sum of the total credits earned in Part II should be divided by seventy-five (75) and multiplied by 100.
  For Example: Assume that the addition of all credits, omitting Numbers 5 and 7 under Part II, equals 67.7. Then 67.7 divided by seventy-five (75), multiplied by 100 equals 90.3 percent. Fractions of 0.5 or higher are increased to the next whole number and fractions of less than 0.5 are dropped. Under these rules, the 90.3 percent would equal ninety percent (90%). The sum of the credits in Parts I and II are transferred to Part III. The sum of the credits in Part III will be the enforcement rating of the Regulatory Agency. (Refer to Section H, #4 for an example.)
3. When an Item requires separate action on the part of the Regulatory Agency with respect to each receiving station or transfer station, compliance is based on the proportion of receiving stations or transfer stations that are included in the rating for which local records show the Item to have been satisfied. If an Item requires more than one (1) test or determination, i.e., Part II, Numbers 2, 4, 6, 8, 9, and 10, then compliance is also based on the proportion of tests or determinations, which according to the Regulatory Agency's records, were made at the required frequency.
  For Example: If only six (6) of the required eight (8) inspections were made in the past two (2) years, the compliance would be 6/8 or seventy-five percent (75%).
4. When an Item requires an action by the Regulatory Agency, which affects the entire control program, quantitative estimates of compliance by the procedure described in the preceding paragraph are not applicable. These Items have the "Percent Complying" column blocked out and the full weight of the Item is debited or credited, depending upon whether the program being rated is satisfying the pertinent provisions of the Grade "A" PMO. In appraising these Items, the SRO's judgement should be based on the attainment of objectives toward which the milk sanitation regulations are directed and not on occasional circumstances or insignificant deviations in procedure.
MILK PLANTS
1. Milk Plant with an Unattached Supply of Raw Milk
  1. 1.) When an individual shipper of pasteurized milk and/or milk products imports all raw milk for pasteurization from outside the jurisdiction of the Regulatory Agency in which the plant is located, only Parts II and III of FORM FDA 2359j-MILK SANITATION RATING REPORT-SECTION B. Report of Enforcement Methods (Page 2), shall be evaluated. If an Item requires more than one (1) test or determination, i.e., Part II, Numbers 2, 4, 5, 6, 7, 8, 9, and 10, then compliance is also based on the proportion of tests or determinations, which according to the Regulatory Agency's records, were made at the required frequency.
    For Example: For an enforcement rating, all required tests must be performed on each individual pasteurizer used to receive credit. Compliance is determined by multiplying the number of pasteurizers (units) by the number of three (3) month periods (quarters) in the rating period. If a plant with four (4) pasteurizers is rated over a two (2) year span and one (1) pasteurizer is not completely tested during one (1) quarter, then compliance is calculated as follows:
    
    4 X 8 = 32 Unit (Quarters), Less One (1) Non-Complying Quarter = 31/32 X 15 = 14.5 Points
    
    For rating purposes, to determine if the required tests have been performed at the required frequency, the interval shall include the designated period plus the remaining days of the month in which the test(s) is due.
  2. 2.) When an Item requires an action by the Regulatory Agency, which affects the entire control program, quantitative estimates of compliance by the procedure described in the preceding paragraph are not applicable. These Items have the "Percent Complying" column of the schedule blocked out, and the full weight of the Item is debited or credited, depending upon whether the program being rated is satisfying the pertinent provision of the Grade "A" PMO. In appraising these Items, the SRO's judgement should be based on the attainment of objectives toward which the milk sanitation regulations are directed and not on occasional circumstances or insignificant deviations in procedure.
  3. 3.) The utilization of milk from a separately rated source, which has a Milk Sanitation Compliance Rating, which is not equal to ninety percent (90%) or greater, or is from an unlisted source, would initiate an immediate withdrawal of the shipper from the IMS List.
  4. 4.) The utilization of milk from a separately rated source, which has an enforcement rating, which is not equal to ninety percent (90%) or greater, is a violation of Section 11 of the Grade "A" PMO and would be debited under Item 4, Part III, FORM FDA 2359j-MILK SANITATION RATING REPORT-SECTION B. Report of Enforcement Rating Methods (Page 2).
  5. 5.) When computing Part III, there will be zero (0) credit in Item 1. It will be necessary to increase the weight for Item 2 to .90 to negate the zero (0) credit in Item 1. (Refer to Section H, #2 for an example.)
    For Example: Total credit in Part II is 88.7, Item 3 has a credit of 3.2 and Item 4 has full credit of six (6) in Part III, the calculations will be as follows:
    
    (88.7 X .90) = 79.8 + 9.2 = 89% Enforcement Rating.
2. Milk Plant with an Attached Supply of Raw Milk
  1. 1.) When an individual shipper of pasteurized milk and/or milk products receives raw milk for pasteurization from an attached supply(ies) within the jurisdiction of the Regulatory Agency in which the plant is located, Parts I, II, and III, on FORM FDA 2359j-MILK SANITATION RATING REPORT-SECTION B. Report of Enforcement Methods (Page 2) shall be evaluated. If raw milk for pasteurization is received from both attached and unattached supplies, only those sources from attached supplies will be evaluated in Part I. Milk from unattached supplies will be evaluated in Item 4, Part III. If an Item requires more than one (1) test or determination, i.e., Part II, Numbers 2, 4, 5, 6, 7, 8, 9, and 10, then compliance is also based on the proportion of tests or determinations, which according to the Regulatory Agency's records, were made at the required frequency.
    For Example: For an enforcement rating of a milk plant, if only eight (8) of the required ten (10) individual dairy products had been sampled at the required frequency during the preceding required time period, the compliance would be 8/10 or eighty percent (80%) under Part II, Number 7.
  2. 2.) When an Item requires an action by the Regulatory Agency, which affects the entire control program, quantitative estimates of compliance by the procedure described in the preceding paragraph are not applicable. These Items have the "Percent Complying" column blocked out and the full weight of the Item is debited or credited, depending upon whether the program being rated is satisfying the pertinent provisions of the Grade "A" PMO. In appraising these Items, the SRO's judgement should be based on the attainment of objectives toward which the milk sanitation regulations are directed and not on occasional circumstances or insignificant deviations in procedure.
  3. 3.) The utilization of milk from a separately rated source, which has a Milk Sanitation Compliance Rating, which is not equal to ninety percent (90%) or greater, or is from an unlisted source, would initiate an immediate withdrawal of the shipper from the IMS List.
  4. 4.) The utilization of milk from a separately rated source, which has an enforcement rating, which is not equal to ninety percent (90%) or greater, is a violation of Section 11 of the Grade "A" PMO and would be debited under Item 4, Part III, FORM FDA 2359j- MILK SANITATION RATING REPORT-SECTION B. Report of Enforcement Rating Methods (Page 2).

E. PREPARATION OF THE SRO's REPORT

PURPOSE
Ratings made by the methods described measure the degree to which the shipper and enforcement practices of a Regulatory Agency conform to the standards and procedures contained in the Grade "A" PMO. Space is provided on FORM FDA 2359j-MILK SANITATION RATING REPORT-SECTION A. Report of Milk Sanitation Rating (Page 1) for presenting a summary of rating results and recommendations of the SRO.
SUMMARY OF RATING RESULTS
Sanitation Compliance Ratings computed in accordance with procedures previously described and other data pertinent to the shipper are entered in the Summary of Rating Results on Form FDA 2359j -MILK SANITATION RATING REPORT-SECTION A. Report of Milk Sanitation Rating (Page 1). When the Sanitation Compliance Rating of raw milk for pasteurization has been combined with the rating(s) of unattached supplies in accordance with the conditions and procedures found under F. PUBLICATION of the "Interstate Milk Shipper's Reports", Sections 2., c., 2.) or 2., c., 3.)B.); the combined rating, rather than the rating of the attached supply is entered in the summary.
SUPPLEMENTARY NARRATIVE REPORT
In the course of conducting a rating and computing ratings, additional facts may become apparent, which if presented, would be of value to the Regulatory Agency in directing the milk sanitation program so as to be more effective. SRO's are urged to prepare a supplementary narrative report of their rating findings. This report should include, but not be limited to, the following:
1. A statement regarding the general status of the milk sanitation program, including both strengths and weaknesses.
2. Discussion of needs for greater program emphasis as indicated by the compliance levels of sanitation Items and enforcement practices found during the rating.
RECOMMENDATIONS OF THE SRO
A summary of the narrative report, including the specific measures recommended for program improvement, is entered on Page 1 of Form FDA 2359j-MILK SANITATION RATING REPORT-SECTION A. Report of the Milk Sanitation Rating, under the heading "Recommendations of the Milk Sanitation Rating Officer". The full report should be discussed in detail with the appropriate officials of the Regulatory Agency. Such discussions contribute to better understanding of the problems involved and provide the Regulatory Agency authorities an opportunity to discuss means of implementing the SRO's recommendations. (Refer to Section H, #1 for an example.)

For all NCIMS HACCP listings complete the NCIMS HACCP SYSTEM REGULATORY AGENCY REVIEW REPORT, which includes an evaluation of the following:
1. Milk plant, receiving station or transfer station holds a valid permit;
2. Milk plant, receiving station or transfer station audited by the Regulatory Agency at the minimum required frequency;
3. Requirements interpreted in accordance with the Grade "A" PMO as indicated by past audits;
4. Pasteurization equipment tested at required frequency (not applicable to receiving stations and transfer stations);
5. Individual and cooling water samples tested and reports on file as required;
6. Samples of milk plant's milk and milk products collected at the required frequency and all necessary laboratory examinations made (not applicable to receiving stations and transfer stations);
7. Sampling procedures approved by PHS/FDA evaluation methods;
8. Permit issuance, suspension, revocation, reinstatement, hearings, and/or court actions taken as required; and
9. Records systematically maintained and current.

F. PUBLICATION OF THE "INTERSTATE MILK SHIPPER's REPORT"

PURPOSE
1. The IMS List-Sanitation Compliance and Enforcement Ratings of Interstate Milk Shippers IMS List) is an electronic publication of CFSAN's Milk Safety Branch (HFS-626), Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740-3835. This is a part of the activities of the PHS/FDA in cooperation with the States in the cooperative program for certification of interstate milk shippers.
2. Triplicate copies or PHS/FDA's electronic version (transmitted via computer) of Form FDA 2359i-Interstate Milk Shipper's REPORT shall be submitted by the State Rating Officer to the appropriate Regional Office of the PHS/FDA for shippers who desire to be listed in the IMS List. (Refer to Section G, #5 and 6 for a copy of the Form.)
  A signed copy of a written "Permission for Publication - interSTAte milk shipper's listing" shall accompany each triplicate set of FORM FDA 2359i-Interstate Milk Shipper's Report, submitted to the PHS/FDA Regional Office for publication in the IMS List. For the submission of PHS/FDA's electronic version, a signed copy of the written "PERMISSION FOR PUBLICATION - INTERSTATE MILK SHIPPER'S LISTING" shall be maintained on file by the Rating Agency for publication in the IMS List and will be reviewed as part of the check rating and/or State Program Evaluation. Once a shipper has been listed, all new ratings must be submitted to the Regional Office even though the shipper has refused to sign a written "Permission for Publication - interSTAte milk shipper's listing". Supporting sampling and laboratory certification reports, as specified in the Procedures, are also necessary for inclusion and retention of the shipper on the list. (Refer to Section G, #10 for a copy of the Form.)
  
  The Sanitation Compliance Rating of a shipper is not published unless the written "Permission for Publication - interSTAte milk shipper's listing" of the shipper concerned has been obtained by the State Milk Sanitation Rating Agency. Milk plants, receiving stations and transfer stations must achieve a Sanitation Compliance Rating of ninety percent (90%) or greater in order to be eligible for a listing in the IMS List. The Sanitation Compliance Rating score for milk plants, receiving stations and transfer stations will not be printed in the IMS List.
PREPARATION OF THE "INTERSTATE MILK SHIPPER's REPORT"
1. Individual Shipper of Raw Milk for Pasteurization
  This shipper is commonly referred to as a BTU. Following the computation of the Sanitation Compliance Rating on FORM FDA 2359k-Status of Raw Milk for Pasteurization and Part I of FORM FDA 2359j-MILK SANITATION RATING REPORT-SECTION B. Report of Enforcement Methods (Page 2), the resultant data will be transferred to FORM FDA 2359i-Interstate Milk Shipper's Report. The earliest rating date shall be the date of the first day of the rating. (Refer to Section H, #11 for an example).
2. Receiving Station or Transfer Station
  Following the computation of the Sanitation Compliance Rating on Form FDA 2359k-Status of Raw Milk for Pasteurization, Form FDA 2359L-Status of Milk Plants, and Parts I, II and III of FORM FDA 2359j-MILK SANITATION RATING REPORT-SECTION B. Report of Enforcement Methods (Page 2), the resultant data will be transferred to FORM FDA 2359i-Interstate Milk Shipper's Report. The earliest rating date shall be the date of the first day of the rating. When receiving and/or transfer stations wish a separate listing and receive raw milk for pasteurization from one (1) or more rated and listed BTU's for trans-shipment, the procedures to be followed shall be that of Section F. Publication of the "Interstate Milk Shipper's Report, 2., c.2) or 2., c.3).
3. Milk Plant
  1. 1.) Attached Supply Only: A plant with a single source of raw milk, both under the jurisdiction of the same Regulatory Agency.
    Following the computation of the Sanitation Compliance Rating on FORM FDA 2359k-Status of Raw Milk for Pasteurization, Form FDA 2359L-Status of Milk Plants, and Parts I, II and III of FORM FDA 2359j-MILK SANITATION RATING REPORT-SECTION B. Report of Enforcement Methods (Page 2), the resultant data will be transferred to FORM FDA 2359i-Interstate Milk Shipper's Report. The earliest rating date shall be the date of the first day of the rating of the farms or plant, whichever is earliest in time.
  2. 2.) Attached Supply and Unattached Supplies: A plant with a source of raw milk for pasteurization under the jurisdiction of the same Regulatory Agency as the plant and one (1) or more sources of raw milk for pasteurization from other separate rated and listed sources.
    Following the computation of the Sanitation Compliance Rating on Form FDA 2359k-Status of Raw Milk for Pasteurization, Form FDA 2359L-Status of Milk Plants, and Parts I, II and III of Form FDA 2359j-MILK SANITATION RATING REPORT-SECTION B. Report of Enforcement Methods (Page 2), the resultant data will be transferred to Form FDA 2359i-Interstate Milk Shipper's Report. The earliest rating date and the Raw Milk Sanitation Compliance Rating shall be computed by the following method:
    
    All unattached supplies shall have a Sanitation Compliance Rating of ninety percent (90%) or greater. The Sanitation Compliance Rating of the attached supply shall be reported as the Raw Milk Sanitation Compliance Rating for the plant. The earliest rating date shall be reported on Form FDA 2359i-Interstate Milk Shipper's Report. In addition, the name of each unattached shipper, during the thirty (30) days preceding the rating, along with the Sanitation Compliance Rating, Volume (cwt.) received and Date of Rating of each shipper shall be listed on the reverse side of FORM FDA 2359i-Interstate Milk Shipper's Report. If milk is received from an unlisted source or from a source having a Raw Milk Sanitation Compliance Rating of less than ninety percent (90%), the PHS/FDA Regional Office shall be notified and the plant shall be immediately withdrawn from the IMS List.
  3. 3.) Unattached Supplies Only: A plant with one (1) or more sources of raw milk received from other rated and listed sources.
    Following the computation of the Sanitation Compliance Rating on Form FDA 2359L-Status of Milk Plants and Parts II and III of FORM FDA 2359j-MILK SANITATION RATING REPORT-SECTION B. Report of Enforcement Methods (Page 2), the resultant data will be transferred to FORM FDA 2359i-Interstate Milk Shipper's Report. The earliest rating date and the Milk Sanitation Compliance Rating shall be computed by one (1) of the following two (2) options:
    1. A.) Option 1: If all raw milk sources have a published, or submitted for publication, Sanitation Compliance Rating of ninety percent (90%) or greater and the plant desires to be listed with the plant rating date, the raw milk will be reported as ninety percent (90%) or listed with an asterisk (*), which denotes all supplies are ninety percent (90%) or greater. This will eliminate the need for frequent updating of FORM FDA 2359i-Interstate Milk Shipper's Report by the State Milk Sanitation Rating Agency. Certain precautions must be taken to ensure that the raw supply remains at or above the listed ninety percent (90%) Sanitation Compliance Rating. The name of each shipper of raw milk for the thirty (30) days preceding the rating must be listed on the reverse side of FORM FDA 2359i-Interstate Milk Shipper's Report, along with their Sanitation Compliance Rating and the Date of Rating. The plant shall be immediately withdrawn from the IMS List when milk is received from an unlisted source or from a source having a Raw Milk Sanitation Compliance Rating of less than ninety percent (90%). The appropriate PHS/FDA Regional Office shall be immediately notified should either of the above events occur.
    2. B.) Option 2: If the plant desires to be listed with the actual Sanitation Compliance Rating of the raw milk, a weighted average of all raw milk sources, the requirements of the preceding Option shall also apply except that:
      1. (i) The earliest rating date of any of the raw milk sources or the plant, whichever is earliest in time, will be shown as the earliest rating date on FORM FDA 2359i-Interstate Milk Shipper's Report.
      2. (ii)The Raw Milk Sanitation Compliance Rating will be prorated on a weighted basis as follows:
        Supply Sanitation Compliance Rating X Percent of Supply =
        
        Unattached Supply #1. 95 X .2. = 19
        Unattached Supply #2. 90 X .3. = 31.5
        Unattached Supply #3. 92 X .4. = 41.4
        Total = 91.9
        
        Raw Milk Sanitation Compliance Rating = 92%
      The SRO shall re-compute the Raw Milk Sanitation Compliance Rating whenever any of the raw milk sources is re-rated and a new FORM FDA 2359i-Interstate Milk Shipper's REPORT shall be submitted to the PHS/FDA Regional Office.
      
      NOTE: The acceptance of milk, which has a Sanitation Compliance Rating score of less than ninety percent (90%), or is from an unlisted source, is a violation of the agreed upon provisions of Options 1 and 2 and would initiate an immediate withdrawal of the shipper from the IMS List.
      
      In the case of a plant utilizing an attached and/or unattached supply(ies), and a supply has an enforcement rating of less than ninety percent (90%), no credit shall be given under Item 4, Part III of FORM FDA 2359j-MILK SANITATION RATING REPORT-SECTION B. Report of Enforcement Methods (Page 2).
PREPARATION OF THE "INTERSTATE MILK SHIPPER's REPORT" FOR HACCP LISTINGS
The provisions of this Section apply to milk plants, receiving stations, and transfer stations listed under the NCIMS HACCP listing procedure, except that:
1. A statement regarding the acceptability, or unacceptability of the HACCP System will be substituted on Form FDA 2359i-INTERSTATE MILK SHIPPER's REPORT for the Sanitation Compliance and Enforcement Rating Scores; and
2. The MILK PLANT, receiving station or transfer station NCIMS HACCP SYSTEM AUDIT REPORT and NCIMS HACCP SYSTEM REGULATORY AGENCY REVIEW REPORT shall be submitted with all FORM FDA 2359i's.

G. EXAMPLES OF RATING AND NCIMS HACCP LISTING FORMS (PDF, 312 kb)

The following pages contain examples of Forms used in IMS ratings/listing audits and check ratings/FDA audits. These Forms include:

Form FDA 2359j-MILK SANITATION RATING REPORT-SECTION A. Report of the Milk Sanitation Rating (Page 1)
Form FDA 2359j-MILK SANITATION RATING REPORT-SECTION B. Report of Enforcement Methods (Page 2)
Form FDA 2359k-Status of Raw Milk for Pasteurization
Form FDA 2359L-Status of Milk Plants (including drying and condensing milk products plants, receiving stations and transfer stations)
Form FDA 2359i-Interstate Milk Shipper's Report
Form FDA 2359i-INTERSTATE MILK SHIPPER's REPORT (Electronic Submission)
Evaluation of Sampling Procedures (BTU) (Part I, Item 9)
Evaluation of Sampling Procedures (Milk Plant, Receiving Station or Transfer Station) (Part II, Item 8)
MILK PLANT receiving station or transfer station NCIMS HACCP SYSTEM AUDIT REPORT
NCIMS HACCP SYSTEM REGULATORY AGENCY REVIEW REPORT
PERMISSION FOR PUBLICATION - INTERSTATE MILK SHIPPER's LISTING

H. EXAMPLES OF HOW TO PROPERLY COMPLETE RATING AND NCIMS HACCP LISTING FORMS (PDF, 312 kb)

The following pages provide examples of Forms that have been completed to demonstrate how observations should be recorded and how the Forms should be completed. These include:

FORM FDA 2359j-MILK SANITATION RATING REPORT-SECTION A. REPORT OF THE MILK SANITATION RATING (Page 1)
FORM FDA 2359j-MILK SANITATION RATING REPORT-SECTION B. REPORT OF ENFORCEMENT METHODS (Page 2) (Plant)
EVALUATION OF SAMPLING PROCEDURES (Plant) (Use to Complete FORM FDA 2359j-MILK SANITATION RATING REPORT-SECTION B. REPORT OF ENFORCEMENT METHODS (Page 2), Part II, Item 8)
FORM FDA 2359j-MILK SANITATION RATING REPORT-SECTION B. REPORT OF ENFORCEMENT METHODS (Page 2) (BTU and Receiving Station)
EVALUATION OF SAMPLING PROCEDURES (BTU) (Use to Complete FORM FDA 2359j-MILK SANITATION RATING REPORT-SECTION B. REPORT OF ENFORCEMENT METHODS (Page 2), Part I, Item 9)
EVALUATION OF SAMPLING PROCEDURES (Receiving Station) (Use to Complete FORM FDA 2359j-MILK SANITATION RATING REPORT-SECTION B. REPORT OF ENFORCEMENT METHODS (Page 2), Part II, Item 8)
FORM FDA 2359j-MILK SANITATION RATING REPORT-SECTION B. REPORT OF ENFORCEMENT METHODS (Page 2) (BTU)
FORM FDA 2359k-STATUS OF RAW MILK FOR PASTEURIZATION
FORM FDA 2359L-STATUS OF MILK PLANTS (including drying and condensing milk products plants, receiving stations and transfer stations)
FORM FDA 2359L-STATUS OF MILK PLANTS (including drying and condensing milk products plants, receiving stations and transfer stations)
FORM FDA 2359i-INTERSTATE MILK SHIPPER's REPORT
FORM FDA 2359i-Interstate Milk Shipper's Report (Electronic Submission)
MILK PLANT, receiving station or transfer station NCIMS HACCP SYSTEM AUDIT REPORT
NCIMS HACCP SYSTEM REGULATORY AGENCY REVIEW REPORT
FORM FDA 2359i-INTERSTATE MILK SHIPPER's REPORT (NCIMS HACCP Listing)
PERMISSION FOR PUBLICATION - INTERSTATE MILK SHIPPER's LISTING

**Table for Computing Percent Violation** (Also available in PDF, 16kb)
Number of Dairies or Plants in Sample
1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	21	22	23	24	25	26	27	28	29	30	31	32	33	34	35	36	37	38	39	40	41	42	43	44	50
100	50	33	25	20	17	14	13	11	10	9	8	8	7	7	6	6	6	5	5	5	5	5	5	4	4	4	4	3	3	3	3	3	3	3	3	3	3	3	3	2	2	2	2	2	1	Number of Plants or Dairies Violating an Item
	100	67	50	40	33	29	25	22	20	18	17	15	14	13	13	12	11	11	10	10	9	9	8	8	8	7	7	7	7	7	6	6	6	6	6	5	5	5	5	5	5	5	5	4	2
		100	75	60	50	43	38	33	30	27	25	23	21	20	19	18	17	16	15	14	14	13	13	12	12	11	11	10	10	10	9	9	9	9	8	8	8	8	8	7	7	7	7	6	3
			100	80	67	57	50	44	40	36	33	31	29	27	25	24	22	21	20	19	16	17	17	16	15	15	14	14	13	13	13	12	12	11	11	11	11	10	10	10	10	9	9	8	4
				100	83	72	63	56	50	45	42	38	36	33	31	29	28	26	25	24	23	22	21	19	19	18	17	17	16	16	15	15	14	14	14	13	13	13	12	12	12	12	11	10	5
					100	86	75	67	60	55	50	46	43	40	38	35	33	32	30	29	27	26	25	24	23	22	21	21	20	19	19	18	18	17	17	16	16	15	15	15	14	14	14	12	6
						100	88	78	70	64	58	54	50	47	44	41	39	37	35	33	32	30	29	28	27	26	25	24	23	23	22	21	21	20	19	19	18	18	18	17	17	16	16	14	7
							100	89	80	73	67	62	57	53	50	47	44	42	40	38	36	35	33	32	31	30	29	28	27	26	25	24	24	26	22	22	21	21	20	20	19	19	18	16	8
								100	90	82	75	69	64	60	56	53	50	47	45	43	41	39	38	36	35	33	32	31	30	29	28	27	26	26	25	24	23	23	22	22	21	21	20	18	9
									100	91	83	77	72	67	63	59	56	53	50	48	46	44	42	40	38	37	36	35	33	32	31	30	29	29	28	27	26	25	25	24	24	23	23	20	10
										100	92	85	79	74	69	65	61	58	55	52	50	48	46	44	42	41	39	38	37	36	34	33	32	31	31	30	29	28	28	27	26	26	25	22	11
											100	92	86	80	75	71	67	63	60	57	55	52	50	48	46	45	43	41	40	39	38	36	35	34	33	32	32	31	30	29	29	28	27	24	12
												100	93	87	81	77	72	69	65	62	59	57	54	52	50	48	46	45	43	42	41	39	38	37	35	35	36	33	33	32	31	30	30	26	13
													100	93	88	82	78	74	70	67	64	61	58	56	54	52	50	48	47	44	44	42	41	40	39	38	37	36	35	34	33	33	32	28	14
														100	94	88	83	79	75	72	68	65	63	60	58	56	54	52	50	48	47	45	44	43	42	43	40	39	38	37	36	35	34	30	15
															100	94	90	85	80	76	73	70	67	64	62	59	57	55	53	52	50	49	47	46	44	43	42	41	40	39	38	37	36	32	16
																100	94	90	85	81	77	74	71	68	65	63	61	59	57	55	53	52	50	49	47	46	45	44	43	42	41	40	39	34	17
																	100	94	90	86	82	78	75	72	69	67	64	62	60	58	56	55	53	51	50	49	47	46	45	44	43	42	41	36	18
																		100	95	90	87	83	79	76	73	70	68	66	63	61	59	58	56	54	53	51	50	49	48	46	45	44	43	38	19
																			100	95	91	87	83	80	77	74	71	69	66	65	63	61	59	57	56	54	53	51	50	49	48	47	46	40	20
																				100	96	91	88	84	81	78	75	72	70	68	66	64	62	60	58	57	55	54	53	51	50	49	48	42	21
																					100	96	92	88	85	82	79	76	73	71	69	68	65	63	61	60	58	57	55	54	52	51	50	44	22
																						100	96	92	89	85	82	79	77	74	72	70	68	66	64	62	61	59	58	56	55	54	52	46	23
																							100	96	92	89	86	83	80	77	75	73	71	69	67	65	63	62	60	59	57	56	54	48	24
																								100	96	93	89	86	83	81	78	76	74	72	70	68	66	64	63	61	60	58	57	50	25
Example: An item violated 16 times in survey of 25 dairy farms equals 64% violation.																									100	96	93	90	87	84	81	79	77	74	72	70	68	67	65	63	62	61	59	52	26
																										100	96	93	90	87	84	82	79	77	75	73	71	69	68	66	65	63	61	54	27
																											100	97	93	90	87	85	82	80	78	76	74	72	70	68	67	65	64	56	28
																												100	97	94	91	88	85	83	81	78	76	74	73	71	69	67	66	58	29
																													100	97	94	91	88	86	83	81	79	77	75	73	71	70	68	60	30
	TABLE FOR COMPUTING PERCENT VIOLATION (Percentage rounded to nearest whole number)																													100	97	94	91	89	86	84	82	80	78	76	74	72	71	62	31
																															100	97	94	92	89	87	84	82	80	78	76	74	73	64	32
																																100	97	94	92	89	87	85	83	81	79	77	75	66	33
																																	100	97	94	92	90	87	85	83	81	79	77	68	34
																																		100	97	95	92	90	88	85	83	81	80	70	35
																																			100	97	95	92	90	88	86	84	82	72	36
																																				100	97	95	93	90	88	86	84	74	37
																																					100	97	95	93	91	88	86	76	38
																																						100	98	95	93	91	89	78	39
																																							100	98	95	93	91	80	40
																																								100	98	95	93	82	41
																																									100	98	96	84	42
																																										100	98	86	43
																																											100	88	44
																																												100	50

APPENDIX A.
GUIDELINES FOR COMPUTING ENFORCEMENT RATINGS
(FORM FDA 2359j-MILK SANITATION RATING REPORT-SECTION B. REPORT OF ENFORCEMENT METHODS (Page 2))

PART I. DAIRY FARMS

NOTE: Enforcement evaluation is based on NCIMS requirements, not on individual State's laws or regulations.

All dairy farms hold valid permits (PMO Section 3 - PERMITS). Prorate by number of farms in compliance.
1. Every dairy farmer, in compliance, holds a valid permit.
2. Permits not transferable with respect to person and/or location.
All dairy farms inspected at least once every six (6) months or as required under Appendix P. (PMO, Section 5 - INSPECTION OF DAIRY FARMS and APPENDIX P. - PERFORMANCE-BASED DAIRY FARM INSPECTION SYSTEM). Prorate by number of farms in compliance.
Every dairy farm inspected at least once every six (6) months or as required by Appendix P.

NOTE: Use Methods, Section D., 1., e. and D., 2., e. as a guide: "The interval shall include the designated period, plus the remaining days of the month in which the inspection is due."
Inspection sheets posted or available (PMO, Section 5 - INSPECTION OF DAIRY FARMS). Prorate by number of farms in compliance.
A copy of the most recent inspection report shall be available at the dairy farm.
Requirements interpreted in accordance with the Grade "A" PMO as indicated by past inspections (PMO, Section 7 - STANDARDS FOR MILK AND MILK PRODUCTS). Prorate by number of farms in compliance.
1. Sanitarian's criterion is neither too lenient nor too stringent.
2. Significant violations, including construction, debited by the sanitarian on the most recent inspection.
3. Sanitarian recognizes violations and debits as appropriate on the previous inspection reports.
Tuberculosis and Brucellosis Certification on file as required (PMO, Section 8 - ANIMAL HEALTH and APPENDIX A. - ANIMAL DISEASE CONTROL). All or nothing Item based on record verification.
1. Located in a Certified Brucellosis - Free Area as defined by USDA and enrolled in the testing program for such areas; or
  1. 1.) Meet USDA requirements for an individually certified herd; or
  2. 2.) Participate in an approved milk ring testing program; or
  3. 3.) Have individual blood agglutination testing done annually.
2. Located in an Area, which has a Modified Accredited Advanced Tuberculosis status or greater as determined by USDA. Other Areas or herds must have passed an annual tuberculosis test or the Area has established a tuberculosis testing protocol that assures tuberculosis protection and surveillance of the dairy industry and is approved by FDA, USDA and the State Regulatory Agency.
3. Tuberculosis and/or Brucellosis certificates on file as required by the Regulatory Agency.
4. Notice of status changes readily available to the Regulatory Agency.
5. Milk from Brucellosis reactor animals withheld as required.
Water samples tested and reports on file as required (PMO, Section 7 - STANDARDS FOR MILK AND MILK PRODUCTS, APPENDIX D. - STANDARDS FOR WATER SOURCES and APPENDIX G. - CHEMICAL AND BACTERIOLOGICAL TESTS). Prorate by number of farms in compliance. A farm missing one (1) water sample during a required time period will not receive any credit for this Item.
1. Samples of private water supplies and recirculated cooling water systems taken upon initial construction/installation and within thirty (30) days after extensive repairs or alterations.
2. Private water supplies sampled every three (3) years.
3. Hauled water (cisterns) sampled in at least four (4) months out of six (6), at the point of use.
4. Recirculated water sampled every six (6) months.
5. Water supplies with buried well seals sampled every six (6) months.
  NOTE: Use PMO, Section 7, Item 8r, ADMINISTRATIVE PROCEDURES #7, as a guide: "To determine if water samples have been taken at the frequency established in this Section, the interval shall include the designated period plus the remaining days of the month in which the sample is due."
6. No sampling required for public, community, or rural water system(s), which are under EPA/State Water Control Authority and in compliance with their requirements.
7. Appropriate follow-up investigation and re-sampling of the supply/system following a positive bacteriological result. (Within thirty (30) days.)
8. Heterotrophic count performed when required by APPENDIX G. of the Grade "A" PMO.
9. Samples submitted to a laboratory acceptable to the Regulatory Agency.
10. Current record of sample results on file at the Regulatory Agency, back to the last rating.
  NOTE: State Water Control Authority requirements, which are less stringent than the Grade "A" PMO, shall be superseded by the Grade "A" PMO. State Water Control Authority requirements, which are more strict than the Grade "A" PMO, shall not be considered in determining the acceptability of water supplies during ratings, check ratings, single-service listing evaluations and audits.
  
  For Example: If the state law required more frequent individual water supply samples to be taken, a SRO conducting a sanitation rating, which includes that farm or milk plant, will now give that farm or milk plant full credit for water sample frequency, if the Grade "A" PMO minimum sampling frequency requirement is met, even though, the State frequency is not met.
  
  Supplies other than individual water supplies, which have been approved as safe by the State Water Control Authority, shall be considered to be acceptable sources, as provided in Section 7 of the Grade "A" PMO, for Grade "A" inspections, as well as for all other IMS purposes, without further inspection of the spring, well or reservoir treatment facility(ies), testing records, etc.
Milking Time Inspection Program established (PMO, Section 5 - INSPECTION OF DAIRY FARMS and Section 6 - EXAMINATION OF MILK AND MILK PRODUCTS). All or nothing Item.
NOTE: Until FDA guidance is developed for a Milking Time Inspection Program; full credit is given for this Item.
At least four (4) samples collected in at least four (4) separate months from each dairy farm's milk supply, during any consecutive six (6) months, except when three (3) months show a month containing two (2) sampling dates separated by at least twenty (20) days, and all necessary laboratory examinations made (PMO, Section 6 - EXAMINATION OF MILK AND MILK PRODUCTS). Prorate by number of farms in compliance.
1. Four (4) samples taken from each producer during any consecutive six (6) month period (Use Methods, Pages 6 and 7 as a guide.)
  NOTE: Use Methods, Section B., 2., e.2.), as a guide for frequency determination.
2. Required bacterial counts, somatic cell counts, drug residue and cooling temperature checks performed on each sample in an official or officially designated laboratory.
Sampling procedures approved by PHS/FDA evaluation methods (PMO, Section 6 - EXAMINATION OF MILK AND MILK PRODUCTS; EML; and STANDARD METHODS FOR THE EXAMINATION OF DAIRY PRODUCTS (SMEDP)).
NOTE: Use Methods, "GUIDANCE FOR COMPUTING ENFORCEMENT CREDIT FOR PART I, ITEM 9 AND/OR PART II, ITEM 8 OF THE "REPORT OF ENFORCEMENT METHODS".
Permit issuance, suspension, revocation, reinstatement, hearings and/or court action taken as required (PMO, Section 3 - PERMITS, Section 5 - INSPECTION OF DAIRY FARMS, Section 6 - EXAMINATION OF MILK AND MILK PRODUCTS and Section 16 - PENALTY). Prorate by number of farms in compliance.
SANITATION REQUIREMENTS
1. Inspected prior to the issuance of a permit.
2. Permit issuance based on compliance.
3. Notice issued for intent to suspend permit if an inspection(s) discloses a violation of a Grade "A" PMO requirement(s). Reinspection(s) made as required.
4. Permit suspension upon violation of:
  1. Section 3 for a serious health hazard or interference by the permit holder in the performance of the Regulatory Agency's duties; or
  2. Section 5 for consecutive violation(s) of the same requirements of Section 7.
    NOTE: PMO, Section 3 states: "The Regulatory Agency may forego suspension of the permit, provided the product or products in violation are not sold or offered for sale as Grade "A" product. A Regulatory Agency may allow the imposition of a monetary penalty in lieu of a permit suspension, provided product or products in violation are not sold or offered for sale as Grade "A" product. Except, that a milk producer may be assessed a monetary penalty in lieu of permit suspension for violative counts."
5. Action to revoke a permit taken upon multiple suspensions.
6. Hearings provided for as required.
7. Reinstatement procedures followed.
  NOTE: PMO, Section 3 states: "Within one (1) week of the receipt of notification of correction, the Regulatory Agency shall make an inspection and as many additional inspections thereafter as are deemed necessary to determine that the applicant's establishment is complying with the requirements."
8. Milk produced during suspension or while a monetary penalty is imposed for repeated inspection violations is not eligible for sale as Grade "A".
PRODUCT COMPLIANCE
1. All milk produced during suspension or while a monetary penalty is imposed for bacterial, somatic cell, cooling temperature or drug residue violation is not eligible for sale as Grade "A".
2. When two (2) out of the last four (4) samples exceed the standards, a written notice is sent, and an additional sample is taken within twenty-one (21) days of the date of the notice, but not before three (3) days.
3. Permit suspension; stop sale; or imposition of a monetary penalty upon violation of:
  1. 1.) Section 3 for serious health hazard; or
  2. 2.) Section 6 for:
    1. i. Three (3) out of the last five (5) samples exceeding the bacterial, somatic cell, or cooling temperature standards; or
    2. ii. "Four (4) in six (6) months" positive antibiotic (not of Appendix N. origin); or
    3. iii. If pesticide contaminated milk is not withheld from sale.
4. Temporary permit issued as required on reinstatement(s) following somatic cell count resampling, which indicates the milk supply to be within acceptable limits; or reinspection (bacterial or cooling temperature standards violation) made within one (1) week following proper notification, except after reinstatement for a drug residue or with resampling for somatic cell standard.
5. "Reinstating accelerated sample(s)" for bacterial, cooling temperature, or somatic cell counts taken not more than two (2) per week on separate days within a three (3) week period.
Records systematically maintained and current (PMO, Section 3 - PERMITS, Section 5 - INSPECTION OF DAIRY FARMS, Section 6 - EXAMINATION OF MILK AND MILK PRODUCTS, and Section 7 - STANDARDS FOR MILK AND MILK PRODUCTS). Make use of both general record-keeping deficiencies and record keeping by farm to determine value. Prorate by number of farms in compliance.
1. Permit records available, accurate and current, including permit suspension, impositions of a monetary penalty, notices, reinstatement, etc. The results shall be entered on appropriate ledger forms. The use of a computer or other information retrieval system may be used.
2. Inspection reports on file as directed by the Regulatory Agency and retained at least twenty-four (24) months. The results are entered on a milk ledger form or computer.
3. Bacterial counts, somatic cell counts, cooling temperatures, drug residues, pesticide results, and water analysis results promptly recorded on a milk ledger form or a computer program for each individual dairy farm. (Use the arithmetic average for bacterial counts, somatic cell counts and cooling temperature determinations when samples are collected from the same farm on the same day from multiple storage tanks.)
4. Within the Rating Period: Plan review file in order and written approval given for construction during the rating period.

PART II. MILK PLANTS

NOTE: Enforcement evaluation is based on NCIMS requirements, not on individual State's laws or regulations.

All milk plants, receiving stations and transfer stations operators hold valid permits (PMO, Section 3 - PERMITS). All or nothing Item.
1. All milk plants, receiving and transfer stations hold a valid permit.
2. Permits retained only by those in compliance with the Grade "A" PMO requirements.
3. Permits not transferable with respect to persons and/or locations.
Milk plants and receiving stations inspected at least once every three (3) months (transfer stations once every six (6) months) (PMO, Section 5 - INSPECTION OF MILK PLANTS). Prorate by number of inspections in compliance with the required frequency.
For Example:

= # of three (3) or six (6) month periods with an inspection conducted

Total # of three (3) or six (6) month periods in rating period
1. Milk plants and receiving stations inspected at least once every three (3) months.
2. Transfer stations inspected at least once every six (6) months.
NOTE: Use Methods, Section D., 1., e. as a guide: "The interval shall include the designated period plus the remaining days of the month in which the inspection is due."
Inspection sheets posted or available (PMO, Section 5 - INSPECTION OF MILK PLANTS). All or nothing Item.
A copy of the most recent inspection report shall be available at the milk plant, receiving station or transfer station.
Requirements interpreted in accordance with the Grade "A" PMO as indicated by past inspections (PMO, Section 7 - STANDARDS FOR MILK AND MILK PRODUCTS.) Prorate by significant interpretation violation(s) not noted on previous inspection reports.
1. Sanitarian's criterion is neither too lenient nor too stringent.
2. Significant violations, including construction, debited by the sanitarian on the most recent inspection.
3. Sanitarian recognizes violations and debits as appropriate on the previous inspection reports.
Pasteurization equipment tested at required frequency (PMO, Section 7 - STANDARDS FOR MILK AND MILK PRODUCTS and APPENDIX I. - PASTEURIZATION EQUIPMENT AND CONTROLS-TESTS). Prorate by number of units per quarter that were correctly tested within the required testing frequency vs. total number of units.
1. Total required tests performed based on pasteurization system(s): (# of Vat Past. + # of HTST Past. + # of HHST Past. + # of Aseptic Systems) at milk plant.
  For Example:
  
  *= # of three (3) month periods X # of pasteurizers properly checked within each period
  
  # of three (3) month periods X Total # of pasteurizers
  
  *NOTE: No credit for a period is given for a pasteurization unit unless all required tests for that unit have been correctly completed and recorded.
2. Test performed at required frequency, including semi-annual and quarterly tests conducted by the Regulatory Agency and daily tests conducted by an operator.
  NOTE: Use Methods, Section D., 4., a.1.) as a guide: "The interval shall include the designated period plus the remaining days of the month in which the test(s) is due."
3. All tests made and properly recorded (required calculations available). The results shall be entered on appropriate ledger forms. A computer or other information retrieval system may be used.
Individual and cooling water samples tested and reports on file as required (PMO, Section 7 - STANDARDS FOR MILK AND MILK PRODUCTS, APPENDIX D. - STANDARDS FOR WATER SOURCES, and APPENDIX G. - CHEMICAL AND BACTERIOLOGICAL TESTS). Prorate by number of water samples tested during the required time period vs. the total number of water tests due per water system.
1. Total required water tests performed based on each water system requiring testing at the plant, receiving or transfer station.
  For Example:
  
  = # of test(s) performed at required frequency per water system X # of water systems
  
  # of test(s) due at required frequency per water system X # of water systems
2. Samples of private water supplies and recirculated cooling water, including sweet water and glycol systems, taken upon initial construction/installation; within thirty (30) days after extensive repairs or alterations; and every six (6) months thereafter.
3. No sampling required for public, community, or rural water system(s), which are under EPA/State Water Control Authority and in compliance with their requirements.
4. Condensing water for milk evaporators and water reclaimed from milk or milk products complying with APPENDIX D. requirements.
5. Hauled water (cisterns) sampled in at least four (4) months out of six (6) months, at the point of use.
6. Water supplies with buried well seals sampled every six (6) months.
  NOTE: Use PMO, Section 7, Item 7p, ADMINISTRATIVE PROCEDURES #7 as a guide: "To determine if water samples have been taken at the frequency established in this Section, the interval shall include the designated six (6) month period plus the remaining days of the month in which the sample is due."
7. Appropriate follow-up investigation and re-sampling of the supply/system following a positive bacteriological result (Within thirty (30) days.)
8. Heterotrophic count performed when required by APPENDIX G. of the Grade "A" PMO.
9. Samples submitted to a laboratory acceptable to the Regulatory Agency.
10. Current record of sample results on file at the Regulatory Agency, back to the last rating.
  NOTE: State Water Control Authority requirements, which are less stringent than the Grade "A" PMO, shall be superseded by the Grade "A" PMO. State Water Control Authority requirements, which are more strict than the Grade "A" PMO, shall not be considered in determining the acceptability of water supplies during ratings, check ratings, single-service listing evaluations and audits.
  
  For Example: If the state law required more frequent individual water supply samples to be taken, a SRO conducting a sanitation rating, which includes that farm or milk plant, will now give that farm or milk plant full credit for water sample frequency, if the Grade "A" PMO minimum sampling frequency requirement is met, even though, the State frequency is not met.
  
  Supplies other than individual water supplies, which have been approved as safe by the State Water Control Authority, shall be considered to be acceptable sources, as provided in Section 7 of the Grade "A" PMO, for Grade "A" inspections, as well as for all other IMS purposes, without further inspection of the spring, well or reservoir treatment facility(ies), testing records, etc.
Samples of each milk plant's milk and milk products collected at the required frequency and all necessary laboratory examinations made (PMO, Section 6 - THE EXAMINATION OF MILK AND MILK PRODUCTS). Prorate by number of products in compliance.
1. During any consecutive six (6) months, at least four (4) samples of raw milk, after receipt by the plant, shall be collected, prior to pasteurization, in four (4) separate months, except when three (3) months show a month containing two (2) sampling dates separated by at least twenty (20) days.
2. During any consecutive six (6) months, at least four (4) samples of each milk product processed, as defined in Sections 1 and 6 of the Grade "A" PMO shall be collected in four (4) separate months, except when three (3) months show a month containing two (2) sampling dates separated by at least twenty (20) days. However, if the production of any Grade "A" condensed or dry milk product, as defined in the Grade "A" PMO, is not on a yearly basis, at least five (5) samples shall be taken within a continuous production period.
3. During any consecutive six (6) months, at least four (4) samples of heat-treated products shall be collected in at least four (4) separate months, except when three (3) months show a month containing two (2) sampling dates separated by at least twenty (20) days.
4. All required examinations performed on each sample (bacterial, coliform, drug residue, phosphatase, and cooling temperature) in an official or officially designated laboratory.
5. Assays of Vitamin A, D, and/or A and D fortified milk and milk products made at least annually in an IMS Listed Laboratory. Credit for vitamin-fortified products is not given unless vitamin analysis is completed and records are available. Each fortified product is evaluated separately.
Sampling procedures approved by PHS/FDA evaluation methods (PMO, Section 6 - EXAMINATION OF MILK AND MILK PRODUCTS; EML; and SMEDP).
NOTE: Use Methods, "GUIDANCE FOR COMPUTING ENFORCEMENT CREDIT FOR PART 1, ITEM 9 AND/OR PART II, ITEM 8 OF FORM FDA 2359j-MILK SANITATION RATING REPORT-SECTION B. REPORT OF ENFORCEMENT METHODS (Page 2).

Items 4 and 7 on the "Evaluation of Sampling Procedures" Form are not applicable for milk plants, receiving and transfer stations when calculating enforcement scores for FORM FDA 2359j-MILK SANITATION RATING REPORT-SECTION B. REPORT OF ENFORCEMENT METHODS (Page 2), Part II, Item 8.

NOTE: Divide by seventy (70) instead of 100 when making the calculations.
Permit issuance, suspension, revocation, reinstatement, hearings and/or court action taken as required (PMO, Section 3 - PERMITS, Section 5 - INSPECTION OF MILK PLANTS, Section 6 - EXAMINATION OF MILK AND MILK PRODUCTS and Section 16 - PENALTIES). Prorate by enforcement action(s) in compliance.
SANITATION REQUIREMENTS
1. Inspected prior to the issuance of a permit.
2. Permit issuance based on compliance.
3. Notice issued for intent to suspend permit if inspection(s) disclose a violation of a Grade "A" PMO requirement(s). Reinspection(s) made as required.
4. Permit suspension upon violation of:
  1. 1.) Section 3 for a serious health hazard or interference by the permit holder in the performance of the Regulatory Agency's duties; or
  2. 2.) Section 5 for sanitation and/or uncorrected critical processing elements; or
  3. 3.) Section 5 for consecutive violation of the same requirement of Section 7.
  NOTE: PMO, Section 3 states: "The Regulatory Agency may forego suspension of the permit, provided the product or products in violation are not sold or offered for sale as Grade "A" product. A Regulatory Agency may allow the imposition of a monetary penalty in lieu of a permit suspension, provided product or products in violation are not sold or offered for sale as Grade "A" product.
5. Action to revoke a permit taken upon multiple suspensions.
6. Hearings provided for as required.
7. Reinstatement procedures followed.
  NOTE: PMO, Section 3 states: "Within one (1) week of the receipt of notification of correction, the Regulatory Agency shall make an inspection and as many additional inspections thereafter as are deemed necessary to determine that the applicant's establishment is complying with the requirements."
8. Milk products processed during suspension or while a monetary penalty is imposed for repeated inspection violations are not eligible for sale as Grade "A".
PRODUCT COMPLIANCE
1. All milk and milk products produced during suspension or while a monetary penalty is imposed for bacterial count, coliform count, cooling temperature or drug residue violations are not eligible for sale as Grade "A".
2. All product violations followed promptly by an inspection to determine the cause(s).
3. When two (2) out of the last four (4) samples exceed the limits, a written notice is sent, and an additional sample is taken within twenty-one (21) days of the date of the notice, but not before three (3) days.
4. When three (3) out of the last five (5) samples exceed the standards; or a positive drug residue or pesticide residue, the permit is immediately suspended.
5. Temporary permit issued as required on reinstatement(s) and reinspection made within one (1) week following proper notification (except for drug residues).
6. "Reinstating accelerated samples" taken not more than two (2) per week, on separate days, within a three (3) week period (except for drug residues).
7. Violation of Vitamin Fortification Levels (Refer to M-I-92-13): Determine the cause and re-sample or withhold product from the market.
8. Positive Phosphatase: Determine the probable cause and if the cause is improper pasteurization it shall be corrected before further sale of milk is allowed.
9. Positive Drug Residues or Pesticide Test: Investigate, determine the probable cause and correct before further sale of milk is allowed.
10. Permit suspension upon violation of:
  1. 1.) Section 3 for serious health hazard; or
  2. 2.) Section 6 for bacterial counts, coliform counts and cooling temperature violations if the product is not otherwise withheld.
11. All permit issuance, suspension, revocation, etc., as required by the Grade "A" PMO.
Records systematically maintained and current (PMO, Section 3 - PERMITS, Section 4 - LABELING, Section 5 - INSPECTION OF MILK PLANTS, Section 6 - EXAMINATION OF MILK AND MILK PRODUCTS, and Section 7 - STANDARDS FOR MILK AND MILK PRODUCTS.) Make use of both general and specific record-keeping deficiencies to determine value.
1. Permit records available, accurate and current, including permit suspension, imposition of a monetary penalty, notices, reinstatement, etc. The results shall be entered on appropriate ledger forms. The use of a computer or other information retrieval system may be used.
2. Inspection reports and equipment tests filed as directed by the Regulatory Agency and retained for at least twenty-four (24) months. The results are entered on a milk ledger form or computer.
3. All test results for bacterial, coliform, cooling temperature, phosphatase, drug residues, pesticide, if available, and vitamin assay promptly recorded on an appropriate ledger or computer for each individual milk and milk product. (Use the arithmetic average for bacterial counts, coliform counts, and cooling temperature determinations when samples are collected of the same milk or milk product from the same plant on the same day from multiple storage tanks or silos.)
4. Records maintained on bacteriological examination of milk containers, if required.
5. Vitamin volume control records complete and on file at the plant as required.
6. Within the Rating Period: Plan review file in order and written approval given for construction during the rating period.

PART III. INDIVIDUAL SHIPPER RATING

Refer to the "Total Credit", Part I value and multiply by "45", if an attached raw supply (farms) is included with the plant listing. (Refer to the instructions below Part III on FORM FDA 2359j-MILK SANITATION RATING REPORT-SECTION B. REPORT OF ENFORCEMENT METHODS (Page 2).) If an attached raw supply (farms) is not included with the plant listing, leave this Item blank.
Refer to the "Total Credit", Part II value and multiply by "45", if an attached raw supply (farms) is included with the plant listing; or by "90%", if only an unattached raw supply(ies) (farms) is utilized. (Refer to the instructions below Part III on FORM FDA 2359j-MILK SANITATION RATING REPORT-SECTION B. REPORT OF ENFORCEMENT METHODS (Page 2).)
All milk and milk products properly labeled (PMO, Section 4 - LABELING).
1. Prorate by Product: Number of different products correctly labeled vs. total number of products, including raw.
2. Include in Label Review:
  1. 1.) A representative label(s) for all products produced, including raw. Products are labeled according to the Grade "A" PMO definition(s) and requirements and applicable CFR's.
  2. 2.) Vehicles hauling milk must be properly identified with the name and address of the milk plant or hauler. (Include under raw milk.)
  3. 3.) Milk cans from producers properly identified. (Include under raw milk.)
  4. 4.) Bills-of-lading and farm weight tickets contain all the required information, including BTU #. (Include under raw milk where applicable.)
Provisions of Section 11 of the Grade "A" PMO followed when milk and milk products are imported. Imported milk includes milk from within the State, other States and foreign countries (PMO, Section 11 - MILK AND MILK PRODUCTS FROM POINTS BEYOND THE LIMITS OF ROUTINE INSPECTION). All or nothing Item.
Rated Milk Supplies:
1. Equal to, or greater than, that of the local supply; or
2. Imported supply with ninety percent (90%) or higher sanitation compliance and enforcement ratings; or
3. Produced or processed under requirements substantially equivalent to the NCIMS. Applicable for supplies produced and/or processed outside the United States and accepted by FDA and the NCIMS.
NOTE: All records must be summarized in ledger form. Computer ledgers are acceptable. Records include:
1. Inspections of farms, milk plants, receiving and transfer stations, samplers, vehicles, etc.;
2. Laboratory information, i.e., raw milk, heat-treated milk, finished milk products, vitamin assays, water, cooling media, etc.); and
3. Equipment tests.

GUIDANCE FOR COMPUTING ENFORCEMENT CREDIT FOR PART I,
ITEM 9 AND/OR PART II, ITEM 8 OF FORM FDA 2359j-MILK
SANITATION RATING REPORT - SECTION B. REPORT
OF ENFORCEMENT METHODS (Page 2)

The "Evaluation of Sampling Procedures" Form is used to determine enforcement credit for Part I, Item 9, FORM FDA 2359j-MILK SANITATION RATING REPORT-SECTION B. REPORT OF ENFORCEMENT METHODS (Page 2) (Dairy Farms), and Part II, Item 8, FORM FDA 2359j-MILK SANITATION RATING REPORT-SECTION B. REPORT OF ENFORCEMENT METHODS (Page 2) (Milk Plant). Items 4 and 7 do not apply when calculating enforcement scores for milk plants, receiving and transfer stations for FORM FDA 2359j-MILK SANITATION RATING REPORT-SECTION B. REPORT OF ENFORCEMENT METHODS (Page 2), Part II, Item 8.

Item 1. Sampling Surveillance Officers (SSO's) Properly Certified
1. All SSO's are certified by FDA.
2. Certification is currently valid (three years).
3. SSO's shall be a certified SRO, Laboratory Evaluation Officer (LEO) or State Regulatory Supervisor per "Procedures" Section V., F., 1.
Item 2. Adequate Training Program Provided
1. Reference material available to samplers.
2. Training program conforms to established procedures.
3. Training program implemented.
4. Copies of training materials and other related information are on file for review.
Item 3. Sampling Surveillance Authority Properly Delegated
1. Proper delegation procedures have been conducted.
2. Only those eligible receive delegated authority.
3. At least five (5) joint bulk milk hauler/sampler evaluations, plus one (1) pasteurized product sampler and/or single-service container/closure exercise, if applicable, with eighty percent (80%) agreement on each Item.
4. Re-delegation conducted at least each three (3) years.
5. Proper certification of industry field person when applicable.
Item 4. Permit Issuance (Applies to Part I-Farms Only)
1. All bulk milk hauler/samplers have a valid permit.
2. Inspected prior to the issuance of a permit.
3. Only bulk milk hauler/samplers who comply with Ordinance requirements shall be entitled to receive a permit.
4. Permits not transferable with respect to persons.
Item 5. Sampler (Including Dairy Plant and Industry Plant Samplers at the Receiving Site) Evaluated Every Two (2) Years and Reports Properly Filed
1. Samplers shall have their sample collection procedures evaluated by a certified SSO or properly delegated regulatory official every two (2) years.
2. Proper agencies are advised of all samplers and of all evaluations annually in accordance with procedures.
Item 6. Sampling Procedures in Substantial Compliance
1. Appraisal of each sampler's compliance done by record review.
2. Appraisal of sampler's compliance.
3. Evaluation criteria neither too stringent nor too lenient.
4. Evaluation up-to-date. (Applies only to Part II-MILK PLANT, Item 8)
Item 7. Permit Suspension, Revocation, Reinstatement, Hearings and/or Court Actions Taken as Required (Applies to Part I-FARMS Only)
1. Action taken on repeat violations of sampling requirements.
2. Re-evaluations made as required.
Item 8. Records Systematically Maintained and Current
1. Records of the delegation of sampling evaluation authority to other State, Local, or industry individuals on file and available for review with the producer or plant records.
2. Records of each sampler evaluation on file and available for review with the producer or plant records.
3. Records for each sampler evaluation entered on individual history cards or computer ledgers.
4. Records of permit issuance, suspension, reinstatement, revocation and hearings on file and available for review.
5. Records of bulk milk hauler/sampler inspections on file.

APPENDIX B.

TABLE OF FARM WATER SUPPLY VIOLATIONS

The following Table was accepted by the NCIMS Executive Board for use as guidance in evaluating farm water supplies. The Table provides guidance, which may be used to differentiate between two (2) point (minor) and five (5) point (major) violations of Section 7, Item 8r of the Grade "A" PMO during State Ratings and FDA Check Ratings.

Primary Violation Areas as Defined by the Grade "A" PMO

Water supply is safe and complies with Appendix D.;
No cross-connections between safe and unsafe supplies;
No submerged inlets;
Well location and construction;
New individual water supplies disinfected prior to use;
All containers/tanks used to transport and protect water are protected from contamination;
Periodic sampling; and
Water testing records current.

**Wells, Springs and Cisterns: Construction and Location**
(Items A, D and F)
Major (5 point)	Minor (2 point)
1. Any openings that allow direct contamination of the well water, such as: Well cap/cover not in proper position on top of casing to protect against contamination (i.e., missing, lying on ground, hanging off edge of casing, etc.); Well cap/cover not impervious; Opening in top of casing (i.e., vent hole, opening around electrical wires, etc.); Well casing or top cracked/perforated with openings to interior of well; Well seal not watertight; and Frost-free style water hydrant out of the top of the well casing.	*1. Any openings that allow indirect* contamination of the well water:** Well cap/cover not tight or overlapping (i.e., set screws, etc. not tightened) but in proper position to protect against contamination; Proper vent (turned down pipe) but unscreened or damaged screen; and Loose wires running from the outside of the well into the well casing from the side or underside of the well cap.
2. Large hole/depression, indication of erosion around well casing or standing water around well casing.	2. Slight depression around well with no evidence of standing water.
3. Well pit does not meet the following requirements: Watertight construction (protected from ground water/rain water); Watertight impervious cover; Watertight impervious (concrete) floor sloped to drain; Operational sump pump or traceable drain to the surface; Dry floor in pit; and Well in bottom of pit protected from contamination using cover, seals, etc.	3. Well pit does not meet the following requirements: Concrete base for pump/machinery at least 12 inches (30.5 centimeters) above the pit floor; and Cover of the overlapping (shoe box) type.
4. Spring box not properly constructed or protected: Spring box and cover do not protect spring from direct contamination, (i.e., uncovered, openings in top, cracks in sides, etc.); Surface drainage not diverted away from spring; and Spring located in open pasture/field with livestock concentrating within 50 feet (15 meters) as evidenced by trampling of ground, accumulation of manure, or a stock tank or cattle feeding area within 50 feet (15 meters) of spring.	4. Spring box not properly constructed or protected: Overflow piping not screened; Spring box cover not overlapping; and Minor construction deficiencies.
5. Water reservoir/cistern/tank construction and use: Constructed to allow contamination of the potable water; and Transfer/distribution system constructed to allow contamination of the water supply or distribution system.	5. Water reservoir/cistern/tank construction: Minor construction problems.
6. Buried well seal: With a bad water sample not brought into compliance.	6. Inaccessibility: Except for seasonal conditions like snow and insulation wrap during winter months, the following water sources/supplies must be accessible for routine inspection and survey evaluation: Above ground wells and well pits; Cisterns, reservoirs and springs; and Stock waterers.
7. Well within 50 feet (15 meters) of contamination source (i.e., sewer lines, septic tank, drain field, cowyard, cattle housing areas without impervious floors, calf pens, waste disposal lagoons, buried gasoline tanks, herbicide/pesticide storage, etc.).	7. Frost-free style water hydrant located within 10 feet (3 meters) of the well without an approved atmospheric vacuum breaker or with the hose connection threads not cut off.
8. Well casing terminating below or at ground level. (Does not include well pits or buried well seals complying with Item 8r of the Grade "A" PMO).	8. Any pit not meeting the construction standards of the Grade "A" PMO, which is located within 10 feet (3 meters) of the well.
9. Well located in a known flood plain with well casing terminating less than 2 feet (0.6 meters) above the highest known flood level.
10. Well located in open pasture/field with livestock concentrating within 50 feet (15 meters) of well as evidenced by trampling of the ground, accumulation of manure, or a stock tank or cattle feeding area within 50 feet (15 meters) of the well*
11. Improperly constructed abandoned well(s) located within 10 feet (3 meters) of well(s) used as source of potable water for the dairy.

* If there is no evidence of livestock concentration around a well casing that is located in a pasture, then this Item should not be debited.

**Water Sampling**
(Items E, G and H)
Major (5 point)	Minor (2 point)
1. Last water sample unsatisfactory.	1. Last sample on record tested safe, but the next sample was not collected/ analyzed within the required time frames: New Permit: Then once every three (3) years; Buried Well Seal: Every six (6) months; Hauled Water: At least four (4) times in separate months during any consecutive six (6) months; and After Any Well Repair: Within thirty (30) days.
2. No record of an initial bacteriological sample on file prior to the issuance of a permit for new farms, without any additional sample results on file for the rating period.
3. Continuous disinfection system, required by the Regulatory Agency, is not operational.
4. On farms with interconnected wells, if the system is constructed and operated so that a single sample will represent all sources, then a single sample is sufficient. If a single sample does not represent all sources, then each individual well must be sampled at the required frequency (M-I-86-9).

**Cross-Connections and Submerged Inlets:Water Sampling**
(Items B and C)
Major (5 point)	Minor (2 point)
1. Submerged inlets: Into non-potable water, (i.e.): Submerged line in a stock tank(s)/stock fountain(s); 2-compartment wash vat(s) containing water or with the drain plugged; Drinking cups; Pre-cooler outlet; Flush down tanks; Water inlet to a CIP/wash vat is submerged in water or solution in the vat; and Chill water tank (sweet water, glycol, etc.).	1. Potential submerged inlets: Single-cased pipe in a stock tank or fountain; Properly working stock tank float located below the overflow rim of the tank; and Water inlet (equipped with an automatic shut-off) to a CIP/wash vat terminates below the rim of the vat, but is not submerged in water or solution. (NOTE: If the float has stuck and it is submerged at the time of the inspection it is a five (5) point debit.)
2. Permanent in-line high pressure pump (power washer): Without acceptable protection, such as: Properly functioning low-pressure cut-off switch with a properly located test valve; and Other methods acceptable to the State Water Control Authority.	2. Portable high pressure water pump (power washer): Without acceptable protection, such as: Separate water supply or reservoir; Properly functioning low-pressure cut-off switch with a properly located test valve; and Other methods acceptable to the State Water Control Authority. (NOTE: Lack of a valve or improperly located valve, used to test the low-pressure cut-off switch is a two (2) point debit.)
3. Cleaner, sanitizer and udder wash injectors (pumps) with water supply connection not properly protected and supply container of greater than one (1) gallon size. Submerged inlet(s) in other chemical containers (i.e., bottles and/or containers of Roundup, 2-4D, etc.), regardless of the size of the chemical container.
4. Anti-siphon vent-type backflow preventer with vent plugged.
5. Use of non-functional or improper devices to protect against submerged inlets and/or cross-connections.
6. Stock tank(s) utilizing center ground pipe as an overflow, where the overflow is flooded and not draining.
7. Discharge hose connecting potable water system directly to the sewer system or manure handling system (i.e., water line terminating below the flood rim of a floor drain).

**Reclaimed Water Not Meeting The Following Criteria:**
(Appendix D., IV. - Water Reclaimed from Heat Exchanger Processes)
Major (5 point)
Sampled before initial approval; Sampled at least once in each six (6) month period; Proper construction of the storage tank (i.e., protected from contamination); No cross-connections between reclaimed water and non-potable water; and Approved chemicals used if water is treated.

Federal/State Food Programs | Guidance

FDA/Center for Food Safety & Applied Nutrition
Hypertext updated by rog/ear May 12, 2008

=	# of three (3) or six (6) month periods with an inspection conducted
	Total # of three (3) or six (6) month periods in rating period

*=	# of three (3) month periods X # of pasteurizers properly checked within each period
	# of three (3) month periods X Total # of pasteurizers

=	# of test(s) performed at required frequency per water system X # of water systems
	# of test(s) due at required frequency per water system X # of water systems

Methods of Making Sanitation Ratings of Milk Shippers

2005 Revision

TABLE OF CONTENTS

PREFACE

METHODS OF MAKING SANITATION RATINGS OF MILK SHIPPERS

A. DEFINITIONS

B. RATING METHODS FOR RAW MILK FOR PASTEURIZATION

C. RATING METHODS FOR MILK PLANTS, RECEIVING STATIONS AND TRANSFER STATIONS

D. COMPUTATION OF ENFORCEMENT RATINGS

E. PREPARATION OF THE SRO's REPORT

F. PUBLICATION OF THE "INTERSTATE MILK SHIPPER's REPORT"

G. EXAMPLES OF RATING AND NCIMS HACCP LISTING FORMS (PDF, 312 kb)

H. EXAMPLES OF HOW TO PROPERLY COMPLETE RATING AND NCIMS HACCP LISTING FORMS (PDF, 312 kb)

APPENDIX A. GUIDELINES FOR COMPUTING ENFORCEMENT RATINGS (FORM FDA 2359j-MILK SANITATION RATING REPORT-SECTION B. REPORT OF ENFORCEMENT METHODS (Page 2))

PART I. DAIRY FARMS

PART II. MILK PLANTS

PART III. INDIVIDUAL SHIPPER RATING

GUIDANCE FOR COMPUTING ENFORCEMENT CREDIT FOR PART I, ITEM 9 AND/OR PART II, ITEM 8 OF FORM FDA 2359j-MILK SANITATION RATING REPORT - SECTION B. REPORT OF ENFORCEMENT METHODS (Page 2)

APPENDIX B. TABLE OF FARM WATER SUPPLY VIOLATIONS

Primary Violation Areas as Defined by the Grade "A" PMO

APPENDIX A.
GUIDELINES FOR COMPUTING ENFORCEMENT RATINGS
(FORM FDA 2359j-MILK SANITATION RATING REPORT-SECTION B. REPORT OF ENFORCEMENT METHODS (Page 2))

GUIDANCE FOR COMPUTING ENFORCEMENT CREDIT FOR PART I,
ITEM 9 AND/OR PART II, ITEM 8 OF FORM FDA 2359j-MILK
SANITATION RATING REPORT - SECTION B. REPORT
OF ENFORCEMENT METHODS (Page 2)

APPENDIX B.

TABLE OF FARM WATER SUPPLY VIOLATIONS