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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)
TABLE OF CONTENTS
PREFACE
TABLE OF CONTENTS
METHODS OF MAKING SANITATION RATINGS OF MILK SHIPPERS
- DEFINITIONS
- 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
- Record Review
- Regulatory Notification and Disposition
- Reinstatement
- COLLECTION OF DATA
- Number of Dairy Farms to be Rated
- Random Selection of Dairy Farms to be Rated
- Number of Bulk Milk Hauler/Samplers to be Evaluated
- Recording of Inspection Data
- Recording of Laboratory and Other Test Data
- COMPUTATION OF SANITATION COMPLIANCE RATINGS
- 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" PM.
- Record Review
- Regulatory Notification
- Industry Notification
- COLLECTION OF DATA
- Recording of Inspection Data
- Recording of Laboratory and Other Test Data
- Recording of Data for Milk Plants, Receiving Stations and Transfer Stations Being Listed Under the NCIMS HACCP Listing Procedure.
- COMPUTATION OF SANITATION COMPLIANCE RATINGS
- COMPUTATION OF ENFORCEMENT RATINGS
- PURPOSE
- RAW MILK FOR PASTEURIZATION ONLY
- RECEIVING STATION OR TRANSFER STATION
- MILK PLANTS
- Milk Plant with an Unattached Supply of Raw Milk
- Milk Plant with an Attached Supply of Raw Milk
- PREPARATION OF THE SRO's REPORT
- PURPOSE
- SUMMARY OF RATING RESULTS
- SUPPLEMENTARY NARRATIVE REPORT
- RECOMMENDATIONS OF THE SRO
- PUBLICATION OF THE "INTERSTATE MILK SHIPPER'S REPORT"
- PURPOSE
- PREPARATION OF THE "INTERSTATE MILK SHIPPER'S REPORT"
- Individual Shipper of Raw Milk for Pasteurization
- Receiving Station or Transfer Station
- Milk Plant
- 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.
- 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.) Records indicating that milk was always shipped to an IMS listed shipper
will suffice for actual test results.
- 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.
- 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.
- 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.) 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.) 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
(7th) 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.) 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.) 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.) 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.) 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.) 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.) 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.) 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
- 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.
- 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.
- 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.
- 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.
- 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.) Records indicating that milk was always shipped to an IMS listed shipper will suffice
for actual test results.
- 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.
- Regulatory Notification
If a load of milk was found to have a positive drug residue, determine if the Regulatory Agency was properly notified.
- 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.
- Recording of Inspection Data
- 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.) 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.) 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.
- Recording of Laboratory and Other Test Data
- 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.) 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.) 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.
- Recording of Data for Milk Plants, Receiving Stations and Transfer Stations Being Listed Under the NCIMS HACCP Listing Procedure
- 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.) 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.) Listing Audit Procedures
- A.) Pre-Audit Management Interview: Review and discuss the milk plant's,
receiving station's or transfer station's HACCP System including:
- (i) The management structure;
- (ii) The Hazard Analysis: Ensure that all milk or milk product hazards are addressed;
- (iii) The HACCP Plan;
- (iv) The Prerequisite Program (PP);
- (v) The flow diagrams; and
- (vi) The products/processes.
- B.) Review past Audit Reports (AR) and corrections of deficiencies and
non-conformities if any.
- C.) In-plant review of implementation and verification of the HACCP System.
- D.) Review records of the HACCP System.
- E.) Review compliance with other applicable NCIMS regulatory requirements*.
- F.) Discuss findings and observations.
- G.) Prepare and issue an AR based on findings of deficiencies and non-conformities.
- H.) Conduct the exit interview.
*Examples of Other Applicable NCIMS Requirements:
- Raw Milk Supply Source;
- Labeling Compliance;
- Adulteration;
- Licensing Requirements;
- Drug Residue Testing and Trace Back Requirements;
- Regulatory Samples in Compliance;
- Approved Laboratory Utilized for the Required Regulatory Tests; and
- Pasteurization Equipment Design, Construction, and Installation.
- 4.) Criteria and Procedures for Denial or Withdrawal of a Listing
- 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:
- (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.
- (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.
- (iii) Drug Residue testing and trace back requirements are not met.
- (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.
- 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:
- (i) HAZARD ANALYSIS: Flow Diagram and Hazard Analysis
conducted and written for each kind or group of milk or milk products
processed.
- (ii) HACCP PLAN: HACCP Plan prepared for each kind
or group of milk or milk products processed.
- (iii) HACCP PLAN CRITICAL LIMITS (CL's): CL's are adequate
to control the hazard identified.
- (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.
- (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.
- (vi) HACCP SYSTEM RECORDS: Information on HACCP records
not falsified.
- (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.
- (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.
- 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.
- 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.)
- 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.)
- 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.
- 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.
- 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
- 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.
- 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.) The period since the last rating, but not less than six (6) months; or
- 2.) The two (2) years preceding the date of the current rating.
- Enforcement rating scores shall be computed utilizing the "Guidelines for Computing Enforcement Ratings", contained in
Appendix A. of this document.
- 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.
- 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
- 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.)
- 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.
- 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.)
- 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.
- For dairy farms inspected under the provisions of Appendix P. of the Grade
"A" PMO, the following rating criteria applies:
- 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.) Dairy farms were re-categorized properly every three (3) months.
- 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
- 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.
- 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.)
- 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%).
- 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
- Milk Plant with an Unattached Supply of Raw Milk
- 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.) 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.) 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.) 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.) 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.
- Milk Plant with an Attached Supply of Raw Milk
- 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.) 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.) 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.) 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:
- A statement regarding the general status of the milk sanitation program, including both
strengths and weaknesses.
- 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:
- Milk plant, receiving station or transfer station holds a valid permit;
- Milk plant, receiving station or transfer station audited by the Regulatory Agency at the minimum required frequency;
- Requirements interpreted in accordance with the Grade "A" PMO as indicated by past audits;
- Pasteurization equipment tested at required frequency (not applicable to receiving stations and transfer stations);
- Individual and cooling water samples tested and reports on file as required;
- 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);
- Sampling procedures approved by PHS/FDA evaluation methods;
- Permit issuance, suspension, revocation, reinstatement, hearings, and/or court actions taken as required; and
- Records systematically maintained and current.
F. PUBLICATION OF THE "INTERSTATE MILK SHIPPER's REPORT"
- PURPOSE
- 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.
- 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"
- 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).
- 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).
- Milk Plant
- 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.) 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.) 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:
- 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.
- 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:
- (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.
- (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:
- 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
- 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 |
