Grade "A" Pasteurized Milk Ordinance (2003 Revision)

Appendices P through Q

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Appendix P. Performance-Based Dairy Farm Inspection System

PREFACE

A performance-based inspection system is an option to the traditional routine inspection frequency of at least once every six (6) months on Grade "A" dairy farms. This option provides States with a choice. For some States, inspecting every farm routinely twice a year may provide effective regulatory oversight and make efficient use of inspection resources. In other States, however, an optional system, which determines routine farm inspection frequency based on producer milk quality and inspection performance may be more desirable, equally effective, and make the most efficient use of limited inspection resources. The overall inspection effort devoted to a performance-based farm inspection system may be more or less than the traditional inspection system, which requires a routine inspection at least once every six (6) months per farm.

INSPECTION INTERVAL AND CRITERIA

Dairy farms will be categorized at least every three (3) months using the previous twelve (12) month farm inspection and milk quality data. The following criteria will be used to categorize farms into four (4) inspection intervals as defined below:

MINIMUM ONE (1) YEAR INSPECTION INTERVAL (ONE (1) INSPECTION EACH TWELVE (12) MONTHS):

All criteria below must have been met for the previous twelve (12) months:

1. No more than one (1) sample with a Standard Plate Count (SPC) >25,000, but less than 100,000;
2. All Somatic Cell Count (SCC) samples ≤ 500,000;
3. No cooling temperature violations;
4. No drug residue violations;
5. No "critical control point" violations observed during farm inspections. Critical violations are identified on the Dairy Farm Inspection Report as:
   1. 10-Cleaning and 11-Sanitization;
   2. 15(d)-Drugs properly labeled and 15(e)-Drugs properly used and stored; and
   3. 18-Cooling (Significant Violations).
6. No violation that creates a substantial risk of adulteration or an imminent health hazard;
7. No more than five (5) violations documented on any inspection sheet;
8. No consecutive inspection violations on any inspection Item;
9. No record of suspended permit, certification or license due to inspection, milk quality or drug residue deficiencies; and
10. Bacteriologically safe water supply at the time of categorization.

NOTE: Farms in this category who are re-categorized to a six (6) month inspection interval for a single violation of one (1) milk quality parameter (SCC > 500,000 or cooling temperature violation) may be re-categorized to the one (1) year inspection interval if all ten (10) criteria listed above are met for the next six (6) months.

MINIMUM SIX (6) MONTH INSPECTION INTERVAL (ONE (1) INSPECTION EACH SIX (6) MONTHS):

All criteria below must have been met for the previous twelve (12) months:

1. May have more than one (1) sample with SPC >25,000;
2. May have one (1) or more SCC sample >500,000;
3. No more than one (1) warning letter issued due to non-compliance of two (2) out of four (4) previous official sample results for SPC and SCC;
4. No cooling temperature violations;
5. No drug residue violations;
6. No "critical control point" violations observed during farm inspections. Critical violations are identified on the Dairy Farm Inspection Report as:
   1. 10-Cleaning and 11-Sanitization;
   2. 5(d)-Drugs properly labeled and 15(e)-Drugs properly used and stored; and
   3. 18-Cooling (Significant Violations).
7. No violation that creates a substantial risk of adulteration or an imminent health hazard;
8. No more than five (5) violations documented on any inspection sheet;
9. No consecutive inspection violations on any inspection Item;
10. No record of suspended permit certification or license due to inspection, milk quality or drug residue deficiencies; and
11. Bacteriologically safe water supply at the time of categorization.

NOTE: Farms meeting the criteria for one (1) year or six (6) month inspection intervals but with less than twelve (12) months of farm inspection and milk quality history, i.e., new farms, will be assigned to a six (6) month inspection interval.

MINIMUM FOUR (4) MONTH INSPECTION INTERVAL (ONE (1) INSPECTION EACH FOUR (4) MONTHS):

Any criteria listed below, results in the farm being placed into this inspection interval for twelve (12) months from the next re-categorization:

1. More than one (1) warning letter issued due to non-compliance of two (2) out of four (4) previous official sample results for SPC and SCC;
2. Farm conditions that caused the Regulatory Agency to take official regulatory action, i.e., warning letter, intent to suspend, reinspection, etc.;
3. One (1) drug residue violation;
4. "Critical control point" violations observed during farm inspections. Critical violations are identified on the Dairy Farm Inspection Report as:
   1. 10-Cleaning and 11-Sanitization;
   2. 15(d)-Drugs properly labeled and 15(e)-Drugs properly used and stored; and
   3. 18-Cooling (Significant Violations).
5. A violation that creates a substantial risk of adulteration or an imminent health hazard;
6. More than five (5) violations on any inspection; and
7. Unsafe water supply at the time of categorization.

MINIMUM THREE (3) MONTH INSPECTION INTERVAL(ONE (1) INSPECTION EACH THREE (3) MONTHS):

Any criteria listed below results in the farm being placed into this inspection interval for twelve (12) months from the next re-categorization:

1. More than one (1) drug residue violation;
2. Any farm suspended from the market by the Regulatory Agency during the previous twelve (12) month evaluation period for any reason other than drug residue violations; and
3. More than one (1) incident where violative farm conditions or milk quality parameters resulted in the Regulatory Agency taking official regulatory action, i.e., warning letter, intent to suspend, reinspection, etc.

NOTE: The above guidelines for Grade "A" farm inspection intervals are not intended to prevent farm inspections at more frequent intervals if in the judgment of the Regulatory Agency more frequent intervals are necessary.

 

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Appendix Q. Operation of Automatic Milking Installations for the Production of Grade "A" Raw Milk for Pasteurization

This Appendix is intended to clarify how AMIs are to perform to be considered in compliance with the Grade "A" PMO. It is formatted to follow the Items as outlined in Section 7. STANDARDS FOR GRADE "A" RAW MILK FOR PASTEURIZATION, ULTRA-PASTEURIZATION OR ASEPTIC PROCESSING. Both requirements and recommendations are discussed.

ITEM 1r. ABNORMAL MILK

AMIs shall have the capability to identify and discard milk from animals that are producing milk with abnormalities. Odor is currently evaluated on a bulk tank basis and should be no different for a herd using AMI technology.

Animals producing milk with abnormalities shall be diverted to a holding pen to be milked immediately prior to the system being cleaned and sanitized. An alternative would be to have the system clean and sanitize the parts of the milking system that came into contact with the milk with abnormalities after any animal producing milk with any abnormality used the system.

ITEM 2r. MILKING BARN, STABLE OR PARLOR - CONSTRUCTION

The AMI milker box shall be treated the same as any other parlor. The goal is a clean environment in which to milk animals. All ventilation air must come from outside the cattle housing area.

ITEM 3r. MILKING BARN, STABLE OR PARLOR - CLEANLINESS

The AMI milker box shall be kept as clean as any milking and equipment cleaning area. It is recommended that the milking platform be regularly flushed with water to remove any manure that may have accumulated.

ITEM 9r. UTENSILS AND EQUIPMENT - CONSTRUCTION

AMIs are the same as any other milking system from a sanitary construction standpoint and shall meet the same standards as a conventional milking system in respect to fit and finish of the milk contact surfaces.

ITEM 10r. UTENSILS AND EQUIPMENT - CLEANING

AMIs are a continuous milking system and shall be shut down to clean at an interval sufficient to prevent the milking system from building up with soils. It is recommended that this interval not to exceed 8 hours.

ITEM 11r. UTENSILS AND EQUIPMENT - SANITIZATION

AMIs shall be sanitized after each cleaning and/or before each use, as is the case with any other milking system.

ITEM 12r. UTENSILS AND EQUIPMENT - STORAGE

AMIs shall have positive air ventilation systems in operation whenever the system is cleaning. The air for this system must come from outside the cattle housing area and should be as clean and dry as practical. This positive air system may also need to run during milking if needed to minimize odor, moisture and/or for pest control.

ITEM 13r. MILKING - FLANKS, UDDERS AND TEATS

AMI manufacturers shall submit data to FDA to show that the teat prepping system employed in their system is equivalent to Item 13r. Administrative Procedures #4: "Teats shall be treated with a sanitizing solution just prior to the time of milking and shall be dry before milking." Each installer shall provide the producer and the Regulatory Agency with a copy of this approval, including a detailed description of the approved procedure. Each producer shall keep a copy on file at the farm.

ITEM 14r. PROTECTION FROM CONTAMINATION

The teat cups of the milking cluster need to be adequately shielded during the udder prepping process to assure that contaminants may not enter through the teat cup and get into the milk.

AMIs are designed to automatically shift from milk to wash; therefore, adequate separation of milk and CIP solution shall be provided to minimize the risk of cross contamination of milk with cleaning and sanitizing solutions. A fail-safe valve system equivalent to an inter-wired block-and-bleed, as referenced in Item15p.(B), shall be located as needed to prevent cross contamination. Separation shall be provided between, milk with abnormalities and milk intended for sale, and between cleaning/sanitizing solutions and milk intended for sale.

AMIs, which have a pipe into the wash vat that is continuously connected to the system, shall have a valving system that provides for an air break equal to the diameter of the wash line.

ITEM 18r. RAW MILK COOLING

For AMIs the raw milk for pasteurization shall be cooled to 10°C (50°F) within four (4) hours or less after starting the milking operation and the milk shall be cooled within two (2) more hours to 7°C (45°F). The bulk milk storage tank temperature should not exceed 7°C (45°F) after that point. Bulk milk tank recording thermometers are recommended.