Alabama Administrative Code › Title 420 - ALABAMA STATE BOARD OF HEALTH › Chapter 420-3-16 - PRODUCTION, PROCESSING, HANDLING OR DISTRIBUTION OF MILK, MILK PRODUCTS AND FROZEN DESSERTS › APPENDICES › Appendix Q - OPERATION OF AUTOMATIC MILKING INSTALLATIONS FOR THE PRODUCTION OF GRADE "A" RAW MILK FOR PASTEURIZATION, ULTRA-PASTEURIZATION, ASEPTIC PROCESSING AND PACKAGING OR RETORT PROCESSED AFTER PACKAGING

Current through Register Vol. 42, No. 9, June 28, 2024
This appendix is intended to clarify how AMIs are to be
				  constructed, installed, perform, monitored, maintained, etc. 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, ASEPTIC PROCESSING AND PACKAGING OR RETORT PROCESSED AFTER
				  PACKAGING. Both requirements and recommendations are provided.
GENERAL REQUIREMENTS FOR AMI COMPUTER
				  SYSTEMS
AMIs have computer systems that are programmed for monitoring
				  and/or controlling various sensors, instrumentation, and the operational state
				  of various devices such as pumps and valves; have data collection, storage, and
				  reporting systems; and have communication network capabilities for multiple
				  uses and locations. While electronic and computer systems can furnish a wide
				  range of process verification and anomaly reporting, these are criteria only
				  for compliance with Items 1r, 13r, and 14r.
The dairy farm shall have an identified representative(s)
				  that has been trained by the AMI manufacturer or AMI manufacturer's designated
				  representative to make program changes to the AMI system.
A manufacturer's written or electronic documentation
				  addressing the computer system's monitoring and controlling functions related
				  to Items 1r, 13r, and 14r shall explain the devices controlled, the sensors or
				  instruments monitored, and testing procedures. A document shall bear the name
				  of the identified representative of the dairy farm and shall be available for
				  review at the dairy farm upon request by the regulatory agency, rating agency
				  and/or the FDA.
This documentation shall address Items 1r, 13r, and
				  14r:
1. The software version used, the devices controlled or
				  monitored and their locations, and the sensors or instruments monitored and
				  their locations.
2. The testing procedures for all of the computer system's
				  controlled and monitoring devices.
3. The procedure for any changes or maintenance to the
				  computers, devices, instrumentation, sensors hardware, etc.
4. Instructions on how to access the information available on
				  the computer system.
Note:
Controls for the devices are verified as
				  directed by the regulatory agency.
The data supporting the electronic reports shall be stored in
				  a database or data archival system. Written or electronic record(s) shall be
				  maintained at the dairy farm identifying changes and verifying compliance with
				  this rule. This record shall contain the name of the identified dairy farm
				  representative assigned to administer the computer system and these record(s)
				  shall be available for review at the dairy farm upon request by the regulatory
				  agency, rating agency and/or the FDA.
A verification of all computer system's controlled functions
				  shall be conducted and documented at the commissioning of the computer system
				  and at additional frequencies as deemed necessary by the regulatory agency.
				  Computer system controlled functions should be reviewed and verified by the
				  regulatory agency during routine dairy farm inspections and by the rating
				  agency and the FDA.
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 farm bulk milk tank/silo basis and shall not be any different
				  for a herd using AMI technology.
The dairy farm shall have a documented procedure in place
				  describing how abnormal milk is properly detected and diverted; and that
				  equipment used for the milking of healthy animals has not become contaminated.
				  The procedure shall also document that a physical change to the AMI system has
				  occurred.
A verification of all computer system's controlled functions
				  responsible for properly detecting and diverting abnormal milk shall be
				  conducted and documented at the commissioning of the computer system. This
				  verification means the visual observation by regulatory agency personnel; or
				  documentation indicating the testing that was completed by an AMI
				  manufacturer's designated representative; or other means accepted by the
				  regulatory agency. Written or electronic information for all required actions
				  shall be maintained at the dairy farm and shall be made available upon request
				  to the regulatory agency, rating agency, and/or the FDA.
Animals producing milk with abnormalities shall be diverted
				  to a holding pen to be milked immediately prior to the milking system being
				  cleaned and sanitized, or the animal(s) are identified through an appropriate
				  identification system so that their milk will be automatically excluded from
				  the milk offered for sale, provided that the parts of the milking system that
				  came into contact with the milk with abnormalities are immediately cleaned and
				  sanitized.
ITEM 2r. MILKING BARN, STABLE, OR PARLOR -
				  CONSTRUCTION
The AMI milker box shall be treated the same as any other
				  milking parlor. The goal is a clean environment in which to milk animals. All
				  ventilation air shall come from outside the cattle housing area. The AMI should
				  be located to provide a clean access for all personnel.
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 and installation standpoint and shall meet the same standards as a
				  conventional milking system in respect to construction, installation,
				  inspectability, the fit and finish of the milk product-contact surfaces,
				  etc.
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 eight (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 milking system is being cleaned and/or sanitized. The air for this
				  ventilation system shall come from outside the cattle housing area and shall be
				  as clean and dry as practical. This positive air ventilation system shall also
				  run during milking if needed to minimize odors, moisture, and/or for pest
				  control.
ITEM 13r. MILKING - FLANKS, UDDERS, AND
				  TEATS
AMI manufacturers shall submit data to the FDA to show that
				  the teat prepping system employed in their milking system is equivalent to Item
				  13r., Administrative Procedures 4 of these rules: "Teats shall be treated with
				  a sanitizing solution just prior to the time of milking and shall be dry before
				  milking." Each AMI installer shall provide the dairy producer and the Health
				  Officer with a copy of this FDA acceptance, including a detailed description of
				  the accepted equivalent procedure. Each dairy producer shall keep a copy of the
				  accepted teat prep protocol along with the appropriate AMI manufacturer's teat
				  prep protocol verification procedures on file at the dairy farm.
A verification of all computer system's controlled functions
				  responsible for proper teat preparation shall be conducted and documented at
				  the commissioning of the computer system. This verification means the visual
				  observation by regulatory agency personnel; or documentation indicating the
				  testing that was completed by an AMI manufacturer's designated representative;
				  or other means accepted by the regulatory agency. Written or electronic
				  information for all required actions shall be maintained at the dairy farm and
				  shall be made available upon request to the regulatory agency, rating agency,
				  and/or the FDA.
ITEM 14r. PROTECTION FROM CONTAMINATION
The teat cups (inflations) of the milking cluster shall be
				  adequately shielded, or variations may be individually evaluated and found to
				  also be acceptable by the FDA and the Health Officer, during the teat prepping
				  process to assure that contaminants shall not enter through the teat cups and
				  get into the milk.
AMIs are designed to automatically shift from milking to
				  cleaning/sanitizing positions; therefore, adequate separation of milk and CIP
				  solution shall be provided to minimize the risk of cross contamination of milk
				  with cleaning and/or sanitizing solutions. A fail-safe valve system providing
				  protection equivalent to an inter-wired block-and-bleed valve arrangement, as
				  referenced in Item 14r of these rules, 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.
Each dairy producer shall keep a copy of the AMI
				  manufacturer's testing verification procedures for the fail-safe valve systems
				  on file at the dairy farm.
AMIs which have a wash line extending into the wash vat that
				  is continuously connected to the milking system shall have a valving
				  arrangement 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,
				  ultra-pasteurization, aseptic processing, and packaging or retort processed
				  after packaging 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 milk in the farm bulk milk
				  tank/silo shall not exceed 7°C (45°F) after that time. Farm bulk milk
				  tank/silo recording thermometers are recommended if not already required by
				  these rules.
Author:
G. M. Gallaspy, Jr.
Statutory Authority:
Code of Ala. 1975,
					 §§
											22-2-2,
					 22-20-7.