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 S - ASEPTIC PROCESSING AND PACKAGING PROGRAM AND RETORT PROCESSED AFTER PACKAGING PROGRAM

Current through Register Vol. 42, No. 9, June 28, 2024
The Aseptic Processing and Packaging Program is designed to
				  include all Grade "A" low-acid ( 21 CFR Part 113) aseptically processed and
				  packaged milk and/or milk products.
The Retort Processed after Packaging Program is designed to
				  include all Grade "A" low-acid ( 21 CFR Part 113) retort processed after
				  packaged milk and/or milk products.
Note:
Retort processed after packaging low-acid
				  milk and/or milk products as addressed in the definition of Milk Products of
				  these rules shall be considered to be Grade "A" milk and/or milk products if
				  they are used as an ingredient to produce any milk and/or milk product defined
				  in the definition of milk products of these rules or if they are labeled as
				  Grade "A" as described in Section 4 of these rules.
Inspections of a milk plant or portion of a milk plant that
				  is IMS listed to produce aseptically processed and packaged low-acid milk
				  and/or milk products and/or retort processed after packaged low-acid milk
				  and/or milk products shall be conducted by the Health Officer in accordance
				  with these rules and the information provided below at least once every six (6)
				  months. The milk plant's APPS or RPPS, respectively, as defined by these rules,
				  shall be exempt from Items 7p, 10p, 11p, 12p, 13p, 15p, 16p, 17p, 18p, and 19p
				  of these rules and shall comply with the applicable portions of 21 CFR Parts
				  108, 110, and 113. The milk plant's APPS and/or RPPS, respectively, shall be
				  inspected by the FDA, or the State Health Officer when designated by the FDA,
				  in accordance with the applicable requirements of 21 CFR Parts 108, 110, and
				  113 at a frequency determined by FDA.
When the APPS, as defined by these rules, is utilized to
				  produce aseptically processed and packaged low-acid milk and/or milk products
				  and pasteurized and/or ultra-pasteurized milk and/or milk products, the APPS
				  shall be inspected and tested by the Health Officer in accordance with the
				  requirements cited in Section 7 of these rules.
ASEPTIC PROCESSING AND PACKAGING PROGRAM AND RETORT
				  PROCESSED AFTER PACKAGING PROGRAM CFR/
GRADE "A" PMO
COMPARISON
				  SUMMARY REFERENCE
PMO, Section 7 Items
Aseptic Program/Retort Program
Authority
1p. Floors - Construction
Floor drains are not required in storage rooms for
								aseptic processed and packaged low-acid milk and/or milk products and retort
								processed after packaged low-acid milk and/or milk products.
PMO
2p. Walls and Ceiling - Construction
Ceiling requirements are exempt in aseptically
								processed and packaged low-acid milk and/or milk products and retort processed
								after packaged low-acid milk and/or milk products dry storage rooms. (Same as
								for dry milk or milk products.)
PMO
3p. Doors and Windows
None
PMO
4p. Lighting and
None
PMO
5p. Separate Rooms
Fabrication of containers and closures for aseptic
								processed and packaged low-acid milk and/or milk products and retort processed
								after packaged low-acid milk and/or milk products within the APPS and/or RPPS,
								respectively, is exempt.
PMO
6p. Toilet - Sewage Disposal
None
PMO
7pac. iWlitaietesr Supply*
The APPS and/or RPPS, respectively, is exempt, but
								shall comply with the CFR.
PMO/CFR
8p. Handwashing Facilities
None
PMO
9p. Milk Plant Cleanliness
None
PMO
10p. Sanitary Piping*
The APPS and/or RPPS, respectively, is exempt, but
								shall comply with the CFR.
PMO/CFR
11p. Construction and Repair of Containers and
								Equipment*
The APPS and/or RPPS, respectively, is exempt, but
								shall comply with the CFR. Paper, plastics, foil, adhesives, and other
								components of containers and closures used in the packaging of milk and/or milk
								products that have been aseptically processed and packaged or retort processed
								after packaged are not required to comply with Appendix J of the PMO; are not
								required to originate from an IMS Listed Source; and are subject to the
								requirements of the CFR.
PMO/CFR
12p. Cleaning and Sanitizing of Containers and
								Equipment*
The APPS and/or RPPS, respectively, is exempt, but
								shall comply with the CFR.
PMO/CFR
13p. Storage of Cleaned Containers and
								Equipment*
The APPS and/or RPPS, respectively, is exempt, but
								shall comply with the CFR.
PMO/CFR
14p. Storage of Single-Service Containers,
								Utensils, and Materials
None
PMO
15p.(A) Protection from Contamination*
The APPS and/or RPPS, respectively, is exempt, but
								shall comply with the CFR.
PMO/CFR
15p.(B) Protection from Contamination - Cross
								Connections*
The APPS and/or RPPS, respectively, is exempt, but
								shall comply with the CFR. APPS and/or RPPS equipment is exempt from the
								separation requirements of the PMO in relationship to instrumented steam blocks
								between milk and milk products and cleaning and/or chemical sanitizing
								solutions.
PMO/CFR
16p. Pasteurization and Aseptic Processing and
								Packaging (A) through (D)*
The APPS and/or RPPS, respectively, is exempt, but
								shall comply with the CFR. The Health Officer is not required to conduct the
								quarterly equipment testing and sealing of aseptic and/or processing equipment.
								Records and recording charts are not required to be reviewed during routine
								inspections, ratings or check ratings.
CFR
17p. Cooling of Milk and Milk Products*
The APPS and/or RPPS, respectively; aseptic
								processed and packaged low-acid milk and/or milk product storage; and retort
								processed after packed low-acid milk and/or milk product storage is exempt, but
								shall comply with the CFR.
PMO/CFR
18p. Bottling, Packaging, and
The APPS and/or RPPS, respectively, is exempt, but
								shall comply with the CFR.
CFR
Container Filling*
19p. Capping, Container Closure, and Sealing and
								Dry Milk Product Storage*
The APPS and/or RPPS, respectively, is exempt, but
								shall comply with the CFR.
CFR
20p. Personnel-Cleanliness
None
PMO
21p. Vehicles
None
PMO
22p. Surroundings
None
PMO
*Note:
In areas of the milk plant where these
				  items are dedicated only to the APPS and/or RPPS, respectively, as defined by
				  these rules, these Items shall be inspected and regulated in accordance with
				  the applicable FDA regulations (21 CFR Parts 108, 110, and
				  113).
Author:
G. M. Gallaspy, Jr.
Statutory Authority:
Code of Ala. 1975,
					 §§
											22-2-2,
					 22-20-7.