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 › Section 420-3-16-.14 - Distribution Of Milk And Milk Products From Points Beyond Local Jurisdiction

Current through Register Vol. 42, No. 9, June 28, 2024
(1) Milk and/or
			 milk products, from points beyond the limits of routine inspection of the ADPH
			 or its jurisdiction, shall be sold in Alabama or its jurisdiction provided they
			 are produced and pasteurized, ultra-pasteurized, aseptically processed and
			 packaged, retort processed after packaging, concentrated (condensed), or dried
			 under regulations which are substantially equivalent to this rule and have been
			 awarded acceptable Milk Sanitation Compliance and Enforcement Ratings; or have
			 been awarded an acceptable HACCP listing, under the NCIMS voluntary HACCP
			 Program as specified in Appendix K; or are from a country that USPHS/FDA has
			 determined, after conferring with the NCIMS, to have in place a public health
			 regulatory program and government oversight of that program that have an
			 equivalent effect on the safety of regulated milk and/or milk
			 products.
(2) Administrative
			 Procedures - This item is deemed to be satisfied when the Health Officer should
			 accept, without their actual physical inspection, supplies of milk, milk
			 products, and frozen desserts from an area or an individual shipper not under
			 their routine inspection, provided:
(a) Upon
			 arrival, raw milk and/or raw milk products for pasteurization shall comply with
			 bacteriological, chemical, and temperature standards of Rule
			 420-3-16-.08 as determined in
			 accordance with Rule
			 420-3-16-.07. Provided, that
			 direct shipped producer milk that is under the supervision of more than one (1)
			 regulatory agency may be exempt from the bacteriological requirement for
			 commingled samples. However, the receiving regulatory agency shall have the
			 right to use the individual producer samples to determine compliance with the
			 bacteriological standards using the individual producer raw milk
			 standards.
(b) After receipt,
			 pasteurized, ultra-pasteurized, aseptically processed, and packaged, retort
			 processed after packaging, concentrated (condensed), or dried milk, milk
			 products, and frozen desserts shall comply with the bacteriological, chemical,
			 and temperature requirements of Rule
			 420-3-16-.08 as determined in
			 accordance with Rule
			 420-3-16-.03,
			 420-3-16-.05, and
			 420-3-16-.13.
Note:
Raw, pasteurized, and ultra-pasteurized
				milk, milk products, and frozen dessert products beyond the limits of routine
				inspection shall be sampled as the Health Officer requires.
(c) The milk, milk products, or frozen
			 desserts are produced and processed under regulations substantially equivalent
			 to these rules.
(d) The supplies
			 are under routine official supervision.
(e) The milk supplies have been awarded by a
			 SRO certified by the FDA, a Milk Sanitation Compliance rating equal to that of
			 the local supply or equal to 90 percent or higher.
(f) The supplies have been awarded by a SRO,
			 certified by the FDA, an Enforcement Rating equal to the local supply, or equal
			 to 90 percent or higher, or if the enforcement rating is below 90 percent on a
			 rating, a re-rating shall occur within six (6) months of this rating. Both the
			 Milk Sanitation Compliance and Enforcement Ratings shall be equal to 90 percent
			 or greater on the re-rating or the supply is considered in violation of this
			 section.
(g) All ratings are made
			 on the basis of procedures outlined in Methods of Making Sanitation Ratings of
			 Milk Shipper's (MMSR).
Note:
Names of interstate milk shippers and their
				ratings, as reported by rating agencies, are contained on the IMS list issued
				electronically by the FDA. This list may be obtained from the FDA website at
				http://www.fda.gov/Food/Guidance Regulation/FederalstateFoodPrograms/ucm20
				07965.htm.
(h) The supplies
			 have been awarded by a SRO, certified by the FDA, a satisfactory listing under
			 the NCIMS voluntary HACCP Program as specified in Appendix K.
(i) The foreign supplies have been awarded a
			 satisfactory listing by a TPC SRO certified by the FDA, under the
			 ICP.
(j) FDA has determined that
			 the foreign country's public health regulatory program and the government
			 oversight of that program have an equivalent effect on the safety of the
			 regulated milk and/or milk product. It is USPHS/FDA's responsibility to
			 determine equivalence and USPHS/FDA shall confer with NCIMS prior to finalizing
			 a determination of equivalence. The foreign government shall provide adequate
			 assurance that the level of public health protection provided by its dairy
			 safety system is equivalent to that provided by the NCIMS program.
(k) Aseptically processed and packaged
			 low-acid milk and/or milk products in the definition of milk products of this
			 rule shall be considered to be Grade "A" milk and/or milk products. The
			 sources(s) of the milk and/or milk products used to produce aseptically
			 processed and packaged low-acid milk and/or milk products shall be IMS listed.
			 Aseptically processed and packaged low-acid milk and/or milk products shall be
			 labeled "Grade "A" and meet Rule
			 420-3-16-.05 labeling
			 requirements of this rule. The milk plant or portion of the milk plant that is
			 producing aseptically processed and packaged low-acid milk and/or milk products
			 shall be awarded a Milk Sanitation Compliance Rating of at least 90 percent and
			 an enforcement rating equal to the local supply, or equal to 90 percent or
			 higher, or if the Enforcement Rating is below 90 percent on a rating, a
			 re-rating shall occur within (6) months of this rating. Both the Milk
			 Sanitation Compliance and Enforcement Ratings shall be equal to 90 percent or
			 higher on the re-rating or the supply is considered in violation of this
			 section. In the case of HACCP/Aseptic listings, an acceptable HACCP listing by
			 a SRO is required. For milk plants that produce aseptically processed and
			 packaged Grade "A" low-acid milk and/or milk products, prior to the milk plant
			 participating in the NCIMS Aseptic Processing and Packaging Program or the
			 Aseptic Pilot Program, the Health Officer's and Rating Agency's personnel shall
			 have completed a training course that is acceptable to the NCIMS and FDA
			 addressing the procedures for conducting regulatory inspections and ratings
			 under the NCIMS Aseptic Processing and Packaging Program or Aseptic Pilot
			 Program. The NCIMS Aseptic Pilot Program addressing aseptically processed and
			 packaged acidified and fermented high-acid milk and/or milk products regulated
			 under 21 CFR Parts 108, 110, and/or 114 shall expire on December 31, 2017,
			 unless extended by future conference action.
(l) Retort processed after packaging low-acid
			 milk and/or milk products as addressed in the definition of milk products of
			 this rule 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 this rule; or if they are labeled as Grade
			 "A" as described in Rule
			 420-3-16-.05. Retort processed
			 after packaging low-acid milk and/or milk products shall be labeled "Grade "A"
			 and meet Rule
			 420-3-16-.05 whenever they meet
			 the provisions cited within the definition of milk products of this rule. The
			 source(s) of the milk and/or milk products used to produce retort processed
			 after packaging Grade "A" low-acid milk and/or milk products shall be IMS
			 listed. The milk plant or portion of the milk plant that is producing retort
			 processed after packaging Grade "A" low-acid milk and/or milk products shall be
			 awarded a Milk Sanitation Compliance Rating of at least 90 percent and an
			 enforcement rating equal to the local supply, or equal to 90 percent or higher;
			 or if the enforcement rating is below 90 percent on a rating, a re-rating shall
			 occur within (6) months of this rating. Both, the Milk Sanitation Compliance
			 and Enforcement Ratings shall be equal to 90 percent or higher on the
			 re-rating; or the supply is considered in violation of this section. In the
			 case of HACCP/Retort listings, an acceptable HACCP listing by a SRO is
			 required. For milk plants that produce retort processed after packaging Grade
			 "A" low-acid milk and/or milk products and prior to the milk plant
			 participating in the NCIMS Retort Processed after Packaging Program, the Health
			 Officer's and Rating Agency's personnel shall have completed a training course
			 that is acceptable to the NCIMS and FDA addressing the procedures for
			 conducting regulatory inspections and ratings under the NCIMS Retort Processed
			 after Packaging Program.