Ala. Admin. Code r. 420-3-16-.14

Current through Register Vol. 43, No. 02, November 27, 2024

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

(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.

Ala. Admin. Code r. 420-3-16-.14

Adopted by Alabama Administrative Monthly Volume XXXVII, Issue No. 01, October 31, 2018, eff. 12/2/2018.

Author: G. M. Gallaspy, Jr.

Statutory Authority:Code of Ala. 1975, §§ 22-2-2, 22-20-7.