Current through Register Vol. 42, No. 11, August 30, 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.