18 AAC 31.740. Bottled drinking water

(a) In addition to other applicable requirements of this chapter, an operator of a food processing establishment who bottles drinking water in this state shall comply with this section and meet the food standard and labeling requirements of 21 C.F.R. 165.110(a) and (c), adopted by reference in 18 AAC 31.011.

(b) If the food processing establishment is also the operator of the Class A public water system used as the source of the bottled water, a copy of one of the following must be on file at the processing establishment:

(1) a valid interim approval to operate, issued under 18 AAC 80.210(i) ;

(2) a valid final approval to operate, issued under 18 AAC 80.210(k) .

(c) In addition to the requirements of this section, an operator of a food processing establishment who bottles drinking water in this state shall ensure that

(1) water to be bottled is obtained only from a source that meets the requirements for a Class A public water system in compliance with 18 AAC 80;

(2) the water before bottling does not exceed the primary maximum contaminant levels in 18 AAC 80.300(b) ; and

(3) if bottled water exceeds the secondary maximum contaminant levels in 18 AAC 80.300(c) , each bottle is labeled on the principal display panel as required by 21 C.F.R. 165.110(c), adopted by reference in 18 AAC 31.011; the label statement required under this paragraph must immediately and conspicuously precede or follow the name of the product.

(d) The operator of the food processing establishment shall ensure that coliform bacteria sampling and analysis from a container of each type of bottled water is conducted weekly by a qualified or certified laboratory that uses the water sampling and analysis procedures in 18 AAC 80. Verification for fecal coliform or E. coli is required; if the laboratory does not verify fecal coliforms, total coliforms will be considered fecal coliforms.

(e) If the results of an analysis under (d) of this section indicate the presence of coliform bacteria, the operator shall

(1) immediately notify the department;

(2) submit additional samples for analysis within 24 hours of receiving notice that the initial sample analysis was positive;

(3) detain the product pending the results of the additional samples;

(4) provide the department with the lot numbers of the product being detained; and

(5) notify the department of the results of the additional samples.

(f) The additional samples required under (e) of this section must consist of a sealed container of bottled water from the same lot as the initial sample, or if sampling from the same lot as the original sample is not possible, from the next available lot.

(g) A bacteria contamination violation occurs if any two samples, either weekly samples or check samples, contain coliform bacteria. If a bacteria contamination violation occurs, the operator shall

(1) take the steps specified in (e) of this section;

(2) analyze the source water for the bottled water; and

(3) repeat the check sampling required under this subsection within 24 hours after receiving the results of the check samples until no coliform bacteria are present in two consecutive check samples.

(h) If a coliform contamination violation occurs, other containers from the same lot or subsequent lots may not be distributed or sold, and other lots may not be produced until the source of contamination is identified and corrected.

(i) If the presence of fecal coliform or E. coli is verified, the owner or operator shall immediately recall the contaminated lot.

(j) At least once every three months, an aerobic plate count analysis shall be done using a bacteriological swab or a rinse from at least four containers and four closures such as bottle tops randomly selected immediately before filling and sealing the bottle. All samples must be free of coliform organisms. The aerobic place count analysis must be done by a qualified or certified laboratory. No more than one of the four samples may exceed more than

(1) one bacteria per milliliter of capacity, or

(2) one colony per square centimeter of surface area.

(k) If test results under (j) of this section indicate the presence of coliform bacteria, the owner or operator shall review the transportation, storage, and bottling procedures to find the source of contamination and immediately correct any deficiencies found. Records of any review conducted under this subsection must be kept as required under (n)(2) of this section.

( l ) In addition to meeting the applicable requirements in 21 C.F.R. 165.110(a) and (c), as adopted by reference in 18 AAC 31.011, bottled water that is bottled in this state and that is labeled as

(1) "glacier water," "pure glacier water," or words of similar meaning must be

(A) the runoff directly from the natural melting of a glacier;

(B) water obtained from the melting of glacier ice at a food processing establishment permitted under this chapter; or

(C) water from a stream that flows directly from a glacier and that has not been diluted or influenced by a non-glacial stream; and

(2) "glacier-blend," "glacially-influenced," or words of similar meaning must be water taken from a

(A) glacial stream that is influenced by a mapped tributary whose headwaters are not from a glacier; or

(B) lake that is fed by a glacial stream;

(m) For purposes of (l) of this section, a mapped tributary is a surface water channel drainage in the state that has been mapped by the United States Department of Interior, United States Geological Survey (USGS) under 43 U.S.C. 31 - 50c.

(n) Bottled water that is bottled in this state and labeled as "glacier water," "pure glacier water," "glacier-blend," "glacially-influenced," or words of similar meaning may

(1) be collected and transported by pipes, tunnels, trucks, or similar devices;

(2) not be altered at the food processing establishment by the addition or deletion of minerals, or by blending the water with water from another source, except that the water may be filtered or otherwise treated; and

(3) be drawn from a catchment that is connected to the stream or lake that is the source of the water.

(o) The following records must be maintained and available for department review:

(1) records of physical inspections of all equipment used for treatment of the water bottled, including distillation, ion-exchange, filtration, ultra-violet treatment, reverse osmosis, carbonation, and mineral addition; those records must include

(A) the date of the inspection;

(B) the conditions found during the inspection; and

(2) results of quarterly samples of containers and closures; those results must include

(A) the date the samples were collected;

(B) the date the samples were analyzed and the name of each individual who analyzed the samples;

(D) any actions taken under (k) of this section;

(3) results of weekly analyses of the bottled water; those results must include

(A) the date the samples were collected and the lot numbers;

(B) the date the samples were analyzed, the type of analyses conducted, and the name and address of the laboratory;

(D) any actions taken under (e) of this section.

(p) Records that are required under (o) of this section may be kept at

(1) the food processing establishment; or

(2) a location other than the food processing establishment, if the records can be produced for the department within 24 hours after a department request.

History: Eff. 5/18/97, Register 142; am 12/19/99, Register 152; am 6/28/2001, Register 158

Authority: AS 17.20.005

Editor's note: An owner or operator who bottles drinking water for interstate commerce may also be subject to 21 C.F.R. 129 and should contact the FDA.

USGS maps may be obtained from the United States Geological Survey, Earth Sciences Information Center, 4230 University Drive, Room 101, Anchorage, AK 99508; phone (907) 786-7011.

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