(A) Product water and operations water.
(1) The product water supply for each bottled water plant shall be from an approved source properly located, protected, and operated; and shall be easily accessible, adequate, and of a safe, sanitary quality.
(2) If different from the product water supply, the operations water supply shall be obtained from an approved source properly located, protected, and operated; and shall be easily accessible, adequate, and of a safe, sanitary quality.
(3) Product water and operations water from approved sources.
(a) Samples of source water are to be taken and analyzed by the plant as often as necessary, but at a minimum frequency of once each year for chemical contaminants and once every four years for radiological contaminants. Additionally, source water obtained from other than a public water system is to be sampled and analyzed for total coliform at least once each week. If any coliform organisms are detected, follow-up testing must be conducted to determine whether any of the coliform organisms are Escherichia coli (E. Coli). This sampling is in addition to any monitoring performed to comply with the E.P.A. or the local board of health requirements, as applicable. Records of approval of the source water by the E.P.A. or the local board of health, as applicable, and of sampling and analyses for which the plant is responsible are to be maintained on file at the plant.
(i) Source water found to contain E. Coli is not considered water of a safe, sanitary quality as required for use in bottled water by paragraph (A)(1) of this rule.
(ii) Before a bottler can use source water from a source that has tested positive for E. Coli, the bottler must take appropriate measures to rectify or otherwise eliminate the cause of E. Coli contamination of that source in manner sufficient to prevent its recurrence.
(iii) A source previously found to contain E. Coli will be considered negative for E. Coli after five samples collected over a twenty-four hour period from the same sampling site that originally tested positive for E. Coli are tested and found to be E. Coli negative.
(b) Test and sample methods shall be those recognized and approved by the E.P.A. or the local board of health, or the director, as applicable, over the approval of the water source and shall be consistent with the minimum requirements set forth in 21 C.F.R. Part 165.110(b)(2011).
(c) Samples of source water shall be tested by a United States environmental protection agency certified laboratory, a state EPA laboratory, or a state certified laboratory.
(d) Finished product water must comply with the bottled water quality standards in 21 C.F.R. Part 165.110(b)(2011) and section 3715.59 of the Revised Code dealing with adulterated foods.
(B) Air under pressure.
Whenever air under pressure is directed at product water or a product water-contact surface, it shall be free of oil, dust, rust, excessive moisture, and extraneous materials; and shall not affect the bacteriological quality of the water.
Five Year Review (FYR) Dates: 07/01/2016 and 09/16/2021
Promulgated Under: 119.03
Statutory Authority: 913.28
Rule Amplifies: 913.26, 913.27
Prior Effective Dates: 7/7/2005, 11/4/2010