Sec. 10.15.11.06. Water Quality Standards and Analyses

A. The person-in-charge shall ensure that:

(1) Except as provided in §B(4) of this regulation, contaminant levels in source water and finished product water do not exceed the maximum allowable concentration for contaminants set forth in 21 CFR §165.110(b);

(2) Except as provided in §A(8) of this regulation, the analyses for all contaminants in source water and finished product water are performed by a certified laboratory using a representative sample and methods set forth in 21 CFR §§165.110(b) and 165.3;

(3) Except as provided in §B of this regulation, a representative sample of source water and finished product water is taken and tested for:

(a) Microbiological contaminants at least once per week;

(b) Chemical contaminants at least once per year; and

(c) Radiological contaminants at least once every 4 years;

(4) The analyses results for sampling required in §A(3) of this regulation are submitted to the Department:

(a) At the time of application for a license pursuant to Regulation .04E(1), (2), (4)(a), F(1)-(3), and G(1) of this chapter;

(b) Upon request within 10 days for microbiological contaminants; and

(c) Except as provided in §B of this regulation, upon request within 30 days for chemical and every 4 years for radiological contaminants;

(5) When a sample is positive for total coliforms:

(a) The total coliforms positive culture medium is analyzed to determine if fecal coliforms are present, except that Escherichia coli may be tested for in lieu of fecal coliforms; and

(b) A resample is taken and submitted for testing within 24 hours;

(6) Except as provided in §B(4) of this regulation, source water that does not meet the water quality standards in §A of this regulation is not bottled or processed as drinking water;

(7) Finished product water that does not meet the water quality standards in §A of this regulation is not offered for human consumption;

(8) A representative sample of source water and drinking water for testing is:

(a) Taken at a location and time that makes the test results indicative of the quality of the source water or drinking water;

(b) Of sufficient volume to allow testing; and

(c) At least 100 milliliters in volume for microbiological testing, regardless of analytical method;

(9) A source water is sampled and tested before any treatment or filtration of the source water;

(10) Drinking water and source water that are not filtered or disinfected during processing do not contain coliform bacteria;

(11) The microbiological contaminants in source water that is filtered or disinfected during processing do not include:

(a) Coliform in excess of 36 most probable number of organisms per 100 milliliters;

(b) Fecal coliform;

(c) Escherichia coli; and

(d) Organisms that by number or type indicate the direct influence of or contamination by surface water; and

(12) The contaminant concentration of trihalomethanes in bottled water does not exceed 10 parts per billion.

B. Exceptions.

(1) If a source water is from a public water supply system in the State or outside the State, the person-in-charge may use public water supply system analyses results or a certificate from the Maryland Department of the Environment or the approving authority to demonstrate compliance with the water quality standards for source water set forth in §A of this regulation.

(2) The Department may waive the requirement for a weekly microbiological analysis of source water that is from a public water supply system in the State or outside the State, if public water supply system analyses results or a certificate from the Maryland Department of the Environment or the approving authority demonstrates compliance with the water quality standards set forth in §A of this regulation.

(3) Mineral water is exempt from the maximum allowable concentration of chloride, iron, manganese, total dissolved solids, and zinc as provided in 21 CFR §165.110(b)(4)(i)(A).

(4) Except for a microbiological contaminant, the Department may approve a source water that contains a contaminant at a level that exceeds the maximum allowable concentration for finished product water based on a review that demonstrates that a treatment of the source water is:

(a) Effective in reducing the contaminant level in the finished product water below the maximum allowable concentration; and

(b) Interlocked with the bottling system so that:

(i) Failure in the treatment inactivates the bottling system; and

(ii) Water is prevented from being bottled.

C. Except for a microbiological contaminant, a person may not process or bottle water from a source water that contains a contaminant at a level that exceeds the maximum allowable concentration for a finished product water, as set forth in §A of this regulation, without written approval from the Department.

D. The person-in-charge shall:

(1) Maintain at the plant:

(a) While processing or bottling a source water as set forth in §§B(4) and C of this regulation, the Department's written approval; and

(b) A record of the required water sampling and analytical results for at least 2 years; and

(2) Make the records available for inspection by the Department.