Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 3
Subtitle 15 - FOOD
Chapter 10.15.11 - Bottled Water
Section 10.15.11.06 - Water Quality Standards and Analyses
Universal Citation: MD Code Reg 10.15.11.06
Current through Register Vol. 51, No. 19, September 20, 2024
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.
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