401 KAR 8:700. Bottled water.
RELATES
TO: KRS 224.10-100, 224.10-110, 21 C.F.R. 129.35, 165.110
STATUTORY
AUTHORITY: KRS 224.10-100, 224.10-110
NECESSITY,
FUNCTION, AND CONFORMITY: KRS 224.10-110 requires the cabinet to enforce the
administrative regulations adopted by the secretary for the regulation and
control of the purification of water for public and semipublic use. This
administrative regulation establishes provisions to assure the purity of water
placed in bottles that will be resold as a food for human consumption or other
consumer use. U.S. EPA does not have a federal regulation relating to bottled water.
Certain provisions of this administrative regulation are more stringent than
the FDA requirements. The cabinet requires that plans, reports, and monitoring
results be submitted to the cabinet to ensure that compliance with all public
health standards is achieved without more frequent, costly on-site inspections,
and that systems monitor for chlorite more frequently to ensure that public
health standards are met for any disinfectant residuals.
Section
1. Applicability. (1) A bottled water system that bottles water within the
Commonwealth shall comply with the provisions of 401 KAR Chapter 8 except:
(a)
Distribution system monitoring and compliance applicable to public water
systems, including provisions for chlorine residual and disinfection by-products;
and
(b)
The public notification requirements of 401 KAR 8:070 and the reporting
requirements of 401 KAR 8:075; and
(2)
Water bottled outside the Commonwealth shall not be subject to this
administrative regulation, regardless of its source.
Section
2. Disinfection and Treatment. (1) Disinfection shall be by chlorination,
ultraviolet light, ozonation, or chlorine dioxide.
(2)
“Filtration”, as defined by 40 C.F.R. 141.2, shall be used for all sources
identified as “surface water” or “groundwater under the direct influence of
surface water”, as defined by 40 C.F.R. 141.2.
(3)
A bottled water system that uses a surface water source may use treatment
techniques that are different from other surface water users if equivalent
treatment is provided.
(4)
Water located in the line after bottling operations cease shall be flushed
before bottling is resumed.
Section
3. Sampling, Monitoring, and Reporting. (1) Analysis shall be performed with a
method established in 401 KAR Chapter 8 in a laboratory that shall be certified
to conduct testing pursuant to 401 KAR 8:040.
(2)
Monitoring results, including the Monthly Operating Report, shall be received
by the cabinet no later than the tenth day of the month following the end of
the reporting period.
(3)
If no treatment or bottling of water occurred during the reporting month, the
bottled water system shall notify the cabinet in its Monthly Operating Report
established in 401 KAR 8:020, Section 2(7), no later than the tenth day of the
following month.
(4)
Microbiological Sampling and Monitoring. A bottled water system shall conduct
microbiological sampling and testing as established in 401 KAR 8:200.
(a)
Each sample shall be taken after water disinfection and prior to the water
being placed in a bottle, with no intervening stagnant storage; or
(b)
A sample may be taken from a bottle immediately after bottling and before the
bottle leaves the plant.
(5)
Turbidity Sampling and Monitoring.
(a)
A bottled water system shall conduct turbidity sampling once every four (4) hours
the system is in operation, regardless of source. The system may substitute
continuous monitoring for grab sampling as established in 401 KAR 8:150,
Section 3(2), and may use the average turbidity value for each four (4) hour
increment to determine compliance with turbidity performance criterion in paragraph
(b) of this subsection.
(b)
The turbidity level of the system’s product water shall be less than or equal
to three-tenths (0.3) nephelometric turbidity units (NTU) in not less than
ninety-five (95) percent of the measurements taken each month, and shall never
exceed one (1) NTU.
(6)
Disinfectant Sampling and Monitoring. Monitoring for disinfectants shall occur
after disinfection but prior to bottling, with no intervening stagnant storage.
(a)
Chlorine dioxide. A bottled water system that uses chlorine dioxide shall
monitor daily for chlorine dioxide.
1.
The Maximum Residual Disinfection Level (MRDL) for chlorine dioxide shall not
exceed 0.8 mg/L.
2.
No two (2) consecutive daily samples shall exceed the MRDL for chlorine dioxide.
3.
A bottled water system shall immediately take steps to lower the level of
chlorine dioxide in finished water if the MRDL for chlorine dioxide is
exceeded.
(b)
Chlorite. A bottled water system that uses chlorine dioxide as a disinfectant
shall monitor for chlorite annually. The Maximum Residual Disinfection Level
(MRDL) for chlorite shall not exceed 1.0 mg/L.
(c)1.
Ozone. A bottled water system that uses ozone shall monitor:
a.
Monthly for bromate; or
b.
Annually for bromate if the system demonstrates that the average bromate
concentration is less than 0.0025 mg/L calculated as a running annual average of
monthly bromate samples.
2.
The Maximum Contaminant Level (MCL) for bromate shall not exceed 0.010 mg/L.
(7)
Chemical contaminants.
(a)
A bottled water system shall monitor for chemical contaminants after treatment
but before bottling, with no intervening stagnant storage.
(b)
A sample may be taken from a bottle immediately after bottling and before the
bottle leaves the plant.
(c)
A bottled water system shall monitor for chemical contaminants:
1.
Annually for inorganic and organic contaminants established in 401 KAR 8:250,
including sodium;
2.
Annually for secondary contaminants established in 401 KAR 8:600, except that a
bottled water system may exceed maximum secondary contaminant levels for
purposes of bottling mineral water or other water if:
a.
Each consumer is informed by labeling as established in 902 KAR 45:050; and
b.
The system obtains written cabinet approval after:
(i)
Submitting secondary contaminant results before and after treatment; and
(ii)
Providing justification for any exceedances;
3.
Annually for lead and copper as established in 401 KAR 8:300;
4.
Annually for total trihalomethanes and haloacetic acids established in 401 KAR
8:510; and
5.
Every four (4) years for radiological contaminants established in 401 KAR
8:550.
(d)
Exception. A bottled water system that uses as its source a public water system
as defined in 40 C.F.R. 141.2 and is subject to 401 KAR Chapter 8 may substitute
the monitoring results of the public water system to satisfy the requirements
of this subsection if the bottled water system submits a letter to the cabinet
postmarked no later than January 30 of each year stating that it shall:
1.
Use the annual results of their public water system source for that calendar
year; and
2.
Conduct monitoring established in this subsection that has not been conducted
by the public water system source.
Section
4. Failure to Comply. (1) A bottled water system that exceeds a MCL or MRDL or
otherwise fails to comply with this administrative regulation shall:
(a)
Immediately cease operations;
(b)
Notify the cabinet as established by 401 KAR 8:020, Section 2(7)(c), and the
Cabinet for Health and Family Services, Department for Public Health; and
(c)
Not resume operations without the written approval of the cabinet and the
Cabinet for Health and Family Services, Department for Public Health.
(2)
Enforcement of this administrative regulation shall be pursued for bottled
water systems in the same manner as other public water systems. (17
Ky.R. 645; eff. 11-15-1990; Am. 23 Ky.R. 2614; eff. 5-14-1997; 31 Ky.R. 211;
780; eff. 1-4-2005; 41 Ky.R. 320; 1051; eff. 12-5-2014.)
