Current through Register Vol. 50, No. 9, March 1, 2024
RELATES TO:
KRS
224.10-100,
224.10-110,
21 C.F.R.
129.35,
165.110
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.
STATUTORY AUTHORITY:
KRS
224.10-100,
224.10-110