401 Kar 8:700. Bottled Water

Link to law: http://www.lrc.ky.gov/kar/401/008/700.htm
Published: 2015

      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.)
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