(A) Sampling and Testing Procedures.

1. (1) Source Water. 105 CMR 500.093(A)(1) applies to both bottled water and carbonated non-alcoholic beverages, except that 500.093(A)(1)(d) applies only to bottled water.

   1. (a) The raw water from the source shall be sampled immediately after it is withdrawn from the source, and analyzed to characterize its microbiological, physical, radiological, and chemical quality. If any of the analyses show the water not to be in compliance with the quality requirements specified in 105 CMR 500.092(A), the water shall be treated to meet the requirements of 105 CMR 500.092(A) and shall be tested after treatment. Sampling and analysis shall be performed as often as necessary, but at a minimum frequency of:

      1. 1. Once each year for chemical and physical contaminants;
      2. 2. Once every four years for radiological contaminants, or as otherwise specified by the Department; and
      3. 3. Once each week for microbiological contaminants.
   2. (b) All analyses shall be conducted by an approved water-testing laboratory in accordance with the testing and methodological requirements specified by EPA's National Primary and Secondary Drinking Water Regulations (40 CFR Parts 141 and 143).
   3. (c) Facilities that use a public water system for source water, without treatment or with only minimal treatment, may satisfy the testing requirements of 105 CMR 500.093(A)(1)(a) and (b) by substituting public water system testing results, or copies of certificates showing full compliance with relevant provisions of the EPA regulations in 40 CFR Parts 141: National Primary Drinking Water Regulations and 143: National Secondary Drinking Water Regulations. Any additional treatment of the source water from a public water system beyond the definition of minimal treatment, i.e., beyond mechanical filtration and/or disinfection, shall require source water analysis pursuant to 105 CMR 500.093(A)(1)(a) and (b); and for bottled water only, submission of results pursuant to 105 CMR 500.093(A)(1)(d).

   4. (d) Bottled Water Only: Each facility shall submit a signed copy of the results from the approved water-testing laboratory of all analyses of its source water as specified in 105 CMR 500.093(A)(1)(a) and (b), or copies of certificates as allowed by 105 CMR 500.093(A)(1)(c), to the Department at the same time as it submits its initial application for a license, and annually thereafter, as follows:

      1. 1. Testing for chemical and physical contaminants performed within the preceding 12 months;
      2. 2. Testing for radiological contaminants performed within the preceding 12 months, for any year in which radiological testing is required; and
      3. 3. Testing for microbiological contaminants performed within the preceding four weeks.

2. (2) Finished Products: Bottled Water

   1. (a) Samples of each type of finished bottled water product produced shall be taken by the facility and analyzed by an approved water-testing laboratory in the manner and frequency specified in 21 CFR § 129.80: Processes and Controls, and consistent with “Quality Standards for Bottled Water”, Massachusetts Department of Public Health, Food Protection Program.
   2. (b) In addition, if any flavor or color is added to the product during the manufacturing process, a representative sample shall be taken immediately prior to the addition of such flavor or color, at the frequency specified in 21 CFR § 129.80: Processes and Controls, and the sample shall be analyzed by an approved water-testing laboratory in the manner and frequency specified in 21 CFR § 129.80.
   3. (c) The methods of analysis shall be any method approved by FDA.

   4. (d) The facility shall submit a signed copy of the results from the approved water- testing laboratory of the analyses of its finished products performed in accordance with 105 CMR 500.093(A)(2)(a) through (c) to the Department. Such results shall be submitted at the same time as it submits its initial application for a license, and annually thereafter, as follows:

      1. 1. Testing for chemical, physical, and radiological contaminants performed within the preceding 12 months; and
      2. 2. Testing for microbiological contaminants performed within the preceding four weeks.

3. (3) Finished Products: Carbonated Non-alcoholic Beverages

   1. (a) Samples of each type of finished carbonated non-alcoholic beverage product shall be taken and analyzed as frequently as necessary to ensure that no product is adulterated.
   2. (b) Routine test results need not be submitted to the Department, but all results shall be maintained by the facility as required by 105 CMR 500.093(D).

(B) Additional Testing of Bottled Water and Carbonated Non-alcoholic Beverages.

1. (1) Notwithstanding any other provisions of 105 CMR 500.000, the Department may require any bottler of bottled water or carbonated non-alcoholic beverages or any applicant for a license to:

   1. (a) Test and submit results to the Department for any substance at any time when the Department has reason to believe that the substance may be present in a water source used by the bottler or in a finished product and may threaten public health, or
   2. (b) Make an assessment of the ongoing potential for contamination of a water source used by the bottler.

2. (2) Whenever a bottler or license applicant has reason to believe that a substance may be present in a water source or in a finished product and may threaten public health, the bottler or license applicant shall:

   1. (a) Notify the Department within 24 hours;
   2. (b) Test the source water or finished product for the substance at a frequency deter­ mined by the Department;
   3. (c) Submit all test results to the Department, and direct the laboratory conducting the testing to submit all test results to the Department, within 24 hours of obtaining the test results; and
   4. (d) Follow the Department's instructions as to whether and under what conditions bottling operations may continue until the problem is resolved.

(C) Unexpected Noncompliance with Quality Standards: Bottled Water or Carbonated Non­ alcoholic Beverages.

1. (1) In-state Facilities.

   1. (a) Source Water. When an in-state facility receives any test result indicating that its water source is not in compliance with any Maximum Contaminant Level listed in 310 CMR 22.00: Drinking Water, or with any other Maximum Contaminant Level promulgated by EPA and in effect, it shall:

      1. 1. Notify the Department within 24 hours;
      2. 2. Test the source water at a frequency determined by the Department;
      3. 3. Submit all test results to the Department, and direct the laboratory conducting the testing to submit all test results to the Department, within 24 hours of obtaining the test results; and
      4. 4. Follow the Department's instructions as to whether and under what conditions bottling operations may continue until the problem is resolved.

   2. (b) Finished Products: Bottled Water. When an in-state facility receives any confirmed test result indicating that any of its finished products are not in compliance with any standard of quality in 21 CFR § 165.110(b), it shall:

      1. 1. Immediately cease all operations until the Department determines that the finished product is in compliance with all applicable quality standards;
      2. 2. Notify the Department within 24 hours;
      3. 3. Conduct appropriate tests at a frequency determined by the Department; and
      4. 4. Submit all test results to the Department, and direct any laboratory conducting the testing to submit all test results to the Department, within 24 hours of obtaining the test results.
2. (2) Out-of-state Facilities: Bottled Water. When an out-of-state facility receives any confirmed test result indicating that any of its finished products are not in compliance with any standard of quality in 21 CFR § 165.110(b), it shall notify the Department within 24 hours.