N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 5-6.16

Current through Register Vol. 46, No. 45, November 2, 2024

Section 5-6.16 - Certification procedures

All bottled or bulk water products sold or distributed in New York State must be certified. The following procedures must be met to apply for certification:

(a) Any person applying for bottled water certification shall, at a minimum, meet the requirements listed below:

(1) Complete and submit a signed application form, GEN 222 Application for Certification of Approval for Distribution of Bottled or Bulk Water.

(2) Submit a statement from the appropriate regulatory agency of the state or country having jurisdiction over the bottling operation, indicating that the facility has been approved to bottle or package water for human consumption. This approval may be a copy of a certificate, license, permit or a letter of approval from the agency. A copy of the laws and regulations on bottled water processing from the regulatory agency having jurisdiction must also be submitted. When another state or country has no program for inspection and approval of bulk or bottled water facilities, the commissioner may make a determination based on an inspection and evaluation by an independent individual or organization knowledgeable in bulk or bottled water handling practices.

(3) Submit an engineering report, plans and specifications for the proposal prepared by a registered professional engineer licensed to practice in New York State or in the state which the facility is located. This submittal must include, but not be limited to, the development of the source, methods used in the bottling operation, the water treatment used and laboratory control of water quality provided and a flow diagram from source through the bottling operation. The report submitted with the application must show compliance with the requirements of this Subpart.

(4) Submit two caps and two labels for each container size of the bottled water product that is to be certified.

(5) Submit complete inorganic chemical, organic chemical, microbiological and radiological analyses for contaminants listed in section 5-6.11 of this Subpart for each source and each finished bottled water product type be distributed in New York State. Results of these analyses must be submitted with the application. Additional analyses may be required, if in the judgment of the commissioner they are needed to determine the acceptability of the source or treatment provided. All analyses must be performed by an approved laboratory and in accordance with the sampling methods as outlined in section 5-6.13 of this Subpart. All analyses must have been performed within the last six months from the date of the application for certification except for the microbiological analyses which must have been performed within 30 days from the date of the application for certification.

(6) Submit a list of names, addresses and telephone numbers of those who are now or are expected to be distributing the product in New York State.

(7) Submit a recall plan in accordance with the requirements as outlined in section 5-6.7 of this Subpart.

(b) Any person applying for a maximum contaminant level exemption of a bottled water product shall, at a minimum, meet the requirements listed below:

(1) An exemption request must be submitted with the above certification data for each chemical or radiological contaminant that exceeds the MCL. No exemption will be given for microbiological or organic chemical MCLs.

(2) The request must include documentation that the 'contaminant exceeding the MCL will not constitute an unreasonable health risk. The documentation must include:

(i) the identification of the contaminant or contaminants exceeding the MCL;

(ii) the concentration level in milligrams per liter of the contaminant, including the maximum, minimum and average value found in the product;

(iii) the target consumer group;

(iv) the consumption pattern in milliliters per day of the consumers based on estimated or actual market surveys; and

(v) the health significance of the higher contaminant concentration level;

(c) Any person applying for bulk water certification shall, at a minimum, meet the requirements listed below:

(1) Complete and submit a signed application form, GEN 222 Application for Certification of Approval for Distribution of Bottled or Bulk Water.

(2) Submit a statement from the appropriate regulatory agency of the State having jurisdiction over the bulk water operation indicating that an inspection of the water source, transporting vehicles and sanitation procedures has been made and is in conformance with the appropriate minimum standards as outlined in this Subpart. When another state has no program for inspection and approval of bulk water operators, the commissioner may make a determination based on an inspection and evaluation by an independent individual or organization knowledgeable in bulk water handling practices.

(3) Submit a report that includes the procedures used in the sanitizing of the tank interior, the name and location of the source water, source treatment, other uses of the tank truck, frequency and type of water quality analyses performed, quantities and frequencies of shipments, primary use of potable water shipped and loading and unloading procedures.

(4) Submit complete inorganic chemical, organic chemical, microbiological and radiological analyses of contaminants as listed in section 5-6.11 of this Subpart for each source to be used. Results of these analyses must be submitted with the application. Additional analyses may be required if, in the judgment of the commissioner, they are needed to determine the acceptability of the source or treatment provided. All analyses must be performed in accordance with the sampling methods as outlined in section 5-6.13 of this Subpart. All analyses must have been performed within the last six months from the date of the application for certification, except for the microbiological analyses which must have been performed within 30 days from the date of the application for certification.

(d) The following conditions must be met to maintain certification approval:

(1) Each year, a statement must be submitted from the appropriate regulatory agency of the state or country having jurisdiction over the bottling facility indicating that the facility has been inspected and approved to bottle or package water for human consumption.

(2) Each month, a form, GEN 221 Report on Bottled Water Operation, must be completed and submitted no later than the 10th of the month following the month of the reporting period. The microbiological sample results on source and finished products must conform to the requirements of sections 5-6.10, 5-6.11 and 5-6.13 of this Subpart. Results of each analysis must be entered on the GEN 221 opposite the date the sample was collected. The quantity of water shipped for distribution in New York State must be entered on the GEN 221 in the daily product column opposite the date of actual shipment.

(3) The required organic chemical, inorganic chemical and radiological analyses on the source and finished water product, must be completed for the calendar year as required in section 5-6.11 of this Subpart.

(4) Any interruption or change in the operation or treatment, or a change of source shall be reported immediately to the State. Submission of plans or an engineering report may be required.

(5) All exemption reqests must be submitted by July 1st for the calendar year. The required annual water quality monitoring data will be reviewed along with any other available data. Besides the submission of data for maintaining approval, the data as outlined in subdivision (b) of this section, must also be submitted.

N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 5-6.16