220.127.116.11 BOTTLED WATER PROCESSING REQUIREMENTS:
A. Specific Bottled Water Processing Definitions, as used in 18.104.22.168:
(1) "adulteration" means the contamination of a bottled water product with any poisonous or deleterious material, substance, or agent that would render the bottled water injurious to health; or if the bottled water consists in part of a contaminated, filthy, impure additive or ingredient; or if the bottled water has been produced, prepared, bottled, or held under unsanitary conditions whereby it may have been rendered unwholesome or injurious to health; or if the container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health;
(2) "bottled water" means water that is from an approved source and is placed in a sealed container or package and is offered for sale for human consumption or other consumer uses:
(3) "bottled water plant" means any place or establishment in which bottled water is prepared for sale; and
(4) "water source" means water for processing bottled water which shall be from a source approved as a “ public water system” as defined and monitored under the New Mexico Drinking Water Regulations.
B. Bottled Water Processing Operational Requirements And Standards:
(1) The bottled water plant operator shall follow generally accepted Good Manufacturing Practice such as contained in 21 CFR Part 129 or the International Bottled Water Association Model Bottled Water Regulations and shall meet all the structural and equipment requirements of 22.214.171.124.A through G of this Part.
(2) Plants that bottle products through lines or equipment used for food or milk products shall demonstrate (assure) that the cleaning process prevents adulteration of the bottled water. Bottled water shall not be transported or stored in bulk tanks used for any non-food product, nor processed or bottled through equipment or lines used for any non-food product.
(3) At the time of application for a permit from the Health Authority, the following information shall be provided, in addition to that required in 126.96.36.199.B, 188.8.131.52.B,C,D,G and H:
(a) a statement describing the proposed water source(s) with a site plan where applicable;
(b) a floor plan layout of the plant with a description of major equipment items;
(c) a description of the cleaning and sanitization process for all containers and equipment and a frequency schedule;
(d) an example of each product label and a description of the batch code system to be used as required in 184.108.40.206.C.
(4) Each bottled water plant operator shall develop and maintain procedures for notification of the Health Authority , for consumer notification, and for product recall. The operator shall implement any such procedure as necessary with respect to any product for which the operator or the Health Authority knows or has reason to believe circumstances exist that may adversely affect product safety for the consumer. Each bottled water product shall exhibit a code that is designed to remain affixed to the container during use and that contains either the date of manufacture or a lot or batch number to facilitate product identification for recall.
C. Bottled Water Labeling Requirements And Batch Code Identification:
(1) All bottled water product labels shall conform to 220.127.116.11.D.
(2) The label shall not state or imply any component or health benefit which cannot be substantiated in fact. Substantiation shall be at the expense of the water bottler.
(3) For any statement on the label implying a specific type of water source, the product shall be from such a source. Terms used to describe the type of finished bottled water product shall conform to 21 CFR Section 165.110 or recognized bottled water industry standards such as the International Bottled Water Association Model Bottled Water Regulations.
(4) A statement of any treatment or type of process used for the finished product shall be included on the label.
(5) There shall be a code system to identify each batch of product, (or continuous run) as to at least date and place of bottling.
(6) Such code may appear on the container or the label but not on the closure (lid, cap).
D. Analytical Requirements:
Unless otherwise provided in this Part, samples shall be collected, prepared, and examined using the most current methods for the examination of drinking water listed in the Code of Federal Regulations (40 C.F.R. 141) or by other methods for the examination of drinking water approved by the United States Environmental Protection Agency.
Examination of samples shall be performed by a laboratory:
(1) approved by the Health Authority;
(2) certified by the United States Environmental Protection Agency (EPA);
(3) certified by the primary enforcement agency in any state that has been granted primacy by EPA; or
(4) certified or accredited by a third-party organization acceptable to a primacy state.
E. Monitoring Requirements:
(1) All water bottling plants shall be required to submit one microbiological sample per finished product per week. A copy of the microbiological analysis report shall be submitted within ten (10) working days of analysis to the Health Authority.
(a) Any coliform or fecal coliform positive result shall require the plant owner or operator to notify the Health Authority within twenty-four (24) hours and to submit a confirmation sample within twenty-four (24) hours.
(b) Compliance with the maximum contaminant level (MCL) for microbiological contamination is based on no more than one positive coliform or fecal coliform sample within twenty-four (24) hours.
(2) If required by the Secretary, initial sampling of a water source shall meet all requirements of the New Mexico Water Supply Regulations, including the following minimum requirements:
(a) Maximum contaminant levels for inorganic compounds.
(b) Maximum contaminant levels for water properties.
(c) Maximum contaminant levels for radionuclides.
(d) Maximum contaminant levels for volatile organic compounds.
(e) Maximum contaminant levels for semi-volatile organic compounds.
(3) More frequent sampling of the finished product(s) or water source shall be conducted when ordered by the Secretary in the event of possible contamination or when changes in the distribution system or treatment processing occurs which may increase the concentration of a contaminant whether listed in the regulations or not. All expenses incurred for sampling, transportation of samples, and sample analysis shall be borne by the water bottler.
(4) A bottled water supplier who knows that a primary Maximum Contaminant Level, as specified in the New Mexico Drinking Water Regulations, has been exceeded or who has reason to believe circumstances exist that may adversely affect the safety of bottled water, including but not limited to source contamination, spills, accidents, natural disasters, or breakdowns in treatment, shall notify the Health Authority within twenty-four (24) hours. F. Record Maintenance:
F. Record Maintenance:
(1) The following records shall be retained for the period of no less than five (5) years:
(a) bacteriological and chemical analyses made pursuant to this Part;
(b) copies of any written reports, correspondence, or communications relating to inspections; and
(c) records concerning any waivers granted to the facility.
(2) The following records shall be retained on the premises at all times:
(a) plans and specifications of the facility and any modification thereof; and
(b) plans and flow charts indicative of the current water bottling processing.
G. Waivers From Source Water Sampling And Testing:
A water bottling plant operator is granted a waiver from sampling a water source, if the water source is a public water supply system for which all sampling requirements outlined in the New Mexico Water Supply Regulations are being met. A water bottling plant operator may not receive a waiver from sampling finished products as required in18.104.22.168.E(1) and (3) of this Part.
[22.214.171.124 NMAC – Rp 7 NMAC 6.1. 701 to 708, 08/12/2000]