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food and drug branch (fdb)

Food Safety Program

ā€‹Retail Water Facility Inspection Procedures and Operating Requirements

California Health and Safety Code (H&SC) Section 111120 requires operators of retail water facilities in California to obtain a Retail Water Facility License issued by the California Department of Public Health, Food and Drug Branch (FDB). A retail water facility (RWF) means any commercial establishment where vended water is sold, and placed in customerā€™s containers, or placed in containers sold or given to customers who come to the establishment to obtain water.

FDB will perform a pre-licensing inspection of your facility to ensure readiness to operate. Once licensed, periodic on-site inspections are conducted to assess compliance with applicable State and Federal laws and regulations. The inspection will include a review of your water quality test results; a review of your equipment maintenance and sanitation records; an on-site inspection of your equipment, labeling, processing, and sanitation operations.

Water Quality Test Results

FDB will review your source water and vended water quality test results during on-site inspections. Source water means water supplied to your facility for processing. Vended or product water refers to the water that has been processed and dispensed at your facility. Water quality test results must be maintained at the RWF and available for review upon request. All testing must be conducted by a certified laboratory.ā€‹

ā€‹ā€‹ā€‹Source water quality testing requirement:

  • Retail water facilities that use a municipal/public water system are exempt from the source water testing requirement; however retail water facilities that do not conduct source water testing must still provide source water quality information. Retail water facilities operators may provide public water system testing results to meet this requirement. Contact your source water supplier for information on how to obtain the water system quality testing results, often referred to as the Annual Water Quality Report, or Consumer Confidence Report.
  • Retail water facilities that use a private water source are subject to additional testing requirements pursuant to H&SC 111080.

Vended (Product) water quality testing requirement:

  • You are required to perform the analyses shown below using a certified laboratory.ā€‹

    ā€‹Type of Analysisā€‹

    ā€‹Testing Requirement

    ā€‹ā€‹Bacteriological, Coliform organisms

    ā€‹Must be conducted every 6 months

    ā€‹Volatile Organic Chemicals (VOCs), including TTHMā€™s

    ā€‹Must be conducted by New RWF operators and as required by FDB*

    ā€‹Lead

    ā€‹ā€‹Must be conducted by new RWF operators and as required by FDB*


* If you change your water treatment process, or replace any water treatment or major equipment, you will be required by FDB to retest your product water for VOCā€™s and Lead prior the renewal of your RWF license.

  • Water sold as Purified water must not exceed 10 mg/L total dissolved solids (TDS); and the operator must monitor the TDS weekly. Weekly TDS monitoring may be conducted by the operator using a handheld conductivity meter. If your vended water is sold/labeled as ā€œPure water,ā€ ā€œAgua pura,ā€ or any similar name that implies the water is purified, it is considered Purified water and must meet the TDS allowable limit and monitoring requirement.
  • You are required to review your water quality analysis results to ensure that your water treatment is effective.

All testing must be conducted by a laboratory certified by the California Environmental Laboratory Accreditation Program (ELAP) or the United States Environmental Protection Agency (USEPA).ā€‹

Equipment and Materials

The RWF equipment must comply with the following standards of design, construction and sanitation.

  • ā€‹Permit easy cleaning and maintenance of all exterior and interior surfaces.
  • Have water contact surfaces that are non-toxic, corrosive-resistant, and non- absorbent.
  • Be constructed of water contact surface materials capable of withstanding repeated cleaning and sanitizing treatments.
  • Have a recessed, or guarded corrosion-resistant dispensing spouts.
  • Have storage tanks that can be closed to exclude all foreign matter and are adequately vented.
  • Have an effective system of handling drip, spillage, and overflow of water.
  • Have a backflow prevention device approved by the department for all connections with the water supply.
  • Dispense water disinfected by ultraviolet light or other method approved by the department prior to delivery into the customerā€™ s container.
  • Be equipped with shutdown devices to be used whenever the disinfection unit fails to function.
  • Be equipped with shutdown devices to be used whenever the TDS content exceeds 10mg/L (for Purified water only).
  • Comply with the American Water Works Association (AWWA) specifications for granular activated carbon.
  • Be maintained in a clean and sanitary condition, free from dirt and vermin.
  • Use a state approved and regulated public water supply or private water source.

ā€‹All equipment and materials used to process and vend water must be suitable for their intended use. You must have specification documents to demonstrate that the following equipment is constructed of appropriate materials and suitable for their intended use.

  • Water treatment process equipment (reverse osmosis unit, granulated activated carbon, filters, deionization unit, etc.)
  • Major equipment (storage tank, pump, backflow prevention device, piping, fittings, etc.).
  • Disinfection unit (as applicable)
    • Ultraviolet disinfection unit (UV dosage of 16,000 Ī¼W-sec/cm2).
    • Ozonator disinfection unit. (0.1 ppm ozone. 5min. contact).

ā€‹ā€‹RWF operators are required to perform maintenance on equipment as frequently as necessary to protect against contamination of vended water and maintain records of the maintenance. Records must be kept for at least two years and copies must be provided to FDB upon request. RWF must maintain the following types of records:

  • A record of physical inspections of equipment. At a minimum, the record must include type of inspection, date of inspection, conditions found, and the performance and effectiveness of such equipment. ā€‹
  • A record of the performance of cleaning and sanitizing solutions. The record should include the date of the performance check, the name of the solutions, and the performance rating.
  • A record of the intensity of the sanitizing agent and the time duration that the agent was in contact with the surface being sanitized. The record should include the date of the activity, the name of the equipment and type f surface being sanitized, the name of the sanitizer, the intensity measurement of the sanitizer, and the sanitizer contact time.

Processing and Sanitary Operations

Any person who processes or vends water must comply with the good manufacturing practices found in Title 21 CFR, Part 129.

  1. All water contact surfaces must be adequately maintained and cleaned as often as necessary to be kept free of scale, evidence of oxidation, or other residue.
  2. All water contact surfaces and any other critical areas must be adequately sanitized after cleaning.
  3. All treatment of product water by reverse osmosis, distillation, ion-exchanging, filtration, ultraviolet treatment, ozonation, or any other process must be done in a manner so as to be effective in accomplishing its intended purpose. All equipment such as membrane, sediment, and carbon filters, resin tanks, and UV light tubes must be inspected, serviced, or replaced as often as necessary for the intended treatment to remain effective.

ā€‹Labels, Advertising, and Promotional Materialsā€‹

If a product designation other than ā€œdrinking waterā€ (e.g., ā€œpurified,ā€ ā€œspring,ā€ ā€œmineralā€) is used on the label or labeling, the water must meet the definition for the terms as specified in H&SC Section 111175 and 21 CFR 165.110(a)(vi).

The information below is required to be displayed in a location that is clearly visible to customers. It must be displayed in both English and Spanish.

  1. ā€‹The name and address of the operator.
  2. The fact that the water is obtained from an approved public water supply or licensed private water source.
  3. A statement describing the treatment process used.
  4. If no treatment process is utilized, a statement to that effect.
  5. A toll-free telephone number or a local telephone number within the area code in which the machine is located that may be called for further information, service, or complaints.
  6. The toll-free telephone number, 1(800) 495-3232, of the departmentā€™s food and drug branch that may be called for complaints or questions.

ā€‹

Food and Drug Branch

1-800-495-3232

FDBfood@cdph.ca.govā€‹

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