Bottled water companies must adhere to the Food and Drug Administration's Good Manufacturing Practices and Quality Standards.  These extensive federal regulations, coupled with state and industry standards, offer consumers assurance that the bottled water they purchase is highly regulated, and of the highest quality.

The International Bottled Water Association (IBWA), representing 85 percent of the bottled water produced and distributed in the United States, has been a longstanding proponent of additional federal regulations for bottled water and has been very active at all levels of local, state and federal government assisting in the development of such regulations.  IBWA members support the promulgation of these regulations because it is consistent with members' goal to assure that bottled water marketed to consumers is safe, good-tasting and of consistently high quality.

Federal Regulation

Bottled water is, like all feed except meat and poultry products, fully regulated by the United States Food and Drug Administration ("FDA").  In fact, in addition to FDA's general food requirements, bottled water is one of only several food product categories that have additional extensive and specific FDA requirements that must be met.  These federal requirements include

• Full application of far-reaching food adulteration and misbranding provisions of federal law;
• Full application of FDA's general food Good Manufacturing Practices ("GMP") regulations;
• Full application of FDA's standard of quality for bottled water; and
• Full application of both civil and criminal penalties for non-compliance with all the above-mentioned FDA requirements.

General Food GMPs

The general GMPs application to foods, including bottled water, contain rules governing:

1.      plant and ground maintenance, including drainage and waste disposal requirements;

2.      plant construction and design;

3.      sanitary maintenance of buildings and fixtures;

4.      sanitary facilities including water supply, plumbing, sewage disposal, etc;

5.      design and maintenance of equipment and utensils;

6.      productions and process controls of raw materials and manufacturing

7.      operations, including sanitation and quality control of receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging and storage of food; and

8.      defect action levels.

Failure to comply with these regulations may render the bottled water product adulterated and subject to regulatory action.

Bottled Water GMPs

The GMPs specific to bottled water processing and bottling rules governing:

1. plant construction and design, including separation of the bottling room, protection of processing operations, adequate ventilation, and enclosure of washing and sanitizing operations:

2. sanitary facilities, including

• approved sources of both product water and operations water;
• minimum once a year analysis of source water for chemical contaminants;
• analysis once every four years of source water for radiological contaminants;
• once a week sampling and analysis of source water for microbiological contaminants;
• use of approved test and sample methods;
• control air under pressure; and
• separation and maintenance of locker and lunch room areas.

3. sanitary operations, including
• adequate sanitation of all product water-contact surfaces;
• adequate drainage and protection from contamination of multi-service containers, utensils, disassembled piping and equipment;
• protection of single containers, caps and seals;
• sanitary filling, capping, closing, sealing and packaging of containers;

4. equipment design and construction, including materials of construction;

5. production and process controls specific to the production and processing of bottled drinking water, including

• sampling and inspection of containers and closures;
• product and sample analysis
• bacteriological analysis once a week of each type of water produced during a day's production;
• chemical physical and radiological analysis at least annually of a representative sample from a batch or segment of a continuous production run off each type of water produced during a day's production;

6. Recordingkeeping

• Maintenance and retention of records of product sample analysis;
• Maintenance of retention of source approvals;
• Maintenance and retention of other GMP records;
• Availability of required records for official review.

Failure to comply with these requirements may render the bottled water product adulterated and subject to regulatory action.

Bottled Water Standard of Quality

Bottled water manufacturers must also ensure that their products meet a federally mandated standard of quality.  This standard of quality contains a wide array of acceptable levels for substances in bottled water.  This regulation includes levels related to microbiological quality, such as the limit on the number of coliform organisms, chemical contaminants, physical quality, such as turgidity, color, and odor; chemical quality, such as the limit on iron; and radiological quality.

As discussed above, the bottled water GMP regulations also set forth appropriate testing methodology and testing timeframes to determine compliance with the standard.  Bacteriological analysis of product samples must be done once a week for each type of water produced during a day's production.  Chemical, physical and radiological analysis must be done at least annually by a representative sample from a batch or segment of a continuous production run for each type of water produced during a day's production.  Bottled water plants must retain all GMP records as well as government approvals of source water for at least 2 years, and make these documents available for official review.

In 1994, IBWA welcomed the release of the FDA's quality standards for lead and copper.  In the case of lead, the FDA established of allowable level of .005 milligrams per liter (mg/L).  By contrast, the current EPA drinking water action level for lead is .015 mg/L.

In December 1994, the FDA added quality standards to those already in place for bottled water.  The regulations set standards for acceptable safe levels of 35 chemicals, including 9 organic chemicals and 26 synthetic chemicals.  IBWA members had already been meeting or exceeding these new standards because members are required to test for the chemicals as part of IBWA's Quality Assurance Program.  The federal regulations affect all bottled water companies, whether they are members of IBWA or not.

For all of the requirements discussed above, non-compliance by a company presents the risk that FDA will take enforcement actions described here.  As with the entire food industry, FDA randomly inspects bottled water facilities.  FDA may inspect any food manufacturing facility, including a bottled water plant.

State Regulation

In addition to FDA's extensive regulatory requirements, the bottled water industry is subject to state regulatory requirements as well.  A significant responsibility of the states is inspecting, sampling, analyzing and approving sources of water.  Under the federal GMP's only approved sources of water can be used to supply a bottling plant.  Another area in which some states have important responsibilities that complement federal regulation is the certification of testing laboratories.  As with any food establishment, the states perform unannounced spot inspections, and some states perform annual inspection.

Industry Regulation

The bottled water industry routinely employs additional measures to further the protection of its product beginning with the source on through to packaging.  One such measure is the facility audits.  International Bottled Water Association ("IBWA") bottler members are required to undergo an annual, unannounced plant inspection.  These inspections are conducted by an outside third-party organization and assess compliance with all applicable regulations.  IBWA currently contracts the services of NSF International to perform these comprehensive audits.  The major areas covered are:

            Plant Construction and Design

                        Addresses building construction, equipment storage, lighting, ventilation,                                sealed systems, room design and piping.

            Sanitary Facilities and Controls

Covers approved sources (including analysis), suitable plumbing, floor drainage, adequate toilet and hand-washing facilities, operations water and other aspects of general sanitary facilities.

            Sanitary Operations

Includes product water contact surfaces, handling of multi-service containers, finished product packaging, cleaning operations, and storage of packaging materials.

            Equipment and Procedures

Evaluates proper use of equipment intended for processing (to the preclusion of product adulteration), documentation of product contact surfaces compliance, storage tank maintenance, designs to preclude operations/product water commingling, and dispensing equipment refurbishing.

            Processes and Controls

Reviews record handling procedures, sampling techniques separation of defective containers, records of equipment inspections and in-house quality control testing, records of finished product testing and all other record keeping requirements.

            Personnel

                        Inspects overall plant personnel sanitation practices.

Clearly, bottled water is fully regulated, at the federal, state and industry levels.  There are extensive and specific FDA requirements that must be met.  Failure to comply will subject the manufacturer and/or product to regulatory action.  There are state requirements that must be met and there are self-imposed industry requirements.  All of these combine to ensure that bottled water remains a highly quality product.

European Economic Community

All European exporters must meet the federal and state standards as applicable.  They must also meet strict standards set by the European Economic Community.  International bottler members that sell products in the U.S. must submit a certificate of inspection to IBWA.

Prepared by:  Patton Boggs, LLP, Washington, DC

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