Sep 26, 2005

Bottled Water: Overview of Federal & State Regulations

Overview of federal, state regulations and industry standards

Bottled water continues to be the fastest-growing product in the beverage category. Whether it is sold in small retail packages, or in larger bottles used in the home and office delivery business, consumers continue to make bottled water their beverage of choice.

The International Bottled Water Association (IBWA) is the authoritative source of information about all types of bottled waters. IBWA’s membership includes U.S. and international bottlers, distributors and suppliers. IBWA works with the U.S. Food and Drug Administration (FDA), which regulates bottled water as a packaged food product, and state governments to set stringent standards for safe, high quality bottled water products.

Statistics by Beverage Marketing Corporation show that U.S. bottled water sales and consumption continue to rise. This upward trend was reflected in 2004 bottled water volume of nearly 6.8 billion gal., an 8.6% increase over 2003, and a 2004 bottled water per capita consumption level of 23.8 gal, compared to 22.1 gal per capita the previous year. These statistics demonstrate continued consumer demand and appreciation for the convenience and good taste of bottled water brands consumed on-the-go.

Bottled water safety and quality result from multiple layers of regulation and standards at the federal, state and industry levels.

Federal Regulation
Bottled water is fully regulated as a food product for safety, quality, production, labeling and identity by the FDA under the Federal Food, Drug and Cosmetic Act (FFDCA) and several sections of Title 21 of the Code of Federal Regulations (CFR).

Standard of Identity. 21 CFR § 165, provides uniform definitions for the following bottled water classifications: bottled, drinking, artesian, ground, distilled, deionized, RO, mineral, purified, sparkling, spring, sterile and well. A bottled water product must bear the appropriate name on its label as reflected in the applicable Standard of Identity definition or it may be deemed misbranded under the FFDCA.

Standard of Quality. 21 CFR § 165 also contains the Standard of Quality for bottled water. This regulation establishes limits for microbiological, physical, chemical and radiological substances for both source water and finished bottled water products. Federal testing frequency and parameters are specified in 21 CFR, Part 129, as part of the Good Manufacturing Practices (GMP) for bottled water. Bottled water is one of the few food products with its own specific GMPs whose regulations address numerous issues for all food production facilities including plant construction and design, sanitary facilities and the design and maintenance of equipment. FDA has established standards for more than 75 substances pursuant to the Standard of Quality for bottled water.

The Hammer Provision of 1996, 21 USC § 349. The Hammer Provision of the FFDCA provides that the Secretary of Health and Human Services shall consult with the Administrator of the EPA in regard to any EPA-proposed changes to the national primary drinking water regulations for public water supplies. Within 180 days of the effective date of such regulations, the Secretary must either promulgate amendments to the regulations applicable to bottled drinking water or publish in the Federal Register reasons for not making such amendments. By law, standards of quality issued for bottled water by FDA must be at least as stringent as those adopted by EPA for tap water.

Being a packaged food product, bottled water is also bound by the Nutrition Labeling Education Act, amendments to the Federal Food, Drug and Cosmetic Act and the full range of FDA protective measures including misbranding; adulteration; FDA enforcement, which includes warning letters, civil (seizure and/or injunction) and criminal penalties; and GMPs designed to enforce product safety and protect consumers. The FFDCA also requires packaged food products to disclose the exact nutritional content of the product by way of a uniform “nutrition facts” panel. For bottled water, the obligation to provide nutrition information arises when an express or implied nutritional claim is made [21 USC § 343 (g)]. Nutritional labeling is also required when nutritional ingredients are added. The essential nutrients and the order in which they must appear are: total calories, calories from fat, total fat, saturated fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium and iron.

State Regulation
State governments may use one of the following approaches in their regulation of bottled water:

Federal/FDA Model. Under the Federal/FDA Model, used in the majority of states, bottled water is treated solely as a food product and subject to the FDA’s extensive food safety and labeling requirements. Bottled water is treated in the same manner as all other packaged food products by the state and, therefore, is subject to the same requirements. Bottled water also may be required to meet certain state-specific labeling and/or quality standards. IBWA supports FDA standards of identity and labeling of bottled water and the need to harmonize the state law with these federal requirements.

Environmental Model. Under the Environmental Model, bottled water is regulated by a particular state’s environmental protection or natural resources department, comparable to that of the EPA. This model, used to some degree in six states, begins at the source of withdrawal and usually includes inspection, sampling, analysis and approval of water sources. With-drawals are generally treated in the same manner as public water sources, thus subject to state regulations similar to the Safe Drinking Water Act, 42 USC 300(f).

Combination. In a majority of states, bottled water is regulated in a manner combining the Federal/FDA and Environmental models. The withdrawal of water at the source is regulated by an EPA-type agency while once packaged, it is then treated like a traditional food product and regulated accordingly. Some states also take responsibility in the certification of testing laboratories. Unannounced inspections are among the steps that some states take to ensure quality in the testing process.

Industry Standards
The bottled water industry also employs additional measures to help ensure product safety and quality beginning with the source on through to packaging. Bottler members of the IBWA must adhere to the IBWA Model Code, which in some cases, is more stringent than FDA, EPA or state regulations, and requires members to undergo an annual, unannounced plant inspection. These inspections are conducted by an independent third-party organization and assess compliance with all applicable regulations. The major areas covered by the IBWA annual inspections are: plant construction and design; sanitary facilities and controls; sanitary operations, equipment and procedures; process and controls; and personnel. As part of the IBWA Model Code, IBWA members voluntarily utilize the principles of Hazard Analysis and Critical Control Point (HACCP) for a science-based approach to bottled water production and safety. FDA recognizes HACCP as a key component of food safety and consumer protection. bw


About the author

Stephen Kay is vice president of communications for IBWA, Alexandria, Va. He can be reached at 800.928.3711;