Bottled Water Regulations

Questions & Answers

I. Regulations

  1. How is bottled water regulated?

Bottled water is a highly regulated product, subject to federal, state and industry standards. The U.S. Food and Drug Administration (FDA), under the Federal Food, Drug and Cosmetic Act (FFDCA or the Act), regulates bottled water as a food product. This includes packaged water sold in smaller containers at retail outlets as well as larger five-gallon containers distributed to the home and office market. Like all food products except meat and poultry (which are regulated by USDA), bottled water is subject to FDA’s extensive food safety and labeling requirements, which include:

 
  • Food adulteration and misbranding provisions;
  • Nutritional labeling provisions;
  • General Good Manufacturing Practices (GMPs);
  • Bottled water GMPs;
  • Bottled water standard of identity; and
  • Bottled water standard of quality, which is as stringent as the U.S. Environmental Protection Agency’s (EPA) standards for public water supplies.

The bottled water industry is further regulated on two additional levels: state standards and trade association standards for International Bottled Water Association (IBWA) members. In addition, all bottled water products imported from countries outside of the U.S. must meet the standards established by their own country as well as comply with all of the U.S. regulations.
  1. What regulations do states impose on the bottled water industry?
    2.

In addition to FDA’s extensive regulatory requirements, the bottled water industry is subject to state regulatory requirements as well. Although some state regulations are more comprehensive than others are, most state regulations either reference federal standards or are analogous to them.

Inspections: A significant responsibility of the state is inspecting, sampling, analyzing and approving sources of water. All of the states have the authority to inspect and review a bottlers’ operations and record keeping. To get a source approved, a bottler needs to have it inspected, and the water needs to be sampled and analyzed to ensure that it is safe to drink. This is a federal requirement under the FDA’s GMPs, which is implemented by an appropriate state agency. Under the federal GMPs, only approved sources of water can be used to supply a bottling plant.

Laboratory Certification: Another area in which some states have important responsibilities that complement federal regulations is the certification of testing laboratories. As with any food laboratory, the states can perform unannounced inspections of bottled water testing laboratories, and some states perform these annually.
  1. When was the bottled water industry first regulated?
    2.

    Since 1938, the FDA has regulated bottled water as a packaged food under the Federal Food, Drug and Cosmetic Act (FFDCA). As a food product, bottled water must be packaged in sealed, sanitary containers. The U.S. Environmental Protection Agency (EPA) has regulated the quality of public water supplies (tap water) delivered to consumers by their local utilities since 1974. By law, FDA regulations for bottled water must be no less stringent than the EPA’s regulations for tap water.

    It is the Good Manufacturing Practices (GMPs) that ensure the safety of all bottled water products from production to packaging to consumption. GMPs were mandated by law under the 1962 Kefauver-Harris Drug Amendments. Some GMPs, which are specific to bottled water processing and bottling, address plant construction and design; sanitary facilities; sanitary operations; equipment design and construction; production and process controls; and record keeping. Bottled water is one of only five food products that have GMPs above what is required of all foods.

    In compliance with the FDA’s standard of quality regulation established in 1974, bottled water manufacturers are also required to ensure that their products adhere to the allowable levels for substances in bottled water, such as those for coliform and lead. This regulation includes levels related to microbiological quality, such as the limit on the number of coliform organisms; physical quality, such as turbidity, color and odor; chemical quality, such as the limits on organic and inorganic chemicals; and radiological quality, such as the limit on radium 226.

    Bottled water manufacturers also must ensure that their products meet the FDA established standard of identity for bottled water products, which was established in 1996. A bottled water product bearing a particular statement of identity, for example "mineral water," must meet the particular requirements of the standard of identity for mineral water to avoid being misbranded. There are definitions for bottled water, drinking water, artesian water, ground water, distilled water, deionized water, mineral water, reverse osmosis water, purified water, sparkling bottled water, spring water, sterile water and well water. If a bottled water is misbranded, it is subject to recall.

  1. Do bottled water and tap water differ in terms of safety and quality regulations?
    2.

The FDA regulates bottled water as a food product and the EPA regulates the quality of public water supplies (tap water) as a utility. To ensure that bottled water is regulated in a manner similar to tap water, the FDA must review all new regulations for tap water to determine if they are applicable to bottled water. If the regulations are applicable, FDA must propose comparable regulations for bottled water within a specified period of time.
  1. How is bottled water different from tap water?
    2.

Consistent quality and taste are two of the principal differences between bottled water and tap water.

While bottled water originates from protected sources (75 percent from underground aquifers and springs), tap water comes mostly from rivers and lakes. Another factor to consider is the distance tap water must travel and what it goes through before it reaches the tap. In compliance with FDA regulations, bottled water is sealed and packaged in sanitary containers.  In the unlikely chance a bottled water product is found to be substandard, it can be recalled. Tap water cannot.
  1. If bottled water is from a municipal source, does the source have to be indicated on the label?

According to FDA regulations, when the source for bottled water comes from a community water system the product label must state that the bottled water is "from a community water system" or "from a municipal source."

However, if the water is subject to distillation, deionization or reverse osmosis, the bottled water product can be legally defined as purified water, demineralized water, deionized water, distilled water or reverse osmosis drinking water and does not have to state on its label that it is "from a community water system" or "from a municipal source." Processing methods such as reverse osmosis remove most chemical and microbiological contaminants.

Only 25 percent of bottled water comes from municipal sources. The remaining 75 percent of bottled water sold in the U.S. comes from natural underground sources, which include springs and wells.

 

II.  FDA Compliance Tests for Bottlers

  1. How frequently is the water tested?
    2.

    In compliance with FDA regulations, bottlers must submit water samples, to either in-house or outside testing labs, to be analyzed for physical, chemical and radiological parameters on an annual basis. For many of the analyses, such as those for inorganic chemicals, an annual schedule is more frequent than what the EPA requires for tap water. Bottlers test their water annually for some pesticides and other synthetic organic compounds (SOCs) and volatile organic compounds (VOCs). Bottlers may apply for and receive waivers based upon past test results, reducing the frequency of testing.

    Bottlers must also test for the presence of bacteria at least weekly for each of their water products for all of the available packaging sizes. Many bottlers have in-house quality control laboratories that conduct a number of on-site tests that include an examination of daily bacteriological analysis, basic physical or chemical parameters, total dissolved solids, pH, turbidity, color and conductivity that may impact the taste of the water. In addition, every bottler must keep the results of their current testing data, which the FDA could ask for at any time.
  1. What is the water tested for?

On an annual basis, bottlers must also analyze finished product samples for the following:

  • Inorganic contaminants (including pH, nitrate, chloride, fluoride, total dissolved solids)
  • Trace metals
  • Minerals (including nickel, mercury and silver)
  • Volatile organic compounds (VOCs)
  • Pesticides and PCBs
  • Herbicides
  • Synthetic organic compounds (SOCs)
  • Gross alpha and beta/radium (radiological analysis)

Many bottlers sell bottled water in states that require additional testing parameters or more frequent testing. In addition to the tests listed above and frequencies cited, bottlers conduct additional internal quality control testing that includes the testing of containers and closures, which are required quarterly. The testing required for microbiological evaluation, fillers and the quality of the air in the bottling facility are conducted on an ongoing basis.

 

III. IBWA’s Model Code

  1. What does it mean when a company says it is a member of IBWA?
    2.

The bottled water produced by IBWA members must meet standards that are, in some cases, stricter than the FDA’s standards. IBWA has developed a quality assurance program called the Model Code, which is a strict set of standards for the safe processing of bottled water. All members of IBWA must meet the standards contained in the Model Code. In fact, the Model Code has been used as model regulation in many states.

Additionally, as a condition of membership, bottlers are subject to an annual, unannounced inspection administered by an independent internationally recognized third-party organization. This inspection assures that all IBWA bottler members meet federal, state and IBWA requirements for the production and sale of bottled water.
  1. How does the Model Code go beyond the FDA regulations for the bottled water industry?

Some of the standards contained in the Model Code actually exceed the FDA regulations currently in place for the bottled water industry.  For example, the Model Code has a 100 parts per billion (ppb) maximum contaminant level (MCL) for chlorine whereas the FDA does not have a standard of quality for chlorine.

IV. IBWA’s Unannounced Inspections

  1. Who does the unannounced inspections?
    2.

NSF International (formerly known as the National Sanitation Foundation), an independent auditing and compliance firm, recognized by the World Health Organization as a Collaborating Center for Food Safety as well as for Drinking Water Safety and treatment, conducts the annual unannounced inspections of IBWA member bottling facilities.  This inspection assures that all IBWA bottler members meet federal, state and IBWA requirements for the production and sale of bottled water.

  1. How does NSF International ensure compliance with the Model Code?

The purpose of NSF International's unannounced inspections is to ensure that IBWA bottler members’ quality standards are in compliance with the requirements of the Model Code. For example, IBWA bottler members must analyze their source and their final bottled water product. On a weekly basis, bulk water shippers must collect samples from each tanker for bacteriological analysis. IBWA presently mandates a schedule of analysis to be implemented by its members. IBWA bottler members submit the full records of their bottled water test results to the NSF International inspector.

  1. What happens if a bottler fails the inspection?

Although rare, if a bottler does fail the inspection, the bottler must take corrective action to rectify the problem. IBWA fully documents and verifies the corrective measures that were taken. Any deficiencies discovered during their unannounced annual inspection must be corrected within 30 days. In addition, a second inspection is performed at the bottler’s expense.

  1. If a bottler fails the inspection, does it mean that they failed to meet Federal Regulations?

Just because a bottler failed IBWA’s unannounced inspections does not necessarily mean that they failed to meet Federal Regulations. In some instances, IBWA’s Model Code standards are more stringent than the FDA regulations currently in place for bottled water.

Glossary

  1. What does "source approval" mean?
    2.

To get a source approved, a bottler needs to have the source inspected, and the water needs to be sampled and analyzed to ensure that it is safe to drink.

  1. What does "source protection" mean?

Source protection involves maintaining the water source in such a way that it is not exposed to, or influenced by, contamination. By selecting appropriate sources, it is possible to ensure that the water taken from the source is not susceptible to environmental contaminants, or any agricultural or industrial pollutants. Combined with source monitoring, source protection is an effective way of ensuring bottled water’s safety and purity.

  1. What does "source monitoring" mean?

Source monitoring involves a series of tests and procedures designed to determine whether a source is suitable for use. For example, on a weekly basis tests are conducted to evaluate the microbiological characteristics of a source. However, sources are tested on an annual basis for chemical, physical and radiological characteristics. Once a source is selected, it is monitored, ensuring bottled water manufacturers that the source of their water continues to be safe and of high quality. In addition, natural underground sources must be inspected, tested and certified by the state or country of origin to be of sanitary quality.

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The International Bottled Water Association (IBWA) is the authoritative source of information about all types of bottled waters. Founded in 1958, IBWA's membership includes U.S. and international bottlers, distributors and suppliers. IBWA is committed to working with the U.S. Food and Drug Administration (FDA), which regulates bottled water as a packaged food product, and state governments -- strengthened by IBWA Model Code -- to set stringent standards for safe, high quality bottled water products. Consumers can contact IBWA at 1-800-WATER-11 or log onto IBWA's web site (www.bottledwater.org) for more information about bottled water and a list of members' brands. Media inquiries can be directed to Gwen Haynes at 703-683-5213 ext 107.

 

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