International Bottled Water Association (Ibwa)

1700 Diagonal Road, Suite 650

Alexandria, VA22314

Phone: 703-683-5213

Fax: 703-683-4074

Web:

INTERNATIONAL BOTTLED WATER ASSOCIATION (IBWA)

Issue Backgrounder:

Bottled Water Study from UniversityMedicalCenterNijmegan, Netherlands

November 2, 2004

Background

On November 1, 2004, researchers from the University Medical Center Nijmegan, Netherlands released a report, which concluded that “high levels of bacterial contamination…was present in commercially bottled mineral water and may pose a health risk to certain patient populations.”

IBWA Response

The report misinforms -- and may cause undue alarm among -- consumers as the substances detected in the sampled bottled mineral waters are based on Heterotrophic Plate Count (HPC), which is a measure of naturally occurring microbes found in a wide array of food products. The World Health Organization (WHO) has found that naturally occurring bacteria, such as those found in bottled water, do not pose a health risk to healthy persons nor immunosuppressed individuals. In some patients who have extreme immunsuppression - such as bone marrow transplant patients, or those with acute leukemia undergoing therapy - all food, regardless of type, including drinking water, is sterilized. These patients are not situated in the normal hospital environment and have special accommodations for food and other needs.

The report authors incorrectly use the term “contamination” to describe their findings. Detection of substances, especially those which have no adverse health affect, does not equal “contamination” of a product and it is incorrect, irresponsible and sensational to characterize these finding as such. Doing so, demonstrates the researchers critical misunderstanding of bottled water and food chemistry and standards.

Moreover, researchers report finding the DNA, or the fragments of the bacteria that were detected. These are quite different from active, living organisms and demonstrate that the protective measures taken by the bottlers were effective in destroying any viable bacteria.

Key Facts

In April 2002, a World Health Organization (WHO) Expert Panel on HPC bacteria determined that the presence of HPC bacteria in water does not pose a health threat. Specifically, the panel concluded “Microorganisms naturally occurring in water are a normal part of the microbiota of bottled waters that meet appropriate safety norms...Pseudomonas aeruginosa and HPC counts are used by some as process management indicators in bottled water production and not as health risk indicators.”

HPC is found in both bottled and municipal waters. In general, HPC organisms serve to prevent the growth of opportunistic pathogens because they have the strength to help overcome harmful bacteria and pathogens that may pose a health threat. There has never been a documented illness associated with HPC.

Both public water and bottled water have some HPC content regardless of treatment method or residual disinfection concentrations. No treatment process used in mass production of drinking water yields a totally sterile product. Sterile waters are not intended nor produced as drinking waters. They are produced for specific uses such as medical applications in the operating room or wound treatments.

Based on science and public health significance, both the U.S. Environmental Protection Agency (EPA) and the US. Food and Drug Administration (FDA) have determined that it is not relevant –and no health benefit -- to impose an HPC limitation requirement for municipal drinking water nor bottled water. The WHO findings confirm the EPA and the FDA’s belief that the presence of HPC bacteria does not pose a health threat. EPA conducted an extensive review of the health effects of HPC prior to promulgating new drinking water regulations in 1991 and the FDA conducted a similar review in generating its bottled water regulations.

For bottled water, the water entering a bottle is free of harmful pathogens. Harmful pathogens cannot develop in the sealed environment provided by the bottle. Once water enters the bottle, the small number of HPC do what they do in nature: they utilize available nutrients and multiply. The dead HPC deteriorate, returning available carbon and nitrogen to the water. Individual species of HPC increase and decrease in numbers over a long period of time. Thus, sampling a particular bottle will only produce a snapshot of the HPC content at that one point in time. Eventually, all the nutrients are utilized and the HPC counts become very low, or even undetectable.

Bottled Water Basics

Bottled water is fully regulated as a packaged food product by the U.S. Food and Drug Administration (FDA) and bound by FDA’s quality, safety, inspection and labeling requirements. Bottled water products are required to comply at all times with FDA Standards of Quality. As with other food products, bottled water is subject to the food adulteration requirements of the Federal Food, Drug and Cosmetic Act and is also subject recall and the full array of FDA enforcement actions, including warning letters, civil (seizure and/or injunction) and criminal penalties.
In addition to federal and state regulations, members of the International Bottled Water Association (IBWA) are required to adhere to standards in the IBWA Model Code that, in several cases, are stricter than FDA and state bottled water regulations. The IBWA Model Code is enforced through a mandatory, annual, unannounced plant inspection by an independent, third-party organization.
All bottled water sold in the United States, regardless of whether it is a domestic or imported brand, must adhere to safety, quality, production and labeling standards required by FDA, states and the industry. In addition, bottled water sold through international commerce is subject to the standards of Codex Alimentarius, the food standards body of the World Health Organization.
Water used to produce bottled water is tested both as it enters the plant, during production and as finished product. Multiple tests and regular screening are performed by trained quality control technicians to evaluate microbial, physical and chemical quality. Such screening can be used to detect the presence of agents that may be an indicator of product contamination. These protection measures and other quality control programs help ensure that substandard products do not reach the market.
Bottled water products are produced utilizing a multi-barrier approach, from source to finished product, that helps prevent possible harmful microorganisms from contaminating the finished product as well as storage, production, and transportation equipment. Measures in a multi-barrier approach may include source protection, source monitoring, reverse osmosis, distillation, filtration, ozonation or ultraviolet (UV) light. Many of the steps in a multi-barrier system may be effective in safeguarding bottled water from microbiological and other contamination. Piping in and out of plants, as well as storage silos and water tankers are also maintained through daily sanitation procedures. In addition, bottled water products are bottled in a controlled, sanitary environment to prevent contamination during the filling operation.
IBWA members are required to employ a HACCP (Hazard Analysis Critical Control Point) approach to quality assurance. This practice scrutinizes every step of the production process – from source to finished product – that are critically important to the safety of the product and puts in place systems to help ensure that all safety and quality control processes are functioning effectively. Identification of risk and severity of health effects and control measures for specific biological, chemical and physical agents are included. Widely used in the food and pharmaceutical industries, the FDA considers HACCP a comprehensive method for assuring product safety.

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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. Strengthened by IBWA Model Code, the Association 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 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 () for more information about bottled water and a list of members' brands. Media inquiries can be directed to IBWA Communications Manager Bridget Wells at 703-683-5213 x 107.