Getting Started in the Bottled Water Business: Water Testing Requirements

Dec. 28, 2000

This is the first in a series of three articles covering bottled water testing, source development and licensing and labeling.

You have a spring on your property producing "the best water you’ve ever tasted," so why not put it in a bottle and sell it?

An undeveloped natural spring can be a diamond in the rough, but getting the water to market may be a little rougher than you thought.

Bottled water is governed by the U.S. Food and Drug Administration (FDA) as a food product with regulatory enforcement at the state level. Each state may adopt the FDA regulations or develop its own state regulations which meet or exceed those established by the FDA.

Annual Testing

The FDA regulations governing bottled water stipulate that analysis is to be performed on each type of finished product water and each non-municipal source water on an annual basis. The testing performed must comply with the FDA Quality Standards 21 CFR Section 165.110 (b).

If the same type of finished product water uses multiple lines that have separate water treatment equipment, each line is required to be tested as a separate product. If all of the water passes through the same water treatment equipment and then is directed to different fillers, you may be able to do "rotational" line testing. For example, the first line can be tested one year and the second line can be tested the next year.

If you use a municipal source or buy water from a source that already is tested to standards that meet your needs (a.k.a. "consecutive water supply"), you do not need to perform your own test on that source water. You can obtain a copy of the current source water results to submit to the regulator(s).

To satisfy International Bottled Water Association (IBWA) requirements, you would need to have annual testing performed to meet Appendix A of the IBWA Model Code on your source and finished product waters.

On finished product water that is to be labeled as "purified," the IBWA and certain states require a USP analysis, which confirms the water meets pharmaceutical standards. Although the FDA regulations do not state that the USP analysis is required on "purified" water, the FDA does require bottlers to meet USP standards for "purified" water. Therefore, a USP analysis is advisable in order to provide documentation upon request. The parameters included in this test can be found in Appendix B of the IBWA Model Code.

Quarterly Testing

The FDA and IBWA require quarterly testing of caps and containers for total coliform bacteria and standard (or heterotrophic) plate count.

The FDA regulations for finished product water have changed to add nine parameters, which previously were stayed. This change results in one year of quarterly testing of each type of finished product water for four SOCs (glyphosate, endothall, diquat and 2,3,7,8-tcdd [dioxin by method 1613]). For current bottlers, these four consecutive quarterly tests are to be completed by February 2002. Bottlers starting production after that date will be required to complete the quarterly testing in the first year of production. (IBWA members must complete the quarterly SOC testing by December 2001.)

Some states have quarterly testing requirements for in-state bottlers, which only is required on a periodic basis, and typically the state will provide a monitoring schedule.

Monthly Testing

The IBWA has recommended monthly bromate and bromide testing for at least four consecutive months. This schedule will help to establish the risk for bromate contamination associated with the finished product water. This recommendation is prompted by the limit for bromate in drinking water of 10 ppb or 0.010 ppm established by the EPA. The FDA is expected to add bromate to the regulations for bottled water analysis. Although bromate testing is not yet required, it is advisable to determine your risk so you can address potential problems before it is regulated. Test results that show you do not have a problem also will be useful should this issue be picked up by the media.

Bromate is a compound formed when water containing bromide is ozonated. Therefore, if your source water does not contain bromide, bromate would not be created in processing. If you add minerals to your water, be sure to get documentation from your supplier that the ingredients meet USP standards. Ingredients such as calcium chloride, magnesium chloride, potassium chloride, etc., may contain bromide if they are not USP grade.

With a limit of 10 ppb, bromate and bromide testing need to be performed with a detection level of 5 ppb or lower. Any testing performed in the past may not have been at this detection level.

Weekly Testing

The FDA and IBWA require weekly testing of your source and finished product water for total coliform bacteria. Certain states also require standard plate count analysis on a weekly basis. Some states have requirements regarding the frequency of bacteria testing for source and finished product water based on the volume of water produced.

Daily Testing

The IBWA requires in-house daily testing for total coliform bacteria on your source and finished product water. In-house daily standard plate count analysis for source and finished product is required by certain states.

These regulations may be subject to change; therefore, you should verify the current requirements with your laboratory representative before ordering any testing.

About the Authors

Barbara L. Marteney and Kristin M. Saltzgiver of National Testing Laboratories Ltd. specialize in consulting with bottled water companies regarding testing requirements. They maintain contacts with bottled water regulators, industry

Table 1: Testing Costs

Approximate Cost Per Product and/or Source Sample
Annual Range: $1,600-$2,500*
USP: $150 ea
Quarterly SOC's: $700 ea
Quarterly Cap and Container: $15 ea**
Bromate/Bromide: $60 ea
Weekly Bacteria: $28 ea

*Cost depends upon which state requirements are to be met and if IBWA member

**Cost per piece. Four of each cap and each container required.

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