FDA Bottled Water Regulations UpdateNine Stayed Parameters and Quarterly Testing Requirements

Dec. 28, 2000
undefinedOn August 6, 1998, the U.S. Food and Drug Administration (FDA) announced that effective February 2, 1999, bottled water must meet the requirements of the National Primary Drinking Water Regulations for the nine stayed parameters, which include: antimony, beryllium, cyanide, nickel, thallium, diquat, endothall, glyphosate, and 2,3,7,8-tcdd (dioxin). Testing for these nine parameters was not required prior to 1996, and since then it has been delayed, awaiting ruling on how testing requirements would be implemented for bottled water.

This announcement requires bottlers to monitor for these nine parameters and comply with the same maximum contaminant levels (MCLs) as established by the U.S. Environmental Protection Agency (EPA). This announcement did not offer clarification as to how frequently bottled water companies will be required to test these nine parameters; whether testing will be required on source water and/or finished product; and if waiver programs will be available.

Frequency of Testing
On April 30, 1999, the International Bottled Water Association (IBWA) issued a memo indicating that the FDA will implement monitoring requirements for the nine parameters in the same manner as EPA regulates for Public Water Supplies (PWS). Therefore, in the first year of compliance, testing of the four synthetic organic chemicals (SOCs)—diquat, endothall, glyphosate, and 2,3,7,8-tcdd (dioxin)—will be required quarterly. Year two and three requirements for these four SOCs are scheduled to be annual.

Beyond the third year, it has not been specified how often the SOC testing will be required. According to PWS requirements, this testing would typically be required once every six to nine years. The other five parameters (antimony, beryllium, cyanide, nickel, thallium) will be required annually.

Bottlers will have three years from inception to complete four consecutive quarters of testing for the four SOCs. This means bottles would need to be in compliance by February 2002. Since the quarterly testing schedule will take a year to complete, testing must begin no later than February 2001 (one year prior to the required completion date).

These requirements apply to finished product water only. At this time no changes are anticipated for source water regulations. The FDA has indicated that waivers will not be available on the testing of bottled water for the nine contaminants.

IBWA and State Requirements
The IBWA and many states already require annual testing for all or some of the nine parameters. The Appendix A of the IBWA Model Code requires all bottler members to analyze for these parameters annually on source water and a minimum of once every three years on finished product water. Since each state may establish bottled water regulations above and beyond the FDA requirements, many states have added all or some of these parameters prior to this announcement.

Three states (Massachusetts, California and Georgia) already have taken action. Each has announced changes to their annual testing requirements based on their interpretation of the August 6th announcement.

The California Department of Health Services and Massachusetts Department of Public Health’s Division of Food and Drugs issued new quality of standards for bottled water, adding the nine contaminants to the annual testing requirements for bottled water finished products. Massachusetts also added them to the annual requirements for non-carbonated, non-alcoholic process waters. (California and Massachusetts already require testing for the stayed parameters on source waters.)

On December 15, 1998, the Georgia Department of Agriculture announced testing for 2,3,7,8-tcdd (dioxin) would be required on source and finished products annually for all applications received after February 2, 1999. The other eight parameters have been required by Georgia since 1997.

Bottled water companies selling in states that require testing for these nine contaminants on both source and finished product water need to continue to perform this analysis on an annual basis. IBWA members will need to continue to perform analysis for the nine parameters in accordance with the Model Code at a minimum. All bottlers should set up a schedule for the quarterly SOC testing (for each type of finished product water) in order to be in compliance by the required completion date.

Bottlers should consult with their laboratory representative to determine their testing schedule to meet all applicable regulations of the FDA and the states in which their water is sold.

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 associations and the FDA regarding regulatory changes and bottled water issues. They have authored numerous articles regarding state, federal and international bottled water regulations. Marteney (ext. 217) and Saltzgiver (ext. 215) may be reached at 800-458-3330 or 440-449-2525; e-mail [email protected].

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