Food Safety and Quality:

Stronger FDA Standards and Oversight Needed for Bottled Water

RCED-91-67, Mar 12, 1991

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Pursuant to a congressional request, GAO assessed the adequacy of the Food and Drug Administration's (FDA) bottled water standards, focusing on the: (1) effectiveness of the FDA oversight program; (2) regulation of drinking water sold in interstate commerce; and (3) reliability of terms and graphics used on bottled water labels.

GAO found that FDA: (1) did not comply with the Federal Food, Drug, and Cosmetic Act's (FFDCA) requirement for timely action on setting maximum levels for bottled water quality standards; (2) exempted mineral water from those standards; (3) and some state regulators were not required to test for contaminants in bottled and mineral water, which could have levels of potentially harmful contaminants not allowed in public drinking water; (4) did not make full use of state inspection and test results and could not ensure that bottlers and bottled water products met existing federal regulations and standards; (5) tested for 5 or fewer of 31 contaminants for which there were standards in 94 percent of the tests GAO reviewed; (6) did not have a complete inventory of bottlers, and lacked jurisdiction to inspect foreign bottling operations; and (7) could improve its oversight of bottled water firms and products by routinely using state inspection and testing results.

Status Legend:

More Info
  • Review Pending-GAO has not yet assessed implementation status.
  • Open-Actions to satisfy the intent of the recommendation have not been taken or are being planned, or actions that partially satisfy the intent of the recommendation have been taken.
  • Closed-implemented-Actions that satisfy the intent of the recommendation have been taken.
  • Closed-not implemented-While the intent of the recommendation has not been satisfied, time or circumstances have rendered the recommendation invalid.
    • Review Pending
    • Open
    • Closed - implemented
    • Closed - not implemented

    Matter for Congressional Consideration

    Matter: Given the FDA history of delays in setting bottled water standards within legislatively required time frames and in view of the additional standards the Environmental Protection Agency (EPA) plans to promulgate in the next few years, Congress may wish to revise section 410 of FFDCA to provide that primary public drinking water standards apply automatically to bottled water after 180 days unless FDA publishes in the Federal Register its reasons for a delay or an exemption from such standards. Alternatively, Congress might authorize EPA to set quality standards for all drinking water.

    Status: Closed - Not Implemented

    Comments: Interest in new bottled water legislation is waning and congressional action on this issue is not expected in 1994. FDA has issued new regulations strengthening oversight of the industry.

    Recommendations for Executive Action

    Recommendation: To improve FDA oversight of bottled water, the Commissioner, FDA, should work with the states to routinely obtain state inspection and test results.

    Agency Affected: Congress

    Status: Closed - Implemented

    Comments: FDA agrees that greater use of state inspection results would improve oversight. FDA officials are working on a program to identify the reliability and availability of each state's inspection data. However, FDA action is not the formal routine program intended by GAO. Such action is not now likely.

    Recommendation: The Commissioner, FDA, should revise FDA regulations to require that bottlers keep all self-monitoring records for at least 5 years, or since the last FDA inspection.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

    Status: Closed - Not Implemented

    Comments: FDA believes that requiring bottlers to keep records for at least 5 years would be burdensome and not worth the benefits. In follow-on report GAO/RCED-92-87, dated February 10, 1992, GAO recommended that FDA reconsider its position on this recommendation, but it has not done so.

    Recommendation: To ensure the performance and reliability of required bottled water tests, the Commissioner, FDA, should seek legislation giving FDA specific authority to require domestic bottlers involved in interstate commerce and foreign bottlers to report to FDA the results of required chemical and radiological tests within 30 days, and violative results from all required tests within 48 hours.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

    Status: Closed - Not Implemented

    Comments: FDA believes that requiring bottlers to report test results would be burdensome and not worth the benefits. In follow-on report GAO/RCED-92-87, dated February 10, 1992, GAO recommended that FDA reconsider its position on this recommendation, but it has not done so.

    Recommendation: To ensure the performance and reliability of required bottled water tests, the Commissioner, FDA, should seek legislation giving FDA specific authority to require domestic bottlers involved in interstate commerce and foreign bottlers to use laboratories that have been certified by federal or state agencies to analyze public drinking water or bottled water, or demonstrate that they can accurately test bottled water quality.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

    Status: Closed - Not Implemented

    Comments: FDA believes that requiring laboratory certification would be costly and not worth the benefits. In follow-on report GAO/RCED-92-87, dated February 10, 1992, GAO recommended that FDA reconsider its position on this recommendation, but it has not done so.

    Recommendation: To protect consumers from potentially contaminated bottled water, the Secretary of Health and Human Services should direct the Commissioner, FDA, to: (1) comply with section 410 of FFDCA, which requires timely setting of bottled water quality standards; and (2) develop and issue mineral water quality standards.

    Agency Affected: Congress

    Status: Closed - Implemented

    Comments: FDA is working to comply with section 410 of FFDCA and develop and issue mineral water quality standards. Some standards have been issued, but not in a timely manner. Other standards have been proposed.