Food Safety and Quality: Stronger FDA Standards and Oversight Needed for Bottled Water
RCED-91-67
Published: Mar 12, 1991. Publicly Released: Apr 12, 1991.
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Highlights
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.
Recommendations
Matter for Congressional Consideration
| Matter | Status | Comments |
|---|---|---|
| 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. |
Closed – Not Implemented
|
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
| Agency Affected | Recommendation | Status |
|---|---|---|
| Food and Drug Administration | 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. |
Closed – Not Implemented
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.
|
| Food and Drug Administration | 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. |
Closed – Not Implemented
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.
|
| Food and Drug Administration | 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. |
Closed – Not Implemented
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.
|
| Food and Drug Administration | To improve FDA oversight of bottled water, the Commissioner, FDA, should work with the states to routinely obtain state inspection and test results. |
Closed – Implemented
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.
|
| Department of Health and Human Services | 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. |
Closed – Implemented
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.
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