Highlights from the Oral Testimony and Question Responses

Deputy Principal Commissioner Dr. Joshua M. Sharfstein
Food and Drug Administration
At the Hearing on the Regulation of Bottled Water
July 8, 2009
Subcommittee on Oversight and Investigation
Committee on Energy and Commerce
U.S. House of Representatives

FDA on Bottled Water Safety:

“In general, FDA’s oversight of bottled water I think can be described as successful. The agency is aware of no major outbreaks of illness or serious safety concerns associated with bottled water in the past decade. “

Later, answering Rep. Greg Waldren’s question on lead in water, FDA stated:

“In fact, I advised the school superintendent to turn-off all the drinking fountains in the Baltimore city public schools because of the problems they were having with lead. And to go with bottled water across the system. In turned out to be cheaper also, given the expense that they had of testing the municipal water because of old buildings and the problems they had with the pipes in the school. So, as a health commissioner, I think there are certain scenarios where, for example, after certain types of disruption of the water supply, the water can unsafe for a period of time, you recommend a switch to bottled water or boil it.”


In a Comparison with Soft Drinks, FDA stated:

“A cola is a food product that is not subject to the Good Manufacturing Practices that exist specifically for bottled water. I would say there is definitely more regulations on bottled water… Bottled water has a whole set of regulations that are really just for bottled water.”

FDA On Interstate Sales of Bottled Water:

“If the bottle comes from outside the state or the cap comes from outside the state, even if it’s just sold within the state, it counts as interstate. And there’s a presumption, I understand, it would be interstate. But in theory, there may be products that could challenge our authority over them although I’m not aware for water they we’ve heard about a problem that we haven’t get able to get to, either directly or through the states.”

FDA On the Use of Recycled Plastic Bottles:

“I’m not aware of any special concerns for recycled plastic. I think if there are concerns people have, they should share them with the agency.”

FDA’s Overview of Bottled Water Regulations:

“FDA has established specific regulations for bottled water in the code of Federal regulations. These regulations include standard of identity regulations that define different types of bottled water, such as spring water verses mineral water and standard of quality regulations that establish allowable levels for chemical, physical, microbial and radiological contaminants. FDA has established Good Manufacturing Practice regulations for the process and bottling of bottled drinking water.

Labeling and GMP regulations for foods in general also apply to bottled water.

"Federal law requires FDA to set similar standards for bottled water as exist for municipal water or explain why they should not apply. FDA has established such standards for over 90 contaminants and in some cases, such as for lead or copper, the FDA limits are stricter for bottled water than for municipal water.
And another point to make in this regard is the way the testing is done is different. For example, take the lead standard. Any test that is high is violative, that is done on FDA-regulated bottled water. For the municipal water, if only a percentage of the samples is above a certain level does the municipal water supply fail that. They’re allowed to have certain failures and not have it as a failure for the municipal water supply. It just illustrates there’s a different approach that’s taken into context.”

FDA Monitoring and Testing of Bottled Water:

“FDA monitors and inspects bottled water products and processing plants as part of its general food safety program. Inspections occur approximately once every one to three years. The Agency inspects violative firms more frequently depending on the number of significance and occurrence of violations. FDA field offices follow-up on consumer and trade complaints and other leads on potentially violative bottled water products. As for other types of food, FDA periodically collects and analyzes samples of bottled water. Samples of foreign bottled water offered for entry may be collected and tested to determine if they are in compliance with the laws and regulations. And last, we test the water for microbial, radiological or chemical contamination.”

FDA and the new e-Coli standard:

“Most recently, on May 29, 2009, FDA published a final rule to require that bottled water manufacturers test source water and finished bottled water products for total coliform organisms and to prohibit distribution of products containing any E.coli indicator of fecal contamination. FDA is also requiring that before a bottler can use source water from a source that tested positive for E.coli, the bottler must take appropriate measures to rectify or eliminate the cause of the problem. And the bottler must keep records of such actions.”

Later, answering Rep. Greg Waldren’s question on E.c oli issues, he stated:

“My understanding is that public water systems are required to collect monthly total coliform samples throughout their distribution systems and that, if they are positive, they must be tested for E.coli. For systems collecting more than 40 samples per month, if more than 5% are positive, that triggers a violation. If it’s less than 40 samples per month, than one positive test triggers a violation. For FDA, bottled water, if there’s any violation, that kicks in. For municipal, if its a lots of tests, then there has to be a certain percentage of the tests filed to trigger a violation.”

FDA On DEHP, he stated:

“We don’t believe it is being used in water bottles or water caps.”