Bottled Water

Bottled Water Regulations

Bottled water is defined by the United States Food and Drug Administration (FDA) as “water intended for human consumption that is sealed in bottles or other containers with no added ingredients except that it may optionally contain safe and suitable antimicrobial agents.” All products meeting the definition for bottled water can be labeled as such.
However, the FDA has created additional identities which can be used instead of the term “bottled water” to identify bottled water products. These terms distinguish types of bottled water based upon the source (spring water, artesian water, well water), treatment processes used (distilled water, demineralized water, reverse osmosis water, deionized water), or the presence or absence of specific constituents of the water (mineral water, purified water, sterile water, and sparkling water). These additional standards of identity can be used in lieu of the term “bottled water.”

Regulations

Federal: The FDA regulates bottled water as a packaged food product. FDA regulations that must be met for food products include requirements regarding naming, good manufacturing practices (GMPs), labeling and quality.

State: All states regulate bottled water. The FDA relies on the states to approve bottled water sources. In addition to this source approval jurisdiction, states have established and enforce their own rules and regulations regarding bottled water.

All 50 U.S. states regulate bottled water produced within their state. Twenty-three states also regulate out-of-state bottlers, requiring manufacturers to provide documentation demonstrating compliance with state requirements and obtain a license, registration, or other approval prior to distributing product.

Standards

Federal: The FDA has established allowable levels for contaminants in bottled water (chemical, physical, microbial and radiological) referred to as the Standards of Quality (SOQ’s). By law FDA standards for bottled water must be as stringent and protective of public health as U.S. Environmental Protection Agency standards for public water supplies. As a result of this stringency, the list of contaminants FDA regulates for bottled water finished products in 21 CFR 165 is very similar to the list of contaminants EPA regulates for public water supplies in 40 CFR. In a few instances FDA has determined that an EPA regulated substance is not applicable to bottled water because the substance is not likely to be found. And, in a few instances, FDA bottled water standards are more stringent than EPA’s public drinking water standards (e.g. copper, fluoride, lead, nickel and phenols).

State: The standard of quality regulations for bottled water are issued under the authority of the Standards of Identity and, therefore, pre-empt state laws that conflict with the FDA Standards of Quality. Several states have regulations which require bottled water be to analyzed for and demonstrate compliance with the additional contaminants not regulated by FDA as listed in the states’ safe drinking water act.

Testing Frequencies

Federal: The FDA outlines the minimum sampling and testing required of source water and final product for the microbiological, chemical and radiological contaminants standards of quality.
The FDA requires that product samples are to be taken and analyzed by the plant “as often as necessary, but at a minimum frequency of” once each week for microbiological contaminants and once each year for chemical and radiological contaminants. This testing must be performed at the frequency specified by FDA. FDA does not allow for waivers or exemptions from this testing.
The FDA also requires bottlers to collect and analyze source water samples “as often as necessary, but at a minimum frequency” of once each year for chemical contaminants, once every four years for radiological contaminants, and once each week for microbiological contaminants. FDA does allow for some exceptions to the source testing frequency if the source originates from a public water system in compliance with the EPA Safe Drinking Water Act or can demonstrate that such a reduction is consistent with state issued waivers under EPA regulations.

In addition to product and source analysis, requires bottlers to analyze product water (water which has been processed through the plant water treatment equipment but has not yet been bottled) “as often as is necessary to ensure uniformity ad effectiveness of the processes performed by the plant.” As well as perform quarterly microbiological sterility tests for Total Coliform and Plate Count on the containers (bottles) and closures (caps) being used.

State: Some states’ bottled water regulations require analysis for some or all of the state regulated contaminants to be performed at a frequency other than that specified by the FDA for source, product or both. This is particularly common in states where bottled water regulations are based in part on the state’s safe drinking water act. Therefore the state requires bottlers to test for contaminants at the same frequency as a public water supplier, such as Kentucky, Pennsylvania and Alaska.

Compliance
Federal: FDA is responsible for verification of compliance:

1. To ensure compliance, the FDA monitors and inspects bottled water products and bottling facilities under its general food safety program.
2. FDA also periodically collects and analyzes samples of bottled water products to verify compliance as part routine plant inspections, follows up on consumer or trade complaints, and customs inspections of foreign bottled water products being imported to the U.S.

State: State’s are responsible for enforcing state bottled water regulations:

1. To ensure compliance with state regulations, states inspect bottled water sources and production facilities located in their state.
2. Some states also collect samples of bottled water from retail shelves for routine compliance checks or in response to consumer or trade complaints. These samples are checked to ensure the manufacturer holds proper licenses and the product is properly labeled.
3. In some cases, states also perform analysis of the bottled water samples for independent verification of compliance with quality standards.

Protection Guarantees

In contrast to water filters, there is protection guarantees for bottled water. Each unit of bottled water product manufactured, sold, or distributed within the United States is required to be in compliance with the labeling and the bottled water standards of quality.

Non-compliant products containing contaminants that exceed the Standard of Quality may be considered adulterated under the FFDCA and subject to FDA enforcement actions including inspection of the facility, use of warning letters, request for voluntary recalls, civil actions (including seizures or injections), and criminal prosecution.

References:
Beverage Bottled Water Final Rule; Federal Register, Volume 60, No. 218, November 13, 1995, pp 57076-57130. [Docket No. 88P-0030]
California Office of Environmental Health Hazard Assessment.
California Code of Regulations: Title 27, Division 4, Chapter 1. 2008. 12 Sept 2008 http://www.oehha.org/prop65/law/pdf_zip/AllProp65RegssList.pdf
Corbett, Ellen. California Senate Bill 220: Vended Water. 2007. 12 Sept 2008 http://info.sen.ca.gov/pub/07-08/bill/sen/sb_0201-0250/sb_220_cfa_20070417_101140_sen_comm.html
The Food and Drug Administration. The Bioterrorism Act of 2002. 1 May 2005 http://www.fda.gov/oc/bioterrorism/bioact.html
The Food and Drug Administration. Code of Federal Regulations 21 CFR Parts 1, 101, 110, 129 and 165. 1 May 2005 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm.
The Food and Drug Administration. FDA Introduces New Technology to Improve Food Security: Electronic Food Facility Registration Goes “Live,” Allowing More Than 400,000 Facilities to Register in Minutes; FDA Reports on Progress in Developing Rapid Tests of Food Contamination: Press Release P03-81 October 16, 2003. 1 May 2005 http://www.fda.gov/bbs/topics/NEWS/2003/NEW00960.html.
The Food and Drug Administration. FDA Issues Final Rule on the Establishment and Maintenance of Records to Enhance the Security of the U.S. Food Supply Under the Bioterrorism Act. Press Release P04-109. December 6, 2004. 1 May 2005 http://www.fda.gov/bbs/topics/news/2004/NEW01143.html.
The Food and Drug Administration. Summary Of Title III, Subtitle A Of The Public Health Security And Bioterrorism Preparedness And Response Act Of 2002. 1 May 2005 http://www.cfsan.fda.gov/~dms/sec-ltr.html#attach-a.
The Food and Drug Administration. Guidance for Industry: Prior Notice of Imported Food: Questions and Answers (Edition 2) May 3, 2004. 1 May 2005 <http://www.cfsan.fda.gov/~pn/pnqagui2.html.
The Food and Drug Administration. Federal Food, Drug, and Cosmetic Act: Section 417-Reportable Food Registry. 12 Sept 2008 http://www.fda.gov/opacom/laws/fdcact/fdcact4a/html.
International Bottled Water Association. Interactive Path to Market. 1 May 2005 http://www.bottledwater.org/public/flash/bottled-water-v33.swf.
Posnick, Lauren M. and Kim, Henry; Bottled Water Regulation and the FDA, Reprinted from Food Safety Magazine August/September 2002 issue. http://www.cfsan.fda.gov~dms/botwatr.html.
Reportable Food Registry as Required by the Food and Drug Administration Amendments Act of 2007; Announcement of Delay in Implementation and Request for Comments; Federal Register, Volume 73, No. 102, May 27, 2008, pp 30405-30406. [Docket No. FDA-2008-N-0298].