Coliform Rule

Coliform Rule


DECEMBER 10, 2001



The U.S. Food and Drug Administration (FDA) issued a proposed total coliform rule for bottled water in 1993. As proposed, the rule did not focus on the central issue, i.e., presence of pathogenic organisms as indicated by the presence of Escherichia coli (E. coli). Therefore, FDA should issue a new proposed rule with provisions necessary to accomplish this goal.

Although FDA’s 1993 proposed rule would have prohibited the presence of any coliform bacteria in water, it did not recognize that coliform testing often produces positive test results that indicate the presence of pathogenic AND non-pathogenic coliform and other organisms. Therefore, it is important that a confirmation test be performed. The purpose of such testing is to determine the presence or absence of harmful (pathogenic) organisms.

The presence of pathogenic organisms clearly must not be permitted in bottled water. However, before water is judged substandard, a sample that tests positive for presence of coliform organisms should be confirmed to determine the presence or absence of E. coli, an internationally-accepted indicator of fecal contamination and potential human pathogens. This would further reduce the risks that would otherwise undermine product integrity and consumer confidence.

A requirement for confirmatory testing is also in line with the U.S. EPA’s Total Coliform Rule for tap water and the World Health Organization’s (WHO) drinking water guidelines, recently incorporated into the Codex Committee on Food Hygiene’s (CCFH) Draft Code of Hygiene for Bottled/Packaged Waters (Other Than Natural Mineral Water). FDA proposed regulating E. coli to CCFH in 1999 through the U.S. Delegation. Regulating E. coli is also in line with FDA microbiological regulations for other food products.


Industry Initiatives

Recognizing the need for a microbiological standard for bottled water, the IBWA Board of Directors adopted a Total Coliform/E. coli Standard of Quality (SOQ), found in Appendix C of the IBWA Model Code, in November, 1999 (attached). The SOQ states that “No Escherichia coli detectable in a 100 ml portion/sample. No validated total coliform detectable in a 100 ml portion/sample as substantiated by retesting.” A policy for evaluating results and determining the disposition of product is included with implementation of the new microbiological SOQ. All IBWA members must now comply with this new SOQ.


The International Bottled Water Association urges the FDA to propose and adopt expeditiously a microbiological standard similar to that adopted by IBWA, through the IBWA Model Code, the WHO, and Codex. This will bring bottled water regulation in line with public water systems and other food product standards. Such action would also be in the public’s best interest.


Appendix C

Escherichia coli and Total Coliform Standard and Policy



No Escherichia coli detectable in a 100 ml portion/sample. No validated total coliform detectable in a 100 ml portion/sample as substantiated by retesting.



A representative unit of production for each package size shall be tested for total coliform (which includes E. coli in this group) during each daily production. If positive for total coliform, an E. coli determination is performed from that test. When a unit of production results in a positive result for coliform organisms by a total coliform method in Standard Methods for the Examination of Water and Wastewater, 20th Edition, the following policy and procedure should be employed:

    1. Immediately analyze 4 additional samples from the same production lot for total coliform. Also examine the original sample for presence of Escherichia coli (E. coli) by a method in Standard Methods, 20th Edition.
    1. Review sampling and analytical procedures to determine if the original sample contamination may have occurred due to sampling or laboratory error. If the review of sampling and analytical procedures demonstrates a source of contamination, such as contaminated media or analyst error, INVALIDATE results and proceed with total coliform analysis of five additional samples from the same lot using uncontaminated media and proper technique.
        1. If the re-sampling does not show E. coli or total coliform, consider the first sample an invalid result.Company plant personnel should use the following guidelines for decisions on the disposition of the lot:
        1. If the original sample AND any of the additional four samples collected are positive for total coliforms or E. coli, consider the results valid and conduct follow up actions pursuant to the company’s recall plan.



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