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SMALL ENTITY COMPLIANCE GUIDE

Small Entity Compliance Guide: Bottled Water and Total Coliform and E. coli March 2010

Read the Federal Register Notice
Final
Docket Number:
FDA-2010-D-0141
Issued by:
Guidance Issuing Office
Human Foods Program

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.

I. Introduction

On May 29, 2009, FDA published a final rule (74 FR 25651) that amended its bottled water standard of quality regulations (21 CFR part 165) by revising the provision for microbiological quality to require that if Escherichia coli (E. coli) is present in bottled water, then the bottled water will be deemed adulterated. FDA also amended its current good manufacturing practice (CGMP) regulations for the processing and bottling of bottled drinking water (21 CFR part 129) (the bottled water CGMP regulation) to (1) provide that source water containing E. coli will not be considered to be of a safe, sanitary quality and will be prohibited from use in the production of bottled water; (2) revise the microbiological testing requirements for finished bottled water products and for source water from other than a public water system (PWS); and (3) introduce new requirements for corrective measures and recordkeeping. Under these new requirements, bottled water manufacturers (bottlers) that obtain their source water from other than a PWS must test their source water at least weekly for total coliform. If any coliform organisms are detected in source water, bottlers must conduct follow-up testing to determine whether any of the coliform organisms are E. coli. Before bottlers can use source water from a source that has tested positive for E. coli, they must take appropriate measures to rectify or eliminate the cause of E. coli contamination of that source and keep records of such actions. Also, if any coliform organisms are detected in weekly total coliform testing of finished bottled water products, bottlers are required to conduct follow-up testing to determine whether any of the coliform organisms are E. coli. The effective date of the final rule is December 1, 2009.

FDA has prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121). This guidance document restates in plain language the legal requirements of the May 29, 2009 final rule set forth in 21 CFR 129 and 165 concerning the contaminants total coliform and E. coli. These regulations are binding and have the full force and effect of the law.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

II. Background

Under section 410(b)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), not later than 180 days before the effective date of a National Primary Drinking Water Regulation issued by the Environmental Protection Agency (EPA) for a contaminant under section 1412 of the Safe Drinking Water Act, FDA is required to issue a standard of quality regulation for that contaminant in bottled water or make a finding that such a regulation is not necessary to protect the public health because the contaminant is contained in water in PWSs, but not in water used for bottled water. In addition, section 410(b)(3) of the FD&C Act requires the standard of quality for a contaminant in bottled water to be no less stringent than EPA’s maximum contaminant level and no less protective of the public health than EPA’s treatment technique requirements for the same contaminant.

In the Federal Register of November 8, 2006 (71 FR 65574), the EPA published the Ground Water Rule (GWR) to provide for increased protection against fecal microbial pathogens in PWSs that use ground water sources (also referred to as ground water systems (GWSs)). EPA established treatment techniques intended to identify and target GWSs that are susceptible to fecal contamination and require such GWSs to monitor and, when necessary, take corrective action to prevent or remove such contamination. In the rule, EPA identified E. coli as an indicator of fecal contamination. EPA also identified appropriate corrective action, compliance monitoring, and public notification requirements. EPA issued the GWR to protect public health because some GWSs may be at risk of supplying water that contains harmful microbial pathogens from fecal contamination. Ingestion of contaminated water can result in mild and self-limiting gastrointestinal illnesses, or more serious and potentially fatal illnesses.

In response to this EPA rulemaking, FDA published the May 29, 2009 final rule. This final rule ensures that FDA’s standards for the minimum quality of bottled water, as affected by fecal contamination, will be no less protective of the public health than those set by EPA for public drinking water.

III. Questions and Answers

  1. What microbiological testing must be performed on source water obtained from other than a PWS?

    Source water obtained from other than a PWS is to be sampled and analyzed for total coliform at least once each week. If any coliform organisms are detected, follow-up testing must be conducted to determine whether any of the coliform organisms are E. coli (21 CFR 129.35(a)(3)(i)).
  2. Is source water found to contain E. coli considered water of a safe, sanitary quality as required for use in bottled water?

    No (21 CFR 129.35(a)(3)(i)).
  3. What must bottlers do before they can use source water from a source that has tested positive for E. coli?
    Bottlers must take appropriate measures to rectify or otherwise eliminate the cause of E. coli contamination of that source in a manner sufficient to prevent its reoccurrence (21 CFR 129.35(a)(3)(i)).
  4. When will a source previously found to contain E. coli be considered negative for E. coli?

    The source will be considered negative for E. coli after five samples collected over a 24-hour period from the same sampling site that originally tested positive for E. coli are tested and found to be E. coli negative (21 CFR 129.35(a)(3)(i)).
  5. Are bottlers required to maintain records of the corrective measures they take for sources that test positive for E. coli?

    Yes. Records describing corrective measures taken in response to a finding of E. coli in source water are to be maintained on file at the plant (21 CFR 129.35(a)(3)(i)).
  6. Must finished bottled water products comply with section 402(a)(3) of the FD&C Act?

    Yes (21 CFR 129.35 (a)(4)(iv)).
  7. What bacteriological testing must be performed on finished bottled water?

    Bottlers must take and analyze at least once a week for total coliform a representative sample from a batch or segment of a continuous production run for each type of bottled drinking water produced during a day's production. The representative sample shall consist of primary containers of product or unit packages of product. If any coliform organisms are detected, follow-up testing must be conducted to determine whether any of the coliform organisms are E. coli (21 CFR 129.80(g)(1)).
  8. What is the standard of microbiological quality established by FDA for total coliform in bottled water?

    The standard of microbiological quality established for total coliform is as follows: (1) Multiple-tube fermentation (MTF) method. Not more than one of the analytical units in the sample shall have a most probable number (MPN) of 2.2 or more coliform organisms per 100 milliliters and no analytical unit shall have an MPN of 9.2 or more coliform organisms per 100 milliliters; or (2) Membrane filter (MF) method. Not more than one of the analytical units in the sample shall have 4.0 or more coliform organisms per 100 milliliters and the arithmetic mean of the coliform density of the sample shall not exceed one coliform organism per 100 milliliters (21 CFR 165.110(b)(2)(i)(A)).
  9. What must be stated on the label when the microbiological quality of bottled water is below that prescribed for total coliform in 21 CFR 165.110(b)(2)(i)(A)?

    If the microbiological quality of bottled water is below that prescribed for total coliform in 21 CFR 165.110(b)(2)(i)(A), the label shall bear the statement of substandard quality specified in § 130.14(a) (21 CFR 130.14(a)) except that, as appropriate, instead of or in addition to the statement specified in § 130.14(a) the following statement shall be used: “Contains Excessive Bacteria” (21 CFR 165.110(c)(1)).
  10. What is the standard of microbiological quality established by FDA for E. coli in bottled water?

    Bottled water containing a substance at a level considered injurious to health under section 402(a)(1) of the FD&C Act, or that consists in whole or in part of any filthy, putrid, or decomposed substance, or that is otherwise unfit for food under section 402(a)(3) of the FD&C Act is deemed to be adulterated. If E. coli is present in bottled water, then the bottled water will be deemed adulterated under section 402(a)(3) of the FD&C Act (21 CFR 165.110(b)(2)(i)(B); 21 CFR 165.110(d)).
  11. What analytical methods are used for determining compliance with the microbiological quality standard for bottled water?

    The analytical methods used for determining compliance with the microbiological quality standard for bottled water are the multiple-tube fermentation or membrane filter methods described in the applicable sections of “Standard Methods for the Examination of Water and Wastewater,” 21st Ed. (2005), American Public Health Association (21 CFR 165.110(b)(2)(ii)).

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