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

Description

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.

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

1

Bottled Water

Keurig Dr Pepper withdrawal due to quality standards

Stakeholders

1

Bottlers

Manufacturers required to test source water and finished products

Technical Details

Substances

2

Total Coliform

Microbiological contaminant used for weekly source water testing; Microbiological quality standard established for total coliform.

E. coli

Example of multi-drug resistant gram-negative bacteria

Testing Methods

3

Membrane filter method

Analytical method used for determining compliance with microbiological quality standards.

Multiple-tube fermentation method

Analytical method used for determining compliance with microbiological quality standards.

Microbiological testing

Used to show if final product contains microorganisms

Identified Hazards

Hazards

1

Fecal microbial pathogens

Risks associated with ground water sources

Standards & References

External Standards

2

Standard Methods for the Examination of Water and Wastewater

Reference for analytical methods used for determining compliance.

Ground Water Rule

EPA rule providing protection against fecal microbial pathogens

Specifications

1

Standard of microbiological quality

FDA established limits for total coliform and E. coli in bottled water.

Related CFR Sections (4)

21CFR165.110§ 165.110 Bottled water.
(a) Identity —Read full regulation →
21CFR130.14§ 130.14 General statements of substandard quality and substandard fill of container.
For the purposes of regulations promulgated under section 401 of the act:Read full regulation →
21CFR129.80§ 129.80 Processes and controls.
(a) Treatment of product water. All treatment of product water by distillation, ion-exchanging, filtration, ultraviolet treatment, reverse osmosis, carbonation, mineral addition, or any other process shall be done in a manner so as to be effective in accomplishing its intended purpose and in accordaRead full regulation →
21CFR129.35§ 129.35 Sanitary facilities.
Each plant shall provide adequate sanitary facilities including, but not limited to, the following:Read full regulation →

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

Adulterated within the meaning of section 402(a)(4)

1

Failure to ensure the treatment of product water is effective

1

Failure to conduct and analyze weekly bacteriological samples

1

Failure to sample and inspect containers and closures

1

Failure to clean and adequately sanitize product water-contact surfaces

1

Treatment of product water was not done in a manner that was effective

1

Process controls did not include parameters associated with the control of a hazard

1