Small Entity Compliance Guide: Bottled Water and Uranium

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

Bottled water manufacturers

Entities required to monitor finished products for DEHP

Technical Details

Substances

1

Uranium

high concentrations of uranium detected in private wells

Testing Methods

4

Method 7120 B

Gamma Spectroscopic Method for water examination

Method 7110 C

Coprecipitation Method for Gross Alpha Radioactivity.

Method 7500-U C

Isotopic Method for determining uranium compliance.

Method 7500-U B

Radiochemical Method for determining uranium compliance.

Identified Hazards

Hazards

1

Increased risk of cancer

Potential health risk from long-term exposure to uranium.

Standards & References

External Standards

1

Standard Methods for the Examination of Water and Wastewater

Reference for analytical methods used for determining compliance.

Specifications

1

30 micrograms per liter

The allowable level for uranium in bottled water.

Related CFR Sections (1)

21CFR165.110§ 165.110 Bottled water.
(a) Identity —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