Small Entity Compliance Guide: Bottled Water and Residual Disinfectants and Disinfection Byproducts

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

2

Bottled water firms

Entities responsible for testing source water for residual disinfectants.

Bottled water manufacturers

Entities required to monitor finished products for DEHP

Technical Details

Substances

8

TTHM

Total Trihalomethanes established allowable level of 0.080 mg/l.

Total trihalomethanes

Disinfection byproduct (DBP) also referred to as TTHM

Haloacetic acids

Disinfection byproduct (DBP) also referred to as HAA5

Chlorite

Disinfection byproduct (DBP) with established allowable levels

Bromate

Disinfection byproduct (DBP) with established allowable levels

Chlorine dioxide

Substance used for sanitizing.

Chlorine

Used in wash water as a process control; antimicrobial substance for wash water control; used as a process control in wash water; Used to prevent cross-contamination during washing

Chloramine

Substance in water causing hemolysis if not filtered; Carbon filter used primarily to remove chlorine and chloramine

Testing Methods

7

Method 4500-ClO2 E

Amperometric Method II for chlorine dioxide.

Method 4500-Cl D

Amperometric Titration Method for residual chlorine.

Method 551.1

Determination of Chlorination Disinfection Byproducts by Liquid-Liquid Extraction and Gas Chromatography.

Method 524.2

Measurement of Purgeable Organic Compounds in Water by Capillary Column Gas Chromatography/Mass Spectrometry.

Method 502.2

Volatile Organic Compounds in Water by Purge and Trap Capillary Column Gas Chromatography.

Method 552.2

Determination of Haloacetic Acids and Dalapon in Drinking Water by Liquid-Liquid Extraction

Method 300.1

Determination of Inorganic Anions in Drinking Water by Ion Chromatography

Identified Hazards

Hazards

1

Cancer

quantitative assessment of the risk for cancer associated with exposure to inorganic arsenic

Standards & References

External Standards

2

ASTM Method D1253-86

Standard Test Method for Residual Chlorine in Water.

Safe Drinking Water Act

Statute under which EPA issues National Primary Drinking Water Regulations

Specifications

5

4.0 mg/l

Allowable level for chloramine and chlorine in bottled water.

0.080 mg/l

Allowable level for TTHM in bottled water.

0.060 mg/l

Allowable level for HAA5 in bottled water

1.0 mg/l

Allowable level for chlorite in bottled water

0.010 mg/l

Allowable level for bromate in bottled water

Related CFR Sections (2)

21CFR129.35§ 129.35 Sanitary facilities.
Each plant shall provide adequate sanitary facilities including, but not limited to, the following:Read full regulation →
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