Are not bottled water and beverage companies already regulated, testing and disclosing data for contaminants regulated by the FDA?

Are not bottled water and beverage companies already regulated, testing and disclosing data for contaminants regulated by the FDA?

In the United States, bottled water is regulated by the Food and Drug Administration (FDA) as a packaged food product. This covers how producers must test both source water and finished bottled water:

1.      Microbiological Testing

·       Finished bottled water: Must be tested at least weekly for total coliforms as well. Detecting coliform triggers confirmatory E. coli testing.

2. Chemical, Physical, and Radiological Tests

• Chemical and physical contaminants (e.g., common inorganic chemicals, pH, turbidity) must be tested at least annually.  

• Radiological contaminants (e.g., radium, uranium, photon/beta emitters) are typically tested once every 4 years for source water and at least annually in finished products under the existing FDA framework.  

These frequencies come from FDA’s interpretation of current good manufacturing practice regulations for bottled water.

3. Records & Compliance

• Bottlers must retain records of testing results and corrective actions for years (FDA requires a minimum retention period, often 2 years or more depending on the test type).  

• Finished products containing contaminants above allowed levels are considered adulterated, triggering enforcement actions.  

4. State & Local Requirements

Many states also have additional rules for bottled water produced or sold in their jurisdiction. For example, some states require:

• Annual chemical/physical testing

• Weekly microbiological tests

• Testing reports submitted to the state

• Use of certified laboratories (e.g., California requires lab certification).  

 5. Comparison with Tap Water

• Tap water (regulated by EPA) often has more stringent reporting and public notification requirements, whereas bottled water may have fewer mandated public disclosures of testing results.  

Will Operation Pure Water standards ever be less stringent than state, federal or international adopted or updated drinking water standards?

No.   Below are current standards for PFAS and Microplastics that are dynamic and expected to change over time.  Once the certification process has been initiated, the Operation Pure Water standards in effect will be used. The certification standards will be updated on an annually.

Region/Country	Type of Limit	Key PFAS Limit(s)a
EU	Enforceable Directive	Sum of 20 PFAS: 100 ng/L; Total PFAS: 500 ng/L (
USA (EPA)	Enforceable MCLs	PFOA & PFOS: 4 ppt; PFHxS/PFNA/HFPO-DA: 10 ppt
Canada	Health-based guideline	Total ~30 ng/L (sum of ~25 PFAS)
Australia	Guideline values	PFOA ~200 ng/L; PFOS ~8 ng/L; PFHxS ~30 ng/L
New Zealand	Standard	PFOA ~560 ng/L; PFOS+PFHxS ~70 ng/L
Japan	Provisional	PFOA+PFOS ~50 ng/L

For Microplastics, regulations are still in the development phase.

Region / Body	Drinking Water Numeric Limit	Monitoring / Methods Requirement	Notes
WHO	No numeric limit	Recommendations for research & management	WHO guidelines don’t mandate limits yet. (WHO CDN)
EU (Directive)	No limit (yet)	Yes: Harmonized monitoring methods mandated	Standardized sampling/analysis methods
ISO International Standards	Not yet	Yes: Measurement & management standards in progress	Provides analytical frameworks.
USA EPA	No federal limit yet	Monitoring petition/discussion	Local definitions being developed (e.g., CA).