To assure that the source used by a plant for bottled water is in compliance with the quality standards set forth in He-P 2102.02, the plant or bulk source ownership shall collect or direct the collection of samples of source water for analysis, in accordance with 21 CFR 129.35, as follows:

1. (a) For chemical and physical standards, samples of source water shall be collected and analyzed at least once each calendar year;
2. (b) For radiological standards, samples of source water shall be collected and analyzed at least once every 4 years; and
3. (c) For microbiological standards, samples of source water shall be collected and analyzed at least once each calendar year if the source is a public water supply, or once each week if the source is not a public water supply.

Source. #12680, eff 11-27-18