Maryland Health - General Section 21-336.1

      (a)      Except as permitted under subsection (b) of this section, bottled water shall:

            (1)      Be obtained from an approved source; and

            (2)      Undergo:

                  (i)      Ozonation or an equivalent disinfection process approved by the Department; and

                  (ii)      When required by the Department, filtration or any other treatment that is necessary for the water to comply with the standards adopted by the Department under § 21-336(e)(1)(ii) of this subtitle.

      (b)      The Department may grant to a bottler a waiver of the filtration and disinfection treatment required under subsection (a) of this section if the Department is satisfied that the filtration and disinfection treatment are not necessary to assure that a bottled water product will consistently comply with the microbiological standards under this subtitle.

      (c)      (1)      Based on the bottler's demonstration of long-term baseline microbiological data that monitors the source and the product, the nature and extent of source monitoring, and source protection and bottling sanitation procedures instituted by the bottler, a waiver may be granted if:

                  (i)      The product and source are in compliance with the Codex Alimentarius standard for natural mineral water, CAC/RS 108, as amended, and the requirements under § 21-336(a)(2) and (e) of this subtitle;

                  (ii)      The product and source are in compliance with the Code of Hygienic Practice of the Codex Alimentarius, Alinorm 85/13A, as amended, for the collection, processing, and marketing of natural mineral water; and

                  (iii)      The bottler has submitted a basic hydrogeological survey of the source, a hydrogeological assessment that demonstrates that the source is not under the direct influence of surface water, and an annual sanitary survey, all of which have been prepared by a professionally qualified hydrogeologist and which demonstrate the integrity of the source.

            (2)      The annual sanitary survey required under paragraph (1)(iii) of this subsection shall include:

                  (i)      Watershed surveillance that includes an inspection of those portions of the drainage area necessary to identify and evaluate actual and probable sources of contamination;

                  (ii)      Evaluation of source construction and protection, and, when appropriate, intake structures and transmission facilities; and

                  (iii)      Evaluation of finished water storage facilities.

      (d)      Once a waiver has been granted under this section:

            (1)      A bottler shall submit an annual report to the Department that demonstrates continued compliance of the source and the product with the Codex Alimentarius standards by:

                  (i)      Testing and approval of the source and product at least once every 2 months by the appropriate authority;

                  (ii)      Microbiological testing:

                        1.      On a weekly basis, as described in the Code of Hygienic Practices of the Codex Alimentarius, Alinorm 85/13A, for the collection, processing, and marketing of natural mineral water; and

                        2.      In accordance with the standards described in 21 CFR 103.35; and

                  (iii)      An annual inspection by an independent organization acceptable to the Department that demonstrates compliance with the Code of Hygienic Practices of the Codex Alimentarius, Alinorm 85/13A, and with the requirements of 21 CFR Part 129 for the collection, processing, and marketing of natural mineral water; and

            (2)      The product shall be bottled:

                  (i)      In an enclosed filling room or chamber that is under positive pressure of filtered purified air; and

                  (ii)      At a facility and with good manufacturing practices that comply with the requirements of 21 CFR Part 129.

      (e)      If a bottled water product is not in compliance with any requirement under subsection (c) or (d) of this section:

            (1)      The Department shall revoke the waiver; and

            (2)      The product shall be subject to the filtration and disinfection treatment requirements under subsection (a) of this section.

      (f)      Except for filtration and disinfection treatment, this section may not be construed to waive any requirement that is applicable under this subtitle to a bottled water product.