2013 Maryland Code
HEALTH - GENERAL
§ 21-336 - Drinking water

§21-336.

(a) (1) In this section, “approved source” means a source of water that is:

(i) Sampled and found through laboratory analysis to comply with:

1. The microbiological standards adopted by the Department, with testing on a monthly basis; and

2. The chemical and radiological standards adopted by the Department, which shall meet or exceed the standards prescribed by the federal Food and Drug Administration, with testing annually for chemical analyses and once every 4 years for radiological analyses; and

(ii) If applicable, constructed and inspected in accordance with regulations adopted by the Department of the Environment under §§ 9-204, 9-1305, and 9-1306 of the Environment Article.

(2) “Approved source” includes:

(i) An artesian well;

(ii) A drilled well;

(iii) A glacier;

(iv) A public water supply;

(v) A spring; and

(vi) A source of mineral water that complies with the standards specified in paragraph (1) of this subsection but fails to meet the standards with respect to those properties of mineral water related to the limitations on chloride, iron, manganese, sulfate, total dissolved solids, zinc, or any other exemptions listed under 21 C.F.R. 165.110.

(3) The Department may approve a source that does not meet standards regulated by the United States Environmental Protection Agency as a secondary standard if the bottler shows by analysis that a particular treatment used reduces the level of contaminants in the bottled water to a level below the maximum contaminant level.

(b) The requirements of this section are in addition to any other provision of law.

(c) Artesian water, mineral water, natural water, purified water, spring water, well water, and any other type of bottled water shall meet the requirements of the standard of identity for bottled water under 21 C.F.R. 165.110(a).

(d) (1) A person may not bottle water unless the person is licensed by the Department under § 21-305 of this subtitle.

(2) The Department may not issue a license if the Department determines that the water is:

(i) Not from an approved source; or

(ii) In any way injurious to the public health.

(3) To apply for a license to bottle water, a bottler shall:

(i) Submit an application to the Department on the form that the Department requires;

(ii) List on the application form the types of bottled water that the applicant proposes to bottle; and

(iii) Pay to the Department an annual fee established by the Secretary under § 2-104 of this article.

(4) While it is effective, a license to bottle water authorizes a bottler to bottle and sell in the State the types of bottled water identified in the license.

(e) (1) (i) A person who is licensed under this section shall submit to the Department the results of:

1. Annual chemical and radiological analyses of a representative sample of the person’s source water and bottled water; and

2. A monthly microbiological analysis of a representative sample of the source water and bottled water.

(ii) The analyses shall demonstrate that the source water and bottled water comply with the chemical, radiological, and microbiological standards adopted by the Department, which shall meet or exceed the standards prescribed by the federal Food and Drug Administration.

(iii) 1. Except as otherwise required by law, mineral water is not subject to the limitations on chloride, iron, manganese, sulfate, total dissolved solids, zinc, or any other exemptions listed under 21 C.F.R. 165.110.

2. Bottled water may not exceed:

A. 10 parts per billion of total trihalomethanes;

B. 5 parts per billion of lead; or

C. 100 parts per billion of chlorine.

(2) (i) Analyses required under this subsection may be performed by a laboratory certified by:

1. A state’s Laboratory Certification Program in accordance with the United States Environmental Protection Agency’s primacy conditions under the Agency’s Public Water System Supervision Program; or

2. The United States Environmental Protection Agency.

(ii) The Department shall accept analyses performed by any laboratory authorized under subparagraph (i) of this paragraph.

(3) A person licensed or registered under this section shall:

(i) For at least 2 years, maintain all inspection and sampling records at the person’s principal place of business; and

(ii) Make inspection and sampling records available to the Department upon request.

(4) Notwithstanding the analyses required under paragraph (1) of this subsection, the Department may sample and analyze any bottled water.

(5) The provisions of this subsection do not prevent the Department from prohibiting the use or sale of bottled water in the State, if, in the judgment of the Department:

(i) The water is shown by analysis to be unfit for drinking;

(ii) The water has been misbranded under § 21-210 of this title; or

(iii) Its quality is in any way injurious to the public health.

(f) Bottled water in individual containers shall be marked on each container with a stencil, stamp, or label that clearly indicates:

(1) The identifying batch code for the water; and

(2) In compliance with subsection (g) of this section, the type of water and any additional ingredients.

(g) Labeling of the type of bottled water and any additional ingredients, as required under subsection (f) of this section, shall conform to the labeling requirements for bottled water under 21 C.F.R. 165.110(a).

(h) In accordance with regulations adopted by the Department, a person licensed under this section shall establish written procedures and implement those procedures to:

(1) Prevent contamination during the processing, packaging, transportation, or storage of bottled water; and

(2) Recall bottled water when the person, the Department, or any other government agency determines that a supply is injurious in any way to the public health.

(i) The Department may suspend or revoke a license issued under this section if the licensee:

(1) Violates or fails to satisfy any requirement of this title or any regulation adopted under this title; or

(2) Fraudulently or deceptively obtains a license.

(j) (1) In addition to any other penalty applicable at law, a person who violates any provision of this section shall be liable for a civil penalty of:

(i) Not less than $1,000 and not more than $5,000 for a first offense; and

(ii) Not less than $5,000 and not more than $10,000 for a second offense within 2 years of the first offense.

(2) Each day on which a violation occurs constitutes a separate offense.

(k) By October 1, 2008, the Department shall adopt regulations to implement the provisions of this section.

(l) (1) The Department shall establish a Bottled Water Advisory Committee to advise and assist the Department in the development and adoption of the regulations required under subsection (k) of this section.

(2) The Advisory Committee shall consist of the following representatives:

(i) The Secretary of Health and Mental Hygiene or the Secretary’s designee, who shall serve as chairman of the Advisory Committee;

(ii) The Secretary of the Environment or the Secretary’s designee;

(iii) A hydrogeologist;

(iv) At least two individuals from the bottled water processing industry;

(v) At least one individual from the bottled water distribution industry;

(vi) At least one individual from the environmental community or consumer advocacy community; and

(vii) At least one consumer of bottled water.

§ 21-336 - 1. Bottled water

(a) Approved source; necessary treatments. -- 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) Waiver of filtration and disinfection treatment -- In general. -- 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) Waiver of filtration and disinfection treatment -- Conditions; annual sanitary survey. --

(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) Waiver of filtration and disinfection treatment -- Continued compliance. -- Once a waiver has been granted under this section:

(1) A bottler shall renew the waiver of the filtration and disinfection treatment provided under subsection (b) of this section on an annual basis if a continuation of operations is desired by submitting a letter of compliance with subsection (c) of this section from a representative of the bottler to the Department.

(2) The representative of the bottler shall certify under personal knowledge and penalty of perjury that the conditions under subsection (c) of this section on which the waiver was granted have not changed.

(3) The representative of the bottler shall have a continuing obligation to notify the Department of any change of a condition under subsection (c) of this section not later than 5 days from the date of the change.

(4) 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 C.F.R. Part 129.

(e) Waiver of filtration and disinfection treatment -- Revocation. -- 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) Construction. -- 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.