Maryland Health - General Section 21-336

Article - Health - General

§ 21-336.

      (a)      (1)      In this section the following words have the meanings indicated.

            (2)      (i)      "Approved source" means a source of water that is:

                        1.      Sampled and found through laboratory analysis to comply with:

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

                        B.      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

                        2.      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.

                  (ii)      "Approved source" includes:

                        1.      An artesian well;

                        2.      A drilled well;

                        3.      A glacier;

                        4.      A public water supply;

                        5.      A spring; and

                        6.      A source of mineral water that complies with the standards specified in subparagraph (i) of this paragraph but fails to meet the standards with respect to those properties of mineral water related to:

                        A.      Limitations on total dissolved solids; and

                        B.      Any maximum contaminant level or quality standard regulated by the United States Environmental Protection Agency only as a secondary standard.

                  (iii)      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.

            (3)      (i)      "Artesian water" means bottled water from a well in which the static water level rises above the top of the aquifer from which the water is drawn.

                  (ii)      "Artesian water" shall meet all the requirements of natural water.

            (4)      (i)      "Mineral water" means bottled water that:

                        1.      Is obtained from a natural spring or by tapping at least 1 borehole into an underground approved source that is geologically and physically protected; and

                        2.      Is clearly distinguishable from other types of water by its specific content of minerals and trace elements that remain constant in the original state at the point of emergence.

                  (ii)      "Mineral water" shall meet all the requirements of natural water.

            (5)      (i)      "Natural water" means bottled water that is:

                        1.      Derived from an aquifer or a glacier; and

                        2.      Except as related to disinfection purposes, not modified by blending with another type of water or by the addition or deletion of dissolved solids.

                  (ii)      "Natural water" includes:

                        1.      Artesian water;

                        2.      Mineral water;

                        3.      Glacier water;

                        4.      Spring water; and

                        5.      Well water.

                  (iii)      "Natural water" does not include water that is derived from a municipal system or public water supply.

                  (iv)      "Natural water" may be collected by means of pipes, pumps, trucks, tunnels, or other devices.

            (6)      "Purified water" means bottled water that:

                  (i)      Is produced by distillation, deionization, reverse osmosis, or any other means approved by the Department; and

                  (ii)      Meets all the requirements of the United States Pharmacopoeia definition of purified water.

            (7)      (i)      "Spring water" means bottled water derived from an underground aquifer from which water flows naturally to the surface of the earth.

                  (ii)      "Spring water" shall be collected:

                        1.      At the natural orifice; or

                        2.      If the water retains all of the physical properties of, and the same composition as, water that flows naturally to the surface of the earth, from a borehole near a spring that intercepts the same source of water as the spring.

                  (iii)      "Spring water" shall meet all the requirements of natural water.

            (8)      (i)      "Well water" means bottled water from a hole drilled in the ground to tap the water of an aquifer.

                  (ii)      "Well water" shall meet all the requirements of natural water.

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

      (c)      (1)      Except as authorized under subsection (d) of this section, 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.

      (d)      (1)      Subject to the requirements of subsection (e) of this section, a person may not sell water in this State that was bottled outside this State unless the person bottling the water has registered the water with the Department.

            (2)      In order to register with the Department, a person shall present to the Department:

                  (i)      A statement of acceptability issued by the appropriate approving authority of the state in which the water is collected, demonstrating that:

                        1.      The source of the water supply and the method of handling the water, as practiced in that state, are not prejudicial to the public health and the method is at least as stringent as those required under this section; and

                        2.      The water is allowed to be sold in the state that issued the statement of acceptability; and

                  (ii)      Any other documents related to public health and safety required of a person applying for a license to bottle water in this State.

            (3)      The provisions of this subsection do not prevent the Department from prohibiting the use or sale of bottled water shipped from outside this 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 in any way is injured by such handling as may be accorded to it after arriving in this State.

            (4)      The Secretary shall establish an annual out-of-state registration fee under this section in accordance with § 2-104 of this article.

      (e)      (1)      (i)      A person who is licensed or registered 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:

                        A.      The limitation on total dissolved solids under 21 CFR 103.35; or

                        B.      Any maximum contaminant level or quality standard that is not a primary standard for purposes of regulation by the United States Environmental Protection Agency under the Safe Water Drinking Act.

                        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 following requirements:

            (1)      Artesian water may be labeled "artesian water" or "natural artesian water";

            (2)      (i)      1.      Mineral water may be labeled "mineral water" or "natural mineral water"; but

                        2.      Bottled water to which minerals have been added:

                        A.      Shall be labeled to disclose what minerals were added; and

                        B.      May not be labeled "mineral water"; and

                  (ii)      The total dissolved solids contained in mineral water shall be:

                        1.      Written on the label; and

                        2.      Stated in milligrams per liter;

            (3)      Purified water shall be labeled "purified water" or by the method of preparation, and the method of preparation shall be stated on the label;

            (4)      Spring water may be labeled "spring water" or "natural spring water";

            (5)      Well water may be labeled "well water" or "natural well water";

            (6)      Bottled water:

                  (i)      May be labeled "naturally carbonated" or "naturally sparkling" if:

                        1.      It contains carbon dioxide that emerges from the source and the water is bottled directly with its entrapped gas; or

                        2.      Carbon dioxide is mechanically separated from the water and is later reintroduced at the same or lower concentration as the concentration that naturally occurs; and

                  (ii)      Shall be labeled "carbonated", "carbonation added", or "sparkling" if it contains carbon dioxide from a manufactured source;

            (7)      (i)      Bottled water may be labeled "drinking water" or "bottled drinking water";

                  (ii)      Except for "purified drinking water", as defined by the United States Pharmacopoeia, at any point during the bottling process, bottled water that is derived from a public drinking water supply, as defined under the Safe Drinking Water Act, shall be labeled "drinking water" or "bottled drinking water", and its approved source shall be stated on the label in a factually accurate manner;

            (8)      (i)      Except as provided under subparagraph (ii) of this paragraph, a licensee or registrant under this section may not label bottled water with a word or a derivative of a word that does not accurately describe the type of bottled water;

                  (ii)      1.      The provisions of subparagraph (i) of this paragraph may not be construed to restrict a word or a derivative of a word that is part of a bottler's trademark, trade name, or company name; but

                        2.      If the word or derivative of a word that is part of the bottler's trademark, trade name, or company name is reasonably construed to mean a type of bottled water, the type of water in the container shall be identified on the same label in typeface at least as large as the typeface used in the trademark, trade name, or company name;

            (9)      Bottled water that meets more than 1 definition under subsection (a) of this section may be labeled as any of its applicable types; and

            (10)      Any additional standards established by the Department.

      (h)      In accordance with regulations adopted by the Department, a person licensed or registered 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 or registration issued under this section if the licensee or registrant:

            (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 or registration.

      (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 March 31, 1993, 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.



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