Code of Massachusetts Regulations
105 CMR - DEPARTMENT OF PUBLIC HEALTH
Title 105 CMR 500.000 - Good Manufacturing Practices For Food
Supplemental Regulations for the Manufacture, Collection, Bottling, and Labeling of Bottled Water and Carbonated Non-alcoholic Beverages
Section 500.091 - Water Source Protection, Treatment, and Modification for Bottled Water and Carbonated Non-alcoholic Beverages

Universal Citation: 105 CMR 500.000 MA Code of Regs 500.091

Current through Register 1531, September 27, 2024

(A) In-state Sources.

(1) Each water source shall comply with 310 CMR 22.00: Drinking Water, with any applicable Massachusetts Department of Environmental Protection (DEP) water supply health advisories or guidelines, and, if applicable, with M.G.L. c. 21G.

(2) The Department and DEP shall cooperate in the approval, inspection, and enforcement of requirements for in-state water sources, pursuant to the terms of the current Memorandum of Understanding (MOU) between the Department of Public Health and the Department of Environmental Protection for In-state Bottled Water Source Review.

(3) Each water source shall be located, developed, and protected to ensure that it is not subject to natural or artificial contamination. If necessary, source water may be treated in order to control natural or artificial contamination. Source water treatment must be approved in accordance with 105 CMR 500.091(A)(4) and (5).

(4) Before a water source is used or substantially modified, or the source water is treated or the treatment is substantially modified, or a new source is used in addition to the existing approved source(s), the source owner shall apply to the Department for approval and shall submit information as required by the application form, including but not limited to:

(a) The type of source (e.g. well, spring);

(b) A detailed location of the source;

(d) Information about the use and treatment of the source and/or the modification of the source or treatment;

(e) If the source is a public water system, the information specified in 105 CMR 500.093(A)(1)(c); and

(f) If the source is not a public water system, the information specified in 105 CMR 500.093(A)(1)(a), and subject to the requirements of 105 CMR 500.093(A)(1)(b).

(5) The Department will forward that portion of the application relating to the water source to DEP. Based on DEP's recommendation and in accordance with current law, the Department shall notify the owner whether the following are approved:

(a) The water source;

(b) Substantial modification to the water source;

(d) Substantial modification to source water treatment.

If the Department determines that approval is not appropriate, it shall notify the owner of the modifications that are necessary in order for approval to be granted.

(6) Prior to the sale of products using any new or substantially modified source or new or substantially modified treatment, the bottler shall submit the following information to the Department:

(a) One label for each container size and brand name of the product that is proposed to be sold; and

(b) If the source is not a public water system, or if the source is a public water system that the bottler treats beyond the definition of minimal treatment, i.e., beyond mechanical filtration and/or disinfection, the results of a complete chemical, physical, microbiological, and radiological analysis of the source water and of each of the different finished products bottled by the facility, as specified in 105 CMR 500.093(A). The analyses shall have been completed within the 12 months prior to the first use of the new or modified source water or treatment, with the exception of the microbiological analysis, which shall have been performed within the four weeks prior to the first such use.

(7) The bottler shall not sell products manufactured with water from the new or substantially modified source or new or substantially modified treatment until written approval is received from the Department.

(8) The bottler may use water from a particular water source in bottling bottled water or carbonated non-alcoholic beverages only when that source and any treatment of that source have a current approval from the Department.

(B) Enforcement Actions with Respect to a Water Source.

(1) The Department may issue an Order to Cease and Desist or summarily suspend approval of the water source if there is a reasonable likelihood that continued use of the water source presents an imminent danger to the public health. An Order to Cease and Desist shall be as specified in 105 CMR 500.206, and summary suspension shall be as specified in 105 CMR 500.207(B), except that all references to "license" and "licensee" shall be replaced by "source approval" and "source owner;" and all references to "facility" shall be replaced by "water source."

(2) The Department may refuse to grant, suspend with notice, or revoke approval of a water source if the water source fails to comply with any DEP requirement or with any applicable requirement of 105 CMR 500.000. Such refusal, suspension, or revocation shall be as specified in 105 CMR 500.207(A) or (C), except that all references to "license" and "licensee" shall be replaced by "source approval" and "source owner;" and all references to "facility" shall be replaced by "water source."

(3) The Department has the authority to commence enforcement proceedings against a water source pursuant to 105 CMR 500.206 through 500.208 in the case of violations with respect to the use or substantial modification of the water source, or treatment or substantial modification of treatment of source water.

(4) If the approval of the water source is subject to condition(s), the Department may enforce the conditions by issuing an order or by commencing an administrative enforcement action.

(1) Out-of-state and foreign water sources shall be licensed or approved by the government agency having jurisdiction, if such jurisdiction issues such licenses or approvals. A copy of the current such license or approval shall be provided to the Department by the bottler upon application and reapplication for a license, and upon substantial modification of the source or source treatment, or upon the addition of a new source. Additional information, including but not limited to hydro-geological reports on source development, site plans, and the like may also be required.

(2) All bottlers who use an out-of-state or foreign water source shall provide documentation to the Department from the appropriate government agency regarding the type of water source to be used in finished products, as specified in 21 CFR 165.110: Bottled Water (e.g. well, spring, etc.). In foreign countries where no such government approval process is available, the company shall provide hydro-geological reports, photographs, and any other documentation requested, in English, to facilitate determination of the type of source as specified in 21 CFR 165.110. The Department will determine the type of source after review of the information provided.

(3) Prior to the sale of products using any new or substantially modified source or new or substantially modified treatment, the bottler shall submit to the Department the information specified in 105 CMR 500.091(A)(4) and (6).

(4) The bottler shall not sell products manufactured with water from the new or substantially modified source or new or substantially modified treatment until written approval is received from the Department.

(D) Maintenance of Records. At all times, the facility shall maintain current records of approval of the source water by the government agency having jurisdiction.

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