105 CMR 500.091
Water Source Protection, Treatment, and Modification for Bottled Water and Carbonated
Non-alcoholic Beverages
(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;
(c) The owner(s) 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;
(c) Treatment to bring source water into compliance with the quality standards in
105 CMR 500.092(A); and/or
(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.
The bottler shall not sell products manufactured with water from the new or sub
stantially 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.
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.
(C) Out-of-state and Foreign Sources,
(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).
The bottler shall not sell products manufactured with water from the new or sub
stantially 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.