Current through Register Vol. 51, No. 19, September 20, 2024
A. The
person-in-charge shall obtain a food processing plant license to operate a
bottled water plant pursuant to the provisions of:
(1) Health-General Article, §21-305,
Annotated Code of Maryland;
(2)
COMAR 10.15.04; and
(3) This
chapter.
B. The
Department shall specify on a food processing plant license the types of
bottled water product that the licensee is authorized to process, package, or
label.
C. The person-in-charge
shall ensure that:
(1) A bottled water plant
is not operated without the license required by Health-General Article,
§21-305, Annotated Code of Maryland;
(2) The required food processing plant
license is conspicuously posted in a bottled water plant; and
(3) The operations in a bottled water plant
are limited to the types of water specified on the license, pursuant to §B
of this regulation.
D. A
person seeking to bottle water in the State shall:
(1) Apply for an annual license in accordance
with Health-General Article, §§21-305, 21-306, and 21-336, Annotated
Code of Maryland;
(2) Submit to the
Department:
(a) Plans and specifications for
a bottled water plant in accordance with Health-General Article, §21-321,
Annotated Code of Maryland; and
(b)
Any applicable requirements as outlined in §§E and F of this
regulation; and
(3) Pay
an annual license fee as specified in COMAR
10.01.17.02E.
E. Specific Application
Requirements - Initial License. A person seeking an initial license in
accordance with Health-General Article, §§21-305, 21-306, and 21-336,
Annotated Code of Maryland, shall submit to the Department the following
specific information:
(1) A microbiological
analysis of each source water completed in accordance with Regulation .06 of
this chapter that is dated within 30 days of the Department's receipt of an
initial license application;
(2) A
chemical and radiological analysis of each source water completed in accordance
with Regulation .06 of this chapter that is dated within 1 year of the
Department's receipt of an initial license application;
(3) For a source water located outside the
State, a statement of acceptability; and
(4) For a type of water manufactured from a
source water without filtration or disinfection, a request for a waiver of
filtration and disinfection that includes:
(a)
Analyses of the source water covering a period of at least 3 years that
indicate compliance with Regulation .06 of this chapter;
(b) Detailed information on methods to
protect the source water;
(c) The
procedures and process for bottling the source water in a sanitary
manner;
(d) A hydrogeological
survey with an assessment conducted by a hydrogeologist, professional engineer,
or the approving authority that determines that the source of water is not
under the direct influence of surface water and meets the requirements set
forth in this chapter;
(e) A
sanitary survey conducted by a hydrogeologist, professional engineer, or the
approving authority that documents an evaluation of the drainage area,
reservoir, and transmission and storage facilities for the source water and
identifies and determines the significance of probable sources of
contamination; and
(f) A statement
that the bottler will notify the Department not later than 5 days from the date
of any change in conditions under which the waiver was granted.
F. Specific Application
Requirements - Renewal Application. A person seeking to renew a license in
accordance with Health-General Article, §§21-305, 21-306, and 21-336,
Annotated Code of Maryland, shall submit to the Department:
(1) A microbiological analysis of each source
water and type of water in accordance with Regulation .06 of this chapter that
is dated within 30 days of the Department's receipt of a license renewal
application;
(2) A chemical
analysis of each source water and type of water completed in accordance with
Regulation .06 of this chapter that is dated within 1 year of the Department's
receipt of the license renewal application;
(3) A radiological analysis of each source
water and type of water completed in accordance with Regulation .06 of this
chapter that is dated within 4 years of the Department's receipt of the license
renewal application;
(4) For a
source water located outside the State, a statement of acceptability;
and
(5) If the renewal application
includes a waiver of filtration and disinfection previously approved by the
Department, a letter of compliance to the Department certifying under personal
knowledge and penalty of perjury that the conditions on which the waiver was
granted have not changed.
G. After receiving an initial license and
before selling or distributing finished product water, the person-in-charge
shall:
(1) Have a microbiological, chemical,
and radiological analysis of each type of water completed in accordance with
Regulation .06 of this chapter;
(2)
Ensure that each type of water meets the water quality standards in Regulation
.06 of this chapter; and
(3) Submit
the analyses to the Department.
H. The Department shall deny an application
for a license if the applicant:
(1) Does not
meet the requirements of, or a regulation promulgated under, Health-General
Article, Title 21, Subtitles 1-3, Annotated Code of Maryland;
(2) Fraudulently or deceptively attempts to
obtain a license; or
(3) Has not
demonstrated that each type of water:
(a) Is
from an approved source;
(b) Meets
the water quality standards in Regulation .06A of this chapter; and
(c) Is not injurious to the public
health.
I.
The Department may suspend or revoke a license if the licensee:
(1) Violates or fails to meet the
requirements of, or a regulation adopted under, Health-General Article, Title
21, Subtitles 1-3, Annotated Code of Maryland; or
(2) Fraudulently or deceptively obtains a
license.
