Sec. 10.15.11.04. Licenses

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 10.01.17.02.

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.