Chapter 11. Bottled Water

“Approved source” has the meaning stated in Health-General Article, §21-336(a), Annotated Code of Maryland.

“Approving authority” means the agency designated in the laws of another state or country to license or permit a source water, public water supply system, or bottled water plant if that source water, public water supply system, or bottled water plant is located outside the State.

“Aquifer” means a formation of soil, sand, rock, gravel, limestone, sandstone, or other geologic material that contains ground water available for collection.

“Artesian water” means the product that meets the standard of identity as set forth in 21 CFR §165.110(a)(2)(i).

“Borehole” means a well tapped into an aquifer for the purpose of removing water from the aquifer for bottling or dispensing.

Bottled Water.

“Bottled water plant” means a food processing plant that:

“Certified laboratory” means a laboratory certified by:

“Community water system” means a public water supply system that:

“Contaminant” means a physical, chemical, biological, or radiological substance or matter in water.

“Department” means the Maryland Department of Health or the Department's designee.

“Drinking water” means water that is intended for human consumption.

“Finished product water” means drinking water in the form in which it is provided to the consumer.

“Ground water” means water from a subsurface saturated zone that is under a pressure equal to or greater than atmospheric pressure.

“Ground water under the direct influence of surface water” means ground water with:

“Mineral water” means the product that meets the standard of identity set forth in 21 CFR §165.110(a)(2)(iii).

“Person-in-charge” means a licensee or other individual responsible for the operation of a bottled water plant.

Public Water Supply System.

“Source water” means the water that is processed into finished product water.

“Spring” means a source of water issuing naturally from the ground, a rock formation, or a fracture onto the land or into a body of water.

“Spring water” means the product that meets the standard of identity set forth in 21 CFR §165.110(a)(2)(vi).

“Statement of acceptability” means the approval issued by the approving authority in a state or country in which the water is collected that demonstrates that a source water quality and a method of handling the water pose no threat to the public health.

“Type of water” means a product that meets one of the standards of identity set forth in 21 CFR §165.110(a)(2).

“Waiver of filtration and disinfection” means written approval from the Department that allows a person to bottle water without filtering and disinfecting the water to exclude and kill microorganisms.

“Well” means a hole made in the ground to:

Process finished product water; and

Design, operate, and maintain a bottled water plant and equipment.

Health-General Article, §21-305, Annotated Code of Maryland;

COMAR 10.15.04; and

This chapter.

A bottled water plant is not operated without the license required by Health-General Article, §21-305, Annotated Code of Maryland;

The required food processing plant license is conspicuously posted in a bottled water plant; and

The operations in a bottled water plant are limited to the types of water specified on the license, pursuant to §B of this regulation.

Apply for an annual license in accordance with Health-General Article, §§21-305, 21-306, and 21-336, Annotated Code of Maryland;

Submit to the Department:

Pay an annual license fee as specified in COMAR 10.01.17.02.

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;

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;

For a source water located outside the State, a statement of acceptability; and

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 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;

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;

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;

For a source water located outside the State, a statement of acceptability; and

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.

Have a microbiological, chemical, and radiological analysis of each type of water completed in accordance with Regulation .06 of this chapter;

Ensure that each type of water meets the water quality standards in Regulation .06 of this chapter; and

Submit the analyses to the Department.

Does not meet the requirements of, or a regulation promulgated under, Health-General Article, Title 21, Subtitles 1 — 3, Annotated Code of Maryland;

Fraudulently or deceptively attempts to obtain a license; or

Has not demonstrated that each type of water:

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

Fraudulently or deceptively obtains a license.

A source of water for finished product water is an approved source;

Within the State, a ground water appropriation permit is obtained from the Maryland Department of the Environment as required in COMAR 26.17.06; and

A spring is constructed, developed, or improved in accordance with §B of this regulation.

A spring is constructed, developed, or improved in accordance with the following requirements:

A spring is constructed, developed, or improved in accordance with a plan made by a registered professional engineer or professionally qualified hydrogeologist that:

A borehole used to obtain spring water:

A well within the State that is used as a source of finished product water is permitted, constructed, and installed in conformance with COMAR 26.04.04;

When bottling artesian water, a hydrogeological report is kept at the plant that shows that the static water level in the well is at some height above the aquifer;

When ground water is a source of finished product water, the ground water is not under the direct influence of surface water;

A statement of acceptability for a source of water is kept on file at the plant and available for inspection by the Department; and

A public water supply system in the State that is used as a source of finished product water is a community water system that complies with COMAR 26.04.01.

Except as provided in §B(4) of this regulation, contaminant levels in source water and finished product water do not exceed the maximum allowable concentration for contaminants set forth in 21 CFR §165.110(b);

Except as provided in §A(8) of this regulation, the analyses for all contaminants in source water and finished product water are performed by a certified laboratory using a representative sample and methods set forth in 21 CFR §§165.110(b) and 165.3;

Except as provided in §B of this regulation, a representative sample of source water and finished product water is taken and tested for:

The analyses results for sampling required in §A(3) of this regulation are submitted to the Department:

When a sample is positive for total coliforms:

Except as provided in §B(4) of this regulation, source water that does not meet the water quality standards in §A of this regulation is not bottled or processed as drinking water;

Finished product water that does not meet the water quality standards in §A of this regulation is not offered for human consumption;

A representative sample of source water and drinking water for testing is:

A source water is sampled and tested before any treatment or filtration of the source water;

Drinking water and source water that are not filtered or disinfected during processing do not contain coliform bacteria;

The microbiological contaminants in source water that is filtered or disinfected during processing do not include:

The contaminant concentration of trihalomethanes in bottled water does not exceed 10 parts per billion.

If a source water is from a public water supply system in the State or outside the State, the person-in-charge may use public water supply system analyses results or a certificate from the Maryland Department of the Environment or the approving authority to demonstrate compliance with the water quality standards for source water set forth in §A of this regulation.

The Department may waive the requirement for a weekly microbiological analysis of source water that is from a public water supply system in the State or outside the State, if public water supply system analyses results or a certificate from the Maryland Department of the Environment or the approving authority demonstrates compliance with the water quality standards set forth in §A of this regulation.

Mineral water is exempt from the maximum allowable concentration of chloride, iron, manganese, total dissolved solids, and zinc as provided in 21 CFR §165.110(b)(4)(i)(A).

Except for a microbiological contaminant, the Department may approve a source water that contains a contaminant at a level that exceeds the maximum allowable concentration for finished product water based on a review that demonstrates that a treatment of the source water is:

Maintain at the plant:

Make the records available for inspection by the Department.

Meets all applicable State and local codes; and

Properly disposes of all wastewater;

Are separate for men and women;

Are provided at the rate of one toilet for every 15 employees; and

Do not open directly into an area in which:

Is separated from other plant operations and storage areas by:

Has conveyor openings only large enough to allow passage of containers;

Is mechanically ventilated using exhaust and supply air fans so that:

Has a floor sloped to floor drains;

Has a floor, walls, and a ceiling that are:

Has a hand sink:

Has lighting that provides a minimum of 40 foot candles on all work surfaces;

Meets the requirements in §E of this regulation; and

Is situated in the plant and has equipment located within the room to minimize postsanitizing contamination of the containers before the containers enter the bottling room;

Conveyor covers that meet the design specifications in Regulation .08 of this chapter; or

Being held in rooms that have finished ceilings that are:

Maintained in a sanitary and working condition;

Provided with instrumentation to allow:

Monitored to verify that process requirements are met; and

Durable and impervious to water;

Are nontoxic and inert to water under the conditions of use;

Do not migrate to or adulterate drinking water;

Are nonporous and nonabsorbent; and

Are corrosion resistant;

Designed, constructed, and maintained to be:

Cleaned and sanitized:

A cleaning and sanitizing solution is:

The design, construction, and maintenance of a clean-in-place piping system prevents the contamination of drinking water by cleaning and sanitizing chemicals; and

The operation of a clean-in-place system using chemicals that are potentially hazardous to public health is controlled and monitored;

Documents the:

Is maintained for at least 2 years after the cleaning, sanitizing, inspection, maintenance, or monitoring activity; and

Is available for inspection by the Department; and

Documents the type and quantity of finished product water produced;

Identifies the initial distribution of the finished product water to facilitate, when necessary, the segregation of specific finished product water that may be adulterated or otherwise unfit for human consumption;

Is maintained for at least 2 years after the control, observation, or monitoring is done; and

Is available for inspection by the Department.

Not used for storage of a nonfood product;

Closed to exclude all foreign matter;

Vented in a sanitary manner; and

Sampled weekly and analyzed for coliform bacteria and standard plate count;

Protected from contamination;

Kept sealed or locked when water for bottling is not being transferred; and

Not susceptible to damage or tampering;

Cleaned and sanitized as often as necessary to maintain a sanitary condition and at least once per week; and

Provided a number or other marking on the outside of the truck; and

Provides the following information for each batch of drinking water delivered:

Is maintained for at least 2 years after the record is made; and

Is available for inspection by the Department.

Protected from contamination; and

If multiservice, adequately cleaned, sanitized, and inspected prior to filling in accordance with 21 CFR §129.80(b)(1), (c), and (d);

Stored in a sanitary manner; and

Before use:

Document the proper cleaning and sanitization of containers;

Are maintained for at least 2 years; and

Are available for inspection by the Department.

Ozonation, exposure to ultraviolet light, or an equivalent disinfection process approved by the Department; and

Filtration or other treatment that is necessary for the water to comply with the standards in Regulation .06 of this chapter;

Is effective in providing the required or intended result;

Is controlled;

Is monitored; and

Uses chemicals, materials, and methods that do not impart substances to the water in a concentration that is toxic, harmful, or deleterious; and

Proven through a review of scientific study to reduce the target microorganisms to an acceptable level;

Approved by the Department;

Controlled;

Monitored; and

Interlocked with the bottling system so that a failure in the filtration or disinfection system inactivates the bottling system and water is prevented from being bottled.

Made of food-grade materials;

Clean and sanitary when filled with finished product water; and

Properly sealed to prevent the contamination of the water after bottling;

Made of food-grade materials;

Clean and sanitary when used; and

Properly sealed onto containers to prevent the contamination of the water after bottling;

The type of water as set forth in Health-General Article, §21-336(c), (f)(2), and (g), Annotated Code of Maryland, 21 CFR §165.110(a), and this chapter;

The name and address of the manufacturer or distributor;

The net fluid measure of the contents of the container in common and metric units; and

A production code as required in Health-General Article, §21-336(f)(1), Annotated Code of Maryland, and 21 CFR §129.80(e); and