In this chapter, the following terms have the meanings indicated. Terms Defined. “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” means: Any water that is sealed in bottles, packages, or other containers and offered for sale for human consumption, including bottled mineral water; and The product that meets the standards of identity set forth at 21 CFR §165.110(a). “Bottled water” does not include: Soft drinks; and A beverage labeled as club soda or seltzer water. “Bottled water plant” means a food processing plant that: Manufactures, packages, or labels bottled water; or Stores water before bottling. “Certified laboratory” means a laboratory certified by: A state's laboratory certification program in accordance with the United States Environmental Protection Agency's primacy conditions under the Agency's Public Water System Supervision Program; The National Environmental Laboratory Accreditation Program; or The United States Environmental Protection Agency. “Community water system” means a public water supply system that: Services at least 15 service connections used by year-round residents; or Regularly serves at least 25 residents throughout the year. “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: Significant occurrence of insects and other macroorganisms, algae, or other large diameter pathogens such as Giardia lamblia or Cryptosporidium; or Significant and relatively rapid shifts in water characteristics such as turbidity, temperature, conductivity, or pH that closely correlate to climatological or surface water conditions. “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. “Public water supply system” means a system providing piped water to the public for human consumption, if the system: Has at least 15 service connections; or Regularly serves an average of 25 individuals daily at least 60 days out of the year. “Public water supply system” includes a collection, treatment, storage, and distribution facility that is: Under the control of the operator of the system and used primarily in conjunction with the system; and A collection or pretreatment storage facility not under the control of the operator of the system that is used primarily in connection with the system. “Public water supply system” does not include a special irrigation district. “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: Explore for ground water; Obtain or monitor ground water; or Inject water into an underground formation from which ground water can be produced. In this chapter, the following documents are incorporated by reference: 21 CFR Part 129, as amended; 21 CFR §165.110, as amended; and 21 CFR §165.3, as amended. The person-in-charge shall comply with this chapter and COMAR 10.15.04 to: Process finished product water; and Design, operate, and maintain a bottled water plant and equipment. If a conflict occurs between the requirements of this chapter and COMAR 10.15.04 regarding bottled water plants and the processing of drinking water, this chapter takes precedence. The person-in-charge shall obtain a food processing plant license to operate a bottled water plant pursuant to the provisions of: Health-General Article, §21-305, Annotated Code of Maryland; COMAR 10.15.04; and This chapter. 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. The person-in-charge shall ensure that: 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. A person seeking to bottle water in the State shall: 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: Plans and specifications for a bottled water plant in accordance with Health-General Article, §21-321, Annotated Code of Maryland; and Any applicable requirements as outlined in §§E and F of this regulation; and Pay an annual license fee as specified in COMAR 10.01.17.02. 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: 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: Analyses of the source water covering a period of at least 3 years that indicate compliance with Regulation .06 of this chapter; Detailed information on methods to protect the source water; The procedures and process for bottling the source water in a sanitary manner; 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; 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 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. 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: 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. After receiving an initial license and before selling or distributing finished product water, the person-in-charge shall: 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. The Department shall deny an application for a license if the applicant: 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: Is from an approved source; Meets the water quality standards in Regulation .06A of this chapter; and Is not injurious to the public health. The Department may suspend or revoke a license if the licensee: 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. The person-in-charge shall ensure that: 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. Spring Requirements. The person-in-charge shall ensure that: A spring is constructed, developed, or improved in accordance with the following requirements: A fissure or opening in the geologic formation from which the water flows into the spring is: Enclosed within an encasement of concrete, tile, steel, or another impervious material; or Otherwise tapped in a manner that ensures the capture of only ground water flowing from the geologic formation; The walls of a spring encasement penetrate the geologic formation from which the water flows to intercept and contain ground water; A spring encasement is provided a cover; The material used in the construction or improvement of the spring does not impart a toxic or deleterious substance to the water; A fence or other physical barrier is used to exclude animals and unauthorized persons from the area within 100 feet of the spring; Water in the spring is transported to the point of bottling or into bulk storage by: Gravity; or When pumping is required, first flowing by gravity to a separate holding reservoir from which it is extracted and delivered to the point of bottling by use of a pump; A spring is protected from direct surface water intrusion and other sources of contamination; and A spring does not contain ground water under the direct influence of surface water; A spring is constructed, developed, or improved in accordance with a plan made by a registered professional engineer or professionally qualified hydrogeologist that: Contains a hydrogeological study and a sanitary survey as set forth in Regulation .04E(4)(d) and (e) of this chapter; and Is approved by the approving authority or the Department; and A borehole used to obtain spring water: Is hydraulically connected to an aquifer that supplies a constantly flowing spring; Contains only water that has all the physical properties before treatment as the water that flows naturally to the surface of the earth or into a body of water; Is shown to comply with §B(1)(g) and (h) of this regulation by a hydrogeological study submitted to the Department; and Is constructed in compliance with §B(2) of this regulation. The person-in-charge shall ensure that: 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. The person-in-charge shall ensure that: 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: Microbiological contaminants at least once per week; Chemical contaminants at least once per year; and Radiological contaminants at least once every 4 years; The analyses results for sampling required in §A(3) of this regulation are submitted to the Department: At the time of application for a license pursuant to Regulation .04E(1), (2), (4)(a), F(1) — (3), and G(1) of this chapter; Upon request within 10 days for microbiological contaminants; and Except as provided in §B of this regulation, upon request within 30 days for chemical and every 4 years for radiological contaminants; When a sample is positive for total coliforms: The total coliforms positive culture medium is analyzed to determine if fecal coliforms are present, except that Escherichia coli may be tested for in lieu of fecal coliforms; and A resample is taken and submitted for testing within 24 hours; 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: Taken at a location and time that makes the test results indicative of the quality of the source water or drinking water; Of sufficient volume to allow testing; and At least 100 milliliters in volume for microbiological testing, regardless of analytical method; 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: Coliform in excess of 36 most probable number of organisms per 100 milliliters; Fecal coliform; Escherichia coli; and Organisms that by number or type indicate the direct influence of or contamination by surface water; and The contaminant concentration of trihalomethanes in bottled water does not exceed 10 parts per billion. Exceptions. 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: Effective in reducing the contaminant level in the finished product water below the maximum allowable concentration; and Interlocked with the bottling system so that: Failure in the treatment inactivates the bottling system; and Water is prevented from being bottled. Except for a microbiological contaminant, a person may not process or bottle water from a source water that contains a contaminant at a level that exceeds the maximum allowable concentration for a finished product water, as set forth in §A of this regulation, without written approval from the Department. The person-in-charge shall: Maintain at the plant: While processing or bottling a source water as set forth in §§B(4) and C of this regulation, the Department's written approval; and A record of the required water sampling and analytical results for at least 2 years; and Make the records available for inspection by the Department. The person-in-charge shall ensure that: The equipment and facilities needed to store, convey, transport, and bottle drinking water and wash and sanitize bottled water containers and bottling equipment and utensils in accordance with this chapter are provided and maintained in a sanitary condition; The water supplied to a fixture is potable and meets the requirements in COMAR 26.04.01; The sewage disposal system for the plant: Meets all applicable State and local codes; and Properly disposes of all wastewater; Toilet rooms: 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: Source water or finished product water is handled, processed, or held; and Containers, utensils, or pieces of equipment are washed or held; A bottling room: Is separated from other plant operations and storage areas by: Tight fitting walls; Ceilings; and Self closing doors; Has conveyor openings only large enough to allow passage of containers; Is mechanically ventilated using exhaust and supply air fans so that: Filtered air is supplied to provide a positive air pressure in the room; and Condensation does not accumulate on room surfaces and equipment; Has a floor sloped to floor drains; Has a floor, walls, and a ceiling that are: Smooth; Easily cleanable; and Impervious to water; Has a hand sink: In the room; or Directly adjacent to the room; and Has lighting that provides a minimum of 40 foot candles on all work surfaces; A bottle washing room, if present: 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; Clean and uncapped containers are protected from overhead contamination before and after filling with water by: Conveyor covers that meet the design specifications in Regulation .08 of this chapter; or Being held in rooms that have finished ceilings that are: Smooth; Easily cleanable; and Free of filth and condensation; and Before making a change, alteration, or addition to equipment or facilities that convey, treat, or bottle drinking water, plans for the change, alteration, or addition are submitted to and approved by the Department, in accordance with Health-General Article, §21-321, Annotated Code of Maryland. The person-in-charge shall ensure that: Equipment for processing drinking water is: Maintained in a sanitary and working condition; Provided with instrumentation to allow: Process control; and Monitoring; Monitored to verify that process requirements are met; and Durable and impervious to water; Materials used as water contact surfaces of equipment and utensils: 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; Water contact surfaces of equipment and utensils are: Designed, constructed, and maintained to be: Smooth; Easily cleanable; Free of difficult to clean internal surfaces; Self-emptying or self-draining if an interior surface; Visible for inspection or the equipment is readily disassembled for inspection; If manually cleaned: Readily accessible for cleaning without tools; or If not readily accessible, readily disassembled for cleaning with the use of simple tools kept available at the equipment; and If cleaned and sanitized by pressurized cleaning-in-place, readily accessible to the cleaning and sanitizing solutions without disassembly; and Cleaned and sanitized: In accordance with 21 CFR §129.80(c) and (d); and As often as necessary to maintain sanitary conditions and prevent the adulteration of drinking water; When pressurized clean-in-place is used: A cleaning and sanitizing solution is: Fully circulated through a fixed system to contact all interior water contact surfaces; Effective in cleaning and sanitizing water contact surfaces; Used in accordance with the chemical manufacturer's instructions; and Removed from equipment and water contact surfaces prior to drinking water for bottling or dispensing coming into contact with the equipment or water contact surface by: Rinsing the equipment or water contact surface with drinking water that is diverted to waste until the cleaning and sanitizing solutions are evacuated; or Other means to evacuate the cleaning and sanitizing solutions and prevent the adulteration of finished product water; 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; A record is made that: Documents the: Proper cleaning and sanitizing of: Water contact surfaces; and Filling and dispensing machines and equipment; Evacuation of cleaning and sanitizing solutions from equipment and water contact surfaces; and Inspection and maintenance of equipment associated with cleaning and sanitizing water contact surfaces; 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 Before new or remodeled bottling equipment is used to produce finished product water, a plan for the equipment design, construction, installation, and maintenance of the equipment is submitted to and approved by the Department. The person-in-charge shall ensure that: A processing operation that involves the source, transport, storage, treatment, or bottling of drinking water is controlled to prevent a hazard; and A record is made that: 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. The person-in-charge shall ensure that: Water stored in bulk or transported for bottling is from an approved source; A storage tank, hose, pump, and piping used for loading, transporting, and unloading water meet the requirements set forth in Regulation .08 of this chapter; A tank used to store drinking water is: 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; The openings in a storage tank and tank truck are: Protected from contamination; Kept sealed or locked when water for bottling is not being transferred; and Not susceptible to damage or tampering; A tank truck used to transport drinking water is: 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 A record is made that: Provides the following information for each batch of drinking water delivered: Name of the water hauler; Tanker truck number; Date of shipment; Name of seller; Location of the source water; and Date of delivery; Is maintained for at least 2 years after the record is made; and Is available for inspection by the Department. The person-in-charge shall ensure that: Containers are: 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); Container caps are: Stored in a sanitary manner; and Before use: Examined for cleanliness; and Washed, rinsed, and sanitized as necessary to prevent contamination of finished product water; and Records are made at the plant that: Document the proper cleaning and sanitization of containers; Are maintained for at least 2 years; and Are available for inspection by the Department. The person-in-charge shall ensure that: Unless a waiver of filtration and disinfection is granted by the Department in accordance with Health-General Article, §21-336.1(b), Annotated Code of Maryland, and this chapter, finished product water has undergone: 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; A drinking water treatment: 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 If filtration or disinfection of water is used to treat product water, the filtration or disinfection system is: 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. The person-in-charge shall ensure that: Finished product water meets the water quality standards set forth in Regulation .06 of this chapter; Containers used in bottling are: 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; Caps and closures are: Made of food-grade materials; Clean and sanitary when used; and Properly sealed onto containers to prevent the contamination of the water after bottling; Water is bottled in a room that meets the standards set forth in Regulation .07E of this chapter; and During bottling, access into the bottling room is limited to persons needed for the bottling process. The person-in-charge shall ensure that: The information required on a container of bottled water is placed on a label attached to the container or marked directly on the container in a way that ensures the information is clear and available to the consumer for the entire shelf life of the bottled water; The following information is placed on a container of bottled water: 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 The label includes all the information required in 21 CFR §165.110(a). Health-General Article, §§18-102, 21-211, 21-234, 21-304, 21-305, 21-306, 21-334, 21-336, and 21-336.1, Annotated Code of Maryland Effective date: March 23, 2009 (36:6 Md. R. 491)