(a) Purpose. These sections establish definitions and standards for the processing and bottling of drinking and vended water. The sections also will supplement §§229.181 - 229.184 of this title (relating to Licensure of Manufacturers of Food and Wholesale Distributors of Food - Including Good Manufacturing Practices) and federal regulations in Title 21, Code of Federal Regulations, Part 165 concerning standards of quality, and Part 129 concerning processing and bottling of bottled drinking water. (b) Requirements for specific standardized beverages. The department adopts by reference Title 21 Code of Federal Regulations, §165.110 concerning the identity, nomenclature, other label statements and label declarations for both bottled and vended water, except as modified by the Texas Board of Health in §229.85(b) of this title (relating to Labeling and Advertising). (c) Definitions. The following words and terms, when used in this chapter, shall pertain to both bottled and vended water and shall have the following meanings unless the context clearly indicates otherwise. (1) Approved source (when used in reference to a plant's product water or operations water)--A source of water and the water therefrom, whether it be from a spring, artesian well, drilled well, municipal water supply, or any other source, that has been inspected and the water sampled, analyzed, and found to be of a safe and sanitary quality according to applicable laws and regulations of State and local government agencies having jurisdiction. The presence in the plant of current certificates or notifications of approval from the government agency or agencies having jurisdiction constitutes approval of the source and the water supply. (2) Artesian water--Water from a well tapping a confined aquifer in which the water level stands at some height above the top of the aquifer is "artesian water" or "artesian well water." (3) Bottled water--Water that is intended for human consumption and that is sealed in bottled or other containers with no added ingredients except that it may optionally contain safe and suitable antimicrobial agents. (4) Department--Department of State Health Services. (5) Distilled water--Water which has been produced by a process of distillation and meets the definition of purified water in the United States Pharmacopeia, 23rd revision, January 1, 1995, which the department adopts by reference. (Copies may be obtained from the United States Pharmacopial Convention, Inc., 12601 Twinbrook Parkway, Rockville, MD 20852). (6) Drinking water--All water from the point of the approved source intended for the purpose of human consumption or which may be used in the preparation of foods or beverages. (7) Fluoridated water--Water containing added fluoride. (8) Ground water--Water from a subsurface saturated zone that is under a pressure equal to or greater than atmospheric pressure. (9) Mineral water--Water containing not less than 250 parts per million (ppm) total dissolved solids (TDS), coming from a source tapped at one or more bore holes or springs, originating from a geologically or physically protected underground water source. (10) Person--Includes individual, partnership, corporation, or association. (11) Purified water--Water that has been produced by distillation, deionization, reverse osmosis, or other suitable processes and that meets the definition of "purified water" in the United States Pharmacopoeia, 23rd revision, January 1, 1995, which the department adopts by reference. (Copies may be obtained from the United States Pharmacopial Convention, Inc., 12601 Twinbrook Parkway, Rockville, MD 20852). (12) Sparkling bottled water--Water that after treatment and possible replacement of carbon dioxide, contains the same amount of carbon dioxide that it had at emergence from the source. (13) Spring water--Water derived from an underground formation from which water flows naturally to the surface of the earth. (14) Sterile water or sterilized water--Water that meets requirements under "Sterility Tests" in the United States Pharmacopeia, 23rd revision, January 1, 1995, which the department adopts by reference. (Copies may be obtained from the United States Pharmacopial Convention, Inc., 12601 Twinbrook Parkway, Rockville, MD 20852). (15) Vended water--Vended water is: (A) water dispensed from any vending machine; or (B) servings of water dispensed in bulk by any operator or consumer from any water dispensing device. (16) Vending machine--Any self-service device which upon insertion of a coin, coins, or token, or upon receipt of payment by other means, dispenses servings of water in bulk, without the necessity of refilling the machine between each operation. (17) Water dispensing device--Any water unit that dispenses water in bulk without the necessity of refilling the machine between operations. This term includes stores that are manned by an operator at all times in which consumers bring containers to be filled by the operator, facilities that are not manned by an operator and where consumers dispense their own water, and vending machines. A water dispensing device may have several dispensing faucets in the case of a store. However, each vending machine is considered a separate water dispensing device. (18) Well water--Water taken from a hole bored, drilled, or otherwise constructed in the ground which taps the water of an aquifer. (d) Other requirements for specific standardized beverages. (1) Artesian water may be collected with the assistance of external force to enhance the natural underground pressure. On request, a bottler or vendor shall demonstrate to the department that the water level stands at some height above the top of the aquifer. (2) For bottled water or drinking water, fluoride may be optionally added within the limitations established in 21 Code of Federal Regulations (CFR) Part 165.110(b)(4)(ii). Bottled water may be used as an ingredient in beverages (e.g., diluted juices, flavored bottled waters). It does not include those food ingredients that are declared in ingredient labeling as "water," "carbonated water," "disinfected water," "filtered water," "seltzer water," "soda water," "sparkling water," and "tonic water." The processing and bottling of bottled water shall comply with applicable regulations in 21 CFR, Part 129. (3) For fluoridated water, the total fluoride content levels cannot exceed levels contained in 21 CFR 165.110(b)(4)(ii). (4) Ground water must not be under the direct influence of surface water as defined in 40 CFR 141.2. (5) Mineral water shall be distinguished from other types of water by its constant level and relative proportions of minerals and trace elements at the point of emergence from the source, due account being taken of the cycles of natural fluctuations. No minerals may be added to this water. (6) Water processed by demineralization that meets the purified water definition may alternatively be called "demineralized water." Alternatively, water that has been processed by deionization may be called "deionized water," and water processed by distillation may be called "distilled water," and water that has been processed by reverse osmosis may be called "reverse osmosis water." Also, if the water has been processed by either of the previously listed methods the water may be called "(blank) drinking water," with the blank being filled in with one of the defined terms describing the method of processing. (7) Spring water shall be collected only at the spring or through a bore hole tapping the underground formation feeding the spring. There shall be a natural force causing the water to flow to the surface through a natural orifice. The location of the spring shall be identified. Spring water collected with the use of an external force shall be from the same underground stratum as the spring, as shown be a measurable hydraulic connection using a hydrogeologically valid method between the bore hole and the natural spring, and shall have all the physical properties, before treatment, and be of the same composition and quality, as the water that flows naturally to the surface of the earth. If spring water is collected with the use of an external force, water must continue to flow naturally to the surface of the earth through the spring's natural orifice. |