(i) The name of 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.” Artesian water may be collected with the assistance of external force to enhance the natural underground pressure. On request, plants shall demonstrate to appropriate regulatory officials that the water level stands at some height above the top of the aquifer.
(ii) The name of water from a subsurface saturated zone that is under a pressure equal to or greater than atmospheric pressure is “ground water.” Ground water must not be under the direct influence of surface water as defined in 40 CFR 141.2.
(iii) The name of 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 and physically protected underground water source, may be “mineral water.” 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.
(iv) The name of 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 Pharmacopeia, 23d Revision, January 1, 1995, which is incorporated by reference in accordance with 5 U.S.C. 551(a) and 1 CFR part 51. (Copies may be obtained from the United States Pharmacopial Convention, Inc., 12601 Twinbrook Pkwy., Rockville, MD 20852 and may be examined at the Center for Food Safety and Applied Nutrition’s Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: *Incorporation by Reference in the CFR | National Archives. *), may be “purified water” or “demineralized water.” Alternatively, the water may be called “deionized water” if the water has been processed by deionization, “distilled water” if it is produced by distillation, “reverse osmosis water” if the water has been processed by reverse osmosis, and “___ drinking water” with the blank being filled in with one of the defined terms describing the water in this paragraph (e.g., “purified drinking water” or “deionized drinking water” ).
(v) The name of water that, after treatment and possible replacement of carbon dioxide, contains the same amount of carbon dioxide from the source that it had at emergence from the source may be “sparkling bottled water.”
(vi) The name of water derived from an underground formation from which water flows naturally to the surface of the earth may be “spring water.” 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 by 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. Plants shall demonstrate, on request, to appropriate regulatory officials, using a hydrogeologically valid method, that an appropriate hydraulic connection exists between the natural orifice of the spring and the bore hole.
(vii) The name of water that meets the requirements under “Sterility Tests” <71> in the United States Pharmacopeia, 23d Revision, January 1, 1995, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 51. (Copies may be obtained from the United States Pharmacopeial Convention, Inc., 12601 Twinbrook Pkwy., Rockville, MD 20852 and may be examined at the Center for Food Safety and Applied Nutrition’s Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: *Incorporation by Reference in the CFR | National Archives. *), may be “sterile water.” Alternatively, the water may be called “sterilized water.”
(viii) The name of water from a hole bored, drilled, or otherwise constructed in the ground which taps the water of an aquifer may be “well water.”