PART 165—BEVERAGES Authority: 21 U.S.C. 321, 341, 343, 343-1, 348, 349, 371, 379e. Source: 60 FR 57124, Nov. 13, 1995, unless otherwise noted. Subpart A—General Provisions § 165.3 Definitions. (a) A lot (1) For purposes of determining quality factors related to manufacture, processing, or packing, a collection of primary containers or units of the same size, type, and style produced under conditions as nearly uniform as possible and usually designated by a common container code or marking, or in the absence of any common container code or marking, a day's production. (2) For purposes of determining quality factors related to distribution and storage, a collection of primary containers or units transported, stored, or held under conditions as nearly uniform as possible. (b) A sample (c) An analytical unit Subpart B—Requirements for Specific Standardized Beverages § 165.110 Bottled water. (a) Identity Description. (2) Nomenclature. (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 Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 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: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (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 Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 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: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (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.” (3) Other label statements. (ii) When bottled water comes from a community water system, as defined in 40 CFR 141.2, except when it has been treated to meet the definitions in paragraphs (a)(2)(iv) and (a)(2)(vii) of this section and is labeled as such, the label shall state “from a community water system” or, alternatively, “from a municipal source” as appropriate, on the principal display panel or panels. This statement shall immediately and conspicuously precede or follow the name of the food without intervening written, printed, or graphic matter, other than statements required by paragraph (c) of this section, in type size at least one-half the size of the statement of identity but in no case of less than one-sixteenth of an inch. (iii) When the label or labeling of a bottled water product states or implies (e.g., through label statements or vignettes with references to infants) that the bottled water is for use in feeding infants, and the product is not commercially sterile under § 113.3(e)(3)(i) of this chapter, the product's label shall bear conspicuously and on the principal display panel the statement “Not sterile. Use as directed by physician or by labeling directions for use of infant formula.” (4) Label declaration. (b) Quality. (1) Definitions. Trihalomethane (ii) Total trihalomethanes (TTHM) (iii) Haloacetic acids (2) Microbiological quality. (A) Total coliform 1 Multiple-tube fermentation (MTF) method. ( 2 Membrane filter (MF) method. (B) E. coli. E. coli (ii) Analyses conducted to determine compliance with paragraphs (b)(2)(i)(A) and (b)(2)(i)(B) of this section and § 129.35(a)(3)(i) of this chapter shall be made in accordance with the multiple-tube fermentation (MTF) or the membrane filter (MF) methods described in the applicable sections of “Standard Methods for the Examination of Water and Wastewater,” 21st Ed. (2005), American Public Health Association. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy from the American Public Health Association, 800 I St. NW., Washington, DC 20001, 202-777-2742 (APHA). You may inspect a copy at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 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: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (3) Physical quality. http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html (i) The turbidity shall not exceed 5 units. (ii) The color shall not exceed 15 units. 1 1 (iii) The odor shall not exceed threshold odor No. 3. 1 (4) Chemical quality. Substance Concentration in milligrams per liter Chloride 1 250.0 Iron 1 0.3 Manganese 1 0.05 Phenols 0.001 Total dissolved solids 1 500.0 Zinc 1 5.0 1 (B) Analyses conducted to determine compliance with paragraph (b)(4)(i)(A) of this section shall be made in accordance with the methods described in the applicable sections of “Standard Methods for the Examination of Water and Wastewater,” 15th Ed. (1980), or “Methods for Chemical Analysis of Water and Wastes,” Environmental Monitoring and Support Laboratory (EMSL), EPA-600/4-79-020, March 1983, U.S. Environmental Protection Agency (EPA), both of which are incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. (C) Analyses for organic substances shall be determined by the appropriate methods set forth below. The methods in paragraphs (b)(4)(i) (C)( 1 2 http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. 3 4 ( 1 ( 2 ( 3 ( 4 (ii)(A) Bottled water packaged in the United States to which no fluoride is added shall not contain fluoride in excess of the levels in Table 1 and these levels shall be based on the annual average of maximum daily air temperatures at the location where the bottled water is sold at retail. Table 1 Annual average of maximum daily air temperatures (°F) Fluoride concentration in milligrams per liter 53.7 and below 2.4 53.8-58.3 2.2 58.4-63.8 2.0 63.9-70.6 1.8 70.7-79.2 1.6 79.3-90.5 1.4 (B) Imported bottled water to which no fluoride is added shall not contain fluoride in excess of 1.4 milligrams per liter. (C) Bottled water packaged in the United States to which fluoride is added must not contain fluoride in excess of 0.7 milligram per liter. (D) Imported bottled water to which fluoride is added must not contain fluoride in excess of 0.7 milligram per liter. (iii) Having consulted with EPA as required by section 410 of the Federal Food, Drug, and Cosmetic Act, the Food and Drug Administration has determined that bottled water, when a composite of analytical units of equal volume from a sample is examined by the methods listed in paragraphs (b)(4)(iii)(E) through (b)(4)(iii)(F), and (b)(4)(iii)(G) of this section, shall not contain the following chemical contaminants in excess of the concentrations specified in paragraphs (b)(4)(iii)(A) through (b)(4)(iii)(D) of this section. (A) The allowable levels for inorganic substances are as follows: Contaminant Concentration in milligrams per liter (or as specified) Arsenic 0.010 Antimony .006 Barium 2 Beryllium 0.004 Cadmium 0.005 Chromium 0.1 Copper 1.0 Cyanide 0.2 Lead 0.005 Mercury 0.002 Nickel 0.1 Nitrate 10 (as nitrogen) Nitrite 1 (as nitrogen) Total Nitrate and Nitrite 10 (as nitrogen) Selenium 0.05 Thallium 0.002 (B) The allowable levels for volatile organic chemicals (VOC's) are as follows: Contaminant Concentration in milligrams per liter Benzene (71-43-2) 0.005 Carbon tetrachloride (56-23-5) 0.005 o- 0.6 p- 0.075 1,2-Dichloroethane (107-06-2) 0.005 1,1-Dichloroethylene (75-35-4) 0.007 cis- 0.07 trans- 0.1 Dichloromethane (75-09-2) 0.005 1,2-Dichloropropane (78-87-5) 0.005 Ethylbenzene (100-41-4) 0.7 Monochlorobenzene (108-90-7) 0.1 Styrene (100-42-5) 0.1 Tetrachloroethylene (127-18-4) 0.005 Toluene (108-88-3) 1 1,2,4-Trichlorobenzene (120-82-1) 0.07 1,1,1-Trichloroethane (71-55-6) 0.20 1,1,2-Trichloroethane (79-00-5) 0.005 Trichloroethylene (79-01-6) 0.005 Vinyl chloride (75-01-4) 0.002 Xylenes (1330-20-7) 10 (C) The allowable levels for pesticides and other synthetic organic chemicals (SOC's) are as follows: Contaminant Concentration in milligrams per liter Alachlor (15972-60-8) 0.002 Atrazine (1912-24-9) 0.003 Benzo(a)pyrene (50-32-8) 0.0002 Carbofuran (1563-66-2) 0.04 Chlordane (57-74-9) 0.002 Dalapon (75-99-0) 0.2 1,2-Dibromo-3-chloropropane (96-12-8) 0.0002 2,4-D (94-75-7) 0.07 Di(2-ethylhexyl)adipate (103-23-1) 0.4 Di(2-ethylhexyl)phthalate (117-81-7) 0.006 Dinoseb (88-85-7) 0.007 Diquat (85-00-7) 0.02 Endothall (145-73-3) 0.1 Endrin (72-20-8) 0.002 Ethylene dibromide (106-93-4) 0.00005 Glyphosate (1071-53-6) 0.7 Heptachlor (76-44-8) 0.0004 Heptachlor epoxide (1024-57-3) 0.0002 Hexachlorobenzene (118-74-4) 0.001 Hexachlorocyclopentadiene (77-47-4) 0.05 Lindane (58-89-9) 0.0002 Methoxychlor (72-43-5) 0.04 Oxamyl (23135-22-0) 0.2 Pentachlorophenol (87-86-5) 0.001 PCB's (as decachlorobiphenyl) (1336-36-3) 0.0005 Picloram (1918-02-1) 0.5 Simazine (122-34-9) 0.004 2,3,7,8-TCDD (Dioxin) (1746-01-6) 3 × 10 −8 Toxaphene (8001-35-2) 0.003 2,4,5-TP (Silvex) (93-72-1) 0.05 (D) The allowable levels for certain chemicals for which EPA has established secondary maximum contaminant levels in its drinking water regulations (40 CFR part 143) are as follows: Contaminant Concentration in milligrams per liter Aluminum 0.2 Silver 0.1 Sulfate 1 250.0 1 (E) Analyses to determine compliance with the requirements of paragraph (b)(4)(iii)(A) of this section shall be conducted in accordance with an applicable method and applicable revisions to the methods listed in paragraphs (b)(4)(iii)(E)( 1 14 http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. ( 1 ( i ( ii http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. ( iii 1 ii ( iv http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. ( 2 ( i ( ii ( iii 1 ii ( 3 ( i ( ii 1 ii ( iii 1 ii ( iv 1 ii ( 4 ( i ( ii 1 ii ( 5 ( i ( ii 1 ii ( 6 ( i ( ii ( iii 1 ii ( iv 1 ii ( v 1 ii ( 7 ( i ( ii ( iii ( iv http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. ( 8 ( i ( ii 1 ii ( iii 1 ii ( 9 ( i ( ii ( 10 ( i ( ii ( iii 1 ii ( iv 1 ii ( v 1 ii ( 11 ( i http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. ( ii ( iii ( iv ( 12 ( i ( ii ( 13 ( i ( ii 1 ii ( iii 1 ii ( 14 ( i http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. ( ii 14 i (F) Analyses to determine compliance with the requirements of paragraphs (b)(4)(iii)(B) and (b)(4)(iii)(C) of this section shall be conducted in accordance with an applicable method or applicable revisions to the methods listed in paragraphs (b)(4)(iii)(F)( 1 22 http://www.archives.gov/federal-register/cfr/ibr-locations.html. ( 1 ( 2 ( 3 ( 4 ( 5 ( 6 ( 7 ( 8 ( 9 ( 10 ( 11 7 9 ( 12 ( 13 ( 14 ( 15 ( 16 ( 17 ( 18 ( 19 ( 20 http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. ( 21 ( 22 (G) Analyses to determine compliance with the requirements of paragraph (b)(4)(iii)(D) of this section shall be conducted in accordance with an applicable method and applicable revisions to the methods listed in paragraphs (b)(4)(iii)(G)( 1 3 ( 1 ( i ( ii ( iii 1 ii ( iv 1 ii ( v 1 ii ( 2 ( i ( ii ( iii 1 ii ( iv 1 ii ( v 1 ii ( 3 ( i 11 i ( ii ( iii ( iv (H) The allowable levels for residual disinfectants and disinfection byproducts are as follows: Substance Concentration in milligrams per liter Disinfection byproducts Bromate 0.010 Chlorite 1.0 Haloacetic acids (five) (HAA5) 0.060 Total Trihalomethanes (TTHM) 0.080 Residual disinfectants Chloramine 4.0 (as Cl 2 Chlorine 4.0 (as Cl 2 Chlorine dioxide 0.8 (as ClO 2 (I) Analysis to determine compliance with the requirements of paragraph (b)(4)(iii)(H) of this section shall be conducted in accordance with an applicable method listed in paragraphs (b)(4)(iii)(I)( 1 7 www.ntis.gov. http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. ( 1 ( 2 ( i ( ii ( 3 ( i ( ii ( iii ( 4 ( i ( ii ( iii ( 5 ( i ( ii ( iii ( iv ( v ( vi ( 6 ( i ( ii ( iii ( iv ( v ( vi ( vii ( 7 ( i 2 ( ii 2 (5) Radiological quality. (A) The bottled water shall not contain a combined radium-226 and radium-228 activity in excess of 5 picocuries per liter of water. (B) The bottled water shall not contain a gross alpha particle activity (including radium-226, but excluding radon and uranium) in excess of 15 picocuries per liter of water. (C) The bottled water shall not contain beta particle and photon radioactivity from manmade radionuclides in excess of that which would produce an annual dose equivalent to the total body or any internal organ of 4 millirems per year calculated on the basis of an intake of 2 liters of the water per day. If two or more beta or photon-emitting radionuclides are present, the sum of their annual dose equivalent to the total body or to any internal organ shall not exceed 4 millirems per year. (D) The bottled water shall not contain uranium in excess of 30 micrograms per liter of water. (ii) Analyses conducted to determine compliance with the requirements of paragraph (b)(5)(i) of this section shall be made in accordance with the methods described in the applicable sections of “Standard Methods for the Examination of Water and Wastewater,” 20th Ed., which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of “Standard Methods for the Examination of Water and Wastewater,” 20th Ed., may be obtained from the American Public Health Association, 1015 15th St. NW., Washington, DC 20005. Copies of the methods incorporated by reference in this paragraph (b)(5)(ii) may also be examined at the National Archives and Records Administration (NARA), or at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (A) Combined radium-226/-228 shall be measured using the following methods: ( 1 ( 2 (B) Gross alpha particle radioactivity shall be measured using the following method: Method 7110 C—“Coprecipitation Method for Gross Alpha Radioactivity in Drinking Water,” which is contained in “Standard Methods for the Examination of Water and Wastewater,” 20th Ed., which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation by reference is given in the introductory text of paragraph (b)(5)(ii) of this section. (C) Beta particle and photon radioactivity shall be measured using the following methods: ( 1 ( 2 3 ( 3 (D) Uranium shall be measured using the following methods: ( 1 ( 2 (c) Label statements. (1) “Contains Excessive Bacteria” if the bottled water fails to meet the requirements of paragraph (b)(2)(i)(A) of this section. (2) “Excessively Turbid”, “Abnormal Color”, and/or “Abnormal Odor” if the bottled water fails to meet the requirements of paragraph (b)(3) (i), (ii), or (iii), respectively, of this section. (3) “Contains Excessive ______,” with the blank filled in with the name of the chemical for which a maximum contaminant level in paragraph (b)(4) of this section is exceeded (e.g., “Contains Excessive Arsenic,” “Contains Excessive Trihalomethanes”) except that “Contains Excessive Chemical Substances” may be used if the bottled water is not mineral water. (4) “Excessively Radioactive” if the bottled water fails to meet the requirements of paragraph (b)(5) of this section. (d) Adulteration. E. coli [60 FR 57124, Nov. 13, 1995] Editorial Note: For Federal Register www.govinfo.gov.