Source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=165.110&amp;st=drinking%20
Timestamp: 2019-05-26 13:24:18
Document Index: 324686241

Matched Legal Cases: ['art 51', 'art 51', 'art 51', 'art 51', 'art 51', 'art 51', 'art 51', 'art 51', 'art 51', 'art 51', 'art 51', 'art 51', 'art 51', 'art 51', 'art 51', 'art 51', 'art 51', 'art 51', 'art 51', 'art 51', 'art 51', 'art 51', 'art 51']

(b) Quality. The standard of quality for bottled water, including water for use as an ingredient in beverages (except those described in the labeling as "water," "carbonated water," "disinfected water," "filtered water," "seltzer water," "soda water," "sparkling water," and "tonic water"), is as follows:
(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. Bottled water shall, when a composite of analytical units of equal volume from a sample is examined by the method described in applicable sections of "Standard Methods for the Examination of Water and Wastewater," 15th Ed. (1980), American Public Health Association, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 (copies may be obtained from the American Public Health Association, 800 I St. NW., Washington, DC 20001, 202-777-2742 (APHA), or a copy may 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 ), meet the following standards of physical quality:
Chloride 1 250.0
Iron 1 0.3
Manganese 1 0.05
Total dissolved solids 1 500.0
o- Dichlorobenzene (95-50-1) 0.6
p- Dichlorobenzene (106-46-7) 0.075
2,3,7,8-TCDD (Dioxin) (1746-01-6) 3 * 10-8
(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 ) through (b)(4)(iii)(E)(14 ) of this section and described, unless otherwise noted, in "Methods for Chemical Analysis of Water and Wastes," U.S. EPA Environmental Monitoring and Support Laboratory (EMSL), Cincinnati, OH 45258 (EPA-600/4-79-020), March 1983, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of this publication are available from the National Technical Information Service (NTIS), U.S. Department of Commerce, 5825 Port Royal Rd., Springfield, VA 22161, or 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.
(1 ) Antimony shall be measured using the following methods:
(ii ) Method 200.8--"Determination of Trace Elements in Water and Wastes by Inductively Coupled Plasma-Mass Spectrometry," Rev. 4.4, April 1991, U.S. EPA, EMSL. The revision is contained in the manual entitled "Methods for the Determination of Metals in Environmental Samples," Office of Research and Development, Washington, DC 20460, (EPA/600/4-91/010), June 1991, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of this publication are available from the National Technical Information Service, U.S. Department of Commerce, 5285 Port Royal Rd., Springfield, VA 22161, or 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.
(iv ) Method D-3697-92--"Standard Test Method for Antimony in Water," contained in the Annual Book of ASTM Standards, vols. 11.01 and 11.02, 1995, American Society for Testing and Materials, 100 Barr Harbor Dr., West Conshohocken, PA 19428, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of this publication are available from American Society for Testing and Materials, 100 Barr Harbor Dr., West Conshohocken, PA 19428, or 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.
(2 ) Barium shall be measured using the following methods:
(iv ) Method D-2036-91--"Standard Test Methods for Cyanides in Water," contained in the Annual Book of ASTM Standards, vols. 11.01 and 11.02, 1995, American Society for Testing and Materials, 100 Barr Harbor Dr., West Conshohocken, PA 19428, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of this publication are available from American Society for Testing and Materials, 100 Barr Harbor Dr., West Conshohocken, PA 19428, or 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.
(8 ) Lead shall be measured as total recoverable metal without filtration using the following methods:
(i ) Method 300.0--"The Determination of Inorganic Anions in Water by Ion Chromatography--Method 300.0," EPA, EMSL (EPA-600/4-84-017), March 1984, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of this publication are available from NTIS, U.S. Department of Commerce, 5285 Port Royal Rd., Springfield, VA 22161, or 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.
(ii ) Method 353.1--"Colorimetric, automated, hydrazine reduction," for nitrate only, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
(13 ) Thallium shall be measured using the following methods:
(i ) Method 279.2--"Atomic Absorption; furnace technique," 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 paragraph (b)(4)(iii)(E) of this section.
(i ) Method 200.8--"Determination of Trace Elements in Waters and Wastes by Inductively Coupled Plasma-Mass Spectrometry," Revision 5.4, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Method 200.8 is contained in the manual entitled "Methods for the Determination of Metals in Environmental Samples--Supplement 1," EPA/600/R-94/111, May 1994. Copies of this publication are available from the National Technical Information Service (NTIS), PB95-125472, U.S. Department of Commerce, 5825 Port Royal Rd., Springfield, VA 22161, or 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.
(ii ) Method 200.9--"Determination of Trace Elements by Stabilized Temperature Graphite Furnace Atomic Absorption," Revision 2.2, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Method 200.9 is contained in the manual entitled "Methods for the Determination of Metals in Environmental Samples--Supplement 1," EPA/600/R-94/111, May 1994. The availability of this incorporation by reference is given in paragraph (b)(4)(iii)(E)(14 )(i ) of this section.
(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 ) through (b)(4)(iii)(F)(22 ) of this section and described, unless otherwise noted, in "Methods for the Determination of Organic Compounds in Drinking Water," Office of Research and Development, EMSL, EPA/600/4-88/039, December 1988, or in "Methods for the Determination of Organic Compounds in Drinking Water, Supplement 1," Office of Research and Development, EMSL, EPA/600/4-90/020, July 1990, or in "Methods for the Determination of Organic Compounds in Drinking Water, Supplement III," EPA National Exposure Research Laboratory, Office of Research and Development, EPA/600/R-95/131, August 1995, including Errata, November 27, 1995. 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. Copies of these publications are available from National Technical Information Service, U.S. Department of Commerce, 5285 Port Royal Rd., Springfield, VA 22161. You may inspect a copy at the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 301-827-6860 or at the National Archives and Records Administration (NARA). Hearing-impaired or speech-impaired individuals may access this number through TTY by calling the toll-free Federal Relay Service at 800-877-8339. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.
(1 ) Method 502.1--"Volatile Halogenated Organic Compounds in Water by Purge and Trap Gas Chromatography," Rev. 2.0, 1989, (applicable to VOC's), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
(6 ) Method 504--"1,2-Dibromoethane (EDB) and 1,2-Dibromo-3-Chloropropane (DBCP) in Water by Microextraction and Gas Chromatography," Rev. 2.0, 1989, (applicable to dibromochloropropane (DBCP) and ethylene dibromide (EDB)), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
(7 ) Method 505--"Analysis of Organohalide Pesticides and Commercial Polychlorinated Biphenyl (PCB) Products in Water by Microextraction and Gas Chromatography," Rev. 2.0, 1989, (applicable to alachlor, atrazine, chlordane, heptachlor, heptachlor epoxide, lindane, methoxychlor, toxaphene, endrin, hexachlorobenzene, hexachlorocyclopentadiene, simazine, and as a screen for PCB's), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
(20 ) Method 1613--"Tetra- through Octa- Chlorinated Dioxins and Furans by Isotope Dilution HRGC/HRMS," Rev. A, 1990, EPA, Office of Water Regulations and Standards, Industrial Technology Division, (applicable to 2,3,7,8-TCDD (Dioxin)), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of this publication are available from USEPA-OST, Sample Control Center, P.O. Box 1407, Alexandria, VA 22313, or 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.
(21 ) Method 506, Rev. 1.1--"Determination of phthalate and adipate esters in drinking water by liquid/liquid extraction or liquid/solid extraction and gas chromatography with photoionization detection," EPA/600/R-95/131, 1995, (applicable to di(2-ethylhexyl)phthalate), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
(2 ) Silver shall be measured using the following methods:
(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 ) through (b)(4)(iii)(I)(7 ) of this section and described in "Method 300.1, Determination of Inorganic Anions in Drinking Water by Ion Chromatography," Rev. 1.0, U.S. EPA, 1997, EPA/600/R-98/118; "Methods for the Determination of Inorganic Substances in Environmental Samples," U.S. EPA, August 1993, EPA/600/R-93/100; "Methods for the Determination of Organic Compounds in Drinking Water-Supplement II," U.S. EPA, August 1992, EPA/600/R-92/129; "Methods for the Determination of Organic Compounds in Drinking Water-Supplement III," U.S. EPA, August 1995, EPA/600/R-95/131; "Standard Methods for the Examination of Water and Wastewater," 19th Ed., American Public Health Association, 1995; and "Annual Book of ASTM Standards," vol. 11.01, American Society for Testing and Materials, 1996, which are incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of the following publications are available from the National Technical Information Service (NTIS): EPA/600/R-95/131 (NTIS number PB95-261616), EPA/600/R-92/129 (NTIS number PB92-207703), EPA/600/R-93/100 (NTIS number PB94-121811), and EPA/600/R-98/118 (NTIS number PB98-169196). NTIS can be contacted at NTIS, U.S. Department of Commerce, 5285 Port Royal Rd., Springfield, VA 22161, 1-800-553-6847 or 703-605-6000, www.ntis.gov. Copies of the publication EPA/600/R-98/118 are also available from the Chemical Exposure Research Branch, Microbiological and Chemical Exposure Assessment Research Division, National Exposure Research Laboratory, U.S. EPA, Cincinnati, OH 45268, 513-569-7757, (FAX) 513-569-7757. Copies of "Standard Methods for the Examination of Water and Wastewater," 19th Ed., are available from the American Public Health Association, 1015 15th Street, NW., Washington, DC 20005. All of the publications cited in paragraph (b)(4)(iii)(I) of this section may 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. Copies of "Annual Book of ASTM Standards," 1996, vol. 11.01, are available from the American Society for Testing and Materials, 100 Barr Harbor Dr., West Conshohoken, PA 19428, or may be examined at the Office of the Federal Register. Copies of the methods incorporated by reference in paragraph (b)(4)(iii)(I) of this section may also 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.
(i ) Method 552.1--"Determination of Haloacetic Acids and Dalapon in Drinking Water by Ion Exchange Liquid-Solid Extraction and Gas Chromatography with Electron Capture Detection," Rev. 1.0. The revision is contained in the manual entitled "Methods for the Determination of Organic Compounds in Drinking Water-Supplement II," U.S. EPA, August 1992, EPA/600/R-92/129, 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 paragraph (b)(4)(iii)(I) of this section.
(ii ) Method 552.2--"Determination of Haloacetic Acids and Dalapon in Drinking Water by Liquid-Liquid Extraction, Derivatization and Gas Chromatography with Electron Capture Detection," Rev. 1.0. The revision is contained in the manual entitled "Methods for the Determination of Organic Compounds in Drinking Water-Supplement III," U.S. EPA, August 1993, EPA/600/R-95/131, 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 paragraph (b)(4)(iii)(I) of this section.
(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.
(2 ) Method 7500- 3H B--"Liquid Scintillation Spectrometric Method," 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.
(2 ) Method 7500-U C--"Isotopic Method" 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) Label statements. When the microbiological, physical, chemical, or radiological quality of bottled water is below that prescribed by paragraphs (b)(2) through (b)(5), of this section, the label shall bear the statement of substandard quality specified in 130.14(a) of this chapter except that, as appropriate, instead of or in addition to the statement specified in 130.14(a) the following statement(s) shall be used:
[60 FR 57124, Nov. 13, 1995; 60 FR 66495, Dec. 22, 1995, as amended at 61 FR 13264, Mar. 26, 1996; 61 FR 14480, Apr. 2, 1996; 63 FR 25769, May 11, 1998; 66 FR 16865, Mar. 28, 2001; 66 FR 17359, Mar. 30, 2001; 66 FR 35373, July 5, 2001; 66 FR 56035, Nov. 6, 2001; 58 FR 15355, Mar. 31, 2003; 68 FR 9881, Mar. 3, 2003; 70 FR 33700, June 9, 2005; 74 FR 25665, May 29, 2009; 76 FR 64813, Oct. 19, 2011; 81 FR 5591, Feb. 3, 2016]