[Title 21 CFR 103.35] [Code of Federal Regulations (annual edition) - April 1, 1996 Edition] [Title 21 - FOOD AND DRUGS] [Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--CONTINUED] [Subchapter B - FOOD FOR HUMAN CONSUMPTION] [Part 103 - QUALITY STANDARDS FOR FOODS WITH NO IDENTITY STANDARDS] [Subpart B - Standards of Quality] [Sec. 103.35 - Bottled water.] [From the U.S. Government Publishing Office]21 FOOD AND DRUGS 2 1996-04-01 1996-04-01 false Bottled water. 103.35 Sec. 103.35 FOOD AND DRUGS FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--CONTINUED FOOD FOR HUMAN CONSUMPTION QUALITY STANDARDS FOR FOODS WITH NO IDENTITY STANDARDS Standards of Quality Sec. 103.35 Bottled water. (a) Definitions. (1) Bottled water is defined as water that is sealed in bottles or other containers and intended for human consumption. Bottled water does not include mineral water or any type of soft drink commonly known as soda water, which is made by absorbing carbon dioxide in potable water. [[Page 161]] (2) Trihalomethane (THM) means one of the family of organic compounds, named as derivatives of methane, wherein three of the four hydrogen atoms in methane are each substituted by a halogen atom in the molecular structure. (3) Total Trihalomethanes (TTHM) means the sum of the concentration in milligrams per liter of the trihalomethane compounds (trichloromethane [chloroform], dibromochloromethane, bromodichloromethane and tribromomethane [bromoform]), rounded to two significant figures. (b) Microbiological quality. Bottled water shall, when a sample consisting of analytical units of equal volume is examined by the methods 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 (copies may be obtained from the Center for Food Safety and Applied Nutrition (HFS- 300), 200 C St., SW., Washington, DC 20204, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC), meet the following standards of microbiological quality: (1) Multiple-tube fermentation method. Not more than one of the analytical units in the sample shall have a most probable number (MPN) of 2.2 or more coliform organisms per 100 milliliters and no analytical unit shall have an MPN of 9.2 or more coliform organisms per 100 milliliters; or (2) Membrane filter method. Not more than one of the analytical units in the sample shall have 4.0 or more coliform organisms per 100 milliliters and the arithmetic mean of the coliform density of the sample shall not exceed one coliform organism per 100 milliliters. (c) 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), which is incorporated by reference (the availability of this incorporation by reference is given in paragraph (b) of this section), meet the following standards of physical quality: (1) The turbidity shall not exceed 5 units. (2) The color shall not exceed 15 units. (3) The odor shall not exceed threshold odor No. 3. (d) Chemical quality. (1)(i) Bottled water shall, when a composite of analytical units of equal volume from a sample is examined by the methods described in paragraph (d)(1)(ii) of this section, meet standards of chemical quality and shall not contain chemical substances in excess of the following concentrations: Substance--Concentration in Milligrams per Liter Arsenic...................................................... 0.05 Chloride..................................................... 250.0 Iron......................................................... 0.3 Manganese.................................................... 0.05 Phenols...................................................... 0.001 Sulfate...................................................... 250.0 Total dissolved solids....................................... 500.0 Zinc......................................................... 5.0 Organics: Endrin (1,2,3,4,10,10-hexachloro-6,7-epoxy- 1,4,4a,5,6,7,8,8a-0cta-hydro-1,4-endo, endo-5,8-dimethano naphthalene).............................................. 0.0002 Total Trihalomethanes...................................... 0.10 (ii) Analyses conducted to determine compliance with paragraph (d)(1)(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,'' 15th Ed. (1980), or ``Methods for Chemical Analysis of Water and Wastes,'' Environmental Monitoring and Support Laboratory, EPA-600/4-82-055, March 1983, U.S. Environmental Protection Agency, both of which are incorporated by reference. Analyses for organic substances shall be determined by appropriate methods described in ``Methods for Organochlorine Pesticides in Industrial Effluents'' and ``Methods for Chlorinated Phenoxy Acid Herbicides in Industrial Effluents,'' November 28, 1973, which are incorporated by reference, and ``Part I: The Analysis of Trihalomethanes in Finished Waters by the Purge and Trap Method,'' Method 501.1 and ``Part II: The Analysis of Trihalomethanes in Drinking Water by Liquid/Liquid Extraction,'' Method 501.2 in 40 CFR part 141, appendix C (45 [[Page 162]] FR 68672; November 29, 1979). The availability of these incorporations by reference are given in paragraph (b) of this section. (2)(i) 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 ------------------------------------------------------------------------ Fluoride Annual average of maximum daily air temperatures ( deg. concentration F) 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 ------------------------------------------------------------------------ (ii) Imported bottled water to which no fluoride is added shall not contain fluoride in excess of 1.4 milligrams per liter. (iii) Bottled water packaged in the United States to which fluoride is added shall not contain fluoride in excess of levels in Table 2 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 2 ------------------------------------------------------------------------ Fluoride Annual average of maximum daily air temperatures ( deg. concentration F) in milligrams per liter ------------------------------------------------------------------------ 53.7 and below........................................... 1.7 53.8-58.3................................................ 1.5 58.4-63.8................................................ 1.3 63.9-70.6................................................ 1.2 70.7-79.2................................................ 1.0 79.3-90.5................................................ 0.8 ------------------------------------------------------------------------ (iv) Imported bottled water to which fluoride is added shall not contain fluoride in excess of 0.8 milligram per liter. (3) Having consulted with the U.S. Environmental Protection Agency (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 (d)(3)(v), (d)(3)(vi), and (d)(3)(vii) of this section, shall not contain the following chemical contaminants in excess of the concentrations specified in paragraphs (d)(3)(i), (d)(3)(ii), (d)(3)(iii), and (d)(3)(iv) of this section. (i) The allowable levels for inorganic substances are as follows: ------------------------------------------------------------------------ Concentration milligrams per Contaminant liter (or as specified) ------------------------------------------------------------------------ Barium.................................... 2 Cadmium................................... 0.005 Chromium.................................. 0.1 Copper.................................... 1.0 Lead...................................... 0.005 Mercury................................... 0.002 Nitrate................................... 10 (as nitrogen) Nitrite................................... 1 (as nitrogen) Total Nitrate and Nitrite................. 10 (as nitrogen) Selenium.................................. 0.05 ------------------------------------------------------------------------ (ii) The allowable levels for volatile organic chemicals (VOC's) are as follows: ------------------------------------------------------------------------ Concentration in Contaminant (CAS Reg. No.) milligrams per liter ------------------------------------------------------------------------ Benzene (71-43-2).............................. 0.005 Carbon tetrachloride (56-23-5)................. 0.005 o-Dichlorobenzene (95-50-01)................... 0.6 p-Dichlorobenzene (106-46-7)................... 0.075 1,2-Dichloroethane (107-06-2).................. 0.005 1,1-Dichloroethylene (75-35-4)................. 0.007 cis-1,2-Dichloroethylene (156-59-2)............ 0.07 trans-1,2-Dichloroethylene (156-60-5).......... 0.1 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 1,1,1-Trichloroethane (71-55-6)................ 0.20 Trichloroethylene (79-01-6).................... 0.005 Vinyl chloride (75-01-4)....................... 0.002 Xylenes (1330-20-7)............................ 10 ------------------------------------------------------------------------ (iii) The allowable levels for pesticides and other synthetic organic chemicals are as follows: ------------------------------------------------------------------------ Concentration Contaminant (CAS Reg. No.) in milligrams per liter ------------------------------------------------------------------------ Alachlor (15972-60-8).................................... 0.002 Atrazine (1912-24-9)..................................... 0.003 Carbofuran (1563-66-2)................................... 0.04 Chlordane (57-74-9)...................................... 0.002 1,2-Dibromo-3-chloropropane (96-12-8).................... 0.0002 2,4-D (94-75-7).......................................... 0.07 Ethylene dibromide (106-93-4)............................ 0.00005 [[Page 163]] Heptachlor (76-44-8)..................................... 0.0004 Heptachlor epoxide (1024-57-3)........................... 0.0002 Lindane (58-89-9)........................................ 0.0002 Methoxychlor (72-43-5)................................... 0.04 Pentachlorophenol (87-86-5).............................. 0.001 PCB's (as decachlorobiphenyl) (1336-36-3)................ 0.0005 Toxaphene (8001-35-2).................................... 0.003 2,4,5-TP (Silvex) (93-72-1).............................. 0.05 ------------------------------------------------------------------------ (iv) The allowable levels for certain chemicals for which EPA has established secondary maximum contaminant levels in its drinking water regulations are as follows: ------------------------------------------------------------------------ Concentration Contaminant in milligrams per liter ------------------------------------------------------------------------ Aluminum................................................. 0.2 Silver................................................... 0.1 ------------------------------------------------------------------------ (v) Analyses to determine compliance with the requirements of paragraph (d)(3)(i) of this section shall be conducted in accordance with an applicable method or applicable revisions to the methods listed in paragraphs (d)(3)(v)(A) through (d)(3)(v)(H) 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, U.S. Department of Commerce, 5825 Port Royal Rd., Springfield, VA 22161, or may be examined at the Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 200 C St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., Suite 700, Washington, DC. (A) Barium shall be measured using the following methods: (1) Method 208.2--''Atomic absorption, furnace technique,'' which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or (2) Method 208.1--''Atomic absorption, direct aspiration,'' 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 (d)(3)(v) of this section. (3) Method 200.7--''Determination of Metals and Trace Elements in Water and Wastes by Inductively Coupled Plasma- Atomic Emission Spectrometry,'' revision 3.3, 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, 5825 Port Royal Rd., Springfield, VA 22161, or may be examined at the Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 200 C St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., Suite 700, Washington, DC. (B) Cadmium shall be measured using the following methods: (1) Method 213.2--''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 (d)(3)(v) of this section. (2) Method 200.7--''Determination of Metals and Trace Elements in Water and Wastes by Inductively Coupled Plasma- Atomic Emission Spectrometry,'' revision 3.3, 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. The availability of this incorporation by reference is given in paragraph (d)(3)(v)(A)(3) of this section. (C) Chromium shall be measured using the following methods: [[Page 164]] (1) Method 218.2--''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 (d)(3)(v) of this section. (2) Method 200.7--''Determination of Metals and Trace Elements in Water and Wastes by Inductively Coupled Plasma- Atomic Emission Spectrometry,'' revision 3.3, 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. The availability of this incorporation by reference is given in paragraph (d)(3)(v)(A)(3) of this section. (D) Mercury shall be measured using the following methods: (1) Method 245.1--''Manual cold vapor technique,'' which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or (2) Method 245.2--''Automated cold vapor 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 (d)(3)(v) of this section. (E) Nitrate and/or nitrite shall be measured using the following methods: (1) Method 353.3--''Spectrophotometric, cadmium reduction,'' which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or (2) Method 353.2--''Colorimetric, automated, cadmium reduction,'' 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 (d)(3)(v) of this section. (3) 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 the National Technical Information Service, U.S. Department of Commerce, 5825 Port Royal Rd., Springfield, VA 22161, or may be examined at the Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 200 C St. SW, Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., suit 700, Washington, DC. (4) Method 353.1--''Colorimetric, automated, hydrazine reduction,'' 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 (d)(3)(v) of this section. (F) Selenium shall be measured using the following methods: (1) Method 270.2--''Atomic absorption, furnace technique,'' which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or (2) Method 270.3--``Atomic absorption, gaseous hydride,'' 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 (d)(3)(v) of this section. (G) Copper shall be measured as total recoverable metal without filtration using the following methods: (1) Method 220.2--Atomic absorption; furnace technique, in ``Methods for Chemical Analysis of Water and Wastes,'' which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 or (2) Method 220.1--Atomic absorption; direct aspiration, in ``Methods for Chemical Analysis of Water and Wastes,'' 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 (d)(3)(v) of this section. (3) Method 200.7--entitled ``Determination of Metals and Trace Elements in Water and Wastes by Inductively Coupled Plasma-Atomic Emission Spectrometry,'' Revision 3.3, April 1991, U.S. EPA, Environmental Monitoring and Support Laboratory (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 [[Page 165]] 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, 5825 Port Royal Rd., Springfield, VA 22161, or may be examined at the Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 200 C St. SW., Washington, DC 20204, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (4) Method 200.8--entitled, ``Determination of Trace Elements in Water and Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' Revision 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,'' 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 (d)(3)(v)(G)(3) of this section. (5) Method 200.9--entitled, ``Determination of Trace Elements by Stabilized Temperature Graphite Furnace Atomic Absorption Spectrometry,'' Revision 1.2, April 1991, U.S. EPA, EMSL. The revision is contained in the manual entitled ``Methods for the Determination of Metals in Environmental Samples,'' 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 (d)(3)(v)(G)(3) of this section. (H) Lead shall be measured as total recoverable metal without filtration using the following methods: (1) Method 239.2--Atomic absorption; furnace technique, from ``Methods for Chemical Analysis of Water and Wastes,'' 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 (d)(3)(v) of this section. (2) Method 200.8--entitled, ``Determination of Trace Elements in Water and Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' Revision 4.4, April 1991. The revision is contained in the manual entitled ``Methods for the Determination of Metals in Environmental Samples,'' June 1991, 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 (d)(3)(v)(G)(3) of this section. (3) Method 200.9--from ``Determination of Trace Elements by Stabilized Temperature Graphite Furnace Atomic Absorption Spectrometry,'' Revision 1.2, April 1991. The revision is contained in the manual entitled ``Methods for the Determination of Metals in Environmental Samples,'' June 1991, 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 (d)(3)(v)(G)(3) of this section. (vi) Analyses to determine compliance with the requirements of paragraphs (d)(3)(ii) and (d)(3)(iii) of this section shall be conducted in accordance with an applicable method or applicable revisions to the methods listed in paragraphs (d)(3(vi)(A) through (d)(3)(vi)(M) 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, 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 Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 200 C St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., Suite 700, Washington, DC. (A) Method 502.1--``Volatile Halogenated Organic Compounds in Water by Purge and Trap Gas Chromatography,'' revision 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 (B) Method 502.2--``Volatile Organic Compounds in Water by Purge and Trap Capillary Column Gas Chromatography with Photoionization and [[Page 166]] Electrolytic Conductivity Detectors in Series,'' revision 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 (C) Method 503.1--``Volatile Aromatic and Unsaturated Organic Compounds in Water by Purge and Trap Gas Chromatography,'' revision 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 (D) Method 524.1--``Measurement of Purgeable Organic Compounds in Water by Packed Column Gas Chromatography/Mass Spectrometry,'' revision 3.0, 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 (E) Method 524.2--``Measurement of Purgeable Organic Compounds in Water by Capillary Column Gas Chromatography/Mass Spectrometry,'' revision 3.0, 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 (F) Method 504--``1,2-Dibromoethane (EDB) and 1,2-Dibromo-3- Chloropropane (DBCP) in Water by Microextraction and Gas Chromatography,'' revision 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 (G) Method 505--``Analysis of Organohalide Pesticides and Commercial Polychlorinated Biphenyl (PCB) Products in Water by Microextraction and Gas Chromatography,'' revision 2.0, 1989 (applicable to alachlor, atrazine, chlordane, heptachlor, heptachlor epoxide, lindane, methoxychlor, toxaphene and as a screen for polychlorinated biphenyl's (PCB's)), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or (H) Method 507--``Determination of Nitrogen- and Phosphorus- Containing Pesticides in Water by Gas Chromatography with a Nitrogen- Phosphorus Detector,'' revision 2.0, 1989 (applicable to alachlor and atrazine), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or (I) Method 508--``Determination of Chlorinated Pesticides in Water by Gas Chromatography with an Electron Capture Detector,'' revision 3.0, 1989 (applicable to chlordane, heptachlor, heptachlor epoxide, lindane, methoxychlor, toxaphene, 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 (J) Method 508A--``Screening for Polychlorinated Biphenyls by Perchlorination and Gas Chromatography,'' revision 1.0, 1989 (used to quantitate PCB's as decachlorobiphenyl if detected in Methods 505 or 508 in paragraph (d)(3)(vi)(G) or (d)(3)(vi)(I) of this section, respectively), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or (K) Method 515.1--``Determination of Chlorinated Acids in Water by Gas Chromatography with an Electron Capture Detector,'' revision 5.0, May 1991 (applicable to 2,4-D, 2,4,5-TP (Silvex) and pentachlorophenol), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or (L) Method 525.1--``Determination of Organic Compounds in Drinking Water by Liquid-Solid Extraction and Capillary Column Gas Chromatography/Mass Spectrometry,'' revision 2.2, May 1991 (applicable to alachlor, atrazine, chlordane, heptachlor, heptachlor epoxide, lindane, methoxychlor, and pentachlorophenol), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or (M) Method 531.1--``Measurement of N-Methylcarbamoyloximes and N- Methylcarbamates in Water by Direct Aqueous Injection HPLC with Post Column Derivatization,'' revision 3.0, 1989 (applicable to carbofuran), 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 (d)(3)(vi) of this section. (vii) Analyses to determine compliance with the requirements of paragraph (d)(3)(iv) of this section shall be [[Page 167]] conducted in accordance with an applicable method and applicable revisions to the methods listed in paragraphs (d)(3)(vii)(A) and (d)(3)(vii)(B) of this section and described, unless otherwise noted, in ``Methods of Chemical Analysis of Water and Wastes,'' 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 (d)(3)(v) of this section. (A) Aluminum shall be measured using the following methods: (1) Method 202.1--``Atomic absorption technique; direct aspiration,'' which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. (2) Method 202.2--``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 (d)(3)(v) of this section. (3) Method 200.7--``Determination of Metals and Trace Elements in Water and Wastes by Inductively Coupled Plasma-Atomic Emission Spectrometry,'' revision 3.3, April 1991, in ``Methods for the Determination of Metals in Environmental Samples,'' which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of the incorporation by reference is given in paragraph (d)(3)(v)(A)(3) of this section. (4) Method 200.8--``Determination of Trace Elements in Waters and Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' revision 4.4, April 1991, in ``Methods for the Determination of Metals in Environmental Samples,'' 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 (d)(3)(v)(A)(3) of this section. (5) Method 200.9--``Determination of Trace Elements by Stabilized Temperature Graphite Furnace Atomic Absorption, Spectrometry,'' revision 1.2, April 1991, in ``Methods for the Determination of Metals in Environmental Samples,'' 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 (d)(3)(v)(A)(3) of this section. (B) Silver shall be measured using the following methods: (1) Method 272.1--``Atomic absorption, direct aspiration,'' which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or (2) Method 272.2--``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 (d)(3)(v) of this section. (3) Method 200.7--``Determination of Metals and Trace Elements in Water and Wastes by Inductively Coupled Plasma-Atomic Emission Spectrometry,'' revision 3.3, April 1991, U.S. EPA, EMSL, in ``Methods for the Determination of Metals in Environmental Samples,'' 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 (d)(3)(v)(A)(3) of this section. (4) Method 200.8--``Determination of Trace Elements in Waters and Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' revision 4.4, April 1991, in ``Methods for the Determination of Metals in Environmental Samples,'' 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 (d)(3)(v)(A)(3) of this section. (5) Method 200.9--``Determination of Trace Elements by Stabilized Temperature Graphite Furnace Atomic Absorption, Spectrometry,'' revision 1.2, April 1991, in ``Methods for the Determination of Metals in Environmental Samples,'' 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 (d)(3)(v)(A)(3) of this section. (e) Radiological quality. (1) Bottled water shall, when a composite of analytical units of equal volume from a sample is examined by the methods described in paragraph (e)(2) of this section, meet standards of radiological quality as follows: [[Page 168]] (i) The bottled water shall not contain a combined radium-226 and radium-228 activity in excess of 5 picocuries per liter of water. (ii) 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. (iii) 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. (2) Analyses conducted to determine compliance with paragraph (e)(1) 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), and ``Interim Radiochemical Methodology for Drinking Water,'' Environmental Monitoring and Support Laboratory, EPA-600/4-75-008 (Revised), March 1976, U.S. Environmental Protection Agency, both of which are incorporated by reference. The availability of these incorporations by reference is given in paragraph (b) of this section. (f) Label statements. Bottled water, the quality of which is below that prescribed by this section, shall be labeled with a statement of substandard quality as follows: (1) When the microbiological quality of bottled water is below that prescribed by paragraph (b) of this section, the label shall bear the statement of substandard quality specified in Sec. 103.5(b). (2) When the physical, chemical, and/or radiological quality of bottled water is below that prescribed by paragraphs (c) through (e) respectively of this section, the label shall bear the statement of substandard quality specified in Sec. 103.5(b) except that, as appropriate, instead of or in addition to the words ``Contains Excessive Bacteria'' the following statement(s) shall be used: (i) ``Excessively Turbid'', ``Abnormal Color'', and/or ``Abnormal Odor'' if the bottled water fails to meet the requirements of paragraph (c) (1), (2), and/or (3), respectively, of this section. (ii) ``Contains Excessive Chemical Substances'', if the bottled water fails to meet any of the requirements of paragraph (d) of this section. The specific chemical(s) may be declared in lieu of the words ``Chemical Substances'' in the statement ``Contains Excessive Chemical Substances''. When a specific chemical is declared, that name by which the chemical(s) is designated in paragraph (d) of this section shall be used. Example: ``Contains Excessive Copper''. (iii) ``Excessively Radioactive'' if the bottled water fails to meet the requirements of paragraph (e) of this section. (g) Adulteration. Bottled water containing a substance at a level considered injurious to health under section 402(a)(1) of the act is deemed to be adulterated, regardless of whether or not the bottled water bears a label statement of substandard quality prescribed by paragraph (f) of this section. [42 FR 14325, Mar. 15, 1977, as amended at 44 FR 12172, Mar. 6, 1979; 46 FR 41037, Aug. 14, 1981; 47 FR 11821, Mar. 19, 1982; 49 FR 10090, Mar. 19, 1984; 54 FR 400, Jan. 6, 1989; 54 FR 24891, June 12, 1989; 58 FR 381, Jan. 5, 1993; 59 FR 26937, May 25, 1994; 59 FR 61535, Dec. 1, 1994; 61 FR 14479, Apr. 2, 1996] Effective Date Note: At 60 FR 57123, Nov. 13, 1995, Sec. 103.35 was removed and reserved, effective May 13, 1996.