[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR165]
 
[Page 521]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 165--BEVERAGES--Table of Contents
 
 
                      Subpart A--General Provisions
 
Sec.
165.3  Definitions.
 
       Subpart B--Requirements for Specific Standardized Beverages
 
165.110  Bottled water.
 
    Authority: 21 U.S.C. 321, 341, 343, 343-1, 348, 349, 371, 379e.
 
    Source: 60 FR 57124, Nov. 13, 1995, unless otherwise noted.
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR165.3]
 
[Page 521-522]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 165--BEVERAGES--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 165.3  Definitions.
 
 
    (a) A lot is:
    (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 consists of 10 subsamples (consumer units), one taken 
from each
 
[[Page 522]]
 
of 10 different randomly chosen shipping cases to be representative of a 
given lot, unless otherwise specified in a specific standard in this 
part.
    (c) An analytical unit is the portion(s) of food taken from a 
subsample of a sample for the purpose of analysis.
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR165.110]
 
[Page 522-539]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 165--BEVERAGES--Table of Contents
 
       Subpart B--Requirements for Specific Standardized Beverages
 
Sec. 165.110  Bottled water.
 
 
    (a) Identity--(1) Description. Bottled water is water that is 
intended for human consumption and that is sealed in bottles or other 
containers with no added ingredients except that it may optionally 
contain safe and suitable antimicrobial agents. Fluoride may be 
optionally added within the limitations established in 
Sec. 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 part 129 of this chapter.
    (2) Nomenclature. The name of the food is "bottled water," 
"drinking water," or alternatively one or more of the following terms 
as appropriate:
    (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 Office of the Federal 
Register, 800 North Capitol St. NW., suite 700, Washington, DC), 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
 
[[Page 523]]
 
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 Office of the Federal Register, 800 North 
Capitol St. NW., suite 700, Washington, DC), 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."
    (3) Other label statements. (i) If the TDS content of mineral water 
is below 500 ppm, or if it is greater than 1,500 ppm, the statement 
"low mineral content" or the statement "high mineral content", 
respectively, shall appear on the principal display panel following the 
statement of identity 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. If the TDS of mineral water is between 500 and 1,500 ppm, no 
additional statement need appear.
    (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 Sec. 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. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections of 
parts 101 and 130 of this chapter.
    (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:
    (1) Definitions. (i) 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.
 
[[Page 524]]
 
    (ii) Total trihalomethanes (TTHM) means the sum of the concentration 
in milligrams per liter of the trihalomethane compounds 
(trichloromethane, dibromochloromethane, bromodichloromethane, and 
tribromomethane), rounded to two significant figures.
    (iii) Haloacetic acids (five) (HAA5) means the sum of the 
concentrations in milligrams per liter of the haloacetic acid compounds 
(monochloroacetic acid, dichloroacetic acid, trichloroacetic acid, 
monobromoacetic acid, and dibromoacetic acid), rounded to two 
significant figures after addition.
    (2) 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 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, 
or a copy may be examined at the Office of the Federal Register, 800 
North Capitol St., NW., suite 700, Washington, DC, or at the Center for 
Food Safety and Applied Nutrition's Library, 200 C St., SW., Washington, 
DC), meet the following standards of microbiological quality:
    (i) 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
    (ii) 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.
    (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), which is 
incorporated by reference (the availability of this incorporation by 
reference is given in paragraph (b)(2) of this section), meet the 
following standards of physical quality:
    (i) The turbidity shall not exceed 5 units.
    (ii) The color shall not exceed 15 units. \1\
---------------------------------------------------------------------------
 
    \1\ Mineral water is exempt from allowable level. The exemptions are 
aesthetically based allowable levels and do not relate to a health 
concern.
---------------------------------------------------------------------------
 
    (iii) The odor shall not exceed threshold odor No. 3.\1\
    (4) Chemical quality. (i)(A) Bottled water shall, when a composite 
of analytical units of equal volume from a sample is examined by the 
methods described in paragraph (b)(4)(i)(B) of this section, meet 
standards of chemical quality and shall not contain chemical substances 
in excess of the following concentrations:
 
------------------------------------------------------------------------
                                                        Concentration in
                       Substance                         milligrams per
                                                              liter
------------------------------------------------------------------------
Arsenic...............................................            0.05
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\ Mineral water is exempt from allowable level. The exemptions are
  aesthetically based allowable levels and do not relate to a health
  concern.
 
    (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) and (C)(2) of this section are incorporated by reference in 
accordance with 5 U.S.C.
 
[[Page 525]]
 
552(a) and 1 CFR part 51 and are described in "Standard Methods for 
Examination of Water and Wastewater," 15th Ed. (1980). Copies may be 
obtained from the American Public Health Association, 800 I St. NW., 
Washington DC 20001, and examined at the Office of the Federal Register, 
800 North Capitol St., NW., suite 700, Washington DC, or the Center for 
Food Safety and Applied Nutrition's Library, 200 C St. NW., Washington 
DC. The methods in paragraphs (b)(4)(i)(C)(3) and (C)(4) are cross-
referenced in 40 CFR part 141, subpart C, appendix C.
    (1) "Methods for Organochlorine Pesticides in Industrial 
Effluents;"
    (2) "Methods for Chlorinated Phenoxy Acid Herbicides in Industrial 
Effluents," November 28, 1973;
    (3) "Part I: The Analysis of Trihalomethanes in Finished Waters by 
the Purge and Trap Method;" which is cross-referenced in 40 CFR part 
141, subpart C, appendix C;
    (4) "Part II: The Analysis of Trihalomethanes in Drinking Water by 
Liquid/Liquid Extraction," which is cross-referenced in 40 CFR part 
141, subpart C, appendix C;
    (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
------------------------------------------------------------------------
                                                            Fluoride
  Annual average of maximum daily air temperatures (    concentration in
                        deg.F)                           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 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 (    concentration in
                        deg.F)                           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
------------------------------------------------------------------------
 
    (D) Imported bottled water to which fluoride is added shall not 
contain fluoride in excess of 0.8 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:
 
------------------------------------------------------------------------
                                             Concentration in milligrams
                Contaminant                 per liter  (or as specified)
------------------------------------------------------------------------
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:
 
------------------------------------------------------------------------
                                                        Concentration in
             Contaminant  (CAS Reg. No.)                 milligrams per
                                                             liter
------------------------------------------------------------------------
Benzene (71-43-2)....................................              0.005
Carbon tetrachloride (56-23-5).......................              0.005
o- Dichlorobenzene (95-50-1).........................              0.6
p- Dichlorobenzene (106-46-7)........................              0.075
1,2-Dichloroethane (107-06-2)........................              0.005
 
[[Page 526]]
 
 
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
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:
 
------------------------------------------------------------------------
                                                        Concentration in
              Contaminant  (CAS Reg. No.)                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
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).....................      3x10-8
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:
 
------------------------------------------------------------------------
                                                        Concentration in
                      Contaminant                        milligrams per
                                                              liter
------------------------------------------------------------------------
Aluminum..............................................               0.2
Silver................................................               0.1
Sulfate \1\...........................................             250.0
------------------------------------------------------------------------
\1\ Mineral water is exempt from allowable level. The exemptions are
  aesthetically based allowable levels and do not relate to a health
  concern.
 
    (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)(13) 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, 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, 
5100 Paint Branch Pkwy., College Park, MD 20740, or at the Office of the 
Federal Register, 800 North Capitol Street NW., suite 700, Washington, 
DC.
    (1) Antimony shall be measured using the following methods:
    (i) Method 204.2--"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.
    (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 Center for Food Safety and Applied 
Nutrition's Library, Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740, or at the Office of the Federal Register,
 
[[Page 527]]
 
800 North Capitol Street NW., suite 700, Washington, DC.
    (iii) Method 200.9--"Determination of Trace Elements by Stabilized 
Temperature Graphite Furnace Atomic Absorption Spectrometry," Rev. 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," 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 
(b)(4)(iii)(E)(1)(ii) of this section.
    (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 Center for Food Safety and Applied Nutrition's Library, 
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740, or at the Office of the Federal Register, 800 North Capitol 
Street NW., suite 700, Washington, DC.
    (2) Barium shall be measured using the following methods:
    (i) 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
    (ii) 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 (b)(4)(iii)(E) of this section.
    (iii) Method 200.7--"Determination of Metals and Trace Elements in 
Water and Wastes by Inductively Coupled Plasma-Atomic Emission 
Spectrometry," Rev. 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 (b)(4)(iii)(E)(1)(ii) of this section.
    (3) Beryllium shall be measured using the following methods:
    (i) Method 210.2--"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.
    (ii) Method 200.7--"Determination of Metals and Trace Elements in 
Water and Wastes by Inductively Coupled Plasma-Atomic Emission 
Spectrometry," Rev. 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 (b)(4)(iii)(E)(1)(ii) of this section.
    (iii) 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. The availability of 
this incorporation by reference is given in paragraph 
(b)(4)(iii)(E)(1)(ii) of this section.
    (iv) Method 200.9--"Determination of Trace Elements by Stabilized 
Temperature Graphite Furnace Atomic Absorption Spectrometry," Rev. 1.2, 
April 1991, U.S. EPA, EMSL. The revision is contained in the manual 
entitled "Methods for the Determination of
 
[[Page 528]]
 
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 (b)(4)(iii)(E)(1)(ii) of this section.
    (4) Cadmium shall be measured using the following methods:
    (i) 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 (b)(4)(iii)(E) of this section.
    (ii) Method 200.7--"Determination of Metals and Trace Elements in 
Water and Wastes by Inductively Coupled Plasma-Atomic Emission 
Spectrometry," Rev. 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 (b)(4)(iii)(E)(1)(ii) of this section.
    (5) Chromium shall be measured using the following methods:
    (i) 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 (b)(4)(iii)(E) of this section.
    (ii) Method 200.7--"Determination of Metals and Trace Elements in 
Water and Wastes by Inductively Coupled Plasma-Atomic Emission 
Spectrometry," Rev. 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 (b)(4)(iii)(E)(1)(ii) of this section.
    (6) Copper shall be measured as total recoverable metal without 
filtration using the following methods:
    (i) Method 220.2--"Atomic Absorption; furnace technique," which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51, or
    (ii) Method 220.1--"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 these incorporation by reference is 
given in paragraph (b)(4)(iii)(E) of this section.
    (iii) Method 200.7--"Determination of Metals and Trace Elements in 
Water and Wastes by Inductively Coupled Plasma-Atomic Emission 
Spectrometry," Rev. 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 (b)(4)(iii)(E)(1)(ii) of this section.
    (iv) 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. The availability of 
this incorporation by reference is given in paragraph 
(b)(4)(iii)(E)(1)(ii) of this section.
    (v) Method 200.9--"Determination of Trace Elements by Stabilized 
Temperature Graphite Furnace Atomic Absorption Spectrometry," Rev. 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," Office of Research and Development,
 
[[Page 529]]
 
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 (b)(4)(iii)(E)(1)(ii) of this section.
    (7) Cyanide shall be measured using the following methods:
    (i) Method 335.1--"Titrimetric; Spectrophotometric" which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51, or
    (ii) Method 335.2--"Titrimetric; Spectrophotometric" which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51, or
    (iii) Method 335.3--"Colorimetric, Automated UV," which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. The availability of these incorporation by reference is given 
in paragraph (b)(4)(iii)(E) of this section.
    (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 Center for Food Safety and Applied Nutrition's Library, 
5100 Paint Branch Pkwy., College Park, MD 20740, or at the Office of the 
Federal Register, 800 North Capitol Street NW., suite 700, Washington, 
DC.
    (8) Lead shall be measured as total recoverable metal without 
filtration using the following methods:
    (i) Method 239.2--"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.
    (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. The availability of 
this incorporation by reference is given in paragraph 
(b)(4)(iii)(E)(1)(ii) of this section.
    (iii) Method 200.9--"Determination of Trace Elements by Stabilized 
Temperature Graphite Furnace Atomic Absorption Spectrometry," Rev. 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," 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 
(b)(4)(iii)(E)(1)(ii) of this section.
    (9) Mercury shall be measured using the following methods:
    (i) 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
    (ii) 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 these incorporation by reference is given 
in paragraph (b)(4)(iii)(E) of this section.
    (10) Nickel shall be measured using the following methods:
    (i) Method 249.1--"Atomic Absorption; direct aspiration," which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51, or
    (ii) Method 249.2--"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 these incorporation by reference is 
given in paragraph (b)(4)(iii)(E) of this section.
    (iii) Method 200.7--"Determination of Metals and Trace Elements in 
Water and Wastes by Inductively Coupled
 
[[Page 530]]
 
Plasma-Atomic Emission Spectrometry," Rev. 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 (b)(4)(iii)(E)(1)(ii) of this section.
    (iv) 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. The availability of 
this incorporation by reference is given in paragraph 
(b)(4)(iii)(E)(1)(ii) of this section.
    (v) Method 200.9--"Determination of Trace Elements by Stabilized 
Temperature Graphite Furnace Atomic Absorption Spectrometry," Rev. 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," 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 
(b)(4)(iii)(E)(1)(ii) of this section.
    (11) Nitrate and/or nitrite shall be measured 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 Center for Food Safety 
and Applied Nutrition's Library, Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, or at the Office of the 
Federal Register, 800 North Capitol Street NW., suite 700, Washington, 
DC.
    (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
    (iii) Method 353.2--"Colorimetric, automated, cadmium reduction," 
for both nitrate and nitrite, which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (iv) Method 353.3--"Spectrophotometric, cadmium reduction," for 
both nitrate and nitrite, which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (12) Selenium shall be measured using the following methods:
    (i) 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
    (ii) 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 (b)(4)(iii)(E) of this section.
    (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.
    (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
 
[[Page 531]]
 
CFR part 51. The availability of this incorporation by reference is 
given in paragraph (b)(4)(iii)(E)(1)(ii) of this section.
    (iii) Method 200.9--"Determination of Trace Elements by Stabilized 
Temperature Graphite Furnace Atomic Absorption Spectrometry," Rev. 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," 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 
(b)(4)(iii)(E)(1)(ii) 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)(20) 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, which are incorporated 
by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. 
Copies of these publications are available from NTIS, 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, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
at the Office of the Federal Register, 800 North Capitol St. NW., suite 
700, Washington, DC.
    (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
    (2) Method 502.2--"Volatile Organic Compounds in Water by Purge and 
Trap Capillary Column Gas Chromatography with Photoionization and 
Electrolytic Conductivity Detectors in Series," 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
    (3) Method 503.1--"Volatile Aromatic and Unsaturated 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
    (4) Method 524.1--"Measurement of Purgeable Organic Compounds in 
Water by Packed Column Gas Chromatography/Mass Spectrometry," Rev. 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
    (5) Method 524.2--"Measurement of Purgeable Organic Compounds in 
Water by Capillary Column Gas Chromatography/Mass Spectrometry," Rev. 
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
    (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
    (8) Method 506--"Determination of Phthalate and Adipate Esters in 
Drinking Water by Liquid-Liquid Extraction
 
[[Page 532]]
 
or Liquid-Solid Extraction and Gas Chromatography with Photoionization 
Detection," applicable to di(2-ethylhexyl) adipate which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51, or
    (9) Method 507--"Determination of Nitrogen- and Phosphorus-
Containing Pesticides in Water by Gas Chromatography with a Nitrogen-
Phosphorus Detector," Rev. 2.0, 1989, (applicable to alachlor, 
atrazine, and simazine), which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (10) Method 508--"Determination of Chlorinated Pesticides in Water 
by Gas Chromatography with an Electron Capture Detector," Rev. 3.0, 
1989, (applicable to chlordane, heptachlor, heptachlor epoxide, lindane, 
methoxychlor, toxaphene, endrin, hexachlorobenzene, 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
    (11) Method 508A--"Screening for Polychlorinated Biphenyls by 
Perchlorination and Gas Chromatography," Rev. 1.0, 1989, (used to 
quantitate PCB's as decachlorobiphenyl if detected in methods 505 or 508 
in paragraph (b)(4)(iii)(F)(7) or (b)(4)(iii)(F)(9) of this section, 
respectively, which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51, or
    (12) Method 515.1--"Determination of Chlorinated Acids in Water by 
Gas Chromatography with an Electron Capture Detector," Rev. 5.0, 1991, 
(applicable to 2,4-D, 2,4,5-TP (Silvex), pentachlorophenol, dalapon, 
dinoseb, and picloram), which is incorporated by reference in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (13) Method 525.1--"Determination of Organic Compounds in Drinking 
Water by Liquid-Solid Extraction and Capillary Column Gas 
Chromatography/Mass Spectrometry," Rev. 2.2, May 1991, (applicable to 
alachlor, atrazine, chlordane, heptachlor, heptachlor epoxide, lindane, 
methoxychlor, pentachlorophenol, benzo(a)pyrene, di(2-ethylhexyl) 
adipate, endrin, hexachlorobenzene, hexachlorocyclopentadiene, and 
simazine), which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51, or
    (14) Method 531.1--"Measurement of N-Methylcarbamoyloximes and N-
Methylcarbamates in Water by Direct Aqueous Injection HPLC with Post 
Column Derivatization," Rev. 3.0, 1989, (applicable to carbofuran and 
oxamyl (vydate)), which is incorporated by reference in accordance with 
5 U.S.C. 552(a) and 1 CFR part 51, or
    (15) Method 547--"Determination of Glyphosate in Drinking Water by 
Direct-Aqueous-Injection HPLC, Post-Column Derivatization, and 
Fluorescence Detection," (applicable to glyphosate), which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51, or
    (16) Method 548--"Determination of Endothall in Drinking Water by 
Aqueous Derivatization, Liquid-Solid Extraction, and Gas Chromatography 
with Electron-Capture Detection," (applicable to endothall), which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51, or
    (17) Method 549--"Determination of Diquat and Paraquat in Drinking 
Water by Liquid-Solid Extraction and HPLC with Ultraviolet Detection," 
(applicable to diquat), which is incorporated by reference in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (18) Method 550--"Determination of Polycyclic Aromatic Hydrocarbons 
in Drinking Water by Liquid-Liquid Extraction and HPLC with Coupled 
Ultraviolet and Fluorescence Detection," (applicable to benzo(a)pyrene 
and other polynuclear aromatic hydrocarbons), which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (19) Method 550.1--"Determination of Polycyclic Aromatic 
Hydrocarbons in Drinking Water by Liquid-Solid Extraction and HPLC with 
Coupled Ultraviolet and Fluorescence Detection," (applicable to 
benzo(a)pyrene and other polynuclear aromatic hydrocarbons), which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. The availability of these incorporation by reference is given 
in paragraph (b)(4)(iii)(F) of this section.
 
[[Page 533]]
 
    (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 Center 
for Food Safety and Applied Nutrition's Library, Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or at 
the Office of the Federal Register, 800 North Capitol St. NW., suite 
700, Washington, DC.
    (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) through (b)(4)(iii)(G)(3) 
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 
(b)(4)(iii)(E) of this section.
    (1) Aluminum shall be measured using the following methods:
    (i) Method 202.1--"Atomic Absorption; direct aspiration 
technique," which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51, or
    (ii) 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 (b)(4)(iii)(E).
    (iii) Method 200.7--"Determination of Trace Elements in Water and 
Wastes by Inductively Coupled Plasma-Atomic Emission Spectrometry," 
Rev. 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 
(b)(4)(iii)(E)(1)(ii) of this section.
    (iv) 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. The availability of 
this incorporation by reference is given in paragraph 
(b)(4)(iii)(E)(1)(ii) of this section.
    (v) Method 200.9--"Determination of Trace Elements by Stabilized 
Temperature Graphite Furnace Atomic Absorption Spectrometry," Rev. 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," 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 
(b)(4)(iii)(E)(1)(ii) of this section.
    (2) Silver shall be measured using the following methods:
    (i) Method 272.1--"Atomic Absorption; direct aspiration 
technique," which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51, or
    (ii) 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 (b)(4)(iii)(E) of this section.
    (iii) Method 200.7--"Determination of Trace Elements in Water and 
Wastes by Inductively Coupled Plasma-Atomic Emission Spectrometry," 
Rev. 3.3, April 1991, U.S. EPA, EMSL. The revision is contained in the 
manual entitled "Methods for the Determination of
 
[[Page 534]]
 
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 (b)(4)(iii)(E)(1)(ii) of this section.
    (iv) 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. The availability of 
this incorporation by reference is given in paragraph 
(b)(4)(iii)(E)(1)(ii) of this section.
    (v) Method 200.9--"Determination of Trace Elements by Stabilized 
Temperature Graphite Furnace Atomic Absorption Spectrometry," Rev. 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," 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 
these incorporation by reference is given in paragraph 
(b)(4)(iii)(E)(1)(ii) of this section.
    (3) Sulfate shall be measured 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. The availability of this incorporation 
by reference is given in paragraph (b)(4)(iii)(E)(11)(i) of this 
section.
    (ii) Method 375.1--"Colorimetric, Automated, Chloranilate," which 
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51, or
    (iii) Method 375.3--"Gravimetric," which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (iv) Method 375.4--"Turbidimetric," which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The 
availability of these incorporation by reference is given in paragraph 
(b)(4)(iii)(E) of this section.
    (H) The allowable levels for residual disinfectants and disinfection 
byproducts are as follows:
 
------------------------------------------------------------------------
                                            Concentration in milligrams
                Substance                            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 Cl2)
  Chlorine...............................  4.0 (as Cl2)
  Chlorine dioxide.......................  0.8 (as ClO2)
------------------------------------------------------------------------
 
    (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
 
[[Page 535]]
 
(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 Office of the Federal Register, 800 North Capitol St. 
NW., suite 700, Washington, DC, or at the Center for Food Safety and 
Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 
20740. 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 Center for Food Safety and Applied Nutrition's Library, 
5100 Paint Branch Pkwy., College Park, MD 20740.
    (1) Bromate shall be measured using the following method: 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, 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.
    (2) Chlorite shall be measured using the following methods:
    (i) Method 300.0--"Determination of Inorganic Anions by Ion 
Chromatography," Rev. 2.1. The revision is contained in the manual 
entitled "Methods for the Determination of Inorganic Substances in 
Environmental Samples," U.S. EPA, August 1993, EPA/600/R-93/100, 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 300.1--"Determination of Inorganic Anions in Drinking 
Water by Ion Chromatography," Rev. 1.0, U.S. EPA, 1997, EPA/600/R-98/
118, 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.
    (3) HAA5 shall be measured using the following methods:
    (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.
    (iii) Method 6251 B--"Disinfection By-Products: Haloacetic Acids 
and Trichlorophenol," which is contained in the book entitled 
"Standard Methods for the Examination of Water and Wastewater," 19th 
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
 
[[Page 536]]
 
by reference is given in paragraph (b)(4)(iii)(I) of this section.
    (4) TTHM shall be measured using the following methods:
    (i) Method 502.2--"Volatile Organic Compounds in Water by Purge and 
Trap Capillary Column Gas Chromatography with Photoionization and 
Electrolytic Conductivity Detectors in Series," Rev. 2.1. 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) Method 524.2--"Measurement of Purgeable Organic Compounds in 
Water by Capillary Column Gas Chromatography/Mass Spectrometry," 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.
    (iii) Method 551.1--"Determination of Chlorination Disinfection 
Byproducts, Chlorinated Solvents, and Halogenated Pesticides/Herbicides 
in Drinking Water by Liquid-Liquid 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 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.
    (5) Compliance with the chloramine standard can be determined by 
measuring combined or total chlorine. The following methods shall be 
used to measure chloramine:
    (i) ASTM Method D1253-86--" Standard Test Method for Residual 
Chlorine in Water," which is contained in the book entitled "Annual 
Book of ASTM Standards," 1996, vol. 11.01, 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 4500-Cl D--"Amperometric Titration Method," which is 
contained in the book entitled "Standard Methods for the Examination of 
Water and Wastewater," 19th 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 paragraph (b)(4)(iii)(I) of 
this section.
    (iii) Method 4500-Cl F--"DPD Ferrous Titrimetric Method," which is 
contained in the book entitled "Standard Methods for the Examination of 
Water and Wastewater," 19th 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 paragraph (b)(4)(iii)(I) of 
this section.
    (iv) Method 4500-Cl G--"DPD Colorimetric Method," which is 
contained in the book entitled "Standard Methods for the Examination of 
Water and Wastewater," 19th 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 paragraph (b)(4)(iii)(I) of 
this section.
    (v) Method 4500-Cl E--"Low-Level Amperometric Titration Method," 
which is contained in the book entitled "Standard Methods for the 
Examination of Water and Wastewater," 19th 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 paragraph 
(b)(4)(iii)(I) of this section.
    (vi) Method 4500-Cl I--"Iodometric Electrode Technique," which is 
contained in the book entitled "Standard Methods for the Examination of 
Water and Wastewater," 19th 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 paragraph (b)(4)(iii)(I) of 
this section.
 
[[Page 537]]
 
    (6) Compliance with the chlorine standard can be determined by 
measuring free or total chlorine. The following methods shall be used to 
measure chlorine:
    (i) ASTM Method D1253-86--"Standard Test Method for Residual 
Chlorine in Water," which is contained in the book entitled "Annual 
Book of ASTM Standards," 1996, vol. 11.01, 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 4500-Cl D--"Amperometric Titration Method," which is 
contained in the book entitled "Standard Methods for the Examination of 
Water and Wastewater," 19th 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 paragraph (b)(4)(iii)(I) of 
this section.
    (iii) Method 4500-Cl F--"DPD Ferrous Titrimetric Method," which is 
contained in the book entitled "Standard Methods for the Examination of 
Water and Wastewater," 19th 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 paragraph (b)(4)(iii)(I) of 
this section.
    (iv) Method 4500-Cl G--"DPD Colorimetric Method," which is 
contained in the book entitled "Standard Methods for the Examination of 
Water and Wastewater," 19th 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 paragraph (b)(4)(iii)(I) of 
this section.
    (v) Method 4500-Cl E--"Low-Level Amperometric Titration Method," 
which is contained in the book entitled "Standard Methods for the 
Examination of Water and Wastewater," 19th 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 paragraph 
(b)(4)(iii)(I) of this section.
    (vi) Method 4500-Cl I--"Iodometric Electrode Technique," which is 
contained in the book entitled "Standard Methods for the Examination of 
Water and Wastewater," 19th 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 paragraph (b)(4)(iii)(I) of 
this section.
    (vii) Method 4500-Cl H--"Syringaldazine (FACTS) Method," which is 
contained in the book entitled "Standard Methods for the Examination of 
Water and Wastewater," 19th 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 paragraph (b)(4)(iii)(I) of 
this section.
    (7) Chlorine dioxide shall be measured using the following methods:
    (i) Method 4500-ClO2 D--"DPD Method," which is 
contained in the book entitled "Standard Methods for the Examination of 
Water and Wastewater," 19th 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 paragraph (b)(4)(iii)(I) of 
this section.
    (ii) Method 4500-ClO2E--"Amperometric Method II," which 
is contained in the book entitled "Standard Methods for the Examination 
of Water and Wastewater," 19th 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 paragraph (b)(4)(iii)(I) 
of this section.
    (5) Radiological quality. (i) Bottled water shall, when a composite 
of analytical units of equal volume from a sample is examined by the 
methods described in paragraph (b)(5)(ii) of this section, meet 
standards of radiological quality as follows:
    (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
 
[[Page 538]]
 
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.
    (ii) Analyses conducted to determine compliance with 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," 15th Ed. (1980), and "Interim 
Radiochemical Methodology for Drinking Water," U.S. EPA, EMSL, EPA-600/
4-75-008 (Revised), March 1976, both of which are incorporated by 
reference. The availability of these incorporations by reference is 
given in paragraph (b)(2) 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 Sec. 130.14(a) of this 
chapter except that, as appropriate, instead of or in addition to the 
statement specified in Sec. 130.14(a) the following statement(s) shall 
be used:
    (1) "Contains Excessive Bacteria" if the bottled water fails to 
meet the requirements of paragraph (b)(2) 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. 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 water bears a 
label statement of substandard quality prescribed by paragraph (c) of 
this section.
 
[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]
 
    Effective Date Note: At 68 FR 9881, Mar. 3, 2003, Sec. 165.110 was 
amended by adding paragraph (b)(5)(i)(D) and by revising paragraph 
(b)(5)(ii), effective December 8, 2003. For the convenience of the user, 
the revised text is set forth as follows:
 
Sec. 165.110  Bottled water.
 
                                * * * * *
 
    (b)* * *
    (5)* * *
    (i)* * *
    (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 Office of the Federal 
Register, 800 North Capital St. NW., suite 700, Washington, DC, or at 
the Center for Food Safety and Applied Nutrition's Library, 5100 Paint 
Branch Pkwy., College Park, MD.
    (A) Combined radium-226/-228 shall be measured using the following 
methods:
    (1) Method 7500-Ra B--"Precipitation 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-Ra D--"Sequential Precipitation Method," which is 
contained in "Standard Methods for the Examination of Water and 
Wastewater," 20th Ed., which is
 
[[Page 539]]
 
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.
    (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) Method 7500-Sr B--"Precipitation 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-\3\H 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.
    (3) Method 7120 B--"Gamma Spectroscopic 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.
    (D) Uranium shall be measured using the following methods:
    (1) Method 7500-U B--"Radiochemical 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.
 
                                * * * * *