Beverages (21 CFR 165.3-165.110)

676 21 CFR Ch. I (4–1–16 Edition) Pt. 165 in section 201(s) of the Federal Food, Drug, and Cosmetic Act (the act), or if they are food additives as so defined, they are used in conformity with regu lations established pursuant to section 409 of the act. Seasoning and stabi lizing ingredients that perform a useful function are regarded as suitable, ex cept that artificial flavorings, artifi cial sweeteners, chemical preserva tives, and color additives are not suit able ingredients in peanut butter. Oil products used as optional stabilizing ingredients shall be hydrogenated veg etable oils. For the purposes of this section, hydrogenated vegetable oil shall be considered to include partially hydrogenated vegetable oil. (d) If peanut butter is prepared from unblanched peanuts as specified in paragraph (b)(2) of this section, the name shall show that fact by some such statement as ‘‘prepared from unblanched peanuts (skins left on).’’ Such statement shall appear promi nently and conspicuously and shall be in type of the same style and not less than half of the point size of that used for the words ‘‘peanut butter.’’ This statement shall immediately precede or follow the words ‘‘peanut butter,’’ without intervening written, printed, or graphic matter. (e) Label declaration. Each of the in gredients used in the food shall be de clared on the label as required by the applicable sections of parts 101 and 130 of this chapter. [42 FR 14475, Mar. 15, 1977, as amended at 47 FR 11834, Mar. 19, 1982; 49 FR 10103, Mar. 19, 1984; 54 FR 24896, June 12, 1989; 58 FR 2886, Jan. 6, 1993; 61 FR 9325, Mar. 8, 1996; 63 FR 14035, Mar. 24, 1998] PART 165—BEVERAGES 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. Subpart A—General Provisions § 165.3 Definitions. (a) A lot is: (1) For purposes of determining qual ity 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 con tainer code or marking, a day’s produc tion. (2) For purposes of determining qual ity factors related to distribution and storage, a collection of primary con tainers or units transported, stored, or held under conditions as nearly uni form as possible. (b) A sample consists of 10 subsamples (consumer units), one taken from each of 10 different randomly chosen ship ping 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. Subpart B—Requirements for Specific Standardized Beverages § 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 § 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 de clared in ingredient labeling as ‘‘water,’’ ‘‘carbonated water,’’ ‘‘dis infected water,’’ ‘‘filtered water,’’ ‘‘seltzer water,’’ ‘‘soda water,’’ ‘‘spar kling water,’’ and ‘‘tonic water.’’ The processing and bottling of bottled water shall comply with applicable reg ulations in part 129 of this chapter. (2) Nomenclature. The name of the food is ‘‘bottled water,’’ ‘‘drinking VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00686 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 677 Food and Drug Administration, HHS § 165.110 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 ‘‘arte sian water’’ or ‘‘artesian well water.’’ Artesian water may be collected with the assistance of external force to en hance the natural underground pres sure. On request, plants shall dem onstrate to appropriate regulatory offi cials that the water level stands at some height above the top of the aqui fer. (ii) The name of water from a sub surface saturated zone that is under a pressure equal to or greater than at mospheric pressure is ‘‘ground water.’’ Ground water must not be under the di rect influence of surface water as de fined 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 pro tected underground water source, may be ‘‘mineral water.’’ Mineral water shall be distinguished from other types of water by its constant level and rel ative proportions of minerals and trace elements at the point of emergence from the source, due account being taken of the cycles of natural fluctua tions. 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 proc esses and that meets the definition of ‘‘purified water’’ in the United States Pharmacopeia, 23d Revision, January 1, 1995, which is incorporated by reference in accordance with 5 U.S.C. 551(a) and 1 CFR part 51. (Copies may be obtained from the United States Pharmacopial Convention, Inc., 12601 Twinbrook Pkwy., Rockville, MD 20852 and may be examined at the Food and Drug Admin istration’s Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, or at the National Archives and Records Administration (NARA). For informa tion on the availability of this mate rial at NARA, call 202–741–6030, or go to: http://www.archives.gov/ federallregister/ codeloflfederallregulations/ ibrllocations.html.), may be ‘‘purified water’’ or ‘‘demineralized water.’’ Al ternatively, 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 ‘‘lll drinking water’’ with the blank being filled in with one of the de fined terms describing the water in this paragraph (e.g., ‘‘purified drinking water’’ or ‘‘deionized drinking water’’). (v) The name of water that, after treatment and possible replacement of carbon dioxide, contains the same amount of carbon dioxide from the source that it had at emergence from the source may be ‘‘sparkling bottled water.’’ (vi) The name of water derived from an underground formation from which water flows naturally to the surface of the earth may be ‘‘spring water.’’ Spring water shall be collected only at the spring or through a bore hole tap ping the underground formation feed ing 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 identi fied. 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 hy draulic connection using a hydrogeologically valid method be tween 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 nat urally 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 meth od, that an appropriate hydraulic con nection exists between the natural ori fice of the spring and the bore hole. (vii) The name of water that meets the requirements under ‘‘Sterility Tests’’ <71>in the United States Phar macopeia, 23d Revision, January 1, VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00687 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 678 21 CFR Ch. I (4–1–16 Edition) § 165.110 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 Con vention, Inc., 12601 Twinbrook Pkwy., Rockville, MD 20852 and may be exam ined at the Food and Drug Administra tion’s Main Library, 10903 New Hamp shire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, or at the National Archives and Records Admin istration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html.), 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 con tent’’ 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 state ment 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 para graphs (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 mu nicipal source’’ as appropriate, on the principal display panel or panels. This statement shall immediately and con spicuously precede or follow the name of the food without intervening writ ten, 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 vi gnettes with references to infants) that the bottled water is for use in feeding infants, and the product is not com mercially sterile under § 113.3(e)(3)(i) of this chapter, the product’s label shall bear conspicuously and on the prin cipal 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 in gredients used in the food shall be de clared 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 (ex cept those described in the labeling as ‘‘water,’’ ‘‘carbonated water,’’ ‘‘dis infected water,’’ ‘‘filtered water,’’ ‘‘seltzer water,’’ ‘‘soda water,’’ ‘‘spar kling water,’’ and ‘‘tonic water’’), is as follows: (1) Definitions. (i) Trihalomethane (THM) means one of the family of or ganic 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. (ii) Total trihalomethanes (TTHM) means the sum of the concentration in milligrams per liter of the trihalomethane compounds (trichloro methane, dibromochloromethane, bromodichloromethane, and tribromomethane), rounded to two sig nificant 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 addi tion. (2) Microbiological quality. (i) Bottled water shall, when a sample consisting of analytical units of equal volume is examined by the methods described in paragraph (b)(2)(ii) of this section, meet the following standards of micro biological quality: (A) Total coliform—(1) Multiple-tube fermentation (MTF) method. Not more than one of the analytical units in the sample shall have a most probable VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00688 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 679 Food and Drug Administration, HHS § 165.110 1 Mineral water is exempt from allowable level. The exemptions are aesthetically based allowable levels and do not relate to a health concern. number (MPN) of 2.2 or more coliform organisms per 100 milliliters and no an alytical unit shall have an MPN of 9.2 or more coliform organisms per 100 milliliters; or (2) Membrane filter (MF) 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 coli form density of the sample shall not exceed one coliform organism per 100 milliliters. (B) E. coli. If E. coli is present, then the bottled water will be deemed adul terated under paragraph (d) of this sec tion. (ii) Analyses conducted to determine compliance with paragraphs (b)(2)(i)(A) and (b)(2)(i)(B) of this section and § 129.35(a)(3)(i) of this chapter shall be made in accordance with the multiple tube fermentation (MTF) or the mem brane filter (MF) methods described in the applicable sections of ‘‘Standard Methods for the Examination of Water and Wastewater,’’ 21st Ed. (2005), Amer ican Public Health Association. The Director of the Federal Register ap proves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy from the American Public Health Asso ciation, 800 I St. NW., Washington, DC 20001, 202–777–2742 (APHA). You may in spect a copy at the Food and Drug Ad ministration’s Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, or at the National Archives and Records Administration (NARA). For informa tion on the availability of this mate rial at NARA, call 202–741–6030, or go to: http://www.archives.gov/ federallregister/ codeloflfederallregulations/ ibrllocations.html. (3) Physical quality. Bottled water shall, when a composite of analytical units of equal volume from a sample is examined by the method described in applicable sections of ‘‘Standard Meth ods for the Examination of Water and Wastewater,’’ 15th Ed. (1980), American Public Health Association, which is in corporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 (copies may be obtained from the American Public Health Association, 800 I St. NW., Washington, DC 20001, 202–777–2742 (APHA), or a copy may be examined at the National Archives and Records Administration (NARA), or at the Food and Drug Administration’s Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, for infor mation on the availability of this ma terial at NARA, call 202–741–6030, or go to: http://www.archives.gov/ federallregister/ codeloflfederallregulations/ ibrllocations.html), meet the following standards of physical quality: (i) The turbidity shall not exceed 5 units. (ii) The color shall not exceed 15 units. 1 (iii) The odor shall not exceed thresh old odor No. 3. 1 (4) Chemical quality. (i)(A) Bottled water shall, when a composite of ana lytical units of equal volume from a sample is examined by the methods de scribed 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: Substance Concentration in milligrams per liter Chloride1 .................................................. 250 .0 Iron1 ......................................................... 0 .3 Manganese1 ............................................ 0 .05 Phenols .................................................... 0 .001 Total dissolved solids1 ............................. 500 .0 Zinc 1 ........................................................ 5 .0 1 Mineral water is exempt from allowable level. The exemp tions are aesthetically based allowable levels and do not re late to a health concern. (B) Analyses conducted to determine compliance with paragraph (b)(4)(i)(A) of this section shall be made in accord ance with the methods described in the applicable sections of ‘‘Standard Meth ods 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 VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00689 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 680 21 CFR Ch. I (4–1–16 Edition) § 165.110 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 ref erence in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 and are de scribed in ‘‘Standard Methods for Ex amination of Water and Wastewater,’’ 15th Ed. (1980). Copies may be obtained from the American Public Health Asso ciation, 800 I St. NW., Washington DC 20001, and examined at the National Ar chives and Records Administration (NARA) , or the Food and Drug Admin istration’s Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039. For information on the availability of this material at NARA, call 202–741– 6030, or go to: http://www.archives.gov/ federallregister/ codeloflfederallregulations/ ibrllocations.html. 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 Pes ticides 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 ex cess of the levels in Table 1 and these levels shall be based on the annual av erage of maximum daily air tempera tures at the location where the bottled water is sold at retail. TABLE 1 Annual average of maximum daily air tem peratures (°F) Fluoride con centration in mil ligrams per liter 53.7 and below .......................................... 2.4 53.8–58.3 ................................................... 2.2 58.4–63.8 ................................................... 2.0 TABLE 1—Continued Annual average of maximum daily air tem peratures (°F) Fluoride con centration in mil ligrams per liter 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 ex cess of levels in Table 2 and these lev els shall be based on the annual aver age of maximum daily air tempera tures at the location where the bottled water is sold at retail. TABLE 2 Annual average of maximum daily air tem peratures (°F) Fluoride con centration in mil ligrams 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 fluo ride 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 de termined 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 con taminants in excess of the concentra tions specified in paragraphs (b)(4)(iii)(A) through (b)(4)(iii)(D) of this section. (A) The allowable levels for inorganic substances are as follows: Contaminant Concentration in milli grams per liter (or as specified) Arsenic ........................................... 0 .010 Antimony ........................................ .006 Barium ........................................... 2 Beryllium ........................................ 0 .004 Cadmium ....................................... 0 .005 Chromium ...................................... 0 .1 VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00690 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 681 Food and Drug Administration, HHS § 165.110 Contaminant Concentration in milli grams per liter (or as specified) 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 fol lows: Contaminant (CAS Reg. No.) Concentration in 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 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: Contaminant (CAS Reg. No.) Concentration in milligrams per liter Alachlor (15972–60–8) ............................ 0 .002 Atrazine (1912–24–9) .............................. 0 .003 Benzo(a)pyrene (50–32–8) ...................... 0 .0002 Carbofuran (1563–66–2) ......................... 0 .04 Chlordane (57–74–9) ............................... 0 .002 Dalapon (75–99–0) .................................. 0 .2 1,2-Dibromo-3-chloropropane (96–12–8) 0 .0002 2,4-D (94–75–7) ...................................... 0 .07 Di(2-ethylhexyl)adipate (103–23–1) ........ 0 .4 Di(2-ethylhexyl)phthalate (117–81–7) ..... 0 .006 Dinoseb (88–85–7) .................................. 0 .007 Diquat (85–00–7) ..................................... 0 .02 Endothall (145–73–3) .............................. 0 .1 Endrin (72–20–8) ..................................... 0 .002 Ethylene dibromide (106–93–4) .............. 0 .00005 Glyphosate (1071–53–6) ......................... 0 .7 Heptachlor (76–44–8) .............................. 0 .0004 Heptachlor epoxide (1024–57–3) ............ 0 .0002 Hexachlorobenzene (118–74–4) ............. 0 .001 Hexachlorocyclopentadiene (77–47–4) ... 0 .05 Lindane (58–89–9) .................................. 0 .0002 Methoxychlor (72–43–5) .......................... 0 .04 Oxamyl (23135–22–0) ............................. 0 .2 Pentachlorophenol (87–86–5) ................. 0 .001 Contaminant (CAS Reg. No.) Concentration in milligrams per liter PCB’s (as decachlorobiphenyl) (1336– 36–3) .................................................... 0 .0005 Picloram (1918–02–1) ............................. 0 .5 Simazine (122–34–9) .............................. 0 .004 2,3,7,8-TCDD (Dioxin) (1746–01–6) ....... 3 × 10¥8 Toxaphene (8001–35–2) ......................... 0 .003 2,4,5-TP (Silvex) (93–72–1) .................... 0 .05 (D) The allowable levels for certain chemicals for which EPA has estab lished secondary maximum contami nant levels in its drinking water regu lations (40 CFR part 143) are as follows: Contaminant Concentration in milligrams per liter Aluminum ................................................... 0.2 Silver .......................................................... 0.1 Sulfate 1 ..................................................... 250.0 1 Mineral water is exempt from allowable level. The exemp tions are aesthetically based allowable levels and do not re late to a health concern. (E) Analyses to determine compli ance with the requirements of para graph (b)(4)(iii)(A) of this section shall be conducted in accordance with an ap plicable method and applicable revi sions to the methods listed in para graphs (b)(4)(iii)(E)(1) through (b)(4)(iii)(E)(14) of this section and de scribed, unless otherwise noted, in ‘‘Methods for Chemical Analysis of Water and Wastes,’’ U.S. EPA Environ mental Monitoring and Support Lab oratory (EMSL), Cincinnati, OH 45258 (EPA–600/4–79–020), March 1983, which is incorporated by reference in accord ance 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. De partment of Commerce, 5825 Port Royal Rd., Springfield, VA 22161, or may be examined at the Food and Drug Administration’s Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796– 2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ federallregister/ codeloflfederallregulations/ ibrllocations.html. (1) Antimony shall be measured using the following methods: VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00691 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 682 21 CFR Ch. I (4–1–16 Edition) § 165.110 (i) Method 204.2—‘‘Atomic Absorp tion; furnace technique,’’ which is in corporated 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 con tained in the manual entitled ‘‘Meth ods for the Determination of Metals in Environmental Samples,’’ Office of Re search 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 Tech nical Information Service, U.S. Depart ment of Commerce, 5285 Port Royal Rd., Springfield, VA 22161, or may be examined at the Food and Drug Admin istration’s Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, or at the National Archives and Records Administration (NARA). For informa tion on the availability of this mate rial at NARA, call 202–741–6030, or go to: http://www.archives.gov/ federallregister/ codeloflfederallregulations/ ibrllocations.html. (iii) Method 200.9—‘‘Determination of Trace Elements by Stabilized Tempera ture Graphite Furnace Atomic Absorp tion 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,’’ Of fice 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 Ma terials, 100 Barr Harbor Dr., West Conshohocken, PA 19428, which is in corporated 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 ex amined at the Food and Drug Adminis tration’s Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, or at the National Archives and Records Administration (NARA). For informa tion on the availability of this mate rial at NARA, call 202–741–6030, or go to: http://www.archives.gov/ federallregister/ codeloflfederallregulations/ ibrllocations.html. (2) Barium shall be measured using the following methods: (i) Method 208.2—‘‘Atomic Absorp tion; furnace technique,’’ which is in corporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or (ii) Method 208.1—‘‘Atomic Absorp tion; direct aspiration,’’ which is incor porated 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 Spectrom etry,’’ Rev. 3.3, April 1991, U.S. EPA, EMSL. The revision is contained in the manual entitled ‘‘Methods for the De termination of Metals in Environ mental 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 in corporation by reference is given in paragraph (b)(4)(iii)(E)(1)(ii) of this sec tion. (3) Beryllium shall be measured using the following methods: (i) Method 210.2—‘‘Atomic Absorp tion; Furnace Technique,’’ which is in corporated 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. VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00692 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 683 Food and Drug Administration, HHS § 165.110 (ii) Method 200.7—‘‘Determination of Metals and Trace Elements in Water and Wastes by Inductively Coupled Plasma-Atomic Emission Spectrom etry,’’ Rev. 3.3, April 1991, U.S. EPA, EMSL. The revision is contained in the manual entitled ‘‘Methods for the De termination of Metals in Environ mental 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 in corporation by reference is given in paragraph (b)(4)(iii)(E)(1)(ii) of this sec tion. (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 con tained in the manual entitled ‘‘Meth ods for the Determination of Metals in Environmental Samples,’’ Office of Re search 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 in corporation by reference is given in paragraph (b)(4)(iii)(E)(1)(ii) of this sec tion. (iv) Method 200.9—‘‘Determination of Trace Elements by Stabilized Tempera ture Graphite Furnace Atomic Absorp tion 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,’’ Of fice 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 Absorp tion; Furnace Technique,’’ which is in corporated 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 Spectrom etry,’’ Rev. 3.3, April 1991, U.S. EPA, EMSL. The revision is contained in the manual entitled ‘‘Methods for the De termination of Metals in Environ mental 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 in corporation by reference is given in paragraph (b)(4)(iii)(E)(1)(ii) of this sec tion. (5) Chromium shall be measured using the following methods: (i) Method 218.2—‘‘Atomic Absorp tion; furnace technique,’’ which is in corporated 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 Spectrom etry,’’ Rev. 3.3, April 1991, U.S. EPA, EMSL. The revision is contained in the manual entitled ‘‘Methods for the De termination of Metals in Environ mental 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 in corporation by reference is given in paragraph (b)(4)(iii)(E)(1)(ii) of this sec tion. (6) Copper shall be measured as total recoverable metal without filtration using the following methods: (i) Method 220.2—‘‘Atomic Absorp tion; furnace technique,’’ which is in corporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or (ii) Method 220.1—‘‘Atomic Absorp tion; direct aspiration,’’ which is incor porated 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. VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00693 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 684 21 CFR Ch. I (4–1–16 Edition) § 165.110 (iii) Method 200.7—‘‘Determination of Metals and Trace Elements in Water and Wastes by Inductively Coupled Plasma-Atomic Emission Spectrom etry,’’ Rev. 3.3, April 1991, U.S. EPA, EMSL. The revision is contained in the manual entitled ‘‘Methods for the De termination of Metals in Environ mental 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 in corporation by reference is given in paragraph (b)(4)(iii)(E)(1)(ii) of this sec tion. (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 con tained in the manual entitled ‘‘Meth ods for the Determination of Metals in Environmental Samples,’’ Office of Re search 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 in corporation by reference is given in paragraph (b)(4)(iii)(E)(1)(ii) of this sec tion. (v) Method 200.9—‘‘Determination of Trace Elements by Stabilized Tempera ture Graphite Furnace Atomic Absorp tion 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,’’ Of fice 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. (7) Cyanide shall be measured using the following methods: (i) Method 335.1—‘‘Titrimetric; Spectrophotometric’’ which is incor porated 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 incor porated 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 Ma terials, 100 Barr Harbor Dr., West Conshohocken, PA 19428, which is in corporated 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 ex amined at the Food and Drug Adminis tration’s Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, or at the National Archives and Records Administration (NARA). For informa tion on the availability of this mate rial at NARA, call 202–741–6030, or go to: http://www.archives.gov/ federallregister/ codeloflfederallregulations/ ibrllocations.html. (8) Lead shall be measured as total recoverable metal without filtration using the following methods: (i) Method 239.2—‘‘Atomic Absorp tion; furnace technique,’’ which is in corporated 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 con tained in the manual entitled ‘‘Meth ods for the Determination of Metals in Environmental Samples,’’ Office of Re search 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 in corporation by reference is given in VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00694 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 685 Food and Drug Administration, HHS § 165.110 paragraph (b)(4)(iii)(E)(1)(ii) of this sec tion. (iii) Method 200.9—‘‘Determination of Trace Elements by Stabilized Tempera ture Graphite Furnace Atomic Absorp tion 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,’’ Of fice 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 incor porated 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 Absorp tion; direct aspiration,’’ which is incor porated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or (ii) Method 249.2—‘‘Atomic Absorp tion; furnace technique,’’ which is in corporated 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 Spectrom etry,’’ Rev. 3.3, April 1991, U.S. EPA, EMSL. The revision is contained in the manual entitled ‘‘Methods for the De termination of Metals in Environ mental 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 in corporation by reference is given in paragraph (b)(4)(iii)(E)(1)(ii) of this sec tion. (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 con tained in the manual entitled ‘‘Meth ods for the Determination of Metals in Environmental Samples,’’ Office of Re search 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 in corporation by reference is given in paragraph (b)(4)(iii)(E)(1)(ii) of this sec tion. (v) Method 200.9—‘‘Determination of Trace Elements by Stabilized Tempera ture Graphite Furnace Atomic Absorp tion 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,’’ Of fice 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. Depart ment of Commerce, 5285 Port Royal Rd., Springfield, VA 22161, or may be examined at the Food and Drug Admin istration’s Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, or at the National Archives and Records Administration (NARA). For informa tion on the availability of this mate rial at NARA, call 202–741–6030, or go to: http://www.archives.gov/ federallregister/ codeloflfederallregulations/ ibrllocations.html. VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00695 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 686 21 CFR Ch. I (4–1–16 Edition) § 165.110 (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 in corporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or (iv) Method 353.3—‘‘Spectrophoto metric, cadmium reduction,’’ for both nitrate and nitrite, which is incor porated 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 Absorp tion; furnace technique,’’ which is in corporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or (ii) Method 270.3—‘‘Atomic Absorp tion; gaseous hydride,’’ which is incor porated 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 Absorp tion; furnace technique,’’ which is in corporated 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 con tained in the manual entitled ‘‘Meth ods for the Determination of Metals in Environmental Samples,’’ Office of Re search 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 in corporation by reference is given in paragraph (b)(4)(iii)(E)(1)(ii) of this sec tion. (iii) Method 200.9—‘‘Determination of Trace Elements by Stabilized Tempera ture Graphite Furnace Atomic Absorp tion 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,’’ Of fice 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. (14) Arsenic shall be measured using the following methods: (i) Method 200.8—‘‘Determination of Trace Elements in Waters and Wastes by Inductively Coupled Plasma-Mass Spectrometry,’’ Revision 5.4, which is incorporated by reference in accord ance with 5 U.S.C. 552(a) and 1 CFR part 51. Method 200.8 is contained in the manual entitled ‘‘Methods for the Determination of Metals in Environ mental Samples—Supplement 1,’’ EPA/ 600/R–94/111, May 1994. Copies of this publication are available from the Na tional Technical Information Service (NTIS), PB95–125472, U.S. Department of Commerce, 5825 Port Royal Rd., Springfield, VA 22161, or may be exam ined at the Food and Drug Administra tion’s Main Library, 10903 New Hamp shire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, or at the National Archives and Records Admin istration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. (ii) Method 200.9—‘‘Determination of Trace Elements by Stabilized Tempera ture Graphite Furnace Atomic Absorp tion,’’ Revision 2.2, which is incor porated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Method 200.9 is contained in the man ual entitled ‘‘Methods for the Deter mination of Metals in Environmental Samples—Supplement 1,’’ EPA/600/R–94/ 111, May 1994. The availability of this incorporation by reference is given in paragraph (b)(4)(iii)(E)(14)(i) of this sec tion. (F) Analyses to determine compli ance with the requirements of para graphs (b)(4)(iii)(B) and (b)(4)(iii)(C) of VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00696 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 687 Food and Drug Administration, HHS § 165.110 this section shall be conducted in ac cordance with an applicable method or applicable revisions to the methods listed in paragraphs (b)(4)(iii)(F)(1) through (b)(4)(iii)(F)(22) of this section and described, unless otherwise noted, in ‘‘Methods for the Determination of Organic Compounds in Drinking Water,’’ Office of Research and Devel opment, EMSL, EPA/600/4–88/039, De cember 1988, or in ‘‘Methods for the De termination of Organic Compounds in Drinking Water, Supplement 1,’’ Office of Research and Development, EMSL, EPA/600/4–90/020, July 1990, or in ‘‘Methods for the Determination of Or ganic Compounds in Drinking Water, Supplement III,’’ EPA National Expo sure Research Laboratory, Office of Re search and Development, EPA/600/R–95/ 131, August 1995, including Errata, No vember 27, 1995. The Director of the Federal Register approves this incorpo ration by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Cop ies of these publications are available from National Technical Information Service, U.S. Department of Com merce, 5285 Port Royal Rd., Spring field, VA 22161. You may inspect a copy at the Division of Dockets Manage ment, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 301–827–6860 or at the National Archives and Records Ad ministration (NARA). Hearing-im paired or speech-impaired individuals may access this number through TTY by calling the toll-free Federal Relay Service at 800–877–8339. For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federal-register/cfr/ibr locations.html. (1) Method 502.1—‘‘Volatile Halo genated Organic Compounds in Water by Purge and Trap Gas Chroma tography,’’ Rev. 2.0, 1989, (applicable to VOC’s), which is incorporated by ref erence 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 Chroma tography with Photoionization and Electrolytic Conductivity Detectors in Series,’’ Rev. 2.0, 1989, (applicable to VOC’s), which is incorporated by ref erence 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 Chro matography,’’ Rev. 2.0, 1989, (applicable to VOC’s), which is incorporated by ref erence 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 Chroma tography/Mass Spectrometry,’’ Rev. 3.0, 1989, (applicable to VOC’s), which is incorporated by reference in accord ance 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 Chro matography/Mass Spectrometry,’’ Rev. 3.0, 1989, (applicable to VOC’s), which is incorporated by reference in accord ance 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-Chloropro pane (DBCP) in Water by Microextrac tion and Gas Chromatography,’’ Rev. 2.0, 1989, (applicable to dibromochloro propane (DBCP) and ethylene dibromide (EDB)), which is incor porated 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 Commer cial Polychlorinated Biphenyl (PCB) Products in Water by Microextraction and Gas Chromatography,’’ Rev. 2.0, 1989, (applicable to alachlor, atrazine, chlordane, heptachlor, heptachlor ep oxide, lindane, methoxychlor, toxaphene, endrin, hexachlorobenzene, hexachlorocyclopentadiene, simazine, and as a screen for PCB’s), which is in corporated 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 Drink ing Water by Liquid-Liquid Extraction or Liquid-Solid Extraction and Gas Chromatography with Photoionization Detection,’’ applicable to di(2-ethyl hexyl) 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 VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00697 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 688 21 CFR Ch. I (4–1–16 Edition) § 165.110 Pesticides in Water by Gas Chroma tography 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 Cap ture Detector,’’ Rev. 3.0, 1989, (applica ble to chlordane, heptachlor, hepta chlor epoxide, lindane, methoxychlor, toxaphene, endrin, hexachlorobenzene, and as a screen for PCB’s), which is in corporated 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 Per chlorination and Gas Chroma tography,’’ 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 incor porated 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 Cap ture Detector,’’ Rev. 5.0, 1991, (applica ble 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 Cap illary Column Gas Chromatography/ Mass Spectrometry,’’ Rev. 2.2, May 1991, (applicable to alachlor, atrazine, chlordane, heptachlor, heptachlor ep oxide, lindane, methoxychlor, pentachlorophenol, benzo(a)pyrene, di(2-ethylhexyl) adipate, endrin, hexachlorobenzene, hexachlorocyclo pentadiene, and simazine), which is in corporated 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 Col umn Derivatization,’’ Rev. 3.0, 1989, (applicable to carbofuran and oxamyl (vydate)), which is incorporated by ref erence 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 Di rect-Aqueous-Injection HPLC, Post Column Derivatization, and Fluores cence 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 Aque ous Derivatization, Liquid-Solid Ex traction, and Gas Chromatography with Electron-Capture Detection,’’ (ap plicable to endothall), which is incor porated 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,’’ (ap plicable to diquat), which is incor porated 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 Ex traction and HPLC with Coupled Ultra violet 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 Ex traction and HPLC with Coupled Ultra violet 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. (20) Method 1613—‘‘Tetra- through Octa- Chlorinated Dioxins and Furans by Isotope Dilution HRGC/HRMS,’’ Rev. A, 1990, EPA, Office of Water Reg ulations and Standards, Industrial Technology Division, (applicable to 2,3,7,8–TCDD (Dioxin)), which is incor porated by reference in accordance VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00698 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 689 Food and Drug Administration, HHS § 165.110 with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of this publication are available from USEPA-OST, Sample Control Center, P.O. Box 1407, Alexandria, VA 22313, or may be examined at the Food and Drug Administration’s Main Li brary, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, or at the National Ar chives and Records Administration (NARA). For information on the avail ability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. (21) Method 506, Rev. 1.1—‘‘Deter mination of phthalate and adipate esters in drinking water by liquid/liq uid extraction or liquid/solid extrac tion and gas chromatography with photoionization detection,’’ EPA/600/R– 95/131, 1995, (applicable to di(2 ethylhexyl)phthalate), which is incor porated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or (22) Method 525.2, Rev. 2.0—‘‘Deter mination of organic compounds in drinking water by liquid-solid extrac tion and capillary column gas chroma tography/mass spectrometry,’’ EPA/600/ R–95/131, 1995, (applicable to di(2 ethylhexyl)phthalate), which is incor porated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. (G) Analyses to determine compli ance with the requirements of para graph (b)(4)(iii)(D) of this section shall be conducted in accordance with an ap plicable method and applicable revi sions to the methods listed in para graphs (b)(4)(iii)(G)(1) through (b)(4)(iii)(G)(3) of this section and de scribed, unless otherwise noted, in ‘‘Methods of Chemical Analysis of Water and Wastes,’’ which is incor porated 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 Absorp tion; 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 Absorp tion; furnace technique,’’ which is in corporated 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 revi sion is contained in the manual enti tled ‘‘Methods for the Determination of Metals in Environmental Samples,’’ Of fice 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 con tained in the manual entitled ‘‘Meth ods for the Determination of Metals in Environmental Samples,’’ Office of Re search 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 in corporation by reference is given in paragraph (b)(4)(iii)(E)(1)(ii) of this sec tion. (v) Method 200.9—‘‘Determination of Trace Elements by Stabilized Tempera ture Graphite Furnace Atomic Absorp tion 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,’’ Of fice 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 Absorp tion; direct aspiration technique,’’ VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00699 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 690 21 CFR Ch. I (4–1–16 Edition) § 165.110 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 Absorp tion; furnace technique,’’ which is in corporated 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 revi sion is contained in the manual enti tled ‘‘Methods for the Determination of Metals in Environmental Samples,’’ Of fice 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 con tained in the manual entitled ‘‘Meth ods for the Determination of Metals in Environmental Samples,’’ Office of Re search 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 in corporation by reference is given in paragraph (b)(4)(iii)(E)(1)(ii) of this sec tion. (v) Method 200.9—‘‘Determination of Trace Elements by Stabilized Tempera ture Graphite Furnace Atomic Absorp tion 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,’’ Of fice 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 in corporation by reference is given in paragraph (b)(4)(iii)(E)(11)(i) of this sec tion. (ii) Method 375.1—‘‘Colorimetric, Automated, Chloranilate,’’ which is in corporated 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 byprod ucts are as follows: Substance Concentration in milligrams per liter Disinfection byproducts Bromate ........................................ 0.010 Chlorite ............................................. 1.0 Haloacetic acids (five) (HAA5) ......... 0.060 Total Trihalomethanes (TTHM) ........ 0.080 Residual disinfectants Chloramine ....................................... 4.0 (as 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 appli cable 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 Chro matography,’’ Rev. 1.0, U.S. EPA, 1997, EPA/600/R–98/118; ‘‘Methods for the De termination of Inorganic Substances in Environmental Samples,’’ U.S. EPA, August 1993, EPA/600/R–93/100; ‘‘Meth ods for the Determination of Organic Compounds in Drinking Water-Supple ment II,’’ U.S. EPA, August 1992, EPA/ VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00700 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 691 Food and Drug Administration, HHS § 165.110 600/R–92/129; ‘‘Methods for the Deter mination of Organic Compounds in Drinking Water-Supplement III,’’ U.S. EPA, August 1995, EPA/600/R–95/131; ‘‘Standard Methods for the Examina tion of Water and Wastewater,’’ 19th Ed., American Public Health Associa tion, 1995; and ‘‘Annual Book of ASTM Standards,’’ vol. 11.01, American Soci ety 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 Na tional Technical Information Service (NTIS): EPA/600/R–95/131 (NTIS number PB95–261616), EPA/600/R–92/129 (NTIS number PB92–207703), EPA/600/R–93/100 (NTIS number PB94–121811), and EPA/ 600/R–98/118 (NTIS number PB98–169196). NTIS can be contacted at NTIS, U.S. Department of Commerce, 5285 Port Royal Rd., Springfield, VA 22161, 1–800– 553–6847 or 703–605–6000, www.ntis.gov. Copies of the publication EPA/600/R–98/ 118 are also available from the Chem ical Exposure Research Branch, Micro biological and Chemical Exposure As sessment 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 avail able from the American Public Health Association, 1015 15th Street, NW., Washington, DC 20005. All of the publi cations cited in paragraph (b)(4)(iii)(I) of this section may be examined at the National Archives and Records Admin istration (NARA), or at the Food and Drug Administration’s Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039. . For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. Copies of ‘‘Annual Book of ASTM Standards,’’ 1996, vol. 11.01, are available from the American Society for Testing and Materials, 100 Barr Harbor Dr., West Conshohoken, PA 19428, or may be examined at the Office of the Federal Register. Copies of the methods incorporated by ref erence in paragraph (b)(4)(iii)(I) of this section may also be examined at the Center for Food Safety and Applied Nu trition’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 Chroma tography,’’ 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 Chroma tography,’’ Rev. 2.1. The revision is contained in the manual entitled ‘‘Methods for the Determination of In organic 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 avail ability of this incorporation by ref erence 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 accord ance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this incor poration by reference is given in para graph (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 Liq uid-Solid Extraction and Gas Chroma tography with Electron Capture Detec tion,’’ Rev. 1.0. The revision is con tained in the manual entitled ‘‘Meth ods for the Determination of Organic Compounds in Drinking Water-Supple ment 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 avail ability of this incorporation by ref erence is given in paragraph (b)(4)(iii)(I) of this section. (ii) Method 552.2—‘‘Determination of Haloacetic Acids and Dalapon in VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00701 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 692 21 CFR Ch. I (4–1–16 Edition) § 165.110 Drinking Water by Liquid-Liquid Ex traction, Derivatization and Gas Chro matography with Electron Capture De tection,’’ Rev. 1.0. The revision is con tained in the manual entitled ‘‘Meth ods for the Determination of Organic Compounds in Drinking Water-Supple ment 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 avail ability of this incorporation by ref erence 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 Meth ods for the Examination of Water and Wastewater,’’ 19th Ed., which is incor porated 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. (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 Chroma tography with Photoionization and Electrolytic Conductivity Detectors in Series,’’ Rev. 2.1. The revision is con tained in the manual entitled ‘‘Meth ods for the Determination of Organic Compounds in Drinking Water-Supple ment 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 avail ability of this incorporation by ref erence 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 Chro matography/Mass Spectrometry,’’ Rev. 1.0. The revision is contained in the manual entitled ‘‘Methods for the De termination 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 in corporation 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 revi sion is contained in the manual enti tled ‘‘Methods for the Determination of Organic Compounds in Drinking Water Supplement III,’’ U.S. EPA, August 1993, EPA/600/R–95/131, which is incor porated 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 meas uring combined or total chlorine. The following methods shall be used to measure chloramine: (i) ASTM Method D1253-86—‘‘ Stand ard 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 in corporated 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—‘‘Ampero metric Titration Method,’’ which is contained in the book entitled ‘‘Stand ard 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 in corporation by reference is given in paragraph (b)(4)(iii)(I) of this section. (iii) Method 4500-Cl F—‘‘DPD Ferrous Titrimetric Method,’’ which is con tained in the book entitled ‘‘Standard Methods for the Examination of Water and Wastewater,’’ 19th Ed., which is in corporated 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 Colori metric Method,’’ which is contained in the book entitled ‘‘Standard Methods for the Examination of Water and Wastewater,’’ 19th Ed., which is incor porated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00702 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 693 Food and Drug Administration, HHS § 165.110 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 Examina tion 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 in corporation by reference is given in paragraph (b)(4)(iii)(I) of this section. (vi) Method 4500-Cl I—‘‘Iodometric Electrode Technique,’’ which is con tained in the book entitled ‘‘Standard Methods for the Examination of Water and Wastewater,’’ 19th Ed., which is in corporated 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. (6) Compliance with the chlorine standard can be determined by meas uring free or total chlorine. The fol lowing methods shall be used to meas ure chlorine: (i) ASTM Method D1253-86—‘‘Stand ard 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 in corporated 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—‘‘Ampero metric Titration Method,’’ which is contained in the book entitled ‘‘Stand ard 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 in corporation by reference is given in paragraph (b)(4)(iii)(I) of this section. (iii) Method 4500-Cl F—‘‘DPD Ferrous Titrimetric Method,’’ which is con tained in the book entitled ‘‘Standard Methods for the Examination of Water and Wastewater,’’ 19th Ed., which is in corporated 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 Colori metric Method,’’ which is contained in the book entitled ‘‘Standard Methods for the Examination of Water and Wastewater,’’ 19th Ed., which is incor porated 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 Examina tion 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 in corporation by reference is given in paragraph (b)(4)(iii)(I) of this section. (vi) Method 4500-Cl I—‘‘Iodometric Electrode Technique,’’ which is con tained in the book entitled ‘‘Standard Methods for the Examination of Water and Wastewater,’’ 19th Ed., which is in corporated 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 Examina tion 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 in corporation by reference is given in paragraph (b)(4)(iii)(I) of this section. (7) Chlorine dioxide shall be meas ured using the following methods: (i) Method 4500-ClO2 D—‘‘DPD Meth od,’’ which is contained in the book en titled ‘‘Standard Methods for the Ex amination of Water and Wastewater,’’ 19th Ed., which is incorporated by ref erence in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The avail ability of this incorporation by ref erence is given in paragraph (b)(4)(iii)(I) of this section. (ii) Method 4500-ClO2E—‘‘Ampero metric Method II,’’ which is contained in the book entitled ‘‘Standard Meth ods for the Examination of Water and Wastewater,’’ 19th Ed., which is incor porated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00703 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 694 21 CFR Ch. I (4–1–16 Edition) § 165.110 by reference is given in paragraph (b)(4)(iii)(I) of this section. (5) Radiological quality. (i) Bottled water shall, when a composite of ana lytical units of equal volume from a sample is examined by the methods de scribed in paragraph (b)(5)(ii) of this section, meet standards of radiological quality as follows: (A) The bottled water shall not con tain a combined radium-226 and ra dium-228 activity in excess of 5 picocuries per liter of water. (B) The bottled water shall not con tain a gross alpha particle activity (in cluding radium-226, but excluding radon and uranium) in excess of 15 picocuries per liter of water. (C) The bottled water shall not con tain beta particle and photon radioac tivity from manmade radionuclides in excess of that which would produce an annual dose equivalent to the total body or any internal organ of 4 millirems per year calculated on the basis of an intake of 2 liters of the water per day. If two or more beta or photon-emitting radionuclides are present, the sum of their annual dose equivalent to the total body or to any internal organ shall not exceed 4 millirems per year. (D) The bottled water shall not con tain 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 meth ods described in the applicable sections of ‘‘Standard Methods for the Examina tion 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 Meth ods for the Examination of Water and Wastewater,’’ 20th Ed., may be ob tained 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 ex amined at the National Archives and Records Administration (NARA), or at the Food and Drug Administration’s Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039. For in formation on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ federallregister/ codeloflfederallregulations/ ibrllocations.html. (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 Examina tion 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 in corporation 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 con tained in ‘‘Standard Methods for the Examination of Water and Waste water,’’ 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 sec tion. (B) Gross alpha particle radioactivity shall be measured using the following method: Method 7110 C—‘‘Coprecipita tion Method for Gross Alpha Radioac tivity in Drinking Water,’’ which is contained in ‘‘Standard Methods for the Examination of Water and Waste water,’’ 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 sec tion. (C) Beta particle and photon radioac tivity shall be measured using the fol lowing methods: (1) Method 7500–Sr B—‘‘Precipitation Method,’’ which is contained in ‘‘Standard Methods for the Examina tion 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 in corporation by reference is given in the introductory text of paragraph (b)(5)(ii) of this section. (2) Method 7500–3H B—‘‘Liquid Scin tillation Spectrometric Method,’’ which is contained in ‘‘Standard Meth ods for the Examination of Water and VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00704 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 695 Food and Drug Administration, HHS Pt. 166 Wastewater,’’ 20th Ed., which is incor porated 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 introduc tory text of paragraph (b)(5)(ii) of this section. (3) Method 7120 B—‘‘Gamma Spectroscopic Method,’’ which is con tained in ‘‘Standard Methods for the Examination of Water and Waste water,’’ 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 sec tion. (D) Uranium shall be measured using the following methods: (1) Method 7500–U B—‘‘Radiochemical Method’’ which is contained in ‘‘Standard Methods for the Examina tion 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 in corporation by reference is given in the introductory text of paragraph (b)(5)(ii) of this section. (2) Method 7500–U C—‘‘Isotopic Meth od’’ which is contained in ‘‘Standard Methods for the Examination of Water and Wastewater,’’ 20th Ed., which is in corporated 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 introduc tory text of paragraph (b)(5)(ii) of this section. (c) Label statements. When the micro biological, physical, chemical, or radio logical 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 sub standard quality specified in § 130.14(a) of this chapter except that, as appro priate, instead of or in addition to the statement specified in § 130.14(a) the following statement(s) shall be used: (1) ‘‘Contains Excessive Bacteria’’ if the bottled water fails to meet the re quirements of paragraph (b)(2)(i)(A) of this section. (2) ‘‘Excessively Turbid’’, ‘‘Abnormal Color’’, and/or ‘‘Abnormal Odor’’ if the bottled water fails to meet the require ments of paragraph (b)(3) (i), (ii), or (iii), respectively, of this section. (3) ‘‘Contains Excessive lll,’’ with the blank filled in with the name of the chemical for which a maximum con taminant level in paragraph (b)(4) of this section is exceeded (e.g., ‘‘Contains Excessive Arsenic,’’ ‘‘Contains Exces sive Trihalomethanes’’) except that ‘‘Contains Excessive Chemical Sub stances’’ may be used if the bottled water is not mineral water. (4) ‘‘Excessively Radioactive’’ if the bottled water fails to meet the require ments of paragraph (b)(5) of this sec tion. (d) Adulteration. Bottled water con taining a substance at a level consid ered injurious to health under section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (the act), or that consists in whole or in part of any filthy, pu trid, or decomposed substance, or that is otherwise unfit for food under sec tion 402(a)(3) 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. If E. coli is present in bottled water, then the bottled water will be deemed adulter ated under section 402(a)(3) of the act. [60 FR 57124, Nov. 13, 1995; 60 FR 66495, Dec. 22, 1995, as amended at 61 FR 13264, Mar. 26, 1996; 61 FR 14480, Apr. 2, 1996; 63 FR 25769, May 11, 1998; 66 FR 16865, Mar. 28, 2001; 66 FR 17359, Mar. 30, 2001; 66 FR 35373, July 5, 2001; 66 FR 56035, Nov. 6, 2001; 58 FR 15355, Mar. 31, 2003; 68 FR 9881, Mar. 3, 2003; 70 FR 33700, June 9, 2005; 74 FR 25665, May 29, 2009; 76 FR 64813, Oct. 19, 2011; 81 FR 5591, Feb. 3, 2016] PART 166—MARGARINE Subpart A—General Provisions Sec. 166.40 Labeling of margarine. Subpart B—Requirements for Specific Standardized Margarine 166.110 Margarine. AUTHORITY: 21 U.S.C. 321, 341, 343, 347, 348, 371, 379e. VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00705 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B