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Incorporation by Reference

Title 21 — Food and Drugs
Material Approved for Incorporation by Reference

21 CFR (100-169) - Food and Drug Administration, Department of Health and Human Services

The Director of the Federal Register has approved, under 5 U.S.C. 552(a) and 1 CFR part 51, the incorporation by reference of the following publications. Incorporations by reference found within a regulation are effective upon the effective date of that regulation. For more information on incorporation by reference, see http://www.archives.gov/federal-register/cfr/ibr-locations.html .

Incorporation by Reference

Reader Aids help people use and understand the eCFR. Reader Aids information is not published in the Code of Federal Regulations.

American Association of Cereal Chemists (AACC)

3340 Pilot Knob Road, St. Paul, Minnesota 55121

Publication CFR Reference
AACC Method 55-99: “Glossary-Barley” as published in the “Approved Methods of the American Association of Cereal Chemists,” pages 1 and 2, Tenth edition, March 2000
101.81(c)(2)(ii)(A)(5)

American Herbal Products Association

4733 Bethesda Ave., Suite 345, Bethesda, MD 20814

Publication CFR Reference
Herbs of Commerce, 1992 edition
101.4(b)

American Public Health Association

1015 Fifteenth Street NW, Washington, DC 20005; Telephone: (202) 777–APHA

Publication CFR Reference
Standard Methods for the Examination of Water and Wastewater, 15th Ed. (1980),
“Methods For Organochlorine Pesticides Industrial Effluents”
165.110(b)(4)
Standard Methods for the Examination of Water and Wastewater, 15th Ed. (1980) “Methods for Chlorinated Phenoxy Acid Herbicides in Industrial Effluents”
165.110(b)(4)
  Method 4500–C1 D Amperometric Titration Method
165.110(b)(4)(iii)(I)
  Method 4500–C1 E Low-Level Amperometric Titration Method
165.110(b)(4)(iii)(I)
  Method 4500–C1 F DPD Ferrous Titrimetric Method
165.110(b)(4)(iii)(I)
  Method 4500–C1 G DPD Colorimetric Method
165.110(b)(4)(iii)(I)
  Method 4500–C1 H Syringaldazine (FACTS) Method
165.110(b)(4)(iii)(I)
  Method 4500–C1 I Iodometric Electrode Technique
165.110(b)(4)(iii)(I)
  Method 4500–CIO\2\D DPD Method
165.110(b)(4)(iii)(I)
  Method 4500–CIO\2\E Amperometric Method II
165.110(b)(4)(iii)(I)
  Method 6251 B: Disinfection By-Products: Haloacetic Acids and Trichlorophenol
165.110(b)(4)(iii)(I)
  Method 7110 C Coprecipitation Method for Gross Alpha Radioactivity in Drinking Water
165.110(b)(5)
  Method 7120 B Gamma Spectroscopic Method
165.110(b)(5)
  Method 7500-3HB Liquid Scintillation Spectrometric Method
165.110(b)(5)
  Method 7500-RA B Precipitation Method
165.110(b)(5)
  Method 7500-Ra D Sequential Precipitation Method
165.110(b)(5)
  Method 7500-Sr B Precipitation Method
165.110(b)(5)
  Method 7500-U B Radiochemical Method
165.110(b)(5)
  Method 7500-U C Isotopic Method
165.110(b)(5)

American Society for Testing and Materials

100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, Telephone (610) 832-9585, FAX (610) 832-9555

Publication CFR Reference
ASTM Method D 1253–86, Standard Test Method for Residual Chlorine in Water
165.110(b)(4)(iii)(I)
ASTM D 2036-91, Standard Test Methods for Cyanides in Water
165.110(b)(4)(iii) (E)(7)(iv)
ASTM D 3697-92, Standard Test Method for Antimony in Water
165.110(b)(4)(iii) (E)(1)(iv)
ASTM E 11–70 Table 1, Annual Book of ASTM Standards, Part 30 (1972)
137.105(a)

AOAC International (Association of Official Analytical Chemists)

481 N. Frederick Ave. Suite 500, Gaithersburg, MD 20877-2417 Telephone: (301) 924–7077

Publication CFR Reference
Journal of the AOAC International, Vol. 78, No. 3, pp. 724–729, (1995)
  Method 991.43, “Determination of Soluble and Insoluble Dietary Fiber in Psyllium-Containing Cereal Products”
101.81(c)(2)(B)(2)
Official Methods of Analysis, 16th Ed. (1995)
101.81(c)
Official Methods of Analysis, 15th Ed. (1990)
101.9(c)(7)(ii)
(g)(2)
155.120(b)(2)(i)
163.5(b)
Official Methods of Analysis, 14th Ed., 1984, including the 4th Supplement (1988)
168.122(d)
Official Methods of Analysis, 14th Ed., 1984
101.100(a)
130.9
160.145
Official Methods of Analysis, 13th Ed., 1980
101.9
101.25(e)(3)
102.23
102.33(b)
105.65(c)(4)(i)
106.30(b)(3)(i), (ii)
114.90
131.110
131.111(f)
131.112(e)
131.115
131.120
131.122
131.123
131.125
131.127
131.130
131.132
131.135
131.136(f)
131.138(e)
131.143
131.144(f)
131.146(e)
131.147
131.149
131.150
131.155
131.157
131.160
131.162
131.170(f)
131.180
131.185
131.187
131.200(d)
131.203(d)
131.206(d)
133.5
135.110
135.130
136.110
136.160
137.105
137.180
137.190
137.200
137.211
137.230
137.250
137.270
Official Methods of Analysis, 13th Ed., 1980
137.300
139.110
139.150
145.110
145.135
145.145
146.113
146.114
146.120
146.132(a)(1)
146.185
150.110
150.140
150.160
155.3
155.130
155.170(b)(1)(vi)
156.3
160.180
161.145
161.173
161.175
161.190
163.111
163.112
164.150
166.110
168.111
168.120
168.122
169.3
Official Methods of Analysis, 12th Ed., 1975
163.110
163.5(a)
Official Methods of Analysis of the AOAC International, 16th edition, 1995, Method 992.28
101.81(c)(2)(ii)(A)
Note: The following materials are available through the Food and Drug Administration at the addresses indicated.

Center for Food Safety and Applied Nutrition (HFF–260), Food and Drug Administration

5100 Paint Branch Parkway, College Park, MD 20740

Publication CFR Reference
Analytical Methodology for Polychlorinated Biphenyls (June 1979)
109.30
Comparative Anatomy and Systematics of the Tunas, “Gennus Thunnus” Fishery Bulletin Vol. 66, No. 1, (1967) pp. 65–130
161.190(a)(2)
Comparison of the Bluefin tuna, Gennus Thunnus—Bureau of Marine Fisheries, Fish Bulletin No. 77, 1950
161.190(a)(2)
“Descriptive Study of Certain Tuna–Like Fishes,” by H.C. Godsil, State of California, Department of Fish and Game, Fish Bulletin No. 97
161.190(a)(2)
“Energy Value of Foods—Basis and Derivation” USDA Handbook (Slightly Revised 1973),
A. L. Merrill and B. K. Watt
101.9(c)(1)(i)(A), (c)(1)(i)(B), (c)(1)(i)(C), (c)(1)(i)(E) and (c)(6)
“Energy Value of Foods—Basis and Derivation” USDA Handbook No. 74, 1955
101.9(c)(3)
“Folic Acid Activity of Some Milk Foods for Babies,” Journal of Dairy Research 35:85–90 (1968)
102.23(c)(5)
“Identification of Low Caries Risk Dietary Components”, by Thomas N. Imfeld, in Monographs in Oral Science, Vol. II, Karger, Basel, Switzerland, 1983
101.80(c)(2)
Journal of the Optical Society of America, Vol. 33, p. 406 (1943)
161.190(a)(7)(iii)
“Protein Quality Evaluation, Sections 5.4.1, 7.2.1 and 8.00, Report of the Joint FAO/WHO Expert Consultation on Protein Quality Evaluation,” Rome, 1990
101.9(c)(7)(ii)(B)
Systematic Study of the Pacific Tunas, Fish Bulletin No. 60, (1944)
161.190(a)(2)
Test procedures for Determination of Permeability of Food Packaging, Inner Wraps (September 1976, revised May 1983)
109.30
“Total Dietary Fiber in Foods, Enzymatic Gravimetric Method, First Action,” Journal of the Association of Official Analytical Chemists 68:399, 1985, as amended at 69:370, 1986
101.9
Methods for Chemical Analysis of Water and Wastes, Environmental Monitoring and Support Laboratory, EPA–600/4–82–055, March 1983, U.S. Environmental Protection Agency
103.35(d)(1)(ii)
Interim Radiochemical Methodology for Drinking Water, Environmental Monitoring and Support Laboratory, EPA 600–4–75–008 (Revised),
March 1976, EPA
103.35(e)(2)
Standard Methods for the Examination of Water and Wastewater (15th Ed.) (1980)
103.35(b), (c), (d)(1)(ii), and (e)(2)

Center for Food Safety and Applied Nutrition, Office of Nutritional Products, Labeling, and Dietary Supplements, Diviaion of Nutrition Science and Policy

5100 Paint Branch Parkway, College Park, MD 20740

Publication CFR Reference
Determination of Stanols and Sterols in Benecol Dressing (February 15, 2000)
101.83(c)(2)(ii)(B)(2)
Determination of Stanols and Sterols in Benecol Softgels (February 15, 2000)
101.83(c)(2)(ii)(B)(2)
Determination of Stanols and Sterols in Benecol Snack Bars (February 15, 2000)
101.83(c)(2)(ii)(B)(2)
Determination of Stanols and Sterols in Benecol Tub Spread (February 15, 2000)
101.83(c)(2)(ii)(B)(2)
Determination of the Sterol Content in Margerines, Halvarines, Dressings, Fat Blends and Sterol Fatty Acid Ester Concentrates by Capilliary Gas Chromatography, February 1, 2000
101.83(c)(2)(ii)(A)(2)

Environmental Protection Agency, Environmental Monitoring and Support Laboratory (EMSL)

Cincinnati, OH 45258

Publication CFR Reference
Available from: National Technical Information Service, 5285 Port Royal Rd., Springfield, VA 22161 Telephone: (703) 487-4650, FAX: (703) 487-4142
Methods for Chemical Analysis of Water and Wastes (EPA–600/4–79–020), March 1983:
Method 202.1—Atomic Absorption technique; direct aspiration
165.110(b)(4)(iii)(G) (1)(i)
Method 202.2—Atomic Absorption; furnace technique
165.110(b)(4)(iii)(G) (1)(ii)
Method 204.2—Atomic Absorption; furnace technique
165.110(b)(4)(iii)(E) (1)(i)
Method 208.1—Atomic Absorption; direct aspiration
165.110(b)(4)(iii)(E) (2)(ii)
Method 208.2—Atomic Absorption; furnace technique
165.110(b)(4)(iii)(E) (2)(i)
Method 210.2—Atomic Absorption; furnace technique
165.110(b)(4)(iii)(E) (3)(i)
Method 213.2—Atomic Absorption; furnace technique
165.110(b)(4)(iii)(E) (4)(i)
Method 218.2—Atomic Absorption; furnace technique
165.110(b)(4)(iii)(E) (5)(i)
Method 220.1—Atomic Absorption; direct aspiration
103.35(d)(3)
165.110(b)(4)(iii)(E) (6)(ii)
Method 220.2—Atomic Absorption; furnace technique
103.35(d)(3)
165.110(b)(4)(iii)(E) (6)(i)
Method 239.2—Atomic Absorption; furnace technique
165.110(b)(4)(E) (8)(i)
Method 239.2—Atomic Absorption; furnace technique
103.35(d)(3)
Method 245.1—Manual cold vapor technique
165.110(b)(4)(iii)(E) (9)(i)
Method 245.2—Automated cold vapor technique
165.110(b)(4)(iii)(E) (9)(ii)
Method 249.1—Atomic Absorption; direct aspiration
165.110(b)(4)(iii)(E) (10)(i)
Method 249.2—Atomic Absorption; furnace technique
165.110(b)(4)(iii)(E) (10)(ii)
Method 270.2—Atomic Absorption, furnace technique
165.110(b)(4)(iii)(E) (12)(i)
Method 270.3—Atomic Absorption, gaseous hydride
165.110(b)(4)(iii)(E) (12)(ii)
Method 272.1—Atomic Absorption; direct aspiration
165.110(b)(4)(iii)(G) (2)(i)
Method 272.2—Atomic Absorption; furnace technique
165.110(b)(4)(iii)(G) (2)(ii)
Method 279.2—Atomic Absorption; furnace technique
165.110(b)(4)(iii)(E) (13)(i)
Method 300.0—The Determination of Inorganic Anions in Water by Ion Chromatography
165.110(b)(4)(iii) (11)(iii)
Method 335.1—Tritrimetric; Spectrophometric
165.110(b)(4)(iii)(E) (7)(i)
Method 335.2—Tritrimetric; Spectrophotometric
165.110(b)(4)(iii)(E) (7)(ii)
Method 335.3—Colorimetric; Automated UV
165.110(b)(4)(iii)(E) (7)(iii)
Method 353.1—Colorimetric automated, hydrazine reduction
165.110(b)(4)(iii)(E) (11)(iv)
(E) (11)(ii)
Method 353.2—Colorimetric automated, cadmium reduction
165.110(b)(4)(E) (11)(ii)
(E)(11)(iii)
Method 353.3—Spectrophotometric, cadmium reduction
165.110(b)(4)(iii)(E) (11)(i), (E)(11)(iv)
Method 375.1—Colorimetric, Automated, Chloromilate
165.110(b)(4)(iii)(G) 3)(ii)
Method 375.3—Gravimetric
165.110(b)(4)(iii)(G) (3)(iii)
Method 375.4—Turbidimetric
165.110(b)(4)(iii)(G) (3)(iv)
Methods for the Determination of Metals in Environmental Samples, Office of Research and Development, (EPA/600/4–91/010, June 1991:
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
103.35(d)(3)
Method 200.7—Determination of Metals and Trace Elements in Water and Wastes by Inductively Coupled Plasma-Atomic Emission Spectrometry
165.110(b)(4)(iii)(E) (2)(iii), (E)(3)(ii), (E)(4)(ii), (E)(5)(iii), (E)(6)(iii), (E)(10) (iii), (G)(1)(iii), (G)(2)(iii)
Method 200.8—Determination of Trace Elements in Water and Wastes by Inductively Coupled Plasma-Mass Spectrometry, Rev. 4.4, April 1991
103.35(d)(3), 165.110(b)(4)(iii)(E) (2)(iii), (E)(3)(ii), (E)(4)(ii), (E)(5)(ii), (E)(6)(iii), (E)(6) (iv), (E)(8)(ii), (E)(10)(iii), (E)(13)(ii), (G)(1)(iv), (G)(2)(iv)
Method 200.9—Determination of Trace Elements in Stabilized Temperature Graphite Furnace Atomic Absorption Spectrometry, Rev. 1.2, April 1991
165.110(b)(4)(iii)(E) (1)(iii), (E)(3)(iv), (E)(6)(v), (E)(8)(iii), (E)(13)(iii), (G)(1)(v), (G)(2)(v)
Method 200.9—Determination of Trace Elements by Stabilized Temperature Graphite Furnace Atomic Absorption Spectrometry, Rev. 1.2, April 1991
103.35(d)(3)
Methods for the Determination of Organic Compounds in Drinking Water, Office of Research and Development, Environmental Monitoring Systems Laboratory, EPA/600/4–88/039, December 1988:
Method 502.1—Volatile Halogenated Organic Compounds in Water by Purge and Trap Gas Chromatography, Rev. 2.0, 1989
103.35(d)(3)
165.110(b)(4)(iii) (F)(1)
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
103.35(d)(3)
165.110(b)(4)(iii) (F)(2)
Method 503.1—Volatile Aromatic and Unsaturated Organic Compounds in Water by Purge and Trap Gas Chromatography, Rev. 2.0, 1989
103.35(d)(3)
165.110(b)(4)(iii) (F)(3)
Method 524.1—Measurement of Purgeable Organic Compounds in Water by Packed Column Gas Chromatography/Mass Spectrometry, Rev. 3.0, 1989
165.110(b)(4)(iii) (F)(4)
Method 524.2—Measurement of Purgeable Organic Compounds in Water by Capillary Column Gas Chromatography/Mass Spectrometry, Rev. 3.0, 1989
165.110(b)(4)(iii) (F)(5)
Method 504—1,2-Dibromoethane (EDB) and 1,2-Dibromo-3-Chloropropane (DBCP) in Water by Microextraction and Gas Chromatography, Rev. 2.0, 1989
165.110(b)(4)(iii) (F)(6)
Method 505—Analysis of Organohalide Pesticides and Commercial Polychlorinated Biphenyl (PCB) Products in Water by Microextraction and Gas Chromatography, Rev. 2.0, 1989
165.110(b)(4)(iii) (F)(7)
Method 507—Determination of Nitrogen- and Phosphorus-Containing Pesticides in Water by Gas Chromatography with a Nitrogen-Phosphorus Detector, Rev. 2.0, 1989
165.110(b)(4)(iii) (F)(9)
Method 508—Determination of Chlorinated Pesticides in Water by Gas Chromatography with an Electron Capture Detector, Rev. 3.0, 1989
165.110(b)(4)(iii) (F)(10)
Method 508A—Screening for Polychlorinated Biphenyls by Perchlorination and Gas Chromatography, Rev. 1.0, 1989
165.110(b)(4)(iii) (F)(11)
Method 515.1—Determination of Chlorinated Acids in Water by Gas Chromatography with an Electron Capture Detector, Rev. 5.0, May 1991
165.110(b)(4)(iii) (F)(12)
Method 524.1—Measurement of Purgeable Organic Compounds in Water by Packed Column Gas Chromatography/Mass Spectrometry
103.35(d)(3)
Method 524.2—Measurement of Purgeable Organic Compounds in Water by Capillary Column Gas Chromatography/Mass Spectrometry
103.35(d)(3)
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
165.110(b)(4)(iii) (F)(13)
Method 531.1—Measurement of N-Methylcarbamoyloximes and N-Methylycarbamates in Water by Direct Aqueous Injection HPLC with Post Column Derivatization, Rev. 3.0, 1989
165.110(b)(4)(iii) (F)(14), 103.35(d)(3)
The Determination of Inorganic Anions in Water by Ion Chromatography—Method 300.0, EPA, EMSL (EPA/600/4–84/017, March 1984
103.35(d)(3)(v)(E)(3)
“Methods for the Determination of Organic Compounds in Drinking Water”, Office of Research and Development, EMSL, EPA/600/4-88-039, December, 1988, Supplement 1, July, 1990:
Method 506—“Determination of Phthalate and Adipate Esters in Drinking Water by Liquid-Liquid Extraction or Liquid-Solid Extraction and Gas Chromatography with Photoionization Detection”
165.110(b)(4)(iii) (F)(8)
Method 547—“Determination of Glyphosate in Drinking Water by Direct-Aqueous-Injection HPLC, Post-Column Derivatization, and Fluorescence Detection”
165.110(b)(4)(iii) (F)(15)
Method 548—“Determination of Endothall in Drinking Water by Aqueous Derivatization, Liquid-Solid Extraction, and Gas Chromatography with Electron-Capture Detection”
165.110(b)(4)(iii)(F) (16)
Method 549—“Determination of Diquat and Paraquat in Drinking Water by Liquid-Solid Extraction and HPLC with Ultraviolet Detection”
165.110(b)(4)(iii) (F)(17)
Method 550—“Determination of Polycyclic Aromatic Hydrocarbons in Drinking Water by Liquid-Liquid Extraction and HPLC with Coupled Ultraviolet and Fluorescence Detection”
165.110(b)(4)(iii) (F)(18)
Method 550.1—“Determination of Polycyclic Aromatic Hydrocarbons in Drinking Water by Liquid-Solid Extraction and HPLC with Coupled Ultraviolet and Fluorescence Detection”
165.110(b)(4)(iii) (F)(19)
Method 1613—“Tetra-through Octa-Chlorinated Dioxins and Furans by Isotope Dilution HRGC/HRMS”, Revision A, 1990, EPA, Office of Water Regulations and Standards
165.110(b)(4)(iii) (F)(20)
Interim Radiochemical Methodology For Drinking Water (600/4–75–008), Revised March 1976
165.110(b)(5)(ii)

International Association for Plant Taxonomy

Koeltz Scientific Books, D-61453 Ko
nigstein, Germany; University Bookstore, Southern Illinois University, Carbondale, IL 62901-4422, Telephone: (618) 536-3321; FAX (618) 453-5207

Publication CFR Reference
International Code of Botanical Nomenclature (Tokyo Code),
1994 Edition
101.4(b)

National Technical Information Service (NTIS)

U.S. Department of Commerce, 5285 Port Royal Road, Springfield, Virginia 22161

Publication CFR Reference
  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, August 1992, Revision 1.0
165.110(b)(4)(iii)(I)
Method 200.8: “Determination of Trace Elements in Waters and Wastes by Inductively Coupled Plasma-Mass Spectrometry” as published in “Methods for the Determination of Metals in Environmental Samples—Supplement 1”, EPA/600/R-94/111, Revision 5.4, May 1994
165.110
Method 200.9: “Determination of Trace Elements by Stabilized Temperature Graphite Furnace Atomic Absorption,” as published in “Methods for the Determination of Metals in Environmental Samples—Supplement 1”, EPA/600/R-94/111, Revision 2.2, 1994
165.110
  Method 300.0—Determination of Inorganic Anions by Ion Chromatography, Revision 2.1
165.110(b)(4)(iii)(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, Revision 2.1
165.110(b)(4)(iii)(I)
  Method 524.2: Measurement of Purgeable Organic Compounds in Water by Capillary Column Gas Chromatography/Mass Spectrometry, Revision 1.0
165.110(b)(4)(iii)(I)
  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, Revision 1.0, August 1993
165.110(b)(4)(iii)(I)
  Method 552.2: Determination of Haloacetic Acids and Dalapon in Drinking Water by Liquid-Liquid Extraction, Derivatization and Gas Chromatography with Electron Capture Detection, Revision 1.0, August 1993
165.110(b)(4)(iii)(I)
Method 300.1: Determination of Inorganic Anions in Drinking Water by Ion Chromatography, Revision 1.0, 1997
165.110(b)(4)(iii)(I)

United States Pharmacopeial Convention

12601 Twinbrook Pkwy, Rockville, MD 20852

Publication CFR Reference
United States Pharmacopeia, 23d Revision, dated January, 1995
165.110(a)(2)
“Psyllium Husk” from U.S. Pharmacopeia, National Formulary, USP 23, NF 18, (1995), p. 1341
101.81(c)(2)(B)(1)
Incorporation by Reference