North Carolina Administrative Code › Title 02 - AGRICULTURE AND CONSUMER SERVICES › Chapter 09 - FOOD AND DRUG PROTECTION › Subchapter B - RULES AND STANDARDS ADOPTED BY REFERENCE › Section 09B .0116 - ADOPTIONS BY REFERENCE

Current through Register Vol. 39, No. 2, July 15, 2024
(a) The Board
				incorporates by reference, including subsequent amendments and editions,
				"Official Methods of Analysis of AOAC," published by the Association of
				Official Analytical Chemists. Copies of this document may be obtained from the
				Association of Official Analytical Chemists International, Department 0742,
				1970 Chain Bridge Road, McLean, VA 22109-0742, at a cost of seven hundred
				thirty dollars ($730.00).
(b) The
				Board incorporates by reference, including subsequent amendments and editions,
				"U.S. Pharmacopeia National Formulary USP XXXIII-NFXXVIII" and supplements,
				published by the U.S. Pharmacopeial Convention, Inc. Copies of this document
				may be obtained from The United States Pharmacopeial Convention, Inc.,
				Attention: Customer Service, 12601 Twinbrook Parkway, Rockville, MD 20852, at a
				cost of eight-hundred fifty dollars ($850.00).
(c) The Board incorporates by reference,
				including subsequent amendments and editions, "ASTM Volume 15.05 Engine
				Coolants and Related Fluids; Halogenated Organic Solvents and Fire
				Extinguishing Agents," published by ASTM International. Copies of this document
				may be obtained from ASTM International, 100 Bar Harbor Drive, West
				Conshohocken, PA 19428-2959, or by visiting
https://www.astm.org/BOOKSTORE/BOS/1505.htm
at a cost of one hundred ninety dollars ($190.00).
(d) The Board incorporates by reference,
				including subsequent amendments and editions, "EPA Manual of Chemical Methods
				for Pesticides and Devices" and supplements, published by AOAC. Copies of this
				document may be obtained online at no cost from the Environmental Protection
				Agency National Service Center for Environmental Publications at
http://nepis.epa.gov/EXE/ZyPURL.cgi?Dockey=2000YS3Y.txt
.
(e) The Board incorporates by reference,
				including subsequent amendments and editions, "Pesticide Analytical Manual,"
				Volumes I and II, published by the United States Department of Health and Human
				Services, Food and Drug Administration. Copies of this document may be obtained
				online at no cost at http://www.fda.gov/Food/Science
				Research/LaboratoryMethods/PesticideAnalysisManualPAM/default.htm.
(f) The Board incorporates by reference,
				including subsequent amendments and editions, "FDA Compliance Policy Guides,"
				published by the United States Department of Health and Human Services, Food
				and Drug Administration. Copies of this document may be obtained online at no
				cost at
http://www.fda.gov/iceci/compliancemanuals/compliancepolicy
				guidancemanual/default.htm
or from the State Information Branch
				(HFC-151), Division of Federal-State Relations, US Food and Drug
				Administration, 5600 Fishers Lane, Room 12-07, Rockville, MD 20857.
(g) The Board incorporates by reference,
				including subsequent amendments and editions, "Bergey's Manual of Determinative
				Bacteriology," Lippincott, Williams & Wilkins Company, Baltimore. Copies of
				this document may be obtained from the Lippincott, Williams & Wilkins
				Company, P.O. Box 1620, Hagerstown, MD 21741 at a cost one hundred forty five
				dollars and ninety nine cents ($145.99).
(h) The Board incorporates by reference,
				including subsequent amendments and editions, "Microbiology Laboratory
				Guidebook," published by the United States Department of Agriculture, Food
				Safety and Inspection Service, Washington, DC. Copies of this document may be
				obtained online at no cost from
http://www.fsis.usda.gov
.
(i) The Board incorporates by reference,
				including subsequent amendments and editions, "FDA Bacteriological Analytical
				Manual," published by the United States Department of Health and Human
				Services, Food and Drug Administration. Copies of this document may be obtained
				online at http://www.fda.gov/Food/FoodScience
				Research/LaboratoryMethods/ucm114664.htm at no charge.
(j) The Board incorporates by reference,
				including subsequent amendments and editions, "Standard Methods for the
				Examination of Dairy Products," published by the American Public Health
				Association. Copies of this document may be obtained from the American Public
				Health Association Publication Sales, P.O. Box 933019, Atlanta, GA at a cost of
				eighty-five dollars and fifty cents ($87.50) for members and one hundred
				twenty-five dollars ($125.00) for non-members.
(k) The Board incorporates by reference,
				including subsequent amendments and editions, "Compendium of Methods for the
				Microbiological Examination of Foods," published by the American Public Health
				Association. Copies of this document may be obtained from the American Public
				Health Association Publication Sales, P.O. Box 933019, Atlanta, GA at a cost of
				one hundred forty seven dollars and fifty cents ($147.50).
(l) The Board incorporates by reference,
				including subsequent amendments and editions, "Bergey's Manual of Systematic
				Bacteriology," Springer Publishing, New York, NY. Copies of this document may
				be obtained from Springer Publishing, 233 Spring Street, New York, NY, 10013 at
				a cost of one hundred fifty-nine dollars ($159.00).
(m) The Board incorporates by reference,
				including subsequent amendments and editions, "Manual of Clinical
				Microbiology," published by the American Society for Microbiology. Copies of
				this document may be obtained from the American Society for Microbiology Press,
				PO Box 605, Herndon, VA 22070, at a cost of two hundred sixty-nine dollars and
				ninety-five cents ($269.95).
(n)
				The Board incorporates by reference, including subsequent amendments and
				editions, "Standard Methods for the Examination of Water and Waste Water,"
				published by American Public Health Association, American Water Works
				Association, and Water Pollution Control Federation. Copies of this document
				may be obtained from the American Public Health Association Publication Sales,
				P.O. Box 933019, Atlanta, GA at a cost of two hundred ninety-five dollars
				($295.00).
(o) The Board
				incorporates by reference, including subsequent amendments and editions, the
				following parts or sections of the Code of Federal Regulations, Title 21,
				Chapter I, as promulgated by the Commissioner of the Food and Drug
				Administration under the authority of the Federal Food, Drug, and Cosmetic Act:
Part or
Section
Description of Part or Section
(1)
1.1
General
(2)
1.3
Definitions
(3)
1.20
Presence of Mandatory Label Information
(4)
1.21
Failure to Reveal Material Facts
(5)
1.24
Exemptions from Required Label Statements
(6)
1.326
Who is Subject to this Subpart?
(7)
1.327
Who is Excluded from All or Part of the Regulations
							 in this Subpart?
(8)
1.328
What Definitions Apply to this Subpart?
(9)
1.329
Do Other Statutory Provisions and Regulations
							 Apply?
(10)
1.330
Can Existing Records Satisfy the Requirements of this
							 Subpart?
(11)
1.337
What Information Must Nontransporters Establish and
							 Maintain to I dentify the
Nontransporter and Transporter Immediate Previous
							 Sources of Food?
(12)
1.345
What Information Must Nontransporter Establish and
							 Maintain to Identify
the Nontransporter and Transporter Immediate
							 Subsequent Recipients of Food?
(13)
1.352
What Information Must Transporters Establish and
							 Maintain?
(14)
1.360
What are the Record Retention
							 Requirements?
(15)
1.361
What are the Record Availability
							 Requirements?
(16)
1.362
What Records are Excluded from this
							 Subpart?
(17)
1.363
What are the Consequences of Failing to Establish, or
							 Maintain Records or Make Them Available to FDA as Required by this
							 Subpart?
(18)
1.368
What are the Compliance Dates for this
							 Subpart?
(19)
2.25
Grain Seed Treated with Poisonous Substances; Color
							 Identification to Prevent Adulteration of Human and Animal Food
(20)
2.35
Use of Secondhand Containers for the Shipment or
							 Storage of Food and Animal Feed
(21)
7.1
Scope
(22)
7.3
Definitions
(23)
7.12
Guaranty
(24)
7.13
Suggested Forms of Guaranty
(25)
7.40
Recall Policy
(26)
7.41
Health Hazard Evaluation and Recall
							 Classification
(27)
7.42
Recall Strategy
(28)
7.45
Food and Drug Administration - Requested
							 Recall
(29)
7.46
Firm-initiated Recall
(30)
7.49
Recall Communications
(31)
7.50
Public Notification of Recall
(32)
7.53
Recall Status Reports
(33)
7.55
Termination of a Recall
(34)
7.59
General Industry Guidance
(35)
70
Color Additives
(36)
73
Listing of Color Additives Exempt from
							 Certification
(37)
74
Listing of Color Additives Subject to
							 Certification
(38)
81
General Specifications and General Restrictions for
							 Provisional Color Additives for Use in Foods, Drugs, and Cosmetics
(39)
82
Listing of Certified Provisionally Listed Colors and
							 Specifications
(40)
100
General
(41)
101
Food Labeling
(42)
102
Common or Usual Name for Nonstandardized
							 Foods
(43)
104
Nutritional Quality Guidelines for Foods
(44)
105
Foods for Special Dietary Use
(45)
106
Infant Formula Requirements Pertaining to Current
							 Good
Manufacturing Practice, Quality Control Procedures,
							 Quality Factors, Records and
Reports, and Notifications
(46)
107
Infant Formula
(47)
108
Emergency Permit Control
(48)
109
Unavoidable Contaminants in Food for Human
							 Consumption and Food-Packaging Material
(49)
110
Current Good Manufacturing Practice in Manufacturing,
							 Packing, or Holding Human Food
(50)
111
Current Good Manufacturing Practice in Manufacturing,
							 Packaging, Labeling, or Holding Operations for Dietary Supplements
(51)
112
Standards for the Growing, Harvesting, Packing, and
							 Holding of Produce for Human Consumption
(52)
113
Thermally Processed Low-Acid Foods Packaged in
							 Hermetically Sealed Containers
(53)
114
Acidified Foods
(54)
115
Shell Eggs
(55)
117
Current Good Manufacturing Practice, Hazard Analysis,
							 and Risk-Based Preventive Controls for Human Food
(56)
118
Production, Storage, and Transportation of Shell
							 Eggs
(57)
120
Hazard Analysis and Critical Control Point (HACCP)
							 Systems
(58)
123
Fish and Fishery Products
(59)
129
Processing and Bottling of Bottled Drinking Water
							 (Except as amended by
							 02 NCAC
							 09C.0700 - Bottled Water)
(60)
130
Food Standards: General
(61)
131
Milk and Cream
(62)
133
Cheeses and Related Cheese Products
(63)
135
Frozen Desserts
(64)
136
Bakery Products
(65)
137
Cereal Flours and Related Products
(66)
139
Macaroni and Noodle Products
(67)
145
Canned Fruits
(68)
146
Canned Fruit Juices
(69)
150
Fruit Butters, Jellies, Preserves, and Related
							 Products
(70)
152
Fruit Pies
(71)
155
Canned Vegetables
(72)
156
Vegetable Juices
(73)
158
Frozen Vegetables
(74)
160
Eggs and Egg Products
(75)
161
Fish and Shellfish (Except Section 161.30 and 161.130
							 through 161.145)
(76)
163
Cacao Products
(77)
164
Tree Nut and Peanut Products
(78)
165
Beverages
(79)
166
Margarine
(80)
168
Sweeteners and Table Syrups
(81)
169
Food Dressings and Flavorings
(82)
170
Food Additives
(83)
172
Food Additives Permitted for Direct Addition to Food
							 for Human Consumption
(84)
173
Secondary Direct Food Additives Permitted in Food for
							 Human Consumption
(85)
174
Indirect Food Additives: General
(86)
175
Indirect Food Additives: Adhesives and Components of
							 Coatings
(87)
176
Indirect Food Additives: Paper and Paperboard
							 Components
(88)
177
Indirect Food Additives: Polymers
(89)
178
Indirect Food Additives: Adjuvants, Production Aids,
							 and Sanitizers
(90)
179
Irradiation in the Production, Processing and
							 Handling of Food
(91)
180
Food Additives Permitted in Food or in Contact with
							 Food on an Interim Basis Pending Additional Study
(92)
181
Prior-Sanctioned Food Ingredients
(93)
182
Substances Generally Recognized as Safe
(94)
184
Direct Food Substances Affirmed as Generally
							 Recognized as Safe
(95)
186
Indirect Food Substances Affirmed as Generally
							 Recognized as Safe
(96)
189
Substances Prohibited from Use in Human
							 Food
(97)
190
Dietary Supplements
(98)
200
General
(99)
201
Labeling
(100)
202
Prescription Drug Advertising
(101)
210
Current Good Manufacturing Practice in Manufacturing,
							 Processing, Packing or Holding of Drugs; General
(102)
211
Current Good Manufacturing Practice for Finished
							 Pharmaceuticals
(103)
225
Current Good Manufacturing Practice for Medicated
							 Feeds
(104)
226
Current Good Manufacturing Practice for Type A
							 Medicated Articles
(105)
250
Special Requirements for Specific Human
							 Drugs
(106)
290
Controlled Drugs
(107)
299
Drugs; Official Names and Established
							 Names
(108)
300
General
(109)
310
New Drugs
(110)
312
Investigational New Drug Application
(111)
314
Applications for FDA Approval to Market New
							 Drug
(112)
320
Bioavailability and Bioequivalence
							 Requirements
(113)
330
Over-the-Counter (OTC) Human Drugs Which Are
							 Generally Recognized as Safe and Effective and Not Misbranded
(114)
331
Antacid Products for Over-the-Counter (OTC) Human
							 Use
(115)
332
Antiflatulent Products for Over-the-Counter Human
							 Use
(116)
361
Prescription Drugs for Human Use Generally Recognized
							 as Safe and Effective and NotMisbranded: Drugs Used in Research
(117)
369
Interpretive Statements Re: Warnings on Drugs and
							 Devices for Over-the-Counter Sale
(118)
809
In Vitro Diagnostic Products for Human
							 Use
(119)
812
Investigational Device Exemptions
(120)
820
Quality System Regulation
(121)
860
Medical Device Classification Procedures
(122)
861
Procedures for Performance Standards
							 Development
(123)
870
Cardiovascular Devices
(124)
882
Neurological Devices
(125)
884
Obstetrical and Gynecological Devices
(126)
895
Banned Devices
(127)
500
General
(128)
501
Animal Food Labeling
(129)
502
Common or Usual Names for Nonstandardized Animal
							 Foods
(130)
507
Current Good Manufacturing Practice, Hazard Analysis,
							 and Risk-Based Preventive Controls for Food for Animals
(131)
509
Unavoidable Contaminants in Animal Food and
							 Food-Packaging Material
(132)
510
New Animal Drugs
(133)
511
New Animal Drugs for Investigational Use
(134)
514
New Animal Drug Applications
(135)
520
Oral Dosage Form New Animal Drugs
(136)
522
Implantation or Injectable Dosage Form New Animal
							 Drugs
(137)
524
Ophthalmic and Topical Dosage Form New Animal
							 Drugs
(138)
526
Intramammary Dosage Form New Animal Drugs
(139)
529
Certain Other Dosage Form New Animal
							 Drugs
(140)
556
Tolerances for Residues of New Animal Drugs in
							 Food
(141)
558
New Animal Drugs for Use in Animal Feeds
(142)
570
Food Additives
(143)
573
Food Additives Permitted in Feed and Drinking Water
							 of Animals
(144)
582
Substances Generally Recognized as Safe
(145)
584
Food Substances Affirmed as Generally Recognized as
							 Safe in Feed and Drinking Water of Animals
(146)
589
Substances Prohibited from Use in Animal Food or
							 Feed
(147)
700
General
(148)
701
Cosmetic Labeling
(149)
720
Voluntary Filing of Cosmetic Product Ingredient
							 Composition Statements
(150)
740
Cosmetic Product Warning Statements
Copies of the Code of Federal Regulations may be obtained at
				  no cost by accessing the website of the U.S. Government Printing Office at
				  http://www.gpoaccess.gov/cfr/index.html.
(p) The Board incorporates by reference,
				including subsequent amendments and editions, "Tolerances and Exemptions for
				Pesticide Chemical Residues in Food," 40 C.F.R. Part 180. Copies of the Code of
				Federal Regulations may be obtained at no cost by accessing the website of the
				U.S. Government Printing Office at
				http://www.gpoaccess.gov/cfr/index.html.
(q) The Board incorporates by reference,
				including subsequent amendments and editions, "Definitions and Standards of
				Identity or Composition," 9 C.F.R. Part 319. Copies of the Code of Federal
				Regulations may be obtained at no cost by accessing the website of the U.S.
				Government Printing Office at
				http://www.gpoaccess.gov/cfr/index.html.
(r) The Board incorporates by reference,
				including subsequent amendments and editions, "Definitions and Standards of
				Identity or Composition,"9
				C.F.R. Sections 381.155 through
				381.170. Copies of the Code of
				Federal Regulations may be obtained at no cost by accessing the website of the
				U.S. Government Printing Office at
				http://www.gpoaccess.gov/cfr/index.html.
(s) The Board incorporates by reference,
				including subsequent amendments and editions, "Labels: Definitions; Required
				Features,"9 C.F.R. Section
				317.2 of the Code of Federal Regulations.
				Copies of Title 9 of the Code of Federal Regulations may be obtained at no cost
				by accessing the website of the U.S. Government Printing Office at
				http://www.gpoaccess.gov/cfr/index.html.
(t) The Board incorporates by reference,
				including subsequent amendments and editions, "Special Handling Label
				Requirements,"9 C.F.R.
				Section 381.125 of the Code of Federal
				Regulations. Copies of the Code of Federal Regulations may be obtained at no
				cost by accessing the website of the U.S. Government Printing Office at
				http://www.gpoaccess.gov/cfr/index.html.
(u) The Board incorporates by reference,
				including subsequent amendments and editions, a document entitled, "Fresh Air
				'2000' - A Look At FDA's Medical Gas Requirements," published by the United
				States Department of Health and Human Services, Food and Drug Administration. A
				copy of this material may be obtained at no cost from the Food and Drug
				Protection Division of the North Carolina Department of Agriculture and
				Consumer Services.
(v) The Board
				incorporates by reference, including subsequent amendments and editions, the
				definition of "dietary supplement" found at
				21 USC
				321(ff).
(w) The Board incorporates by reference,
				including subsequent amendments and editions, the definition of "processed
				food" found at 21 USC
				321(gg).
(x) The Board incorporates by reference,
				including subsequent amendments and editions, the definition of "major food
				allergen" found at 21 USC
				321(qq).
(y) The Board incorporates by reference,
				including subsequent amendments and editions, the definition of "knowingly" or
				"knew" found at 21 USC
				321(bb).
(z) The Board incorporates by reference,
				including subsequent amendments and editions, the definition of "animal feed"
				found at 21 USC
				321(w).
Authority
				  G.S.
				  106-139;
				  106-245.16;
				  106-245.22;
				  106-245.32;
				  106-267;
				  106-284.41;
Eff.
				  December 14, 1981;
Amended Eff. May 1, 2013; January 1, 2011; June
				  1, 2004; April 1, 2003; June 1, 1995; April 1, 1992; June 1, 1988; October 1,
				  1987;
Pursuant to
				  G.S.
				  150B-21.3A, rule is necessary without
				  substantive public interest Eff. March 22, 2015;
Amended Eff.
				  February 1, 2019; May 1, 2018.