2 N.C. Admin. Code 9B.0116

Current through Register Vol. 39, No. 11, December 2, 2024

Section 09B .0116 - ADOPTIONS BY REFERENCE

(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).

02 N.C. Admin. Code 09B .0116

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.

Authority G.S. 106-139; 106-267; 106-267.2;
Eff. December 14, 1981;
Amended Eff. January 1, 2011; June 1, 2004; April 1, 2003; June 1, 1995; April 1, 1992; June 1, 1988; October 1, 1987.

Amended by North Carolina Register Volume 32, Issue 23, June 1, 2018 effective 5/1/2018.

Amended by North Carolina Register Volume 33, Issue 17, March 1, 2019 effective 2/1/2019.