10A NCAC 15 .0104         incorporation by reference

(a)  For purposes of the rules in this Chapter, the following rules, standards, and other requirements are hereby incorporated by reference including any subsequent amendments and editions:

(1)           The following parts of 21 CFR Subchapter J:

(A)          Part 1000, "General;"

(B)          Subpart A 1000.1, "General Provisions - General;"

(C)          Subpart A 1000.3(a) through (j),(k),(1), and (n) through (t), "Definitions;"

(D)          Subpart A 1000.15, "Examples of electronic products subject to the Radiation Control for Health and Safety Act of 1968;"

(E)           Part 1002, "Records and Reports;"

(F)           Subpart A 1002.1(a) and (c)(4), "Applicability;"

(G)          Subpart D 1002.31, "Preservation and inspection of records;"

(H)          Part 1003, "Notification of Defects of Failures to Comply;"

(I)            Subpart A 1003.1, "Applicability;"

(J)            Subpart A 1003.2, "Defect in an electronic product;"

(K)          Subpart C 1003.21, "Notification by the manufacturer to affected persons;"

(L)           Part 1010, "Performance Standards for Electronic Products - General;"

(M)         Subpart A 1010.1, "Scope;"

(N)          Subpart A 1010.2(a),(b), and (d), "Certification;"

(O)          Subpart A 1010.3, "Identification;"

(P)           Subpart A 1010.4(a) and (d), "Variances;"

(Q)          Part 1020, "Performance Standards for Ionizing Radiation Emitting Products;"

(R)          Section 1020.20, "Cold-cathode gas discharge tubes;"

(S)           Section 1020.30, "Diagnostic x-ray systems and their main components;"

(T)           Section 1020.31, "Radiographic equipment;"

(U)          Section 1020.32, "Fluoroscopic equipment;" and

(V)          Section 1020.33, "Computed tomography (CT) equipment."

(2)           "Agreement Between the United States Atomic Energy Commission and the State of North Carolina for Discontinuance of Certain Commission Regulatory Authority and Responsibility within the State Pursuant to Section 274 of the Atomic Energy Act of 1954, as Amended," signed July 21, 1964.

(b)  The rules, standards and other requirements incorporated by reference in Paragraph (a) of this Rule are available free of charge at:

(1)           https://www.ecfr.gov/current/title-21/chapter-I/subchapter-J for Part (a)(1)(A) through (a)(1)(V) of this Rule, and

(2)           https://www.nrc.gov/cdn/nmss/pdf/ncagreements.pdf for the agreement between the NRC and the State of North Carolina.

History Note:        Authority G.S. 104E-7(a)(2); 104E-15(a)and (b)(1); 104E-25(b); 150B-19(5)(b); 150B-21.6;

Eff. February 1, 1980;

Amended Eff. November 1, 1989; June 1, 1989; October 1, 1984;

Transferred and Recodified from 10 NCAC 03G .2204 Eff. January 4, 1990;

Amended Eff. January 1, 1994; May 1, 1992;

Temporary Amendment Eff. August 20, 1994, for a Period of 180 Days or until the permanent rule becomes effective, whichever is sooner;

Amended Eff. October 1, 2013; November 1, 2007; May 1, 2006; January 1, 2005; August 1, 2002; April 1, 1999; August 1, 1998; May 1, 1995;

Transferred and Recodified from 15A NCAC 11 .0104 Eff. February 1, 2015;

Readopted Eff. May 1, 2025.