10A NCAC 15 .0308         Licenses and radiation safety requirements for irradiators

(a) Persons irradiating objects or materials using sealed sources containing radioactive materials shall comply with the provisions of 10 CFR 36, which are hereby incorporated by reference including subsequent amendments and editions, except that the requirements of 10 CFR 170 shall not apply, as follows:

(1)           10 CFR 36.1, "Purpose and scope;"

(2)           10 CFR 36.2, "Definitions," except that references to common defense and security shall not apply;

(3)           10 CFR 36.11, "Application for a specific license," except that the requirements of Paragraph (b) of this Rule shall be met;

(4)           10 CFR 36.13, "Specific licenses for irradiators;"

(5)           10 CFR 36.15, "Commencement of construction;"

(6)           10 CFR 36.17, "Applications for exemptions;"

(7)           10 CFR 36.19, "Requests for written statements;"

(8)           10 CFR 36.21, "Performance criteria for sealed sources;"

(9)           10 CFR 36.23, "Access control;"

(10)         10 CFR 36.25, "Shielding;"

(11)         10 CFR 36.27, "Fire protection;"

(12)         10 CFR 36.29, "Radiation monitors;"

(13)         10 CGR 36.31, "Control of source movement;"

(14)         10 CFR 36.33, "Irradiator pools;"

(15)         10 CFR 36.35, "Source rack protection;"

(16)         10 CFR 36.37, "Power failures;"

(17)         10 CFR 36.39, "Design requirements;"

(18)         10 CFR 36.41, "Construction monitoring and acceptance testing;"

(19)         10 CFR 36.51, "Training;"

(20)         10 CFR 36.53, "Operating and emergency procedures;"

(21)         10 CFR 36.55, "Personnel monitoring;"

(22)         10 CFR 36.57, "Radiation surveys;"

(23)         10 CFR 36.59, "Detection of leaking sources;"

(24)         10 CFR 36.61, "Inspection and maintenance;"

(25)         10 CFR 36.63, "Pool water quality;"

(26)         10 CFR 36.65, "Attendance during operations;"

(27)         10 CFR 36.67, "Entering and leaving the radiation room;"

(28)         10 CFR 36.69, "Irradiation of explosive or flammable materials;"

(29)         10 CFR 36.81, "Records and retention periods;" and

(30)         10 CFR 36.83, "Reports," except that reports required by this Rule shall be made to the agency at the address shown in Rule .0111 of this Chapter unless directed otherwise by the agency, in lieu of the United States Nuclear Regulatory Commission (NRC).

(b) Applications shall be made on forms provided by the agency. One copy of the application and supporting material shall be submitted to the agency by e-mail at Licensing.RAM@dhhs.nc.gov, or at the address shown in Rule .0111 of this Chapter in lieu of the NRC:

(1)           Persons applying for new radioactive materials licenses, or for the renewal of existing radioactive materials licenses, shall submit an Application for Radioactive Materials License. The following information shall appear on the application:

(A)          legal business name and mailing address;

(B)          physical address(es) where radioactive material shall be used or possessed. The application shall indicate if radioactive materials shall be used at temporary jobsites;

(C)          the name, telephone number, and e-mail address of the Radiation Safety Officer;

(D)          the name, telephone number, and e-mail address of the individual to be contacted about the application. If this individual is same as the Radiation Safety Officer, the application shall so state;

(E)           the application shall indicate if the application is for a new license, or for the renewal of an existing license, by marking the corresponding check box;

(F)           if the application is for the renewal of an existing license, the license number shall be provided on the application;

(G)          applicants shall indicate the type and category of license as shown on the form by marking the corresponding check box; and

(H)          the printed name, title, and signature of the certifying official. The certifying official shall be an individual employed by the business or licensee, who is authorized by the licensee to sign license applications on behalf of the business or licensee.

(2)           Persons applying for an amendment to an existing license shall submit an Application for Amendment of Radioactive Materials and Accelerator Licenses. The following information shall appear on the application:

(A)          the license number;

(B)          amendment number of the current license;

(C)          expiration date of the license;

(D)          licensee name as it currently appears on the license;

(E)           the name, telephone number, and e-mail address of the Radiation Safety Officer;

(F)           the name, telephone number, and e-mail address of the individual to be contacted about the application. If this individual is same as the Radiation Safety Officer, item 5b on the application shall be left blank;

(G)          applicants shall provide a description of the action requested by marking the corresponding checkbox in item 6a. If the check box next to "Other" is marked in item 6a, provide a brief description of the action requested in the space provided in item 6b;

(H)          explanation of the action requested; and

(I)            the printed name, title, and signature of the certifying official. The certifying official shall be an individual employed by the business or licensee who is authorized by the licensee to sign license applications on behalf of the business or licensee.

(3)           Applications specified in this Rule are available at: https://radiation.ncdhhs.gov/rms/rmsforms2.htm(Rev01).htm.

(c) Copies of the regulations incorporated by this Rule are available free of charge at https://www.nrc.gov/reading-rm/doc-collections/cfr/part036/.

History Note:        Authority G.S. 104E‑7; 104E‑10(b);

Eff. February 1, 1980;

Amended Eff. January 1, 2005; January 1, 1994;

Transferred and Recodified from 15A NCAC 11 .0308 Eff. February 1, 2015;

Amended Eff. March 1, 2017;

Readopted Eff. May 1, 2024.