LICENSING OF RADIOACTIVE MATERIALS

Section 16.100 - Licensing requirements for use of radioactive materials

Licensing requirements for use of radioactive materials.

(a) A person may manufacture, produce, acquire, receive, possess, prepare, use or transfer any radioactive materials only in accordance with a specific license issued by the Department or as allowed in paragraphs (b) or (c) of this section.

(b) A specific license is not required for persons who comply with all applicable requirements for a general license as set forth in section 16.101 of this Part.

(c) A specific license is not required for persons who comply with all applicable requirements to qualify for an exemption as set forth in section 16.4 of this Part or other exemptions provided for in this Part or for the removal of source material from its place of deposit in nature.

Effective Date: 
Wednesday, May 8, 2013
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Section 16.101 - General licenses

16.101 General licenses.(13) General licenses provided in Appendix 16-A, Table 6, infra, are effiective without the filing of an application with or the issuance of a licensing document by the department. _________________________________________________________________________ FOOTNOTE (13): Radioactive material possessed or used under a general license is subject to the requirements of sections 16.6 through 16.17 set forth under the heading "General Provisions" of this Part. _________________________________________________________________________

Effective Date: 
Wednesday, January 8, 1997
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Section 16.102 - Applications for specific licenses

16.102 Applications for specific licenses.

(a) An application for a license for any radioactive material shall be filed in triplicate on, and shall contain completely and accurately all information called for by, a written form prescribed by the department. The application may incorporate by clear and specific reference information contained in any previous application, supplementary statement, notification or report filed with the department.

(b) At any time subsequent to the filing of an application for a license and before the termination of a license issued in response thereto, the department may require the applicant to submit one or more supplementary statements containing additional information to enable the department to determine whether such application should be approved or denied, or whether a previously issued license should be amended, suspended or revoked.

(c) Each application or supplementary statement shall be signed by either the applicant personally or a person duly authorized by the applicant to sign for and on the applicant's behalf.

(d) A single application may apply for more than one license or for a license covering more than one radioactive material.
 

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Section 16.103 - General requirements for issuing specific licenses

16.103 General requirements for issuing specific licenses. The department will approve an application for, and issue in response thereto, a specific license to transfer, receive, possess and use any radioactive material, if the department determines that the following requirements have been met:

(a) the applicant's proposed use, equipment, facilities and procedures will protect public health and safety, and will minimize danger to life and property, from radiation hazards;

(b) the applicant's radiation detection and measuring instrumentation is appropriate for the uses of radioactive materials requested in the application;

(c) the applicant, (or the applicant's personnel if the applicant is not an individual), is qualified by training and experience to use such radioactive material for each purpose covered by the application so as to protect public health and safety and to minimize danger to life and property from radiation hazards; and

(d) the applicant submits sufficient information to support a determination that the requirements of this section are satisfied.
 

Effective Date: 
Wednesday, December 30, 1992
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Section 16.104 - Conditions of specific licenses

16.104 Conditions of specific licenses.

(a) It is hereby made a condition of each specific license:

(1) that the licensee thereunder shall comply with all applicable provisions of the State Public Health Law, of all other laws now or hereafter in effect, and with all applicable rules, regulations, codes and orders now or hereafter in effect of the department and of all appropriate regulatory agencies;

(2) that neither such license, nor any right, title or interest in, of or to such license, shall be disposed of by assignment, transfer or otherwise, either voluntarily or involuntarily, either directly or indirectly, unless the department shall, after securing complete and accurate pertinent information, have approved in writing of such disposal;

(3) that the licensee shall confine his possession and use of licensed radioactive material to such location or locations and for such purpose or purposes as the license may authorize; provided, however, that except as otherwise provided in such license or this Part, such license shall be deemed to authorize the licensee to transfer the material covered by such license to any other person authorized to receive it by the department, the State Department of Labor, the New York City Department of Health, the United States Nuclear Regulatory Commission or any agreement State; and

(4) that the licensee shall notify the department by letter within 30 days if an authorized user, radiation safety officer or radiation therapy physicist permanently discontinues performance of duties under the license; and

(5)(i) that each licensee shall notify the department in writing immediately following the filing of a voluntary or involuntary petition for bankruptcy under any chapter of Title 11 (Bankruptcy) of the United States Code by or against:

(a) The licensee;

(b) An entity (as that term is defined in 11 U.S.C. 101(14)) (see section 16.200 of this Part) controlling the licensee or listing the license or licensee as property of the estate; or

(c) An affiliate (as that term is defined in 11 U.S.C. 101(2)) (see section 16.200 of this Part) of the licensee.

(ii) This notification must indicate:

(a) The bankruptcy court in which the petition for bankruptcy was filed; and

(b) The date of the filing of the petition.

(6) that any license covering the use of special nuclear material in the course of which licensed use additional special nuclear material is produced, shall be deemed to cover any such special nuclear material so produced; provided, however, that the total quantity of special nuclear material possessed by the licensee is not sufficient to form a critical mass.

(b) The department may at any time set forth in any license or incorporate by reference therein, additional conditions, restrictions or requirements applicable to the licensee's transfer, receipt, possession or use of the radioactive material covered by such license in order to protect the public health and safety and to minimize danger to life and property from radiation hazards.
 

Effective Date: 
Wednesday, December 30, 1992
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Section 16.105 - Duration, expiration and termination of specific licenses

16.105 Duration, expiration and termination of specific licenses.

(a) Except as otherwise provided in this subdivision, each specific license will expire at the end of the expiration date stated in such license. If any licensee duly files with the department not less than 30 days prior to such expiration date, an application in accordance with section 16.102 for the renewal of his license or for a new and superseding license, such license shall not be deemed to have expired until the department has finally determined such application.

(b) The department may terminate any specific license upon the written request of the licensee.
 

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Section 16.106 - Renewal or amendment of specific licenses

16.106 Renewal or amendment of specific licenses. Any application by a licensee for the renewal or amendment of his license shall be considered as an application for a license and shall be filed in accordance with section 16.102; and any such application for amendment shall set forth the reasons for such requested amendment. In considering any such application for renewal or amendment, the department will apply the requirements set forth in section 16.103 as appropriate corrective amendment of a license may be issued by the department at any time upon its initiative.
 

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Section 16.107 - Amendment, suspension or revocation of licenses

16.107 Amendment, suspension or revocation of licenses. Specific and general licenses shall be subject to amendment, suspension or revocation by reason of amendment of the State Public Health Law, enactment or amendment of any other applicable law, amendment of the State Sanitary Code (Chapter I of this Title) or amendment or promulgation of any other applicable rule, regulation, or order. The department may amend, revoke or suspend any license in whole or in part, for:

(a) any material misstatement in the application therefor or in any supplementary statement thereto;

(b) any condition revealed by such application, supplementary statement, report, record, inspection or other means, which would warrant the department to refuse to grant a license on an original application; or

(c) any violation or failure to observe any of the applicable terms or provisions of such license, the State Public Health Law, this Part, or any other applicable rule, regulation, code or order now or hereafter in effect.
 

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Section 16.108 - RESERVED

16.108 Reserved.

Effective Date: 
Wednesday, January 8, 1997
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Section 16.109 - Licensees and contractors of the United States Nuclear Regulatory Commission and the United States Department of Energy within the State.

16.109 Licensees and contractors of the United States Nuclear Regulatory Commission and the United States Department of Energy within the State. (a) Each person who holds a license from the United States Nuclear Regulatory Commission authorizing activities within the State shall be exempt from the requirements of this Part with respect to such activities during the period that such license is valid, provided, however, that such person:

(1) shall afford the department and health officer having jurisdiction access to all records which such person is required to maintain pursuant to the United States Nuclear Regulatory Commission's rules and regulations or pursuant to the provisions of the United States Nuclear Regulatory Commission license,

(2) shall afford the department and health officer having jurisdiction opportunity to sample effluents, and to conduct such measurement or survey of levels of radiation and radioactive contamination as will not substantially interfere with or interrupt any activities licensed by the United States Nuclear Regulatory Commission, and

(3) shall afford the department and health officer having jurisdiction access to the facilities of such person in order to accomplish the foregoing review of records, sampling of effluents and conduct of measurements or surveys.

(b) Each United States Nuclear Regulatory Commission contractor or subcontractor and each United States Department of Energy contractor and subcontractor of the following categories operating within the State shall be exempt from the requirements of this Part to the extent that such contractor or subcontractor under such contract transfers, receives, possesses or uses sources of radiation:

(1) prime contractors performing work for the United States Department of Energy at United States government-owned or controlled sites, including the transportation of sources of radiation to or from such sites and the performance of contract services during temporary interruptions of such transportation;

(2) prime contractors performing research in, or development, manufacture, storage, testing or transportation of, atomic weapons or components thereof;

(3) prime contractors using or operating nuclear reactors or other nuclear devices in a United States government-owned vehicle or vessel; and

(4) any other prime contractor or subcontractor when the State and the United States Nuclear Regulatory Commission or the United States Department of Energy jointly determine that:

(i) under the terms of the contract or subcontract there is adequate assurance that the work thereunder can be accomplished without undue risk to the public health and safety; and

(ii) the exemption of such contractor or subcontractor is otherwise appropriate.
 

Effective Date: 
Wednesday, January 8, 1997
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Section 16.110 - Licensure and inspection of radioactive materials; fees authorized

16.110 Licensure and inspection of radioactive materials; fees authorized. Provided that a written schedule of the licensing and inspection fees to be charged has been submitted to and approved by the State Commissioner of Health, any county, part-county or city health district having a population of more than 2,000,000 which has established substitute licensure requirements acceptable to the State Department of Health pursuant to the provisions of paragraph (3) of subdivision (b) of section 16.1 of this Part is authorized to charge adequate and reasonable fees for the licensing and inspection of radioactive materials not exceeding the estimated cost of such services except that, with the approval of the State Commissioner of Health, one or more of such services may be rendered without charge.
 

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Section 16.111 - Transfer of radioactive material

16.111 Transfer of radioactive material.

(a) No licensee shall transfer radioactive material except as authorized pursuant to this section.

(b) Except as otherwise provided in his license and subject to the provisions of subdivisions (c) and (d) of this section, any licensee may transfer radioactive material:

(1) to the department;(14)

(2) to the United States Nuclear Regulatory Commission;

(3) to any person exempt from the regulations in this Part to the extent permitted under such exemption;

(4) to any person authorized to receive such material under terms of a general license or its equivalent, or a specific license or equivalent licensing document, issued by the department, the United States Nuclear Regulatory Commission, or any agreement State, or to any person otherwise authorized to receive such material by the Federal Government or any agency thereof, the department, or any agreement State; or

(5) as otherwise authorized by the department in writing.

(c) Before transferring radioactive material to a specific licensee of the department, the United States Nuclear Regulatory Commission or the licensing agency of an agreement State, or to a general licensee who is required to register with the department, the United States Nuclear Regulatory Commission or the licensing agency of an agreement State prior to receipt of the radioactive material, the licensee transferring the material shall verify that the transferee's license authorizes the receipt of the type, form and quantity of radioactive material to be transferred.

(d) The following methods for the verification required by subdivision (c) of this section are acceptable:

(1) the transferor may have in his possession, and read, a current copy of the transferee's specific license or registration certificate;

(2) the transferor may have in his possession a written certification by the transferee that he is authorized by license or registration certificate to receive the type, form and quantity of radioactive material to be transferred, specifying the license or registration certificate number, issuing agency and expiration date;

(3) for emergency shipments the transferor may accept oral certification by the transferee that he is authorized by license or registration certificate to receive the type, form and quantity of radioactive material to be transferred, specifying the license or registration certificate number, issuing agency and expiration date; provided that the oral certification is confirmed in writing within 1O days;

(4) the transferor may obtain other sources of information compiled by a reporting service from official records of the department, the United States Nuclear Regulatory Commission or the licensing agency of an agreement State as to the identity of licensees and the scope and expiration dates of licenses and registrations; or

(5) when none of the methods of verification described in paragraphs (1) through (4) of this subdivision are readily available, or when a transferor desires to verify that information received by one of such methods is correct or up-to-date, the transferor may obtain and record confirmation from the department, the United States Nuclear Regulatory Commission or the licensing agency of an agreement State that the transferee is licensed to receive the radioactive material.

(e) Preparation for shipment and transport of radioactive material shall be in accordance with the provisions of section 16.17 of this Part.

________________________________________________________________________ FOOTNOTE (14): A license may transfer material to the department only after receiving prior approval from the department. _______________________________________________________________________
 

Effective Date: 
Wednesday, January 8, 1997
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Section 16.112 - Fingerprinting and criminal background check requirements

Section 16.112 Fingerprinting and criminal background check requirements

(a) Applicability.

This section applies to any licensee who possesses, or is authorized to possess, radioactive material that is: (1) listed in Table 1 (“Radionuclides of Concern”) of this Section and (2) in a quantity equal to or exceeding that listed in Table 1.

(b) Definitions

(1) Trustworthiness and Reliability (T&R) Official means an individual appointed by the licensee who is responsible for determining the trustworthiness and reliability of another individual requiring unescorted access to one or more radioactive materials identified in Table 1 of this section.

(2) "Affected individual" means an individual who has or is seeking unescorted access to radioactive material identified in Table 1 of this section in a quantity equal to or exceeding that listed in Table 1.

(3) "Unescorted access" means access without an escort to radioactive material identified in Table 1 of this section which is in a quantity equal to or exceeding that listed in Table 1.

(c) The T&R Official, if he/she does not require unescorted access, must be deemed trustworthy and reliable by the
Licensee in accordance with its Increased Controls license conditions before making a determination regarding the
trustworthiness and reliability of another individual. If the T&R Official requires unescorted access, the Licensee must
consider the results of the Federal Bureau of Investigation (FBI) identification and criminal history records check before
approving a T&R Official.

(d) Prior to requesting fingerprints from any individual, the Licensee shall provide a copy of this section to that person.

(e) Upon receipt of the results of FBI identification and criminal history records checks, the Licensee shall control such information as specified in subdivision (i) of this section and its Increased Controls license conditions.

(f) Specific Requirements Pertaining to Fingerprinting and Criminal History Records Checks

(1) Each Licensee subject to the provisions of this section shall fingerprint each
affected individual.

(2) For affected individuals employed by the Licensee for three years or less, and for affected individuals who are nonlicensee personnel, such as physicians, physicists, house-keeping personnel, and security personnel under contract, trustworthiness and reliability shall be determined, at a minimum, by verifying employment history, education, personal references, and fingerprinting and the review of an FBI identification and criminal history records check.

(3) The Licensee shall also obtain independent information to corroborate that provided by the employee (e.g. seeking references not supplied by the individual). For an affected individual employed by the Licensee for longer than three years, trustworthiness and reliability shall be determined, at a minimum, by a review of the employee's employment history with the Licensee and fingerprinting and an FBI identification and criminal history records check.

(4) Service provider Licensee employees who are affected individuals shall be escorted unless they are determined to be trustworthy and reliable by a NRC-required background investigation. Written verification attesting to or certifying the person’s trustworthiness and reliability shall be obtained by the Licensee from the Licensee providing the service.

(5) The Licensee must submit one completed, legible standard FBI fingerprint card (Form FD-258,ORIMDNRCOOOZ)1 for each affected individual, to the NRC's Division of Facilities and Security. The name and address of the individual (T&R Official) to whom the criminal history records should be returned must be included with the submission.

(6) The Licensee shall review and use the information received from the FBI identification and criminal history records check as part of its trustworthiness and reliability determination required by its Increased Controls license conditions.

(7) The Licensee shall notify each affected individual that his/her fingerprints will be used to secure a review of his/her criminal history record and inform the affected individual of the procedures for revising the record or including an explanation in the record, as specified in subdivision (h) of this section.

(8) Fingerprints for unescorted access need not be taken if an employed individual

(e.g., a Licensee employee, contractor, manufacturer, or supplier) is:

(i) An employee of the United States (U.S.) Nuclear Regulatory Commission (NRC) or of the Executive Branch of the U.S. Government who has undergone fingerprinting for a prior U.S. Government criminal history check;

(ii) A Member of Congress;

(iii) An employee of a member of Congress or Congressional committee who has undergone fingerprinting for a prior U.S. Government criminal history check;

(iv) The Governor or his or her designated State employee representative;

(v) Federal, State, or local law enforcement personnel;

(vi) State Radiation Control Program Directors and State Homeland Security Advisors or their designated State employee representatives;

(vii) Representatives of the International Atomic Energy Agency (IAEA) engaged in activities associated with the U.S./IAEA Safeguards Agreement who have been certified by the NRC; or

(viii) documentation is provided which demonstrates that the employed individual has been favorably-decided by a U.S. Government program involving fingerprinting and an FBI identification and criminal history records check within the last five calendar years of the effective date of this regulation, or documentation is provided which demonstrates that any person has an active federal security clearance. Written confirmation from the agency/employer which granted the federal security clearance or reviewed the FBI criminal history records results based upon a fingerprint identification check must be provided. The Licensee must retain this documentation for a period of three (3) years from the date the employed individual no longer requires unescorted access associated with the Licensee's activities.

(9) All fingerprints obtained by the Licensee pursuant to this section must be submitted to the NRC. Additionally, the Licensee shall submit a certification of the trustworthiness and reliability of the T&R Official as determined in accordance with 16.112(c) to the NRC with each submission of fingerprints.

(10) The Licensee shall review and use the information received from the FBI identification and criminal history records check and consider it as part of its trustworthiness and reliability determination, in conjunction with the trustworthiness and reliability requirements set forth in its Increased Controls license conditions, in making a determination whether to grant an affected individual unescorted access. The Licensee shall use any information obtained from a criminal history records check solely for the purpose of determining an affected individual's suitability for unescorted access.

(11) The Licensee shall document the basis for its determination whether to grant, or
continue to allow, an affected individual unescorted access.

(12) Licensees shall notify the Department and the U.S. NRC Headquarters Operations Office by telephone within 24 hours if the results from a FBI identification and criminal history records check indicate an individual is listed on the FBI Terrorist Screening Data Base.

(g) Prohibitions

(1) A Licensee shall not base a final determination to deny an affected individual unescorted access solely on the basis of information received from the FBI involving:

(i) an arrest more than one (1) year old for which there is no information regarding the disposition of the case, or

(ii) an arrest that resulted in dismissal of the charge or an acquittal.

(2) A Licensee shall not use information received from a criminal history records check obtained pursuant to this section in a manner that would infringe upon the rights of any individual under the First Amendment to the Constitution of the United States or Article 1 of the New York State Constitution, nor shall the Licensee use the information in any way which would discriminate among individuals on the basis of race, religion, national origin, sex, or age.

(h) Right to Correct and Complete Information

Prior to any final adverse determination, the Licensee shall make available to the affected individual the contents of any criminal records obtained from the FBI for the purpose of assuring correct and complete information. Written confirmation by the individual of receipt of this notification must be maintained by the Licensee for a period of one (1) year from the date of the notification. If, after reviewing the record, an affected individual believes that it is incorrect or incomplete in any respect and wishes to change, correct, or update the alleged deficiency, or to explain any matter in the record, the individual may initiate challenge procedures. These procedures include either a direct application by the individual challenging the record to the agency (i.e., law enforcement agency) that contributed the questioned information, or a direct challenge as to the accuracy or completeness of any entry on the criminal history record to the FBI Identification Division.2 The Licensee must provide at least ten (10) days for an individual to initiate an action challenging the results of a FBI criminal history records check after the record is made available for his/her review. The Licensee may make a final unescorted access determination based upon an individual’s criminal history record only upon receipt of the FBI's confirmation or correction of the record. Upon a final adverse determination on unescorted access the Licensee shall provide the individual its documented basis for denial. Unescorted access shall not be granted to an individual during the review process.

(i) Protection of Information

(1) Each Licensee who obtains a criminal history record on an affected individual pursuant to this section shall establish and maintain a system of files and procedures for protecting the record and the personal information in the record from unauthorized disclosure.

(2) The Licensee may not disclose the record or personal information collected and maintained to persons other than the affected individual, his/her representative, or to those who have a need to access the information in performing assigned duties in the process of determining unescorted access. No individual authorized to have access to the information may disseminate the information to any other individual whose job duties do not require such information.

(3) The personal information obtained on an affected individual from a criminal history record check may be transferred to another Licensee if the Licensee holding the criminal history record check receives the affected individual's written request to provide the information contained in his/her file, and the receiving Licensee verifies information such as the affected individual's name, date of birth, social security number, sex, and other applicable physical characteristics for identification purposes.

(4) The Licensee shall make criminal history records, obtained under this section, available for examination by an authorized representative of the Department to determine compliance with this section.

(5) The Licensee shall retain all fingerprint and criminal history records from the FBI, or a copy if the affected individual's file has been transferred, for three (3) years after termination of employment or determination of unescorted access (whether unescorted access was approved or denied). After the required three (3) year period, these documents shall be destroyed by a method that will prevent reconstruction of the information in whole or in part.

1. Copies of these forms may be obtained from NRC. The Licensee shall establish procedures to ensure that the quality of the fingerprints taken results in minimizing the rejection rate of fingerprint cards due to illegible or incomplete cards. Licensees must have fingerprints taken by local law enforcement (or a private entity authorized to take fingerprints) because an authorized official must certify the identity of the person being fingerprinted. If the FBI advises the fingerprints are unclassifiable based on conditions other than poor quality, the Licensee must submit a request to NRC for alternatives. When those search results are received from the FBI, no further search is necessary. The NRC will receive and forward to the submitting Licensee all data from the FBI as a result of the Licensee's application(s) for criminal history records checks, including the FBI fingerprint record(s).

2. In the latter case, the FBI forwards the challenge to the agency that submitted the data and requests that agency to verify or correct the challenged entry. Upon receipt of an official communication directly from the agency that contributed the original information, the FBI Identification Division makes any changes necessary in accordance with the information supplied by that agency (see 28 CFR Part 16.30 through 16.34).

 

Table 1: Radionuclides of Concern
Radionuclide
Quantity of Concern1 (TBq)
Quantity of Concern2 (Ci )
Am-241
0.6
16
Am-241/Be
0.6
16
Cf-252
0.2
5.4
Cm-244
0.5
14
Co-60
0.3
8.1
Cs-137
1
27
Gd-153
10
270
Ir-192
0.8
22
Pm-147
400
11,000
Pu-238
0.6
16
Pu-239/Be
0.6
16
Ra-226
0.4
11
Se-75
2
54
Sr-90 (Y-90)
10
270
Tm-170
200
5,400
Yb-169
3
81
Combinations of radioactive materials listed above3
See Footnote Below4

1 The aggregate activity of multiple, collocated sources of the same radionuclide should be included when the total activity equals or exceeds the quantity of concern.

2 The primary values used for compliance with this Order are tera becquerel (TBq).

3 Radioactive materials are to be considered aggregated or co-located if breaching a common physical security barrier (e.g., a locked door at the entrance to a storage room) would allow access to the radioactive material or devices containing the radioactive material.

4 If several radionuclides are aggregated, the sum of the ratios of the activity of each source, i of radionuclide, n, A(i,n), to the quantity of concern for radionuclide n, Q(n), listed for that radionuclide equals or exceeds one. That is:

Effective Date: 
Wednesday, June 17, 2009
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