12VAC5-481 Virginia Radiation Protection Regulations

REGULATIONS

Vol. 32 Iss. 12 - February 08, 2016

TITLE 12. HEALTH

STATE BOARD OF HEALTH

Chapter 481

Final Regulation

REGISTRAR'S NOTICE: The following regulatory action is exempt from Article 2 of the Administrative Process Act in accordance with § 2.2-4006 A 4 c of the Code of Virginia, which excludes regulations that are necessary to meet the requirements of federal law or regulations, provided such regulations do not differ materially from those required by federal law or regulation. The State Board of Health will receive, consider, and respond to petitions by any interested person at any time with respect to reconsideration or revision.

Title of Regulation: 12VAC5-481. Virginia Radiation Protection Regulations (amending 12VAC5-481-451).

Statutory Authority: § 32.1-229 of the Code of Virginia.

Effective Date: March 9, 2016.

Agency Contact: Steve Harrison, Director, Office of Radiological Health, Department of Health, 109 Governor Street, Richmond, VA 23219, telephone [phone], FAX [phone], or email [e-mail].

Summary:

The federal Nuclear Regulatory Commission adopted 10 CFR Part 37, Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material effective March 19, 2013, which required Virginia to adopt compatible regulations within three years of that date to maintain its status as an Agreement State. This action amends 12VAC5-481-451 to comply with this federal requirement. The amendments include definitions of Category 1 and Category 2 radioactive materials; requirements for background investigations and access authorization programs; protection of background information; physical protection requirements during use, which includes a security program and coordination with local law-enforcement agencies; physical protection in transit; and recordkeeping.

12VAC5-481-451. Increased controls and fingerprinting Physical protection of Category 1 and Category 2 quantities of radioactive material.

A. Any licensee who possesses or uses an aggregated quantity of Category 1 or Category 2 radioactive material equal to or in excess of those in subdivision 1 of this subsection shall establish a physical protection program that meets all requirements detailed in this section.

1. Radionuclides of concern.

Radionuclide	Quantity of concern (TBq)1,2	Quantity of concern (Ci)1,2	Category 1 (TBq)1,2	Category 1 (Ci)1,2	Category 2 (TBq)1,2	Category 2 (Ci)1,2
Am-241	0.6	16	60	1,620	0.6	16.2
Am-241/Be	0.6	16	60	1,620	0.6	16.2
Cf-252	0.2	5.4	20	540	0.2	5.4
Cm-244	0.5	14	50	1,350	0.5	13.5
Co-60	0.3	8.1	30	810	0.3	8.1
Cs-137	1	27	100	2,700	1	27
Gd-153	10	270	1,000	27,000	10	270
Ir-192	0.8	22	80	2,160	0.8	21.6
Pm-147	400	11,000	40,000	1,080,000	400	10,800
Pu-238	0.6	16	60	1,620	0.6	16.2
Pu-239/Be	0.6	16	60	1,620	0.6	16.2
Ra-226	0.4	11	40	1,080	0.4	10.8
Se-75	2	54	200	5,400	2	54
Sr-90 (Y-90)	10	270	1,000	27,000	10	270
Tm-170	200	5,400	20,000	540,000	200	5,400
Yb-169	3	81	300	8,100	3	81
Combinations of radioactive materials listed above3	See footnote below4				See footnote 4 below

¹The aggregate activity of multiple, collocated sources of the same radionuclides should be included when the total activity equals or exceeds the quantity of concern Category 1 or Category 2 threshold.

²The primary values used for compliance are TBq. The curie (Ci) values are rounded to two significant figures for informational purposes only.

³Radioactive materials are to be considered aggregated or collocated if breaching a common physical 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.

⁴If 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 Category 1 or Category 2 threshold for radionuclide n, Q_n, listed for that radionuclide equals or exceeds one. [(aggregated source activity for radionuclide A) / (quantities of concern for radionuclide A)] + [(aggregated source activity for radionuclide B) / (quantities of concern for radionuclide B)] + etc…. ≥ 1.

2. A licensee that possesses radioactive waste that contains Category 1 or Category 2 quantities of radioactive material is exempt from the requirements of this section.

3. A licensee that possesses radioactive waste that contains discrete sources, ion-exchange resins, or activated material that weighs less than 2,000 kg (4,409 lbs) is not exempt from the requirements of this section. The licensee shall implement the following requirements to secure the radioactive waste:

a. Use continuous physical barriers that allow access to the radioactive waste only through established access control points;

b. Use a locked door or gate with monitored alarm at the access control point;

c. Assess and respond to each actual or attempted unauthorized access to determine whether an actual or attempted theft, sabotage, or diversion occurred; and

d. Immediately notify the local law-enforcement agency (LLEA) and request an armed response from the LLEA upon determination that there was an actual or attempted theft, sabotage, or diversion of the radioactive waste.

B. The following increased controls apply to licensees who, at any given time, possess radioactive sources greater than or equal to the quantities of concern of radioactive material listed in subsection A of this section.

1. In order to ensure the safe handling, use, and control of licensed material in use and in storage, each licensee shall control access at all times to radioactive material quantities of concern and devices containing such radioactive material (devices), and limit access to such radioactive material and devices to only approved individuals who require access to perform their duties.

a. The licensee shall allow only trustworthy and reliable individuals, approved in writing by the licensee, to have unescorted access to radioactive material quantities of concern and devices. The licensee shall approve for unescorted access only those individuals with job duties that require access to such radioactive material and devices. Personnel who require access to such radioactive material and devices to perform a job duty, but who are not approved by the licensee for unescorted access, must be escorted by an approved individual.

b. For individuals employed by the licensee for three years or less, and for nonlicensee personnel, such as physicians, physicists, housekeeping 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. The licensee shall also, to the extent possible, obtain independent information to corroborate that provided by the employee (i.e., seeking references not supplied by the individual). For individuals employed by the licensee for longer than three years, trustworthiness and reliability shall be determined, at a minimum, by a review of the employees' employment history with the licensee and fingerprinting and an FBI identification and criminal history records check.

c. Service provider licensee employees shall be escorted unless determined to be trustworthy and reliable by an NRC-required background investigation. Written verification attesting to or certifying the person's trustworthiness and reliability shall be obtained from the licensee providing the service.

d. The licensee shall document the basis for concluding that there is reasonable assurance that an individual granted unescorted access is trustworthy and reliable, and does not constitute an unreasonable risk for unauthorized use of radioactive material quantities of concern. The licensee shall maintain a list of persons approved for unescorted access to such radioactive material and devices by the licensee.

2. In order to ensure the safe handling, use and control of licensed material in use and in storage, each licensee shall have a documented program to monitor and immediately detect, assess, and respond to unauthorized access to radioactive material quantities of concern and devices. Enhanced monitoring shall be provided during periods of source delivery or shipment, where the delivery or shipment exceeds 100 times the limits in subsection A of this section.

a. The licensee shall respond immediately to any actual or attempted theft, sabotage, or diversion of such radioactive material or of the devices. The response shall include requesting assistance from a local law-enforcement agency (LLEA).

b. The licensee shall have a prearranged plan with LLEA for assistance in response to an actual or attempted theft, sabotage, or diversion of such radioactive material or of the devices that is consistent in scope and timing with a realistic potential vulnerability of the sources containing such radioactive material. The prearranged plan shall be updated when changes to the facility design or operation affect the potential vulnerability of the sources. Prearranged LLEA coordination is not required for temporary job sites.

c. The licensee shall have a dependable means to transmit information between, and among, the various components used to detect and identify an unauthorized intrusion, to inform the assessor, and to summon the appropriate responder.

d. After initiating appropriate response to any actual or attempted theft, sabotage, or diversion of radioactive material or of the devices, the licensee shall, as promptly as possible, notify the agency at [phone] during normal business hours and [phone] after hours and the NRC HQ Operations Center at [phone].

e. The licensee shall maintain documentation describing each instance of unauthorized access and any necessary corrective actions to prevent future instances of unauthorized access.

3. Transportation.

a. In order to ensure the safe handling, use, and control of licensed material in transportation for domestic highway and rail shipments by a carrier other than the licensee, for quantities that equal or exceed those in subsection A of this section but are less than 100 times those in subsection A of this section, per consignment, the licensee shall:

(1) Use carriers that:

(a) Use package tracking systems;

(b) Implement methods to assure trustworthiness and reliability of drivers;

(c) Maintain constant control and/or surveillance during transit; and

(d) Have the capability for immediate communication to summon appropriate response or assistance.

(2) Verify and document that the carrier employs the measures listed in subdivision (1) above.

(3) Contact the recipient to coordinate the expected arrival time of the shipment.

(4) Confirm receipt of the shipment.

(5) Initiate an investigation to determine the location of the licensed material if the shipment does not arrive on or about the expected arrival time. When, through the course of the investigation, it is determined the shipment has become lost, stolen, or missing, the licensee shall immediately notify the agency at [phone] during normal working hours and (804) 674-2400 after hours and the NRC HQ Operations Center at [phone]. If after 24 hours of investigating, the location of the material still cannot be determined, the radioactive material shall be determined missing and the licensee shall immediately notify the agency at [phone] during normal working hours and [phone] after hours and the NRC HQ Operations Center at [phone].

b. For domestic highway and rail shipments, prior to shipping licensed radioactive material that exceeds 100 times the quantities in subsection A of this section per consignment, the licensee shall:

(1) Notify the NRC (Director, Office of Nuclear Material Safety and Safeguards, U.S. NRC, Washington, DC 20555), in writing, at least 90 days prior to the anticipated date of shipment. The NRC will issue the Order to implement the Additional Security Measures (ASMs) for the transportation of Radioactive Material Quantities of Concern (RAM QC). The licensee shall not ship this material until the ASMs for the transportation of RAM QC are implemented or the licensee is notified otherwise, in writing, by the NRC.

(2) Once the licensee has implemented the ASMs for the transportation of RAM QC, the notification requirements of subdivision 1 of this subsection shall not apply to future shipments of licensed radioactive material that exceeds 100 times the quantities listed in subsection A of this section. The licensee shall implement the ASMs for the transportation of RAM QC.

c. If a licensee employs a Manufacturer/Distributor (M&D) licensee to take possession at the licensee's location of the licensed radioactive material and ship it under its M&D license, the requirements of subdivision a and b above shall not apply.

d. If the licensee is to receive radioactive material greater than or equal to the quantities listed in subsection A of this section, per consignment, the licensee shall coordinate with the originator to:

(1) Establish an expected time of delivery; and

(2) Confirm receipt of transferred radioactive material. If the material is not received at the expected time of delivery, notify the originator and assist in any investigation.

4. In order to ensure the safe handling, use, and control of licensed material in use and in storage, each licensee that possesses mobile or portable devices containing radioactive material in quantities greater than or equal to the limits in subsection A of this section shall:

a. For portable devices, have two independent physical controls that form tangible barriers to secure the material from unauthorized removal when the device is not under direct control and constant surveillance by the licensee.

b. For mobile devices:

(1) That are only moved outside of the facility (e.g., on a trailer), have two independent physical controls that form tangible barriers to secure the material from unauthorized removal when the device is not under direct control and constant surveillance by the licensee.

(2) That are only moved inside a facility, have a physical control that forms a tangible barrier to secure the material from unauthorized movement or removal when the device is not under direct control and constant surveillance by the licensee.

c. For devices in or on a vehicle or trailer, licensees shall also utilize a method to disable the vehicle or trailer when not under direct control and constant surveillance by the licensee.

5. The licensee shall retain documentation required by this section for three years after these increased controls are no longer effective.

a. The licensee shall retain documentation regarding the trustworthiness and reliability of individual employees for three years after the individual's employment ends.

b. Each time the licensee revises the list of approved persons required in subdivision 1 d of this subsection or the documented program required by subdivision B 2 of this section, the licensee shall retain the previous documentation for three years after the revision.

c. The licensee shall retain documentation on each radioactive material carrier for three years after the licensee discontinues use of that particular carrier.

d. The licensee shall retain documentation on shipment coordination, notifications, and investigations for three years after the shipment or investigation is completed.

e. After the licensee is terminated or amended to reduce possession limits below the quantities of concern, the licensee shall retain all documentation required by this section for three years.

6. Detailed information generated by the licensee that describes the physical protection of radioactive material quantities of concern is sensitive information and shall be protected from unauthorized disclosure.

a. The licensee shall control access to its physical protection information to those persons who have an established need to know the information and are considered to be trustworthy and reliable.

b. The licensee shall develop, maintain and implement policies and procedures for controlling access to, and for proper handling and protection against unauthorized disclosure of, its physical protection information for radioactive material covered by this section. The policies and procedures shall include the following:

(1) General performance requirement that each person who produces, receives, or acquires the licensees sensitive information, protect the information from unauthorized disclosure;

(2) Protection of sensitive information during use, storage, and transit;

(3) Preparation, identification or marking, and transmission;

(4) Access controls;

(5) Destruction of documents;

(6) Use of automatic data processing systems; and

(7) Removal from the licensee's sensitive information category.

C. Fingerprinting.

1. Licensees who possess radionuclides in quantities greater than those listed in subsection A of this section shall establish and maintain a fingerprinting program that meets the following:

a. Each licensee subject to these provisions shall fingerprint each individual who is seeking unescorted access to risk significant radioactive materials equal to or greater than the quantities listed in subsection A of this section. The licensee shall review and use the information received from the Federal Bureau of Investigation (FBI) identification and criminal history records check and ensure that the provisions in this subsection are satisfied;

b. The licensee shall notify each affected individual that the fingerprints will be used to secure a review of his criminal history record and inform the individual of the procedures for revising the record or including an explanation in the record as specified in subdivision 3 of this subsection;

c. Fingerprints for unescorted access need not be taken if an employed individual (e.g., a licensee employee, contractor, manufacturer, or supplier) is relieved from the fingerprinting requirement by 10 CFR 73.61, or any person who has been favorably decided by a U.S. government program involving fingerprinting and an FBI identification and criminal history records check (e.g., National Agency Check, Transportation Worker Identification Credentials in accordance with 49 CFR Part 1572, Bureau of Alcohol Tobacco Firearms and Explosives background checks and clearances in accordance with 27 CFR Part 555, Health and Human Services security risk assessments for possession and use of select agents and toxins in accordance with 42 CFR Part 73, Hazardous Material security threat assessment for hazardous material endorsement to commercial drivers license in accordance with 49 CFR Part 1572, Customs and Border Patrol's Free and Secure Trade Program (Note 1: within the last five calendar years, or any person who has an active federal security clearance provided in the latter two cases that they make available the appropriate documentation; Note 2: Written confirmation from the agency/employer that 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 years from the date the individual no longer requires unescorted access to certain radioactive material associated with the licensee's activities.));

d. All fingerprints obtained by the licensee pursuant to this section must be submitted to the NRC (Office of Administration, Security Processing Unit, Mail Stop TWB-05 B32M, US NRC, Washington, DC 20555-0012) for transmission to the FBI. Additionally, the licensee shall submit a certification of the trustworthiness and reliability of the Trustworthy & Reliability (T & R) Official as determined in accordance with subdivision 5 of this subsection. (See the NRC's website at www.nrc.gov for more information on submitting fingerprints, including pricing and address changes). The licensee shall review the information received from the FBI and consider it, in conjunction with the trustworthiness and reliability requirements of subdivision B 1 of this section, in making a determination whether to grant unescorted access to certain radioactive materials;

e. The licensee shall use any information obtained as part of a criminal history records check solely for the purpose of determining an individual's suitability for unescorted access to risk significant radioactive materials equal to or greater than the quantities listed in subsection A of this section; and

f. The licensee shall document the basis for its determination whether to grant or continue to allow unescorted access to risk significant radioactive materials equal to or greater than those listed in subsection A of this section.

2. Prohibitions. A licensee shall not base a final determination to deny an individual unescorted access to certain radioactive material solely on the basis of information received from the FBI involving: an arrest more than one year old for which there is no information of the disposition of the case, or an arrest that resulted in dismissal of the charge or an acquittal. A licensee shall not use information received from a criminal history 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, nor shall the licensee use the information in any way that would discriminate among individuals on the basis of race, religion, national origin, sex, or age.

3. Right to correct and complete information. Prior to any final adverse determination, the licensee shall make available to the 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 year from the date of the notification. If, after reviewing the record, an 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 direct application by the individual challenging the record to the agency (i.e., law-enforcement agency) that contributed the questioned information, or direct challenge as to the accuracy or completeness of any entry on the criminal history record to the Assistant Director, Federal Bureau of Investigation Identification Division, Washington, DC 20537-9700. 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.

The licensee must provide at least 10 days for an individual to initiate an action challenging the results of an FBI identification and criminal history records check after the record is made available for his review. The licensee may make a final unescorted access to certain radioactive material determination based upon the criminal history record only upon receipt of the FBI's ultimate confirmation or correction of the record. Upon a final adverse determination on unescorted access to certain radioactive material, the licensee shall provide the individual its documented basis for denial. Unescorted access to certain radioactive material shall not be granted to an individual during the review process.

4. Protection of information.

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

b. The licensee may not disclose the record or personal information collected and maintained to persons other than the subject individual, his representative, or to those who have a need to access the information in performing assigned duties in the process of determining unescorted access to certain radioactive material. No individual authorized to have access to the information may re-disseminate the information to any other individual who does not have a need to know.

c. The personal information obtained on an individual from a criminal history record check may be transferred to another licensee if the licensee holding the criminal history record check receives the individual's written request to re-disseminate the information contained in his file, and the gaining licensee verifies information such as the individual's name, date of birth, social security number, sex, and other applicable physical characteristics for identification purposes.

d. The licensee shall make criminal history records obtained under this section available for examination by an authorized representative of VDH to determine compliance with the regulations.

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

5. Trustworthy & Reliability Official.

a. The licensee shall provide under oath or affirmation, a certification to the agency that the T & R Official (an individual with the responsibility to determine the trustworthiness and reliability of another individual requiring unescorted access to the radioactive materials identified in subsection A of this section) is deemed trustworthy and reliable by the licensee as required in subdivision 5 b below.

b. The T & R Official, if he does not require unescorted access, must be deemed trustworthy and reliable by the licensee in accordance with the requirements of subdivision B 1 of this section 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 fingerprinting and the review of an FBI identification and criminal history records check as a component in approving a T & R Official.

6. The licensee shall notify the agency at [phone] and the NRC HQ Operations Center at [phone] within 24 hours if the results from an FBI identification and criminal history records check indicate that an individual is identified on the FBI's Terrorist Screening Data Base.

7. Prior to requesting fingerprints from any individual, the licensee shall provide a copy of 12VAC5-481-451 to that individual.

B. Background investigations and access authorization program.

1. Personnel access authorization requirements for Category 1 or Category 2 quantities of radioactive material.

a. Each licensee that possesses an aggregated quantity of radioactive material that equals or exceeds the Category 2 threshold shall establish, implement, and maintain its access authorization program in accordance with the requirements in this subsection. An applicant for a new license and each licensee that would become newly subject to the requirements in this subsection upon an amendment request of its license shall implement the requirements of this subsection, as appropriate, before taking possession of an aggregated quantity of radioactive material that equals or exceeds the Category 2 threshold. Any licensee that has not previously implemented the increased control requirements of this section shall implement the provisions of this subsection before aggregating radioactive material to a quantity that equals or exceeds the Category 2 threshold.

b. Licensees shall subject the following individuals to an access authorization program:

(1) Any individual whose assigned duties require unescorted access to Category 1 or Category 2 quantities of radioactive material; and

(2) Reviewing officials.

c. Licensees shall approve for unescorted access to Category 1 or Category 2 quantities of radioactive material only those individuals whose assigned job duties require unescorted access to Category 1 or Category 2 quantities of radioactive material.

d. Licensees need not subject the categories of individuals listed in subdivision 5 a of this subsection to the investigation elements of the access authorization program.

2. Access authorization program requirements.

a. Granting unescorted access authorization.

(1) Licensees shall implement the requirements of this subsection for granting initial or reinstated unescorted access authorization.

(2) Individuals who have been determined to be trustworthy and reliable shall also complete the security training required by subdivision C 2 c of this section before being allowed unescorted access to Category 1 or Category 2 quantities of radioactive material.

b. Reviewing officials.

(1) Reviewing officials are the only individuals who may make trustworthiness and reliability determinations that allow individuals to have unescorted access to Category 1 or Category 2 quantities of radioactive materials possessed by the licensee.

(2) Each licensee shall name one or more individuals to be reviewing officials. After completing the background investigation on the reviewing official, the licensee shall provide under oath or affirmation a certification that the reviewing official is deemed trustworthy and reliable by the licensee. The fingerprints of the named reviewing official shall be taken by a law-enforcement agency, a federal or state agency that provides fingerprinting services to the public, or a commercial fingerprinting service authorized by a state to take fingerprints. The licensee shall recertify that the reviewing official is deemed trustworthy and reliable every 10 years in accordance with subdivision 3 c of this subsection.

(3) Reviewing officials shall be permitted to have unescorted access to Category 1 or Category 2 quantities of radioactive material.

(4) Reviewing officials cannot approve other individuals to act as reviewing officials.

(5) A reviewing official does not need to undergo a new background investigation before being named by the licensee as the reviewing official if:

(a) The individual has undergone a background investigation that included fingerprinting and an FBI criminal history records check and has been determined to be trustworthy and reliable by the licensee; or

(b) The individual is subject to a category listed in subdivision 5 a of this subsection.

c. Informed consent.

(1) Licensees may not initiate a background investigation without the informed and signed consent of the subject individual. This consent shall include authorization to share personal information with other individuals or organizations as necessary to complete the background investigation. Before a final adverse determination, the licensee shall provide the individual with an opportunity to correct any inaccurate or incomplete information that is developed during the background investigation. Licensees do not need to obtain signed consent from those individuals who meet the requirements of subdivision 3 b of this subsection. A signed consent shall be obtained prior to any reinvestigation.

(2) The subject individual may withdraw his consent at any time. Licensees shall inform the individual that:

(a) If an individual withdraws his consent, the licensee may not initiate elements of the background investigation that were not in progress at the time the individual withdrew his consent; and

(b) The withdrawal of consent for the background investigation is sufficient cause of denial or termination of unescorted access authorization.

d. Any individual who is applying for unescorted access authorization shall disclose the personal history information that is required by the licensee's access authorization program for the reviewing official to make a determination of the individual's trustworthiness and reliability. Refusal to provide, or the falsification of, any personal history information required by this subsection is sufficient cause for denial or termination of unescorted access.

e. Determination basis.

(1) The reviewing official shall determine whether to permit, deny, unfavorably terminate, maintain, or administratively withdraw an individual's unescorted access authorization based on an evaluation of all the information collected to meet the requirements of this subsection.

(2) The reviewing official may not permit any individual to have unescorted access until the reviewing official has evaluated all the information collected to meet the requirements of this subsection and determined that the individual is trustworthy and reliable. The reviewing official may deny unescorted access to any individual based on information obtained at any time during the background investigation.

(3) The licensee shall document the basis for concluding whether or not there is reasonable assurance that an individual is trustworthy and reliable.

(4) The reviewing official may terminate or administratively withdraw an individual's unescorted access authorization based on information obtained after the background investigation has been completed and the individual granted unescorted access information.

(5) Licensees shall maintain a list of persons currently approved for unescorted access authorization. When a licensee determines that a person no longer requires unescorted access or meets the access authorization requirement, the licensee shall remove the person from the approved list as soon as possible, but no later than seven working days, and take prompt measures to ensure that the individual is unable to have unescorted access to the material.

f. Licensees shall develop, implement, and maintain written procedures for implementing the access authorization program. The procedures shall include the provisions for the notification of individuals who are denied unescorted access. The procedures shall include provisions for the review, at the request of the affected individual, of a denial or termination of unescorted access authorization. The procedures shall contain a provision to ensure that the individual is informed of the grounds for the denial or termination of unescorted access authorization and allow the individual an opportunity to provide additional relevant information.

g. Right to correct and complete information.

(1) Prior to any final adverse determination, licensees shall provide each individual subject to this subsection with the right to complete, correct, and explain information obtained as a result of the licensee's background investigation. Confirmation of receipt by the individual of this notification shall be maintained by the licensee for a period of one year from the date of the notification.

(2) If, after reviewing his criminal history record, an individual believes that it is incorrect or incomplete in any respect and wishes to change, correct, update, or explain anything in the record, the individual may initiate challenge procedures. These procedures include direct application by the individual challenging the record to the 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 Federal Bureau of Investigation, Criminal Justice Information Services (CJIS) Division, ATTN: SCU, Mod. D-2, 1000 Custer Hollow Road, Clarksburg, WV 26306 as set forth in 28 CFR 16.30 through 28 CFR 16.34. In the latter case, the Federal Bureau of Investigation (FBI) will forward the challenge to the agency that submitted the data and will request that the agency 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 will make any change necessary in accordance with the information supplied by that agency. Licensees shall provide at least 10 days for an individual to initiate action to challenge the results of an FBI criminal history records check after the record being made available for his review. The licensee may make a final adverse determination based upon the criminal history records only after receipt of the FBI's confirmation or correction of the record.

h. Records.

(1) The licensee shall retain documentation regarding the trustworthiness and reliability of individual employees for three years from the date the individual no longer requires unescorted access to Category 1 or Category 2 quantities of radioactive material.

(2) The licensee shall retain a copy of the current access authorization program procedures as a record for three years after the procedure is no longer needed. If any portion of the procedure is superseded, the licensee shall retain the superseded material for three years after the record is superseded.

(3) The licensee shall retain the list of individuals approved for unescorted access authorization for three years after the list is superseded or replaced.

3. Background investigations.

a. Before allowing an individual unescorted access to Category 1 or Category 2 quantities of radioactive material or to the devices containing the material, licensees shall complete a background investigation of the individual seeking unescorted access authorization. The scope of the investigation shall encompass at least the seven years preceding the date of the background investigation or since the individual's 18th birthday, whichever is shorter. The background investigation shall include at a minimum:

(1) Fingerprinting and an FBI identification and criminal history records check in accordance with subdivision 4 of this subsection;

(2) Verification of true identity of the individual who is applying for unescorted access authorization. A licensee shall review official identification documents (e.g., driver's license; passport; government identification; certificate of birth issued by the state, province, or country of birth) and compare the documents to personal information data provided by the individual to identify any discrepancy in the information. Licensees shall document the type, expiration, and identification number of the identification document or maintain a photocopy of identifying documents on file in accordance with subdivision 6 of this subsection. Licensees shall certify in writing that the identification was properly reviewed and shall maintain the certification and all related documents for review upon inspection;

(3) Verification of employment history, including military history. Licensees shall verify the individual's employment with each previous employer for the most recent seven years before the date of application;

(4) Verification that the individual participated in the education process during the claimed period;

(5) Completion of reference checks to determine the character and reputation of the individual who has applied for unescorted access authorization. Unless other references are not available, reference checks may not be conducted with any person who is known to be a close member of the individual's family, including but not limited to, the individual's spouse, parents, siblings, or children, or any individual who resides in the individual's permanent household. Reference checks under this subsection shall be limited to whether the individual has been and continues to be trustworthy and reliable;

(6) To the extent possible, obtain independent information to corroborate the information provided by the individual (e.g., seek references not supplied by the individual); and

(7) If a previous employer, educational institution, or any other entity with which the individual claims to have been engaged fails to provide the information or indicates an inability or unwillingness to provide information within a timeframe deemed appropriate by the licensee but at least after 10 business days of the request or if the licensee is unable to reach the entity, the licensee shall document the refusal, unwillingness, or inability in the record of investigation and attempt to obtain the information from an alternate source.

b. Individuals who have been determined to be trustworthy and reliable for unescorted access to Category 1 or Category 2 quantities of radioactive material in accordance with 12VAC5-481-451, "Increased controls and fingerprinting," as effective on October 3, 2008, can continue to have unescorted access to Category 1 and Category 2 quantities of radioactive material without further investigation. These individuals shall be subject to the reinvestigation requirement of subdivision 3 c of this subsection.

c. Licensees shall conduct a reinvestigation every 10 years for any individual with unescorted access to Category 1 or Category 2 quantities of radioactive material. The reinvestigation shall consist of fingerprinting and an FBI identification and criminal history records check in accordance with subdivision 4 of this subsection. The reinvestigations shall be completed within 10 years of the date on which these elements were last completed.

4. Requirements for criminal history records checks of individuals granted unescorted access to Category 1 or Category 2 quantities of radioactive material.

a. General performance objective and requirements.

(1) Except for those individuals listed in subdivision 5 a of this subsection and those individuals grandfathered under subdivision 3 b of this subsection, each licensee subject to the provisions of this section shall fingerprint each individual who is to be permitted unescorted access to Category 1 or Category 2 quantities of radioactive material. The licensee shall submit all collected fingerprints to the NRC for transmission to the FBI. The licensee shall use the information received from the FBI as part of the required background investigation to determine whether to grant or deny further unescorted access to Category 1 or Category 2 quantities of radioactive materials for that individual.

(2) The licensee shall notify each affected individual that his fingerprints will be used to secure a review of his criminal history record and shall inform him of the procedures for revising the record or adding explanations to the record.

(3) Fingerprinting is not required if a licensee is reinstating an individual's unescorted access authorization to Category 1 or Category 2 quantities of radioactive material if:

(a) The individual returns to the same facility that granted unescorted access authorization within 365 days of the termination of his unescorted access authorization; and

(b) The previous access was terminated under favorable conditions.

(4) Fingerprints do not need to be taken if an individual who is an employee of a licensee, contractor, manufacturer, or supplier has been granted unescorted access to Category 1 or Category 2 quantities of radioactive material, access to safeguards information, or safeguards information-modified handling by another licensee based upon a background investigation conducted under this subsection, regulations or Fingerprint Orders from another agreement state, or 10 CFR Part 73. An existing criminal history records check file may be transferred to the licensee asked to grant unescorted access in accordance with the provisions of subdivision 6 c of this subsection.

(5) Licensees shall use the information obtained as part of a criminal history records check solely for the purpose of determining an individual's suitability for unescorted access authorization to Category 1 or Category 2 quantities of radioactive materials, access to safeguards information, or safeguards information-modified handling.

b. Prohibitions.

(1) Licensees may not base a final determination to deny an individual unescorted access authorization to Category 1 or Category 2 quantities of radioactive material solely on the basis of information received from the FBI involving:

(a) An arrest more than one year old for which there is no information of the disposition of the case; or

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

(2) Licensees may not use information received from a criminal history records check obtained under this subsection in a manner that would infringe upon the rights of any individual under the First Amendment to the Constitution of the United States, nor shall licensees use the information in any way that would discriminate among individuals on the basis of race, religion, national origin, gender, or age.

c. Procedures for processing of fingerprint checks.

(1) For the purpose of complying with this subsection, licensees shall submit to the U.S. Nuclear Regulatory Commission, Director, Division of Facilities and Security, 11545 Rockville Pike, ATTN: Criminal History Program/Mail Stop T-03B46M, Rockville, MD, 20852-2738, one completed, legible standard fingerprint card (form FD-258, ORIMDNRCOOOZ), electronic fingerprint scan, or, where practicable, other fingerprint record for each individual requiring unescorted access to Category 1 or Category 2 quantities of radioactive material. Copies of these forms may be obtained by writing the Office of Information Services, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, by calling [phone], or by email to [e-mail]. Guidance on submitting electronic fingerprints can be found at http://www.nrc.gov/site-help/e-submittals.html.

(2) Fees for processing of fingerprint cards are due upon application. Licensees shall submit payment with the application for the processing of fingerprints through corporate check, certified check, cashier's check, money order, or electronic payment, made payable to the "U.S. NRC." (For guidance on making electronic payments, contact the Security Branch, Division of Facilities and Security at [phone].) Combined payment for multiple applications is acceptable. The NRC publishes the amount of the fingerprint check application fee on the NRC public website. To find the current fee amount, go to the Electronic Submittals page at http://www.nrc.gov/site-help/e-submittals.html and see the link for the Criminal History Program under Electronic Submission Systems.

(3) The NRC will forward to the submitting licensee all data received from the FBI as a result of the licensee's application for a criminal history records check.

5. Relief.

a. Fingerprinting, identification and criminal history records checks, and other elements of the background investigation required by this subsection are not required for the following individuals prior to granting unescorted access to Category 1 or Category 2 quantities of radioactive material:

(1) An employee of the NRC or of the executive branch of the U.S. government who has undergone fingerprinting for a prior U.S. government criminal history records check;

(2) A member of Congress;

(3) An employee of a member of Congress or congressional committee who has undergone fingerprinting for a prior U.S. government criminal history records check;

(4) The governor of a state or his designated state employee representative;

(5) Federal, state, or local law-enforcement personnel;

(6) State radiation control program directors and state homeland security advisors or their designated employee representatives;

(7) 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;

(8) Emergency response personnel who are responding to an emergency;

(9) Commercial vehicle drivers for road shipments of Category 2 quantities of radioactive material;

(10) Package handlers at transportation facilities such as freight terminals and railroad yards;

(11) Any individual who has an active federal security clearance and provides the appropriate documentation. Written confirmation from the agency or employer that granted the federal security clearance or reviewed the criminal history records check shall be provided to the licensee. The licensee shall retain this documentation for a period of three years from the date the individual no longer requires unescorted access to Category 1 or Category 2 quantities of radioactive material; and

(12) Any individual employed by a service provider licensee for whom the service provider licensee has conducted the background investigation for the individual and approved the individual for unescorted access to Category 1 or Category 2 quantities of radioactive material. Written verification from the service provider shall be provided to the licensee. The licensee shall retain the documentation for a period of three years from the date the individual no longer requires unescorted access to Category 1 or Category 2 quantities of radioactive material.

b. Fingerprinting and identification and criminal history records checks required by this subsection are not required for an individual who has had a favorably adjudicated U.S. Government criminal history records check within the last five years, under a comparable U.S. Government program involving fingerprinting and an FBI identification and criminal history records check, and the individual provides the appropriate documentation. Written confirmation from the agency or employer that reviewed the criminal history records check shall be provided to the licensee. The licensee shall retain this documentation for a period of three years from the date the individual no longer requires unescorted access to Category 1 or Category 2 quantities of radioactive material. These programs include, but are not limited to:

(1) National Agency Check;

(2) Transportation Worker Identification Credentials (TWIC) under 49 CFR Part 1572;

(3) Bureau of Alcohol, Tobacco, Firearms, and Explosives background check and clearances under 27 CFR Part 555;

(4) Health and Human Services security risk assessments for possession and use of select agents and toxins under 42 CFR Part 73;

(5) Hazardous material security threat assessment for hazardous material endorsement to commercial driver's license under 49 CFR Part 1572; and

(6) Customs and Border Protection's Free and Secure Trade (FAST) Program.

6. Protection of information.

a. Each licensee that obtains background information on an individual under this subsection shall establish and maintain a system of files and written procedures for protection of the record and the personal information from unauthorized disclosure.

b. The licensee may not disclose the record or personal information collected and maintained to persons other than the subject individual, his representative, or to those who have a need to have access to the information in performing assigned duties in the process of granting or denying unescorted access to Category 1 or Category 2 quantities of radioactive material. No individual authorized to have access to the information may disseminate the information to any other individual who does not have a need to know.

c. The personal information obtained on an individual from a background investigation may be provided to another licensee:

(1) Upon the individual's written request to the licensee holding the data to disseminate the information contained in that individual's file; and

(2) The recipient licensee verifies information such as name, date of birth, social security number, gender, and other applicable physical characteristics.

d. The licensee shall make background investigation records obtained under this subsection available for examination by an authorized representative of the agency to determine compliance with the regulations and laws.

e. The licensee shall retain all fingerprint and criminal history records (including data indicating no record) received from the FBI, or a copy of these records if the individual's file has been transferred, on an individual for three years from the date the individual no longer requires unescorted access to Category 1 or Category 2 quantities of radioactive material.

7. Access authorization program review.

a. Each licensee shall be responsible for the continuing effectiveness of the access authorization program. Each licensee shall ensure that access authorization programs are reviewed to confirm compliance with the requirements of this subsection and that comprehensive actions are taken to correct any noncompliance that is identified. The review program shall evaluate all program performance objectives and requirements. The review shall be performed at least annually.

b. The results of the reviews, along with all recommendations, shall be documented. Each review report shall identify conditions that are adverse to the proper performance of the access authorization program; the cause of the conditions and, when appropriate, recommend corrective actions; and corrective actions taken. The licensee shall review the findings and take additional corrective actions necessary to preclude repetition of the condition, including reassessment of the deficient areas where indicated.

c. Review records shall be maintained for three years.

C. Physical protection requirements during use.

1. Security program.

a. Each licensee that possesses an aggregated Category 1 or Category 2 quantity of radioactive material shall establish, implement, and maintain a security program in accordance with the requirements of this subsection. An applicant for a new license and each licensee that would become newly subject to the requirements of this subsection upon an amendment request for modification of its license shall implement the requirements of this subsection, as appropriate, before taking possession of an aggregated Category 1 or Category 2 quantity of radioactive material. Any licensee that has not previously implemented the requirements of this subsection shall provide written notification to the agency at least 90 days before aggregating radioactive material to a quantity that equals or exceeds the Category 2 threshold.

b. Each licensee shall establish, implement, and maintain a security program that is designed to monitor and, without delay, detect, assess, and respond to an actual or attempted unauthorized access to Category 1 or Category 2 quantities of radioactive material.

c. Each licensee's security program shall include the program features, as appropriate, described in subdivisions 2 through 8 of this subsection.

2. General security program requirements.

a. Security plan.

(1) Each licensee identified in subdivision 1 a of this subsection shall develop a written security plan specific to its facilities and operations. The purpose of the security plan is to establish the licensee's overall security strategy to ensure the integrated and effective functioning of the security program required by this subsection. The security plan shall, at a minimum, (i) describe the measures and strategies used to implement the requirements of this subsection and (ii) identify the security resources, equipment, and technology used to satisfy the requirements of this subsection.

(2) The security plan shall be reviewed and approved by the individual with overall responsibility for the security program.

(3) A licensee shall revise its security plan as necessary to ensure the effective implementation of agency requirements. The licensee shall ensure that (i) the revision has been reviewed and approved by the individual with overall responsibility for the security program and (ii) the affected individuals are instructed on the revised plan before the changes are implemented.

(4) The licensee shall retain a copy of the current security plan as a record for three years after the security plan is no longer required. If any portion of the plan is superseded, the licensee shall retain the superseded material for three years after the record is superseded.

b. Implementing procedures.

(1) The licensee shall develop and maintain written procedures that document how the requirements of this subsection and the security plan will be met.

(2) The implementing procedures and revisions to these procedures shall be approved in writing by the individual with overall responsibility for the security program.

(3) The licensee shall retain a copy of the current procedure as a record for three years after the procedure is no longer needed. Superseded portions of the procedure shall be retained for three years after the record is superseded.

c. Training.

(1) Each licensee shall conduct training to ensure that those individuals implementing the security program possess and maintain the knowledge, skills, and abilities to carry out their assigned duties and responsibilities effectively. The training shall include at a minimum, instruction on:

(a) The licensee's security program and procedures to secure Category 1 or Category 2 quantities of radioactive material, and the purpose and function of the security measures employed;

(b) The responsibility to report promptly to the licensee any condition that causes or may cause a violation of agency requirements;

(c) The responsibility of the licensee to report promptly to the local law-enforcement agency and the agency any actual or attempted theft, sabotage, or diversion of Category 1 or Category 2 quantities of radioactive material; and

(d) The appropriate response to security alarms.

(2) In determining those individuals who shall be trained on the security program, the licensee shall consider each individual's assigned activities during authorized use and response to potential situations involving actual or attempted theft, diversion, or sabotage of Category 1 or Category 2 quantities of radioactive material. The extent of the training shall be commensurate with the individual's potential involvement in the security of Category 1 or Category 2 quantities of radioactive material.

(3) Refresher training shall be provided at a frequency not to exceed 12 months and when significant changes have been made to the security program. This training shall include (i) review of the training requirements of this subsection and changes made to the security program since the last training; (ii) reports on all relevant security issues, problems, and lessons learned; (iii) relevant results of agency inspections; and (iv) relevant results of the licensee's program review and testing and maintenance.

(4) The licensee shall maintain records of the initial and refresher training for three years from the date of the training. The training records shall include dates of the training, topics covered, a list of licensee personnel in attendance, and related information.

d. Protection of information.

(1) Licensees authorized to possess Category 1 or Category 2 quantities of radioactive material shall limit access to and prevent the unauthorized disclosure of their security plan, implementing procedures, and the list of individuals who have been approved for unescorted access.

(2) Efforts to limit access shall include the development, implementation, and maintenance of written policies and procedures for controlling access to and for proper handling and protection against unauthorized disclosure of the security plan and implementing procedures.

(3) Before granting an individual access to the security plan or implementing procedures, licensees shall:

(a) Evaluate an individual's need to know the security plan or implementing procedures; and

(b) If the individual has not been authorized for unescorted access to Category 1 or Category 2 quantities of radioactive material, the licensee shall complete a background investigation to determine the individual's trustworthiness and reliability. A trustworthiness and reliability determination shall be conducted by the reviewing official and shall include the background investigation elements contained in subdivisions B 3 a (2) through (7) of this section.

(4) Licensees need not subject any individual to background investigation elements for protection of information if that individual is included in the categories of individuals listed in subdivisions B 5 a (1) through (12) of this section or is a security service provider employee, provided written verification that the employee has been determined to be trustworthy and reliable, by the required background investigation in subdivisions B 3 a (2) though (7) of this subsection, has been provided by the security service provider.

(5) The licensee shall document the basis for concluding that an individual is trustworthy and reliable and should be granted access to the security plan or implementing procedures.

(6) Licensees shall maintain a list of persons currently approved for access to the security plan or implementing procedures. When a licensee determines that a person no longer needs access to the security plan or implementing procedures or no longer meets the access authorization requirements for access to the information, the licensee shall remove the person from the approved list as soon as possible, but no later than seven working days after the determination, and take prompt measures to ensure that the individual is unable to obtain the security plan or implementing procedures.

(7) When not in use, the licensee shall store its security plan and implementing procedures in a manner to prevent unauthorized access. Information stored in nonremovable electronic form shall be password protected.

(8) The licensee shall retain as a record a copy of the information protection procedures and the list of individuals approved for access to the security plan or implementing procedures for three years after the document has been superseded.

3. Local law-enforcement agency (LLEA) coordination.

a. A licensee subject to this subsection shall coordinate, to the extent practicable, with an LLEA for responding to threats to the licensee's facility, including any necessary armed response. The information provided to the LLEA shall include:

(1) A description of the facilities and the Category 1 and Category 2 quantities of radioactive materials along with a description of the licensee's security measures that have been implemented to comply with this subsection; and

(2) A notification that the licensee will request a timely armed response by the LLEA to any actual or attempted theft, sabotage, or diversion of Category 1 or Category 2 quantities of material.

b. The licensee shall notify the agency within three business days if:

(1) The LLEA has not responded to the request for coordination within 60 days of the coordination request; or

(2) The LLEA notifies the licensee that the LLEA does not plan to participate in coordination activities.

c. The license shall document its efforts to coordinate with the LLEA. The documentation shall be kept for three years.

d. The licensee shall coordinate with the LLEA at least every 12 months, or when changes to the facility design or operation adversely affect the potential vulnerability of the licensee's material to theft, sabotage, or diversion.

4. Security zones.

a. Licensees shall ensure that all aggregated Category 1 or Category 2 quantities of radioactive material are used or stored within licensee-established security zones. Security zones may be permanent or temporary.

b. Temporary security zones shall be established as necessary to meet the licensee's transitory or intermittent business activities, such as periods of maintenance, source delivery, and source replacement.

c. Security zones shall, at a minimum, allow unescorted access only to approved individuals by:

(1) Isolation of Category 1 and Category 2 quantities of radioactive materials by the use of continuous physical barriers that allow access to the security zone only through established access control points. A physical barrier is a natural or man-made structure or formation sufficient for the isolation of the Category 1 or Category 2 quantities of radioactive material within a security zone;

(2) Direct control of the security zone by approved individuals at all times; or

(3) A combination of continuous physical barriers and direct control.

d. For Category 1 quantities of radioactive material during periods of maintenance, source receipt, preparation for shipment, installation, or source removal or exchange, the licensee shall, at a minimum, provide sufficient individuals approved for unescorted access to maintain continuous surveillance of sources in temporary security zones and in any security zone in which physical barriers or intrusion detection systems have been disabled to allow such activities.

e. Individuals not approved for unescorted access to Category 1 or Category 2 quantities of radioactive material shall be escorted by an approved individual when in a security zone.

5. Monitoring, detection, and assessment.

a. Monitoring and detection.

(1) Licensees shall establish and maintain the capability to continuously monitor and detect without delay all unauthorized entries into its security zones. Licensees shall provide the means to maintain continuous monitoring and detection capability in the event of a loss of the primary power source, or provide for an alarm and response in the event of a loss of this capability to continuously monitor and detect unauthorized entries.

(2) Monitoring and detection shall be performed by:

(a) A monitored intrusion detection system that is linked to an onsite or offsite central monitoring facility;

(b) Electronic devices for intrusion detection alarms that will alert nearby facility personnel;

(c) A monitored video surveillance system;

(d) Direct visual surveillance by approved individuals located within the security zone; or

(e) Direct visual surveillance by a licensee designed individual located outside the security zone.

(3) A licensee subject to this subsection shall also have a means to detect unauthorized removal of the radioactive material from the security zone. This detection capability shall provide:

(a) For Category 1 quantities of radioactive material, immediate detection of any attempted unauthorized removal of the radioactive material from the security zone. Such immediate detection capability shall be provided by electronic sensors linked to an alarm, continuous monitored video surveillance, or direct visual surveillance; and

(b) For Category 2 quantities of radioactive material, weekly verification through physical checks, tamper indicating devices, use, or other means to ensure that the radioactive material is present.

b. Licensees shall immediately assess each actual or attempted unauthorized entry into the security zone to determine whether the unauthorized access was an actual or attempted theft, sabotage, or diversion.

c. For personnel and automated or electronic systems supporting the licensee's monitoring, detection, and assessments system, licensees shall:

(1) Maintain continuous capability for personnel communication and electronic data transmission and processing among site security systems; and

(2) Provide an alternate communication capability for personnel, and an alternative data transmission and processing capability, in the event of a loss of the primary means of communication or data transmission and processing. Alternative communications and data transmissions systems may not be subject to the same failure modes as the primary systems.

d. Licensees shall immediately respond to any actual or attempted unauthorized access to the security zones, or actual or attempted theft, sabotage, or diversion of Category 1 or Category 2 quantities of radioactive material at licensee facilities or temporary job sites. For any unauthorized access involving an actual or attempted theft, sabotage, or diversion of Category 1 or Category 2 quantities of radioactive material, the licensee's response shall include requesting, without delay, an armed response from the LLEA.

6. Maintenance and testing.

a. Each licensee subject to this subsection shall implement a maintenance and testing program to ensure that intrusion alarms, associated communication systems, and other physical components of the systems used to secure or detect unauthorized access to radioactive material are maintained in operable condition and are capable of performing their intended function when needed. The equipment relied on to meet the security requirements of this subsection shall be inspected and tested for operability and performance at the manufacturer's suggested frequency. If there is no frequency suggested by the manufacturer or the frequency specified is greater than three months, the testing shall be performed at least quarterly, not to exceed three months.

b. The licensee shall maintain records on the maintenance and testing activities for three years.

7. Requirements for mobile devices. Each licensee that possesses mobile devices containing Category 1 or Category 2 quantities of radioactive material shall:

a. Have two independent physical controls that form tangible barriers to secure the material from unauthorized removal when the device is not under direct control and constant surveillance by the licensee; and

b. For devices in or on a vehicle or trailer, unless the health and safety requirements for a site prohibit the disabling of the vehicle, the licensee shall utilize a method to disable the vehicle or trailer when not under direct control and constant surveillance by the licensee. Licensees shall not rely on the removal of an ignition key to meet this requirement.

8. Security program review.

a. Each licensee shall be responsible for the continuing effectiveness of the security program. Each licensee shall ensure that the security program is reviewed to confirm compliance with the requirements of this subsection and that comprehensive actions are taken to correct any noncompliance that is identified. The review shall include the radioactive material security program content and implementation. The review shall be conducted at least annually, not to exceed 12 months.

b. The results of the review, along with all recommendations, shall be documented. Each review report shall identify conditions that are adverse to the proper performance of the security program, the cause of the condition, corrective actions taken, and, when appropriate, recommend corrective actions. The licensee shall review the findings and take any additional corrective actions necessary to preclude repetition of the condition, including reassessment of the deficient areas where indicated.

c. The licensee shall maintain the review documentation for three years.

9. Reporting of events.

a. The licensee shall immediately notify the LLEA after determining that an unauthorized entry resulted in an actual or attempted theft, sabotage, or diversion of Category 1 or Category 2 quantity of radioactive material. As soon as possible after initiating a response, but not at the expense of causing delay or interfering with the LLEA response to the event, the licensee shall notify the agency by telephone at 804-864-8150 during normal business hours and 804-624-2400 after hours. In no case shall the notification to the agency be later than four hours after the discovery of any attempted or actual theft, sabotage, or diversion.

b. The licensee shall assess any suspicious activity related to possible theft, sabotage, or diversion of Category 1 or Category 2 quantities of radioactive material and notify the LLEA as appropriate. As soon as possible but not later than four hours after notifying the LLEA, the licensee shall notify the agency by telephone [phone] during normal business hours and 804-624-2400 after hours.

c. The initial telephonic notification shall be followed within a period of 30 days by a written report submitted to the agency. The report shall include sufficient information for agency analysis and evaluation, including identification of any necessary corrective actions to prevent future instances.

D. Physical protection in transit.

1. Additional requirements for transfer of Category 1 and Category 2 quantities of radioactive material. A licensee transferring a Category 1 or Category 2 quantity of radioactive material to a licensee of the agency, the NRC, or another agreement state shall meet the license verification provisions listed in this subdivision instead of those listed in 12VAC5-481-570.

a. Any licensee transferring Category 1 quantities of radioactive material to a licensee of the agency, the NRC, or another agreement state, prior to conducting such transfer, shall verify with the NRC's license verification system or the license issuing authority that the transferee's license authorizes the receipt of the type, form, and quantity of radioactive material to be transferred and that the licensee is authorized to receive radioactive material at the location requested for delivery. If the verification is conducted by contacting the license-issuing authority, the transferor shall document the verification. For transfers within the same organization, the licensee does not need to verify the transfer.

b. Any licensee transferring Category 2 quantities of radioactive material to a licensee of the agency, the NRC, or another agreement state, prior to conducting such transfer, shall verify with the NRC's license verification system or the license-issuing authority that the transferee's license authorizes the receipt of the type, form, and quantity of radioactive material to be transferred. If the verification is conducted by contacting the license-issuing authority, the transferor shall document the verification. For transfers within the same organization, the licensee does not need to verify the transfer.

c. In an emergency where the licensee cannot reach the license-issuing authority and the license verification system is nonfunctional, the licensee may accept a written certification by the transferee that it is authorized by license to receive the type, form, and quantity of radioactive material to be transferred. The certification shall include the license number, current revision number, issuing agency, expiration date, and for a Category 1 shipment, the authorized address. The licensee shall keep a copy of the certification. The certification shall be confirmed by use of the NRC's license verification system or by contacting the license-issuing authority by the end of the next business day.

d. The transferor shall keep a copy of the verification documentation as a record for three years.

2. Applicability of physical protection of Category 1 and Category 2 quantities of radioactive material during transit.

a. For shipments of category 1 quantities of radioactive material, each shipping licensee shall comply with the requirements for physical protection contained in subdivisions 3 a, 3 e, 4, 5 a (1), 5 b (1), 5 c, 6 a, 6 c, 6 e, 6 g, and 6 h of this subsection.

b. For shipments of Category 2 quantities of radioactive material, each shipping licensee shall comply with the requirements for physical protection contained in subdivisions 3 b through 3 e, 5 a (2), 5 a (3), 5 b (2), 5 c, 6 b, 6 d, 6 f, 6 g, and 6 h of this subsection.

c. The shipping licensee shall be responsible for meeting the requirements of this subsection unless the receiving licensee has agreed in writing to arrange for the in-transit physical protection required under this subsection.

3. Preplanning and coordination of shipment of Category 1 or Category 2 quantities of radioactive material.

a. Each licensee that plans to transport, or deliver to a carrier for transport, licensed material that is a Category 1 quantity of radioactive material outside the confines of the licensee's facility or other place of use or storage shall:

(1) Preplan and coordinate shipment arrival and departure times with the receiving licensee;

(2) Preplan and coordinate shipment information with the governor or the governor's designee of any state through which the shipment will pass to discuss the state's intention to provide law-enforcement escorts and identify safe havens; and

(3) Document the preplanning and coordination activities.

b. Each licensee that plans to transport, or deliver to a carrier for transport, licensed material that is a Category 2 quantity of radioactive material outside the confines of the licensee's facility or other place of use or storage shall coordinate the shipment no-later-than arrival time and the expected shipment arrival with the receiving licensee. The licensee shall document the coordination activities.

c. Each licensee that receives a shipment of a Category 2 quantity of radioactive material shall confirm receipt of the shipment with the originator. If the shipment has not arrived by the no-later-than arrival time, the receiving licensee shall notify the originator.

d. Each licensee that transports or plans to transport a shipment of a Category 2 quantity of radioactive material and determines that the shipment will arrive after the no-later-than arrival time provided pursuant to subdivision 3 b of this subsection, shall promptly notify the receiving licensee of the new no-later-than arrival time.

e. The licensee shall retain a copy of the documentation for preplanning and coordination and any revision thereof as a record for three years.

4. As specified in subdivision 3 of this subsection, each licensee shall provide advance notification to the agency and the governor of a state, or the governor's designee, of the shipment of licensed material in a Category 1 quantity, through or across the boundary of the state, before the transport or delivery to a carrier for transport of the licensed material outside the confines of the licensee's facility or other place of use or storage.

a. Procedures for submitting advance notification;

(1) The notification shall be made to the agency and to the office of each appropriate governor or governor's designee. The contact information, including telephone and mailing addresses, of governors and governor's designees is available on the NRC website at http://nrc-stp.ornl.gov/special/designee.pdf. The notification to the agency shall be in accordance with 12VAC5-481-150.

(2) A notification delivered by mail shall be postmarked at least seven days before transport of the shipment commences at the shipping facility.

(3) A notification delivered by any means other than mail shall reach the agency at least four days before the transport of the shipment commences and shall reach the office of the governor or the governor's designee at least four days before transport of a shipment within or through the state.

b. Each advance notification of shipment of Category 1 quantities of radioactive material shall contain the following information, if available at the time of the notification:

(1) The name, address, and telephone number of the shipper, carrier, and receiver of the Category 1 radioactive material;

(2) The license numbers of the shipper and receiver;

(3) A description of the radioactive material contained in the shipment, including the radionuclides and quantity;

(4) The point of origin of the shipment and the estimated time and date that shipment will commence;

(5) The estimated time and date that the shipment is expected to enter each state along the route;

(6) The estimated time and date of arrival for the shipment at the destination; and

(7) A point of contact, with a telephone number, for current shipment information.

c. Revision notice.

(1) The licensee shall provide any information not previously available at the time of the initial notification, as soon as the information becomes available but not later than commencement of the shipment, to the agency and the governor of the state or the governor's designee.

(2) A licensee shall promptly notify the agency and governor of the state or the governor's designee of any changes to the information provided in accordance with this subdivision.

d. Each licensee who cancels a shipment for which advance notification has been sent shall send a cancellation notice to the agency and the governor of each state or to the governor's designee previously notified. The licensee shall send the cancellation notice before the shipment would have commenced or as soon thereafter as possible. The licensee shall state in the notice that it is a cancellation and identify the advance notification that is being canceled.

e. The licensee shall retain a copy of the advance notification and any revision and cancellation notices as a record for three years.

5. Requirements for physical protection of Category 1 and Category 2 quantities of radioactive material during shipment.

a. Shipments by road.

(1) Each licensee who transports or delivers to a carrier for transport in a single shipment a Category 1 quantity of radioactive material shall:

(a) Ensure that movement control centers are established that maintain position information from a remote location. These control centers shall monitor shipments 24 hours a day, seven days a week and have the ability to communicate immediately, in an emergency, with the appropriate law-enforcement agencies;

(b) Ensure that redundant communications are established that allow the transport to contact the escort vehicle, when an escort vehicle is used, and movement control center at all times. Redundant communications may not be subject to the same interference factors as the primary communication;

(c) Ensure that shipments are continuously and actively monitored by a telemetric position monitoring system or an alternative tracking system reporting to a movement control center. A movement control center shall provide positive confirmation of the location, status, and control over the shipment. The movement control center shall be prepared to promptly implement preplanned procedures in response to deviations from the authorized route or a notification of actual, attempted, or suspicious activities related to the theft, loss, or diversion of a shipment. These procedures will include, but not be limited to, the identification of and contact information for the appropriate LLEA along the shipment route;

(d) Provide an individual to accompany the driver for those highway shipments with a driving time period greater than the maximum number of allowable hours of service in a 24-hour duty day as established by the U.S. Department of Transportation Federal Motor Carrier Safety Administration. The accompanying individual may be another driver; and

(e) Develop written normal and contingency procedures to address (i) notifications to the communication center and law-enforcement agencies; (ii) communication protocols that shall include a strategy for the use of authentication codes and duress codes and provisions for refueling and other stops, detours, and locations where communication is expected to be temporarily lost; (iii) loss of communication; and (iv) responses to an actual or attempted theft or diversion of a shipment.

(f) Each licensee who makes arrangements for the shipment of Category 1 quantities of radioactive material shall ensure that drivers, accompanying personnel, and movement control center personnel have access to the normal and contingency procedures.

(2) Each licensee that transports Category 2 quantities of radioactive material shall maintain constant control and surveillance during transit and have the capability for immediate communication to summon appropriate response or assistance.

(3) Each licensee who delivers to a carrier for transport in a single shipment a Category 2 quantity of radioactive material shall:

(a) Use carriers that have established package tracking systems. An established package tracking system is a documented, proven, and reliable system routinely used to transport objects of value. In order for a package tracking system to maintain constant control and surveillance, the package tracking system shall allow the shipper or transporter to identify when and where the package was last and when it should arrive at the next point of control;

(b) Use carriers that maintain constant control and surveillance during transit and have the capability for immediate communication to summon appropriate response or assistance; and

(c) Use carriers that have established tracking systems that require an authorized signature prior to releasing the package for delivery or return.

b. Shipments by rail.

(1) Each licensee who transports, or delivers to a carrier for transport, in a single shipment a Category 1 quantity of radioactive material shall:

(a) Ensure that rail shipments are monitored by a telemetric position monitoring system or an alternative tracking system reporting to the licensee, third-party, or railroad communications center. The communications center shall provide positive confirmation of the location of the shipment and its status. The communications center shall implement preplanned procedures in response to deviations from the authorized route or to a notification of actual, attempted, or suspicious activities related to the theft or diversion of a shipment. These procedures will include, but not be limited to, the identification of and contact information for the appropriate LLEA along the shipment route; and

(b) Ensure that periodic reports to the communications center are made at preset intervals.

(2) Each licensee who transports, or delivers to a carrier for transport, in a single shipment a Category 2 quantity of radioactive material shall:

(a) Use carriers that have established package tracking systems. An established package tracking system is a documented, proven, and reliable system routinely used to transport objects of value. In order for a package tracking system to maintain constant control and surveillance, the package tracking system shall allow the shipper or transporter to identify when and where the package was last and when it should arrive at the next point of control;

(b) Use carriers that maintain constant control and surveillance during transit and have the capability for immediate communication to summon appropriate response or assistance; and

(c) Use carriers that have established tracking systems that require an authorized signature prior to releasing the package for delivery or return.

c. Each licensee who makes arrangements for the shipment of Category 1 quantities of radioactive material shall immediately conduct an investigation upon discovery that a Category 1 shipment is lost or missing. Each licensee who makes arrangements for the shipment of Category 2 quantities of radioactive material shall immediately conduct an investigation, in coordination with the receiving licensee, of any shipment that has not arrived by the designated no-later-than arrival time.

6. Reporting of events.

a. The shipping licensee shall notify the appropriate LLEA and the agency within one hour of its determination that a shipment of Category 1 quantities of radioactive material is lost or missing. The appropriate LLEA would be the law-enforcement agency in the area of the shipment's last confirmed location. During the investigation required by this subsection, the shipping licensee will provide agreed upon updates to the agency on the status of the investigation.

b. The shipping licensee shall notify the agency within four hours of its determination that a shipment of Category 2 quantities of radioactive material is lost or missing. If, after 24 hours of its determination that the shipment is lost or missing, the radioactive material has not been located and secure, the licensee shall immediately notify the agency.

c. The shipping licensee shall notify the designated LLEA along the shipment route as soon as possible upon discovery of any actual or attempted theft of diversion of a shipment or suspicious activities related to the theft or diversion of a shipment of a Category 1 quantity of radioactive material. As soon as possible after notifying the LLEA, the licensee shall notify the agency upon discovery of any actual or attempted theft or diversion of a shipment, or any suspicious activity related to the shipment, of Category 1 radioactive material.

d. The shipping licensee shall notify the agency as soon as possible upon discovery of any actual or attempted theft or diversion of a shipment, or any suspicious activity related to the shipment, of a Category 2 quantity of radioactive material.

e. The shipping licensee shall notify the agency and the LLEA as soon as possible upon recovery of any lost or missing Category 1 quantities of radioactive material.

f. The shipping licensee shall notify the agency as soon as possible upon recovery of any lost or missing Category 2 quantities of radioactive material.

g. The initial telephonic notification required by subdivisions 6 a through 6 d of this subsection shall be followed within a period of 30 days by a written report submitted to the agency. The report shall include the following information:

(1) A description of the licensed material involved, including kind, quantity, and chemical and physical form;

(2) A description of the circumstances under which the loss or theft occurred;

(3) A statement of disposition, or probable disposition, of the licensed material involved;

(4) Actions that have been taken, or will be taken, to recover the material; and

(5) Procedures or measures that have been, or will be, adopted to ensure against a recurrence of the loss or theft of licensed material.

h. Subsequent to filing the written report, the licensee shall also report any additional substantive information on the loss or theft within 30 days after the licensee learns of such information.

E. Records.

1. Each record required by this section shall be legible throughout the retention period specified. The record may be the original or a reproduced copy or a microform, provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, and specifications shall include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.

2. Licensees shall maintain the records that are required by this section for the period specified. If a retention period is not otherwise specified, these records shall be retained until the agency terminates the facility's license. All records related to this section may be destroyed upon agency termination of the facility license.

VA.R. Doc. No. R16-4629; Filed January 21, 2016, 11:20 a.m.