Issue Date: 08/24/11 1 87134

NRC INSPECTION MANUAL MSSA/RMSB

INSPECTION PROCEDURE 87134

MEDICAL BROAD-SCOPE PROGRAMS

PROGRAM APPLICABILITY: 2800

87134-01 INSPECTION OBJECTIVES

01.01 To determine if licensed activities are being conducted in a manner that will protect 

the health and safety of workers, the general public and patients.

01.02 To determine if licensed activities are being conducted in accordance with 

U.S. Nuclear Regulatory Commission (NRC) requirements.

87134-02 INSPECTION REQUIREMENTS

The inspector should conduct the inspection in a manner that will allow him/her to develop 

conclusions about licensee performance relative to the following focus areas: 1) Security 

and control of licensed material; 2) Shielding of licensed material; 3) Comprehensive safety 

measures; 4) Radiation dosimetry program; 5) Radiation instrumentation and surveys; 6) 

Radiation safety training and practices; and 7) Management oversight; 8) Licensee review 

of licensed activities performed by contracted personnel; and 9) Other medical uses of 

byproduct material or radiation from byproduct material. Based on selected observations 

of licensed activities, discussions with licensee staff, and as appropriate, a review of 

selected records and procedures, the inspector should determine the adequacy of a 

licensee=s radiation safety program relative to each of the above focus areas. If the 

inspector concludes that licensee performance is satisfactory from a general review of 

selected aspects of the above focus areas, the inspection effort expended in reviewing that 

particular focus area will be complete. If the inspector determines that the licensee did not 

meet the performance expectation for a given focus area, the inspector should conduct a 

more thorough review of that aspect of the licensee=s program. The increased inspection 

effort may include additional sampling, determination of whether the licensee=s procedures 

are adequate, and a review of selected records maintained by the licensee documenting 

activities and outcomes. The above focus areas are structured as a performance 

expectation and address the activities or program areas most commonly associated with 

measures that prevent overexposures, medical events, or release, loss or unauthorized 

use of radioactive material.

The NRC Inspector shall not under any circumstances knowingly allow an unsafe work 

practice or a violation which could lead to an unsafe situation to continue in his/her 

presence in order to provide a basis for enforcement action. Unless an inspector needs to 

intervene to prevent an unsafe situation, direct observation of work activities should be 

conducted such that the inspector=s presence does not interfere with patient care or a 

patient=s privacy.
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Discussion of the inspector=s observations and interviews with the workers should not occur 

during the preparation for, or delivery of medical treatment, if possible. When practicable, 

the inspector should exercise discretion when interviewing licensee staff in the presence of 

patients so that the discussions do not interfere with licensee staff administering patient 

care. However, there may be cases when it is appropriate to discuss such matters at such 

times that would allow an inspector to ascertain the adequacy of the licensee=s 

administration of the radiation safety program.

In reviewing the licensee's performance, the inspector should cover the period from the last 

to current inspection. However, older issues preceding the last inspection should be 

reviewed, if warranted by circumstances, such as incidents, noncompliance, or high 

radiation exposures.

02.01 Security and Control of Licensed Material. The inspector should independently 

verify through direct observations of licensed activities, discussions with cognizant licensee 

representatives, and if necessary, a review of selected records, that the licensee=s 

performance has controlled access to and prevent loss of licensed material so as to limit 

radiation exposure to workers and members of the public to values below NRC regulatory 

limits.

02.02 Shielding of Licensed Material. The inspector should independently verify through 

direct observations of licensed activities, discussions with cognizant licensee 

representatives, and if necessary, a review of selected records, that the licensee=s 

performance has maintained shielding of licensed materials in a manner consistent with 

operating procedures and design and performance criteria for devices and equipment.

02.03 Comprehensive Safety Measures. The inspector should independently verify 

through direct observations of licensed activities, discussions with cognizant licensee 

representatives, and if necessary, a review of selected records, that the licensee=s 

performance has implemented comprehensive safety measures to limit other hazards from 

compromising the safe use and storage of licensed material.

02.04 Radiation Dosimetry Program. The inspector should independently verify through 

direct observations of licensed activities, discussions with cognizant licensee 

representatives, and a review of selected records, that the licensee=s performance has 

implemented a radiation dosimetry program to accurately measure and record radiation 

doses received by workers or members of the public as a result of licensed operations.

02.05 Radiation Instrumentation and Surveys. The inspector should independently verify 

through direct observations of licensed activities, discussions with cognizant licensee 

representatives, and if necessary, a review of selected records, that the licensee has 

implemented radiation instrumentation in sufficient number, condition, and location to 

accurately monitor radiation levels in areas where licensed material is used and stored.

02.06 Radiation Safety Training and Practices. The inspector should independently verify 

through direct observations of licensed activities, discussions with cognizant licensee 

representatives, and if necessary, a review of selected records, that the licensee=s 

performance has ensured that workers are knowledgeable of radiation uses and safety 

practices; skilled in radiation safety practices under normal and accident conditions; and 

empowered to implement the radiation safety program.
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02.07 Management Oversight. The inspector should independently verify through direct 

observations of licensed activities, discussions with cognizant licensee representatives, 

and if necessary, a review of selected records, that the licensee=s performance for 

implementing a management system is appropriate for the scope of use and is able to 

ensure awareness of the radiation protection program, ALARA practices are implemented 

when appropriate, and assessments of past performance, present conditions and future 

needs are performed and that appropriate action is taken when needed.

02.08 Licensee Review of Licensed Activities Performed By Contracted Personnel. The 

inspector should independently verify through direct observations of licensed activities, 

discussions with cognizant licensee representatives, and if necessary, a review of selected 

records, that the licensee examines licensed activities performed by contracted personnel.

02.09 Other Medical Uses of Byproduct Material or Radiation from Byproduct Material. 

Due to the advancements of medical research and development, new emerging medical 

technologies are always on the forefront of providing optimal medical care to patients. In 

accordance with NRC regulations, the licensee may use byproduct material or a radiation 

source approved for medical use which is not specifically addressed in subparts D through 

H of Part 35. During discussions with cognizant licensee representatives and direct 

observations made during the inspection, the inspector may encounter new emerging 

technologies being used. If an inspector encounters such activity and uses, the inspector 

should contact NRC regional management as soon as practicable. If further verification of 

such use is needed, the region should contact FSME for further guidance.

87134-03 INSPECTION GUIDANCE

General Guidance

A determination regarding safety and compliance with NRC requirements should be based 

on direct observation of work activities; interviews with licensee workers, demonstrations by 

appropriate workers performing tasks regulated by NRC, independent measurements of 

radiation conditions at the licensee=s facility, and where appropriate, a review of selected 

records. A direct examination of these licensed activities and discussions with cognizant 

workers should be a better indicator of the performance of a licensee's overall radiation 

safety program than a review of selected records alone.

Some of the requirement and guidance sections of this procedure instruct the inspector to 

"verify" the adequacy of certain aspects of the licensee's program. Whenever possible, 

verification should be accomplished through discussions, direct observations, and 

demonstrations by appropriate licensee personnel.

Once an inspector has conducted a review of the applicable elements of a focus area in a 

broad capacity (e.g., looked at the Abig picture@) and has not identified any safety 

significant concerns within that area, the inspector should conclude inspection of that focus 

area. The inspector should note that not all of the following elements outlined below in a 

particular focus area need to be reviewed by the inspector if he/she concludes from 

selected observations, discussions and reviews that the licensee=s performance is 

adequate for ensuring public health and safety.

However, if the inspector during a review of selected elements of one of the focus areas 

concludes that there may be a significant safety concern, a more detailed review may be 
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appropriate. A more detailed review may include further observations, demonstrations, 

discussions and a review of selected records. In the records reviewed the inspector should 

look for trends in those areas of concerns, such as increasing radiation levels from area 

radiation and removable contamination surveys, and occupational radiation doses. 

Records such as surveys, receipt and transfer of licensed materials, survey instrument 

calibrations and training may be selectively examined until the inspector is satisfied that for 

those areas of concerns, the records may or may not substantiate his/her concerns. If the 

inspector substantiates a significant safety concern regarding a particular matter, it may be 

more appropriate to discuss this matter with NRC regional management. During the 

inspection, some records that are more closely related to health and safety (e.g., personnel 

occupational radiation exposure records, medical events and incident reports) may be 

examined in detail since a review of such records is necessary to ascertain the adequacy 

of the implementation the radiation safety program for that particular element of a focus 

area.

If the inspector finds it appropriate when an apparent violation has been identified, the 

inspector should gather copies from the licensee, while onsite, of all records that are 

needed to support the apparent violation. In general, inspectors should use caution before 

retaining copies of licensee documents, unless they are needed to support apparent 

violations, expedite the inspection (e.g., licensee materials inventories), or make the 

licensing file more complete. In all cases where licensee documents are retained beyond 

the inspection, follow the requirements of IMC 0620. Especially ensure that the licensee 

understands that the retained record will become publicly available, and give the licensee 

the opportunity to request withholding the information pursuant to the requirements of 

10 CFR 2.790(b)(1).

The inspector should keep the licensee apprized of the inspection findings throughout the 

course of the onsite inspection and not wait until the exit meeting to inform licensee senior 

management.

Whenever possible the inspector should keep NRC regional management informed of 

significant findings (e.g., safety hazards, willful violations, and other potential escalated 

enforcement issues) identified during the course of the inspection. This will ensure that the 

inspector is following appropriate NRC guidance under such circumstances.

Specific Guidance.

03.01 Security and Control of Licensed Material.

a. Adequate and Authorized Facilities. Changes to the licensee=s facilities since the 

last onsite inspection should be discussed with licensee representatives since the 

licensee is allowed to make such changes to their facility without an amendment 

request in accordance with 10 CFR 35.15(c). Based on direct observations made 

during tours of the licensee=s facility, the inspector should independently verify that 

access to licensed material received, used, and stored is secured from 

unauthorized removal, and the licensee uses processes or other engineering 

controls to maintain exposures as low as is reasonably achievable (ALARA).

b. Adequate Equipment and Instrumentation. Through discussions with cognizant 

licensee representatives, direct observations of licensed activities, and if 

necessary, a review of selected records, the inspector should ensure that 

equipment and instrumentation used by the licensee is appropriate to the scope of 
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the licensed program. The inspector should independently verify through direct 

observations that survey instruments have been calibrated in accordance with 

10 CFR 35.61. The inspector should have cognizant licensee staff demonstrate 

how the instrument works and performs. The inspector should ask the individuals 

what actions are taken when radiation detection equipment is non-functional. 

During the inspection, the inspector should independently verify that for those 

survey and monitoring instruments available for use have current calibrations 

appropriate to the types and energies of radiation to be detected.

Licensee evaluation of equipment defects or failures to comply that are associated 

with significant safety hazards. The inspector should verify a licensee developed 

procedures under 10 CFR 21.21 to identify and report safety component defects 

and, when needed, the procedures were implemented and NRC is also aware of 

the report.

c. Receipt and Transfer of Licensed Materials. Through discussions with cognizant

licensee representatives, direct observations made during tours of the licensee=s 

facility, and if necessary, a review of selected records, the inspector should verify 

that the licensee has received and transferred licensed materials in accordance 

with NRC and applicable U.S. Department of Transportation (DOT) regulations and 

license conditions.

Through discussions with cognizant licensee representatives, direct observation of 

licensed activities, and if necessary, a review of selected records, the inspector 

should verify that the licensee has methods for picking up, receiving, and opening 

packages that address how and when packages will be picked up, radiation 

surveys and wipe tests of packages to be done on receipt, and procedures for 

opening packages (such as the location in the facility where packages are 

received, surveyed, and opened). From those discussions, observations and 

reviews, if necessary, the inspector should determine what actions are taken if 

surveys reveal that packages are contaminated in excess of specified limits, and/or 

radiation levels that are higher than expected. If packages arrive during the course 

of an inspection, the inspector should observe, when practical, personnel 

performing the package receipt surveys.

Through discussions with cognizant licensee representatives and if necessary, a 

review of selected records, the inspector should review the licensee=s materials 

accounting system. The inspector should note that sometimes, a small broadscope facility will generally need to maintain receipt records, disposal records, and 

records of any transfers of material. However, a large broad-scope facility may 

need a sophisticated accounting system which provides accurate information on 

the receipt of material, its location, the quantity used and disposed of, the amount 

transferred to other laboratories operating under the same license, and the amount 

remaining after decay. From those discussions and reviews, if necessary, the 

inspector should determine if accounting systems consider radioactive material 

held for decay-in-storage, near-term disposal, or transfer to other licensees. In 

both types of accounting systems, the inspector should ensure that the licensee 

has performed routine audits of those systems to ensure the accuracy of the 

system.

Through discussions with cognizant licensee representatives and if necessary, a 

review of selected records, the inspector should ascertain if the licensee has an 
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adequate method of determining that transfers of licensed material are made to 

recipients licensed to receive them (e.g., licensee obtains a copy of the recipient's 

current license before the transfer).

d. Transportation. Through discussions with cognizant licensee representatives, 

direct observations made during the conduct of the inspection, and if necessary, a 

review of selected transportation records, the inspector should verify that the 

licensee's hazardous material training, packages and associated documentation, 

vehicles (including placarding, cargo blocking, and bracing, etc.), and shipping 

papers are adequate and in accordance with NRC and DOT regulatory 

requirements for transportation of radioactive materials. Furthermore, from those 

discussions and reviews, if necessary, the inspector should verify if any incidents 

had occurred and that they were appropriately reported to DOT and NRC.

For further inspection guidance, the inspector should refer to IP 86740, "Inspection 

of Transportation Activities." Inspectors should also refer closely to "Hazard 

Communications for Class 7 (Radioactive) Materials," the NRC field reference 

charts on hazard communications for transportation of radioactive materials, which 

contain references to the new transportation requirements, and are useful field 

references for determining compliance with the transportation rules on labeling, 

placarding, shipping papers, and package markings.

e. Material Security and Control. Through direct observations made during tours of 

the licensee=s facility and discussions with cognizant licensee representatives, the 

inspector should verify that the licensee has maintained adequate security and 

control of licensed material. From those observations, the inspector should note 

areas where radioactive materials are used and stored. From further observations 

and discussions, the inspector should verify that licensed material in storage, in 

controlled or unrestricted areas, is secured from unauthorized removal or access. 

Also, the inspector should verify that the storage areas are locked and have limited 

and controlled access. For licensed material not in storage, in controlled or 

unrestricted areas, the inspector should verify that such material is controlled and 

under constant surveillance or physically secured. Controls may include a 

utilization log to indicate when, in what amount, and by whom, radioactive material 

is taken from and returned to storage areas. In addition, the inspector should verify 

that access to restricted areas is limited by the licensee.

f. Written Directives. During the onsite inspection, the inspector should observe and 

interview individuals as they perform applicable duties to determine that individuals 

are knowledgeable about the need for written directives and if the licensee=s written 

directives, as implemented, effectively ensure that radiation from byproduct 

material will be administered as directed by the authorized user in accordance with 

10 CFR 35.41. The review should include consideration of the licensee=s 

implementation of a continuous improvement in the following processes: 

monitoring, identification, evaluation, corrective action, and preventative measures. 

If necessary, the inspector should review selected records of written directives to 

confirm that these issues are adequately addressed in accordance with 

10 CFR 35.2040.

g. Patient Release. Through discussions with cognizant licensee representatives, 

direct observations made during the conduct of the inspection, and if necessary, a 

review of selected records, the inspector should determine if a licensee is 
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knowledgeable about patient release criteria and that a process exists to establish 

that a patient administered radiopharmaceuticals or permanent implants containing 

radioactive material is releasable from control in accordance with 10 CFR 35.75.

1. The inspector should note that the patient release criteria permit licensees to 

release individuals from control if the TEDE to any other individual is not 

likely to exceed 0.5 rem. Through discussions with cognizant licensee 

representatives and if necessary, a review of selected records, the inspector 

should verify that the licensee has taken adequate measures to ensure that 

patients have been released in accordance with 10 CFR 35.75.

2. Through further discussions the inspector should verify that the licensee is 

familiar with the requirements in 10 CFR 35.75(b) to provide instructions to 

released individuals if the dose to any other individual is likely to exceed 

0.1 rem. The inspector should note that, in general, the licensee is required 

to give instructions, including written instructions, on how to maintain doses 

to other individuals as low as is reasonably achievable. The inspector may 

determine how the licensee is demonstrating compliance with this 

requirement by discussing the content of the instructions with appropriate 

licensee staff. If concerns are identified from those discussions, the 

inspector may find it necessary to review the sample instructions given to 

patients. If the licensee is required by the rule to provide instructions to 

breast-feeding women, the inspector should verify through further 

discussions and reviews, if necessary, that the instructions include guidance 

on the interruption or discontinuation of breast-feeding and information on 

the potential consequences of failure to follow the guidance.

3. Through discussions with cognizant licensee representatives and if 

necessary, a review of selected records, the inspector should verify that if the 

TEDE to a breast-feeding child could exceed 0.5 rem if the breast-feeding 

were continued, the licensee has maintained documentation that instructions 

were provided in accordance with 10 CFR 35.75(d).

h. Medical Events. Through discussions with cognizant licensee representatives, the 

inspector should determine if the licensee is knowledgeable of and in compliance 

with the requirements for identification, notification, reports, and records for medical 

events as required by NRC regulatory requirements. If necessary, the inspector 

should conduct a review of selected records to independently verify those 

discussions with such individuals. If from those reviews a previously unidentified 

medical event is identified by the inspector, the inspector should: 1) remind the 

licensee of the need to comply with the reporting requirements described in 

10 CFR 35.3045, "Report and Notification of a Medical Event;" and 2) follow the 

procedure for reactive inspections and the guidance provided in Management 

Directive 8.10, "NRC Medical Event Assessment Program." Upon identification of 

such an event, the inspector should notify NRC regional management as soon as 

possible to ensure that appropriate guidance is given and matters are reviewed 

before completing the inspection.

i. Posting and Labeling. During tours of the licensee=s facilities, the inspector should 

determine by direct observations whether proper caution signs are being used at 

access points to areas containing radioactive materials and radiation areas. During 

the conduct of the inspection the inspector should observe labeling on packages or 
Issue Date: 08/24/11 8 87134

other containers to determine that proper information (e.g., isotope, quantity, and 

date of measurement) is recorded.

During tours of the licensee=s facilities, the inspector should verify that radiation 

areas have been conspicuously posted, as required by 10 CFR 20.1902. The 

inspector should determine that areas occupied by radiation workers for long 

periods of time and common-use areas have been controlled in accordance with 

licensee procedures and be consistent with the licensee's ALARA program.

During tours of the licensee=s facilities, the inspector should observe locations 

where notices to workers are posted. The inspector should verify that applicable 

documents, notices, or forms are posted in a sufficient number of places to permit 

individuals engaged in licensed activities to observe them on the way to or from 

any particular licensed activity location to which the postings would apply in 

accordance with 10 CFR 19.11, 20.1902, and 21.6.

j. Inventories. Through discussions with cognizant licensee representatives, direct 

observations made during tours of the licensee=s facility, and if necessary, a review 

of selected records, the inspector should verify that the licensee is conducting a 

semi-annual inventory of all sealed sources in accordance with 10 CFR 35.67(g). If 

appropriate, the inspector should independently verify through direct observations 

or a review of selected records of receipt and transfer to determine that the 

quantities and forms of licensed material possessed and used by the licensee are 

as authorized in the license.

NOTE: Item k. below only applies to those licensees authorized to possess sufficient 

quantities of source or special nuclear materials that the licensee is required to report the 

receipt, transfer or disposal of these materials to the Nuclear Materials Management and

Safeguards System (NMMSS). IMC 2800, Enclosure 7 contains specific guidance.

k. Through interviews with the RSO or other responsible licensee personnel, along 

with the review of relevant records, verify that the licensee has fulfilled the 

applicable reporting requirements relating to the NMMSS.

1. Discuss the location of all subject material possessed by the licensee. 

Compare the licensee=s most recent record of physical inventory performed 

with the information documented in the licensee=s NMMSS account on the 

DOE/NRC Form 742, AMaterial Balance Report.@

2. Review the licensee=s records documenting the receipt, transfer or disposal 

of NMMSS-reportable materials. Compare these records to the NMMSS TJ45 report. Verify that each set of records properly documents and accounts

for any receipt, transfer or disposal of NMMSS-reportable materials that may 

have occurred subsequently to the most recent filing of the DOE/NRC Form 

742 by the licensee.

3. Verify the information listed on the licensee=s inventory record by walking 

down the licensee=s facility and (if practicable) visually identifying, at a 

minimum, a representative sample of the materials that the licensee reports 

possession of to NMMSS. If appropriate, verify the presence of the subject 

material with a radiation survey instrument. 
Issue Date: 08/24/11 9 87134

NOTE: The inspector should not ask licensee personnel to open any

container or otherwise change the container’s shielding to facilitate this 

survey.

4. Review administrative information listed in the NMMSS-provided D-3 report 

with licensee personnel to ensure that the information is up to date. Verify 

that licensee personnel are cognizant of the need to make any required 

changes and the processes available for making any needed corrections.

l. Waste Storage and Disposal. The inspector should note that generally, 

radionuclides used in nuclear medicine facilities have half-lives of 120 days or less 

and can be decayed in storage until surveys are indistinguishable from 

background, then be disposed of as non-radioactive waste.

Through discussions with cognizant licensee representatives, direct observations 

made during tours of the licensee=s facility, and if necessary, a review of selected 

records, the inspector should verify the following areas, when appropriate:

1. Waste disposed in accordance with 10 CFR 35.92;

2. Waste compacted in accordance with license conditions;

3. Waste storage containers properly labeled and area properly posted in 

accordance with 10 CFR 20.1902 and 20.1904; and

4. Waste was returned from a landfill due to radioactive contamination.

For further inspection guidance, the inspector should refer to IP 84850, 

"Radioactive Waste Management-Inspection of Waste Generator Requirements of 

10 CFR Part 20 and 10 CFR Part 61"; and Information Notice (IN) 94-07, ASolubility 

Criteria for Liquid Effluent Releases to Sanitary Sewerage Under the Revised 

10 CFR Part 20.@

m. Effluents. Through discussions with cognizant licensee representatives and if 

necessary, a review of selected records, the inspector should verify that releases 

into a public sanitary sewerage system and septic tanks , if any, are consistent with 

the form and quantity restrictions of NRC regulatory requirements. If the inspector 

determines that a review of selected records is necessary, the inspector should pay 

particular attention to the licensee=s documentation for demonstrating that the 

material is readily soluble (or readily dispersible biological material) in water. If a 

review of selected records is necessary, the inspector should examine the waste 

release records generated since the last inspection, annual or semiannual reports, 

pertinent nonroutine event reports, and a random selection of liquid and airborne 

waste release records.

For liquid wastes, the inspector should determine through further discussions, 

observations and reviews, if necessary, if the licensee has identified all sources of 

liquid waste; evaluated treatment methods to minimize concentrations (such as the 

use of retention tanks); and complies with the regulatory requirements for disposal 

into sanitary sewerage.
Issue Date: 08/24/11 10 87134

Through further discussions, direct observations made during tours of the 

licensee=s facility, and reviews, if necessary, the inspector should verify that 

waste-handling equipment, monitoring equipment, and/or administrative controls 

are adequate to maintain radioactive effluents within NRC regulatory requirements 

and are ALARA (This should include xenon or other gas waste, also). For further 

inspection guidance, the inspector should refer to IP 87102, "Maintaining Effluents 

from Materials Facilities As Low As Is Reasonably Achievable (ALARA)."

03.02 Shielding of Licensed Material. Through observations and interviews, an inspector 

should determine that the licensee implemented appropriate shielding for various 

processes and types of use, especially for situations when large quantities are handled or 

when processes involve frequent handling of licensed materials.

a. Process, Engineering Controls, and Hot Cells. Processing equipment, ventilation, 

and exhaust systems should be sufficient to provide safe use, handling, and 

storage of the materials in use. The inspector should evaluate whether the licensee 

is following license commitments for process and storage systems and equipment, 

such as glove boxes, hot cells, remote-handling devices, shields and shielding 

devices, ventilation systems, and retention tanks. For hot cells, the inspector 

should evaluate the control of entry and egress of personnel, and removal of 

material and decontamination procedures. For glove boxes, the inspector should

evaluate procedures for routine maintenance (leak testing, filter loading, etc.), and 

removal of material and decontamination procedures. For temporary or portable 

shielding, the inspector should confirm that the licensee adequately controls 

movement of the shielding to prevent inadvertent or unauthorized removal.

The inspector should review the adequacy of shielding during maximum loading of 

hot cells and gloveboxes. Verify, by surveying the areas near manufacturing 

processes to ensure the continued adequacy of shielding. If the licensee initiates 

new processes in existing hot cells or gloveboxes, verify that the licensee has 

evaluated the adequacy of shielding before beginning the new process.

b. Shielding for Large Quantities of Bulk Material. Verify that the licensee maintains 

adequate shielding for large quantities of stock or bulk radioactive materials. Verify 

that such shielding cannot be easily removed or opened. Verify that the licensee 

maintains adequate lifting equipment for such shields and that the equipment 

includes adequate safeguards to prevent dropped loads. Ensure that licensee 

personnel are aware of lifting equipment load limitations and that the limitations are 

not exceeded.

c. Unit Shielding. Verify that the licensee maintains an adequate supply of shields for 

unit quantities of radioactive materials (i.e., vials, syringes, individual sources, etc.) 

and that licensee personnel use the shields when handling the containers. 

Unshielded containers of hard-beta- and gamma-emitting radionuclides should not 

be directly handled by personnel. Verify that unit shields are adequate for the 

quantities of radioactive materials typically contained therein.

d. Shielding of Transferred Materials. Verify that the shielding included in packaging 

of materials that are transferred within the confines of the licensee=s facility or to a 

carrier for transport/transfer to an off site location conforms to that described in the 

SSD registry or license documents, as appropriate. The licensee may not make 

changes to the size, shape, or contents (i.e., lead versus stainless steel) of the 
Issue Date: 08/24/11 11 87134

shielding materials without prior approval of the NRC or the Agreement State that 

approved the registry, as applicable. Observe SSD that are ready for shipment and

verify that the external radiation levels are consistent with the registry sheet/license 

document. Otherwise, determine that DOT requirements for shielding are met.

e. Shielding During Routine and Non-Routine Maintenance. By interviewing selected 

maintenance personnel, review the licensee=s maintenance practices for equipment 

and components that include shielding for radiological safety. Determine that 

maintenance personnel verify, either through their own or health physics staff 

surveys, that radiological conditions are within acceptable limits prior to the removal 

of shielding from equipment, entering rooms or areas (such as bunkers or hot cells) 

normally posted as high radiation or very high radiation areas, or entering tanks or 

vessels that normally contain or have contained radioactive materials. Verify that 

shielding removed for maintenance and opened access panels are properly 

replaced prior to lifting of maintenance holds when equipment is returned to 

service.

For maintenance activities that include potentially significant radiological conditions, 

such as high dose rates (>100 millirem per hour general area or > 1 rem per hour 

contact) or contamination levels (>100,000 disintegrations per minute per 100 

square centimeters), determine whether the licensee has established more 

stringent radiation work permit (RWP) requirements, such as more detailed pre-job 

briefing of personnel, appropriate protective clothing, and/or constant job coverage 

by a health physics technician. 

03.03 Comprehensive Safety Measures. During tours of the licensee=s facilities, the 

inspector should be aware of potential industrial safety hazards for referral to the 

U. S. Department of Labor's Occupational Safety and Health Administration.

During tours of the facility and discussions with cognizant licensee representatives, the 

inspector should verify that the licensee=s radioactive waste and licensed material are 

protected from fire and the elements, the integrity of packages containing licensed 

material is adequately maintained, areas used to store licensed material are properly 

ventilated, and adequate controls are in effect to minimize the risk from other hazardous 

materials.

03.04 Radiation Dosimetry Program. The inspector can find specific inspection guidance 

for this area in IP 83822, "Radiation Protection."

a. Radiation Protection Program. Through discussions with cognizant licensee 

representatives and if necessary, a review of selected records, the inspector should

verify that the licensee has developed, implemented and maintained an adequate 

radiation protection program commensurate with the licensee's activities, that the 

program includes ALARA provisions, and that the program is being reviewed by the 

licensee at least annually, both for content and implementation in accordance with 

10 CFR 20.1101.

b. Occupational Radiation Exposure. From a review of selected occupational 

radiation dosimetry reports and discussions with cognizant licensee 

representatives, the inspector should determine that occupational radiation 

exposures received by workers are within NRC regulatory limits 

(e.g., 10 CFR 20.1201, 1202, 1207, and 1208). If from those reviews and 
Issue Date: 08/24/11 12 87134

discussions the inspector determines that a worker had exceeded an NRC 

regulatory limit, the inspector should immediately contact NRC regional 

management to discuss the matter and determine what steps need to be taken in 

following up on this matter.

10 CFR 19.13(b) requires that each licensee shall advise each worker annually of 

the worker's dose, as shown in dose records maintained by the licensee. Through 

discussions with cognizant licensee staff and management, the inspector should 

verify that the licensee has advised workers of their doses annually. The licensee 

must advise all workers for whom monitoring is required. The licensee must advise 

these workers of doses from routine operations, and doses received during 

planned special exposures, accidents, and emergencies. If the inspector cannot 

conclude from those discussions that workers had been advised of their 

occupational dose annually, then a records review may be more appropriate to 

confirm that the licensee had conducted this required task. The report to the 

individual must be in writing and must contain all the information required in 

10 CFR 19.13(a).

c. Personnel Dosimeters. Through direct observations made during the onsite 

inspection, the inspector should independently verify that appropriate personal 

dosimetry devices are worn by appropriate licensee personnel. The inspector 

should verify that dosimetry devices appropriate to the type, energy of emitted 

radiation, and the anticipated radiation fields have been issued to facility personnel. 

In addition, the inspector should verify that dosimeters are processed by a 

National Voluntary Laboratory Accreditation Program approved and accredited 

processor.

Through discussions with cognizant licensee representatives and a review of 

selected records, the inspector should evaluate the adequacy of the licensee's 

methods used to assess the SDE to the portion of the skin of the extremity 

expected to have received the highest dose. The inspector should give particular 

attention to the distance between the location that is likely to have received the 

highest dose when sources are manipulated manually (even when shields are 

used) and where the extremity monitor is worn.

d. Internal Dosimetry. Through interviews with cognizant licensee representatives, 

and records review, if appropriate, verify that measurements for internal deposition 

of licensed materials are performed and evaluated in accordance with 

10 CFR 20.1501.

03.05 Radiation Instrumentation Surveys and Leak Tests.

a. Equipment and Instrumentation.

1. During the conduct of the inspection, the inspector should verify through 

discussions with cognizant licensee representatives, direct observations of 

licensed activities, and if necessary, a review of selected records, that 

equipment and instrumentation used to conduct licensed activities are 

appropriate to the scope of the licensed program, operable, calibrated, and 

adequately maintained in accordance with NRC regulatory requirements and 

the manufacturer=s recommendations. The inspector should verify that:
Issue Date: 08/24/11 13 87134

(a) The radiation survey instruments have been calibrated in accordance 

with10 CFR 35.61;

(b) The instruments used to measure the activity of unsealed byproduct 

material meet the requirements of 10 CFR 35.60; and

(c) Licensees that use molybdenum-99/technetium-99m generators 

measure and record the molybdenum-99 concentration after the first 

eluate, in accordance with 10 CFR 35.204, to ensure that humans are 

not administered a pharmaceutical containing more than 

0.15 microcuries of molybdenum-99 per millicurie of technetium-99m.

The inspector should independently verify through direct observations that 

survey instruments have been calibrated at the required frequency in 

accordance with 10 CFR 35.61. The inspector should have cognizant 

licensee staff demonstrate how the instrument works and performs. The 

inspector should ask the individuals what actions are taken when radiation 

detection equipment is non-functional. During the inspection, the inspector 

should independently verify that for those survey and monitoring instruments 

available for use have current calibrations appropriate to the types and 

energies of radiation to be detected. For those licensee=s that calibrate their 

own instruments, the inspector should have cognizant licensee staff perform 

or demonstrate how those activities are conducted in order to demonstrate 

the technical adequacy of the licensee=s calibration procedures.

2. When appropriate, the inspectors should confirm that the licensee is 

knowledgeable in identifying and reporting defects in accordance with Part 

21. This will vary dependent upon the scope of the licensee=s program.

b. Area Radiation Surveys. During tours of the licensee=s facility, the inspector should 

verify by direct observations and independent measurements, that area radiation 

levels are within NRC regulatory limits, and that those areas are properly posted. 

The inspector should have the licensee spot-check area radiation levels in selected 

areas using the licensee's own instrumentation. However, the inspector must use 

NRC radiation survey instruments for independent verification of the licensee's 

measurements. (The inspector's instruments shall be calibrated and sourcechecked before he/she leaves the NRC regional office.) The inspector should 

conduct such surveys as further discussed in Section 0312.

If practical and when appropriate, the inspector should observe licensee staff 

conduct area radiation and removable contamination surveys, to determine the 

adequacy of such surveys. The inspector should verify the types of instruments 

used, and whether they are designed and calibrated for the type of radiation being 

measured.

c. Leak Tests. During the conduct of the inspection, the inspector should verify that 

leak tests of sealed or contained sources are performed at the required frequency 

found in 10 CFR 35.67(b) or license conditions. Through discussions with 

cognizant licensee representatives, direct observations, and if necessary, a review 

of selected records, the inspector should verify that the leak test is analyzed in 

accordance with 10 CFR 35.67(c). If records of leak test results show removable 

contamination in excess of the regulatory requirements of 0.005 microcuries (185 
Issue Date: 08/24/11 14 87134

becquerels) or approved level included in a license condition, the inspector should 

verify that the licensee made the appropriate notifications per 10 CFR 35.67 (e) 

and removed the source from service.

03.06 Radiation Safety Training and Practices.

a. General Training. During the onsite inspection, the inspector should discuss with 

cognizant licensee staff how, and by whom, training is conducted and the content 

of the training provided to workers.

Through discussions with cognizant licensee representatives and if necessary, a 

review of selected records, the inspector should verify, pursuant to 10 CFR 19.12, 

that instructions have been given to individuals who in the course of employment 

are likely to receive in a year an occupational dose in excess of 1 milliSievert 

(100 mrem). The inspector should note that it is the licensee=s management=s 

responsibility to inform the workers of precautions to take when entering a 

restricted area, kinds and uses of radioactive materials in that area, exposure 

levels, and the types of protective equipment to be used. The workers should also 

be informed of the pertinent provisions of NRC regulations and the license, and the 

requirement to notify management of conditions observed that may, if not 

corrected, result in a violation of NRC requirements. Also, the inspector should 

verify that authorized users and workers understand the mechanism for raising 

safety concerns.

Of the training program elements, training given to authorized users and nuclear 

pharmacists, and those individuals under the supervision of authorized users and 

nuclear pharmacists, is of primary importance. The inspector should interview one 

or more users of radioactive materials to independently verify that they have 

received the required training. The inspector should note that the training should 

be (and in most cases is required to be) provided to workers before the individual's 

performance of licensed activities.

If necessary, the inspector may need to review selected records of personnel 

training to the extent that the inspector is satisfied that the training program is being 

implemented as required.

During the inspection, the inspector should observe related activities and discuss 

the radiation safety training received by selected individuals to ensure that 

appropriate training was actually received by these individuals. From those 

observations and discussions, the inspector should verify that authorized users, 

authorized nuclear pharmacists and supervised individuals understand the 

radiation protection requirements associated with their assigned activities. The 

licensee's radiation safety training may include, but is not limited to, demonstrations 

by cognizant facility personnel, formal lectures, testing, films, "dry runs" for more 

complex or hazardous operations, and for authorized nuclear pharmacists’

instruction in the preparation of radioactive drugs.

b. Operating and Emergency Procedures. Through discussions with cognizant 

licensee representatives, direct observations of licensed activities, and if 

necessary, a review of selected records, the inspector should verify that licensee 

staff are knowledgeable in conducting licensed activities in accordance with the 

licensee=s operating procedures.
Issue Date: 08/24/11 15 87134

Discuss with cognizant licensee representatives, or if practicable, observe licensee 

personnel conduct periodic tests, especially for scenarios involving events that 

would require reporting to the NRC under 10 CFR 20.2202.

Some licensees may have agreements with other agencies (e.g., fire, law 

enforcement, and medical organizations) regarding response to emergencies. The 

inspector should discuss with cognizant licensee representatives what has been 

done to ensure that agencies (involved in such agreements) understand their roles 

in emergency responses.

c. Safety Instruction for Personnel Caring for Non-Releasable Patients. Through 

discussions with cognizant licensee representatives and if necessary, a review of 

selected records, the inspector should verify that the licensee provides radiation 

safety instruction for all personnel caring for patients who cannot be released under 

10 CFR 35.75, in accordance with10 CFR 35.310. The inspector should note that 

radiation safety instruction must be conducted initially and at least annually and be 

commensurate with the duties of the personnel.

d. Specialized Training. The inspector should note that specialized instruction 

required in 10 CFR 35.27 was provided to supervised users using material for 

medical uses or preparing byproduct material for medical use. The inspector 

should note that authorized users and research laboratory personnel should 

receive periodic radiation safety training commensurate with their use of licensed 

materials. For example, these individuals should know how and when to use

radiation survey instrumentation, fume hoods, and protective gear. They should 

know procedures concerning waste disposal, bioassays, surveys, inventories, etc. 

Also, if the licensee uses licensed material for therapeutic purposes, training 

specific to the types of therapy performed should be provided to the nursing staff 

and others caring for these patients. This training should include personnel who do 

not directly deal with patients, such as housekeeping, maintenance, security, etc. 

The training should also include such topics as contamination control, ALARA, 

emergency procedures, and sealed source identification. The inspector should 

determine that personnel are appropriately trained through interviews, 

demonstration, and direct observation of licensed activities.

e. Protective Clothing. Through direct observations of licensed activities and 

discussions with cognizant licensee representatives, the inspector should verify 

that radiation workers are provided with, and wear, the appropriate protective 

clothing commensurate with activities being performed. The observation of the 

protective clothing that research lab personnel or other applicable staffs wear 

during their work activities should provide the inspector with an acceptable means 

of reviewing this requirement. If the inspector identifies a concern with this 

practice, the inspector should discuss this practice with appropriate licensee 

representatives to ensure that licensee staff are following licensee procedures for 

wearing adequate protective clothing.

03.07 Management Oversight. The inspector should interview cognizant licensee 

representatives to gain information concerning organization, scope, and management 

oversight of the radiation safety program.
Issue Date: 08/24/11 16 87134

a. Organization. During the conduct of the inspection, the inspector should interview 

cognizant licensee representatives to discuss the current organization of the 

licensee=s program. The licensee's organizational structure will usually be found in 

the license application and may involve one or more individuals. The inspector 

should review with cognizant licensee representatives the licensee's organization 

with respect to changes that have occurred in personnel, functions, responsibilities, 

and authorities since the previous inspection. Through discussions with cognizant 

licensee representatives, the inspector should determine the reporting structure 

between executive management, the RSO, and the Chairperson of the RSC, and 

other members of the RSC. Through discussions with cognizant licensee staff, the 

inspector should determine whether the RSO has sufficient access to licensee 

management. Through further discussions with cognizant licensee 

representatives, the inspector should determine if changes in ownership or staffing 

have occurred. If the owner or individuals named in the license have changed, the 

inspector should determine whether the licensee has submitted appropriate 

notification to NRC. This information must be provided whenever changes in 

ownership or personnel named in the license are made. Through discussions with 

cognizant licensee management the inspector should determine if changes have 

occurred, or are anticipated, and ask personnel to confirm (to the inspector's 

satisfaction) that no changes have taken place. If there have been no changes in 

the organization since the previous inspection, there is no need to pursue this 

element in further detail. If there have been changes in ownership, the inspector 

should discuss this matter with appropriate licensee representatives and NRC 

regional staff (e.g., license reviewers) to ensure that proper actions will be taken in 

response to the changes in ownership.

Through discussions with cognizant licensee representatives, the inspector should 

review any organizational change in the RSO position, authorities, responsibilities, 

and reporting chains. The inspector should be sensitive to changes that reduce the 

ability of the RSO to resolve concerns or issues related to the safe conduct of the 

radiation protection program. The inspector should discuss with cognizant licensee 

management representatives and the RSO about the RSO's authority and about 

any changes that may impact upon the RSO's duties, responsibilities, or 

effectiveness.

b. Scope of Program. Through discussions with cognizant licensee staff and direct 

observations of licensed activities, the inspector can obtain useful information 

about the types and quantities of material, frequency of use, incidents, etc. From 

those discussions and direct observations made during tours of the licensee=s 

facilities, the inspector will be able to discern the actual size and scope of the 

licensee's program, and to determine if significant changes have occurred since the 

previous inspection. Through further discussions inspector should determine if 

multiple places of use are listed on the license. In cases where there are multiple 

sites/satellite facilities, the inspector should determine if inspections should be 

performed at all sites. This decision should be based on IMC 2800, "Materials 

Inspection Program," and regional policy for performing inspections at satellite 

facilities. From those observations and discussions, the inspector should verify 

that the locations of use are as authorized in the license. If the inspector 

determines that there are locations of use not authorized under the license, the 

inspector should discuss this matter with appropriate licensee representatives to 
Issue Date: 08/24/11 17 87134

ensure that the license is amended to allow the unauthorized location of use in 

accordance with 10 CFR 35.13 and/or 35.14. Furthermore, the inspector should 

determine if licensed activities conducted at such locations were conducted in 

accordance with NRC regulatory requirements and the licensee=s license.

In reviewing the scope of the licensee=s program in this area, the inspector should 

discuss information that includes the numbers of laboratories, permit holders, lab 

personnel, and locations of use; human research and medical use activities; mobile 

nuclear medicine services; distribution of pharmaceuticals under 10 CFR Part 35 

license; and principal types and quantities of licensed materials used.

c. Radiation Program Administration. In the course of interviewing cognizant licensee 

personnel, the inspector should determine if management oversight is sufficient to 

provide the licensee=s staff with adequate resources and authority to administer the 

licensed program. In the review to verify implementation of the radiation safety 

program, the inspector should pay particular attention to the scope of the program, 

frequency of licensee audits, and the use of qualified auditors. If necessary, the 

inspector should review selected procedures for recording and reporting 

deficiencies to management; and methods and completion of follow-up actions by 

management.

1. RSO. The RSO is the individual, appointed by licensee management and 

identified on the license, who is responsible for implementing the radiation 

safety program. The inspector should independently verify through 

discussion and direct observations of licensed activities that this individual is 

knowledgeable about the program, and ensures that activities are being 

performed in accordance with approved procedures and the regulations. 

The inspector should verify that, when deficiencies are identified, the RSO 

has sufficient authority, without prior approval of the RSC, if applicable, to 

implement corrective actions, including termination of operations that pose a 

threat to health and safety.

2. RSC. Through discussions with cognizant licensee representatives, direct 

observations of licensed activities, and if necessary, a review of selected 

records, the inspector should note if the licensee is required to maintain an 

RSC in accordance with 10 CFR 35.24(f). If applicable, through discussions 

with cognizant Radiation Safety Committee (RSC) representatives, the 

inspector should independently verify that topics of discussion during RSC 

meetings included ALARA reviews, incidents, generic communications, 

authorized users and uses, safety evaluations, audits, and medical events, 

as defined in 10 CFR 35.2, etc. From those discussions, the inspector 

should verify that the committee is made up of representatives from each 

type of program area, the RSO, a representative of the nursing service, and 

a representative from management. If time permits, the inspector should 

review meeting minutes (and interview selected committee members when 

practical) to determine the committee's effectiveness.

From those discussions, the inspector should determine if the RSC has been 

aggressive in seeking out areas needing improvement, rather than just 

responding to events and information from outside sources. The inspector 
Issue Date: 08/24/11 18 87134

should also determine whether the RSC has recommended any specific 

actions and assess the implementation of those recommendations. The 

inspector's review should be of sufficient depth and detail to provide an 

overall assessment of the committee's ability to identify, assess, and resolve 

issues. Also, the inspector should determine the effectiveness of the RSC to 

communicate the results of audits and trending analyses to appropriate 

personnel performing licensed activities.

Broad-scope medical programs may be authorized to conduct research 

involving the use of radioactive drugs or radiation-emitting devices in 

humans. Such research may require U.S. Food and Drug Administration 

(FDA) approval. In addition, approval to conduct research studies also 

requires input from an IRB, an RDRC, or other appropriate committee(s), 

including the RSC. The inspector should confirm that the licensee has 

received FDA approval, if required, and that studies involving the use of 

radioactivity in humans have been reviewed by the appropriate committee(s). 

The inspector should review the interaction between the RSC and the IRB 

and/or RDRC to assure compliance with the requirements in 10 CFR 35.6 as 

further discussed below in Section 3.10.K.

3. Audits. The frequency and scope of audits of the licensed program will vary. 

However, the inspector should note that at a minimum, medical licensees are 

required by 10 CFR 20.1101(c) to review the radiation safety program 

content and implementation at least annually. The results of audits should 

be documented. If time permits, the inspector should examine these records 

with particular attention to deficiencies identified by the auditors, and note 

any corrective actions taken as a result of deficiencies found. If no corrective 

actions were taken, the inspector through discussions with cognizant 

licensee representatives should determine why the licensee disregarded 

deficiencies identified during audits, and whether the lack of corrective 

actions caused the licensee to be in non-compliance with regulatory 

requirements.

d. Authorized Individuals. Authorized individuals (physicians, nuclear pharmacists, 

and medical physicists) are appointed by the licensee. The inspector should 

independently verify that the authorized individual meets the training and 

experience criteria in Part 35, are trained in accordance with the approved criteria, 

and have knowledge commensurate with operational duties.

The inspector should noted that the regulations in 10 CFR 35.11(b) allow an 

individual to receive, possess, use, or transfer byproduct material for medical use 

"under the supervision of" the authorized user, unless prohibited by license 

condition. Also, these regulations do not specifically require that the authorized 

user be present at all times during the use of such materials. The authorized 

user/supervisor is responsible for assuring that personnel under his/her supervision 

have been properly trained and instructed, pursuant to 10 CFR 35.27(a), and is 

responsible for the supervision of operations involving the use of radioactive 

materials whether he/she is present or absent.
Issue Date: 08/24/11 19 87134

Authorized users of licensed material for non-human use are generally designated 

by the RSC. The inspector should review the process of approving users through 

interviews with users, RSC members, and the RSO. The procedure for designating 

users can be found in the license documents. Verify that the authorized user 

received training in accordance with approved criteria and/or Part 35, and has 

knowledge commensurate with operational duties.

e. Authorized Uses. Through discussions with cognizant licensee staff and direct 

observations made during tours of the licensee=s facilities, the inspector should 

independently verify that the licensee's use of byproduct material (e.g., cell 

labeling, iodinations, animal research) is limited to that which is authorized in the 

license.

f. Financial Assurance and Decommissioning. The decommissioning recordkeeping 

requirements are applicable to all materials licensees, including licensees with only 

sealed sources, and are specified in 10 CFR 30.35(g). These records should 

contain, among other information: 1) records of unusual occurrences involving the 

spread of contamination in and around the facility, equipment, or site; 2) as-built 

drawings and modifications of structures and equipment in restricted areas where 

radioactive materials are used and/or stored, and locations of possible inaccessible 

contamination; and 3) records of the cost estimate performed for a 

decommissioning funding plan or the amount certified for decommissioning. This 

list is not all-inclusive of the information and requirements given in 

10 CFR 30.35(g). The inspector should ensure that the licensee has such 

decommissioning records, that the records are complete, that they are updated as 

required, and that the decommissioning records are assembled or referenced in an 

identified location.

Some licensees may release rooms within a building for unrestricted use, without a 

license amendment. The release of these areas may fall outside of the reporting 

requirements in the Decommissioning Timeliness Rule if the licensee continues to 

conduct other activities in the same building. During the onsite inspection, the 

inspector should identify the rooms that have been released since the last 

inspection and perform random confirmatory measurements for selected rooms 

(e.g., randomly sample selected areas, not survey 100%); to verify that radiation 

and contamination levels are below release limits. Licensee survey records and 

other documentation should be reviewed to verify that the basis for releasing each 

room is adequately documented in the licensee's decommissioning records. If 

during the confirmatory survey, the inspector identifies levels above release limits, 

the inspector should inform appropriate licensee representatives as soon as 

practicable to review the matter, determine what appropriate actions need to be 

taken to address the matter, determine if members of the public have been 

received radiation exposures that exceeded NRC regulatory limits, and assess 

those possible exposures. If the inspector determines that a member of the public 

may have received radiation exposures that exceeded NRC regulatory limits, the 

inspector should immediately contact NRC regional management for further 

guidance.

Licensees submit financial assurance instruments and/or decommissioning plans 

for a specific set of conditions. Occasionally, those conditions may change over 
Issue Date: 08/24/11 20 87134

time and the licensee may not notify NRC. The inspector should be aware of 

changes, in radiological conditions, while inspecting a licensee's facility, that would 

necessitate a change in the financial assurance instrument and/or 

decommissioning plan, especially where the radiological conditions deteriorate and 

the financial assurance instrument or decommissioning plan may no longer be 

sufficient. In preparation for the inspection, the inspector should determine the

dates that the financial assurance instrument and decommissioning plan (if 

applicable) were submitted to NRC. During the inspection, through observations 

made during tours of the facilities, discussions with cognizant licensee personnel, 

and a review of selected records, the inspector should determine whether the 

radiological conditions at the licensee's facility have changed since the documents 

were submitted to NRC. If conditions have changed and the adequacy of the 

financial assurance instrument and/or decommissioning plan is in doubt, the 

inspector should contact regional management as soon as practicable from the 

licensee's site to discuss the situation.

Additionally, some licensees are required to maintain decommissioning cost 

estimates and funding methods on file. If the licensee uses a parent company 

guarantee or a self-guarantee as a funding method, the inspector should verify that 

the licensee has a Certified Public Accountant certify each year that the licensee 

passes a financial test. The financial test ratios for parent company guarantees 

and self-guarantees are specified in Section II, Appendix A and Appendix C, 

respectively, to Part 30.

g. Decommissioning Timeliness. Through discussions with cognizant licensee 

representatives and direct observations, the inspector should determine whether 

the license to conduct a principal activity has expired or been revoked. If the 

license remains in effect, the inspector should determine if the licensee has made 

a decision to cease principal activities at the site or in any separate building. 

Finally, the inspector should determine if there has been a 24-month duration in 

which no principal activities have been conducted in such areas. A principal 

activity is one which is essential to the purpose for which a license was issued or 

amended, and does not include storage incidental to decontamination or 

decommissioning. If the licensee meets any of the above conditions, the 

decommissioning timeliness requirements apply.

The inspector should note that the requirements of 10 CFR 30.36, 40.42 and 70.38 

do not apply to released rooms within a building where principal activities are still 

on-going in other parts of the same building. Once principal activities have ceased 

in the entire building, then the decommissioning timeliness requirements will take 

effect.

The inspector should note that the NRC has a stringent enforcement policy with 

respect to violations of the decommissioning timeliness requirements. Failure to 

comply with the Decommissioning Timeliness Rule (failure to notify NRC, failure to 

meet decommissioning standards, failure to complete decommissioning activities in 

accordance with regulation or license condition, or failure to meet required 

decommissioning schedules without adequate justification) may be classified as a 

Severity Level III violation and may result in consideration of monetary civil 

penalties or other enforcement actions, as appropriate.
Issue Date: 08/24/11 21 87134

Decommissioning timeliness issues can be complex. For situations where an 

inspector has questions about the licensee's status and whether the 

decommissioning timeliness standards apply, he/she should contact NRC regional 

management as soon as practicable for further guidance.

For planning and conducting inspections of licensees undergoing 

decommissioning, the inspector should refer to IMC 2602, "Decommissioning 

Oversight and Inspection Program for Fuel Cycle Facilities and Materials 

Licensees;" IP 87104, "Decommissioning Inspection Procedure for Materials 

Licensees;"; and NUREG/BR-0241, ANMSS Handbook for Decommissioning Fuel 

Cycle and Materials Licensees.@

h. Generic Communications of Information. Through discussions with cognizant 

licensee management and the RSO as well as through direct observations made 

during tours of the licensee=s facility, the inspector should verify that the licensee is 

receiving the applicable bulletins, information notices, FSME Newsletter, etc., and 

that the information contained in these documents is disseminated to appropriate 

staff personnel. The inspector should also verify that the licensee has taken 

appropriate action in response to these NRC communications, when a response is 

required.

i. Notifications and Reports. Through discussions with cognizant licensee 

representatives and if necessary, a review of selected records, the inspector should

determine the licensee's compliance for notifications and reports to the 

Commission. The licensee may be required to make notifications following loss or 

theft of material, overexposures, incidents, high radiation levels, safety-related 

equipment failure, medical events, dose to an embryo/fetus or a nursing child, etc.

From those discussions and reviews, the inspector should verify that notifications 

and/or reports were appropriately submitted to NRC and individuals, if applicable. 

If the inspector determines that the licensee failed to submit such notifications 

and/or reports, the inspector should bring this matter to the attention of appropriate 

licensee representatives as soon as practicable for follow up and compliance to the

appropriate NRC regulatory requirements.

j. Special License Conditions. Some licenses will contain special license conditions 

that are unique to a particular practice or procedure, such as the use of equipment 

for nonmedical purposes. In these instances, through discussions with cognizant 

licensee representatives, the inspector should verify that the licensee understands 

the additional requirements, and maintains compliance with the special license 

conditions. The inspector should also note that some special license conditions 

may state an exemption to a particular NRC requirement.

k. Research Involving Human Subjects. The inspector should verify through 

discussions with cognizant licensee representatives if research is conducted 

involving human research subjects. If applicable, the inspector must verify that this 

type of research satisfy the following conditions: 1) All research is conducted, 

supported, or regulated by another Federal Agency that has implemented AFederal 

Policy for Protection of Human Subjects@ (10 CFR 35.6), or the licensee is 
Issue Date: 08/24/11 22 87134

authorized to conduct such research; 2) the licensee obtains informed consent 

from the subjects, as defined and described in the Federal Policy; and 3) the 

licensee obtains prior review and approval from an Institutional Review Board, as 

defined and described in the Federal Policy.

03.08 Licensee Review of Licensed Activities Performed by Contracted Personnel.

Licensees may contract personnel to perform licensed activities. The licensee is 

responsible for any violations of NRC regulatory requirements that result from activities 

conducted by contract personnel operating under the license. The inspector should 

independently verify through direct observations of licensed activities, discussions with 

cognizant licensee representatives, and as necessary, a review of selected records, that 

the licensee is reviewing work completed by contracted personnel who perform licensed 

activities in the same manner that all other licensed activities are reviewed. The inspector 

should verify that all parties to contractual arrangements are aware of their respective 

duties and responsibilities, as well as the reporting and feedback mechanisms 

implemented to ensure that appropriate actions are taken to address the contractor’s 

findings, particularly, potential regulatory violations.

a. Potential Problems. Though contract personnel can provide significant 

support to a radiation safety program, potential problems may be associated 

with their use. Common problems include: 1) Failure of the contract 

personnel to complete all required tasks in the specified manner or time 

frame; 2) Licensee assumes that all work was completed and fails to review 

the work of the contract personnel; 3) Licensee fails to correct problems 

identified by the contract personnel; 4) Failure of licensee to review work 

performed by contract personnel who work outside of normal working hours; 

5) Hiring contract personnel who are not qualified or experienced; 6) Contract 

personnel are not able to dedicate time to fulfill the contract agreement.

03.09 Other Medical Uses of Byproduct Material or Radiation from Byproduct Material. 

Due to the advancements of medical research and development, a variety of new medical 

uses of byproduct material or radiation from byproduct material are always on the forefront 

of providing optimal medical care to patients. Due to the increase in these various new 

medical uses of byproduct material or radiation from byproduct material, the regulations 

were revised to allow licensees the ability to use such uses in order to provide optimal 

patient care. In accordance with the regulations in 10 CFR 35.1000, the licensee may use 

byproduct material or a radiation source approved for medical use which is not specifically 

addressed in subparts D through H of this part if the licensee has submitted the information 

required by 10 CFR 35.12(b) through (d); and the licensee has received written approval 

from the NRC in a license or license amendment and uses the material in accordance with 

the regulations and specific conditions the NRC considers necessary for the medical use of 

the material. During discussions with cognizant licensee representatives and direct 

observations made during inspections, the inspector may encounter various new medical 

uses of byproduct material or radiation from byproduct material being used that have not 

been specifically amended to a licensee=s license. If an inspector encounters such a use, 

the inspector should contact regional management as soon as practicable to independently 

verify that such use is authorized under the regulations. If further verification of such use is 

needed, the region should contact FSME for further guidance.
Issue Date: 08/24/11 23 87134

For further inspection guidance, refer to IMC 2800.

87134-04 REFERENCES

IMC 0620 -- “Inspection Documents and Records”

IP 86740 – “Inspection of Transportation Activities”

MD 8.10 -- “NRC Medical Event Assessment Program”

IP 84850 – “Radioactive Waste Management – Inspection of Waste Generators

Requirements of 10 CFR Part 20 and 10 CFR Part 61”

IN-1994-07 – “Solubility Criteria for Liquid Effluent Releases to Sanitary Sewage Under 

The Revised 10 CFR Part 20”

IP 87102 – “Maintaining Effluents from Materials Facilities As Low As Reasonable 

Achievable”

IP 83822 – “Radiation Protection”

IMC 2602 – “Decommissioning Inspection Program for Fuel Cycle Facilities And

Materials Licensees”

NUREG/BR-0241 – “NMSS Handbook For Decommissioning Fuel Cycle and Materials

Licensees”

IMC 2800 – “Materials Inspection Program”

END
Issue Date: 08/24/11 Att. 1-1 87134

Attachment 1 – Revision History for IP 87134

Commitment 

Tracking 

Number

Issue Date Description of Change Training 

Needed

Training 

Completion 

Date

Comment 

Resolution 

Accession Number

N/A 10/24/2002 New IP that incorporates 

the revised 10 CFR Part 

35. Replaces IP 87119.

N/A

N/A 09/28/2005 Revised to refer to new 

IMC 2800.

None N/A

N/A ML111610518

08/24/11

CN 11-014

Researched commitments 

for 4 years and found 

none.

Revised to incorporate text 

regarding licensee 

responsibility for contract 

person

None N/A ML112130656