Issue Date: 08/24/11 1 87131

NRC INSPECTION MANUAL MSSA/RMSB

INSPECTION PROCEDURE 87131

NUCLEAR MEDICINE PROGRAMS,

WRITTEN DIRECTIVE REQUIRED

PROGRAM APPLICABILITY: 2800

87131-01 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.

87131-02 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; 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 
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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.

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.
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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.

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, 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 the inspection, the inspector may encounter new 

emerging technologies being used that have not been specifically amended to a 

licensee’s license. If an inspector encounters such activity and uses, the inspector 

should contact NRC regional management as soon as practicable to independently 

verify that such use is authorized under NRC regulatory requirements. If further 

verification of such use is needed, the region should contact NMSS for further guidance.

87131-03 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 
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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 “big 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 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 MC 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 apprised of the inspection findings throughout 

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

senior management.
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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.

03.01 Security and Control of Licensed Material.

a. Adequate and Authorized Facilities. Descriptions of the facilities are generally 

found in the application for a license and subsequent amendments that are 

usually tied down to a license condition as submitted by the licensee in 

accordance with 10 CFR 35.13. 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.

1. Through discussion 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 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.

2. If appropriate, the inspector should verify that the licensee has established 

and implemented procedures to identify and report safety component 

defects in accordance with 10 CFR 21.

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 
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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 relatively small 

facility will generally need to maintain receipt records, disposal records, and 

records of any transfers of material. However, a large 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 

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, 
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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 

knowledgeable about patient release criteria and that a process exists to 

establish that a patient administered radiopharmaceuticals or therapeutic 

quantities of 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 for 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 
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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 breastfeeding 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 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 
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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.

k. Waste Storage and Disposal. 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 

radioactive waste is stored and controlled in a secure and safe manner, and that 

radiation levels in unrestricted areas surrounding the storage area do not 

exceed NRC regulatory limits. Through further discussions, observations, and 

reviews, if necessary, the inspector should verify that disposals of decay-instorage waste are performed in accordance with NRC regulatory requirements.

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 nonradioactive 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, 

“Solubility Criteria for Liquid Effluent Releases to Sanitary Sewerage Under the 

Revised 10 CFR Part 20.”

l. 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 
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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.

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).

In addition, from those discussions, observations and reviews, if necessary, the 

inspector should verify that effluent monitoring systems and the associated 

analytical equipment are adequate to detect and quantify effluents with sufficient 

sensitivity, and whether they are maintained, calibrated, and operated in 

accordance with the manufacturer's recommendations.

Furthermore, from those discussions, observations and reviews, if necessary, 

the inspector should verify that all significant release pathways are monitored, all 

unmonitored pathways have been characterized, and all surveillance procedures 

for effluents are being implemented by the licensee.

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. In an application for a license, a licensee must 

commit to develop, implement, and maintain procedures under 10 CFR 20.1101 and 10 

CFR 20.1301 for safe use of unsealed byproduct material. Through observations and 

interviews, the inspector should assess the actual implementation of ALARA procedures 

which include shielding of licensed material.

a. Syringe and Vial Shields. Determine a sufficient number, type, and condition of 

syringe and vial shields are being used to protect workers and members of the 

public from unnecessary radiation. Verify labeling of syringe and vial shields 

required by 10 CFR 35.69. 
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b. Shielding in the Hot Lab. Determine use of shielding for waste receptacles, 

storage containers, generator systems, and work areas to protect workers in the 

hot lab.

c. Shielding for Nuclear Medicine Therapy. Determine use of shielding for 

administration of therapeutic quantities of byproduct material to protect workers 

and family members of the patient who may be present. To limit doses to 

workers and individual members of the public, a licensee may use portable 

shielding in patient rooms or the licensee may have installed permanent 

shielding in certain patient rooms designated for patients that cannot be 

released under 10 CFR 35.75. In an application for a license, the applicant 

would have described the shielding along with calculations to estimate dose 

levels. For portable shields, an applicant would also commit to develop 

administrative procedures for proper use and placement of the shields within a 

patient room.

If shielding is not evident, then the inspector should assess the licensee’s procedure 

and further evaluation of radiation doses to workers and members of the public 

respectively under 10 CFR 20.1201, 20.1301, and 20.1302. The inspector should verify 

that the licensee instructed workers under 10 CFR 19.12 about shielding. The licensee 

may have determined that shielding was not indicated under certain conditions to 

protect the patient or human research subject from a non-radiological hazard which has 

significant health and safety consequences to the patient or human research subject. 

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 
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exposures received by workers are within NRC regulatory limits (e.g., 10 CFR 

20.1201, 1202, 1207, and 1208). If from those reviews and 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 and Surveys.

a. Equipment and Instrumentation.

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

discussions with cognizant licensee representatives, direct observations, 

and if necessary, a review of selected records, that equipment and 

instrumentation used to conduct licensed activities are appropriate to the 
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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:

(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;

(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 source-checked 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 
Issue Date: 08/24/11 14 87131

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 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 
Issue Date: 08/24/11 15 87131

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 authorized nuclear 

pharmacists instruction in the preparation of drugs.

b. Operating and Emergency Procedures. During the conduct of the inspection, 

the inspector should verify through direct observations of licensed activities, if 

practical, licensee personnel perform tasks at selected work stations to verify 

that such licensed activities are performed in accordance with the licensee’s 

operating procedures. Through discussions with cognizant licensee staff, the 

inspector should verify that for those individuals interviewed understand and 

implement procedures establish by the licensee and are aware of procedural 

revisions. If appropriate, the inspector should review the licensee's emergency 

procedures to determine that these procedures are adequate to ensure 

compliance to NRC regulatory requirements.

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. 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 licensee staff wears 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.
Issue Date: 08/24/11 16 87131

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.

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 and the RSO. 

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 
Issue Date: 08/24/11 17 87131

MC 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 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 lab personnel, 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 authority, without prior approval of that, when 

deficiencies are identified, the RSO has sufficient authority to implement 

corrective actions, including termination of operations that pose a threat to 

health and safety.

2. 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 
Issue Date: 08/24/11 18 87131

audits, and whether the lack of corrective actions caused the licensee to 

be in non-compliance with regulatory requirements.

d. Authorized Users. Authorized users (physicians, nuclear pharmacists, and 

medical physicists) are named on the license. 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.

e. Authorized Uses. The inspector should determine from observing the use of 

licensed material, discussing the activities with cognizant licensee personnel, 

and if necessary, from a review of selected records, that the type, quantity, and 

use of licensed material at the licensee's facility are as authorized by the 

license. From those observations, discussions, and reviews, if necessary, the 

inspector should verify that the total activity of licensed material does not exceed 

the maximum activity authorized either in the license or in the design 

specifications of the device’s sealed source device registration certificate.

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 
Issue Date: 08/24/11 19 87131

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 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.
Issue Date: 08/24/11 20 87131

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 Decommissioning Timeliness Rule became effective on August 15, 1994. If 

the license has expired or been revoked, or if the licensee has made a decision 

to permanently cease principal activities, and the licensee provided NRC 

notification before August 15, 1994, then August 15, 1994, is considered to be 

the date for initiating the decommissioning calendar (i.e., date of notification). If 

there has been a 24-month duration in which no principal activities have been 

conducted at the location before the effective date of the rule, but the licensee 

did not notify NRC, then the 24-month time period of inactivity is considered to 

be initiated on August 15, 1994, and the licensee must provide notification to 

NRC within either 30 or 60 days of August 15, 1996 (depending on whether the 

licensee requests a delay).

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.

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 MC 2602, "Decommissioning 

Inspection Program for Fuel Cycle Facilities and Materials Licensees"; IP 87104, 

"Decommissioning Inspection Procedure for Materials Licensees"; and 

NUREG/BR-0241. “NMSS 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, NMSS 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.
Issue Date: 08/24/11 21 87131

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, safetyrelated 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 followup 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 non-medical 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. 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 “Federal Policy for Protection of Human Subjects” (10 CFR 35.6), 

or the licensee is 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.

Potential Problems. Though contract personnel can provide significant support to a 

radiation safety program, potential problems may be associated with their use. Common 
Issue Date: 08/24/11 22 87131

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 in ways 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.

For further inspection guidance, refer to MC 2800.

87131-04 REFERENCES

IP 86740 – “Inspection of Transportation Activities”

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”

IMC 2800 – “Materials Inspection Program”

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

Material Licensees”

IP 87104 – “Decommissioning Inspection Procedure for Materials Licensees”
Issue Date: 08/24/11 23 87131

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

Licensees”

END
Issue Date: 08/24/11 Att 1-1 87131

Attachment 1 – Revision History for IP 87131

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. 

None N/A

N/A ML111610509

08/24/11

CN 11-014

Researched commitments for 4 

years and found none.

Revised to incorporate text 

regarding licensee responsibility 

for contract personnel.

None N/A ML111810193