Text

Requests That Recipient Issue Encl IP 87117 for Use by Regions.Summary of Comments & Resolutions Encl
	ML20217K961
Person / Time
Issue date:	04/28/1998
From:	Cool D; NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Gillespie F; NRC (Affiliation Not Assigned)
References
	IP-87117, NUDOCS 9805040224
	Download: ML20217K961 (50)
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Ap ril 28, 1998 MEMORANDUM TO: Frank P. Gillespie, Director Division of Inspection and Support Programs, NRR 1 I

FROM: Donald A. Cool, Director a d9M~300 D7 Division of Industrial and ~

Medical Nuclear Safety, NMSS l

SUBJECT:

REQUEST TO ISSUE INSPECTION PROCEDURE l 87117, RADIOPHARMACY PROGRAMS l

We request that you issue the attached Inspection Procedure (IP) 87117 for use by the regions. It was distributed to the regions in draft form for review and comment. A summary of comments and resolutions is also attached.

i This is another in a series of inspection procedures that will result from revision of the inspection procedures in IP 87100 to eliminale the checklist approach and substitute a performance based approach using an " Inspection Record" and " Inspection References." This document, when issued, will replace the existing guidance in IP 87100 for inspection of radiopharmacy programs. :

Attachments: As stated.

cc: R. Blough, RI 16AGc.cir, IMtJSj M58 D. Collins, Rll S Msgcse7,jfqfg ggg C. Pederson, Rlll R. Scarano, RIV R. Bangart, OSP .

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l MEMORANDUM TO: Frank P. Gillespie, Director l Division of Inspection and Support Programs, NRR

FROM: Donald A. Cool, Director ,f, /

l Division of Industrial and Medical Nuclear Safety, NMSS

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SUBJECT:

REQUEST TO ISSUE INSPECTION PROCEDURE 87117, RADIOPHARMACY PROGRAMS We request that you issue the attached Inspection Procedure (IP) 87117 for use by the j regions. It was distributed to the regions in draft form for review and comment. A summary of comments and resolutions is also attached.

l This is another in a series of inspection procedures that will result from revision of the l inspection procedures in IP 87100 to eliminate the checklist approach and substitute a l performance based approach using an " Inspection Record" and " Inspection References." This document, when issued, will replace the existing guidance in IP 87100 for inspection of radiopharmacy programs.

Attachments: As stated.

cc: R. Blough, RI D. Collins, Ril C. Pederson, Rill R. Scarano, RIV R. Bangart, OSP l

l CONTACT: Ronald E. Zelac, NMSS/IMNS l (301)415-6316 l

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DOCUMENT ISSUING FORM j To: NRR. DISP. Director j From: Donald A. Cool. Director. Division of industrial and Medical Nuclear Safety. NMSS (Originating Director)

1. Number and title of document 87117. Radiocharmacv Proarams

2. Type of document 3. Type of action

_ Manual Chapter (MC) linspection Procedure (IP) 1New document (number)

_. Appendix _ Temporary Instruction (TI) _1 Revision (of IP 87100)

_ Technical Guidance _10 CFR Guidance _ Deletion I

4.a. If a new IP is being prepared, state its need or purpose, whether it is for the " Core" Inspection Program, the SALP category it applies to, the direct inspection hours needed to i perform it, and the inspection frequency. !

b. If a Tl or IP is being revised, state the reason for the revision, and if applicable,the resulting change in direct inspection hours or FTE, if any.

Core Program: 1.Yes_No SALP Category: N/A DIE: N/A Inspection Frequency: N/A j l

Statement: This orocedure is to be used in olace of IP 87100 for the insoection of radiocharmacv licensee oroarams. It reflects a oerformance based insoection aooroach.

Comoared to IP 87100. it chances the format. eliminates the field notes. adds an insoection ;

record section. and adds a references section.

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c. For any proposed addition in direct inspection hours that results from a or b above, state the increase in proposed hours and identify where the proposed corresponding reduction in direct inspection hours is to occur (Note: the total " Core" hours is a fixed number and cannot be increased without permission from the NRR Office Director).

DIE increase resulting from 4a or 4b: N/A Proposed reduction, IP No.:N/A Details of reduction: Ne l d. If new training requirements or the revision of current training requirements are needed as

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the result of the new IP, Tl or revision of existing procedures, these should be identified.

The group responsible for establishing and presenting the training should also be identified New training course required? _Yes XNo i

l Revision to existing training course? 1Yes _No l

Lead Branch for establishing training:

Training to be given by:

Brief description of proposed training: Add discussion on the revised format of the l

orocedure.

l S. Attach a WP6.1 floppy disk with a hard copy of the document.

a. Has document been reviewed by the technical editor? lyes _No if not, state why

6. Special exhibits (anything that cannot be put in Wordperfect such as drawings, reductions, or block diagrams) are attached?

_Yes XNo _N/A

7. Attach a summary of comments and resolutions. State comment, its source, and if not adopted why. Is summary attached? lyes _No _N/A

8. All approval signatures must be obtained in the order listed below: Check items 1-7 above and ensure all documents (floppy disk with file in Wordperfect & hard copy, special exhibits, comment summary and resolution, and any background information) are attached to this form beforg uting)t for vals.

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a. Rona E. Zelac .7 . d.

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'ginator/D e PIPB, Manual Coord./Date b.

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iginator Branch Chief /date PIPB, Branch Chief /Date

c. I oF 6. / b o f.

IMNS Division Dire'ctor/Date DISP, NRR, Director /Date ,

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9. Date received by PIPB 10. Change notice number and issue Manual Coordinator date:

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INSPECTION PROCEDURE 87117 RADIOPHARMACY PROGRAMS COMMENT RESOLUTION Reaion 11. ,

1. Comment: ]

Inspection Procedures cover, in broad terms, the areas to be addressed in an inspection. It should be explicitly stated, however, that not every element of the procedure must be addressed. In order to improve efficiency as well as safety, the inspectors must be able to concentrate on those areas that, in their training and experience, they know most safety relevant items will be.

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1. Resolution:

The suggested statement appears in the prominently boxed guidance in Appendix A, Medical Teletherapy inspection Record, at the beginning of Part Il-Inspection i Documentation (page A-3). Accordingly, no change was made.

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2. Comment:

In Part Il-Inspection Documentation, it would be helpful to incorporate the references at the end of each section instead of having to consult a separate sheet.

2. Resolution:

Appendix B is intended to serve as a listing of applicable regulatory documents that may prove helpful to the inspector in orecarina for an inspection. It was not provided to serve as a prompt during an inspection. Also, the inspection record was prepared tu briefly state summary topics, without details requiring review during an inspection, and to specifically avoid the appearance of a checklist approach. Accordingly, no changes were made.

Reaion IV:

1. Comment:

We believe the revised IPs have still not hit the mark in terms of field note format. We believe an all-or-nothing approach to the " narrative vs. checklist" format is not the best solution. The perspective in Region IV is that some inspection areas lend themselves i

more to a general narrative format and some to a more detailed checklist format. This would suggest more of a hybrid field note format.

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5 j 1. Resolution:

I The consensus that prompted revision of the 87100 series procedures was that it was desirable to discontinue the checklist approach to inspection of materials facilities. The decision to use the present format was jointly reached by regional and headquarters management at the January,1997 Division Directors Counterpart Meeting. How=ver, if l experience with the use of the narrative format procedures indicates that such a hybM

would be the optimum approach, then the matter will be reconsidered.

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2. Comment:

The new field notes nov! require extensive narrative description, requiring much more time to record (more lika . formal report). This new approach requires more work to document the inspection.

2. Resolution:

As noted in comment and resolution (1), Region ll, not every element of the procedure must be addressed during each inspection. The documentation required for areas covered need only provide sufficient detail to describe what activities and procedures were observed and/or demonstrated to, in part, substantiate the inspection findings.

Also, the format is identical to that in IP 87115, " Nuclear Medicine Programs," which was pilot tested without significant comments on this point. Finally, the decision to use the present format was jointly reached by regional and headquarters management at the January,1997 Division Directors Counterpart Meeting; it is not subject to change at this time, but will be reconsidered after reasonable field experience.

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3. Comment. i The former check list field notes have been reduced to appendices called " Inspection References." These references are too general to be of real use during the heat of an inspection.

3. Resolution:

See comment and resolution (2), Region 11, above. No changes were made.

4. Comment:

I also disagree with the approach taken in the draft inspection procedures to deemphasize the review of records (see page 1 of procedure). Records review is ;

important since it often leads to identification of problem areas in the licensee's program l l

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9 that do not see the light of day even if personnel are interviewed or observed in the performance of licensed activities.

4. Resolution:

l The wording is similar to that in the presently used IP 87100, Licensed Materials Programs, and identical to that which appears in the also presently used IP 87110, industrial / Academic Research Programs, and IP 87120, Industrial Radiography t

Programs. In all of these IP's, the intent is to emphasize the importance of a mix of activities, including review of records, to an effective inspection. No changes were L

made.

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l NRC INSPECTION MANUAL IM08 l

INSPECTION PROCEDURE 87117 RADIONARMACY PROGRAMS PROGRAM APPLICABILITY: 2800 87117-01 INSPECTION OBJECTIVES 01.01 To determine if licensed activities are being conducted in a manner that will protect the health and safety of workers and the general public.

01.02 To determine if licensed programs are being conducted in accordance with I U.S. Nuclear Regulatory Commission (NRC) requirements. l 87117-02 INSPECTION REQUIREMENTS A review of the licensed activities will be commensurate with the scope of the licensee's program. A determination regarding safety and compliance with NRC requirements will be based on direct observation of work activities, interviews with workers, demonstrations by workers performing tasks regulated by NRC, and independent measurements of radiation conditions at the facility, rather than exclusive reliance on a review of records.

In reviewing the licensee's performance, the inspector should cover the period from the last to current inspections. However, older issues preceding the last inspection should be reviewed, if warranted by circumstances such as incidents, noncompliance, or high radiation exposures.

Some of the following areas may not be applicable to all radiopharmacy licenses.

02.01 Preoaration. The inspector shoul allow adequate time to prepare for the ,

inspection. Preparation will include reviewing documents, making travel arrangements. coordinating with appropriate personnel, notifying appropriate State agencies. and selecting necessary equipment. In particular, the inspector shall identify whether any license amendments have been issued since the last inspection, or whether the licensee has informed NRC of any major program changes since the last inspection. The inspector shall also review any regional event logs and files to determine if the licensee has had any incidents or events since the last inspection.

02.02 Entrance Briefino. When the inspector arrives at the licensee's facility, he/she will inform the radiopharmacy manager of the purpose and scope of the inspection.

87117 Issue Date: XX/XX/XX

9 02.03 General Overview

a. Oraanization. Interview cognizant licensee representatives about the current organization of the program. Examine the licensee's organization with respect to changes that may have occurred in personnel, functions, responsibilities, and authorities since the previous inspection. Identify the reporting relationship and management structure between the licensee's executive management and the Radiation Safety Officer (RS0).

b. Scone of Proaram. Interview the cognizant personnel to determine the types and quantities of licensed materials received, distributed, and redistributed, numbers of facilities served, staff size, etc.

c. Management Oversiaht. In the course of interviewing cognizant personnel, determine if management oversight is sufficient to provide the licensee staff with adequate resources and authority to administer the licensed program.

1. RSO - Determine whether the RSO has sufficient authority and fulfills the appropriate duties commensurate with the size and scope of licensed activities.

2. Audits - Verify that audits are performed as required. Verify that ,

the results of the audit are reviewed and addressed. !

d. Authorized Nuclear Pharmacists. Verify that authorized nuclear

)harmacists (ANPs) meet the criteria described in 10 CFR 32.72(b) and lave been approved by the licensee to perform and/or supervise licensed activities. Ensure that notifications regarding changes in ANPs. if a)plicable have been made in accordance with 10 CFR 35.14 Determine that t1e licensee is registered / licensed by U.S. Food and Drug Administation (FDA) or a State agency, as a nuclear pharmacy.

02.04 Walk-Throuah Orientation Tour. Perform a walk-through tour of the licensed f acility to make general observations about the condition of the facility and the licensed activities being performed. ,

l 02.05 Facilities. Verify that the facility conforms to that described in the l license application: that material receipt, use. and storage areas are secured; and that the licensee uses processes or other engineering controls (e.g. . negative pressure) to maintain doses as low as is reasonably achievable (ALARA). l 02.06 Eouioment and Instrumentation

a. Verify that equipment and instrumentation is appropriate, operable, calibrated, adequately maintained. and conforms to that described in the license.

b. Verify that the licensee has established and implemented procedures to identify and report safety component defects per the requirements of 10 CFR Part 21.

02.07 Materials

a. Receiot and Transfer of Licensed Material. Verify that the licensee is receiving packages and making transfers of licensed material in accordance 87117 Issue Date: XX/XX/XX

n with NRC and a pplicable U.S. Department of Transportation (DOT) regulations and 'icense conditions. Verify that the licensee has an adequate method to account for all materials received, possessed, stored, and used to ensure compliance with possession limits.

b. Authorized Uses. Determine, by observing the use of licensed material, discussing the activities with licensee personnel, and reviewing records, that the type, cuantity, and use of licensed material at the licensee's facility are autlorized by the license. To the extent practical, ensure.

by physical confirmation, that the licensee's inventory is complete and accurate.

c. Material Security and Contrql. Verify that the licensee has established procedures for maintaining security and control of licensed material. and that these procedures are understood and implemented by appropriate personnel. Verify that licensed material in storage. in controlled or unrestricted areas, is secure from unauthorized removal or access. Verify that licensed material, not in storage, in controlled or unrestricted areas, is controlled and under constant surveillance. Verify that access to restricted areas is limited by the licensee.

02.08 Trainina

a. General Trainina. Verify that appropriate training and initial instructions are being accomplished as specified in the license and/

or regulations.

b. Doeratina and Emeraency Procedures. Verify that operational procedures are being followed by observing licensee personnel perform tasks at selected work stations and by a comparison of their activities with established procedures. Also examine the licensee's emergency procedures to determine that these procedures are as approved by NRC. Through discussions with workers, verify that licensee personnel understand and implement the established procedures and are aware of procedural revisions. Document in the inspection inspection record what activities the inspector observed.

i Discuss with the licensee's representatives, or observe, the conduct of periodic tests and drills, especially for scenarios involving fires and large releases of radioactive material.

02.09 Area Radiation and Contamination Control

a. Area Survevs. Verify during observations and by direct measurements.

that the radiation levels are within the limits of 10 CFR Part 20. and that these areas are properly posted. Confirm that the licensee representatives conduct surveys in accordance with procedures described in the license documents.

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b. Leak Tests. Verify that leak tests of sealed sources are performed at the required frequency. Also verify that leak tests are analyzed in accordance with the license. If records of leak test results show contamination in excess of the regulatory requirements, verify that the licensee made appropriate notifications and removed the source from service.

Issue Date: XX/XX/XX 87117

, c. Contamination Control. Verify that the licensee performs weekly surveys for removable contamination in all areas where radiopharmaceuticals are routinely prepared administered, or stored. If the licensee has had spills or other incidents of contamination exceeding the licensee's trigger levels, verify that the licensee has taken appropriate actions.

d. Protective Clothina. Verify that radiation workers are provided with, and wear, the appropriate protective clothing, commensurate with activities being performed.

02.10 Radiation Protection I a. Radiation Protection Proaram. Verify that the licensee has developed and implemented a written radiation protection program commensurate with the I

licensee's activities. that the program includes ALARA provisions, and that the program is being reviewed at least annually, both for content and implementation.

b. Radiation Protection Procedures. Verify that changes in the radiological protection procedures made since the last inspection are consistent with regulations and license requirements. [ Note that some procedures may require prior NRC approval before the licensee can make changes.]

c. Instruments and Eauioment. Verify that radiation protection instruments and equipment are operable. have the 3 roper alarm settings (if applica-ble). and are calibrated and checced for appropriate response in accordance with 10 CFR 32.72 requirements license requirements, and licensee procedures.

d. Personnel Dosimeters. Verify that personnel dosimetry devices are worn by appropriate licensee personnel. Dosimetry devices appropriate to the type, energy or emitted radiation, and the anticipated radiation fields should have been issued to facility personnel. Verify that dosimeters are processed by a National Voluntary Laboratory Accreditation Program-approved and-accredited processor.

Verify that pursuant to 10 CFR 19.13(b). the licensee advises each worker annually of the worker's dose as shown in records maintained by the licensee pursuant to the provisions of 10 CFR 20.2106. " Records of individual monitoring results."

e. Bioassavs. Verify that bioassays are performed in accordance with license and regulatory requirements. Verify that the methods and the equipment used to perform bioassays have been approved and calibrated.

02.11 Waste Maneaement

a. Waste Storaae and Disoosal. Verify that the 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 the limits of 10 CFR 20.1301 " Dose limits for individual members of the public."

Verify that disposal of decay-in-storage waste is performed in accordan with the regulations and license conditions. Verify that the licensee is conducting appropriate surveys and defacing radioactive material labels before disposing of the waste.

l 87117 Issue Date: XX/XX/XX

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I s Review the licensee's procedures and records to verify that each shipment of radwaste intended for offsite disposal is accompanied by a shipment manifest that includes all the required information.

Review the licensee's procedures and records to verify that each package of radwaste intended for shipment to a licensed land disposal facility is labeled, as appropriate, to identify it as Class A. B. or C waste (in j accordance with the classification criteria of 10 CFR 61.55 [ Subsection i III.A.2 of Appendix F to 10 CFR 20.1001-20.2401]).

Verify through review of records and public sanitary sewerage system, if are any,consistent procedures thatform with the releases and into a

quantity restrictions of 10 CFR 20.2003. Pay particular attention to the licensee's documentation for demonstrating that the material is readily soluble (or readily dispersible biological material) in water. l l

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b. Effluents. Verify that effluent releases to sanitary sewerage and septic tanks are according to 10 CFR 20.2003 and 20.1003. respectively, and that treatment or disposal of waste by incineration is according to 10 CFR 20.2004.

Review and verify that waste-handling equipment, monitoring ecuipment, and/or administrative controls are adequate to maintain racioactive effluents within the limits established by the license and other regulatory requirements, and are ALARA.

Determine the quality of the relevant procedures and the degree to which l ALARA techniques are incorporated into them. Determine the extent to which process and engineering controls are used to minimize effluents.

Determine whether 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 03erated in accordance with manufacturer's recommendations and good health p1ysics practices.

Determine if all significant release pathways are monitored, all un-monitored pathways have been characterized. and all surveillance procedures for effluents are being implemented.

Additional inspection requirements are specified in Inspection Procedure (IP) 87102. " Maintaining Effluents from Materials Facilities As Low As Is Reasonably Achievable (ALARA)." Verify whether U.S. Environmental Protection Agency (EPA) referral forms for air effluents have been sent to the appropriate EPA regional office, with a copy to NRC Headquarters, per IP 87102.

c. Transfer. Verify that wastes are transferred to an authorized recipient specifically licensed to receive radioactive waste.

d. Records. Verify that records of waste storage. transfer, and disposal are maintained in accordance with the requirements of Part 20 and the license.

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e. Financial Assurance and Decommissionina. For all licensees. including sealed source licensees. review the licensee's records of information important to the safe and effective decommissioning of the facility.

Verify + hat the records are complete. updated. and assembled 1

Issue Date: XX/XX/XX 87117 l

. appropriately, in accordance with the requirements in 10 CFR 30.35(g).

Review the licensee's list of restricted areas required under 10 CFR 30.35(g)(3) and determine whether laboratories or other rooms have been released since the last inspection. If areas have been released. verify that the licensee has adequately decontaminated each room and documented the basis for releasing each room. Document the location of the released rooms in the inspection record, and document your findings regarding the adequacy of the licensee's decontamination.

Verify whether radiological conditions at the facility have changed since the financial assurance instrument and/or decommissioning plan was submitted such that either document needs to be changed to address the new radiological conditions. Examples of changes are radiological incidents such as spills or process upsets. Unauthorized changes by the licensee to processes, types of licensed materials, possession limits, or chemical or physical forms of licensed materials may also prompt a reevaluation of whether the financial assurance instrument and/or decommissioning plan remains sufficient. If the inspector identifies changes that may affect the financial assurance instrument or decommissioning plan. he/she should immediately notify regional management.

If a parent company guarantee or a self-guarantee is used to ensure decommissioning financial assurance, review the licensee's financial assurance file to ensure that 10 CFR Part 30. Appendix A or Appendix C requirements are met,

f. Decommissionino Timeliness. Review compliance with the Decommissioning Timeliness Rule requirements in 10 CFR 30.36(d) through (h). This is one area of the inspection record that should be completed on all inspections.

If the license to conduct principal activities has expired or has been revoked; if the licensee has made a decision to permanently cease 3rincipal activities at the site or in any separate building: or if there las been a 24-month duration when no principal activities were conducted at the site or in any separate building. then the decommissioning timeliness requirements in 10 CFR 30.36, 40.42. 70.38. or Part 72 apply.

If this is the case com)lete in full the " Decommissioning Timeliness Inspection record." Attac1 ment A to Appendix A.

02.12 Transoortation. Verify that the licensee's procedures and documentation are sufficient to ensure that licensed material is transported in accordance with 10 CFR Part 71 and DOT regulations for transportation of radioactive materials.

02.13 Postina and Labelina. Verify that the licensee has posted the appropriate documents, notices, forms, and caution signs. as required. Also verify that containers of licensed material are labeled appropriately.

02.14 Generic Communications of Information. Confirm that the licensee is receiving the applicable bulletins. information notices. NMSS Newsletter, etc.

Verify that the licensee has taken appropriate action in response to l these notices.

02.15 Notifications and Reoorts. Determine compliance with the regulations and l license requirements for notification and reports to NRC.

02.16 Soecial License Conditions. If applicable, review the licensee's compliance with any special license conditions.

87117 Issue Date: XX/XX/XX 1 I

- 02.17 Jndeoended and Confirmatory Measurements. Compare and verify, on a sampling basis. survey results or data that are used by the licensee to show compliance with the regulations or license conditions. Conduct independent measurements to ascertain the radiological conditions of the facility. Conduct these independent measurements on all inspections under this inspection procedure (IP). unless warranted by special circumstances. If independent measurements were not made provide a justification in the inspection record explaining why independent measurements were not aerformed. The inspector shall use radiation detection instruments that are catibrated, at a minimum, on an annual basis.

02.18 Research Involvina Human Subjects. Verify that research involving human subjects is conducted in conformity with the provisions of 10 CFR 35.6.

02.19 Year-2000 Issues. Verify that the licensee has reviewed its computer software to ensure that any potential year-2000 problems have been identified and corrected.

02.20 Exit Meetina. The inspector will conduct an exit meeting with radiopharmacy management and the RSO to discuss the preliminary inspection j findings including any apparent violations. safety-related concerns, and any unresolved items identified during the inspection. Discuss any negative Performance Evaluation Factors (PEFs) and encourage the licensee to respond to the PEFs of concern. For further guidance, refer to IP 87101. " Performance Evaluation Factors."

l 02.21 Post-Insoection Actions. After an inspection. the inspector shall i summarize the findings with his/her appropriate NRC supervisor. This is {

especially important if there are. or are expected to be, controversial issues arising from the findings.

Inspectors shall also meet with regional licensing staff when any pertinent licensing issues are raised during the inspection, when inspection findings impact on any licensing actions, to discuss the licensee's PEF results, or to give feedback on how the licensee has addressed recent licensing actions. This meeting shall be documented in the inspection record.

Additionally, in some instances, inspection findings will warrant communication with enforcement staff. Office of Investigations staff. State liaison staff, or Federal agencies with whom NRC has Memoranda of Understanding (MOUs). Similarly.

if information related to year-2000 problems and solutions is obtained. it is to l be conveyed to the NMSS Year-2000 Coordinator.

The inspector will ensure that inspection findings are clearly documented and reported to the licensee, as appropriate. The inspector shall also follow the requirements of Inspection Manual Chapter (IMC) 0620. " Inspection Documents and Records." regarding notifying the licensee that retained information is subject to public disclosure and giving the licensee the opportunity to request l

withholding it (see IMC 0620. Section 04.06.b.).

87117-03 INSPECTION GUIDANCE General. An examination of the licensee's records should not be considered the primary part of the inspection program. Rather. observations of activities in progress, equipment, facilities and use areas. etc. , will be a better indicator of the licensee's overall radiation safety program than a review of records. alone-.

Issue Date: XX/XX/XX 87117

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, 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.

l Whenever possible, verification should be accomplished through discussions. l observations, and demonstrations. I In the records reviewed, look for trends such as increasing doses or effluent releases. Records such as surveys. waste disposal, effluent releases, receipt l and transfer of licensed materials, training, utilization logs, and air samplirg may be examined randomly until the inspector is satisfied that the records are being maintained and are complete. Other records that are more closely related to health and safety (such as personnel dose-monitoring records and incident i reports) should be examined in detail. The type of records that were reviewed l and the time periods covered by these records should be noted in the appropriate

" Basis for Findings" section(s) of the inspection inspection record.

l Retain a copy of each pertinent record that is needed to substantiate an inspection finding, such as a violation. Those copies shall be attached to the l inspection inspection record or, when applicable. to a written inspection record.

When an inspector identifies an apparent violation, he/she 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 i violations: expedite the inspection (e.g. . licensee materials inventories); or !

l make the licensing file more complete. In all cases where licensee documents are retained beyond the inspection, follow the requirements of IMC 0620. Especially l ensure that the licensee understands that the retained record will become publicly available, and give the licensee the opportunity to request withholdirg ;

l the 'aformation, 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 inspection and not wait until the exit meeting.

Whenever possible the inspector should keep NRC management informed of significant findings (e.g.. safety hazards willful violations. and other potential escalated enforcement issues) identified during the course of the inspection.

i 03.01 PrenaratiOD. Before the inspection, the inspector should do l the following:

e Review the licensee's previous inspection history (at a minimum review the past two inspections), the license. and the status of any allegations or incidents. Note the licensee's commitments in response to previous violations. for followup during the inspection:

Review regional event / incident logs, event / incident files, and the docket file to determine wh !her the licensee was involved in any incidents or events. If NRC did receive notification of an incident, review that incident during the inspection and document the licensee's followup in the inspection record:

o In the inspection record. cuplete the administrative information, the inspection compliance history, the listing of any license amendments or program changes since the last inspection and the description of any incidents or events that have occurred since the last inspection:

87117 Issue Date: XX/XX/XX l

i i o Determine the dates that the licensee submitted the most recent financial j assurance instrument and decommissioning plan (if applicable): l

Discuss the licensee's program with previous inspector (s) and/or license reviewer (s) as necessary:

Notify the appropriate State radiation control program personnel 1

Review pending licensing actions l

e Obtain a map of the area and/or directions:

Make travel arrangements and prepare itinerary:

Select calibrated instruments and perform source check;

Select appropriate documents: and 1

Select appropriate equipment to take. l In selecting the appropriate documents, the inspector should consider taking the applicable regulations, inspection record, generic communications, license. NRC forms. etc.

In selecting the appropriate equipment the inspector should consider the type of licensee to be inspected. The equipment may include safety glasses and shoes, sample vials. wipes, pocket dosimeters. alarming rate meters, etc.

During the inspection, focus (among othe areas) on whether the licensee is in compliance with any license amendments issued since the last inspection or with any program changes described by the licensee since the last inspection. This requires review of documentation submitted 1.1 support of the licensing action, before the inspection. The inspection represents NRC's first opportunity to verify whether the licensee has enacted the most recent changes to the license.

03.02 Entrance Briefina. After arriving on site, the inspector should inform ;

the licensee's management representative of the purpose and scope of the inspection to be performed. Radiopharmacies are open for business very early in ;

the morning (e.g. 1:00 a.m.). Occasionally an inspection should be performed during the processing of the first-run doses. This would be an excellent time to observe the licensee's activities even though the pharmacy staff will be very busy and the manager may not be available. When early morning irispections are performed, the inspector should not disrupt the flow of production, but should use this time to observe the activities of the pharmacists, drivers, dispatchers, and office personnel.

The purpose of the entr2.nce briefing is to inform licensee management that an inspection is being conducted, and to indicate the tentative schedule for discussing or reviewing selected inspection items with various licensee staff personnel. However, in some instances, the inspector may only need to inform management of NRC's presence on site, and apprise management that an exit l

briefing will be conducted. at the end of the inspection, which will detail the l inspection findings.

l Issue Date: XX/XX/XX 87117

. 03.03 General Overview. The inspector will interview the cognizant licensee representatives to gain information concerning organization, scope, and management oversight of the radiation safety program.

a. Oraanization. The licensee's organizational structure will usually be found in the license application and may involve one or more individuals.

Determine the reporting structure among executive management. the RSO. and the other members of the staff. Determine whether the RSO has sufficient l access to licensee management. Through discussions with licensee staff, i the inspector should determine if changes in ownership or staffing have l occurred. If the owner or individuals named in the license have changed.

l determine whether the licensee has submitted appro]riate notification to NRC. This information must be provided whenever clanges in ownership or

! personnel are made (except for some licenses where only responsibilities l are defined). Ask licensee management if changes have occurred, or are anticipated, and ask personnel to confirm (to the inspector's satisfac-tion) that no changes have taken place. If there have been no changes in i the organization since the previous inspection, there is no need to pursue i this element in further detail.

l 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 ask licensee management and the RSO about the RS0's authority and about any changes that may impact on the RSO's duties. responsibilities, or effectiveness.

I b. Scooe of Proaram. Through discussions with licensee personnel, the l inspector can obtain useful information about the types and quantities of l material, frequency of use. incidents. etc. which cannot always be gained l by reviewing records alone. This is also an opportunity for the inspector l to discern the actual size and scope of the licensee's program, and to

' determine if significant changes in activities have occurred since the

! previous inspection. The information obtained should include the number of staff. number of customers served, number of doses dispensed daily, pharmacy duty hours. number and activity of generators received, etc.

c. Manaaement Oversicht. The inspection is a verification of the licensee's

, implementation of the required program. In the review to verify l implementation. the inspector should pay particular attention to the scope l of the program: frequency of licensee audits and the use of qualified l

auditors; procedures for recording and reporting deficiencies to management: and methods and completion of followup actions by management

1. RSO - The RSO is the individual, appointed by licensee management and identified cn the license, who is responsible for implementing t7e I radiation safety program. The inspector should verify that this l irdividual is knowledgeable about the program and ensures that activities are being performed in accordance with approved ]rocedures and the regulations. The inspector should verify tlat, when deficiencies are identified. the RSO has sufficient authority.

without prior management approval, to implement correci.iva acticas.

including termination of operations that pose a threat to health and safety.

87117 Issue Date: XX/XX/XX

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, 2. Audits - The frequency and scope of audits of the licensed program l will vary. However, note that, at a minimum, licensees are required l by 10 CFR 20.1101(c) to review the radiation safety program content and implementation at least annually. Typically, larger radiopharmacy licensees have a corporate radiation safety staff who conduct periodic audits covering all aspects of the licensed program.

The results of all audits should be documented. 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, 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.

e d. MP_s ANPs may either be named on the license or appointed by the l licensee. For those appointed by the licensee. verify that these individuals are qualified as ANPs in accordance with 10 CFR 32.72 (b) and have knowledge commensurate with their operational duties.

! The regulations in 10 CFR 32.72(b)(2) permit the nuclear pharmacy licensee to have an individual "under the supervision of" an authorized nuclear pharmacist prepare radioactive drugs for medical use. These regulations i

do not specifically require that the authorized user be present at all times during the use of such materials. However, the authorized user / supervisor is responsible for assuring that personnel under his/her i

supervision have been properly trained and instructed. pursuant to 10 CFR I 35.25(b), and is responsible for the supervision of operations involving the use of radioactive materials whether he/she is present or absent.

i

03.04 Walk-Throuah Orientation Tour. The inspector should make initial I observations of licensed activities to determine that materials are being safely i handled and that good health physics practices are followed. The inspector should look at areas of use, storage, and disposal to make an initial assessment l of the licensee's ALARA program with regard to facility design, engineering ;

controls, housekeeping practices, etc. In addition, observations should include i dose preparation and quality control activities, package surveys before transfer i to the end users, waste handling, and iodine encapsulations. The inspector should ensure that observations of activities are documented in the inspection l inspection record. !

03.05 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. The actual or as-built facility should be configured to provide safe working areas separated from unrestricted areas and sufficient access controls to preclude unauthorized entry. The inspector should also be l l

aware of potential industrial safety hazards for referral to the U.S. Department of Labor's Occupational Safety and Health Administration (OSHA).

i j 03.06 Eauioment and Instrumentation

! a. Equipment and instrumentation should be appropriate to measuring the radioactivity of radioactive drugs and be in accordance with 10 CFR 32.72(c). The inspector should verify that survey instrumentation has the appropriate range of use. The inspector should also verify that the survey instruments are calibrated at the amropriate frequency and checked for operability before use. All sur .c.f . sampling, and monitoring instruments should have current calibrations appropriate to the types and ,

Issue Date: XX/XX/XX 87117

energies of radiation to be detected. The technical adequacy of calibration procedures at facilities that perform their own calibrations should be examined. Processing equipment, fume hoods, ventilation, and exhaust systems should be sufficient to provide safe use handling, and storage of the materials in use. Appropriate shielding should be available for syringes and vials, and should be appropriate for photon and beta emitters.

The inspector should verify that dose calibrators are calibrated in accordance with procedures and at the appropriate intervals. These calibrations include linearity, geometric dependence, accuracy. and constancy tests. Appropriate performance criteria for these checks may be found in the license. If generators are used, the inspector should verify that molybdenum-99 breakthrough tests are performed on each elution in accordance with 10 CFR 30.34(g) and licensed procedures. If practical, the inspector should ask licensee representatives to demonstrate a constancy test and/or breakthrough procedure to ensure compliance with procedures,

b. Inspectors should verify that licensees have procedures for reporting defects in accordance with Part 21. The complexity of the procedures will vary. t

c. Verify that the required records are maintained for instrument checks and calibrations.

03.07 Materials

a. Receint and Transfer of Licensed Materials. Package receipt and transfer procedures will be found in the license documents. These procedures should be carefully reviewed before an inspection is conducted. By discussions with the licensee, determine if the procedures have been changed or modified. Some changes will require a license amendment, whereas other minor changes (updating telephone numbers, editing procedures for clarity, etc.) may not require NRC approval. Randomly examine procedures used by the licensee to determine if they are in accordance with those identified in the license documents, and determine whether these changes warrant a license amendment.

The procedures for picking up, receiving, opening. and transferring packages should include how and when packages will be picked up, radiation surveys and wipe tests, and procedures for opening packages (such as the location in the facility where packages are received, surveyed. and opened). The procedures also should include what actions are to be taken if surveys reveal packages that are contaminated in excess of specified )

limits, and/or radiation levels that are higher than expected limits. The inspector should, when practical, observe personnel perform the package receipt and transfer procedures.

The inspector should randomly examine records of package surveys and also determine if inventories for each radionuclide are within the license limits. In this regard, records of inventories after receipt and transfer should indicate / demonstrate that the materials on hand at any one time are within the licensee's possession limit. When practical. the records examined should be compared with a physical inventory of materials possessed 87117 Issue Date: XX/XX/XX

The licensee should have a system that accounts for all licensed material.

The accounting system should provide accurate information on the receipt and transfer of material, its location. the quantity used and disposed of.

I and the amount transferred to customers. The accounting system should also consider radioactive material held for decay-in-storage.

1 l b. Authorized Uses. Authorized uses of licensed material will be found in I the license and referenced license documents. Licenses will list the isotopes, physical or chemical forms, and the maximum possession limits.

The inspector should physically examine the inventory of radioactive

! material on hand or examine records of receipt and transfer to determine l that quantities and forms are as authorized. Additionally, the inspector should verify that the licensee's use of licensed material is limited to that which is authorized in the license.

L 1

c. Material Security and Control . Examine areas where licensed materials are l used and stored. Storage areas should be locked and have limited and controlled access. Licensed material use areas should be under constant surveillance or physically secured. The licensee should have procedures for access controls. Controls may include a utilization log to indicate

! when licensed material is taken from and returned to storage areas. The l ins]ector should verify that adequate controls are in place and worcing effectively.

03.08 Trainino

a. General Trainina. Certain kinds of training and instruction are found in l the regulations; how they are implemented will be found in the license.

l Discuss with the P.nensee how, and by whom. training is conducted and the content of the training provided to workers (generally found in the license documents).

Verify. pursuant to 10 CFR '19.12. that initial instructions have been given to individuals who in the course of employment are likely to receive in excess of 100 millirem (1 mSv) in a year. Under the basic instructions, it is management's responsibility to inform the workers of l precautions to take when entering a restricted area, kinds and uses of radioactive materials in that area, exposure levels, and the types of I 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 l corrected, result in a violation of NRC requirements. Also verify that authorized users and workers understand the mechanism for raising j safety concerns.

l Of the training program elements in the license application. training given to authorized users, and those individuals under the supervision of l authorized users. is of primary importance. One or more users of licensed materials should be interviewed to determine that they have received the required training both in the basic instructions and in that specified in the license application. For some licensees., this includes specific l training needed to perform infrecuent procedures and prepare and use licensed material in research stuciies or in production. 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.

l Issue Date: XX/XX/XX 87117

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Randomly examine records of training of personnel and attendant examinations or tests (if applicable) to the extent that the inspector is satisfied that the training program is being implemented as required.

, Where examinations are required. read a few of the examination cuestions to ascertain that they are indicative of what the worker shoulc know to carry out his/her responsibilities.

The inspector should also observe related activities and discuss the radiation safety training received by selected individuals, to ensure that appropriate training was actually received by' these individuals.

Authorized users and supervised individuals should understand the radiation protection requirements associated with their assigned l activities. The licensee's radiation safety training may include, but is i

not limited to, demonstrations by cognizant facility personnel, formal I lectures, testing, films, and " dry runs" for more complex or hazardous operations. Specialized training should be provided for drivers.

l dispatchers, and other personnel involved in such activities as delivery l of licensed material to customers, handling and processing of radioactive waste, quality control of products, and production of iodine-131 cap,ules.

b. Doeratina and Emeraency Procedures. Operating and emergency procedures will be found in license applications and may vary from step-by-step procedures to more generalized procedures for lower-inspection-priority ;

licenses. The emergency procedures will be approved by NRC and reviewed l

and updated by the licensee. Any revision requ res an amendment to the license. ,

1 Some licensees may have agreements with other agencies (e.g., fire, law j enforcement, and medical organizations) regarding response to emergencies. i Discuss with the licensee's representatives what has been done to ensure that agencies (involved in such agreements) understand their roles in emergency responses.

03.09 Area Radiation and Contamination Control

a. Area Survevs. The inspector may ask the licensee to spot-check radiation levels in selected areas, using the licensee's own instrumentation.

However, the inspector must use NRC's instruments for independent verification of the licensee's measurements. (The inspector's instruments shall be calibrated and source-checked before he/she leaves the regional office.)

i If practical, observe how licensees conduct surveys to determine the adequacy of surveys. Also note the types of instruments used, and whether they are designed and calibrated for the type of radiation being measured.

l The inspector should determine if workers take smears or instrument !

readings in areas that are readily accessible to facility personnel. '

Particular attention should be given to counter tops, dispensing areas.

l desks, waste processing rooms, and storage areas. The survey activities should be at a specified frequency in accordance with the related licensee procedures. Observe how tests are analyzed and the results obtained. The inspector should also perform independent measurements, as needed to verify licensee assumptions or measurements.

l 87117 Issue Date: XX/XX/XX j i

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b. Leak Tests. Through discussions with licensee personnel and/or by demonstration of leak-test 3rocedures, the inspector should verify that leak tests are performec in accordance with the manufacturer's recommendations and/or license.

c. Contamination Control. The inspector should verify that the licensee's survey procedures and counting equipment are adequate to detect and control radionuclide contamination. Verify that personnel are aware of prohibitions on eating, drinking, and smoking in areas where contamination may be present. Verify that proper procedures for checking personnel contamination are observed when leaving contaminated areas. Also, verify that waste is being disposed of in proper containers, and that mouth pipetting is n~ot practiced. The inspector may choose to examine the instrument calibration records (efficiency checks. lower limit-of-detection calculations, geometry, linearity, etc.) physical location of l

! counting instruments, methods of detection, and wipe-sample locations.

Additionally, when appropriate. the inspector should consider taking l confirmatory wipe samples, l

d. Protective Clothina. If practical, the observation of the protective clothing that personnel wear during their work activities should provide the inspector with an acceptable means of reviewing this requirement.

Requirements for protective clothing and other devices may be found in the licensee's procedures or on precautions posted at the entrance to centrolled areas.

( 03.10 Radiation Protection. Speci fic guidance is set forth in IP l 83822." Radiation Protection "

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.

Verify through discu3sions with workers and management, and through records

! review, that the licensee has advised workers of their doses annually. The licensee must advise all workers for whom monitoring is required (an(' therefore, dose records are required). The licensee must advise these workers of internal l and external doses from routine operations, and doses received during planned

( special exposures. accidents. and emergencies. The report to the individual must l be in writing and must contain all of the information required in 10 CFR 19.13(a).

03.11 Waste Manaaement

a. Waste Storaae and Discosal. Verify that the waste is 3rotected from fire l

and the elements, that package integrity is adequate ~y maintained. that i

the storage area is properly ventilated, and that adequate controls are in effect to minimize the risk from other hazardous materials. Verify that the licensee has appropriate methods to track the items in storage.

( Inspection effort should be directed at verifying that written procedures have been established in a manner approved by management. The procedures should be readily available to any persons having responsibility for low-level waste classification and preparation for transfer of such wastes to land-disposal facilities or having responsibility for disposal by release into a public sanitary sewerage system.

For further inspection guidance, refer to IP 84850. " Radioactive Waste Management-Inspection of Waste Generator Requirements of 10 CFR Part 20 Issue Date: XX/XX/XX 87117

. and 10 CFR Part 61" and IN 94-07. " Solubility Criteria for Liquid Effluent Releases to sanitary Sewerage Under the Revised 10 CFR Part 20."

b. Ef fluents . Examine the radioactive material release records generated since the last inspection, all annual or semiannual reports. all pertinent non-routine event reports, and a random selection of liquid and airborne waste release records. Although radio)harmacys rarely release radioactive l licuid effluents, the inspector shou ~ d determine if such releases occur anc whether they are in accordance with Part 20 limits.

Review the licensee's ALARA goals, and determine if they are sufficiently I

challenging, yet realistic. Determine if the licensee understands and implements these goals. Determine if the licensee has calculated annual doses resulting from air effluents and if the doses are: (1) within the licensee's ALARA goals (as described in its radiation protection ,

program): (2) exceed the licensee's ALARA goals; or (3) uncertain because there is insufficient information or basis for determination. Review the licensee's history in meeting ALARA goals, and its corrective actions when the goals were not met.

For further inspection guidance, refer to IP 87102.

c. Transfer. Ascertain if the licensee has an adequate method of determining l that recipients of radioactive wastes are licensed to receive such waste (i.e. , licensee obtains a copy of the waste recipient's current license before the transfer),

d. Records. Each licensee is required to maintain records of the disposal of licensed material made under 10 CFR 20.2002-2005.10 CFR part 61. and disposal by burial in soil. These records must be retained until the Commission terminates each pertinent license requiring the record. The inspector should review these records to verify that disposals are made in accordance with the applicable regulations, and that records are complete and accurate for each type of disposal

e. Financial Assurance and Decommissionina. The decommissioning record-keeping requirements are applicable to all materials licensees including licensees with only sealed sources. dnd are specified in 10 CFR 30.35(g).

These records should contain, among other information: (1) records of spills or other unusual occurrences involving the spread of contaminatim in and around the facility, equipment, or site (when contamination remains after cleanup. or when contaminates may have spread to inaccessible areas such as seepage into concrete): (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 (e.g., buried pipes): (3) except for areas with only non-leaking sealed sources or byproduct materials with half-lives of less than 65 days. a single document detailing restricted areas and formerly restricted areas, buried waste, areas requiring decontamination that are outside of restricted areas, and areas outside of restricted areas that, if the license expired, would have to be decontaminated or approved for disposal; and (4) 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). On all inspections, including inspections of sealed source licensees. the inspector should ensure that the licensee has such decommissioning records. that the records are complete. that they are 87117 Issue Date: XX/XX/XX

updated as required, and that the decommissioning records are assembled or referenced in an identified location.

, Some licensees may release laboratories or other 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. Inspectors should identify the rooms that have been released since the last inspection and perform confirmatory measurements 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.

Licensees submit financial assurance instruments and/or decommissioning i 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. Then during the inspection, through observations, discussions with licensee 3ersonnel, and records review the inspector should determine whether t1e 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 immediately contact regional management, from the licensee's site, to discuss the situation.

Additionally, some licensees are required to maintain decommissicqing 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 10 CFR Part 30.

f. Decommissionina Timeliness. Determine whether the license to conduct a principal activity has expired or been revoked. If the license remains in effect. determine if the licensee has made a decision to cease principal activities at the site or in any separate building or outdoor area, including burial grounds. Finally, determine if there has been a 24-month duration in which no principal activities have been conducted in l such areas. A principal activity is one that is essential to the purpose !

for which a license was issued or amended, and does not include storage I incidental to decontamination or decommissioning. If the licensee meets any of the' above conditions, the decommissioning timeliness requirements i l

apply, and the inspector must complete the " Decommissioning Timeliness l Inspection inspection record." Attachment A to Appendix A.

The requirements of 10 CFR 30.36, 40.42, and 70.38 do not apply to released rooms within a building where principal activitles are still on-going in other parts of the same building. However, in those cases, the i

Issue Date: XX/XX/XX 87117

inspector should follow the guidance in Section 03.11.e.. above, regarding confirmatory measurements of the released area. 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.

In completing the Attachment A inspection record, specific guidance is needed regarding the timing of the notification requirements. If the license has expired or been revoked, or if the licensee has made a decision to permanently cease principal activities, and the licensee j orovided NRC notification before Auaust 15. 1994, then August 15. 1994, is considered to be the date for initiating the decommissioning calendar 1 (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).

There is an exemption to the decommissioning timeliness requirements. The .

provisions in the Decommissioning Timeliness Rule. in 10 CFR 40.42(d)(4). ,

for the 24-month period of inactivity: 40.42(f), for the content of the decommissioning plan; and 40.42(g). for the timing of completion of the plan do not apply to the reclamation of waste disposal areas and/or tailings impoundments at uranium recovery facilities and thorium mills.

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 immediately contact reaional management. l For planning and conducting inspections of licensees undergoing decommissioning, refer to IMC 2602. " Decommissioning Inspection Program for Fuel Cycle Facilities and Materials Licensees": IP 87104 .

" Decommissioning Inspection Procedure for Materials Licensees"; and the I draft Decommissioning Manual Chapter and Handbook.

03.12 Transoortation. The inspector should review: the licensee's hazardous material training: Jackages and associated documentation; vehicles (including placarding, cargo alocking, and bracing. etc.): shipping papers; and any incidents reported to DOT. This is an ideal area for the inspector to make observations of the licensee's drivers / couriers practices. The DOT and NRC regulations for transportation of radioactive materials were recently revised, and the revisions generally became effective April 1,1996.

l 87117 Issue Date: XX/XX/XX l

l- For further inspection guidance, refer to IP 86740. " Inspection of Transportatim l

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 i references for determining compliance with the transportation rules on labeling, i placarding. shipping papers, and package markings.

l 03.13 Postina and Labelina. The inspector should determine whether proper l

caution signs are being used at access points to areas containing licensed materials, radiation areas, and those areas containing airborne radioactive l materials. Section 20.1903 provides exceptions to posting caution signs. When i applicable, the inspector should also randomly examine signals and alarms to determine operability. The inspector should also randomly observe labeling on i packages or other containers, to determine that proper information (e.g..

I isotope, quantity, and date of measurement) is recorded.

Areas with radiation hazards should be conspicuously posted, as required by 10

! CFR 20.1902. Depending on the associated hazard, controls may include tape.

l rope, or structural barriers to prevent access. If volatile licensed materials are used in an area, such an area should be controlled for airborne contamination. High-radiation areas should be strictly controlled, to prevent unauthorized or inadvertent access. Such controls may include, but are not limited to, direct surveillance, locking the high-radiation area, warning lights, and audible alarms. Areas occupied by radiation workers for long periods of time )

l and common-use areas should be controlled in accordance with licensee procedures 1 and be consistent with the licensee's ALARA program.

l l The inspector should also examine locations where notices to workers are posted.

l Applicable documents, notices. or forms should be 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. l 03.14 Generic Communications of Information. Through discussions with licensee management and the RSO. the inspector should verify that the licensee is receiving the applicable bulletins. information notices. NMSS Newsletter, etc..

l and that the information contained in these documents is disseminated to appropriate staff personnel. Also verify that the licensee has taken appropriate action in response to these NRC communications, when a response is required.

l 03.16 Notifications and Reoorts. The inspector should determine the licensee's

! compliance for notifications and reports to the Commission. For example.10 CFR (

32.72 requires the licerisee to notify the Commission within 30 days of approving an ANP as user of licensed material. The licensee may be required to make notifications after loss or theft of material, overexposures incidents, high-radiation levels, safety-related equipment failure, etc. Additionally, some licensees are required to make annual reports to NRC.

Through discussions with licensee personnel, and by a review of representative records, the inspector should verify that notifications and/or reports were appropriately submitted to NRC.

03.16 Soecial License Conditions. Some licenses will contain special license conditions that are unique to a particular practice, procedure, or piece of equipment used by the licensee. In these instances, the inspector should verify that the licensee understands the additional requirements, and maintains I

l Issue Date: XX/XX/XX 19 - 87117

compliance with the special licer se conditions. The inspector should also note that some special license conditions will state an exemption to a particular NRC requirement. Check if misadministrations occurred that were attributable to the pharmacy. If so. verify that appropriate corrective actions have been taken to prevent recurrence.

03.17 Indeoendent and Confirmatory Measurements. The inspector should perform independent and confirmatory measurements in restricted, controlled, and unrestricted areas of the licensee's facility. Independent measurements should be performed on all inspections, unless exceptional circumstances make it l

impossible to perform the measurements (e.g., inspector's detection equipment malfunctions during an inspection trip). Measurements of dose rates at the boundaries of restricted areas should be performed at the surfaces of the most accessible planes. Examples of measurements + hat may be performed include area radiation surveys, wipe samples, soil samples, leak tests. air-flow measurements.

l etc. These measurements should be taken in licensed material-use areas, storage I

areas, effluent release points, etc. Confirmatory measurements are those whereby the inspector compares his/her measurements with those of the licensee's.

Indepencent measurements are those performed by the inspector independently of the licensee's measurements. To perform the independent or confirmatory measurement, use NRC radiation detection equipment tnat is calibrated, at a l

minimum, on an annual basis.

03.18 Research Involvino Heman Subiects: This type of research must satisfy the following conditions: (1) A 1 research is conducted. supported or regulated by l 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.

3 03.19 Year-2000 Issues. Verifying that the licensee has reviewed its computer software to ensure that any potential year-2000 problems have been identified and corrected can be accomplished. in part, by covering the following points: (a) confirm that the licensee received Information Notice 96-70. " Year 2000 Effect on Computer System Software." and Information Notice 97-61. "U. S. Department of Health and Human Services Letter to Medical Device Manufacturers, on the Year 2000 Problem"; (b) inform the licensee of the NRC list server on the year-2000 problem, and encourage its use in sharing any identified problems and solutions:

(c) determine whether the licensee has identified any potential problems, and if so, taken corrective action. (Note that if information related to year-2000 licensee-identified problems and associated corrections is obtained during the inspection the inspector is to convey it to the NMSS Year-2000 Coordinator.)

03.20 Exit Meetina. When the inspection is over, there should be an exit meeting with the most senior licensee representative present at the facility.

If a senior management representative is unavailable for the exit meeting. the l inspector may hold a preliminary exit meeting with appropriate staff on site.

However, there must be a formal exit meeting with a senior management representative (and the licensee's RSO. if not present at the preliminary exit meeting) as soon as practical after the inspection. This meeting will usually l be held by telephone conference call.

I i During the exit meeting, the licensee representatives should be told the '

preliminary inspection findings -- inclucing any negative PEFs. apparent violations of regulatory requirements, safety related concerns, or unresolved 87117 Issue Date: XX/XX/XX

items identified during the inspection -- and the status of any previously identified violations. The licensee must immediately address any significant safety concerns.

If the inspector identifies safety concerns or violations of significant regulatory requirements that affect safe operation of a licensee facility. the licensee must initiate prompt corrective action. The inspector should not leave the site until the licensee fully understands the concern and has initiated corrective action. If the inspector and the licensee disagree over how significantly the concern impacts continued safe operation of the facility, regional management should be notified immediately.

Although deficiencies identified in some areas (e.g., workers' knowledge of the Part 20 requirements) are not always violations, the inspector should bring such deficiencies to the attention of licensee management at the exit meeting and also in the cover letter transmitting the inspection record or Notice of Violation.

03.21 East-Insoection Actions. Regional office policy will dictate with whom

~

the inspector will review his or her inspection findings (e.g. , the inspector's supervisor), following the guidance in IMC 2800. " Materials Inspection Program."

The inspector should discuss the findings in the detail that is commensurate with the scope of the licensee's program. Violations items of concern (e.g. ,

negative PEFs), and unresolved items should be discussed in sufficient depth for management to make appropriate decisions regarding enforcement actions, referral to other State and Federal agencies, and decisions on the scheduling of future inspections of the licensee's facility. l 1

The inspector should also discuss inspection findings with licensing staff. This information exchange can be particularly useful if the licensee is having its license renewed or has recently submitted a license amendment request. The l inspector should inform licensing staff about how the licensee has addressed (or l failed to address) special license amendments or recent licensing actions.

Licensing information requested by the licenst.e should also be discussed with the licensing staff.

Inspectors should be aware that NRC has entered into several MOUs. with other Federal agencies, that outline agreements on items such as exchange of information and evidence in criminal proceedings. The inspector should ensure that the exchange of information relevant to inspection activities is made in accordance with the appropriate MOU.

l The inspector may report the results of inspections to the licensee either by issuing an NRC Form 591 or a regional office letter to the licensee, following l

the guidance in IMC 2800. The inspector must also ensure that the findings are

documented in the inspection inspection record and/or inspection record, in

' sufficient detail for the reader to determine what requirement was violated, how it was violated, who violated the requirement, and when it was violated. Copies of all licensee documents needed to support the violation should be attached to the inspection record. The inspection record should not be used as merely a checklist to note areas reviewed. It should be used to describe what procedures or activities were observed and/or demonstrated by the licensee during the inspection, and any items of concern identified that were not cited as a violation of regulatory requirements.

Inspectors may complete the inspection record either by hand or electronically.

If the inspector is documenting the inspection record in electronic format the sub-items under major sections that are not applicable or not reviewed an be 87117 Issue Date: XX/XX/XX L-

deleted. However, the heading itself (e.g. , " Radioactive Waste Management." or

" Transportation") should remain in the inspection record, and the inspector should enter appropriate remarks about why the section-is not applicable or not reviewed.

For further inspection guidance, refer to Section 07.04 of IMC 2800, l

87117-04 REFERENCES A listing of IMCs and IPs applicable to the inspection program for materials licensees can be found in Section 2800-11 of IMC 2800. Inspectors are to use these documents as guidelines in determining the inspection requirements for operational and radiological safety aspects of various types of licensee activities.

Specific references to regulatory recuirements can be found in the " Radiopharmacy Inspection References" appendix, fo' lowing this IP.

END Appendices:

A. " Radiopharmacy Inspection Record"

8. " Radiopharmacy Inspection References" l

87117 Issue Date: XX/XX/XX

r- ,

APPENDIX A RADIOPHARMACY INSPECTION RECORD Region Inspection record No. License No.

Licensee (Name & Address): Docket No.

i l

I Licensee

Contact:

. Telephone No.

Priority: Program Code:

l Date of Last inspection:

Date of This inspection:

Type of Inspection: ( ) Announced ( ) Unannounced

( ) Routine ( ) Special

( ) Initial Next inspection Date l

( ) Normal ( ) Reduced ( ) Extended Justification for change in normal inspection frequency:

Summary of Findings and Actions: ,

( ) No violations cited, clear NRC Form 591 or regional letter issued

( ) Non-cited violations

( ) Violation (s), Form 591 issued

( ) Violation (s), regional letter issued

( ) Followup on previous violations Inspector (s) Date (Sign Name) l (Print Name)

Approved Date (Sign Name)

(Print Name)

! Issue Date: XX/XNXX A-1 87117, Appendix A

e PART l-LICENSE, INSPECTION, INCIDENT / EVENT, AND ENFORCEMENT HISTORY

1. AMENDMENTS AND PROGRAM CHANGES:

(License amendments issued since last inspection, or program changes noted in the license.)

AMENDMENT # DATE SUBJECT

2. INSPECTION AND ENFORCEMENT HISTORY:

(Unresolved issues; previous and repeat violations; Confirmatory Action Letters; and orders.)

l

3. INCIDENT / EVENT HISTORY:

(List any incidents, or events, reported to U.S. Nuclear Regulatory Commission since the last inspection. Citing "None" indicates that regional event togs, event files, and the licensing file have no evidence of any incidents or events since the last inspection.)

l i

i l

i 87117, Appendix A A-2 issue Date: XX/XX/XX

e o

PART ll-INSPECTION DOCUMENTATION References that correspond to each inspection documentation topic are in IP 87117, l Appendix B, Radiopharmacy inspection References.

The inspection documentation part is to be used by the inspector to assist with the performance of the inspection. Note that not all areas indicated in this part are required to be addressed during gggh inspection. However, for those areas not covered during the inspection, a notation ("Not Reviewed" or "Not Applicable") should be made in each section, where applicable.

1 All areas covered during the inspection should be documented in sufficient detail to describe what activities and procedures were observed and/or demonstrated. In addition, the types of records that were reviewed and the time periods covered by those records should be noted. If the licensee demonstrated any practices at your request, describe those demonstrations. The observations and demonstrations you describe in this report, along with measurements and some records review, should substantiate yourinspection findings.

l Attach copies of alllicensee documents and records needed to support violations.

l l

1. ORGANIZATION AND SCOPE OF PROGRAM:

l (Management organizationalstructure; Radiation Safety Officer (RSO); type, quantity, and l frequency of byproduct material use; staff size; number of facilities served; distribution and i redistribution of materials; oversight by Food and Drug Administration / State) l l

l l

I J

l 2. MANAGEMENT OVERSIGHT: ;

(Management support to radiation safety; RSO; authorized nuclear pharmacists and change notifications; supervision of drug preparation by the ANP; program audits or inspections; as low as reasonably achievable (ALARA) reviews; staff coverage) l l

l Issue Date: XX/XX/XX A-3 87117, Appendix A l

t S

3. FACILITIES:

(Facilities as described; uses; control of access; fire protection; engineering controls; shielding; ventilation systems; maintenance program)

4. EQUIPMENT AND INSTRUMENTATION:

(Operable and calibrated survey instruments and dosimetry; area and process monitors; maintenance; shielding; generators; procedures; 10 CFR Part 21 procedures; calibration records; fixed radiation monitors)

! 5. MATERIAL USE. CONTROL. AND TRANSFER:

l (Materials and uses authorized; security and control of licensed materials; and procedures J

! for receipt and transfer of licensed material; iodine handling) <

1 I

l 87117, Appendix A A-4 Issue Date: XX/XX/XX i

I

6. OPERATING AND EMERGENCY PROCEDURES:

(Procedure development and availability; manufacturer's instruction; emergency preparedness; assistance arrangement with outside agencies)

\

7. AREA RADIATION SURVEYS :

(Radiological survey locations and frequencies; leak tests; inventories; handling of 1 radioactive materials; protective clothing; personnel monitors; safety precautions in l preparation and use of drugs; records and reports; public doses) 1

8. TRAINING AND INSTRUCTIONS TO WORKERS:

(Training and retraining requirements and documentation; interviews and observations of routine work; staff knowledge of all routine activities; 10 CFR Parts 19 and 20 requirements; emergency response) s

(

i l

1 issue Date: XX/XX/XX A-5 87117, Appendix A

5 s

9. RADIATION PROTECTION:

(Radiation protection program with ALARA provisions; access control; dosimetry; exposure evaluations; dose and survey records and reports; annual notifications to workers; bulletins and other generic communications) 1 1

10. DECOMMISSIONING:

(Records relevant to decommissioning; decommissioning plan / schedule; notification requirements; cost estimates; funding methods; financial assurance; Timeliness Rule requirements; changes in ram.igical conditions since decommissioning plan was submitted)

11. TRANSPORTATION:

(Quantities and types of license laterial shipped; packaging design requirements; shipping papers; hazardous matu, 4 (HAZMAT) communication procedures; return of sources; procedures for monitoring tsdiation and contamination levels of packages; HAZMAT training; and records and reports.)

l 87117, Appendix A A-6 Issue Date: XX/XX/XX

5 C

12. NOTIFICATIONS AND REPORTS:

(Overexposure and misadministration reports; administrative changes in RSO, s authorized users, and physicist; reports to individuals)

13. POSTING AND LABELING:

(Notices; license documents; regulations; bulletins and generic information; area ,

postings; and labeling of containers of licensed material) l

14. MISADMINISTRATION:

(Review misadministration cases, if any, and ensure appropriate corrective actions were

, taken.)

l l

e issue Date: XX/XX/XX A-7 87117, Appendix A

i 6

15. JNQEPENDENT AND CONFIRMATORY MEASUREMENTS:

(Areas, both restricted and unrestricted, surveyed and measurements made; comparison of data with licensee's results and regulations; and instrument type and calibration date)

! i l

l l

l l 16. VIOLATIONS. NON-CITED VIOLATIONS. AND OTHER SAFETY ISSUES:

(State requirement and how and when licensee violated the requirement. For non-cited violations, indicate why the violation was not cited. Attach copies of alllicensee I documents needed to support violations.)

l l

t

, 17. PERSONNEL CONTACTED:

(identify licensee personnel contacted during tne anspection (including those individuals contacted by telephone).]

l Use the following identification symbols:

Individual (s) present at entrance meeting

Individual (s) present at exit meeting 87117, Appendix A A-8 issue Date: XX/XX/XX l

i

s

18. PERFORMANCE EVALUATION FACTORS:

A. Lack of senior management involvement with the radiation safety program and/or RSO oversight ()Y()N B. RSO too busy with other assignments ()Y()N C. Insufficient staffing ()Y()N D. RSC fails to meet or functions inadequately () N/A ()Y()N E. Inadequate consulting services or inadequate audits conducted ( ) N/A ()Y()N Remarks (consider the above assessment and/or other pertinent PEFs with regard to the licensee's oversight of the radiation safety program):

19. Soecial Conditions or issues:

l (Special license conditions; year-2000 effects of computer software) l l

I Issue Date: XX/XX/XX A-9 87117, Appendix A

e, 4

PART111-POST-INSPECTION ACTIVITIES

1. REGIONAL FOLLOWUP ON PEFs:

i j

2. DEBRIEF WITH REGIONAL STAFF:

(Post-inspection communication with supervisor, regionallicensing staff, Agreement State Officer; and/or State Liaison Officer) l l

j l

l l

l i

3. YEAR-2000 ISSUES: !

(Convey, to the NMSS Year-2000 Coordinator, all year-2000 licensee-identified I problems and corrective actions taken.) i END 87117, Appendix A A-10 issue Date: XX/XX/XX

1 s

~

i APPENDIX A- ATTACHMENT A DECOMMISSIONING TIMELINESS INSPECTION ATTACHMENT Licensee:

Date of Inspection:

1. COMPLIANCE WITH DECOMMISSIONING T!MELINESS RULE (NOTE: Repeat the answers given in Section 12 of the main body of the inspection record. The issues in subsequent sections, are dependent on the answers to these questions.)

A. License to conduct a principal activity has expired or been revoked. ()Y()N B. Licensee has made a decision to permanently cease principal activities, at the entire site, or any separate buildings, or any outdoor areas, including inactive burial grounds. ()Y()N C. A 24-month duration has passed in which no principal activities have been conducted under the license at the site, or at any separate buildings, or any outdoor areas, including inactive burial grounds. ()Y()N D. If "Yes" to either A or B or C above:

(1) Identify Site / Bldg / Area:

(2) Date of occurrence of A, B, or C:

2. NOTIFICATION REQUIREMENTS ;

A. Licensee has provided written notification to U.S. Nuclear Regulatory Commission within 60 days of the occurrence of 1.A.,1.B., or

[

1.C.,above. ()Y()N i

If "Yes," date of notification:

l B. If the licensee is requesting to delay initiation i

of the decommissioning process, the licensee bal provided written notification to NRC within 30 days of occurrence of 1.A.,1.B.,

or 1.C.,above ( ) N/A ( ) Y ( ) N If "Yes," date of notification:

Basis for Findings:

l Issue Date: XX/XX/XX AA-1 Appendix A, Att. A

s l

.- l

3. DECOMMISSIONING PLAN / SCHEDULE REQUIREMENTS A. Licensee is required to submit a decommissioning )

plan per 10 CFR 30.36(g),40.42(g),70.38(g), or !

10 CFR Pad 727 ()Y()N I

If "No" to 3.A., answer the following items B. - F.:

B. The decommissioning work scope is covered by current license conditions. ()Y()N C. Decommissioning has been initiated within 60 days l of notification to NRC, or NRC has granted a delay. ()Y()N D. If licensee has initiated decommissioning, give dato the decommissioning was initiated:

Initiation date:

E. If decommissioning has been completed, it was completed within 24 months of notification to NRC. ( ) N/A ( ) Y ( ) N F. If decommissioning is still scheduled to be completed, it is on schedule to be completed within 24 months of notification to NRC. ( ) N/A ( ) Y ( ) N Basis for Findings:

1 I

87117, Appendix A, Att. A AA-2 issue Date: XX/XX/XX

l i If "Yes" to 3.A., answer the following items G. - J.:

G. The decommissioning plan has been submitted to NRC within 12 months of notification ()Y()N If"Yes,"date of submittal:

1 if NRC approved, date of NRC approval:

H. Has the licensee submitted an alternative schedule request? ()Y()N If"Yes,"date of submittal:

1. If decommissioning has been completed, it was completed within 24 months after approval of the decommissioning plan ( ) N/A ( ) Y ( ) N J. If decommissioning is still scheduled to b; completed, it is on schedule to be completed within 24 months after approval of the decommissioning plan. ( ) N/A ( ) Y ( ) N Basis for Findings:

4 Violations identified, if any; l

issue Date: XX/XX/XX AA-3 Appendix A, Att. A l

F ,

APPENDIX B RADIOPHARMACY INSPECTION REFERENCES

1. ORGANIZATION AND SCOPE OF PROGRAM i

License application and applicable license conditions.

l

2. MANAGEMENT OVERSIGHT l

l A. Authorized Nuclear Pharmacist 10 CFR 32.72 Manufacture, preparation, or transfer, for cornmercial distribution, of radioactive drugs containing byproduct material, for medical use under 10 CFR Pad 35.

B. Radiation Safety Officer Applicable license conditions.

C. Audits, Reviews, or inspections 10 CFR 20.1101 Radiation protection programs.

10 CFR 20.2102 Records of radiation protection programs.

Applicable license conditions.

D. As Low As Reasonably Achievable 10 CFR 20.1101 Radiation protection programs.

Applicable license conditions.

3. FACILITIES I

A. Access Control 10 CFR 20.1601,1602 Control of access to high/very high radiation areas.

10 CFR 20.1801 Security of stored material.

10 CFR 20.1802 Control of material not in storage. j Applicable license conditions. 1 l'

B. Engineering Controls 10 CFR 20.1101 Radiation protection programs.

Applicable license conditions .

4. EQUIPMENT AND INSTRUMENTATION A. Dose calibrator and Assay Instrumentation i 10 CFR 32.72 Manufacturing, preparation, or transfer.

Applicable license conditions.

Issue Date: XX/XX/XX B-1 87117, Appendix B i

8. Survsy Instrum::nts 10 CFR 20.2103 Records of surveys.

Applicable license conditions.

C. Safety Component Defects 10 CFR 21.21 Notification of failure to comply or existence of a defect '

and its evaluation.

l 5. MATERIAL USE. CONTROL. AND TRANSFER I

A. Security and Control

\

) 10 CFR 20.1003 Definitions (restricted area and unrestricted area). .

l 10 CFR 20.1801 Security of stored material. l 10 CFR 20.1802 Control of material not in storage. l l B. Receipt and Transfer of Licensed Material 10 CFR 20.1302 Compliance with dose limits for individual members of the public. '

10 CFR 20.1906 Procedures for receiving and opening packages.

10 CFR 20.1501 Surveys.

10 CFR 20.2103 Records of surveys.

10 CFR 30.41 Transfer of byproduct material.

10 CFR 30.51 Records of receipt and transfer. '

10 CFR 32.72 Manufacturing, preparation, or transfer.

l 6. AREA RADIATION SURVEYS AND CONTAMINATION CONTROL A. Area Surveys 10 CFR 20.1302 Compliance with dose limits for individual members of the public. '

10 CFR 20.1501 General.

l 10 CFR 20.2103 Records of surveys.

10 CFR 20.2107 Records of dose to individual members of the public.

Applicable license conditions.

B. Leak Tests and Inventories Applicable license conditions.

l l 7. TRAINING AND INSTRUCTIONS TO WORKERS General i 10 CFR 19.12 Instruction to workers.

General requirements for issuance of specific licenses.

10 CFR 30.33 Knowledge of 10 CFR Part 20 radiation protection procedures and requirements.

Applicable license conditions.

87117, Appendix B B-2 issue Date: XX/XX/XX

V ,,

8. RADIATION PROTECTION A. Radiation Prot:ction Program l

1. Exposure evaluation l 10 CFR 20.1501 General.

2. Programs 10 CFR 20.1101 Radiation protection programs. j B. Dosimetry

1. Dose Limits ,

10 CFR 20.1201 Occupatio1al dose limits for adults.

10 CFR 20.1202 Complian';e with requirements for summat;on of I external nd internal doses.

10 CFR 20.1207 Occuptbonal dose limits for minors.

10 CFR 20.1208 Ouses to an embryo / fetus.

Applicable license conditions.

2. External 10 CFR 2103 Determination of external case from airborne i radioactive material.

! 10 CFR 20.1501 General.

10 CFR 20.1502 Conditions requiring individual monitoring of external and internal occupational dose.

Applicable license conditions.

C. Records j l 10 CFR 19.13 Reports to workers.

10 CFR 20.2102 Recctds of radiation protection programs.

10 CFR 20.2103 Records of surveys.

10 CFR 20.2104 Determination of prior occupational dose.

, 10 CFR 20.2106 Records of individual monitoring results.

! Applicable license conditions.

9. RADIOACTIVE WASTE MANAGEMENT A. Disposal 1 l 10 CFR 20.1904 Labeling containers.

10 CFR 20.2001 General requirements.

l 10 CFR 20.2103 Records of surveys.

10 CFR 20.2108 Records of waste disposal.

10 CFR 20.2003 Disposal by release into sanitary sewerage.

IN 94-07 Solubility Criteria for Liquid Effluent Releases to Sanitary Sewerage Under the Revised 10 CFR Part 20. I i

Issue Date: XX/XX/XX B-3 87117, Appendix B

r ,,

e' B. Efflu::nts 1

j 1. General 1

Maintaining Effluents from Materials Facilities IP 87102 As Low As Reasonably Achievable (ALARA).

l 2. Release to septic tanks 1 10 CFR 20.1003 Definitions (sanitary sewerage).

l 10 CFR Part 20, Effluent Concentrations.

l App. B, Table 2 j 3. Incineration of waste 10 CFR 20.2004 Treatment or disposal by incineration.

4. Control of air effluents and ashes

! 10 CFR 20.1201 Occupational dose limits for adults.

10 CFR 20.1301 Dose limits for individual members of the public.

10 CFR 20.1501 General.

10 CFR 20.1701 Use of process or other engineering controls.

Applicable license conditions.

C. Waste Management 1

1. General i

l 10 CFR 20.2001 General requirements. 1 Radioactive Waste Management - Inspection of ;

IP 84850 Waste Generator Requirements of 10 CFR Part 20 i and 10 CFR Part 61. I

2. Waste compacted i i Applicable license conditions.

l 3. Waste storage areas 10 CFR 20.1801 Security of stored material.

10 CFR 20.1902 Posting requirements.

10 CFR 20.1904 Labeling containers.

Applicable license conditions.

4. Packaging, Control and Tracking 10 CFR Part 20, Requirements for Low-Level Waste Transfer for Appendix F Disposal at Land Disposal Facilities and Manifests.

10 CFR 20.2006 Transfer for disposal and manifests.

10 CFR 61.55 Waste classification.

10 CFR 61.56 Waste characteristics.

5. Transfer l

87117, Appendix B B-4 issue Date: XX/XX/XX

j~ ,e 10 CFR Part 20, Requirem:nts for low-1: vel waste transfer for Appendix F disposal at land disposal facilities and manifests.

10 CFR 20.2001 General requirements.

10 CFR 20.2006 Transfer for disposal and manifests.

6. Records 10 CFR 20.2103 Records of surveys.

10 CFR 20.2108 Records of waste disposal.

10. DECOMMISSIONING 10 CFR 30.36 Expiration and termination of licenses and decommissioning of l sites and separate buildings or outdoor areas.

IMC 2602 Decommissioning Inspection Program for Fuel Cycle Facilities and Materials Licensees.

IP 87104 Decommissioning inspection Procedure for Materials Licensees.

IMC 2605 Decommissioning Procedures for Fuel Cycle and Materials Licensees.

NUREG/BR-0241 NMSS Handbook for Decommissioning Fuel Cycle and Materials Licensees.

11. TRANSPORTATION A. General NRC Charts Hazard Communication for Class 7 (Radioactive) Materials.

10 CFR 71.5 Transportation of licensed material.

Tl 2515/133 Implementation of Revised 49 CFR Parts 100-179 and 10 CFR Part 71.

B. Shippers - Requirements for Shipments and Packaging

1. General Requirements 49 CFR Part 173, Class 7 (radioactive) materials.

Subpart 1 49 CFR 173.24 General requirements for packagings and packages.

49 CFR 173.448 General transportation requirements.

49 CFR 173.435 Table of A and A 2values for radionuclides.

i

2. Transport Quantities 10 CFR 71.4 Definitions.

a. All quantities 10 CFR 71.4 Definitions.

49 CFR 173.410 General design requirements.

49 CFR 173.441 Radiation level limitations.

49 CFR 173.443 Contamination control.

49 CFR 173.475 Quality control requirements prior to each shipment of Class 7 (radioactive) materials.

49 CFR 173.476 Approval of special form Class 7 (radioactive) materials.

Issue Date; XX/XX/XX B-5 87117, Appendix B

V .& l' l

!* b. Limited quantities 49 CFR 173.421 Excepted packages for limited quantities of i Class 7 (radioactive) materials.

49 CFR 173.422 Additional requirements for excepted packages containing Class 7 (radioactive) materials.

c. Type A quantities i

49 CFR 173.412 Additional design requirements for Type A packages.

49 CFR 173.415 Authorized Type A packages.

49 CFR 178.350 Specification 7A; general packaging, Type A.

d. Type B quantities IP 86740, Section 2 Inspection of transportation activities.

e. LSA material and SCO 49 CFR 173.403 Definitions 49 CFR 173.427 Transport requirements for low specific activity (LSA) Class 7 (radioactive) materials and surface contaminated objects )

(SCO). I l

i

3. HAZMAT Communication Requirements 49 CFR 172.200-205 Shipping papers.

i 49 CFR 172.300-338 Marking.

49 CFR 172.400-450 Labeling. ;

49 CFR 172.500-560 Placarding. l 49 CFR 172.600-604 Emergency response information. 1 C. HAZMAT Training l

49 CFR 172.702 Applicability and responsibility for training and testing.

49 CFR 172.704 Training requirements ,

i D. Transportation by Public Highway 49 CFR 171.15 Immediate notice of certain hazardous materials incidents.

49 CFR 171.16 Detailed hazardous materials incident reports. l 49 CFR 177.800 Purpose and scope of this part and responsibility for !

compliance and training. I 49 CFR 177.816 Driver training.

49 CFR 177.842 Loading and unloading: Class 7 (radioactive) material.

12. NOTIFICATIONS AND REPORT.S 10 CFR 19.13 Notifications and reports to individuals.

10 CFR 20.2201 Reports of theft or loss of licensed material.

10 CFR 20.2202 Notification of incidents.

10 CFR 20.2203 Reports of exposures, radiation levels, and concentrations of radioactive material exceeding the constraints or lirnits.

10 CFR 30.50 Reporting requirements.

87117, Appendix B B-6 issue Date: XX/XX/XX I

! l l l

i

( '

,6

Manufacture, preparation, or transfer for commercial distribution.

10 CFR 32.72 Applicable licensa conditions.

i

13. POSTING AND LABELING j 10 CFR 19.11 Posting of notices to workers.

10 CFR 21.6 Posting requirements.

10 CFR 20.1902 Posting requirements. J l 10 CFR 20.1903 Exemptions to posting requirements. l l 10 CFR 20.1904 Labeling containers.

10 CFR 20.1905 Exemptions to labeling requirements. '

Applicable license conditions

14. INDEPENDENT AND CONFIRMATORY MEASUREMENTS l

No references.

15. VIOLATIONS. NON-CITED VIOLATIONS. AND OTHER SAFETY ISSUES ;

i NUREG/BR-0195, Rev.1 NRC Enforcement Manual.

NUREG-1600 General Statement of Policy and Procedures for NRC Enforcement Actions.

16. PERSONNEL CONTACTED No references.

17. PERFORMANCE EVALUATION FACTORS IP 87101 Performance Evaluation Factors. l 1

I END l

i Issue Date: XX/XX/XX B-7 87117, Appendix B

ML20217K961

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