ML20125B141

Application for Renewal of License SNM-1345

ML20125B141
Person / Time
Site:	07001366
Issue date:	02/07/1983
From:	Herdt J HEALTH & HUMAN SERVICES, DEPT. OF
To:	NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
Shared Package
ML20125A572	List: IA-84-789, Responds to FOIA Request for Documents Re NRC Insps of Medical Facilities in Washington,Dc,Montgomery & Prince Georges Counties,Md & Arlington & Fairfax Counties,Va from 1981 Until 841004.App a Documents Encl ML20125B058 ML20125B141 ML20125B757
References
FOIA-84-789 NUDOCS 8506110328
Download: ML20125B141 (2)

Text

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0 EPARTMENTOF hen TH & HUMAN SERVICES Public Hzith Irvica i

NationalInstitutes of Health Bethesda, Maryland 202o5 l f&

P aterials Licensing Branch February 7, 1983 L. S. Nuclear Regulatory 4 Commission h ashington, D. C. 20555 tear Sir or Ms:

his letter is to request that the National Institutes of Health's special ruclear materials license SNM-1345, due to expire April 30, 1983, concerning g lutonium pacemakers be renewed / amended so that the following authorized activities may continue:

a) Explantation and return of said devices to manufacturer for proper disposal.

To consider the return of one pacemaker stored but not i

impianted.

b) Continued monitoring of patients with implanted devices.

1;he aforementioned activities shall be conducted by the licensee whose name qnd mailing address as they should appear in items one(1) and two(2); should read:

1.

Department of Health and Human Services 2.

National Institutes of Health Building 21 g

Room 112 Bethesda, Maryland 20205 lhe number and type of pluton,ium pacemakers to be authorized under SNM-1345 a re:

Ten (10) Coratomic C-101 Plutonium Pacemakers e-J,,,.

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One (1) ARCO NU-5 Plutonium Pacemaker 1herefore the current posession limits covered in item eight(8) need be 3amended to:

8a) 2.5 grams (10 individual sources not to exceed 250 milligram each) 8b) 0.420 grams (1 source not to exceed 420 milligrams) e g

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Page 2 5 Authorization for the Coratamic C-100 pacemakers is no longer required as no latients have implanted pacers with this model type.

Therefore item 9b should le amended to read:

9b) Implantation in humans as a component of Coratomic Model C-101 nuclear powered cardiac pacemakers for clinical evaluation purposes in accordance with Numan Clinical Protocol for the Coratomic C-101 Radioisotope Powered Cardiac Pacer", dated November 1,1975.

P esently no update is required to the list of authorized physicians as stated the current license. No additional changes or amendments are requested at is time other than those previously mentioned.

All activities shall cientinue in accordance with conditions stated in license SNM-1345 as most irecently amended June 24, 1982.

1 If you have any questions regarding this application for renewal or need f

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urther information, please contact Dr. R. J. Augustine, Radition Safety Officer, NIH. We appreciate your consideration of this renewal.

Sincerely yours, A

f. O' Jean'A.W rdt, M.D.

Chaffman, Radiation Safety Comittee, NIH b,,'

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_, O License Nos: 19-00296-11 0:cket Nos: 30-01786 19-00296-12 30-07724

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19-00296-17 19-00296-18 30-06922 19-00296-19 30-08478 SNM-1345 30-17777 30-17787 70-1366 Department of Health and Human Services N:,tional Institute of Health ATTH: Thomas E. Malone Acting Director 20014 B;thesda, Maryland 22/81-01; Gentlemen:

30-01786/81-01; 30-07724/81-01;30-069 Combined Inspection Nos.30-08478/81-01;'30-17777/81-01; 3

Subject:

letter 19, 1982, in response to our This refers to your letter dated March 18, 1981.

documented dated December Thank you for informing us of the corrective and preventi in your letter.

your licensed program.

Your cooperation with us is appreciated.

Sincerely, c r ;;,......... _,i.

. % f,t c c f Rocoa4 M J Thomas T. Martin, Director 7 Division of Engineering and Technical L

Programs cc:

Public Document Room (POR) Center (NSIC)

Nuclear Safety Information State of Maryland, Region I Docket Room (with concurrences) bec:

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DEPARTMENT OF' HEALTH AND HUMAN SERVICES o

PUBLIC HEALTH tERVICE NATIONAL INSTITUTES oF HEALTH asTHaseA MAnyt ANO asons i-MAR 191531 n

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i Thomas T. Martin, Director, Division of Engineering and Technical Inspection j

. United States Nuclear Regulatory Comunission l

Region I 631 Park' Avenue King of Prussia, Pennsylvania 19406 Docket No. 30-1786 License No. 19-00296-10

Dear Sir:

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This is in reply to your letter of 18 December 1981 regarding your findings during Inspection No. 81-01. We appreciate the considerable effort undertaken on the part of your staff in conducting what was characterized by Dr. Glenn as a " Systematic Review of Licensee Perfor-mance", and the thought that is reflected in your' report. We recognize I

the dilemma posed by finding a small quantity of unsecured licensed material in an unrestricted area and appreciate your recognition that the material did not create a hazard significant enough to impose a i

civil penalty. This problem was corrected innnediately and we are taking additional steps to prevent future occurrences.

.The importance of more directly involving management in securing comp-liance with radiation safety objectives is recognized and will be accomplished through new procedures we are implementing. These and other, concerns addressed in your letter are discussed in more detail in 1 t'he attachments I through IY to this letter.

j I sa confident that the actions we are takids wilk reqq1ve the problems discussed in your letter. If you need clarification of'*any of the i

material presented, please do not hesitate to contact Mr. Roger W. Broseus, Radiation Safety Officer, NIH, Building 21, Room 112; phone (FTS) 496-2254.

Sinceral yours,

- f Thomas E. Malone, Ph.D.

U Acting Director, NIH i

Attachments A uniW oo m o n,,/E*//

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Attachment I.

Failure to adequately secure licensed material (violation; i

NRC FINDING:

Reference Appendix A, Notice of Violation, Item A, and, DETAILS, Item 12.)

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RESPONSE

The two items of non-compliance specifically referenced in Appendix A, Item 12 - storage of waste in a hallway and I-125 storage in an unlocked refrigerator - were corrected during or shortly after the inspection.

i Since the inspection, the Radiation Safety Branch (RSB) has given added emphasis to this problem area in its surveillance, training and information, and other activities.

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Waste in hallways:

i In March of 1981, the RSB reviewed radioactive waste handling procedures f

This at the NIH and issued a reminder of procedures (Attachment I-1).

was mailed to authorized users (principal users of radioactive materials) and individual users working under their supervision - approximately This material is also included as a handout during safety 4

courses presented by the RSB, and the lectures dealing with this subject 4000 persons.

Increased attention is being given to were also reviewed and improved.

waste handling practices during surveillance activities by RSB and In those isolated instances where poor survey contractor personnel.

practice is found, corrective action is taken in an expeditious fashion.

The waste is moved immediately to a restricted area or to the wasteThe infractio processing area in Building 21. authorized users and a follow-up survey is mad l

The NIH stands in substantial compliance with i

practice does not recur.

good practice on this item.

Storage of radionuclides in hallways:

i Our experience in implementing our current policy regarding the storage of radionuclides in refrigerators and freezers located in corridors has l

been less than satisfactory (this policy, contained in our letter of 23 June 1978, allowed for storage in corridors of greater than exempt quantities in locked refrigerators and freezers; lesser quantities wereBeca i

not required to be locked).

in implementing this policy, we are changing it as follows:

The USE of radionuclides in corridors will be specifically we may permit the use of 1.

prohibited, with one exception: In certain buildings, it is nuclear counters in corridors.

quite difficult to locate bulky counters, usually of the i

We consider the presence multi-sample type, in laboratories.

of nuclear counters in corridors to be acceptable because the samples used in such devices are very low in activity Indeed, the NRC recognized that the activity content 4

content.

of most liquid scintillation vials is quite low in its 11, 1981 (46FR16230).

(This change to 10 CFR 20 of March class of samples is representative of those most frequently used at biomedical research institutions such as ours).

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The policy relating to STORAGE of radionuclides in ccrridsro we will continue to permit the 2.

will be changed as follows:

storage of esempt quantities of radionuclides in corridorsThe without their being in a locked refrigerator or cabinet.

storage of greater than exempt quantities in corridors will, however, be specifically prohibited.

We anticipate that this change in policy will overcome the problems experienced but that it will take a period of time to LapleLent due toWe will allow a the impact it will have on space utilization.

grace period for bmplementation by our research staff; after that time, d in the RSB will be authorized to impound radioactive materials founThe authorized corridors in violation of this policy.

be in violation of this policy will have his or her authorization suspended for a period of at least one week by the Chairman, Radiation Committee, and be required to indicate in writing the actions taken to correct theAny re deficiency and prevent future violations.

will result in severe disciplinary measures being taken.

Other issues:

In your discussion relating to the above topics, it was stat b

has no system for accounting for licensed materials (Appendix A 16, Item 12).

i to discuss forthrightly the complexities involved in administer ng a To portray radiation safety program at an institution so large as ours.

these complexities as a system lacking controls is to grossly over future inspection is conducted; in the meantime, let us briefly describe the situation.

our accountability and control procedures and describe corrective actions we are implementing to overcome the problems we perceived your representatiy to have identified during the inspection.

All radioactive material shipments are received through the RSB's a

facilities located in Building 21; exceptions to this procedure are rare (e.g., irradiators are delivered directly to the facility where they are The RSB controls the distribution of these shipments i

to be installed).

to ensure they are only delivered to authorized user laboratories.

Users are responsible for maintaining contrql over their materials and for maintaining records on receipt and dispositioE ofir,4dionuclides, Wastes are returned to e.g., on form NIH-88-16 (Attachment I-2). Building 21 for appropr are handled through the RSB to assure proper packaging and transfer toT appropriately licensed facilities.

inventory program; maintains strict control on materials which are required to be utilized in Building 21; maintains strict accountability for sealed sources in association with its leak testing program; and administers a strict accountability program for brachytherapy sources.

(Further information relating to our control system is contained in the 19-00296-10, and accompanying application for our licenses, especially correspondence.)

RSB personnel perceivcd during the inspection that your principal concerns

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ri Pagn 3 are with accountability for those materials which account for the great majority (in terms of numbers) of radionuclide shipments received at the The NIH those distributed to and used in research'1aboratories.

We are necessarily NIH:

receives about 18,000 such shipments per year.

dependent upon the authorized users of these materials to maintainWe control over and ensure proper disposition of licensed materials.

will collect data relating to material accountability that may assist in your evaluations during the next inspection. This activity will involve a random selection of shipments received by the NIH and the tracking of those shipments to ensure that its accountability is adequate; violation of good practice will be resolved as described in Attachment III of this reply.

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Attcchment I-1 Ptss 4 Nntional Institutes of H:cith RADIOM. IVE WASTE P!0CEDUES FOR LABORATORIES T

"RADIMCTIE ilASE" means any and all wastes that contain, or are contaminated with, any radioactive material used in the laboratory.

This includes liquids, solids, trash, animal carcasses and excreta, used scintillation counting liquids, etc.

RADI0ACTI E WASTE shall not be thrown in the ordinary trash cans or poured down the drain. Waste and trash which are not radioactive should never be thrown in with radioactive wastes. The cost to NIH for disposing of radioactive waste is very high.

Please help reduce this cost by keeping non-radioactive trash out of the radioactive waste!

RADIMIW WASTE shall fEWR be stored or Placed in HALWAYS or other PlBLICAREAS.

LlallD RADI@CTIE ilASTE must be kept separate from dry waste and placed in plastic carboys or other secure containers, tightly capped, and properly labelled with " CAUTION-RADI0 ACTIVE MATERIALS".

Liquid waste carboys can be requested from the waste pickup contractor (call 490-8100). Never fill the carboy above the line indicated (or to a height greater than the maximum diameter of the container). Containers which are over-filled will not be removed until you reduce the volume to the proper level. S'olid or dry wastes must never be put in the liquid wasta containers. Always place absorbent paper under the liquid waste carboy.

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.+a DRY er SOLID PADI0 ACTIVE WASTE shsuld b2 picccd in cpicimi Icb211sd containers which can be requested from the waste pickup contractor (call 490-8100). Absorbent pads may be placed in the bottom of dry waste containers to absorb any residual liquid which may adhere to waste items. Always place absorbent paper under the dry waste container.

SiORT Half-LIFE MW (radioactive half-life of less than 30 days) must be kept separate from [QM HA[f-LIE WASTES (half-life of 30 days or greater).

If necessary, use separate carboys or dry waste containers for each category, labelled with the radionuclide(s).

fRHES, SCALPELS,PASTEURPIPtilts,andanyothersharpobjectsmustbe capped and put in a cardboard box or suitable container (NIH Stock Number 4-0701) to prevent injury to waste pickup personnel, before placing them in the radioactive waste container.

LITID SCIllTILLATim VIALS containing radioactive liquid must be eishely capped and placed in the original shipping tray. The tray should be labelled with " CAUTION-RADIOACTIVE MATERIALS" and note the radionuclide(s).

The shipping tray will be picked up upon request.

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BFIY LIWID SCitiTIMTim VIALS which are contaminated with radioactivity l

l should also be capped and placed in the shipping tray.

(JM SCl(([ILLATIm WITifE LITID (not radioactive) should be dispeaed as a hazardous chemical waste and not put with radioactive waste.

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. Full or

@f% @jl[lTi M should be capped if they contain liquid.

for pickup, or empty gamma tubes should be placed in the original trays lined cardboard container.

they can be put in a properly labelled plastic-BIN RAI)l0ACilVE WASTES must be autoclaved or for pickup.

agent otherwise inactivated before releasing these wastes CARCIEGBilC, PYROR0RIC, or other highly T0XIC or HAZAR in the radioactive waste should be clearly identified and precaution t pickup taken to provide for safe handling by the radioactive was e Plans for the proper disposal of these materials should be

' personnel.

i tages of reviewed with the Radiation Safety Branch in the early des gn s an experiment.

1. 11R CARCASSES containing radioactivity must b1 placed in Large animal carcasses.(dogs, monkeys, etc.) after polyethylene bags.

b 4-bagging must be placed in a cardboard container (NIH Stock Num e fit A large carcass should be cut up, if necessary to properly 0780).

Each carton must be conspicuously marked " CAUTION-in the container.

f RADIOACTIVE MATERIALS", along with the radionuclide and the If carcasses are to be held more l

radioactivity at a specified date.

If they will be frozen.

than 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br />, they should be refrigerated or held more than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, they must be frozen.

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1. 11% D(CfETA containing radioactivity should be co11=ct I

TIVE MATERIALS",

suitable container, and labelled with " CAUTION-RADIOAC noting the radionuclide and amount of radioactivity.

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P g3 4c RADIATIQ1 E RA M from ceseca rcdiccceiva w::co chn11 nst excoca 2.5 millirem per hour in the laboratory. Radiation dose rates in hallways i

and other public areas resulting from waste (and other radiatien sources) in the laboratory must be limited to less than 2 millirem in any hour or 100 millirem in any 7-day period.

If necessary, shield the stored wastes to comply with these limits.

PIO4JP of PADI0 ACTIVE WASTE can be requested by CALLIM the radioactive waste contractor at 490-8100.

At the tLee of the request be prepared to provide the following information:

1.

Your name, building, and room number.

2.

Type of waste, i.e.,

liquid, solid, carcasses, liquid scintillation vials, etc.

3.

The radionuclide(s) in the waste.

4.

The estimated amount of activity for each radionuclide.

5.

Any special instructions.

Q.ESTIGIS or SPECIAL PIGlBE involvins radioactive wastet call the Radiation Safety Branch for assistance: 496-5774.

Radiation Safety Branch Division of Safety National Institutes of Health

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Pag 2 6 NRC FINDING: Mouth pipetting of solutions in a restricted area (violation; Reference Appendix A. Notice of Violation. Item B, and, DETAILS, Item 6.f.)

RESPONSE

The deficiency noted in Building 10, Room 11D07 was corrected expedi-tiously by securing the agreement of laboratory personnel to use remote pipetting aids. Subsequent follow-up surveys have shown the lab area to be in compliance. RSB staff is continuing efforts to ensure that indivi-duals working in restricted areas do not pipet by mouth. This includes giving emphasis to proper pipetting practice in training courses and during surveillance activities.

In addition, we will issue a memorandum to radiation users informing them of the necessity of using pipecting aids, rather than pipetting by mouth, in restricted areas.

This and the activities of RSB personnel should correct any misunderstandings that some individuals may have about the appropriateness of pipetting non-radioactive materials in restricted areas.

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Attachment III.

Page 7 NRC FINDING: Failure to communicate audit results to required level of i

management (Deviation from written conniement; Reference your cover-letter, and DETAILS, Item 4.)

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RESPONSE

Our review of the commitment made in our letter of 13 April 1979 and the procedures needed to haplement it indicates that the commitment went far beyond what is needed to meet the spirit and intent of management involvement.

For example, we believe that providing a complete list of laboratories inspected to top management is unnecessary and would not provide the best basis for useful management involvement. Many deficiencies are corrected during the surveys conducted by RSB staff and its contractor l

personnel, or shortly thereafter as a result of follow-up actions. The r

procedures to involve quagement will be revised as outlined below; these procedures will be Laplemented within three months.

I.

The Radiation Safety Branch and/or Chairman, Radiation Committee will report the following to the Scientific Director of the appropriate Institute, on a monthly basist l

1.

Those instances wherein RSS staff is unable to elicit l

corrective action in a timely manner through their interactions with the research staff, as evidenced by continuation of problems noted at the time of a follow-up survey.

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will be given to problems that may lead to violation of f

regulations and license conditions.

i 2.

Patterns of performance that reflect laxity on the part of authorized users in maintaining good radiation safety practices, 1

as exemplified by repeated occurrences of problems that had been previously corrected through the efforts of RS8 personnel.

3.

The Radiation Safety Officer or Chairman of the Radiation l

Committee will report other problems that, in their judgement, I

may be appropriately resolved through the management chain, or

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serve to keep management informed regarding the status of radiation safety in his or her Institute.

h II.

In those cases where the Chairman, Radiation Committee, suspends l

or revokes the authorization of investigators to possess and utilize l

licensed materials, the appropriate Scientific Director will be L

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informed immediately.

This will also be accomplished when the NIH

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l notifies the NRC of overexposures, theft or loss of licensed i

materials, and other incidents as required by 10 CFR 20.402-405.

Copies of the reports identified will also be provided to the Deputy 1

Director for Science for his information. Scientific Directors will be i

responsible for assuring that corrective action is taken and that the l

Radiation Committee Chairman is advised of the corrective steps that l

have been taken, results achieved, and actions taken to avoid further

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violations. Unsatisfactory responses will be referred to the Deputy Director for Science for final resolution.

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r Peg 2 8 Other Issues:

In your letter sucmarizing the findings of your inspection, you requested a discussion of " actions taken or planned to improve communi-cations between the Radiation Safety Staff and laboratories and to improve your management control systems..." especially with regard to the assignment and terminations of radiation workers. We are planning to initiate the following steps to facilitate this improvement.

For each person authorized by the Radiation Committee, a memorandum from the Radiation Safety Officer will be placed in that individual's personnel file regarding actions to be taken when an authorized user terminates his or her assignment at the NIH or transfers to a facility not covered by our broad license.

The action will require that the RSB be notified by the personnel office of the appropriate Institute of the date that the individual will terminate or transfer, so that an orderly transfer of radioactive materials charged to that person can be effected.

This will also allow for the reassignment of radiation workers who are not authorized users to a new authorized user.

The Division of Personnel Management, NIH, will issue NIH's instructions for such notification to personnel offices of the Institutes.

The RSB will prepare and distribute the formal papers to the personnel offices for each authorized user's personnel file. This management control system should prevent the termination of an authorized user without the knowledge of the RSB.

This system should be in effect by April 1, 1982.

For those individual radiation workers who are not authorized users, the RSS will be kept informed of separations from NIH by being sent computer printouts which identify such individuals on a monthly basis.

For new employees, a system is under development in the Division of Safety (DS) which would require the Institutes' personnel offices to inform DS of new employees or appointees. A questionaire will be completed by employees to assist the DS in identifying new employees who may be working in situations that require DS oversight or interaction with the employee.

This schene will be structured to identify new radiation workers to the RSB so that they may be registered with RSB and receive the necessary training, personnel monitors, etc.

It is expected that such a screening system for new employees will be operational by October 1, 1982.

Attachment IV.

Page 9 NRC FINDING: Failure to maintain records of audits (Deviation from written comunitment; Reference DETAILS, Item 7.b.)

RESPONSE

The individual assigned to supervision of radioactive waste disposal operations has been instructed to maintain written records of quarterly audits. His supervisor, the Radiation Safety Officer, will ensure that this occurs, and, the NIH is in compliance with this commitment.

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JUN 2.n 1982 Docket No. 30-01786 License No. 19-00296-10 Department of Health and Human Services National Institutes of Health ATTN:

W. Emmett Barkley, Ph.D.

Director, Division of Safety Bethesda, Maryland 20205 Gentlemen:

Subject:

ORAU Report-Environmental Surveys Around NIH, Bethesda, Maryland This refers to your letter dated June 1, 1982, in response to our letter daced May 8, 1982.

Thank you for providing your comments on the suggestions contained in the ORAU Report and your plans to review your er.vironmental monitoring program.

We are pleased that you found the study results helpful.

Your cooperation with us is appreciated.

Sincerely, or1s1881 SAM Q

MYu cM P OKI L-f John D. Kinneman, Chief Materials Radiological Protection Section cc:

Public Document Room (POR)

Nuclear Safety Inforpation Center (NSIC)

State of Maryland /

Roger Broccus, Radiation Safety Officer /

bec:

Region I Docket Room (w/ concurrences)

R. Wilde, NMSS (with letter from NIH) b~

Y McGinness/ntm Kinneman

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DEPARTM ENT OF llE AL..( & IIUM AN SERVICES Public Hxlth S;rvico in NationalInstitutes of Health Bethesda, Maryland 20205 JUN 1 1982 Mr. John D. Kinneman, Chief Materials Radiological Protection Section U.S. Nuclear Regulatory Com:nission Region I 631 Park Avenue King of Prussia, PA 19406

Dear Mr. Kinneman:

This is in reply to your letter of May 3, 1982, regarding the report of the environmental survey performed at the National Institutes of Health by personnel of Oak Ridge Associated Universities in August 1981.

We are pleased with the results of the survey. They indicated that direct radiation levels in unrestricted areas were within Federal guide-lines, the radionuclide concentrations in stack effluents (with one exception) and in the sanitary drains were within allowable limits, and that there was no evidence of environmental accumulation of radionuclides attributable to NIH operations, except for low levels of I-125 and H-3 in the immediate vicinity of Building 21.

The final conclusion that our envirorsental monitoring and control program is adequate and that reliable data are being generated for confirming compliance with Federal regula-tions is reassuring to us.

The one exception to stack effluents being in compliance was due to a ruptured charcoal filter which, as noted in the report, has been replaced.

In addition, the exhaust fan for this particular system has recently been renovated.

The NIH Radiation Safety Branch is currently reviewing the environmental monitoring program, including consideration of the usage of radionuclides in each building, the volume of air exhausted, the filtration provided, and the history of effluent measurements to determine if the current monitoring program needs revision. We will keep you advised of the results of this review and any changes in the monitoring program.

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4 Page 2 - Mr. John D. Kinneman, Chief Thank you for giving NIH the opportunity to participate in the study, and please give our compliments to Bernadette Rocco and the project staff of Oak Ridge Associated Universities for the fine report of the study.

Sincerely yours, A'/

,W. Emmett Barkley, P D.

Director Division of Safety cc:

Donald Nussbaumer NRC Robert Corcoran, State of Maryland Bernadette Rocco, ORAU

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t JUN 8 1983 Docket No. 3048478 License No. 19-00296 17 s

Department of Health and Human Services National Institutes of Health ATTN:

R. J. Augustine, Ph.D.

Radiation Safety Officer Bethesda, Maryland 20205 Gentlemen:

Subject:

Shipment of AECL Gamma Cell 40 -

This refers to ycur letter dated March 15, 1983.

Thank you for informing us of the shipment on February 25, 1983, of an AECL Gamma Cell 40 irradiator from NIH, Bethesda, Maryland, to the NIH Frederick Cancer Research Center in Freder-ick, Maryland. You explained that even though this irradiator was packaged in accordance with applicable regulations, the package was of foreign manufacture and had not received appropriate approval for shipments of radioactive material g

t:ithin the United States.

This shipment may represent a violation of the conditions of your license and/or NRC and DOT regulations. You are advised that for such shipments in the future you should obtain an exemption fr.om this requirement by application to both the Department of Transportation and the U. S. Nuclear Regulatory Commission.

We will review this matter during the next inspection of your licensed activities.

Your cooperation with us in this matter is appreciated.

Sincerely, origimi Alp

• N1 John D. Kinneman, Chief Nuclear Materials Section A *

't cc:

j*,

6 Public Document Room (POR)

Nuclear Safety Information Center (NSIC)

State of Maryland bec:

R:gion I Docket Room (w/ concurrences)

R. Mcdonald, NMSS (w/ incoming letter)

R. Gr

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5/24/83 0FFICIAL RECORD COPY

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Public Health Servica EEFARTMENTCF HEA 'N 4. HUMAN SERVICES NationalInstitutes of Health Bethesda, Maryland 20205 March 15, 1983 Mr. John Kinneman U.S. Nuclear Regulatory Commission Region I 631 Park Avenue King of Frussia, FA 19406

Dear Mr. Kinneman:

This is to advise you that an AECL Cassnacell 40 irradiator containing approx 25, 1983, from NIH, instely 3600 curies of Cs-137 was transferred on Februaryto the NIH Frederick Cancer 19-00296-17) h Bethesda, MD (NRC License No.

19-21091-01 issued to t e Research Facility, Frederick, MD (NRC License No.The irradiator was packaged in facility contrattor, Frogram Resources Inc.).accordance with 10 d been The irradiator had not been uncrated and set up at NIH, Bethesda, but ha 4

in storage for a period of time and was than transported, still in itsil original shipping crate, to the Frederick, MD location by the same commerc from riggers and haulers char initially brought the irradiator to Bethesda Canada.

dian The NIH had not registered (if applicable) with the DOT as a user of Cana Certificate No. CDN/2028/B(U)T revalidated by DOT as Certificate No.

A copy of these USA /0132/B(U)T-Revision 1, at"the time of the shipment.

certificates is enclosed for your information.

Sincerely.

,09. En R. J. Augussi e,Jph.D.

Radiation Safety 6fficer, NIH l

l Enclosures Director, Fuel Cycle and Material Safety Division, NRC Chief, Transportation Certification Branch, FCMSD, NRC cet Director, Office of Hazardous Materials Regulation, DOT D @/v M M Y,

he,O RESEARCH AND SPECIAL PRoGCAMS AoMINISTRATloN DEPARTMENT OF TRANSPORTATION WASHINGTON. O C. 20590 IAEA CERPIFICATE OF CD4PE. DTP MmiORITY T

Type B Radioactive Material Package Design,

naranto; Certificate Number USA /0132/B(U)T (Bevision 1)

(Bevalidation of Canadian Certificate CDN/2028/B(U)T)

This establishes that the packaging design described herein, when loaded with the authorized radioactive contents, has been certified on September, 19, 1980 by the National CaTetent Authority of Canada (Appendix A), as meeting the regulatory requirments for Type B packaging for radioactive materials as prescribed in IAEAl Regulations and constitutes a revalidation of that certif,1cate in accordance with ss 49 CFR 173.393b and 173.395(b)

(3) of the USAd Regulations for the transport of radioactive materials.

I.

Package Identification - Gamacell 40 Irradiator.

II.

Packacing Descripticn - Packaging authorized by this certificate consists of two leet-shielded steel weldments mounted on a single akid within a plywood shipping case measuring approximately 2130 m (84") long, 990 m (39") wide and 1730 m (68") high and weighing about 3,000 kg (7,500 pounds).

III.

Authorized Radioactive Contents

'Ihe authorized contents consist of radioactive materials as not more than 4,000 curies of cesitan-137 as further limited in Canadian Certificate CDN/2028/B(U)T (Appendix A).

IV. General Q)nditions -

Each user of this certificate nust have in his possession a copy of a.

this certificate.

b.

Each user of this certificate, other than Atomic Energy of Canada, Ltd.

Ottawe, Canada shall register his identity in writing to the Offica of Hazardous Materials Regulatims, Materials Transportation Bureau, U. S.

Department of Transportation, Washington, D. C. 20590, This certificate does not relieve any consignor or carrier fran em-c.

pliance with any requirment of the Goverment of any country through or into which the package is to be transported.

V.

Marking and Labelint - In addition to the markings procribed in Canadian Certificate CDN/202W/B(1)T the package nust also bear the marking USA /0132/B(U) as well as the other marking and labels prescribed by the USA Hegulations.

La P gs 2 Certificate Number USA /0132/B(U)T, Fev.1 Expiration Date - This certificate, unless rened, expires on Septarber VI.

30, 19t$3.

Itis certificate is issued in accordance with the requiranents of the IAEA and USA Regulations ard in response to the Septenber 26, 1980 petition by G. E.

Dillingham, Ogdensburg, N. Y. ard in consideration of the associated information provided in Caruwlian Certificate CDN/2028/B(U)T (Apperdix A).

i Certified by afaun Alma n /9%

R. R. Rawl (Date)

Designated U. S. Conpetent Authority for the International Transportation of Radioactive Office of Hazardous Materials Regulation Materials Transportation Iktreau U. S. Department of Transportation Washington, D. C. 20590

1. Safety Series No. ti, Regulations fcr the Safe Transport of Radioactive Materi 1973 Revised Editicm", published by the International Atanic Energy Agency (IAEA),

Vienna, Austria.

2Title 49, Code of Federal Regulations, Part 100-199, USA.

Revision 1 issued to incorporate Revision 2 of Carwitan certificate Cal /2028/B(U)T, extend e51 ration data and reflect conformance with the 1973 IAEA regulations.

I

Commin.de contr6kr I.

Atomc Energy Controi Board de renergie atomque 19 Septeter 1980 s

w=

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w.- - -.

30-A2-175 RADIOACTIVE MATERIAL TWE B(U) PACKAE DESIGN AND SHIPbETT CERTIFICATE CDN/2028/B(U)T, REVISICN 2 1his certifies that the packaging, as described, vben loaded with the authorized radioactive ccntents and prepared for @.irnt in accordance with the instnetiens described below, has been denanstrated to meet the regulatory requirienents prescribed for Type B(U) packages and shipnent as described in IAEA (1) and Canadian rwgulaticns (2)(3)(4)(5) as appropriate, for the transportaticn cf radioactive material.

Each shipper tmder this authorization, other than the original applicant, shall register his identity with the Atcmic menJy Ccntrol Board prior to his first use of this authorizaticn and shall certify that he possesses the necessary instru:tions for prwperaticn of the package for shipnent.

1his Certificate does not relieve the shipper and carrier frun ccrrpliance with any rwquiriment of the goverrrnent of any cotntry thrrugh or into *ich the package will be transported.

PACKAE IDENTIFICATICN:

Gstmacell 40 Irradiator.

PACKAGING DESCRI NION Gamacell 40 Irradiator as described cm Atcmic merv/ of Canada Limited, Cu....cial Prubets drawing AlO244 (Rev. F) consisting of two steel-encased, 150 m thick lead-shielded 152 m soun:e heads.

Ea6 head is mounted separately cm the stporting skid. 1he lower head is enclosed in a metal cabinet and mounted at a stru:tural steel base. Each sourre head is ccrnpletely wrapped within thermal insulaticn. The irradiator asserrbly is shipped within a plywood shipping case having overall dimensions of 2130 m length by 990 m width by 1730 m hei@t.

1he containment systern for each source head consists of the source capsule, the scurre drawer, the shipping and plate and spacer, and the steel-encased lead-shielded body. The total wei@t of the package is 3384 kg.

i 1his package shall bear the ccrrpetent authority identificaticn mark "CIN/2028/B(U)T".

AUfNCRIZID RADIOACTIVE CCNTDfrS tbt more than a total of 144 TBq (4',000 curies) of cesiun-137 in the form of cesium. chloride caprissed powder pellets contained within two AfrL-CP C161 r

l Type 8 do@le-walled welded stainless steel capsules (one cgsule in each 1

irradiator head). The total decay heat load is not more than 20 Setts.

P.O. Box 1046 C.P.1046 Onsas. Canada Ortswe Canada Page 1 of 4 l

K1P W KIP W L

SHIIHENT 1he package shall be prepared for shipnet in accordance with AfrL-CP Spec Po.121 "The Preparation of Type B(U) B(M) Packages Containing Radioactive Sourt:es Prior to Shipnent" (Rev. C) and shall be further prepared for shipnent ed shipped and carried in E - erhe with the most recent Canadian Regulaticns for road (2), rail (3), marine (4) and air (5) transport ed with the intemational regulations (1). 1his certificate authorizes shipnmt by read, rail, marine ed air transport.

1his Certificate is issued in accordance with the IAEA Regulations (1),

the Atcmic Dwtw Cetrol Regulaticris (2), and by agreement with Canadian trasportation rwgulatory authorities.

EXPIRY DA1E 1his certificate egirus 30 September 1963.

4 Page 2 of 4 1

'l

' C^rtificd byt Endorscd 07:

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J. G. Q M$nus

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Chiof - Safeguards - Nuclear !!ateriald Director of Operation Liccnsing Division Railway Transport Committee Directorate of Licensing Canadian Transport Commission Atczic Energy Control Board Ottawa, CANADA P. O. Box 1046 Ottcwa, CANADA (A3 ting competent authority for rocd transport)

ANW

' R. L. Bolduc 7 p.G. W. Graves, Director Dircctor, Aeronautical Licensing Ship Safety Branch cnd Inspection Branch Canadian Coast Guard Civil Aeronautics Transport Canada Tecnsport Canada Ottawa, CANADA Ott wa, CANADA REFTRDCES (1) IAEA "Regtdatims for the Safe Transport of Radioactive Materials",

1973 Edition Safety Series No. 6, Intemational Atomic Diergy Agency, Vierina STI/ PUB /323.

(2) Atomic Diergy Control Reg.ilaticris, SCR/74-334 dated 4 June 1974, and anendwit s o R / 78-5 8 d a t e d 16 J an u a ry 19 78.

(3) Reg.tlations for the Transportation of Dungen:us Ccmodities by Rail, as issued by the Caiadian Transport Comissicri.

(4) DCO "Intemational Dungerous Goods Code". A p licable to carriage by water bome vessel.

(5) IATA " Restricted Articles Regulations". Aplicable to carriage by ai r.

s Revisics) 1:

12 February 1979. Authorized Radioactive Ccntents and Shipnerit notified. References modified.

Revisicas 2: 19 Septarrber 1960. Packaging Descripticri modified.

Expiry date changed.

.i Page 3 of 4

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21 MAR 1984 License No. 19-00296-10 Docket No. 030-01796 Department of Health & Human Services National Institute of Health ATTN: Dr. James B. Wyngarden Director 9000 Rockville Pike Bathesda, Maryland 20205 Gentlemen:

Inspection No. 030-01796/84-01

Subject:

i This refers to the routine safety inspection conducted by Mr. C. R License No.

of activities authorized by NRC h

and to the discussions of our findings held by Mr. C. Rowe wit 22-24, 1984 office on February tion.

Dr. Barkley and Dr. Augustine of your staff, at the conclusion of the i 19-00296-10 The inspection was an examination of activities conducted under yo Commission's rules they relate to radiation safety and to compliance with theThe inspection cons and regulations and the conditions of your license.

interviews with selective examinations of procedures and representative records, by the inspector.

personnel, measurements made by the inspector, and observations Within the scope of this inspection, no violations were observed.

In accordance with Section 2.790 of the NRC's " Rules of Practice l

d in Title 10, Code of Federal Regulations, a copy of this letter will be p ace the Public Document Room.

Your cooperation with us in this matter No reply to this letter is required.

is appreciated.

thhhigned Byr JohnD. Kinneman fThomasT. Martin,DirectorDivision of Enginee Technical Programs cc w/ encl:

Public Document Room (PDR)

,qf fg Nuclear Safety Information Center (NSIC) 6 d f)

/ Of State of Maryland Dr. Augustine, Radiation Safety Officer bec w/ encl:

Region I Docket Room (w/ concurrences)

Senior Operations Officer (w/o enc 1) b TP TP OL30-01796/84 0001.0.0 nuema 3 $

OFFICIAL RECORD COPY we/ cop 03/16/84 A$'

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6 MEDICAL

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, REGION I Fcrm 198-C (July 821

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LICENSE NO: / k -COAf/ - /8 DOCKET NO. (s) ON 'O/

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LICENSEE CONTACT:

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LICENSE NO: /N"88M NM -"/d CATEGmY M 8/ PRI(RITY:

J2 CATEGORY PRIORITY:

CATEGORY PRIORITY:

INSPECTION DATE (s): [ M / b / 2. / k M.

amansM TYPE OF INSPECTION: O SPECIAL C2 g

MROUTIE g imiammru w ED M YSHIFT C OTHER SUlmARY OF FINDINGS AND ACTICN CI NO NONCOMPLIANCE, CLEAR 591 ISSUED C ACTION ON PREVIOUS MCNC0ffLIANCE, APPENDIX B Cg2f NO NONCOMPLIANCE, LETTER C AONCOMPLIANCE, APPENDIX A O NONC(BFLIANCE, 591 ISSUED M UPPLEMENTAL INF0, APPENDIX C RECDPMENDATIONS SEE BASIS IN APPENDIX C O CHANGE CATEGORY TO:

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Quly 821 787108 - Medical Page of INSPECTION PLAN AND REPORT NUMBER Date:

a Plan Approved:

Licensee:

License No.

Scheduled for Post Inspection Module No. '

Inspection Items Inspection Status 30703B i

Management Meeting - Entrance g

and Exit Interviews l

(Required) t f

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787108 (Required)

Followup on-Noncompliance ~

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su.u a v.i 4 a vem i s r,.u (July 82)

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IntSPECTION REPORT NIMIE.R Page of 787108 - Medical AREAS INSPECTED AND FINDINGS Licensee:

License No:

Amendment No:

IliSPECTION ITEMS CRITERIA FINDING 1.

Organization Lic cond O

Striacture of organization as described in #

Scope r ? Patient load? /

h NOTES & REMARKS:

b Y["

yp' n y ?%d. ~L'd SW 2.

Licensee Internal Audits Lic Cond d

Scope and frequency of audits as required?

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Conducted by appropriate persons? V e

e Records maintained?

V Reviewed by management? /

p I

Deficiencies identified and corrected? V g

NOTES & REMARKS:

3.

Training and Qualification of Personnel Lic Cond O

Training & retraining conducted as required?

Written & oral exams conducted?

M Examination results reviewed,by management?

Ms Instructions to workers per 19.127 17.12

/p g; /

/N( g M M W Authorized users? On license? Available Lic Cond in emergency?

/

W' /$0 3

. NOTES & REMARKS:

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4.

Radiation Protection Procedures Lic Cond O

Procedures available and implemented?

Identify radiopharmaceutical and dose (s)?

Cover handling of patients receiving thera-l peutic doses? Cover handling of cadavers?

l l

Close out surveys on Patients receiving 35.14 (b)(5)(v) temporary implants?

Emergency procedures for spills, etc7 Personnel understand procedures?

NOTES & REMARKS:

i 7

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INSPECTION REPORT N Page of 787108 - Medical AREAS INSPECTED AND FINDINGS Licensee:

License No:

knenh ent No:

INSPECTION ITBI CRITERIA FINDING 5.

Use of Materials Procurement and use as required? Authorized form 35.14(b)

& route of administration?

Special tests (moly breakthrough, leak tests, etc) 35.14(b)(4) required?

Inventory of brachytherapy sourcec7 35.14(b)(5)

Oose calibration thesis per*crued?

k Posting & labeling as required?

'20.203 NOTES & REMARKS:

6.

Storace of Materiais d

Material securid in both restricted and 20.207 unrestricted arees? Adequately?

NOTES & REMARKS:

~

7.

Facilities Lic Cond b

,s f

As described in lic cond or application?

Any changes made? Adequacy?

N07ES & REMARKS:

l 8.

Instruments Lic Cond O

Survey meters & instruments adequate for program?

Instruments & meters operable? Calibrated?

Calibration adequate?

NOTES & REMARKS:

INSPECTION REPORT NUN 8ER Pag) of 787108 - Medical i

AIEAS INSPECTED AIEl FINDINGS Licensee:

License No:

Amendment No INSPECTION ITEMS CRITERIA FINDING 9.

Receipt and Transfer of Meterial d

20.205 rogugpr pickup, receiving.

g Written Survey of packages when received?

20.205(c)(1) p adh j

Records of survey of packages?

2D.401(b) p Transfer of materials proper? Transfer 33.41, 30.51 h

records maintained?

AuthcH 2ed containers used? Shipping papers 71.5 v

& package labels proper for packages on hand?

\\

NOTES & REMARKS:

b

10. Personnel Protection - External V

Personnel monitoring contmls adequate?

20.101, 20.202 Exposures minimized?

Exposure records (NRC-4 or 5) maintained?

20.102(b),20.401(a)

Available for employee review?

Surveys conducted? Adequate?

20.201 /

Records of monitoring, surveys?

20.401 Levels in unrestricted areas within limits?

20.1, 20.105 (Particularly amund nuclear med. hot lab moms of brachytherapy patients) ~

g 8

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My f.'U" y3o00 + W i

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11. Personnel Protection - Internal Airbo me concentrations in restricted areas?

20.103 (Xe-133, patients treated with I-131)

Exposures to minors?

20.104 Posting of airborne radioactivity areas?

20.203(d)

Survey, maritoring bioassay adequate for airbo-ne 20.201 radioactivity, surface contamination?

20.401 Records maintained?

Procedures for use of Xe-133 followed?

AM f2-ME NOTES & REMARKS:

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- INSPECTION REPORT NLSSER Page of 7871M -- Medical AREAS INSPECTED AND FINDINGS Licensee:

License No:

Amendment No:

INSPECTION ITEM CRITERIA FINDING d

12. Effluent Controls. Waste Discosal Release of effluents conto 11ed?

20.106,20.33 (particularly Ze-133 redioiodine where used) niaste disposals contmiled?

20.301, 20.303, 20.304. 20.305 Pmcodures, records maintained?

20.401. Lic Cond Surveys made? Adequate?

20.401 NGIES & RFMutKS:

.\\

d

13. Notifications and Resorts To individuals?

19.13 Overexposures, excessive levels & concentrations.

20.403, 20.405 incidents?

Personnel exposures and monitoring, termination 20.407,20.408 reports?

Theft or loss of licensed materialf 20.402 Nisadministrations?

35.41-35.45 MN NOTES & REMARKS:

2 r

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14. Posting of Notices i

Part 20, license & documents, procedures.

19.11(a) notice of violations posted?

NRC-3 posted?

19.11(c)

NOTES & REMARKS:

b

15. Other License Conditions e

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License No:

Amendment No:

INSPECTION ITEMS CRITERIA FINDING

16. Confimatory Measurements b

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Calibration Due Date:

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INSPECTION REPORT MBEER Page of APPDt0IX A - DOCUIENTATION OF NONCGFt.IANCE f

Licensee:

License No:

4 Refemnce Basis for noncompliance Report item 10 CR Lic cond Type n/c Report item 10 CR

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Lic Cond Type n/c Report item 10 CR Lic Cond Type n/c Report item 10 CR

,a Lic Cond Type n/c i

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I REGION I Rim 198-C.# 3

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(July 82).

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IH5PECTIGI IEPORT IRBSER Page of APP GDIX 8 - LIC DSEE ACTION ON PREVIOUS INSPECTION FINDINGS Licenses:

License No:-

Identification and suneary of action taken Status Report As:

Type n/c:

Describe:.

Action taken:

OPEN aME 2

Report Re:

Type n/c:

Describe:

Actice takes:

OPS

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CLOSED Report No:

Type n/c:

Describe:

Action taken:

OPEN CLOSED t

Report No:

Type n/c:

Describe:

^

Action taken:

9 PEN CLOSED J,,-

s Report No:

Type n/c:

Descr:be i

Action taken:

OPEN CLOSED Report No:

Type n/c:

Describe Action taken:

OPEN CLOSED

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- REGION I Fonn 198-C.5 3

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(July 82)'

Pag 2 of INSPECTION REPORT MLEWR APPENDIX C - SUPPLEMENTARY INFORMATION License No:

Licensee:

I

( ) Uncorrected / repeated nonce pitance

( )Unnsolveditems

( ) Unusual occurrence, conditions. etc

(

Inspector's consents

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MTIOML INSTITUTES OF HEALTH - RADIATION SAFETY ORGANIZATIONAL CHART 1

DIRECTOR, NIH Dr. James B. Wynnenrden j

OFFICE OF RESEARCH SERVICES i

e' Dr. Edwin D. Becker MDIATIGI SAFETY COMITTEE I

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-.-::erde OlVISION OF SAFETY

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8 RADIATION SAFETY BRANCH ECUPATIONAL ENVIRONENTAL OCCUPATI0ML I

Dr. R.J. Ausustine, Chief SAFETY & HEALTH PROTECTION EDICAL L

and 8 RANCH BRANCH SERVICE Radiation Safety Officer "I"

FIRE PREVENTION

& CONTROL BRANCH Jackie Duley Frances Rejevich

" TRAINING OFFICER Pete Doob If l

HEALTH PHYSICS SECTION,

RADIATION SUPPORT SECTION I

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James Austin, Chief Robert Zoon, Chief Valerie Brockett Anita Magill Mardalee Dickinson Lorraine Chandler Joseph Ford Doanld Driver Samuel Fountain Ted Fowler Earl Johnson Shawn Coogins Israel Futnas John Howley Cary Sommer Lynn Jenkins Clesorn Wilson Richard Kagan Christine Kieler Michael Levy Bruce Smith I

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Beverly Steffey

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RADIATION SAFETY BRANCH Health Physicists are assigned to speciric areas.

CALL your AREA HEALTH PHYSICIST ror inrormation and assistance......................... 496-57711 Building / Floors Primary -

Backup Health Physicist Health Physicist

! 21 James Austin Bob Augustine 2,3,4 & 5.

John Howley Donald Driver g

6,7,8 & 9 Donald Driver John Howley

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B3 to~4 Bruce Smith Shawn Googins 10/ Floors 5 to 8 Shawn Googins Bruce Smith 10/ Floors 9 to 13 Michael Levy Lynn Jenkins 29, 29A, 30 Lynn Jenkins Michael Levy

- 32A & 36 Richard Kagan Ted Fowler 37 6, 41 Ted Fowler Richard Kagan Danac, Parklawn, Mardalee Dickinson James Austin 18, & 28

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