ML20203F411

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Ack Receipt of 980121 Progress Rept Addressing Integrated Matls Performance Evaluation Program Teams Recommendations & Suggestions for New Mexico Radiation Control Program
ML20203F411
Person / Time
Issue date: 02/06/1998
From: Bangart R
NRC OFFICE OF STATE PROGRAMS (OSP)
To: Floyd W
NEW MEXICO, STATE OF
References
NUDOCS 9802270300
Download: ML20203F411 (3)


Text

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i Mr. William M. Floyd, Progr:m M: nager

'

  • Bur :u of Haz;rdous cnd Radioactivo M:teri:Is FEB 0 0128 i

. Department of Environment 4

. 2044 Galisteo Road P.O. Box 28110 Santa Fe, NM 87502 I

Dear Mr. Floyd:

Thank you for your January 21,1998, (bimonthly) progress report addressing the Integrated Materials Performance Evaluation Program (IMPEP) team's recommendations and suggestions .

" I fer the New Mexico Radiation Control Program. Your report indicates significant improvements 1 in the program and increased support from State management. We have no questions about the report.

As explained in Mr. Hugh L. Thompson's December 30,1997 letter to Secretary Weidler, the Management Review Board recommended heightened oversight of the New Mexico program.

On January 23,1998, we held the first monthly conference call between NRC and New Mexico.

The call provided a good forum for increased communications between our organizations. The next conference call is scheduled for February 19,1998 at 3:00 p.m. EST during which we will discuss the January progress troort. The next written progress report is due April 1,1998. A ,

follow up review will be performed July 610,1998.

We appreciate the positive actions that you and your staff have taken and are continuing to implement with regard to our comments. I look forward to our agencies continuing to work  :

cooperatively in the future.

Sincerely, Original 8 ed a R arch,hanh, Nector Office of State Programs cc: M. Weidler, Secretary New Mexico Environment Department

. E. Kelley, Director

%, Water and Waste Management Division 3

J B. J. Garcia, Chief Bureau of Hazardous and Radioactive Materials i Qistribution: j L '. DIR RF (8S 14) HThompson, EDO RParis, OR ,

i SDroggitis KCyi, OGC New Mexico File J KSchneider CPaperiello, NMSS (

at CMaupin/ASPO TMartia, AEOD DCD (SP01) PDR (YES) n1 GDeegan, NMSS RBarrett, AEOD g W DCool, NMSS SMoore, NMSS TCombs, OCA c% FCombs, NMSS TFrazee, WA C 10 -R th FCameron, OGC JHornor, RIV/WC Ed HNewsome, OGC CHackney, RIV LHowell, RIV LMcLean, RIV H, .I H. H. c H. -

DOCUMENT NAME: G;tLJRt98ACKLTR.i4M n /

To receive e top > of thle doc'4fnent, ind6cate In the bos: "C" a Copy without attachmentendoah / 'a Cop' with attachmenvencbsure M a No copy OFFICE REGIONlli z C OSP /, ]c pspj$ OSP;(4 gje l NAME JLynch:kk '7-- & LRakovan W PHl?ohaus,' RLBangari W DATE 02/.0 98 02/5/98 02d /98 02(%/98 9002270300 900206 OSP FILE CODE: SP AG 19 -

PDR STPRG ESONM PDR

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NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 3004H001 t

y..... February 6,1998 Mr. Wdliam M. Floyd, Program Manager Bureau of Hazardous und Radioactive Materials Department of Environment 2044 Galisteo Road P.O. Box 26110 Santa Fe, NM 87502

Dear Mr. Floyd:

Thank you for your January 21,1998, (t$nonthly) progress report addressing the Integrated Materials Performance Evaluation Pcoci . n (IMPEP) team's recommendations and suggestions for the New Mexico Radiation Control Prow sm. Your report indicates significant improvements in the program and increased support from State management. We have no questions about the report.

As explained in Mr. Hugh L. Thompson's December 30,1997 letter to Secretary Weidler, the Management Review Board recommended heightened oversight of the New Mexico program.

. On January 23,1998, we held the first monthly conference call between NRC and New Mexico.

The call provided a good forum for increased communications between our organizations. The l next confererece callis scheduled for February 19,1998 at 3:00 p.m. EST during which we will discuss the January progress report. The next written progress report is due April 1,1998. A follow up review will be performed July 610,1998.

We appreciate the positive actions that you and your staff have taken and are continuing to l implement with regard to our comments. I look forward to our agencies continuing to work cooperativ*ly in the future.

Sincerely, M

l{bliii 0*f Richard L. Bangart Director /

Office of State Programs cc: M. Weidler, Secretary New Mexico EnWronment Department E. Kelley, Director Water and Waste Management Division B. J. Garcia, Chief Bureau of Hazardous and Radioactive Materials

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.. - 02/10/P c T.A.SK.C.OMP.LET.E.D NEW MEXICO BI MONTHLY PRL,RESS REPORT ADDRESSING IMPEP T.A.SK..D.ESCR.IPT..

.. .... . . IONTEAM SUGGESTIONS AND RECOMMENDATIONS

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PROJECT,, STATUS - OSP DUE DATE: 02/10/98 PLANNED ACC. -N LEVEL CODE - 1

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DCHsn Ll State cf New Mexico fill,

<*'* ENVIRONMENTDEPARTMENT Hazardous & A'adioactive Materials Bureau s:)w 4x g, V 1

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CARY E. ,90HNSON fax (605)8271644 nut nwlts oovuxo, ucatrasr EDCAR T. THORNToN.lil vuvrrsscutrar January 21,1998 s

Richard L Bangart, Director Office of State Programs 3O 3

U.S. Nuclear Regulatory Commission M Washington, DC 20555-0001 9 C.

Dear Mr. Bangart:

As per Mr. Hugh L Thompson's request in his letter dated December 30,1997, to New Mexico Environment Secretary Mark E. Weidler, I am submitting the first of the requested bi monthly progtess reports addressing the JMPEP team's suggestions and recommendations.

I appreciate the courtesy and concern expressed by the IMPEP review team and the members of the MRB and thank all of you for the advice and recommendations given to improve the new Mexico Radiation Control Program We look forward to working cooperatively with the NRC in the future.

Please call me at (505)8271862 diould you have any questions.

Sincerely,

.n f.

(/)//Al/4 Yf N Q Williten M. Floyd Program Manager cc: Mark Weidler, Secretary New Mexico Em'ironment Department Ed Kelley, Director Water and Waste Management Division Benito J. Garcia, Chief Hazardous and Radioactive Materials Bureau 1

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ACTIONS DOCUMDnA110N AND PROCEDURES ADOPTED BY NEW MIDOCO RCP TO ADDRESS MRB CONCERNS 1 l l

DURODUC110N: Bokm is a summary list of su6sesdans and ramm-ndadons WaN by the  :

IMPEP Review Tenna as requiring nodon by the State:

J l

1. De review team recommends that the nuclear pharmacy inspeedon toquency be snodi8ed eom 2 years to 1 year. (Seedon 3.1) i Renponse
As Attachment 1 indicates, inspeedon toquency for nuclear pharmacies has been .

l Increased tom once every 2 years to annually. The two year inspection toquency being used previously was based on that reoornmaaded in out dated copy ofIMC l 2800.

l 2. The review team reco:nmends that initial inspeedons oflicensees be performed within 6 j months oflicensee's receipt of material and commencanent of operations, consistent with

, IMC 2800. (Section 3.1) 4 4

Response: The Bureau Chie( who signs all newly issued licenses, has estailished a hard copy se

{ for new licenses in his osce and will track new license inspections on a six month basis. The RCP Program manager has established a tickler Sie and will remind I

inspectors oflaptons coming due during a two-month block at least a month in advance. De computer database will likewise Dag newly lasued licenses which need to be inspected within six nuwelm Additionally, a standard condition has been added to wJ 'Mi Lwmaan instructing licensee to notify RCP within ten days of roosipt 4

oflicensed material.

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3. Th6 review team recommends that the tracking systern be revised to allow initial l .

inspections to be readily identi6ed to staff and management. (Section 3.1)

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) Respoem: Computer printouts of Eosneces showing inspections coming due will be generated the last week of every month A copy of this prietout will be given to both management and hispecsion staff. His has been done for the month of October and January 1998, and win continue

to be done the last Weak of evey Inonth. '

I i I

4. The review team recommends that the State increase the sannber of reciprocity inspeedons i to bettw evnluste the heakh and safety implications of out-of-state companies working in i New Madoo. (Seedon 3.1) i l

. Response: When noti 8 cation is received of an out of state licensee's impending entry into the state, the RCP Program Managw wiu make a copy of notiSostion form and forward to individual l assigned that geographical area. Every attempt win be made to conduct an unannounced inspeedon j of the reciprocal licensee. If unannounced la=-Jons are not possible due to inability to locate l liced* Ovmented phone calls will be made to obtain directions to Sold site or to coordiaste a meeting t m n RCP Staff and reciprocal licensee to aHow accompanied visit to Seld site. If staff workload, unavailability of staff or other considerations do not allow for inspections of reciprocal licensees in 6 eld locations, the RCP Program Manager wiU indicate on noti 6 cation fonn why

inspection were not conducted. Master reciprocity inspection $le will be maintained by RCP Program Manager in Fanta Fe. Reciprocal license inspections will be coordinated with routine tapJons of State licensees whenever possible to maidmlae use ofin-state travel funding Program goal willbe to conduct on site inspections of a minimum of 50% of all Priority 1 and 2 reciprocal licenses. As ofDecember 1997, eight redprocity inspections have been accomplished, including seven of priority 1 and 2 licensees. This amounts to and inspeedon ratio of 73% of all reciprocallinaaaaan entering the state.
5. The review team recommends that the State malatala the RCP staffing level to at least the level which adsted throughout the review period. (Section 3.2) 2 4

1 Raponse: ne two Environmental Specialist positions vacated since the IMPEP review wars  !

approved Ibr hire and were advertised Ibr appucent laterviews. A total of 19 appucations beve been ,

, reasived. All appucants have submitted resumes and copies of state r;ge appuestions. We ,

are in the process ofreguesting a ro. ranking of applicant spi =HA=daan tom State Personnel to better  ;

re8ect actual qualifications.

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! 6. De twiew team reaanwnands that the State provide training personnel in the areas of medical l

brachytherapy and irradiator technology. (section 3.2),

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. Response: Dr. Tom Kirby, Mediani Physidst at the University ofNew Mexico Cancer Treatment ,

l Center, provided brachytherapy training to RCP staff on October 14,1997, and will provide ro6esher i

training to program rtaff annually, nors are currently brachytherapy programs et four hospitals in

[ the State. -

Paul Ripley, RSO et Ethic on EndoSurgery's 5 million curie Co.60 inadiator in Albuquerque, has

approved RCP staff attendance at pool irradiator training to be offered by Nordion sometime in l4- January 1998. This training will be updated on an annual baals. There are currently two pool
irradiators in the State: the one at Ethic rm and a 20,000 curie Co 60 model used for instructional i

and research purposes at the University of New Mexico.

]

l New Mexico RCP staff observed all operations pertaining to production, ananying, packaging and

ahipping of radiopharmaceutical kits at Syncor Radiopharmacy on November 6,1997.

l RCP staff recalved training in dose calibrator aanmanry, accuracy, linearity and geometry L dependonos, as well as the receipt, asasy and radiation monitoring ofincoming radiopharmacenticals at Los Alamos Medical Center on November 19,1997.

7.- The review team recommends that the State develop a formalized training program comparable to IMC 1246, '7cemal QiaEAamiaa Programs in the Nuclear Material Safety and Safeguard Program Area."(Section 3.2) 1 3

,s

., Response: De State is in the process of dweloping a fbrmalized training program comparable l to IMC 1246. De States c(Tesas, Colorado and Arizona have been contacted about the possibility of providing on-hands training to ?be New Madoo RCP maff.

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8. De twiew team suggests that heamatadaa oflicense twiewer's actions be malr**laad in i

Econse files. (Section 3.2) i

Response
Several documents verbally identified by the IMPEP rwiew team as being missing tom license Ales were in ibet present in the Albuquerque RCP of5ce. Since the IMPEP rwiew, all j Ales have been retumed to the centralized Santa Fe RCP of5ce. De importance of de==aar*= don for every. action taken by staffin response to lir=ana==' requests has been discussed at RCP staff
meetings A telephone log sheet has been inserted at the tant ofevery Hoense folder for documenting 4

conversations. All requests for additional material hom licensees will benceforth be in writing

9. De twiew team recommends that the State inspectors attempt to observe licensee operations or demonstrations during all inspections. (Section 3.4) f Response: Program Management has begun more 6equent accompaniments ofjunior staff and I

will continue doing so as new staff are hired. A total of 15 license inspections have occurred since

, the IMPEP rwiew where management has accompanied staff. De Standard Operating Procedures Manual for License Inspections has been revised, and a copy has been made available to each staff member. De importance ofperformancebased-inspections has been haaad at RCP staff n;eetings and inspection forms have been finalized reflecting p formance-based la==*!ons. The importance of interviews with workers, independent measurements, status of previous violations, and the j substance of discussions during exit interviews with management are reSocted in the newly revised inspection report forms.

With the relocation of au but one inspector to a centralized location, the Program Manager will now be able to discuss inspections thoe-to-fhee with inspectors and thereby will be able to ascertain what wu found during inspections, and what additional material needs to be addressed, ne one non-4

\

eentral osce inspector will persondy bring d inspeedon ibnns to the central of5ce end discuss i Andings with the Program Manager as inspeedons are accomplished.  ;

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10. E tyview team Wa that the State inspectors conduct independent measurements f

on d inspections. (Section 3.4) i l

l Response: RCP staff have been advised of the importam of taking independent measurements 4

i en d lang=viana De State Mar ** 1.aborstory Division (SI.D) is working more closely whh the RCP la detennining Program needs (Quarterly meetings are now being held between SLD and the t l RCP to determine analytical needs of tt.e RCP and radiochselstry capabilkies of SLD). Indspendent measurements have been made on d Inspections since the IMPEP Review.  ;

I

11. The review team recommends that the State increase the rigor of reviewing technical health
physics issaes during inspeceions, and increase the breadth and scope ofinspections. (Seedon

l 3.4)

Response: Inspection forms and Inspection Gih Daannarna have been revised to resect the importance ofin-depth inspections. Monthly staff meetings have been initiated and will to discuss revised forms and guidance ha=*a Minutes of these meetings have been kept showing the scope ,

of these discussions.

12. The review team suggests that the State inspectors attempt to interview ancillary workers during inspections. (Section 3.4)

Response: RCP staff have been reminded of the importance ofinterviewing ancillary workers during inspection, ne provisions of Subpart 10, Section 2005, New Macico Radiation Protection Regulations, which pertain to consultadon with workers during inspections have been diammad during staffmeetings 5

I l.

13. The review team r===aada that the State inspectors attempt to conduct formal adt meetings with the senior licensee managanent on d inspections. (Section 3.4)  !

Response: Inspeadon Ibrms and inspeedon guidance daa=aata now indicate that "the closeout l

conferenos should be held with the Hosasee's highest level of management available," and that l

" inspectors should always contact upper management upon entering a ibcility." The importance of  ;

coe W upper management as a foBowup, if upper management is unavailable at time of  ;

lespeedon, has been discumed et staff ametings. Senior Ma% adt interviews have been held on au ' ;+s= conducted sinos the DdPEP Review.

14. '!he review team recommends that the State develop a formal process for reviewing licensee responses to de6ciency letters and closing open de6dencies. (Section 3.4)

Response: All responses will be tracked using ticider file. Both the RCP Program Manager (initially) and the Bureau Chief will sign off on the adequacy oflicensee response. Requests for additional information are now made in writing, with copies of all correspondence placed in license i folders.

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15. - The review team suggests that the State develop a formal process for inspectors and license I

reviewers to document and transmit pertinent information to each other for follow-up.  ;

(Section 3.4) I l

Response: Weekly staff meetings are now being held to discuss the previous week's activities.

RCP Program Manager and inspectors discuss information resuhirig Bom previous week's inspection ,

efforts. Any need for documentation is satis 6ed in writing.

16. 'Ihe review team suggests that the State develop a process for ensuring that inspection Ales are complete, that all appropriate State daa=aata are prepared and fuod, and that licensee responses are received and fUed. (Section 3.4) 6

)

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_ - . _ _ _ _ ____________a

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. Response: Bad inspector wiu be bold assponalble for ensuring that an inspection su nasigned l to hirn or bor are complete and that responses to letters of viola' ion are received in timely manner, in accordance with item 14, adequacy of twponses is now approved by both Program Managw ana Bureau Chief. Latters in reply to licensee :seponses wiu be signed by Program Manager Program ,

Managw is reviewing license Ses each time dtcle of correspondence" is completed pertaining to licensing action, inspection, or incident.

17. The review team recommends that the State begin de='*ating all trips to licensees' or applicants' &cilities when inspecting licensed activities, performing special taWm, or performing pre licensing site visits during construction. (Section 3.4)

Response: The importance of docunantation has been discuased at RCP stasmeetings. All information gained through trips to licensed facilities is now documented via memoranda to Se signed oEon by RCP Program Manager,

18. 'Ihe review team recviror, ends that the State management exercise more stringent supervisory review ofinspection reports. (Section 3.4)

Response: By relocating all but one of the RCP inspectors to a centralized location, inspection reports are no longer being allowed to accumulate without management review in Seld oEce. Both Program Manager and the Bureau Chief are reviewing license responses to cited violations for adequacy and are signing oFon reviews. Program Manager is signing oFon au documents entered inSes.

19. The review team suggests that the State complete its revision of the laWon report forms, ensuring that each set of forms covers all key areas for the type of ficensee being inspected, and that RCP inspectors begin using the standardized form (s). (Section 3.4)

Response: All inspection report forms are being Analimi and copies have been distributed to 7

1' P:

l .. staff. Staff have been advised as to bow inspection ibnns are to be oosupleted during staff training meetings.

20. The review team reoormaanda that the State make onsite, daaunaaead kr. 4,4cas of j

l j incideota, allegations, or miandmialarrations with potendal health and safety aftincts (i.e.,

source dha, possible over exposures, lost sources, aaa#amlaattaa, etc.) (Section 3.5) l Response
A guidance document has been written outlining the armadard operating procedures

!, to be foBowed in response to incidents involving radioactive materials. A copy of these daannarits

has been provided to each RCP staff member. 'Ibe contents of these inddent response guidance
domment have been dismssed at RCP staff meetings. NRC has indicated satisfhetion with wrrent I

report forms and the mannst that incidents are now being investigated and documented.

! 21. 'Ihe review team recommends that the State create an incident and allegation . yerdog form

that would, at a minimum, identify the person taking the initial report, list the name and telephone number of the reporting party, provide the details of the incident or allegation as reported, record the State's conversation with the licent;.se or individual, describe corrective actions takun by the licensee, describe the investigation conducted by the State and the resuhs, list citations or other regulatory actions, show the date the investigation was closed i

out and justl8 cation for closure, show date(s) incident was reported to the NRC or other agencies, and provide spaces for the signatures of the investigator and supervisor. A copy of the form should be maintained in the incident & and in the license file. (Section 3.5) l Response: Incident and allegation report forms have been developed by the RCP which incorporate all of the above, Additionally, standard operating procedures have been developed for both incident and allegation investigations and made available to Program Staff.

22. The review team recommends that the State establish a protocol for making independent investigations and evaluations of the licensee's actions. (Section 3.5) 8

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Respoem: A protocol has bem developed Ar making independent invowigadons and waluating

the licens='s aedoms.

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23. ne rwiew team W. that the state inhiate procedurn to ease incidents are

&"s d y at tas east inspeedon to verify that the licensee's corrsedvs actions have been l

4

'=7mi(Secdon 3.5) ,

I Response: A esperate section enthled "InddentarReports" has been incorporated into inspection ibrms giving infbrmation on types ofincidents that may have occurred since last inspe Aion and to address notification reports and corrective actions. De importance of completing this section has l

l been stressed with RCP staff.

j 24. De twiew team suggests that when evaluating incidents, the State cite appropriate items of j de6ciencies when applicable. (Section 3.5) i Response: Deficiency letters are being sent to any licensee where a breakdown of procedures l '

occurred resuhing in a repcitable incident. Management imerviews are being held to discuss cause ofincident, rnalts and corrective actions taken.

l 25. De review team recommends that the State: (a) set up a separate incident and allegation Se l system in the Santa Fe ofBee, keeping all documents and records pertaining to an incident in l one location, with the data cross referenced to the licensarmWJon Ses thers and in the i

Albuquerque ofBce, and (b) establish a system to centrally los and track the progress of l

incidents and allegations. (Section 3.5) '

Response: De incident and allegation Se system has been moved flrom the Albuquerque ofEce

j. to the Santa Fe ofBce. A new Incident / Allegation Checklist has been developed, as well as a new incident /Alloration Report Form. Tlw NMED database is being utilised to track all incidents and

] ausgenions and forwarded to NRC. A chronology We (hard copy) will also be kept in the Santa Fe 9

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( ,, esco, and a ticider Sie has been ==WM o ttrack the progress ofincidents and ausgations. . l t .  ;

26. De twiew team recommends that the Sate develop and implement written procedura for

! reponding to events invo%g remnm6ve massial and conduct training sessions until au staff l

' 1 are ibily trained and quali6ed in emergency response. (Section 3.5) i Response: Written procedma era in place Ibr responding to events invoMag radioactive material

and stafrhu been instructei in their use. [

r 1

{ 27. De twiew team susseets that the State keep expending the allegation procedures to include I

procedures for notifying the person maldng the auegation of the resuhs of the investigation 1

and including the ausgation in the event reporting form, tracking system, and emergency

response procedures (Section 3.5)

Response: A guldance document is now in place covering various aspects of allegation procedures, including the noti 6 cation of the person maldng the ellegation. Auegations are being tracked by the Program Manager & entered into database as ifit were reportable incident.

i 28. The review team recommends that the State expedite promulgation of the compatibility.

related regulations now overdue and those which are due within the next 12 months. (Section 4.1.2)
Response
Subpart 3, Section 311. G.4.a through d (pagm 3 32 through 3 33) contains the i

compatibility language for " Decommissioning Roccrd keepics and IJoense Termination; Documentation Additions" and was adopted by the New Madoo EIB, April 3,1995, and became l l effsetive May 3,1995.  ;

Language iom the Federal Register (61 FR 24669) was approved by the Radiation Technical Advisory on-1(RTAC) for inclusion under Subpart 3, Seedon 311.0 (page 3 32) NMAC3.1. De j RTAC wul recommend adopdon of these changes by the Environmental Improvement Board.

10

i) 1,

SelfOuarantes as an Addhional Financial MMa= "10 CFR Parts 30,40, sad 70  ;

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===ad==ma (58 FR 68726 and 59 FR 1618) that became afootive on January 28,1994, and which i became due on January 28,1997. Language tom the Federal Register (58 FR 68726 and 59 FR t 1618) was approved by the Radiation Technical Advloory Coundl (RTAC) at their September 24, j 1997 meetire Air indasion in Subpert 4, NMAC3.1. The RTAC will re===aad adoption of these  ;

changes to the Environmental 1- ; .._ . Board.

2

Work aami== on !nserting language ibr the fbliowing ===ad==ata to the New Mexico Radiation l

Protection Reguladons. Once the insertions have been made, the amended regulations will be taken l [

j beibre the RTAC br approval prior to subadttal to the Environmenta! ?=; .. " Board. (These i will be adopted no later than May 1998):

l. Timeliness in Ds;= '=M.g of Materials Facilities, "10CFR Parts 30,40 and 70 amendments.

l

2. Preparation, Transfer fbr Commercial Distribution and Use of Byproduct Material for l Medical Use, "10 CFR Parts 30, 32, and 35 amendments." ,
3. I.ow-level Waste Shipment Manifest Information and Reporting, "10 CFR parts 20

! and 61 amendments."

l 4. Frequency of Medical Examinations for Use of Respiratory Protection Equipment, "10 CFR Part 20 amendments."

5. Radiation Protection Requirements
Amended Dennitions and Criteria, "10 CFR Parts l 19 and 20 amendments."

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6. Medical Administration ofjindician and Radioactive Materials,10 CFR hrts 20 and l 35 amendments."
7. Clari6 cation ibr E+:-:+= '- '# ,; Funding Requirements, "10 CFR Parts 30,40, and

, 70 amendments."

8. Compatibility with the International Atomic Energy Agency, "10 CFR Part 71 amendment."
9. Tenninstion or Traneller ofIJoensed Activities: Record keeping Requirements, "10 CPR Parts 20 and 30."

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29. The review team susseets that a Sie be maledaw with the rever letters and enadng  !

commpondence of all draA or Anal regulations sent to the NRC. (Secdon 4.1.2).

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Response: All NRC4eleted consspondence pertaining to regulation developenent is kept in  ;

separate Als for easy access.

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