ML20134H271

From kanterella
Jump to navigation Jump to search
Discusses Upcoming Meeting W/Advanced Medical Sys Re Apparent Violations Included in Nov 7 & Dec 6 Insp Rept
ML20134H271
Person / Time
Issue date: 12/22/1994
From: Grobe J
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III)
To: Axelson W, Berson B, Combs F
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III), NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
Shared Package
ML20127A948 List:
References
FOIA-96-444 NUDOCS 9702110227
Download: ML20134H271 (1)
v • d • e


Text

. - . . - . ..- . .. - . - . . - - -. -.~-- . . . . ~ . . _ _ . . . . -

I From: John A. Grobe (JAG) i To: WLA, BAB1, FCC, JXDl, JRG1, OGJ, SHL, JRM4, WJS2, NHS, i Date: Thursday, December 22, 1994 4:43 pm Q) Agfyaq gj g ---

, subject: Meeting with AMS N/ II i F 00 m b s w m . u -

'c1*=-

f&ows,eap o c.4Cicco,& ep,,w,,e/g i

AMS consel, Henry Billingsley, will prepare a list of issues that they would j $ g g g like to discuss with the NRC regarding the apparent violation of 30 CFR

! 20.2003. This list will be forwarded to my attention before 1/3/95. On tha j day, I will distribute it to all interested parties and determine whether

/$

////

there is need and we can support a meeting with the licensee. The licensee is g holding open 1/11 on their schedules.

' /S///

We with need the 11/7 to keep in mind and 12/6 that wereports.

inspection established a very the We issued unique set with reports of circumstances no NOV g

and listing the violations as " apparent violations." Further we stated that b0 we would meet with the licensee to discus's the apparent violations and determine the appropriate enforcement actions. This is very similar to ,the

) normal enforcement process. We will discuss next year the best way to proceed on these apparent violations.

Have a very happy and safe holiday season. See you next year!!

Jack h

l 9702110227 970129 PDR FOIA ENGLISH96-444 PDR d

}

3 DEC 2 21994 .

f l Advanced Medical Systems, Inc.

ATTN: -David Cesar, Treasurer i' 121 North Eagle Street Geneva, 0H 44041 i RE: APPLICATION FOR RENEWAL OF NRC LICENSE 34-19089-01 l

l

Dear Mr. Cesar:

a l The renewal process enables NRC to reevaluate licensed programs which have been in operation for a five year period. During this five year period many j licensees find that their programs have changed along with their business j goals and operations and that NRC regulations and policy have also changed.

l Therefore, we require that licensees provide us with a complete license

! renewal application, describing all aspects of their licensed operations and

{ radiation. safety program and procedures as if they were applying for an NRC i

i license for the first time, without reference to previously submitted documents. This renewal process was discussed with you by Roy Caniano and j John Madera during a management visit to your facility in April 1994.

l We have reviewed your ap' plication dated November 29, 1994, and are

.)

disappointed to find that you did not provide sufficient information to

! evaluate your program activities and procedures. Ccnsequently, you will need i to resubmit your application with the following subject areas appropriately

, addressed without any reference to previous correspondence:

i e

1. Radioactive Material f Your application provided the appropriate elements, mass numbers, chemical and physical forms, and maximum amount of the material you will

! possess at any one time. However, you did not provide the necessary i information concerning the disposition of the materials and activity j which you have eliminated from previously licensed authorization.

i Therefore, in order for us to evaluate your request for a reduction in

possession limits, please provide appropriate documentation which will

! account for the material you have transferred and/or disposed of.

Also, please indicate /approxir.; ate the type and quantity (activity) of

radioactive material currently possessed at your facility.
Specifically, provide information concerning your current inventory of radioactive material to include the quantities of material you possess

] in the form of sealed sources, bulk sources, facility contamination and i

both liquid and solid redwiste. This should be added to your. .

radioactive material possession limits in items 6., 7., and 8. of your NRC license. ,

w n - .-

9 ,.

Advanced Medical Systems, Inc. 2. Intended Use of Radioactive Material Your application did not provide any information concerning intended use of the materials requested. Please provide information concerning the use of radioactive materials at your London Road facility, including-possession incident to decommissioning and/or transfer to an authorized individual or entity. Specifically, you will need to provide detailed information concerning service operations (procedures, etc.).

3. Management Control and Responsibility
a. Senior Manaaement Resubmit a copy of your organizational chart illustrating the reporting path of the Radiation Safety Committee and/or. Chairman of the Committee to Senior Management.

Submit a statement, signed by upper management, empowering the Radiation Safety Officer (RS0). The statement must describe the RS0's authority to oversee the licensed program, the responsibility for control and direction of the radiation safety program, and the authority to terminate licensed activities which pose a healt.h and safety risk.

b. Radiation Safety Officer Staff (RSOS)

Provide an assessment regarding the adequacy of staff (including both numbers and qualifications) to support and maintain your radiation safety program. The assessment may be general, however, enough information should be provided to relate required services (e.g., audits, retraining, bioassay, response to emergencies, etc.), to facilities covered (e.g., number of laboratories, users, special uses, etc.).

c. Radiation Safety Officer Submit a description of the duties and responsibilities of your RSO. The typical duties of a RSO would be:

(1) To ensure that the usa of radioactive materials is by or under the direct supervision of individuals specifically listed on your license.

(2) To ensure that all users (where appropriate) wear personnel monitoring equipment when using radioactive materials.

(3) To ensure that radioactive materials are properly secured against unauthorized removal at all times when,not in use.

l l

l DEC 2 2 W Advanced Medical Systems, Inc. l l

(4) To perform routine inspections of all areas using or storing radioactive materials.

(5) To ensure that the terms and conditions of your license are l

met, and that all required records are maintained.

(6) To immediately halt any activity judged to be a threat to health, safety, the environment or a violation of the l

conditions of your license or the regulations.

d. Audit Program i

Radiation Safety Officer and Staff Audits Describe the audit mechanism implemented by the R50 and.his staff to determine tcepliance with the terms and conditions of the NRC license. Your audit program should include:

(1) routine unannounced inspections of each area where material is used and stored; (2) evaluation of worker / technician training through discussion and observation of work practices, and; (3) performance of independent surveys of work and storage area.

4. Trainino Program:

Confirm that training provided pursuant to 10 CFR 19.12 will include all occupational workers and ancillary personnel whose duties may require them to work in the vicinity of radioactive material. In addition, please commit to providing this training before new personnel assume their duties with, or in the vicinity of radioactive material, during annual refresher training, and whenever there is a significant change in duties, regulations, or the terms of the license. Also, confirm that you will maintain records of this training. Records should include the names of the attendees, topics, and date of training.

Your formal training program for authorized users (sealed source handlers) and service personnel must be provided. This program can be i

' as previously submitted, however it should be re-submitted to reflect all pertinent changes, e.g. manag,ement structure, administration, technical aspects, etc.

5. Facilities and Eauipment Submit a detailed diagram of the facilities for each location where radioactive material will be used. Include a description of area (s) ,

i assigned for receipt and storage (including waste). Your diagram (s) should show:

t l s I Y

e i

s KC 2 2 %4 i Advanced Medical Systems, Inc. a. Adjacent areas across the walls from use and storage areas.

b. Descriptions of the ventilation system with pertinent airflow rates for locations where radioactive material may become airborne.
c. A specified scale with indicated dimensions.
d. Appropriate postings / labels to identify laboratories, work areas, and equipment e.g., fume hoods, s protective clothing change areas,pecial etc. sinks, preparation areas,_
6. Radiation Safety Procram:

Your radiation safety program must outline the formal requirements necessary to maintain control of your licensed activities. These controls and provisions are related to organization and management, procedures, recordkeeping, material control and accounting, and management review to ensure safe operations under the license. Your radiation safety program description should be in narrative form, and should follow the subject matter presented in Section 10 of the enclosed Regulatory Guide 10.5 Revision 3, as it relates to your program.

Specifically, please respond to the following Items:

a. 10.2: Administrative Procedures;
b. 10.2.1: Control of Procurement and Use;
c. 10.2.3: Emergency Procedures;
d. 10.2.4: Operating and Handling Procedures;
e. 10.2.5: Other Procedures (i.e., Standard Operating Procedures);
f. 10.3: Inventory and Accountability;
g. 10.4: Audits and Appraisals;
h. 10.4.1: Management and Radiation Safety Committee Audits;
i. 10.4.2: Radiation Safety Officer and Staff Audits
j. 10.6: Exposure Control and Monitoring;
k. 10.6.1: External
1. 10.6.2: Internal
m. Facility Survey Program (ISP procedures);
n. Survey Instrument Calibration Program (ISP procedure);
o. Leak Test Program (ISP procedure); and
p. 11: Waste Management The areas addressed in Regulatory Guide 10.5, as outlined above, can also be addressed by referencing specific AMS ISP procedures (your SOP) and/or other procedures that you have instituted to manage your radiation safety.prqgram.

However, these manuals / procedures must be submitted in their entirety for our review. This was discussed with you and Mr. Meschter on December 6, 1994, during a teiephone conference. '

Advanced Medical Systems, Inc. DEC 2 21994

7. Emeroency Plan:

10 CFR 30.32 i)(3) requires that you provide an Emergency Plan in accordance i w(th the guidance provided in Regulatory Guide 3.67 has been previously provided to you. This is a requirement for new licensees as well as those who are up for renewal. Your application failed to provide an updated copy of your Emergency Plan. The updated i

version must reflect changes in management control, administration, technical aspects, etc. that have occurred since initial acceptance of your Emergency Plan by the NRC. Please follow the guidance in 1

Regulatory Guide 3.67, and submit your plan for our review.

8. Decommissioning Fundino Plan and Financial Assurance Mechanism:

i In order for us to complete our review of your renewal application and issue a renewed license, we need to review and accept your l

Decommissioning Funding Plan (DFP) and financial assurance mechanism.

Pursuant to 10 CFR 30.35(c)(2), you were required to submit your DFP with your license renewal application which was required to be submitted by December 1, 1994 (10 CFR 30.36). While you failed to comply with these requirements, you indicated in your renewal application dated November 29, 1994 that your DFP will be submitted by December 31, 1994.

Should your DFP not be submitted by December 31, 1994, this matter will l be reviewed for appropriate enforcement action.

i

9. Waste Manaaement:

You should describe your methods for disposal of radioactive waste.

-Your application should include, where appropriate for the types of waste involved, provisions for monitoring and segregating waste i (radioactive from nonradioactive, short half-life from long, liquid from i

solid waste). The following items should be considered and addressed in your application:

a.

Transfers to a recipient (usually a waste disposal service company or the original supplier) properly licensed to receive such waste in accordance with paragraph 20.2001(a)(1) of 10 CFR Part 20.

State the name and license number of the receiving company.

b. Storage of radioactive material with half-lives greater than 65 days should be characterized regarding volume and anticipated time in residence at your facility prior to disposal. The NRC does not consider storage as a substitute for final disposal of radioactive waste. Other than storage for radioactive decay, low level radioactive waste (LLW) should be stored only when dis capacity is unavailable and for no longer than is necessary,posal e.g.,

no longer than 2 years. NRC Information Notice No. 90-09,

" Extended Interim Storage of Low-Level Radioactive Waste For Fuel

~

I l

/

Advanced Medical Systems, Inc. DEC 2 2196 i l

Cycle and Material Licensees", outlines the provisions and requirements for interim storage. If you find that the interim  :

t storage provision applies to your program, it will be necessary  :

for you to address in your application the information outlined in the Information Notice. '

c. Release into air or water pursuant to 20.2003(a)(1) of 10 CFR Part
20. You should discuss the monitoring and control mechanisms in place to ensure compliance with the appropriate requirements. t We will continue our review of your application upon receipt of this '

information. Please reply in duplicate. within 30 days, and refer to Control t Number 397891. ,

If you have any questions or require clarification on any of the information stated above, you may contact me at (708) 829-9834.

Sincerely,  !

i i

Original Signed By  !

John A. Grobe, Chief I' Nuclear Materials Inspection Section 2 4

Enclosures:

' i

1. Regulatory Guide 10.5, Rev.3 '
2. Regulatory Guide 3.67
3. IN 90-09 cc/w enclosures: Robert Meschter, RSO 1020 London Rd.

Cleveland, OH 44110 Mayor Michael White, Cleveland Lisa Mehringer, Cleveland Irv Ball, cuyahoga County Robert Owen, Ohio Erwin Odeal, NE0RSD DOCUMENT NAME: M:

r. u . ,v.n e \03016055.DF4 wm c .c.,y .n n ov.n.w.

u . u.e.,, e .c.,v e .n.ch-nu.-i.-

OFFICE DRSS/ Rill. ( DRSS/ Rill c DRSS/ Rill ( DRSS/RIII_,d f.

NAME KNull:bt La ih DRMader L c' WJSlawinski 4 1 JAGrobe # j DATE 12/0/94 s 12/ /94 12/2>/94 V 12/ '. .'/ 94/

OFFICIAL RECORD COPY l

.;. . ,;:. ._: ; ...?..

. . . w n ,m .. . .;

i . : ., . . . :,, , .

(...,-. . . ....

>. .... ~

r.u ..t . .-

,-l}w

.y  ;?.

y. .lfQ.y - a v . .: . , .. >...

. . . ;f p}..  : . '. y, ', '

-~

' * , , * - ~

[w . '.-

, l ,  ;:.:.  :. .. :y. w';. y- y' : . ;. 7. . . . . - 's. .l ; ~ Q a *

, :r.,

. . . ...c.,x. .

.,r - . . . . t . 2 . ** ~ . . r *.sy . *5

'. . . : ~, .m '

r m .' .:m.# %:<. %}' : " .-? J^ .%+ Aa jM.d.ht.n.M

<. (.'. M ir.} .: G:' . (i. .

dOCKEY8i +M 5.-3.!. J.5

. . ~ . / W.:.:.:. . . t . :~.. . . ' '. ... y u s y ce &

.y

, GTi'Q

^

7 V ;... .__.f. . . . f. ,;;. _ . ;:>;.L , 7. 5;%,!.? '.. a.[s; . . :3.i.F;;:.). . '. , . . :n;.:=.

T"- ~ " . . . . . -# ~

' '~~ *- C,. ~

.C. O A L I T I O N December28,1994.+O....

'W- / - N . T> ,.'. C M . M 1 1. 1. .: P, 3 .'5 3 / . c i. H. S... F..

c.. .a .. .m,.. . . . .

.  : u , . . . . . i _ . . . .-- .. ~ . . - < w n., .. v v. g .m . e. ,.: . e.. . .a

- 3606 Bridge Avenue a-

. US Nuclear Regulatory

. . .a .

Comm,ss:,on -. e a?  ;. ' *

' .e"

~ m 0FF> c .s 3 -y'IC'Eh@. 5tCR'ETARY  : <.

i

, . C'l av'lind, Ohio 44113 4

..- x .

p'. - 216 *281

  • 6468' [# Flm S#b '. ]I-;. :.f /y g Frx 216
  • 281
  • 5112 11555 Rockville Pike 4i 'OIJ.0/.' '. > g.. OCKEIlh'GEE .

w

- Ro. ckville, MD 20852 .

4.1.W if: e 2 ., 3. .

a 1

s ..h * : '. .M,

- e,.a'- . t . -

.'W .

c,e. - . . . _ . ., J,; .3.;;.M.

. .,v .. 'JuM,.

r .~.p.f' . a

./.

. TRUSTEES - .. . .;. 4,_: ;;3 g#c s: s..; .- . , , S.z , 3 7,.p,  : . .

7,', y,

{', Q , ,

m ~ - *-

.4.am h rs.esa ca ,

re: . Reques't for Hearingi Operating l License A .- . .%*. M D e..@ 2 M*.,, M-A* J.M c V<M.. t . a. W

- ==.wa.- "a ~ ~ -- -

I Advanced Medical S t..> .

A ',, '* % - -. == O 'O. a ca , C. leveland, Ohio.. ys.tems,Inc...

~..'. . .:.:

~ . fr. J 'f. .u,*{ 'M.t:e.td f.lif MmN .

..t. .;n".. 4'n .o

.. ,. ,,, ,,e,, a.

, .a . .. m. m.. r.f;.' .

. , - -- . . - ' v*- .

4 v :s.

.fy- . - - .

.s  % - . W . - -

o

'., .ama,

.--* ceae . To Whom It-Maj Concern, .. . '.i. ' 'JG'./

.~'. . . y..av.. .#..u....r. .w..r 3,.

e t. , .Q. .?W. l.3 -..n..: , .;.

' 3-

7. . .

,_m.-.,,

v

. . ~w , e :

~

. - - - ,, 3 ...~

s

.c c .

2- - -. ' In accordance with.10.CFR 2.1205, The Earth Day' Coalition, ,re.qtiests a hearing ,

. . ' , l. ?

'""""'~~3 ,y regarding the opding license for the Advanced Medical Systems, Inc. (AMS) " .1 L. M N .. . ~ a. - o. regarding their possession of radioactive materials. We would prefer this hearing to ber i

. . . .. * **~"'

" w, ""'~c';~.'O,

, t . E, held in Cleve. land so neighbors. of this fa.cility and interested. m. embers of northeast Ohio can fully PaniciPate.. -

- e u'- 1 ,m.

/,. . .?. "

the.p

',,,.,,c We believe that AMS has repeatedly failed to adequatelyiccou".. -'" ; ., :

c .

' . m a.= -

nt forand J

'"I Zl0 contain theirlicensed radioactive materials..AMS has demonstrated alack.of  : w

& cQ a- o ,-

ability to abide by their license to safely possess and not contaminate tlieirjown facility L.},,

and the environment in northeast Ohio. '.u. fOf- . N -M.V.;. '..e ' .i! . P vr.

.'.(

c-. %'2 The Earth Day Coalition is most' concerned about the Extensive'cobaltti079. . J'.

'q.. .

. w ,: "c "." contamination on-site at this facility asit is in'a residential neighborbood of the city of E '

, . ~

Cleveland. It is our understanding that there is'little or nb, and cenainly inadeq emergency planning for the AMS facility in Colinwood if there would be a natural. 41:0

'S l umsonycouken. .

J i' w .- d disaster, fire, flooding, intmsion, cobalt 60or continue' where itmishaps from AMS  : ' employ 2 '""* *""c '."7.l also concerned about the extensive on-site has been and has the .h c./ - **".*.0.,

c. c"";'etlll:

ability to continue to.be inadven.ently re!. eased.into.the surro.undmg'. neighborhood (and l ;,.%

..,.c. c. w . ..... ..,

rc ~ ultimately residents), either by att or water (ram).fe > .f .' ~

. .' T

. 1% We are 'also'very concemed about the past and coritinuing bontamination of our ~ .* Y,.

?u '""" *'"*"" T,;%"".*

e public wastewater treatment plants, the Southerly and the Eastdrly pl' ants 'of the . . : l ~fd

_. .%"l*7.tl: northeast Ohio. Regional Serer District in Cleveland, OhiofUltimatelf, the releases of) 9;

' cobalt 60 from the AMS sewer to the wastewater plants end up in the Cuyahoga River.Q

, *"o"'.'." l"C' J

""'"" ""'O.^.~# E and Lake Erie, the source of drinking water fo~r millions of people. As you know, a.3 ' y.y

"""u.,

% '.*.d,0 m.illion Pci/g particle of cobalt 60 was found at the- Southerly. Exten.,sive ., . co.ntamination c Nj.

. . s . .a,

,c still exists on-site at the Southerly .w ; . .. c:.e - . m.p . 4 ".m , 3 . ~. r . .

. n ..  :. ;, c. . . . .

.O - Z'*,*,:7 ,

. The Earth Day Coalition is.a n6n-profit environmental education.and ad iocacy M... .,

~ "Tl".'.'*."., . organintion located iri Cle'veland, Ohio'. Our interest in this hearing'is not commercial , 9 J" ' "'*".",,, *."".,'.;. ,f '". ll.l.l.'or financial. We are interested strictly.in public- ,educ.ati'on n and. . . ...a and 'mformatio.

~ , . . . - ..

u n .enviroilmentalissueS. ' ,. ;l-- / , .* .

e ,(. . q. , . ,. S. . y ; '.C f.3! * /. '.4 ^i .S -W .' .q ',~2. - -

s.,ie. v m m.o.  %...v-

**"*"' "*T,." "O'.""' .

> Thank you' for yosi* attention ~to our c ' oncems. f .'A Y. ';g .

2' ^.'.1 2.'.

, . ' ;.. . . ;,.e , ; . y ,. _ a;. .; . . :,; l . .? ;.qip ;'., ,Q.; . ?l, < 0;.,p ~C;x.:  ;*M;  ;. 7. '.V:

aso vscower en . . . ., , F,.

.? . . ~ . , - ;;': 2 m. . : ? < .- ,4 ? .. : s v .y g."jv y ' ' ., ;g".t f. g.A q ' .; . .,*; : - n. . ,-. s y'; ,'.

  • 8inCCrely' ,3 l'
  • ?.'*. ;. * * ' Q. . ' '  ;?;11: c.,; ('.'. A'? 4-

. *g.yj ' . . Qq.y,Wn >la;p* g q~;.;a. . . 1. . .-.y ur.&.. s'

. , , . se n. *.. . G n.( :; . ;;., y't .lp ..-t ::s.f , y .';:)i's.f. efyl. , . ..

e n ,o,,

cmm s ,.e e.,,o.e.cean

\.ceo n

e.

j,.;jgr; j ,,,,,,y, ..t..

. . .: - e. * ..

3 .g ; . g.,.pt $. ,. .,;;. y. . ,..;, ,,,. g. . . . . . -, 4/, ; t ,. Q

,4. .A. ,g . , ;.c[,A . ,, ,N

. . .o :

. c.g.f,.;,,

.c. , ,

' ; .- ,,.,.-i.. . ;y . .

.]..e.. -., p . ; . .

c q.,;t

.. g . - *:.s.y,,y.e

...t* f T.J. . .r dl$s.3M.:,p%..

-. , s,

. .g p.{.6 ,

. ,'. .t .--- f.

7 . r '. " ' " . ' ' , Ip; C \(( ,E s,.

".**, ,C** *f.* t.

a.u.",a. +.. y;. . . .

. ; . ...c.. ,,. . .[3' ,.

,'! ,w , ' w.. y.. y' .;e' ,y.

.'. Q. f ,. ' , .' .f

. ~. I*. .' . ' . . ... .

  • 5
  • The masen sf T e Ee* Day Cosaton is to buAc e ((gjg'"fgg .

l.- l'y '

)

,. . lls "..

,,e ,-l

. r n .w om.w. ,a vo. w.e ... . ..< '.[.. 7: . :n 2 :, . .,.

, .no prtracarig a common omvi,cmme.ual ogs ios .

as. .- <.'.. '. .*. '*,p' ,; %

.' ,t

?- *.".?.E

,',L,..-'. .,u

..en to people at esomeast One - Est,1990 , '%

-~ .

. '.';, , ;/./'.!'.'.... ^ ; ;. '

.- * *r .

  • - . .s.

-[,

[*.dje.. ,v *~

  • l[ a3 . -i 1. _ av d { (' * , ;..' ., , * [ , y.

, h .n s p

. h 5.,se. d, f, ,g, - v r.

~.

=

,

Retrieved from "https://kanterella.com/w/index.php?title=ML20134H271&oldid=2873647"