ML20134B568
| ML20134B568 | |
| Person / Time | |
|---|---|
| Issue date: | 10/10/1996 |
| From: | Craig Gordon NRC |
| To: | NRC |
| Shared Package | |
| ML20134B359 | List: |
| References | |
| NUDOCS 9701300206 | |
| Download: ML20134B568 (6) | |
Text
.'
From:
Craig Gordon To:l WND1.WNP9(CHM) 1 Date:
10/10/96 5:0_8pm -
Subject:
Maine fax -Reply i
Cardelia i
The lettsr looks OK but l really think we should wait to receive the letter from the state rather than responding to a fax,
- , j.
S Craig
,1 i
CC:
.CWH M thafr[
e*o m 1 w auu p.
1h e swin> im thoio A m = 4 J cn0 6 t.
1 1hin W>
t 4
9 4
4 9701300206 961029 PDR STPRG ESGME h[
PDR s,
, m
TEL:
Oct 09'96 13:24 No.007 P.01 i
},
lO NOBULL A
n JUST THE FAX d/ 4
!\\
'd N RADIATION CONTROL PROGRAM jj STATE HOUSE STATION 10
/, /-
AUGUSTA. ME 04333 l*,,
-(
. ~.
s
,k
~
'< ?r*
~*
p k.f.:
' t. { <,.,hm '
- <f;',;
'.~
FAX:W 2374172 VC.'"? 207 237 5676 -
.f i
TO: (Q,-/[
/ &,,'
OJ'f i
\\
2t
- W L sqvc DATE:
/O-9-/4 PAGE 1 OF.[g PAGES
- Vdd, f,,& Au aba/ rA,, ped I'- # "S
- r ( g,,.,, & + /i b b A L u A '
.p n,,
t 7 1<,.,<fs., fawnAi (ci/ rw 't 20 Y ~ 2/ F W*_
/
8**Q
k-UNITED STATES t
f H
NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20eeH001 1
I October 29,19%
N' Robert Schell, PE, Manager Radiological Health Program
. State House, Station 10 4
151 Capitol Street l
Augusta, Maine 04333-0011
Dear Mr. Schell:
I-This is in response to the fax dated October 9,1996 from Mr. Shawn Seeley, Radioactive I
i Materials inspector, Maine Radiological Health Program. Mr. Seeley's fax responded to a
' concern raised in my October 1,1996 letter to Dr. DoraAnne Mills regarding the Binax,
' inc. licensa. In the October 1,1996 letter, a response was requested concerning how the -
t
. Maine radiation control program would be addressing the application of the emergency planning (EP) rule to the Binax, Inc., license. The fax (enclosed) from Mr. Seeley provided i
en amendtnant to the Binax, Inc. license, which indicated that the possession limit for j
iodine-125 (1-125) had been reduced to 7.5 curies. The NRC regulations provide that an emergency plan is needed if the authorized possession limit on a license exceeds 10 curies i
of I 125; thus, an emergency plan is no longer applicable to the Binax, Inc license.
The actions taken by the Maine radiation control program have adequately addressed our i
earlier comment and recommendation regarding the adoption of the EP rule. In view of these actions and the information provided in letter dated July 23,1996 from Dr. Philip i..
Haines, NRC agrees with the Maine radiation control program deferral of the adoption of i
the EP rule since there are no licensees in the State subject to this rule. If a license application subject to the provisions of this rule is received subsequent to this letter, applicable provisions of the EP rule should be incorporated through license condition or i
through other legally binding means.
l We appreciate the prompt action taken by the Maine radiation control program.
?
Sincerely, 1
IC 1$t fVU d4 Richard L. Bangart, Director
{
Office of State Programs
Enclosures:
y As stated cc w/ encl:
Dr. DoreAnne Mills, M.D., Director of Bureau of Health L
W. Clough Toppan, State Liaison Officer i
Shawn Seeley, Radioactive Materials inspector p
]
)
0 [. 0 h.
'Oct 09'96' 13:24 t40.007 P.02
^
TEL-3 k
t UNITE) 87ATES '
j y
.j NUCLEAR REGULATORY COMMIS$10N j[
/
'e WASHmeToN, D.C. 30eas-coot gg p;
%....++
October 1, 1996 7,
'7p<.ceive, s g
g.' j o
. e,.
g k..t i
\\
Dae v.,
,o DoraAnne Mills, M.D.
yt '~'.. g'# '
Director, Bureau of Health Meine Department of Human Services-
.11 State House Station 161 Capitol Street Auguste, Maine 04333-0011 Deer Dr. Mills:
This is in response to the lotter dated July 23,1996 from Philip Haines, Acting Director, Bureau of Health which responded to the comments and recommendations from our March 21,1996 review of tho McIne radiation control program. The responses provided detailed information on how the Maine radiation control program has addressed, or is addressing, our recommendations. We appreciate the positive actions that the Maine radiation control program has taken with regard to our comments and recommendations.
However, we bellove additional action is needed by the Maine radiation control program to resolve one comment and recommendation. This comment concerns the application of the emergency planning rule requirements to a Maino licensee, Binax. In your response, you indicated that this licensee currently physically possesses matorial below that requinng submittal of an emer0ency plan; however, the Binax license authorizes the company to possess amounts of material which require en emergency plan. The amount of radioactive material authorized by the licenso, not the amount in actual possession by the licensee, should determine whether an emergency plan is required. In light of this, the Maine radiation control program should either request the submittal of an emergency plan by Binax, condition the Binax license to reduce its authorized possession limit, or if justified, formally exempt the licenson from this requirement.
Wo request a response addressing this issuo regarding the omorgency planning rule. In addition, we will review the status of other comments and recommendations as a part of our next program review.
~
Thank you for your support of the Maine program.
Sincerely, N RA C a AA Ric ard L. Bangart, Directo Office of State Programs s
cc:
R. Schell, RCP -
l W. Clough Toppen. State Liaison Of ficer
% !b1913203 lp,
~
~ '~
~09'96' 13:25 No.007fP.03 l
STATE OFIt AINE '
. e.-
DerAaTucNT or HU.staN Senvices -
y 11 STATE HOUSE STATION g
AUGUSTA. M AINE 04333 001:
ANGV5 6 KINO. A '
KCVIN W CCf4CANfCN
. w.speca.
ceuwst4.44 -
i October 9,1996
~ Roger Piasio, President Binax, Inc.
l 217 Read Street Portland, Maine.04103 2
Dear Mr. Piasio:
Please find enclosed the amendment to your State of Maine Materials License number 05243-01. Please review the enclosed document carefully and.W. hat you understand
. all conditions. If there are any errors or que*---
Division of Health Engineering at 287-8401, so that we can provk ind answers.
Please be advised that you must conduct yot h.
active materials in accordance with the conditions of your State of /
license application, and State of Maine reg, (j{%
ions made in your IU consequences to f
. employees and the public can result from failt
\\0 f
equirements, tae Department expects licensees to pay meticulot_._
....v uetail and to achieve a high standard of compliance with Maine regulations.
You will be periodically inspected by the. State of Maine Radiation Control Program as delineated in Section A 5 and Anpendix A to Part C. Failure to' conduct your program as specified above could result in enforcement action against you as specified in Part B of the Maine Rules Relating to Radiation Protection.
We wish you success in operating a safe and effective licensed program.
Sincerely, l
Robert J. Schell, P.E., Manager Radiation Control Program Division of Health Engineering
%"4.
TEL:
Oct 09'96 13:25 No.007 P.04 STATE OF MAINE Licenso No 243 0 MATERIALS LICENSE Amendment No. 6 8
Pursuant to the Mame Radiadon Statutes (22 MRSA 677) and Maine Department of Human Services regulations on radiat i
(10-144A CMR 220). and in reliance on statements and repre>entations heretofore made by the licensee, a heense authorizing the beensee to re: we, acquire, poness, and transfer radioactne matenal as designated below.and to use such I
material for the purposeis) and at the place (s) dcs:gnated below. Thh license is subyct to all applicable rules. regulations a
)
of the Maine Department of Human Services now or hereaf ter in effect and to any conditions spe:ified below.
)
l'
- l. Name Binax. inc.
This Ucense is issued m sccordance with arrmpondence dated October 3,1996
. :. Address
- 3. Ueense Number
' Amendment Number l
217 Read Street 05243-01 6
Portland, Maine 04103
- 4. E.xpiruuen Date f
September 30.1998
)
- 5. Radionuchde
- o. Form of Mater:a!
7.
Matimum Activity A. lodine 125 A.Any A. 7.5 Curies l
B. lodine 120
- 8. Sealed Source B. 2 microcunes l
8.
AU THORIZED USE A.
For the receipt, possession, storage research, development and manufacture of radioimmuncassay kits for distnbution to persons authorized to receive the licensed material pursuant to the terms and conditions of a specific license issued by the l
Nuclear Regu!atory Commission or an Agreement State.
B. For calibration ofinstruments.
l 1
CONDn IONS
~
9.
Licensed material may be used only at the licensee's facilities at 217 Read Street.
Portland, Maine.
]
10.
A Licensed material shall be used by. or under the supervision of Timothy Marsh, David G. Cabral, Pamela Angell, or Myron Whipkey.
f B.
The Radiation Safety Officer for this license is Myron Whipkey.
11.
Licensed material shall not be used in or on human beings.
12.
Scaled sources or detector colls containing licensed material shall not be opened or sources removed form source holders or detector cells by the licensee.
i I
13.
The licensec is authorized to hold radioactive matenal with a physical half-life of less than 65 days for decay-in-storage before disposal in ordinary trash provided:
A.minimum of ten (10) half-lives. Radioactive wasto to be disposed of in this m I
TEL:
Oct 09'96 13':26 No.007 P.05 Pego 2 of 2 i
STATE OF MAINE License No. 05243-01 1
^ * " ' " * " " '
MATERIALS LICENSE Supplementary Sheet B.
Prior to disposal as normal waste, radioactive waste shall be surveyed in accordance with procedures described in the licensee's application to determine that its i
radioactivity cannot be distinguished from background. The survey conducted prior to disposal must confirm that the radioactivity of the waste cannot be distinguished from bac'< ground. All radiation labeis shall be removed or obliterated.
14.
Except as specifically provided otherwise in this license, the licenseo shall conduct its program in accordance with the statements, representations, and procedures contained in the documents including any enclosures, listed below. The Agency's regulations shall govern unless the statements, representations and procedures in the licensee's application and correspondence are more restrictive than the regulations.
A. Application dated July 19,1993 B. Amendment dated August 12,1993 C, Letter dated Augu.st 26,1993 D. Letter dated October 1,1993 E. Letter dated October 14,1993 F. Letter dated October 1C,1993 G. Letter dated January 3,1994 H. Letter dated March 30,1994 1.
Letter dated October 3,1996
~
l 1
1 1
l j
i j
a I
w 1
Date: October 9.1996
/-/-
IRobepJ.'Schell P.E., Manager Radration Control Program 5
Division of Health Engineering f
I
e
- TEL:
Oct 09'96 13:26 No.007 P.06
, 7 r. :-
- AS. J $ *lttti
>".9?L Ar40. :.tAtf#E N t010$a
- .*y=
.h; Jb ot RA fivt OPFICES Ch? h 5751
-i e
..;. JE A GE AVICE i
'4 '
- '.t 99
- .l
,'J17% s 4012 October 3,1996 Mr.. lay flyland Radiological Health Program Dept. of flunnin Services Div. of11ealth Engineering State 11ouse Station #10 Augusta, Maine 04333
Dear Mr. Hyland,
This letter concerns an amendment to Binax's State of-Maine Materials License # 05243-01. As we discussed over the phone the 10 Curie possession limit for Iodine-125 is in excess of what we actually have here at the facility.
Therefore, 've request to lower our Indine-125 possession limit to 7.5 Curies.
Also we request to remove from section 10.A. the following personnel:
Benjamin T. Priest and Elaine J. Lachance.
If you have any questions concerning this request, please contact me at 207-4 772-3988 Ext-169.
i Sincerely, 1
/
-) o
/
'Yp w. f /
/ L' k e _. (i l
T, Myron D. Whipkey Radiation Safety Officer
/O q lJ o J,
/
RogerfN. Piasio President & CEO I
e
'(.
E
-