ML20006D412

From kanterella
Jump to navigation Jump to search
Discusses Sample Evaluations of Airborne Releases by NRC Matl Licensees & Forwards List of Furnished Relevant Matl Licensing Guidance & Regulatory Guides
ML20006D412
Person / Time
Issue date: 02/06/1990
From: Glenn J
NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To: Boyle R
NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
References
NUDOCS 9002130161
Download: ML20006D412 (22)


Text

<

1

~

l

[

t 6 FEB 0 6 1990 o

s l

MEMORANDUM FOR:

Regis Boyle, Acting Chief Regulatory Branch Division of low-Level Waste Management and Decommissioning, LLWM FROM:

John E. Glenn, Chief Medical, Academic, and Commercial i

Use Safety Branch Division of Industrial and

[

Medical Nuclear Safety, NMSS

SUBJECT:

SAMPLE EVALUATIONS OF AIRBORNE RELEASES BY 4

1RC MATERIALS LICENSEES i

At the meeting with the Environmental Protection Agency (EPA) on January T9, 1990 Robert Bernero agreed to furnish written documents to EPA. On February 2,1990, I furnished copies of relevant materials licensing guidance, regulatory guic'es and chapters from the NRC Inspection Manual to Chad Glenn of your Branch. A list of furnished documents are shown in Enclosure 1.

On January 29, 1990, I contacted Region I and requested that they obtain sample records showing the types of information and evaluations maintained by licensees to show compliance with NRC's effluent regulations (10 CFR 20.106.) February 2,1990 Region I provided three examples of different types of information and analysis used by licensees to demonstrate compliance.

E. R. Squibb and Sons, Inc., is a major supplier of radiopharmaceuticals (including iodine-131) in New Brunswick, New Jersey. Squibb performs stack sampling and as demonstrated in Enclosure 2 has sufficient 9 ta to project doses as function of distance from the exhaust stack.

Pitman-Moore, Inc., uses iodine-125 infrequently to label compounds for research purposes. As shown in Enclosure 3, they have used known use and ventilation data with assumed release fractions and filter efficiencies to calculate an annual release concentration. Although not very accurate, the resulting concentrations were low enough at the stacks.that the region did not require additional data or evaluation.

Carnegie Mellon University (CMU) is a typical university using iodine I

isotopes in research by graduate faculty and students. During an inspection, sg they were cited for not evaluating releases from a particular hood. The related correspondence is shown in Enclosure 4.

In their response, CMU yf M,4 presented rougi calculations to show compliance with release concentrations b

p4M 78R2282;62 3 06 Da RI mHB COW PDC k

i

jf I

IIB O f Nug o

e Mr. Regis Boyle

.P.

5 l

and agreed to perform stack sampling on a limited basis.

In acknowledging CMU's actions, the region emphasized that menitoring needed to be extensive enough to demonstration compliance in a variety of situations.

Original Signed By :

John E. Glenn, Chief Medical, Academic, and Concercial Use Safety Branch Division of Industrici and Medical Nuclear Safety, NMSS l

tnclosures: As stated cc: Chad Glenn, LLWM r

DISTRIBUTIDN w/ench JEGlenn IMNS Central Files NP.C File Center IMAB r/f HMSS r/f RECunningham GSjoblom Y

l DFC: IMAB J.......................................................................

NA llenn:ht i

DATE 2/ [/90 OFFICIAL RECOPD COPY i

v s

l'

.c' e

LICENSING GUIDAt!CE FC-85-14 Standard Review Plan (SRP) - Nuclear Phanacies FC-85-7 SRP - Type A Licenses FC-87-2 SRP - Medical Use FC-84-14 Directive on Radiological Contingency Planning FC-84-21 Directive on Incineration REGULATORY GUIDES 8.9 Bioassay Programs 8.10 ALARA Philosophy 8.18 Medical ALARA 8.20 1-125 & 1-131 Bioassay 8.21 Health Physics Surveys at Manufacturing Plants 8.23 Radiation Surveys at Medical Institutions 8.25 Air Sampling Instruments - Calibration 10.2 Guide for Academic Licensing 10.4 Guide for Source Material Licensing 10.5 Guide for Type A Licensing 10.7 Guide for Snell Laboratory Licensing 10.8 Guide for Medical Use Licensing NUREG-0267 - ALARA at Medical Institutions INSPECTION GUIDANCE Manual Chepter.2800 - Materials Inspection Program Inspection Procedure 87100 - Licensed Materials Programs Inspection Procedure 83822 - Radiation Protection J

FE8 0,2 '.90 13:53 HRC RI DRSS P02 l

.), /AN 31 '98168f9 SQUIBO IM EC/@ SUPPGtt

' ' ~

f F"'

F pw.

s

+

i t

July 11,1983 Mr. John Grash.

Ibalth Physics Manager E.R. Squibb & Sons,.Trc.

P.O. Box 191 How Brunswick, 3C 08903 l

Imar ochnt

'Jhe beta done calculations presented below were bened cm the inforrration i

provided.

'the data for the horizontal and vertical disperslen ot.afficients(q'and q rer,m::tively) were taken freer. " Meteorology and Atenic Enargy",.1968, David H. Slads, Editor.

' assed on the calcula*icns the noximum annual beta dose rate 'culd be 2.6.v,10-3 miiiirads/ year at 100 notars for stability category 3.

If we use a Gaality Factor of 1.7, we have dose equivalent of 4.44 x 10-3 i

tulliram. 'Jho gamma done rate iir negligible and the thyroid does would be 2.14 #11 bun.

'Ibe data and calculatiers 'aru attaahed.

If you have any questions, give M 'a Call.

)

Wry truly yours, 1

l Edward D. Scalsky, CMP Enclosuras J

i I

)

' FEB 02 ' 90 13: 54 HRC RI DRSS P03

-ow.

.w vi...wo

<w

. ' ;..,JAN 31 '90 16:58 53UtBB WW EC/GIA SL.PPORT P.3/15 l

oiven:

l 3

D Beaust volue = 79,641 ft / min = 2.25 x 10 ceAmek or 2.5 x 10~11 h I

concentration'in exhaust = 2,5 x 10 ci/oc Ccncentration along contar line of pitna l

X =

o = nelease ants (dSi) sec Q = Horisontal dispersion coefficient (neters) q = Vartical dispersion coefficient (neters)

R = Wind speed 2.68 notars/sec

=

i H = stack Height 17.6 meters

=

3

-2,3 1 ft = 2.832 x 10

-10

/

isCI

= 1 x 10

.M Ci oc r

i i

D h

e

+

0' I

q e

.,r-,

er m

' m m

m.

FEB 92 '90 13:55 NRC RI DRSS PO4 enn e.

-,o JMS 31 '90 16:58 SQUIBB WW EC/QA SUPPORT P.4/15 I

t f

I U e

6g,

-4

-2 2.5 x 10~11 h x

,,,39,yn 2.832 x 10

,gg Q = 79,641 x

I and 9.39 x 10 x 3.15x10

= 29,5788 = 29.58 #P 7*

anc year year i

i l

i 1

y 5(

)

E O

e x = wge; A 4

4 cp_ 32 m3 4 ) 10 e

ese-cc -_

e c.

?

X=

0 TT 87 (a) t'a-(88)

(h)*

g b

8 e

  • Me "

W )2 H

(

)

f I

XTM Cl.),0 x 10 e

l

=

wc c n 3o i

t e

e

?

e 9

l L

t l-l e

w-

F5B 02 '90 13:55 NRC RI DRSS P05 w.

[AN 31 '9016tS1 SQUIBB 144 EC/QA SLPPORT P.5/10

.t.

(maters) i t

(Meters)

A

_B C

~

D E

y 100 22 16 l'3 e

5.s 4

32 23 16 u

4 200 43 300 65 47 34 23 13 13 i

500 102 77 56 37 2a 19 1000

210 --

140 102 63" 42 2a '

r i

O (::s. tars)

DIS'5NCE l

Meters A

B C

D E

F l

l-100 1s 19

'7 e 2o

't 1 1K l

96n 32

_ 21 16 8.7 5.8 3

300 57 32 22 13 8.7 4.8 500 130 57 36 IS 13 7.8 780 103 68 33 23 14 000

,-~

,n.

- -.. ~

.,.v...

. ~ ~..

FEB 02 '90 13:56 NRC RI DRSS P06 vnn w.

<w J5N 31 '90 16:31 SQUIBB 14J CC/04 SLPPORT P.6/10 l

p

?..

Ub b Oteters /sec)

(Metars)

A B

C D

E F

3 100 2.962x10 1.616x103 8.642x102 3,3xio2 1,51x102

$4 4

3 3

2 2

200 1.L58x10 5.655x103 3.1x10 1.17x10 5.86x10 2.02x10 4

3 3

3 2

300 3.118x104 1.266x10 6.29x10 2,$2x10 1.32x10 5.25x10 5

4 4

500 1.116x10 3.69x10 1.7x10

  • 5.92x103 3

3 I

3.06x10 1.25x10 3

3 0

5 4

1.75x10 a.13x10 4.5x10 1000 1.378x10 1.21x10 5.84x10

- l i

Q

[h O \\

TPQ q R

- m

~7

-6 4

~6

-5 loo 3.17x10 5.81x10 1.09x10 2.85x10 6.22x10 1.74x10

-8 200 8.1x10 1.66x10' 3.03x10 8.03x10 1.6X10 4.65x10

~

~

~8 3o0 3.0lx10 7.42x10~8 I.49x10~7

~7

~7 1.79x10

3.73x10 7.12x10

~8

-8

~8

-7

~7

~7 500 8.41x10 2.54x10 5.52x10 1.59x10 3.07x10 7.5x10 4

N

-10

~8

~8 1.ux10 2.0 M O 1000 6.8x10 7.76x10-9 1.61x10 5.37x10 A

FEB 02 '90 13:57 HRC RI DRSS P07 w n., we

<w ow.ww

.w.

iAN31'9016:52 SQUIBB 144 CC/QA SUPPORT P.7/15-y j

f Cu Distance stability category

,1 A

B C

D E

r 100 1.1 1.47 2.23 3.59 5.68 11 200 0.55 0.8381 1.1 2.023, 3.034 5.87 300-

.0.3087 0.55 0.800 1.354 2.023

,3.667 i

500 0.1354 0.3088 0.4889 0.9263 1.354 2.256 5000 0.0226 0.1709 0.2588 0.533 0.7652 1.257 e

i h

, ~ %(h)

.100 0.5461 0.3394 0.0832 0.0016 9.87x10-8 5.31x10-27 i

4 i

200 0.8596 0.7038" 0.546 0.1292

.0100 3.29x10

~3

'300 0.9535 0.8596 0.7261 0.3998 0.1292 1.20x10

, l-500 c.9909' O 9275 0.8874 0.6511 0.3999 7.85x10

}

l 1000 0.9997 O!986 0.9671 0.8676 0.7462 0.4538 1

L l

s l

l J

j

\\,

FEB 02 '90 13 58 HRC RI DRSS POS j

V Mil QA FW &VeV4 r03 i

,/AN 31 '90 16:53 SQu!BB 14/ CC/QA SLPPORT P.8/15 i

i h) 0 X =(#$$C g, s

l t

s 3

CINCDOMTON (JiC1/m ),

[

1 DISTMCC FDB2Z.ITY CMEDfE (Meters)

A B

C D'

E F

~7

~7

~8 '

100 1.73x10 1.97x10 9.07x10~8 4.56x10 6.14x10~ U 9.29x10

~8

~7

~7

~7

~8'"

.200 8.43x10 1.17x10 1.65x10

,1.04x10 1.6x10 1.53x10~D

-8

~8

~7

~7

~8 300 2.87x10 6.37x10 1.0Bx10 1.49x10 9.2x10'8 2.15x10

~8

~8

~8

~7

~8 500 8.4x10 2.40x10 4.90x10 1.41x10~7 1.23x10 5.88x10

-0

~8

~8

~8

~8 1000 6.80x10 7.65x10 1.56x10~8 4.66x10 8.58x10 9.48x10 CCNCD@A2TCN (M Ci/oc)

DIS 7.ANCC (Meters)

A B

'C D

E F

~U

~14

~U

~D

~38 100 1.73x10 1.97x10 9.07x10 4.56x10 6.14x10 9.29x10

~14 1.17x10~ U 1.65x10 l.04x10 1.6x10 1.53x10

~U

~13

~14

~

200 8.43x10

~14

-14

-13

~14

~D 300 2.87x10 6.37x10 1.08x10 1.49x10 9.2x10 2.15x10

-15

~14

~14

~13

~14 500 8.4x10 2.40x10 4.9x10 1.41x10 1.23x10 5,. 8Bx10

~D

-14

~14

~14

-14 1000 6.8x10 7.65x10 1.5'6x10 4.66x10 8.58x10 9'.48x10

~

4

, - - ~

~

r FEB 02 ',90 13:59 NRC RI DRSS P09 l

.~.....

, JAN 31 '9lD 16:53 50rJIBB IM CC/GA SUPPORT P.9/15 J

~

i t

a0.23Y,X D

p 1

( = 0.42 X M DOSE: (RADS /SEC) e DISTNCE:

A B

C D

E F

100 7.27x10 8.27x10 3.8x10 l.9x10'*D 2.58x10-19 3.9x10-34

~14

~1'

~

200 3.54x10 4.9x10 6.9x10 4.37x10 6.72x10 6.43x10-20 l

-14

~D

-14

~14

~

i l

~14

~14

~14

~14

~3 300 1.2x10 2.67x10 4.5x10 6.26x10~14 3.86x10 9.03x10

~14

~14

-14 5.9xib-14 5.,17x10 2.47x10 500 3.5x10 1.0x10~14 2.06x10

~

0

~1

~14

~14

i

-16

~O

~

1000 2.86x10 3.2x10 6.55x10 1.96x10 3.6x10 3.98x10 t

4 9

9 g

l 9

4 e

0 es

FEB 02 '90 13:59 NRC RI DRSS P10 JAN 31 '90 16 54 SQUIBB 144 EC/QA SUPPORT

. F.16/1'J Beta rose (Millirads/ year) i

.x,

.ars)

).

E c

ti.

I r

l 150

~3

~3 1.2x10'3 5.9x10-5 8.12x10 1.23x107

~8 27 2.2940 2.6x10 200 1,11xif 1.54x10 2.17x10 1.38x10 2.12x10~4. 2.0W~I 3

~3

~3

~3 l

300

~#

~3

~3

~3

-5 3.78x10 8.42x10 1.42x10 1.97x10 1 72x10

2. 84x10 500 1,'3do-4 l3.15x10 6.5x10 1.86x10 1.63x10 7.78x10

~4

~4

~3

~3

~4 I

~4

~4

~4

~3 1.25x10I' 1000 9.01x10 1.4x10

'2.1x10 6.17x10 1.14x10 Beta Dose (Millirads/ year) c.

. paddi? g x 3.15 x 10 x 103M ds 7

year t

1 i

9 L

g t

1 e

9 O

FEB 02-'90 14:00 NRC RI DRSS P11 JHN 41 *70 Age 04 ra&

,fAH '31 '90 16:54 SQUIBS lel EC/WI S.r m P.11/13 D = 0.25 E X I

n = (0.25)

(0.38785) x 9

D=

0.1 X I

Rads /see a u sei.

04ttra)

A

_B C

D E

y

-14

~14 100 1.73x10

-1.97x10 9.07x10 4.56x10" 6.14x10" 9.29x10 e

200 g,43xio 1.17x10'

~14

~14 1.6x10"D l.53x10

-20

~

l.65x10 1.04x10 1

^

300

~U 2.87x10' 6.37x10 1.08x10-14 1.49x10 9.2x10 2.15x10' I

~

~

500

- 8.4xio-2.5-2.4x10 4.9x10

_14 14

-15

-15

~

1.41x1o 1,,3x10 5.s m 0 1000 6.8x10 7.65x10f0 1.56x10

~D

~U

~D

~17

~

~

4.66x10 8.58x10 9.48x10 t

0 3

94 e

O g

6

$f G

t b

o e

4 9

4 e

g e

e d

e O

4 e

g 4

e

FEB 02 '90 14:01 NRC RI DRSS P12 VMn sa

rv awese i 64, P.12/15 J M 31 '90 16 S5 SQU1BB LM EC/CA SLFPORT.

?,'

Gama Does (ML111 rads / year) l nww. a. -

I l

e g

7 (M? tars) 5.

E c

~4

-6

~10

-28 00

~4

'2.6x10 1.2x10'4 5.9x10 8.12x10 1.23x10 2.29x10 p2'.03x10 0

~4

~4

-5 i1.54x10'4 2.17x10 1.3tx10 2.12x10 200 1.11x10 300' 3.78x10 8.4240 1.42x10'4 J1.97x10 1.22x10 2.84x10

~5-

-5

~4

~4 4

, 1,ix16-5

,i 500 3.15x10-5

-S 1.86x10 1.63x10'4 7.78x10

~4 n

4 e.

=.

4 et e

4 e

e e

e g

e e

4 9

4 e

s 10

- Trciv70~14f01 HRC'RI DRSS P13 onn we

<w i

JAN 31 '90 !&855 SQU295144 EC/QA SLMORT i

P.1F15

't 7

, a> 2.0x10 cc/ day

_24 hours)

(

P - cegan burden (a ci) i I,= Intake par day U = Daily tptake t

i i

f = Fraction of am>unt taken h that is deposited in opipan of reference.

a i

t f,=.25 i

U = f,I I=

BR X

Conc.

7 "

x 1.97 x 10 I = 2.0 x 10

= 3.94x10

  • N Ey oc day

-6

~7 U = -(.23) (3.94x10

)

9.062 x 10 Ad

=

tt steady stata - equilibriun.

day U-P y =-1,44 T,0

~

T = effective half life (days) l 131 To = 7.6 days for I i

i P = (1.44) (T (U) = (1.44) (7.6 day)

(9.062x10'7 % ) = 9.92x10

.%Ci P = 9.92 x 10' W Ci = constant organ burden (worst' case) i (51.2) (9.92x10 ) (.23)

[

= 5.84x10-6 W

~D = 51.2

=

20

- Annd DE. = 5. 84x10-6 x 365 days

= 0.00213 rea = 2.13 nrem.

r L

l-L 11 P

l-

FEB 02

',n.,9014:02 NRC RI DRSS P14 i

e.

.~

..e, Jr41,31 '9016:56 SQUIBB W EC/QA S M i "' ~

. P.ic/15' I=

armathing Rata x Ccncontration h

7 (h) x C I(

)'s 2 x 10

,~

ttars)

A B

'C D-E F

-6

-8

~U 3.46x10 j.94x10 1.81x10 9.3h0 1.23x10 1.86x10-30 4

-6

-6

~7 U

200 1.69x10 2.34x10 3.3x10 2.08x10 3.2x10 306xif 2*

s.7mr' 1.2mr5 2.16 m '

2.38a0 1.84x1r5 4.3 m -8 4

500 1.68x10 4.8x10 9.8x10 2.82x10 2.46x10 '

1.18x10

~7

~7

~7 4

~

~8

~7

-7

~7 1000

. 1. 36x10 1.53x10 3.12x10 9.32x10 1.72x10 1.9x10

':hyroid Burden at Brai11 brian P=1. 44T,U s (1. 44) (7.6) (.23) I P=2.517.I P

r

>utu laters)

A E

C D

E T'

-6

-6

-6

-7

-n 4.68 2

  • 100 s.71x10 9.97x10 4.56x10 2.34x10 3.1x10

-6

~0

-6

~U 200 4.25x10 5.89x10 8.31x10~0 5.24x10 8.05x10~7 f7.7x10 300 1.44x10 -

3.2x10 5.44x10 7.5x10 4.63x10 1.08x10'I

-6

-6

-6

-6

~0 7.1x10 '

6.1Sx10 2.97x10 I

.21x10 '

500,.

4.'23x10~7

~

~

1 2.47x10

-8

~7

~7

-6

-6

-6 3.42x10 3.85x10 7.85x10 2.35x10 4.33x10 s.78x10 1000 4

u

~

FEB 02 '90 14:03 NRC RI DRSS P15 Sot [Iis MEC/CA SUPPo.RT N 31 '93 16:36 ew ata oo. a niv e.nt mt.

(wamy) p:13,13 6=51.2 I L = $1.2 (P) (.23) = (.5888)

P m

20 Rlibid da

(!4rters)

A B

C D

l' F

6 i

100

-6

~0 1.3840'7 1.83x10' U 2.*76x10' N I

i 5.13x10 5.87x10 2.68x10 200 2.5x10

' 3.46x10 4.89x10 3.09x10 4.74x10'7 M.' 5W-12

-6 4

-6 4

l I

-8 I

~0

-6 4.4x10'6 2.73x10

. 6.3640 300 8.48x10'I-1.88x10 3.2x10

~7

~8 4

500 2.'49xiO

7. ux10 1.45x10

4.18x10 3.64x10 1.75x10 1

~

c

-8

~7

~0 2.55x10

2.81x10 i

2.01x10 2.27x10' 4.62x10 1.38x10 1000 Annual Thymid tese rauivalent (Md.11irem_)

5 3 $ M.65x10 IE = b(***)

(365 days) x10 g

uutars)

A B

C D

E T

>nsiva

-2 6.6x10-6 1x10-2j 100 1.87 2.14 0.98 5.03x10 r

-6 1.13 0;17-1.56x10 200 0.91 1.26 1.79

-2 300 0,31 0.690

1. 17 1.61 0.99 2.'32x10 f0.26 0.'53 1.53' 1.33 0.64.

,500 0.09

-3

-2 1000 7.3x10 8.27x10 0.17 0.51 0.93 1.*03 e

4 g

13

i g 92 ;90 14 07 HRC RI DRSS PS2 s,

~.

i i

M 111965 i

License No. 29-15623-03 Docket No. 030-17022 Control No. 02886 i

Pitman-Moore, Inc.

ATTN: Richard J. Skalski Assosicate, Regulatory Af fairs Route 579 and Postley Drive Washington Crossing, New Jersey 05560 t

Gentlemen:

In order to complete our review of your application dated September 11, 1984,

-i and subsequent letter dated March 26, 1985, please provide additional informa-tion in the following areas-i 1.

Please submit a specific calculation of iodine concentrations in effluent

't air based on your facility specific parameters aiid the anticipated program load. Your calculation should include the following:

The activity that will be handled on a weekly or monthly basis (e.g.,

a.

3 todinations/ week, 1 militcurie/iodination)

.l b.

The estimated percentage of iodine lost per experiment or iodination.

Assume a 10% loss unless a smaller value can be documented or I

substantiated.

c.

The actual time that the hood will be operating d.

Specific parameters such as exhaust rates and filter efficiencies I

If you are unable to demonstrate by calculation that the limits in 10 CFR 20.106 will not be exceeded, please submit in detail a description of the procedures and equipment that will be used to moriitor the concentration of iodine in the effluent to ensure that applicable limits are not exceeded.

2.

Please confirm that animals that have been injectod with I-125 will be

)

l housed in cages that will be kept in a fume hood.

l 3.

Specify the company that will provide calibration service for your survey meters and indicate the license number that act.horizes them to provide such a service.

4.

We recommend that your procedures for receiving radioactive material during off-duty hours include instructions to security personnel to detain the carrier until the RSO arrives if the package is wet or appears to be damaged.

Upon his arrival, the RSO can determine if either he or the delivery vehicle is contaminated.

3 ws5I51TT seos16 0FFICIAL RECORO COPY 813 - 0001.0.0

~

RGdkSKP

.d

EB 02 ' 90 14: 14 NRC RI DRSS P02 i

o'.

I 11, 1985 RESIONSE TO COMMENTS CONTAINED IN NRC'S LETTER DATED APRIL 29-1$623-03; RELATIVE TO PITMAN-MOORE'S RENEWAL LICENSE APPLICATION No.

DOCKET NO. 030-17022: CONTROL NO. 02886 Please submit a specific calculation of iodine concentrations Concent 1 in effluent air based on your facility specific parameters and the anticipated program load.

Your calculation should include the followings The activity that will be handled on a weekly or monthly z

a.

basis (e.g., 3 lodinations/ week, 1 millicurie/iodination).

t We foresee one iodination per month with an activity of 0.5 to l

Response

1.0 millicurie/lodination.

The estimated percentage of iodine lost per experiment or Comment 1(b) :

Assume a 10% loss unless a smaller value can be

~

todination.

documented or substantiated.

Response

We assume a 10% loss.

The actual time that the hood will be operating.

Comment 1(c) :

The hood will be operating 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, nonstop.

Response

t Specific parameters such as exhaust rates and filter efficien-Comment 1(d) :

cies.

The exhaust rates and filter ef ficiencies relative to the fume

Response

hood were previously reported in our application dated Septem-ber 11, 1964, page 10 and are repeated here for convenience:

The isotope )ab is designed in such a manner that it is under negative pressure, and all air is drawn into the hood, where it passes through a 24' H x 24' W x $

1/2' D HEPA filter, tested af ter installation to insure it s 99.974 efficiency on 0.3 micron size par-ticles by the DOP test. Gases pascing this filter are then passed through a 24' H x 24' W x 8 1/2' D grid containing 30 pounds of activated charcoal before being exhausted to the air.

The linear velo-city in the duct work is 900 CFM. The exhaust stack is 7 feet above the finished roof elevation, which is 26 feet above ground levels there are no adjacent taller buildings.

FE8 $2 '90 14 15 HRC RI DRSS P03 l

t l

t

(

RESPONSE TO COMMENTS (Continued)

Comment 1 If you are unable to demonstrate by calculation that the f

(Continued) limits in 10 CFR 20.106 will not be exceeded, ple6se submit in detail s' description of the procedures and equipment that will be used to monitor the concentration of iodine in the effluent to ensure that applicable limits are not exceededm

Response

The limits specified in 10 CFR 20.106 Appendix B will be adhered to and will not be exceeded.

Comment 2 Please confirm that animals that have been injected with I-125 will be housed in cages that will be kept in a fume hood.

j r

Response

At Pitman-Moore, any animal that has been injected with I-125 will be housed in cages that will be kept in a fume hood.

Comment 3

t,pecify the company that will provide calibration service for your survey meters and indicate the license number that author-ites them to provide such a service.

Response

Eithor of the following companies will provide calibration ser-vices for the Eberline Instrument Corporation RM-19 survey meters a.

Eberline Instrument Corporation

^'

312 Miami Street West Columbia, South Carolina 29169 (803) 796-3604 License No.155 - Amendment 12 (South Carolina Dept. of 11ealth & Environmental Control)

OR b.

Teledyne Isotopes 50 Van Buren Avenue Westwood, New Jersey 07675 (201) 664-7070 License No. 29-00055-06 Comment 4

We recommend that your procedures for receiving radioactive material during off-duty hours include instructions to security personnel to detain the carrier until the RSO arrives if the package is wet or appears to be damaged. Upon his arrival, the RSO can determine if either he or the delivery vehicle is con-taminated.

Response

Pitman-Moore's procedure for receiving radioactive isotopes during off-duty hours has been revised to incorporate instruc-tions for handling wet or damaged packages.

This procedure is attached on the following page.

~ - - -

M B,02 '90 14815 HRC RI DRSS PO4

~

,sh' i

i e

PRoctDURE FOR RECEIVING RADIOACTIVE ISOTOPES DURING OFF-DUTY HOUPS 1.

If an ordet is received by the Security Department after normal working hours, the following procedure should be usedt Notify Radiation Protection Cfficer immediately (609-424-8479).

a.

b.

The order (package) should be delivered to the Radioltotope Laboratory (Room L-1428) and placed in the hood.

~

A note should be placed on the entrance door of the Radioisotope c.

Laboratory indicating the time of delivery and the security officer's name.

d.

If the package is wet or appears to be damaged, detain the carrier until the Radiation Protection Officer Arrives (RPO).

Upon his arti-val, the RPO will determine if the carrier or the delivery vehicle are contaminated.

I t

t

FEB 92 '90 14818 NRC RI DRSS P07

.73.,;..

s. m...., ~,.o,

.c,i SNss

[

YntP*mt OR vtstAL COWInsATNm AsconD me g;

o,

u....

Jt o..... = t a v.n i

eineoa saume wnesmoons.

(

A fer emim===l inns 1

U nt$ P (vr)n7-rvy

o. m u.

bc Sels o

i i

-Idd,.,k 6.w,g 3

m

.. i E..

1 WJ l@D ?.st-3700 souven m c=

/<! 'd r / h h k f M / E b l W S

/

i mamsay i./fAr hi,sk<weddewk/2r.Judw &

Mg/

  • WAs*V 1

r-unz A s &[

c i

63 yepws.s sha

/prb &d

}. jf,eyeed.d.nde /Wa4A+ /5df

\\

1 "OI!!CIAl. RECORD COPr

\\

MUs REFERRED TO:

a

~

action asoussrso O Aoviss usor ACTION TAKEN, d0 -fcA+

  • M1

IA/#5'

  • er, N r.

. maw

--n---

--,,--.w-,

w e.n...

-r,

.--.n.---

.n.

FE8,02 '90 14 16 HRC RI DRSS P05 t

t a, -

i

/,.

(.

i

.t t

IR PITMAN MOORE Th % \\b l

PS May 3, 1985

[

?

I U.S. Nuclear Regulatory Commission i

Region 1 631 Park Avenue King of Prussia, PA 19406 i

Attn John Miller RE:

License No. 29-15623-03 Docket No. 030-17022 Control No. 02886 Dear Mr. Millert i

In reference to your telephone conversation with Dr. Babu on May 2, 1985, the 125 maximum amount of 1 that would be released per year per m1 would be less f

than 9 X 10-13 microcuries/ml which is less than 2% of the amount allowed per 10 CPR 20, Appendix B, nam ly 8 X 10-11 The corresponding calculation f

is shown on the attached page.

i We trust this meets with your approval.

Please do not hesitate to call if there are any questions.

Sincerely, PITMAN-MOORE, INC.

.(

eupaa-

)

Richard J. Skalski Senior Regulatory Affairs Associate RJSalas

.j Enclosure cc U. M. Babu

-gy,Ly8}l**"l, et c a c- ::::: ta

....... s. c r 033 %

"0FFICIAl. RECORD C0Fr M.18

FEB. 82 ' 90 14 17 NRC RI DRSS-P06 O

.c

/

([.

(

l ls.

i i

calculation I

i l

Maximum Quantity of 1125 Released per Year?

1.

No of iodinations per month = 1 l

per year = 12 l

Amount of 1125 used per lodination = 1 met per year = 12 met j

i 2.

Percentage of 1125 lost per experiment = 104.

g Amount of 1125 lost per year = 10% of 12 mei = 1.2 mei 3.

Filter efficiency = 99% minimum (usually 99.97%)

3 4.

Amount of g125 not trapped by the filter per year

= 14 of 1.2 mei = 0.012 mei = 12 uci 5.

The amount of air filtered through the hood = 900 cubic feet per minute t

There are 28,320 cubic centimeters in a cubic feet.

No. of cubic centimeters of air filtered through the hood

= 28,320 x 900 = 2.5488 x 107 per minute.

or 1.5293 x 109 per hour or 3.6703 x 1010 per day or 1.3396 x 1013 per year l

conclusions f

1 L

Amount of 1125 released per year /ml. =

12 uet 1.3396 x 102J mis.

= 8.9576 x 10-13 uci/ml.

Amount allowed as per 10 CPR 20, Appendix B 8 x 10-11

=

l

F.mironmeestal licahh & Safr d

Pl Mell n R"ifit "",t ;"*

y 4

$000 forbn Avenue Pimburgh PA !$213 3890 412 268 3013/6984 June 9,1989

)

i i

Mr. John D. Kitineman, Chief i

Nuclear Materials Safety Section B l

Division of Radiation Safety l

and Safeguards l

Nuclear Regulatory Commission, Region l l

l 475 Allendale Road L

King of Prussia, PA 19406

Dear Mr. Kinneman:

Whlie we are not in total agreement with your assessment (Routine

]

I ins >ection No.89-001) of our controls for the radiolodinations performed at

. CN U, we will pcriorm additional surveys to verify the adequacy of our system.

The detailed actions to be taken are outlined in the attachment to this letter.

.s i

A file containing all data and conclusions will be maintained for review by

)

future NRC Inspectors.

Any questions regarding these actions should be directed to Peter Collopy at (412)268 3013.

Sincerely, M

g#

m_,. _ _..,

l FMED R GEWS DR. MORTON KAPLAN Vice President, Vice Chairman, Business Affairs Radiation Safety Committee l

l l

i bl.i C.

s..

ii.s.

,.... 2II

=== m an p 91017 '

l

$$3okoh-os PNV O

l ot' MNVAl QtILSMV1

i 4

NRC FINDING:

10 CFR 20.201(b) requires that each licensee make such surveys as may be necessary to comply with all sections of Part 20. As defined in 10 CFR 20.201(a), ' survey" means an evaluation of the radiation hazards incident to the production, i

use, release, disposal, or presence of radioactive materials or other sources of radiation under a specific set of conditions, i

Contrary to the above, surveys were not made to assure compliance with 10 CFR 20.106, which Ilmits the yearly average concentration of radioactive material in air discharged to unrestricted aree Specifically, as of April 12, 1989, an inadequate evaluation was made of the concentration of iodine 125 in the effluent air discharged from a hood where one to two millicuries of iodine 125 were used In todinations approximately six times per year.

CMU RESPONSE:

An evaluation of the potential airborne release was performed by CMU. This evaluation (see attached) was for work where a release of greater than 500 uCl could occur.

As shown in a recent Washington University School of Medicine stud is 1x10'3. y (see attached), the release fract on available Consequently, work with less than 12 (2 in total releases ) reater than 500 uCl.mCl/exper.,6x/yr. m g

To verify that the i

discharge limits are not exceeded, CMU will monitor the exhaust air when the radiolodinations continue. Monitorthy the exhaust air will be discontinued if the results indicate less than 10% of the permissible release limits are achieved.

)

o 3.

w..e nu w

..s a..

a...

t l

RESPONSE TO AND CORRECTIVE ACTIONS FOR NRC INSPECTION 89 FINDINGS NRC FINDING:

Condition 20 of License No. 37 00602 01 requires that licensed materhl be possessed and used in accordance with statements, representations and procedures contained in the application dated August 29,1985.

Item No.10.4.6.2, Bloassays, requires the licensee to perform bloassays and follow action levels specified in Regulatory Guide' 8.20, Rev.1, cated September 1979. 8.20 requires that an evaluation be made and written justification provided by the licenses for not performing bioassays following radiolodinations using greater than one millicurie of lodine-125 in a fume hood.

Contrary to the above, as of April 12,198g, the licensee did not perform an adequate evaluation nor provide written justification for not conducting bloassays following radiolodinations using 1 to 2 millicuries of lodine 125 in a fume hood.

CMU RESPONSE:

Bloassays had been performed during the initial radiolodinations trials.

The results of these bloassays indicated no uptake of radiolodine (< 3nCl),

in addition, there has never been any Indication of personnel or surface contamination resulting from the lodinations. Both of these are usually excellent predictors of the generation of altbome radioactive material.

Discussions with Radiation Safety personnel at other institutions (notably, the University of Pittsburgh) confirmed that the uptake of radiolodine la barely measurable when working with quantitles less than 2 millicuries. However, as the inspector has pointed out, a more rigorous verification of these findings is needed. CMU has stopped all radiolodinations until the following is completec.

1.

A personal air sampling system including cartridge analysis is established for the radiolodinations.

Once the sampling system is established, radiolodinations will be allowed to continue.

Personnel will receive a bloassay (i.e. a thytold scan) for all lodinations. The air sampling data and results of the thyroid scan will be compared and evaluated. if both results show the quarterly intake does not exceed 0.8 uCi for 125, then a written 1

justification for suspending bloassays will be prepared and submitted.

...._..n...o e

IId Md 61'I^

~

. 0; 3

1

~

S'S S-e b$' EON $

b

,,} fR gA_g7_y 4

lir'iftil OflH it t fi l nf 8 2' *1 l r. l { m j g g,.g g g., g,, g g g7 g, g

j f t ( e. *. *

  • e
  • 0 3 ie 3. c,,,,,,,.,,...,,,,,,, _.

11,'$ t s tit i t r { s :. t-

/

I4'"1.

r: r t ii i i st s r..) i mi ri a q ot t g, n,

,g,n (if f i nei I,s ej

,"I e i,,,,,,,,,, j, s,.. g UM I P M'P e f.o Ertvi rnnment l 'a i t rrIei i < 41 rN, r,3 tit r pyi.,

ii a t e.I f,, i,i eym Mrstirl ( 1 ni.,

i-Mmt i trit im er1onrr *

  • ,t.ie i s ir, t b r> 1 te n e t - Iimr 1
3. e ;,,

l' Ili't i stil t esi r g g i, ne g g,, i l.i nr i F1

,prg g

( **.y

,gsg,(j jy y,g i

fI

/mi ri t ( 's. q>t'

"' (17 /t<>

n, - 'y3t' i,

t il s i ecr liiir er t r t <.1 f.el in t:

Refereices:

1.

Dt ip t w i l

'"I Handlinct

<raut1onn 2.

t of F R ; i s t.ynd n, gjy g n, r t c t. cc-t i on y no p g,.4 p j g,

{

3.

1 (. Rr "'

l-l.

I V

'l I'

a l

Appco x A '.

Salt 3)t4 bg Di w 4 b w a, sh t Cwe

_______....m

r tu mm aun

<, ~

t t

.s Operations and Support, Session 111 Phil tsorio presiding L

Th3 Fraction of Activity Released as Alrborne Activity During Typical Radiolodinations l

p hhn Elchling p

Coshington Univorally School of Medicine l

t I.

(b) Etnuent monitoring Air samplere employing i

AH8 TRACT activated charcoal filters were used to monitor Evaluations of radiolodino concentrations released the average concentration of altborne activity of l

to non restricted areas are required for each release the effluent air from fumeboods in which redlo-site In order to ascertain lodinations were performed. Knowledge of (1)

E' ' meters, knowledge of the any sign posting require, the trapped activity. (2) the fumchood and air I

monts and to demonstrate esmpler flow rates and (3) the activity used in compliance with effluent the experiment yields the parameter sought, concentration lim!ts and ful.

providing the sampled air is representative of Allment of the ALAR A cor.-

the fumehood effluent air, cept. Such surveys may be The fraction (f) of activity released as airborne j

by physical measurement or activity was computed for 152 radiolodinations. The by calculation. An evalue-results are se follows:

tion based on cajeulation requires, among other para, Method of Number of Mean Value Assessing,f, Radio-of f, fraction of redlolodine lodinations estivity used in the work that le roleesed as airborne activity. Approximately 150 measurements have been Effluent 8ampling 31

7. 6 r 10.g mods of this fraction for many variations of the popu-Filter Analysta 121 8.6 = 10

1:e radiolodination techniques--(l) chloramine T. (2) astoperoxidase and (3) lodine monochloride. The Compoalte 162 8.4 = 10..

mun value of the fraction to date le 0.4 = 10*

  • with a Standard Deviation
5. 7 = 10' '

ettndard deviation of 5.7 = 10.

The mix of radiolodination techniques used in this INTRODt1CT!ON study was approximately 50 percent chloramine T.

40 percent tactoperoxidase and 10 percent monochlo-The U.S. Nuctuar Regulatory Commiselon rid e. Ilowever, the experimental variations were sub-rxquires posting of a " Caution Airborne Radioactiv-stantialin that most of the 72 different licensee Ity" sign at certain releast: sites if the airborne con-locations where radiolodinations are performed were contration at the exhaust vent ever exceeds a included in the study. ThapHvity range used oer sp;cified value -the restricted area limit for the iodination was 0.5 to 25 mcl and nracticany eII~of the cettrial. The Commission also requires evaluations to ugigjp,dLnations employed *I.

4 demonstrate compliance with concentration limits for airborne activity ralescas te nonrestricted areas and DISCUSSION urges licennees to demonstrate fulfillment of the ALARA concept with regart! to environmental retesses, It is often convenient to demonstrate fulfillment of certain regulations and goals by calculation. This Knowledge of (1) the permitted concentratice a la particularly true for certain altborne releases if (2) the discharge characteristics of the exhaust. '3) the licensee has many potential low level release sites, th) totivity employed in the work and (4) the f; etion Washington University and affiliated institutions cur-ratused allows these evaluations to be made by calcu-rently have 72 different altes where radiolodinations lation.

are regularly performed with I mCl or more of radio-lodine per reaction.

METilODS AND RESULTS An appropriate evaluation le whether the exhaust The fraction of acttwity used in radiolodinutions site should be either permanently or transiently th:t la released as airborne activity was determined posted with a " Caution - Airborne Radioactivity" sign by ttro different methods for many variations of the and, accordingly. designated as a restricted area.

popular redletodination techniques -(l) chloramine T linowledge of (1) the permitted airborne concentra-(2) 1:ctoperoxihee and (3) todine monochloride. The tion. (2) the discharge rate of the exhaust. (3) the two methods were as follows:

activity employed and (4) the fraction released 611ows i (c) - Msv mushsts - The activities trapped by evaluation of whether "elgn posting" is indicated.

activated charcoal filters serving the exhausts For this purpose we average the concentration over a of eithee "minl hoods" or gloveboxes were one h6ur period of time and use a value for the determined after ex eriments in which known released fraction equal to the mean value plus twice activities of redloto Ine had been employed.

the standard deviation of the mean (m + 2o). Use of this value provides a statistical conDdence of 97.7 CRBO Proceedings ( ~hw. fe-4, N, un en'j d W%N, GW% Nw ! )

90

=

y.

.h{g. yQ ;;;g; Qt *:

7 1

'gforcent that no single lodination et -aceed ths col.J-f eulated eencontrol a.

.: 4 gig.uusiion is.lon. live.t. The.v,"iue e.m loye.d.f:r t..

. i

><..i-e A second evaluation le the demoneiration that the i

ALARA goal of limiting airborne rolesses of redlo-settwity to ponrestricted areas to 10 percent of

-i federal limite le being achieved.- For thle evaluation l

it le eseumed that 10 or more lodinellone are perforni-

'ed at each atte per year, and the celeulated concen-tretion et the release point le everaged over o calen-der year. It een be shown that the probability of

)

tbtaining en everage reloose fraction for e sub set of L

' 10 releases that le 1.8 times the established mean j

fraction (0.4 m 10)le less than 0.08 (< 1 percent).

Thus, the value for the mean release trWion used f;r the ALARA demonettetton calculation to 1.S(0.4 =

10 ') = 1.3 = IJ.

Use of thle value provides a 99+

percent stettetical onnfidence that the actual everage I

L-concentration et the release point does not exceed the computed everage concentration.

l CONCIA1810N t

1 0

Rnowledge of the fraction of activity used in radiolodinetton renetions that le rolessed as airbosce -

l eettvity may be pertinent for certeln radiological B

cvelustione. Dgte from approximately ISO experimente L

ouggest that the mean value of thle parameter le of the order of 8.4 = 10*

  • lbr the popular radiolodinetton t:chniques. The standard devietton of the parameter use fDund to be 6.7 = 10'.'.

li M

L, t

L Y

Convictione are more dangerous enemies of truth than lies.

Friedrich Nietnehe CRSO Proceedlngs 91 d.

9 h

A i

'P h A A.ft A '

. n c 2....

+k y,'e.

ag

t. 4

~

a; r

OCT 171988

i Docket No.J030-14472' o

License No. 37-00602-03 Carnegie-Mellon University ATTN:' Dr. Morton Kaplan, Vice-Chairman of Radiation Safety Committee 5000 Forbes Avenue j

?

Pittsburgh, Pennsylvania 15213 1

Gentlemen:

I

Subject:

Inspection No. 030-14472/89-001 q

This refers to.your letter dated June 9,1989, in response to our letter t-

]

15, 1989.

H dated May

' Thank you for informing us ef the corrective and preventive actions documented in your letter.- These actions will be examined during a future inspection-of I

your licensed program, i

Please note that a written justification for suspending bioassays following the-types of radioiodinations you currently perform need not be submitted to the NRC.

However, such a justification should be available for review during-future j

NRC inspections,.

In: addition, several measurements of a limited parameter, the results of which are even an order of magnitude (less than 10% of the limit) below the limit are not, in and of themselves, sufficient-justification for concluding that an t

adequate survey has been made and ceasing the measurements.

You.must-assure that the data gener.ated continue to reflect the actual circumstances during later,' unmonitored activities.

Changing techniques, suppliers, and variability in the ability of the operator to follow procedures exactly may cause changes in the release fraction.

You should assure that' sufficient monitoring (both

. measurements of effluent concentrations and observations of other variables) continues;to assure compliance.

Your cooperation with us is appreciated.

Sincerely, Original Signed By:

Rancis M. Costello John D. Kinneman, Chief Nuclear Materials Safety Section 8 Division of Radiation Safety and Safeguards OFFICIAL RECORD COPY RL CARNEGIE - 0001.0.0 10/05/89

,I 89-1031-0074 891017 RETURN ORIGINAL TD RE01 LIC30 i

3 l :n=f 37-00602-03 PNU REGION I U

,g y


I----

..g.

y

.r 3

s

Y, g h_ *

?g }ju f.Ji. p ti [

/

Carnegie-Mellon University 2

q

.Y cc:

.Public Document Room-(POR)

" Nuclear Safety. Information Center (NSIC)

Commonwealth of Pennsylvania

~

Peter Collopy, Radiation Safety Officer bec:-

Region I Docket Room (w/ concurrences)

R. B. Provencher, RI t

a

+.

)

' i t

-i M

FM i

fRI:0RSS RI:DRS Pro

-Kinneman f (vencher/bc 10/ 1/89 10/P7/89-0FFICIAL RECORD COPY RL CARNEGIE - 0001.1.0 10/05/89

-o s a

.