ML20197E807

Guidelines for Bioassay Requirements for Tritium

ML20197E807
Person / Time
Issue date:	10/19/1977
From:	NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
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ML20197E811	List: ML20197E807
References
81029, NUDOCS 8008200130
Download: ML20197E807 (7)

Text

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Apipendix F q

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t GUIDELINES FOR BI0 ASSAY REQUIREMENTS FOR TRITIUM

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Nuclear Regulatory Comission Division of Fuel Cycle and Naterial Safety l

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October 19, 1977 AB/REA (j'

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. BI0 ASSAY REQUIREMENTS FOR TRITIUM l l

I. Conditions Requiring Bioassay ,

A. Routine Bioassay is required when quantities processed by 7' 1

. an individual at any one time, or total amou'nt processed per 3 month, exceed those for the respective foms of tritium as s a

shown in the attached Table 1.

L B. Above 0.1 of, but less than, the levels in Table 1, routine j -

bioassay is required unless a written justification is submitted for not perfoming bioassays.

C. Except as stated in I.D. below, bioassay is not required for process quantities less than 0.1 of those in Table 1.

D. Special bioassay measurements should be perfomed to verify the effectiveness of respiratory protection devices and other protective clothing. If an individual wearing a respiratory protective device or protective clothing is subjected to a concentration of tritium in air (in any fom) such that his or -

her intake with no protection would have exceeded that which would result from exposure for 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> per week for 13 weeks

! at uniform concentrations of tritium in air as specified in Appendix B, Table I, Column I,10 CFR 20,* bioassays should be [

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CMultiplying the concentration given in Appendix B, 5 x 10-6 pCi/ml,by 5 6.3 x 108 ml gives the corresponding quarterly intake of tritium by G inhalation. This is assumed equal to the uptake of tritium (as HTO) by E absorption through the skin unless the form of tritium in the air can be i demonstrated to have lower uptakes. The total uptake, including skin absorption, would be assumed to be about 6.3 mci, which delivers a dose connitment of about 1.25 rems to standard man. .

_ (gpo %i/,L) t [ L.3 ' e i'd ; 3': t IDY 3.1s so

performed to determine the resulting actual tritium intake' These special bioassay procedures should also be conducted, for personnel B l

wearing respirators, if for any reason the average tritium concen- i i

tration in air and the duration of exposure are unknown. ).

II. Who Should Participate -

All workers involved in the processing of tritium, under conditions '

specified in I above, or sufficiently close that intake is possible, should participate.

III. What Tvoes of Bioassays Should be Performed A. Baseline (including Pre-employment, or Pre-operational Urinalysis, not more than one month prior to beginning work with tritium requiring bioassay under Section I above).

B. Routine Urinalysis C. Post-operational. Within one month of last possible exposure to tritium.

D. Diaonostic. Within one week of any sample exceeding levels e

given as action points in Section V below. SeeV.A.2.(d). '

IV. How Often

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l A. Initial Routine Samples Within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> following entry of an individual into an area where operations require bioassay according to Section I.A and CONTRotno, g 7 g g g

, B above, and then every two weeks or more frequently thereafter as long as the individual is working with 3 H. 3 '-

B. After 3 t!onths i'

The sampling frequency selected in accordance with Section IV.A

above may be changed to quarterly if, after 3 months, the following 3 conditions are met: '

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(1) The average urinary tritium concentration from specimens obtained during the 3-month period does not exceed 3 mci /1, (2) Where measurements of the concentration of tritium in air are required as a condition of the license,'the quarterly average concentration (uti/ml) to which w~orkers are exposed, 8

multiplied by the factor 6.3 x 10 ml, does not exceed 0.8 mci, and (3) The working conditions during the 3-month period, with respect to the potential for tritium exposure, are representative of working conditions during the period l

in which a quarterly urinalysis frequency is employed, and there is no reasonable expectation that the criteria 1

given in (1) and (2) above will be exceeded.

V. Action Points and Corresponding' Actions A. Bi-Weekly or More Frequent Sampling j

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1. If urinary excretion rates exceed 5 pCi/ liter, but are less l

than 50 ACi/ liter, the following course of action should be s.,

taken: j[

. -(a) a survey of the operations involved, including air {

t and area monito -), should be carried out to determine s

. i the cause(s) of exposure and evaluate potential for further larger exposures. ,.

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(b) Implement any reasonable corrective actions indicated in the survey that may lower the potential for further exposures.

(c) A repeat urine sample should be taken within one week of the previous sample and should be evaluated within a week after collection.

(d) Any evidence from (a) and (b) indicating that further work in the area might result in an employee receiving a dose commitment in excess of the limits established in 520.101 should serve as cause to remove the employee from work in this operation until the source of exposure is t

discovered and corrected.

2. If urinary excretion rates exceed 50 uti/ liter, the following course of action should be taken:

(a) Carry out all steps as in 1.(a) to (d) above.

(b) If the projected dose commitment exceeds 5 rems, report i the incident to the NRC in accordance with 520.403 of 10 CFR Part 20.

(c) Refer the case to appropriate medical / health physics consultation for recommendations regarding therapeutic [' '

procedures that may be carried out to accelerate removal I of tritium from the body and reduce the dose as low as  !

' P reasonably achievable.

(d) Carry out repeated sampling (urine collections of at -

- least 100 m1 each) at approximately one-week intervals, at least until samples shew an excretion rate less than 5 pCi/ liter. If there is a possibility of long-term organte compartments of tritium that require evaluation, continue sampling as long as necessary to ensure that appreciable exp,osures to these other compartments do not go undetected.

B. Quarterly Sampling Carry out actions at levels as indicated under A. above, and if the exeretion rate continues to exceed 5 xCi/ liter, also I

l reinstitute biweekly (or rore frequent) sampling for at least the

.next 6-month period, even when urinary excretion falls below 5Sti/ liter.

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HT cr T GAS HTO .D "I$fj INSEAlfDPROCESS NUCLE 0 TIDE MORE istAN 10K .

HTO FORM VESSELS PRECURSORS OF IllERT 1l 0 3-

• 2 TYPES OF OPERATION (& forms other OR OTHER -

MSU0"1s }

PROCESSES IN OPEN ROOM OR DENCH, WITH O.1 Ci 100 Ci 0.01 Ci 0.01 Ci/K g FJSSIBLE ESCAPE OF TRITIUM FROM PRQCESS .

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'!ESSELS ,

l'i:CCESSES WITil POSSIBLE ESCAPE OF TRITIUM, CARRIED OUT WITHIN A FUME H000 0F ADEQUATE 1 Ci 1000 Ci 0.1 Ci 0.1 Ci/K 9 EESIGil, FACE VELOCITY, AND PERFORMANCE . .

liELIABILITY ,

Ff:0 CESSES CARRIED OUT WITHIN Gf 0VE00XES, 10 Ci 10,000 Ci 1 Ci 1 Ci/K9 nRDil!ARILY CLOSED, BUT WITH POSSIBLE It!: LEASE OF TRITIUM FROM PROCESS AND 2CCASIONAL EXPOSURE TO CONTAMINATED BOX

• Ai0 COX LEAKAGE , ,

e Table 1 -

ACTIVITYLEVELSORCONCENTRATIONSABOV5WHICHBI0ASSAYSHALLBEREQUIRED

'hnatities present ( <10Kg) may be considered either the amount processed by an individual at any one time (when pecidental intake is more likely), or the amount of activity entered into process (throughput) during any one month dwlan routine handling of repeated batches is the more likely source of exposure). Concentrations in the right-Pi.?:':! column may be used when activity .in process is always diluted in more than 10Kg of other reagents, as in g iuclear reactor coolant systems.

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U.S. NUCLEAR REGULATORY COMMISSION see.$r$*sN

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@=o.fREGULATORY GUIDE

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OFFICE OF STANDARDS DEVELOPMENT Appendix G l

REGULATORY OUIDE 8.20 APPLICATIONS OF BIDASSAY FOR l-125 AND l-131 "

A. INTRODUCTION vitro of materials excreted or removed from the Section 20.108, " Orders Requiring Furnish-ing of Bioassay Services," of 10 CFR Part 20,

' Standards for Protection Against Radiation.' Intake-The total quantity of radioactive indicates that the Nuclear Regulatory Commis- maternal entering the body.

clon (NRC) may incorporate into a license pro-visions requiring a specific program of In vivo measurements-Measurement of gn=ma-bixssay measurements as necessary or or x-radiation emitted from radioactive materia' 1

l disirable to aid in determining the extent of an located within the body for the purpose of detecting or estimating the quantity of rad 2o- l individual's exposure to concentrations of active material present.

radi: active material. In certain cases, the l requirement of bionssay may also be included in <

ths license by reference to procedures specify- In vitro measurements-Measurement of radio-ing in vivo measurements, measurements of activity in samples of material excreted from radioactive material in excreta, or both. the human body.

This guide provides criteria acceptable to the C. REGULATORY POSITION NRC staff for the development and implementa-ti:n of a bionssay program for any licensee 1. Conditions Under which Biosassy ls Necessary handling or processing I-125 or I-131. It further provides guidance to such licensees a. Routine 1 bloassay is necessary when an

• regarding the selection of workers who should individual handles in open form unsealed 2 i part2cipate in a program to detect and measure quant 2 ties of radioactive iodine that exceed possible internal radiat2on exposure. The guide those . shown in Table 1 of this guide. The is programmatie in nature and does not deal quantities shown in Table I apply to both the with Izessurement techniques and procedures. quantity handled at any one time or integrated as the total amount of activity introduced into a l S. DISCUSSION ##"" *" "' I" "'# *I '

period. I I

Tha topics treated in this guide include de-17rminations of (1) whether bionssay should be b. When quantitles handled in unsealed perfcrmed. (2) frequencies of bioassay, (3) form are greater than 10% of Table 1 values.

who r.hould participate, (4) the actions to take

=Iaan andacete substamure casares fne annous sasue bissd on bioassay results, and (5) the partie- ,

uhr results that should initiate such actions. scheI,we,d and nputable basu to summat spunens for tacassa:.,,, ,,,,,

er to repert for la evo measurements. Eatber redaoeSe 3 . A. c-Far the user's convenience, the following "

12rms are presented with their definitions as M. u.e'nu."e,'OQ,",,'; 'n'^du,"ir $NN Ues us2d in this guide; 3 aowe,er. a keenne any wun to corneerste numato from uncalysa data with m mvo detert:st:r s sance there are adequate refersaces an the hterature tc bra T'iois say-The determinat2on of the kind , devue bioassay measurements, thas g'uade does set an c.b c e reco ended analyncal proceduns. a.en tosiansme: onei.:e quantity or concentration, and location of adept procedures er entaan services best suates tc ats e=2

' radioactive material in the human body by ""-

dirset (in vivo) measurement or by analysis in es discussion a the footnote to Table 1 of taas rLee LFENRC REGUI.ATORY GUIDES R Comments should be sent to the Sureten of the Commisnon. L' 5 e

Geldes an loved to describe and make evaBeble to the Nuclear Reeulatory Commismon. hashmatos. D.C. 20555. Arten.

c met eds acceptable to the NRC staff ofimplementing sputfsc tion Docketing and sernce Branch.

cf the Commiscon's re etions. to dehneste techruques used the Caff in evaluetag spec problems or poefulsted accidents.or The guides are humed h the feBowtas see tened dMemons es prende guidance to appbcants Breulatory Gusdes an not utsts. . Power Ructors entse for lations, and comphance esth them ts not . Products Methods used. Reerarch and Teet Reactors . Transportetion solutsens dafferent from those att out in the s wul . Fuels and Matenals Facihtees he acceptable if they pronde a basu for the fsndags reeuasite to 8. Occupstsona) Health hauance se seetmeance of a permit se bcense by the Cemv==the on. 4. Environmental and sitms 9. Antitrust and Tananaa! Revie*

5. Notenals and Plant Protection 30. General Coenments and opgestions for bnprovements b these susdes are Copies of boued guides may be purchased at the current Government &

, encoureted at all times, and ides wul be eensed, as spyropnote.to Pnnems Office pnce A subeenption arrnce for future guides m ere t

I accommodate eesmuseets an to reflect new hfortnation er espen. ic dmmons b evaDable throush the Governtnent prmting Office.

ence. Thas guide was ereised as a result of substaatsve somments ormataos es the abacription arrnce and current GPO pnces me?

surewed from the pubiac and addational staff aview. obtained b wrinna the U.S Nuclear aceulatory commasmon.

I tuashastos. D.C. 34535. Attention: Pubbconoms sales Mansser.

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. e Toutina bioassry may still be :tecessary u;dir certain circum:tanc23. A written justifiestion 3. Types af Beoassays That huid Be Perfzrmed for not performing such measurements should a. Baseline (rreemployment or oreopera-be prepared and recorded for subsequent re-view during NRC inspections whenever bio- q$onal). Prior to begmnmg work with radso-assay is not performed and the quantities active iodine in sufficient quantity that bio-handled exceed 30% of the levels in Table 1. massy is specified in regulatory position 1.

c. Except as stated in regulatory posi- b. Routine.

regulatory position At the 4. frequency specified in tion 2.e, bioassay is not required when pro- *.

eess quantities handled by a worker are less than 10% of those in Table 1. c. Emerrency. As soon as possible after any!

incident that might cause thyroid uptakes to exceed burdens given in regulatory post !

(1. In nuclear reactor instAUations, employ- tion 5.a(2), so that actions recommended in' ees should be bioassayed by an in vivo count within 30 days after the end of exposure in effective. posit 2on 5.a(2)(b) can be most regulatory work locations where concentrations exceeded, I or might have exceeded, 9 x 10** pCi/ml averaged over any 40-hour period. Table 1 and a

d. Postoperationaland with Separation Phys-regulatory position 4 regarding frequency of gal. A bionssay should be perforned with2r 2 bioassays are not applicable to reactor weeks of the last possible exposure to 1-125 or licensees. I-131 when operations are being disconimued or when the worker is terminating activaties with potential exposure to these radionuchdes.

e. Special bioassay measurements should be performed to verify the effectiveness of e. Diarnostie. Followup bioassay should be respiratory protect 2cn devices and protective performed withm 2 weeks of any measurements clothing. If an individual wearmg a respiratory exceeding levels given as action points in protective device or protective clothing is sub- regulatory position 5 in order to conftrin the jected to a concentrat2on of I-125 or I-131 (in initial results and, in the case of a smgle any form) in air such that his or her intake intake , to aHow an estimate of th effect2ve with no protection would have exceeded the half-life of radiciodine in the thyroid.

limits spee2fied in paragraph 20.103(a)(1) of 10 CFR Part 20,8 bioassays should be per- 4. Frequency formed to determine the resulting actual 1-125 s. Init2al Routine. Except in situations cr I-131 intake. These special bioassay proce.

dures should also be conducted for personnel where thyroid burdens may exceed quantities '

wearing respirators if for any reason the I-125 specified in regulatory position 5.a(2), a bio '

assay sample or measurement should be er I-131 concentration in air and the duration obtamed within 72 hours8.333333e-4 days <br />0.02 hours <br />1.190476e-4 weeks <br />2.7396e-5 months <br /> following entry of an

'cf exposure are unknown or cannot be conser.

avatively estimated by calculation, individual into an area where bioassay is performed in accordance with regulatory posi-tions 1 and 2 (but waiting at least 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> for

2. Participation

.. distribution of a major part of the iodme to the thyroid *) and every 2 weeks or more frequently thereafter as long as the conditions All workers handling radioactive iodine or described in regulatory positions 1 and 2 sufficiently close to the process so that intake exist. When work with radioactive iodine is on '

is possible (e.g., within a few meters and in the an infrequent basis (less frequently than every' same room as the worker handling the t sterial) should participate in bicassay pro- 2 weeks), bioassay should be performed withm 10 days of the end of the work period durmg grams described in regulatory position 1. which radioactive lodine was handled sooner than 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> unless emergencya:tiens (but not to obtain an early prognosis and thyroid

% upires ne e.acentreuens y no en append 2 a to blocking treatment are appropriate *).

30 crn rart 20. Tatte 1. column 1. s a to

• ucuni for 3125 (soluble) and 8 a 10 ' wCa/sl for 1131 (soluble). by s 3 a 10' m2 eins me corruponaan evarterty estae or ne nopecuve

b. After 3 Months. When a periodic meas-me.n u by aman;suon Taue quarterly intnau would be about urement frequency has been selected in si vci ter 1 12s and 5 7 vei for :-131. =bieb would si'e

• accordance with regulatory position 4.a, it may thyrond aese emanausent of about 7 s runs to a 20-seas tarroad mirenied ever au rotun same unant effecon half b'u et 42., be changed to quarterly if, after 3 months, all ders for 112s and 7.s days for 1131 and usang a quahty factes the following condit2ons are met: .

ter) et 1.7 te salculate effecun aasiaterrenon enerry a me esse er 112s. (Taas er er 3.7 as used ter eosservataan, even (1) The average thyroid burden for theurb the laternataosa! Cammassion sa Radaological Protecnon each individual working in a given area was beve puthabed a Gr of 1. because esse caJeulations an son (1989) and tae Nataosal Councal en maan focent scientafac htersrure save suggested the use of GF veJues *NCRP Report Me s5. 'Protocoes of the ThTrond clar:d e hagier man 1 for electros er beta emergies of 0.03 MeV or the Inst of ases-) Radascon Protectaan Reluees of Radassadane.* NotaenaJ Co.anc.:oc and august 3,1977, p. 21. Mansurementa, weshastton. D C. .

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$ess than' O.12 pCi of I-125, le s than 0.04 pCi f 20.103 cf 10 CFR Part 20 to b cxceeded, the of *I-131, arid less than th2 corresponding pro- lic:nsse ch:uld restrict the trorker from portion:ts amiunts of a mixture af thssa furthsr cap:sure until the cource 'of exposure suchdes during the initia13-month period; is discovered and corrected.

(2) The quarterly average radioiodine (c) Corrective actions that will eli=.

concentration (pCi/ml) in air breathed by any inste or lower the potential for further expo.

worker (as obtained when measurements of sures should be implemented.

1 radiciodine concentrations in air are required) does not exceed 25% of the concentration values (d) A repeat bloatpsy should be i for " soluble"(s) iodine given in Appendix B to taken within 2 weeks of the . previous measure-10 CFR Part 20, Table I, Column 1, (5 x 10-8 ment and should be evaluated within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> pCi/ml for I-125 and 9 x 10** pCi/ml for I-131), after measurement in order to confirm the i.e., 25% of these concentrations multiplied by presence of internal radiofodine and to obtain the" total air breathed by an employee at work an estimate of its effective half-life for use in du-ing one calendar quarter, 6.3 x los al, estimating dose commitment. )

does not exceed 0.8 pCi of I-125 or 1.4 pCi of I-131. The appropriate proportionate amount 5 (e) Reports or notification must be of a mixture of these nuclides should be used provided as required by ll 20.405, 20.40E, 1 as a guide when both I-125 and I-131 are and 20.409 of 10 CFR Part 20 or as regtu. red present; and by conditions of the beense pursuant to i 20.108 of 10 CFR Part 20.

(3) The working conditions during the 3-month period with respect to the potential for (2) If the thyroid burden at any time exposure are representative of working condi- exceeds 0.5 pCi of I-125 or 0.14 pCi of I-131, tions during the period in which the quarterly the following actions should be taken.

bioassay frequency will be employed, and there is no reasonable expectation that the criteria in (a) Carry out all steps described in regulatory positions 4.b(1) and 4.b(2) above regulatory position 5.a(1).

will be exceeded.

(b) As soon as possible, refer the '

c. After Use of Respiratory Protection De- case to appropriate medical consultats:n for l vices.Between 6 and 72 hours8.333333e-4 days <br />0.02 hours <br />1.190476e-4 weeks <br />2.7396e-5 months <br /> after respiratory recommendations regarding therapeutic proce-protective devices, suits, hoods, or gloves are dures that may be carried out to accelerate '

used to limit exposure as stated in regulatory remo. val of radioactive iodine from the body. !

l position 1.e. This should be done within 2-3 hours after

• exposure when the time of exposure is known '

For individuals placed on a quarterly so that any prescribed thyroid blocking agent schedule, sampling should be randomly distri- would be effe"ive.* I buted over the quarter but should be done within one week after a procedure involving (c) Carry out repeated measurements the handhng of I-125 or I-131. This will pro- at approximately 1-week intervals at least until vide a mere representative assessment of expo- the thyroid burden is less than 0.12 pCi of I-125 sure conditions or 0.04 pCi of I-131. If there is a possibility of 5 Action Points and Comsponding Actions ag N C Spmnis poneg M25 or I-131 that require evaluation, continue meas-

a. Biweekly or More Frequent Measurements urements as long as necessary to ensure that appreciable exposures to these other compart-(1) Whenever the thyroid burden at the ments do not go undetected.

time of measurement exceeds 0.12 pCi of I-125 or 0.04 pCi of I-131, the following actions b. Quarterly Mea surement s . Carry out should be taken: actions at levels as indacated under regulatory position 5.a(1) and (2). If measurements and

(a) An investigation of the opera- surveys indicate an appreciable likelihood that tions involved, including air and other in-plant a worker will receive further exposures surveys, should be carried out to determine exceeding the criteria of regulatory posi-l~ the causes of exposure and to evaluate the tions 4.b(1) and 4.b(2), reinstitute biweekly potential for further exposures, or more frequent bionssays.

(b) If the investigation indicates that further work in the area might result in cuposure of a worker to concentrations that D. IMPl.EMENTATION

trould cause the haiting intakes established in

! *s., app naam a to ma wee The purpose of this section is to provide in-er .ne ma am rer .t.arve.ter. a a..eripoon esa .m msie fomation to applicants and heensees regard 2ng i

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.C0 DRC staff's plans fir itsing this regulat:ry incorporatzd in thsir licens2s in cec:rdance guide. with 6 20.108 c,f 10 CFR Part 20.

Except in those cases in which the applicant If an applicant or licensee wishes to use the or Meensee proposes an acceptable alternative method described in this regulatory guide on method , the staff will use the methods or before December 15, 1979, the pertinent i l described berein after December 15, 1979, in portions of the application or the licensee's '

i evaluating the radiation protection programs of performance will be evaluated on the basis of Meenseca who bsve bioassay requirements this guide. ,

Table I ACTIVITY LEVELS ABOVE WHICH BIOASS AY FOR I 125 OR I 131 IS NECESSARY Activit) Handled in Unsealed Form MaLins Bionssay Necessar>

• Volatile Bound to or Nom olatile Types of Operation Dispersible* Agent

• Processes in open room or bench, with possible escape 1 aCi 10 mC2 of iodine from process vessels Processes with possible escape of iodine carried out 10 aCi 100 mC2 within a fume hood of attequate design, face velocity, pad performance reliabilat) .

Processes carried out within gloveboxes, ordinarily 100 mci 1000 mci (

c30 sed, but with possible release of iodine from process and occasional exposure to contam2nated box and box leakage uguanisties may be eensidered the cumulative enount an process bandled by a worker dureg a 3 month per od, e g , the total quantaty mtroduced into e chassical er physical process ever a 3 month peraod, or en one er more ocessions m that persod, by opening stock reegent containers from which redsoectave endine may escape Quantat,es an the right hand solumn may be used when it een be shown that activity in process is always chemicaUy bound and processed an such a manner that 1-125 or 3131 wiU renam in nonvolatile form and daluted to concentrations less than 0 I mC /eg of menvoletde egent. Capsules (such as gelatan capsules given to patients for daagnostac tests) may be considered to contam the rednesedane in nonfree form, and bseessay would not be necessary unless e capsule were inadvertently opened (e g eropped and erwahed). However, certain compounds where radiosodme la normasly bound are known to release redsonodee when the maternal as an process, and the left-hand column may then be appbcable in those laboratories workang on!) m ath I 136 in todassamunassay (RI A) kata, the quantities of I-125 are very emeu and an less volatile forms, thus, bocassas requirements may be judged from the right hand rehamn in faeld operations, where reagent contaaners are opened outdoors for ebnple operstaons such as pourvig hquid solutions, the above table does not apply. baosssa) shculd t,e performed whenever en individust employee handles an open form (e g., en open bottle or contamer) more than 50 pCs s' any one same -

operetsens ineolving the routine use of I-135 or 1-131 in en open room or bench should be discouraged whenes er 1

practacable, sealed bottles or containers boldmg more than 0 3 aCa of I-125 or 1 138 should be opened et least initish witban hoods beving adequate fece velocataes of 0.s m/secy.

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I APPENDIX A SUGGESTED REFERENCES TO ASSIST IN ESTABLISHING A BIOASSAY PROGR AM In response to public comments, this list of publications is provided to assist the licensee in est Eshing measurements and administrative procedures for a bioassay program appropriate to tance in establishing analytical procedures or services.tions. This list is not intended

1. American Nationa] Standard. ANSI N44.3-1973, i

" Thyroid Radioiodine Uptake Measurements Radiological Protection, Pergamon Press,!

Using a Neck Phantom," Amerier.n National Oxford, p. 17, 1968. '

• Standards Institute, Inc.,1430 Broadway, .

New York, N.Y. 20018, approved 9. ICRP Publication 20A, "The Assessment of August 24, 1973. Internal Contamination Resultmg free Recurrent or Prolonged Uptakes," Reco=- :

2. R. C. Brown, "28 51 Ingestions in Research mendations on of the International Commission ,

Personnel " Operational Health Physics, Radiological Protection , Perga=en pp. 276-278, 1976, proceedmgs of the Presu, Oxford,1969.

Ninth Midyear Topical Symposium of the Health Physics Society, Denver, Colorado, 10. A. L. Orvis, "What Is a ' Reportable' Thy-February 1976 (P. L. Carson , W. R. roid Burden?" op. cit. , Ref. 2. , pp. 266-271.

Hendee, and D. C. Hunt, Eds. , Central Rocky Mountain Chapter, Health Physics Society, P.O. Box 3229, Boulder, Colorado 11. P. Plato, A. P. Jacobson, and S. Homan, '

80303,$15). "In Vivo Thyroid Monitoring for lodine-131 in the Environment," Int. J. A Radiat . and Isotopes, voT~ 27! pp.prlied

3. E. J. Browning, K. Banerjee, and W. E. 545,1976~

Reisinger, Jr. , " Airborne Concentration of 539- l-I-131 in a Nuclear Medicine I.aboratory " J.  ;

Nucl. Med. , vol.19, pp.1078-1081,1976. 12. Radiological Protection Bulletin 25, Working with Iodine-125," National Radio-" Safe ,

4. J. G. Dare and A. H. Deutchman, "The logical Protection Board, Harwell, Didcot, Decay Scheme of Iodine-125 and Its Rela- Oxon, England, pp. 19-20, 1978.

tionship to Iodine Bioassay," op. cit., 13. R. P. Rossi, J. Ovadia K. Renk A. S.

Ref. 2, pp. 250-254.

Johnston, and S. . Pinsky, " Radiation

5. B. C. Fasiska, " Radiation Safety Proce- Safety Considerations in the Management of ;

durn and Contamination Control Practices Patients Receiving Therapeutic Doses of -

Involved in Hi as11," op. cit. , Ref. 2, pp. 279-286.

py Cases ," op.gh cit. ,I.evel I-131 Ref. 2, pp. Thyroid 287-291.Thera-

24. C. T. Schmidt. " Thyroid Dosimetry of 8851

6. A. Gavron and Y. Feige, " Dose Distribu- and an Instrumental Bioassay Procedure,"l tion and Maximum Permissible Burden of Prorram and Abstracts: Twenty-Third An g 5851 in the Thyroid Gland " Health nual Cont-~ on Bion s say. EnvironmentP and Analytical Chemistry, Physics, vol. 23, pp. 491-499,1972.

Ep t . 15,16, 1977.

IDO-12063,

, 7. B. Y. Howard, " Safe Handling of Radio-e nodinated Solutions," op. cit. , Ref. 2, pp. 15. A. Taylor, J. W. Verba , N. P. Ala:rak:.

247-249. and W. C. McCutchen, " Monitoring of I-125 Contamination Using a Portable Scintillatsen S. ICRP Publication 10, " Report of Commit- Camera," J. Nucl. Med. , vol.19, pp. 431 '

432, 1978.

tee IV on Evaluation of Radiation Doses to Body Tissues from Internal Contamination Due to Occupational Exposure," Recommen- 16. Technical Reports Series No.148, " Control dations of the International Commission on of Iodine in the Nuclear Industry," Inter :

national Atomic Energy Agency, Vienna.1973.;

S.20-5 i

!. . . . _ ~ . . . . . . , .

APPENDIX B CALCULATION OF ACTION LEVELS FOR MIXTURES OF l.125 AND 1131 B.1 Centroning lastantaneous Thyroid Burdens period wInen air concentration data are avail- l Regulatory position 4.b(1) is based on con- able to assess the potential exposure of the

t. rolling the instantaneous amount in the thy- worker either to random single intakes or to variable or constant continuous dxposures. The roid and is taken as 25% of the maximum per- quantities of 0.8 pC. of I-125 and 1.4 pC of 1-missible organ burden (MPOB) of I-125 or I-131 131 were obtained by calculating 25% of the that would give a dose rate of 0.6 rea/ week if total quarterly intakes of 3.2 pCi of 1-125 or I

continuously present in the thyroid. If a mix- 5.7 pCi of I-131 (see footnote 3) that would be ture of both nuclides is present in the thyroid inhaled when breathing a total of 6.3 x 105 ml and X is the fractional activity that is I-125, a per quarter working at the standard man 3-month interval may be resumed when the breathing rate for 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> per week for 13 total activity of I-125 and I-131 is below weeks.

0.12X + 0.04(1 - X) Example Example  !

If the average quarterly concentrations esti-  !

mated from air sampled in a worker's breathing '

If the measurements of I-125 and 1-131 in a mone are 3 x 10** pCi/ml for I-125 and 5 x 10**

worker's thyroid are 0.10 pCi of I-125 and 0.05 pCi/ml for 1-131, the total quarterly intakes pCi of I-131, the fractional I-125 activity is are: l X = 0.10/(0.10 + 0.05) 3 x 10** x 6.3 x los = 1.89 pCi 1-125

= 0.667 Then 5 x 10-s x 6.3 x 10s = 3.15 pCi I-1"*1 Total = 5.04 pCi 0.12X + 0.04(1 - X) = 0.12(0.667) + 0.04(0.33)

0.0932 Also, X, the proportion of I-125, is 1.89/5.04

0.375 Total = 0.10 + 0.05 = 0.15 pCi Thus, in this case, the worker involved Thus the control level for maintaining thould remain on the biweekly (or more fre- biweekly or more frequent bionssay checks is:

quent) schedule and should not be put on the quarterly frequency. 0.8X + 1.4(1 - X) = 0.8(0.375) + 1.4(1 - 0.375)

Total = 1.18 pCi for this mixture.

B.2 ControRans Totallatakes Since the intake of 5.04 pCi is greater than Regulatory position 4.b(2) is based on con- 1.18, this employee should stay on the more

~ trolhng total intakess during a quarterly frequent bioassay schedule.

'Taeter smas huse teiaquarterly antaku are a dirrerent pnpor-am saa 13 ano an ne xross. Taas deterence MD# D* #8 d in the above calculations do not imply e2 e neu2t er me rnet ea permissaie eene.oinuens an any given degree of accuracy of mea-t:mnely propernona: a errecuee ha:t hen =nerus an Myos

• ' surement. Enough digits are carried to N'e#

ias*"Nes***n'y'* s*en*Eu'"us*m'sa*ke 'oU a*en*#l allow following the arathmetic for pur-balanced by an equal raie er almanues from ee organ. PoEes of the examples.

I l

4.20-6

j ATTACHMENT #16

] Formal Training in Radiation Safety (MS) PATRICIA HAWTHORNE

a. Principles and practices of radiation protection a

- On the job training

b. Radioactivity _ measurement standardization and monitoring techniques and instruments

- On the job training

c. Mathematics and calculations basic to the use and measurement of radioactivity

- On the job training

d. Biological effects of radiation

- On the job. training i

i s

ATTACHMENT #16 Formal Training in Radiation Safety

+

(MS) ANNE M. HORACZEK _.

a. Principles and practices of radiation protection

- Radiobiology, Wayne State U. - 1 semesteE11961

- NIOSH Training Course #584 Ionizing Radiation

b. Radioactivity measurement standardization and' monitoring techniques and. instruments

- Radiobiology, Wayne State U.

- NIOSH Training Course #584 ,

- On the job training

c. Mathematics and calculations basic to the use and measurement of radioactivity

- Physics, U. of Mich. - 1 yr. 1957 1 re

^

- Calculus, Wayne State U. - 1 yr. 1967

d. Biological effects of radiation

- Radiobiology, Wayne State U.

- NIOSH Training Course #584 s

CONTROLNO. 810 2 9

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

( .- ..

. ATTACHMENT #16 Formal Training in Radiation -Safety (DR) CHARLES W. WHITAKER

a. Principles and practices of radiation protection i, - Radioactive Tracers, Brigham Young Univ.,

1 semester 1973 ,

- On the job training

b. Radioactivity measurements, standardization and monitoring techniques and instruments

- Radioactive Tracers, Brigham Young Univ.

- On the job training

c. Mathematics and calculations basic to the use

, and~ measurement of radioactivity

[ - Radioactive Tracers, Brigham' Young Univ.

3 - Physics, B.Y.U., 1966-67

! - Calculus, B.Y.U., 1966-67

d. Biological effects of radiation

- Radioactive Tracers, Brigham Young Uni.

- General Microbiology, B.Y.U., 1970

- On the job training i

.I

. 4 r

ATTACHMENT #17 Experience Maximum Where Experience Duration of Individual Isotope Amount Was Gained Experience Type of Use (Ms.) Anne M. Horaczek I-125 1.5 mc Parke-Davis /W.L. 11 yrs. 1. Labeling globulin proteins

2. Allergen test kit assays C-14, P-32, Parke-Davis /W.L. 3 yrs. Making synthetic S-35 media for tissue culture I-125, Parke-Davis /W.L. 11 yrs. Detroit & Rochester C-14, H-3, Isotope Safety P-32, S-35, Officer N y -63 g$ (Ms. Patricia Hawthorne I-125 10.0 uc Parke-Davis /W.L. 6 yrs. Routine screening 5 of plasma for p! hepatitis antigen 2

9 (Dr.) Charles W. Whitaker I-125 1.0 mc Mt. Sinai School 3 yrs. Radioimmunoassay 00 f Medicine for monoclonal g, antibodies P-32 1.0 mc 2 yrs. DNA/RNA gene b3 sequencing 43 _

H-3, C-14 1. i0 mc Brigham Young 9 yrs. Labeling viral Univ. Proteins and nucleic acid

__ ___